National Academies Press: OpenBook
« Previous: Front Matter
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 1
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 2
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 3
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 4
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 5
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 6
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 7
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 8
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 9
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 10
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 11
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 12
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 13
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 14
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 15
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 16
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 17
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 18
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 19
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 20
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 21
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 22
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 23
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 24
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 25
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 26
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 27
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 28
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 29
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 30
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 31
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 32
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 33
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 34
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 35
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 36
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 37
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 38
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 39
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 40
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 41
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 42
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 43
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 44
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 45
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 46
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 47
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 48
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 49
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 50
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 51
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 52
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 53
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 54
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 55
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 56
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 57
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 58
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 59
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 60
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 61
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 62
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 63
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 64
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 65
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 66
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 67
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 68
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 69
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 70
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 71
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 72
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 73
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 74
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 75
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 76
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 77
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 78
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 79
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 80
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 81
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 82
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 83
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 84
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 85
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 86
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 87
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 88
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 89
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 90
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 91
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 92
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 93
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 94
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 95
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 96
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 97
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 98
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 99
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 100
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 101
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 102
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 103
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 104
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 105
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 106
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 107
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 108
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 109
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 110
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 111
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 112
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 113
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 114
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 115
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 116
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 117
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 118
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 119
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 120
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 121
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 122
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 123
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 124
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 125
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 126
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 127
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 128
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 129
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 130
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 131
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 132
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 133
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 134
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 135
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 136
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 137
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 138
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 139
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 140
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 141
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 142
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 143
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 144
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 145
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 146
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 147
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 148
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 149
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 150
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 151
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 152
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 153
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 154
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 155
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 156
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 157
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 158
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 159
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 160
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 161
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 162
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 163
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 164
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 165
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 166
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 167
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 168
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 169
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 170
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 171
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 172
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 173
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 174
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 175
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 176
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 177
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 178
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 179
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 180
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 181
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 182
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 183
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 184
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 185
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 186
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 187
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 188
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 189
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 190
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 191
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 192
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 193
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 194
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 195
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 196
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 197
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 198
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 199
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 200
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 201
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 202
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 203
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 204
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 205
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 206
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 207
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 208
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 209
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 210
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 211
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 212
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 213
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 214
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 215
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 216
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 217
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 218
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 219
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 220
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 221
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 222
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 223
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 224
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 225
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 226
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 227
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 228
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 229
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 230
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 231
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 232
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 233
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 234
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 235
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 236
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 237
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 238
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 239
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 240
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 241
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 242
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 243
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 244
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 245
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 246
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 247
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 248
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 249
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 250
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 251
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 252
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 253
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 254
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 255
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 256
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 257
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 258
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 259
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 260
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 261
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 262
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 263
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 264
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 265
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 266
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 267
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 268
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 269
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 270
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 271
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 272
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 273
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 274
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 275
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 276
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 277
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 278
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 279
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 280
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 281
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 282
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 283
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 284
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 285
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 286
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 287
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 288
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 289
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 290
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 291
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 292
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 293
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 294
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 295
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 296
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 297
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 298
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 299
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 300
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 301
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 302
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 303
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 304
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 305
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 306
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 307
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 308
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 309
Suggested Citation:"Part 1: Assessment Program Profiles and Report Citations." Institute of Medicine. 1988. Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources. Washington, DC: The National Academies Press. doi: 10.17226/1090.
×
Page 310

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Part ~ Assessment Program Profiles anc! Report Citations

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Part I: Assessment Program Profiles arid Report Citations This part has two major sections. Beginning on page 3 are profiles of 68 medical technology assessment programs, with citations of their approximately 3,200 complet- ed, ongoing, and planned assessments. The assessment program profiles are listed alphabetically by name of parent organization. Following the profiles, beginning on page 254, is a subject index to report citations, to be used for locating citations on particular subjects among the profiles. The index has approximately 1,900 subject terms. These terms are listed alphabetically, each followed by one or more relevant assessment report codes. Each code has a two letter prefix . .. . indicating an assessment program and a number indicating the report's placement in the list of citations at the end of the program's profile earlier in Part 1. A list of prefixes and their respective programs is shown on page 252, immediately preceding the subject index.

AMERICAN ACADEMY OF NEUROLOGY American Academy of Neurology Practice Committee 2221 University Overdue SE, Suite 335 Minneapolis, MN 55414 612-623-81 15 Contact: Richard P. Hames, Director, Division of Medical Services and Communica- tions; William H. Stuart M.D., 105 Collier Rd. NW, Suite 1030, Atlanta, GA 30309, 404-351-2270; or John P. Conomy M.D., Department of Neurology, Cleveland Clinic Foundation, 9500 Euclid Ave., Cleveland, OH 44106, 216-444-5555. Overview: The American Academy of Neurology (AAN) is a 9,000-member medical specialty society founded in 1948. The Academy's major objectives are to stimulate the growth and development of the specialty of clinical neurology and clinical neurologists. The AAN Practice Committee assesses the clinical effectiveness of drugs, devices, and procedures involving the neurosciences. Purpose: To review and evaluate clinical, procedural, and technological requests for opinion received by the Academy. Primary iIItended users: Providers, generally; physicians; health/medical professional associations; third party payers; government regulators. Technologies: Medical or.surmr~71 brnr~l.q~.r~ it Fir vw, 5vvwv c, ~v~ww~ ~ MA ~ ~ V A~- Intervention: Treatment, diagnosis, rehabilitation. Stage: New, established or widespread practice, obsolete. Properties: Effectiveness; safety; efficacy; cost; service requirements; acceptance/adop- tion level; ethical, legal, social implications. Selection process: Individual practitioners in neurology and neurosurgery, medical organizations, and third party payers can request that an assessment be conducted. All requests must be in writing and sent to the Academy office. Requests are submitted to the Practice Committee for opinion and inclusion on the agenda. The Practice Commit- tee does not set assessment topic priorities. The Committee, acting as a group, assesses all questions submitted to it, although the Committee has rejected such complicated topics as organ transplantation. 3

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Methods: Group judgment, expert opinion. The Practice Committee receives reports from several subcommittees that are, in most cases, chaired by a Practice Committee member. The subcommittees consider the procedure/treatment question and exercise one of two options: 1) develop recommen- dation for full committee as to whether the treatment/procedure is established, investi- gational, unacceptable, or indeterminate (as defined in accordance with the American Medical Association (AMA) Diagnostic and Therapeutic Technology Assessment plan); or 2) defer recommendation pending further research/study by subcommittee members. At each of the four regularly scheduled meetings per year the Practice Committee reviews and acts on the recommendations of the subcommittees. Practice Committee actions are then submitted to the Academy Executive Board as information items. The following statement is incorporated into every response to a request for opinion: "This response is provided as a service of the American Academy of Neurology. It is based on current scientific and clinical information through (date of evaluation), and does not represent endorsement by the AAN of particular diagnostic and therapeutic procedures or treatment." When major questions or issues confront the Committee, such as the use of magnetic resonance imaging as a diagnostic procedure, a wider consensus is sought. Working with the Council of Medical Specialty Societies (CMSS), the AMA, and other organiza- tions, a consensus panel is convened and a position paper developed on the technology . . . In question. The turnaround time from selection of assessment topic to reporting of findings ranges from 1 week to 6 months. Assessors: The Practice Committee is composed of 16 members from across the country who represent the interests and concerns of the practitioner. Assessment reports include: Who sponsored/commissioned/ supported the assess- ment; stage of life-cycle of technology when assessed; recommendations for practice, future assessments, technology development, research. Dissemination: Assessment results are disseminated through the minutes of the Prac- tice Committee and through correspondence with other medical organizations and practitioners. The Academy office maintains a listing of Practice Committee decisions and responds to inquiries about procedures/treatment. The Council of Medical Spe- cialty Societies also distributes Practice Committee assessments. Budget: The assessment program is not budgeted as a separate activity. The approxi- mate cost per assessment is not known. Use: The Academy disseminates assessment results to its membership. Based on inquires received, third party payers rely on Practice Committee opinions in making reimbursement decisions. 4

AMERICAN ACADEMY OF NEUROLOGY Completed Reports AA1 American Academy of Neurology, Practice Com- mittee. Extracranial-intracranial bypass surgery for treatment or prevention of stroke. 1986 Feb. tExpert opinion, Group judgment] AA2 . Hyperbaric oxygen therapy for treatment of senility, multiple sclerosis, and cerebral edema. 1986 Feb. tExpert opinion, Group judgment] AA3 . Apheresis (therapeutic) in the treatment of Guillain-Barre Syndrome.1985 fun. LExpert opin- ion, Group judgment] AA4 . Apheresis in treatment of systemic lupus erythematosus. 1985 fun. tExpert opinion, Group judgment] AA5 . Percutaneous transluminal angioplasty (PTA). 1985 Feb. tExpert opinion, Group judgment] AA6 . Topographic mapping. 1985. Feb. LEx- pert opinion, Group judgment] AA7 . Apheresis in treatment of chronic relaps- ing polyneuropathy. 1984 Feb. LExpert opinion, Group judgment] AA8 . Autopsies on patients with slow virus dis- eases. 1984 Nov. [Expert opinion, Group judgments AA9 . EEG guidelines for epileptic mentally re- tarded.1984 Nov. [Expert opinion, Groupjudgment] AA10 . Electromyographic biofeedback in treat- ment of hyperactivity. 1984 Feb. [Expert opinion, Group judgment] AA11 . Electronystagmography. 1984 Jun. LEx- pert opinion, Group judgment] AA12 . Functional integration in the alleviation of chronic muscular pain and spasticity. 1984 Feb. LExpert opinion, Group judgment] AA13 . Nuclear magnetic resonance. 1984 Feb. fExpert opinion, Group judgment] AA14 . Sterotactic cingulatomy. 1984 Nov. LEx- pert opinion, Group judgment] AA15 . Amyotrophic lateral sclerosis injected modified neurotoxin for treatment. 1983 Feb. fEx- pert opinion, Group judgment] AA16 . Edinburgh Masker for stuttering. 1983 Jun. tExpert opinion, Group judgment] AA17 . Histamine desensitization for cluster headache. 1983 Jun. [Expert opinion, Group judg- ment] AA18 . Melodic intonation therapy for aphasia. tExpert opinion, Group judgment] AAl9 . Modified neurotoxin in the treatment of ALS. 1983 fun. fExpert opinion, Group judgment] AA20 . Plasmapheresis in treatment of multiple sclerosis. 1983 Feb. fExpert opinion, Group judg- ment] AA21 . Plasmapheresis in treatment of myasthe- nia gravis. 1983 Feb. fExpert opinion, Group judg- ment] AA22 . Somatosensory evoked response. 1983 Nov. tExpert opinion, Group judgment] AA23 . Trancutaneous electrical nerve stimula- tion for treatment of acute pain for ambulatory pa- tients. 1983 Nov. fExpert opinion, Group judgment] AA24 . Twenty-four hour EEG ambulatory monitoring. 1983 Jun. tExpert opinion, Group judg- ment] AA25 . Biofeedback for headaches. 1982 Jun. [Expert opinion, Group judgment] AA26 . Carotid infusion of BCNU for glioblas- toma multiforme. 1982 Jun. tExpert opinion, Group judgment] AA27 . Cerebellar stimulator implantation for cerebral palsy. 1982 Oct. tExpert opinion, Group judgment] AA28 . Cerebellar stimulator implantation.1982 Jun. LExpert opinion, Group judgment] AA29 . Cochleostomy with neurovascular trans- plant in treatment of Meniere's Disease. 1982 Oc- t.tExpert opinion, Group judgment] AA30 . EEG monitoring-ambulatory. 1982 Apr. fExpert opinion, Group judgment] AA31 . EEG monitoring during open-heart sur- gery and immediate post-operative period. 1982 Oct. LExpert opinion, Group judgment] AA32 . Negative pressure respirators for home use in chronic neuromuscular disease. 1982 Oct. LEx- pert opinion, Group judgment] AA33 . Spinal cord stimulation for treatment of cerebral palsy. 1982 Jun. tExpert opinion, Group judgment] AA34 . Taste and smell clinics. 1982 Jun. fEx- pert opinion, Group judgment] AA35 . Acupuncture.1981 Jul. [Expert opinion, Group judgment] AA36 . Apheresis for multiple sclerosis. 1981 ~ul. FExpert opinion, Group judgment] 5

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY AA37 . EEG interpretation and brain stem evoked response. 1981 Jul. fExpert opinion, Group judgment] AA38 . Electrical nerve stimulation of post-sur- gical pain. 1981 Apr. fExpert opinion, Group judg- ment] AA39 . Electrical stimulation for treatment of Bell's Palsy. 1981 Apr. tExpert opinion, Group judg- ment] AA40 . Electrical stimulation for treatment of facial nerve palsy.1981 May. [Expert opinion, Group judgment] AA41 . Histamine therapy for Men~tre's Dis- ease. 1981 Jul. LExpert opinion, Group judgment] AA42 . Prolotherapy.1981 Jul. Expert opinion, Group judgment] AA43 . Visual evoked potentials. 1981 Jul. tEx- pert opinion, Group judgment] American Academy of Ophthalmology Ophthalmic Procedures Assessment Program PO Box 7424 655 Beach Street San Francisco, CA 94120-7424 415-561-8500 AA44 . Biofeedback treatment for migraine headache. 1980 Apr. LExpert opinion, Group judg- ment] AA45 . Continuous EEG monitoring during surgery. 1980 Apr. tExpert opinion, Group judg- ment1 AA46 . Intracranial pressure monitors. 1980 Oct. FExpert opinion, Group judgment] AA47 . Neurosonology. 1980 Mar. FExpert opinion, Group judgment] AA48 . Spinal stimulation for multiple sclerosis. 1980 May. tExpert opinion, Group judgment] AA49 . Transfer factor treatment in multiple sclerosis. 1980 Apr. fExpert opinion, Group judg- ment] AA50 . Ultrasonic arteriography. 1980 May. fExpert opinion, Group judgment] Contact: Lea Gamble, Director Health Policy Research; or David L. Guyton, M.D., Chairman, Committee on Ophthalmic Procedures Assessment, Wilmer Ophthalmo- logical Institute, the Johns Hopkins Hospital, Baltimore, MD 21205, 301-955-8314. Overview: The American Academy of Ophthalmology (AAO) is a professional associa- tion composed of over 14,000 physicians trained in the specialty of ophthalmology. It offers a wide range of membership services including continuing education programs, public and professional information materials, and scientific meetings. The Ophthal- mic Procedures Assessment Program is the medical technology assessment program of the AAO. Purpose: To present state-of-the-science information about ophthalmic technologies that will help Academy members make informed decisions about patient care. Primary intended users: Physicians, third party payers, government regulators. Technologies: Medical or surgical procedure, drug, device. Ophthalmology-related orphan drugs and products, diagnostic and therapeutic de- vices, and medical and surgical procedures are assessed. Intervention: Treatment, diagnosis. 6

AMERICAN ACADEMY OF OPHTHALMOLOGY Stage: Nell', emerging, established or widespread practice. Sufficient information must be available in the scientific literature to develop assess- ments. Properties: Safety, effectiveness, efficacy. Comprehensive assessments usually follow this format: definition of terms, including development of technique or procedure, extent of current use; clinical implementa- tion, including indications for use, comparison to conventional methods, advantages/ disadvantages, patient population most likely to benefit, and effectiveness; safety; qualifications necessary to use technique; and current research and summary. Selection process: Academy members, public and private third party payers, and government agencies can request that assessments be conducted. Requests will also be accepted from other sources. Usually requests for assessments are written inquiries asking the Academy's position/opinion on a certain technology. Inquiries from individ- uals and private third party payers are frequently received over the telephone, but the AAO requires that a written request be submitted. The Committee on Ophthalmic Procedures Assessment sets priorities. Technologies to be assessed must be within the scope of ophthalmology, and sufficient scientific information on which to base a decision must be available. If new information is available that substantially changes . ~ . . . .. Information contained In an assessment, a reassessment of the technology will be . . . 1nltlatec A. Methods: Information syntheses, group judgment, expert opinion, epidemiological and other observational methods. The scientific literature in refereedjournals is reviewed and expert opinion and group judgment is sought in order to reach consensus. After a decision to evaluate a technol- ogy has been made, the following four steps are followed: 1) an expert is identified who develops a draft with references; 2) the draft is reviewed by other experts, generally AAO members, the Committee, staff, and legal counsel; 3) if substantial changes are needed, a revised draft is recirculated to all reviewers and, generally, a conference call is held to discuss differences in interpretation of findings in the literature; and 4) once a draft is acceptable to the reviewers, it is submitted to the Academy's Board of Directors for approval. For noncontroversial technologies, the average turnaround time from selection of assessment topic to reporting of findings is 6 to 9 months. For controversial technol- ogies the turnaround time can extend into years. Assessors: The Committee is composed of three Academy members, staffed by the Academy's Office of Health Policy Research, and assisted by the membership of the Academy. Academy members participate as reviewers, as in-depth consultants, or by preparing the original draft assessment. A total of 400 Academy members, covering 40 technical areas, have agreed to participate, in some capacity, in the assessment effort. These members participate voluntarily and without remuneration. When appropriate, experts from related fields are consulted. 7

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Assessment reports include: Who conducted the assessment; description of the tech- nology; properties assessed; sources of data/information; findings or conclusions; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, principles; development of the technol- ogy. Dissemination: Printed reports; journal articles; press conferences/news releases, TV/ radio broadcasts, video products. The Academy prints the assessment reports, and notices of completed assessments appear in the AAO membership newsletter. The assessments are published in the AAO's scientific journal, displayed at the AAO annual meeting, and are mailed to specific organizations and interested individuals. l he Academy's Order Department accepts telephone and written requests for assessment reports. Copies are provided free of charge. Budget: $7,500. Funding source: 100 percept sponsors/members dues, contributions. Use: Assessment reports are considered an educational service to the members and are provided in response to inquiries from the media, third party payers, and the public. Private and public third party payers use them to make policy decisions about coverage. Their purpose for requesting an assessment is generally stated. Related activities: At the 1986 AAO annual meeting, the Committee on Ophthalmic Procedures Assessment sponsored a special scientific session entitled, "Radial Kerato- tomy in Perspective." The purpose of this session was to have opthalmolog~sts repre- senting a range of opinions address key questions about the procedure. Completed Reports AB1 American Academy of Ophthalmology. Epikerato- phakia procedures for the correction of severe hyper- opia, myopia, and keratoconus. San Francisco, CA: American Academy of Ophthalmology, expected completion October 1987. "Information syntheses, Expert opinion] AB2 . Punctal occlusion for the dry eye. San Francisco, CA: American Academy of Ophthalmolo- gy, 1987. [Information syntheses, Expert opinions AB3 . Punctoplasty for siccakeratitis. San Fran- cisco, CA: American Academy of Ophthalmology, ex- pected completion June 1987. "Information synthe- ses, Expert opinions AB4 . Radial keratotomy for myopia. San Fran- cisco, CA: American Academy of Ophthalmology, ex- pected completion October, 1987. "Information syn- theses, Expert opinion] AB5 . Cataract surgery in the 1980's. San Fran- cisco, CA: American Academy of Ophthalmology, 1987. "Information syntheses, Expert opinion] 8 AB6 . Keratophakia and keratomileusis: safety and effectiveness. San Francisco, CA: American Academy of Ophthalmology, 1986. [Information syn- theses, Expert opinions AB7 . Thymoxamine: the need for orphan drug status. San Francisco, CA: American Academy of Ophthalmology, 1986. [Information syntheses, Ex . . pert opinions AB8 . Botulinum toxin therapy of eye muscle disorders: safety and effectiveness. San Francisco, CA: American Academy of Ophthalmology, 1984. [Information syntheses, Expert opinion] AB9 Committee on Ophthalmic Procedures Assess- ment. "American Academy of Ophthalmology] Car- bon dioxide laser surgery in head and neck surgery. San Francisco, CA: American Academy of Ophthal- mology, 1984. "Information syntheses, Expert opin- ion] AB10 . "American Academy of Ophthalmology] Cyanoacrylate tissue adhesive. San Francisco, CA: American Academy of Ophthalmology, 1984. tInfor- mation syntheses, Expert opinion]

AMERICAN ACADEMY OF OPHTHALMOLOGY AB11 . American Academy of Ophthalmology] Therapeutic contact lenses for recurrent corneal ero- sion. San Francisco, CA: American Academy of Oph- thalmology, 1984. Information syntheses, Expert . . Opmlon AB 12 Keltner ~L. fAmerican Academy of Ophthalmol- ogy] Academy recommendation: automated peri- metry. Ophthalmology 1984;91:51-56. [Information syntheses, Expert opinion] American Academy of Pediatrics 141 Northwest Point Boulevard PO Box 927 Elk Grove Village, IL 60009-0927 3 12-228-5005 Contact: lean Lockhart, M.D. AB13 Trokel S. "American Academy of Ophthalmolo- gy] Academy recommendation: ophthalmic neodym- ium YAG lasers: safety and effectiveness. Ophthal- mology 1984;91:539-42. Information syntheses, Ex . . pert opinion AB14 American Academy of Ophthalmology. Laser trabecular surgery for open-angle glaucoma. San Francisco, CA: American Academy of Ophthalmolo- gy, 1983. fInformation syntheses, Expert opinion] Overview: The American Academy of Pediatrics (AAP) is a professional association composed of pediatricians and pediatric medical and surgical subspecialists. The Acad- emy promotes optimal physical, mental, and social health for infants, children, adoles- cents, and young adults. It provides a range of services including advocacy for children and pediatrics, health systems delivery research, public information and education, continuing medical education, and analyses and review of child health policy issues. The Academy's technology assessment activities are an integral part of the information gathering and advisory functions of the numerous AAP Committees. Purpose: The AAP Committees keep abreast of developments in the field and advise the membership and Executive Board on topics within the committees' areas of exper- tise. Primary intended users: General public; physicians; health/medical professional asso- ciations; government regulators; public policy-makers, legislators; policy research or- ganizations; liability, malpractice insurers. Technologies: Drug, device, medical or surgical procedure, support system, organiza . ~ . . . tuna or administrative system. Intervention: Prevention, diagnosis, treatment, rehabilitation. Stage: Emerging, new, established or widespread practice. Properties: Safety; efficacy; effectiveness; service requirements; system impact; ethical, legal, social implications. Selection process: Topic suggestions can come from any source. Usually, assessment topics are suggested by committee members, AAP members, or through other organi- zational requests. The AAP accepts telephone and written requests and occasionally relies on formal contracts. For example, the Food and Drug Administration contracted 9

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY with the AAP for advice relative to infant formulas and drugs. AAP staff screen the requests and then the appropriate committee considers the question. Assessment topic priorities are set by the individual committee and the Academy. Methods: Information syntheses, expert opinion, group judgment. The assessment method varies from committee to committee and by issue, although all committees generally rely on a type of group judgment. For statements, committees usually proceed in the following manner: 1) general discussion of issue; 2) preparation of first draft by committee member; 3) extensive review and preparation of bibliogra- phy by same member (in some cases, this information is reviewed by outside consul- tants); 4) presentation of second draft and discussion by committee; and, 5) revision of draft, if necessary. All reports must be approved by the Executive Board of the AAP. The average turnaround time from selection of assessment topic to reporting of findings ranges from 4 months to 1 year. Assessors: AAP has committees in such areas as adolescence, bioethics, drugs, fetus and newborn, hospital care, infectious diseases, nutrition, radiology, and surgery. Each committee consists of experts in the topic area. Committees can also bring in consul- tants for additional expertise on particular reports. Dissemination: Printed reports; advisories to members/constituents; press confer- ences/news releases, TV/radio broadcasts. Committees issue reports with the assessment findings. For smaller scale projects a note is made in the minutes or a recommendation given to the AAP Executive Board. AAP Committee statements are published in Ped~atrics or information may appear in AAP News. Occasionally, letters are sent to government agencies such as the Environmental Protection Agency or the Consumer Product Safety Commission. Some reports are distributed directly to the AAP members, such as the Report of the Committee on Infectious Diseases (the "Red Book". Budget: Not provided. Related activities: The AAP publishes a quarterly newsletter, Child Health Financing Report, which contains the latest information about child health financing for privately insured children and those covered by Medicare. The Academy also sponsors an annual meeting, educational programs, and continuing education courses. Completed Reports AC1 American Academy of Pediatrics, Committee on Hospital Care. Emergency services. Pediatrics (To be published). AC2 , Committee on Hospital Care. Guidelines for air and ground transportation. Pediatrics (To be published). AC3 , Committee on Hospital Care. Quality as- surance of hospital care of children. Pediatrics (To be published). 10 AC4 , Committee on Practice and Ambulatory Medicine. Screening for vision problems. Pediatrics (To be published). AC5 , Committee on Accident and Poison Pre- vention. Revised first aid for the choking child. Pedi- atrics 1986 Jun. AC6 , Committee on Child Health Financing. Medicaid policy statement. Pediatrics 1986 May. AC7 , Committee on Disabilities. Screening for developmental disabilities. Pediatrics 1986 Sep.

AMERICAN ACADEMY OF PEDIATRICS AC8 , Committee on Disabilities. Transition of severely disabled children from hospital or chronic care facilities to the community. Pediatrics 1986 Sep. AC9 , Committee on Early Childhood, Adop- tion, and Dependent Care. Oral and dental aspects of child abuse and neglect. Pediatrics 1986 Sep. ACID , Committee on Nutrition. Prudent life- style for children: dietary fat and cholesterol. Pediat- rics 1986 Sep. AC11 , Committee on Practice and Ambulatory Medicine. Vision screening and eye examination in children. Pediatrics 1986 fun. AC12 , Committee on Research. Guidelines for the Pediatric Cancer Center and the role of such cen- ters in diagnosis and treatment. Pediatrics 1986 Jun. ACID , Committee on School Health. CPR train- ing in the school. AAP News 1986 Jan. AC14 , Committee on School Health. School attendance of children and adolescents with human T Iymphotropic virus III/lymphadenopathy-associated virus infection. Pediatrics 1986 Mar. ACID , Committee on School Health. School health examinations. AAP News 1986 Feb. ACID , Committee on Infectious Diseases. Pre- vention of hepatitis B virus infections. Pediatrics 1985 Feb. AC17 , Committee on Bioethics. Proposed guidelines on genetic engineering. Pediatrics 1985 Jun. AC18 , Committee on Disabilities. Assisting disa- bled children. Pediatrics 1985 Jun. ACl9 , Committee on Disabilities. Provision of related services for children with chronic disabilities. Pediatrics 1985 Apr. AC20 , Committee on Drugs. "Inactive" ingredi- ents in pharmaceutical products. Pediatrics 1985 Oct. AC21 , Committee on Drugs. Behavioral and cognitive effects of anticonvulsant therapy. Pediatrics 1985 Oct. AC22 , Committee on Drugs. Guidelines for the elective use or conscious use of sedation, deep seda- tion, and general anesthesia in pediatric patients. Pe- diatrics 1985 Aug. AC23 , Committee on Environmental Hazards. Smokeless tobacco-a carcinogenic hazard to chil- dren. Pediatrics 1985. AC24 , Committee on Fetus and Newborn. High risk newborn care. Pediatrics 1985 Jul. ACES , Committee on Fetus and Newborn. Home phototherapy. Pediatrics 1985 Soul. AC26 , Committee on Fetus and Newborn. Vita- min E and the prevention of retinopathy of prematu- rity. Pediatrics 1985 Aug. AC27 , Committee on Hospital Care. Child life programs for hospitalized children. Pediatrics 1985 Sep. AC28 , Committee on Hospital Care. Guidelines for pediatric intensive care units. Pediatrics 1983 Sep. AC29 , Committee on Infectious Diseases. lIe- mophilus type b polysaccharide vaccine. Pediatrics 1985 Aug. AC30 , Committee on Infectious Diseases. Rec- ommendations for using pneumococcal vaccine in children. Pediatrics 1985 Jun. AC31 , Committee on Infectious Diseases. Rec- ommendations for using pneumococcal vaccine in children. Pediatrics 1985 fun. AC32 , Committee on Nutrition. Nutritional needs of low-birth-weight infants. Pediatrics 1985 May. AC33 , Committee on Nutrition. Use of oral fluid therapy and posttreatment feeding following enteritis in children in a developed country. Pediatrics 1985 Feb. AC34 , Committee on Practice and Ambulatory Medicine. Computers in your practice. Pediatrics 1985 Jul. AC35 , Committee on Practice and Ambulatory Medicine. High risk newborn care. Pediatrics 1985 Jul. AC36 , Committee on School Health. Health education and schools. Pediatrics 1985 Jun. AC37 , Committee on Screening Genetics. Ma- ternal phenylketonuria. Pediatrics 1985 Aug. AC38 , Committee on Adolescence. A policy reference guide to the AAP's Council Committee and Executive Board statements. 1984. AC39 , Committee on Drugs. Ethanol in liquid preparations intended for children. 1984. AC40 , Committee on Drugs. Antimicrobial pro- phylaxis in pediatric surgical patients. Pediatrics 1984 Sep. AC41 , Committee on Infectious Diseases. Anti- microbial prophylaxis in pediatric surgical patients. Pediatrics 1984 Sep. 11

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY AC42 , Committee on Infectious Diseases. Per- tussis vaccine. Pediatrics 1984 Aug. AC43 , Committee on Nutrition. Imitation and substitute milks. Pediatrics 1984 Jun. AC44 , Committee on Research. Fetal research. Pediatrics 1984 Sep. AC45 , Committee on School Health. Adminis- tration of medication in school. Pediatrics 1984 Sep. AC46 , Committee on School Health. Alcohol abuse education in schools. Pediatrics 1984 Sep. AC47 , Committee on School Health. Guidelines for urgent care in schools. Pediatrics 1984 Jul. AC48 , Committee on School Health. Heat stress and school closings. Pediatrics 1984 Aug. AC49 , Committee on Sports Medicine. Health appraisal guidelines for day camps and residence camps. Pediatrics 1984 fun. AC50 , Committee on Nutrition. The use of whole cow's milk in infancy. Pediatrics 1983 Aug. AC51 , Committee on Adolescence. Rape and the adolescent. Pediatrics 1983 Nov. AC52 , Committee on Adolescence. The role of the pediatrician in substance abuse counseling. Pedi- atrics 1983 Aug. AC53 , Committee on Bioethics. Treatment of critically ill newborns. 1983. AC54 , Committee on Drugs. Growth hormone in treatment of children with short stature. 1983. AC55 , Committee on Drugs. "Look-alikes." Pe- diatrics 1983 Aug. AC56 , Committee on Drugs. Benzyl alcohol: toxic agent in neonatal units. Pediatrics 1983 Sep. AC57 , Committee on Drugs. Dimethyl sulfox- ide (DMSO). Pediatrics 1983 Tan. AC58 , Committee on Drugs. New therapy for severe cystic acne. Pediatrics 1983 Aug. AC59 , Committee on Drugs. Valproate terato- genicity. Pediatrics 1983 Jun. AC60 , Committee on Early Childhood, Adop- tion, and Dependent Care. Gonorrhea in prepubertal children. Pediatrics 1983 Apr. AC61 , Committee on Fetus and Newborn. Ben- zyl alcohol: toxic agent in neonatal units. Pediatrics 1983 Sep. 2 AC62 , Committee on Nutrition. Soy-protein formulas: recommendations for use in infant feeding. t19831 AC63 , Committee on Nutrition. Commentary on parenteral nutrition. Pediatrics 1983 Apr. AC64 , Committee on Nutrition. Toward a pru- dent diet for children. Pediatrics 1983 Jan. AC65 , Committee on Research. Reducing the toll of injuries in childhood requires support for a focused research effort. Pediatrics 1983 Nov. AC66 , Committee on Sports Medicine. Sports and the child with epilepsy. Pediatrics 1983 Dec. AC67 American Academy of Pediatrics, Committee on Fetus and Newborn. Criteria for early infant dis- charge and follow-up evaluation. Pediatrics 1982 Dec. AC68 , Committee on Disabilities. The Doman- Delacato treatment of neurologically handicapped children. Pediatrics 1982 Nov. AC69 , Committee on Drugs. Psychotropic drugs in pregnancy and lactation. Pediatrics 1982 Feb. AC70 , Committee on Drugs. Valproic acid: benef~ts and risks. Pediatrics 1982 Aug. AC71 , Committee on Hospital Care. Preoper- ative chest radiographs. Pediatrics 1983 May. AC72 , Committee on Infectious Diseases. Aspi- rin and Reye syndrome. Pediatrics 1982 Jun. AC73 , Committee on Nutrition. Promotion of breast feeding. 1982. AC74 , Committee on Research. Guidelines for health supervision of pediatric visits as recommended by the American Academy of Pediatrics Committee on Practice and Ambulatory Medicine. News and Comment 1982 May. AC75 , Committee on Screening Genetics. New issues in newborn screening for phenylketonuria and congenital hypothyroidism. Pediatrics 1982 Jan. AC76 , Committee on Sports Medicine. Risks in long distance running for children. Pediatrics 1982 Jun. AC77 , Committee on Nutrition. Nutritional as- pects of obesity in infancy and childhood. Pediatrics 1981 Dec. AC78 , Committee on Nutrition. Breast feeding and contraception. 1981 AC79 , Committee on Nutrition. Breast feeding and contraception. 1981.

AMERICAN ACADEMY OF PEDIATRICS AC80 , Committee on Nutrition. Plant fiber in- take in pediatric diet. 1981. AC81 , Committee on Nutrition. Sodium intake for infants in the U.S., 1981. AC82 , Committee on Nutrition. Nutrition and lactation. Pediatrics 1981 Sep. AC83 , Committee on Adolescence. Contracep- tion for the adolescent. Pediatrics 1980 Mar. AC84 , Committee on Drugs. Anticonvulsants and pregnancy. Pediatrics 1980 Feb. AC85 , Committee on Drugs. Medroxyproges- terone acetate (Depo-Provera). Pediatrics 1980 Mar. AC86 , Committee on Drugs. Naloxone use in newborns. Pediatrics 1980 Mar. AC87 , Committee on Nutrition. Vitamins and mineral supplement needs. 1980. AC88 , Committee on Nutrition. Encouraging breast-feeding. Pediatrics 1980 Mar. AC89 , Committee on Nutrition. Human milk banking. Pediatrics 1980 Apr. AC90 , Committee on Nutrition. On the feeding of supplemental foods to infants. Pediatrics 1980 J un. AC91 , Committee on Radiology. Comparison radiographs of extremities in childhood: recom- mended usage. Pediatrics 1980 Mar. AC92 , Committee on Radiology. Excretory orography for evaluation of enuresis. Pediatrics 1980 Mar. AC93 , Committee on Screening Genetics. Pre- natal diagnosis for pediatricians. Pediatrics 1980 Jun. AC94 , Committee on Adolescence. Pregnancy and abortion counseling. Pediatrics 1979 fun. AC95 , Committee on Disabilities. Current ap- proaches to evaluation and management of children with myelomeningocele. Pediatrics 1979 Apr. AC96 , Committee on Sports Medicine. Acci- dental hypothermia. Pediatrics 1979 fun. AC97 Committee on Drugs. Camphor: who needs it? Pediatrics 1978 Sep. AC98 , Committee on Drugs. Commentary on anthelmintics. Pediatrics 1978 Aug. AC99 , Committee on Drugs. Effect of medica- tion during labor and delivery on infant outcome. Pediatrics 1978 Sep. AC100 , Committee on Drugs. PUVA: a caution. Pediatrics 1978 Aug. AC101 , Committee on Drugs. Treatment of congenital hypothyroidism. Pediatrics 1978 Sep. AC102 , Committee on Drugs. Unapproved uses of approved drugs: the physician, the package insert, and the FDA. Pediatrics 1978 Aug. AC103 , Committee on Drugs. Use of codeine- and dextromethorphan-containing cough syrups in pediatrics. Pediatrics 1978 Tut. AC104 , Committee on Nutrition. Juice in ready-to-use bottles and nursing bottle caries. 1978. AC105 , Committee on Nutrition. Breast-feed- ing. Pediatrics 1978 Oct. AC106 , Committee on Radiology. Radiation of pregnant women. Pediatrics 1978 Jan. AC107 , Committee on Radiology. Water-solu- ble contrast material. Pediatrics 1978 {ul. AC108 , Committee on Nutrition. Nutritional aspects of vegetarianism, health foods and fad diets. Pediatrics 1977 Mar. AC109 , Committee on Screening Genetics. Screening school children for urologic disease. Pedi- atrics 1977 Aug. AC110 , Committee on Drugs. Adverse reac- tions to iodide therapy of asthma and other pulmo- nary diseases. Pediatrics 1976 Feb. ACl l l , Committee on Drugs. Generic prescrib- ing. Pediatrics 1976 Feb. AC112 , Committee on Nutrition. Commentary on breast-feeding and infant formulas, including pro- posed standards for formulas. Pediatrics 1976 Feb. AC113 , Committee on Bioethics. AAP code of ethics for the use of fetuses and fetal material for research. 1975 AC114 , Committee on Fetus and Newborn. Re- port of the Ad Hoc Task Force on Circumcision. Pediatrics 1975 Oct. AC115 , Committee on Disabilities. Early identi- fication of children with learning disabilities: the pre- school child. Pediatrics 1973 Nov. 13

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY American College of Cardiology/Amer~can Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures American College of Cardiology 91 ~ ~ Old Georgetown Road Bethesda, MD 20814 30 1-897-5400 American Heart Association National Center 7320 Greenville Avenue Dallas, TX 75231 2 14-373-6300 Contact: Charles Fisch, M.D., Chairman ACC/AHA Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures; David Feild, Associate Execu- tive Vice President, American College of Cardiology; or Kathryn A. Taubert, Ph.D., Science Consultant, American Heart Association 214-706-1455. Overview: The American College of Cardiology (ACC) is a professional medical society composed of physicians and scientists. Its mission is to ensure optimal care for persons with cardiovascular disease or the potential for developing cardiovascular disease and to contribute to the prevention of cardiovascular disease through educa- tional and socio-economic activities. The American Heart Association (AMA) is a voluntary health agency supported by public contributions and the donated time of volunteers. Its mission is to reduce premature death and disability from cardiovascular disease and stroke. The Task Force on the Assessment of Diagnostic and Therapeutic Cardiovascular Procedures is a technology assessment program jointly sponsored by the AHA and the ACC. Purpose: To define the role of noninvasive and invasive diagnostic and therapeutic procedures in the diagnosis and management of cardiovascular disease. Prunary intended users: Physicians. Technologies: Medical or surgical procedure. Specifically, diagnostic and therapeutic cardiovascular procedures are assessed. Intervention: Diagnosis, treatment. Stage: Established or widespread practice. Properties: Effectiveness, indications/contraindications. Selection process: Members of the American College of Cardiology or the American Heart Association can submit, in writing, requests for assessments to the Chairman of the ACC/AHA Task Force. The Task Force meets at least twice a year to discuss possible future assessments. Recommendations are forwarded to the officers of the 14

AMERICAN COLLEGE OF CARDIOLOGY/AMERICAN HEART ASSOCIATION American College of Cardiology and the American Heart Association. The possibility of updating published assessment reports is currently under discussion. Methods: Information syntheses, expert opinion, group judgment. As part of the assessment process a series of committee meetings are held. As the assessment report develops, information is shared, via mail, between Task Force mem- bers. The approximate turnaround time from selection of assessment topic to report- ing of findings is 18 months. Assessors: Task Force members are physicians who specialize in cardiovascular medi- cine. Assessment reports include: The purpose of the assessment, who sponsored/commis- sioned/supported the assessment, who conducted the assessment, description of the technology. Dissemination: Journal articles. Reports are published simultaneously in the Journal of the American College of Cardiology and Circulation. Copies of the assessment reports can be obtained by contacting the headquarters offices of the American College of Cardiology or the American Heart · . . Assoclatlon. -\ Budget: $25,000. The approximate direct costs per assessment ranges from $10,000 to $15,000. Volunteer time committed to this effort is significant and is not calculated in this amount. Funding source: 50 percent American College of Cardiology, 50 percent American Heart Association. Use: The Task Force assessment activities are described in Institute of Medicine, Committee on Evaluating Medical Technologies in Clinical Use. Assessing medical tech- nologaes. Washington, DC: National Academy Press, 1985. Related activities: Services available to ACC members include a government relations department that promotes cardiovascular issues, the Cardiology and Affiliates in Training newsletters, an endowments program, professional awards programs, and continuing education opportunities. The 14 Scientific Councils of the AHA generate state-of-the-art and position papers concerning specific areas of cardiovascular disease such as arteriosclerosis, cardiovascu- lar radiology, cardiovascular surgery, and thrombosis. The Association provides ap- proximately $50 million annually for scientific research and additional support for public education programs. The AHA advocates legislation for research and education in the field. Completed Reports AD1 O'Rourke RA, Chatterjee K, Dodge HT, et al. fAmerican College of Cardiology/American Heart Association Task Force on Assessment of Cardiovas- cular Procedures] Guidelines for clinical use of cardi- ac radionuclide imaging. ~ Am Coll Cardiol 1986 Dec;8:1471-83. EGroup judgment] AD2 Schlant RC, Blomqvist CG, Brandenburg RO, et al. [American College of Cardiology/American Heart Association Task Force on Assessment of Cardiovas- cular Procedures] Guidelines for exercise testing. J Am Coll Cardiol 1986;8:725-738. tGroup judgments 15

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY ADS Frye RL, Collins,,, DeSanctis RW, et al. [American College of Cardiology/American Heart Association Task Force on Assessment of Cardiovascular Proce- dures] Guidelines for permanent cardiac pacemaker implantation. ,i,,Am Coll Cardiol 1984;4:434-42. (Group judgments Ongoing Assessments AD4 American College of Cardiology/American Heart Association Task Force on Assessment of Cardiovas- cular Procedures. Guidelines for ambulatory electro- cardiographic monitoring. Ongoing. [Group judg- ment] ADS . Guidelines for clinical intracardiac elec trophysiologic studies. Ongoing. [Group judgment] ADO . Guidelines for coronary angiography. Ongoing. [Group judgment] AD7 . Guidelines for percutaneous transluminal coronary angioplasty (PICA). Ongoing. [Group judgments American College of Obstetricians and Gvnecolomsts Committee Opinions 600 Marylanct Avenue SW Washington, DC 20024 202-638-5577 Contact: Shirley A. Shelton, Associate Director, Division of Practice Activities; or the ACOG Resource Center. Overview: The American College of Obstetricians and Gynecologists (ACOG) is a not- for-profit, professional organization comprised of more than 26,000 physicians trained in the specialty of obstetrics and gynecology. The purpose of the organization is to promote and maintain high standards for women's health care by providing quality continuing education for its members and establishing patient care standards. ACOG is governed by an Executive Board composed of seven selected officers from the mem- bership and ten District representatives. The Committee Opinions program is one of two technology assessment programs sponsored by the College. Purpose: To provide members and other interested parties with state-of-the-art infor- mation on the clinical application of new technologies. Primary intended users: Physicians, third party payers, public policy-makers, legisla- tors. Technologies: Medical or surgical procedure, drug, device. The committees assess new devices, equipment, and other therapeutic modalities for the treatment of reproductive disorders in women. Intervention: Treatment, diagnosis. Stage: New, emerging, established or widespread practice. Technologies are assessed as they are being applied to clinical practice. Properties: Electiveness, safety, service requirements. 16

ACOG/COMMfFrEE OPINIONS Selection process: Within the ACOG structure, the Executive Board, Health Care Commission, or individual members can request that an assessment be conducted. The College also receives requests from third party carriers and government agencies. Only written requests are accepted. Assessment topic priorities are set by the Executive Board, Health Care Commission, and the committee to whom the request is referred. All existing opinions/statements are reviewed within 18 to 24 months from date of publication for relevance and accuracy. Methods: Information syntheses, expert opinion, group judgment. A subject is selected and referred to a committee. The committee elects a member to review the literature and draft a preliminary report citing literature references. The committee discusses the preliminary draft, achieves consensus on areas of controversy, and submits a revised report to an expert panel for review and comment. Information from reviewers is synthesized and a final report prepared for review by the Health Care Commission and Executive Board prior to publication. At any step along the way, when agreement is in doubt, the advice of further technical experts may be sought. The turnaround time from selection of the ~.cf>.c.cm~nt tonic to r`~'hlir~t;^rl ~f the findings ranges from 18 to 24 months. ~_ A ~ ^ ~ ~ .~. ~- 6_ ~ < .IL ~ Ad. ~ AL At_ C4. ~ l V 1 ~By 1 ~ 1 1 ~ Assessors: Committee members represent the academic and the clinical practice com- munities, are geographically dispersed, and reflect a wide range of practice settings. Panel experts are chosen because of their recognized authority in the chosen subject. The Health Care Commission and the Executive Board members are academicians, clinical practice generalists, and subspecialists. Assessment reports include: Description of the technology; sources of data/informa- tion; findings or conclusions; how the technology works, including theory, principles; whether the technology is experimental, investigational, or considered acceptable clini- cal practice. Dissemination: Advisories to memberslconstituents, printed reports. Assessments are published as committee opinions and are disseminated to the College membership as an insert in the monthly ACOG newsletter. The reports are available upon request to all other interested parties. Budget: $15,000. Currently, the assessment activity is considered part of the charge of the obstetric and gynecologic standing committees and is not identified separately within the committee budget. Therefore, the approximate cost per assessment is not known. Approximately $15,000 is allocated for printing and distribution of the reports to the membership. Funding source: 100 percent parent organization. Use: When appropriate, the report conclusions are conveyed in other documents prepared by the ACOG (such as educational resources) and used in responding to individuals and organizations requesting specific information. Third party carriers use the reports for insurance purposes and to determine if the technology is viewed as clinically applicable. Members use the reports to determine if the state-of-the-art of the technology is appropriate for application to their practices. The publications ACOG Standards for Obstetric-Gynecologic Services, Guidelines for Perinatal Care, and Precis, a compendium of current information in the specialty, reflect commit- tee opinions where applicable. New editions of these publications appear every 3 years. 17

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Related activities: The College produces a scientific, refereed journal that primarily reports research and the results of controlled clinical studies. These reports, along with those published in similarjournals, provide the data with which committees form their opinions. The College also issues Technical Bulletins (see separate profile on ACOG Committee on Technical Bulletins), conducts an annual scientific meeting with sympo- sia on new information in the specialty, and offers free-standing postgraduate courses on a variety of topics, many of which convey information on technologic advances and, where applicable, committee opinions. The College also provides a contraceptive slide rule for lay persons which spells out the risks/benef~ts, advantages/disadvantages, cost, and mortality rates for various forms of contraceptives . Completed Reports AE1 American College of Obstetricians and Gynecolo- gists, Committee Opinion. Clinical use of bromocrip- tine. Pending. [Information syntheses] AE2 . Teratogenicity of steroids. Pending. tIn- formation syntheses] AE3 . Ultrasonography in the monitoring of fol- licular growth. Pending. fInformation syntheses] AE4 . Hysteroscopy. Revised 1986 Jan. [Infor- mation syntheses] AE5 . The use of cryosurgery in the treatment of CIN. Revised 1986 Nov. LInformation syntheses] AE6 . Contraception for women in their later reproductive years. 1985 Dec. [Information synthe- ses] AE7 . Current role of electronic heart rate moni- toring in labor. Revised 1985 Jul. fInformation syn- theses] AE8 . Endometrial sampling. 1985 Jun. fInfor- mation syntheses] AE9 . Prophylactic use of antibiotics with ab- dominal hysterectomy. fInformation syntheses] American College of Obstetricians and Gynecologists Committee on Technical Bulledns 600 Maryland Avenue SW Washington, DC 20024 202-638-5577 AE10 . Anticonvulsants and pregnancy. Revised 1984 {ul. [Information syntheses] AEll . Carbon dioxide laser. Revised 1984 Apr. fInformation syntheses] AE12 . Fetoscopy. Revised 1984 Jul. ~Informa- tion syntheses] AE13 . Human in vitro fertilization and embryo placement. 1984 Apr. fInformation syntheses] AE14 . Microsurgery. 1984 Apr. fInformation syntheses] AE15 . Needle aspiration cytology in the evalua- tion of breast lesions. 1984 Tun. [Information synthe- ses] AE16 . Breast-feeding and contraception. 1981 May. LInformation syntheses] AE17 . ACOG statement on periodic cancer screening for women.1980 Jun. fInformation synthe- ses] AE18 . ACOG statement on mammography. 1979 Sep. fInformation syntheses] Contact: Rebecca Rinehart, Associate Director of Publications, Division of Education; or the ACOG Resource Center. 18

ACOG/COMMIPrEE ON TECHNICAL BULLETINS Overview: The American College of Obstetricians and Gynecologists (ACOG) is a not- for-profit, professional organization comprised of more than 26,000 physicians trained in the specialty of obstetrics and gynecology. The purpose of the organization is to promote and maintain high standards for women's health care by providing quality continuing education for its members and establishing patient care standards. ACOG is governed by an Executive Board composed of seven elected officers from the member- ship and ten District representatives. The Committee on Technical Bulletins is one of two technology assessment programs sponsored by the College. Pulpose: To provide practicing physicians with timely information on the latest proven techniques of clinical practice in the specialty. Primary intended users: Physicians. Technologies: Medical or surgical procedure, drug, device. The Committee assesses the management of specific reproductive disorders, treatment therapies, and the application of new technologies. Inte~vendon: Treatment, prevention, diagnosis. Stage: Established or widespread practice, new. Technologies are assessed when they are determined to have widespread applicability . . . . . In c Inca practice. Properties: Effectiveness, service requirements, acceptance/adoption level. Selection process: The Committee on Technical Bulletins is responsible for surveying current clinical knowledge to determine the need to address new topics or to update existing Bulletins. Topics can also be suggested by the Learning Resources and the Health Care Commissions, other standing committees, the Executive Board, and indi- vidual members. Requests for assessments are made by Committee consensus and are submitted in writing. Assessment topic priorities are set by the Committee in consulta- tion with the Learning Resources Commission. Technical Bulletins generally are reviewed for relevance and accuracy within 3 years from date of publication unless new information requires earlier attention. Methods: Expert opinion, group judgment. Once a topic is selected by the Committee on Technical Bulletins, an expert on the topic is chosen to prepare a manuscript. The Committee reviews the author's draft and achieves consensus on areas of disagreement between members and the author. A revised draft is submitted to the Learning Resources Commission. Information from the reviewers is synthesized, consensus is reached regarding any further unresolved matters, and a final report is prepared for review by the Executive Board prior to publication. The turnaround time from selection of the topic to the publication of findings averages between 18 to 24 months. 19

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Assessors: Committee members are geographically dispersed and are representatives of the academic and clinical practice communities. Authors are recognized authorities in the topics selected. The Learning Resources Commission and the Executive Board members are academicians, clinical practice generalists and subspecialists. Assessment reports include: Description of the technology; sources of data/informa- tion; findings or conclusions; how the technology works, including theory, principles. Dissemination: Printed reports, advisories to members/constituents. Assessments are published as Technical Bulletins and the results are disseminated to the College membership as an insert in the monthly ACOG newsletter. Requests for copies of the Technical Bulletins should be directed to the ACOG Distribution Center at the Washington, DC address. Budget: $95,000. The approximate cost per assessment is $5,000 exclusive of Commit- tee budget. Funding source: 100 percent parent organization. Use: The College uses the Technical Bulletins to keep members informed regarding accepted clinical management techniques. Insurers report that they have introduced the Bulletins as evidence in malpractice suits, by both plaintiffs and defendants. Trial lawyers have also used the Bulletins. The publications ACOG Standards for Obstetric-Gynecologic Services, Guidelines for Per7natal Care, and Prects, a compendium of current information in the specialty, reflect, where applicable, the findings of Technical Bulletins. New editions of these publications appear every 3-4 years. Program evaluation: The ACOG Division of Education periodically asks participants and members attending courses and annual meetings to evaluate the usefulness of educational offerings. Technical Bulletins consistently have been rated high by respon- dents. Related activities: ACOG produces a scientific, refereedjournal that primarily reports research and the results of controlled clinical studies. The College also issues committee opinions (see separate profile on ACOG Committee Opinions), conducts an annual scientific meeting with symposia on new information in the specialty, and offers free- standing postgraduate courses on a variety of topics, many of which convey informa- tion on technology advances. The College also provides a contraceptive slide rule for lay persons that spells out the risks/benef~ts, advantages/disadvantages, cost, and mortality rates for various forms of contraceptives. Completed Reports AF1 American College of Obstetricians and Gynecolo- gists, Committee on Technical Bulletins. Antimicrobi- al therapy for gynecologic infections. 1986 Oct. (Technical bulletin no. 971. fExpert opinion] AF: . Estrogen replacement therapy. 1986 fun. (Technical bulletin no. 931. [Expert opinion] 20 A173 . Management of diabetes mellitus in preg- nancy. 1986 May. (Technical bulletin no. 921. FExnert . . Opmlon -,- .---r- AF4 - . Management of isoimmunization in preg- nancy. 1986 Jan. (Technical bulletin no. 901. fExpert . . Opmlon

ACOG/COMMIPrEE ON TECHNICAL BULLETINS AF5 . Management of preeclampsia. 1986 Mar. (Technical Bulletin no. 911. [Expert opinion] AF6 . Management of the breech presentation. 1986 Aug. (Technical bulletin no. 951. tExpert opin- ion] AF7 . Genitourinary fistula. 1985 Tan. (Techni- cal bulletin no 831. LExpert opinion] AF8 . Gonorrhea and chlamydia infections. 1985 Nov. (Technical bulletin no. 891. fExpert opin- ion] AP9 . Management of endometriosis.1985 Mar. (Technical bulletin no. 851. fExpert opinion] AF10 . Blood component therapy. 1984 Jul. (Technical bulletin no. 781. fExpert opinion] AFll . Carcinoma of the endometrium. 1984 Mar. (Technical bulletin no. 751. LExpert opinion] AF12 _ . Carcinoma of the vulva.1984 Jun. (Tech- nical Bulletin no. 771. [Expert opinion] AF13 . Cervical cytology: evaluation and man- agement of abnormalities.1984 Oct. (Technical bulle- tin no. 81~. tExpert opinion] AF14 . Prevention of Rho(D) isoimmunization. 1984 Aug. (Technical bulletin no. 791. fExpert opin- ion] AF15 . Septic shock.1984 Mar. (Technical bulle- tin no. 751. LExpert opinion] AF16 . Hemorrhagic shock. 1984 Dec. (Techni- cal bulletin no. 82~. Expert opinion] AF17 . Automobile passenger restraints for chil- dren and pregnant women.1983 Dec. (Technical bul- letin no. 741. LExpert opinion] AF18 . Cancer of the ovary. 1983 Oct. (Techni- cal bulletin no. 731. fExpert opinion] AFl9 . Diagnosis and management of invasive cervical carcinomas. 1983 May. (Technical bulletin no. 691. [Expert opinion] AF20 . Dysmenorrhea. 1983 Mar. (Technical bulletin no. 681. tExpert opinion] AF21 . Epidemiology and diagnosis of breast disease.1983 Sep. (Technical bulletin no.71 ~. fExpert . . ~ opmlonJ AF22 . Osteoporosis.1983 Oct. (Technical bulle- tin no. 72~. fExpert oppinion] AF23 . Anesthesia for cesarean section. 1982 May. (Technical bulletin no. 65~. fExpert opinion] AF24 . Dysfunctional uterine bleeding. 1982 Sep. (Technical bulletin no. 661. fExpert opinion] AF25 . Immunization during pregnancy. 1982 May. (Technical bulletin no. 64~. fExpert opinion] AF26 . Prenatal detection of neural tube defects. 1982 Oct. (Technical bulletin no. 671. fExpert opin- ion] AF27 . Diagnostic ultrasound in obstetrics and gynecology. 1981 Oct. (Technical bulletin no. 631. fExpert opinion] AF28 . Neonatal metabolic diseases. 1981 ~an. (Technical bulletin no. 60~. [Expert opinion] AF29 . Rubella-a clinical update. 1981 Jul. (Technical bulletin no. 621. tExpert opinion] AF30 . Management of gestational trophoblastic neoplasia.1980 Dec. (Technical bulleltin no.59~. tEx . . ~ pert op~n~onJ AF31 . Pregnancy, work, and disability. 1980 May. (Technical bulletin no. 58~. tExpert opinion] AF32 . Cigarette smoking and pregnancy. 1979 Sep. (Technical bulletin no. 531. [Expert opinion] AF33 . Diagnosis and management of missed abortion and antepartum fetal death. 1979 Nov. (Technical bulletin no. 55~. LExpert opinion] AF34 . Methods of midtrimester abortion. 1979 Dec. (Technical bulletin no. 561. tExpert opinion] AF35 . Induction of labor. l 978 May. (Technical bulletin no. 491. fExpert opinion] AF36 . Sexually transmitted diseases (STD): oth- er than gonorrhea and syphilis. (Technical bulletin no. 511. 1978 Jul. [Expert opinion] AF37 . Classification and staging of malignant tumors in the female pelvis. 1977 Jun. (Technical bulletin no. 471. LExpert opinion] AF38 . Communication of sexual problems in office gynecology. 1977 Apr. (Technical bulletin no. 451. FExpert opinion] AF~ . Intrapartum fetal monitoring. 1977 Jan. ~ - - nical bulletin no. 441. tExpert opinion] A1740 . Prevention of hospital-acquired urinary tract infections in gynecology patients. 1977 May. (Technical bulletin no. 46~. fExpert opinion] AF41 . Fetal blood sampling. 1976 Oct. (Techni- cal bulletin no. 42~. FExpert opinion] AF42 . Oral contraception 1976 Jul. (Technical bulletin no. 41~. LExpert opinion] AF43 . Prevention of Tay-Sachs disease: carrier identification and genetic counseling. 1976 Jan. (Technical bulletin no. 341. LExpert opinion] ~1

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY AF44 . Urinary incontinence in the female. 1979 Feb. (Technical bulletin no. 36~. [Expert opinion] American College of Physicians Clinical Efficacy Assessment Project 4200 Pine Street Philadelphia, PA 19104 215-243-1200; 800-523-1546 Contact: Linda {ohnson White, Director; or John R. Ball, M.D. AF45 . Fetal heart rate monitoring. 1975 Jun. (Technical bulletin no. 32~. tExpert opinion] Overview: The American College of Physicians (ACP) is a national medical society with a membership of over 63,000 internists and related subspecialists. It works to uphold health care standards through its activities in continuing education, health policy analysis, quality assurance, and medical technology assessment. The Clinical Efficacy Assessment Project (CEAP) is an expansion of the College's participation in the Blue Cross and Blue Shield Association's Medical Necessity Project beginning in 1976, which identified outmoded tests in order to curtail reimbursement for unnecessary medical procedures. Recognizing the need for complete and accurate technology assessment on a continuing basis, the ACP expanded the program in 1981 with a 3-year grant from the John A. Hartford Foundation of New York City. In 1984, the CEAP became a fully funded activity of the College. Beginning in 1986, ACP has accepted contributions to the CEAP from interested individuals and organizations. PuIpose: To help physicians practice high-quality, more efficient, and cost-effective medicine. CEAP recommendations are intended to provide physicians with current information and guidelines regarding the use of tests, procedures, and therapies and the rationale for such recommendations founded on both the literature and broad- based expert opinion. Primary intended users: Providers, generally; physicians; other care givers; health/ medical professional associations; third party payers; government regulators; public policy-makers, legislators; policy research organizations. Technologies: Medical or surgical procedure, drug, device, organizational or administra- tive system. Inte~vendon: Du~gnos?s, prevention, treatment, rehabilitation. Stage: Establ~ ed or widespread practice, new, obsolete. Properties: Eff racy, safety, effectiveness, cost, service requirements. Selection process: The Clinical Efficacy Assessment Subcommittee identifies potential technologies for CEAP evaluations by reviewing policy needs, practitioner opinion, academic opinion, recent journal articles, and professional meetings focusing on emerging technologies. Recommendations and requests also are received from other ACP committees as well as outside organizations. In selecting technologies to be evalu- ated, the Clinical Efficacy Assessment Subcommittee examines the following attributes: 22

AMERICAN COLLEGE OF PHYSICIANS 1) degree of interest to practitioners of internal medicine, whether or not internists are directly responsible for its application; 2) potential for wide application, or prevalence of current usage; 3) potential for significant benefit if widely applied; and 4) potential for risk if widely applied, particularly in relation to potential benefit. The Subcommittee will consider requests from College members and others for reeval- uation of a statement if the request contains compelling documentation. Staff also solicit advice from the Council of Subspecialty Societies, the Council of Medical Socie- ties, and other experts as to the availability of new information on a technology. If substantive, new information is available, the Subcommittee will consider reassessment. Methods: Information syntheses, expert opinion, group judgment, cost analyses. Notice of a pending CEAP evaluation is published in Annals of Internal Medicine, ACP Observer, New England Journal of Medicine, and the International Journal of Technology Assessment in Health Care. The notices invite comments from interested parties. For special or major evaluations, other specialtyjournals may be asked to publish notices of CEAP evaluations. ACP staff, in consultation with the CEA Subcommittee, select the appropriate member societies of the Council of Subspecialty Societies (CSS) and Council of Medical Societies (CMS) to review the technology in question. These societies are asked to provide opinion and data on the safety, efficacy, effectiveness, and cost of the technology, as well as to identify other experts (proponents, opponents, and those who are neutral on the topic) to provide information on the technology. Consultants undertake a comprehensive review of the scientific literature. Assessments of other organizations are reviewed and, when possible and necessary, information regarding ongoing clinical trials is obtained. A synthesis of this information, the com- ments from persons responding to the published notices, and the opinions of the CSS/ CMS members and other experts form the scientific base of the CEAP evaluation. Consultants assess a technology by the method best suited to the topic. The methods include, but are not limited to, data synthesis, meta-analysis, clinical decision analysis, and consensus development. At times, a combination of methods is used. When possible, risk-benefit and cost-effectiveness analyses are performed. The approximate turnaround time from selection of assessment topic to reporting of findings is 9 months to 1 year. Assessors: Physicians trained in clinical epidemiology, statistics, economics, decision analysis, and technology assessment are commissioned to conduct CEAP evaluations. These physicians are selected from candidates suggested by the CEAP Subcommittee, members of the Technology Assessment Committee of the Society for Research and Education in Primary Care Internal Medicine (SREPCIM), and others. When the evaluation of a specific topic requires special expertise, the principal consultant is asked to collaborate with a qualified content expert in the assessment of the topic. Assessment reports include: Abstract; who sponsored/commissioned/supported the assessment; who conducted the assessment; description of the technology; stage of life- cycle of technology when assessed; properties assessed; procedure used for the assess r ~ . / r . I' ~ r `, . ~ . /. r .. .' ~ meet; sources ot data/~ntormat~on; methods tor collecting data/~ntormat~on; methods for analyzing/synthesizing data/information; results; findings or conclusions; limita- tions of findings; implications of findings for practice; recommendations for practice, 23

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY future assessments, technology development, research; how the technology works, including theory, principles. CEAP statements have five components: 1) a general description of the technology, its uses, potential uses, and rationale; 2) an overview of the safety of the technology; 3) a review of the technology's efficacy; 4) information on its cost; and 5) appropriate conclusions and recommendations. Areas requiring further research also are summa- rized. Key points in the statement refer to the appropriate published literature and the effective date of the literature review is noted. A detailed and referenced background paper that supports and provides the rationale for the CEAP statement and recom- mendations also is developed. Wheren.s the CFAP ~t~t~m~nt fallows ~ ct~nHOr~ Armor .1 1 1 ~. ~ A^~_A.~ ^~ ~ ~ V ~ -~,~]L4~$ ~ VIA AAA~ one oacKgrouncl paper may be prepared in the style best suited to the analysis of the subject. Dissemination: CEAP statements become position papers of the American College of Physicians upon approval by the Board of Regents. The position and background papers are submitted to ACP Observer and to Annals of Internal Medicine for publication. If the Annals declines to publish the position paper, it is published in full in ACP Observer. If the Annals accepts the position paper for publication, an abstract will be published in ACP Observer. Thus, all College members and many others receive all CEAP statements through these publications. Background papers that are not pub- lished in Annals remain the property of their authors and may be submitted to other journals for publication. In addition, the International~ournalfor Technology Assessment in Health Care has been given permission to republish abstracts of all ACP position papers. Single copies of CEAP statements are available free of charge from the College. A three-ring binder Clinical Efficacy Reports, containing the full collection of CEAP state- ments is available from ACP. In 1987, ACP published the manual Common Diagnostic Tests: Use and Interpretation, available from the ACP publications department. The purpose of this manual is to help physicians determine when diagnostic tests are likely to make desirable differences in patient care. Based on a critical review of published articles, the manual provides recommendations for using selected tests in cardiopulmonary medicine, hematology, infectious diseases, oncology, and other diagnostic applications. The manual calls for additional research for tests for which the published literature is insufficient for making well founded recommendations. The manual chapters are derived from pa- pers commissioned by the Blue Cross and Blue Shield Association for its Medical Necessity Project. These were reviewed through the CEAP process, approved by the ACP, and published in the Annals of Internal Medicine. The appendices are texts of the Blue Cross and Blue Shield Medical Necessity guidelines. Budget: $150,000. If the total program budget is divided by the number of assessments per year, the cost is $10,000. Approximate consultant cost per assessment is $3,500. Funding sources: 95 percent parent organization; 5 percent foundations, other private grants. Use: CEAP statements are used by third party payers, training directors in residency programs, and as an educational service to college members as evidence of its commit- ment to quality care. 24

AMERICAN COLLEGE OF PHYSICIANS The establishment of the Association of Ambulatory Cardiac Catheters (AACC) was a direct result of a CEAP paper. The AACC is now organizing quality assurance activities with the objective of receiving iCAH accreditation for freestanding units. The CEAP endoscopy papers were cited in the 1985 presidential address to the American Gastro- enterology Association. CEAP is described in Institute of Medicine, Committee on Evaluating Medical Tech- nolog~es in Clinical Use. Assessing medical technologies. Washington, DC: National Acade- my Press, 1985. Program evaluation: As part of its grant award, the John A. Hartford Foundation stipulated and funded an evaluation of the CEAP. In 1983, the Blue Cross and Blue Shield Association conducted the evaluation which included a questionnaire that was sent to all major third party payers and government agencies. Recipients were asked about their knowledge of the CEAP, if the reports were relevant, and if the CEAP reports were used for educational and policy-setting purposes. Findings indicated that CEAP reports were used for educational and policy-setting purposes. The program was not modified as a result of the evaluation, but the mailing list was expanded. Completed Reports AG1 American College of Physicians, Clinical Efficacy Assessment Project. A comparative assessment of cor- onary artery bypass surgery and percutaneous trans- luminal coronary angioplasty. Expected completion 1988. "Information syntheses] AG2 . Allergy testing. Expected completion 1988. "Information synthesesJ AG3 . Chemical aversion therapy in the treat- ment of alcoholism, expected completion 1988. [In- formation syntheses] AG4 . Clinical ecology, expected completion 1988. "Information syntheses] AG5 . Exercise thallium scanning, expected completion 1988. [Information syntheses] AGO . How to study the carotid arteries, expect- ed completion 1988. [Information syntheses] AG7 . How to study the gallbladder, expected completion 1988. [Information syntheses] AGO . Intravenous pyelography, expected com- pletion 1988. [Information syntheses] AG9 . Laboratory evaluation of the patient after myocardial infarction, expected completion 1988. [Information syntheses] AGED . Preoperative pulmonary function tests, expected completion 1988. [Information syntheses] AGl l . Rehabilitation of the myocardial infarc- tion patient, expected completion 1988. [Information syntheses] AG12 . Bone mineral densitometry, 1987. [In- formation syntheses] AG13 . Magnetic resonance imaging of the brain and spine, 1987. "Information syntheses] AG14 . Methotrexate for rheumatoid arthritis, 1987. [Information syntheses] AG15 . Parenteral nutrition, 1987. [Information syntheses] AG16 . A comparative assessment of standard and computed tomography in the evaluation of neo- plasms of the chest. 1986. [Information syntheses] AG17 . Automated ambulatory blood pressure monitoring. Ann Intern Med 1986; 104:275-8. tInfor- mation syntheses] AG18 . Cardiokymography. ACP Observer 1986 Jan:8,10. [Information syntheses] AGl9 . Congestive heart failure and thoracente- sis, 1986. "Information syntheses] AG20 . Pneumococcal vaccine. Ann Intern Med 1986;104:118-120 AG21 . The diagnostic spinal tap. Ann Intern Med 1986;104:880-5,840-8. [Information syntheses] AG22 . Apheresis in chronic inflammatory de- myelinating polyneuropathy and in renal transplan- tation. Ann Inter Med 1985; 103:630-3. [Information syntheses] AG23 . Biofeedback for gastrointestinal disor- ders. Ann Intern Med 1985;103:291-3,240-44. [In- formation syntheses] ~5

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY AG24 . Biofeedback for headaches. Ann Intern Med 1985;102:128-31. [Information syntheses] AG25 . Biofeedback for hypertension. Ann In- tern Med 1985;102:709-15. "Information syntheses] AG26 . Biofeedback for neuromuscular disor- ders. Ann Intern Med 1985;102:854-8. [Information syntheses] AG27 . Colonoscopy: management of colorectal neoplasia. 1985. "Information syntheses] AG28 . Diagnostic thoracentesis and pleural bi- opsy. Ann Intern Med 1985;103:799-802. tInforma- tion syntheses] AG29 . Esophagogastroduodenoscopy (EGD). [Information syntheses] AG30 . Lithotripsy. Ann Intern Med 1985;103:626-9. [Information syntheses] AG31 . Screening for breast cancer. Ann Intern Med 1985; 103: 143-6,79-85. "Information syntheses] AG32 . The safety and efficacy of ambulatory cardiac catheterization in the hospital and free stand- ing setting. Ann Intern Med 1985: 103;294-8. tInfor- mation syntheses] AG33 . Thrombolysis for evolving myocardial infarction. Ann Intern Med 1985; 103:463-9. [Infor- mation syntheses] AG34 . Apheresis in chronic severe rheumatoid arthritis. 1984. [Information syntheses] AG35 . Clinical usefulness of hemoglobin A1C measurements. Ann Intern Med 1984; 101 :710-3. [Information syntheses] AG36 . Efficacy of endoscopic retrograde cho- langiopancreatography (ERCP) and endoscopic ret- rograde sphincterotomy (ERS). 1984. "Information syntheses! AG37 . Endocardial electrical stimulation. Ann Intern Med 1984; 100:452-4. [Information syntheses] AG38 . Endoscopic injection sclerotherapy. Ann Intern Med 1984;100:608-10. [Information synthe- ses] AG39 . Ergonovine provocative testing. Ann In- tern Med 1984; 100: 152-2. [Information syntheses] AG40 . Heparin infusion pumps. Ann Intern Med 1984;100:305-6. fInformation syntheses] AG41 . FIepatitis B vaccine. Ann Intern Med 1984; 100: 149-50. [Information syntheses] 26 AG42 . Radiologic methods to evaluate bone mineral content. Ann Intern Med 1984;100:108-11. "Information syntheses] AG43 . 13C and 14C glycocholate tests. 1983. [Information syntheses] AG44 . 13C and 14C glycocholate, H2 breath, 13C trioctanoin, and 14C triolein breath tests. 1983. tInformatton syntheses] AG45 . 14C xylose breath test. 1983. tInforma- tion syntheses! AG46 . Home blood glucose monitoring. Ann Intern Med 1983;99:272-4. "Information syntheses] AG47 . Hyperbaric oxygen therapy: acute, trau- matic peripheral ischemia. 1983. [Information syn- theseSl AG48 . Hyperbaric oxygen therapy: chronic vas- cular insufficiency. 1983. "Information syntheses] AG49 . Hyperbaric oxygen therapy: decubitus ulcers. 1983. [Information syntheses] AG50 . Hyperbaric oxygen therapy: senility. tIn- formation syntheses] AG51 . Lactulose H2 breath test. 1983. [Infor- mation syntheses] AG52 . Management of diabetes mellitus: com- puterized insulin infusion pumps. Ann Intern Med 1983;99::272-4. "Information syntheses] AG53 . Management of diabetes mellitus: exter- nal infusion pumps. Ann Intern Med 1983;99:272-4. "Information syntheses] AG54 . Management of diabetes mellitus: pan- creatic transplants. Ann Intern Med 1983-,99:272-4. "Information syntheses] AG55 . Percutaneous transluminal angioplasty: carotid, vertebral, and subclavian arteries. Ann Intern Med 1983;99:864-9. "Information syntheses] AG56 . Percutaneous transluminal angioplasty: coronary arteries. Ann Intern Med 1983;99:864-9. fInformation syntheses] AG57 . Percutaneous transluminal angioplasty: iliac, femoral, and popliteal arteries. Ann Intern Med 1983;99:864-9. "Information syntheses] AG58 . Percutaneous transluminal angioplasty: renal arteries. Ann Intern Med 1983;99:864-9. tIn- formation syntheses] AG59 . The dexamethasone suppression test. Ann Intern Med 1983;100:307-8. [Information syn- theses]

AMERICAN COLLEGE OF PHYSICIANS AG60 . The H2 breath test. 1983. [Information syntheses] AG61 . Antilymphocyte (ALG) and antithymo- cyte (ATG) globulin in renal transplantation. 1982. [Information syntheses. AG62_ . Bentonite flocculation test.1982. [Infor- mation syntheses] AG63 . DNA antibody test. 1982. [Information syntheses] AG64 . Immunotherapy of cancer.1982. [Infor- mation syntheses] AGG5 . Kunkel test (total serum gammaglobu- lin). 1982. tInformai'on syntheses] AG66 . Phonocardiography.1982. [Information syntheses] AG67 .24-hour sphygmomanometry.1981. [In- formation syntheses] AG68 .25 hydroxyvitamin D level.1981. tInfor- mation syntheses] AG69 . Cytotoxic food testing. 1981. tInforma- tion syntheses] AG70 . Gastric analysis by the capsule method (Heidelberg). 1981. "Information syntheses] AG71 . Human tumor cell drug sensitivity assay in the treatment of solid tumors. 1981. "Information syntheses] American College of Radiology Task Force on Breast Cancer ~89~ Preston White Drive Reston, VA 22091 703-648-8925 AG72 . Hyperbaric oxygen therapy: aciinomy- cosis. 1981. "Information syntheses] AG73 . Hyperbaric oxygen therapy: arthritis. 1981. "Information syntheses] AG74 . Hyperbaric oxygen therapy: osteomyeli- tis. 1981. "Information syntheses] AG75 . Intracutaneous titration. 1981. [Infor- mation syntheses] AG76 . Intravenous histamine therapy. 1981. [Information syntheses] AG77 . Management of histapenia.1981. [Infor- mation syntheses] AG78 . Radioallergosorbent technique (RAST). 1981. tInformanon syntheses] AG79 . Ultrasonic arter~ography, B mode.1981. "Information syntheses] AG80 . Ultrasonic arteriography, B-scan and Doppler ultrasound. 1981. [Information syntheses] AG81 . Hemodialysis for the treatment of schizophrenia. 1980. "Information syntheses] AG82 . Urine autoinflection. 1980. [Information syntheses] AG83 . Whole body hyperthermia for cancer patients. 1980. "Information syntheses] Contact: Marie Zinninger, M.S.N., Coordinator; Gerald Dodd, M.D., Chairman, Task Force on Breast Cancer. Overview: The American College of Radiology (AC R) serves radiologists with pro- grams addressing the practice of radiology and the delivery of comprehensive radio- logical health services. The purposes of the ACR are to advance the science of radiolo- gy, improve radiologic service to the patient, study the economic aspects of the practice of radiology, and encourage improved and continuing education for radiologists and allied professional fields. The ACR has more than 20,000 members and fellows in diagnostic and therapeutic radiology, radiologic physics, and related disciplines. ACR members participate in commissions and committees that prepare publications and conduct programs directed 27

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY to meeting member needs. These include quality assurance, practice and accreditation, management consulting, professional placement, self-evaluation, continuing educa- tion, manpower, practice management, and the development and conduct of special scientific courses needed in the field. The subject of this profile is the ACR Task Force on Breast Cancer. Purpose: To coordinate the activities of various ACR committees concerned with mammography and breast cancer. These include the Committee on Breast Cancer, Committee on Breast Imaging, Committee on Mammography Equipment, the Com- mittee on Mammography Accreditation of the Commission on Radiologic Practice, and the ACR/American Cancer Society Joint Committee on Mammography. Issues ad- dressed by the Task Force include education of radiologists and referring physicians, mammography policy statements and guidelines, mammography quality assurance, and liaison with other national medical organizations such as the American Cancer Society. Primary intended users: Physicians; patients; health/medical professional associations; . . . . vo untary assomat~ons, organizations. Technologies: Medical or surgical procedure, device. Intervention: Diagnosis, prevention. The major emphasis of the program is on early detection of breast cancer. Stage: Established or widespread practice. Properties: Safety; effectiveness; cost; ethical, legal, social implications. Selection process: ACR assessments are requested by such outside organizations as the Office of Health Technology Assessment, American Cancer Society (ACS), Blue Cross and Blue Shield Association, the Conference of Radiation Control Programs Directors, Inc., and other sources. In addition, they may be requested by ACR members and other physicians, and by the ACR committees cited above that work with the Task Force. Assessment priorities are normally set by the Task Force. Methods: Group judgment, information syntheses, expert opinion, cost analyses, epide- miological and other observational methods. Assessments are generally initiated by the Committee on Breast Cancer, Committee on Breast Imaging, Committee on Mammography Equipment, Committee on Mammog- raphy Accreditation, or ACR/ACS Joint Committee on Mammography, as appropri- ate. Reports are often drafted jointly by committee members and staff. When a consensus is reached at the committee level, it is forwarded to the Task Force for review and approval. The Task Force normally meets twice a year, though it may meet more often as needed. Upon Task Force approval, reports are submitted to the ACR Board of Chancellors for acceptance. The final endorsement comes at the ACR annual meeting where the ACR Council of approximately 175 physicians acts upon a resolution. Average turnaround time for assessments is approximately one year. As guidelines are based on current available information, they are to be revised as more is learned about the control of breast cancer. Thus, in 1986 the Task Force issued ~8

AMERICAN COLLEGE OF RADIOLOGY supplementary statements to the 1982 policy statement on mammography; these supplementary statements addressed the capabilities and limitations of mammography in the detection and diagnosis of breast cancer and performance guidelines for mam- mography. Assessors: The Task Force on Breast Cancer has 14 members. Of these, 12 are physicians and 2 are radiological physicists. There are 10-12 members on each of the committees; members are gynecologists, surgeons, radiation oncologists, internists, pathologists, family practitioners, and members of other or~ni7.~tiOn.c clash ~ the American Cancer Society and National Cancer Institute. C, ~_ ~ _ ~at,. ^~ Assessment reports include: Purpose of the assessment; relationship of the assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/supported the assessment; description of the technology; stage of life-cycle of technology when assessed; properties assessed; sources of data/information; findings or conclusions; limitations of findings; implica- tions of findings for practice; recommendations for practice, future assessments, tech- nology development, research; how the technology works, including theory, principles. Dissemination: Printed reports; advisories to members/constituents; press conference/ news releases, TV radio broadcasts, video products; clearinghouses. Individual Task Force policy statements are available from the ACR at no charge. Policy statements also appear in the newsletter ACR Bulletin. The ACR Mammography Resource Kit includes the policy statements on mammography, as well as reprints of other organizations' statements on mammography, order forms for public service announcements, information about mammography training programs, mammogra- phy bibliography, audiovisual materials on mammography, protocol information for patients, and related educational and reference materials. The kit is available upon written request to ACR members at no charge and to others for $25. Use: Portions of ACR policy statements on mammography appear in publications of the National Cancer Institute, American Cancer Society, and other organizations. ACR policy statements on mammography help form the basis for recommended mammog- raphy guidelines issued by medical specialty organizations such as the American Col- lege of Obstetricians and Gynecologists and the American Academy of Family Physi- cians. ACR mammography guidelines are also cited in guidelines and suggested state regulations offered by the Conference of Radiation Control Program Directors, used by many state radiation control programs. ACR policy statements have been cited in assessments by the Blue Cross and Blue Shield Association, the Office of Health Technology Assessment, and other agencies. For example, ACR opinions have been used in the Blue Cross and Blue Shield Association Medical Necessity guidelines on bronchoscopy (1977), angiocardiography (1977), angiography (1977), diagnostic imaging (1984), and routine preoperative and general hospital admission chest x-rays (19871. ACR opinions have also been cited in the National Council on Radiation Protection and Measurements Report No. 85, Mammography: A User's Guide (1986~; State of New York Department of Health memorandum Quality Assurance Programs for Providers of Mam- mography Services (1987~; and the Food and Drug Administration Center for Devices and Radiological Health Mammographic Phantom Evaluation Project Report (1983~. 29

MEDICAL TECHNOLOGY ASSESSMENT DfRECTORY Articles written by Task Force members on topics related to mammography policy statements appear in the published periodical literature and in texts. Examples are the following: McClelland, R. Feig SA. Guidelines for mammography. In Feig SA, McClelland R. eds. Breast carcinoma: current diagnosis and treatment. New York: ACR and Masson, 1983:365- 69. Bird RE, McClelland R. How to initiate and operate a low-cost screening mammogra- phy center. Radiology 1986;161~21:43-47. Budget: The Task Force operations budget is approximately $26,000. This amount does not include the value of the time volunteered to the Task Force by the member radiologists, physicists, and other professionals; it also does not include costs for the other committees involved in generating statements. Related activities: The Task Force on Breast Cancer coordinates and cosponsors with the American College of Pathologists, ACS, and American SocietY for Therapeutic v , - ~ ~ ~ ~ ~ · · ~ ~ ~ ~ . Kacllology and oncology a olennlal Rational conference on breast cancer. 1 ne ARK and the ACS have a liaison committee to support the ACS Breast Cancer Detection Awareness Program to educate asymptomatic women and their physicians in the importance of breast cancer detection, including screening mammography. The ACR Mammography Accreditation Program, directed by the ACR Committee on Practice Accreditation and assisted by the Task Force on Breast Cancer, provides voluntary peer review and evaluation services of mammography facility staff qualifica- tions, equipment, quality control and quality assurance programs, image quality and breast dose. Facilities meeting the criteria of the Mammography Accreditation Pro- gram are given a 3-year accreditation, a certificate for each approved mammography unit, and a listing on the ACS referral list of approved mammographic centers. The Patterns of Care Study of cancer treatment, which has been supported by the National Cancer Institute and conducted by ACR since 1971, has conducted surveys of structure, process, and outcomes for a national sample of radiation treatment facilities. As part of the study, ACR assembled review committees of radiation therapists to reach consensus in the form of decision trees for the management of ten disease types in which radiation therapy is involved. The ACR Practice Accreditation Program in Radiation Oncology, which evolved from the Patterns of Care Study, provides a voluntary quality assurance service for radiation therapy facilities. This program in- volves individual facility visits modeled in order to provide feedback to radiation therapists on their practice relative to regional and national norms established through the Patterns of Care Study. Based on site visits by teams of selected ACR member surveyors, the ACR Practice Survey Program is a voluntary review and evaluation service offered to diagnostic , ~ , ~ ~ . ~ . . . ~ . . ~ , . . . . . radiologists in a variety of practice settings. Both accreditation and consultative surveys are available. Additional ACR publications related to technology assessment include the following. ACR policy statements on computed tomography, imaging center guidelines, magnetic resonance, and obstetrical/ultrasound examination guidelines. Acceptance testing protocols: a systematic approach to evaluation of radiology equipment. 1983. SO

AMERICAN COLLEGE OF RADIOLOGY Imaging equipment compendium: a comparative reference of equipment characteristics. 1983. 1985 update, supplement. List of MR sites. Planning guides for radiologic installations. Proceedings of the Eighth Conference on Computer Applications in Radiology. 1984. Completed Reports AH1 American College of Radiology, Task Force on Breast Cancer. Policy statement on oscillating grids for mammography equipment. Expected 1987. tGroup judgment] AH2 . Resolution no. 1: supplementary mam- mography statement. 1986 Sep. [Group judgment] AH3 . Resolution no. 2: mammography per formance guidelines. 1986 Sep. EGroup judgment] AH4 . Policy statement: breast cancer screening centers. 1985. EGroup judgment] AH5 . Policy statement on sonography for the detection and diagnosis of breast disease. 1984. (Group judgment] AH6 . Policy statement on thermography for the detection of breast cancer. 1 983 Sep 28. tGroup judg ment1 AH7 _ . Statement of the preservation of mammo- grams. 1983. [Group judgment] AH8 . Policy statement: guidelines for mam- mography. 1982 Sep 22. EGroup judgment] American Dental Association Council on Dental Materials, Instruments. and l~auinment 2 ~ ~ East Chicago Avenue Chicago, IL 6061 3 12-440-2507 Contact: Dr. P.L. Fan, Associate Secretary. -~7 - --~-r~ Overview: The American Dental Association (ADA) is a professional association that provides a variety of services to assist its members practice dentistry and deliver health care to the public. The ADA's objectives include encouraging the improvement of the public's health, promoting the art and science of dentistry, and representing the interests of the dental profession and the public that it serves. The Council on Dental Materials, Instruments, and Equipment is one of two technology assessment programs sponsored by the ADA; the other being the Council on Dental Therapeutics. The Council was established in 1966 to centralize the ADA's activities in the standardization and evaluation of dental materials, instruments, and equipment. This activity had been initiated by the Association in 1928 at the National Bureau of Standards. The Council performs its duties through its Specification Program, Evaluation Pro- grams (which include the Certification Program, the Acceptance Program and the Recognition Program), Complaint Report Program, and Status Report Program. This profile focuses on the Acceptance Program component. Additional information on other Council activities can be found in the Council's textbook, Dentists' Desk Reference: Materials, Instruments and Equipment. 31

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Purpose: To evaluate materials, instruments, and equipment for which evidence of safety and usefulness has been established by biological, laboratory, or clinical evalua- tions and for which physical standards or specifications do not exist. Primary intended users: General public, patients, health product manufacturers, dentists. Technologies: Device. The following are examples of product areas presently covered by the Council's Acceptance Program: alloys for cast dental restorative and prosthetic devices, autoclave sterilizers, composite resin materials for occlusal restorations, crown and bridge resins, electrosurgical devices; x-ray equipment, denture adherents, denture cleansers, endos- seous implants, glass ionomer cements, denture cleaning devices, nitrous oxide/oxygen sedation machines and devices, oral irrigating devices, orthodontic bracket attachment materials, powered oral hygiene devices, precision attachments, processing devices for radiographic film; scaling/stain removal devices, and visible radiation emitting devices. Intervention: Treatment, prevention, diagnosis. Stage: New, emerging, established or widespread practice. Properties: Effectiveness, safety, efficacy. Selection process: Commercial products are evaluated at the request of the manufac- turer or distributor, or at the Council's initiative. All submissions and other information are sent in writing to the Council. Only complete submissions will be accepted; partial submissions will be returned. Each submission must include a summary report cover- ing all information on safety and efficacy of the material, instrument, or item of equipment. Submissions normally include the following: name and use of item; patent number relating to product; composition, physical, and chemical properties of dental materials; materials used in construction and method of operation of a device; and evidence of safety and usefulness of the product based on in vitro, biological, and clinical evalua- tions. Evidence of safety and usefulness of the product may be in the form of published reports or unpublished information obtained from appropriate scientific studies using in vitro, biological, and clinical observations. Methods: Information syntheses, expert opinion, group judgment, bench testing. The Council evaluates the information available and arrives at a decision, classifying the product as "acceptable," "provisionally acceptable," or "unacceptable." Products classi- fied as "acceptable" usually retain that status for 3 years. Acceptance is renewable and may be reconsidered at any time. If there is a change in manufacturer or distributor of the product, the acceptance automatically expires. "Acceptable" products are listed in Dentists' Desk Reference: Materials, Instruments and Equipment. The manufacturer or distributor may use the Seal of Acceptance and the Council's authorized statement. "Provisionally acceptable" products consist of those that lack sufficient evidence to justify classification as "acceptable," but for which there is reasonable evidence of safety 32

ADA/CouNc~ ON DENTAL MATERIALS, INSTRUMENTS, AND EQUIPMENT and usefulness including clinical feasibility. The Council may authorize the use of a suitable statement to specifically define the area of usefulness. Products in this classifi- cation category are reviewed each year and ordinarily are not continued for more than 3 years. "Unacceptable" products are those that are obsolete, markedly inferior, useless, or dangerous to the health of the user. Dissemination: Acceptable products are listed in the ADA publication Dentists' Desk Reference: Materials, Instruments and Equipment and in the journal of the American Dental Association. See for example, Product listing: classified dental materials, instruments, and equipment. ~ Am Dent Assoc 1986 Dec.; 1 13: 1013-1015. Budget: Not available. Funding source: 100 percent parent organization. Evaluators and consultants donate their time. Use: The information is used by the ADA membership and the public. Related Activities: The Council's Certification Program evaluates products and classi- fies them as "certified" when they meet formal certification requirements. The results of the Certification Program are also published in the journal of the American Dental , . . Association. Completed Reports Al1 American Dental Association, Council on Dental Materials, Instruments and Equipment. Dentin bond- ing systems: an update. ~ Am Dent Assoc 1987; 114:91-95. AJ2 . Dental endosseous implants. I Am Dent Assoc 1986;113:949-950. AJ3 . Posterior composite resins. ~ Am Dent Assoc 1986;112:717-709. A}4 . Posterior composite resins: an update. Am Dent Assoc 1986; 113:950-952. AJ5 . The effects of blue light on the retina and the use of protective filtering glasses. ~ Am Dent As- soc 1986; 112:533-535. AM . Recent developments in materials and process for ceramic crowns. ~ Am Dent Assoc 1985; 110:548-549. AJ7 . Report on base metal alloys for crown and bridge applications: benefits and risks. I Am Dent Assoc 1985;111:479-483. AJ8 . Status report on professional scaling and stain-removal devices. ~ Am Dent Assoc 1985; 111 :801-802. AM . Visible light-cured composites and activat- ing units. ~ Am Dent Assoc 1985; 110: 100-103 AJ10 , Council on Dental Research, and Council on Dental Therapeutics. Hydroxylapatite, beta trical- cium phosphate, and autogenous and allogenic bone for filling periodontal defects, alveolar ridge augmen- tation, and pulp capping. ~ Am Dent Assoc 1984; 108:822-831. A}ll , Council on Dental Therapeutics. Patch tests for sensitivity to mercury or nickel. ~ Am Dent Assoc 1984;108:381. AJ12 . Classification system for cast alloys. J Am Dent Assoc 1984;109:766. AJ13 . Mouth protectors and sports team den- tists. J Am Dent Assoc 1984;109:84-87. A}14 . Recommendations in dental mercury hy- giene, 1984. J Am Dent Assoc 1984; 109:617-619. AJ15 . Recommendations in radiographic prac- tices, 1984. J Am Dent Assoc 1984; 109:764-765. AJ16 . Reported sensitivity to glass ionomer lut- ing cements. I Am Dent Assoc 1984;109:617-619. AJ17 . Resin dental bonding systems. I Am Dent Assoc 1984;108:240-241. AJ18 . Status report on enamel bonding of com- posites, preformed laminate, and laboratory fabricat- ed resin veneers. J Am Dent Assoc 1984; 109:762-764. 33

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY A}l9 . Denture cleansers. I Am Dent Assoc 1983; 106:77-79. AJ20 . Pit and fissure sealants. ~ Am Dent Assoc 1983;107:465. AJ21 . Safety of dental amalgam. ~ Am Dent Assoc 1983; 106:519-520. AJ22 . Status report on amalgamators. ~ Am Dent Assoc 1983; 107:639-640. A}23 . Status report on posterior composites. I Am Dent Asso 1983; 107:71-75. A}24 . Status report: the periodontal ligament injection. ~ Am Dent Assoc 1983; 106:222-224. AJ25 . Biological effects of nickel-containing dental alloys. J Am Dent Assoc 1982;104:501-505. AJ26 . Biological effects of radiation from dental radiography. J Am Dent Assoc 1982;105:275-281. AJ27 . High copper-content amalgam alloys. J Am Dent Assoc 1982; 105: 1077- 1080. AJ28 . Recommendations for radiographic darkrooms and darkroom practices. ~ Am Dent Assoc 1982; 104:636-637. AJ29 . State of the art and science of bonding in orthodontic treatment. ~ Am Dent Assoc 1982; 105:844-850. A}30 . Status report on beta titanium orthodon- tic wire. ~ Am Dent Assoc 1982;105:684-685. AJ31 . Status report on microf~lled composite restorative resins. J Am Dent Assoc 1982-105:488- 492. AJ32 . Status report on precious metal scrap. Am Dent Assoc 1982; 105: 1080-1081. AJ33 . Status report: dental visible light-curing units. ~ Am Dent Assoc 1982;104:505. American Dental Association Council on Dental Therapeutics 2 ~ ~ East Chicago Avenue Chicago, TE 6061 3 1 2-440-2523 Contact: Kenneth H. Burrell, Secretary. AJ34 . A status report on resilient denture base materials. I Am Dent Assoc 1981;103:450-451. AJ35 . ADA Council issues updated mercury hygiene measures recommended. ADA News 1981 Sep 7. AJ36 . Classification and definition of alloys used for casting substrates for porcelain veneering. Am Dent Assoc 1981; 103:755-757. AJ37 . Council update on "adhesion" and "adhe- sive" materials. I Am Dent Assoc 1981; 103:252-253. AJ38 . Current status of sterilization instru- ments, devices, and methods for the dental office. Am Dent Assoc 1981; 102 :683-689. AJ39 . How to improve shade matching in the dental operatory. ~ Am Dent Assoc 1981;102:209- 210. AJ40 . Porcelain-metal alloy compatibility: crite- ria and test methods. ~ Am Dent Assoc 1981; 102:71- 72. AJ41 . Recommendations in radiographic prac- tices. ~ Am Dent Assoc 1981; 103: 103- 104 AJ42 . The desirability of using radiopaque plas- tics in dentistry: a status report. J Am Dent Assoc 1981; 102:347-349. AJ43 . Council position on nitrous oxide scav- enging and monitoring devices. J Am Dent Assoc 1980; 101:62. A}44 . Council reevaluates position on dental endosseous implants. ~ Am Dent Assoc 1980; 100:247. AJ45 . Prevention of problems with removable partial dentures. J Am Dent Assoc 1980; 100:919-921. A}46 . Status report on low-gold-content alloys for fixed prostheses. J Am Dent Assoc 1980; 100:237- 240. Overview: The American Dental Association (ADA) is a professional association that provides a variety of services to assist the profession in delivering health care to the 34

ADA/COUNCIL ON DENTAL THERAPEUTICS public. The ADA's objectives include encouraging the improvements of the public's health, promoting the art and science of dentistry, and representing the interests of the members of the dental profession and the public that it serves. The Council on Dental Therapeutics is one of two technology assessment programs sponsored by the ADA; the other being the Council on Dental Materials, Instruments, and Equipment. The Council supplies reliable information and confers a seal of acceptance, provisional acceptance, and unacceptance on recently developed dental products. Purpose: To study, evaluate, and disseminate information on 1) the proper use of dental therapeutics, their adjuncts, and dental cosmetic agents offered to the public or profession; and 2) aspects of the dental practice environment related to the health of dentists, dental auxiliaries, and the public. Primary intended users: General public, patients, dentists. Technologies: Drug, medical or surgical procedure. Examples of technologies evaluated by the Council are: topical fluoride preparations, analgesics, antianxiety agents, anticholinergic drugs, antihistamines for control of aller- gic reactions, artificial salivas, astringents for gingival retraction, chemical disinfecting/ sterilizing agents, corticosteroids, fluoride dentrifices, fluoride mouthrinses, formocre- sol preparations, hand antiseptics, hemostatic agents, hypochlorite substances, inhala- tion anesthetics, local anesthetics, muscle relaxants, nutritional supplements, oral anti- septics, periodontal dressings, pharmaceutical aids, phenolic compounds, respiratory stimulants, root canal calcium chelating agents, sedatives and hypnotics, sterilizing agents, topical Protestants. vasoconstrictor.s once zinc ovirle nren~r~ti~nc _ _ _, ~- r r ~ . ~-. ~ A A V . Intervention: Prevention, diagnosis, and treatment. Stages: New, emerging, established or widespread practice. Properties: Safety, efficacy, effectiveness. The Council also considers if the products meet standards of acceptance with respect to composition, advertising, and labeling. Selection process: Commercial products are evaluated at the request of a manufactur- er or distributor, or at the Council's initiative. Any firm may submit appropriate products to the Council for the consideration of acceptance. Communications must be submitted in writing through the Secretary of the Council. The Manufacturers normally submit the following types of information: product name, composition, physical and chemical properties of product; evidence of safety and effectiveness; government regulations related to the product; and promotional . materla s. Methods: Information syntheses, expert opinion, group judgment, bench testing. The steps required for the review of products in the Council's acceptance program depend on several factors. For example, if a product is essentially the same as an existing accepted product and does not require chemical analysis by the Council's laboratory or review by consultants, the process will require fewer steps. 35

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY After consideration of a product has been completed, the Council classifies the product as "accepted," "provisionally accepted," or "unaccepted." Products are generally accept- ed for three years. Acceptance is renewable and may be reconsidered at any time. If there is a change in the product's manufacturer or distributor, the acceptance automat- ically expires. "Accepted" products include those for which there is adequate evidence of safety and effectiveness. They may use the Council's "Seal of Acceptance" and/or an authorized statement, unless otherwise provided. "Provisionally accepted" products include those for which there is reasonable evidence of safety and effectiveness, but which lack sufficient evidence of dental effectiveness to justify being accepted. These products meet other qualifications and standards established by the Council. "Unaccepted" products include those for which the Council has determined that there is no substan- tial evidence of effectiveness, or that a question of safety exists. . Dissemination: Accepted products are listed in Accepted Dental Therapeutics and may be described in suitable reports in the journal of the American Dental Association See for example, Product listing: accepted therapeutic products. ~ Am Dent Assoc 1986 Dec; 1 13: 1018-1023. When it is in the best interest of the public or the profession, the Council may submit reports on unaccepted products for publication in the journal of the American Dental Association. Budget: Not available. Funding source: 100 percent parent organization. Evaluators and consultants donate their time. Use: The information is used by the ADA membership and the public. Completed Reports AK1 American Dental Association, Council on Dental Therapeutics, Council on Dental Materials, Instru- ments, and Equipment. The use of root canal filling materials containing paraformaldehyde: a status re- port. T Am Dent Assoc 1987 Jan; 114:95. AK? . American Dental Association, Council on Dental Therapeutics. Acceptance of Promise with Fluoride and Sensodyne-F toothpastes for sensitive teeth.] Am Dent Assoc 1986; 113 :673-5. AK3 . Guidelines for acceptance of chemothera- peutic products for the control of supragingival den- tal plaque and gingivitis. T Am Dent Assoc 1986; 112:529-32. AK4 . Recommendations for evaluating agents for the reduction of dentinal hypersensitivity. T Am Dent Assoc 1986; 112:709-10. AK5 , Council on Prosthetic Services and Dental Laboratory Relations. Guidelines for infection control in the dental office and the commercial dental labora- tory. ~ Am Dent Assoc 1985; 110:969-72. AK6 . Acceptance of OMNI-II disinfectant for instruments and equipment. J Am Dent Assoc 1985; 110. 36 AK7 . Acceptance of Sensodyne toothpaste for sensitive teeth. J Am Dent Assoc 1985; 110. AK8 . Prevention of bacterial endocarditis: a committee report of the American Heart Association. ~ Am Dent Assoc 1985; 110. AK9 . Herpes simplex virus disease: implications for dentalpersonnel. Jam Dent Assoc 1984;108:381- 2. AK10 , Council on Dental Research and Council on Dental Therapeutics. Report of symposium: root surface caries. J Am Dent Assoc 1983; 106. AKl l American Dental Association. Report of the Pres- ident's Conference on the examination, diagnosis, and management of temporomandibular disorders. J Am Dent Assoc 1983; 106:75-7. AK12 American Dental Association, Council on Dental Therapeutics. Evaluation of Denquel Sensitive Teeth toothpaste. ~ Am Dent Assoc 1982;105. AK13 . Council accepts Aim with sodium mono- fluorophosphate. J Am Dent Assoc 1980;101:822. AK14 . Council accepts dilution claims for Spori- cidin. J Am Dent Assoc 1980; 100:918. AK15 _ . Office emergencies and emergency kits. J Am Dent Assoc 1980; 101.

AMERICAN DIABETES ASSOCIATION American Diabetes Association 1660 Duke Street Alexandria, VA 22314 703-549- 1500 Contact: Richard Kahn, Ph.D., Assistant Executive Vice President. Overview: The American Diabetes Association (ADA) is a not-for-profit membership association that promotes efforts to prevent and cure diabetes and works to improve the well-being of people with diabetes and their families. It provides professional education programs, patient information materials/programs, research grant awards, and public awareness about diabetes. ADA's technology assessment activities include sponsoring consensus conferences, developing position papers, and publishing review articles. Purpose: To provide health professionals and the public with accurate and comore- hensive information about technologies relevant to diabetes. Primary intended users: General public; people concerned about their health; pa- tients; providers, generally; physicians; other care givers; health product manufactur- ers; health/medical professional associations; health industry associations; consumer associations; employers; unions and other employee organizations; third party payers; government regulators; voluntary associations, organizations; biomedical researchers; reporters, writers, news media; information/computer industry; labs, blood banks; public policy-makers, legislators; policy research organizations. Technologies: Drug, device, medical or surgical procedure, support system, organiza- tional or administrative system. Intervention: Diagnosis, treatment, rehabilitation. Stage: New, established or widespread practice. Properties: Safety; efficacy; effectiveness; cost; cost-benefit; cost-effectiveness; service requirements; acceptance/adoption level; system impact; economic implications; ethi- cal, legal, social implications. Selection process: ADA board members and officers, professional members, and other agencies and institutions can request that an assessment be conducted. Written requests are submitted to the volunteer leadership or senior staff. The volunteer leadership sets the assessment topic priorities. Methods: Information syntheses, expert opinion, group judgment, cost analyses. The assessment process is conducted in committee meetings, symposia, and confer- ences. The approximate turnaround time from selection of assessment topic to report- ing of findings is 6 months. 37

MEDICAL ~CHNOL~Y ASSESSMENT DI~CTORY Assessors: The assessors have expertise in a wide variety of areas related to diabetes including medicine, nutrition, exercise, law, and public health. Assessment reports include: The purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; who conducted the assessment; description of the technology; properties assessed; procedure used for the assessment; sources of dataJ information; methods for collecting dataJinformation; methods for analyzing/synthe- sizing dataJinformation; results; findings or conclusions; limitations of findings; impli- cations of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, prin- ciples; development of the technology; coverage/reimbursement status of the technol- ogy. Dissemination: Printed reports; journal articles; advisories to memberslconstituents; press conferences/news releases; TV/radio broadcasts, video products. The ADA accepts telephone and written requests for copies of assessment reports. Budget: $100,000. The approximate cost per assessment ranges from $1,000 to $50,000. Funding sources: 5 percent government grants/contracts; 15 percent founda- tions, other private grants; 80 percent sponsors/members dues, contributions. Use: The ADA uses the assessment reports and position statements as a guide for new program development and as an authoritative source of information. Reports are cited in government documents, newspaper articles, lay public magazines, and other publi- cations. Related activities: The ADA conducts an annual scientific session at which hundreds of original research reports are presented. The Association sponsors an annual post- graduate course, a research symposium, and other conferences intended to dissemi- nate new information or to provide a forum for discussing important topics related to diabetes. Completed Reports AL1 American Diabetes Association, Consensus Devel- opment Panel. Consensus statement on self-monitor- ing of blood glucose. Diabetes Care 1987;10:95-99. [Expert opinion, Group judgment] AL2 American Diabetes Association, Task Force of the Council on Nutrition Sciences and Metabolism. Posi tion statment on use of noncaloric sweeteners. 1987. [Expert opinion, Group judgment] AL3 American Diabetes Association. Nutritional recom- mendations and principles for individuals with diabe- tes mellitus. Diabetes Care 1987;10:126-132. tExpert opinion, Group judgment] 38 AL4 American Diabetes Association and the Centers for Disease Control, Task Force on Financing Quality Health Care for Persons with Diabetes. Third-party reimbursement for diabetes outpatient education. 1986. [Expert opinion, Group judgment] AL5 American Diabetes Association. Position statment on polydextrose.1986. [Expert opinion, Group judg- ment] AL6 . Bedside blood glucose monitoring in hos- pitals. Diabetes Care 1986;9:89. [Expert opinion, Group judgment]

AMERICAN DIABETES ASSOCIATION AL7 . Gestational diabetes mellitus. Diabetes Care 1986;9:430-431. LExpert opinion, Group judg- ment] AL8 . Continuous subcutaneous insulin infu- sion. Diabetes 1985 ;34:946. LExpert opinion, Group judgment] American Gastroenterolog~cal Association Patient Care Committee c/o John Balint, M.D. Chairman, Department of Medicine Albany Medical College 47 New ScotIanc! Avenue Albany, NY 12208 5 18-445-5376 Contact: John Balint, M.D. AL9 . Office guide to diagnosis and classification of diabetes mellitus and other categories of glucose intolerance. Diabetes Care 1981 ;4:335. LExpert opin- ion, Group judgment] AL10 Olefsky {M, Crapo P. fAmerican Diabetes Associ- ation] Fructose, xylitol, and sorbitol. Diabetes Care 1980;3:390-393. LExpert opinion, Group judgment] Overview: The American Gastroenterological Association (AGA) is a professional society for gastroenterologists concerned with patient care education, research, and public policy. Purpose: To evaluate the safety and efficacy of new diagnostic and treatment modal- ities in digestive diseases and to develop effective and affordable methodologies for data collection. Primary intended users: Patients; physicians; acute facility administrators; health product manufacturers; health/medical professional associations; third party payers; government regulators; biomedical researchers; public policy-makers, legislators. Technologies: Device, drug, medical or surgical procedure. Specifically, endoscopic instrumentation for diagnosis and treatment, new imaging technology, and nutritional support systems are assessed. Intervention: Treatment, diagnosis. Stage: New, emerging, established or widespread practice. Properties: Effectiveness, safety, cost-benefit, cost-effectiveness, acceptance/adoption level. Selection process: Anyone can request that an assessment be conducted. Generally, Committee members initiate a request, although the Committee will respond to re- quests from any organization. The Committee sets assessment topic priorities and decides on the most appropriate response to a request. Methods: Information syntheses, expert opinion, group judgment, epidemiological and other observational methods. 39

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Committee members conduct the assessment process and are assigned specific tasks to complete. Assessments are based largely on literature reviews, although, the Commit- tee wants to develop questionnaire methods for prospective evaluations. The turn- around time from selection of assessment topic to reporting of findings ranges from 6 months to 2 years. Assessors: The Patient Care Committee consists of practicing gastroenterologists, surgeons, endoscopists, and pediatric gastroenterologists. Assessment reports include: The purpose of the assessment; stage of life-cycle of technology when assessed; properties assessed; procedure used for the assessment; sources of dataJinformation; methods for collecting data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; and recom- mendations for practice, future assessments, technology development, research. Dissemination: Printed reports, journal articles. Assessment results are published in the journal Gastroenterology and are presented at AGA meetings. Copies of the assessments can be requested from the Patient Care Committee. Budget: Not available. The approximate cost per assessment is not known. In general, Committee members donate their time. Funding source: 100 percent parent organiza- tion. Related activities: The Patient Care Committee sponsors symposia at their annual meeting that are designed to help the practicing gastroenterologist evaluate and prop- erly use diagnostic and treatment modalities. Completed Reports Ongoing Assessments AM1 Sitzman JV, Pitt HA. "American Gastroenterologi-AM3 American Gastroenterological Association, Patient cat Association, Patient Care Committee] GuidelinesCare Committee. Diagnostic procedures in jaundice. Ongoing. for total parenteral nutrition. Gastroenterology 1987 (in press). AM2 Kreek M}, Balint {A. "American Gastroenterologi cal Association, Patient Care Committee] "Skinny needle" cholangiography: results of a pilot study of a voluntary prospective method for gathering risk data on new procedures. Gastroenterology 1980;78:598 604. "Information syntheses] 4o AM4 American Gastroenterological Association, Patient Care Committee. Diagnostic procedures in noncar- diac chest pain. Ongoing.

AMERICAN HOSPITAL ASSOCIATION American Hospital Association Hospital Technology Series Program Division of Clinical Services ant! Technology 840 North Lake Shore Drive Chicago, IL 6061 3 12-280-6084 Contact: Henry C. Alder, Director; Suzanna Pribyl, Manager, Technology Policy and Planning; or Susan A. Frankel, Manager, Marketing and Publications. Overview: The American Hospital Association (AMA) is a trade association that repre- sents member hospitals, providing advocacy, policy development, publications, data services, educational programs, and special projects. Its Hospital Technology Series Program, initiated in 1982, is a health care technology evaluation and information dissemination program for hospital administrators. Purpose: To assist hospital administrators in making prudent and informed manage- ment decisions regarding new and existing technologies to support clinical services . . . . P annlng actlvltles. Primary intended users: Providers, generally; acute facility administrators; long-term ~ . . . . . care tea lty aummlstrators. Technologies: Device, support system. The Program deals primarily with service implications of technological advances on the planning and delivery of clinical services from the hospital perspective. The Program generally does not evaluate procedures, although they are discussed insofar as they bear upon strategic equipment and service choices. Intervention: Diagnosis, treatment. Properties: Service requirements, system impact, efficacy, effectiveness, cost, cost-benefit, cost-effectiveness, acceptance/adoption level, economic implications. Evaluations also consider manufacturer issues, such as vendor stability, the capacity for technologies to be upgraded, and other compared attributes of competing technol- ogies. Although evaluations do not include brand name ratings, they sometimes pro- vide brand-specific information, such as cost and installation information and service support arrangements. Specifically, evaluations are most concerned with the following: 1) cost and organizational implications, 2) installation costs, 3) staffing and training requirements, 4) probable number of patients affected, 5) effects on other hospital resources, and 6) effectiveness (not patient outcomes, but effects on the use of hospital resources, such as inpatient versus outpatient stay and average length of stay). Selection process: Program staff select subjects for assessment after reviewing their importance to hospital management, especially their impact on costs. Technologies are reassessed based on new information and the perceived needs of hospitals. Reassess- ments follow the same format as the original assessments. 4

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Methods: Information syntheses, expert opinion, cost analyses. Evaluations consist of syntheses of the literature, focused interviews with manufactur- ers and users, and compilations of reported experience by users in such areas as negotiating purchase contracts and common mistakes made in implementation. The approximate turnaround time from selection of assessment tonic to reporting of findings is 6 months. - -r - ~ ~~~~o ~ Assessors: The evaluations are conducted or directed by staff of the Division of Clinical Services and Technology who have expertise in hospital and business administration, health care administration, and clinical engineering. Outside consultants with medical and scientific expertise are also employed. Assessment reports include: Who conducted the assessment; description of the tech- nology; properties assessed; results; findings or conclusions; implications of findings for practice; recommendations for practice, future assessments, technology develop- ment, research; how the technology works, including theory, principles; development of the technology; procurement/deployment information; regulatory agency approval status; coverage/reimbursement status of the technology. Dissemination: Printed reports, journal articles, advisories to members/constituents. ];'_ _ 1 ~ ~ __ 1 ~ 1 _ ~- 7 ~ ~ , . Evaluation ~lnalngs are reported in Guideline iceports issued approximately 4 times a year and disseminated to member hospitals. Selected Guideline Reports are summarized in Hospitals magazine. They may be obtained as part of a subscription to the AHA Hospital Technology Series or ordered separately for a nominal fee. In addition to Guideline Reports the AHA Hospital Technology Series includes the following: Executive Briefing; an overview of major developments affecting hospitals' use of tech- nology in the delivery of patient care; directed to hospitals' chief executive officers and distributed monthly. Technology Scanner; a collection of categorized summaries of articles relevant to hospital technology, drawn from more than 80 medical and technical journals. Directed to hospital administrators and distributed monthly. Special Reports; brief updates on current technological issues. Budget: $368,000. Funding sources: 100 percent sales of subscriptions and reports. Use: Approximately 1,700 hospitals subscribe to the Hospital Technology Series. Related activities: The AMA's Division of Clinical Services and Technology also pro- duces MediTrends, an environmental assessment of clinical services focusing on medical technology. Completed Reports AN1 American Hospital Association, Hospital Technol- ogy Series Program. Positron emission tomography. 1987. (Guideline report) [Information syntheses, Ex- pert opinion, Cost analyses] 42 AN2 . Radiation therapy planning. 1987. (Guideline report) [Information syntheses, Expert opinion, Cost analyses]

AMERICAN HOSPITAL ASSOCIATION AN3 . Topographic brain mapping. 1987. (Guideline report) fInformation syntheses, Expert opinion, Cost analyses] AN4 . Cine-CT: progress and opportunities. 1986. (Guideline report) FInformation syntheses, Ex- pert opinion, Cost analyses] AN5 . Implementing laser technology in the community hospital. 1986. (Guideline report) [Infor- mation syntheses, Expert opinion, Cost analyses] AND . Purchasing a satellite receiving earth ter- minal. 1986. (Guideline report) "Information synthe- ses, Expert opinion, Cost analyses] AN7 . Lithotripters. 1985. (Guideline report) fInformation syntheses, Expert opinion, Cost ana- lyses] AND . NMR issues for 1985 and beyond. l 985. (Guideline report) "Information syntheses, Expert opinion, Cost analyses] ANSI . Picture archiving and communication sys- tems. 1985. (Guideline report) "Information synthe- ses, Expert opinion, Cost analyses] AN10 . A medical device recall and reporting system. 1984. (Guideline report) [Information syn- theses, Expert opinion, Cost analyses] ANl l . Adult volume ventilators. 1984. (Guide- line report) [Information syntheses, Expert opinion, Cost analyses] AN12 . Bar coding technology applications in health care. 1984. (Guideline report) AN13 . Computerized tomographic scanners. 1984. (Guideline report) fInformation syntheses, Ex- pert opinion, Cost analyses] AN14 . Echocardiography. 1984. (Guideline re- port) "Information syntheses, Expert opinion, Cost analyses] AN15 . Equipment acquisition under prospec- tive payment. 1984. (Guideline report) "Information syntheses, Expert opinion, Cost analyses] AN16 . Microcomputers in hospitals. 1984. (Guideline report) [Information syntheses, Expert opinion, Cost analyses] AN17 _ . Trends in nuclear medicine. 1984. (Guideline report) fInformation syntheses, Expert opinion, Cost analyses] AN18 . Materials management information sys- tems. 1983. (Guideline report) fInformation synthe- ses, Expert opinion, Cost analysesJ ANl9 . Medicare technology assessment. 1983. (Guideline report) fInformation syntheses, Expert opinion, Cost analyses] AN20 . Nuclear magnetic resonance (NMR). 1983. (Guideline report) fInformation syntheses, Ex- pert opinion, Cost analyses] AN21 . Automated indirect blood pressure measurement devices. 1982. (Guideline report) fIn- formation syntheses, Expert opinion, Cost analyses] AN22 . Automated infusion devices. 1982. (Guideline report) fInformation syntheses, Expert opinion, Cost analyses] AN23 . Autotransfusion units. 1982. (Guideline report) fInformation syntheses, Expert opinion, Cost analysesJ AN24 . Buying and selling used medical equip- ment. 1982. (Guideline report) "Information synthe- ses, Expert opinion, Cost analyses] AN25 . Clinical laboratory information systems. 1982. (Guideline report) tInformaton syntheses, Ex- pert opinion, Cost analyses] AN26 . Computerized arrhythmia monitoring systems. 1982. (Guideline report) "Information syn- theses, Expert opinion, Cost analyses] AN27 . Digital subtraction angiography. 1982. (Guideline report) "Information syntheses, Expert opinion, Cost analyses] AN28 . Ethylene oxide sterilization. 1982. (Guideline report) fInformation synthesis, expert opinion, Cost analyses] AN29 . Evaluation methods for intensive care units. 1982. (Guideline report) fInformation synthe- ses, Expert opinion, Cost analyses] AN30 . Medicare technology assessment. 1982. (Guideline report) fInformation syntheses, Expert opinion, Cost analyses] AN31 . Medicare technology assessment. 1981. (Guideline report) fInformation syntheses, Expert opinion, Cost analyses] 43

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY American Medical Association Council on Scientific Affairs 535 North Dearborn Street Chicago, IL 60610 3 12-645-5335 Contact: William R. Hendee, Ph,D., Secretary; or Vicki Grosso, Council and Commit- tee Coordinator. Overview: The American Medical Association (AMA) is a professional association that provides a wide range of services and products to advance the field of medicine. The Council on Scientific Affairs was formed in 1976 by the AMA. Purpose: To provide accurate, balanced, and up-to-date information on medical tech- nology to the practicing medical community and to communicate the concerns and opinions of physicians to the health care community. Primary intended users: General public; people concerned about their health; pa- tients; providers, generally; physicians; acute facility administrators; long-term care facility administrators; other care givers; health product manufacturers; health/medi- cal professional associations; health industry associations; consumer associations; em- ployers; unions and other employee organizations; third party payers; government regulators; voluntary associations, organizations; biomedical researchers; public policy- makers, legislators. Technologies: Medical or surgical procedure, drug, device. Intervention: Diagnosis, treatment, prevention, rehabilitation. Stage: Emerging, new, established or widespread practice, obsolete. Properties: Safe0, effectiveness, efficacy. Selection process: Any responsible party may request an assessment. Requests are made to the Secretary or Council members. The members of the Council then set the . . . priorities tor assessment. Methods: Group judgment, information syntheses, expert opinion. Issues of importance to the practicing medical community are identified. Often expert panels are organized and charged with addressing pertinent issues. Reports are devel- oped by the panel and submitted to the Council for approval. In other cases, issues are analyzed by staff. Reports are developed and reviewed by three or four consultants. They are then submitted to the Council for approval. The approximate turnaround time from selection of assessment topic to reporting of findings is 6 to 12 months. Assessors: The Council has access to experts in all areas of medicine. Assessment reports include: Abstract; the purpose of the assessment; description of the technology; stage of life-cycle of technology when assessed; properties assessed; sources of data/information; results; findings or conclusions; limitations of findings; 44

AMA/COUNCIL ON SCIENTIFIC AFFAIRS implications of findings for practice; recommendations for practice, future assess- ments, technology development, research; how the technology works, including the- ory, principles; development of the technology. Dissemination: Printed reports; journal articles; advisories to members/constituents; press conferences/news releases, TV/radio broadcasts, video products. The reports are 20-25 pages in length with an initial synopsis. The results are dissemi- nated through the Journal of the American Medical Association JAMA) or the popular press. Copies of the assessment reports may be obtained from [AMA or by requesting reprints. Budget: $613,782. The cost per assessment varies. Funding source: 100 percent parent . . Organlzatlon. Use: The AMA uses the assessment reports as a source of information for physicians to incorporate in their decision-making processes. Completed Reports AO1 American Medical Association, Council on Scien- tific Affairs. Drugs and athletes- Progress Report. 1986. [Group judgment] AO2 _ . Glucocorticoid-induced osteonecrosis. 1986. tGroup judgment] AO3 . Herpes simplex and school children. 1986. tGroup judgment] AO4 . Lasers in medicine and surgery. iAMA 1986 Aug 15;256~7):900-907. tGroup judgment] AO5 . OTC diet preparations containing phen- ylpropanolamine (Resolution 100, I-85). 1986. [Group judgment] AO6 . Preventing death and disability from fires by the new rapid response automatic sprinklers and smoke detectors (Resolution 2, A-851. 1986. (Group judgment] AO7 _ . Safe use of radioactive materials in medi- cal practice (Resolution 66, A-851. 1986. tGroup judg- ment1 AO8 . Statement on liver transplantation. 1986. [Group judgment! AO9 . The Heimlich maneuver interim report (Resolution 52, I-85~. 1986. [Group judgment] AO10 . Use of immunosuppressants in organ transplantation. 1986. tGroup judgment] AO11 . AMA diagnostic and treatment guide- lines concerning child abuse and neglect. JAMA 1985 Aug 9;254~61:796-800. tGroup judgment] AO12 . Aspartame: review of safety issues. JAMA 1985 Jul 18;254:400-402. tGroup judgment] AO13 . Autopsies: interim report (Substitute Resolution 11, A-841. 1985. tGroup judgment! AO14 . Current status of therapeutic plasma- pheresis and related techniques. JAMA 1985 Feb 8;253:819-825. [Group judgmentJ AO15 . Dementia. 1985 tGroup judgment] AO16 . Drugs and athlete~ interim report. 1985. (Group judgment] AO17 . Guidelines for handling parenteral an- tineoplastics. JAMA 1985 Mar 15;253: 1590-1592. ~Group judgment1 AO18 . Guidelines for reporting estimates of probability of paternity. J-AMA -1985 Jun 14;253:3298. [Group judgment] AO19 . Harmful effects of UVA and UVB light. 1985. tGroup judgment] AO20 . SI units for clinical laboratory data. JAMA 1985 May 3;253:2553-2554. tGroup judg- ment] AO2 1 . Saccharin: review of safety issues. TAMA 1985 Nov 8;254~18~:2622-2624. tGroup judgment] AO22 . Scientific status of refreshing recollec- tion by the use of hypnosis. ~AMA 1985 Apr 5;253: 1918-1923. tGroup judgment] AO23 . The use of cardiac pacemakers in medi- cal practice..JAMA 1985 Oct 11;254 (14) 1952-1954. tGroup judgment] AO24 . Vitamin preparations as dietary supple- ments and as therapeutic agents. 1985. iGroup judg- ment] 45

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY AO25 . Xenografts: Review of the literature and current status. TAMA 1985 Dec 20;254~23~:3353. tGroup judgment; Information syntheses] AO26 . Caffeine labeling. JAMA 1984 Aug 10;252:803-806. tGroup judgment] AO27 . Chelation therapy. 1984. tGroup judg- ment] AO28 . Combined modality approaches to can- cer therapy. JAMA 1984 May 11;251:2398-2407. [Group judgment] AO29 . Early detection of breast cancer. JAMA 1984 Dec 7;252:3008-3011. tGroup judgment] AO30 . Nicotine chewing gum for cessation of smoking. 1984. [Group judgment] AO31 . Percutaneous transluminal angioplasty. MAMA 1984 Feb 10;251:764-768. tGroup judgments AO32 . Prescription Abuse Data Synthesis (PADS) Project and the AMA prescription drug abuse activity. 1984. tGroup judgment] AO33 . The acquired immunodeficiency syn- drome. JAMA 1984 Oct 19;252:2037-2043. (Group judgment] AO34 .A guide to the hospital management of · ~ r · . . .. Injuries arising trom exposure to or unto ring Ionizing radiation. 1983. tGroup judgment] AO35 . AMA's role in technology assessment (Resolution 131 (A-83~. 1983. tGroup judgment] AO36- . Calcium channel blocking agents. JAMA 1983 Nov 11 ;250:2522-2524. (Group judgment] AO37 . Choking: the Heimlich maneuver (ab- dominal thrust' vs. back blows. 1983. (Group judg- ment] AO38 . Cochlear implants. JAMA 1983 Jul 15;250:391-392. [Group judgment] AO39 . Dietary and pharmacologic therapy for the lipid risk factors. JAMA 1983 Oct 14;250:1873- 1879. tGroup judgment] AO40 . Effects of competition in medicine. JAMA 1983 Apr 8;249: 1864-1868. tGroup judg- ment] AO41 . Estrogen replacement in the meno- pause. JAMA 1983 Jan 21;249:359. tGroup judg- ment] AO42 . Exercise programs for the elderly.1983. [Group judgment] 46 AO43 . In-utero fetal surgery: (Resolution 73 (I- 81). JAMA 1983 Sep 16;250: 1443-1444. [Group judgment] AO44 . Maternal alcohol use. JAMA 1983 May 13;249:2517-2521. tGroup judgment] AO45 . Medical evaluations of healthy persons. JAMA 1983 Mar 25;249: 1626-1633. tGroup judg- ment1 AO46 . Methaqualone, abuse limits its useful- ness. JAMA 1 983 Dec 9; 250:3052. [Group judgments AO47 . Nonsmoking in hospitals. 1983. tGroup judgment] AO48 . Pharmaceutical dissolution of gallstones. JAMA 1983 Nov 4;250:2373-2374. tGroup judg ment] AO49 . Update on venereal disease. 1983. [Group judgment] AO50 . AMA involvement in prevention and treatment of child abuse and neglect (Substitute Reso- lution 75, A-81). 1982. [Group judgment] AO51 . Addition of thiamine to alcoholic bever- ages (Resolution 140, A-8 11. 1982. tGroup judgment] AO52 . Continuous ambulatory peritoneal dialy- sis. JAMA 1982 Nov 12;248:2340. tGroupjudgmentJ AO53 . Dimethyl sulfoxide. TAMA 1982 Sep 17;248:1369. tGroup judgment] AO54 . Drug abuse related to prescribing prac- tices. TAMA 1982 Feb 12;247:864. [GroupjudgmentJ AO55 . Genetic counseling and prevention of birth defects. JAMA 1982 Jul 9;248:221. tGroup judgment] AO56 . Health care needs of a homosexual pop- ulation. JAMA 1982 Aug 13;248:736. (Group judg- ment] AO57 . Infant formula marketing (Resolution 155, A-81). 1982. tGroup judgment] AO58 . Maternal serum a-fetoprotein monitor- ing. JAMA 1982 Mar 12;247:1478. tGroup judg- ment] AO59 . Pneumococcal, influenza and hepatitis-B vaccine (Resolution 75, A-82). 1982. tGroup judg- ment] AO60 . Acupuncture. 1981. EGroup judgment] AO61 . Electronic fetal monitoring. JAMA 1981 Nov 20;246:2370. tGroup judgment]

AMA/COUNCIL ON SCIENTIFIC AFFAIRS AO62 . Evalution of iridology. 1981. tGroup judgment] AO63 . Hypnotic drugs and treatment of insom- nia. JAMA 1981 Feb 20;245:749. tGroup judgment] AO64 . Indications and contraindications for ex- ercise testing. JAMA 1981 Aug 28;2a~6: 1015. tGroup judgment] AO65 . Marijuana, its health hazards and thera- peutic potentials. {AMA 1981 Oct 16;246: 1823. tGroup judgment] AO66 . Medical care for indigent and culturally displaced obstetrical patients and their newborns. Committee on Maternal and Child Health. JAMA 1981 Mar 20;245: 1159. tGroup judgment] AO67 . Organ donor recruitment. JAMA 1981 Nov 13;246:2157. tGroup judgments AO68 . Physician-supervised exercise programs in rehabilitation of patients with coronary heart dis- ease. JAMA 1981 Apr 10;245:1463. tGroup judg- ment] American Medical Association Diagnostic arid Therapeutic Technology Assessment 535 North Dearborn Street Chicago, IL 60610 3 12-645-4530 AO69 . Prescription of tranquilizers and antide- pressants for women (Board of Trustees report X, I- 80). 1981. [Group judgment] AO70 . Health care technology assessment- 1980. 1980. [Group judgment] AO71 . Hypoglycemic treatment, guidelines for the non-insulin-dependent diabetic. MAMA 1980 May 23-30;243:2078. tGroup judgment] AO72 . Importance of diagnostic computerized tomographic scanning. 1980. tGroup judgment] AO73 . Infant nutrition (Resolution III, I-78.) 1980. tGroup judgment] AO74 . Marijuana in the 80's. 1980. [Group judgment] AO75 . Progress in adoption of SI units. 1980. tGroup judgment] AO76 . The nutritive quality of processed foods: general policies for nutrient additions. 1980. tGroup judgment] Contact: William T. McGivney, Ph.D., Director; or Andrea L. Schneider, Program Administrator. Telex 910-221-0300. Overview: The American Medical Association (AMA) is a professional association that provides a wide range of services and products to advance the field of medicine. The Diagnostic and Therapeutic Technology Assessment program (DATTA) was estab- lished by the AMA in 1982. Purpose: To provide accurate, balanced, and up-to-date information on medical tech- nology to the practicing medical community; and to communicate the concerns and opinions of physicians to other constituents of the health care community. Primary intended users: General public; people concerned about their health; pa- tients; providers, generally; physicians; acute facility administrators; long-term care facility administrators; other care givers; health product manufacturers; health/medi- cal professional associations; health industry associations; consumer associations; em- ployers; unions and other employee organizations; third party payers; government regulators; voluntary associations, organizations; biomedical researchers; public policy- makers; legislators. 47

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Technologies: Medical or surgical procedure, drug, device. Intervention: Diagnosis, treatment, prevention, rehabilitation. Stage: New, emerging, established or widespread practice, obsolete. Properties: Safety, effectiveness, efficacy. Selection process: Any responsible party may request that an assessment be conducted. Written requests should be submitted to the Director. The DATTA Subcommittee, Director, and AMA Executive staff set assessment tonic priorities. The need to reassess the technologies is considered periodically. Methods: Expert opinion, information syntheses. 1~ A TT A ~1 ~· . 1 ~ - 1 ~ ~A ~ V V V V UA! IA formulates questions to examine the safety and effectiveness of a technology when applied for very specific indications. Individuals with expertise in the topic are selected from a reference panel and asked (by mail) to rate the safety and effectiveness of the technology as established, investigational, or unacceptable. Panelists are encour- aged to provide supporting data and relevant considerations. The evaluations of the panelists are collated, compiled, and synthesized with an extensive analysis of the biomedical literature. The approximate turnaround time from selection of topic to reporting of findings is 120 days. Assessors: DATTA is operated by AMA staff under direction of a subcommittee of the AMA Council on Scientific Affairs. Staff selects panelists for each assessment from a reference panel of 1,000 physicians appointed by the Council on Scientific Affairs. Panelists represent a broad spectrum of specialties and subspecialties. Assessment reports include: Description of the technology; stage of life-cycle of technology when assessed; properties assessed; sources of data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, principles. Dissemination: Printed reports; journal articles; advisories to members/constituents; press conferences/news releases, TV/radio broadcasts, video products. The assessment reports contain an initial synopsis and are usually 8 to 10 pages in length. DATTA results are usually published in the journal of the American Medical Association, disseminated in the popular press, and are distributed to certain individuals and organizations on a mailing list. Individual copies of DATTA reports may be obtained from the AMA. Subscriptions to the DATTA series, including new and past reports and the newsletter AMA Tech, are available from the AMA. Budget: $380,000. The approximate cost per assessment is $15 000. Funding source: 100 percent parent organization. a Use: The AMA uses the assessment reports as a source of information for physicians to use for decision-making purposes. They are also used by third party payers, group practices, specialty societies, individual patients, public policy-makers. Articles describ- ing the program include the following citations: 48

AMAIDIAGNOSTIC AND THERAPEUTIC TECHNOLOGY ASSESSMENT Institute of Medicine, Committee on Evaluating Medical Technologies in Clinical Use. Assessing medical technologies. Washington, DC: National Academy Press, 1985. Monaco GP, Burke RL. Insurance as gatekeeper part two: policy obstacles in unprov- en methods litigation. Forum 1985;spring. Petitti DB. Competing technologies, implications for the cost and complexity of medical care. New Engl ~ Med 1986 Dec 4. Rose M, Leibenluft RF. Antitrust implications of medical technology assessment. New Engl J Med 1986.Jun 5. The following assessment reports of the Office of Health Technology Assessment (National Center for Health Services Research and Health Care Technology Assess- ment) reference DATTA statements: 1983 Anti-gastroesophageal reflex implantation Diathermy as a physical therapy modality Fully automated ambulatory blood pressure monitoring of hypertension 1984 Ambulatory electroencephalographic (EEGJ monitoring External open-loop pump for the subcutaneous infusion of insulin in diabetes Implantable pumpfor chronic Hepburn therapy S. treptokinase infusion for acute my ocardial infarc- tion Transplantation of the pancreas 1985 Apherests in the treatment of guillian-barre syndrome Extracorporeal shock wave lithotr~psy (ESWL) procedure for treatment of kidney stones Patient selection criteria for percutaneous transluminal coronary ang~oplasty of a stenotic lesion in a single coronary artery Percutaneous ultrasound procedures for the treatment of kidney stones Reassessment of cardiokymography (No longer valid) Transurethral ureteroscopic lithotrapsy procedures for the treatment of kidney stones Completed Reports API American Medical Association, Diagnostic and Therapeutic Technology Assessment. Ablation of ac- cessory pathways in Wolff-Parkinson-White Syn- drome. Mar 31, 1986. tExpert opinion, Information syntheses] APE . Angelchik antireflux prosthesis treatment of gastroesophageal reflex. JAMA 1986 Sep 12. tEx- pert opinion, Information syntheses] AP3 . Autologous bone marrow transplantation. }AMA 1986.Jul 4. tExpert opinion, Information syn- theses] AP4 . BCG immunotherapy in bladder cancer. Mar 31, 1986. tExpert opinion, Information synthe- ses] AP5 . Cardiac rehabilitation services. Jul 16, 1986.1iExpert opinion, Information syntheses] APO . Garren gastric bubble for morbid obesity. JAMA 1986 Dec 19. Expert opinion, Information syntheses] AP7 . Mammographic screening for breast can- cer. Oct 19, 1986. tExpert opinion, Information syn- theses] 49

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY AP8 . Microsurgical reconstruction for brachial plexus injury. Jul 16, 1986. tExpert opinion, Informa- tion syntheses] AP9 . Continuous arteriovenous hemofiltration (CAVH) for fluid removal. JAMA 1985 Mar 1. [Ex- pert opinion, Information syntheses] AP10 . Diagnostic intraoperative ultrasound. tAMA 1985 Jul 12. [Expert opinion, Information syntheses] APll . Endoscopic electrocoagulation for gas- trointestinal hemorrhage. JAMA 1985 May 11. [Ex- pert opinion, Information syntheses] AP12 . Endoscopic laser photocoagulation for gastrointestinal hemorrhage. JAMA 1985 May 11. [Expert opinion, Information syntheses] APES . Endoscopic thermal coagulation for gas- trointestinal hemorrhage. JAMA 1985 May 11. tEx- pert opinion, Information syntheses] AP14_ . Endoscopic topical therapy for gastroin- testinal hemorrhage. JAMA 1985 May 11. tExpert opinion, Information syntheses] APES . Enhanced computed tomography in head trauma. JAMA 1985 Dec 20. tExpert opinion, Information syntheses] AP16 . Non-invasive extracorporeal lithotripsy for disruption of kidney stones Update. Feb 15, 1985. tExpert opinion, Information syntheses] AP17 . Sperm penetration assay in identifying male infertility. JAMA 1985 Oct 11. [Expert opinion, Information syntheses] AP18 . Sterotactic cingulatomy treatment for psychiatric disorders. JAMA 1985 Nov 15. [Expert opinion, Information syntheses] APl9 . Apnea monitoring for 24-hour surveil- lance of newborns at risk for sudden infant death syndrome. JAMA 1984 Tan 27. tExpert opinion, In- formation syntheses] AP2O . Bone marrow transplantation in child- hood leukemia. JAMA 1984 Apr 27. [Expert opinion, Information syntheses] AP21 . Cardiokymography for (non-invasive) cardiological diagnosis. JAMA 1984 Feb 24. tExpert opinion, Information syntheses] AP22 . Diaphanography (transillumination of the the breast) for cancer screening. JAMA 1984 Apr 18. tExpert opinion, Information syntheses] AP23 . Endoscopic transurethral nephrolitho- tomy for disruption of kidney stones. JAMA 1984 Dec 21. [Expert opinion, Information syntheses] 5O AP24 . Gastric restrictive surgery for morbid obesity. JAMA 1984 {un 8. tExpert opinion, Informa- tion syntheses] AP25 . Hyperthermia treatment for cancer Update. Sep 17, 1984. ~Expert opinion, Information syntheses] AP26 . Implanted electrospinal stimulator for scoliosis. JAMA 1984 May 25. tExpert opinion, Infor- mation syntheses] AP27 . Percutaneous nephrolithotomy for kid- ney stone removal. JAMA 1984 Dec 2. tExpert opin- ion, Information syntheses] AP28 . 24-hour ambulatory EEG monitoring for diagnosing seizure disorders. JAMA 1983 Dec 23. tExpert opinion, Information syntheses] AP29 . Biofeedback for managing vascular and tension headaches. JAMA 1983 Nov 14. tExpert opinion, Information syntheses] AP30 . C02 laser for the treatment of gyneco- logic malignancies. JAMA 1983 Aug 5. [Expert opin- ion, Information systheses] AP31 . Chelation therapy (with EDTA) for ath- erosclerosis. ~AMA 1983 Aug 5. [Expert opinion, In- formation syntheses] AP32 . Cranial electrostimulation for treatment of anxiety and/or depression. {AMA 1984 Feb 24. tExpert opinion, Information syntheses] AP33 . Diathermy for treating musculoskeletal conditions. JAMA 1983.Jul 22-29. tExpert opinion, Information syntheses] AP34 . Implantable infusion pump for continu- ous drug therapy. JAMA 1983 Oct 14. tExpert opin- ion, Information syntheses] AP35 . Mandatory EKG prior to elective sur- gery. JAMA 1983 Jul 29. tExpert opinion, Informa- tion syntheses] AP36 . Quantitative EEG (fast Fourier trans- form analysis) operative monitoring of cerebrovascu- lar status. JAMA 1983 Jul 15. tExpert opinion, Infor- mation syntheses] AP37 . Radial keratotomy for the treatment of myopia. JAMA 1983 Jul 15. tExpert opinon, Infor- mation syntheses] AP38 . Thermography (electronic and liquid crystal) for diagnosing low-back pain. Ongoing. [Ex- pert opinion, Information synthesesJ

AMA/DRUG EVALUATIONS American Medical Association Drug Evaluations 535 North Dearborn Street Chicago, IL 60610 3 12-645-4560 (contact: Donald R. Bennett, M.D., Ph.D., Director; or Marilyn A. Mayo, Assistant to the Director. Telex 910-221-0300. Overview: The American Medical Association (AMA) is a professional association that provides many services and products to advance the field of medicine. The AMA Drug Evaluations section was established in 1971, however, the Department of Drugs has been a part of the AMA for 75 years. Every 2 to 3 years it publishes the reference book Drug Evaluations; the sixth edition was published in 1986. Purpose: To provide physicians and other health care professionals with up-to-date, objective information on the clinical use of drugs and to serve as a reference source for practical, comparative, evaluative information on drug therapy. Primary intended users: Providers, generally; physicians; health product manufactur- ers; health/medical professional associations; public policy-makers, legislators. Technologies: Drug. Intervention: Treatment. Stage: Emerging, new, established or widespread practice, obsolete. Properties: Safety, efficacy, effectiveness. Selection process: Assessment topics are identified primarily by AMA scientific staff review of current drug utilization. Occasionally, requests are received from physicians. The requests are submitted to the Director who sets priorities in consultation with the Drug Evaluations editor and scientific staff. Methods: Information syntheses, expert opinion. The staff of the AMA Department of Drugs prepares chapters based on the current scientific literature. The chapters are reviewed by consultants and the medical staffs of the appropriate pharmaceutical manufacturers. Following consensus revision, the chapters are reviewed by designees or members of the American Society for Clinical Pharmacology and Therapeutics (ASCPT). For the sixth edition, more than 500 distin- guished consultants contributed their comments to the draft versions. Thus, this publication is a joint scientific contribution to the field of applied therapeutics by the AMA, a large consultant body, and the ASCPT. The consultants have expertise in pharmacology and therapeutics. A new edition of Drug Evaluations is produced every 2 to 3 years. Assessors: AMA professional staff, medical staff of pharmaceutical manufacturers, and expert consultants in pharmacology and therapeutics participate in the assess- ments. 51

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Assessment reports include: Description of the technology; stage of life-cycle of technology when assessed; properties assessed; sources of data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works. including theory. orincinles. The text descrihe.s ~nnro~ri- mately 2,000 drugs. O ~ 1 1 ~rr~~-~ Dissem~nation: The text is sold by the AMA directly and by a commercial publisher. Budget: The cost of producing each text is $1,500,000; this averages $500 for each drug evaluation. Funding source: 100 percent parent organization. Use: Drug Evaluations provides physicians information on comparative drug therapy to improve their prescribing practices. There are numerous citations in the biomedical literature to this text. Completed Reports AQ1 American Medical Association. Drug evaluations. Philadelphia:Saunders, 1986. "Information synthe- ses, Expert opinion] American Society for Gastrointestinal Endoscopy Committee on Technology Assessment 13 Elm Street Manchester, MA 0 ~ 944 61 7-927-8330 Contact: William T. Maloney, Executive Director; or John H. Bond Tr., M.D., Chair- man, Veterans Administration Hospital, 54th St. and 48th Ave. South, Minneapolis, MN 55417,612-725-6767. Overview: The purposes of the American Society for Gastrointestinal Endoscopy (ASGE) are 1) to further knowledge of gastrointestinal disease through the use of endoscopic techniques in clinical practice and research; 2) to establish and maintain the highest standards of practices for the diagnostic and therapeutic use of gastrointestinal endoscopic methods; 3) to provide guidelines for training programs and to further the teaching of gastrointestinal endoscopy; 4) to assist all those involved with health care as it relates to gastrointestinal endoscopy; and 5) to facilitate development of improved instruments of gastrointestinal endoscopy. The Society has 3,840 members. Its activities include educational, audiovisual, scien- tific, and research programs, as well as publication of a bimonthly journal Gastrointesti- nal Endoscopy and guidelines and statements on training and practice. Various activities relating to technology assessment were organized under the direction of a five-member Committee on Technology Assessment in May 1986. The Society functions as an information source, and is capable of offering expert and consensus opinions and other assistance in matters that relate to gastrointestinal endoscopic technology. 52

AMERICAN SOCIETY FOR GASTROINTESTINAL ENDOSCOPY Purpose: To explore and define technology issues that apply to gastrointestinal endos- copy. Primary intended users: Providers, generally; physicians. Technologies: Device, medical or surgical procedure. Interest is focused primarily on the use in clinical practice of emerging and established gastrointestinal endoscopic procedures and other technical procedures that relate to endoscopy. The Society is also concerned with the development and assessment of new instruments and techniques as well as innovative uses of existing methods and instru- ments. ~ Intervention: Diagnosis, treatment. Stage: Emerging, new, established or widespread practice, obsolete. Existing and established endoscopic methods and related instruments are assessed. Emerging procedures and instruments are also assessed, especially those that appear likely to be adopted by large numbers of physicians who use endoscopy. Properties: Safety, efficacy, effectiveness, cost-effectiveness. Emphasis is on the correct use of endoscopic instruments and techniques with respect to accepted indications and contraindications, safety considerations, effectiveness, and cost-effectiveness, and on training in endoscopic procedures. Selection process: The ASGE Governing Board directs the activities of the Technology Assessment Committee. In some instances the Board directs that specific questions be reviewed while in other cases, committees may recommend areas for study that they consider important or controversial. The Society solicits the views of its members, usually by means of questionnaires and surveys, to identify problem areas. All ASGE statements on the use of endoscopic procedures are updated periodically, and out-of-date statements are withdrawn. Methods: Group judgment, information syntheses, expert opinion, cost analyses. The Society has several assessment procedures, including information gathering and syntheses. In this process, published information is reviewed, the opinions of expert consultants are solicited, and conclusions are formulated by a panel of experienced endoscopists. The ASGE conducts prospective studies of various problems pertaining to the use of endoscopy in which members submit data according to a protocol. One of the most useful has been the National ASGE Survey on Upper Gastrointestinal Bleeding (Silver- stein FE, et al. GastrointestEndosc 1981;27:73-103) which included the participation of 277 members. . A comprehensive review of a specific technology requires about 9 to 12 months, although this is highly variable and depends on the complexity of the problem. Assessors: Society members who participate in technology assessment have extensive , . . . . . clinical experience In endoscopy. They are usually acknowledged experts in specific 53

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY areas of endoscopy as well as established investigators who have made significant contributions to the field in its technical and clinical aspects. Assessment reports include: Description of the technology; properties assessed; pro- cedure used for the assessment; sources of dataJinformation; methods for collecting dataJinformation; methods for analyzing/synthesizing data/information; results; find- ings or conclusions; limitations of findings; implications of findings for practice; recom- mendations for practice, future assessments, technology development, research. Dissemination: Printed reports, journal articles. The conclusions that result from a review process may be formulated as a guideline statement with recommendations directed to Society members and the medical com- munity at large. Statements, recommendations, and reviews are usually published as pamphlets or monographs, which are available free from the Manchester office. Budget: Not provided. The approximate cost of an assessment. based on the number of meetings to generate a report, is $5,000 to $25,000. A complex review of a broad area or an intricate problem that requires considerable discussion might require great- er funding. Use: The ASGE uses the assessments to promote high standards of practice, patient care, and training in matters that pertain to endoscopy. Although the work of the ASGE as a professional society is primarily directed toward practicing physicians, it is also available to health care institutions, government agencies, certifying bodies, orga- nizations that regulate health care delivery, and virtually any organization with legiti- mate interests in health care. It is also available to the general public. It is the ASGE's impression that some of these groups have used its reports, but this usage is not tracked. Related activities: The results and conclusions of investigative work sponsored by the ASGE and relating, at times, to technology assessment are usually presented in open forums such as the plenary session of the Society and in the Society'sjournal, Gastrointes- tinal Endoscopy. Completed Reports AS1 Boyce HW. Treatment of esophageal stenosis. In: American Society for Gastrointestinal Endoscopy, Committee on Technology Assessment. Therapeutic gastrointestinal endoscopy: an information resource manual. 1987. "Information syntheses, Expert opin- ion, Group judgment, Cost analyses] AS2 Fleischer DE. Esophageal cancer: laser treatment. In: American Society for Gastrointestinal Endoscopy, Committee on Technology Assessment. Therapeutic gastrointestinal endoscopy: an information resource manual. 1987. "Information syntheses, Expert opin- ion, Group judgment, Cost analyses] 54 AS3 Jensen DM. Gastrointestinal angiomata: current diagnosis and treatment. In: American society for Gastrointestinal Endoscopy, Committee on Technol- ogy Assessment. Therapeutic gastrointestinal endos- copy: an information resource manual. 1987. tInfor- mation syntheses, Expert opinion, Group judgment, Cost analyses] AS4 Johnston TH. Ulcer hemorrhage heater probe treatment. In: American Society for Gastrointestinal Endoscopy, Committee on Technology Assessment. Therapeutic gastrointestinal endoscopy: an informa- tion resource manual. 1987. [Information syntheses, Expert opinion, Group judgment, Cost analyses]

AMERICAN SOCIETY FOR GASTROINTESTINAL ENDOSCOPY AS5 Kozarek RA. Balloon dilation. In: American Socie- ty for Gastrointestinal Endoscopy, Committee on Technology Assessment. Therapeutic gastrointesti- nal endoscopy: an information resource manual. 1987. "Information synthesis, Expert opinion, Group judgment, Cost analyses] AS6 Mellow MH. Endoscopic laser treatment of colon cancer. In: American Society for Gastrointestinal En- doscopy, Committee on Technology Assessment. Therapeutic gastrointestinal endoscopy: an informa- tion resource manual. 1987. "Information syntheses, Expert opinion, Group judgment, Cost analyses] AS7 Overholt BE. Ulcer hemorrhage laser treatment. In: American Society for Gastrointestinal Endoscopy, Committee on Technology Assessment. Therapeutic gastrointestinal endoscopy: an information resource manual. 1987. "Information syntheses, Expert opin- ion, Group judgment, Cost analyses] AS8 Papp JP. Control of upper gastrointestinal bleeding by monopolar electrocoagulation. In: American Soci- ety for Gastrointestinal Endoscopy, Committee on Technology Assessment. Therapeutic gastrointesti- nal endoscopy: an information resource manual. 1987. "Information syntheses, Expert opinion, Group judgment, Cost analyses] AS9 Ponsky {L. Percutaneous endoscopic gastrostomy and jejunostomy. In: American Society for Gastroin- testinal Endoscopy, Committee on Technology As- sessment. Therapeutic gastrointestinal endoscopy: an information resource manual. 1987. [Information synthesis, Expert opinion, Group judgment, Cost an- alyses] AS10 Protell RL. Ulcer hemorrhage-bicap probe treat- ment. In: American Society for Gastrointestinal En- doscopy, Committee on Technology Assessment. Therapeutic gastrointestinal endoscopy: an informa- tion resource manual. 1987. "Information sytheses, Expert opinion, Group judgment, Cost analyses] ASH Silvis SE. Endoscopic retrograde sphincterotomy (ERS,. In: American Society for Gastrointestinal En- doscopy, Committee on Technology Assessment. Therapeutic gastrointestinal endoscopy: an informa- tion resource manual. 1987. "Information synthese- s;Expert opinion, Group judgment, Cost analyses] AS12 Sivak MV. Sclerotherapy of esophageal varices. In: American Society for Gastrointestinal Endoscopy, Committee on Technology Assessment. Therapeutic gastrointestinal endoscopy: an information resource manual. 1987. "Information syntheses, Expert opin- ion, Group judgment, Cost analyses] AS13 Wayne JD. Colonoscopic polypectomy. In: Amer- ican Society for Gastrointestinal Endoscopy, Commit- tee on Technology Assessment. Therapeutic gastro- intestinal endoscopy: an information resource man- ual. 1987. "Information syntheses, Expert opinion, Group judgment, Cost analyses] AS14 Webb WA. Esophageal and gastric foreign bodies: endoscopic removal. In: American Society for Gastro- intestinal Endoscopy, Committee on Technology As- sessment. Therapeutic gastrointestinal endoscopy: an information resource manual. 1987. [Information syntheses, Expert opinion, Groupjudgment, Cost an- alyses] AS15 American Society for Gastrointestinal Endoscopy. Appropriate use of gastrointestinal endoscopy. 1986 Jun. AS16 . Flexible sigmoidoscopy. Revised 1986 Mar. AS17 . Standards of practice for gastrointestinal endoscopy. Revised 1986 Mar. AS18 . Statement of endoscopic training. Re- vised 1986 Mar. ASl9 . The role of colonoscopy in the manage- ment of patients with colonic polyps. Revised 1986 May. AS20 . The role of colonoscopy in the patients with inflammatory bowel diseases. Revised 1986 May. AS21 . The role of endoscopy in the manage- ment of esophagitis. Revised 1986 Mar. AS22 . The role of endoscopy in the manage- ment of the patient with peptic ulcer disease. Revised 1986 Mar. AS23 . The role of endoscopy in the manage- ment of upper gastrointestinal hemorrhage. Revised 1986 Mar. AS24 . The role of endoscopy in the patient with lower gastrointestinal bleeding. 1986 May. AS25 . The role of endoscopy in the surveillance of premalignant conditions of the upper gastrointesti- nal tract. Revised 1986 Mar. 55

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Battelle Memorial Institute Battelle Human Affairs Research Centers 4000 NE 4Ist Street Seattle, WA 98105 206-525-3130 Battelle Meclical Technology Assessment Program 2030 M Street NW Washington, DC 20036 202-785-8400 Contact: Roger W. Evans, Ph.D., Senior Research Scientist, Human Affairs Research Centers; Bryan R. Luce, Ph.D., Director, Medical Technology Assessment Program. Overview: The Battelle Memorial Institute is a nonprofit organization devoted to the advancement and use of science and technology. The Battelle Human Affairs Research Centers is a component of the Pacific Northwest Division of Battelle Memorial Insti- tute. Assessments of health care technologies are undertaken by the Health and Population Study Center in Seattle, and by the Medical Technoloy Assessment Pro- gram (MEDTAP) in Washington, DC. Pur Pose: To assess medical technologies. Primary intended uses: General public; patients; providers, generally; physicians; acute facility administrators; health product manufacturers; health/medical profes- sional associations; health industry associations; employers; third party payers; govern- ment regulators; reporters, writers, news media; public policy-makers, legislators. Technologies: Drug, device, medical or surgical procedure, support system, organiza- tional or administrative system. Intervention: Treatment, prevention, diagnosis, rehabilitation. Stage: New, emerging, established or widespread practice. Properties: Cost-effectiveness; effectiveness; cost; service requirements; acceptance/ adoption level; economic implications; ethical, legal, social implications; health status effects; reimbursement implications. Selection process: Anyone can request that an assessment be conducted; requests do not follow a specific format. All assessments are done through either a contract or grant. Generally the sponsor, whether it is industry or government, sets assessment . . . . topic priorities. Methods: Cost analyses, information syntheses, expert opinion, groupjudgment, model- ing, epidemiological or other observational methods, prospective economic clinical trials/studies, retrospective cost-effectiveness studies, quality of life questionnaires, cost of illness simulation techniques. 56

BATTELLE MEMORIAL INSTITUTE The assessment process varies depending upon the issue addressed. The turnaround time from selection of assessment topic to reporting of findings averages 1 year but ranges from 4 months to 3 years. Assessors: The assessors have expertise in conducting cost effectiveness research, quality of life~ealth status measurement, and prospective economic clinical studies. Assessment reports include: Abstract; the assessment's intended audience; the pur- pose of the assessment; relationship of this assessment to prior or concurrent assess- ments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; proper- ties assessed; procedure used for the assessment; sources of dataJinformation; methods for collecting data/information; methods for analyzing/synthesizing dataJinformation; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, principles; where technology is in use; regulatory agency approval status; coverage/reimbursement status of the tech nology. Dissemination: Printed reports, journal articles. Copies of assessments may be obtained by writing to: Battelle Human Affairs Research Centers or to Battelle MEDTAP. For the National Heart Transplantation Study and the National Kidney Dialysis and Kidney Transplantation Study, Battelle printed a total of some 80 Update Series reports on various aspects of these major studies. All are available from Battelle; some have been published in journals. Due to agreements with its clients, Battelle MEDTAP is unable to provide a complete list of ongoing assess- ments. Budget: $200,000. The cost per assessment ranges from $40,000 to $3,000,000. Fund- ing source: 100 percent private industry contracts. Use: Most assessments are used for health policy and reimbursement decisions or marketing purposes. The Battelle National Heart Transplant Study was particularly important in assisting the Health Care Financing Administration and the Secretary of the U.S. Department of Health and Human Services in formulating Medicare reim- bursement policy. Battelle's assessment activities are described in Institute of Medicine, Committee on Evaluating Medical Technologies in Clinical Use. Assessing medical technologies. Washing- ton, DC: National Academy Press, 1985. Completed Reports BA1 Luce BR, Ellrodt AG, Camaeron JM, Reidinger M. tBattelle Medical Technology Assessment Program] Managing acute hypertension: cost considerations. Am I Emer Med 1986;6(supplement):31-34. tCost analyses1 BA2 Health Industry Manufacturers Association. tBat- telle Medical Technology Assessment Program] A guide to cost-effectiveness analysis for medical device and diagnostic manufacturers. Washington, D.C.: Health Industry Manufacturers Association, 1985. (HIMA Report Number B5-2, HIMA Research Re- port Series Number 3~. tCost analyses1 BA3 Battelle Human Affairs Research Centers. Nation- al Heart Transplantation Study, Final Report to the Health Care Financing Administration. 1984. BA4 Battelle Human Affairs Research Centers. Nation- al Kidney Dialysis and Kidney Transplantation Study, Final Report submitted to the Health Care Financing Administration. 1984. 57

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Ongoing Assessments BA5 Battelle Human Affairs Research Centers. Cost-ef- fectiveness of cyclosporine as primary immunosup- pressive therapy for kidney transplantation recipi- ents, sponsored by the Health Care Financing Ad . . . _ . mmlstratlon. ongoing. Blue Cross and Blue Shield Association Medical Necessity Program 676 North St. CIair Street, ~ Ith Floor Chicago, IL 6061 3 12-440-5577 BAG Battelle Medical Technology Assessment Pro- gram. Cost-effectiveness of the implantable cardiac defibrillator. Ongoing. Contact: Susan Gleeson, Executive Director, Technology Management Department; David Tennenbaum. Manager, Medical Necessity Program 312-440-6155. Overview: The Blue Cross and Blue Shield Association represents member Blue Cross and Blue Shield plans and advises them on health care insurance issues. As an associa- tion, it provides medical, financial, and administrative consultation and technical assis- tance to member plans. The identification of obsolete procedures by Blue Cross and Blue Shield plans began in 1975 with the California Blue Shield Medical Policy Committee. The Medical Necessity Program was begun in 1976 under the National Association of Blue Shield Plans (which merged in 1978 with the Blue Cross Association to form the Blue Cross and Blue Shield Association), representing one of the first national private initiatives to assess medical technology for coverage purposes. Since its inception, the Program has worked in cooperation with such organizations as the American College of Physicians, the Ameri- can College of Radiology, and the American College of Surgeons. As a result of its participation in the Medical Necessity Program, the American College of Physicians established the Clinical Efficacy Assessment Project. Purpose: To provide advice to member Blue Cross and Blue Shield plans on the clinically appropriate uses of existing medical technologies. Primary intended users: Physicians, medical policy staff, Blue Cross and Blue Shield plans. Technologies: Medical or surgical procedure, device. Intervention: Diagnosis, treatment, rehabilitation. Stage: Established or widespread practice, obsolete. Properties: Effectiveness, efficacy, medical necessity. Selection process: Blue Cross and Blue Shield plans submit requests for assessments to Program staff. The staff sets assessment topic priorities in consultation with a Medical Advisory Panel comprised of medical directors from selected Blue Cross and Blue Shield plans. Technologies are reassessed when an ongoing review of new clinical evidence suggests this is warranted. 58

BCBS/MEDICAL NECESSITY PROGRAM Methods: Information syntheses, expert opinion. The Program commissions experts on the respective assessment topics to develop comprehensive literature review articles. A Medical Necessity Program conference may be held where national medical organization representatives review the commissioned articles. Draft clinical guidelines based on the articles are also reviewed. Final guidelines are then developed by Program staff in consultation with the commissioned experts. Recently, several medical necessity topics have been assessed by the Clinical Efficacy Assessment Subcommittee of the American College of Physicians. The approximate turnaround time from selection of assessment topic to reporting of findings is 1 year. Assessors: Both external consultants and internal staff have medical, clinical, and research expertise including data analysis and interpretation. Assessment reports include: Who conducted the assessment; description of the tech- nology; properties assessed; results; findings or conclusions; recommendations for practice, future assessments, technology development, research. Dissemination: Advisories to memberslconstituents; printed reports; journal articles; press conferences/news releases, TV/radio broadcasts. The Association distributes Medical Necessity Program Guidelines to Blue Cross and Blue Shield plans. The plans generally publicize the Guidelines and distribute them to provid- ers in their service area. Guidelines can be obtained from the Association upon request. The literature review articles are published by the authors in medical peer-reviewed journals. Budget: $350,000. Funding source: 100 percent parent organization. Use: The literature review articles and Medical Necessity Guidelines constitute clinical advice to the plans, which use them in establishing their medical policies. Organizations such as the American College of Physicians have endorsed many Medical Necessity Program products. Guidelines are often used by health care institutions' utilization review and quality assurance programs. The Program is cited in the following documents: Government Accounting Office. OPM should promote medical necessity programsforfederal Employees' health insurance. 1980 Jut 29. Greenberg G and Derzon RA. Determining health insurance coverage of technolo~v: problems and options. Med Care 1 98 1; 1 9( 1 0~: 967-78. O OJ Institute of Medicine, Committee for Evaluating Medical Technologies in Clinical Use. Assessing medical technologies. Washington, DC: National Academy Press, 1985. Lewin and Associates. A forward plan for Medicare coverage and technology assessment. 1986 Dec. Completed Reports BC1 Blue Cross and Blue Shield, Medical Necessity Program. Activated partial thromboplastin time and prothrombin time. 1987. fInformation syntheses] BC2 . Arterial blood gas analysis. 1987. tInfor- mation syntheses] BC3 . Biochemical profiles in ambulatory screening and preadmission testing of adults. 1987. [Information syntheses] 59

MEDICALI~CHNOLOGY ASSESSMENT DIRECTORY BC4 . Blood cultures. 1987. [Information syn- theses] BC5. . Blood urea nitrogen concentration and serum creatinine concentration. 1987. [Information syntheses] BC6 . Carcinoembryonic antigen. 1987. tInfor- mation syntheses] BC7 . Cardiac enzyme assays in the diagnosis of myocardial infarction. 1987. [Information syntheses] BC8 . Complete blood count and leukocyte dif- ferential count. 1987. [Information syntheses] BC9 . Erythrocyte sedimentation rate.1987. tIn- formation syntheses] BC10 . Routine preoperative and general hospi- tal admission chest x-rays.1987. [Information synthe- ses] BC11. . Routine preoperative and general hospi- tal admission electrocardiograms. 1987. [Information syntheses] BC12 . Serum electrolytes and serum osmolality. 1987. [Information syntheses] BC13 . Syphilis tests.1987. [Information synthe- ses] BC14 . Throat cultures and rapid test for diag- nosing group A streptococcal pharyngitis. 1987. [In- formation syntheses] BC15 . Urinalysis, urine culture, and other tests in the diagnosis of women with acute dysuria. 1987. "Information syntheses] BC16 . Anticoagulant therapy in the myocardial infarction patient. 1985. "Information syntheses] BC17. . Cardiac exercise stress test. 1985. tInfor- mation syntheses] BC18 . Cardiokymography. 1985. "Information syntheses] BC19. . Coronary angiography and cardiac cath- eterization. 1985. fInformation syntheses] BC20 . Doppler flow velocity study. 1985. [In- formation syntheses] BC21 . Echocardiogram. 1985. "Information syntheses] BC22 . Electrocardiogram. 1985. [Information syntheses] BC23 . Intensive cardiac care unit. 1985. tInfor mation syntheses] BC24 . Outpatient cardiac rehabilitation. 1985. "Information syntheses] 60 BC25 . Permanent cardiac pacemakers. 1985. [Information syntheses] BC26 . Serum lipoprotein evaluation. 1985. [In- formation syntheses] BC27 . Vectorcardiogram. 1985. [Information syntheses] BC28 .CT scan in the evaluation of headaches, cerebrovascular disease and dementia. 1984. tInfor- mation syntheses] BC29 . Chest x-ray examinations. 1984. [Infor- mation syntheses] BC30 . Diagnostic imaging in the evaluation of breast disease. 1984. "Information syntheses] BC31 . Head CT scan and ultrasound in the pediatric patient. 1984. [Information syntheses] BC32 . Outmoded radionuclide imaging proce- dures. 1984. [Information syntheses] BC33 . Radionuclide bone scan and x-ray of bones in the evaluation of bone metastases. 1984. [Information syntheses] BC34 . Radionuclide brain scan in the evaluation of adult intracranial disease. [Information syntheses] BC35 . Ultrasound and x-ray pelvimetry in ma- ternity care. 1984. [Information syntheses] BC36 . Upper gastrointestinal fluoroscopic study. 1984. "Information syntheses] BC37 . Routine admission testing medical ad- missions. 1983. [Information syntheses] BC38 . Routine admission testing surgical ad- missions. 1983. [Information synthesesJ BC39 . Diagnostic studies for respiratory pa- tients: arterial blood gas analysis. 1982. [Information syntheses] BC40. . Diagnostic studies for respiratory pa- tients: pulmonary function tests. 1982. "Information synthesesJ BC41 . Oxygen therapy. 1982. [Information syntheses] BC42 . Respiratory therapy: aerosol therapy. 1982. "Information syntheses] BC43 . Respiratory therapy: incentive spirome- try. 1982. [Information syntheses] BC44 . Respiratory therapy: intermittent posi- tive pressure breathing. 1982. [Information synthe- ses] BC45. . Respiratory therapy: postural drainage. 1982. "Information syntheses]

BCBS/TECHNOLOGY EVALUATION AND COVERAGE PROGRAM Blue Cross and Blue Shielc' Association Technology Evaluation and Coverage Program 676 North St. CIair, ~ Ith Floor Chicago, 1[1~ 606 3 1 2-440-5577 Contact: Susan Gleeson, Executive Director, Technology Management Department. Overview: The Blue Cross and Blue Shield Association represents member Blue Cross and Blue Shield plans and advises them on health care insurance issues. As a trade association, it provides medical, financial, and administrative consultation and technical assistance publications. Its Technology Evaluation and Coverage (TEC) Program was formally established in 1985, having evolved from activities originally begun under the National Association of Blue Shield Plans in the late 1960s. Purpose: To provide advice to member Blue Cross and Blue Shield plans to assist them in determining the eligibility for coverage of new and emerging technologies. Primary intended users: Blue Cross and Blue Shield plans. Technologies: Device, medical or surgical procedure, support system. Intervention: Treatment, diagnosis. Stage: New, emerging. Properties: Effectiveness, safety, efficacy, cost, cost-effectiveness, service requirements. In order to be recommended as eligible for coverage: (1) a technology must have final approval from the appropriate government regulatory agency, e.g., Food and Drug Administration; (2) scientific evidence must permit conclusions concerning the effect of the technology on health outcomes; (3) the technology must improve the net health outcome; (4) the technology must be as beneficial as any established alternative; and (5) the improvement must be attainable outside the investigational settings. Methods: Information syntheses, expert opinion, group judgment, cost analyses. TEC staff or commissioned experts review and synthesize the published literature. Responses to specific assessment criteria underlie and define the process. A Medical Advisory Panel appointed by the Association monitors the validity of the process and outcome. Approximate turnaround time from selection of assessment topic to reporting of findings is 3 to 6 months. Assessors: The Medical Advisory Panel includes seven physicians who are medical directors of Blue Cross and Blue Shield plans, as well as non-voting outside experts. Assessors have expertise in the medical, clinical, ethics, and research fields, including data analysis and interpretation. Assessment reports include: The purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; description of the technology; properties assessed; 61

MEDICAL I~CHNOLOGY ASSESSMENT DIRECTORY procedure used for the assessment; sources of data/information; findings or conclu- sions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how the technol- ogy works, including theory, principles. Dissemination: Advisories to memberslconstituents, printed reports. Advisory bulletins, newsletters, and reports are distributed to member plans. TEC evaluations are available only from the Blue Cross and Blue Shield Association and are normally made available only to member Blue Cross and Blue Shield plans. Budget: $600,000. Funding source: 100 percent parent organization. Use: The Association uses the reports only to provide advice to member plans. The coverage recommendations associated with each report, however, appear to be rapidly communicated among affected providers and other health insurance carriers. One example of outside use is the citation of the Association's document, Extracorporeal shock wave lithotrapsy: clinical assessments, utilization and cost projects, May 1985 in a publica- tion issued by the Congressional Office of Technology Assessment: Effects offederal policies on extracorporeal shock wave lithotrapsy, 1985. The Program is cited in the following documents: Greenberg G and Derzon RA. Determining health insurance coverage of technology: problems and options. Med Care 198 1; 1 9 ( 1 0) :96 7-7 8. Institute of Medicine, Committee for Evaluating Medical Technologies in Clinical Use. Assessing medical technologies. Washington, DC: National Academy Press, 1985. Lewin and Associates. A forward planfor Medicare coverage and technology assessment. 1986 Dec. COmP1eted RePO~S BS1 Blue Cross and Blue Shield Association, Technol- ogy Evaluation and Coverage Program. Absorptio- metry, dual photon for osteoporosis monitoring. 1986. "Information syntheses] BS2 . Absorptiometry, single and dual photon. 1986. "Information syntheses] BS3 . Ambulatory uterine monitoring. 1986. "Information syntheses] BS4 . Angelchik antireflux prosthesis. 1986. tIn- formation syntheses] BS5 . Automated and semi-automated ambula- tory blood pressure monitoring. 1986. "Information syntheses] BS6 . Automatic im plan table cardioverter defi- brillator. 1986. "Information syntheses] BS7 . Bone marrow transplantation, allogeneic. 1986. "Information syntheses] BS8 . Bone marrow transplantation, autologous. 1986. "Information syntheses] 62 BS9 . Chorionic villi sampling. 1986. tInforma- tion syntheses] BS10 . Collagen implants. 1986. "Information syntheses] BS11 . Continuous arteriovenous hemofiltra- tion. 1986. (Information syntheses] BS12 . Continuous passive motion device. 1986. BS13 . Corneal endothelial cell microscopy. 1986. tInformatiaon syntheses] BS14 . Electrical bone growth stimulation. 1986. "Information synthesesJ BS15 . Electrical nerve stimulation (implantable spinal cord stimulator).1986. "Information syntheses] BS16 . Electrical nerve stimulation of the ear. 1986. "Information syntheses] BS17 . Epidural analgesia therapy. 1986. tInfor- mation syntheses]

BCBS/TECHNOLOGY EVALUATION AND COVERAGE PROGRAM BS18 . Epikeratophakia. 1986. "Information BS28 . Nasal continuous positive airway pres syntheses] BSl9 . Extracranial-intracranial artery bypass surgery. 1986. "Information syntheses] BS20 . Gastric bubble. 1986. "Information syn theses] BS21 . Home phototherapy for neonatal jaun dice. 1986. "Information syntheses] BS22 . Hyperthermia, local. 1986. "Information syntheses] BS23 . Implantable infusion pump. 1986. tIn formation syntheses] BS24 . In vitro fertilization. 1986. "Information syntheses] BS25 . Iontophoresis. 1986. "Information syn theses] BS26 . Isolated limb perfusion. 1986. tInforma i~on syntheses] BS27 . Lacate infusion for panic disorder.1986. "Information syntheses] Brandeis University Health Policy Center Organ Procurement Project 415 South Street Waltham, MA 02254 6 1 7-736-3900 sure. 1986. "Information syntheses] BS29 . Nd:YAG laser gastrointestinal bleed- ing. 1986. "Information syntheses] BS30 . Nd:YAG laser posterior capsulotomy. 1986. [Information synthesesJ BS31 . Nd:YAG laser tracheo-bronchial ob- struction. 1986. "Information syntheses] BS32 . Psoralens and ultraviolet A (PUVA). 1986. [Information syntheses] BS33 . SIDS (home apnea monitoring of sib- lings). 1986. "Information syntheses] BS34 . Signal averaged ECG. 1986. tInforma- tion syntheses] BS35 . Sperm penetration assay. 1986. tInfor- mation syntheses] BS36 . Videofluoroscopic evaluation in speech pathology. 1986. "Information syntheses] Contact: {effrey Prottas, Senior Research Associate; or Helen Levine Batten, Research Associate. Overview: The Brandeis University Health Policy Center studies, develops, and dem- onstrates aspects of national health policy. The Organ Procurement Project f~rst con- ducted an evaluation of the organ procurement system in 1983. Surveys of key medical professionals, donor families, and the general public were undertaken in 1984-1986. Currently, a study of the causes of failure to transplant organs and a reevaluation of the organ procurement system are in progress. Purpose: To improve the supply and distribution of cadaveric organs. Primary intended users: General public; health/medical professional associations; government regulators; public policy-makers, legislators. Technologies: Organizational or administrative system, support system. Intervention: Administration. 63

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Stage: Established or widespread practice, emerging, new. Properties: Service requirements; cost-effectiveness; economic implications; ethical, legal, . . . . sofa. . Imp canons. Methods: Epidemiological and other observational methods. Case studies, survey research, and cost-data analysis are the methods used to conduct assessments. The turnaround time from selection of assessment topic to reporting of findings varies. Assessors: The assessors have extensive experience and expertise in organ procure- ment and medical sociology. Assessment reports include: Abstract; the assessment's intended audience; the pur- pose of the assessment; relationship of this assessment to prior or concurrent assess- ments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; proper- ties assessed; procedure used for the assessment; sources of data/information; methods for collecting dataJinformation; methods for analyzing/synthesizing dataJinformation; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research. Dissemination: Printed reports, journal articles. Copies of assessment reports are available upon request. Budget: The budget and cost per assessment varies. Funding source: 100 percent parent organization. Use: The assessment reports are used to further the development of national health policy. Completed Reports BU1 Batten HL, Prottas ~M. fBrandeis University, Health Policy Center, Organ Procurement Project] Kind strangers: families of organ donors. Health Af- fairs, forthcoming. tEpidemiological and other obser- vational methods] BU2 Prottas {M, Batten HL. tBrandeis University, Health Policy Center, Organ Procurement Project] Attitudes and incentives in organ procurement: re- port to the Health Care Financing Administration. 1986 Apr. tEpidemiological and other observational methods] BUS Prottas iM. (Brandeis University, Health Policy Center, Organ Procurement Project] Organ procure- ment in Europe and the United States. Millbank Mem Fund Q 1985;63~1~:94-126. tEpidemiological and other observational methods] 64 BU4 Prottas iM. iBrandeis University, Health Policy Center, Organ Procurement Project] The structure and effectiveness of the U.S. procurement system. Inquiry 1985;22~4~365-376. [Epidemiological and other observational methods] BUS Prottas JM. IiBrandeis University, Health Policy Center, Organ Procurement ProjectJ Encouraging al- truisms: public attitudes and the marketing of organ donation. Milbank Mem Fund Q 1983;61:278-306. tEpidemiological and other observational methods] BUS Prottas JM. tBrandeis University, Health Policy Center, Organ Procurment Project] Obtaining re- placements: the organizational framework of organ procurement. .{ Health Polit Policy Law 1983;8~2~:235-250. [Epidemiological and other ob- servational methods] .

CALIFORNIA MEDICAL ASSOC"TION California Medical Association Medical Practice Opinion Program PO Box 7690 San Francisco, CA 94 ~ 20-7690 4 1 5-863-5522 Contact: Robert Sparacino, Manager, Department of Specialty Sections and Scientific Programs. Overview: The California Medical Association (C MA) is a not-for-profit, voluntary professional medical association whose members number almost 34,000. Its principal services include legislative advocacy, insurance programs, peer review, financial man- agement, continuing medical education, socio-economic research and reports, and administration of accreditation and licensing programs for hospitals. The Medical Practice Opinion Program began in 1972 and since its inception, approximately 350 opinions have been issued. Purpose: To provide CMA's members, its component medical societies, and other interested organizations with objective, authoritative, scientific opinion on questions of medical practice in California. The opinions offered are based on training, experience, and literature reviewed by specialists. The opinions are advisory only and are not intended to be interpreted as directives, instructions, or policy statements. Opinions are always subject to revision as dictated by new information. Primary intended users: General public; physicians; health/medical professional asso- ciations; health industry associations; unions and other employee organizations; third party payers; government regulators; voluntary associations, organizations. Technologies: Drug, device, medical or surgical procedure. Intervention: Diagnosis, treatment. Stage: New, emerging, established or widespread practice, obsolete. Properties: Acceptance/adoption level, safety, effectiveness, limitations of use. Selection process: CMA members, component medical societies, voluntary/profession- al medical associations, government agencies, third party payers or any other organiza- tion with a vital interest in a subject may pose a question for review. Requests must be submitted in writing and include background material that describes the technology in question. Staff, in collaboration with the chairmen of CMA's 24 advisory panels and the chairman of the Commission on Quality Care Review, set the assessment topic priorities. Topics are generally addressed in the order received. An issue that demands immediate attention is processed promptly. All opinions are reviewed annually by the appropriate advisory panels and the Com- mission on Quality Care Review. Some subjects warrant review within that annual interval. Methods: Group judgment, expert opinion, information syntheses. 65

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Following approval of the question by the appropriate advisory panel chairman, staff prepares a questionnaire with background material that typically includes policy or position statements from state/national organizations; testimonials from physicians who are known to be expert in the field; and a selection of recent, pertinent journal articles. Advisory panel members review the material and submit their opinions individually; these opinions are the foundation of the consensus opinion. Some questions involve more than one panel. Staff prepare the consensus opinion which is subject to the review and approval of the panel chairmen, the panel members and, finally, the Commission on Quality Care Review. Once approved, the opinion is sent to the original inquirer and then published in The Western.Journal of Medicine, the official scientific publication of California and eight other western state medical associations and five research societies. The approximate turnaround time from selection of assessment topic to reporting of findings is 4 months. Complex questions involving multiple panels usually take longer. Assessors: Officers of the state's principal specialty societies, California medical school department chairmen, and representatives of C MA's 24 specialty sections comprise the membership of each advisory panel, which includes an equal number of private practicing physicians and full-time medical school faculty physicians. Assessment reports include: The purpose of the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when as- sessed; properties assessed; implications of findings for practice; how the technology works, including theory, principles; regulatory agency approval status. Dissemination: Printed reports; journal articles; advisories to members/constituents. Copies of medical practice opinions can be obtained by calling or writing the CMA Department of Specialty Sections and Scientific Programs, in the Division of Scientific and Educational Activities. Budget: $15,000. Funding source: 100 percent sponsors/members dues, contributions. Use: The CMA provides the opinions to its members and component medical societies as a member service and will share them with persons or or~anization.s o~.sirle its immediate membership as a public service. 1 ~ Generally, health associations, government agencies, and insurance companies most frequently initiate CMA's review of new technologies. The opinions assist these organi- zations in formulating their own views on the scientific standing of new medical or surgical procedures. Program evaluation: Internal monitoring of the program is performed by the Com- mission on Quality Care Review and the Scientific Board's 24 advisory panels. Howev- er, no formal evaluation of the program has been conducted. Completed Reports CA1 California Medical Association, Medical Practice Opinion Program. Arthroscopic stapling of an unsta- ble shoulder. 1985 Sep. (Medical Practice Opinion #335) tGroup judgment] 66 CA2 . Diagnosis of obstructive sleep apnea in children. 1987 Feb. (Medical Practice Opinion #346) [Group judgment]

CALIFORNIA MEDICALASSOCIATION CA3 . Hubbard method of detoxification. 1987 Apr. (Medical Practice Opinion #347) [Group judg- ment] CA4 . Topographic brain mapping. 1987 Mar. (Medical Practice Opinion #345) [Group judgment] CA5 . Ambulatory monitoring of uterine activi- ty.1986 Jul. (Medical Practice Opinion #342) tGroup judgments CA6 . Contralateral breast surgery following mastectomy. 1986 Feb. (Medical Practice Opinion #338) tGroup judgment] CA7 . Epikeratophakia in children.. 1986 Dec. (Medical Practice Opinion #344) tGroup judgment! CAB . Gastric bubble for treatment of obesity. 1986 Aug. (Medical Practice Opinion #343) tGroup judgments CA9 . Hospital admission following rigid eso- phagoscopy. 1986 Jul. (Medical Practice Opinion #339) [Group judgment] CA10 . Sleep studies for obstructive sleep apnea. 1986 Feb. (Medical Practice Opinion #340) tGroup judgment] CAll . Vertebral artery surgery. 1986 Sep. (Medical Practice Opinion #341) [Group judgment] CA12 . Acoustic impedance testing in school screening. 1985 Sep. (Medical Practice Opinion #325) [Group judgment] CA13 . Anticholinergic drugs for nicotine addic- tion. 1985 May. (Medical Practice Opinion #322) tGroup judgment] CA14 . Assistant surgeon at cataract surgery. 1985 May. (Medical Practice Opinion #324) tGroup judgments CA15 . Assistant surgeon at elective abdominal tubal ligation. 1985 Nov. (Medical Practice Opinion #333) [Group judgment] CA16 . Chorionic villus biopsy.1985 Sep. (Medi- cal Practice Opinion #328) tGroup judgment] CA17 . Cytoxan therapy for multiple sclerosis. 1985 Oct. (Medical Practice Opinion #329) tGroup judgment] CA18 . Discography for cervical and lumbar dis- orders. 1985 Feb. (Medical Practice Opinion #317) tGroup judgmentJ CA19 . Early detection of lung cancer. l 985 Dec. (Medical Practice Opinion #337) [Group judgmentJ CA20 . Echocine for diagnosis of sinusitis. 1985 Jun. (Medical Practice Opinion #318) tGroup judg- ment] CA21 . Extracorporeal shock-wave lithotripsy. 1985 Sep. (Medical Practice Opinion #32) {Group judgment] CA22 . In vitro fertilization. 1985 Jun. (Medical Practice Opinion #278) [Group judgments CA23 . Indications for tonsillectomy. 1985 Dec. (Medical Practice Opinion #326) tGroup judgment] CA24 . Intraosseous pressure measurement. 1985 Oct. (Medical Practice Opinion #334) (Group judgment] CATS . Laser irradiation for pain of Charcot- Marie-Tooth disease. 1985 May. (Medical Practice Opinion #321) [Group judgment] CA26 . Laser therapy for planter warts. 1985 May. (Medical Practice Opinion #320) [Group judg- ment] CA27 . Magnetic resonance imaging. 1985 Sep. (Medical Practice Opinion #277) tGroup judgment] CATS . Microsurgery in the treatment of infertil- ity. 1985 Aug. (Medical Practice Opinion #308) [Group judgment] CA29 . Neurostimulation for urethral sphincter spasticity.1985 Dec. (Medical Practice Opinion #336) (Group judgment] CA30 . Permanent eyeliner.1985 Nov. (Medical Practice Opinion #332) tGroup judgment] CA31 . Radial keratotomy for myopia. 1985 Apr. (Medical Practice Opinion #244) EGroup judg- ment] CA32 . Reconsideration of percutaneous and transluminal coronary angioplasty.1985 Feb. tGroup judgments CA33 . Stereotactic heavy-ion irradiation for ar- teriovenous malformations. 1985 Sep. (Medical Prac- tice Opinion #316) (Group judgment] CA34 . Suction lipectomy. 1985 Dec. (Medical Practice Opinion #286) (Group judgment] CA35 . Transmission of disease via mouth to mouth resuscitation. 1985 June. (Medical Practice Opinion #323) tGroup judgment] CA36 . Treatment of rheumatoid arthritis with flagyl. 1985 Oct. (Medical Practice Opinion #330) tGroup judgment] 67

MEDICALI~CHNOLOGY ASSESSMENT DIRECTORY CA37 . Treatment of rheumatoid arthritis with sex hormones. 1985 Oct. (Medical Practice Opinion #331) tGroup judgment] CASE . YAG laser for posterior lens capsules. 1985 Apr. (Medical Practice Opinion #319) (Group judgment] CA39 . Assistant surgeon for arthroscopic pro- cedures. 1984 Apr. (Medical Practice Opinion #239) (Group judgment] CA40 . Assistant surgeon for septorhinoplasty. 1984 ~an. (Medical Practice Opinion #307) tGroup judgment] CA41 . Aversion therapy for alcoholism. 1984 Feb. (Medical Practice Opinion #311) [Group judg- ment] CA42 . Biochemical biopsy. 1984 Nov. (Medical Practice Opinion #285) tGroup judgments CA43 . Cardiac pacemakers.1984 Mar. (Medical Practice Opinion #291) tGroup judgment] CA44 . Computed tomography-multiplanar reconstruction. 1984 Nov. (Medical Practice Opinion #310) [Group judgment] CA45 . Cranial electrotherapy stimulation.1984 Nov. (Medical Practice Opinion #315) tGroup judg- ment] CA46 . Cytotoxic testing for food allergy. 1984 Feb. (Medical Practice Opinion #265) [Group judg- ment] CA47 . Heart-lung transplantation. 1984 Sep. (Medical Practice Opinion #309) (Group judgment] CA48 . Immunotherapy for melanoma. 1984 Feb. (Medical Practice Opinion #305) tGroup judg- mentJ CA49 . Immunotherapy for treatment of can- cer. 1984 {ul. (Medical Practice Opinion #204) tGroup judgment] CA50 . Intradermal provocative titration/diag- nosis of food allergy. 1984 Feb. (Medical Practice Opinion #293' tGroup judgment] CA51 . Kinetic therapy for lumbago. 1984 Nov. (Medical Practice Opinion #312) (Group judgment] CA52 . Radioallergosorbent test (RAST) 1984 Dec. (Medical Practice Opinion #255) tGroup judg- mentl CA53 . Rinkel serial intracutaneous titration/di- agnosis. 1984 Feb. (Medical Practice Opinion #295) tGroup judgmentJ 68 CA54 . Sublingual challenge technique/diagno- sis of food allergy. 1984 Feb. (Medical Practice Opin- ion #294) tGroup judgment] CA55 . Temporomandibular joint procedure. 1984 Feb. (Medical Practice Opinion #270) tGroup judgmentJ CA56 . Tuberculosis surveillance program for hospital employees. 1984 Oct. (Medical Practice Opinion #304) tGroup judgment] CA57 . Use of sclerosant injections for neck, back and lower extremity pain. (Medical Practice Opinion #313) tGroup judgment] CA58 . Video electroencephalographic monitor- ing. 1984 Nov. (Medical Practice Opinion #314) [Group judgment] CA59 . Barbiturate coma. 1983 Feb. (Medical Practice Opinion #280) tGroup judgment] CA60 . Bilio-pancreatic bypass surgery for obesi- ty. 1983 Mar. (Medical Practice Opinion #284) tGroup judgment] CA61 . Biofeedback. 1983 Aug. (Medical Prac- tice Opinion #240) tGroup judgment] CA62 . Collagen implant. 1983 Apr. (Medical Practice Opinion #283) tGroup judgment] CA63 . Computerized tomography for lumbar spine. Feb 1983. (Medical Practice Opinion #282) tGroup judgment] CA64 . Continuous passive motion for stiffening conditions. 1983 Mar. (Medical Practice Opinion #306) tGroup judgment] CA65 . Endothelial cell counts.1983 Sep. (Medi- cal Practice Opinion #303) tGroup judgment1 CA66 . Ericsson sex selection method.1983 Sep. (Medical Practice Opinion #298) (Group judgment] CA67 . Hyperbaric oxygen therapy. 1983 Sep. (Medical Practice Opinion #243) tGroup judgmentJ CA68 . Hyperthermia treatment for cancer. 1983 Oct. (Medical Practice Opinion #296) tGroup judgment] CA69 . Interferon for the treatment of cancer. 1983 Sep. (Medical Practice Opinion #299) tGroup judgment] CA70 . Interferon for the treatment of infec- tious diseases. 1983 Sep. (Medical Practice Opinion #300) tGroup judgment] CA71 . Intravenous streptokinase after myocar- dial infarction. 1983 June. (Medical Practice Opinion #287) tGroup judgment]

CALIFORNIA MEDICAL ASSOCIATION CA72 . Laser photoradiation therapy for carci- CA89 . Needleless insulin injection. 1982 Dec. noma. 1983 Feb. (Medical Practice Opinion #279) tGroup judgment] CA73 . Liver transplantation. 1983 Sep. (Medi cal Practice Opinion #297) tGroup judgment] CA74 . Nissen's fundoplication gastric reser voir reduction for morbid obesity. 1983 May. (Medi cal Practice Opinion #290) tGroup judgment] CA75 . Noninvasive muscle stimulators for pre vention of muscle atrophy.1983 Tut. (Medical Practice Opinion #292) tGroup judgment] CA76 . Palatopharyngoplasty for the treatment of snoring. 1983 Dec. (Medical Practice Opinion #301 ~ tGroup judgment! CA77 . Rectal mucosal replacement. 1983 Nov. (Medical Practice Opinion #288) tGroup judgment] CA78 . Stapedectomy for otosclerosis.1983 Sep. (Medical Practice Opinion #302) [Group judgment] CA79 . Thrombolytic therapy for pulmonary embolism. 1983 Feb. (Medical Practice Opinion #281) tGroup judgment] CA80 . Assistant surgeon for laser iridotomy. 1982 Jul. (Medical Practice Opinion #272) [Group judgments CA81 . Bone densitometry. 1982 Nov. (Medical Practice Opinion #254) tGroup judgment] CA82 . Challenge food testing for depression. 1982 Feb. (Medical Practice Opinion #257b) tGroup judgment] CA83 . Challenge food testing for respiratory disorders. 1982 Feb. (Medical Practice Opinion #257c) tGroup judgment] CA84 . Challenge food testing for rheumatoid arthritis.1982 Feb. (Medical Practice Opinion #257a) (Group judgment] CA85 . Constant blood pressure monitoring. 1982 Aug. (Medical Practice Opinion #275) tGroup judgment] CA86 . Human tumor stem cell assay. 1982 ~ul. (Medical Practice Opinion #273) tGroup judgment] CA87 . Intraarterial BCNU chemotherapy. 1982 Oct. (Medical Practice Opinion #276) tGroup judgment1 CA88 . Methylethylketone damage of the im mune system. 1982 Nov. (Medical Practice Opinion #261) (Group judgment] (Medical Practice Opinion #274) tGroup judgment] CA90 . Plasmapheresis for rheumatoid arthritis. 1982 Aug. (Medical Practice Opinion #263) tGroup judgment] CA91 . Plasmapheresis for six conditions. 1982 Sep. (Medical Practice Opinion #249) tGroup judg- ment1 CA92 . Sleep disorder therapy. l 982 Dec. (Medi- cal Practice Opinion #271) [Group judgment] CA93 . Thermography for spinal problems. 1982 Jul. (Medical Practice Opinion #269) tGroup judgment! CA94 . Transcutaneous electrical nerve stimula- tion. 1982 Jul. (Medical Practice Opinion #82) [Group judgment] CA95 . Viral and bacterial vaccines for arthritis. 1982 Jun. (Medical Practice Opinion #268) tGroup judgment] CA96 . Anesthesia by hypnosis. 1981 Aug. (Medical Practice Opinion #250) [Group judgment1 CA97 . Cochlear implant for deafness. 1981 Aug. (Medical Practice Opinion #178) tGroup judg- ment] CA98 . DMSO. 1981 Jan. (Medical Practice Opinion #248) [Group judgment1 CA99 . Esterine for treatment of rheumatoid arthritis. 1981 Dec. (Medical Practice Opinion #253) [Group judgment] CA100 . Heart transplants. 1981 Dec. (Medical Practice Opinion #252) [Group judgment] CA101 . High gastric bypass for morbid obesity. 1981 Feb. (Medical Practice Opinion #246) tGroup judgment] CA102 . Intermittent positive pressure breath- ing. 1981 Aug. (Medical Practice Opinion #259) tGroup judgment] CA103 . Paper radioallergosorbent test (PRAST) 1981 Aug. (Medical Practice Opinion #256) (Group judgment1 CA104 . Plasmapheresis treatment of multiple sclerosis. 1981 Dec. (Medical Practice Opinion #212) tGroup judgment] CA105 . Singer-Blom valve operation. 1981 ~ul. (Medical Practice Opinion #262) tGroup judgment] CA106 . Stat-tek glucose analyzer for diabetes. 1981 Aug. (Medical Practice Opinion #260) tGroup judgment] 69

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY CA107 . Clinical ecology. 1980 Dec. (Medical Practice Opinion #264) tGroup judgments CA108 . Injections of universal bacterial anti- ment] gen. 1980 Jan. (Medical Practice Opinion #210) tGroup judgment] CA109 . Microsurgical lumbar discectomy. 1980 Feb. (Medical Practice Opinion #238) [Group judg CBO (Centraal Begeleidingsorgaan voor de Intercollegiale Toetsing) National Organization for Quality Assurance in Hospitals Consensus Development Program PO Box 20064, ChurchillIaan ~ ~ 3502 LB Utrecht, The Netherlands (31-30) 96-06-47 Contact: Evert Reerink, M.D., Ph.D., Executive Director. Overview: CBO is an independent foundation established in 1979 by the National Specialists Organization in the Netherlands and the Dutch Association of Medical Directors of Hospitals. The Board of Trustees consists of representatives of those organizations, the National Hospital Association, the Society of Dutch Sick Funds, the Society of Private Insurance Companies, the Royal Netherlands Medical Association, and the Ministry of Welfare, Health and Culture. CBO is a World Health Organization Collaborating Center for Quality Assurance in Health Care. This profile describes the CBO consensus development program. Purpose: To develop statements that facilitate a uniform approach among hospital clinicians in dealing with patient problems of national concern. Primary intended users: Providers, generally; physicians; acute facility administrators; long-term care facility administrators. Technologies: Medical or surgical procedure. Intervention: Diagnosis, treatment, prevention, rehabilitation. Stage: Established or widespread practice. Properties: Safes, effectiveness, service requirements, acceptance/adoption level. Selection process: CBO selects the assessment topics from suggestions made by the hospitals. Topics may be reassessed when consensus statements are out of date, e.g., are 5 or more years old, or when the findings of consensus efforts are inconclusive. Blood transfusion therapy is the first topic to be reassessed. Methods: Group judgment, expert opinion. Panels consisting of 6 to 20 experts are given 6 to 18 months to produce a draft consensus report. The draft report contains 2- to 4-page papers individually authored by the panelists and a draft consensus statement consisting of as many as 30 numbered statements on the topic generated by the panelists. The report is put into a booklet and 7O

CBO/NATIONAL ORGANIZATION FOR QUALITY ASSURANCE IN HOSPITALS circulated to a larger group of health care workers interested in the topic. This larger group usually between 100 to 150 people, but sometimes more-convenes for a 1- day meeting to review the draft report with the panelists. Following this meeting, the panel completes a final consensus statement in narrative form. Assessors: Consensus panels are usually composed of physician specialists relevant to the topic (e.g., neurosurgeons, radiologists, and dermatologists); a few panels have included other types of personnel (e.g., laboratory technicians for blood transfusion therapy panel, nurses for treatment of bedsores panel, and epidemiologists for follow- up colorectal cancer panel). Assessment reports include: The first five assessment reports appeared in narrative form only. All subsequent statements have appeared first as draft statements in booklet form that include table of contents, list of participants, introductory paragraph, the short papers individually authored by the panelists, and the draft numbered consensus statements. The final statements are narratives distilled from the draft booklets. Final statements may reflect disagreements among panel members. Dissemination: The draft consensus statements in booklet form and the final state- ments are available from the CBO. The final statements are also published approxi- mately 1 year following their release in the Nederlands Tydschrtft voor Geneeskunde (Dutch Journal of Medicine). Only one report, on melanoma of the skin (1984) has been translated into English; all others are in Dutch. Budget: The entire CBO budget is approximately $900,000, some $135,000 of which is devoted to consensus activities. CBO is funded from levies applied to Dutch hospitals based on their number of beds. Use: CBO has attempted to gauge the impact of some consensus statements. CBO staff have worked with hospital quality assurance committees to determine whether consen- sus guidelines on melanoma of the skin and blood transfusion therapy have been incorporated into quality assurance criteria and practices. Related activities: CBO is devoted to enhancing quality assurance in Dutch hospitals. It assesses and works to improve the quality of procedures in specific hospitals, assists in setting criteria for quality assurance, and provides a second-opinion service. CBO also offers assistance to other organizations in assessing new technologies, developing infor- mation systems, and developing clinical protocols. Because of statutory limitations, CBO is not engaged in research. Completed Reports CB1 CBO (Centraal Begeleidingsorgaan voor de Inter- collegiale Toetsing) Consensus Development Pro- gram. Diagnosis of atopic syndrome. 1987. tDutch language only] Group judgment, Expert opinion] CB2 . Follow-up colorectal cancer.1987. [Dutch language only] [Group judgment, Expert opinion] CB3 . Hemophilia. 1987. tDutch language only] tGroup judgment, Expert opinion] CB4 . Hypercholesterolemia. 1987. [Dutch lan- guage only] tGroup judgment, Expert opinion] CB5 . Prevention of herpes neonatorum. 1987. tDutch language only] (Group judgment, Expert . . opinion CB6 . Suspect lymph nodules in the neck. 1987. tDutch language only] tGroup judgment, Expert . . ~ opinions 71

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY CB7 . Total hip prostheses.1987. fDutch lan- guage only] [Group judgment, Expert opinions CB8 . Diagnosis of deep venous thrombosis. 1986. tDutch language only] EGroup judgment, Ex . . pert opinion CB9 . Non-scrotal testis. 1986. [Dutch language only] [Group judgment, Expert opinion] CB10 . Treatment of bedsores. 1986. FDutch language only] tGroup judgment, Expert opinion] CBl l . Foot problems of diabetic patients. 1985. fDutch language only] (Group judgment, Expert . . opinion CB12 . Osteoporosis. 1985. EDutch language only] tGroup judgment, Expert opinion] CB13 . Prevention of bedsores. 1985. fDutch language only] Group judgment, Expert opinion] College of American Pathologists Surveys Program 5202 OIc! Orchard Road Skokie, 1I, 60077-1034 3 1 2-966-5700 CB14 . Solid solitary thyroid nodule. 1985. [Dutch language only] [Group judgment, Expert . . Oplmon CB15 . Melanoma of the skin. 1984. [Group judgment, Expert opinon] CB16 . Severe brain damage. 1984. fDutch lan- guage only] tGroup judgment, Expert opinion] CB17 . Thrombocytes transfusion policy. 1984. [Dutch language only1 EGroup judgment, Expert . . Opmlon CB18 . Mammography policy.1983. EDutch lan- guage only] (Group judgment, Expert opinion] CBl9 . Traumatic lesions of the back. 1983. tDutch language only] tGroup judgment, Expert . . Oplnlon CB20 . Blood transfusion therapy. 1982. FDutch language only] tGroup judgment, Expert opinion] Contact: William E. Williamson, Director Laboratory Improvement Programs. Overview: The College of American Pathologists is a professional association dedicat- ed to serving the needs of its members in the fields of pathology, medicine, and patient care. With over 10,000 members, its services include periodicals, educational programs, Professional Affairs Assistance, and other programs. The College's Surveys Program is an ongoing assessment of laboratory technology that provides subscribing laboratories with an evaluation of their own accuracy and preci- sion. This Program began with circulation of samples to assess the technology in limited areas of clinical chemistry and hematology. Over the past 25 years the program has grown to over 50 surveys, assessing the technology of virtually all areas of laboratory medicine. The program currently provides technology assessment information to over 12,000 participating laboratories in the United States and several foreign countries. Purpose: To assess laboratory technology and to provide individual subscribing labora- tories with these assessments as well as evaluations of their own accuracy and precision. Primary intended users: Labs, blood banks. Technologies: Device, medical or surgical procedure, support system. Laboratory methods, systems, and instrument performance are assessed. Intervention: Diagnosis, treatment. 72

COLLEGE OF AMERICAN PATHOLOGISTS Stage: Established or widespread practice, new, obsolete. Properties: Safety, effectiveness, acceptance/adoption level. The Program assesses the laboratories for safety and effectiveness with respect to accuracy and precision of results. Based on performance, assessments provide mecha- nisms for determining acceptance and level of technology. Selection process: Any medical laboratory may request that an assessment of its performance be conducted and compared with its peers. Since this is a voluntary program, laboratories need only to subscribe to the surveys in which they wish to participate. Assessment topics are determined and prioritized by CAP committees of experts in the laboratory discipline involved in the technology assessment. Methods: Bench testing. Unknown simulated patient samples (e.g., blood products, spinal fluid, urine) are sent quarterly to participating laboratories. Laboratories are given a certain amount of time to analyze samples for specified constituents and return data for computer analysis of performance. Selection of assessment topics (simulated patient sample content) is determined 18 months prior to the surveys. However, the actual turnaround time for the assessment process, from the standpoint of the participant, is approximately 8 weeks from receipt of samples for analysis to reporting of findings. Assessors: The expert committees that operate the various assessment programs are made up of pathologists and doctoral scientists with expertise in the given area of technology assessment. Assessment reports include: The assessment's intended audience; relationship of this assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; sources of data/information; methods for collecting data/information; methods for analyzing/synthesizing data/information; results; find- ings or conclusions; limitations of findings; where technology is in use. Dissemination: Printed reports, journal articles, advisories to members/constituents. Assessment products include CAP Surveys Program quarterly summary reports, CAP conference proceedings, articles in Archives of Pathology and Laboratory Medicine and the quarterly CAP newsletter, Summing Up. The summary reports are mailed to participat- ing laboratories listing their own results and summarizing the results of all participants. Generally, summary reports are available only to participants. Conference proceedings and Summing Up can be purchased from CAP. Selected studies are published in the . ·~ . soent~c literature. Budget: $15,000,000. Funding source: 85 percent sponsors/members dues, contribu- tions; 15 percent parent organization. Use: The CAP uses the assessments to monitor the state of the art. Members of the expert committees also use the assessments as the basis for articles in professional journals. 73

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Scientific professionals may use the reports for the noncommercial purpose of scientific or educational advancement as defined in the CAP copyright. Generally permission is requested prior to publication. Government and regulatory agencies also use the results to establish compliance and regulatory requirements. Program evaluation: Various Federal agencies assess the Program to determine com- pliance with Federal Equivalency Requirements. The CAP evaluated the Surveys Program in 1981 as the result of a database conference it sponsored that was attended by representatives of clinical laboratories, the diagnostic industry, and government. The conference participants requested the evaluation be- cause they regarded the CAP database as an important resource for the advancement of technology in the clinical laboratory field. The College funded the evaluation, which consisted of compiling data from its clinical laboratory improvement programs for the years 1970 to 1980. The resulting compen- dium, Data ReCap 1970-1980: A Compilation of Data from the College of American Patholo- g~sts Clinical Laboratory Improvement Program, was published in 1981 and documented laboratory performance over the decade and the state of the art in 1980. Related activities: The quarterly newsletter Summing Up highlights various areas of technology assessment based upon the surveys performance. Annual conferences are sponsored by the various expert committees of the Surveys Program which, based upon the technology assessments, focus on the relevance of clinical laboratory testing to patient care. These conferences periodically review and redefine analytical goals based upon the performance assessments of the Surveys Program. As new specialized tech- nologies emerge, new committees are formed to monitor and assess performance. Completed Reports CP1 Howanitz Pi, ed. Quality assurance in physician office, bedside, and home testing. Skokie, IL: College of American Pathologists. Expected 1987. tExpert opinion, Bench testing] CP2 Triplett DA, ed. Advances in coagulation testing: interpretation and application. Skokie, IL: College of American Pathologists. Expected 1987. [Expert opin- ion, Bench testing] CP3 Smith tW, ed. The role of clinical microbiology in cost-effective health care. CAP Conference/1984. Skokie, IL: College of American Pathologists, 1985. Expert opinion, Bench testing] CP4 Rippey JH, Nakamura RM, eds. Diagnostic immu- nology: technology assessment and quality assurance. CAP Conference/1983. Skokie, IL: College of Ameri- can Pathologists, 1984. tExpert opinion, Bench test- ing] CP5 Homburger HA, ed. Clinical and analytical con- cepts in enzymology. CAP Conference/1982. Skokie, IL: College of American Pathologists, 1983. tExpert opinion, Bench testing] 74 CP6 Polesky HE, Walker RH, eds. Safety in transfusion practices. CAP Conference/Aspen 1980. Skokie, IL: College of American Pathologists, 1981. tExpert opinion, Bench testing] CP7 Sommers HM, ed. Clinical relevance in microbiolo- gy. CAP Conference/Aspen 1979. Skokie, IL: College of American Pathologists, 1981. tExpert opinion, Bench testing] CP8 Triplett DA, ed. Standardization of coagulation assays: an overview. CAP Conference/Aspen 1980. Skokie, IL: College of American Pathologists, 1981. tExpert opinion, Bench testing] CP9 Keitagaes PW, Nakamura RM, eds. Diagnostic im- munology: current and future trends. CAP Confer- ence/Aspen 1978. Skokie, IL: College of American Pathologists, 1980. tExpert opinion, Bench testing] CP10 Koepke JA, ed. Differential leukocyte counting. CAP Conference/Aspen 1977. Skokie, IL: College of American Pathologists, 1978. tExpert opinion, Bench testing]

CONGRESS OF THE UNITED STATES, O"ICE OF TECHNOLOGY ASSESSMENT Congress of the Uniter! States Office of Technology Assessment Health Program Washington, D.C. 205 ~ 0 202-228-6590 a Contact: Clyde I. Behney, Program Manager for Health. Overview: The Office of Technology Assessment (OTA) is a nonpartisan analytical support agency that serves the U.S. Congress. The Office was authorized in 1972, funded in late 1973, and began full operations in 1974. The Health Program was established in 1975. OTA has three operating divisions: the Energy, Materials, and International Security Division; the Science, Information and Natural Resources Division; and the Health and Life Sciences Division. Within the Health and Life Sciences Division are three pro- grams: the Food and Renewable Resources Program; the Biological Applications Program; and the Health Program. This profile deals primarily with assessment activi- ties of the Health Program. OTA is governed by a 12-member bipartisan Congressional board of six senators and six representatives. The board is advised by an Advisory Council of 10 public members eminent in science, technology, and education, appointed by the board. The Comptrol- ler General of the United States and the director of the Congressional Research Service of the Library of Congress are also members. The OTA director is appointed by the board and serves as a nonvoting member. Purpose: To help Congress anticipate and plan for the consequences of technological applications, and to examine the ways, expected and unexpected, in which technology affects people's lives. The OTA clarifies for Congress both the range of policy options and the potential impacts of adopting each option, but it makes no formal recommen- dations. The OTA also provides advice to Congressional committee members and staff, presents testimony at hearings, and conducts workshops with committees. Although the OTA is responsible to the needs of the Congress and its products are designed for use by the Congress, they have a wider applicability as well. Primary intended users: Legislators, government regulators, public policy-makers. Technologies: Drug, device, medical or surgical procedure, support system, organiza- tional or administrative system, personnel. The OTA focuses its evaluation efforts on broad policy technological issues or on case studies from which further research questions or generalizable lessons can be gained. Intervention: Prevention, diagnosis, treatment, rehabilitation. Stage: New, established or widespread practice, emerging, obsolete. Properties: Safety; efficacy; cost-effectiveness; effectiveness; cost; acceptance/adoption lev- el; system impact; economic implications; ethical, legal, social implications. The scope of OTA assessments is quite broad, reflecting the extent to which legislative policy issues are influenced by technological developments. 75

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Selection process: Under OTA statute, studies may be initiated by a request from a Congressional committee chairman. The OTA Will also respond formally to requests for information from any member of Congress or any Congressional committee. OTA staff members screen the proposed study to determine what resources and time it might require and what modifications it might need to suit the OTA'S resources and Congressional needs. The staff then presents a formal study proposal to the OTA Board, which makes the final decision on whether to undertake it. Methods: Information syntheses, expert opinion, modeling, cost analysis. The OTA generally does not support original research, but synthesizes existing knowl- edge from the medical and health policy literature with the help of expert advisors. The OTA staff develops an initial draft with advice from an expert advisory panel appointed for each main report. The draft is then circulated for review and comment to groups and experts both in the government and in the private sector. Advisory panel assistance includes review and comment, although its consensus is not sought for report content or findings and reports are not formally approved by the panel. OTA staff are responsible for drafting the final report. Case studies of specific technologies have been used often in conjunction with reports dealing with broad issues such as studies of cost- effectiveness and cost-benefit analyses of technologies. Such case studies usually are prepared by experts under commissions from the OTA and occasionally by OTA staff. The bulk of OTA's work involves comprehensive, in-depth assessments that may take 18 months or more to complete. It is also provides shorter responses to meet Congres- sional needs, largely based on information in past and current assessments. OTA can structure longer-range assessments so that the results, in various stages, can be sent to Congress in the form of interim reports. Assessors: OTA multidisciplinary staff teams plan, direct, and draft all assessments. Staff members have expertise in such areas as medicine, law, sociology, epidemiology, statistics, public health, public policy, and biology. The Health Program has about 13 permanent staff and 12 to 14 other in-house staffon temporary appointments. Outside contract work is usually for special material to be included in OTA reports. OTA uses expert advisory panels as a way of ensuring that reports are objective, fair, and authoritative. The Health Program is advised regarding overall planning by a standing 15-member Health Program Advisory Committee composed of experts in a variety of fields relevant to health care technology assessment. This committee generally is not involved directly in specific studies. The staff rely extensively on the broad technical and professional resources of the private sector, including universities, research organi- zations, industry, and public interest groups. Assessment reports include: Abstract; the purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technol- ogies intended for similar purposes; who sponsored/commissioned/supported the as- sessment; who conducted the assessment; description of the technology; stage of life- cycle of technology when assessed; properties assessed; procedure used for the assess- ment; sources of data/information; methods for collecting data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, principles; development of the technol- ogy; where technology is in use. 76

CONGRESS OF THE UNITED STATES, OUNCE OF TECHNOLOGY ASSESSMENT Dissemination: Printed reports; journal articles; press conferences/news releases; TV/ radio broadcasts, video products; briefings to Congressional committees and staff. Reports approved by the OTA Director are sent to the Technology Assessment Board and to the requesting Congressional committeefs). Summaries are also sent to all members of Congress and then the report and summary are released to the public. Summaries of all OTA reports are available free of charge from the OTA. OTA studies are also available from the U.S. Government Printing Office or the National Technical Information Service. Budget: $1.6 million (fiscal year 19871. The approximate cost per assessment is $400,000 to $700,000. Funding source: 100 percent parent organization. Use: OTA reports have generally been well-received by Congress and the various sectors of the health care industry. Because of the nature of congressional decisions, it is difficult to attribute legislative change or other congressional actions to any one factor. However, in several instances Congress has based funding and policy decisions on OTA report findings. The OTA Health Program is described in: Institute of Medicine, Committee on Evaluating Medical Technologies in Clinical Use. Assessing medical technologies. Washing- ton, DC: National Academy Press, 1985. Related activities: The OTA was mandated by Congress to select and appoint the members of the Prospective Payment Assessment Commission (ProPAC), which ad- vises the Secretary of DHHS regarding the hospital prospective payment system used for Medicare. The OTA acts as an observer and evaluator of ProPAC, reports annually to Congress on the functioning of the Commission, and appoints replacement commis- sioners each year. The OTA has similar responsibilities for the Physician Payment Review Commission. Completed Reports CU1 Congress of the United States, Office of Technol- ogy Assessment. Assessing the quality of medical care. Washington, D.C.: U.S. Government Printing Office. To be completed in Spring 1988. CU2 . Diagnostic and predictive medical tests. Washington, D.C.: U.S. Government Printing Office. To be completed in Spring 1988. CU3 . Drug labeling in developing countries. Washington, D.C.: U.S. Government Printing Office. To be completed in Winter 1988/89. CU4 . Nontraditional methods of cancer man- agement. Washington, D.C.: U.S. Government Print- ing Office. To be completed in Summer 1988. CUB . Carcinogen regulatory policy. Washing- ton, D.C.: U.S. Government Printing Office. To be completed Spring 1987. CUB . Clinical staffing issues in the Indian Health Service. Washington, D.C.: Of fire of Technol- ogy Assessment. Special report. To be released in Spring 1987. CU7 . Effectiveness and costs of ambulatory to- codynamometry. Washington, D.C.: U.S. Govern- ment Printing Office. To be completed in Spring 1987. CUB_ . Immuno-augmentative therapy. Wash- ington, D.C.: U.S. Government Printing Office. To be completed in Winter 1987/1988. CUB . Mammography screening for the Medi- care population. Washington, D.C.: Office of Tech- nology Assessment. To be completed in Summer 1987. CU10 . Mental health services for children. Washington, D.C.: U.S. Government Printing Office, January 1987. 77

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY CUll . Review of study comparing inpatient hospital costs in the Veterans Administration to those in non-VA facilities. Washington, D.C.: Office of Technology Assessment. To be completed in Febru- ary 1987. CU12 . Technology and child health. Washing- ton, D.C.: U.S. Government Printing Office. To be completed in Spring 1987. CU13 . Extracorporeal shock-wave lithotripsy. Washington, D.C.: U.S. Government Printing Office, May 1986. (Health technology case study series #36) CU14 . Indian health care. Washington, D.C.: U.S. Government Printing Office, April 1986. CU15 . Nurse practitioners, certified nurse-mid- wives, and assistants: a policy analysis. Washington, D.C.: U.S. Government Printing Office, December 1986. (Health technology case study series #37) CU16 . OTA's second report on the Prospective Payment Assessment Commission (special report). Washington, D.C.: Office of Technology Assessment, March 1986. CU17 . Passive smoking in the workplace: select- ed issues. Washington, D.C.: Office of Technology Assessment, May 1986. CU18 . Payment for physician services: strate- gies for Medicare. Washington, D.C.: U.S. Govern- ment Printing Office, February 1986. CUl9 . Technologies for detecting heritable mutations in human beings. Washington, D.C.: U.S. Government Printing Office, September 1986. CU20 . Blood policy and technology. Washing- ton, D.C.: U.S. Government Printing Office, January 1985. CU21 . Evaluation of HCFA's Part A data base. Washington, D.C.: Office of Technology Assessment, July 1985. CU22 . Medical devices and the Veterans Ad- ministration. Washington, D.C.: U.S. Government Printing Office, February 1985. CU23 . Medicare's prospective payment system: strategies for evaluating cost, quality, and medical technology. Washington, D.C.: U.S. Government Printing Office, October 1985. CU24 . OTA's first report on the Prospective Payment Assessment Commission (special report). Washington, D.C.: Office of Technology Assessment, March 1985. 78 CU25 . Preventing illness and injury in the work- place. Washington, D.C.: U.S. Government Printing Office, April 1985. CU26 . Replacing the Rosebud Sioux Hospital: number of beds and whether a surgical suite is need- ed. Washington, D.C.: Office of Technology Assess- ment, August 1985. CU27 . Review of the Public Health Service's response to AIDS. Washington, D.C.: U.S. Govern- ment Printing Office, February 1985. CU28 . Status of biomedical research and relat- ed technology for tropical diseases. Washington, D.C.: U.S. Government Printing Office, September 1985. CU29 . Technologies for managing urinary in- continence. Washington, D.C.: U.S. Government Printing Office, July 1985. (Health technology case study series #33) CU30 . The cost effectiveness of digital subtrac- tion angiography in the detection of cerebrovascular disease. Washington, D.C.: U.S. Government Print- ing Office, May 1985. (Health technology case study series #34) CU31 . The effectiveness and costs of continu- ous ambulatory peritoneal dialysis. Washington, D.C.: U.S. Government Printing Office, September 1985. (Health technology case study series #35) CU32 The hemodialysis equipment and dispos- ables industry. Washington, D.C.: U.S. Government Printing Of fice, December 1984. (Health technology case study series #32) CU33 . Federal policies and the medical devices industry. Washington, D.C.: U.S. Goverment Print- ing Office, October 1984. CU34 . Intensive care units: costs, outcome, and decisionmaking. Washington, D.C.: U.S. Govern- ment Printing Off~ce, October 1984. (Health technol- ogy case study series #28) CU35 . Medical technology and costs of the Medicare program. Washington, D.C.: U.S. Govern- ment Printing Office, July 1984. CU36 . Nuclear magnetic resonance imaging technology: a clinical, industrial, and policy analysis. Washington, D.C.: U.S. Government Printing Office, September 1984. (Health technology case study series #27) CU37 . The Boston elbow. Washington, D.C.: U.S. Government Printing Office, November 1984. (Health technology case study series #29)

CONGRESS OF THE UNITED STATES, O"ICE OF TECHNOLOGY ASSESSMENT CU38 . The contact lens industry. Washington, D.C.: U.S. Government Printing Office, December 1984 (Health technology case study series #31) CU39 . The health effects of fish oil. Washing- ton, D.C.: Office of Technology Assessment, Febru- ary 1984. CU40 . The market for wheelchairs: innovations and public policy. Washington, D.C.: U.S. Govern- ment Printing Office, November 1984. (Health tech- nology case study series #30) CU41 . The use of immunosuppressive drugs in kidney transplantation. Washington, D.C.: Office of Technology Assessment, March 1984. ClJ42 . Update of Federal activities regarding the use of pneumococcal vaccine. Washington, D.C.: U.S. Government Printing Office, May 1984. CU43 . Assistive devices for severe speech im- pairments. Washington, D.C.: U.S. Government Printing Office, December 1983. (Health technology case study series #26) CU44 . Diagnosis-related groups (DRGs) and the Medicare program: implications for medical tech- nology, Washington, D.C.: U.S. Government Printing Office, July 1983. CU45 . Quality and relevance of research and related activities at the Gorgas Memorial Laboratory. Washington, D.C.: U.S. Government Printing Office, August 1983. CU46 . Technology and learning disabilities. Washington, D.C.: U.S. Government Printing Office, December 1983. (Health technology case study series #25) CU47 . The effectiveness and costs of alcoholism treatment. Washington, D.C.: U.S. Government Printing Office, March 1983. (Health technology case study series #22) CU48 . The impact of randomized clinical trials on health policy and medical practice. Washington, D.C.: U.S. Government Printing Office, August 1983. CU49 . The safety, efficacy, and cost effective- ness of therapeutic apheresis. Washington, D.C.: U.S. Government Printing Office, July 1983. (Health tech- nology case study series #23) CU50 . Variations in hospital length of stay: their relationships to health outcomes. Washington, D.C.: U.S. Government Printing Office, August 1983. (Health technology case study series #24) CU51 . Assessment of four common X-ray pro- cedures. Washington, D.C.: U.S. Government Print- ing Office, April 1982. (Health technology case study series #19) CU52 . Cardiac radionuclide imaging and cost- effectiveness. Washington, D.C.: U.S. Government Printing Office, May 1982. (Health technology case study series # 13) CUSS . MEDLARS and health information poli- cy. Washington, D.C.: U.S. Government Printing Of- fice, September 1982. CU54 . Mandatory passive restraint systems in automobiles. Washington, D.C.: U.S. Government Printing Office, September 1982. (Health technology case study series #20) CUSS . Medical technology under proposals to increase competition in health care. Washington, D.C.: U.S. Government Printing Office, October 1982. CUSS . Postmarketing surveillance of prescrip- tion drugs. Washington, D.C.: U.S. Government Printing Of rice, November 1982. CU57 . Selected telecommunications devices for hearing-impaired persons. Washington, D.C.: U.S. Government Printing Of lice, December 1982. (Health technology case study series #21) CUSS . Strategies for medical technology assess- ment. Washington, D.C.: U.S. Government Printing Office, September 1982. CUSS . Technology and handicapped people. Washington, D.C.: U.S. Government Printing Office, May 1982. CU60 . Technology transfer at the National In- stitutes of Health. Washington, D.C.: U.S. Govern- ment Printing Office, March 1982. CU61 . The artificial heart: cost, risks, and bene- fits. Washington, D.C.: U.S. Government Printing Of- fice, May 1982. (Health technology case study series #9) CU62 . Allocating costs and benefits in disease . . . . . prevention: an app lcatlon to cervical cancer screen- ing. Washington, D.C.: U.S. Government Printing Office, May 1981. (Health technology case study se- ries #7) CUSS . Assessing selected respiratory therapy modalities: trends and relative costs in the Washing- ton, D.C. area. Washington, D.C.: U.S. Government Printing Office, July 1981. (Health technology case study series #12) 79

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY CU64 . Benefit and cost analysis of medical in- terventions: the case of cimetidine and peptic ulcer disease. Washington, D.C.: U.S. Government Print- ing Office, September 1981. (Health technology case study series #11? CU65 . Cost-benefit/cost-effectiveness of medi- cal technologies: a case study of orthopedic joint im- plants. Washington, D.C.: U.S. Government Printing Office, September 1981. (Health technology case study series #14) CU66 . Cost-effectiveness of automated multi- channel chemistry analyzers. Washington, D.C.: U.S. Government Printing Office, April 1981. (Health technology case study series #4) CU67 . Cost-effectiveness of influenza vaccina- tion. Washington, D.C.: U.S. Government Printing Office, December 1981. CU68 . Elective hysterectomy: costs, risks and benefits. Washington, D.C.: U.S. Government Print- ing Office, October 1981. (Health technology case study series #15) CU69 . Formal analysis, policy formulation, and end-stage renal disease. Washington, D.C.: U.S. Gov- ernment Printing Office, April 1981. (Health technol- ogy case study series #1) CU70 . Periodontal disease: assessing the effec- tiveness and costs of the Keyes technique. Washing- ton, D.C.: U.S. Government Printing Office, May 1981. (Health technology case study series #5) CU71 . Policy implications of computed tomog- raphy (CT) scanners: an update. Washington, D.C.: U.S. Government Printing Office, January 1981. CU72 . Screening for colon cancer. Washington, D.C.: U.S. Government Printing Office, April 1981. (Health technology case study series #3) CU73 . Surgery for breast cancer. Washington, D.C.: U.S. Government Printing Office, October 1981. (Health technology case study series #17) CU74 . Technologies for determining cancer risks from the environment. Washington, D.C.: U.S. Government Printing Of lice, June 1981. CU75 . The cost-effectiveness of bone marrow transplant therapy and its policy implications. Wash- ington, D.C.: U.S. Government Printing Office, May 1981. (Health technology case study series #6) CU76 . The cost-effectiveness of upper gastroin- testinal endoscopy. Washington, D.C.: U.S. Govern- ment Printing Office, May 1981. (Health technology case study series #8) 80 CU77 . The costs and effectiveness of neonatal intensive care. Washington, D.C.: U.S. Government Printing Office, August 1981. (Health technology case study series #10) CU78 . The costs and effectiveness of nurse practitioners. Washington, D.C.: U.S. Government Printing Office, July 1981. (Health technology case study series #16) CU79 . The feasibility of economic evaluation of diagnostic procedures: the case of CT scanning. Washington, D.C.: U.S. Government Printing Office, April 1981. (Health technology case study series #2) CU80 . Compensation for vaccine-related inju- ries. Washington, D.C.: U.S. Government Printing Office, November, 1980. CU81 . Methodological issues and literature re- view. Washington, D.C.: U.S. Government Printing Office, September 1980. (Background paper #1 of the Series on implications of cost-effectiveness analy- sis of medical technology) CU82 . The efficacy and cost effectiveness of psychotherapy. Washington, D.C.: U.S. Government Printing Office, October 1980. (Health technology case study series #18) CU83 . The implications of cost-effectiveness analysis of medical technology. Washington, D.C.: U.S. Government Printing Office, August 1980. CU84 . The management of health care technol- ogy in ten countries. Washington, D.C.: U.S. Govern- ment Printing Office, October 1980. (Background paper #4 of the Series on implications of cost-effec- tiveness analysis of medical technology) CUSS . A review of selected federal vaccine and immunization policies. Washington, D.C.: U.S. Gov- ernment Printing Office, September 1979. CU86 . Computer technology in medical educa- tion and assessment. Washington, D.C.: U.S. Govern- ment Printing Office, September 1979. CU87 . Assessing the efficacy and safety of medi- cal technologies. Washington, D.C.: U.S. Government Printing Office, September 1978. CUBS . Policy implications of computed tomog- raphy (CT) scanners. Washington, D.C.: U.S. Gov- ernment Printing Office, August 1978. CU89 . Cancer testing technology and saccharin. Washington, D.C.: U.S. Government Printing Office, October 1977. CU90 . Policy implications of medical informa- tion systems. Washington, D.C.: U.S. Government Printing Office, November 1977.

CONGRESS OF THE UNITED STATES, OFFICE OF TECHNOLOGY ASSESSMENT CU91 . Development of medical technology: op- CU92 . Drub bioeouivalence. Washington. D.C.: portunities for assessment. Washington, D.C.: U.S. Government Printing Office, August 1976. Duke University Center for Health Policy Research and Education Box GM, Duke Station Durham, NC 27706 919-684-3023 v ~ O U.S. Government Printing Office, July 1974. Contact: David M. Eddy, M.D., Ph.D., Director. Telex 802829 DUKTELCOM DURM. Overview: The Center for Health Policy Research and Education (CHPRE) was creat- ed in 1980 with a core grant from the Duke Endowment. From the start, it has focused on the development and application of methods to assess health technologies. It also works to analyze particular health practices and to educate policy makers. Its products are technology assessment methods, assessments, and educational programs. Purpose: To develop methods of technology assessment, to improve health by evalua- tion of particular health practices, and to educate policy makers. Primary intended users: Providers, generally; physicians; acute facility administrators; health product manufacturers; health/medical professional associations; health indus- try associations; employers; third party payers; government regulators; voluntary associations, organizations; public policy-makers, legislators. Technologies: Drug, device, medical or surgical procedure. Assessments have focused on the impact of technologies on individuals as well as on populations. Intervention: Prevention, treatment, diagnosis, rehabilitation. Stage: Emerging, new, established or widespread practice, obsolete. The program is concerned with controversial technologies at any stage. Properties: Efficacy, cost-effectiveness, safety, effectiveness, cost, system impact, economic . . . Imp canons. Selection process: Any organization may request that an assessment be conducted, including third party payers; state, federal, and international governments; hospitals; health maintenance organizations; professional societies; health industries; trade asso- ciations; and venture capitalists. Assessment topic priorities are set by the Center staff. Major criteria are: 1) a request from a major organization currently facing a decision about the technology; 2) the importance (magnitude of the health and economic impact) of the health problem and the expected difference made by the technology; 3) the degree of uncertainty or 81

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY controversy about the technology; and 4) the existence of methodological issues (antici- pated difficulty and novelty of the analysis). Reassessments are performed at the request of an organization or when new informa- tion becomes available that could modify the results of an active assessment (an assess- ment still being used for decisions). Methods: Information syntheses; expert opinion; group judgment; modeling; cost ana- lyses. Existing information is analyzed to estimate the effect of the technology on important health and economic outcomes. Typically, quantitative methods are used to interpret and synthesize the information, and to estimate effects that have not been or can not be observed experimentally (e.g., life expectancy and population effects). To the greatest extent possible, analyses rest on empirical observations. When unavoidable, expert judgments are formally incorporated into the assessment. Assessments are typically performed in eight steps: 1) problem formulation (per- formed in conjunction with the requesting organization); 2) information gathering; 3) model development; 4) analysis; 5) preparation of drafts; 6) cycles of external review and revision; 7) approval; and 8) final report. Turnaround time from selection of assessment topic to reporting of findings depends on the time constraints of the requesting organization, prior familiarity with the assessment problem, and the review process. The time ranges from 1 week to 2 years; the average is 6 months. Assessors: Assessors are experts in medicine, statistics, mathematics, operations re- search, computer science, and law. Assessment reports include: Abstract; the purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technol- ogies intended for similar purposes; who sponsored/commissioned/supported the as- sessment; who conducted the assessment; description of the technology; properties assessed; procedure used for the assessment; sources of data/information; methods for collecting data/information; methods for analyzing/synthesizing data/information; re- sults; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research. Dissemination: Printed reports, journal articles, advisories to members/constituents. Assessment results are also disseminated by the requesting organizations through their own channels. Copies of assessment reports are available scientific literature. upon request or in the open Budget: $1,000,000. Assessments cost CHPRE from $3,000 to $60,000; charges have ranged from no charge to $45,000. Funding sources: 10 percent parent organization; 30 percent government grants/contracts; 60 percent foundations, other private grants. Use: Duke University does not formally use the assessment reports. The requesting organizations have used the results to help set third party coverage policies, to design practice standards, to draft legislation, to develop recommendations for national policy, and to design national health programs. The use of assessments is usually known 82

DUKE UNIVERSITY because CHPRE staff works with the requesting organization through the implementa- tion stage. In addition, assessment authors are frequently invited to speak on their topics. Examples of use include the following: 1) publication by the American Cancer Society of the ACS Guidelines on the Cancer-Related Health Checkup; 2) publication by the World Health Organization of Control of Oral Cancer in Developing Countries; 3) adoption by the National Cancer Institute of a computer program for Setting National Cancer Control Przoraties for the Year 2000 and 4) acceptance by the Minister of Health, Chile, of recommendations for cancer control priorities. . Program evaluation: In 1986, the Hartford Foundation evaluated CHPRE at the end of a 3-year grant that funded the development and application of a new set of assess- ment methods. An independent consultant to the Foundation read project reports and background material and visited the Center for 1 day. The evaluation's findings were positive. Following the evaluation, the Center received a second grant from the Foun- dation to continue development of the assessment method. Related activities: Computer software is being prepared to enable others to use some of the quantitative technology assessment methods developed at the Center. CLIPRE plans to offer several 1-day seminars to acquaint researchers and policy-makers with technology assessment methods developed by the Center. Completed Reports DC1 Adar R. Critchfield GC, Eddy DM. EDuke Univer- sity, Center for Health Policy and Education] A confi- dence profile analysis of the results of percutaneous transluminal angioplasty in the treatment of ischemic femoropopliteal artery disease, expected publication 1988. "Information syntheses] DC2 Critchfield GC, Eddy DM. ~ ~ A confidence profile analysis of the effectiveness of disulfiram in the treatment of chronic alcoholism. Med Care, sub- mitted for publication. fInformation syntheses] DC3 Critchfield GC, Eddy DM. ~ ~ Screening for osteoporosis, expected publication 1988. fInforma- tion syntheses] DC4 Eddy DM, Hasselblad V, McGivney W. Hendee W. ~ ~ The value of mammography screening for women age 40-49, submitted for publication. fInfor- mation synthesesJ DC5 Eddy DM. ~ ~ Screening by mammography for women over age 65, reassessment, expected publi- cation 1988. fInformation syntheses] DC6 . ~ ~ Screening for breast cancer, re- assessment, expected publication 1988. fInformation syntheses] DC7 . ~ ~ Screening for cervical cancer, reassessment, expected publication 1988. fInforma- tion syntheses] DC8 . ~ ~ Screening for colorectal cancer, reassessment, expected publication 1988. FInforma- tion syntheses] DC9 . ~ ~ Screening for glaucoma, reas- sessment, expected publication 1988. fInformation syntheses] DC10 . ~ ~ Screening for lung cancer, re- assessment, expected publication, 1988. fInformation syntheses] DC11 Gavin NI, Hasselblad V, Eddy DM. ~ ~ The role of adjuvant tamoxifen treatment of postmeno- pausal women with stage II breast cancer, expected publication 1988. fInformation syntheses] DC12 Hasselblad V. ~ ~ Analysis of the preven- tion of mental retardation by screening for maple syrup urine disease, expected publication 1988. fIn- formation syntheses] DC13 Brandeau ML, Eddy DM. ~ ~ The workup of the asymptomatic patient with a positive fecal oc- cult blood test. Med Decis Making 1987;7:32-46. fIn- formation syntheses] DC14 Eddy DM, Wolpert RL, Rosenberg ML. ~ ~ Estimating the effectiveness of interventions to pre- vent youth suicides: a report to the Secretary's Task Force on Youth Suicide. 1987. LInformation synthe- ses] / / 83

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY DC15 Eddy DM, Nugent FW, Eddy JF, et al. ~ ~ Screening for colorectal cancer in a high-risk popula- i~on: results of a mathematical model. Gastroenterol- ogy 1987;92:682-692. [Information syntheses] DC16 Eddy DM. ~ ~ The use of confidence pro- files to assess tissue-type plasminogen activator. In: Califf RM, Wanger GS, eds. Acute coronary care. Boston: Martinus Nijhoff Publishing, 1987. tInfor- mation syntheses] DC17 . ~ ~ Priorities for cancer control in Chile. Report prepared for the World Health Organi- zation. 1986. "Information syntheses] DC18 . ~ ~ Priorities for cancer control in India. Report prepared for the World Health Organi- zation. 1986. fInformation syntheses] DCl9 . ~ ~ The effectiveness, cost, & cost- effeci~veness of breast cancer screening with annual mammography & breast physical exam. for women over 65. Report prepared for Committee on Ways & Means, Subcommittee on Health, U.S. House of Rep- resentatives. 1986 Jan 7. LInformation syntheses] DC20 Eddy JF, Eddy, DM. ~ ~ The value of cor- neal endothelial cell microscopy for cataract surgery. Report prepared for the Blue Cross and Blue Shield Association. 1986. "Information syntheses] DC21 Eddy DM. ~ ~ Priorities for cancer control in Chile. Report prepared for the World Health Or- ganizai~on. 1985. "Information syntheses] DC22 . ~ ~ Priorities for cancer control in India. Report prepared for the World Health Organi- zation. 1985. "Information syntheses] ECR! Health Devices Program 5200 Butler Pike Plymouth Meeting, PA 19462 2 15-825-6000 DC23 A WHO Meeting ~ ~ Control of oral cancer in developing countries. Bull WHO 1984;62:817-830. FInformation syntheses] DC24 . ~ ~ The economic impact of can- cer and cancer prevention in private industry. Report prepared for the American Cancer Society.1984. tIn- formation syntheses] DC25 Eddy DM, Eddy JF, Sanders LE. ~ ~ Surgi- cal treatment of obesity. Evidence of effectiveness and risks. Report prepared for the North Carolina Blue Cross and Blue Shield Asociation.1983. [Information syntheses] DC26 Eddy DM, Sanders L, Eddy J. ~ ~ The value of screening for glaucoma with tonometry. Surv Ophthalmol 1983;28: 194-205. [Information synthe- ses] DC27 Eddy DM. ~ ~ Appropriateness of cervical cancer screening. Gynecol Oncol 1981; 12:S168-187. fInformation syntheses] DC28 . ~ J Screening for colon cancer: a technology assessment. 1981. (Office of Technology Assessment background paper #2: case studies of medical technologies) "Information syntheses] DC29 . ~ :1 Guidelines for the cancer-relat- ed checkup: recommendations and rationale. CA-A Cancer J Clin 1980;30: 193-240. fInformation synthe- ses] Contact: Robert Mosenkis, Vice President of Publications. Telex 510-660-8023. Tele- fax 2 15-834-1275. Overview: ECRI, formerly the Emergency Care Research Institute, is an independent not-for-profit corporation that works to improve the quality of patient care. It provides a wide range of services dealing with health care technology including research, evalua- tion, assessment, consulting, environmental testing, and publications development. The Health Devices Program (HDP) was established by ECRI in 1971. Purpose: To conduct assessments that provide independent, objective judgment for selection, purchase, and use of medical instruments, equipment, and systems; to func 84

ECRI HEALTH DEVICES PROGRAM . ton as a clearinghouse for investigating and resolving hazards and deficiencies in medical devices; and to encourage the improvement of medical devices through an informed marketplace. Primary intended users: Providers, generally; physicians; acute facility administrators; biomedical researchers. Technologies: Device, support system, organizational or administrative system. All types of diagnostic and therapeutic medical devices, equipment, and support systems, as well as some preventive and rehabilitative technologies are assessed. Exam- ples range from disposables, such as incontinent pads and suction canisters, to electric beds, patient monitoring systems, anesthesia machines, infusion and imaging technol- ogies, and clinical laboratory instruments. Comparative evaluations are usually con- ducted within a product category. Intervendon: Treatment, prevention, diagnosis, rehabilitation. Stage: Established or widespread Practice, new. Properties: Effectiveness, safety, efficacy, cost, cost-effectiveness, service requirements, acceptance/adoption level, performance, ease of use, reliability, and appropriateness of use. Selection process: Hospital members of the Health Devices Program may request that an assessment be conducted. ECRI/HDP may also determine the need for an evalua- tion based on inquiries received from member hospitals. Requests for assessments are made either informally by telephone conversation with staff members, by written correspondence, or by responding to periodic HDE member surveys. Topic selection is based on the volume of inquiries received from ECRI/HDP member hospitals; the ECItI's senior staffs experience regarding a product's importance to hospitals and to safe, efficacious, and cost-effective patient care; and the results of membership ques . . tlonnalres. Device categories are reassessed when member hospitals request more current infor- mation than is available from previous evaluations. This normally occurs when a significant number of new product models appear on the market in a given category. Methods: Bench testing, information syntheses, expert opinion, group judgment, cost analyses, clinical trials. The ECRI/HDP comparative evaluations are based on ECRI laboratory and clinical evaluations. Laboratory evaluations are conducted in ECRI's facility, and clinical stud- ies (in viva evaluations of device performance) are conducted in selected member hospitals. Evaluations follow appropriately reviewed medical/scientific protocols devel- oped by ECRI. There is an extensive review process that involves both in-house and independent reviewers, typically including clinicians with special expertise in the sub- ~ect area. The approximate turnaround time from selection of assessment tonic to resorting of findings is 6 to 9 months. rid -~ ^~ rid As ~ 85

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Assessors: Evaluations are conducted primarily by engineers, physicians, and chemists. As needed, ECRI's interdisciplinary staff collaborate on evaluations. ECRI employs more than 120 full-time staff with expertise in medical, engineering, and analytical sciences. Assessment reports include: Abstract; the purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technol- ogies intended for similar purposes; description of the technology; stage of life-cycle of technology when assessed; properties assessed; procedure used for the assessment; sources of data/information; methods for collecting data/information; methods for analyzing/synthesizing data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, principles; development of the technology; procurement/deployment informa- tion; product recall history, liability actions. Dissemination: journal articles; advisories to members/constituents; clearinghouses, data/citation bases, on-line services. Specifically, abstracts are published in Health Devices Alerts and are available in an online database. For each evaluation, a comprehensive report is published containing tables that show the product's characteristics and performance on each evaluation criterion. Model- specific listings of advantages and disadvantages and ratings (e.g., recommended, not recommended) are also included. All reports are published in ECRI's monthlyjournal, Health Devices which began publication in 1971. Health Devices also contains reports of hazards with medical devices, as reported by ECRI/HDP member hospitals and investi- gated by ECRI engineers. Copies of individual issues of Health Devices may be purchased from ECRI's Circulation Department. Hospitals and others may become members of the Health Devices Pro- gram and receive subscriptions to the weekly Health Devices Alerts, the bimonthly journal, Health Technology: Critical Issues for Decision Makers, and telephone consultation privileges. Individual subscriptions to Health Devices alone are not available. Summaries of relevant evaluations are also published in the Technology for Health Care family of seven specialized monthly newsletters. Health Devices is not indexed by the National Library of Medicine for the MEDLARS system. However, indexes and database search- es are available directly from ECRI. Budget: $2,000,000. Based on the type of device being evaluated, the cost per assess- ment ranges from $40,000 to $100,000. Funding source: 100 percent sponsors/mem- bers dues, contributions. Use: Assessments reports are used by ECRI to serve the health care community and patients in the nation's hospitals. These reports are also used by members of the Health Devices Program (which includes hospitals representing about 70 percent of all acute- care beds in the U.S.) in a variety of ways involving selection, acquisition, and use of medical devices. Regular surveys of ECRI/HDP members and an annual membership renewal rate exceeding 95 percent provide indications of the value of these evaluations to member hospitals. Numerous specific product improvements have been directly attributed to ECRI/HDP evaluations. For instance, following an extensive 1973 study of electrosur- gical machines, most manufacturers undertook major redesign to improve safety. Over the past decade 90 percent of the nation's inventory of these devices has been replaced. The impact has been significant; fewer electrosurgical burns are reported to ECRI. ECRI estimates that cost savings in the hundreds of millions of dollars can be attributed to ECRI evaluations and other technology-related efforts on behalf of member hospi 86

ECRIHEALTH DEVICES PROGRAM tars. One example is the National Electrical Code controversy over isolated power in anesthetizing locations. ECRI assessment activities are described in Institute of Medicine, Committee on Evalu- ating Medical Technologies in Clinical Use. Assessing medical technologies. Washington, DC: National Academy Press, 1985. Related activities: The Health Devices Program is closely related to other ECRI activities including: the Technology Assessment Program; a technology risk manage- ment program that produces the four-volume Hospital R ask Control information service; accident investigation, forensic engineering, engineering and management consulta- tion; and field technical services for hospitals. COmP1etedRePOr~ EH1 ECRI Health Devices Program. Carbon dioxide monitors. Health Devices 1986;15:255-85. EH2 . Continuous passive motion (CPM) leg ex- ercisers. Health Devices 1986;15:3-22. EH3 . LEG monitors. Health Devices 1986; 15:71-95. EH4 . Electric beds. Health Devices 1986; 15- 299-316. EH5 . Electrosurgical active electrode pencils, hand controlled. Health Devices 1986;15:151-77. EH6 . Neonatal ventilators. Health Devices 1986; 15:219-46. EH7 . Patient care management system, Space- Labs. Health Devices 1986; 15: 286-94. EH8 . Peritoneal dialysis cyclers. Health Devices 1986; 15:31-61. EH9 . Sphygmomanometers, automatic. Health Devices 1986; 15: 187-208. EH10 . Surgical drapes. Health Devices 1986; 15:111-40. EH11 . Arrhythmia monitoring systems, com- puterized. Health Devices 1985; 14:287-319. EH12 . Batteries, zinc air. Health Devices 1985; 14:209-211. EH13 . Electrode monitoring systems, electro- surgical. Health Devices 1985; 14: 115-31. EH14 . Infusion controllers. Health Devices 1985; 14:219-256. EH15 . Oxygen-air proportioners. Health De- vices 1985;14:263-76. EH16 . Physiologic monitoring systems. Health Devices 1985; 14: 143-182. EH17 . Positive end expiratory pressure (PEEP) valves. Health Devices 1985;14:379-99. EH18 . Suction canisters (aspirator collection bottles). Health Devices 1 985; 1 4:4 1 1 -34. EH19 . Suction regulators. Health Devices 1985; 14: 191-209. EH20 . Blood warmers. Health Devices' 1984; 13: 191-219. EH21 . Disposable pressure transducers. Health Devices 1984; 13: 268-90. EH22 . Electrocardiographs, three-channel. Health Devices 1984; 13 :235-59. EH23 . Enteral feeding pumps. Health Devices 1984; 14:9-30. EH24 . Infant radiant warmers. Health Devices 1984; 13:119-45. EH25 . Infusion pumps. Health Devices 1983- 84; 13:31-62. EH26 . Patient bed scales. Health Devices 1984; 13:75-91. EH27 . Pneumatic tourniquets. Health Devices 1984;13:299-316. EH28 . Anesthesia unit gas scavengers. Health Devices 1983;12:267-286. EH29 . Blood gas/pH analyzers. Health Devices 1983; 12:59-78. EH30 . Defibrillators, line-powered. Health De- vices 1983; 12:291-314. EH31 . External transcutanaeous pacemakers, Pace*Aid Model 50C. Health Devices 1983;13:3-13. EH32 . Heat and moisture exchange humidifi- ers. Health Devices 1983; 12: 155-67. EH33 . Incontinent pads. Health Devices 1983; 12: 108-18. EH34 . Oxygen analyzers. Health Devices 1983; 12: 183-97. 87

MEDICALI~CHNOLOGY ASSESSMENT DIRECTORY EH35 . Oxygen monitors, transcutaneous. Health Devices 1983; 12:213-51. EH36 . Suction canisters (aspirator collection bottles). Health Devices 1 983; 1 2: 1 27-49. EH37 . Surgical gloves, latex. Health Devices 1983;12:83-98. EH38 . Arrhythmia monitoring systems, com- puterized. Health Devices 1982; 11:211-247. EH39 . Electronic intermittent thermometers. Health Devices 1982; 12:3-20. EH40 . Ethylene oxide sterilizers. Health De- v~ces 1982; 11 :287-301. EH41 . Fetal monitors. Health Devices 1982;11:123-44. EH42 . Infant incubators. Health Devices 1982; 11: 191-9. ECR! Technology Assessment Program 5200 Butler Pike Plymouth Meeting, PA 19462 2 15-825-6000 EH43 . Infant transport incubators. Health De- vices 1982;11:179-91. EH44 . Infusion controllers. Health Devices 1982; 11 :75-96. EH45 . Operating room ECG monitors. Health Devices 1982; 11: 155-74. EH46- . Physiologic monitoring systems. Health Devices 1982; 11:211-47. EH47 . Surgical case carts. Health Devices 1982; 11:311-24. EH48 . Surgical case carts. Health Devices 1982; 12:33-9. EH49 . Volume ventilators. Health Devices 1982; 11 :264-83. EH50 . X-ray film processors. Health Devices 1982; 11 :99-115. Contact: Malin VanAntwerp, Director of Policy Analysis. Telex 510-660-8023. Telefax 2 15-834-1275. Overview: ECRI, formerly the Emergency Care Research Institute, is an independent, not-for-profit corporation that works to improve the quality of patient care. It provides a wide range of services dealing with health care technology including research, evalua- tion, assessment, consulting, environmental testing, and publications development. The Technology Assessment Program (ECRI/TAP) was established by ECRI in 1981. Purpose: To provide to interested parties assessments of emerging and regularly used health care technologies. Primary intended users: Providers, generally; physicians; acute facility administrators; other care givers; health product manufacturers; health/medical professional associa- tions; health industry associations; consumer associations; employers; third party pay- ers; government regulators; voluntary associations, organizations; financial analysts, consultants; reporters, writers, news media; information/computer industry; labs, blood banks; public policy-makers, legislators; policy research organizations; lawyers; liability, malpractice insurers. Technologies: Device, medical or surgical procedure, support system. Primarily diagnostic and therapeutic equipment are assessed. Occasionally, surgical procedures and clinical laboratory diagnostics are assessed. Intervention: Treatment, diagnosis, rehabilitation. Stage: New, emerging, established or widespread practice, obsolete. 88

ECRI TEC~OLOGY ASSESSMENT PROGRAM Technologies are generally assessed when it is appropriate for a "typical" hospital (i.e., smaller than a tertiary care/medical center hospital but at least a 200-bed facility) to consider acquiring the technology, and sometimes when a technology may be unsafe or obsolete. Properties: Effectiveness; safety; efficacy; cost; cost-effectiveness; service requirements; acceptance/adoption level; system impact; economic implications; ethical, legal, social . .. . 1mpllcatlons. Selection process: Assessment topics and priorities are set by ECRI/TAP staff. Deci- sions are based on their review of clinical journals, manufacturing/industry trade literature, and input from other ECRI staff (clinical/biomedical engineers, hospital consultants, etc.) who have contact with hospitals. A technology is reassessed when the previously published material becomes significantly outdated by more recent develop ments. Methods: Information syntheses, expert opinion, group judgment, cost analyses. A comprehensive review, evaluation, and synthesis of the published literature is at the core of the assessment process. EC3~I in-house experts, nationally prominent clinicians, and others familiar with the technology conduct a thorough three-step review of draft assessment reports. The average turnaround time from selection of assessment topic to reporting of findings is 2 to 3 months. Assessors: The primary assessors are members of ECRI's interdisciplinary policy analysis staff which includes attorneys and experts in health care administration and planning. As needed, additional assessors are selected from ECRI's 120-member, full- time staff, or from among outside clinicians. The staff have expertise in medicine, engineering, and other relevant disciplines. 1 ~ Assessment reports include: Abstract; the assessment's intended audience; the pur- pose of the assessment; relationship of this assessment to prior or concurrent assess- ments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; proper- ties assessed; procedure used for the assessment: sources of rl~t~/inform~tion meth~ric or_ ~1 . 1 . / r ~ A A ^ _ A A ~ ~ V ~ _ ^ ~ ~ ~ ~~ A. }L ~ 4 ~ A A A A ~ ~ ~ J ]L A ~ A A A ~ HA 1~ ~ ~ for co~ecung aarann~ormat~on; methods for analyzing/synthesizing data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works, including theory nrinrinlec clev'~lonm~nt of the ~ ~ _1_ _ 1 _ _ . / ~1 ~ o ~ ~ ~ ~ _ l_ _ _ ~ ~ ~ ~ ~ ~ A ~ ~ ~ ~ ~ ~ ~ ~ ^ ^ ~ ~;nno~ogy; procuremenuc~ep~oyment information; where technology is in use; regula- tory agency approval status; coverage/reimbursement status of the technology. Disseminadon:~tournal articles. The assessment products are comprehensive assessment reports and New Technology Briefs. Both comprehensive technology assessment reports and New Technology Briefs are published, beginning with the`}anuary/February 1987 issue, in ECRI's new Health Technology: Critical Issues for Decision Makers. This journal combines two previous ECRI publications, the Journal of Health Care Technology and Issues in Health Care Technology, which had been published since 1984 and 1981, respectively. Copies of the assessments 89

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY can be acquired by subscribing to Health Technology (either independently or by mem- bership in the Health Devices Program) or purchasing single copies; reports are not available separately. Individual copies of back issues of the journal of Health Care Technology may also be purchased from ECRI's Circulation Department. Budget: $300,000. The approximate cost of an assessment ranges from $3,000 to $15,000 depending on the report's length and comprehensiveness. Funding sources: 67 percent sponsors/members dues, contributions; 33 percent subscriptions to Health Technology. Use: Reports are used to support consulting and technical advice provided by ECRI personnel to hospitals. Based on responses from reader surveys, reports receive wide circulation in hospitals and are used for a variety of purposes, such as equipment acquisition and replacement decisions. Perhaps the most-cited of any assessment report is "Deaths during General Anesthesia," published in the journal of Health Care Technol- ogy 1985;1:55-75, which was reprinted in full in the Newsletter of the American Society of Anesthesiologists. ECRI assessment activities are described in Institute of Medicine, Committee on Evalu- ating Medical Technologies in Clinical Use. Assessing medical technologies. Washington. DC: National Academy Press, 1985. Program evaluation: The only evaluations of the program have been reader surveys conducted on 3 occasions by the two ECRI predecessor publications. Related activities: The Technology Assessment Program is closely related to ECRI's Health Devices Program (HDP); all HDP members receive Health Technology as one of their membership benefits. The ECRI/TAP staff also work closely with other ECRI activities. These include a technology risk management program that produces the four-volume Hospital Risk Control information service; accident investigation, forensic engineering, engineering, and management consultation; and field technical services for hospitals. Completed Reports ET1 ECRI Technology Assessment Program. Artificial urinary sphincters. Issues Health Care Technol 1986;sec.5.U.1. [Information syntheses] ET2 . Automatic im plantable card love rte ride f~- brillator. Issues Health Care Technol 1986;sec.5.D.3. "Information syntheses] ET3 . Bone mineral assessment, noninvasive (dual photon absorptiometry and quantitative com- puted tomography). J Health Care Technol 1986;2:183-200. "Information syntheses] ET4 . Cardiokymography. Issues Health Care Technol 1986;sec.5.C.8. [Information syntheses] ET5 . Chorionic villus sampling (CVS). Issues Health Care Technol 1986;sec.5.C.6. "Information syntheses] 90 ET6 . Clinical use of mass spectrometers. Issues Health Care Technol 1986;sec.5.M.2. "Information syntheses] ET7 . Computer-processed EEG monitoring during surgery. Issues Health Care Technol 1986;sec.5.E.4. "Information syntheses] ET8_ . Extracorporeal membrane oxygenation (ECMO) for newborn respiratory failure. Issues Health Care Technol 1986;5.E.6. "Information syn- theses] ET9 . Gastric bubble. Issues Health Care Tech- nol 1986;sec.5.G.1. "Information syntheses] ET10 . Image transmission and data compres- sion. J Health Care Technol 1986;3:83-93. ~Informa- tion syntheses]

ECRI TECHNOLOGY ASSESSMENT PROGRAM ETl l . Interpretive reporting of clinical labora- tory test results. ~ Health Care Technol 1986;2:269- 82. [Information syntheses] ET12 . Legal system, insurance, and health care: the liability problem. ~ Health Care Technol 1986;2:247-68. "Information syntheses] ET13 . Low-osmolality radiographic contrast agents. Issues Health Care Technol 1986;sec.5.L.4. [Information syntheses] ET14 . Medicare payment for new technologies. Health Care Technol 1986;3: 13-32. [Information syntheses] ET15 . Multichannel cochlear implants for pro- found deafness. Issues Health Care Technol 1986;sec.5.C.7. "Information syntheses] ET16_ . Percutaneous balloon valvuloplasty. Is- sues Health Care Technol 1986;sec.5.P.9. fInforma- tion syntheses] ET17 . Percutaneous transluminal coronary an- gioplasty (PTCA). Issues Health Care Technol 1986;sec.5.P.2. "Information syntheses] ET18 . Personal emergency response system (PERS). Issues Health Care Technol 1986;sec.5.P.10. [Information syntheses] ETl9 . Physician office laboratories. I Health Care Technol 1986;3:95-115. "Information synthe- ses] ET20 . Pulse oximeters. Issues Health Care Technol 1986;sec.5.0.1. "Information syntheses] ET21 . SPECT imaging. ~ Health Care Technol 1986;3:33-62. [Information syntheses] ET22 . Temporary external noninvasive pace- makers. Issues Health Care Technol 1986;sec.5.P.11. "Information syntheses] ET23 . Three-dimensional computed tomogra- phy. Issues Health Care Technol 1986;sec.5.T.6. tIn- formation syntheses] ET24 . Two-dimensional Doppler echocardio- graphy. Issues Health Care Technol 1986;sec.5.E.5. "Information syntheses] ET25 . Urinalysis, automated. ~ Health Care Technol 1986;2:201-10. "Information syntheses] ET26 . Angelchik gastroesophageal antireflux prosthesis. Issues Health Care Technol 1985;sec.5.A.4. "Information syntheses] ET27 . Automated microbiology systems. Issues Health Care Technol 1985;sec.5.M.5. "Information syntheses] ET28 . Automated microbiology systems. T Health Care Technol 1985; 1:213-30. [Information syntheses] ET29 . Bone marrow transplantation. Issues Health Care Technol 1985;sec.5.B.5. "Information syntheses] ET30 . CT-assisted stereotactic neurosurgery. Issues Health Care Technol 1985;sec.5.S.3. tInfor- mation syntheses] ET31 . Continuous passive motion (CPM) de- vices. Issues Health Care Technol 1985 ;sec.5.C.4. tIn- formation syntheses] ET32 . Deaths during general anesthesia. J Health Care Technol 1985;1:155-75. "Information syntheses] ET33 . Digital subtraction angiography (DSA). J Health Care Technol 1 985; 1: 1 77-2 1 2. "Information syntheses] ET34 . Freestanding imaging centers. J Health Care Technol 1985; 1 :257-278. "Information synthe- ses] ET35 . Hyperthermia treatment of tumors. Is- sues Health Care Technol 1985;sec.5.H.2. tInforma- tion syntheses] ET36 . Imatron high-speed CT scanner. Issues Health Care Technol 1985;sec.5.C.5. [Information synthesis] ET37 . Implantable vascular access ports. Issues Health Care Technology 1985;sec.5.V.2. tInforma- tion syntheses] ET38 . Laser angioplasty for atherosclerosis. Is- sues Health Care Technol 1985 ;sec.5.L.3-. tInforma- tion syntheses] ET39 . Leukocyte differential counters, auto- mated. J Health Care Technol 1985;2:51-72. tInfor- mation syntheses] ET40 . Magnetic resonance imaging (MRI). ~ Health Care Technol 1985;2:23-50. (Information syntheses] ET41 . Monitoring of exhaled C02 levels during anesthesia. Issues Health Care Technol 1985;sec.5.M.4. [Information syntheses] ET42 . Patient-controlled analgesia. Issues Health Care Technol 1985;sec.5.P.8. [Information syntheses] ET43 . Streptokinase thrombolysis of coronary arteries. Issues Health Care Technol 1985;sec.5.T.1. [Information syntheses] 91

MEDICALIECHNOLOGY ASSESSMENT DIRECTORY ET44 . Therapeutic apheresis. ~ Health Care Technol 1 985; 1 :279-98. "Information syntheses] ET45 . Thermography for breast cancer pre- screening. Issues Health Care Technol 1985;sec.5.T.5. "Information syntheses] ET46 . Tumor markers. J Health Care Technol 1985;2: 105-28. "Information syntheses] ET47 . Two-dimensional Doppler echocardio- graphy. J Health Care Technol 1985;2:129-50. tIn- formation syntheses] ET48 . Cementless hip prosthesis. Issues Health Care Technol 1984;sec.5.H.3. "Information synthe- ses] ET49 . Digital imaging storage and retrieval. ~ Health Care Technol 1984; 1: 13-38. "Information syntheses] ETSO . Dual-photon absorptiometry for bone mineral content. Issues Health Care Technol 1984;sec.5.A.3. "Information syntheses] ET51 . Extracorporeal shock-wave lithotripsy (ESWL'. Issues Health Care Technol 1984;sec.5.L.2. "Information syntheses] ET52 . Percutaneous nephrostomy. Issues Health Care Technol 1984;sec.5.N.1. "Information syntheses] ET53 . Photoradiation therapy (PRT) of tumors. Issues Health Care Technol 1984;sec.5.P.6. tInfor- mation syntheses] ET54 . Plasminogen activator thrombolysis of coronary arteries. Issues Health Care Technol 1984;sec.5.T.4. "Information syntheses] ET55 . Plethysmography for diagnosing deep vein thrombosis. Issues Health Care Technol 1984;sec.5.P.7. [Information syntheses] ET56 . Prenatal alpha-fetoprotein (AFP) testing. Issues Health Care Technol 1984;sec.5.A.2. fInfor- mation syntheses] ET57 . Surgery for morbid obesity. Issues Health Care Technol 1984;sec.5.S.2. "Information syntheses] ET58 . Therapeutic drug monitoring (TDM). ~ Health Care Technol 1984; 1 :39-61. "Information syntheses] ET59 . Transcatheter therapeutic embolization. Issues Health Care Technol 1984;sec.5.E.3. fInfor mation syntheses] 92 ET60 . X-ray image digitizing systems. Issues Health Care Technol 1984;sec.5.D.4. "Information syntheses] ET61 . Chemonucleolysis of herniated lumbar disks. Issues Health Care Technol 1983;sec.5.C.3. fInformation syntheses] ET62 . Collagen implants for smoothing skin. Issues Health Care Technol 1983;sec.5.C.2. tInfor- mation syntheses] ET63 . Digital radiography and fluoroscopy. Is- sues Health Care Technol 1983 ;sec.5.D.2. tInforma- tion syntheses] ET64 . Mobile computerized ECG interpretive systems. Issues Health Care Technol 1983;sec.5.E.2. "Information syntheses] ET65 . Noninvasive bilirubinometers. Issues Health Care Technol 1983;sec.5.B.4. "Information syntheses] ET66 . Penile prostheses. Issues Health Care Technol 1983 ;sec.5.P.5. "Information syntheses] ET67 . Percutaneous lithotripsy of kidney stones. Issues Health Care Technol 1983;sec.5.L.1. "Information syntheses] ET68 . Percutaneous transluminal angioplasty (PTA) of peripheral arteries. Issues Health Care Technol 1983 ;sec.5.P.4. [Information syntheses] ET69 . Single-channel cochlear implants for profound deafness. Issues Health Care Technol 1983;sec.5.C.1. "Information syntheses] ET70 . Transcutaneous C02 monitors. Issues Health Care Technol 1983 ;sec.5.M.3. "Information syntheses] ET71 . Transdermal delivery of nitroglycerin. Issues Health Care Technol 1983;sec.5.T.2. tInfor- mation syntheses] ET72 . Transrectal ultrasound of the prostate. Issues Health Care Technol 1983;sec.5.T.3. tInfor- mation syntheses] ET73 . Automatic indirect blood pressure moni- tors. Issues Health Care Technol 1982;sec.5.B.2. tIn- formation syntheses] ET74 . Blood substitute. Issues Health Care Technol 1982;sec.5.B.3. "Information syntheses] ET75 . Diagnostic and operative arthroscopy. Issues Health Care Technol 1982;sec.5.A.1. tInfor- mation syntheses]

ECRIIECHNOLOGY ASSESSMENT PROGRAM ET76 . Dual-energy scanned projection radiog- raphy. Issues Health Care Technol 1982;sec.5.D.1. "Information syntheses] ET77 . Hyperbaric oxygen (HBO) therapy. Is- sues Health Care Technol 1982 ;sec.5.H.1. [Informa- tion syntheses] ET78 . Implantable drug infusion pumps. Issues Health Care Technol 1982;sec.5.I.4. "Information syntheses] ET79 . Intra-aortic balloon pumps. Issues Health Care Technol 1982;sec.5.I.3. "Information syntheses] ET80 . Multiprogrammable pacemakers. Issues Health Care Technol 1982;sec.5.P.3. "Information syntheses] ET81 . Multiprogrammable pacemakers. Issues Health Care Technol 1982;sec.5.P.3. "Information syntheses] ET82 . Radial keratotomy. Issues Health Care Technol 1982 ;sec.5.R.1. "Information syntheses] ET83 . Bone growth stimulators. Issues Health Care Technol 1981;sec.5.B.1. "Information synthe- ses] FOOD and Drug A]miniS~aHOn 5600 FiSherS Lane ROCkVi]Ie, M D 20857 301-443-5470 ET84 . Evoked potential (EP) response measure- ment. Issues Health Care Technol 1981;sec.5.E.1. fInformation syntheses] ET85 . High-frequency ventilators. Issues Health Care Technol 1981;sec.5.V.1. "Information syntheses] ET86 . Insulin delivery devices. Issues Health Care Technol 1981 ;sec.5.I.2. fInformation syntheses] ET87 . Insulin infusion systems (controlled). Is- sues Health Care Technol 1981 ;sec.5.I.1. tInforma- tion syntheses] ET88 . Noninvasive blood gas oxygen monitors. Issues Health Care Technol 1981;sec.5.M.1. tInfor- mation syntheses] ET89 . Remote control fluoroscope units. Issues Health Care Technol 1981;sec.5.F.1. fInformation syntheses] ET90 . Therapeutic plasmapheresis. Issues Health Care Technol 1981;sec.5.P.1. "Information syntheses] Individual profiles on the Food and Drug Administration's Center for Devices and Radiological Health, Center for Drugs and Biologics, and the Center for Food Safety and Applied Nutrition follow this overview of the agency. The Food and Drug Administration (FDA) is a component of the Public Health Service (PHS) within the U.S. Department of Health and Human Services (DHHS). Its pur- pose is to ensure that: (1) food is safe and wholesome; (2) drugs (both human and veterinary), biological products, such as vaccines and blood for transfusion, and medi- cal devices are safe and effective; (3) cosmetics are safe; (4) the use of radiological products does not result in unnecessary exposure to radiation; and (5) all of these products are honestly and informatively labeled. The FDA accomplishes its mission through premarket clearance; monitoring, using inspections, investigations, and surveillance; compliance activities involving corrections and penalties; promulgation of regulations; and bioresearch monitoring and good laboratory practices. The body of law defining FDA's authority is comprehensive, providing a variety of controls required by the nature of the market, the products, and potential risks. 93

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Statutes include: the Food, Drug, and Cosmetic Act (FD&C Act); the Public Health Service Act (PHS Act of 1944~; the Fair Packaging and Labeling Act of 1966; and the Orphan Drug Act of 1983. Federal laws define the requirements applicable to firms dealing in interstate com- merce, as well as the authority of the agency that will administer and enforce each law. The FDA must make regulations telling how the law is to be applied. Regulations also describe the approval processes for many individual products and set forth required standards of product composition or performance. All FDA regulations, amendments, and other notices are published in the Federal Register, issued daily by the Federal Government. The FDA's principal components include: the Commissioner, Deputy Commissioner, and the staff and line organizations. The line organizations concerned with technology assessment are the four product-oriented centers: Center for Devices and Radiological Health, Center for Drugs and Biologics, Center for Food Safety and Applied Nutrition, and the Center for Veterinary Medicine. The first three are described separately in this directory. The National Center for Toxicological Research is a part of FDA's science foundation. The Center for Devices and Radiological Health is responsible for ensuring the safety and effectiveness (efficacy) of medical devices, as provided for by the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act; and eliminating unneces- sary human exposure to man-made radiation from medical, occupational, and con- sumer products, as provided for by the Radiation Control for Health and Safety Act of 1968. The Center for Drugs and Biologics (CDB) is responsible for ensuring that all human- use drugs and biologics manufactured for interstate sale are safe and effective (effica- cious) and that product labeling is truthful and informative. The Center for Food Safety and Applied Nutrition (CFSAN) regulates foods and cosmetics to ensure that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that cosmetics are safe and made from appropriate ingredi- ents; and that the labeling of foods and cosmetics is truthful and informative. General information on the FDA's other functions may be obtained from the Associate Commissioner for Consumer Affairs at the above address. News of FDA activities is also available through the FDA Consumer, a magazine issued 10 times a year by the U.S. Government Printing Office, Washington, DC 20402; stock no. 717-009-00000-2; $17 per year. Food and Drug Administration Center for Devices and Radiological Health 12720 Twinbrook Parkway Rockville, MD 20857 301-443-5807 Contact: Bobbi Dresser, Program Analyst, (for general information). 94

FDA/CENTER FOR DEVICES AND RADIOLOGICAL HEALTH Overview: The FDA Center for Devices and Radiological Health (CDRH) is responsi- ble for ensuring the safety and effectiveness (efficacy) of medical devices, as provided for by the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act; and eliminating unnecessary human exposure to man-made radiation from medical, occu- pational, and consumer products, as provided for by the Radiation Control for Health and Safety (RCHS) Act of 1968. CDRH classifies each type of device into the appropriate regulatory control category (Class I, devices requiring only general controls; Class II, devices requiring standards; and Class III, devices requiring premarket approval). CDRH applies general controls, such as labeling, registration, listing, Good Manufacturing Practices, and repair/re- place/refund requirements. It develops performance standards for Class II devices; conducts premarket review of new devices through the premarket notification, pre- market approval, and product development protocol provisions of the Amendments; and encourages the discovery and development of useful new devices, while protecting the rights and safety of human subjects in testing of devices. In the area of radiological health, CDRH conducts epidemiological and experimental research to assess the risk from various forms and sources of radiation; develops radiation measurement instruments and methods useful in evaluating radiation-emit- ting devices and products; develops performance standards for radiation-emitting devices and products; develops guidelines for the use of radiation-emitting devices and products to prevent unnecessary radiation exposure; and implements survey programs to determine trends in, and the current state of the use of radiation-emitting devices and products. The CDRH review and approval process generates Premarket Approval Applications (PMAs), Summaries of Safety and Effectiveness Data (SSED), and other reports. Purpose: To ensure the safety and effectiveness of medical devices; to eliminate unnecessary human exposure to man-made radiation from medical, occupational, and consumer products; and to educate consumers, industry, and health professionals to enable them to make more informed judgments. (Note: CDRH assessment activities primarily address efficacy as the term is used in this Directory, especially with regard to premarket approval of new devices. The agency- uses the term effectiveness in characterizing its activities because this term is ~.~1 in the agency's legislative language.) Primary intended users: General public; people concerned about their health; pa- tients; providers, generally; health product manufacturers. Technologies: Devices, medical or surgical procedure, support system. Intervention: Diagnosis, treatment, prevention. Stage: Emerging, new, established or widespread practice, obsolete. Emerging and new technologies are assessed to prevent problems; mature technologies are assessed to solve problems. Properties: Safety; efficacy; effectiveness. 95

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Medical devices are assessed for safety and effectiveness (efficacy) in their broadest sense; certain radiological screening procedures are also assessed for medical produc- tivity. Selection process: Manufacturers submit an application to initiate PMAs. Other topics are selected internally and assessment of topic priorities are established as part of the program planning process. New information, particularly awareness of an unforeseen problem, can lead to reassessment. Methods: Information syntheses, group judgment, expert opinion for device premarketing approval; also, epidemiological and other observational methods for postmarketing surveillance of devices and for radiological health. The assessment process is usually conducted by panels who base their assessments on information synthesized by CDRH staff. Some assessments are prepared internally by the scientific staff. PMAs have a statutory turnaround time of 180 days; other projects may average 2 to 3 years, with a range from 1 to 5 years. Assessors: The panel members are usually clinicians who are experts in the field and may be experienced in the use of similar technologies. Assessment reports include: Abstract; the assessment's intended audience; the pur- pose of the assessment; relationship of this assessment to prior or concurrent assess- ments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; proper- ties assessed; procedure used for the assessment; sources of data/information; methods for collecting data/information; methods for analyzing/synthesizing data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; development of the technology; regulatory agency approval status; summary of pre-clinical and clinical data. Dissemination: Printed reports, journal articles. Reports are available from either the National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161 or the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. Assessment results may also be published in the Federal Register. Budget: Not provided. The approximate cost for a PMA is $24,000 and for x-ray criteria, $270,000. Funding source: 100 percent parent organization. Use: SSEDs, by statute, are required for the information of parties outside the organi- zation. Other types of assessments are used to develop educational or regulatory strategies. Based on requests for copies and references in other documents, the assess- ments are used by manufacturers, other government agencies, and foreign govern- ments. Modifications of medical practice indicate that physicians also use the assess- ments. 96

FDAICENTER FOR DEVICES AND RADIOLOGICAL HEALTH Related activities: CDRH coordinates several postmarketing surveillance activities for medical devices and in vitro diagnostic (laboratory) products. The Device Experience Network (DEN) is a computer database system that collects, stores, and retrieves problem reports for these products submitted voluntarily by health professionals. The Medical Device and Laboratory Product Problem Reporting Program (POP) provides DEN with its primary source of device experience information. PRP is funded by FDA, and is conducted by the United States Pharmacopeia. The Medical Device Reporting (MDR) database, established following enactment of the 1984 MDR regulations, con- tains mandatory reports from manufacturers and importers pertaining to device per- formance failures and malfunctions that have resulted in injury, death, or any hazard to safety. Completed Reports FA1 Alcon Laboratories, Inc. (Food and Drug Adminis- tration, Center for Devices and Radiological Health] Scanlens (Scafilcon A contact lens): summary of safety and effectiveness. 1987 Jan 16. (PMA no. P850033- 000). FA2 Paragon Optical Inc. [ ] Paraperm E.W. blue rigid gas permeable contact fen: summary of safety and effectiveness. 1987 Feb 18. (PMA no. P850038-000). FA3 Precision-Cosmet., Inc. ~ ~ Kelman (TM) omnific II model 2100: summary of safety and effec- tiveness. 1987 Feb 2. (PMA no. P850059-000). FA4 Scimed Life Systems, Inc. ~ ~ Scimed PTCA dilatation catheter: summary of safety and effective- ness. 1987 Ian 16. (PMA no. P860019-000). FA5 Stericon Laboratories. ~ ~ Stericon saline so- lution: summary of safety and effectiveness.1987 fan 16. (PMA no P850070-000). FA6 Abbott Laboratories. ~ ~ Abbott anti-delta diagnostic kit (RIA): summary of safety and effective- ness. 1986 Aug 7. (PMA no. P850062-000). FA7 Advanced Biosearch Assn. ~ ~ Orthopak (R) bone growth stimulator: summary of safety and effec- tiveness. 1986 Apr 9. (PMA no. P850022-000). FA8 Akorn, Inc. ~ J Sodium chloride tablets, USP: summary of safety and effectiveness. 1986 Mar 14. (PMA no. 850037-000). FA9 Allergan Pharmaceuticals, Inc. ~ ~ Oxysept system: summary of safety and effectiveness. 1986 Nov 20. (PMA no. P850088-000). FA10 American Edwards Division of American Supply Corporation. ~ ~ Duromedics bileaflet heart valve: summary of safety and effectiveness. 1986 Sep 26. (PMA no. P850006-000). FA11 American Edwards Laboratories. ~ ~ Amer. Ed. Labs. PTCA: summary of safety and effec- tiveness. 1986 Tul 9. (PMA no. P850021-000). FA12 American Medical Electronics, Inc. ~ ~ Phy- sio-stim (TM) I & II Model 6000 & 7000: summary of safety and effectiveness. 1986 Apr 18. (PMA no. P850007-000). FA13 Barnes-Hind Inc. [ ~ Softmate (R) hydro- gen peroxide disinfection system: summary of safety and effectiveness. 1986 Oct 6. (PMA no. P840066- 000). FA14 Bausch & Lomb (R) i ; B & L (R) (Amefo- con A) oxygen permeable lens: summary of safety and effectiveness. 1986 Aug 7. (PMA no. P830050- 000). FA15 Bausch & Lomb (R). ~ ~ B & L sterile all purpose solution & contact cleaner: summary of safe- ty and effectiveness. l 986 Dec 16. (PMA no. P830002- 000). FA16 Bausch & Lomb. ~ ~ B & L Sensitive Eyes (TM) saline/cleaning solution: summary of safety and effectiveness. 1986 Jul 7. (PMA no. 850036-000). FA17 Bausch & Lomb. ~ 1 B & L Therma-zyne, Fizziclean: summary of safety and effectiveness. 1986 Nov 5. (PMA no. P850093-000). FA18 Bausch & Lomb. ~ ~ Sensitive eyes chemical disinfectant: summary of safety and effectiveness. 1986 Jan 2. (PMA no. P840020-000). FA19 Bausch & Lomb. ~ ~ Silsoft (Elastofilcon A) contact lenses: summary of safety and effectiveness. 1986 Feb 2. (PMA no. P850068-000). FA20 Blairex Laboratories, Inc. ~ ; Blairex sterile saline solution: summary of safety and effectiveness. 1986 Mar 6. (PMA no. P850045-000). 97

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY FA21 Briggs Ophthalmics Corp. ~ ~ Sunsoft (Methafilcon A) hydrophilic contact lens: summary of safety and effectiveness. 1986 Aug 7. (PMA no. P850077-001). FA22 Briggs Ophthalmics Corporation. [ ] Sun- soft (Methaf~lcon A) hydrophilic contact lens: summa- ry of safety and effectiveness.1986 Mar 28. (PMA no. P850077-000). FA23 CTL, Inc. [ ] Customeyes (TM) 45L & 55L (Bufilcon A): summary of safety and effectiveness. 1986 Jul 1. (PMA no. P850057-000). FA24 CTL, Inc. ~ ~ Customeyes 70L & 79L (Li- dofilcon A & B): summary of safety and effectiveness. 1986~iul 1. (PMA no. P850058-0()0). FA25 Cardiac Pacemakers, Inc. ~ ~ Models 925, 2040, 2041, 6564: summary of safety and effective- ness. 1986 Jan 24. (PMA no. P840068-000). FA26 Carl Zeiss, Inc. ~ ~ Visulas Nd:Yag laser: summary of safety and effectiveness. 1986 Aug 7. (PMA no. P850083-000). FA27 C:ilco, Inc. ~ ~ Sodium chrondroitin sulfate: summary of saf'ety and effectiveness. 1986 Nov 5. (PMA no. P82()()79-()00). FA28 (~ilco. [ ] Viscoat (TM): summary of safety and ef'f'ectiveness. 1986 ~un 6. (PMA no.P840064- ()()()). FA29 C:oast (~ontact Lens, Inc. ~ ~ Hydra (Metha- filc`'n A) contact lens: summary of saf'ety and effec- tiveness. 1986 Aug 7. (PMA no. P850()79-001). FA30 (~oast C:ontact Lens, Inc. ~ ; Hydrasoft (Methaf~lcon A) contact lens: summary of safety and ef'fectiveness. 1986 Mar 28. fPMA no. P850079-000). FA31(:oburn Optical Industries. ~ ~ Intraocular lens: summary of safety and ef'fectiveness. 1986 Dec 16. (PMA no. P860002-000). FA32 Coburn Optical. ~ ]~} loop posterior cham- bc~r type lI 0 & I0: summary of safety and effective- ness. 1986 ~ul 1. (PMA no. P840039-000). FA33(:oherent Medical Division. ~ ~ Neodymiu- m:Yag ophthalmic laser system 9900: summary of saf'ety and effectiveness. 1986 Dec 31. (PMA no. PS3()054-00o) FA34 C:oopervision Cilco. ~ ~ Optiflex anterior chamber lenses (L1-L5): summary of safety and effec- tiveness. 1986 ~un 18. (PMA no. P8200035-000). FA35C:oopervision Cilco. ~ ~ SM-1, CR-1, & GR- l IOL S: summary of safety and effectiveness. 1986 Jun 11. (PMA no. P840060-000). 98 FA36 Coopervision, Inc. ~ ~ Coopervision perox- ide system: summary of safety and e~ctiveness.1986 Mar 12. (PMA no. P830023-000). FA37 Coopervision, Inc. ~ ~ Mirasoak (TM) rins- ing, disinfecting & storage solution: summary of safe- ty and effectiveness. 1986 Aug 18. (PMA no. P810038-000). FA38 Coopervision. ~ ~ Miraflow extra strength cleaner: summary of safety and effectiveness. 1986 Nov 5. (PMA no. P850055-000). FA39 Corometrics Medical Systems, Inc. Model 515 neonatal monitor: summary of safety and effectiveness. 1986 Jan 31. (PMA no. P840037-000). FA40 Custom Tint Lab., Inc. ~ ~ Permatint (R): summary of safety and effectiveness. 1986 Mar 14. (PMA no. P820059-000). FA41 Custom Tint Lab., Inc. ~ ; Permatint (R): summary of safety and effectiveness. 1986 Mar 26. (PMA no. P820059-000). FA42 Datoscope Corporation. ~ ~ Novacol (TM) textured collagen hemostatic agent: summary of safe- ty and effectiveness. 1986`Jul 7. (P\IA no. P850023- 000). FA43 Dey Laboratories, Inc. ~ ~ Dey-vial (R): summary of safety and effectiveness. 1986 Apr 1. (PMA no.P840061-000). FA44 Elscint, Inc. ~ J Gyrex, models S3500 & S5000: summary of safety and effectiveness.1986 Sep 9. (PMA no. P840007-000). FA45 Ethicon, Inc. ~ ~ PDS suture (dyed): sum- mary of safety and effectiveness. 1986 [ul 22. (PMA no. N18331-016). FA46 Food and Drug Administration, Center for De- vices and Radiological Health. A practioner's guide to the ultrasonic therapy equipment standard. 1986. (NTIS Order No. PB86-113933/AS). FA47 . Basic concepts in the selection of patients for dental x-ray examinations. 1986. (GPO Stock No. 017-015-00230-6, NTIS Order No. PB86- 126067/ AS). FA48 . Computer program for absorbed'dose to the breast in mammography. 1986. (GPO Stock No. 017-015-00228-4, NTIS Order No. PB86-114774/ AS). FA49 . Embryo, fetus, infant . . . recommenda- tions to minimize diagnostic nuclear medicine expo- sure. 1986. (FDA Pub No. FDA86-8254).

FDA/CENTER FOR DEVICES AND RADIOLOGICAL HEALTH FA50 . Evaluation of radiation exposure from diagnostic radiology examinations technique/expo- sure guides for the craniocaudal projection in mam- mography. 1986. (NTIS Order No. PB86-126075/ AS). FA51 . Evaluation of radiation exposure from diagnostic radiology examinations: general recom- mendations. 1986. (NTIS Order No. PB86-125903/ AS). FA52 . Problem definition study: rubella anti- body testing. 1986. (NTIS Order No. PB86- 131935~. FA53 . Recommendations for evaluation of radi- ation exposure from diagnostic radiology examina- tions. 1986. (NTIS Order No. PB86- 125846/AS). FA54 .To cement or not to cement? or has the FDA approved the use of this device? 1986. (FDA Pub No. FDA86-4202~. FA55 Gambro, Inc. ~ ~ Gambro fiber plasma- filter: summary of safety and effectiveness. 1986 Jul 7. (PMA no. P83006-000~. FA56 Gish Biomedical, Inc. ~ ~ Micro Yag Nd:Yag laser system: summary of safety and effec- tiveness. 1986 May 30. (PMA no. P850063-000~. FA57 Gynotech, Inc. ~ ~ Dilapan (TM): summary of safety and effectiveness. 1986 Jun 11. (PMA no. P840045-000~. FA58 Helitrex, Inc. ~ ~ Collacote (TM): summary of safety and effectiveness. 1986 tan 2. (PMA no. P840062-000~. FA59 Hilitrex, Inc. ~ ] Helistat (TM) absorbable collagen hemostatic sponge: summary of safety and effectiveness. 1986 Jan 2. (PMA no. P850010-0001. FA60 Hybritech Inc. ~ J Tandem (R)-R carcin- oembryonic antigen assay: summary of safety and effectiveness. 1986 Jul 1. (PMA no. P840019-000~. FA61 Hybritech Inc. ~ ~ Tandem-it PSA immun- oradiometric assay: summary of safety and effective- ness. 1986 Apr 9. (PMA no. P850048-0001. FA62 Iolab Corp. ~ ~ Model 91-50 IOL: summa- ry of safety and effectiveness. 1986 Feb 14. (PMA no. P820044-000~. FA63 Iolab. ~ ~ Microruptor MR-2 Nd:Yag laser system: summary of safety and effectiveness. 1986 Mar 28 (PMA no. P840012-0001. FA64 Kontur Kontact Lens Co. Inc. ~ ~ Kontur soft (Methafilcon A) contact lens: summary of safety and effectiveness. 1986 Aug 7. (PMA no. P850078- 0001. FA65 Kontur Kontact Lens Co. Inc. ~ ~ Kontur soft (Methaf~lcon A) contact lens: summary of safety and effectiveness. 1986 Mar 28. (PMA no. P850078- 0001. FA66 Litton Datamedix. ~ ~ Litton transcutan- eous C02 system: summary of safety and effective- ness. 1986 Sep 26. (PMA no. P850087-0001. FA67 Medi-tech. ~ ~ Med-tech coronary balloon dilatation catheter system: summary of safety and ef- fectiveness. 1986 Feb 10. (PMA no. P840040-000~. FA68 Medtronic, Inc. ~ ~ Activitrax models 8400, 8402, 8403: summary of safety and effectiveness. 1986 Jul 11. (PMA no. P850051-0001. FA69 Medtronic, Inc.; ~ Medtronic (R) scoliosis system, model 3100-2: summary of safety and effec- tiveness. 1986 Jan 2. (PMA no. P840022-0001. FA70 Medtronic, Inc.; ~ Steroid tip (TM) model 4503 & 4003 transvenous pacing: summary of safety and effectiveness. 1986 Aug 22. (PMA no. P830061- 0001. FA71 Medtronic. ~ ~ Model 5525 transvenous atrial & Model 5025 ventrical: summary of safety and effectiveness. 1986 Aug 22. (PMA no. P850089-000~. FA72 N & N Menicon Inc. ~ ~ (Mafilcon) soft contact lenses: summary of safety and effectiveness. 1986 Dec 17. (PMA no. PB00031-0001. FA73 National Patent Development Corp. ~ ~ GE-lOlE caries removal agent/system: summary of safety and effectiveness. 1986 May 2. (PMA no. P830035-000~. FA74 Oculua Contact Lens Company. ~ ~ Ocusil (TM) contact lens: summary of safety and effective- ness. 1986 tan2. (PMA no. P840050-0001. FA75 Ocumed Inc. ~ ~ Sodium chloride tablets 250 MG: summary of safety and effectiveness. 1986 Mar 12. (PMA no. P850016-000~. FA76 Optical Radiation Corporation. ~ ~ Styles 31-34 posterior IOLS: summary of safety and effec- tiveness. 1986 Jun 18. (PMA no. P830056-0001. FA77 Organon Teknika C`orp. ~ ~ Hepanostika (TM) HBEAG/anti HBE microelisa (TM) system: summary of safety and effectiveness. 1986 Jul 1. (PMA no. P840070-000~. FA78 Pacemaker Systems, Inc. a Siemens Co. ~ ~ DDD pulse generator 674: summary of safety and effectiveness. 1986 Sep 8. (PMA no. P840014-0001. FA79 Paco Pharmaceutical Services, Inc. ~ ~ Non- preserved saline solution: summary of safety and ef- fectiveness. 1986 Sep 23. (PMA no. P850025-000~. 99

MEDICAL IrCHNOLoGy ASSESSMENT DIRECTORY FA80 Paco Pharmaceutical Services, Inc. ~ ~ Sor- bic acid preserved daily cleaner: summary of safety and effectiveness. 1986 Nov 10. (PMA no. P850076- 000~. FA81 Paco Pharmaceutical Services, Inc. ~ ~ Sor- bic acid preserved lens lubricant: summary of safety and effectiveness. 1986 Oct 9. (PMA no. P850075- 0001. FA82 Paco Research Corp. ~ ~ Charter Labs sa- line solution: summary of safety and effectiveness. 1986 Dec 17. (PMA no. P840069-000). FA83 Permeable Contact Lenses, Inc. ~ ~ SOP lens (TM): summary of safety and effectiveness.1986 Jan 21. (PMA no. P840055-000~. FA84 Phillips Medical Systems, Inc. ~ ~ Gyroscan (TM): summary of safety and effectiveness. 1986 Sep 16. (PMA no. P840063-0001. FA85 Roche Diagnostic Systems. ~ ~ Cobas bact: summary of safety and effectiveness. 1986 Jul 7. (PMA no. P840065-000~. FA86 Sarn, Inc. [ ~ Therapore (TM) system: summary of safety and effectiveness. 1986 Dec 24. (PMA no. 850092-0004. FA87 Seecor, Inc. [ ~ Stat-Pace II: summary of safety and effectiveness. 1986 Jul 1. (PMA no.P840002-0001. FA88 Sharplan Lasers Inc. ~ ~ Model 702: sum- mary of safety and effectiveness. 1986 May 8. (PMA no. P850060-000~. FA89 Sorin Biomedica, Fiat, USA Inc. [ ~ AB- Core K hepatitis B core antigen 1251: summary of safety and effectiveness. 1986 Apr 10. (PMA no. P850044-000~. FA90 Stericon Laboratories. [ ~ Crystalens saline spray: summary of safety and effectiveness. l 986 Mar 24. (PMA no. P850065-000~. FA91 Syntex Opthalmics Inc. [ ~ Polycon contact lens: summary of safety and effectiveness. 1986 Feb 10.(PMA no. N18120-015~. FA92 Telectronics LTD. [ ~ Telectronics pasar model 4171 PG: summary of safety and effectiveness. 1986 Nov 10. (PMA no. P850027-000~. FA93 Thompson CGR Medical Corp. ~ ~ Magnis- can 5000 MRI System: summary of safety and effec- tiveness. 1986 Oct 6. (PMA no. 850043-000~. FA94 Toray Industries Inc. ~ ~ Toray soft contact lenses: summary of safety and effectiveness. 1986 Mar 5. (PMA no. P840044-000~. ~oo FA95 Travenol Labs, Inc. ~ ~ Gamma dab (1251) AFP RIA kit: summary of safety and effectiveness. 1986 Jun 17. (PMA no. P790032-0004. FA96UCO Optics, Inc. [ ~ Aquasept II: summa- ry of safety and effectiveness. 1986 Feb 14. (PMA no. N 17679-008~. FA97 University Optical Products Co. [ ~ The Boston lens II Alges (R) bifocal contact lens: summary of safety and effectiveness. 1986 Jan 24. (PMA no. P850008-000~. FA98 University Optical Products Company. [ ~ Alges (TM) (Hefilcon A) contact lens: summary of safety and effectiveness. 1986 Apr 28. (PMA no. P850002-000~. FA99 W.L. Gore & Assoc., Inc. [ ~ Gore-Tex (R) expanded PTFE suture: summary of safety and effec- tiveness.l986 Feb 28. (PMA no. P820083-000~. FA100 W.L. Gore & Associates, Inc. ~ ~ Gore-tex expanded PTFE prosthetic ligament: summary of safety and effectiveness. 1986 Nov 18. (PMA no. P850074-000~. FA101 Wesley-Jessen. [ ~ Durasoft 4 (ofilcon A) spherical hydrophilic lens: summary of safety and effectiveness. 1986 Aug 14. (PMA no. P85~. FA102 Alcon Labs., Inc. [ ~ Polquat disinfection system: summary of safety and effectiveness. 1985 Sep 18. (PMA no. P830034-000~. FA103 Allergan. [ ~ Model no. ALS-IV heat dis- infection unit: summary of safety and effectiveness. 1985 May 20. (PMA no. P840054-000~. FA104 Bausch & Lomb. [ ~ B & L 58 (TM) (Eta- filcona) contact lens: summary of safety and effective- ness. 1985 Sep 23. (PMA no. P850039-0001. FA105 Bausch & Lomb. [ ~ B & L Sensitive Eyes (TM) daily cleaner: summary of safety and effective- ness. 1985 Jul 9. (PMA no. P830013-000~. FA106 Cardiac Pacemakers, Inc. [ J AID-B auto- matic implantable cardiovertor def~brillator: summa- ry of safety and effectiveness.1985 Nov 15. (PMA no. P830060-000~. FA107 Centers for Disease Control. [ ~ AFP mid- pregnancy reference preparation: summary of safety and effectiveness. 1985 Jan 3 (PMA no. P820077- 0001. FA108 Cilco. [ ~ Cilco Nd:Yag laser: summary of safety and effectiveness. 1985 Sep 11. (PMA no. P840047-000~.

FDA/CENTER FOR DEVICES AND RADIOLOGICAL HEALTH FA109 Clin-Therm Corporation. ~ ~ Clini- Therm Mark I/IV: summary of safety and effective- ness. 1985 Sep 11. (PMA no. P840015-0001. FA110 Coopervision Inc. ~ ~ Horizon (TM) Yag laser model 2000: summary of safety and effective- ness. 1985 Aug 15. (PMA no. P850001-000~. FAlll Davis & Geck. ~ ~ Novafil (TM): summary of safety and effectiveness. 1985 Nov 18. (PMA no. P840041-000). FA112 Depuy, Inc. [ ] New Jersey integrated knee replacement system: summary of safety and ef- fectiveness. 1985 May 20. (PMA no. P830055-0001. FA113 Depuy, Inc. ~ ; New Jersey integrated knee replacement system: summary of safety and ef- fectiveness. 1985 May 20. (PMA no. P830055-002J. FA114 Dornier System GMBH. ~ ~ Dornier litho- tripter, model HM3: summary of safety and effective- ness. 1985 Jan 16. (PMA no. P840008-000~. FA115 Drs. Lloyd and Mary Garren. ~ ~ Garren gastric bubble: summary of safety and efectiveness. 1985 Oct 29.(PMA no. P840025-0004. FA116 Food and Drug Administration, Center for De- vices and Radiological Health. Assessment and modi f~cation of clinical utility in diagnostic radiology: the oral cholecystogram and the upper gastrointestinal examinations. 1985. (NTIS order no. PB-85-246916/ AS). FA117 . Evaluation of radiation exposure from diagnostic radiology examinations (technique/expo- sure guides for the dental bitewing projection). 1985. (FDA pub no. 85-8245~. FA118 . Extremity radiography following trau- ma: an overview. 1985. (GPO Stock No. 017-015- 00224- 1, NTIS order no. PB85- 115053~. FAll9 . Handbook of glandular tissue doses in mammography. 1985. (NTIS order no. PB85- 209914/AS). FA120 . Patient exposure reduction during sco- liosis radiography. 1985. (GPO stock no. 017-015- 00227-61. FA121 . Quality control guide for sunlamp products. 1985. (NTIS order no. PB85-124808~. FA122 . Recommendations for quality assur- ance programs in nuclear medicine facilities. (GPO stock no. 017-015-00225-0, NTIS order no. 85- 145720/AS). FA123 . Reducing patient exposure during sco- liosis radiography. 1985. (FDA pub no. FDA 85- 8252~. FA124 . Surface cracking of polyurethane tub- ing resulting from subcutaneous implantation in dogs. 1985. (NTIS order no. PB85- 171619/AS). FA125 . Therapeutic microwave and shortwave diathermy: a review of thermal effectiveness, safe use, and state of the art: 1984. 1985. (GPO stock no. 017- 015-00226-8, NTIS order no. PB85- 170165/AS). FA126 Frigitronics, Inc. ~ ~ Saturn II (TM) (Syn- ergicon A) contact lens: summary of safety and effec- tiveness. 1985 Mar 22 (PMA no. P840004-000J. FA127 General Electric, Co. ~ ~ GE signa magnet- ic resonance diagnostic imaging system: summary of safety and effectiveness. 1985 Jun 5. (PMA no. P830074-0001/ FA128 Heyer Schulte Corp. ~ ~ Sauflon (R) PW (Lidofilcon B': summary of safety and effectiveness. 1985 May 10. (PMA no. P790020-008~. FA129 Heyer Schulte Corp. [ ] Sauflon (r) 70 (Lidofilcon A): summary of safety and effectiveness. 1985 May 10 (PMA no. P790020-002~. FA130 Hoffman-La Roche Inc. ~ ~ CEA-Rooche (R) EIA: summary of safety and effectiveness. 1985 Jun 12. (PMA no. P840027-000~. FA131 Hybritech, Inc. l l Tandem (R)-E AFP: summary of safety and effectiveness. 1985 May 23. (PMA no. P840035-0004. FA132 Hydracon. [ ] Hydracon (R) contact lenses: summary of safety and effectiveness. 1985 Nov 19. (PMA no. P820017-001). FA133 International Hydron Corp. [ ] X-70 soft contact lens: summary of safety and effectiveness. 1985 May 10. (PMA no. P830047-000~. FA134 [ohnson & Johnson. ~ ~ 3-Coil (TM) colla- gen absorbable hemostat: summary of safety and ef- fectiveness. 1985 Nov 15. (PMA no. 830079-000~. FA135 Kallestad Labs, Inc. ~ l Quantitope 1251 AFP kit and control serum: summary of safety and effectiveness. 1985 Feb 17. (PMA no. PB00025-0004. FA136 Lasers for Medicine, Inc. ~ ~ Phototome (TM) system 2700: summary of safety and effective- ness. 1985 Sep 18. (PMA no. P850019-000~. FA137 McGhan/3M. ~ ~ Styles 30 & 31 posterior chamber IOLS: summary of safety and effectiveness. 1985 Oct 17. (PMA no. P830040-0001. FA138 Medical Inc. ~ ~ Omniscience prosthetic cardiac valve: summary of safety and effectiveness. 1985 Sep 11. (PMA no. P830039-000~. ~o'

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY FA139 Medical Lasers, Inc. [ ~ Meditec OPL3 Nd:Yag laser: summary of safety and effectiveness. 1985 Feb 21. (PMA no. P830025-000). FA140 Medtronic, Inc. ~ ~ Itrel (R) totally im- plantable spinal cord stimulation system: summary of safety and effectiveness. 1985 Ian 2. (PMA no. P840001-000). FA141 National Patent Development Corporation. ~ ~ Hydron hydrophilic contact lens: summary of safety and effectiveness. 1985 Nov 18. (PMA no. P78007-016). FA142 Nucleus LTD. ~ ~ Nucleus multichannel implantable hearing prosthesis: summary of safety and effectiveness. 1985 Dec 9. (PMA no. P840024-000). FA143 Optical Plastic Research. ~ ~ Softview spherical & toric contact lens: summary of safety and effectiveness. 1985 Feb 20. (PMA no. P830003-000). FA144 Paris Contact Lens Lab. ~ ~ Softsite (Hefil- con A) contact lens: summary of safety and effective- ness. 1985 Nov 21. (PMA no. N17793-006). FA145 Pharmafair, Inc. ~ ~ Saltair tablets (250MG): summary of safety and effectiveness. 1985 Jun 5. (PMA no. P840034-000). FA146 Product Development Corp. ~ ~ Soft hy- drophilic contact lens: summary of safety and effec- tiveness. 1985 Nov 21. (PMA no. P850041-000). FA147 Repro-Med System, Inc. ~ ~ Repro-Med- THD: summary of safety and effectiveness. l 985 ~an 25. (PMA no. P820034-000). FA148 Salvatori Ophthalmics, Inc. ~ ~ Synsoft (TM) (polymacon) bifocal contact lens: summary of safety and effectiveness. 1985 Mar 22. (PMA no. P840006-000). FA149 Siemans Medical Systems, Inc. ~ ~ Magne- tom: summary of safety and effectiveness.1985 Jan 2. (PMA no. P830081-000). FA150 Soft Lense Inc. ~ ~ Hydrocurve II bifocal lens: summary of safety and effectiveness. 1985 Mar 22. (PMA no. N 17752-016). FA151 Surgidev Corp. ~ ~ Style 17 & 17A posteri- or chamber IOLS: summary of safety and effective- ness. 1985 Oct 17. (PMA no. P830033-000). FA152 University Optical Products Company. ~ ~ Alges (TM) (Hefilcon A) contact lens: summary of safety and effectiveness. 1985 Dec 4. (PMA no. 850002-000). 102 FA153 Visiontech, Inc. ~ ~ Sauflon PW-70 A & B: summary of safety and effectiveness. 1985 Jun 19. (PMA no. P840031-000). FA154 Wesley Jessen. ~ ~ Airlens (R) (Airfocon A) lens blue & clear: summary of safety and effective- ness. 1985 Jan 18. (PMA no. P830070-000). FA155 Wesley-Jessen. ~ ~ Durasoft (R) 3 for ex- tended wear: summary of safety and effectiveness. 1985 Sep 11. (PMA no. P830039-000). FA156 3M. ~ ~ 3M brand cochlear implant sys- tem/house design: summary of safety and effective- ness. 1984 Dec 24. (PMA no. P830069-000). FA157 Abbott Laboratories. ~ ~ Abbott CEA-EIA kit: summary of safety and effectiveness. 1984 Aug 21. (PMA no. P830066-000). FA158 Abbott Labs. ~ ~ Corzyme (TM)-M diag- nostic kit: summary of safety and effectiveness. 1984 tan 26. (PMA no. P830014-000). FA159 Abbott. t_ ~ Abbott AFP: summary of safe- ty and effectiveness.1984 Jul 25. (PMA no. P780005- 000). FA160 Advanced Optical Inc. ~ ~ Softics (TM) (polymacon): summary of safety and effectiveness. 1984 Ju13. (PMA no. P830012-000). FA161 Alden Optical Labs., Inc. ~ ] AL-47 soft contact lens: summary of safety and effectiveness. 1984 Mar 9. (PMA no. P820078-000). FA162 Allergan Optical. ~ ~ The soft lens ther- mal disinfecting unit: summary of safety and effec- tiveness. 1984 Jan 4. (PMA no. P820082-000). FA163 Allergan Pharmaccuticals, Inc. ~ ~ ND:Yag posterior capsulotomy model 100: summary of safety and effectiveness. 1984 Nov 26. (PMA no. P830062-000). FA164 Amersham Corporation. [ ~ Amersham AFP: summary of safety and effectiveness.1984Jul 6 (PMA no. P78006-000). FA165 Analytab Products, Inc. [ ~ Uniscept (TM): summary of safety and effectiveness.1984 Apr 25. (PMA no. P830028-000). FA166 BSD Medical Corp. [ ~ BSD 1000 hyper- thermia system: summary of safety and effectiveness. 1984 Aug 27. (PMA no. P820088-002). FA167 BSD Medical Corporation. [ ~ BSD 1000 hyperthermia system: summary of safety and effec- tiveness. 1984 Jan 25. (PMA no. P820088-000).

FDA/CENTER FOR DEVICES AND RADIOLOGICAL HEALTH FA168 Barnes-Hind Pharmaceuticals.; ~ Gas permeable regimen: summary of safety and effective- ness. 1984 Apr 25. (PMA no. P820053-000~. FA169 Biotronik Sales, Inc. ~ ~ Diplos model 03: summary of safety and effectiveness. 1984 Apr 6. (PMA no. P820076-000). FA170 CIBA Vision Care Corporation. ~ ~ Ciba- tint (TM) tinting process: summary of safety and ef- fectiveness. 1984 Apr 10. (PMA no. P820086-000~. FA171 Coburn Optical Industries, Inc. ~ ~ Neo- dymium-Yag op laser OPL-3: summary of safety and effectiveness. 1984Sep 7. (PMA no. P830064-0001. FA172 Coherent Medical Division. ~ ~ Neody- mium:Yag ophthalmic laser system 9900.: summary of safety and effectiveness. 1984 Soul 30. (PMA no. P830054-0001. FA173 Comfort Flex Hydrophilics Inc. ~ ~ TRI POL 43 contact lens: summary of safety and effective- ness. 1984 Apr 17. (PMA no. P780013-004~. FA174 Diasonics, Inc. ~ ~ Diasonics NMR imag- ing system: summary of safety and effectiveness.1984 Apr 25. (PMA no. P830053-000J. FA175 Dow Corning Wright ~ ~ CMW bone ce- ment: summary of safety and effectiveness. l 984 Apr 24. (PMA no. N18466-0001. FA176 EM Labs. ~ ~ Palacos R bone cement: sum- mary of safety and e~ectiveness. 1984 Feb 28. (PMA no. P810020-000~. FA177 Fonar Corp. ~ ~ Fonar NMR whole body scanner beta 3000: summary of safety and effective- ness. 1984 Nov 13. (PMA no. P830076~. FA178 Food and Drug Administration, Center for De- vices and Radiological Health. A basic quality assur- ance program for small diagnostic radiology facilities. 1984. (NTIS order no. PB84- 119098~. FA179 . A study of DC defibrillator safety and performance performance and safety standard- volume II. 1984. (NTIS order no. PB84- 188838~. FA180 . A study of the common characteristics, hazards, and performance problems of endoscopes and endoscopic accessories. 1984. (NTIS order no. PB84- 187202~. FA181 . An investigation of cerebrospinal fluid shunt valves test results for twenty-five valves: final report Phase III. FA182 . Computerized treatment planning sys- tems proceedings of a symposium held at Henry Ford Hospital, Detroit, Michigan. 1984. (NTIS order no. 84-1551181. FA183 . Development of test methods and draft standard for cardiac monitors. l 984. (NTIS order no. PB84- 187756~. FA184 . Development of test methods for dis- posable ECG electrodes Volume I. 1984. (NTIS or- der no. PB84-193960~. FA185 . Evaluation of automated differential cell counting devices Volume I: review of literature and labeling. 1984. (NTIS order no. PB84-189356~. FA186 . Hypodermic thermocouple tissue cry- ometers. 1984. (NTIS order no. PB84- 190776~. FA187 . Instrumentation for nonionizing radia- tion measurement. 1984. (NTIS order no. 84- 180603~. FA188 . Investigation and studies in electrosur- gery. 1984. (NTIS order no. PB84- 191634~. FA189 . Problem definition study in liquid crys- tal ~rehead temperature strips. 1984. (NTIS order no. PB84-187483~. FAl90 . Prosthetic heart valves: a study of in vitro performance, phase II final report part II.1984. (NTIS order no. PB84-162387~. FAl91. . Prosthetic heart valves: a study of in vitro performance, phase II f~nal report part III. 1984. (NTIS order no. PB84-162395~. FA192 . Prosthetic heart valves: a study of in vitro performance, phase II final report part 1. 1984. (NTIS order no. PB84- 162379~. FA193 . Safety and performance of angiograph- ic and lymphographic injectors. 1984. (NTIS order no. PB84-195544~. FA194 . Safety and performance of resuscita- tors. 1984. (NTIS order no. PB84-195635~. FA195 . Safety and performance of ventilators. 1984.(NTIS Order no. PB84-188721~. FA196 . Standard for cardiac monitors, heart rate meters, and alarms. 1984. (NTIS Order no. PB84-188812~. FA197 Frontier Contact Lense. ~ ~ Hydro mare lenses (hydrophilic): summary of safety and effective- ness. 1984 Sep 17. (PMA no. N18033-006~. FA198 Hydracon. ~ ~ Hydracon (R) contact lenses: summary of safety and effectiveness. 1984 Aug 7. (PMA no. P820017-002~. FAl99 Intermedics Inc. ~ ~ Cosmos (TM) system: summary of safety and effectiveness. 1984 Apr 25. (PMA no. P830026-000~. IO3

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY FA200 Intermedics, Inc. ~ ~ Cybertach (TM) 60 pulse generator & programmer: summary of safety and effectiveness. 1984 Dec 12. (PMA no. P820022- 000). FA201 Medtronic, Inc. ~ ~ Isomed (R) electro- spinal orthosis single channel S: summary of safety and effectiveness. 1984 Jan 25. (PMA no. P810062- 000). FA202 Metrosoft, Inc. ~ ~ Metro 55 (Methafilcon A): summary of safety and effectiveness. 1984 Soul 3. (PMA no. P830077-000). FA203 Ocu-Ease Optical Products, Inc. ~ ~ Ocu- flex: summary of safety and effectiveness. 1984 Apr 25. (PMA no. P820051-000). FA204 Organon Teknika Corp. [ ] Curesis plas- ma separator: summary of safety and effectiveness. 1984 Nov 9. (PMA no. P830010-000). FA205 Pacesetter Systems Inc. ~ ~ Model 283 pulse generator & model 370/375 supports: summary of safety and effectiveness. 1984 Apr 20. (PMA no. P830045-000). FA206 Picker International. ~ ~ Nuclear magnet- ic resonance scanner models NMR 1000: summary of safety and effectiveness. 1984 ~un 8. (PMA no. P830052-000). FA207 Polymer Technology Corporation. ~ ] Boston lens (R) lens-clear: summary of safety and effectiveness. 1984 tan 27. (PMA no. P820065-000). FA208 Radiometer! America. ~ ~ Radiometer TCM- 10 transcutaneous carbon dioxide monitor: summary of safety and effectiveness. 1984 Apr 13. (PMA no. P800043-002). FA209 Radionics, Inc. ~ ] Cosman ICP tele-sen- sor (R): summary of safety and effectiveness. 1984 Nov 21. (PMA no. P820012-000). FA210 Salvatori Ophthalmics, Inc. ~ ~ Paraperm 02 clear & blue lens: summary of safety and effective- ness. 1984 Apr 25. (PMA no. 820062-000). FA211 Syntex Ophthalmics Inc. ~ ~ Soft contact lens: summary of safety and effectiveness. 1984 Tan 17. (PMA no. N 17987-007). FA2 12 Technicare Corporation. ~ ~ Teslacon (TM) NMR imaging system: summary of safety and effectiveness. 1984 Apr 25. (PMA no. P830051-000). FA213 Vision Ease Contact Lens Co. ~ ~ VE soft hydrophilic contact lens: summary of safety and ef- fectiveness. 1984 Mar 9. (PMA no. P830049-000). IO4 FA214 Wampole Labs. ~ ~ AFP RIA kit: summa- ry of safety and effectiveness. 1984 Feb 17. (PMA no.P76001 -000). FA215 Abbott Labs. ~ ~ Abbott AFP-EIA diag- nostic kit for cancer: summary of safety and effective- ness. 1983 Jul 19. (PMA no. P820060). FA2 16 Alcon Laboratories, Inc. ~ ~ Micro-therm disinfectant unit: summary of safety and effective- ness. 1983 Jan 25. (PMA no. P820041-000). FA217 Alcon Laboratories, Inc. ~ ~ Opti-clean (TM) LC 1323: summary of safety and effectiveness. 1983 May 13. (PMA no. P820036-000). FA218 Alcon Labs, Inc. ~ ~ Alcon enzyme clean- er: summary of safety and effectiveness. 1983 ~an 25.(PMA no. P820001-000). FA219 Allergan Medical Optics. [ ~ Model AC10 & AC20 IOLS: summary of safety and effectiveness. 1983 Aug 16. (PMA no. P810056-000). FA220 Allergan Medical Optics. ~ ~ Models PC 10 & PC21: summary of safety and effectiveness. 1983 Jun 17. (PMA no. P820049-000). FA221 Allergan Pharmaceut~cals, Inc. ~ ~ Lens Plus (TM): summary of safety and effectiveness. l 983 Jul 19. (PMA no. P820050-000). FA222 Amcon Inc. [ ~ The Amcon Way Plus: summary of safety and effectiveness. 1983 Feb 22. (PMA no. P800069-002). FA223 Apothecary Products, Inc. l ~ The nor- maline kit: summary of safety and effectiveness.1983 Jun 17. (PMA no. P800055-002). FA224 Asahi Chemical Industry America, Inc. ~ ~ Plasmaflo AP-05H Asahi plasma separator: summary of safety and effectiveness. 1983 Aug 12. (PMA no. P820033-000). FA225 Avicon, Inc. ~ ~ Microfibrillar collagen he- mostat non-woven web: summary of safety and effec- tiveness. 1983 Feb 15. (PMA no. P800002-000). FA226 Barnes-Hind/Hydrocurve, Inc. ~ ~ Soft lens salt tablets: summary of safety and effectiveness. 1983 Jul 29. (PMA no. P800067-000). FA227 Bausch & Lomb Optics Center. ~ l Sensi- tive Eyes (TM) saline & cleaning solution: summary of safety and effectiveness. 1983 Sep 16. (PMA no. P820031-000). FA228 Bausch and Lomb. i Devics and Radiologi- cal Health] 03/04 (TM) lens series: summary of safety and effectiveness. 1983 Aug 16. (PMA no. N16895- 025).

FDAdCENTER FOR DEVICES AND RADIOLOGICAL HEALTH FA229 Blairex Laboratories, Inc. ~ ~ The Blairex system: summary of safety and effectiveness. 1983 Feb 18. (PMA no. PB00028-003). FA230 Boehringer Mannheim Diagnostics Inc. ~ ~ Micur-mic systems: summary of safety and effectiveness. 1983 Soul 19. (PMA no. P820073-000~. FA231 C.C. Kelly Enterprises. ~ ~ Eyerisol (R): summary of safety and effectiveness. 1983 May 31. (PMA no. P810034-000~. FA232 CIBA Vision Care ~ ~ Salt tablets: summa- ry of safety and effectiveness. 1983 Feb 18. (PMA no. P810015-001~. FA233 CIBA Vision Care Corporation. ~ ~ Septi- con (TM) disinfection regimen for use with . . .: sum- mary of safety and effectiveness. 1983 Apr 8. (PMA no. P820040-000~. FA234 CIBA Vision Care Corporation. ~ ~ Soft- con (Vifilcon A) soft contact extended wear lens: sum- mary of safety and effectiveness. 1983 Apr 29. (PMA no. P820021-000~. FA235 Cabot Medical Corp. ~ ~ Lamicel (TM): summary of safety and effectiveness. 1983 Jul 19. (PMA no. P820075-000~. FA236 Cilco, Inc. ~ ~ Models IS & IP: summary of safety and effectiveness. 1983 Apr 26. (PMA no. P800049-000~. FA237 Cilco, Inc. ~ ~ Posterior chamber intraocu- lar lenses: summary of safety and effectiveness. 1983 Apr 1. (PMA no. P810018-001). FA238 Con-cise. ~ ~ Paraperm 02 contact lens clear & blue: summary of safety and effectiveness. 1983 Dec 8. (PMA no. P820061-000~. FA239 Contact Lens Corporation of America. ~ ~ Softact II (polymacon): summary of safety and effec- tiveness. 1983 Aug 5. (PMA no. P830006-000~. FA240 Coopervision Cilco. ~ ~ Model AC (ACI- AC5~: summary of safety and effectiveness.1983 Apr 12. (PMA no. P810001-000~. FA241 Coopervision, Inc. [ ~ Heatcase (TM): summary of safety and effectiveness. 1983 Jul 19. (PMA no. P830001-000~. FA242 Cordis Corp. ~ ~ Gemini (R) theta model 415A cardiac pacer: summary of safety and effective- ness. 1983 Dec 7. (PMA no. P830007-000~. FA243 Custom Tint Lab., Inc. ~ ~ Permatint (R): summary of safety and effectiveness. 1983 Nov 9. (PMA no. P820059-000~. FA244 Depuy (R). ~ ~ Prosthesis, hip, hemi-femo- ral, metal: summary of safety and effectiveness. 1983 Sep 16. (PMA no. P820024-0001. FA245 Dow Corning Corporation. ~ ~ Silicon(R) (silafilcon A) contact lens daily wear: summary of safe- ty and effectiveness.1983 Dec 12. (PMA no. P800054- 0041. FA246 Eaton Medical Corporation. ~ ~ Easy Eyes (TM): summary of safety and effectiveness. 1983 ~ul 19. (PMA no. P830009-000~. FA247 Electro-Biology, Inc.; ~ Scolitron (TM) stimulator: summary of safety and effectiveness.1983 Feb 25. (PMA no. P820008-000~. FA248 Food and Drug Administration, Center for De- vices and Radiological Health. Investigation of the risks & hazards with devices associated with peritoneal dialysis (including intermittent dialysis & continuous ambulatory peritoneal dialysis) & sorbent regenerat- ed dialysate delivery systems. 1983. (NTIS order no. PB83- 175984~. FA249 . Vascular catheter devices: a study of safety and performance volume 1. 1983. (NTIS or- der no. PB83-144659~. FA250 . Vascular catheter devices: a study of safety and performance volume 2. 1983. (NTIS or- der no. 83-1446671. FA251 Frigitronics, Inc. ~ ~ Opus-III contact lenses: summary of safety and effectiveness. l 983 Sep 2. (PMA no. P82007al-0001. FA252 Frigitronics, Inc. ~ ~ Softmark: summary of safety and effectiveness. 1983 Jul 19. (PMA no. P820027-0001. FA253 Horizon Pharmacal, Inc. ~ ~ The Horizon system: summary of safety and effectiveness. 1983 Feb 18. (PMA no. P810009-0021. FA254 Hydracon. ~ ~ Hydracon (R) contact lenses: summary of safety and effectiveness. 1983 Mar 25. (PMA no. P820017-000~. FA255 Intermedics Intraocular Inc. ~ ~ Models 011 & 011 B iridocapsular IOLS: summary of safety and effectiveness. 1983 Jan 25. (PMA no. P810042- 0001. FA256 Intermedics Intraocular Inc. ~ ~ Models 019B, 019C, 019E, 019F, 019J, 019K: summary of safety and effectiveness. 1983 Feb 25. (PMA no. P810055-000~. FA257 Kestrel. ~ ~ Kestrel no. 695 heater: sum- mary of safety and effectiveness. 1983 Jun 10. (PMA no. P820087-0001. IO5

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY FA258 Marlin Industries. ~ ~ Marlin squeeze bot- tle & Marlin salt tablets: summary of safety and effec- tiveness. 1983 Feb 18. (PMA no. P800038-001~. FA259 Medtronic, Inc. ~ ~ Versatrax model 7000 universal A-V pulse generator: summary of safety and effectiveness. 1983 Jan 7. (PMA no. P820003- 000). FA260 Narco Scientific. ~ ~ Monitoring system TCPC02: summary of safety and effectiveness. 1983 Feb 15. (PMA no. P820025-000). FA261 National Patent Development Corporation. ~ ~ Hydron (TM) saline system (135 & 250 mg): summary of safety and effectiveness. 1983 Feb 25. (PMA no. P810047-002). FA262 New England Nuclear. ~ J Rianen (TM) (3H) progestin receptor assay kit: summary of safety and effectiveness. 1983 Oct 12. (PMA no. P820052- 000). FA263 Optacryl Inc. ~ ~ Optacryl 60-clear: sum- mary of safety and effectiveness. 1983 Dec 8. (PMA no. P820056-000). FA264 Optech, Inc. ~ ~ Optech fre-flex soft con- tact lens: summary of safety and effectiveness.l983 Feb 15. (PMA no. P810050-000~. FA265 Osmed, Inc. ~ ~ Drilac cubes (TM): sum- mary of safety and effectiveness. 1983 Feb 25. (PMA no. P800012-000). FA266 Pacesetter Systems, Inc. ~ ~ Programalith (TM) model 223 pulse generator 398 P.: summary of safety and effectiveness. 1983 Feb 25. (PMA no. P820023-000). FA267 Paragon Optical Inc. [ ] Paraperm 02 contact lens: summary of safety and effectiveness. 1983 Dec 8. (PMA no. P820063-000). FA268 Parker Hannitin Corporation. ~ ~ Cryo- max (TM): summary of safety and effectiveness. l 983 Feb 18. (PMA no. P820002-000). FA269 Pharmacia Diagnostics. ~ ~ Healon: sum- mary of safety and effectiveness. 1983 Feb 8. (PMA no. P810031-000). FA270 Precision-Cosmet Co., Inc. ~ ~ Circular open loop posterior IOLS & Kratz elliptic: summary of safety and effectiveness. 1983 Aug 9 (PMA no. P820072-000). FA271 Precision-Cosmet, Co. ~ ~ AMVISC (R): summary of safety and effectiveness. 1983 Nov 28. (PMA no. P810025-000). 6 FA272 Professional Supplies. [ ] The soft rinse system: summary of safety and effectiveness. 1983 Feb 18. (PMA no. P800060-003). FA273 Sensormedics. ~ ~ Cutaneous gas moni- tor: summary of safety and effectiveness. 1983 Sep 16. (PMA no. P830008-000). FA27i St. Jude Medical Inc. ~ ~ Bileaflet-center opening cardiac valve: summary of safety and effec- tiveness. 1983 Mar 1. (PMA no. P810002-000~. FA275 Storz Instrument Co. ~ ~ Lincoff-design scleral buckling balloon catheter: summary of safety and effectiveness. 1983 Nov 21. (PMA no. P820009- 000). FA276 Telectronics, Inc. ~ ~ Autima (TM) model 2251 & model 2600: summary of safety and effective- ness. 1983 Mar 11. (PMA no. P820018-000). FA277 Travenol Laboratories. ~ ~ Plasma separa- tion system: summary of safety and effectiveness. 1983 Nov 3. (PMA no. P820032-0001. FA278 Upjohn.t ~ Gelfoam: summary of safety and effectiveness. 1983 Aug 29. (PMA no. N 18286-000~. FA279 Wesley ~esson Inc. ~ ~ Durasoft (R) Trufo- cal (TM): summary of safety and effectiveness. 1983 Jun 3. (PMA no. N17852-0081. FA280 Advanced Catheter Systems. ~ ~ Simpson- Robert coronary balloon dilatation catheter: summa- ry of safety and effectiveness. l 982 Mar 26. (PMA no. P810046-000). FA281 Allergan Pharmaccuticals. [ ~ Lens-wet (TM): summary of safety and effectiveness.1982 May 14. (PMA no. P800065-000). FA282 Amcon Inc. ~ ~ Nor-Sa-Tab: summary of safety and effectiveness. 1982 Feb 19. (PMA no. P800069-000). FA283 American Medical Products Corporation. ~ ~ Collastat: summary of safety and effective- ness. 1982 Jan 5. (PMA no. P810006-000). FA284 Apothecary Products, Inc. ~ ~ The nor- maline kit: summary of safety and effectiveness.1982 Jan 12. (PMA no. P800(155-000). FA285 Avery Labs, Inc. ~ ~ Spinal epidural elec- trode for P.E.N.S. models E-355: summary of safety and effectiveness. 1982 Mar 2. (PMA no. P810033- 000). FA286 Barnes-Hind Pharmaceuticals, Inc. i ~ Softmate weekly cleaning solution: summary of safety and effectiveness. 1982 Mar 26. (PMA no. P810017- 0001.

FDAJCENTER FOR DEVICES AND ~ DIOLOGICAL HEALTH FA287 Bausch & Lomb. ~ ~ Sensitive eyes (TM) saline solution: summary of safety and effectiveness. 1982 Nov 11. (PMA no. P810039-000J. FA288 Bausch and Lomb. ~ ] Softens (r) polyma- con P.A.1 series: summary of safety and effectiveness. 1982 Dec 17. (PMA no. N16895 019~. FA289 Biochem International Inc. ~ ~ Lifespan (TM) 100 TCPC02 monitor: summary of safety and effectiveness. 1982 Oct 1. (PMA no. P820019-000~. FA290 CIBA Vision Care. ~ ~ Weicon (R) (Tefili- con) hydrophilic contact lens: summary of safety and effectiveness. 1982 {ul 27. (PMA no. P810005-002~. FA291 Central Pharmaceuticals, Inc. ~ ] Cen- tral's pharm. salt tablets for disinfection: summary of safety and effectiveness. 1982 Tan 15. (PMA no. P810030-000~. FA292 Cobe Laboratories, Inc. ~ ] Cobe century (R) TPE system: summary of safety and effectiveness. 1982 Mar 9. (PMA no. P810023-000~. FA293 Coburn Optical Industries, Inc. i_ ~ Bink- horst & Fedorov I iris clip IOLS: summary of safety and effectiveness. 1982 Aug 31. (PMA no. P800027- 0001. FA294 Cooper Labs, Inc. ~ ] Clerz lubricating & rewetting eye drops: summary of safety and effective- ness. 1982 tul 13. (PMA no. PB00034-000~. FA295 Coopervision Cilco. ~ ~ Posterior chamber intraocular lenses: summary of safety and effective- ness. 1982 Aug 31. (PMA no. P810018-000~. FA296 Coopervision, Inc. ~ ~ Cooper (TM) 38 (polymacon' hydrophilic contact lens: summary of safety and effectiveness. 1982 May 21. (PMA no. P810057-0001. FA297 Coopervision, Inc. ~ ~ Mirasol (TM): sum- mary of safety and effectiveness. 1982 {an 12. (PMA no. P810008-000~. FA298 Coopervision, Inc. ~ ~ Models B-13F (P- 10) & B- 1 H (P- 11): summary of safety and effective- ness. 1982 May 25. (PMA no. P810032-000~. FA299 Cordis Corp. ~ ~ Cordis sequicor theta models 233D & 233E: summary of safety and effec- tiveness. 1982 Dec 10. (PMA no. P820014-000~. FA300 Danker and Wohlk, Inc. ~ ~ Danker sili- cone lens (Dimefocon-A): summary of safety and ef- fectiveness. 1982 Jun 13. (PMA no. P790010-000~. FA301 . Quality assurance in nuclear medi- cine proceedings of an international symposium and workshop, held in Washington, D.C., April 27- 29. 1981. 1982. (GPO Stock No. 017-015-00221-7, NTIS Order No. PB84- 199306~. FA302 Genetics Lab. ~ ] Bioflow (TM': summary of safety and effectiveness. 1982 tul 20. (PMA no. P800064-0001. FA303 Hewlett-Packard Co. ~ ~ H-P capnometer model 47210A, option A10 cutaneous: summary of safety and effectiveness. 1982 Apr 13. (PMA no. P810043-000~. FA304 Horizon Pharmacal, Inc. [ ] The Horizon system: summary of safety and effectiveness. 1982 Jan 12. (PMA no. P810009-000~. FA305 Howmedica, Inc. ~ ] Deklene (TM): sum- mary of safety and effectiveness. 1982 ~un 4. (PMA no. P810028-000~. FA306 Interface Biomedical Labs., Inc. ~ ] Su- perstat: summary of safety and effectiveness. 1982 Jun 25. (PMA no. P810040-000~. FA307 Intermedics Infusaid, Inc. ~ ] Infusaid implantable infusion pump model 100, 200, 4: sum- mary of safety and effectiveness. 1982 Mar 26. (PMA no. P800036-000~. FA308 International Hydron Corporation. ~ Hydron (TM) saline system (135 & 250 mg): summa- ry of safety and effectiveness. 1982 Apr 9. (PMA no. P810047-000~. FA309 International Hydron Corporation. ~ ] Hydron (R) lens care unit: summary of safety and effectiveness. 1982 Oct 9. (PMA no. P820007-0001. FA310 Johnson and Johnson Co. ~ ] Chamber lens models 101,101 B,101T: summary of sa~ty and effectiveness. 1982 Mar 26. (PMA no. P790027-000~. FA311 Kontron Cardiovascular Inc. ~ ] Kontron cutaneous PC02 monitor: summary of safety and ef- fectiveness. 1982 Jun 18. (PMA no. P810037-000~. FA312 Medtronic, Inc. ~ ] Medtronic (r) Hall prosthetic heart valve: summary of safety and effec- tiveness. 1982 Jan 29. (PMA no. P790018-000~. FA313 Metrosoft, Inc. ~ ] Metrosoft (TM) II (po- lymacon) hydrophilic contact: summary of safety and effectiveness. 1982 Sep 24. (PMA no. P820026-000~. FA314 Orange Medical Instruments. ~ ] Trans- conjunctival oxygen monitor: summary of safety and effectiveness. 1982 Nov 19. (PMA no. P820011 -000~. IO7

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY FA315 Pharmacia, Irlc. ~ ~ Medallion (R): sum- mary of safety and effectiveness. 1982 Jan 1. (PMA no. P810060-000). FA316 Precision-Cosmet. ~ ~ Tennant (TM) & Kelman (TM) type II: summary of safety and effec- tiveness. 1982 Apr 20. (PMA no. PB00016-000~. FA317 Professional Pharmaceal Co. ~ ~ Salt tab- lets: summary of safety and effectiveness.1982 Tan 5. (PMA no.P810003-000~. FA318 Professional Supplies. ~ J The soft rinse system: summary of safety and effectiveness. 1982 Jan 1. (PMA no. P800060-000~. FA319 Radionics, Inc. [ ~ Cosman ICP Tele-sen- sor (R): summary of safety and effectiveness. 1982 Oct 1. (PMA no. P820012-000~. FA320 Richards Medical Co. ~ ~ Osteo ceramic hip: summary of safety and effectiveness. 1982 Dec 10. (PMA no. P810048-0001. FA321 Salvatori Ophthalmics, Inc. [ ~ (Polyma- con) contact lenses: summary of safety and effective- ness. 1982 Sep 17. (PMA no. P820005-000~. FA322 Sherman Labs, Inc. ~ ~ Sof! Pro-clean con- tact lens cleaner: summary of safety and effectivness. 1982 Jul 23. (PMA no. P810041-000~. Fooc! and Drug Administration Center for Drugs and Biolog~cs 5600 Fishers Lane Rockville, MD 20857 30 1-443-2894 FA323 Siemens-Elema Pacmaker Div. ~ ~ Endo- cardial pacemaker lead w/carbon tip: summary of safety and effectiveness. 1982 Sep 24. (PMA no. P800041-000). FA324 Standard Pharmacal Corp. [ ] Lens-sol: summary of safety and effectiveness. 1982 Mar 26. (PMA no. P810012-000). FA325 Syntex Ophthalmics Inc. [ ] Polycon con- tact lerls: summary of safety and effectiveness. 1982 Sep 21 (PMA no. N18120-008). FA326 Teledyne, Inc. [ ] Sleep sentry (TM): summary of safety and effectiveness. 1982 Sep 17. (PMA no. P81004-000). FA327 Unilab, Inc. [ ] Kiel Surgibone: summary of safety and effectiveness. 1982 Jun 18. (PMA no. P800044-000). FA328 Warner Lambert. [ ] Autobac MTS plus test system: summary of safety and effeci~veness. 1982 Mar 26. (PMA no. P810024-000). FA329 Soft Lense Inc. [ ~ Hydrocurve: summary of safety and effectiveness. 1980 Jan 11. (PMA no. N 17752-000). FA330 Soft Lense Inc. [ ~ Hydrocurve: summary of safety and effectiveness. 1980 Mar 14. (PMA no. N17752-001). Contact: Don McLearn (for general information); Linda Carter (for information on new SBAs) 301-443-4330; or FOI staff (Freedom of Information inquiries) 301-443- 6310. Overview: The FDA Center for Drugs and Biologics (CDB) is responsible for ensuring that all human drugs and biologics manufactured for interstate sale are safe and effective and that product labeling is truthful and informative. Drugs and biologics are evaluated to prevent potentially dangerous or ineffective drugs, vaccines, toxoids, immune sera, antigens and allergenic products, and blood and blood products from entering the nation's health care system. For many newly approved drugs, CDB prepares a Summary Basis of Approval (SBA). Purpose: To evaluate and approve new drugs for marketing on the basis of safety and effectiveness (efficacy), to assure that these drugs are properly labeled, and to share with the public the key facts on which approval is based. ~o8

FDA/CENTER FOR DRUGS AND BIOLOGICS Primary intended users: General public; people concerned about their health; pa- tients; providers, generally; health product manufacturers. Technologies: Drug. Human-use drugs for therapeutic use are assessed. Intervention: Treatment, prevention, diagnosis. Stage: New. SBAs are prepared when the drug is released for use in the practice of medicine. Properties: Safety, efficacy, effectiveness. Selection process: The CDB has criteria that determine which drugs justify an SBA. No one can request that an assessment be done beyond the intended target group of a given drug. Methods: Information syntheses, expert opinion, for premarketing approval; epidemiologi cat and other observational methods for postmarketing surveillance. Preparations of the SEA is based on information generated by the New Drug Applica- tion process, through which manufacturers submit information for new drug approval. The approval process actually involves two stages, called the Investigational New Drug (IND) and the New Drug Application (NDA). Before CDB will permit a new drug to be tested on humans, the drug's sponsor must file an IND. The IND contains the drug's structural formula, the results of animal testing, the -proposed protocol for clinical testing on humans, and other data. The CDB reviews the IND to determine whether the data are complete and sufficient to initiate clinical trials. After the trials, but before marketing, the manufacturer files an NDA, which must contain full information about the proposed product, including the results of the clinical testing. When the claims for safety, efficacy, and labeling have been approved, the drug may go on the market, but the manufacturer must continue to send periodic reports on adverse reactions and other aspects of drug experience. The CDB may require changes of labeling or take other actions because of dangers that are revealed in this way. If a manufacturer wants to change a drug with an approved NDA for example, to claim a new use for it a supplemental NDA may have to be filed and approved. The average total approval time for an NDA, i.e., from receipt by the CDB of the application to the approval date, is approximately 2 years. This includes time required by the manufacturer to provide information in response to agency actions, which average 6 months. Assessors: Each IND and NDA is reviewed by a team of FDA scientists a physician, pharmacologist, a chemist, a pharmacokineticist, and a biometrician (usually, a biolo- gist, and a microbiologist. The Center may also present important NDAs to advisory committees, whose recommendations are valued but are not binding. The Summary Basis of Approval is generally developed collaboratively by the CDB and the NDA sponsor, with experts on medicine, biostatistics, chemistry, pharmacology, and toxicology. On occasion, the sponsor may develop a draft and submit it to the CDB. log

MEDICALIECHNOLOGY ASSESSMENT DIRECTORY Assessment reports include: Results, findings or conclusions, regulatory agency ap- proval status. Dissemination: Printed reports; clearinghouses, data/citation bases, on-line services. SBAs are available through the FDA's Freedom of Information Office, 301-443-6310, and from the National Technical Information Service, 5285 Port Royal Rd., Spring- hleld,VA22161. Budget: $250,000. The approximate cost per assessment is under $5,000. Funding source: 100 percent parent organization. Use: Pharmaceutical firms use the SBAS as a source of information on the industry. They are also reviewed by consumer advocates, health professionals in universities, arid others. Related activities: The CDB issues an annual list of Approved Drug Products with monthly updates. Subscriptions are available for $103 per year through the U.S. Government Printing Office, Washington, DC 20204; stock no. 917-001-00000-6. CDB coordinates a number of postmarketing surveillance programs, including sponta . . neons reaction reporting programs, adverse reaction registries, and research pro- grams. Manufacturers are required to send problem reports to CDB; many health professionals and hospitals send them voluntarily. The Drug Product Problem Report- ing Program (DPPR), maintained by the United States Pharmacopeia, is a computer database containing voluntary reports from providers on problems experienced when pharmaceutical products are received, used, or dispensed. These might include unsat- isfactory packaging, labeling, or insert information; poor pharmaceutical quality, stabil- ity; therapeutic effectiveness, or related characteristics. Completed Reports FD1 Food and Drug Administration, Center for Drugs and Biologics. Acetohydroxamic acid.1987. (Summa- ry basis of approval, NDA # 18-749~. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD2 . Allopurinol 100 ma. 1987. (Summary ba- sis of approval, NDA # 18-832~. "Information synthe- ses, Expert opinion, Epidemiological and other obser- vational methods, Clinical trials, Bench testing] IDS . Allopurinol 300 ma. 1987. (Summary ba- sis of approval, NDA #- 18-832~. "Information synthe- ses, Expert opinion, Epidemiological and other obser- vational methods, Clinical trials, Bench testing] ~4 . Betamethasone dipropionate. 1987. (Summary basis of approval, NDA #19-136~. [Infor- mation syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] Too IDS . Betamethasone dipropionate. 1987. (Summary basis of approval, NDA #19-137~. [Infor- mation syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] ID6 . Betamethasone dipropionate. 1987. (Summary basis of approval, NDA #19-1381. [Infor- mation syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] ID7_ . Bronalide inhaler system. 1987. (Summa- ry basis of approval, NDA #18-340~. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD8_ . Bumetanide injectable. 1987. (Summary basis of approval, NDA #18-226~. [Information syn- theses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing]

FDAICENTER FOR DRUGS AND BIOLOGICS Fug . Bumetanide tablets.1987. (Summary basis of approval, NDA # 18-225~. "Information syntheses, Expert opinion, Epidemiological and other observa tional methods, Clinical trials, Bench testing] FD10 .- Clonidine. 1987. (Summary basis of ap proval, NDA # 18-891). "Information syntheses, Ex pert opinion, Epidemiological and other observation al methods, Clincial trials, Bench testing] FD11 . Clotrimazole. 1987. (Summary basis of approval, NDA # 18-827~. "Information syntheses, Expert opinion, Epidemiological and other observa tional methods, Clinical trials, Bench testing] E D12 . Dopamine HC1.1987. (Summary basis of approval substitute, NDA # 19-099) "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD13 . Dopamine HC1.1987. (Summary basis of approval substitute, NDA # 19-0991. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD14 . Enalapril maleate/hydro-chlorothiazide. 1987. (Summary basis of approval substitute, NDA # 19-221~. [Information syntheses, Expert opinion, Epi demiological and other observational methods, Clini cal trials, Bench testing] FD15 . Hydromorphone HC1.1987. (Summary basis of approval, NDA # 19-034~. "Information syn theses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FI)16 . Ibuprofen. 1987. (Summary basis of ap proval, NDA #18-989~. [Information syntheses, Ex- FD28_ pert opinion, Epidemiological and other observation al methods, Clinical trials, Bench testing] ID17 . Ibuprofen. 1987. (Summary basis of ap proval, NDA #19-012~. "Information syntheses, Ex pert opinion, Epidemiological and other observation al methods, Clinical trials, Bench testing] FD18 . Potassium chloride. 1987. (Summary ba sis of approval substitute, NDA # 19-123~. tInforma tion syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD19 . Potassium chloride. 1987. (Summary ba sis of approval, NDA # 19-439~. [Information synthe ses, Expert opinion, Epidemiological and other obser vational methods, Clinical trials, Bench testing] FD20 . Potassium chloride. 1987. (Summary ba sis of approval, NDA# 19- 123~. "Information synthe ses, Expert opinion, Epidemiological and other obser vational methods, Clinical trials, Bench testing] FD21 . Potassium citrate. 1987. (Summary basis of approval, NDA # 19-071). "Information syntheses, Expert opinion, Epidemiological and other observa- tional methods, Clinical trials, Bench testing] FD22 . Propranolol HC1 liquid.1987. (Summary basis of approval substitute, NDA# 19-536~. [Infor- mation syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD23 . Propranolol SR/hydrochlorothiazide. 1987. (Summary basis of approval, NDA # 19-059~. fInformation syntheses, Expert opinion, Epidemio- logical and other observational methods, Clinical tri- als, Bench testing] FD24 . Propranolol hydrochloride. 1987. (Sum- mary basis of approval, NDA # 18-553~. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD25 . Ranitidine HC1.1987. (Summary basis of approval NDA # 18-703~. fInformation syntheses, Expert opinion, Epidemiological and other observa- tional methods, Clinical trials, Bench testing] FD26 . Ranitidine HC1.1987. (Summary basis of approval substitute, NDA # 19-593~. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testingJ FD27 . Sodium cellulose phosphate.1987. (Sum- mary basis of approval, NDA # 18-757~. fInformation syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] _. Triamterene and hydrochlorothiazide. 1987. (Summary basis of approval, NDA # 19-129~. fInformation syntheses, Expert opinion, Epidemio- logical and other observational methods, Clinical tri- als, Bench testing1 FD29 . Verapamil HC1.1987. (Summary basis of approval substitute, NDA # 19-152~. fInformation syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD30 . Verapamil. 1987. (Summary basis of ap- proval substitute, NDA # 18-817/S-003~. tInforma- tion syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD31 . Alclometasone dipropionate. 1983. (NTIS order no. PB83-915901). [Information synthe- ses, Expert opinion, Epidemiological and other obser- vational methods, Clinical trials, Bench testing1

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY FD32 . Aminocaproic acid injection. 1983. (NTIS order no. PB83-915901~. [Information synthe- ses, Expert opinion, Epidemiological and other obser- vational methods, Clinical trials, Bench testing] FD33 . Betamethasone valerate. 1983. (NTIS order no. PB83-915902J. "Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD34 . Chymopapain. 1983. (NTIS order no. PB83-915901). [Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD35 . Ciclopirox olamine. 1983. (NTIS order no. PB83-915901~. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD36 .Dextromethorphanresincomplex.1983. (NTIS order no. PB83-915901. [Information synthe- ses, Expert opinion, Epidemiological and other obser- vational methods, Clinical trials, Bench testing] FD37 . Diethylpropion hydrochloride. 1983. (NTIS order no. PB83-915901 J. "Information synthe- ses, Expert opinion, Epidemiological and other obser- vational methods, Clinical trials, Bench testing] FD38 . Diltiazem hydrochloride. 1983. (NTIS order no. PB83-915901~. "Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD39 . Econazole nitrate.1983. (NTIS order no. PB83-915901). [Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testin] FD40 . Etomidate.1983. (NTIS order no. PB83- 91590~. [Information syntheses, Expert opinion, Epi- demiological and other observational methods, Clini- cal trials, Bench testing] FD41 . Guanabenz acetate. 1983. (NTIS order no. PB83-9159034. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD42 . Guanadrel sulfate. 1983. (NTIS order no. PB 83-915901). "Information syntehese, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD43 . Human insulin (recombinant DNA or- gin) isophane suspension. 1983. (NTIS order no. PB83-915901~. "Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] ~2 FD44 . Hydrocortisone butyrate. 1983. (NTIS order no. PB83-915901~. [Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD45 . Nadolol-bendroflumethiazide. 1983. (NTIS order no. PB 83-915903~. "Information syn- theses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD46 . Pentazocine FIC1 and naloxone HC1. 1983. (NTIS order no. PB83-915901~. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD47 . Praziquantel, 1983. (NTIS order No. PB83-915901~. "Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD48 . Regular human insulin (recombinant DNA origin) injection. 1983. (NTIS order no. PB83- 915901). "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trails, Bench testing] FD49 . Selenium sulfide.1983. (NTIS order no. PB83-915902~. fInformation syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD50 . Technetium Tc 99m albumin colloid kit. 1983. (NTIS order no. PB83-915902~. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD51 . Tioconazole. 1983. (NTIS order no. PB83-915902~. [Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD52 . Triazolam.1983. (NTIS order no. PB83- 915901). [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD53 . Vidarabine. 1983. (NTIS order no. PB83-915903~. LInformation syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD54 . Xenon Xe 127 gas. l 983 (NTIS order no. PB83-915901). "Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD55 . 8% amino acid injection. 1982. (NTIS order no. PB82-915904~. [Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing]

FDA/CENTER FOR DRUGS AND BIOLOGICS FD56 .Acyclovir. 1982. (NTIS order no. PB82- 915902~. fInformation syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD57 .:Albuterol sulfate.1982. (NTIS order no. PB82-915903~. "Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD58 . Alprazolam. 1982. (NTIS order no. PB82-9159011. "Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD59 . Alprostadil (PEEK. 1982. (NTIS order no. PB82-915901~. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD60 . Amcinonide. 1982. (NTIS order no. PB82-915901). "Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD61 . Amiloride HC1. 1982. (NTIS order no. PB82-915901~. "Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD62 . Amiloride HCl/hydrochlorothiazide. 1982. (NTIS order no. PB82-915901~. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD63 . Aminophylline, USP.1982/ (NTIS order no. PB82-915903~. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD64 . Azatadine maleate & pseud. sulfate. 1982. (NTIS order no. PB82-915902~. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD65 . Azlocillin sodium.1982. (NTIS order no. PB82-915904~. fInformation syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD66 . Bacampicillin hydrochloride. 1982. (NTIS order no. PB82-915902~. "Information synthe- ses, Expert opinion, Epidemiological and other obser- vational methods, Clinical trials, Bench testing] FD67 . Benoxaprofen. 1982. (NTIS order no. PB82-915903~. "Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD68 . Bupivacaine hydrochloride.1982. (NTIS order no. PB82-915901~. [Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD69 . Buprenorphine HC1.1982. (NTIS order no. PB82-915901~. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD70 . CaC12, MgCl, Kcl, & NaCl. 1982. (NTIS order no. PB82-9159021. fInformation syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD71 . Carbamazopine. 1982. (NTIS order no. PB82-9159011. [Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD72 . Cephradine. 1982. (NTIS order no. PB82-915901~. [Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD73 . Ceruletide diethylamine. 1982. (NTIS order no. PB82-915901). [Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD74 . Cromolyn sodium. 1982. (NTIS order no. PB82-915903~. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD75 . Desoximetasone. 1982. (NTIS order no. Pb82-915902~. "Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD76 . Diflunisal. 1982. (NTIS order no. PB82- 915904~. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD77 . Digoxin. 1982. (NTIS order no. PB82- 915904~. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD78 . Disopyramide phosphate. 1982. (NTIS order no. PB82-915904~. [Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD79 . Estramustine phosphate sodium. 1982. (NTIS order no. PB82-915901). "Information synthe- ses, Expert opinion, Epidemiological and other obser- vational methods, Clinical trials, Bench testing] ~3

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY FD80 . Ethynodiol diacetate with ethinyl estradi- ol. 1982. (NTIS order no. PB82-915901). [Informa- tion syntheses, Expert opinion, Epidemiological, and other observational methods, Clinical trials, Bench testing] FD82 . . Gemfibrozil. 1982. (NTIS order no. PB82-915901 J. "Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD82 . Gemfibrozil. 1982. (NTIS order no. PB82 915901~. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD83 . Gonadorelin HC1.1982. (NTIS order no. PB82-915904~. [Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD84. . Hydrocortisone butyrate. 1982. (NTIS order no. PB82-915902~. [Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD85 . Ibuprofen.1982. (NTIS order no. PB82- 9159021. "Information syntheses, expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD86 . Indomethacin. 1982. (NTIS order no. PB82-915901~. [Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD87 . Indomethacin. 1982. (NTIS order no. PB82-915902~. [Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD88 . Intravenous fat emulsion. 1982. (NTIS order no. PB82-915901). [Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD89 . Isotretinoin. 1982. (NTIS order no. PB82-915903~. [Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD90 . Malathion.1982. (NTIS order no. PB82- 915904~. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD91 . Methoxsalen. 1982. (NTIS order no. PB82-915903~. "Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] ~4 FD92 . Metoclopramide HC1. 1982. (NTIS or- der no. PB82-915903~. [Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD93 . Metronidazole injection, 0.5%. 1982. (NTIS order no. PB82-915904~. [Information synthe- ses, Expert opinion, Epidemiological and other obser- vational methods, Clinical trials, Bench testing] FD94 . Miconazole nitrate. 1982. (NTIS order no. PB82-915902~. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD95 . Miconazole nitrate. 1982. (NTIS order no. PB82-915904~. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD96 . Moxalactam disodium. 1982. (NTIS or- der no. PB82-915901~. [Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, clinical trials, Bench testing] FD97 . NaCl, KC1, MgSO4, NaPO4, & KPO4. 1982. (NTIS order no. PB82-915901~. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing1 FD98 . Niclosamide. 1982. (NTIS order no. PB82-9159031. [Information syntheses, Expert opin- ion, Epidemiological and other observational meh- tods, Clinical trials, Bench testing] FD99 . Nifedipine. 1982. (NTIS order no. PB82-915901). "Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD100 . Norethindrone & ethinyl estradiol. 1982. (NTIS order no. PB82-9159021. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD101 . Pentazocine hydrochloride and acet- aminophen. 1982. (NTIS order no. PB82-915904~. "Information syntheses, Expert opinion, epidemio- logical and other observational methods, Clinical tri- als, Bench testing] FD102 . Pentetate indium disodium In 111. 1982. (NTIS order no. PB82-9159021. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD103 . Peritoneal dialysis solutions in plastic containers. 1982. (NTIS order no. PB82-915901~. "Information syntheses, Expert opinion, Epidemio- logical and other observational methods, Clinical tri- als, Bench testing]

FDAdCENTER FOR DRUGS AND BIOLOGICS FD104 . Pindolol, 1982. (NTIS order no. PB82- 9159041. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD105 . Piroxicam. 1982. (NTIS order no. PB82-915903~. "Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD106 . Salts solution plus dextrose and gluta- thione disulfides. 1982. (NTIS order no. PB82- 915901). [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD107 . Silver sulfadiazine. 1982. (NTIS order no. PB82-915902~. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD108 . Sterile piperacillin sodium.1982. (NTIS order no. PB82-915901~. [Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD109 . Streptozocin. 1982. (NTIS order no. PB82-915903~. FD110 . Sucralfate. 1982. (NTIS order no. PB82-915901). [Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD111 . Sulfadoxine and pyrimethamine. 1982. (NTIS order no. PB82-915901). "Information synthe- ses, Expert opinion, Epidemiological and other obser- vational methods, Clinical trials, Bench testing] FD112 . Technetium Tc 99M succimer kit.1982. (NTIS order no. PB82-915903~. "Information synthe- ses, Expert opinion, epidemiological and other obser- vational methods, Clinical trials, Bench testing] FD113 . Technetium Tc 99m disofenin kit. 1982. (NTIS order no. PB82-915902~. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD114 . Theophylline in 5% dextrose injection . . ~n p ast~c container. 1982. (NTIS order no. PB82-915904~. "Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD115 . Timolol maleate & hydrochlorothia- zide. 1982. (NTIS order no. PB82-915901~. fInfor- mation syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD116 . Tobramycin.1982. (NTIS order no.82- 915901~. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD117 . Trazodone HCI. 1982. (NTIS order no. PB82-915901). "Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD118 . Trimethoprim tablets. 1982. (NTIS or- der no. PB82-915904~. "Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD119 . Verapamil HCL.1982. (NTIS order no. PB82-915902~. [Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD120 . 0.45% sodium chloride injection, USP. 1981. (NTIS order no. PB81 -9159091. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD121 . 0.9% sodium chloride injection, USP. 1981. (NTIS order no. PB81-9159091. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD122 . 10% Dextrose injection, USP. 1981. (NTIS order no. PB81-915909~. "Information synthe- ses, Expert opinion, Epidemiological and other obser- vational methods, Clinical trials, Bench testing] FD123 . 5% Dextrose & 0.3% NaC1 Inj., USP. 1981. (NTIS order no. PB81-915909~. ~Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD124 . 5% Dextrose & 0.9% NaC1 Inj., USP. 1981. (NTIS order no. PB81-9159091. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD125 . 5% Dextrose in lactated Ringer's injec- tion in polyolefin bottle. 1981. fInformation synthe- ses, Expert opinion, Epidemiological and other obser- vational methods, Clinical trials, Bench testing] FD126 . Aminoglutethimide.1981. (NTIS order no. PB81-915901~. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD127 . Amoxicillin. 1981. (NTIS order no. PB81 -915901). "Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing1 ~5

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY FD128 . Atenolol. 1981. (NTIS order no. PB81- 915911~. fInformation syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FDl29 . Azathioprine. 1981. (NTIS order no. PB81 -915907~. [Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD130 . Beclomethasone dipropionate. 1981. (NTIS order no. PB81 -915912~. "Information synthe- ses, Expert opinion, Epidemiological and other obser- vational methods, Clinical trials, Bench testing] FD131 . Bethanidine sulfate.1981. (NTIS order no. PB81-9159081. fInformation syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD132 . Bromocriptine mesylate. 1981. (NTIS order no. PB81-915912~. "Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD133 PB81 -915907~. fInformation syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] .. Captopril. 1981. (NTIS order no. FD134 . Chlorhexidine gluconate. 1981. (NTIS order no. PB81-915911~. [Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD135 . Chlorpheniramine maleate pseudoe- phedrine sulfate. 1981. (NTIS order no.PB81- 915906~. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD136 . Clorazopate dipotassium. 1981. (NTIS order no. PB81 -915904~. "Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD137 . Cyclothiazide. 1981. (NTIS order no. PB81-915905~. [Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD138 . DTIC (Dome). 1981. (NTIS order no. PB81 - 15907~. fInformation syntheses, Expert opin- ion, epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD139 . Diazepam. 1981. (NTIS order no. PB81 -915906~. "Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] ~6 FD140 . . Dopamine hydrochloride injection. 1981. (NTIS order no. PB81-915908~. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD141 . Ergoloid mesylates. 1981. (NTIS order no. PB81-915904~. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD142 . Erythromycin base (enteric-coated pel- lets). 1981. (NTIS order no. PB81 -915904~. [Infor- mation syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD143 . Extended purif~ed beef insulin zinc sus- pension. 1981. (NTIS Order no. PB81 -915909~. [In- formation syntheses, Expert opinion, Epidemiologi- cal and other observational methods, Clinical trials, Bench testing] FD144 . Furosemide injection. 1981. (NTIS or- der no. PB81-915908~. [Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD145 . Furosemide tablets. 1981. (NTIS order no. PB81 -915911). [Information syntheses, expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD146 . Halazepam. 1981. (NTIS order no. PB81 -915912~. ~Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD147 . Hexachlorophene. 1981. (NTIS order no. PB81-915904J. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD148 . Hexachlorophene. 1981. (NTIS order no. PB81-915909~. fInformation syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD149 . Ibuprofen. 1981. (NTIS order no. PB81-915908~. "Information syntheses, expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FDlS0 . Intravenous fat emulsion. 1981. (NTIS order no. 81-9159041. [Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD151 . Iodoxamate meglumine. 1981. (NTIS order no. PB81-915911~. [Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing.

FDAdCENTER FOR DRUGS AND BIOLOGICS FD152 . Iron dextran Inj. USP. 1981. (NTIS FD163 _ order no. PB81-915906~. "Information syntheses, Ex pert opinion, Epidemiological and other observation al methods, Clinical trials, Bench testing] FD153 ; Isophane purified beef insulin suspen sion. 1981. (NTIS order no. PB81-915909~. [Infor mation syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD154 . Isophane purified pork insulin suspen sion. 1981. (NTIS order no. PB81-915910~. [Infor mation syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing FD155 . Isosulfan blue. 1981. (NTIS order no. PB81 -9159104. [Information syntheses, Expert opin ion, Epidemiological and other observational meth ods, Clinical trials, Bench testing] FD156 . Ketoconazole. 1981. (NTIS order no. PB81 -915909~. "Information syntheses, Expert opin ion, Epidemiological and other observational meth ods, Clinical trials, Bench testing] FD157 . Lidocaine HC1 in TO dextrose in plastic container (PL-146~. 1981. (NTIS order no. PB81 9159071. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD158 . Lidocaine hydrochloride, USP sterile powder. l 981. (NTIS order no. PB81-915905. tInfor mation syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD159 . Methyldopa. 1981. (NTIS order no. PB81 -915911. [Information syntheses, Expert opin ion, Epidemiological and other observational meth ods, Clinical trials, Bench testing] FD160 . Metolazone. 1981. (NTIS order no. PB81 -915905~. "Information syntheses, Expert opin ion, Epidemiological and other observational meth ods, Clinical trials, Bench testing] FD161 . Mezlocillin sodium. 1981. (NTIS order no. PB81-915912~. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD162 . Multiple electrolyte injection. 1981. (NTIS order no. PB81-915901~. "Information synthe ses, Expert opinion, Epidemiological and other obser vational methods, Clinical trials, Bench testing] . Nitroglycerin for injection. l 981. (NTIS order no. PB81-915912~. "Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD164 . Phenylpropanolamine hydrochloride chlorpheniramine maleate. 1981. (NTISorder no. PB81-915910~. [Information syntheses, expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD165 . Potassium chloride 1981. (NTIS order no. PB81-915901~. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD166 . Prompt purified beef insulin zinc sus- pension. 1981. (NTIS order no. PB81 -915909~. tIn- formation syntheses, Expert opinion, Epidemiologi- cal and other observational methods, Clinical trials, Bench testing] FD167 . Purified beef insulin zinc suspension. 1981. (NTIS order no. PB81-915909~. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD168 . Purified pork insulin injection. 1981. (NTIS order no. PB81-915909~. "Information synthe- ses, Expert opinion, Epidemiological and other obser- vational methods, Clinical trials, Bench testing] FD169 . Ringer's irrigation, USP in flex contain- ers. 1981. (NTIS order no. PB81-9159061. tInforma- tion syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD170 . Saralasin acetate. 1981. (NTIS order no. PB81-915908~. "Information syntheses, Expert opinion, Epidemiological and- other observational methods, Clinical trials, Bench testing] FD171 . Secretin. 1981. (NTIS order no. PB81- 915908~. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD172 . Sisomicin sulEate. 1981. (NTIS order no. PB81-915901~. "Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] FD173 . Sodium nitroprusside. l 981. (NTIS or- der no. PB81-915912) "Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing1 ~7

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY FD174 . Sterile cefotaxime sodium.1981. (NTIS order no. PB81-915906~. "Information syntheses, Ex- pert opinion, Epidemiological and other observation- al methods, Clinical trials, Bench testing] FD175 . Sterile water for injection, USP. 1981. (NTIS order no. PB81-915909~. "Information synthe- ses, Expert opinion, Epidemiological and other obser- vational methods, Clinical trials, Bench testing] FD176 . Sulfamethoxazole and trimethoprim. 1981. (NTIS order no. PB81-915909~. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] I7D177 . Technetium 99m oxidronate kit. 1981. (NTIS order no. PB81-9159051. [Information synthe- ses, Expert opinion, Epidemiological and other obser- vational methods, Clinical trials, Bench testing] FD178 . Technetium Tc 99m medronate kit. 1981. (NTIS order no. PB81 -915905~. [Information syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testings Food and Drug Administration Center for Food Safety and Applied Nutrition Color for Drugs and Devices 200 C Street SW, HFF-214 Washington, DC 20204 202-485-0099 Special Purpose Infant Formulas 200 C Street SW, HFF-204 Washington, DC 20204 202-245-3117 FD179 . Temazopam. 1981. (NTIS order no. PB81-915905). [Information syntheses, Expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD180 . Trimethoprim/sulfamethoxazole.1981. (NTIS order no.81 -915908~.1iInformation syntheses, Expert opinion, Epidemiological and other observa- tional methods, Clinical trials, Bench testing] FD181 . Verapamil. 1981. (NTIS order no. PB81 -915911). [Information syntheses, expert opin- ion, Epidemiological and other observational meth- ods, Clinical trials, Bench testing] FD182 . Zomepirac sodium. 1981. (NTIS order no. PB81-915901~. fInformation syntheses, Expert opinion, Epidemiological and other observational methods, Clinical trials, Bench testing] Contact: Alan Rulis, Chief, Regulatory Chemistry Branch, (Colors for Drugs and Devices program) or Nicholas Duy, Chemist (Special Infant Formula program). Overview: The FDA Center for Food Safety and Applied Nutrition (CFSAN' is primarily responsible for regulating foods and cosmetics. CFSAN is also responsible for assessment activities including: 1 ) the regulation of color additives in drugs and medical devices (as well as foods), and 2) the regulation of infant formulas that are prescribed as special diets. Both activities are federally mandated. The Special Infant Formulas program was implemented in 1986, pursuant to the Infant Formula Act of 1980, concerning special infant diets for inborn errors of metabolism and other special medical needs arising from such conditions as extreme low birthweight. Purpose: To ensure the safety and suitability of colors added to foods, drugs, and devices and to ensure the safety and effectiveness of special purpose infant formulas. ~8

FDA/CENTER FOR FOOD SAFETY AND APPLIED NUTRITION Primary intended users: Health product manufacturers; health industry associations; government regulators. Technologies: Drug, device, for color additives; medical or surgical procedure (i.e., special diet for medical reasons) for special infant formulas. intervention: Treatment, diagnosis, rehabilitation for color additives; treatment for spe- cial infant formulas. Stage: Emerging, new, established or widespread practice for color additives and for special infant formulas. Properties: Safety for color additives; safety, efficacy, effectiveness for special infant formulas. Selection process: Manufacturers of both color additives and special infant formulas must request FDA assessment of their products. Exempted from this requirement are additives known as GRAS (generally recognized as safe) and "prior sanctioned." The latter are substances the FDA determined to be safe before the 1958 Food Additives amendment. For color additives, the FDA is developing a program to reassess the safety of each previously approved additive in light of new scientific evidence and to remove unsafe ones from the market. Reassessments of infant formulas are conducted if the agency receives information that infants are being harmed by a product or by a similar product. Methods: Information syntheses, expert opinion, group judgment, bench testing. For color additives, manufacturers submit test data that show the substance is safe and functional. The FDA then announces in the Federal Register that an additive petition has been filed. After experts have reviewed the data, CFSAN announces approval of the additive through a regulation, also published in the Federal Register. Under a provision that has become known as the "Delaney Clause," the agency is prohibited by law from approving any additive found to cause cancer in test animals. The agency conducts laboratory toxicology studies only in cases when already marketed products experience problems. Laboratory testing is also conducted for certification of purity of color additives that have potential for toxic contaminants. For special infant formulas, the manufacturers submit the formulas for assessment. The formulas are assessed within the agency. The agency does conduct some laborato- ry analysis of special infant formula samples. The approximate turnaround time from selection of assessment topic to reporting of findings varies widely. Assessors: Experts in chemistry, toxicology, and environmental assessment review color additives. Infant formulas are assessed within the CFSAN by experts in nutrition, diet, chemistry, medicine, and food technology. ~9

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Assessment reports include: The assessment's intended audience; the purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; who sponsored/com- missioned/supported the assessment; description of the technology; stage of life-cycle of technology when assessed; properties assessed; results; findings or conclusions; limitations of findings; implications of findings for practice; regulatory agency ap- proval status; product recall history, environmental impact. Dissemination: Advisories; press conferences/news releases, TV/radio broadcasts, vid- eo products. Assessments of color additives are announced in the Federal Register. Assessments of special infant formulas will be disseminated primarily through advisor- ies to manufacturers and to foreign health agencies. Copies may be obtained by contacting the FDA's Freedom of Information Office or the CFSAN contact person given above. Budget: Not provided. The approximate cost of an assessment is $40,000 for color additives and $10,000 for special infant formulas. Funding source for color additives: 97 percent parent organization, 3 percent manufacturers; funding source for special purpose infant formulas: 100 percent parent organization. Use: The FDA uses the CFSAN's assessments to permit or deny use of the product or to require modifications. The assessments are also used by the manufacturers. Program evaluation: The Colors for Drugs and Devices program is reviewed periodi- cally by Congress. Related activities: The CFSAN also certifies the purity of colors for drugs and devices that have a potential for problems with toxic contaminants. Completed reports: The first assessment reports for special infant formulas should be available in 1988 or 1989. Georgetown University Medical Center Institute for Health Policy Analysis 2 ~ 2 ~ Wisconsin Avenue NW, Suite 220 Washington, DC 20007 202-625-21 15 Contact: Seymour Perry, M.D., Deputy Director. Overview: The Institute for Health Policy Analysis, a not-for-profit research institute, conducts research on and analyzes important national health policy issues. The Insti- tute established its Technology and Health Care Program in 1983. Purpose: To improve the public's understanding of national health policy issues and to aid the process by which policy is set within the government. 120

GEORGETOWN UNI1[ERSITY Primary intended users: General public; people concerned about their health; pa- tients; providers, generally; physicians; health/medical professional associations; health industry associations; consumer associations; unions and other employee organiza- tions; third party payers; reporters, writers, news media; policy-makers. Technologies: Device, medical or surgical procedure. Intervention: Diagnosis, treatment. Properties: Safety; effectiveness; efficacy; cost; cost-benefit; cost-effectiveness; ethical, legal, social implications. Selection process: Assessments may be requested by staff or by an outside organiza- tion. However, as a matter of policy, the Institute will not conduct an assessment for an outside group unless funding is obtained from multiple sources, so as to avoid any perception of bias. Requests are made either in writing or at a meeting, and Institute staff determine which assessment topics have priority. Methods: Group judgment, information syntheses, expert opinion. Workshops and conferences are the program's chief assessment method. The first step after selecting a topic is to establish a small planning committee of people outside the organization to develop the questions to be addressed, identify speakers, and plan other aspects of the workshop or conference. A neutral panel also is chosen. The approximate turnaround time from selection of assessment topic to reporting of findings is 4 to 6 months for a workshop and 12 to 18 months for a conference. Assessors: Committee and panel members are experts in medical and technical areas or in other areas such as health economics, ethics, or law. Assessment reports include: Abstract; the assessment's intended audience; the pur- pose of the assessment; relationship of this assessment to prior or concurrent assess- ments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; proper- ties assessed; procedure used for the assessment; sources of data/information; methods for collecting data/information; methods for analyzing/ synthesizing data/information; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; where technology is in use: re~ulatorv Deny ~norov~1 ct~t,~c rov~r~/r~imh,~r~ ~ ~ ~ - ° ~ ~ --an ~ ~ Or r ~ ~ ~ ~ ~ ^~ ment status of the technology. Dissemination: Printed reports, journal articles. The Institute publishes a newsletter and maintains a mailing list. Results may also be reported in the lay press. The reports may be obtained, upon request, from the Institute. Budget: $250,000. The approximate cost for a workshop is $25,000 to $30,000 and for a conference, $75,000 to $100,000. Funding sources: 50 percent parent organization; 10 percent government grants, contracts; 10 percent foundations, other private grants; 30 percent sponsors/members dues, contributions. 121

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Use: The Institute's reports have been used in a variety of ways. The proceedings of two of its conferences on the reuse of disposable medical devices, for example, were used by several groups, including the Association for the Advancement of Medical Instrumentation, the American Society for Testing and Materials, and Congressional committees. Related activities: The Institute also sponsors the following programs: Financial Com- pensation for Disease and Disability, a Unit of Advanced Studies, and the Program on Science and the Media. Completed Reports GUI Georgetown University Medical Center, Institute for Health Policy Analysis. Reuse of disposable medi- cal devices: legal liability and public policy issues. (In press) "Information syntheses, Expert opinion, Group judgment, Cost analyses] GU2 Chu F. Novak N. Radany MH, Perry S. tGeorge- town University Medical Center, Institute for Health Policy Analysis] Reuse and reprocessing of disposable medical devices. ~ Health Care Technol 1986; 3: 5- 12. [Information syntheses, Expert opinion, Groupjudg- ment, Cost analyses] GUS Chu F. [Georgetown University Medical Center, Institute for Health Policy Analysis] Changing atti- tudes toward reusing medical devices. Health Span- Report of Health Bus Law 1986;3: 14-8. "Information syntheses, Expert opinion, Groupjudgment, Cost an- alyses] GU4 Georgetown University Medical Center, Institute for Health Policy Analysis. New medical technologies in a cost containment environment: implantable anti- tachyarrhythmia devices. Washington, DC: Institute for Health Policy Analysis, 1986. "Information syn- theses, Expert opinion, Groun iucl~men~ (mar ~n~- lyses] GUS Georgetown University Medical Center, Institute for Health Policy Analysis. National Health Services and Practice Patterns Survey. Report on fully auto- mated blood pressure monitoring: current and fu- ture applications. Washington, DC: Institute for Health Policy Analysis, 1986. "Information syntheses, Expert opinion, Group judgment, Cost analyses] . . --r ~-- ~, ~ 122 GUS Perry S. "Georgetown University Medical Center, Institute for Health Policy Analysis] Reuse of medical devices intended for single use only. Health Care Instrum 1985;1:4-8. "Information syntheses, Expert opinion, Group judgment, Cost analyses] GU7 Perry S. "Georgetown University Medical Center, Institute for Health Policy Analysis] Reusing dispos- able medical devices raises ethical, legal and cost ques- tions. Bus Health 1985;2:53-4. "Information synthe- ses, Expert opinion, Group judgment, Cost analyses] GUS Georgetown University Medical Center, Institute for Health Policy Analysis. Conference proceedings: International Conference on the Reuse of Disposable Medical Devices in the 1980s. Washington, DC: Insti- tute for Health Policy Analysis, 1984. "Information syntheses, Expert opinion, Group judgment, Cost an- alyses] Ongoing Assessments GUS . Therapeutic drug substitution: legal lia- bility. Ongoing. Planned Assessments GU10 . Extended wear contact lenses. Planned. GUll . Home health technologies. Planned. GU12 . Orphan devices in health care. Planned. GU13 . Regionalization of medical technologies. Planned.

HARVARD SCHOOL OF PUBLIC HEALTH Harvard School of Public Health Institute for Health Research 677 Huntington Avenue Boston, MA 02115 61 7-729-5657 Contact: Howard S. Frazier, M.D. Overview: The Institute for Health Research is a medical technology assessment program sponsored by Harvard University and the Harvard Community Health Plan. The technology assessment activities were initiated in 1965 by the Center for the Analysis of Health Practices of Harvard University, the precursor to the current Institute. Purpose: To enhance the understanding of innovation and its consequences in the health sector. Primary intended users: Providers, generally; physicians; acute facility administrators; other care givers; health/medical professional associations; third party payers; govern- ment regulators; public policy-makers, legislators. Technologies: Device, medical or surgical procedure, support system, organizational or . . . ac ministrative system. Intervention: Treatment, diagnosis. Stage: New, established or widespread practice, obsolete. Properties: Efficacy; safety; cost; cost-effectiveness; service requirements; system im- pact; economic implications; ethical, legal, social implications. Selection process: An Institute investigator or nonmember (e.g., government agency) can request that assessments be conducted. The Institute Executive Committee sets assessment topic priorities based on research interest, opportunities for methodologic advances, or the potential impact of the technology or assessment. The Committee also examines the comparative advantage of the Institute over other organizations when . . . . setting priorities. Methods: Information syntheses, expert opinion, group judgment, cost analyses, epidemi- ological and other observational methods, clinical trials, meta-analysis. The turnaround time from selection of assessment topic to reporting of findings is 1 to 2 years. Assessors: The assessors have expertise in the areas of medicine, surgery, dermatology, pediatrics, economics, statistics, policy analysis, psychology, law, and social psychology. Assessment reports include: The purpose of the assessment; who sponsored/commis- sioned/supported the assessment; who conducted the assessment; description of the technology; stages of life-cycle of technology when assessed; properties assessed; proce- dure used for the assessment; sources of data/information; methods for collecting data/ 123

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY information; methods for arlalyzirlg/synthesizing data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommenda- tions for practice, future assessments, technology development, research; how the technology works, including theory, principles. Dissemination: journal articles, printed reports. Budget: $300,000. The cost per assessment is highly variable ranging from $5,000 to $250,000. Funding sources: 30 percent parent organization; 40 percent government grants/contracts; 30 percent foundations, other private grants. Related activities: The Institute offers short postgraduate courses for medical educa- tors and others. The courses include materials on aspects of technology assessment and cost effectiveness analysis. Completed Reports HA1 Hussain S. Belidegrun A, Seltzer SE, Feldstein ML, et al. "Harvard School of Public Health, Institute for Health Research] CT differentiation of malignant from benign adrenal masses. Am J Roentgenol, in press. [Epidemiological methods1 HA2 Stern RS and members of the 16-center PUVA Follow-up Study. "Harvard School of Public Health, Institute for Health Research] Long-term utilization of PUVA therapy for psoriasis evidence for efficacy and cost savings. ~ Am Acad Dermatol, in press. [Clin- ical trials] HAS Stern RS, Pass TM, Komaroff AL. "Harvard School of Public Health, Institute for Health Re- search] Topical versus systemic agent treatment for papulopustular acne: A cost-effectiveness analysis. Arch Dermatol, in press. "Information syntheses] HA4 Thompson M, Cohen A, Palmer H. "Harvard School of Public Health, Institute for Health Re- search] Decision making on clinical use of electronic fetal monitors. Semin Fam Med. in press. tEpidemio- logical methods] HAS Weinstein MC. "Harvard School of Public Health, Institute for Health Research] Economic techniques for technology assessment. In: Rutten F. Reiser S. eds. Economics of medical technology. Springer-Vering, in press. tCost analyses] HAS Sandberg SI, Barnes BA, Weinstein MC, Braun P. "Harvard School of Public Health, Institute for Health Research] Elective hysterectomy: benefits, risks and costs. Med Care 1985;23: 1 067- 1 085. [Infor- mation syntheses] 124 HA7 Stason WE, Barnes BA. [Harvard School of Public Health, Institute for Health Research] Effectiveness and costs of continuous ambulatory peritoneal dialy- sis (CAPD). Washington, D.C.: U.S. Congress, Office of Technology Assessment, July 1985. (Health Tech- nology Case Study 35, OTA-HCS-35) "Information syntheses] HAS Stason WB, Localio AR. "Harvard School of Public Health, Institute for Health Research] Magnetic reso- nance imaging: clinical efficacy, costs and policy con- siderations. Blue Cross and Blue Shield Association, 1985. [Information synthesesJ HAS Li Tem, Sherman H. Cook EF, et al. "Harvard School of Public Health, Institute for Health Re- search] The selective impact of a cardiology data bank on physician's therapeutic recommendations. Medical Decision Making 1984;4~21:165-177. tEpidemiologi- cal methodsJ HA10 Shepard DS, Karon SL. "Harvard School of Pub- lic Health, Institute for Health Research] The market for wheelchairs: innovations and federal policy. Washington, D.C.: U.S. Congress, Office of Technol- ogy Assessment, 1984. Health Technology Case Study 30, OTA-HCS-30) "Information syntheses] HAll Fineberg HV, Wittenberg J., Ferrucci J. Meuller P. Simeone I, Goldman i. "Harvard School of Public Health, Institute for Health Research] The clinical value of body computed tomography over time and technologic change. Am J Roentgenol 1983;141 :1067-1072. tEpidemiological methods] HA12 Berwick DM, Komaroff AL. "Harvard School of Public Health, Institute for Health Research] Cost effectiveness of lead screening. N Eng J Med 1982;306:1392-1398. [Information syntheses]

HARVARD SCHOOL OF PUBLIC HEALTH HA13 Fineberg HV, Stason WB. "Harvard School of Public Health, Institute for Health Research] Cost- effectiveness of alternative diagnostic strategies for coronary artery disease. Circulation 1982;66(III):80- 86. "Information syntheses] HA14 Kaufman SL, Shepard DS. "Harvard School of Public Health, Institute for Health Research] Costs of neonatal intensive care by day of stay. Inquiry 1982; 19: 167-178. tEpidemiological methods] . HA15 Liang M, Komaroff A. "Harvard School of Public Health, Institute for Health Research] Roentgeno- grams in primary care patients with acute low back pain. Arch Intern Med 1982; 142: 1108-1112. tEpide- miological methods] HA16 Stason WB, Fortess E. "Harvard School of Public Health, Institute for Health Research] Case study #13: Cardiac radionuclide imaging and cost effective- ness. In: Implications of cost-effectiveness analysis of medical technology. Office of Technology Assess- ment, U.S. Congress, 1982. fInformation syntheses] HA17 Weinstein MC, Stason WB. "Harvard School of Public Health, Institute for Health Research] Cost- effectiveness of coronary artery bypass surgery. Cir- culation 1982;66(Suppl III):III56-III66. iInforma- tion syntheses] HA18 Fineberg HV, Pearlman LA. "Harvard School of Public Health, Institute for Health Research] Benefit- and-cost analysis of medical interventions: the case of cimetidine and peptic ulcer disease. In: The implica- tions of cost-effectiveness analysis of medical technol- ogy/background paper #2: case studies of medical technologies. Office of Technology Assessment, U.S. Congress. Washington, D.C.: U.S. Government Print- ing Of rice, 1981. "Information syntheses] HAl9 Thompson MS, Cohen AB. "Harvard School of Public Health, Institute of Health Research] Decision analysis: electronic fetal monitoring. In: Wortman PM, ed. Methods for evaluating health services. Bev- erly Hills: Sage, 1981. tEpidemiological methods] HA20 Weinstein MC, Pearlman LA. Harvard School of Public Health, Institute for Health Research] Case study on cost-effectiveness of automated multichan- nel chemistry analyzers. The implications of cost-ef- fectiveness analysis of medical technology back- ground paper #2: case studies of medical technol- ogies. Office of Technology Assessment, U.S. Congress. Washington, D.C.: U.S. Government Print- ing Office, 1981. tEpidemiological methods] HA21 Fineberg HV, Wittenberg J. "Harvard School of Public Health, Institute for Health Research] Evalua- tion of computed tomography in pancreatic cancer. Bull Cancer (Paris) 1 980 ;67: 390-394. FEnidemiolo~i- cal methods] ~ -r ~A_ HAM Wittenberg], Fineberg HV, Ferrucci IT Jr, Si- meone IF, Mueller PR, van Sonnenberg E, Kirkpat- rick RH. "Harvard School of Public Health, Institute for Health Research] The clinical efficacy of comput- ed body tomography. II. Am ~ Roentgenol 1980; 134:1111-1120. tEpidemiological methodsJ HA23 Fineberg HV, Wittenberg J. Ferruci IT, Jr. tHar- vard School of Public Health, Institute for Health Research] The clinical value of diagnostic tests: CT as a prototype. IN: Margulis A, Burhenne Hl, eds. Ali- mentary tract radiology: abdominal imaging, v. 3. St. Louis, Missouri: C.V. Mosby, 1979. [Epidemiological methods] HA24 Fineberg HV. "Harvard School of Public Health, Institute for Health Research] Assessing the diagnos- tic contribution of imaging tests: computed tomogra- phy and ultrasound of the pancreas. In: Alperovitch A, de Dombal FT, Gremy F. eds. Evaluation of effica- cy of medical action. New York: Elsevier-North Hol- land, 1979. fEpidemiological methodsJ HAM Fineberg HV. t Harvard School of Public Health, Institute for Health Research] Gastric freezing: a study of diffusion of a medical innovation. In: Medi- cal techonology and the health care system: a study of the diffusion of equipment-embodied technology. Washington, D.C.: National Academy of Sciences, 1979. tEpidemiological methods] HA26 Fineberg HV. "Harvard School of Public Health, Institute for Health Research] Medical technology policies and computed tomography. Ann Intern Med 1979;90: 114-115. Information syntheses] HA27 Koplan JP, Schoenbaum SC, Weinstein MC, Fra- ser DW. "Harvard School of Public Health, Institute for Health Research] Pertussis vaccine an analysis of benefits, risks and costs. N Eng J Med 1979;301:906- 911.1iInformation syntheses; HA28 Thompson M. "Harvard School of Public Health, Institute for Health Research] Prenatal diagnosis and public policy. In: Milunsky A, ed. Genetic disorders and the fetus: diagnosis, prevention and treatment. New York: Plenum Press, 1979. fInformation synthe- ses] ~5

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY HA29 Weinstein MC. Harvard School of Public Health, Institute for Health Research] Economic eval- uation of medical procedures and technologies: pro- gress, problems, and prospects. In: Medical technol- ogy. Washington, D.C.: National Center for Health Services Research, 1979. (NCHSR Research Proceed- ings Series, DHEW pub. no. (PHS) 79-3254) tCost analyses] HA30 Neuhauser D. "Harvard School of Public Health, Institute for Health Research] Cost effective clinical decision making: are routine pediatric preoperative chest X-rays worth it? Ann Radiol (Paris) 1978;21 :80- &3. "Information syntheses] HA31 Neutra RR, Fienberg SE, Greenland S. Friedman EA. "Harvard School of Public Health, Institute for Health Research] Effect of fetal monitoring on neo- natal death rates. N Eng J Med 1978;299:324-326. tEpidemiological methods] HA32 Wittenberg }, Fineberg HV, Black EB, Kirkpat- rick RH, Schaffer DL, Ikeda MK, Ferrucci IT in "Harvard Medical School, Institute for Health Re- search] The clinical efficacy of computerized body tomography. Am J Roentgenol 1978;131:5-14. tEpi- demiological methods] HA33 Barnes BA, Barnes AB. "Harvard School of Pub- lic Health, Institute for Health Research] Evaluation of surgical therapy by cost-benefit analysis. Surgery 1977;82:21-33. "Information syntheses] Hastings Center 255 Elm Road Briarcliff Manor, NY ~ 05 ~ 0 9 14-762-8500 Contact: Paul Homer, Assistant to the Director. HA34 Bunker I, Barnes B. Mosteller F. eds. Costs, risks, and benefits of surgery. New York: Oxford Universi- ty Press, 1977. "Information syntheses] HA35 Fineberg HV, Bauman K, Sossman M. "Harvard School of Public Health, Institute for Health Re- search]Computerizedcranialtomography:effecton diagnostic and therapeutic plans. JAMA 1977 ;238 :224-227. fEpidemiological methods] HA36 Fineberg HV, Parker GS, Pearlman LA. tHar- vard School of Public Health, Institute for Health Research] CT scanners: distribution and planning status in the United States. N Eng I Med 1977;297:216-218. tEpidemiological methods] HA37 Neuhauser D, ~onsson E. "Harvard School of Public Health, Institute for Health Research] Mana- gerial response to new health care technology: coro- nary artery bypass surgery. In: Abernathy WJ, Shel- don A, Prahalad CK, eds. The management of health care. Cambridge: Ballinger Press, 1975. "Information syntheses] HA38 Neuhauser D, Lewicki A. "Harvard School of Public Health, Institute for Health Research] What do we gain from the sixth stool guaiac? N Eng J Med 1975;293:226-228. tEpidemiological methods] Overview: The Hastings Center is a nonprofit corporation formerly known as the Institute of Society, Ethics and Life Sciences. Since its founding in 1969, the Center has addressed ethical issues arising from advances in health and medicine, the natural sciences, and the social and behavioral sciences. The Center has about 11,000 individ- ual members, including 2,200 libraries. Membership fees range from $38 for students to $48 for institutions and libraries. Purpose: To carry out nonpartisan research on pressing ethical issues; to develop educational programs and literature; and to assist universities, legislators, and profes- sional organizations in coping with moral problems. 126

HASTINGS CENTER Primary intended users: General public; providers, generally; health/medical profes- sional associations; third party payers; government regulators; public policy-makers, legislators; policy research organizations. Technologies: Drug, device, medical or surgical procedure, support system, organiza- tional or administrative system. Most Hastings Center work is conducted by research groups that address certain technological areas. Among those currently active are groups on health policy research, chronic illness, neonatology, genetic screening, and organ transplantation. Intervention: Prevention, diagnosis, treatment. Stage: Emerging, new, established or widespread practice. By examining technologies already in use- such as dialysis and heart transplants and those currently under development, the members of the health policy research group aim to arrive at some consensus that may prove useful to researchers and policy-makers who face difficult decisions about the appropriate direction for financing and distribut- ing new medical technologies. Properties: Ethical, legal, social implications. The Center is especially interested in highlighting the role played by regulatory agen- cies and committees in monitoring new technologies. Research groups have addressed the ethical, social, and legal issues in genetic counselling and genetic engineering; occupational health; death and dying; and alternative forms of care for the terminally ill. The death and dying research group, established in 1970, has examined the moral, social, and legal issues of the care of the dying engendered by advanced medical technology. Subjects included organ transplantation and the definition of death, the termination of treatment of dying patients, and the allocation of scarce resources to the dying. A successor group examined the goals of medicine and their relationship to death, suffering, and well-being. It examined changing social attitudes and practices toward childbirth; the difficulties of treating pain that appears to be psychological in origin; and the nature of suffering in a life-threatening illness, including the role of hospices. The current group examines decisions to forgo various life-sustaining tech- nologies. Selection process: Subjects for assessments may originate from many sources, includ- ing Center staff, fellows of the Center, medical societies and professional organizations, government agencies, foundations, and subscribing members of the Center. The selection of project topics is generally made by Center staff, as approved by the board of directors. In some cases, final selection is made by foundation approval of project grant proposals made by the Center. Methods: Information syntheses, expert opinion, group judgment. The Center works primarily through small, multidisciplinary study groups of about 10 to 12 outside specialists. Each group is set up to address a particular set of problems, and may meet 4 or 5 times over 12 months or more. Groups usually meet first for informal planning in response to staff suggestions. Work plans are finalized and 127

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY approved by groups, then approved by the Center director or associate director. Groups often discuss relevant case studies or case histories, and may use a consensus development format. Reports and guidelines go through numerous drafts by Center staff and subgroups. Turnaround time from selection of assessment topic to reporting of findings varies among types of projects. Most studies range from 6 to 12 months, although some have taken 2 to 3 years. The Center must also respond quickly to certain types of requests, such as requests to present testimony at Congressional hearings and requests from State and local government agencies. Dissemination: Printed reports, journal articles. The bimonthly Hastings Center Report is devoted to case studies, court decisions, other news, and articles regarding ethical problems of the biomedical, behavioral, and social sciences and issues in professional and applied ethics. Published since 1971, this is the Center's primary means of communication with its members and the general public. Other publications include monographs, reports, and books resulting from project work. Also, Center staff publish papers on ethical issues in medical technology, speak at medical conferences, and respond to inquiries from attorneys and journalists. Budget: The annual budget of the Center is about $1.5 million, including about $250,000 devoted to studies in health and medicine. Funding sources: 56 percent foundations, other private grants; 44 percent sponsors/members dues, contributions, publications, workshops, other sources. Technology assessment activities are supported directly by foundations such as the General Electric Foundation, the Charles A. Dana Foundation, and the Pettus-Crowe Foundation and by general funds from the Hastings Center's budget. Use: Use of studies varies. For example, the program on ethical problems of research on human subjects monitors government regulations regarding human subjects re- search, develops educational and training programs and related activities, and serves as a resource for institutional review boards. A 198 1 Hastings report, The Hastings Center: Ethics in the 80s. listed a variety of activities in which it had participated to indicate both the scope of its work and range of possible impact. The Center is described in: Institute of Medicine, Committee on Evaluating Medical Technologies in Clinical Use. Assessing medical technologies. Washington, DC: National Academy Press, 1985. Related activities: The Hastings Center conducts an educational workshop program for teachers and other professionals throughout the country, and sponsors study programs for graduate and undergraduate students and visiting scholars. The Center holds workshops on problems in the ethical and legal assessment of new technologies and week-long seminars on medical ethics. Completed Reports HC1 Caplan A. (The Hastings Center] Should fetuses or infants be used as organ donors? Bioethics, forth- coming. HC2 Bermel J. (The Hastings Center] Mothers vs. their babies in fetal therapy. Dialog Pediat Urol 1986 Jan. 128 HC3 Callahan D. [The Hastings Center] How technol- og,v is reframing the abortion debate. Hastings Cent Rep 1986 Feb. c, _ _ . HC4 Callahan D. tThe Hastings Center] Public policy and the cessation of nutrition. In: Lynn J. ed. By no extraordinary means: the choice to forgo life-sustain- ing food and water. University of Indiana Press, 1986.

HASTINGS CENTER HC5 Caplan A. [The Hastings Center] A new dilemma: quality, ethics and expensive merlicn1 terLn~l~`ri`~c NY Med Q 1986;6~1~. HC6 Caplan A. [The Hastings Center] Ethics of in vitro fertilization. Primary Care 1986 fun. HC7 Caplan A. iThe Hastings Center] The morality and immorality of reuse. Renal Life. 1986 Oct. HC8 Cohen C. iThe Hastings Center] Autonomy and equity in the ICU. Hastings Cent Rep 1986. HC9 Cohen C. (The Hastings Center] Ethical and legal considerations in the care of the infant with end stage renal disease whose parents elect conservative thera- py. Pediatr Nephrol 1986. Health Care Financing Administration Bureau of Eligibility, Reimbursement, and Coverage East Builcling, Room 401 6325 Security Boulevard Baltimore, MD 21207 30 1-594-9690 HC10 Cohen C. tThe Hastings Center] Ethical prob ', lems in the clinical practice of anesthesia. In: Dekorn feld T. ed. Textbook of anesthesia. 1986. HCl l Wolf S. The Hastings Center] Ethics committees in the courts. Hastings Cent Rep 1986 {un. HC12 The Hastings Center. Ethical, legal and policy issues pertaining to solid organ procurement: a re- port of the Project on Organ Transplantation. 1985 Oct. Contact: Robert E. Wren, Director, Office of Coverage Policy; or Barton McCann, M.D., 301-594-9370. Overview: The Health Care Financing Administration (HCFA) is responsible for administering the Medicare program, provided for in title XVIII of the Social Security Act, and Federal participation in the Medicaid program. FICFA will spend approxi- mately $84 billion for Medicare and $27 billion for Medicaid in 1988. Almost 400 million individual Medicare claims were processed in 1987. The Medicare law provides coverage for broad categories of benefits, including inpa- tient and outpatient hospital care, skilled nursing facility care, home health care, and physicians' services. It places general and categorical limitations on the coverage of the services furnished by certain health care practitioners. Medicare payment is prohibited for any expenses incurred for items and services "which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the function- ing of a malformed body member." HCFA regulations do not define "reasonable and necessary," and the regulations do not denote a process for how this term is to be applied. The process used for making Medicare coverage determinations is largely a decentral- ized one. Most decisions are made by the 35 carriers, 54 fiscal intermediaries, and 54 professional review organizations (PROs) that contract with DHHS to review and adjudicate Medicare claims. (In general, carriers administer hospital services and relat- ed aspects of Part A of Medicare, intermediaries administer physician claims and other aspects of Part B. and PROs review appropriateness of services, utilization, and related aspects of delivery of services under Medicare.) 129

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Although most "reasonable and necessary" coverage issues can be decided by contrac- tors based on the Medicare statute, regulations, and policy precedents, some cannot be resolved without seeking additional expertise. Some 20 to 30 procedures per year are subject to a centralized technology assessment process coordinated by the HCFA Central Office. These issues are referred within HCFA to the Bureau of Eligibility, Reimbursement and Coverage (BERC), which assists in development of national policy on coverage, payment, and eligibility of services under Medicare and Medicaid. HCFA's Medicaid responsibilities deal primarily with guidelines for appropriate insti- tutional settings for services, eligibility for services, payment limitation rates, and other administrative matters. HCFA does not set technology policy for Medicaid programs, which are administered by the States, although the States often look to Medicare coverage rules for guidance. State Medicaid programs do follow HCFA policy regard- ing discontinuation of coverage for certain drugs- generally old ones-found by the FDA to be less than effective and that are no longer to be marketed for certain . . . nc .lcatlons. Purpose: To determine whether items and services are, or continue to be, reasonable and necessary for Medicare coverage purposes. Primary intended users: Patients; providers, generally; physicians; acute facility ad- ministrators; long-term care facility administrators; other care givers; health product manufacturers; third party payers; government regulators; public policy-makers, legis- lators. Technologies: Device, medical orsur~ical procedure. drug. suDoort .SV.Stem Or~ni7~tiOn~1 , . . . Or administrative system. <;: 1 <: 1 1 ~ Medicare coverage of drugs is treated differently from procedures. Current Medicare manual instructions provide for coverage of drugs that have been approved for mar- keting by FDA, except when a particular use has been expressly disapproved or withdrawn from the market by the FDA or designated as not covered in a national HCFA instruction. Intervention: Diagnosis, treatment, rehabilitation. Stage: New, established or widespread practice, obsolete. Coverage questions may concern either new or unusual technologies, or those that are believed to be outmoded and no longer reasonable and necessary. Properties: Safety; effectiveness; efficacy; cost; cost-effectiveness; service requirements; acceptance/adoption level; system impact; economic implications; ethical, legal, social . . . Imp 1catlons. Selection process: Coverage inquiries normally come through the HCFA regional offices from a number of sources, usually Medicare contractors. Inquiries are also raised by individual beneficiaries, physicians and other health care providers, health product manufacturers, public officials, professional associations, and government agencies. Other coverage issues are raised during HCFA's ongoing review of medical practice, and in the course of hearings on disputed claims. 13O

HCEA/BUREAU OF ELIGIBILITY, REIMBURSEMENT, AND COVERAGE Medicare contractors have the discretion within HCFA national coverage determina- tions, rulings, or manual instructions to decide coverage issues identified in the claims review process. When a claim for a new or otherwise questionable technology is received for which national HCFA policy does not exist, contractors are authorized to make "reasonable or necessary" decisions with respect to the technology, taking into account the frequency, duration, and the setting in which it was furnished. Such decisions are usually made in consultation with the contractor's own medical staff and local medical specialty groups. Thus, coverage of any particular technology may vary among contractors. If contractors cannot resolve a question locally, or believe a national coverage determi- nation may be necessary, the issue is referred to the HCFA Central Office through a HCFA regional office. Assessment priorities are set by the HCFA Central Office, based on Medicare significance, notenri~1 One cliffi~i~n ~nr1 I~~] Or In_ yarding the technology. ~. ~ ~MA _V-~_ ~Ad_ ~ MA ~_~Al~1 ~ V ~_1 ~] 1 ~ ~ecnno~og~es may be reassessed when new or forthcoming published information indicates the need for reconsideration of an assessment. HCFA may choose to reassess an item or service that is already excluded or covered under the Medicare program. This might occur if, in a previous assessment, PHS suggests a reevaluation of a technology at a later date. Methods: Information syntheses, group judgment, expert opinion, cost analyses. The assessment process involves the HCFA Central Office staff and Physicians Panel, the PHS, and the national medical community. Upon receiving ~ rover~e iCC,~f~ The Rli~l)~ ~f ~1.~_~ ~_ __ 1 ~1 ~ ~ O _ ~ v v ~ _ ~ ~ ^ ^ ~ ~ Ball talc ~ UdL~OUl1Q p~[ oasea on a medical literature search, the status of any EDA action, administrative aspects of the issue, current applicable Medi- care coverage ~uideline.s and ~nv ~v~il~hlP ~ccPccm~ntc from other ~=`r-~;7-t;~ O ~ 7 ~--- --a; -~ ~ BAA_ TV_-VA44~_Ai$~= AA BAAS ~t Q1 5~111~1~11~- The background paper is presented to the HCFA Physicians Panel for review. The Panel meets once every 6 to 8 weeks in closed session. Based on the background paper, other evidence, and discussion, the Panel may recommend that the technology be: (1) covered or not covered, (2) referred to PHS on either an informal inquiry basis or with a request for a full assessment, (3) covered or not at the discretion of the particular Medicare contractor pending receipt of more information, or (4) subject to a special study or action (e.g., as in the case of the special study on heart transplantation commissioned by HCFA.) When a referral is made to PLIS, it is made to the NCHSR Office of Health Technology Assessment (OHTA). In the case of an informal request (known as an inquiry) OHTA conducts a review of the medical literature, discusses the issue with other government agencies and medical groups, and responds to the specific questions raised by HCFA. Handling of requests for full assessments varies according to the topic, though usually involves an announcement in the Federal Register soliciting comments from interested parties, seeking information from other agencies and medical groups, an extensive literature search, and synthesis of this information. (This process is described in the profile on OHTA in this Directory.) HCFA coverage decisions are based on recom- mendations from the PHS and other available sources of public comment and expert opinion. For those issues referred to OHTA, HCFA coverage decisions have nearly always been consistent with OHTA's recommendations. The time to complete an assessment generally ranges from 6 months to 2 years, depending upon the quality of available information, potential impact on the Medicare population, and availability of alternative technologies. 13]

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Reassessments are conducted as are those for new technologies, except that decisions to withdraw coverage call for publication of a notice in the Federal Register announcing that intent. Assessors: The HCFA Physicians Panel includes about eight HCFA staff physicians, as well as other HCFA staff members with health financing expertise. Ex officio members of the Panel include representatives from OHTA, NIH, and FDA. Depending upon the assessment topic, other experts may be consulted as well. HCFA is establishing referral lists of experts in particular technological areas from other Federal agencies to be called upon for consultation on coverage decisions. Assessment reports include: Description of the technology; findings or conclusions; coverage/reimbursement status of the technology. National Medicare coverage decisions made by HCFA usually appear as guidelines in the Medicare Coverage Issues Manual provided to Medicare contractors. (Some coverage decisions require no revision of the manual.) Rather than being assessment reports as such, the guidelines in the Manual usually consist of at most several sentences describ- ing a technology, whether it is covered or not, and if so, under what conditions it is covered. A few guidelines, such as those on cardiac pacemaker evaluation services (section 50-1 in the Manual) and magnetic resonance imaging (50-13), are 3 to 4 pages long. The background papers prepared by HCFA staff for the Physicians Panel and the OHTA assessments on which many HCFA coverage decisions are based are more detailed reports. See the Completed Reports section at the end of this profile for an example of a Manual coverage guideline. Although most coverage guidelines derive from the assessment process described in this profile, the Manual includes some coverage guidelines set by statutory changes and other rulings. Examples are the guidelines on laser procedures (section 35-52 in the Manual), artificial hearts and related devices (65-15J, and enteral and parenteral nutri- tional therapy (65-101; these guidelines are not associated with assessment reports. A coverage decision that was not subject to normal OHTA or HCFA assessment proce- dures was the 1986 ruling on heart transplantation, based in part on the findings of the special DHHS-sponsored study completed in 1984 by the Battelle Human Affairs Research Centers. Dissemination: Printed reports; press conferences/news releases, TV/radio broadcasts, video products. . After a final HCFA coverage decision is made, the guidelines are disseminated via the Medicare Coverage Issues Manual and through public notice of rules, regulations, and informally through correspondence and public presentations. Background papers prepared for the Physicians Panel are for internal use only. The Medicare Coverage Issues Manual (HCFA Publication 6J is available from the U.S. Government Printing Office, Washington, DC 20402. The Manual is updated about 15 to 20 times a year by transmittal sheets sent to its users. Individual guidelines are available from HCFA. Budget: The budget for the HCFA Office of Coverage Policy was approximately $2,000,000 in 1986. This figure does not include the cost of OHTA assessments, the value of consultation from outside experts, and related assessment costs; and does include the cost of a variety of Medicare and Medicaid coverage activities not directly pertinent to technology assessment. Funding source: 100 percent parent organization. 132

HCFA/BUREAU OF ELIGIBILITY, REIMBURSEMENT, AND COVERAGE Use: HCFA coverage decisions are used as a basis for Medicare coverage policy. Coverage decisions made by other government entities and private third party payers are also Influenced by the guidelines. The Medicare coverage process is described by HCFA in: Medicare Program; Proce- dures for Medical Services Coverage Decisions; Request for Comments, Federal Regas- ter; 52~82), April 29, 1987, 15560-62. The HCFA assessment activity has been evaluated in the following two reports spon- sored by DHHS: Lewin and Associates. A forward plan for Medicare coverage and technology assessment. Prepared for the Assistant Secretary for Planning and Evaluation, Department of Health and Human Services, 1986. Macro Systems, Inc. Technology assessment and coverage decasion-making in the Department of Health and Human Services. Prepared for the Assistant Secretary for Planning and Evaluation, Department of Health and Human Services, 1984. Related activities: BERC staff members participate in meetings and conferences spon- sored by other organizations conducting technology assessment. BERC also convenes regular meetings with medical directors of HCFA contractors to discuss coverage, payment, and medical review issues. Completed Reports: AS discussed above under Assessment Reports, HCFA coverage decisions appear as guidelines in the Medicare Coverage Issues Manual and normally do not generate assess- ment reports other than those provided by OHTA. Therefore, no listing of HCFA assessment reports is shown here; the reader may consult the profile on OHTA in this Directory for a listing of assessments conducted for HCFA. For purposes of illustration, the following HCFA national coverage guideline appear- ing in the Medicare Coverage Issues Manual is reproduced here. This HCFA coverage decision followed a 1985 OHTA assessment report, Implantable Automatic Cardioverter- Defilmllators. 35-85 IMPLANTATION OF AUTOMATIC DEFIBRILLATORS (Effective for serv- ices performed on and after 1-24-86.) The implantable automatic defibrillator is an electronic device designed to detect and treat life-threatening tachyarrhythmias. The device consists of a pulse generator and electrodes for sensing and defibrillating. The implantation of an automatic defibrillator is a covered service only when used as a treatment of last resort for patients who have had a documented episode of life-threatening ventricular tachyarrhythmia or cardiac arrest not associated with myocardial infarction. Patients must also be found, by electro- physiologic testing, to have an inducible tachyarrhythmia that proves unresponsive to medication or surgical therapy (or be considered unsuitable candidates for surgical therapy). It must be emphasized that unless all of the above described conditions and stipulations are met in a particular case, including the inducibility of tachyarrhythmia, etc., implan- implantation of an automatic defibrillator cannot be covered. 133

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Health Care Financing Administration Office of Research ant! Demonstrations Oak Meadows Building, Room 2-B-12 6325 Security Boulevard Baltimore, MD 21207 301-597- 1435 Contact: Joel Broida, Research Analyst. Overview: The Office of Research and Demonstrations (ORD), Health Care Financing Administration (HCFA) is a Federal agency that directs more than 300 research, evaluation, and demonstration projects. ORD's activities are carried out by three major components- the Office of Research, the Office of Demonstrations and Evaluations, and the Office of Operations Support. The Office of Research conducts and supports data collection efforts and research on health care providers, reimbursement, benefi- ciary behavior, and health care utilization. The Office of Demonstrations and Evalua- tions funds, manages, and evaluates pilot programs that test new ways of delivering and financing Medicare and Medicaid services. The Office of Operations Support provides ORD-wide administrative direction for its research, demonstration, and evaluation projects, which includes the budget and accounting operations; grants, cooperative agreements, and contracts-award process; and publications and information resources program. Purpose: To carry out research, evaluation, and demonstration projects related to the administration and operation of the Medicare and Medicaid programs. A major focus is on expenditures as they relate to reimbursement, coverage, eligibility, and manage- ment alternatives. Study activity also examines program impact on beneficiary health status, access to services, utilization, and out-of-pocket expenditures. The behavior and economics of health care providers and the overall health care industry are also topics ~ · . . Ot Investigation. Primary intended users: Providers, generally; acute facility administrators; long-term care facility administrators; health industry associations; employers; unions and other employee organizations; third party payers; government regulators; biomedical re- searchers; public policy-makers, legislators; policy research organizations. Technologies: Organizational or administrative system, drug, device, medical or surgical procedure, support system. Intervention: Prevention, diagnosis, treatment, rehabilitation. Stage: New, established or widespread practice. Generally, devices and procedures are assessed after they have been introduced in the clinical setting. Properties: Effectiveness, cost, cost-effectiveness, safety, efficacy, cost-benefit, service re- quirements, acceptance/adoption level, system impact, economic implications. Selection process: Requests for assessments may originate either within the agency or from outside it, through Medicare insurance contractors, other third party payers, 134

HCFAJOFFICE OF RESEARCH AND DEMONSTRATIONS physicians, intermediaries, and other persons. Some requests come in the form of unsolicited grant applications. Questions about reassessments are usually decided in HCFA's Bureau of Eligibility, Reimbursement, and Coverage. Methods: Information syntheses, expert opinion, group judgment, modeling, cost analyses, epidemiological and other observational methods. Assessments are conducted in-house or extramurally through contracts, grants, and cooperative agreements. Assessment reports include: Abstract; the assessment's intended audience; the pur- pose of the assessment; relationship of this assessment to prior or concurrent assess- ments of the technology or other technologies intended for similar purposes; who conducted the assessment; description of the technology; stage of life-cycle of technol- ogy when assessed; properties assessed; procedure used for the assessment; sources of data/information; methods for collecting data/information; methods for analyzing/ synthesizing data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assess- ments, technology development, research; how much the assessment cost; how the technology works, including theory, principles; development of the technology; pro- curement/deployment information; where technology is in use; regulatory agency approval status; coverage/reimbursement status of the technology; product recall histo- ry, liability actions. Dissemination: Printed reports; journal articles; advisories to members/constituents; press conferences/news releases, TV/radio broadcasts, video products; clearinghouses, data/citation bases, online services, specifically, the NTIS database. As extramural projects are Completed, the final reports are placed with the National Technical Information Service (NTIS). For those projects with final reports at NTIS, the accession number is necessary when ordering. Further information may be ob- tained from: NTIS, Document Sales, 5285 Port Royal Rd., Springfield, VA 22151,703- 487-4650. A select number of final reports is published by HCFA under its Grants and Contracts Reports Series. These reports are available for sale from the U.S. Government Printing Office (GPO). Reports must be ordered by title and stock number directly from GPO: Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. In addition, results from intramural and extramural research projects and demonstra- tions are often featured in the Health Care Financing Review, the agency's quarterly journal. The journal also offers synopses on newly awarded research and demonstra- tion projects being funded by HCFA. The Review is available on a subscription basis from the GPO for $18.00 ($22.50 foreign). Budget: Not provided. Funding source: 100 percent parent organization. Use: HCFA uses the assessment reports to assess new methods and approaches for providing quality health care while containing costs and to help make policy decisions on coverage and reimbursement of services for Medicare beneficiaries. The reports are also used by the research community, other Government agencies, universities, and other interested parties in the private sector such as private health insurers. 135

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Completed Reports HF1 A demonstration and evaluation of a preventive services package to provide early detection of illness and monitoring high-risk Medicare beneficiaries. In: Office of Research and Demonstrations, Health Care Financing Administration. Health care financing sta- tus report: research and demonstrations in health care financing. Jan 1986. (HCFA Pub. No. 03219). HF2 A demonstration of cost control and patient satis- faction resulting from the relaxation of the maximum public enrollment rule for HMO's. In: HF3 A longitudinal study of case-mix outcomes and resource use in nursing homes. In: HF4 A national study of resource-based relative value scales for Physician Services. In: HF5 AFDC/Medicaid eligibility impact on prenatal care use. In: HF6 Acquisition and analysis of state Medicaid data. In: HF7 Alcoholism services under Medicare and Medic- aid: Illinois demonstration. In: HF8 Alcoholism services under Medicare and Medic- aid: Michigan demonstration. In: HF9 Alcoholism services under Medicare and Medic- aid: New Jersey demonstration. In: HF10 Alcoholism services under Medicare and Medic- aid: New York demonstration. In: HFll Alcoholism services under Medicare: Connecticut demonstration. In: HF12 Alcoholism services under Medicare: Oklahoma demonstration. In: HF13 Alternate models for prepaid capitation of health care services for Medicare beneficiaries~regon. In: HF14 American Association of Retired Persons' In- formed Buyer Program. In: HF15 An analysis of long-run rate setting strategies for risk-based contracting under Medicare. In: HF16 An evaluation of "Life-Continuum of Care" resi- dential centers in the United States. In: HF17 An independent evaluation of the reliability of the standardized Medreview Instrument. In: HF18 Analysis of Medicare routine costs under alterna- tive assumptions. In: HFl9 Analysis of NMCUES data. In: 136 HF20 Analysis of long-term care payment systems. In: HF21 Analysis of physician fee information from sever- al sources. In: HF22 Analysis of physician pricing behavior, third-par- ty administrative practices. In: HF23 Analysis of the 1982 Long-Term Care Survey. In: HF24 Analysis of the 1982 survey of informal care I. givers. n: HF25 Annual reports to Congress on the impact of the Medicare Hospital prospective payment system. In: HF26 Appropriateness of hospitalization: a compara- tive analysis of reliability and validity of the Appropri- ateness Evaluation Protocol and the Standardized Medreview Instrument. In: HF27 Aspects of physician behavior in Medicare and Medicaid. In: HF28 Assess (State) tax incentives as a means of strengthening the informal support system for the elderly. In: HF29 Assessment of emerging technologies for the treatment of end-stage renal disease. In: HF30 Assignment rates revisited. In: HF31 California State Copayment Project In: HF32 Can geriatric nurse practitioners improve nurs- ing home care? In: HF33 Capitation payment system for all end-stage renal disease services. In: HF34 Case mix and resource use in hospital emergency room settings. In: HF35 Case-managed medical care for nursing home . patients. In: HF36 Case-mix measure for long-term ca\re Medicare patients. In: HF37 Changes in the distribution of Medicare expendi- tures. In: HF38 Children's Hospital Case-Mix Classification Sys- tem Project. In: HF39 Comparative analysis of the costs and outcomes of kidney transplants. In: HF40 Comparison by state of SNF/ICF types: beds, staffing, utilization, and ownership. In:

HCFA/O~ICE OF RESEARCH AND DEMONSTRATIONS HF41 Comparison of quality of life of end-stage renal disease patients. In: HF42 Comparison of the cost and quality of home health and nursing home care. In: _ HF43 Competitive managed health plans for AFDC Medicaid recipients. In: HF44 Consumer as a partner in medical cost contain- ment. In:- HF45 Cost of care information to consumers. In: HF46 Costs, outcomes, and competition in the End- Stage Renal Disease Program. In: HF47 Creating diagnosis-related-group-based physi- cian reimbursement schemes: a conceptual and em- pirical analysis. In: HF48 Demonstration and evaluation of competitive bid- ding as a method of purchasing durable medical equipment. In: HF49 Demonstration and evaluation of competitive bid- ding as a method to purchase clinical laboratory serv- ices. In: HF50 Demonstration of community-wide, alternative long-term care model. In: HF51 Determination of health maintenance organiza- tion capitation rates for Medicare beneficiaries. In: HF52 Develop the technology of aide sharing into a transferable form for use by home health agencies to reduce home health costs. In: HF53 Developing incentive systems to increase the sup- ply of cadaveric kidneys for transplants. In: HF54 Development of a case-mix based reimbursement method for hospital outpatient departments and free- standing clinics. In: HF55 Development of staging for six rehabilitation con- ditions and a cross-reference system with their respec- tive diagnois-related groups. In: HF56 Development, pilot testing, and refinement of valid outcome measures for the home care setting. In: HF57 Diagnosis-related groups and nursing resources. In: HF58 Diagnosis-related groups refinement for nursing care. In: HF59 Diagnosis-related groups refinement using meas- ures of disease severity. In: HF60 Diagnostic mix, illness severity, and costs in teach- ing and nonteaching hospitals. In: HF61 Disease-specific severity adjustments to diagnosis- related groups. In: HF62 Disproportionate share hospitals: costs and case mix. In: HF63 Economic and clinical outcomes of three drub cost-containment strategies in Medicaid. In: HF64 Economics of diagnosis-related-group-based phy- sician reimbursement. In: HF65 Effects of alternative family support strategies. In: HF66 Encouraging appropriate care for the chronically ill elderly: a controlled experiment to evaluate the impacts of incentive payments on nursing home ad- missions, discharges, case mix, care, outcomes,and costs. In: HF67 End-Stage Renal Disease Nutritional Therapy Study. In: HF68 End-stage renal disease annual report to Con- gress. In: HF69 End-stage renal disease competitive bidding dem- onstration. In: HF70 Enrollment of Medicare beneficiaries under a unique intra-health maintenance organization com- petition model. In: HF71 Evaluability assessment of the Medicare prospec- tive payment system on long-term care. In: HF72 Evaluation of l\/Iassachusetts case-managed medi- cal care for nursing home patients. In: HF73 Evaluation of Medicaid competition demonstra- tions. In: HF74 Evaluation of Medicare health maintenance orga . . . . . nlzatlon aemonstratlon proJects. In: HF75 Evaluation of Municipal Health Services Pro- gram. In:_ HF76 Evaluation of National Rural Swing-Bed Pro- gram. In: HF77 Evaluation of Obstetrical Access Pilot Project. In: HF78 Evaluation of coordinated community-oriented, long-term care demonstration. In: HF79 Evaluation of health maintenance organization (HMO) capitation demonstrations. In: HF80 Evaluation of prepaid managed health care dem- onstration. In:_ 137

HF81 Evaluation of prepaid risk-bearing care organiza- tion. In: HF82 Evaluation of social health maintenance organiza- tion demonstrations. In: HF83 Evaluation of the Arizona health care cost-con- tainment system. In: HF84 Evaluation of the Medicare competition demon- strations. In: HF85 Evaluation of the Medicare mental health demon- stration. In: HF86 Evaluation of the alcoholism services demonstra- tion. In: HF87 Evaluation of the impact of second opinions for elective surgery. In: HF88 Evaluation of the urban health clinics demonstra- tion. In: HF89 Evaluation of three-state demonstration in nurs- ing home quality assurance. In: HF90 Feasibility of incorporating CPT-4 codes for phy- sician billing into the diagnosis-related groups system for in-hospital Medicare surgical patients. In: HF91 Foot care coverage study. In: . HF92 Further analysis of the medical doctor diagnosis- related groups algorithms. In: HF93 Geriatric Continence Research Project. In: HF94 Health Care Plus: the Lutheran Medical Center program for prepaid managed health care. In: HF95 Health Status at Discharge Research Project. In: HF96 Health care alternatives within Title XIX: evalua- tion of alternative reimbursement methods to provid- ers of primary care medical services. In: HF97 Health care services for children under Medicaid. In: HF98 Health services utilization study. In: HF99 Home health agency prospective payment dem- onstration. In: HF100 Home respiratory therapy services. In: HF101 Home services for functionally disabled adults. In: HF102 Hospice patient outcomes and quality of care. In: 138 MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY HF103 Impact of DRG-based prospective payment sys- tem on quality of care for hospitalized Medicare pa- tients. In: HF104 Impact of Medicare fee freeze and participation agreements on physicians. In: HF105 Impact of Medicare's prospective payment sys- tem and private sector initiatives: the Blue Cross and Blue Shield Organization's experiences. In: HF106 Impact of physician supply and regulation on physician fees and utilization of services. In: HF107 Impact of psychological intervention on health care utilization and costs: a prospective study. In: HF108 Impact of the prospective payment system on the quality of inpatient care. In: HF109 Implications of the National Hospice Study for hospice prospective reimbursement. In: HF110 Improving New York State's Nursing Home Quality Assurance Program. In: HF111 Incentive prospective payment system for hospi- tals through fiscal intermediaries (Massachusetts). In: HF112 Incentive reimbursement plan for Medicaid home health services. In: HF113 Incorporating the cost of ambulatory care into case-mix based hospital reimbursement. In: HF114 Independent broker: coordinating open enroll- ment for Medicare health maintenance organizations and competitive medical plans. In: HF115 Information for prudent insurance choices. In: HF116 Learning from and improving diagnosis-related groups for end-stage renal disease patients. In: ~F117 Long-term care of aged individuals with hip fractures: public versus private costs. In: HF118 Long-term care residential services for develop- mentally disabled people. In: HFll9 Longitudinal studies of local area hospital use. In: HF120 Longitudinal study of the impact of prospective reimbursement under Medicaid on nursing home care in Maine. In: HF121 Malpractice component of the Medicare eco- nomic index. In:

HCFA/O~ICE OF RESEARCH AND DEMONSTRATIONS HF122 Massachusetts Health Care Panel Study of E1- derly- Wave IV. In: HF123 Measuring the cost of case mix using patient management categories. In: HF124 Medicaid child health care evaluation. In: HF125 Medicaid program evaluation. In: HF126 Medicaid program evaluation: cluster I. In: HF127 Medicaid program evaluation: cluster II. In: HF128 Medicaid program evaluation: cluster III. In: HF129 Medicaid tape-to-tape ambulatory services pro- ject. In: HF130 Medicaid tape-to-tape: data and analysis. In: HF131 Medicaid voucher demonstration. In: HF132 Medical doctor diagnosis-related groups algo- rithms. In: HF133 Medicare Prospective Capitation Demonstration Project. In: HF134 Medicare and Medicaid data book. In: HF135 Medicare automated data retrieval system. In: HF136 Medicare clinical social worker demonstration. In: HF137 Medicare competition demonstrations. In: HF138 Medicare health maintenance organization ad- ditional benefits. In: HF139 Medicare reimbursement regression to the mean. In: HF140 Medicare-Medicaid payment policies and capital formation. In: HF141 Medigap study of comparative effectiveness of state regulations. In: HF142 Methods of improving case mix and severity of illness classification for use in the Medicare prospec- tive payment system. In: HF143 Metropolitan Comprehensive Care Program: a health systems organization demonstration. In: HF144 Missouri Medicaid Prepaid Health Demonstra- tion Project. In: HF145 National Hospice Study. In: _ HF146 National Hospital Rate-Setting Study. In: HF147 National Kidney Dialysis and Kidney Trans- plantation Study. In: HF148 National and cross-national study of long-term care populations. In: HF149 New Tersey mobile intensive care system. In: HF150 New York Ambulatory Care Reimbursement Project. In: HF151 New York State case-mix, prospective reim- bursement system for long-term care. In: HF152 Noncertified hospice cost analysis. In: HF153 Nonintrusive outcome measures: identification and validation. In: HF154 Organ Donor Education Project. In: HF155 Payment options for nonphysician anesthetists under the prospective payment system. In: _ HF156 Physician reimbursement and continuing care under Medicaid in Suffolk County, New York. In: HF157 Planning study: phase I of a major study of national long-term care policies. In: HF158 Population-based study of hospice. In: HF159 Post-surgical mortality among the aged for com- mon operations. In: HF160 Prenatal care and its relationship to Medicaid costs. In: HF161 Prevention of falls in the elderly. In: HF162 Prevention of future utilization of health and long-term care services. In: HF163 Program for prepaid managed health care. In: HF164 Prospective payment beneficiary impact study. In: HF165 Prospective payment in rehabilitation hospitals and programs. In: HF166 Prospective payment of physicians. In: HF167 Prospective payment system and post-hospital care: use, cost, and market changes. In: 139

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY HF168 Prospective payment system for acute and chronic care hospitals in Maryland. In: _ HF169 Prospective reimbursement system based on pa- tient case mix for New Jersey hospitals. In: HF170 Quality and effectivness of preventive medical care. In: HF171 Quality assurance sampling: a statistical quality- control approach to inspection of care. In: HF172 Quality of life among life-care facility and com- munity residents: A comparison. In: HF173 Reducing inappropriate use of inpatient medi- cal, surgical, and pediatric services-extension of the Appropriateness Evaluation Protocol. In: HF174 Registered dietitians in home care. In: HF175 Rehospitalization after surgery among Medicare enrollees. In: HF176 Relative effectiveness and cost of transplantation and dialysis in end-stage renal disease. In: HF177 Research on competitive forces driving Medi- care utilization. In: HF178 Resource utilization groups: validation and re- finement of a case-mix system for long-term care re- imbursement. In: HF179 Respite care co-op for impaired elderly. In: HF180 Response of Massachusetts acute-care hospitals to the Massachusetts Cost-Containment Act. In: HF181 Responsibility of children for financing institu- tional care: potential response and possible adjust- ments. In: HF182 Section 1619 study on the working disabled. In: HF183 Selected analyses of the prospective payment system's impact on hospital's behavior In: HF184 Self-care home computer program to reduce health care costs. In: HF185 Senior Group Health Plan Waiver-Only Medi- care Competition Demonstration Program. In: HF186 Severity of illness and diagnosis-related groups in selected cancers. In: HF187 Severity of illness in end-stage renal disease pop- ulation in northern Florida. In: HF188 Social Health Maintenance Organization Project for long-term care. In: 14O HF189 South Carolina Community Long-Term Care Project. In: HF190 State Medicaid nursing home policies, utiliza- tion, and expenditures. In: HFl91 Statewide Medicaid competition demonstration. In: HF192 Studies evaluating Medicaid home- and commu- nity-based services: a report to Congress. In: HF193 Studies of Medicare use before death. In: HF194 Study of Medicare-funded heart transplants. In: HF195 Study of high-cost infants under Medicaid. In: HF196 Study of long-term care quality and reimburse- ment in teaching and nonteaching nursing homes. In: HF197 Study of the quality and effectiveness of experi- mental fixed-price Medicare Part A intermediary contracting. In: HF198 Systematic examination of factors that promote home care by the family. In: HFl99 Test of the out-of-pocket cost savings as an in- centive for changing beneficiary choice behavior. In: HF200 Texas Long-Term Care Case-Mix Reimburse- ment Project. In: HF201 The economy and efficacy of Medicare reim- bursement for preventive services. In: HF202 The impact of Medicaid home and community- based waiver services for the mentally retarded in Maine. In:_ HF203 The nature, process, and modes of hospice care delivery. In: HF204 The relation of surgical volume and other fac- tors to mortality after surgery. In: HF205 Title XVIII Hospice Benefit Program evalua- tion (Medicare). In: HF206 Urban health clinics demonstration. In: HF207 Use of Medicare services by disabled enrollees under 65 years of age. In: HF208 Use of services by the dually entitled (cross- overs). In: HF209 Waiver-Only Competition Project for Southern California, Illinois, Indiana, and Texas. In:

HEALTH COUNCIL OF THE NETHERLANDS Heaith COUnCi! Of The NetherIan&S PO BOX 90.517 2509 EM The Hague The NetherianUS (3 I-70) 47- 14-4 ~ Contact: Dr. Henk Rigter, Executive Director. Overview: The Health Council of The Netherlands is a not-for-profit, independent advisory council funded by the Government of The Netherlands. The Council was established in 1903 and its position was recomfirmed in the Health Act of 1956. Purpose: To advise the government about the "state of science" with respect to health care and environmental protection. Primary intended users: General public; people concerned about their health; pa- tients; providers, generally; physicians; acute facility administrators; long-term care facility administrators; other care givers; health product manufacturers; health/medi- cal professional associations; health industry associations; consumer associations; em- ployers; unions and other employee organizations; third party payers; government regulators; voluntary associations, organizations; biomedical researchers; financial ana- lysts, consultants; reporters, writers, news media; information/computer industry; labs, blood banks; public policy-makers, legislators; policy research organizations; lawyers. Technologies: Drug, device, medical or surgical procedure, support system, organiza- tional or administrative system, environmental protection technologies. Intervention: Prevention, treatment, diagnosis, rehabilitation. Stage: Ne7uJ, emerging, established or widespread practice, obsolete. Properties: Safety; efficacy; effectiveness; cost; cost-benefit; cost effectiveness; service requirements; acceptance/adoption level; system impact; economic implications, ethi- cal, legal, social implications; psychological issues. Selection process: Although financed by the government, the Council operates as an independent agency. The Council selects assessment topics, sets priorities, and decides how an assessment should be conducted. The government may also formally request advice on specific topics. The Council is free to issue reports at its own initiative. Reports are updated regularly. Staff members, Council members, or committee mem- bers may suggest reassessments to the President of the Council. Methods: Group judgment, information syntheses, expert opinion, modeling, cost ana- lyses, epidemiological and other observational methods. The Council's assessment activities emphasize state-of-the-art syntheses. For each sub- ject, the President or Vice-President of the Council appoints a multidisciplinary com- mittee of experts. At any given time, about 65 committees are at work, involving a total of approximately 600 persons (members and non-members of the Council). The approximate turnaround time from selection of assessment topic to reporting of findings is 18 months. 141

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Assessors: Committee members have expertise in medical specialties, economics, psy- chology, sociology, law, ethics, management, physics, chemistry, and biology. Assessment reports include: Abstract; the assessment's intended audience; the pur- pose of the assessment; relationship of this assessment to prior or concurrent assess- ments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; proper- ties assessed; procedure used for the assessment; sources of dataJinformation; methods for collecting data/information; methods for analyzing/synthesizing dataJinformation; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, principles; development of the technology; procurement/deployment information; where technolo~v is in use: cover- age/reimbursement status of the technology. a, ~ Dissemination: Printed reports; journal articles; advisories to profession, hospitals; press conferences/news releases, TV/radio broadcasts, video products. In general, the reports of the Council are public. They are printed and distributed by the Council and sent to the press and interested organizations and individuals. Most reports have an English summary; this is only the first step in making the publications accessible to an international audience. The Council plans to produce an English newsletter, to be published 3 times a year. The first issue is scheduled to appear in 1987. Budget: $1.7 million. The approximate cost per assessment is $70,000. Funding sources: 90 percent government grants/contracts; 5 percent foundations, other private grants; 5 percent sales of assessments, consultant services. Use: Although formally addressed to the government, some reports of the Council are directly relevant to health care professionals. For example, most hospitals in The Netherlands use reports issued by the Council as a reference source for radiation protection and prevention of hospital infections. Program evaluations: In 1983, the government established a national commission to evaluate the Council. The evaluation consisted of interviews and the results were very . . positive. Related activities: The Council publishes a newsletter, sponsors symposia, and serves a clearinghouse function for medical technology assessment in The Netherlands. Completed Reports HN1 Health Council of The Netherlands. C02. 1987 HN2 . Transplantation issues. 1987. HN3 . Ultrasound. 1987. HN4 _ . Artificial procreation. 1986. (English summary only). HNS . Dialysis and kidney transplantation.1986. [English summary only]. ~42 HN6 . Inhalation sedation in dentistry. 1986. "English summary only]. HN7 . Inhalation sedation in dentistry. 1986. "English summary only]. HN8 . Magnetic resonance spectroscopy. 1986. [English summary only]. HN9 . Mental health care. 1986. [English sum- mary only].

HEALTH COUNCIL OF THE NETHERLANDS HN10 . Monoclonal antibodies. 1986. HNll . Monoclonal antibodies. 1986. fEnglish summary only]. HN12 . Otitis media. 1986. fEnglish summary only]. HN13 . Pain treatment. l 986. LEnglish summary only]. HN14 . Positron emission tomography. 1986. LEnglish summary only]. HN15 . Sexually transmitted diseases. 1986. "English summary only]. HN16 . Suicide. 1986. LEnglish summary only]. HN17 . Therapeutic hemapheresis. 1986. FEng- lish summary only]. HN18 . Very low energy diets. 1986. fEnglish summary only]. HNl9 . Allogenic bone marrow transplantation. 1985. (English summary only). HN20 . Classification of and standards for ra- dionuclide laboratories. 1985. (English summary only). HN21 . Guidelines for radiation protection in hospitals and out-patient departments.1985. (English summary only). HN22 . Minimal brain dysfunction. 1985. (Eng- lish summary only). HN23 . Second report on AIDS: clinical, psycho- social and ethical aspects. 1985. (English summary only). HN24 . Cardiac surgery. 1984. HN25 . Brain death criteria. 1983. HN26 . Hepatitis B. 1983. HN27 . Neonatal intensive care. 1982. HN28 . Hypertension. 1978. HN29 . Recent developments in anesthesiology. 1978. HN30 . Transsexualism. 1977. HN31 . Use of antibiotics. 1977. HN32 . Coronary heart surgery. 1976. HN33 . Preventing hospital infections. 1976. Ongoing Assessments HN34 . AIDS (acquired immune deficiency syn- drome). Ongoing. HN35 . Admission of new sera and vaccines. Ongoing. HN36 . Alternative medicine. Ongoing. HN37 . Anorexia nervosa and boulimia. Ongo ~ng. HN38 . Biotechnology: new avenues of re search. Ongoing. HN39 . Bone marrow transplantation. Ongoing. HN40 . Breast feeding (contamination of milk). Ongoing. HN41 . Chymopapain. Ongoing. HN42 . Diagnosis and treatment of the fetus. Ongoing. HN43 . Dialysis. Ongoing. HN44 . Endoscopy. Ongoing. HN45 . Fetal surgery. Ongoing. HN46 . Food irradiation. Ongoing. HN47 . Hair analysis. Ongoing. HN48 . In vitro fertilization. Ongoing. HN49 . Innovations in medical technology. On go~ng. HN50 . Lasers. Ongoing. HN51 . Lithotryptor. Ongoing. HN52 . Liver transplantation. Ongoing. HN53 . Medical equipment: priorities in re search and development. Ongoing. HN54 . Minimal brain dysfunction. Ongoing. HN55 . Monoclonal antibodies, advice on regu- latory issues. Ongoing. HN57 . NMRMRI. Ongoing. HN58 . National vaccination program. Ongo ~ng. HN59 . Osteoporosis. Ongoing. HN60 . Otitis media. Ongoing. HN61 . PET-scan. Ongoing. HN62 . Pain treatment and clinics. Ongoing HN63 . Pediatric surgery. Ongoing. HN64 . Prevention of hospital infections. Ongo ~ng. HN65 . Psychogeriatrics. Ongoing. 143

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY HN66 . Psychosurgery. Ongoing. HN67 . Screening for breast cancer. Ongoing. HN68 . Screening for neural tube defects. On go~ng. HN69 . Stress and health. Ongoing. HN70 . Suicide. Ongoing. HN71 . Transplantation: ethical and legal; kid ney; heart; liver; pancreas; bone marrow. Ongoing. HN72 . Treatment of kidney stone disease. On- go~ng. HN73 . Ultrasound. Ongoing. HN74 . Vaccination against haemophilus in- fluenzae B. Ongoing. HN75 . Vaccination against influenza. Ongoing. Health and Welfare Canada Health Services and Promotion Branch Institutional and Professional Services Division Guidelines for Institutional Programs Ottawa, Ontario KlA IB4 Canada 613-954-8623 Planned Assessments HN76 . Home care. Planned. HN77 . Lasers. Planned. HN78 . Medical, ethical, and legal implications of advances in genetics. Planned. HN79 . Post marketing surveillance of drugs. Planned. HN80 . Radiation risks. Planned. HN81 . Synthetic growth hormone. Planned. Contact: David L. Martin, Consultant in Health Technology or Donald F. Moffatt, Director, Institutional and Professional Services Division. Overview: The Institutional and Professional Services Division is a government agency that provides leadership in the development of Canada's health services system. The Guidelines for Institutional Programs is a technology assessment program that issues guidelines on specific health services. Purpose: To provide guidelines for the planning. or~ani7.ntion .ct~ffin~ And] ~r`Pr~tinn of institutional health programs. _ o ~ - - ~ ~_ 7 ~ ~ ~ ~ ~- ~-r ~ ~ ~ ~ ~ Primary intended users: Providers, generally; physicians; acute facility administrators; long-term care facility administrators; health/medical professional associations; gov- ernment regulators; labs, blood banks; public policy-makers; legislators; lawyers; pro- vincial and regional health planners. Technologies: Device, medical or surgical procedure, support system, organizational . · . . Or aumlnlstratlve system. Technologies with a major impact on institutional resources, provincial fiscal resources, or patient well-being are assessed. 144

HEALTH AND WELFARE CANADA Intervention: Treatment, diagnosis, rehabilitation. Stage: New, established or widespread practice. Assessments are generally conducted after the initial introduction of a technology; many assessments address how technologies should be implemented in established systems. Properties: Service requirements, effectiveness. A technology's requirements for medical and allied health staff preparation and main- tenance of skills, support services, and other resources are assessed. Selection process: Provincial ministries of health usually request that an assessment be conducted. Occasionally health professional associations, other institutions, or individ- uals initiate a request. Requests are submitted to the appropriate federal/provincial review committee for approval. The committee also sets assessment topic priorities. Anyone can suggest the periodic review of a guideline. Methods: Group judgment, information syntheses. Departmental staff prepares information syntheses on a specific technology. An expert panel meets on several occasions and then drafts a report. It requires 8 months to prepare the report and obtain the review committee's approval. An additional 6 months is needed to edit, translate, and publish the final report. Assessors: The assessors' areas of expertise cover a broad range of disciplines. Assessment reports include: Abstract; the assessment's intended audience; the pur- pose of the assessment; who sponsored/commissioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technol- ogy when assessed; properties assessed; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, principles; development of the technology; minimum requirements in terms of workload support services. ~, Dissemination: Printed reports, journal articles. Assessment results are disseminated using a mailing list and are publicized in profes- sional journals. Copies of the reports may be requested from the provincial or federal health ministry. Budget: $400,000. The approximate cost per assessment is $30,000 plus department staff time ( 1 man-year each). Funding source: 100 percent parent organization. Use: The government uses the guidelines to promote uniform health care standards for all Canadians. Provincial ministries, hospital administrators, and others use the guidelines for planning purposes. Program evaluation: The Division requested an evaluation of the program to deter- mine relevance and to identify potential improvements. Funded by the government, a private consulting firm (RMS Consultants) conducted the evaluation from November 145

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY 1985 to March 1986. Based on interviews with provincial and hospital administrators, it was learned that the program is well received but marketing of products needed improvement. Within current budget constraints, efforts are being made to increase awareness of the program. The evaluation's findings were distributed to the provincial . . . ministries. Related activities: The Division is involved in several related activities including con- sensus development conferences; surveys of hospital practices; and consultant services, particularly to interpret report recommendations. Completed Reports HW1 Subcommittee on Institutional Program Guide- lines. tHealth and Welfare Canada, Health Services and Promotion Branch, Institutional and Profession- al Services Division] Rehabilitation medicine program guidelines. 1986. "Information syntheses, Expert opinion, Group judgment] HW2 . Spinal cord injury program guidelines. 1986. fInformation syntheses, Expert opinion, Group judgment] HW3 . Stroke program guidelines. l 986. fInfor- mation syntheses, Expert opinion, Group judgment] HW4 . Burn unit guidelines. Revised 1985. [In- formation syntheses, Expert opinion, Group judg- ment] HW5 . Child and youth long term services guidelines. 1985. FInformation syntheses, Expert opinion, Group judgment! HW6 . Nuclear medicine units in hospitals. 1985. "Information syntheses, Expert opinion, Group judgment] HW7 . Prehospital emergency care services. 1985. [Information syntheses, Expert opinon, Group judgment] HW8 Subcommittee on Special Services in Hospitals. tHealth and Welfare Canada, Health Services and Promotion Branch, Institutional and Professional Services Division] The reuse of disposables: an infor- mation report. 1985. [Information syntheses, Expert opinion, Group judgment] HW9 . Diagnostic ultrasound facilities in hospi- tal guidelines. 1985. "Information syntheses, Expert opinion, Group judgment] HW10 . Hospital day medicine unit guidelines. 1984. LInformation syntheses, Expert opinion, Group judgment] HW11 . Addiction services in hospitals guide- lines. 1984. FInformation syntheses, Expert opinion, Group judgment] 146 HW12 . Adult long-term institutional care. 1984. [Information syntheses, Expert opinion, Group judgment] HW13 . Child and adolescent services in general hospitals.1982. fInformation syntheses, Expert opin- ion, Group judgment] HW14 . Day surgery unit guidelines. 1982. tIn- formation syntheses, Expert opinion, Group judg- ment] HW15 . Pulmonary function laboratories guide- lines. 1982. FInformation syntheses, Expert opinion, Group judgment] HW16 . Child adolescent psychiatric services provided by general hospitals. 1981. [Information syntheses, Expert opinion, Group judgment] HW17 Subcommittee on Institutional Program Guide- lines. (Health and Welfare Canada, Health Services and Promotion Branch, Institutional and Profession- al Services Division] Computed tomography guide- lines. 1980. FInformation syntheses, Expert opinion, Group judgment] HW18 Subcommittee on Special Services in Hospitals. tHealth and Welfare Canada, Health Services and Promotion Branch, Institutional and Professional Services Division] Regional Renal Failure Program. 1980. LInformation syntheses, Expert opinion, Group judgment] HWl9 . Adult psychiatric services provided by general hospitals guidelines. 1979. fInformation syn- theses, Expert opinion, Group judgment] HW20 . Geriatric units in hospitals, geriatric day hospital guidelines.1979. [Information syntheses, Ex- pert opinion, Group judgment] HW21 . Intensive care unit guidelines. 1979. fInformation syntheses, Expert opinion, Groupjudg- ment] HW22 . Perinatal intensive care unit guidelines. 1979. fInformation syntheses, Expert opinion, Group judgment]

HEALTH AND WELFARE CANADA HW23 . Diabetic day care unit guidelines. 1978. fInformation syntheses, Expert opinion, Groupjudg- ment] HW24 . Patient hostel unit guidelines. 1978. ~In- formation syntheses, Expert opinion, group judg- ment] HW25 . Respiratory technology service unit guidelines. 1978. [Information syntheses, Expert opinion, Group judgment] Johns Hopkins Program for Medical Technology and Practice Assessment Center for Hospital Finance and Management 624 North Broadway, Room 305 Baltimore, MD 2 ~ 205 30 1-955-2300 Contact: Earl P. Steinberg, M.D., Director, Johns Hopkins Hospital, 624 North Broad- way, Baltimore, MD, 21205. Overview: The Johns Hopkins Program for Medical Technology and Practice Assess- ment was established in July 1986 to merge the functions of the Johns Hopkins Center for Hospital Finance and Management and the Johns Hopkins Office of Medical Practice Evaluation. As a collaborative effort of the Johns Hopkins School of Medicine, the Johns Hopkins School of Hygiene and Public Health, the Johns Hopkins Hospital, and the Johns Hopkins Health System, it draws together a multidisciplinary faculty to address both broad medical technology matters and issues of institutional concern. Purpose: (1) To assess the clinical efficacy and financial implications of new and established medical technologies in order to assist hospitals and other providers in making informed decisions concerning the acquisition and use of certain technologies; (2) to evaluate the short- and long-term cost and quality implications of alternative technologies and practice patterns; (3) to assess the relative costs and benefits of alternative medical practices; (4) to examine the clinical and economic impacts of health care payment innovations; (5) to provide information to ensure that appropriate reimbursement is available for medical technologies, procedures and services; and (6) to influence State and Federal policy-makers concerning the financing and regulation of health care delivery with particular attention to technology use and medical practice patterns. Primary intended users: Providers, generally; physicians; acute facility administrators; health product manufacturers; health/medical professional associations; health indus- try associations; employers; third party payers; government regulators; reporters, writers, news media; public policy-makers, legislators; policy research organizations. Technologies: Device, drug, medical or surgical procedure, support system, organiza . . . . . tlona or administrative system. Intervention: Diagnosis, prevention, treatment, rehabilitation. Stage: New, emerging, established or widespread practice, obsolete. 147

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Properties: Cost-effectiveness; safety; efficacy; effectiveness; cost; cost-benefit; service requirements; acceptance/adoption level; system impact; economic implications; ethi- cal, legal, social implications. Technologies are assessed for their clinical impacts, including their efficacy and effec- tiveness, effect on patient outcome and on physicians' use of other technologies and resources. Assessments also include evaluations of technologies' actual and potential economic effects from the perspective of providers, payers, patients, and society as a whole. Selection process: Assessments are initiated by Program faculty after consultation with members of the medical staff and administration of the Johns Hopkins Medical Institu- tions. Outside parties, including hospitals, hospital systems or other providers, govern- ment agencies, insurers, employers, private industry, or foundations may suggest assessments that would be of particular interest to them. Requests for assessments are made by telephone call, memorandum, letter, or request for proposal. The Program faculty set assessment topic priorities based on several criteria: resources required, feasibility in terms of available data and funding timeliness, and relevancy. Decisions to initiate an assessment are also based on the recommendations of the Program's Adviso- ry Board. Priority is given to issues that have important clinical, economic, and policy implications; capitalize on the multidisciplinary strengths of Program faculty; and have particular interest and concern to the Johns Hopkins Hospital and Health System. Final decisions regarding the performance of assessments are made by the Pro~ram's Director and Co-Director. , ~ Methods: Cost-analyses, Information syntheses, expert opinion, group judgment, mod- eling, epidemiological and other observational methods, clinical trials. The Program conducts original research and synthesizes existing knowledge from the health services and medical literature. Generally, assessments are conducted by teams of researchers under the direction of a project manager. Teams first develop a set of medically important and policy-relevant issues to be addressed in the assessment and then develop methods of addressing those issues. Frequently government or medical experts are consulted in developing the project's issues, approach, scope, and purpose. Some assessments will be completed in 3 or 4 months, others in 12 to 15 months. The average turnaround time is expected to be 8 months. Assessors: The assessors have expertise in medicine, health economics, health care financing, business, health policy, and public health, computer science, artificial intelli- gence, decision analysis, cost effectiveness analysis, clinical epidemiology and educa- tion. Each of the physicians involved in technology assessment also has clinical responsi- bilities at the Johns Hopkins Hospital and continues to be involved in the practice of mu. oevera~ or one analysts nave previous experience in government policy- making. The Program's Advisory Board consists of a representative from each of the schools, from the Johns Hopkins Hospital, and from the Johns Hopkins Health System, so there is a direct link between the Program, the hospital, and the health ~:_:~ ~ _r .~ . . ~ system. Assessment reports include: Abstract; the assessment's intended audience; the pur- pose of the assessment; relationship of this assessment to prior or concurrent assess- ments of the technology or other technologies intended for similar purposes; who 148

JOHNS HOPKINS PROGRAM FOR MEDICAL TECHNOLOGY sponsored/commissioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; proper- ties assessed; procedure used for the assessment; sources of dataJinformation; methods for collecting data/information; methods for analyzing/synthesizing data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; development of the technology; where technology is in use; regulatory agency approval status; coverage/reimbursement status of the technology. Dissemination:~IournG[l articles; printed reports; press conferences/news releases, TV/ radio broadcasts, video products. Assessment results are disseminated through publication of articles and reports; semi- nars sponsored by the Johns Hopkins School of Hygiene and Public Health; presenta- tions at professional society conferences; meetings with public and private officials; and press releases and press conferences. In some instances, project sponsors, such as manufacturers, are likely to publish or disseminate their own reports based on Pro- gram findings. Budget: $165,000. The cost per assessment will depend on the type of assessment undertaken. Costs are expected to vary considerably, ranging from small ($15,000) contracts to $800,000 clinical trials. Most assessments are expected to cost $20,000 to $100,000. Funding source: 90 percent parent organization, 10 percent government grants/contracts. The School of Medicine, School of Hygiene and Public Health, and the Johns Hopkins Hospital each contributed $50,000 per year for the first 2 years of the Program. This funding is being used to initiate Program activities. it is expected that in the future the Program will be supported both by grants and contracts to perform specific assessments and contributions to support the Program more generally. Use: The Program provides a means to assist the Johns Hopkins Hospital and the Johns Hopkins Health System administrators and medical staff in decisions regarding the acquisition of new technologies and optimal use of existing resources. Assessment results will be shared with administrators and medical staff. Ongoing Assessments JHl Johns Hopkins Program for Medical Technology and Practice Assessment. A synthesis of the published literature regarding the comparative toxicity of high osmolar and low osmolar radiographic contrast dyes. Ongoing. JH2 . An analysis of economic and policy issues related to the introduction of low osmolar radio- graphic contrast dyes. Ongoing. }H3 . An assessment of the potential effects of changes in supply purchasing behavior and arrange- ments in hospitals on quality of care. Ongoing. H4 . Analysis of the comparative cost-effective- ness of alternative strategies for managing acute heart attacks, including use of thrombolytic drugs, such as tissue plasminogen activator and steptokinase, and emergency coronary angioplasty. Ongoing. Planned Assessments H5 . A clinical trial at determining the compar- ative nephrotoxicity and comparative cost-effective- ness of low osmolar versus high osmolar radiographic contrast dyes. Planned. JH6 . An analysis of automatic implantable car- diac defibrillatory (AICDs). Planned. 149

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY H7 . An analysis of the comparative costs of inpatient versus outpatient surgery for several types of surgery. Planned. H8 . An analysis of the potential cost implica- tions of Medicare of unbundling of services (particu- larly diagnostic services provided by hospitals). Planned. H9 . An assessment of automatic blood pres- sure monitoring. Planned. JH10 . An evaluation of patterns of utilization of CT scanners, with particular attention to variations in practice patterns. Planned. Kings Fund Centre for Service Development Kings Funcl Forum Consensus anct Controversies in Medicine 126 Albert Street London NWl, England (44-~) 267-61 ~ ~ Contact: Dr. J. Spiby. Overview: The Kings Fund Centre for Service Development is a not-for-profit foun- dation that promotes good practice in health care organizations. The first Kings Fund Forum Consensus and Controversies in Medicine conference was held in 1984. Purpose: To produce consensus statements. Primary intended users: General public; patients; providers, generally; physicians; acute facility administrators; long-term care facility administrators; other care givers; health/medical professional associations; consumer associations; government regula- tors; voluntary associations, organizations; biomedical researchers; financial analysts, consultants; reporters, writers, news media; public oolicv-makers. legislators nolirv research organizations; lawyers. ~, ~ r-~~~~ Technologies: Medical or surgical procedure, support system, organizational or adminis- trative system. Intervention: Prevention, diagnosis, treatment, rehabilitation. Stage: Established or widespread practice, new. Properties: Efficacy; effectiveness; cost; cost-benefit; cost-effectiveness; service re- quirements; system impact; economic implications; ethical, legal, social implications. Selection process: Suggestions for assessment topics are accepted from anyone, al- though the Steering Group provides major input to the selection process. The Steering Group sets assessment topic priorities. Methods: Group judgment. The assessment process is conducted as a consensus conference. The average turn- around time from selection of assessment topic to reporting of findings is 1 year. 15O

KINGS FUND CENTRE FOR SERVICE DEVELOPMENT Assessors: Consensus panels consist of medical professionals and laymen who repre- sent mixed areas of expertise. Assessment reports include: Consensus statement; the purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/sup- ported the assessment; who conducted the assessment; properties assessed; procedure used for the assessment; sources of data/information; methods for collecting data/ information; methods for analyzing/synthesizing data/information; results; findings or conclusions; recommendations for practice, future assessments, technology develop- ment, research. Dissemination: Printed reports; journal articles; press conferences/news releases, TV/ radio broadcasts, video products. Budget: $30,000. The approximate cost per assessment is $15,000. Funding sources: 50 percent foundations, other private grants; 50 percent sponsors/members due, . . contr1 buttons. Program evaluation: To review the usefulness of the Kings Fund Forum, the Project Coordinator is conducting a survey which was initiated in May 1986. Completed Reports KF1 King's Fund. (King's Fund Centre for Service De- velopment. King's Fund Forum Consensus and Con- troversies in Medicine] Treatment of primary breast cancer: the Second King's Fund Forum. 1986. Lewin and Associates, Inc. Medical Technology Group 1090 Vermont Avenue NW, Suite 700 Washington, DC 20005 202-842-2800 Contact: Wayne Roe, Vice President. KF2 King's Fund. Tinges Fund Centre for Service De- velopment. King's Fund Forum Consensus and Con- troversies in Medicine] Coronary artery bypass sur- gery: the First UK Consensus Development Confer- ence. 1984. Overview: Lewin and Associates is a for-prof~t consulting firm specializing in the health care field. It offers a range of services including hospital strategic planning; HMO, PPO, and insurance industry consulting; strategic market analysis for medical technology product firms; and health policy consulting for federal, state, and local governments and private sector organizations. The Medical Technology Group pro- gram was initiated in 1985; since then numerous retrospective and prospective studies have been conducted. Purpose: To assist technology developers, providers, purchasers, and payers to devel- op objective, sophisticated, empirical analyses on the impacts of new and existing technologies. 151

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Primary intended users: Providers, generally; physicians; health product manufactur- ers; health/medical associations; third party payers; government regulators; public policy-makers, legislators. Technologies: Drug, device, medical or surgical procedure, support system, organiza- tional or administrative system. Intervention: Treatment, prevention, diagnosis, rehabilitation. Stage: New, established or widespread practice. Properties: Cost, safety, effectiveness, cost-effectiveness, service requirements, econom . . . . 1C 1mP. 1Cat10nS. Properties assessed depend on the client's information need and audience. Selection process: Anyone can request that an assessment be conducted. Requests are made through client inquiries and occasionally the nro~r~m tie f~rm~1 12 lisps Ctq{f and clients set assessment topic priorities. ~J ~--- r- ~ ·~^ ~ i-,. V~11 Methods: Information syntheses, cost analyses, expert opinion, group jwilgment, modeling. As part of the assessment process, staff conduct statistical studies, prepare quantitative simulation models, collect primary data from prospective trials, and analyze Lewin databases and private insurance claims. The approximate turnaround time from selection of assessment topic to reporting of findings depends on the study and ranges from 4 months to 2 years. Assessors: The assessors have expertise in clinical medicine, economics, statistics, health policy, and modeling. Frequently, outside academic/research consultants are used. Assessment report include: The assessment's intended audience; the purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; who sponsored/com- missioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; properties assessed; proce- dure used for the assessment; sources of data/information; methods for collecting data/ information; methods for analyzing/synthesizing data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommenda- tions for practice, future assessments, technology development, research; where tech- nology is in use; regulatory a~encv anoroval .9t~t,~.s cover~/r`>imh,~rc`>m~nt `:~1a rep the technology. ~_ _ a_ ~1 ~ J ~1 ~7 ~'id ~ ~7 V1 ulssemmation: printed reports; journal articles; advisories to members/constituents; public presentations; private meetings with policy-makers. If an assessment report is not proprietary, copies may be obtained through the Lewin and Associates library. Budget: Not available. 152 ,~

KINGS FUND CENTRE FOR SERVICE DEVELOPMENT Use: Public and private third party payers use the assessment reports in formulating reimbursement policy. For example, Lewin and Associates recently conducted a reim- bursement analysis of a new cardiovascular device. The results of the study have been used by public and private insurers to develop reimbursement policy. Other studies have been submitted to the Health Care Financing Administration and the Prospective Payment Assessment Commission. Completed Reports LE1 fLewin and Associates, Inc.] The safety, efficacy, and cost effectiveness of home intravenous antibiot- ics. 1986 Feb. Information syntheses, Modeling, Cost analyses] Linkoping University Center for Medical Technology Assessment S-581 83 Linkoping, Sweden (46-13) 28-10-00, Ext. 2310 LE2 Roe W. Anderson M, Strauss M, Arnold T. Gong }, Eresian K. fLewin and Associates, Inc.] Technology assessment and coverage decision making. 1986 Oct. fInformation syntheses, Modeling, Cost analyses] Contact: Bengt ionsson, Ph.D., Director; or Ann Bonair, Research Assistant. Overview: The Center for Medical Technology Assessment (CMT) is an independent research unit at Linkoping University. The Center was established in fall 1984 after an agreement between Linkoping University and the Ostergotland County Council, the local government's health unit. Inauguration took place in April 1985. Purpose: To develop a long-term knowledge base and methodology pertinent to medical technology assessment; to initiate, support and undertake medical technology assessment in a joint medical, economic, and social perspective; to identify areas of medical technology in need of evaluation in terms of cost, benefits, diffusion potential, and relevant social and ethical consequences; and to organize and support courses, seminars, conferences, and information exchange and dissemination in the field. Primary intended audience: Providers, generally; physicians; health product manu- facturers; health/medical professional associations; health industry associations; third party payers; government regulators; reporters, writers, news media; public policy- makers, legislators. Technologies: Medical or surgical procedure, drug, device, support system, organization- al or administrative system. Intervention: Treatment, prevention. Stage: Emerging, new, established or widespread practice. Properties: Safety; efficacy; effectiveness; cost; cost-benefit; cost-effectiveness; service requirements; acceptance/adoption level; system impact; economic implications; ethi- cal, legal, social implications. 153

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Selection process: Executive Committee members, health care providers, government agencies, and health product manufacturers can request, through formal and informal contacts with the CMT Director, that an assessment be conducted. Assessment topic priorities are guided by CMT's internal framework and objectives. The Director de- cides if the CMT will undertake a requested assessment after screening the proposed study. The screening process includes determination of resource and time require- ments. Methods: Information syntheses, expert opinion, modeling, cost analyses, epidemio- logical and other observational methods, clinical trials. . . Drafts of assessments are presented at staff seminars before the final report is written. The turnaround time from selection of assessment topic to reporting of findings varies from 6 months to 2 years. Assessors: CMT has a multidisciplinary staff representing economics, business admin- istration, medicine, biomedical engineering, philosophy, and nursing. Depending on the assessment topic, experts from different areas may be added to the staff team on a temporary basis. Assessment reports include: The purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/supported the assess- ment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; properties assessed; procedure used for the assessment; sources of data/information; methods for collecting data/information; methods for analyzing/synthesizing data/information; results; findings or conclusions; limitations of findings; implication of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, principles; development of the technology; procurement/deployment informa- tion; where technology is in use; coverage/reimbursement status of the technology. Dissemination: Printed reports; journal articles; advisories to members/constituents; press conferences/news releases, TV/radio broadcasts, video products. Abstracts and lists of assessment reports are published in the CMT Newsletter. The Newsletter is distributed free of charge to approximately 1000 subscribers primarily in the health care sector. Five issues of the CMT Newsletter have been published; the first issue in English was published in January 1987. Assessment results are also disseminat- ed at conferences and seminars. The CMT accepts telephone and written requests for . ~ copies ot assessment reports. Budget: $270,000. The approximate cost per assessment is $7,500. Funding sources: 60 percent parent organization; 10 percent government grants foundations, other private grants. , contracts; 30 percent Use: Linkoping University uses the CMT's assessment reports in courses and as back- ground papers for conferences. Based on personal communications, CMT staff are aware that other researchers in the field, physicians, and health care administrators use the assessment reports for various purposes. 154

LINK0PING UNIVERSITY Related activities: An international conference on quality of life was held in September 1986; the proceedings will be published in English. Educational activities include undergraduate courses and a postgraduate course in medical technology assessment. The CMT Director is the Associate Editor for the journal of Health Economics and is also a member of the following committees: Nordic Planning Group for Health Services Research, the Government Committee for Research about the Public Sector, the Exec- utive Committee of the European Association of Programmes in Health Service Stud- ies, and the Scientific Advisory Board, National Board of Health and Welfare, Sweden. In collaboration with the World Health Organization's European Program for Health Technology Assessment, the University Library, and the Health University in Linko- ping, the CMT is establishing a clearinghouse on the evaluation of medical technology literature. It is anticipated that the clearinghouse will be operational in late 1987. Completed Reports LU1 Bjork S. Bonair A. ~Linkoping University, Center for Medical Technology Assessment] Quality of life measurements. 1986. (Discussion series paper #7J (Swedish language only) "Information syntheses] LU2 Carlsson P. Jonsson. ~Linkoping University, Cen- ter for Medical Technology Assessment] Medical technology assessment in a macroeconomic perspec- tive-a study of the introduction of cimetidine for treatment of ulcers. 1986. (Discussion series paper #1) "Swedish language only] (Cost analyses, Epidemi- ological methods] LU3 Carlsson P. Tiselius HO. ~Linkoping University, Center for Medical Technology Assessment] Evalua- tion of extracorporeal shock-wave lithotripsy treat- ment for upper urinary tract calculi the first year experiences. 1986. (Discussion series paper #10) (Swedish language only] Cost analyses, Clinical trials, Epidemiological methods] LU4 ~onsson B. ~Linkoping University, Center for Med- ical Technology Assessment] Cost benefit analysis of hepatitis-B vaccination.1986. (Discussion series paper #12) "Information syntheses] LU5 ~onsson B. ~Linkoping University, Center for Med- ical Technology Assessment] Economic aspects of prevention as a health technology. 1986. (Discussion series paper #3) "Swedish language only] tInforma- tion syntheses] LU6 Tonsson, B. ~Linkoping University, Center for Medical Technology Assessment] Economic aspects of health care provision is there a current crisis? 1986. (Discussion series paper #4) LU7 Tonsson, B. ~Linkoping University, Center for Medical Technology Assessment] The economics of drug regulation. 1986. (Discussion series paper #5) Information syntheses] LU8 Karlsson CT. [Linkoping University, Center for Medical Technology Assessment] Economics of os- seointegrated implants a prestudy. 1986. (Discus- sion series paper #8) "Swedish language only] tCost analyses, Epidemiological methods] LU9 Levin, LA. ~Linkoping University, Center for Med- ical Technology Assessment] Economic consequences of postinfarction prophylaxis with beta-blockers: a cost effect study of metoprolol treatment. 1982. (Dis- cussion series paper #2) "Swedish language only] tCost analyses, Epidemiological methods] Ongoing Assessments LU10 Linkoping University, Center for Medical Tech- nology Assessment. Alternative treatments in stroke-assessment of cost and social implications. Ongoing. LU11 . Assessment of quality of life and medical resource requirements in patients with rheumatoid arthritis-evaluation of cooperation between primary health care and specialized care. Ongoing. LU12 . Economics of ossointegrated implants. Ongoing. LU13 . Ethical issues in medical technology as- sessment. Ongoing. LU14 . Health care information systems and cost-effectiveness: a review of methodological issues and assessment methods. Ongoing. LU1S . Medical technology in primary health care- an explorative study. Ongoing. LU16 . Quality of life and pharmacotherapy in angina pectoris. Ongoing. LU17 . The cost of prostate cancer in a defined population. Ongoing. 155

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Planned Assessments LU18 . Development of simulation models for LU2O . Economic aspects of prevention as a use in cost-effeci~veness studies. Planned. health care technology. Planned. LUl9 . Diffusion of innovations methodologi- LU21 . Methodological issues in quality of life cal issues. Planned. measurements, health indicators, and utility index. Planned. McGill University Department of Epidemiology and Biostatistics 1020 Pine Avenue West Montreal, Canada H3A lA2 5 14-392-4740 Contact: Dr. Walter O. Spitzer, Chairman, Department of Epidemiology and Biostatis- tics 514-392-4741. Overview: McGill University, a public institution, established its Department of Epide- miology and Biostatistics in 1964. Technology assessment is an integral part of the Department's research function. Purpose: To provide teaching, research, and consultation in epidemiology, statistics, and community medicine. Primary intended users: General public, people concerned about their health, pa- tients, government regulators. Technologies: Drug, medical or surgical procedure, organizational or administrative system. Intervention: Prevention, diagnosis, treatment. Stage: Emerging, new, established or widespread practice. Properties: Safety, efficacy, effectiveness, cost, cost-effectiveness. Selection process: Assessments are an integral part of the Department's research function. They are initiated as a result of interaction between the investigators and the person or organizations interested in the results. Assessment topic priorities also emerge from this interaction. Methods: Information syntheses, expert opinion, group judgment, cost analyses, epi- demiological and other observational methods, clinical trials. The approximate turnaround time from selection of assessment topic to reporting of findings is 2 years. Assessors: Assessors are experts in epidemiology, biostatistics, community medicine, and various substantive areas such as cancer, nephrology, and adverse drug reactions. 156

MCGILL UNIVERSITY Assessment reports include: Abstract; the assessment's intended audience; the pur- pose of the assessment; relationship of this assessment to prior or concurrent assess- ments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; proper- ties assessed; procedure used for the assessment; sources of dataJinformation, methods for collecting dataJinformation; methods for analyzing/synthesizing data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, principles, where technology is in use. Dissemination: Printed reports; journal articles; advisories to members/constituents; press conferences/news releases, TV/radio broadcasts, video products. Copies of assessments can be acquired through the publishers, the authors, or the Chairman of the Department. Budget: Variable. The cost of individual assessments varies. Funding sources: 75 percent government grants/contracts; 25 percent foundations, other private grants. Completed Reports MG1 Clark DC, Hanley.tA, Geoghegan S. Vinet D. McGill University, Department of Epidemiology and Biostatistics] The effectiveness of a desensitizing toothpaste in treating dentinal hypersensitivity. J Per- iodontol Res 1985;20:212-219. MG2 Clark DC, Hanley JA, Stamm JEW, Weinstein PL. [McGill University, Department of Epidemiology and Biostatistics] An empirically based system to estimate the effectiveness of caries-preventive agents: a com- parison of the effectiveness estimates of APE gels and solutions and fluoride varnishes. Caries Res 1985; 19:83-95. MG3 Hutchinson TA, Harvey CE. EMcGill University, Department of Epidemiology and Biostatistics] Sur- vival with different forms of dialysis treatment-a prognostically controlled comparison. ~ Am Soc Artif Inter Organs 1985;8: 13-17. MG4 Hutchinson TA, Michaud L, Thomas DC. McGill University, Department of Epidemiology and Biosta- tistics] Comparison of survival with dialysis and renal transplanation -the effect of the method of statistical analysis on results. T Am Soc Artif Intern Organs 1985;8: 18-21. MG5 Ostrowsky IT, Lippman A, Scriver CR. EMcGill University, Department of Epidemiology and Biosta- tistics] Cost-benefit analysis of thalassemia disease prevention program. Am I Public Health 1985;75:732-736. MG6 Parfrey PS, Hutchinson TA, Harvey C, Guttman RD. [McGill University, Department of Epidemiology and Biostatistics] Transplantation versus dialysis in diabetic patients with renal failure. Am J Kidney Dis 1985;5: 112-116. MG7 Parfrey PS, et al. fMcGill University, Department of Epidemiology and Biostatistics] The impact of re- nal transplantation on the course of hepatitis B liver disease. Transplantation 1985;39:610-615. MG8 Robitaille Y. Kramaer MS. fMcGill University, De- partment of Epidemiology and Biostatistics] Does participation in prenatal courses lead to heavier ba- bies? Am J Public Health 1985;75:1186-1189. MG9 Strom BL, Melmon KL, Miettinen OS. EMcGill University, Department of Epidemiology and Biosta- tistics] Post marketing studies of drug efficacy: why? Am I Med 1985;78:475-480. MG10 Strom BL, Melmon KL, Miettinen OS. [McGill University, Department of Epidemiology and Biosta- tistics] Post-marketing studies of drug efficacy: a per- spective. Arch Intern Med 1985; 145: 1791- 1793. MGl l Tousignant P. Hollomby D, Guttman RD. [McGill University, Department of Epidemiology and Biostatistics] Transplantation and home hemodialy- sis: their cost-effectiveness in the treatment of end stage renal disease. I Chronic Dis 1985;38. ~57

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY MG12 (McGill University, Department of Epidemiology and Biostatistics] The nurse practitioner revisted: slow death of a good idea. (Editorial retrospective) N Engl ~ Med 1984; 130: 1049-1051. MG13 Boivin IF, Hutchinson GB, Lyden M, Godbold I, Chorosh }, Schottenfeld D. McGill University, De- partment of Epidemiology and Biostatistics] Second primary cancers following treatment of Hodgkin's disease. ~ Natl Cancer Inst 1984;72:233-241. MG14 Fox ZR, Dupont C, Kramer MS, Stewart tH. McGill University, Department of Epidemiology and Biostatistics] A double-blind crossover comparison between Phyllocontin and Theo-Dur in asthmatic children. In: Turner-Warwick M, Levy I, eds. New perspectives in theophylline therapy. London: Royal Society of Medicine, 1984:29-37. MG15 FIutchinson TA, Thomas DC, Lemieux TC, Har- vey CF. [McGill University, Department of Epidemi- ology and Biostatistics1 A prognostically controlled comparison of dialysis and renal transplantation. Kid- ney Int 1984;26:44-51. MG16 Kramaer MS, Naimark LE, Leduc DG. McGill University, Department of Epidemiology and Biosta- tistics] Is antipyresis harmful? Proceedings of the Am- bulatory Pediatric Association 1984 annual meeting, San Francisco. 1984:88. MG17 Parfrey PS, Hutchinson TA, Lowry RP, Knaack J. Guttman RD. McGill University, Department of Epidemiology and Biostatistics] Causes of late allo- graft failure and the role of azathioprine reduction. Transplant Proc 1984; 16: 1100-1102. MG18 Parfrey PS, et al. McGill University, Department of Epidemiology and Biostatistics] The diagnostic and prognostic value of renal allograft biopsy. Transplan- tation 1984;38~6~:586-590. MGl9 Shamian I, Clarfield AM, Maclean J. McGill University, Department of Epidemiology and Biosta- tistics] A randomized trial of intra-hospital relocation of geriatric patients in a tertiary-care teaching hospi- tal. ~ Am Geriatr Soc 1984; 32: 794-800. MG20 Spitzer WO. McGill University, Department of Epidemiology and Biostatistics] The periodic health examination: 1. Introduction. Can Med Assoc I 1984; 130: 1376-1278 MG21 The Task Force on the Periodic Health Examina- tion. W.O. Spitzer, Chairman. tMcGill University, De- partment of Epidemiology and Biostatistics] The pe- riodic health examination: 2. 1984 update. Can Med Assoc ~ 1984; 130: 1278-1285. 158 MG22 Williams [I, Hanley ~A. (McGill University, De- partment of Epidemiology and Biostatistics] Assess- ing and diffusing today's medical technologies. Di- mens Health Serv 1 984; 6 1 (7): 1 0- 1 4. MG23 Wood-Dauphinee SS, et al. tMcGill University, Department of Epidemiology and Biostatistics] A ran- domized trial of team care following stroke. Stroke 1984; 15:864-872. MG24 Battista RN, Spitzer WO. (McGill University, De- partment of Epidemiology and Biostatistics] Adult . . . cancer prevention m primary care: contrasts among primary care settings in Quebec. Am ~ Public Health 1983;73(9): 1040-1041. MG25 Battista RN. [McGill University, Department of Epidemiology and Biostatistics] Adult cancer preven- tion in primary care: patterns of practice in Quebec. Am I Public Health 1983;73~9J: 1036-1039. MG26 Grover S. Gagnon G. Flegel K, Hoey JR. (McGill University, Department of Epidemiology and Biosta- tistics] Improving appointment-keeping by patients new to a hospital medical clinic with telelphone or mailed reminders. Can Med Assoc J 1983; 129: 1101- 1103. MG27 Loeser I, Zvagulis I, Hercz L, Pless IB. (McGill University, Department of Epidemiology and Biosta- tistics] The organization and evaluation of a comput- er-assisted centralized immunization registry. Am J Public Health 1983;73~11~: 1298-1301. MG28 McNeil BJ, Hanley JA. McGill University, De- partment of Epidemiology and Biostatistics] Critical questions regarding a new diagnostic technology: a case study using computed tomography (CT) of the head. In: Culyer AJ, Horisberger, eds. Economic and medical evaluation of health care technologies, pro- ceedings of Wolfsberg Conference. 1983. MG29 Thomson ME, Kramer MS. McGill University, Department of Epidemiology and Biostatistics] Meth- odological standards for controlled clinical trials of perinatal contact: studies of early contact and mater- pal-infant behavior. Pediatrics 1983;73:294-300. MG30 Hutchinson TA, Cole CH, Kaye M. [McGill Uni- versity, Department of Epidemiology and Biostatis- tics] Chronic ambulatory peritoneal dialysis versus other dialysis therapy-a matched cohort study. Clin Res 1982;30:431A.

MCMASTER UNIVERSITY McMaster University Department of Clinical Epidemiology ant! Biostatistics 1200 Main Street Hamilton, Ontario L8N 325 Canada 416-525-9140, Ext. 2425 Contact: Dr. Peter Tugwell, Chairman, Department of Clinical Epidemiology and Biostatistics. Telex 061-8347. Overview: The Department of Clinical Epidemiology and Biostatistics was founded as part of the medical school at McMaster University in 1967. The University provides health care services, research, and education. Purpose: To provide rigorous evidence on the effectiveness and efficiency of health care interventions and to improve medical practice. Primary intended users: Providers, generally; physicians; acute facility administrators; long-term care facility administrators; other care givers; health product manufactur- ers; health/medical professional associations; third party payers; government regula- tors; voluntary associations, organizations; biomedical researchers; financial analysts, consultants; reporters, writers, news media; information/computer industry; public policy-makers, legislators; policy research organizations. Technologies: Medical or surgical procedure, drug, device, support system, organization- al or administrative system. Intervention: Treatment, prevention, diagnosis, rehabilitation. Stage: New, emerging, established or widespread practice. Although technologies have been assessed at a variety of points in their life-cycles, the focus is usually upon emerging technologies or major established ones for which there is not rigorous evidence. Properties: Effectiveness, safety, efficacy, cost, cost-benefit, cost-effectiveness, service requirements, acceptance/adoption level, system impact, economic implications. The evaluative focus is on efficiency, effectiveness, community effectiveness and effi- ciency in both pecuniary and quality of life terms. Selection process: An assessment may be requested by clinical colleagues, funding agencies, public policy authorities. Assessments are made by clinical colleagues ap- proaching members of the Department for methodological assistance; or external agencies may invite grant and contractual arrangements. Assessment topic priorities are based on external interest and support, internal expertise, and availability of . . . appropriate Investigators. Methods: Clinical trials, information syntheses, expert opinion, group judgment, mod- eling, cost analyses, epidemiological and other observational methods. 159

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Randomized controlled clinical trials and the utilization of other prospective designs are the primary methods used. Most assessments are done in the context of"manage- ment" trials with randomization. The approximate turnaround time from selection of assessment topic to reporting of findings is 3 years. Assessors: The assessors have expertise in the areas of study and trial design; data collection, management, analysis, interpretation; economic evaluation; and quality of life assessment. Assessment reports include: Abstract; the assessment's intended audience; the pur- pose of the assessment; relationship of this assessment to prior or concurrent assess- ments of the technolo~v or other technologies intents for similar nilrr~^c`~c ~Arhm ~ ~ ~ _ _ ~ ~ ^ V ~-^ ~ ~ ~ ~ ^ ~ ~ 4 ~ By ~ a_ ~ ~ ~ ~ 1 A ~ ~ / . , , _ _ sponsored/commlssloned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; proper- ties assessed; procedure used for the assessment; sources of data/information; methods for collecting dataJinformation; methods for analvzin~/svnthesizin~ rlnt~/inform~tion _1 ~ _ ~1 - ~. , (Z. , _ ~_ ~ ~ ^, .. . . ~ . . .. _ results; Conings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research. Dissemination: journal articles; printed reports; press conferences/news releases, TV/ radio broadcasts, video products; clearinghouses, data/citation bases, on-line services. Assessment results are disseminated primarily through published journal articles, supplemented by reports, testimony, media interviews, and continuing medical educa- tion. Copies of assessments are available in the open scientific literature. Budget: $4,000,000. The approximate cost of each assessment is $90,000. Funding sources: 25 percent parent organization; 25 percent government grants/contracts; 25 percent foundations, other private grants; 25 percent sponsors/members, contribu- tions. Use: Reports and publications are made available to clinicians, hospital administrators, and other interested parties. These assessment reports have had an impact in several areas. For example, the results of hypertension screening studies have influenced public health policy in Canada; related studies on compliance and treatment have contributed to the increasing effectiveness of hypertension control; and rigorous stud- ies on the detection and treatment of deep vein thrombosis have also influenced clinical practice but have had a less pervasive impact. Related activities: The Department of Clinical Epidemiology and Biostatistics offers, within the Faculty of Health Sciences, a Master's of Health Science in Design, Measure- ment, and Evaluation. Through the Rockefeller Foundation it participates as a training center for the International Clinical Epidemiology Network for medical school faculty members in less developed countries. Completed Reports MM, Birkett NJ, Evans CE, Haynes RB, et al. [McMas- ter University, Department of Clinical Epidemiology and Biostatistics] Hypertension control in two Cana- dian communities: evidence for better treatment and overlabelling. ~ Hypertension 1986;4:369-374. ~60 MM2 Haynes RB. fMcMaster University, Department of Clinical Epidemiology and Biostatistics] Physician interventions to improve compliance. Geriatr Consul- tant 1986 Tul/Aug:20.

MCMASTER UNIVERSITY MM3 Haynes RB. [McMaster, Department of Clinical Epidemiology and Biostatistics] Is weight loss an ef- fective treatment for hypertension? The evidence against. Can ~ Physiol Pharmacol 1986;64:825-830. MM4 EC/IC Bypass Study Group. tMcMaster Universi- ty, Department of Clinical Epidemiology and Biosta- tistics] Failure of extracranial-intracranial arterial by- pass to reduce the risk of ischemic stroke. New Eng Med 1985;313: 1191-1200. MM5 Gent M, Blakely JA, Hachinski V, et al. [McMaster University. Department of Clinical Epidemiology and Biostatistics] A secondary prevention, randomized tri- al of suloctidil in patients with a recent history of thromboembolic stroke. Stroke 1985;16~3~. MM6 Haynes RB. tMcMaster University, Department of Clinical Epidemiology and Biostatistics] Office management of patient compliance in the treatment of hypertension. Pract Cardiol 1985; 11 :63. MM7 Haynes RB. tMcMaster University, Department of Clinical Epidemiology and Biostatistics] Initial therapy for patients with uncomplicated hyperten- sion. Can Fam Physician 1985;31:321. MM8 Hull RD, Hirsch I, Carter C}, et al. [McMaster University, Department of Clinical Epidemiology and Biostatistics] Diagnostic value of ventilation-perfusion lung scanning in patients with suspected pulmonary embolism. Chest 1985;88:819. MM9 Evans CE, Haynes RB, Gilbert [R. Taylor DW, Sackett DL, Johnston M. [McMaster University, De- partment of Clinical Epidemiology and Biostatistics] Educational package on hypertension for primary care physicians. Can Med Assoc J 1984;130:719. MM10 Johnston ME, Gibson ES, Terry CW, et al. tMcMaster University, Department of Clinical Epide- miology and Biostatistics] Effects of labelling on in- come, work and social function among hypertensive employees. ~ Chron Dis 1984;37~61:417-423. MM11 McDonald LA, Sackett DL, Haynes RB, Taylor DW. tMcMaster University, Department of Clinical Epidemiology and Biostatistics] Labelling in hyper- tension: a review of the behavioral and psychological consequences. ~ Chron Dis 1984;37~12~:933-942. MM12 Gafni A, Gibson ES, iohnston M, et al. fMcMas- ter University, Department of Clinical Epidemiology and Biostatistics] Is there a trade-off between income and health? the case of hypertensive steelworkers in Canada. Inquiry 1983;20:343-349. MM13 Hull R. Delmore T. Carter C, et al. tMcMaster University, Department of Clinical Epidemiology and Biostatistics] Adjusted subcutaneous heparin versus warfarin sodium in the long-term treatment of ve- nous thrombosis. New Eng J Med 1982;306: 189-194. MM14 Hull R. Hirsch }, Sackett DL, et al. [McMaster University, Department of Clinical Epidemiology] Replacement of venography in suspected venous thrombosis by impedance plethysmo~raphv and I- fibrinogen 1981 ;94: 12-15. ~ A J leg scanning. Ann Intern Med MM15 Hull R. Hirsh J. Sackett DL, et al. [McMaster University, Department of Clinical Epidemiology and Biostatistics] Clinical validity of a negative venogram in patients with clinically suspected venous thrombo- sis. Circulation 1981;64:622. MM16 Logan AG, Milne Bl, Achber C, Campbell WP, Haynes, RB. fMcMaster University, Department of Clinical Epidemiology and Biostatistics] Cost-effec- tiveness of a worksite hypertension treatment pro- gram. Hypertension 1981 ;3~21: 211 -218. MM17 Gent M, Barnett HJM, Sackett DL, Taylor DW. fMcMaster University, Department of Clinical Epide- miology and Biostatistics] A randomized trial of aspi- rin and sulfinpyrazone in patients with threatened stroke: results and methodologic issues. Circulation 1980;62(Suppl V):V-97. MM18 Haynes RB, Sackett DL, Gibson ES, et al. [McMaster University, Department of Clinical Epide- miology and BiostatisticsJ Improvement of medica- tion compliance in uncontrolled hypertension. Lancet 1976;(June 12): 1265. 161

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Medical Research Council National Health and Welfare Canacia Jeanne Mance Builcling, Tunney's Pasture Ottawa, Ontario KlA OW9 Canada 6 13-954- 1959 Contact: Lewis Slotin, Ph.D., Director, Programs Branch. Overview: The Medical Research Council of Canada (MRC) is one of three Federal granting agencies responsible for supporting research conducted primarily in universi- ties and their affiliated institutions. The other agencies, the Natural Sciences and Engineering Research Council (NSERC) and the Social Sciences and Humanities Re- search Council (SSHRC), are responsible for the areas indicated by their names. Both the MRC and the NSERC operated originally within the framework of the National Research Council of Canada; the first became fully autonomous in 1969, the second in 1978. The SONIC, also established in 1978, encompasses programs administered originally by the National Research Council of Canada. The MRC does not conduct research programs of its own; it is dedicated entirely to the provision of grants and awards for the support of extramural research. Purpose: According to the Medical Research Act (R.S., c.M-9), the Council's function is to: "(a) promote, assist, and undertake basic, applied, and clinical research in Canada in the health sciences; and (by advise the Minister of National Health and Welfare Canada in respect of such matters relating to such research as the Minister may refer to Council for its consideration." Primary intended users: Biomedical researchers. Technologies: Drug; device; medical or surgical procedure. Generally, MRC supports basic primary research rather than evaluations of technol- ogies or interventions. (The National Health Research and Development Program is the major source of funds within the Department of National Health and Welfare for the support of extramural research and related scientific activities in public health, health care organization, and health care delivery.) Intervention: Diagnosis, treatment. Stage: Emerging, new, established or widespread practice. Properties: Efficacy; effectiveness; ethical, legal, social implications. Ethical considerations are addressed in an agreement between MRC and the applicant regarding investigations involving human subjects, care and use of experimental ani- mals, and research involving biohazards. Selection process: The Council accepts applications designed to achieve the objectives set out in the Federal Main Estimates, which are: "to help attain the quality and scale of research in the health sciences essential to the maintenance and improvement of health services." Application forms are available from the Council or from the dean's office at ~62

MEDICAL RESEARCH COUNCIL, CANADA any Canadian school of medicine, dentistry, pharmacy, or veterinary medicine. Fur- ther information on specific types of grants, application requirements, and deadlines is found in the MRC's Grants anal Awards Guide, issued annually. The guide its nv~il~hle hv contacting the MRC. Methods: Group judgment, expert opinion, clinical trials. , ~, The Council is comprised of 22 members representing the scientific and lay communi- ty, and its programs are administered by a staff of 53. In carrying out its grant-making functions, it is assisted by 37 peer review committees drawn chiefly from universities in Canada. The Council also makes wide use of external referees from Canada and other countries. For some applications, the Council may arrange for a site visit and ask reviewers to prepare a report following such a visit. Dissemination: Grants awarded by the MRC are listed in Reference Last of Health Science Research in Canada 1984-1985. Single copies are available upon request from the Council. The Council does not disseminate research results or final reports. Findings or results of MRC-sponsored research should be obtained directly from the individual or organization conducting the research. Budget: $164,236,000. Funding source: 100 percent parent organization. Completed reports: Cited below are a selection of the grants that the Council awarded in 1984-1985. Grants were selected from the Reference Lot based on their relevance to technology assessment as used in this Directory. Completed Reports MR1 Albisser AM. "Hospital for Sick Children, Toron- toJ "Medical Research Council-Canada] Clinical ap- plications of an artificial pancreas. (Grant period 1975-1985). MR2 Allen PS. [Department Medicine, University A1- berta] [Medical Research Council-Canada] In-vivo medical applications of nuclear magnetic resonance. (Grant period 1984-1985~. MR3 Barbeau A. [Clinical Research Institute of Montre- al] "Medical Research Council-Canada] Etiology and treatment of Parkinson's disease (with a study of eff~- cacy and side effects of levodopa therapy). (Grant period 1973-1985~. MR4 Bergeron C. [Department Pathology, University Toronto] [Medical Research Council-Canada] Ca- nadian brain tissue bank. (Grant period 1983-1985~. MR5 Bitter-Suermann H. [Department Surgery, Dal- housie University] [Medical Research Council-Can- ada] Liver preservation. (Grant Period 1984-1985~. MR6 Bronskill MJ. [Princess Margaret Hospital, Toron- to] [Medical Research Council-Canada] Physical studies of NMR imaging. (Grant period 1983-1985~. MR7 Chang EJH. [Department Computer Science, University Victoria] [Medical Research Council Canada1 Computer assisted medical reasoning. (Grant period 1984-1985~. MR8 Chernick V. "Department Pediatrics, University Manitoba] [Medical Research Council~anada] Clinical trial of naloxone in birth asphyxia. (Grant period 1983-1985~. MR9 Chouinard G. "Department Psychiatry, McGill University] (Medical Research Council-Canada] A clinical trial of L-dopa in the prevention of tardive dyskinesia and in the long-term treatment of Parkin- sonian side effects induced by neuroleptics. (Grant period 1982-1985~. MR10 Chouinard G. [Department Psychiatry, McGill University] "Medical Research Council-CanadaJ Controlled clinical trials of lithium and tryptophan in the treatment of patients with bipolar affective disor- ders. (Grant period 1982- 1985~. MRll Chouinard G. [Louis-H. La Fontaine Hospital, Montreal] [Medical Research Council-Canada] A controlled clinical trial of rubidium in chronic schizo- phrenia. (Grant period 1983-1985~. 163

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY MR12 Clark DC. "Department Dentistry, McGill Uni- versity] iMedical Research Council-Canada] The preventive effect of fluoride varnishes on dental car- ies: three year community trial. (Grant period 1981- 1985~. MR13 Daniel RK. [Department Plastic Surgery, McGill University] [Medical Research Council Canada] Surgical reconstruction utilizing microsurgical tissue transplants. (Grant period 1984- 1985~. MR14 Fenster A. [Princess Margaret Hospital, Toron- to] "Medical Research Council-Canada] Investiga- tions of new imaging system and dose reduction. (Grant period 1979-1985~. MR15 Garfinkel PK. iDepartment Psychiatry, Universi- ty Toronto] "Medical Research Council-Canada] Bu- limia: Neuroendocrine evaluation, relationship to ef- fective disorder and treatment with carbamazepine. (Grant period 1983-1985~. MR16 Guttman FM. "Montreal Children's Hospital] [Medical Research Council-Canada] Long term or- gan preservation. (Grant period 1979-1985~. MR17 Inch WR. [Department Radiation Oncology, University Western Ontario] "Medical Research Council-Canada] Nuclear magnetic resonance to monitor lung injury. (Grant period 1983-1985~. MR18 Jugdutt, BI. "Department Medicine, University Alberta] [Medical Research Council Canada] Pres- ervation of ischemic myocardium. (Grant period 1983- 1985~. MRl9 Man GCW. [Department Medicine, University Alberta] [Medical Research Council-Canada] The effect of high frequency oscillatory ventillation. (Grant period 1983- 1985~. MR20 Mclachlan KR. [Department Dentistry, Universi- ty Manitoba] "Medical Research Council-Canada] The effectiveness of loops and auxiliary appliances in continuous arch orthodontic therapy. MR21 Miller JE. [Montreal General Hospital Research Institute] Medical Research Council-Canada] Opti- mization of f~xation of artif~cial joint components to bone-the prevention of loosening in total joint arth- roplasty. MR22 Milner M. [Department Biomedical Engineering, University Toronto] "Medical Research Council- Canada] Therapeutic and orthotic aspects of electro- stimulation in paediatric cerebral palsy. (Grant period 1981-1985). 164 MR23 Morales A. "Department Urology, Queens Uni- versity] [Medical Research Council-Canada] The validation of nocturnal and sexual erections in the etiological diagnosis of impotence. (Grant period 1984-1985~. MR24 Morales A. [Department Urology, Queens Uni- versity] [Medical Research Council Canada] A con- trolled clinical trial of yohimbine in the treatment of impotence. (Grant period 1981-1985~. MR25 Nattel S. "Department Pharmacology and Thera- peutics, McGill University] "Medical Research Coun- cil-Canada] Effects of antiarrhythmic drugs on ar- rhythmias related myocardial infarction. (Grant peri- od 1981- 1985~. MR26 Pape KE. [Hospital for Sick Children, Toronto] (Medical Research Council-Canada] A prospective study of the evolution and outcome of cystic brain damage in the preterm infant utilizing diagnostic ul- trasound brain scans. MR27 Paty DW. [Department Medicine, University British Columbia] "Medical Research Council-Cana- da] A therapeutic trial of interferon in multiple scle- rosis (MS). (Grant period 1983- 19851. MR28 Paty DW. [Department Medicine, University British Columbia] [Medical Research Council-Cana- da] Interferon therapeutic trial in M~supplemental application. (Grant Period 1984- 19851. MR29 Paty DW. "Department Medicine, University British Columbia] [Medical Research Council-Cana- da] NMR imaging in MS, I: The nature of the lesion. (Grant period 1984- 1985~. MR30 Paty DW. [Department Medicine, University British Columbia] [Medical Research Council-Cana- da] NMR imaging in MS, II, diagnosis of the disease and quantitation. (Grant period 1984-1985~. MR31 Podgorsak EB. "Department Radiation Oncolo- gy, McGill University] "Medical Research Council Canada] Noninvasive thermometry and hyperther- mia in cancer treatment. (Grant period 1982-1985~. MR32 Podgorsak FB. "Department Radiation Oncolo- gy, McGill University] "Medical Research Council Canada J Radiographic imaging by solid state electro- static techniques. (Grant period 1981-1985~. MR33 Pomier-Layrargues G. "Department Medicine, University Montreal] [Medical Research Council Canada] Treatment of portal hypertension a ran- domized clinical trial. (Grant period 1984-1985~. MR34 Poznansky MJ. [Department Physiology, Univer- sity Alberta] "Medical Research Council-Canada] Soluble enzyme-albumin polymers: new approaches to enzyme therapy. (Grant period 1976-19854.

MEDICAL RESEARCH COUNCIL, CANADA MR35 Price M. "Department Ophthalmology, Universi- ty British Columbia] Medical Research Council- Canada] The development calf electrodiagnostic tests to detect early chronic open angle glaucoma. (Grant period 1983-1985~. MR36 Pritchard KI. "Department Medicine, University of Toronto] "Medical Research Council~anada] A trial of adjuvant therapy in post menopausal women with axillary node positive breast cancer. (Grant peri- od 1984-1985). MR37 Racz W}. "Department Pharmacology, Queens University] [Medical Research Council~anada] Ac- etaminophen induced hepatotoxicity. (Grant period 1983-1985). MR38 Roder ~C. [Department Microbiology and Im- munology, Queens University] "Medical Research Council~anada] The application of human hybri- doma technology to cancer and autoimmune disease. (Grant period 1983-1985). MR39 Schachar NS. "Department Surgery, University Calgary] Investigation of optimal methods of cryo- preservation of osteoarticular allografts for transplan- tation. (Grant period 1984- 1985). MR40 Sherwin BB [Sir Mortimer B. Davis-}ewish Gen- eral Hospital, Montreal] "Medical Research Council- Canada] Long-term effects of androgen and/or estro- gen on psychosexual functioning, hormone levels, and lipid metabolism in surgically menopausal wom- en. (Grant period 1984- 1985) Medical Technology and Practice Patterns Institute National Health Services ant! Practice Patterns Survey 2233 Wisconsin Avenue NW, Suite 302 Washington, DC 20007 202-333-8841 Contact: Dennis I. Cotter, Director. MR41 Szarek W. "Department Chemistry, Queens Uni- versity] Radiopharmaccutical development for posi- tron imaging. (Grant period 1981 - 1985~. MR42 Trachtenberg I. "Department Surgery, Universi- ty Toronto] "Medical Research Council~anada] Hormonal control of human prostatic cancer. (Grant period 1980-19851. MR43 Trevithick JR,. "Department Biochemistry, Uni- versity Western Ontario] "Medical Research Coun- cil~anada] Microwave and heat-induced cataracts: prevention by vitamin E and chronic studies of low level pulsed irradiation. (Grant period 1983-1985~. MR44 Tugwell P. "Department Medicine, McMaster University] "Medical Research Council~anada] Clinical trials computer network. (Grant period 1984- 1985). MR45 Viviani GR. [Department Surgery, McMaster University] [Medical Research Council~anada] Biomechanical studies of surgical systems to correct spinal deformities. (Grant period 1982-1985~. MR46 Ward RH. [Medical Genetics, University British Columbia] [Medical Research Council~anada] Identifying pregnancies at high risk for neural tube defects. (Grant period 1984-1985~. Overview: The Medical Technology and Practice Patterns Institute (MTPPI) was initiated at the Institute for Health Policy Analysis, Georgetown University Medical Center. In July 1986, MTPPI was established as an independent entity, separate from Georgetown, to allow broad participation by the health care industry. MTPPI is in the process of affiliating with organizations representing the health care industry. The National Health Services and Practice Patterns Survey (NHSPPS) was the first MTPPI program. Purpose: To provide current information regarding adoption and use of new medical technologies to health care providers, hospital administrators, and policy makers to 165

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY assist them in making appropriate navments for new once e~m~>r~in~r tf~rLn~l^crim~ The ~ -~ --r r ~ ~ r ~ -~~~ r-J ~-_A^~V ^~^ ^~ ~..&,&~ ~AAA~_A 51~5 ~llllVl~l~- 1 aft o~ect~ve Is to avoid financial barriers to these technologies for all categories of patients. NHSPPS seeks to accomplish this through collection and analysis of primary data, education, and the exchange of information on resource requirements and changes in practice patterns resulting from use of new medical technologies. Primary intended users: Providers, generally; acute facility administrators; health product manufacturers; health/medical professional associations; health industry asso- ciations; third party payers; government regulators. Technologies: Drug, device, medical or surgical procedure. Intervention: Diagnosis, treatment. Stage: Emerging, new, established or widespread practice. Properties: Cost, cost-effectiveness, service requirements, economic implications. In order to encourage the optimal use of a technology, the NHSPPS is primarily concerned with assessing a technology's costs, charges, practice pattern variation, and . . . up Eaton. Selection process: Requests for assessments come from hospitals, third party payers, clinicians, medical specialty societies, and industry. NHSPPS reports include mail-in forms that recipients may use to suggest assessment topics. Assessment topics are approved by the MTPPI Governing Boards. Methods: Information syntheses, cost analyses. Approximately 50 medical centers/hospitals participate in the NHSPPS Program. The process includes four activities: 1) collection and analysis of hospital cost and utilization information; 2) solicitation of judgment by participating hospitals reporting appropri- ate applications and costs of new technologies; 3) development and distribution to participating hospitals of reports on study findings; and 4) submission of NHSPPS results to appropriate government agencies for their consideration of diagnosis-related group (DRG) assignment and reimbursement. Anonvmitv of inclivirl,~1 h~cnit~1 Acts lo maintained in all NHSPPS studies. . --I ~vim - ~a~l1 1~llorro Collect monitors a specific new or emerging technology over a 3 to 4 year period during the early phase of diffusion. Individual projects end when there is general agreement among providers regarding third party payment or other policy concerns for a specific technology. Reports for each technology involved in the survey are updated and generated annually. NHSPPS reports are comprised of hospital data collected during the previous year. MTPPI reports are conducted by a core staff and associates from other institutions with expertise relevant to particular assessments. Assessors: Staff and associates have expertise in bioengineering, medicine, law, public health, and economics. Once the new MTPPI governing board is appointed, it will have approximately 18 members representing medical professionals, insurers, hospitals, manufacturers, others from the health care industry, and community representatives. 166

MEDICAL TECHNOLOGY AND PRACTICE PATTERNS INSTITUTE Assessment reports include: Abstract; who sponsored/ commissioned/supported the assessment; who conducted the assessment; description of the technology; properties assessed; procedure used for the assessment; sources of data/information; results; findings or conclusions; recommendations for practice, future assessments, technology development, research; regulatory agency approval status; coverage/reimbursement status of the technology. Dissemination: Printed reports; journal articles; advisories to member/constituents press conference/news releases. MTPPI publishes two types of reports. NHSPPS Public Policy Reports are available to the public. Approximately 20 to 50 pages in length, they include aggregate and average cost, payment, and utilization data on technologies used by the national sample of participating hospitals and related narrative discussion. NHSPPS National Average Amounts Reports are available only to participating hospitals; they provide the hospitals with information comparing their respective experiences with national averages. Public policy report prices range from $19 to $40; rates are discounted for member hospitals that participate in the surveys. NFISPPS reports can be ordered from MTPPI. MTPPI mails notices about report availability and related information to over 4,000 health care related organizations and professionals. Reports are also distributed to congressional and executive branches of government and insurance companies. Budget: The annual budget for all MTPPI activities is $425,000, including $250,000 for NHSPPS. Funding sources: 10 percent foundations, other private grants; 75 percent sponsors/members dues, contributions; 15 percent sales of assessments, consul- tant services. Use: The first NHSPPS public policy report on extracorporeal shockwave lithotripsy was used in reassigning DRG levels by the Prospective Payment Assessment Commis- sion. Findings have appeared in such publications as: Technology Reimbursement Re- ports Beige Sheet, COTH Report, Hospitals, Washington Actions on Health, Trench in Health Business, and reports of the Prospective Payment Assessment Commission. Related Activities: The Medical Technology Forum is a new program that sponsors conferences on selected medical technology topics. It serves as a catalyst to focus the expertise of public and private organizations on issues such as costs and quality of care, third party payer coverage and reimbursement policy, equitable access to care, and regulating the distribution and use of major medical technologies. The first forum was held on fully automated ambulatory blood pressure monitoring. Forum reports are made public. The Hospital Stay Charge Profile (HSCP) is a new service that provides MTPPI client hospitals with computer analysis of: (1) current demand for acute-care services, (2) resources consumed during the hospital stay, and (3) practice pattern information related to the care given Medicare beneficiaries. This includes analyses of public and private health care costs and utilization databases (e.g., Medicare's MEDPAR and PATBILL data) and data collected from client hospital discharge records. HSCP reports that address public policy issues may be made public subject to agreement by the client and MTPPI. 167

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Completed Reports MT1 Medical Technology and Practice Patterns Insti- tute. Ambulatory blood pressure monitoring. 1987. MT2 . Bone marrow transplantation. 1987. MT3 . Cochlear implantation. 1987. MT4 . Cochlear implants outpatient training. 1987. MT5 . Dialysis treatment for end stage renal disease (inpatient). 1987. MT6 . Dialysis treatment for end stage renal disease (outpatient). 1987. MT7 . End tidal carbon dioxide monitoring. 1987. MT8 . Endocardial electrical simulation. 1987. MT9 . Extracorporeal shockwave lithotripsy (in- paiient). 1987. MT10 . Extracorporeal shockwave lithotripsy (outpatient). 1987. MTll . Fetal heart monitoring. 1987. National Center for Health Services Research and Health Care Technology Assessment Parklawn Building, Room 18-05 5600 Fishers Lane Rockville, MD 20857 30 1-443-5650 MT12 . Gastric bubble for treatment of morbid obesity. 1987. MT13 . Heart transplantation. 1987. MT14 . Left ventricular assist device. 1987. MT15 . Liver transplantation. 1987. MT16 . Magnetic resonance imaging (inpatient). 1987. MT17 . Magnetic resonance imaging (outpa iient). 1987. MT18 . Percutaneous lithotripsy. 1987. MT19 . Percutaneous transluminal coronary an- gioplasty. 1987. MT20 . Pulse oximetry. 1987. MT21 . Total parenteral nutrition (inpatient). 1987. MT22 . Total parenteral nutrition (outpatient). 1987. Individual profiles on two assessment-related programs of the National Center for Health Services Research and Health Care Technology Assessment, the Division of Extramural Research and the Office of Health Technology Assessment, follow this overview of the agency. In addition, the agency's National Advisory Council on Health Care Technology Assessment is described in the organizational resources section of this Directory. The National Center for Health Services Research and Health Care Technology Assessment (NCHSR/HCTA) is part of the Office of the Assistant Secretary for Health, Public Health Service (PHS), U.S. Department of Health and Human Services (DHHS). NCHSR/HCTA is the primary source of federal support for research on problems related to the quality and delivery of health services. NCHSR/HCTA pro- grams evaluate health services, assess technologies, and improve access to new scientific and technical information for research users. NCHSR/HCTA's research is targeted to the needs of health care policy-makers, those who operate hospitals and other health care institutions, and those who are responsible for health care expenditures. 168

NATIONAL CENTER FOR HEALTH SERVICES RESEARCH NCHSR/HCTA's extramural research program is directed toward health promotion and disease prevention, technology assessment, the role of market forces in the delivery of health care, primary care, and state and local health problems. It provides support for investigator-initiated projects in these areas conducted at universities, nonprofit organizations and institutions, and by industry. The NCHSR/HCTA intramural research program conducts studies that have immedi- ate as well as long-term policy relevance. It addresses four major health care issues in the following programs: the Hospital Studies Program, the Health Services for the Aged Studies Program, the National Health Care Expenditures Study, and the Health Status and Health Promotion Studies Program. The Office of Health Technology Assessment (OHTA) conducts evaluation of the safety and clinical effectiveness of medical technologies in order to provide federally funded agencies such as the Health Care Financing Administration (HCFA) with medical and scientific information to assist in policy formulation involving issues relat- ed to Medicare or other coverage. The NCHSR/HCTA has a National Advisory Council on Health Care Technology Assessment to advise the Secretary of DHHS and the Director of NCHSR/HCTA with respect to the performance of NCHSR/HCTA technology assessment activities. The National Advisory Council is described in another section of this Directory. Inquiries about NCHSR/HCTA and its programs may be directed to the NCHSR/ HCTA Publications and Information Branch, 301-443-4100. NCHSR/HCTA research reports are available for sale through the U.S. Department of Commerce, National Technical Information Service (NTIS), 703-487-4650. Reports are announced in the NTIS Government Reports Announcements and Index and NTIS Abstract Series 44. Abstracts may be accessed directly through two online databases: the NTIS database, and the National Library of Medicine's MEDLARS Health Planning and Administration file. Research reports of particular interest are published by NCHSR/HCTA in its own publication series. Information materials are available on various topics, including NCHSRIHCTA Research Activities, which announces the availability of NCHSR/HCTA research results in journals, books, reports, and papers. A publications list will be sent on request. National Center for Health Services Research arid Health Care Technology Assessment Division of Extramural Research 5600 Fishers Lane, Room ~ SA- ~ 9 Rockville, MD 20857 30 1-443-2080 Contact: lames R. Ullom; or Maria Friedman, Publications and Information Branch 30 1-443-4 1 00. Overview: The National Center for Health Services Research and Health Care Tech- nology Assessment (NCHSR/HCTA) is the primary source of federal support for research on problems related to the quality and delivery of health services. NCHSR/ 169

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY HCTA programs evaluate health services, assess technologies, and improve access to new scientific and technical information for research users. This profile addresses the NCHSR/HCTA Division of Extramural Research. An over- view of the NCHSR/HCTA is provided immediately preceding this profile. Another profile in this section describes the NCHSR/HCTA Office of Health Technology Assessment. The NCHSR/HCTA National Advisory Council of Health Technology Assessment is described in the organizational resources section of this Directory. NCHSR/HCTA's extramural research program is directed toward health promotion and disease prevention, technology assessment, the role of market forces in the delivery of health care, primary care, and state and local health problems. It provides support for investigator-initiated projects in these areas conducted at universities, nonprofit organizations and institutions, and by industry. Purpose: To provide support for health services research, including investigations on specific health care technologies, methods to improve technology assessment, and ways to monitor and affect the introduction and use of health care technologies. Primary intended users: General public; patients; providers, generally; physicians; acute facility administrators; long-term care facility administrators; health/medical professional associations; health industry associations; consumer associations; employ- ers; unions and other employee organizations; third party payers; government regula- tors; voluntary associations, organizations; biomedical researchers; reporters, writers, news media; information/computer industry; public policy-makers, legislators; policy research organizations. Technologies: Device, drug, medical or surgical procedure, support system, organiza- tional or administrative system. Intervention: Treatment, prevention, diagnosis. Stage: Established or widespread practice, new, obsolete. Properties: Effectiveness; cost-effectiveness; system impact; safety; efficacy; cost; cost-bene- fit; service requirements; acceptance/adoption level; economic implications; ethical, legal, social implications. Selection process: Most projects are initiated by outside investigators through the formal grant application process established by NCHSR/HCTA Applications are re- viewed by nonfederal peer panels and by the National Advisory Council on Health Care Technology, and are selected for funding based on their scientific merit and their potential for improving the cost-effectiveness and quality of health services. Disserta- tion research grants are available. Assessment topic priorities are developed by the Director of NCHSR/HCTA with the input and advice of the Director of Extramural Research, senior NCHSR/HCTA staff, advisory councils, study sections, and health services researchers. Methods: Epidemiological and other observational methods, information syntheses, expert opinion, group judgment, modeling, cost analyses, clinical trials, bench testing. Grant project periods can be as long as 5 years, but most projects are completed within 3 years. 17O

NCHSR/DIVISION OF EXTRAMURAL RESEARCH Assessors: Assessors are experts in the areas of medicine, health, nursing, economics, epidemiology, biostatistics, computer sciences, informatics, and sociology. Assessment reports include: Abstract; the purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technol- ogies intended for similar purposes; who sponsored/commissioned/supported the as- sessment; description of the technology; stage of life-cycle of technology when assessed; properties assessed; procedure used for the assessment; sources of dataJinformation; methods for collecting data/ information; methods for analyzing/synthesizing dataJ information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; where technology is in use. Dissemination: journal articles; printed reports; clearinghouses, dataJcitation bases, online services, specifically, the National Library of Medicine MEDLARS and National Technical Information Service (NTIS) databases. Results are also disseminated through NCHSR/FICTA publications and presentations at professional meetings. Reports are disseminated to State and local users. Copies of reports may be obtained by contacting the NCHS1RJHCTA Publications and Informa- tion Branch. Budget: $4,000,000. Grant awards vary greatly, with the average being approximately $500,000 for a 3-year study. Funding source: 100 percent parent organization. Use: NCHSR/HCTA uses assessment reports as the basis for policy recommendations and testimony before Congress. Based on references in the literature, the reports are also used outside the agency. The general programs of the Division of Extramural Research are described in the Catalog of Federal Domestic Assistance and in the NCHSRIHCTA Program Note, September 1986. Completed Reports NA1 McDonald C}, Tierney WM. [National Center for Health Services Research and Health Care Technol- ogy Assessment, Division of Extramural Research] The medical gopher: a microcomputer system to help find, organize, and decide about patient data. West Med. in press. NA2 Anderson JG. ~ ~ Use of an HIS by physi- cians and nurses. 1985 Aug. (NTIS order no. PB86- 121126/AS) NA3 Antczak AA, Tang J. Chalmers TC. [ ] Quality assessment of randomized control trials in dental research. I. Methods. ~ Periodont Dis 1986;21 :305-314. NA4 Antczak AA, Tang {, Chalmers TC. Quality assessment of randomized control trials in dental research. II Results. J Periodent Res 1986;21:315-321. NA5 Eisenberg JM, et al. ~ ~ Derived thresholds in medical decision making. 1986 Mar.(NTIS order no.PB86-219359/AS) NA6 Frankel N. et al. ~ 1 Utilization of lung scans by clinicians. ~ Nucl Med 1986 Mar;27~3):366-369. NA7 Henderson MG. ~ I Resource utilization in alternative ambulatory care sites. 1986. (NTIS order no. PB86-102662) NAB Lee KL, et al. ~ ~ Predicting outcome in coronary disease: statistical models versus expert cli- nicians. Am ~ Med 1986 Mar;27~31:366-369. NA9 Perrin ~M, Valvona }, Sloan FA. ~ ~ Chang- ing patterns of hospitalization for children requiring surgery. Pediatrics 1986 Apr;77~41:587-592. NA10 Ray WA, et al. ~ ~ Reducing long-term diazopam prescribing in office practice: a controlled trial of educational visits. JAMA 1986 Nov;256~18):2536-2539. 171

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY NAl l Rovner DR, et al. ~ ~ Validity of structured cases to study clinical judgment. 1986 Jan. (NTIS order no. PB86-226222/AS) NA12 Schaffner W. Ray WA, Federspiel CF. Improving prescribing in outpatient practice. 1985 Oct. (NTIS order no. PB86-218997/AS) NA13 Shwartz M et al. ~ ~ A deep model of the incidence of dental caries on proximal surfaces. Med Decision Making 1986 Jan-Mar;b(1~:42-48. NA14 Sloan FA, Perrin TM, Valvona }. ~ ~ In- hospital mortality of surgical patients: is there an em- piric basis for standard setting? Surgery 1986 Apr;99~41:446-453. NA15 Smith CC. ~ ~ Microchip medicine. Am- bassador 1986 Apr; 19~4) :20-22. NA16 Tierney WM, Hui SC, McDonald CJ. ~ ~ Delayed feedback of physician performance versus immediate reminders to perform preventive care. Med Care 1986 Aug;24~8~:659-666. NA17 Zimmerman ~E, et al. ~ ~ The use and implications of do not resuscitate orders in intensive care units. JAMA 1986 Jan 17;255~3~:351-356. NA18 Bleich HC. ~ ~ Clinical computing in a teaching hospital. N Engl J Med 1985 Mar 31~12~:756-764. NAl9 Bunker JP. ~ ~ Outcomes of total hip re- placement using northern California claims data: a pilot study. 1985 Aug. (NTIS order no. PB86- 129574/as, inventory only) NA20 Burton BK, Dillard RG, Clark EN. ~ ~ MSAFP screening: the effect of participation on anxi- ety and attitudes toward pregnancy in women with normal results. Am ~ Obset Gynecol 1985; 152 : 540- 543. NA21 Burton BK, Dillard RG, Clark EN. ~ ~ The psychological impact of "false positive" MSAFP eleva- tions. Am ~ Obstet Gynecol 1985; 151 :77-82. NA22 Califf RM, et al. ~ ~ Prognostic value of a coronary artery jeopardy score. T Am Coll Cardiol May 1985;5(5):1055-1063. NA23 Christian CL. ~ ~ Total knee replacement study. 1985 Apr. (NTIS order no. PB85-236909/AS) NA24 Darnell ~C, et al. ~ ~ After hours telephone access to physicians with access to computerized medi- cal records. Med Care 1985 Jan;23~1~:20-26. NA25 Doubilet P. et al. ~ ~ Probabilistic sensitivity analysis using Monte Carlo simulation. Med Decision Making 1985 Feb;5~2~:157-177. 172 NA26 Eisenberg MS, Hallstrom A, Bergner LG. ~ ~ Defibrillation by emergency medical techni- cians. 1983 May. (NTIS order no. PB85-163632/AS'. NA27 Feinstein AR, Sosin DM, Wells CK. ~ ~ The Will Rogers phenomenon: stage migration and new diagnostic techniques as a source of misleading statis- tics for survival in cancer. N Engl J Med 1985 {un 20;312~25): 1604-1608. NA28 Fineberg HV, Marks H. ~ ~ Development and diffusion of automated chemistry analyzers. l 985 Feb. (NTIS order no. PB85-105696) NA29 Fineberg HV. ~ ~ Technology assessment: achievements, capabilities and future directions. Med Care 1985 May;23~5~:663-671. NA30 Harrell FE, Lee KL. ~ ~ In: Sen PK, ed. Biostatistics: statistics in biomedical, public health and environmental sciences. North Holland: Elsevier Sci- ence Publishers,1985:333-433. NA31 Harris PJ, et al. ~ ~ Nonfatal myocardial infarction in medically treated patients with coronary artery disease. Am J Cardiol 1980 Dec;46:937-942. NA32 Hlatky MA, et al. ~ ~ Am T Cardiol 1985 Feb;55:325-329. NA33 Kaplan EB, et al. ~ ~ The usefulness of preoperative laboratory screening. JAMA 1985 Jun;253~24~:3576-3589. NA34 Komaroff A1, et al. ~ ~ Cost-effective strate- gies in ambulatory care.1985. (NTIS order no. PS85- 135366) NA35 Lasch KE. ~ ~ Political culture of medical technology assessment. 1985 Feb. (NTIS order no. PB86- 119054/AS) NA36 Pryor DB, et al. ~ ~ Clinical databases- accomplishments and unrealized potential. Med Care 1985 May 23~5~:648-662. NA37 Pryor DB. ~ ~ In: Califf RM, Wagner GS, eds. Acute coronary care: principles and practice. 1985:473-478. NA38 Ray WA, Schaffner W. Federspiel CF. ~ ~ Persistence of improvement in antibiotic prescribing practice. JAMA 1985 Mar;253~12~:1774-1776. NA39 Ray WA, Schaffner W. Federspiel CF. ~ ~ Persistence of improvement in antibiotic prescribing practice. JAMA 1985 Mar;253~12~:1774-1776. NA40 Ray WA, et al. ~ ~ Improving antibiotic prescribing in outpatient practice: nonassociation of outcome with prescriber characteristics and measures of receptivity. Med Care 1985 Nov;23~11~:1307-1313.

NCHSR/DIVISION OF EXTRAMURAL RESEARCH NA41 Reddecord KM, Taylor RB. ~ ~ Education, training, professional certification, and work patterns of directors in interstate laboratories. Am ~ Clin Pathol 1985 Apr;83~4~:480-485. NA42 Russell LB. ~ ~ Evaluating preventive med- ical care as a health strategy. 1985. (NTIS order no. PB85-208163/AS) NA43 Scitovsky AA. ~ ~ Medical cost changes of selected illnesses, 1971- 1981. 1985 Jul. (NTIS order no. PB86-155553/AS) NA44 Showstack TA, Stone MH, Schroeder SA. Changes in the use of medical technologies, 1972-1982: a study of ten inpatient diagnoses. 1985. (NTIS order no. PB85-183929/AS) NA45 Sloan FA. ~ ~ Diffusion of surgical technol- ogy. 1985 Jul. (NTIS order no. PB86- 124559/AS) NA46 Tierney WM, McDonald Cal, McCabe C. ~ ~ Serum potassium testing in diuretic-treated outpatients: a multivariate approach. Med Decision Making 1985;5~1~:89-104. NA47 Wagner GS. ~ ~ The effectiveness of mo- bile intensive care. 1985. (NTIS order no. PB85- 191211/AS) NA48 Weinstein MC, Stason WB.t ~ Cost-effec . . . . t~veness ot ~ntervent~ons to prevent or treat coronary heart disease. Annu Rev Public Health 1985 Jun;6:41-63. NA49 Whiting-O'Keefe QE, et al. ~ ~ A comput- erized summary medical record system can provide more information than the standard medical record. JAMA 1985 Sep 6;254(9~: 1185- 1192. NA50 Winickoff RN, et al. ~ ~ Limitations of pro ., . . . . . vlcler 1nterventlons 1n ~ypertenslon qua lty assurance. Am ~ Public Health 1985 ~an;75~1~:43-46. NA51 Wortman PM, Yeaton WH. ~ ~ Cumulat- ing quality of life results in controlled clinical trials of coronary artery bypass graft surgey. Controlled Clin Trials 1985 Dec;6~4~:289-305. NA52 Yeaton WH and Wortman PM. ~ ~ Medical technology assessment: the evaluation of coronary ar- tery bypass graft surgery using data synthesis tech- niques. Int J Technol Assessment Health Care 1985 Jan; 1~1~:125-1416. NA53 Avorn J. ~ ~ De-marketing and administra- tive strategies in prescription drug use. 1984. (NTIS order no. PB84-182781) NA54 Avorn ~L. ~ ~ Benefit and cost analysis in geriatric care: turning age discrimination into health policy. N Engl J Med 1984 May;310~20~:1294-1301. NA55 Avorn, JL. ~ ~ Drug revolution places pre- scribing practices in question. Bus Health 1984 Mar; 1~4~:353-39. NA56 Barnett GO. ~ ~ The application of com- puter-based medical record systems in ambulatory practice. N Engl J Med 1984 Jun;310~25~:1643-1650. NA57 Brand DA. ~ ~ An x-ray screening protocol for extremity injuries. 1984. (NTIS order no. PB84- 111384) NA58 Braun P. ~ ~ Elective hysterectomy: bene- fits, risks, and costs. 1984. (NTIS order no. PB84- 240126) NA59 Cohen, S. ~ ~ Development, implementa- tion and preliminary evaluation of monitoring and intervention of therapeutic actions system (MINER- VA). 1984 Jun. (NTIS order no. PB85-138493/AS) NA60 Conrad D, Milgrom P. Kiyak A. ~ ~ Insur- ance plan effects on dental provider treatment for elderly patients. Med Care 1984 May;22~5~:;430-445. NA61 Cox tR. ~_ ~ A medical information systems design methodology. 1984 Aug. (NTIS order no. PB86-212388/AS) NA62 Eisenberg MS, et al. ~ ~ Treatment of ven- tricular fibrillation: emergency medical technician de- fibrillation and paramedic services. JAMA 1984 Apr;251 ~ 131: 1723-26. NA63 Fries iF. ~ ~ Assessment of technology in chronic disease. 1984. (NTIS order no. PB84- 200237) NA64 Fries JF. ~ ~ The chronic disease data bank: first principles to future directions. J Med and Philos 1984 May;9~2~:161-180. NA65 Gehlbach SH, et al. ~ 1 Improving drug prescribing in a primary care practice. Med Care 1984 Mar;22~3~: 193-201. NA66 Grossman M, et al. ~ ~ An economic analy- sis of community health centers. 1984. (NTIS order no. PB84-159185) NA67 Mackenzie EJ. ~ :1 Injury severity scales: overview and directions for future research. Am J Emerg Med 1984 Nov;2~6~:537-549. NA68 Payne BC. ~ ~ Burn care facility study. 1984. (NTIS order no. PB84-240688) NA69 Poddercord M, Taylor RN. ~ ~ Evaluation of laboratory quality assurance activities.1984. (NTIS order no. PB84-205913) NA70 Pryor DB, et al. ~ ~ Am J Cardiol 1984 Jan;53: 18-22 173

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY NA71 Pryor DB, et al. ~ ~ Prognostic indicators from radionuclide angiography in medically treated patients with coronary artery disease. Am I Cardiol 1984 Tan;53:18-22. NA72 Rikli AK, Leonard MS. ~ ~ End stage renal disease: resource forecasting by predictive model. 1981. (NTIS order no. PB81-141665) NA73 Seigel. [_ ~ The effects of a computerized drug order review system. 1984. (NTIS order no. PB84-156199) NA74 Sherman H. ~ ~ The dollar rank order of diagnostic tests used with specific problems in pri- mary medical encounters. 1984. (NTIS order no. PB85-113843) NA75 Sherman H. ~ ~ Surveillance effects on community physician test ordering. Med Care 1984 Jan;22~1):80-83. NA76 Simborg DW. ~ :I Evaluation of a summary medical record system. 1984 (NTIS order no. PB84- 100247) NA77 Soumerai SB, Avorn ~L. ~ ] Efficacy and cost-containment in hospital pharmacotherapy: state- of-the-art and future directions. Milbank Mem Fund Q 1984;63~3). NA78 Stead EA. ~ ~ A medical database ap- proach to evaluate technology.1984. (NTIS order no. PB84-200559) NA79 Thomas KA}. ~ ~ The influence of incuba- tor air temperature on the respiratory responses of preterm infants. 1986 Mar. (NTIS order no. Pb86- 218096/AS) NA80 Wagner DP, Draper EA. [ ~ Acute Physiol- ogy and Chronic Health Evaluation (APACHE II) and Medicare reimbursement. Health Care Finance Rev 1984 Nov;annual suppl:91-105. NA81 Wayne DP, et al. ~ ~ International use of APACHE. Med Decision Making 1984 Fall;4~3~:297- 313. NA82 Widerhold G. ~ ~ Automated ambulatory medical record systems in the U.S.1984. (NTIS order no. PB84-118884) NA83E ~ MEDIPHOR: drug interaction facts. St. Louis, MO: JB Lippinott Co, 1983. NA84 Avorn JL, Soumerai SB. ~ ~ Improving drug-therapy decisions through educational out- reach: a randomized controlled trial of academically based "detailing." N Engl ~ Med 1983 ~un; 308~24~: 1457-1463. 174 NA85 Barnett GO, et al. ~ J A computer-based monitoring system for follow-up of elevated blood pressure. Med Care 1 983 Apr;2 1 (4~:400-409. NA86 Beardsley RS, Freeman JM, Appel FA. ~ ~ Anticonvulsant serum levels are useful only if the physician appropriately uses them: an assessment of the impact of providing serum level to physician data. Epilepsia 1983 Jun;24~6~:330-335. NA87 Blazer DG, et al. ~ ~ The risk of anticholin- ergic toxicity in the elderly: a study of prescribing practices in two populations. ~ Cardiol 1983 Jan;38(1~:31-35. NA88 Brand DA, et al. [_ ~ A protocol for select- ing patients with injured extremities who need x-rays. N Engl ~ Med 1983 Feb;306~6~:333-339. NA89 Brian EW. ~ ~ Evaluation of automated hospital data management systems in 100-300 bed hospitals. 1983. (NTIS order no. PB83-153437~. NA90 Fine EG ~ ~ An evaluation of the 911 sys- tem. 1983 (NTIS order no. PB83- 137968~. NA91 Gibbons RJ, et al. ~ ~ The use of radionu- clide angiography in the diagnosis of coronary artery disease; a logistic regression analysis. Circulation 1983 Oct;68~4~: 740-746. NA92 Hanky JA, McNeil BJ. ~ ~ A method of comparing the areas under receiver operating charac- teristic curves derived from the same cases. Radiology 1983 Sep;148~3~:839-843. NA93 Knaus WA. ~ ~ Changing the cause of death. JAMA 1983 Feb;249(8): 1059-1060. NA94 Koespell TD, et al. ~ ~ The Seattle evalua- tion of computerized drug profiles effect on provid- er activities. Med Care 1983 May 21~5~:498-507. NA95 McDonald C l, Mazzuca SA, McCabe GP. ~ ~ How much of the "placebo effect" is really statistical regression? Stat Med 1983 Feb;2:417-427. NA96 Newman M. ~ ~ J Emerg Med Serv 1983 Jan;8~1~:74-78. NA97 Polister P. ~ ~ The evaluation and use of repeated medical tests: logical and statistical consider- ations. 1983. (NTIS order no. PB83- 173716) NA98 Pryor DB, et al. ~ ~ Early discharge after myocardial infarction. Ann Intern Med 1983 Oct;99~4~:528-538. NA99 Ruthow IM. ~ ~ Surgical decision making and operative rates. 1983. (NTIS order no. PB83- 141929)

NCHSR/DIVISION OF EXTRAMURAL RESEARCH NA100 Schaffner W. et al. ~ ~ Improving antibi- otic prescribing in of fire practice. JAMA 1983 Oct;250(13): 1728-1732. NA101 Wagner DP, Wineland TD, Knaws WA. ~ ~ Health Care Financ Rev 1983 Fall;5~1~:81- 86 NA102 Wagner DP, et al. ~ ~ Identification of low-risk monitoring patients within a medical-surgical intensive unit. Med Care 1983 May;21~4~:4425-434. NA103 Wheller ARC, et al. ~ ~ The effects of burn severity and institutional differences on the costs of care. Med Care 183 Dec;21~12~:1192-1203. NA104 ~ ~ The effect of immediate access to a computerized medical record on physician test order- ing: a controlled clinical trial in the emergency room. Am ~ Public Health 1982 Ju1;72~7~:698-702. NA105 Avorn ~L, Chen M, Hartley R. ~ ~ Scien- tific versus commercial sources of influence on the prescribing behavior of physicians. Am ~ Med 1982 Ju1;72:4-8. NA106 Blum RL. ~ ~ Discovery, confirmation, and incorporation of causal relationships from a large time-oriented clinical data base: the RX Project. Com- put Biomed Res 1982; 15~2~: 164-187. NA107 Brand DA. ~ ~ A computer audit to im- prove ER drug prescribing. 1982. (NTIS order no. PB82-253188). NA108 Champion HR. ~ Measurement of pa tient illness severity. Crit Care Med 1982 Aug; 10~8):552-553. NA109 Cohen, SN, et al. ~ Development, imple mentation and evaluation of drug interactions by a pharmacy oriented reporting system.1982 (NTIS or der no. PB82-140757) NA110 Dibner AS, Lowry L, Morris ~N. ~ ~ Us- age and acceptance of an emergency alarm system by the elderly. Gerontologist 1982;22~6):538-539. NA111 Knaus WA, et al. ~ ~ A comparison of intensive care in the USA and France. Lancet 1982 Sep:642-646. NA112 Knaus WA, et al. ~ ~ Evaluating outcome from intensive care: a preliminary multihospital com- parison. Crit Care Med 1 982; 1 0~8) :49 1 -496. NA115 Mosteller F. ~ ~ Improving the precision of clinical trials. Am ~ Public Health 1982 May;72~5~:430. NA116 Scheffler RM, et al. ~ ~ Severity of illness and the relationship between intensive care and sur- vival. Am ~ Public Health 1982 May;72~5~:449-454 NA117 Simborg DW, et al. ~ ~ A hospital local area communication network: the first year's experi- ence. IEEE 1982:479-481. NA118 Tompkins RK, Koepsell TO. ~ ~ Experi- mental evaluation of computerized drug profiles. 1982. (NTIS no. PB82-265257) NAll9 Wagner D, Knaws W. Draper E. ~ ~ In: Blum B. ed. Proceedings: Sixth Annual Symposium on Computer Applications in Medical Care, October 30-November 2, 1982, IEEE Computer Society, 727- 731. NA120 Berwich DM, Cretin S. Keeler E. ~ ~ Cho- lesterol, children, and heart disease: analysis of alter- natives. Pediatrics 1981 Nov;68~5~:721-730, 1981. NA121 Thy J. et al. ~ ~ Short procedure units: impact and performance factors. 1981. (NTIS order no. PB81-195851) NA122 Draper EA, Wagner DP, Knaws WA. ~ ~ The use of intensive care: a comparison of a universi- ty and community hospital. Health Care Financ Rev 1981 Dec;3~2~:49-64. NA123 Eisenberg M, Hallstrom A, Bergner L. ~ ~ The ACLS score: predicting survival from out of hos- pital cardiac arrest. JAMA 1981 Ju1;246~1):50-52. NA124 Evans RW. ~ ~ Quality of self-care (home) and facility hemodialysis. 1981. (NTIS order no. PB81- 140477) NA125 Hallstrom A, Eisenberg MS, Bergner L. ~ ~ Modeling the effectiveness and cost-effec- tiveness of an emergency service system. Soc Sci Med 1981 Mar; 15c(1): 13-17. NA126 Keller MD, et al. ~ ~ The impact of mobile coronary care units. 1981. (NTIS order no. PB81- 13381) NA127 Pittman TT. ~ ~ Health information sys- tem transferability evaluation. l 981. (NTIS order no. PB81-206500) NA113 Lubeck D. ~ ~ Cost-benefit analysis of NA128 Ruchlin HS, Morris }N. t i Cost-benefit heart disease research. 1982. (NTIS order no. PB82- analysis of an emergency alarm and response system: 194556) a case study of a long term care program. Health Serv Res 1981 Spring; 16~11:65-80. NA129 Sherwood S. ~ ~ Effects of an emergency alarm and response for the aged. 1981. (NTIS order no. PB81- 137259) NA114 McDonald C]. ~ ~ A controlled trial of a quality assurance mechanism. 1982. (NTIS order no. PB82-265539) 175

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY NA130 Strauss I, et al. ~ ~ Evaluation of emergen- cy room referral system. 1981. (NTIS order no. PB81-231755) NA131 Wiederhold GC, Blum RL. ~ ~ Integrat- ing medical knowledge and clinical data banks. 1981. (NTIS order no. PB81-227233) NA132 Eisenberg MS, Bergner L, Hallstrom A. ~ ~ Out-of-hospital cardiac arrest: improved survival with paramedic services. Lancet 1980 Apr 12:812-814. NA133 Harris PI, et al. ~ ~ The prognostic signifi- cance of 50% coronary stenosis in medically treated patients with coronary artery disease. Circulation 1980 Aug:62~21:240-248. NA134 Harris Pi, et al. ~ ~ Outcome in medically treated coronary artery disease. Ischemic events: non- fatal infarction and death. Circulation 1980 Oct;62~4~:718-726. NA135 Stiles GL, Rosati RA, Wallace AG. ~ ~ Clinical relevance of exercise-induced ST segment elevation. Am I Cardiol 1980 Dec;46:936. National Center for Health Services Research and Health Care Technology Assessment Office of Health Technology Assessment 5600 Fishers Lane, Room ISA-27 Rockville, MD 20857 301-443-4990 Contact: Enrique D. Carter, M.D., Director; or Morgan N. Jackson, M.D., Deputy Director. Telex 301-443-6463,301-443-1719, or 301-443-1726. Telefax 301-443-2706. Overview: The National Center for Health Services Research and Health Care Tech- nology Assessment (NCHSR/HCTA) is the primary source of federal support for research on problems related to the quality and delivery of health services. NCHSR/ HCTA programs evaluate health services, assess technologies, and improve access to new scientific and technical information for research users. This profile addresses the NCHSR/HCTA Office of Health Technology Assessment. An overview of the NCHSR/HCTA is provided immediately preceding the profile on the NCHSR/HCTA Division of Extramural Research. The NCHSR/HCTA National Advisory Council on Health Technology Assessment is described in the organizational resources section of this Directory. The NCHSR/HCTA Office of Health Technology Assessment (OHTA) has direct responsibility for assessing technologies and making Public Health Service (PHS) rec- ommendations in response to requests from federally funded programs such as the Health Care Financing Administration (HCFA) and the Office of the Civilian Health and Medical Program of the Uniformed Services (OCHAMPUS). OHTA (originally as the Office of Health Research, Statistics, and Technology) assumed these responsibil- ities following the dissolution of the National Center for Health Care Technology in 1981. OHTA also collects and maintains data on organ transplants in the U.S. Purpose: To provide the clinical and scientific basis on which federally reimbursed health programs may develop coverage policies. Primary intended users: Providers, generally; physicians; acute facility administrators; long-term care facility administrators; other care givers; health/medical professional associations; consumer associations; employers; unions and other employee organiza 176

NCHSR/OFFICE OF HEALTH TECHNOLOGY ASSESSMENT lions; third party payers; government regulators; biomedical researchers; public poli- cy-makers, legislators; policy research organizations; Federal health programs. Technologies: Device, medical or surgical procedure, drug. Intervention: Diagnosis, treatment, prevention, rehabilitation. Stage: Established or widespread practice, emerging, new, obsolete. Properties: Safety, effectiveness, efficacy, cost, cost-effectiveness, acceptance/adoption level. Selection process: Assessments are requested by federally reimbursed programs, such as HCFA and OCHAMPUS. In the case of HCFA, the first step in the selection process is a joint discussion of the issues by the Physicians Panel, a formal HCFA review board. The second step is a written interagency memorandum to the OHTA, by the requester. HCFA and the OHTA Program Director determine priorities for assessment topics. Reassessments are also requested through HCFA and reviewed by the Physicians Panel, which decides whether there is enough new information to warrant reassess- ment. In other cases, OHTA itself makes plans to reopen an issue after a specified time period, with HCFA concurrence. Methods: Information syntheses, expert opinion, cost analyses. When the HCFA Physicians Panel decides that a technology warrants an assessment, a formal written request is submitted to the OHTA. The OHTA announces impending assessments in the Federal Register, inviting comments from appropriate federal agen- cies. It seeks advice from medical associations, manufacturers' groups, and experts in the medical and life sciences. A literature search is also performed. The OHTA staff then synthesizes the available information and develops the PHS recommendation. Once HCFA has made its coverage decision, the OHTA disseminates its findings in an assessment report. The average turnaround time from selection of topic to reporting of findings is 10 months. Assessors: Assessments are conducted by OHTA staff in cooperation with outside experts and other federal agencies. OHTA is staffed by approximately 7 physicians and 2 non-physician professionals, as well as support staff. Assessment reports include: Abstract; the purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technol- ogies intended for similar purposes; who sponsored/commissioned/supported the as- sessment; who conducted the assessment; description of the technology; properties assessed; sources of data/information; methods for collecting data/information; results; findings or conclusions; how the technology works, including theory, principles; regu- latory agency approval status. Dissemination: Printed reports, advisories to members/constituents, memoranda of recommendation. Reports are disseminated through direct mailings. They may be requested by contact- ing NCHSR/HCTA Publications and Information Branch, 5600 Fishers Lane, Room 18-12, Rockville, MD 20857, 301-443-4100. Reports are also available through the 177

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161, 703-487-4650. Reports are published occasionally in the professional literature. Budget: $789,000. The approximate cost per assessment is $ 15,000 to $20,000. Fund- ing source: 100 percent parent organization. Use: Assessment reports are used by the OHTA to make policy recommendations to HCFA and OCHAMPUS. Third party reimbursers, providers, hospital administrators, health policy-makers and analysts, and government officials have reported using the assessments as well. The impact of the OUTA's assessments is exemplified by Liver Transplants, which constitutes the formal basis for federal policy on this procedure. The program has been described in: Marshall tE, Carter ED. The role of the OHTA in medicine coverage decisions. ~ Health Care Technol 1986;3~2~:75-78. Institute of Medicine, Committee on Evaluating Medical Technologies in Clinical Use. Assessing medical technologies. Washington, DC: National Academy Press, 1985. Program evaluation: The OHTA program has beers evaluated by several groups and individuals including a 1984 study conducted by Macro Systems, Inc., and a 1986 study conducted by Lewin and Associates, both for the Office of the Assistant Secretary for Planning and Evaluation, Department of Health and Human Services. The program is also described in SN Finkelstein et al., ~ Health Care Technol 1984; 1~2~:89-102. Completed Reports NC1 National Center for Health Services Research and Health Care Technology Assessment, Office of Health Technology Assessment. Angelchik anti-re- flux prosthesis. 1986. NC2 . Apheresis in the treatment of systemic lupus erythematosus (SLE). 1986. NC3 . Cochlear implants. 1986. NC4 . Continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea. 1986. NC5 . Dual photon absorptiometry for measur- ing bone mineral density. 1986. NC6 . Endoscopic electrocoagulation of upper gastrointestinal bleeding. 1986. NC7 . Fully automated blood pressure monitor- ing of hypertension. 1986. NC8 . Hemodialyzer reuse. 1986. NC9 . Hemofiltration as a substitute for hemodi- alysis. 1986. NC10 . Hemoperfusion in conjunction with de- feroxamine for the treatment of aluminum toxicity or iron overload in ESRD patients. 1986. 178 NCl l . Laboratory tests for the management of ESRD dialysis patients. 1986. NC12 . Single photon absorptiometry for mea- suring bone mineral density. 1986. NC13 . 24-hour ambulatory esophageal pH monitoring. 1985. NC14 . Allogenic bone marrow transplantation for indications other than aplastic anemia and leuke- mia. 1985. NC15 . Apheresis in the treatment of Guillain- Barre syndrome. 1985. NC16 . Autologous bone marrow transplanta- tion (ABMT). 1985. NC17 . Bilateral carotid body resection. 1985. NC18 . Debridement and other treatment of mycotic toenails. 1985. NCl9 . Extracorporeal shock wave lithotripsy (ESWL) procedures for the treatment of kidney stones. 1985. NC20 . Implantable automatic cardioverter-de- f~brillators. 1985. NC21 . Magnetic resonance imaging (MRI). 1985.

NCHSR/O"ICE OF HEALTH TECHNOLOGY ASSESSMENT NC22 . Patient selection criteria for percutane- ous coronary angioplasty of a stenotic lesion in a sin- gle coronary artery. 1985. NC23 . Percutaneous ultrasound procedures for the treatment of kidney stones. 1985. NC24 . Portable hand-held x-ray instrument (lixiscope). 1985. NC25 . Reassessment of cardiokymography. 1985. NC26 . Stereotactic cingulatomy as a means of psychosurgery. 1985. NC27 . Transurethral ureteroscopic lithotripsy procedures for the treatment of kidney stones. 1985. NC28 . 13CO2 breath test for diagnosing bile acid malabsorption. 1984. NC29 . 13CO2 breath test for diagnosing fat malabsorption. 1984. NC30 . Ambulatory electroencephalographic (EEG) monitoring. 1984. NC31 . Apheresis in the treatment of chronic relapsing polyneuropathy. 1984. NC32 . Apheresis used in preparation for kid- ney transplant. 1984. NC33 . Carbon dioxide lasers in head and neck surgery. 1984. NC34 . Diagnostic endocardial electrical stimula- tion. 1984. NC35 . Electrotherapy for treatment of facial nerve paralysis. 1984. NC36 . External counterpulsation. 1984. NC37 . External open-loop pump for the subcu- taneous infusion of insulin in diabetics. 1984. NC38 . Hyperbaric oxygen for treatment of chronic peripheral vascular insufficiency. 1984. NC39 . Hyperbaric oxygen in treatment of sev- ered limbs. 1984. NC40 . Hyperbaric oxygen therapy for acute cerebral edema. 1984. NC41 . Implantable pump for chronic heparin therapy. 1984. NC42 . Intraoperative ventricular mapping. 1984. NC43 . Laser trabeculoplasty (LTP) for open angle glaucoma. 1984. NC44 . Local hyperthermia for treatment of su- perficial and subcutaneous malignancies. 1984. NC45 . Nd:YAG laser for posterior capsuloto- mies. 1984. NC46 . Neuromuscular electrical stimulation in the treatment of disuse atrophy in the absence of nervous system involvement. 1984. NC47 . Noninvasive method of monitoring car- diac output by doppler ultrasound. 1984. NC48 . Percutaneous transluminal angioplasty for obstructive lesions of arteriovenous dialysis fistu- las. 1984. NC49 . Percutaneous transluminal angioplasty for obstructive lesions of the aortic arch vessels. 1984. NC50 . Streptokinase infusion for acute myocar- dial infarction. 1984. NC51 . Transcutaneous electrical nerve stimula- tion for acute pain treatment for ambulatory patients. 1984. NC52 . Transillumination light scanning for the diagnosis of breast cancer. 1984. NC53 . Transplantation of the pancreas. 1984. NC54 . Anti-gastroesophageal reflux implanta- tion. 1983. NC55 . Apheresis for the treatment of Goodpas- ture's syndrome and membranous proliferative glo- merulonephritides. 1983. NC56 . Cardiokymography. 1983. NC57 . Closed-loop blood glucose control de vice. 1983. NC58 . Computer enhanced perimetry. 1983. NC59 . Diathermy as a physical therapy modal ity. 1983. NC60 . EEG monitoring during open heart sur gery. 1983. NC61 . Electroversion therapy for the treatment of alcoholism. 1983. NC62 . 1983. NC63 . Fully automated ambulatory blood pres- sure monitoring of hypertension. 1983. NC64 . Hyperbaric oxygen for treatment of acti- nomycosis. 1983. External infusion pump for heparin. 179

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY NC65 . Hyperbaric oxygen therapy for treat- ment of crush injury and acute traumatic peripheral ischemia. 1983. NC66 . Implantable chemotherapy infusion pump for the treatment of liver cancer. 1983. NC67 . Lactose breath hydrogen test for the diagnosis of lactose malabsorption. NC68 . Lactulose breath hydrogen test for small bowel bacterial overgrowth and small bowel transit time. 1983. NC69 . Liver transplantation. 1983. NC70 . Negative pressure respirators. 1983. NC71 . Photokymography. 1983. NC72 . Plasma perfusion of charcoal filters for treatment of pruritis of cholestatic liver disease. 1983. NC73 . Thermography for breast cancer detec- tion. 1983. NC74 . Topical oxygen therapy in the treatment of decubitus ulcers and persistent skin lesions. 1983. NC75 . Ambulatory blood pressure monitoring in ~ypertenslves using semiautomatic, patlent-actlvat- ed portable devices. 1982. NC76 . Apheresis for multiple sclerosis. 1982. NC77 . Bendien's test for cancer and tuberculo sis. 1982. NC78 . Bolen's test for cancer. 1982. NC79 . Bone mineral studies. 1982. NC80 . Carbon dioxide laser surgery for select ed conditions. 1982. NC81 . Electrotherapy for treatment of facial nerve paralysis (Bell's Palsy). 1982. NC82 . Endothelial cell photography. 1982. NC83 . Gastric freezing for peptic ulcer disease. 1982. NC84 . Home blood glucose monitors. 1982. NC85 . Hyperbaric oxygen therapy for treat ment of arthritic diseases. 1982. NC86 . Hyperbaric oxygen therapy for treat- ment of chronic refractory osteomyelitis. 1982. NC87 . Hyperbaric oxygen therapy for treat- ment of multiple sclerosis. 1982. NC88 . Hyperbaric oxygen therapy for treat- ment of organic brain syndrome (senility). ~80 NC89 . Hyperbaric oxygen therapy for treat- ment of soft tissue radionecrosis and osteoradione- crosis. 1982. NC90 . Melodic intonation therapy. 1982. NC91 . Obesity and protein supplemented fast- ing. 1982. NC92 . Percutaneous transluminal angioplasty for treatment of stenotic lesionsof a single coronary artery. 1982. NC93 . Percutaneous transluminal angioplasty in treatment of stenotic lesions of the renal arteries. 1982. NC94 . Photoplethysmography. 1982. NC95 . Plasmapheresis and plasma exchange for thrombotic thrombocytopenic purpura. 1982. NC96 . Rehfuss test for gastric acidity. 1982. NC97 . Rheumatoid vasculitis therapeutic apheresis. 1982. NC98 . Serum seromucoid assay. 1982. NC99 . Alcohol aversion therapy. 1981. NC100 . B-mode scan in peripheral arterial dis ease. 1981. NC101 . Cytotoxic leukocyte test for the diag nois of food allergy. 1981. NC102 . Desoxyribonucleic acid-bentonite floc- culation for the diagnosis of rheumatoid arthritis. 1981. NC103 . Ethylenediamine-tetra-acetic acid (EDTA) chelation therapy for atherosclerosis. 1981. NC104 . Hydrotherapy (whirlpool) baths for treatment of decubitus ulcers. 1981. NC105 . Intracranial pressure measurement. 1981. NC106 . Intracutaneous (intradermal) and sub- cutaneous provocative and neutralization testing and neutralization therapy for food allergies. 1981. NC107 . Percutaneous transluminal angioplasty in treatment of the lower extremities. 1981. NC108 . Shortwave diathermy. 1981. NC109 . Stereotaxic depth electrode implanta- tion prior to surgical treament of focal epilepsy. l 981. NC 110 . Sublingual provocative testing and neu- tralization therapy for food allergies. 1981

NCHSR/O"ICE OF HEALTH TECHNOLOGY ASSESSMENT NC111 . The Kunkel test for estimating total NC132 . Chemical aversion therapy for treat serum gamma globulin levels in patients with rheu- ment of alcoholism. Ongoing. matoid arthritis. 1981. NC112 . The of use anti-inhibitor coagulant complex (activated prothrombin-complex concen trate) in the treatment of patients with hemophilia A and antibodies to factor VIII. 1981. NC113 . The role of joint scans using techne tium-99m pertechnetate in diagnosing and assessing therapeutic gain in arthritis. 1981. NC114 . The use of human tumor stem cell drug sensitivity assays for predicting anticancer drug ef fects. 1981. NC115 . The use of the bentonite flocculation test in the diagnosis of rheumatoid arthritis. 1981. NC116 . The use of the mycoplasma comple ment fixation test in the diagnosis of rheumatoid ar thritis. 1981. NC117 . Therapeutic apheresis for rheumatoid arthritis. 1981. NC118 . Tinnitus maskers. 1981. NC119 . Transcutaneous electrical nerve stimu lation for acute postoperative incision pain. 1981. NC120 . Transsexual surgery. 1981. NC 121 . Ultraviolet absorbing or reflecting spec tacle lenses for aphakic and pseudophakic patients. 1981. NC122 . Ultraviolet light for treatment of decu bitus ulcers. 1981. NC123 . Urine autoinflection (autogenous urine immunization). 1981. Ongoing Assessments NC124 . Adult liver transplantation. Ongoing. NC125 . Bone mineral density studies: comput ed tomography. Ongoing. NC126 . Bone mineral density studies: radio graphic absorptiometry. Ongoing. NC127 . Cardiac catheterization in a freestand ing setting. Ongoing. NC128 . Cardiac rehabilitation program serv ices. Ongoing. NC129 . Cardiointegram as an alternative to stress test or thallium stress test. Ongoing. NC130 . Cardiokymography. Ongoing. NC131 . Carotid endarterectomy. Ongoing. NC133 . Coverage of gating devices and the use of surface radio frequency coils ~n conjunct~on with magnetic resonance imaging (MRI) procedures. On- go~ng. NC134 . Development of criteria for speech pa- thologist's services for dysphagia. Ongoing. NC135 . Diagnostic tests for impotency: devices (Snap-gauge, Rigi-scan). Ongoing. NC136 . Diagnostic tests for impotency: papav . . . . . erlne 1nJectlons. ngolng. NC137 . Diagnostic tests for impotency: plethys- mography. Ongoing. NC138 . Drug delivery systems: external infu- sion pumps for IV antibody therapy. Ongoing. NC139 . Drug delivery systems: external infu- sion pumps for rehydration therapy. Ongoing. NC140 . Drug delivery systems: external pump for chemotherapy for other than liver cancer. Ongo- ing. NC141 . Drug delivery systems: external pumps for morphine for pain of nonmalignant origin. Ongo- ing. NC142 . Drug delivery systems: implantable pumps for chemotherapy for other than liver cancer. Ongoing. NC143 . Drug delivery systems: implantable pumps for infusion of drugs for congestive heart fail- ure. Ongoing. NC144 . Drug delivery systems: implantable pumps for morphine (analgesia) intractable cancer pain. Ongoing. NC145 . Drug delivery systems: implanted pumps for morphine for pain of nonmalignant ori- gin. Ongoing. NC146 . Endoscopic photocoagulation for up- per gastrointestinal hemorrhage. Ongoing. NC147 . Extra-intracranial artery bypass sur- gery in the treatment of strokes. Ongoing. NC148 . Intermittent positive pressure breath- ing (IPPB therapy). Ongoing. NC149 . Percutaneous transluminal coronary angioplasty when multi-vessel disease is involved (re- assessment). Ongoing. NC150 . Real time cardiac monitors. Ongoing. 181

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY NC151 . Reassessment of autologous bone mar- row transplantation (AB MT). Ongoing. NC152 . Thermography for indications for oth- er than breast lesions. Ongoing. NC153 . Transilluminai~on light scanning for use in detection of diseases of the breast. Ongoing. NC154 . Treatment of kidney stones transur- ethral ureteroscopic lithotripsy. Ongoing. NC155 . Treatments for impotency: surgical treatments. Ongoing. National Health Research ant! Development Program Jeanne Mance Building, Room 513 Tunney's Pasture Ottawa, Ontario KlA IB4 Canada 613-954-8543 NC156 . Treatments for impotency: Erect-aid system. Ongoing. NC157 . Treatments for impotency: drug injec- tions. Ongoing. NC158 . Treatments for impotency: other sig- nificant therapeutic modalities. Ongoing. NC159 . Treatments for impotency: papaver- ine. Ongoing. NC160 . Treatments for impotency: penile ar- tery bypass. Ongoing. Contact: Sheena M. Lee, Director, Research Administration Division; or Information Officer 613-954-8549. Overview: The National Health Research and Development Program (NHRDP) is a government agency that supports scientific activities to provide the Department of National Health and Welfare with the information needed to fulfill its statutory func- tions and responsibilities. The NHRDP funds extramural research focusing on public health and health services delivery issues. The technology assessment activities are an integral part of the extramural research program. Purpose: To fund public health and health services management research through the . . competitive grant process. Primary intended users: General public; health/medical professional associations, government regulators; voluntary associations, organizations; biomedical researchers; public policy-makers, legislators; policy research organizations. Technologies: Organizational or administrative system, drug, device, medical or surgical procedure, support system. Intervention: Treatment, prevention, diagnosis, rehabilitation. Stage: Established or widespread practice, new. Drugs and specific treatments are assessed usually after clinical efficacy has been established and biomedical studies have been completed. Rehabilitation devices are assessed after the basic engineering phases have been completed. ~82

NATIONAL HEALTH RESEARCH AND DEVELOPMENT PROGRAM, CANADA Properties: Effectiveness, safety, cost, cost-benefit, cost-effectiveness, service require- ments, system impact, economic implications. Selection process: Any Canadian researcher can submit a research protocol to the NHRDP. The protocol must be submitted as part of a formal research application. Peer review competition is used to evaluate the protocol's methodological acceptability. Department officials assess the relevance to Department programs. Methods: Epidemiolog~cal and other observational methods, modeling, cost analyses. A variety of assessment methods may be selected at the discretion of the investigators. The approximate turnaround time from selection of assessment tonic to reporting of findings is 3 to 4 years. Assessors: The assessors are usually university or hospital faculty. ~rig --an __ Dissemination: The NHRDP does not use a standard format for reporting assessment results. All research projects are required to submit five copies of a final report. The final reports are available through interlibrary loan. Further dissemination is primarily the researchers responsibility. Most results are published in academic journals. Budget: $19,000,000. The approximate cost for a 3-year project is $60,000 to $80,000. Funding source: 100 percent parent organization. Use: The NHRDP uses the reports to assist in the planning and delivery of health care services in Canada. Based on interlibrary loan requests, the library has some potential data on outside use of the reports. After 10 years of supporting research in this area, the number of published reports and references to NHRDP-funded research are too numerous to mention. Related activities: The NHRDP directly supports the research community through other activities including training and career grant awards and funding for conferences and workshops. The conferences and workshops must be sponsored by Canadian organizations, held in Canada, and address health care research issues. Completed Reports ND1 Aierre YN, Waters BGH. iNational Health Re- search and Development Program~anada] Eryth- rocyte membrane enzyme and lithium in manic-de- pressive disorder. 1986. (Grant No. 6606-2149-521. ND2 Broder I. ~ ~ A study of the health status of residents in homes insulated with urea formaldehyde foam, before and after remedial measures are under- taken. 1986. (Grant No. 6606-2286-03~. ND3 Brown RE, Schipper, H. ~ ~ Electronic dia- phanography (E/DPG) as an adjunct to the early diag- nosis of breast cancer. 1986. (Grant No. 6607-1304- 07~. ND4 Buchanan WW, Kragg G. Tugwell R. ~ ~ A trial to assess the efficacy of peer group rehabilitative counselling in patients with rheumatoid arthritis. 1986. (Grant No. 6606-1941-43~. ND5 Burrunham RC, Binns B. ~ ~ Etiology and therapy of acute salpingitis. 1986. (Grant No. 6607- 1323-54~. ND6 Burton HJ. ~ ~ Factors influencing outcome of home and satellite care dialysis. 1986. (Grant No. 6606-2304-051. ND7 Bytes JA. ~ ~ An assessment of a survey instrument designed to diagnose children's beha- vioural disorders. 1986. (Grant No. 6606-2245-041. 183

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY ND8 Cadman D. ~ ~ Mental health problems as- so~ciated with chronic physical disability in children: prerequisites for a family-focused preventive mental health strategy. 1986. (Grant No. 6606-2899-43~. ND9 Cameron R.; Horlick L, Shepel L. ~ ~ To- ward an economical, broadly accessible weight control program: the refinement and evaluation of a corre- spondence approach. 1986. (Grant No. 6606-2588- 42). ND10 Chamberg LW, Mohide AK, Tugwell P. Bayne R. Pill ML, Nightingale H. ~ ~ Randomized trial of resident care quality assurance by criteria mapping in nursing homes. 1986. (Grant No. 6606-2450-44~. NDll Chandra RK. ~ ~ Influence of nutritional counselling and support on immunocompetence, nu- tritional status and illness in the elderly. 1986. (Grant No. 6601-1063-56). ND12 ChapmanJS, Pike R. Segalowitz S. [ ] Inci- dence and degree of laterality preference and cere- bral dominance for speech as related to prematurely born 5 1/2 year olds' degree of perinatal stress and cognitive functioning. Effects of hospital and home intervention programmer in preventing deficits of language comprehension skills in prematurely born 5 1/2 year olds. 1986. (Grant No. 6606-1956-431. ND13 Chipman ML. ~ ~ Population-based stud- ies of corneal graft outcome. 1986. (Grant No. 6606- 2671-46). ND14 Chretien M, M'Bikay M. ~ ~ Screening of bronchogenic adenocarcinoma: development of a model to use tumour markers. 1986. (Grant No. 6605-2299-52). ND15 Cohen MM. ~ ~ A population-based study of cervical screening in Manitoba. 1986. (Grant No. 6607-1401-53). ND16 Cole EH, Cattran DC. ~ ~ A controlled trial of plasmapheresis in idiopathic rapidly progressive glomerulonephritis.1986. (Grant No.6606-2372-52). ND17 Colle E. ~ ~ Study of siblings of patients with type I insulin dependent diabetes mellitus: tests which predict the development of disease. 1986. (Grant No. 6605-2390-54). ND18 Collins }. ~ ~ An evaluation of infertility therapy in Canadian infertility clinics. 1986. (Grant No. 6606-2628-44). NDl9 Conine TA. ~ ~ A controlled randomized trial of two seat cushions in the prevention of decubi- tus ulcers in institutionalized elderly persons. 1986. (Grant No. 6610- 1493-55). 184 ND20 Conrath DW. ~ ~ The effect of health care practice and environmental factors on the health of, and the use of health care services by, Native Canadi- ans. 1986. (Grant No. 6606-2309-05). ND21 Cott A. ~ ~ Intervention in disability and chest pain associated with (a) mitral valve prolapse and (b) no known cardiac disease: a cognitive-behav- ioral approach. (Grant No. 6606-2250-05). ND22 Crawhall, J. ~ ~ Effect of D-penicillamine on circulating immune complexes and rheumatoid factor. What is the mechanism of its therapeutic ac- tion? 1986. (Grant No. 6605- 1758-52). ND23 Cunningham A}. ~ ~ A randomized con- trol trial of a brief behavioural training group pro- gramme for alleviating psychological distress in can- cer patients. 1986. (Grant No. 6606-2884-44). ND24 Curry L. ~ ~ Improving physician man- power distribution and cost effectiveness of training: an application of individual difference theory. 1986. (Grant No. 6606-2982-55). ND25 D'Arcy C. ~ J Phobia, anxiety and alcohol- ism: evaluating a behavioural treatment program. 1986. (Grant No. 6608-1182-43). ND26 Detsky A, Baker JP, Jeejeebhoy KN. ~ ~ Predicting nutrition-associated complications in hos- pitalized patients. 1986. (Grant No.6606-2362-42). ND27 Doehring DG ~ ~ Reading in hearing-im- paired children: word recognition skills of children educated by auditory-oral methods.1986. (Grant No. 6605-2452-45). ND28 Dubois S. ~ ~ Validity of food records and dietary recalls in elderly subjects. 1986. (Grant No. 6605-2284-42). ND29 Duncan PG. ~ ~ The influence of anesthe- sia and surgery on the outcome of pregnancy pilot analysis. 1986. (Grant No. 6607- 1289-53). ND30 Durance JP. ~ J Modular sockets in the prosthetic fitting of below-knee amputees (evalua- tion). 1986 (Grant No. 6606-2315-01). ND31 Edgar L}. ~ ~ Implementation and evalua- tion of a rehabilitative approach as a part of normal nursing care of cancer patients. 1986. (Grant No. 6605-2223-46). ND32 Eyssen GE. ~ ~ Methods of assessing neu- rological abnormality for use in remote areas. 1986. (Grant No. 6606-2216-55). ND33 Fancott T. ~ ~ A prototype ambulatory ECG tape analysis system. 1986. (Grant No. 6605- 2052-51).

NATIONAL HEALTH RESEARCH AND DEVELOPMENT PROGRAM, CANADA ND34 Ferguson HB. ~ ~ Assessment of cognitive functioning in learning disabled children. 1986. (Grant No. 6606-2096-46~. ND35 Fernie GR. ~ ~ An evaluation of computer- aided design of trans-tibial prosthetic sockets. 1986. (Grant No. 6606-3024-51~. ND36 Fernie GR. ~ ~ Balance training device for stroke rehabilitation. 1986. (Grant No. 6606-3023- 45~. ND37 Fernie GR. ~ ] High speed dimensional shape sensor for clinical application.1986. (Grant No. 6606-2404-51~. ND38 Fernie GR. ~ ~ Use of trunk shape mea- surements to quantify scoliotic deformity. 1986. (Grant No. 6606-2995-51~. ND39 Foort }. ~ ~ A modular exoskeletal system for supporting heavy disabled people in the sitting position. 1986. (Grant No. 6610- 1291 -51). ND40 Foort l. ~ ~ Amputee fitting standard shape processing. 1986. (Grant No. 6610-1289-51~. ND41 Foort J. ~ ~ Tabular orthoses for stabilizing body joints. 1986. (Grant No. 6610- 1290-51). ND42 Frasure-Smith N. ~ ~ The long-term out- comes of the ischemic heart disease life stress moni- toring program. 1986. (Grant No. 6605-2388-44~. ND43 Frasure-Smith N. ~ ~ The psychosocial outcomes of coronary bypass surgery: a study of pa- tient and spouse adjustment during the first post- surgical year. 1986. (Grant No. 6605-2021-44~. ND44 Fried PA. ~ ~ Long-term effects of mater- nal soft drug use on the development of pre-school children. 1986. (Grant No. 6606- 1887-46~. ND45 Friel ~K. ~ ~ Trace element supplementa- tion of pre-term infants. l 986. (Grant No.6602- 1087- 56~. ND46 Frost BL, Mason ~L. ~ ~ The development and evaluation of a portable vibrotactile auditory prosthetic device for the profoundly deaf. 1986. (Grant No. 6606- 1959-51). ND47 Garner DM. ~ ~ Cognitive therapy for an- orexia nervosa and bulimia. 1986. (Grant No. 6606- 2666-46~. ND48 Gartrell JW. ~ ~ Evaluation study of com- munity-based health demonstration programs at Alexsis. Hobbema, and Saddle Lake Reserves. 1986. (Grant No. 6609-1361-55~. ND49 Gillam S. ~ ~ Development of subunit vac- cine against rubella virus by recombinant DNA tech- nology. 1986. (Grant No. 6610- 1314-08~. ND50 Gilman JP. ~ ~ Methods survey-genetic toxicology tests using cultured mammalian cells. 1986. (Grant No. 6606-3145-55~. ND51 Glueckauf RL. ~ ~ Assertion training for disabled persons in wheelchairs. 1986. (Grant No. 6606-2255-01~. ND52 Gravel RA. ~ ~ Genetic complementation analysis in clinical diagnosis. 1986. (Grant No. 6606- 1932-52~. ND53 Halliday ML. ~ ~ Investigation to deter- mine the usability of existing statistical data gathering systems to describe and monitor hepato bilary disease in Ontario and other provinces. 1986. (Grant No. 6606-239743~. ND54 FIarding GRM. ~ ~ Epidemiology and strategies for management of hospital-acquired cath- eter-associated urinary tract infections in women after catheter removal. 1986. (Grant No. 6607- 1351 -54~. ND55 Hirst M. ~ ~ Toward a non-invasive screen for susceptibility to alcoholism. 1986. (Grant No. 6606-2676-52~. ND56 Humphries TW. ~ ~ The effects of sensory integrative therapy on selected aspects of functioning in learning disabled children. l 986. (Grant No.6606- 2441-43~. ND57 Hunter A. ~ ~ The use of chorionic villi biopsy for the first trimester diagnosis of genetic dis- eases. 1986. (Grant No. 6606-2681-52~. ND58 Irvine EJ. ~ ~ A prospective study to com- pare diagnostic agreement and cost-effectiveness of air contrast barium enema plus flexible sigmoidos- copy with colonoscopy in rectal bleeding. 1986. (Grant No. 6606-2974-42~. ND59 Tamieson DG. ~ ~ Assessment and rehabili- tation of hearing impairment: a phoneme oriented approach.1986. (Grant No. 6609-1298-511. ND60 Jamieson DG. ~ ~ Optimizing procedures for prescribing and fitting hearing aids. 1986. (Grant No. 6609- 1343-45~. ND61 Jewett M. ~ ~ Evaluation of oxybutynin chloride and metoclopramide in the treatment of de- trusor instability in the elderly. 1986. (Grant No. 6606-2677-531. ND62 Johnston CC. ~ J Comparison of prepara- tion for surgery in children undergoing major and minor surgery. 1986. (Grant No. 6605-1955-04~. 185

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY ND63 Tones BD, Chouinarad G. ~ ~ Clinical ap- plication of the neuroleptic radio receptor assay in the management of schizophrenia. 1986. (Grant No. 6605-1867-44). ND64 ~ongbloed L. ~ ~ Leisure skills training program with stroke survivors: a double blind study. 1986. (Grant No. 6610-1455-45~. ND65 Kaplan B}. [ ] Nutrition and behavior in hyperactive children. 1986. (Grant No. 6609-1211- 44~. ND66 Kragg GR, Stokes B. [ ~ The effects of comprehensive home physiotherapy and supervision on patients with ankylosing spondylitis-A random- ized controlled trial.1986. (Grant No.6606-2385-43~. ND67 Kramer MS. [ ] Infant determinants of childhood adiposity: the effectiveness of prophylactic nutrition. 1986. (Grant No. 6605- 1693-43~. ND68 Larson C. ~ ~ Perinatal intervention pro- ject: the effectiveness of prenatal and postpartum home visiting. 1986. (Grant No. 6605- 1878-44~. ND69 Laxdal OK. ~ ~ A study of the effectiveness of continuing medical education in improving physi- cian performance. 1986. (Grant No. 6608-1144-07~. ND70 LeTouze D. [ ~ "Hospital of the future" forum development. l 986. (Grant No.6613- 1280-X). ND71 Lederman S. ~ ~ Adapting a descriptive analysis of hand movements during identification of object properties for use with patients with sensory impairment of the hand. 1986. (Grant No. 6606- 2850-55~. ND72 Levison H. [ ~ The effects of home care chest physiotherapy on the pulmonary function of patients with cystic fibrosis a three year study to evaluate the effects of postural drainage with me- chanical percussion.1986. (Grant No.6606-2355-44~. ND73 Love E, Cruickshank B. ~ ~ A study in Canadian women of the clinical efficacy and accept- ability of the cervical cap as a method of reversible contraception. 1986. (Grant No. 6613- 1232-X). ND74 Lupien PI, Dagenais GR, Moorjani S. [ ~ An approach to reversibility of atherosclerosis. 1986. (Grant No. 6605-2079-52~. ND75 Lytton H. ~ ~ Effects of short-term interac- tion coaching with mothers of preterm infants. 1986. (Grant No. 6609-1275-44~. ND76 Maclean HM. ~ ~ Mothering in the context of multiple roles: preventive health implications. 1986. (Grant No. 6606-2696-42~. 186 ND77 Martin BA, Kedwood HB, Kramer PM. ~ ~ Electroconvulsive therapy for psychogeriatric pa- tients: evaluation of new stimulus waveform technol- ogy. 1986. (Grant No. 6606-2460-444. ND78 Martin RH. ~ ~ The effect of cryopreserva- tion on the frequency of chromosome abnormalities in human sperm. 1986. (Grant No. 6609- 1319-52~. ND79 Mathias RG. ~ ~ To evaluate the effective- ness of a syndromic approach to treatment of sexually transmitted infections in Northern communities. 1986. (Grant No. 6610-1463-54~. ND80 Matthews VL. [ ~ Assessment of the feasi- bility of estimating incidence of ischemic heart disease (from available data-sets). 1986. (Grant No. 6608- 1162-55~. ND81 McGrath P. [ J Development of a self-ad- ministered treatment for adolescent migraine. 1986. (Grant No. 6606-2674-44~. ND82 McGrath PA. ~ ~ Paediatric pain and beha- vioural medicine: pain assessment and the role of an endogenous opiate system in pain relief by psycholog- ical intervention. 1986. (Grant No. 6606-2244-04~. ND83 McLachlan DR, Dalton A}. [ ~ Aluminum chelation in Alzheimer's disease: a therapeutic pro- posal. 1986. (Grant No. 6606-2330-08~. ND84 Miller AB. [ J National study of screening for breast cancer. 1986. (Grant No. 6613- 1149-X). ND85 Miller RS. [ ~ Psychological preparation for stressful medical procedures: heart catheteriza- tion. 1986. (Grant No. 6606-2640-441. ND86 Milner M, Levison H. [ J Evaluation of relaxed breathing and its augmentation with biofeed- back upon bronchospasm induced by methacholine in paediatric patients with chronic asthma. 1986. (Grant No. 6606-2113-53~. ND87 Milner M, Lotto W. McNaughton SH, Parnes PH. [ ] Creative programming by non-speak- ing physically disabled persons through computer and interface adaptations. 1986. (Grant No. 6606- 2116-51~. ND88 Milner M. [_ ] The effects of proximal tibial osteotomy and tibial tubercle elevation on knee and ankle joint loading. 1986. (Grant No. 6606-2740-51~. ND89 Mitchell A. [ ] Pilot study: a randomized controlled trial of supportive care for patients with ulcerative colitis. 1986. (Grant No. 6606-2769-431. ND90 MorrisonJB. [ ] Online clinical assessment of muscular activity in lower limb disability. 1986. (Grant No. 6610- 1309-51).

NATIONAL HEALTH RESEARCH AND DEVELOPMENT PROGRAM, CANADA ND91 Nicholson RL. ~ ~ Nuclear magnetic reso- nance imaging: clinical evaluation and future impact on health care. 1986. (Grant No. 6606-2240-03~. ND92 Oldridge NB. ~ ~ Comprehensive early re- habilitation after myocardial infarction (MI). 1986. (Grant No. 6606-2724-441. ND93 Overburg O. Jackson WE, West ML. ~ ~ Determinates of successful use of low vision aids: an interdisciplinary study to correlate ophthalmological and psychological variables. 1986. (Grant No. 6605- 1799-43~. ND94 Pabst HF. ~ ~ BCG vaccine take in babies with and without maternal PPD sensitization. 1986. (Grant No. 6609-1205-54~. ND95 Parnes PH. ~ ~ Towards development of a modular universal wheelchair tray system for com- munication control and ADL.1986. (Grant No.6605- 3006-51~. ND96 Patla AK. ~ ] Development and implemen- tation of an adapted movement notation system for clinical use. 1986. (Grant No. 6606-2399-51). ND97 Patrick }. ~ ~ Nutritional resuscitation of children with cerebral palsy: does the amount and type of dietary lipid in enteral feeds influence mem- brane function? 1986. (Grant No. 6606-2684-52~. ND98 Patrick I. ~ ~ The nutritional requirements for energy, potassium and zinc for rapid "catch-up" growth in children with cystic fibrosis. 1986. (Grant No. 6606-2303-07~. ND99 Perlman K. ~ ~ Dietary studies with new insulin delivery systems for the treatment of diabetes mellitus. 1986. (Grant No. 6606-2451-521. ND100 Piper WE. ~ ~ A controlled study of pa- tient suitability and outcome in short term, individual psychotherapy. 1986. (Grant No. 6609- 1367-46~. ND101 Pless IB. ~ ~ Social support & counselling in the prevention of psychosocial maladjustment in children with chronic illness. 1986. (Grant No. 6605- 2060-43~. ND102 Postl BD. ~ ] Epidemiology and therapy of group A streptococcal disease in northern Native communities. 1986. (Grant No. 6607-1320-54~. ND103 Prato FS. ~ ~ Effects on human and rat learning and behavior of radio frequency waves and magnetic fields associated with NMR imaging. 1986. (Grant No. 6606-2300-03~. ND104 Putman RW, Curry L. ~ ~ An assessment of the impact on health outcomes of patient care ap- praisal in the ambulatory setting. 1986. (Grant No. 6603-1138-46~. ND105 Ramsey RA. ~ ~ Multi-dimensional re- sponse of chronic low-back pain patients to a multi- modal treatment program: a controlled study. 1986. (Grant No. 6605-2311-46~. ND106 Rang MC, Milner M. ~ ~ Preoperative and postoperative gait assessments as a guide in plan- ning tendon transfers about the ankle joint in chil- dren with cerebral palsy. 1986. (Grant No. 6606- 2110-51~. ND107 Richardson MF. ~ ~ Construction and testing of a motorized variable-height wheelchair. 1986. (Grant No. 6606-2123-55~. ND108 Robertson ~MD. ~ ~ Does supplementary vitamin E prevent cataracts? 1986. (Grant No. 6606- 2445-43~. ND109 Robinson, GC. ~ ~ The impact of pacdia- tric hospital-based ambulatory care upon pacdiatric hospital utilization in B.C. during the past decade. 1986. (Grant No. 6610- 1411 -46~. NDllO Rock GA. ~ ~ A clinical research project to study the role of plasma exchange and plasma infu- sion in the treatment of thrombotic thrombocytope- nic purpura. 1986. (Grant No. 6613-1158-46~. NDll1 Rock GA. ~ 1 An evaluation of the effects of various plasticizers and/or leachables contained in plastic medical devices on blood components, blood donors, and patients. 1986. (Grant No. 6613-1239- 52~. ND112 Rock GA. ~ ~ Development of an im- proved procedure for the production of factor VIII for use in the treatment of hemophilia A. 1986. (Grant No. 6613-1209-52~. ND113 Rock GA. ~ ~ Development of immunora- diometric assay for the measurement of factor VIII procoagulant antigen using monoclonal antibodies to procoagulant factor VIII. 1986. (Grant No. 6613- 1178-52~. ND114 Rock GA. [ ] Storage of platelets for 5 days-optimization of conditions by factorial analysis. 1986. (Grant No. 6613-1208-52~. ND115 Rock GA. ~ ~ The role of plasma ex- change in the management of immune thrombocyto- penia. 1986. (Grant No. 6613- 1164-52~. ND116 Rock GA. ~ :} Toxicological evaluation of plasticizers and their metabolites leaching from plastic medical devices into human plasma. l 986. (Grant No. 6613-1177-52~. ND117 Roos LL, Ross NP. ~ ~ A collaborative analysis of common surgical procedures. l 986. (Grant No. 6607-1197-44~. 187

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY ND118 Roos NP, Howens B. Mossey JM. ~ ~ Health services use, morbidity & mortality among the elderly: longitudinal study of the relationship be- tween needs, psycholog. & social factors & health service use, morbidity & mortality among the elderly in Manitoba. 1986. (Grant No. 6607- 1157-46~. NDll9 Rooser W. ~ ~ Evaluation of a patient, nurse and physician reminder system for screening procedures in family practice. l 986. (Grant No.6606- 2374-43). ND120 Roy EA. ~ ~ Disruptions to limb, oral and verbal praxis: assessment and remediation. 1986. (Grant No. 6606-2459-51). ND121 Sacks S. ~ ~ Prevention of neonatal herpes simplex virus infection: a cost-effectiveness compari- son of low risk versus high risk screening. 1986. (Grant No. 6610- 1421 -54~. ND122 Saunders (:G, Morrison JB, Foort J. Amputee fitting standard shape processing (sealing) Part II. 1986. (Grant No. 6610- 1369-51~. ND123 Scherer K, Farrell P. ~ ~ A project for measuring the quality of nursing care in Manitoba. 1986. (Grant No. 6607-1238-46~. ND124 Schipper H. Levitt M. ~ ~ Development and validation of a cancer specific quality of life index. 1986. (Grant No. 6607- 1284-06~. ND125 Schneider BH. [ ] Individualized inter- vention for social competence. 1986. (Grant No. 6606-2264-07~. ND126 Schnell BR. ~ ~ The development of a Canadian hospital pharmacy workload measurement system. 1986. (Grant No. 5608- 1113-461. ND127 Schwartzman AK, Serbin LA, Ledingham JE. ~ ~ Identification of children at risk for adult schizophrenia for preventive and early treatment programs: a longitudinal study. 1986. (Grant No. 6605- 1865-441. ND128 Schwarz RD. ~ ~ An assessment of the need for radiological evaluation of all girls with recur- rent urinary infection. 1986. (Grant No. 6603- 1201 - 42~. ND129 Scott KE. ~ ~ Evaluation of enhanced community reproductive care a randomized clinical trial of a community reproductive care program. 1986. (Grant No. 6603- 1127-44~. ND130 Scott RN, Dunfield VA. ~ ~ Design and evaluation of myoelectric controls. 1986. (Grant No. 6604-1029-51~. 188 ND131 Scott RN. ~ ~ Functional tests for upper extremity amputees. 1986. (Grant No. 6604-1048- 51~. ND132 Scott RN. ~ ~ Infants and myoelectric prostheses. 1986. (Grant No. 6604-1056-51~. ND133 Seshia SS, Shwedyk E. ~ ~ Computerized EEG data base from prolonged ambulatory 4 channel (cassette) recordings in children. 1986. (Grant No. 6607- 1257-42~. ND134 Seshua SS. ~ ~ Prediction of outcome in nontraumatic coma in children. 1986. (Grant No.6607- 1358-44~. ND135 Sharp AR. ~ ~ Resolution enhanced pulsed NMR investigation of normal, preneoplastic and neoplastic systems. 1986. (Grant No. 6604-1042- 03~. ND136 Shephard RJ, Ward GR. ~ ~ Training re- sponses of blind and of deaf children. 1986. (Grant No. 6606-2279-55~. ND137 Short RH. ~ ~ The role of problem-solv- ing in the readjustment of closed head injured adults. 1986. (Grant No. 6609- 1238-461. ND138 Shwedyk E, Quanbury AO, Marinic J. Sequential myoelectric processor evaluation. 1986. (Grant No. 6607- 1332-51). ND139 Shwedyk E, Sesha S. ~ ~ Pattern recogni- tion system for ambulatory electroencephalograms: design and evaluation. 1986. (Grant No. 6607-1352- 51~. ND140 Simeon JG. ~ ~ Biological and beha- vioural factors associated with methylphenidate ther- apy of attention deficit and conduct disorders in chil- dren. 1986. (Grant No. 6606-2407-52~. ND141 Skinner HA. ~ ~ Computerized lifestyle assessment of medical patients: early intervention for alcohol problems. 1986. (Grant No. 6606-3002-43~. ND142 Smith A, MacMurray SB, Goodman JT. ~ ~ A comparison of crib-o-gram and brain- stem electric response audiometry in the screening of hearing loss in high risk neonates. 1986. (Grant No. 6606- 1924-431. ND143 Soldin S. ~ J Development of a definitive procedure for the measurement of digoxin. 1986. (Grant No. 6606-2709-52~. ND144 Spence L, Bishai FR, Sekla LH. ~ ~ Appli- cation of ELISA to monitoring for activity of western equine encephalitis.1986. (Grant No.6606-2368-54~.

NATIONAL HEALTH RESEARCH AND DEVELOPMENT PROGRAM, CANADA ND145 Spevack MG,, Monks RC. ~ ~ Assessment of cognitive abilities in severe closed head injury pa- tients. 1986. (Grant No. 6605- 1851 -46~. ND146 Spitzer WO. ~ ~ Evaluation of factors af- fecting reintegration of cancer patients to normal working patterns. 1986. (Grant No. 6605-1926-05~. ND147 Stancer HC, Persad E. ~ ~ A study to determine genetic vulnerability to depressive illness- es. Strategies for prevention. 1986. (Grant No. 6606- 2280-04~. ND148 Stewart M. ~ ~ Illness after measles- mumps-rubella (MMR) vaccination a study using the health diary method. 1986. (Grant No. 6606- 3028-43~. ND149 Stich HF. ~ ~ Application of the micronu- cleus test to exfoliated human urinary cells for quanti- tating exposures to lifestyle factors and industrial car- cinogens. 1986. (Grant No. 6610- 1329-52~. ND150 Stuchly SS. ~ ~ Radiowave and microwave dosimetry in human models. 1986. (Grant No. 6606- 2455-52~. ND151 Sullivan SJ. ~ ~ Electromyographic bio- feedback and the learning process in the treatment of hemiplegia. 1986. (Grant No. 6605-2415-45~. ND152 Tefft BM. ~ ~ Public beliefs, attitudes, and behavioural intentions regarding the mentally ill and community mental health services. 1986. (Grant No. 6607-1395-42~. ND153 TelnerJ, Knott V. ~ ~ Early neurochemi- cal and neurophysiological predictors of antidepres- sant response outcome. 1986. (Grant No. 6606-2710- 52~. ND154 Tevaarwerk G}M. ~ ~ An evaluation of treatment modalities and adjuncts in diabetes melli- tus. 1986. (Grant No. 6606-2646-441. ND155 Thibert R], Draisey TF. ~ ~ Development of new reagents for the determination of serum bili- rubin in neonates. 1986. (Grant No. 6606-2131-52~. ND156 Tomkins DJ. ~ ~ Validation of in vivo somatic cell mutation tests in human populations. 1986. (Grant No. 6606-2688-52~. ND157 Tredwell SJ, Saunders CG. ~ ~ A clinical study of shadow moire contourography as a useful assessment of the effects of orthotic treatment of cur- vature of the spine. 1986. (Grant No.6610-1366-51~. ND158 Tredwell SJ. ~ ~ Pelvic stabilizer for pos- tural control. 1986. (Grant No. 6610-1422-51~. ND159 Urbach GI. ~ ~ Immunodiagnosis of hu- man ovarian cancer.1986. (Grant No.6606-2908-541. ND160 Voelker CA, Martin JC. ~ ~ Management Information Systems Project. 1986. (Grant No. 6613- 1195-X). ND161 Wainberg MA. ~ ~ Development of an antigen detection assay and a neutralization assay for HTLV-III. Studies on transmission and infectivity. 1986. (Grant No. 6605-2450-X). ND162 Walker MC. ~ ~ The development of hu- man monoclonal antibodies against HLA antigens. 1986. (Grant No. 6605-2035-52~. ND163 Wall tC. ~ ~ An evaluation of out-patient physiotherapy and a home exercise program in the restoration and improvement of locomotor function in residual hemiplegia. 1986. (Grant No. 6603-1161- 01~. ND164 Warrington R}. ~ ~ Assessment of the migration inhibition test in the diagnosis of hypersen- sitivity to food additives and salicylates in chronic urti- caria. 1986. (Grant No. 6607- 12878-08~. ND165 White DR. ~ ~ Evaluation of a behavioral- development treatment for childhood obesity. 1986. (Grant No. 6605- 1876-42~. ND166 Wiens E, Kumpula VW, Hill GB. [ ~ Ear- ly detection of colorectal cancer in Northern Alberta. 1986. (Grant No. 6609- 1243-53~. ND167 Wong }. ~ ~ Effects of an experimental program on post-hospital adjustment of early dis- charged patients. 1986. (Grant No. 6603-1198-46~. ND168 Woogh CM. ~ ~ Kingston psychiatric re- cord linkage system.1986. (Grant No.6606-2880-43~. ND169 Wright LA, Breckenridge WC. ~ ~ Devel- opment of a definitive method for serum cholesterol. 1986. (Grant No. 6606-2331-521. ND170 Zemore R. Shepel LF. ~ ~ Coping with breast cancer and mastectomy. 1986. (Grant No. 6608- 1170-42~. ND171 Zerr SJ. ~ ~ The evaluation of child care in the home. 1986. (Grant No. 6606-2238-55~. ND172 Browne RB, Salanta PA, Bryne CM, Streiner DL, Roberts RS, Truscott. ~ ~ Long term fol- low-up of burn victims psychosocial adjustment: a historical perspective cohort analytic study to estimate avoidable need. 1985. (Grant No. 6606-2349-43~. ND173 Cooper BA. [ ~ Evaluation and develop- ment of assays for B12 and folate. 1985. (Grant No. 6605- 1784-52~. ND174 Feldman W, Corber ST, Quinn A. [ ~ Assessment of ambulatory health needs of adoles- cents. 1985. (Grant No. 6606-2289-07~. 189

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY ND175 Fontaine R. Chouinard G. ~ ~ Long term study of different treatment modalities in chronically anxious patients. 1985. (Grant No. 6605-1870-44~. ND176 Gauthier L, Gauthier S. ~ ~ Group reha- bilitation as an adjunct to medical therapy in idiopath- ic Parkinson's disease. l 985. (Grant No.6605- 1946-05 ND177 Gray {D, Renton KW. ~ ~ Drug elimina- tion during respiratory tract infections. 1985. (Grant No. 6603-1150-52~. ND178 Gripton I. ~ ~ A social research and devel- opment project on adolescent contraceptive practice. 1985. (Grant No. 6609-1264-X). ND179 Hillman E. ~ ~ Evaluation of an outreach program to promote utilization of health and devel- opmental screening for three-year-old children. 1985. (Grant No. 6601- 1042-44~. ND180 Hislop TG. ~ ~ Coordinated studies of the courses, methods of diagnosis, prognosis and impact on lifestyle of breast cancer in British Columbia.1985. (Grant No. 6610-1215-44) ND181 tewett M, Fernie G. ~ ~ Evaluation of neuropharmacologic agents in the management of urinary dysfunction of the elderly. 1985. (Grant No. 6606-2141-53~. ND182 Larochelle P. ~ ~ Long-term clinical trial on the treatment of hypertension in patients above the age of 55 years and with signs of arterio-athero- sclerosis. 1985. (Grant No. 6605-1933-X). ND183 Lotto WN, Milner M. ~ ~ Evaluations and development of powered mobility aids for two-to-five year olds with neuromusculoskeletaal disorders. 1985. (Grant No. 6606-2114-511. ND184 McGrath P. Durieux Smith A, Goodman IT. ~ ~ Compliance to hearing aid use in the class- room. 1985. (Grant No. 6606-2297-51). ND185 Mowat DL. ~ ~ An outreach program to promote utilization of health and developmental screening for three-year-old children (Demonstra- tion). 1985. (Grant No. 6601 - 1041 -44~. ND186 Newell E. ~ ~ Development of a clinical evaluation scheme to test the efficacy of shoe insole materials used in the treatment of metatarsalgia asso- ciated with rheumatoid arthritis. 1985. (Grant No. 6606-2144-51). 0 ND187 Penner DW. ~ ~ Quality control (quality evaluation) for diagnostic surg~cal pathology and cy- topathology. 1985. (Grant No. 6607-1279-55~. ND188 Penner JL. ~ J Development of a serotyp- ing scheme for campylobacter fetus subspecies jejuni for epidemiological investigations. 1985. (Grant No. 6606-1832-54~. ND189 Piper MC. ~ ~ Effect of early physical therapy on the neuromotor status of the high risk infant. 1985. (Grant No. 6605- 1754-51~. NDl90 Rickert WS, Robinson ~C. ~ ~ Develop- ment of a practical and inexpensive technique for large scale monitoring of exposure to cigarette tar. 1985. (Grant No. 6606-2360-52~. NDl91 Rock GA. ~ ~ A clinical research project to study the role of plasma exchange in the treatment of Rh disease. 1985. (Grant No. 6613-1156-52~. ND192 Sauter WF, Galway RH, Gillespie R. ~ ~ Development of onionized (layered) upper extremity prosthetic sockets forjuvenile amputees.1985. (Grant No. 6606-2115-55~. ND193 Scott RN. ~ ~ Evaluation of moire topog- raphy in sclerosis monitoring.1985. (Grant No.6604- 1055-51~. ND194 Scott RN. ~ ~ Moire topography in scolio- sis monitoring. 1985. (Contract No. 6604-1049-51~. ND195 Tomkins DJ. ~ ~ In vivo tests for somatic cell mutation in man. 1985. (Grant No. 6606-2074- 52~. ND196 Williams CN. ~ ~ Prevalence and patho- genesis of cholesterol gallstones in Halifax: preven- tion of recurrence by diet changes after medical disso- lution therapy. 1985. (Grant No. 6603- 1125-44~. ND197 Winter DA. ~ ~ Ambulation profiles: cor- relation with biomechanical variables as a quantif~er of gait dysfunction. 1985. (Grant No. 6606-2313-01). ND198 Zemore R. Shepel LF. ~ ~ Psychosocial adjustment to breast cancer. 1985. (Grant No. 6608- 1128-42~.

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE National Heart, Lung, and Blood Institute National Heart, Blood Vessel, flung, and Blooc! Program Office of Program Planning anct Evaluation National Institutes of Health Building 3 I, Room 5A 9000 Rockville Pike Bethesda, MD 20892 30 1-496-3620 Contact: Carl A. Roth, Ph.D, {.D., Chief, Program Analysis and Evaluation Branch. Overview: The National Institutes of Health (NIH) is the principal biomedical re- search agency of the Federal government. NIH is composed of 12 bureaus and institutes and six research and support divisions. The National Heart, Lung, and Blood Institute (NHLBI) is the second largest in terms of funding. It was established in 1948 as the National Heart Institute. With a growing awareness of national health problems, it was redesignated the National Heart and Lung Institute in 1969 and in 1976 was redesignated the National Heart, Lung, and Blood Institute. Purpose: To serve the overriding strategy of the Institute's national program. This strategy is represented by the biomedical research and clinical applications spectrum in which the products of research flow from basic research and clinical research to anolier1 research and development and practical health care. -- Errs Primary intended users: General public; people concerned about their health; pa- tients; providers, generally; physicians; health product manufacturers; health/medical professional associations; health industry associations; consumer associations; employ- ers; unions and other employee organizations; voluntary associations, organizations; biomedical researchers; reporters, writers, news media; labs, blood banks. Technologies: Medical or surgical procedure, drug, device, support system. NHLBI also devotes considerable attention to the roles of smoking, diet, and other aspects of lifestyle and the environment in heart ~nc1 v~c`~l~r HiC`~f~C l'~n<r rlic~~c-c and blood diseases. ~V _ ~ V V ~ ~ ~ ~ 5 ~ ~ ~ ~ ~ ~ ~ ~ ~ Intervention: Treatment, prevention, diagnosis. Stage: Nell', emerging, established or widespread practice, obsolete. According to the Institute, emerging technologies are those under development that appear likely to be used in the practice of medicine within 4 years. New technologies are those that may have passed the stage of clinical trials but are not yet widely disseminat- ed, or those that are moving into general use without benefit of clinical trials. The last group are those established technologies that are currently undergoing or likely to undergo major changes in use or costs as a result of new research findings, or for which serious concerns have been raised concerning safety and effectiveness. Properties: Effectiveness; safety; efficacy; ethical, legal, social implications. The principal concerns of NHLBI assessment activities are safety and efficacy. The planning and conduct of research reported by NHLBI, particularly clinical trials, are 191

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY subject to detailed review of ethical considerations. The Institute does conduct some cost studies, such as in-house studies to demonstrate the cost-effectiveness of its clinical trials. It must also evaluate the cost-effectiveness of the Federal investment in the National Heart, Blood Vessel, Lung, and Blood Program, and make recommendations regarding future resource allocations. Selection process: Large-scale clinical trials are usually initiated by Institute staff, advisory groups, and other biomedical scientists and health care researchers. The smaller, grant-supported clinical trials are usually initiated by investigators who apply for grants. Consensus development conferences are initiated by the Institute, Office of Medical Applications of Research (OMAR), other government agencies, or the public. If the concept of a large-scale clinical trial is approved by the Institute, a request for proposal (REP) or request for application (RFA) is prepared and advertised. The REP or RFA defines the program requirements and describes the criteria by which the proposals will be evaluated. Consensus development conferences may be requested by the Institute, OMAR, other government agencies, and the public. Institute Advisory Groups, Institute staff, and the National Heart, Lung, and Blood Advisory Council all set assessment topic priorities throughout the processes of concept development and initiation of assessments. The NHLBI reassesses technologies in light of new scientific evidence of efficacy or of long-term adverse effects not apparent in short-term studies, and gives suggested new uses for established technologies. Methods: Clinical trials, information syntheses, expert opinion, group judgment, epide- miological and other observational methods, bench testing. If NHLBI makes a commitment to conduct a trial, subject recruitment and clinical intervention begin.- Generally subjects are not recruited simultaneously, and thus the recruitment and intervention activities proceed together. Once the trial is under way, it is managed by a complex of committees composed of the investigators, advisors, and Institute staff. Often, the central organizational element of the trial is a steering committee that provides overall scientific direction for the study at the operational level. Various subcommittees appointed by the steering committee are responsible for reviewing such matters as patient adherence, quality control, nonfatal events, natural history, mortality classification, bibliography, and editorial review. An assembly of investigators representing all of the clinical and logistical coordinating centers reports to the steering committee. A policy data-monitoring board which does not include any of the trial investigators acts in a senior advisory capacity to the NHLBI on policy matters throughout the trial's duration. It periodically reviews study results and evaluates the study treatments for beneficial and adverse effects, and consults on such major policy decisions as trial safety and termination. chances in Protocol. meas- urement procedures, and publication. ---I-- --- I-------' Analysis continues during the trial. By the time the trial is ended, much of the analysis concerning the major question may already have been completed. However, only in rare cases such as those in which a trial is not double-blind and the trends are extraordi- nary, might the findings of a trial be published during its course. The duration of clinical trials supported by NHLBI has ranged from 2 to 18 years (including patient follow-up), averaging about 6.6 years, although interim assessments 192

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE and other reports are made during the longer trials. Consensus conferences, state-of- the-art conferences, and workshops generally take about 1 year to plan. Assessors: NHLBI technology assessment activities entail the participation of the full complement of biomedical research and health care delivery personnel. Various advi- sory groups also include representatives of other professions. As noted above, mem- bers of the National Heart, Lung, and Blood Advisory Council include scientists and others who are lay community members with a demonstrated interest in health areas relevant to the program area of the Institute. The study sections that review proposals are composed of nonfederal scientists selected for their competence in the particular scientific areas for which a study section has review responsibilities. Assessment reports include: Abstract; the purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technol- ogies intended for similar purposes; who sponsored/commissioned/supported the as- sessment; who conducted the assessment; description of the technology; stage of life- cycle of technology when assessed; properties assessed; procedure used for the assess- ment; sources of data/information; methods for collecting data/information; methods for analyzing/synthesizing data/information; results; findings or conclusions; limita- tions of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research. Dissemination: journal articles; printed reports; press conferences/news releases, TV/ radio broadcasts, video products. NHLBI promotes and disseminates assessment findings through workshops; informa- tion centers; and prevention, education, and control programs. The Institute also disseminates information through professional societies, educational programs such as the National High Blood Pressure Education Program, clearinghouses such as the High Blood Pressure Information Center, interactions with industry representatives, and activities of the Institute's Office of [Prevention, Education, and Control. Copies of assessments are available in the open scientific literature. Many special reports can be obtained from the Communications and Public Information Branch, NHLBI, NIH, Building 31 Room 4A-31, 9000 Rockville Pike, Bethesda, MD 20892. Budget: $29,000,000. The cost of large scale clinical trials ranges between $1.6 million and $142.3 million. Funding source: 100 percent parent organization. Use: The NHLBI uses the assessment reports for planning and evaluation. The NIH and NHLBI conducted an evaluation of the impact of clinical trials on medical practice. The study evaluated the relationship between the dissemination of the clinical trial results and subsequent physician knowledge and medical practice. The two trials, both supported by NHLBI, were the Coronary Drug Project (CDP) reported in 1976 and the Aspirin Myocardial Infarction Study (AMIS) which was completed in 1979 with results disseminated in 1980. Following AMIS, there was a small increase in the number of physicians who said aspirin was of unproven benefit for post-myocardial infarction use, but most physicians still heavily prescribed aspirin. NHLBI assessment activities are described in Institute of Medicine, Committee on Evaluating Medical Technologies. Assessing medical technologies. Washington, DC: Na- tional Academy Press, 1985. 193

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Program evaluations: NHLBI has sponsored several evaluations of its assessment program and clinical trials. Listed below are the evaluation project names followed by citations to published documents about the evaluation or its findings. 1. Evaluation of Clinical Trial Coordinating Center Model Project. The University of Maryland conducted this study from June 1976 to June 1979. The following reports were submitted to the NHLBI. I. Study design and methods II. RFPs for coordination centers: a content evaluation III. The contract process for selecting coordination centers V. Terminology VI. Phases of a multicenter clinical trial X. Management of coordinating centers XIV. Enhancement of methodological research in the field of clinical trials XVI. CCMP manuscripts presented at the Annual Symposia on Coordinating Clinical Trials 2. Evaluation of the Impact of Clinical Trials on Medical Practice. Market Facts, Inc. conducted this study from September 1978 to January 1982. Markets Facts, Inc. The impact of clinical trials on physician knowledge and practice. 1982 hIar. 3. Evaluation of the Impact of Adenine on Blood Banking. JRB Associates conducted this study from June 1979 to June 1983. Cummings PD, Cerveny RP, Wallace EL, et al. Impact of adenine on blood banking. 1983 Jul. 4. Evaluation of Regimen Compliance in Long-term Clinical Trials. The University of Maryland conducted this study from June 1979 to September 1984. Howard I, Whittemore AS, Hoover Id, Panos M, and the Aspirin Myocardial Infarction Study Research Group. How blind was the patient blind in AMIS? Clin Pharmacol Ther 1982;32:543-553. Mattson ME, Friedman LM. Issues in medication adherence assessment in clinical trials of the National Heart, Lung, and Blood Institute. Controlled Clin Trials 1984;5 :488-496. Mattson ME, Curb ~D, McArdle R. and the AMIS and BHAT Research Groups. Participation in a clinical trial: the patients' point of view. Controlled Clin Trials 1985;6: 156-167. Byington AP, Curb ~D, Mattson ME for the Beta-Blocker Heart Attack Trial Research Group. Assessment of Double-Blindness at the conclusion of the Beta-Blocker Heart Attack Trial. [AMA 1 985 ;253: 1 733- 1 736. 5. Assessment of the Impact of the Hypertension Detection and Follow-up Program (HDFP). NHLBI Staff conducted this study from January 1981 to October 1982. National Heart, Lung, and Blood Institute. Conference on the implications of the Hyperten- sion Detection and Follow-up Program, November 30, 1982. 194

NATIONAL HEART,LUNG,AND BLOOD INSTITUTE 6. Evaluation of the Impact of the Coronary Primary Prevention Trial: Baseline Measurement of Practice Before Release of Clinical Trial Results. National Capitol Systems conducted this study from July 1983 to June 1984. National Capitol Systems, Inc. Determination of medical practice regarding coronary heart disease risk factors: baseline measurements of practice before release of results of the Coronary Pry y Prevention Trial. final report. 1984 Apr. 7. Evaluation of the Impact of the Coronary Primary Prevention Trial (CPPT) on Clinical Practice: Measurement of Practice after Release of Clinical Trial Results. National Capitol Systems conducted this study from October 1985 to October 1986. The findings have not yet been published. 8. Evaluation of the Impact of the Coronary Primary Prevention Trial (CPPT) on Public Attitudes, Knowledge, and Behavior Regarding Serum Cholesterol and Other Risk Factors for Coronary Heart Disease. This study was conducted by the Food and Drug Administration and NHLBI staff from January 1984 to September 1985. The findings have not yet been published. Completed Reports NH1 Curb ~D, Borhani NO, Blaszkowski TP, et al. [National Heart, Lung, and Blood Institute] Patient perceived side effects to antihypertensive drugs. Community Health, accepted for publication. NH2 Beta-Blocker Heart Attack Study Group. ~ ~ The Beta-Blocker Heart Attack Trial: coop- erative trial-preliminary report. JAMA 1986;246:2073-2074. NH3 Friedman LM, Byington RP, Capone R}, et al. for the Beta-Blocker Heart Attack Trial Research Group. ~ ~ Effect of propranolol in patients with myo- cardial infarction and ventricular arrhythmia. I Am Coll Cardiol 1986;7: 1-8. NH4 Hulley SB, Feigal DW, Ireland CC, et al. The Systolic Hypertension in the Elderly Program (SHEP): the first three months. 1986. J Am Ger Soc 1986;34: 101-105. NH5 Muller JE, Turi ZG, Store PH, et al. and the MILIS Study Group.t ~ Digoxin therapy and mortality after myocardial infarction. Experience in the MILIS Study. N Eng J Med 1986;314:265-271. NH6 Wheelan K, Mukharji I, Rude RE, et al. and the MILIS Study Group.t ~ Sudden death and its relation to QT-internal prolongation after acute myo- cardial infarction: two year follow-up. Am ~ Cardiol 1986;57:745-750. NH7 Buchwald H. Fitch L, Varco RL. ~ ~ Ileal bypass for hyperlipidemia. World J Surg 1985:9;850- 859. NH8 Buchwald H. Fitch L, Varco RL. ~ J Partial ileal bypass; hypercholesterolemia; atherosclerosis. In: Nyhus LM, Nelson RL, feds): Blackwell Scientific Publ Inc. Boston, MA, 1985, in press. NH9 Buchwald H. Fitch L, Varco RL. ~ ~ Surgi- cal intervention in atherosclerosis: partial ileal bypass and the Program of Surgical Control of the Hyperlip- idemias (POSCH). Int Encyclo Pharm Therapy, 1985 (in press). NH10 Buchwald H. ~ ~ Partial ileal bypass: a sur- gical approach to cholesterol lowering. In: Perspec- tives in lipid disorders. New York: McGraw-Hill Pub- lishing Co., 1985:Vol 3. NHl l Byington R. Goldstein S. for the BHAT Research Group. ~ ~ Association of digitalis therapy with mortality in survivors of acute myocardial infarction: observation in the Beta-Blocker Heart Attack Trial. I Am Coll Cardiol 1985;6:976-982. NH12 Byington RP, Curb DJ, Mattson ME for the Beta- Blocker Heart Attack Trial Research Group. ~ ~ Assessment of double-blindness at the con- clusion of the Beta-Blocker Heart Attack Trial. JAMA 1985;253~12~:1733-1766. NH13 Collaborative Group on Antenatal Steroid Ther- apy. ~ ~ Prevention of respiratory distress syn- drome: effect of antenatal dexamethasone adminis- tration. Hospital and follow-up studies. 1985 [NIH Publication No. 85-26951 NH14 Curb Dl, Borhani NO, et al. ~ ~ Long-term surveillance for adverse effects of antihypertensive drugs. JAMA 1985;253:3263-3268. 195

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY NH15 Cutler JA, Neaton JD, Hulley SB et al. ~ ~ Coronary heart disease and all-cause mortality in the Multiple Risk Factor Intervention Trial: subgroup findings and comparisons with other trials. Prev Med 1985; 14:293-311. NH16 Gersh B}, Kronmal RA, Schaff HV, et al. ~ ~ Comparison of coronary artery bypass sur- gery and medical therapy in patients 65 years of age or older. a nonrandomized study from the Coronary Artery Surgery Study (CASS) registry. N Engl J Med 1985;313:217-224. NH17 Grimm RH, Neaton ~D, McDonald M, et al for the Multiple Risk Factor Intervention Trial Research Group. ~ ~ Beneficial effects from systematic dosage reduction of the diuretic chlorthalidone: a randomized study within a clinical trial. Am Heart 1985; 109:858-864. NH18 Grimm RH, Neaton ~D, McDonald M, et al. ~ ~ Beneficial effects from systematic dosage reduction of the diuretic, chlorthalidone: a random- ized study within a clinical trial. Am Heart T 1985;109:858-864. NHl9 Hennekens C, Eberlein K. ~ ~ A random- ized trial of aspirin and beta-carotene among U.S. physicians. Prev Med 1985:Appendix VI. NH20 Hillis LD, Borer J. Braunwald E, et al. ~ ~ High dose intravenous streptokinase for acute myo- cardial infarction: preliminary results of a multicenter trial. ~ Am Coll Cardiol 1985;6:957-962. NH21 Hulley SB, Furberg CD, Gurland B{, et al for the SHEP Research Group. ~ ~ The Systolic Hy- pertension in the Elderly Program (SHEP): antihy- pertensive efficacy of chlorthalidone. Am ~ Cardiol 1985;56:913-920. NH22 Hypertension Detection and Follow-up Program Cooperative Group. ~ ~ Five-year findings of the Hypertension Detection and Follow-up Program. Prevention and reversal of left ventricular hypertro- phy with antihypertensive drug therapy. Hyperten- sion 1985;7:105-112. NH23 Hypertension Detection and Follow-up Program Cooperative Research Group. ~ ~ Mortality findings for stepped-care and referred-care partici- pants in the Hypertension Detection and Follow-up Program, stratified by other risk factors. Prev Med 1985; 14:312-335. NH24 Karnegis TN, Matts JP, Tuna N and the POSCH Group. ~ ~ Development and evolution of elec- trocardiographic Minnesota Q-Qs codes in patients with acute myocardial infarction. Am Heart T 1985; 110:452-459. 196 NH25 Karnegis JN, Matts JP, Tuna N. et al and the POSCH Group. [ ] Quantitative assessment of left ventricular function after myocardial infarction using the Minnesota Q-Qs codes for resting electro- cardiograms. Cathet Cardiovasc Diagn 1985;11:393- 400. NH26 Kuller L, Farrier N. Borhani N. et al. ~ Relationship of diuretic therapy and serum magne- sium levels among participants in the Multiple Risk Factor Intervention Trial. Am ~ Epidemiol 1985; 122: 1045-1059. NH27 Langford HG, Blautox MD, Oberman A, et al. ~ ~ Dietary therapy slows the return of hyper- tension after stopping prolonged medication. JAMA 1985;5:657-664. NH28 Long JM. ~ ~ Discovery and confirmation of causal relationships in a large medical record data- base: a POSCH experiment. Society for Clinical Tri- als, Annual Conference, 1985. NH29 Long, JM. ~ ~ The POSCH secondary in- tervention trial. Proc Int Cong Prev Cardiology, Mos- cow, 1985. NH30 Mattson M, Curb JD, McArdle R and the AMIS and BHAT Research Group. ~ ~ Participation in a clinical trial: the patient's point of view. Con- trolled Clin Trial 1985; 6: 156- 167. NH31 Morganroth }, Lichstein E, Byington R. ~ ~ Beta-Blocker Heart Attack Trial: impact of propran- olol therapy on ventricular arrhythmias. Prev Med 1985; 14:346-357. NH32 Multiple Risk Factor Intervention Trial Research Group. ~ ~ Baseline rest electrocardiographic abnormalities, antihypertensive treatment, and mor- tality in the Multiple Risk Factor Intervention Trial. Am J Cardiol 1985 ;55: 1 - 15. NH33 Multiple Risk Factor Intervention Trial Research Group. ~ 1 Exercise electrocardiogram and coronary heart disease mortality in the Multiple Risk Factor Intervention Trial. Am ~ Cardiol 1985;55: 16- 24. NH34 Passamani E, David B. Gillespie Ml, et al. ~ 1 A randomized trial of coronary artery by- pass surgery: survival of patients with a low ejection fraction. N Engl J Med 1985;312:1655-1671. NH35 Rifkind BM. ~ ~ The Lipid Research Clin- ics Coronary Primary Prevention Trial. Heartbeat 1985; 1 :7-8.

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE NH36 Shekelle RB, Gale M, Norusis M for the Aspirin Myocardial Infarction Study Research Group. ~ ~ Type A score (}enkins activity survey) and risk of recurrent coronary heart disease in the Aspirin Myocardial Infarction Study. Am ~ Cardiol 1985;56:221-225. NH37 TIMI Study Group. [ ] Special report. The Thrombolysis in Myocardial Infarction (TIMI) Trial. Phase I findings. N Engl ~ Med 1985;312:932- 936. NH38 Brensike JF, Levy RI, Kelsey SF, et al. [ ] Effects of therapy with cholestyramine on progres- sion of coronary arteriosclerosis: results of the NHLBI Type II Coronary Intervention Study. Circu- lation 1984:69;313-324. NH39 Byington RP for the Beta-Blocker Heart Attack Trial Research Group. [ ~ Beta-Blocker Heart Attack Trial-design, methods and baseline results. Controlled Clin Trials 1984;4:382-437. NH40 CASS Principal Investigators and Their Asso- ciates. [ :I Coronary Artery Surgery Study (CASS): a randomized trial of coronary artery bypass surgery: myocardial infarction and mortality in the randomized trial. N Engl J Med 1984;310:750-758. NH41 Collaborative Group on Antenatal Steroid Ther- apy. [ ~ Effects of antenatal dexamethasone administration in the infant: long-term follow-up. Pediatr 1984;104:259-267. NH42 Connett JE, Stamler J. [ ~ Responses of Black and white males to the special intervention pro- gram of the Multiple Risk Factor Intervention Trial. Am Heart J 1984;108~3~:839-849. NH43 Croft CH, Rude RE, Lewis SE, et al. [ ~ Comparison of left ventricular function and infarct size in patients with and without positive technetium- 99m pyrophosphate myocardial scintigrams after myocardial infarction: analysis of 357 patients. Am J Cardiol 1984;53:421-428. NH44 DeMets DL, Hardy R. Friedman LM, et al. [ ~ Statistical aspects of early termination in the Beta-Blocker Heart Attack Trial. Controlled Clin Tri- als 1984;5:362-372. NH45 Furberg CD, Hawkins CM, Lichstein E for the Beta-Blocker Heart Attack Study Group. ~ : Effect of propranolol in postinfarction patients with mechanical or electrical complications. Circulation 1984;69:761-765. NH46 Goldstein S. Friedman L, Hutchinson, R et al and the Aspirin Myocardial Infarction Study Research Group. ~ ~ Timing, mechanism and clinical set- ting of witnessed deaths in postmyocardial infarction patients. J Am Coll Cardiol 1984;3: 1111-1117. NH47 Hypertension Detection and Follow-up Program Cooperative Group. ~ ~ Five-year findings of the Hypertension Detection and Follow-up Program: mortality by race-sex and blood pressure level: a fur- ther analysis. ~ Community Health 1984;9:314-327. NH48 Hypertension Detection and Follow-up Program Cooperative Research Group. ~ ~ The effect of antihypertensive drug treatment on mortality in the presence of testing electrocardiographic abnormali- ties at baseline: the HDFP experience. Circulation 1984;70:996- 1003. NH49 Hypertension Detection and Follow-up Pro- gram. ~ ~ Effect of stepped-care treatment on the incidence of myocardial infarction of the Hyper- tension Detection and Follow-up Program. Hyperten- tion 1984;6(Suppl 1). NH50 Langford HG, Blaufox MD, Oberman A, et al. ~ ~ Effect of weight loss on the return of hyper- tension after withdrawal of prolonged antihyperten- sive therapy. In: Nutritional Prevention of Cardiovas- cularDisease. 1984:311-315. NH51 Langford HG, Oberman A, Borhani NO, et al. ~ ~ Black-white comparison of indices of coro- nary heart disease and myocardial infarction in the stepped-care cohort of the Hypertension Detection and Follow-Up Program. Am Heart J 1984; 108~31:797-801. NH52 Langford HG, Schlundt D, Levine K. ~ ~ Sodium restriction in hypertension. Compr Ther 1984;10:6-11. NH53 Lasser N. Grandits G. Caggiula A, et al. ~ ~ Effects of antihypertensive therapy on plasma lipids and lipoproteins in the Multiple Risk Factor Interven- tion Trial. Am J Med 1984;76:52-66. NH54 Levy RI, Brensike JF, Epstein SF, et al. ~ The influence of changes in lipid values induced by cholestyramine and diet on progression of coronary artery disease: results of the NIILBI Type II Coro- nary Intervention Study. Circulation 1984;69:325- 337. NH55 Lipid Research Clinics Program. ~ ~ The Lipid Research Clinics Coronary Primary Prevention Trial results. I. Reduction in incidence of coronary heart disease. JAMA 1984;251:351-364. 197 '1

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY NH56 Lipid Research Clinics Program. ~ J The Lipid Research Clinics Coronary Primary Prevention Trial results. II. The relationship of reduction in inci- dence of coronary heart disease to cholesterol-lower- ing. JAMA 1984;251:365-374. NH57 Muller TE (ed), Braunwald E, Mock MB, et al. (assoc. eds). ~ ~ Multicenter Investiga- tion of the Limitation of Infarct Size (MILTS). Design and methods of the clinical trial. An investigation of beta-blockade and myaluronidase for treatment of acute myocardial infarction. Am Heart Assoc Mono- graph 1984; 100: 1-134. NH58 Rifkind BM. ~ ~ The Lipid Research Clin- ics Coronary Primary Prevention Trial: results and implication. Am ~ Cardiol 1984;54:30C-34C. NH59 Roberts R. Croft C, Gold HK, et al. and the MILIS Study Group.t ~ Effect of propranolol on myocardial-infarct size in a randomized blinded muliicenter trial. N Eng T Med 1984; 311 :218-225. NH60 Shekelle R. ~ ~ Diuretic treatment of hy- pertension and changes in plasma lipids over six years in the Multiple Risk Factor Intervention Trial. In: Paolette R et al. (eds). Endpoints for cardiovascular drug studies. New York: Raven, 1984:216. NH61 Wing R. Caggiula A, Nowalk M, et al. ~ ~ Dietary approaches to the reduction of blood pres- sure: the independence of weight and sodium/potas- sium interventions. Prev Med 1984; 13: 233-234. NH62 Beta-Blocker Heart Attack Trial Research Group. ~ ~ A randomized trial of propranolol in patients with acute myocardial infarction. II. Mor- bidity results. JAMA 1983;250:2814-2819. NH63 Buchwald H. Moore RB, Rucker Rd. et al. ~ ~ Clinical angiographic regression of atheros- cerosis after partial ileal bypass. Artherosclerosis 1983;46: 117. NH64 CASS Principal Investigators and Their Asso- ciates. ~ ~ Coronary Artery Surgery Study (CASS): a randomized trial of coronary artery bypass surgery: quality of life in patients randomly assigned to treatment groups. Circulation 1983;68:951-960. NH65 CASS Principal Investigators and Their Asso- ciates. ~ ~ Coronary Artery Surgery Study (CASS): randomized trial of coronary artery bypass surgery: survival data. Circulation 1983;68:939-950. 198 NH66 CASS Principal Investigators and Their Asso- ciates. ~ ~ Coronary Artery Surgery Study (CASS): a randomized trial of coronary artery bypass surgery: comparability of entry characteristics and survival in randomized patients and nonrandomized patients meeting randomization criteria. J Am Coll Card 1983;3:114-128. NH67 Davis KB, Chatman BR, Killip T. et al. ~ ~ Effect of coronary bypass surgery on operative mor- tality and survival patterns in subsets of patients with left main coronary artery disease. In: Hammermeis- ter KE, ed. Coronary bypass surgery. New York: Praeger Scientific, 1983:99-127. NH68 Davis KB, Kennedy ~W, Berger RL, et al. [_ ~ Operative mortality in the CASS registry. In: Hammermeister KE ed. Coronary bypass surgery. New York: Praeger Scientific, 1983:99-127. NH69 Frommer PL, Fisher LD, Moek MB, et al. ~ ~ The Coronary Artery Surgery Study: a ran- domized trial in the context of the registry. In: Ham- mermeister KE, ed. Coronary bypass surgery. New York: Praeger Scientific, 1983:57-82. NH70 Furberg CD, Byington RP for the BHAT Re- search Group. ~ ~ What do subgroup analyses reveal about differential response to beta-blocker therapy? The Beta-Blocker Heart Attack Trial expe- rience. Proceedings of the Workshop on Implications of Recent Beta-Blocker Trials for Post-Myocardial In- farction Patients. Circulation 1983;67(Supplement I):I-98. NH71 Gersh BJ, Kronmal RA, Frye RL, et al. ~ ~ Coronary arteriography and coronary artery bypass surgery: morbidity and mortality in patients ages 65 years or older: a report from the Coronary Artery Surgery Study. Circulation 1983 ;67 :483-490. NH72 Goldstein, S. ~ ~ Propranolol therapy in patients with acute myocardial infarction: the Beta- Blocker Heart Attack Trial. Circulation 1983;67(Suppl 1):53-57. NH73 Hardy RJ, Hawkins CM. ~ ~ The impact of selected indices of anti-hypertensive treatment on all- cause mortality. Am J Epidemiol 1983;117:566-574. NH74 Heaton RK, Grant I, McSweeny J. et al. ~ ~ Psychologic effects of continuous and nocturnal oxy- gen therapy in hypoxemic chronic obstructive pulmo- nary disease. Arch Intern Med 1983; 143: 1941-1947. NH75 Holmes DR, Vliestra RE, Fisher LD, et al. ~ ~ Follow-up of patients from the Coronary Artery Surgery Study (CASS) potentially suitable for percutaneous transluminal coronary angioplasty. Am Heart J 1983; 106:981 -988.

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE NH76 Hughes GH, Schnaper HW. ~ ~ The Sys- tolic Hypertension in the Elderly Program. Int T Men- tal Health 1983; 1 1:76-97. NH77 Intermittent Positive Pressure Breathing Trial Group. ~ ~ Intermittent positive pressure breathing therapy of chronic obstructive pulmonary disease a clinical trial. Ann Intern Med 1983;99:612-620. NH78 Keogh BA, Bernardo I, Hunninghake GW, et al. ~ ~ Effect of intermittent high dose parenteral corticosteroids on the alveolitis of idiopathic pulmo- nary fibrosis. Am Rev Respir Dis 1983;127:18-27. NH79 Lichstein E, Morganroth I, Harrest R. et al. ~ ~ Effect of propranolol on ventricular ar- rhythmia: the Beta-Blocker Heart Attack Trial Expe- rience. Circulation 1983;67(Suppl I):5-10. NH80 Ryan TJ, Bailey KR, McCabe CH, et al. ~ ~ The effects of digitalis on survival in high-risk pa- tients with coronary artery disease: the Coronary Ar- tery Surgery Study (CASS). Circulation 1 983 ;67: 735- 742. NH81 Smith WM. [ ] Isolated systolic hyperten- sion in the elderly. In: Mild hypertension. New York: Raven Press, 1983. NH82 Wassertheil-Smoller S. Langford HG, Blaaufox MD, et al. ~ ~ Diuretics and salt-restriction in blood pressure control. In: Winick M ed. Nutrition and drugs. New York: iohn Wiley and Sons Inc. 1983: 175-189. NH83 Brensike ~F, Kelsey SF, Passamani ER, et al. ~ ~ National Heart, Lung, and Blood Institute Type II Coronary Intervention Study: design, meth- ods, and baseline characteristics. Controlled Clin Tri- als 1982:3;91-111. NH84 Buchwald H. Fitch L, Moore RL. ~ ~ Over- view of clinical trials of lipid intervention for athero- sclerotic cardiovascular disease. Controlled Clin Tri- als 1982;3:271-283. NH85 Buchwald H. Moore RB, Matts JP, et al. ~ ~ The Program on the Surgical Control of the Hyper- lipidemias: a status report. Surgery 1982;92:654. NH86 Buchwald H. Moore RB, Varco RL. ~ ~ Surgery in the therapy of atherosclerosis: partial ileal bypass. In: Arteriosclerosis: clinical evaluation and therapy. MTP Press Limited, International Medical Publication, 1982. NH87 Buchwald H. Rucker RD Jr, Moore RB, et al. ~ ~ Regression of atherosclerosis by surgical cholesterol reduction. In: Noseda CI, et al. eds. Lipo- proteins and coronary atherosclerosis. Elsevier Bio- medical Press, 1982:417. NH88 Curb ~D, Hardy Ri, Labarthe DR, et al. ~ ~ Reserpine and breast cancer in the Hypertension De- tection and Follow-up Program. Hypertension 1982;4(2):307-311. NH89 Fisher LD, Lundberg ED, McBride R. et al. ~ ~ The design of a database management sys- tem, C2, for research use in the Coronary Artery Surgery Study (CASS). In: Proceedings of the Fif- teenth Hawaii International Conference on Systems Sciences, 1982, Volume II, Software, Hardware, De- cision Support Systems, Special Topics. North Holly- wood, CA: Western Periodicals Co., 1982. NH90 Hymowitz N. ~ ~ The Multiple Risk Factor Intervention Trial: a four year evaluation. Int J Ment Health 1982; 11 :44-67. NH91 Hypertension Detection and Follow-up Program Cooperative Group. ~ ~ Five-year findings of the Hypertension Detection and Follow-Up Progra- m.III. Reductions in stroke incidence among persons with high blood pressure. JAMA 1982;247:633-638. NH92 Hypertension Detection and Follow-up Program Cooperative Group. ~ ~ The effect of treat- ment on mortality in "mild" hypertension: results of the Hypertension Detection and Follow-up Program. N Engl J Med 1982;307:976-980. NH93 Lipid Research Clinics Program. ~ ~ Re- cruitment for clinical trials: the Lipid Research Clinics Coronary Primary Prevention Trial experience. Its implications for future trials. (AHA Monograph No. 93) Circulation 1982;66:IV1-IV78. NH94 Long JM, Brasshear JR, Matts JP, et al. The evolution of a large clinical database. Proceed- ings of Medcomp 1982;82:224-229. NH95 Lundberg ED, McBride R. Rawson TE, et al. ~ ~ A data base management system developed for the Coronary Artery Surgery Study (CASS) and other clinical studies. In: Riddle K, Thurber P. Keen P. et al. eds. Proc of the 15th Hawaii Internat Conf on Systems Sciences, 1982, Vol II, Software, Hardware, Decision Support Systems, Special Topics, North Hol- lywood, CA: Western Periodicals Co, 1982:484-500. NH96 Mock MB, Ringvist I, Fisher LD, et al. ~ ~ Survival of medically treated patients in the Coronary Artery Surgery Study (CASS) registry. Circulation 1982;66:562-568. NH97 Multiple Risk Factor Intervention Trial Research Group. [ ] Multiple Risk Factor Intervention Trial: risk factor changes and mortality results.JAMA 1982;248: 1465-1477. 199

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY NH98 Ockene I, Hymowitz N. Sexton M, Broste S. ~ ~ Comparison of patterns of smoking behav- ior change among smokers in the Multiple Risk Fac- tor Intervention Trial (MRFIT). Prev Med 1982;11:621-638. NH99 Shulman N. Cutter G. Daugherty R. et al. ~ ~ Correlates of attendance and compliance in the Hypertension Detection and Follow-Up Program. Controlled Clin Trials 1982;3: 13-27. NH100 Smith EO, Curp ID, Hardy RJ, et al. ~ ~ Clinic attendance in the Hypertension Detection and Follow-Up Program.' Hypertension 1982;4:710-715. NH101 Vlietstra RE, Kronmal RA, Frye RL, et al. ~ ~ Factors affecting the extent and severity of coronary artery disease in patients enrolled in the Coronary Artery Surgery Study. Arteriosclerosis 1982;2:208-215. NH102 Wassertheil-Smoller S. Langford HO, Blaufox MD et al. ~ ~ Rate of hypertension return after withdrawal of prolonged antihypertensive therapy. Clin Sci 1982;63(Suppl 81:4235-4255. NH103 Benfari R. Sherwin R. ~ ~ The Multiple Risk Factor Intervention Trial after 4 years: a sum- ming-up. Prev Med 1981; 10:544-546. NH104 Berger RL, Davis KB, Kaiser GC, et al. ~ ~ Preservation of the myocardium during coronary artery bypass grafting. Circulation 1981;64 (Supplement II):II61-II66. NH105 Beta-Blocker Heart Attack Trial Research Group. ~ ~ A randomized trial of propranolol in patients with acute myocardial infarction.]. Mortal- ity results. JAMA 1982;247: 1707-1713. NH106 Beta-Blocker Heart Attack Trial Research Group. ~ J Beta-Blocker heart attack trial-de- sign features. Controlled Clin Trials 1981;2:275-285. NH107 Caggiula A, Christakis G. Farrand M, et al. ~ ~ The Multiple Risk Factor Intervention Trial (MRFIT). IV. Intervention on blood lipids. Prev Med 1981; 10:443-475. NH108 Chaitman BR, Bourassa MG, Davis K, et al. ~ ~ Angiographic prevalence of high-risk coro- nary artery disease patient subjects (CASS). Circula- tion 1981 ;64:360-367. NH109 Chaitman BR, Fisher LD, Bourassa MG, et al. ~ ~ Effect of coronary bypass surgery on surviv- al patterns in subsets of patients with left main coro- nary artery disease. Report of the collaborative study in Coronary Artery Surgery (CASS). Am J Cardiol 1981 ;48:765-777. 200 NH110 Cohen J. Grimm R Jr, Swith W. ~ ~ Multi- ple Risk Factor Intervention Trial (MRFIT). VI. In- tervention on blood pressure. Prev Med 1981; 10:501 - 518. NH111 Collaborative Group on Antenatal Steroid Therapy. ~ ~ Effect of antenatal dexametha- sone administration on the prevention of respiratory distress syndrome. Am T Obstet Gynecol 1981;141:276-287. NH112 Coronary Drug Project Research Group. ~ ~ Implications of findings in the Coronary Drug Project for secondary prevention trials in coro- nary heart disease. Circulation 1981 ;63: 1342- 1350. NH113 Fisher LD, Kennedy TW, Chaitman BR, et al. ~ ~ Diagnostic quantif~cation of CASS (Coro- nary Artery Surgery Study) clinical and exercise test results in determining presence and extent of coro- nary artery disease: a multivariate approach. Circula- tion 1981 ;63:987-1000. NH114 Hodgkin JE and Zorn KG. ~ ~ Intermit- tent positive pressure breathing (IPPB) in the outpa- tient management of chronic obstructive pulmonary disease (COPD): description of the NIH clinical trial. Respir Care 1981; 26: 1095- 1104. NH115 Howard JM, DeMets D, and the BHAT Re- search Group. ~ ~ How informed is informed consent? The BHAT experience. Controlled Clin Trials 1981 ;2 :287-303. NH116 Hughes G. Hymowitz N. Ockene }, et al. ~ ~ The Multiple Risk Factor Intervention Trial (MRFIT). V. Intervention on smoking. Prev Med 1981; 10:476-500. NH117 Kennedy JW, Kaiser GC, Fisher LD, et al. [ ~ Clinical and angiographic predictors of op- erative mortality from the collaborative study in Coro- nary Artery Surgery (CASS). Circulation 1981 ;63;793-802. NH118 Neaton }, Broste S. Cohen L, et al. ~ ~ The Multiple Risk Factor Intervention Trial (MRFIT). VII. A comparison of risk factor changes between the two study groups. Prev Med 1981; 10:519-543. NH119 Principal Investigators of CASS and Their As- sociates. ~ ~ National Heart, Lung, and Blood Institute Coronary Artery Surgery Study. Circulation 1981;63 (AHA Monograph No. 79~:I1-I81. NH120 Strauss RG, Connett JE, Gale RP, et al. ~ ~ A controlled trial of prophylactic granulocyte transfu- sions during initial induction chemotherapy for acute myelogenous leukemia. N Eng J Med 1981 ;305 :597- 60.~.

NATIONAL HEART, LUNG,AND BLOOD INSTITUTE NH121 Winston D}, Ho WG, Gale RP. ~ ~ Pro- phylactic granulocyte transfusions during chemo- therapy of acute nonlymphocytic leukemia. Ann In- tern Med 1981;94:616-622. NH122 Zukel PO, Schnaper H. ~ ~ The Multiple Risk Factor Intervention Trial (MRFIT). I. Historical perspectives. Prev Med 1981; 10:387-401. NH123 Aspirin Myocardial Infarction Research Group. ~ ~ Aspirin Myocardial Infarction Study: de- sign, methods and baseline results. DHEW Pub. No. (NIH) 80-2106, 1980. NH124 Aspirin Myocardial Infarction Research Group. ~ ~ A randomized controlled trial of aspirin in persons recovered from myocardial infarction. JAMA 1980;243:661-669. NH125 Aspirin Myocardial Infarction Study Research Group. ~ ~ The Aspirin Myocardial Infarction Study: final results. Circulation 1980;60(Suppl V)V79-V84. NH126 Beta-Blocker Heart Attack Trial Study Group. ~ ~ Beta-Blocker Heart Attack Trial Study pro- tocol. DHHS Pub No. (NIH)81-2209, 1980. NH127 Borhani NO. ~ ~ Clinical ramifications of the Hypertension Detection and Follow-Up Program: SC yields lower mortality and morbidity. Symposia Reporter 1980;4~2):16. NH128 Coronary Drug Research Group. ~ ~ As- pirin in coronary heart disease. Circulation 1980;62(Suppl V):V59-V62. NH129 Coronary Drug Research Project Group. ~ ~ Influence of adherence to treatment and response of cholesterol on mortality in the Coronary Drug Project. N Eng ~ Med 1980;303:1038-1041. NH130 Cowan L, Detels R. Farbar M, et al. Residential mobility and long-term hypertension. Community Health 1980;5: 159-166. NH131 Cutter G. Heyden S. Kasteler ], et al. Mortality surveillance in collaborative trials. Am Public Health 1980;70:394-400. NH132 Farrand ME, Majonnier L, (for the MRFIT Group). ~ ~ Nutrition in the Multiple Risk Fac- tor Intervention Trial (MRFIT). T Am Dietetic Assn 1980;76:347-351. NH133 Gosselin A], Fisher L, Judkins MP, et al. ~ ~ An estimate of the number of possible can- didates from the C;ASS registry. Proceedings of the workshop on percutaneous transluminal coronary angioplasty June 15-16, 1979, March 1980:89-100. (U.S. Department of Health, Education and Welfare, NIH Publication No. 80-2030~. NH134 Kennedy JW, Kaiser GC, Fisher LD, et al. ~ ~ Multivariate discriminant analysis of the clinical and angiographic predictors of operative mortality from the Collaborative Study in Coronary Artery Surgery (CASS). J Thorac Cardiovasc Surg 1980;80:876. NH135 Knopp RH. ~ ~ Test of the lipid hypothe- sis: the Coronary Primary Prevention Trial (CPPT) of the Lipid Research Clinics Program. In: Gotto AM, Jr., ed. Proceedings of the Fifth International Sympo- sium on Atherosclerosis. Springer-Verlag 1980:509- 512. NH136 Kuller L, Neaton }, Caggiula A, et al (for the MRFIT Group). ~ ~ Primary prevention of heart attacks: the Multiple Risk Factor Intervention Trial. Am J Epidemiol 1980; 112: 185- 199. NH137 Langford HG. ~ ~ Clinical ramif~cations of the Hypertension Detection and Follow-Up Pro- gram: HDFP methodology and results: overview. Symposia Reporter 1980;4~21:3-6. NH138 Long TM, Brashear TR, Matts TP, et al. ~ ~ The POSCH Information Management System: ex- perience with alternative approaches. ~ Med Systems 1980;4:355-366. NH139 Lusher ~M, Shapiro SS, Palascak JE, et al. ~ ~ Efficiency of prothrombin-complex con- centrates in hemophiliacs with antibodies to Factor VIII. N Eng T Med 1980;303:421. NH140 Moore RB, Buchwald H. Varco RL, and the Participants in the Program on the Surgical Control of the Hyperlipidemias. ~ ~ The effect of par- tial ileal bypass on plasma lipoproteins. Circulation 1980;62:469-476. NH141 Nocturnal Oxygen Therapy Trial Group. ~ ~ Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Ann Intern Med 1980;93:391-398. NH142 Nocturnal Oxygen Therapy Trial Study Group. ~ 1 Is 12-hour oxygen as effective as 24-hour oxygen in advanced chronic obstructive pulmonary disease with hypoxemia? (The Nocturnal Oxygen Therapy Trial NOTT). Chest 1980;78:419-420. NH143 Remmell PS, Benfari RC (for the MRFIT Group). ~ ~ Assessing dietary adherence in the Multiple Risk Factor Intervention Trial (MRFIT). II. Food record rating as an indicator of compliance. J Am Dietetic Assn, 1980;76:357-360. NH1M Remmell PS, Gorder DD, Hall Y, et al (for the MRFIT Group). [ ] Assessing dietary adher- ence in the Multiple Risk Factor Intervention Trial (MRFIT). I. Use of a dietary monitoring tool. J Am Dietetic Assn 1980;76:351-356. 201

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY NH145 Rifkind B. Goor R. ~ ~ Lipid Research Clinics Coronary Primary Prevention Trial. In: Fu- magalli R. Kritchevsky D, Paoletti R. eds. Drugs af- fecting lipid metabolism. Elsevier, North Holland Biomedical Press, 1980: 151 - 157. NH146 Russell RO, Wayne JOB, Kronenfeld I, et al. ~ ~ Surgical versus medical therapy for treat- ment of unstable angina: changes in work status and family income. Am ~ Cardiology 1980;45: 134- 140. NH147 Stamler I, Borhani NO. ~ ~ Interview: HDFP mortality and morbidity. Hypertension Report 1980; 1(1): 12-14. NH148 Stamler I. ~ ~ Clinical ramifications of the Hypertension Detection and Follow-Up Program: benefits of treatment outweigh risks. Symposia Re- porter 1980;4~2~:12-14. NH149 Szmuness W. Stevens CE, Harley E{, et al. ~ ~ Hepatitis B vaccine: demonstration of effi- cacy in a controlled clinical trial in high-risk popula- tion in the United States. N Eng ~ Med 1980;303:833- 841. NH150 Unstable Angina Pectoris Study Group. ~ ~ Unstable Angina Pectoris Study National Cooperative Study Group to compare medical and surgical therapy. III. Results in patients with S-T seg- ment elevation during pain. Am ~ Cardiology 1980;45:819-824. National Institute of Child Health and Human Development Office of Planning and Evaluation Building 3 I, Room 2A ~ 0 9000 Rockville Pike Bethscia, MD 20892 30 1-496- 1 877 NH151 Hypertension Detection and Follow-Up Pro- gram Cooperative Group. ~ ~ Five year find- ings of the Hypertension Detection and Follow-Up Program. I. Reduction in mortality of persons with high blood pressure including mild hypertension. JAMA 1979;242:2562-2571. NH152 Hypertension Detection and Follow-Up Pro- gram Cooperative Group. ~ ~ Five-year find- ings of the Hypertension Detection and Follow-Up Program: II. Mortality by race-sex and age. {AMA 1979;242:2572-2577. NH153 Unstable Angina Pectoris Study Group. ~ ~ Unstable Angina Pectoris National Cooper- ative Study Group to compare medical and surgical therapy. II. In-hospital experience and initial follow- up results in patients with one, two and three vessel disease. Am ~ Cardiol 1978;42:839-848. NH154 Williams DO, Passamani ER, et al. ~ ~ Intravenous recombinant tissue-type plasminogen ac- avator in patients with acute myocardial infarction: a report from the NHLBI Thrombolysis in Myocardial Infarction Trial. Circulation 1986;73:338-346. Contact: fames G. Hill, Chief Office of Planning and Evaluation. Telex 494-8446. Overview: The National Institute of Child Health and Human Development (NICHD) supports and conducts research to help families have healthy children at the time they are wanted, to prevent disease and disability among children, to foster normal development, and to insure that each child will have a healthy and productive life. The NICHD Technology Assessment/Transfer program was initiated in 1978. Purpose: To maintain an awareness of technologies used in fields related to NICHD's mission and to conduct assessments of technologies with high public interest and importance. 202

NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT Primary intended users: General public; people concerned about their health; pa- tients; providers, generally; physicians; other care givers; health product manufactur- ers; health/medical professional associations; health industry associations; consumer associations; third party payers; government regulators; voluntary associations, organi- zations; biomedical researchers; reporters, writers, news media; public policy-makers, legislators; policy research organizations; lawyers; liability, malpractice insurers. Technologies: Medical or surgical procedure, drug, device, support system. Intervention: Prevention, diagnosis, treatment, rehabilitation. Stage: Ne7v, emerging, established or widespread practice. Properties: Effectiveness; safety; efficacy; cost; cost-benefit; ethical, legal, social implica- tions. Selection Process: Requests for assessment can come from any source, but most suggestions come from Institute staff, advisory groups, and professional associations within the scope of the Institute's mission. In addition, an annual request for assess- ment topics is sent to the NICHD research programs and the primary professional organizations within the Institute's mission. Topics submitted are reviewed and analyzed by the Office of Planning and Evaluation (OPE) according to the criteria for selection of consensus topics developed by the Office of Medical Applications of Research (OMAR), NIH. In addition, relevance to the NICHD mission and research priorities are considered. The OPE Analysis of the suggested topics is reviewed by the Director, NICHD and a list of topics (usually two or three) are selected for formal assessment during the year. The selected topics are reviewed with OMAR to determine which will be consensus development conferences. Remaining topics are subjected to full scale assessment (e.g. prenatal and perinatal factors in brain injury, contents of prenatal care) or a workshop (e.g. malpractice issues in childbirth). Technologies are reassessed when, in the judgment of Institute staff, sufficient new information is available. For example, when the clinical trial on chorion villi sampling is complete, antenatal diagnosis will be reassessed. Methods: Group judgment, information synthesis, expert opinion, cost analyses, epide- miological and other observational methods, clinical trials. Task Force, expert panels and workshops are used for conducting assessments. Once a topic is selected, a planning meeting is held. Three tasks are completed: 1 ) selection of a chairperson; 2) specification of the types of individuals to serve on the panel; and 3) identification of the questions to be answered by the panel. With the assistance of the National Library of Medicine, a major literature search is undertaken. The panel meets for the first time. Armed with their questions, the results of the literature search, and other information (e.g. hearings or new data sets), the panel drafts a report containing the draft consensus statement. The draft report is circulated among interested organi- zations and individuals who are encouraged to submit written comments and/or give oral testimony at the consensus meeting. The next step is a consensus conference that is open to the public. It consists of a summary presentation of the draft report by the members of the panel, invited comments, presentation of additional data not consid- ered by the panel, testimony from individuals and organizations, and a closed executive 203

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY session in which the panel resolves and includes additional information and prepares the final statement. The panel chairperson concludes the conference by delivering the final consensus statement in an open session. The approximate turnaround time from selection of assessment tonic to reporting of findings ranges from 1 to 2 years. 1 ~ Assessors: The expertise of the panel members varies with the technology. At a minimum the group is composed of basic scientists, academic physicians, epidemiolo- gists, practicing physicians, and consumer representatives. Assessment reports include: The assessment's intended audience; the purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; who sponsored/com- missioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; properties assessed; proce- dure used for the assessment; sources of dataJinformation; methods for collecting data/ information; methods for analyzing/synthesizing data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommenda- tions for practice, future assessments, technology development, research; how the technology works, including theory, principles; development of the technology. Dissemination: Printed reports, journal articles; advisories to members/constituents; press conferences/news releases, TV/radio broadcasts, video products. Results are disseminated using mailing lists, working with professional organizations such as the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists, and at professional and lay meetings. Copies of assessment reports can be obtained from the Office of Research Reporting, NICHD, Bldg. 31, Room 2A32, 9000 Rockville Pike, Bethsda, MD 20892, (3011496-5133. Budget: $200,000. The approximate cost per assessment is $200,000. Funding source: 100 percent parent organization. Use: Based on an analysis of requests, practicing physicians, health consumers, re- searchers, and physician residency training programs use the assessment reports. ~7 The following articles reference the NICHD program: Hill, JG. Technology assessment at the National Institute of Child Health and Human Development: an alternative model. In: Wisniewski HM, Snider DA, eds. Mental retardation: research, education, Ant technology transfer. New York: Annals of the New York Academy of Sciences 1986;477: 351-355. Shino, et al. Recent trends in C/B and trial of labor rates in the U.S. MAMA 1987;257~4~. Completed Reports NK1 National Institute of Child Health and Human Development. Infantile apnea and home monitoring. Bethesda, MD: National Institute of Child Health and Human Development, 1987 (in press). iGroup judg- ment, Expert opinion] 204 NK2 International Childbirth Education Association, National Institute of Child Health and Human Devel- opment, Division of Maternal and Child Health. Mal- practice issues in childbirth. Minneapolis, MN: Inter- national Childbirth Education Association, 1985. [Group judgment, Expert opinion]

NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT NK3 National Institute of Child Health and Human Development, National Institute of Neurological and Communicative Disorders and Stroke. Prenatal and per~natal factors associated with brain disorders. Be- thesda, MD: National Institutes of Health, 1985. (NIH publication no.85-1149) [Groupjudgment, Ex . . pert opinions NK4 National Institute of Child Health and Human Development. Diagnostic ultrasound imaging in pregnancy. Bethesda, MD: National Institute of Child Health and Human Development, 1984. (NIH publi- cation no.84-667) EGroupjudgment, Expert opinion] NK5 . Cesarean childbirth. Bethesda, MD: Na- i~onal Institute of Child Health and Human Develop- ment, 1981. (NIH publication no. 82-2067) (Group judgment, Expert opinion] NK6 . Antenatal diagnosis. Bethesda MD: Na- i~onal Institute of Child Health and Human Develop- ment, 1979. (NIH publication no. 80-1973) EGroup judgment, Expert opinion] National Institutes of Health Consensus Development Program Building I, Room 210 9000 Rockville Pike Bethesda, MD 20892 301-496-1143 Ongoing Assessments NK7 , Division of Maternal and Child Health. Content of prenatal care. Ongoing. tGroup judg- ment, Expert opinion] Planned Assessments NK8 . Antenatal diagnosis of hereditary disease (an update of the 1979 Conference on Antenatal Di- agnosis). Planned. tGroupjudgment, Expert opinion] NK9 . Modification of inappropriate behavior in the mentally retarded. Planned. [Group judgment, Expert opinion] NK10 . Safety and efficacy of oral contracep iives. Planned. EGroup judgment, Expert opinion] Contact: Michael I. Bernstein, Director of Communications, Office of Medical Applica- tions of Research. Overview: The National Institutes of Health (NIH) is the principal biomedical re- search agency of the Federal Government. The NIH Office of Medical Applications of Research (OMAR) operates the NIH Consensus Development Program which con- ducts consensus conferences. The conferences are jointly sponsored by OMAR and one or more of the NIH Institutes; other Public Health Service (PHS) agencies occa- sionally join in the sponsorship. Pulpose: To evaluate in a public forum the use of biomedical technologies, to publish a consensus statement relevant to the public at large that provides guidelines for practi- tioners on the use of the technology, and to disseminate this information to the intended audience. Primary intended users: General public; providers, generally; physicians; biomedical researchers. Technologies: Drug, device, medical or surgical procedure, support system. 205

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Intervention: Prevention, diagnosis, treatment, rehabilitation. Stage: New, established or widespread practice. Most often the program focuses on new information. This information can pertain to existing technologies, making them obsolete, or to emerging technologies. Properties: Safety, efficacy, effectiveness, service requirements. Selection process: Most often topics are selected by the NIH leadership as part of the NIH-wide planning process. At times topics are requested for consideration by other PHS agencies or organizations outside the government. Requests are submitted to OMAR. Assessment topic priorities are set by the OMAR Director in consultation with the NIH Coordinating Committee on Assessment and Transfer of Technology. Meet- ings can be held to reassess topics; for example adjuvant chemotherapy for breast cancer was recently reexamined. Methods: Group judgment, information syntheses, modeling. OMAR uses consensus conferences as its assessment method. A consensus panel, after listening to expert presentations, develops a consensus statement. This statement is a response to a set of questions presented to the panel. The average turnaround time from selection of assessment topic to reporting of findings is 1 year. Assessors: The assessors' areas of expertise include biomedical research, clinical prac- tice, biostatistics, epidemiology, and public policy. Assessment reports include: The assessment's intended audience; the purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; who sponsored/com- missioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; properties assessed; proce- dure used for the assessment; sources of data/information; methods for collecting data/ information; methods for analyzing/synthesizing data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommenda- tions for practice, future assessments, technology development, research. Dissemination: Printed reports; journal articles; advisories to members/constituents; press conferences/news releases, TV/radio broadcasts, video products. The consensus statements are widely disseminated through targeted mailing lists, dedicated TV networks such as the Hospital Satellite Network, and professional jour- nals such as the journal of the Amer~can Medical Association Copies of consensus state- ments are available from OMAR. Budget: $900,000. The approximate, all-inclusive cost per conference is $95,000. Funding source: 100 percent parent organization. Use: Summary statements are widely used by practitioners as well as the public in considering care and patient management. Impact has been shown recently by the significant sales increases of certain drugs following the consensus conferences on 206

NIH CONSENSUS DEVELOPMENT PROGRAM osteoporosis and blood cholesterol. The use of these drugs was recommended in the summary statements. The following articles describe the Consensus Development Program: Institute of Medicine, Committee on Evaluating Medical Technologies in Clinical Use. Assessing medical technologies. Washington, DC: National Academy Press, 1985. ~acoby I, Mullan F. The town meeting for technology: the maturation of consensus conferences. JAMA 1985 Aug;254~81. {acoby, I. The Consensus Development Program of the National Institutes of Health: current practices and historical perspectives. Internl; Technol Assessment Health Care 1985 Jun;1~2~. A Rand note: "Treatment of eight NIH Consensus Development Conferences in the biomedical literature." 1986 Sep. Program evaluation: During 1982 to 1986, the Rand Corporation conducted an evaluation of the Consensus Development Program's impact. Funded by OMAR, the study included lengthy questionnaires responded to by physicians, a detailed hospital chart-audit, and analyses based upon literature searches. The findings suggested that while the program has a positive impact, some elements of the process can be im- proved. Evaluation results are continuously introduced to improve topic selection, synthesis of data, the conduct of the group process, and dissemination methods. The Rand Corporation report will be available shortly upon request from the Rand Corporation, Santa Monica, California. See also: Wortman P. Vinokura A, and Sech- rest L. Evaluation of NIH consensus development process: phase I: final report. Center for Research on Utilization of Scientific Knowledge, Institute for Social Research, Univer- sity of Michigan, Ann Arbor. 1982;Sep. Completed Reports NL1 National Institutes of Health, Consensus Develop- ment Program. Assessment methods for decisions about long-term care. (Consensus Development Con- ference Statement, Oct 19-21, 1987~. [Group judg- ment1 NL2 . Differential diagnosis of cementing dis- eases. (Consensus Development Conference State- ment, Jul 6-8, 1987~. (Group judgment! NL3 . Magnetic resonance imaging. (Consensus Development Conference Statement, Oct 26-28, 1987~. tGroup judgment] NL4 . Management of clinically localized pros- tate cancer. (Consensus Development Conference Statement, Jun 15-17 19871. tGroup judgment] NL5 . Newborn screening for sickle cell disease and other hemoglobinopathies. (Consensus Develop- ment Conference Statement, Apr 6-8 19871. tGroup judgment] NL6 . Diet and exercise in noninsulin-depen- dent diabetes mellitus. (Consensus Development Conference Statement, Dec 8-10 1986~. tG-roupjudg- ment] NL7 . Impact of routine HTLV-III antibody testing of blood and plasma donors on the health of the public. (Consensus Development Conference Statement, Jul 7-9 1986~. tGroup judgment] NL8 . Infantile apnea and home monitoring. (Consensus Development Conference Statement, Sep 29-Oct 1 19864. tGroup judgment] NL9 . Integrated approach to the management of pain. (Consensus Development Conference State- ment, May 19-21 1986~. (Group judgment] NL10 . Platelet transfusion therapy. (Consensus Development Conference Statement, Oct 6-8 1986~. [Group judgment] 207

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY NLll . Prevention of venous thrombosis and pulmonary embolism. (Consensus Development Con- ference Statement, Mar 24-26 19861. [Group judg- ment] NL12 . The utility of therapeutic plasmapheresis for neurological disorders. (Consensus Development Conference Statement, Jun 2-4 19861. [Group judg- ment1 NL13 . Adjuvant chemotherapy for breast can- cer. (Consensus Development Conference Statement, Sep 9- 11 1985~. [Group judgment] NL14 . Anesthesia and sedation in the dental office. (Consensus Development Conference State- ment, Apr 22-24 1985~. [Group judgment] NL15 . Electroconvulsive therapy. (Consensus Development Conference Statement, Jun 10- 12 1985~. [Group judgments NL16 . Health implications of obesity. (Consen- sus Development Conference Statement, Feb 11 - 13 19851. [Group judgment] NL17 . Travelers' diarrhea. (Consensus Devel- opment Conference Statement, Jan 28-30 1985~. [Group judgments NL18 . Analgesic-associated kidney disease. (Consensus Development Conference Statement, Feb 27-29 19841. tGroup judgment] NL19 . Diagnostic ultrasound imaging in preg- nancy. (Consensus Development Conference State- ment, Feb 6-8 19844. tGroup judgment] NL20 . Fresh frozen plasma: indications and risks. (Consensus Development Conference State- ment, Sep 24-26 19841. [Group judgment] NL21 . Limb-sparing treatment of adult soft- tissue sarcomas and osteosarcomas. (Consensus De- velopment Conference Statement, Dec 3-5 19841. [Group judgments NL22 . Lowering blood cholesterol to prevent heart disease. (Consensus Development Conference Statement, Dec 10- 12 19841. Group judgment] NL23 . Mood disorders: pharmacologic preven- tion of recurrences. (Consensus Development Con- ference Statement, Apr 24-26 19841. [Group judg- ment] NL24 . Osteoporosis. (Consensus Development Conference Statement, Apr 2-4 19841. [Group judg- ment] NL25 . Critical care medicine. (Consensus De- velopment Conference Statement, Mar 7-9 19831. (Group judgment] zo8 NL26 . Dental sealants in the prevention of tooth decay. (Consensus Development Conference State- ment, Dec 5-7 1983~. (Group judgments NL27 . Drugs and insomnia: the use of medica- tions to promote sleep. (Consensus Development Conference Statement, Nov 15-17 19831. EGroup judgment] NL28 . Liver transplantation. (Consensus Devel- opment Conference Statement, Jun 20-23 19831. (Group judgment] NL29 . Precusors to malignant melanoma. (Con- sensus Development Conference Statement, Oct 24- 26 1983~. [Group judgment] NL30 . Treatment of hypertriglyceridemia. (Consensus Development Conference Statement, Sep 27-29 19831. EGroup judgmentJ NL31 . Clinical applications of biomaterials. (Consensus Development Conference Statement, Nov 1-3 19821. [Group judgment] NL32 . Defined diets and childhood hyperactivi- ty. (Consensus Development Conference Statement, Jan 13-15 1982~. [Group judgment] NL33 . Total hip joint replacement. (Consensus Development Conference Statement, Mar 1-3 1982~. [Group judgment] NL34 . Computed tomographic scanning of the brain. (Consensus Development Conference State- ment, Nov 4-6 1981). tGroup judgment] NL35 . Diagnosis and treatment of Reye's syn- drome. (Consensus Development Conference State- ment, Mar 2-4 1981). [Group judgment] NL36 . Adjuvant chemotherapy of breast can- cer. (Consensus Development Conference Statement, Jul 14-16 19801. EGroup judgmentJ NL37 . CEA as a cancer marker. (Consensus Development Conference Statement, Sep 29-Oct 1 19801. [Group judgmentJ NL38 . Cervical cancer screening: the pap smear. (Consensus Development Conference State- ment, Jul 23-25 19801. [Group judgment] NL39 . Cesarean childbirth. (Consensus Devel- opment Conference Statement, Sep 22-24 19801. EGroup judgment] NL40 . Coronary artery bypass surgery: scien- tific and clinical aspects. (Consensus Development Conference Statement, Dec 3-5 1980~. [Group judg- ment]

NIH CONSENSUS DEVELOPMENT PROGRAM NL41 . Endoscopy in upper GI bleeding. (Con- sensus Development Conference Statement, Aug 20- 22 19801. EGroupjudgmentJ NL42 . Febrile seizures. (Consensus Develop- ment Conference Statement, May 19-21 1980~. EGroup judgment] NL43 . Thrombolytic therapy in thrombosis. (Consensus Development Conference Statement, Apr 10-12 1980~. EGroup judgment] NL44 . Amantadine: does it have a role in the prevention and treatment of influenza? (Consensus Development Conference Statement, Oct 15-16 19791. tGroup judgment] NL45 . Antenatal diagnosis. (Consensus Devel- opment Conference Statement, Mar 5-7 19791. EGroup judgment] NL46 . Estrogen use and postmenopausal wom- en. (Consensus Development Conference Statement, Sep 13-14 19791. EGroup judgment] NL47 . Improving clinical and consumer use of blood pressure measuring devices. (Consensus Devel- opment Conference Statement, Apr 26-27 19791. EGroup judgment] NL48 . Intraocular lens implantation. (Consen- sus Development Conference Statement, Sep 10-11 19791. tGroup judgment] NL49 . Pain, discomfort, and humanitarian care. (Consensus Development Conference State- ment, Feb 16 19791. EGroup judgment] NL50 . Removal of third molars. (Consensus Development Conference Statement, Nov 28-30 19791. EGroup judgment] NL51 . Steroid receptors in breast cancer. (Con- sensus Development Conference Statement, Tun 27- 29 19791. EGroup judgment] NL52 . The treatment of primary breast cancer: management of local disease. (Consensus Develop- ment Conference Statement, Jun 5 19791. EGroup judgment] NL53 . The use of microprocessor-based "intelli- gent" machines in patient care. (Consensus Develop- ment Conference Statement, Oct 17-19 1979~. EGroup judgment] NL54 . Transfusion therapy in pregnant sickle cell disease patients. (Consensus Development Con- ference Statement, Apr 23-24 19791. EGroup judg- ment] NL55 . Availability of insect sting kits to non physicians. (Consensus Development Conference Statement, Sep 14 19781. EGroup judgment] NL56 . Dental implants: benefit and risk. (Con- sensus Development Conference Statement, Jun 13- 14 19781. [Group judgment] NL57 . Indications for tonsillectomy and adenoi- dectomy: phase I. (Consensus Development Confer- ence Statement, Jul 20 1978~. tGroup judgment] NL58 . Mass screening for colo-rectal cancer. (Consensus Development Conference Statement, June 26-28 19781. [Group judgment] NL59 . Mass screening for lung cancer. (Consen- sus Development Conference Statement, Sep 18-20 19781. EGroup judgment] NL60 . Supportive therapy in burn care. (Con- sensus Development Conference Statement, Nov 10- 11 19781. [Group judgment] NL61 . Surgical treatment of morbid obesity. (Consensus Development Conference Statement, Dec 4-5 19781. EGroup judgment] NL62 . Treatable brain diseases in the elderly. (Consensus Development Conference Statement, Jul 10- 11 19781. (Group judgment] NL63 . Breast cancer screening. (Consensus De- velopment Conference Statement, Sep 14- 16 1977~. EGroup judgment] zag

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY National Library of Medicine Builcling 3S, Room 2S 8600 Rockville Pike Bethesda, MD 20894 30 1-496-8834 Contact: Elliot R. Siegel, Ph.D., Special Assistant for Operations Research; or Robert Mehnert, Chief, Office of Public Inquiries and Publications Management 301-496- 6308. Overview: The National Library of Medicine (NLM) was established in 1836 as the Library of the Army Surgeon General's Office. Transferred in 1956 to the National Institutes of Health in the U.S. Public Health Service, the Library today collects materials exhaustively in all major areas of the health sciences. To aid in the dissemina- tion and exchange of information, the Library produces specialized medical bibliogra- phies such as Index Medicos, and the computer-based Medical Literature Analysis and Retrieval System (MEDLARS). One component of the Library, the Lister Hill National Center for Biomedical Com- munications, conducts and supports research in techniques for recording, storing, retrieving, and communicating health information. Another, the Division of Extramu- ral Programs, supports research on the generation, organization, and utilization of health information. Both are concerned with technology assessment. ^~ ~ _ _ 1 . 1 · · ~ glucose; ~ O evaluate new anct existing biomedical information technologies that help disseminate information and facilitate its use by health professionals and others. Primary intended users: Patients; providers, generally; physicians; acute facility ad- ministrators; long-term care facility administrators; other care givers; health product manufacturers; health/medical professional associations; health industry associations; third party payers; government regulators; voluntary associations, organizations; bio- medical researchers; reporters, writers, news media; information/computer industry; labs, blood banks; public policy-makers, legislators; policy research organizations. Technologies: Support system. Assessments include, but are not limited to, systems for information storage, retrieval, and dissemination; teaching/learning systems; artificial intelligence or ~,rn`~rt c`~ct~rmc and the management of health information. Stage: New, emerging, established or widespread practice, obsolete. rut ~: ~cl l 1 · 1 ~ ~ ^ r = ~ ~ my_ A A l ~ ~ Properties: Effectiveness, cost, cost-benef~t, cost-effectiveness, service requirements, ac- ceptance/adoption level, system impact, economic implications. Selection process: Assessments may be requested by intramural research and develop- ment staff; NLM management; and officials of the National Institutes of Health, the Department of Health and Human Services, and Congress. Selection is influenced by the source of the request, the information needs of the biomedical community, poten- tial impact on the performance of the Library's statutory mission, and availability of funds. Technologies involved in NLM's own internal operations, such as MEDLARS, are evaluated and improved periodically. 210

NATIONAL LIBRARY OF MEDICINE Methods: Epidemiolog~cal and other observational methods, information syntheses, expert opinion, group judgment, cost analyses, bench testing. Assessments are performed in-house by research and development and operations staff and extramurally through grants. Whenever feasible, evaluations are designed to allow for the participation of those who will be affected by the product or service, including health professionals and researchers. Assessments are generally carried out within a period of 6 to 8 months. Evaluations lasting up to 3 years may be appropriate in certain instances, when the study design incorporates both formative and summative features. Assessment reports include: Abstract; the assessment's intended audience; the pur- pose of the assessment; relationship of this assessment to prior or concurrent assess- ments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; proper- ties assessed; procedure used for the assessment; sources of data/information; methods for collecting data/information; methods for analyzing/synthesizing data/information; results; findings or conclusions; limitations of findings; recommendations for practice, future assessments, technology development, research; how much the assessment cost; how the technology works, including theory, principles; development of the technol- ogy; procurement/deployment information; where technology is in use. Dissemination: Printed reports; journal articles; advisories to members/constituents; press conferences/news releases, TV/radio broadcasts, video products; clearinghouses, data/citation bases, on-line services. Reports are routinely sent to the original requester. Study reports may be filed with the National Technical Information Service (NTIS), the Educational Resources Informa- tion Center (ERIC), and similar document distribution centers. NLM staff report study findings at meetings and in the professional literature, as well. Budget: $500,000. The approximate cost of an assessment ranges from $25,000 to $125,000, depending on the nature and amount of external support services required. Funding source: 100 percent parent organization. Use: Evaluation studies have affected NLM's research and development activities as well as its products and services. For instance, 1) a field test and evaluation of the Hepatitis Knowledge Base System resulted in the adoption of computer conferencing technology as an important feature of the NLM information systems; 2) a survey of the users of the Library's Videocassette Loan Program led to an expansion of the program; and 3) a comparative study of the coverage of the medical behavioral services by MEDLARS and other databases resulted in the NLM's reconsidering its indexing and . . coverage po 1cles. Colleagues in the information and computer science communities keep abreast of the latest research and development activities at NLM. In addition, the Nation's biomedical library network uses NLM as a leader and role model for technological advancements affecting information transfer. Research scientists at the OCLC adapted the NLM's methodology and evaluation strategy in the design of an evaluation of alternative searching strategies for online catalogs. For a discussion see: Markey K. The Dewey decimal classification as a library 211

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY user's tool in an online catalog. In: Flood B. Witiak I, Hogan TH, comps. Proceedings of the American Society for Information Science 47th annual meeting, 1984. White Plains, NY: Knowledge Industry Publications, 1984: 121-5. Frequent reference is made in the literature to NLM's development and assessment of the Hepatitis Knowledge Base System and to other assessment activities at the Library. NLM assessment activities are described in Institute of Medicine, Committee on Evalu- ating Medical Technologies in Clinical Use. Assessing medical technologies. Washington, DC: National Academy Press, 1985. Completed Reports NM1 iNational Library of Medicine] Health profession- als use of MEDLINE. Bethesda, MD: National Li- brary of Medicine, 1987. [Epidemiological and other observational methods] NM2 La Croix EM. National Library of Medicine] A comparison of interlibrary loan requests received by the National Library of Medicine: 1959 and 1984. Bull Med Libr Assoc 1987 Jan (in press). LEpidemio- logical and other observational methods] NM3 iNational Library of Medicine] Medical education in the information age. Proceedings of the Sympo- sium on Medical Informatics. Washington, DC: Asso- ciation of American Medical Colleges, 1986. tEpide- miological and other observational methods] NM4 (National Library of Medicine] Evaluation of med- ical information science in medical education. Adopt- ed by the Executive Council of the Association of American Medical Colleges, Washington, DC, Janu- ary 23, 1986. T Med Educ 1986;61 :487-543. [Epide- miological and other observational methods] NM5 Griffith BC, White HD, Drott MC, Saye ID. tNa- tional Library of Medicine] Tests of methods for eval- uating bibliographic databases an analysis of the Na- tional Library of Medicine's handling of literatures in the medical behavioral sciences. T Am Soc Info Sci 1986;37:261-70.tEpidemiologicalandotherobserva- tional methods] NM6 Bratton B. Brooks CM, Holland GJ, Weinholtz D, Jackson }. [National Library of Medicine] Study of the audiovisual selection and acquisition process in health professions education. Ames, IA: Iowa State Univer- sity, 1985. (NTIS order no. PB86-10813/XAB) [Epi- demiological and other observational methods] NM7 Kopp If. ENational Library of Medicine] Research and writing in the history of health sciences, 1970- 1982: a quantitative analysis of NLM's HISTLINE database. Bull Med Libr Assoc 1985;73: 146-152. tEpidemiological and other observational methods] 212 NM8 Siegel ER, Spann M, Collins KA, Hazard G. Woodsmall RM. [National Library of Medicine] Re- port on the CHEMLINE evaluation study. Bethesda, MD: National Library of Medicine, 1985. fEpidemio- logical and other observational methods] NM9 Woelfel JC, Tesorero J. [National Library of Med- icine] An evaluation of CHEMLINE: the results of a survey of users by the National Library of Medicine. Vienna, VA: Market Dynamics, Inc. 1985. LEpidemi- ological and other observational methods] NM10 "National Library of Medicine] An analysis of the National Library of Medicine's (NLM) handling of the medical behavioral sciences' (MBS) literatures. Fi- nal report. (Five volumes plus executive summary). Bethesda, MD: National Library of Medicine, 1984. fEpidemiological and other observational methods] NMll Siegel ER, Kameen K, Sinn SK, Weise FO. ENa- tional Library of Medicine] A comparative evaluation of the technical performance and user acceptance of two prototype online catalog systems. Info Technol Libr 1984;3:35-46. LEpidemiological and other obser- vational methods] NM12 Ullmer E, Kuenz M, Seibert W. National Library of Medicine] Audiovisual evaluation survey final re- port. Bethesda, MD: Lister Hill Center, National Li- brary of Medicine, 1983. tEpidemioloQical and other observational methods] joy NM13 Watson L. "National Library of Medicines NLM videocassette interlibrary loan program report. Be- thesda, MD: Audiovisual Resources Section, National Library of Medicine, 1983. tEpidemiological and oth- er observational methods] NM14 Roderer NK, King DW, McDonald DD, Bush CG. "National Library of Medicine] Evaluation of the Hepatitis Knowledge Base System. Rockville, MD: King Research, Inc., 1981. iEpidemiological and oth- er observational methods]

NATIONAL LIBRARY OF MEDICINE NM15 [National Library of Medicine] Performance evaluation of a satellite-linked experimental network. IEEE Trans Aerosp Electron Syst 1980;16:771-82. LEpidemiolog~cal and other observational methods] NM16 [National Library of Medicine] Biomedical com- munications experiments using the communications technology satellite: technical evaluation. Bethesda, MD: Lister Hill Center, National Library of Medicine, 1979. (NTIS order no. PB-80-11 1-0 16/GEE). tEpide- miological and other observational methods] Ongoing Assessments NM17 "National Library of Medicine] Development of evaluation methodologies to assess NLM's coverage of new biomedical literatures. Bethesda, MD: National Library of Medicine. Ongoing. tEpidemiological and other observational methods] NM18 (National Library of Medicine] Evaluation of PC- oriented training packages for the NLM chemical and toxicological online files. Bethesda, MD: National Li- brary of Medicine. Ongoing. tEpidemiological and other observational methods! NMl9 "National Library of Medicine] Evaluation of the Technological Innovations in Medical Education (TIME) Project. Bethesda, MD: Lister Hill Center, National Library of Medicine. Ongoing. tEpidemio- logical and other observational methods] NM20 ENational Library of Medicine] Evaluation of the scope and coverage of NLM's TOXLINE. Bethesda, MD: National Library of Medicine. Ongoing. [Epide- miological and other observational methods] NM21 iNational Library of Medicine] Field test and evaluation of MEDLINE on optical disk. Bethesda, MD: National Library of Medicine. Ongoing. tEpide- miolog~cal and other observational methods] NM22 "National Library of Medicine] Testing of a gen- eral methodology for the evaluation of expert systems in medicine. Bethesda, MD: Lister Hill Center, Na- tional Library of Medicine. Ongoing. tEpidemiologi- cal and other observational methods] Netherlands Organization for Applied Scientific Research Medical Technology Unit (TNO) PO Box :~S 2300 AD Leiden The Netherlands (31-71) 21-4441 Contact: G.~. van Keulen. Overview: The Netherlands Organization for Applied Scientific Research is an inde- pendent, not-for-profit organization created by law. It conducts research in the health, nutrition, industrial, and defense areas. The Medical Technology Unit (TNO) is a medical technology assessment program that evaluates medical devices. Purpose: To establish the safety, efficiency, and effectiveness of medical devices; to examine the technical and ergonomic properties of medical devices; and to give information and advice to health care institutions. Primary intended users: Acute facility administrators; long-term care facility adminis- trators; health product manufacturers; government regulators; liability, malpractice insurers; clinical engineers. Technologies: Device. Intervention: Diagnosis, treatment. 213

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Stage: New, established or widespread practice. Properties: Safety, efficacy, effectiveness. Selection process: There are no strict procedures established for requesting an assess- ment. Any party who can pay for an assessment can request that one be conducted. The Medical Technology Unit (TNO) sets assessment topic priorities in consultation with the National Hospital Institute or the party funding the assessment. Methods: Expert opinion, group judgement, bench testing. The approximate turnaround time from selection of assessment topic to reporting of findings is 1 year. Assessment reports include: The purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/supported the assess- ment; who conducted the assessment; description of the technology; properties as- sessed; procedure used for the assessment; sources of dataJinformation; methods for collecting data/information; methods for analyzing/synthesizing data/information; re- sults; findings or conclusions; how the technology works, including theory, principles; procurement/deployment information; regulatory agency approval status; product recall history, liability actions. Dissemination: Printed reports. An online network to Dutch hospitals is planned. Copies of assessment reports may be ordered from the Advisory Center of the Medical Technology Unit (TNO). Budget: $1.5 million. The approximate cost per assessment varies between $50,000 to $100,000. The cost depends on the complexity of the device and the number of different types of devices to be evaluated. Funding sources: 70 percent parent organi- zation; 30 percent sales of assessments, consultant services. The annual budget amount includes the following activities: evaluating a single device for the manufacturer; testing devices for manufacturers to prove compliance with regulations; developing functional specifications for devices with respect to safety, efficacy, and effectiveness; advising hospital technicians and administrators in the safe and effective use of devices; and offering courses for hospital technicians in quality control. Completed Reports NS1 Netherlands Organization for Applied Scientific Research, Medical Technology Unit (TNO). Syringe pumps for non-ambulatory use. 1986. NS2 . Drip-rate controlled and volumetric infu- sion pumps. 1984. NS3 . Defibrillators. 1983. NS4 . Portable def~brillators. 1983. NS5 . Bloodwarmers for use during transfusion. 1981. 214 NS6 . Electro-encephalographs. 1981. NS7 . Heart monitors. 1981. NS8 . Intensive care convection incubators. 1981. NS9 . External pacemakers. 1978. NS10 i . Sphygmomanometers. 1978. NSll . Three channel (phone) electrocardio graphs. 1977. NS12 . One channel electrocardiographs. 1975.

NETHERLANDS ORGANIZATION FOR APPLIED SCIENTIFIC RESEARCH Ongoing Assessments NS13 . Ambulatory insulin pumps. Ongoing. tExpert opinion, Group judgment, Bench testings testing] Policy Analysis, Inc. Meclical Technology Cost-Effectiveness Program 1577 Beacon Street Brookline, MA 02146 617-232-4400 Contact: Gerry Oster, Vice President. NS14. . Ultra-sound physiotherapy equipment. Ongoing. [Expert opinion, Group judgment, Bench Overview: Policy Analysis, Inc. is a business, founded in 1973, that conducts cost- benefit and cost-effectiveness analyses for organizations in both the public and private sectors. Its Medical Technology Cost-Effectiveness Program was started in 1982. Purpose: To provide state-of-the-art analyses of the cost-effectiveness of new and existing medical technologies, including drugs, devices, and diagnostic products. Primary intended users: Patients; providers, generally; physicians; acute facility ad- ministrators; health product manufacturers; health/medical professional associations; health industry associations; third party payers; government regulators; reporters, writers, news media; public policy-makers, legislators; policy research organizations. Technologies: Drug, device, medical or surgical procedure, organizational or adminis- trat~ve system. Intervention: Prevention, diagnosis, treatment. Stage: New, established or widespread practice. Properties: Cost-effectiveness, safety, efficacy, effectiveness, cost, cost-benefit, economic . . . imp Locations. Selection process: Any funding organization, private or public, may request an evalua- tion, beginning usually with informal discussions that lead to a formal written request. Assessment topic priorities are generally set by the funding organization. Methods: Information syntheses, modeling, cost analyses, epidemiological and other observational methods, clinical trials. The approximate turnaround time from selection of assessment topic to reporting of findings is 6 months to 2 years. Assessors: Assessors typically are experts in medicine, economics, and epidemiology. 215

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Assessment reports include: Abstract; the purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technol- ogies intended for similar purposes; who sponsored/commissioned/supported the as- sessment; who conducted the assessment; description of the technology; properties assessed; procedure used for the assessment; sources of data/information; methods for collecting data/information; methods for analyzing/synthesizing data/information; re- sults; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; coverage/reimbursement status of the technology. Dissemination: Journal articles. Reprints are available upon request. Budget: $750,000. Costs of assessments start at $50,000. Funding sources: 10 percent government grants/contracts; 90 percent sales of assessments, consultant services. Use: Funding organizations use the reports to address issues of concern regarding the cost-effectiveness of particular drugs, devices, or diagnostic products among patients, providers, and third-party payers. Completed Reports PA1 Oster G. Epstein AM. tPolicy Analysis, Inc.] The cost-effectiveness of cholestyramine in the prevention of coronary heart disease: whom should we treat? JAMA, submitted for publication. PA2 Oster G. Huse DM, Delea TE, Savage DD, Colditz GA. tPolicy Analysis, Inc.] Cost effectiveness of labeta- lol and propranolol in the treatrnen~ of hvn~rt~ncimn among blacks. 1987 Mar. PA3 Oster G. Tuden RL, Colditz GA. [Policy Analysis, Inc.] A cost-effectiveness analysis of prophylaxis against deep-vein thrombosis in major or orthopedic surgery. JAMA 1987;257:203-208. Brew ~^ ~ ~ Project HOPE Center for Health Affairs 2 Wisconsin Circle, Suite 500 Chevy Chase, MD 208 ~ 5 301-656-7401 PA4 Oster G. Tuden RL, Colditz GA. [Policy Analysis, Inc.] Prevention of venous thromboembolism after general surgery: a cost effectiveness analysis of alter- native approaches to prophylaxis. Am ~ Med 1987 (in press) PA5 Oster G. Epstein AM. [Policy Analysis, Inc.] Pri- mary prevention and coronary heart disease: the eco- nomic benefits of lowering serum cholesterol. Am Public Health 1986;76:647-656. · ~, PA6 Oster G. Huse DM, Delea TE, Colditz GA. [Policy Analysis, Inc.] Cost-effectiveness of nicotine gum as an adjunct to physician's advice against cigarette smoking. JAMA 1986;256:1315-1318. Contact: Gail Wilensky, Ph.D., Vice President; or Louis P. Garrison, fir., Ph.D., Deputy Director. Overview: Project HOPE (Health Opportunity for People Everywhere) is the principal activity of the People-to-People Health Foundation, Inc., an independent, nonprofit corporation headquartered in Millwood, Virginia. Founded in 1958, Project HOPE is currently conducting health sciences education and training programs in 18 countries. 216

PROJECT HOPE This profile addresses a division of Project HOPE, the Center for Health Affairs (CHA), which conducts research and policy analysis primarily related to issues of the U.S. health care system, as well as those of other countries. Purpose: To conduct health policy research and analysis for private and public sector needs. With regard to assessment, CHA examines the interaction of technologies and their financing, and presents options regarding technologies to policy makers. In particular, CHA provides technical assistance to the Prospective Payment Assessment Commission (ProPAC) for updating and improving the Medicare Prospective Payment System (PPS), such as modifying diagnosis-related groups (DRGs) and studying the impact of the PPS on utilization of technologies. Primaryintended users: Providers, generally; physicians; acute facility administrators; long-term care facility administrators; third party payers; government regulators; public policy-makers, legislators; policy research organizations. Technologies: Organizational or administrative system, medical or surgical procedure, device. Intervention: Treatment, prevention, diagnosis. Stage: New, established, widespread. Properties: Cost, cost-effectiveness, service requirements, system impact, economic impli- cations. Selection process: Under its task order agreement with ProPAC, CHA responds to assessment requests that originate with ProPAC commissioners or staff. Methods: Cost analyses, information syntheses, expert opinion, groupjudgment, model- ing. CHA reports are written primarily by staff members who draw upon a variety of experts and information sources in industry and the medical community. In addition, CHA is studying the use of physician panels, in face-to-face settings and using Delphi- style mail surveys, as a means for making adjustments in the PPS. These panels have been used in such exercises as developing lists of complications and comorbidities for DRGs in order to improve the ability of the system to capture variations in cost among patients, modifying surgical classes and hierarchies in selected diagnostic categories, and determining the scientific and technological component of the discretionary ad- justment factor used in the PPS to account for changes in the cost of hospital services. Turnaround time for assessments ranges from 2 to 8 months, averaging about 6 months. Assessors: CHA staff members have backgrounds in such fields as economics, health policy administration and management, political science, public policy, sociology, and computer science. Physicians and other experts are used for panels and as consultants as needed. Assessment reports include: Abstract; assessment's intended audience; purpose of the assessment; who sponsored/commissioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when 217

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY assessed; properties assessed; procedure used for the assessment; sources of dataJ information; methods for collecting data/information; methods for analyzing/synthe- sizing dataJinformation; results; findings or conclusions; limitations of findings; impli- cations of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, prin- ciples; regulatory agency approval status; coverage/reimbursement status of the tech- nology. Dissemination: Reports are presented in monographs to ProPAC and other organiza- tions, in journal articles, and in oral presentations. Reports are available from CHA. Budget: The CHA budget is approximately $1.5 million, about one-third of which is devoted to assessment activities described here. Funding sources: 67 percent govern- ment grants/contracts; 33 percent foundations, other private grants. Use: A number of CHA report recommendations have been adopted by ProPAC and used by the Department of Health and Human Services (DHHS) in making adjust- ments in the PPS. For example, as a result of the CHA analysis of PPS payments for expensive prosthetic and implantable devices, ProPAC recommended to DHHS that adjustments be made to the labor portion of the standardized amount for some DRGs involving these devices. The CHA analysis of heterogeneity of DRGs involving lympho- mas and leukemias prompted ProPAC to recommend to DHHS that a separate DRG be created for acute leukemia patients and that other modifications to the assignment of the remaining patients be made. DHHS adopted one part of the recommendation that acute leukemias be assigned to a newly created DRG. Based on CHA recommenda- tions regarding cardiac pacemakers, ProPAC recommended reclassification of cases based on pacemaker type and reassignment of some cases involving pacemaker re- placement. Related activities: Among its related activities, CHA is evaluating the impact of work- site health promotion programs at several major corporations. CHA is also studying the impact of corporate intervention in health benefits redesign and utilization review on the use of health services by employees. CHA has assisted DHHS in outlining recom- mendations for coverage of catastrophic illness. Staff members are examining the- potential impact of HMOs and other competitive medical plans on quality of care and access to technology. Completed Reports PHI Project HOPE, Center for Health Affairs. A pilot study in the use of physican panels to develop-specific lists of complications and comorbidities for Medicare diagnosis-related groups (for Prospective Payment Assessment Commission). 1987 {an. Group judg- ment] PH2 . A technology-specific approach to esti- mating the scientific and technological component of the discretionary adjustment factor for excluded hos- pitals: options and issues. (for Prospective Payment Assessment Commission). 1987 Feb. [Cost analyses] 218 PH3 . A technology-specif~c approach to esti- mating the scientific and technological component of the discretionary adjustment factor: options and is- sues. (for the Prospective Payment Assessment Com- mission). 1987 Feb. tCost analysesJ PH4 Garrison LP, Wilensky GR. "Project Hope Center for Health Affairs] Cost containment and technology. Health Affairs 1986;Summer:46-58. "Information syntheses] PH5 Project Hope, Center for Health Affairs. A pilot study in the use of physician panels; to modify surgi- cal classes and hierarchies in selected major diagnostic categories. (for Prospective Payment Assessment Commission). 1986 Dec. tGroup judgment]

PROJECT HOPE PH6 . Developing alternative DRG classifica- nons for Medicare cases involving cardiac pacemak- ers. (for Prospective Payment Assessment Commis- sion). 1986 Aug. fInformation syntheses, Cost ana- lyses] PH7 . Evaluating the heterogeneity of DRGs involving lymphomas, leukemias, and chemotherapy and developing alternative classifications of dis- charges. (for Prospective Payment Assessment Com- mission). 1986 Aug. fInformation syntheses, Cost an- alyses] PH8 . PPS payments for expensive devices: is- sues and evidence. (for Prospective Payment Assess- ment Commission). 1986 Aug. ECost analyses] PH9 _ . Paying for heart transplantation under Medicare. (for Prospective Payment Assessment Commission).1986 Feb. fInformation syntheses, Cost analyses] PH10 . Review of evidence in literature relevant to the measurement of hospital case mix index. (for Prospective Payment Assessment Commission). 1986 {ul. fInformation syntheses] Prospective Payment Assessment Commission 300 Seventh Street SW, Suite 30IB Washington, DC 20024 202-453-3986 PHll _ . Background paper on cataract surgery and physician payment under the Medicare program. (for U.S. Congress, Office of Technology Assess- ment). 1985 Oct. fInformation syntheses, Cost ana- lyses1 Ongoing Assessments PHIL . A review of the cost-effectiveness of home health care services. Ongoing, expected 1987. fInformation syntheses, Cost analyses] PH13 . Access to technology and quality of care in capitated plans. Ongoing. expected completion 1987.1iInformation syntheses] PH14 . Evaluating the clinical and resource het- erogeneity in DRG 468. (for Prospective Payment As- sessment Commission). Ongoing; expected 1987. fIn- formation syntheses] PH15 . The effect of PPS on the diffusion and use of medical technologies. (for Prospective Payment Assessment Commission). Ongoing, expected 1987. fInformation syntheses] PH16 . Work site health promotion program evaluation. Ongoing, expected 1987. "Information syntheses] Contact: Donald A. Young, Executive Director; or Judith D. Moore 202-453-3871. Overview: The Prospective Payment Assessment Commission (ProPAC) is an inde- pendent agency that was established by Congress under the Social Security Act Amend- ments of 1983 (PL 98-21~. The Commission is an advisory body and does not exercise regulatory or appeals functions. Purpose: To recommend to the Congress and the Secretary of Health and Human Services (HHS) an appropriate percentage change in the payments made under the Medicare prospective payment system (PPS) for in-patient hospital services, and to recommend adjustments to the diagnosis-related groups (DRG) classification and weighting factors. These recommendations may concern specific technologies or prac- tice patterns. Primary intended users: Third party payers; public policy-makers, legislators. Technologies: Organizational or administrative system, drug, device, medical or surgical procedure, support system. 219

MEDICAL TEC~OLOGY ASSESSMENT DIRECTORY ProPAC is primarily interested in those technologies having the greatest impact on the Medicare population. Intervention: Treatment, diagnosis, rehabilitation. Stage: blew, emerging, established or widespread, obsolete. The Commission withholds making recommendations until the technology is FDA- approved and is covered or about to be covered by Medicare. Properties: System impact; safety; efficacy; effectiveness; cost; cost-benefit; cost-effec- tiveness; service requirements; acceptance/adoption level; economic implications; ethi- cal, legal, social implications. Other attributes that are assessed include number and distribution of Medicare pa- tients affected, number and distribution of hospitals affected; financial impact on hospitals; financial impact on Medicare beneficiaries; estimate of impact on quality of care, access to care, or innovation and technology changes; complexity of the analysis that would be required; availability of data; and the likelihood improvements could be made in DRG classification and weights. Selection process: Requests for assessments are made through telephone contact, correspondence, meetings, and public comment at Commission meetings. Commis- sioners on the Diagnostic and Therapeutic Practices Subcommittee prioritize topics brought to their attention by ProPAC staff and then send them to the full Commission for final approval. ProPAC monitors ongoing activities and performs reassessments as necessary. Permanent DRG assignment should be reconsidered within a period not to exceed 3 years. Methods: Cost analyses, information syntheses, expert opinion, groupjudgment, model- ing. The assessment process consists of 3 stages: 1 ) identification of topics for consideration, 2) initial staff review, and 3J indepth analysis. There are two types of indepth analyses: 1) a comprehensive analysis of a specific technology or a practice pattern, and 2) a comprehensive analysis of generic issues related to case-mix measurement or payment. The approximate turnaround time from selection of assessment tonic to reporting of findings varies from a few weeks to over a year. . O Assessors: The assessors have expertise in medical/clinical specialties, economics, com- puter programming, medical record coding, and statistics. Assessment reports include: The purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/supported the assess- ment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; properties assessed; procedure used for the assessment; sources of data/information; methods for collecting data/information; methods for analyzing/synthesizing data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, principles; development of the technology; where technology is in use; regula 220

PROSPECTIVE PAYMENT ASSESSMENT COMMISSION tory agency approval status; coverage/reimbursement status of the technology; tech- nology's impact on the Medicare population. Dissemination: Printed reports; advisories to members/constituents; press conferences/ news releases; open public meetings. ProPAC accepts telephone and written requests for copies of assessment reports. A mailing list is maintained for those interested in receiving meeting announcements, agendas, and reports. Budget: $1.5 million. The approximate cost per assessment is $50,000 to $100,000. Funding source: 100 percent Congressional appropriations. Use: ProPAC is mandated to report annually to the Congress and the Secretary of WHS its recommendations on the prospective payment system. The technology assess- ments are incorporated into the recommendations. The recommendations made in ProPAC's annual reports are reviewed by the Secretary of HHS as potential areas for PPS modification. These modifications, based upon selected ProPAC recommenda- tions, can be found in the final Medicare PPS regulations for fiscal year 1986 and fiscal year 1987 published in the September 3, 1985 and September 3, 1986 Federal Register, respectively. Congressional committees also use ProPAC's assessments. ProPAC is described in Institute of Medicine, Committee on Evaluating Medical Tech- nologies in Clinical Use. Assessing medical technologies. Washington, DC: National Acade- my Press, 1985. Program evaluation: The U.S. Congress Office of Technology Assessment (OTA) is required to report annually on all phases of ProPAC's operations, including technology assessment. The first OTA report covered ProPAC's first year in operation and was issued in March 1985. The second OTA report was issued in March 1986. The OTA Health Program Advisory Committee provided advice and comment to the OTA on its oversight activities related to ProPAC; however, the content is the responsibility of the OTA and does not constitute consensus or endorsement by the advisors. General conclusions from both the first and second OTA reports find ProPAC's overall per- formance to be exceptionally high. OTA concluded that "the process by which ProPAC conducts its analyses and delivers them to the Congress is an effective one." ProPAC has continued its assessment program without major modifications. The following docu- ments present OTA's findings: Office of Technology Assessment, First report on the Prospective Payment Assessment Commission (ProPACJ. Washington, DC: Office of Tech- nology Assessment, 1985. Office of Technology Assessment. Second report on the Prospec- tive Payment Assessment Commission (ProPA C'. Washington, DC: Office of Technolo~v Assessment, 1986. --i,, Related Activities: The Commission is required to collect and assess information on regional variations in medical practice; the length of hospitalization; and the safety, efficacy, and cost-effectiveness of new and existing medical and surgical procedures, practices, services, and technologies. In meeting this requirement, ProPAC has, among other things, convened panels of experts and organized conferences. 221

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Completed Reports PP1 Burn DRGs. In: Prospective Payment Assessment Commission. Technical appendixes to the report and recommendations to the Secretary, U.S. Department of Health and Human Services, April 1, 1986. Wash- ington, DC: Government Printing Office, 1986: 124- 126. "Information syntheses, Cost analyses] PP2 Cardiac pacemakers. In: Prospective Payment As- sessment Commission. Technical appendixes to the report and recommendations to the Secretary, U.S. Department of Health and Human Services, April 1, 1986. Washington, DC: Government Printing Office, 1986:99-101. "Information syntheses, Cost analyses] PP3 Extracorporeal shockwave lithotripsy. In: Prospec- tive Payment Assessment Commission. Technical ap- pendixes to the report and recommendations to the Secretary, U.S. Department of Health and Human Services, April 1,1986 Washington, DC: Government Printing Office, 1986:112-114. "Information synthe- ses, Cost analyses] PP4 Implantable defibrillator. In: Prospective Payment Assessment Commission. Technical appendixes to the report and recommendations to the Secretary, U.S. Department of Health and Human Services, April 1, 1986. Washington, DC: Government Print- ing Office, 1986:103. "Information syntheses, Cost analyses] PP5 Lymphomas, leukemia, and chemotherapy. In: Prospective Payment Assessment Commission. Tech- nical appendixes to the report and recommendations to the Secretary, U.S. Department of Health and Hu- man Services, April 1, 1986. Washington, DC: Gov- ernment Printing Office, 1986: 121-123. [Informa- tion syntheses, Cost analyses] PP6 Magnetic resonance imaging. In: Prospective Pay- ment Assessment Commission. Technical appendixes to the report and recommendations to the Secretary, U.S. Department of Health and Human Services, April 1, 1986. Washington, DC: Government Pr~nt- ing Office, 1986: 107-111. PP7 PPS payments for expensive prosthetic and im- plantable devices and other medical supplies. In: Pro- spective Payment Assessment Commission. Technical appendixes to the report and recommendations to the Secretary, U.S. Department of Health and Hu- man Services, April 1, 1986. Washington, DC: Gov- ernment Printing Office, 1986:87-96 fInformation syntheses, Cost analyses] PP8 Penile prostheses. In: Prospective Payment Assess- ment Commission. Technical appendixes to the re- port and recommendations to the Secretary, U.S. De- partment of Health and Human Services, April 1, 1986. Washington, DC: Government Printing Office, 1986: 104- 106. [Information syntheses, Cost analyses] 22? PP9 Upper extremity procedures. In: Prospective Pay- ment Assessment Commission. Technical appendixes to the report and recommendations to the Secretary, U.S. Department of Health and Human Services, April 1, 1986. Washington, DC: Government Print- ing Office, 1986:115-117. iInformation syntheses, Cost analyses] PP10 Prospective Payment Assessment Commission. Medicare prospective payment and the American health care system: report to the Congress, February 1986. Washington, DC: Government Printing Office, 1986. "Information systheses, Cost analyses] PPll . Report and recommendataions to the Secretary, U.S. Department of Health and Human Services, April 1, 1986. Washington, DC: Govern- ment Printing Office, 1986. [Information syntheses, Cost analyses] PP12 . Technical appendixes to the report and recommendations to the Secretary, U.S. Department of Health and Human Services, April 1, 1986. Wash- ington, DC: Government Printing Of lice, 1986. [In- formation syntheses, Cost analyses] PP13 Intraocular lens implants. In: Prospective Pay- ment Assessment Commission. Technical appendixes to the report and recommendations to the Secretary, U.S. Department of Health and Human Services, April 1, 1985. Washington, DC: Government Print- ing Office, 1985: 101-105. "Information syntheses, Cost analyses] PP14 Percutaneous transluminal coronary angioplasty. In: Prospective Payment Assessment Commission. Technical appendixes to the report and recommen- dations to the Secretary, U.S. Department of Health and Human Services, April 1,1985. Washington, DC: Government Printing Office, 1985: 105-111. tInfor- mation syntheses, Cost analyses; PP15 Prospective Payment Assessment Commission. Report and recommendations to the Secretary, U.S. Department of Health and Human Services, April 1, 1985. Washington, DC: Government Printing Office, 1985. "Information syntheses, Cost analyses] PP16 . Technical appendixes to the report and recommendations to the Secretary, U.S. Department of Health and Human Services, April 1, 1985. Wash- ington, DC: Government Printing Office, 1985. fIn- formation syntheses, Cost analyses]

STEERING COMMITTEE ON FUTURE HEALTH SCENARIOS Steering Committee on Future Health Scenarios Commission on Future Health Care Technology Room BCB 203 PO Box 5406 2280 HK Rijwijk The Netherlands (31-70) 40-72-05 Contact: R.F. Schreuder, LL.M, Secretary Ministry of Welfare, Health and Cultural Affairs; or David Banta, (31-70) 47- 14-41. Overview: The Steering Committee on Future Health Scenarios (STG) was set up in 1983 by the State Secretary of Welfare, Health and Cultural Affairs. The Committee's chief task is to create "scenarios" of possible and desirable futures in the field of public health and health care. A scenario may be defined as a description of the current situation in a society (or part of it), or potential and desirable future situations and a description of a series of events which could lead from the former to the latter. The health scenarios are used to increase the anticipatory and priority-setting ability of policy-making in the field of health and health care. The findings are incorporated in strategic policy documents and also serve as a basis for future planning. The Steering Committee decides on topics to be studied, setting priorities on the basis of social relevance and the opportunities for research into future developments. For each topic an independent scenario committee is established; the STG appoints the chairman and its members. Attached to each committee is a research team comprised of experts in the relevant field as well as experts in scenario research. The activities of each scenario committee are divided into five stages: preliminary research, formulation of draft report, organization of symposia to discuss results, draft of final report, and the development of a monitoring system to update the information collected. The STG has established scenario committees on the following topics: aging (1983), cardiovascular diseases (1983), life styles (1983), oncology (1983), accidents and trau- mas (1985), care of the elderly, and Amsterdam in the year 2010 (19851. Currently, the STG is considering the feasibility of scenario committees on the following topics: health and environment, health and labor, mental health, chronic diseases, primary health care, and dental care. The scenario project on medical technology is known as the Commission on Future Health Care Technology and was established in 1983. Renewal of Commission activi- ties following the end of the scenario project in September 1987 is under consideration. This profile describes the Commissions's activities. Purpose: To identify future health care technologies and to conduct prospective assessments of health care technologies of the future. Primary intended users: General public; providers, generally; consumer associations; third party payers; government regulators; reporters, writers, news media; public policy-makers, legislators; policy research organizations. Technologies: Drug, device, medical or surgical procedure. 223

MEDICAL TEC~OLOGY ASSESSMENT DIRECTORY Intervention: Prevention, diagnosis, treatment. Stage: Emerging, future. Properties: Cost; service requirements; system impact; economic implications; ethical, legal, social implications. Methods: Information syntheses, expert opinion, group judgment, modeling, cost analyses. The staff prepare a draft paper on the assessment topic using the scientific literature, consultation with experts, and modeling, if appropriate. Outside reviewers discuss the paper and it is revised as necessary. The revised paper undergoes a second external review by a broad-based group of experts. Any revisions are incorporated and the final paper is then submitted to the Commission for approval. The approximate turnaround time from selection of assessment topic to reporting of findings is 1 year. Assessors: The assessors' areas of expertise include technology assessment, medicine law, and pharmacology. Assessment reports include: The purpose of the assessment; who sponsored/commis- sioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; properties assessed; proce- dure used for the assessment; sources of data/information; methods for collecting dataJ information; methods for analyzing/synthesizing dataJinformation; results; findings or conclusions; limitations of findings; implications of findings for practice; how the technology works, including theory, principles; where technology is in use; regulatory agency approval status; coverage/reimbursement status of the technology. Dissemination: Printed reports; journal articles; advisories to members/constituents; press conferences/news releases, TV/radio broadcasts, video products. Copies of assessment reports are available, on request, from the Steering Committee on Future Health Scenarios. Copies may also be purchased directly from the publisher: Kluwers Publishers, Bohn Scheltema, PO Box 13079, 3507 LB Utrecht, The Nether- lands. Budget: $300,000. The approximate cost per assessment is $25,000. Funding source: 90 percent parent organization, 10 percent World Health Organization. Use: The Steering Committee relies on the n.~.~.~.cment renort~ when f~rm,~l~tin~ policy recommendations. The World Health Organization, the Health Council of the Netherlands, students, and faculty have also used the reports. -arm ,^_,, an, Completed Reports SC1 Steering Committee on Future Health Scenarios, Commission on Future Health Care Technology (Netherlands). Prospective assessment of future health care technology: applications of the neurosci- ences. 1987. 224 SC2 . Prospective assessment of future health care technology: biotechnology and new vaccines. 1987.

STEERING COMMITTEE ON HrTunE HEALTH SCENARIOS SC3 . Prospective assessment of future health SC6 . Prospective assessment of future health care technology: digital imagery. 1987. care technology: lasers in cardiovascular surgery. SC4 . Prospective assessment of future health 1987. care technology: genetic screening. 1987. SC5 . Prospective assessment of future health care technology: home care technology. 1987. SC7 . Prospective assessment of future health care technology: monoclonal antibodies and diagnos- iickits.1987. Swectish Planning and Rationalization Institute of the Health Services Technology Assessment and Health Economics Box 27310 102 54 Stockholm, Sweden (46-~) 663-05-60 Contact: Stefan Hakansson Ph.D. Director; Pia Maria ~onsson, M.D.; or Eric Paulson, M.D. Telfax 46-~-60 35 10. Overview: The Technology Assessment and Health Economics program is sponsored by the Swedish Planning and Rationalization Institute of the Health Services (SPRI). SPRI is a government agency that provides health authorities in the Swedish county councils with recommendations for health care. Purpose: To provide the county councils with recommendations on new and estab- lished medical technologies. Primary intended users: General public, physicians, acute facility administrators, health product manufacturers, health/medical professional associations, government regulators, public policy-makers, legislators. Technologies: Medical or surgical procedure. Preventive, diagnostic, and therapeutic technologies are assessed. Intervention: Diagnosis. Stage: New. Properties: Cost-e~ectiveness. Selection process: Program staff, board members, and clinicians can request that an assessment be conducted. The requests are usually generated by the staff. In collabora- tion with clinicians, the staff set the assessment topic priorities. This process is based on actual or perceived problems in the health services. Methods: Cost analyses; surveys; interviews, before and after investigations; randomized controlled trials. Working with clinicians, program staff conduct assessments. There is a 2-year turn- around time from selection of assessment topic to reporting of findings. 225

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Assessors: The assessors have expertise in economics, medicine, and statistics. Assessment reports include: Abstract; the assessment's intended audience; the pur- pose of the assessment; relationship of this assessment to prior or concurrent assess- ments of the technology or other technologies intended for similar purposes; who sponsored/supported the assessment; who conducted the assessment; description of the technology; properties assessed; procedure used for the assessment; sources of data/information; methods for collecting data/information; methods for analyzing/ synthesizing datalinformation; results; findings or conclusions; implications of findings for practice; recommendations for practice, future assessments, technology develop- ment, research; how technology works, including theory principles; development of the technology; where technology is in use; coverage/reimbursement status of the technology. Dissemination: Printed reports. Using internal files reports are mailed to predetermined target groups in the health services. Copies of assessment reports may be obtained by writing to SPRI. Budget: $500,000. The approximate cost per assessment is $100,000. Funding source: 100 percent parent organization. Use: The assessment reports are frequently used in health planning within Sweden. For an example see: Lindgren E, ~onsson E, Neuhauser D. Controlling medical tech- nology in Sweden. In: Implications of cost-effectiveness analysis of medical technology. Wash- ington DC: Office of Technology Assessment, U.S. Congress, 1980. Related activities: SPRI and its equivalent institutes in other Scandinavian countries, i.e. Finish Hospital League, Norwegian Institute of Hospital Research, and the Danish Hospital Institute, havejointly set up a body for collaboration on technology assessment activities. This body is called NEMT: Nordic Evaluation of Medical Technology. NEMT is presently finishing a study on nuclear magnetic resonance in the Nordic countries. SPRI, in collaboration with the Swedish Medical Research Council, is also responsible for the Consensus Development Conferences Program in Sweden. Confer- ence topics have included: the artificial hip, treatment of myocardial infarction, treat- ment of depressive disorders, sight improving surgery, diagnostic imaging of liver cancer, diagnosis and treatment of stroke, and urinary incontinence among adults. The technology assessment program at SPRI is related to a small program of technol- ogy assessment at the Karolinska Institute (The Stockholm School of Medicine). The Karolinska Institute program includes one ongoing project on treatment methods for obesity costs, risks, and benefits. A randomized controlled trial for the treatment of leukemia is also planned. This project will examine bone marrow transplantation versus chemotherapy. Completed Reports SP1 Swedish Planning and Rationalization Institute of the Health Services. Spri technology report 8: treat- ment with insulin infusion pump: cost and effects. 1987. [Cost analyses, Epidemiological and other ob- servational methods] 226 SP2 Swedish Planning and Rationalization Institute of the Health Services and the Swedish Medical Re- search Council. Diagnosing and treatment of stroke. 1986. [Cost analyses, Epidemiological and other ob- servational methods]

SPRI SP3 . Urinary incontinence in adults.1986. (Cost analyses, Epidemiological and other observational methods] SP4 Swedish Planning and Rai~onalizai~or~ Institute of the Health Services. Spri technology report 7: MRT magnetic resonance tomography: experience in Swe- den. 1986. [Cost analyses, Epidemiological and other observational methods] SP5 Swedish Planning and Rationalization Institute of the Health Services and the Swedish Medical Re- search Council. Diagnostic imaging of liver cancer. 1985. iCost analyses, Epidemiological and other ob- servational methods] SP6 Swedish Planning and Rationalization Institute of the Health Services. Spri technology report 6: digital subtraction ang~ography economical, medical, tech- nical and planning aspects. 1985. "Swedish language only] tCost analyses, Epidemiological and other ob- servational methods] SP7 . Spri technology report 5: how can we assess medical technology? 1984. [Cost analyses, Epidemio- log~cal and other observational methods] SP8 Swedish Planning and Rationalization Institute of the Health Services and the Swedish Medical Re- search Council. Sight improving surgery. 1984. tCost analyses, Epidemiological and other observational methods] SP9 . Treatment of depressive diseases. 1984. tCost analyses, Epidemiological and other observa- tional methods] United Kingdom Department of Health and Social Securi Supplies Technology Division Medical Devices Evaluation Programme 14 Russell Square London WC I B SEP England (44-1) 636-6811, Ext. 3248 Contact: Derek E. Weston. Telex 88 3669. Telefax 01 637 8990. SP10 . Treatment of myocardial infarction. 1983. [Cost analyses, Epidemiological and other ob- servational methods] SP11 . The artificial hip. 1982. [Cost analyses, Epidemiological and other observational methods] SP12 Swedish Planning and Rationalization Institute of the Health Services. Spri technology report 4: must we assess medical technology? 1982. [Cost analyses, Epidemiological and other observational methods] SP13 . Spri technology report 2: CT scanning in Sweden~osts and effectiveness. 1981. (Spri report 73) [Cost analyses, Epidemiological and other obser- vational methods] SP14 . Spri technology report 3: cost effective- rless analysis in health care. 1981. tCost analyses, Epi- demiological and other observational methods] Ongoing Assessments SP15 . Artificial lens implantation: a cost-effec- tiveness analysis. Ongoing. [Cost analyses, Epidemio- logical and other observational methods] SP16 . Mammography screening for breast can- cer: a randomized controlled cost-effectiveness analy- sis. Ongoing. tCost analyses, Epidemiological and oth- er observational methods] city Overview: The United Kingdom Department of Health and Social Security (DHSS) operates the Medical Services Evaluation Programme. The DHSS started the evalua- t~on Programme in the 1 960s to satisfy the growing need within the National Health Service . (NHS) for guidance in selecting suitable medical devices. The DHHS promotes the production and supply of safe and effective medical equipment; supports the research, 227

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY development, and evaluation of equipment; and provides technical advice to equip- ment suppliers and users in the NHS. Purpose: To assist prospective purchasers of medical devices in making an informed choice from the products available. Primary intended users: Providers, generally; physicians; acute facility administrators; long-term care facility administrators; other care givers; health product manufactur- ers; health/medical professional associations; health industry associations; labs, blood banks. Technologies: Device. Devices related to a wide range of technologies are assessed. They are frequently, although not exclusively, electrically powered. Intervention: Treatment, diagnosis, rehabilitation. Stage: New, emerging, established or widespread practice. Devices are usually evaluated when they become established in the marketplace, but sometimes when a production model is first available. Properties: Safe0, efficacy, effectiveness, costs. The following attributes of a device are assessed: safety in use for both operators and patients, performance (against specifications), standard of construction, ease of repair, availability and cost of spare parts, standard of user information, and user reactions. Selection process: The DHSS accepts written and verbal requests for assessments from all segments of the National Health Service. The Supplies Technology Division, DHSS in consultation with the NHS set assessment topic priorities using the following criteria: the equipment is 1) widely used, 2) relatively expensive, 3) complex (making technical judgment difficult), and 4) available in a variety of models (making selection difficult). Methods: Bench testing, expert opinion, epidemiological and other observational meth- ods. Assessment methods vary according to the type of device being evaluated. Physical tests for safety and performance are conducted and are supplemented by user question- naires. In the last 10 years, Centers of Continuous Evaluation have been established within the NHS to continually examine a single equipment category. A list of the current Centers and the equipment category evaluated is provided at the end of this profile. Each Center familiarizes itself with the category of equipment; develops test methods; and produces relevant, well-informed, and up-to-date information. General- ly, reports from the Centers discuss several models of competing equipment, identify the advantages/disadvantages of each model, and give recommendations on models preferred in different circumstances. The equipment is not evaluated in clinical use, which limits the value of the information somewhat. The evaluation activity is based on these continuous assessments and is supplemented by individual examinations of single items of equipment. Approximately 50 evaluations are conducted annually. In most cases, each item of equipment is subjected to each of the following assessment procedures: 1) a technical assessment against current safety and performance stan 228

UNITED KINGDOM DEPARTMENT OF HEALTH AND SOCIAL SECURITY cards, using draft versions if final standards do not yet exist; a subjective assessment of the construction quality, the serviceability and the likely reliability; and 3) a period of user experience to establish its clinical acceptability, in operational and ergonomic terms. All findings and results relating to a particular model are discussed with the manufacturer or suppliers, who are given an opportunity to comment in writing. Assessors: The assessors are scientists, engineers, technicians, nurses, and clinicians in the National Health Service units and specialized evaluation centers. The approximate turnaround time from selection of assessment topic to reporting of findings is 18 months for a full evaluation including user experience and 9 to 12 months for technical evaluation. Assessment reports include: The assessment's intended audience; the purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; who sponsored/com- missioned/supported the assessment; who conducted the assessment; description of the technology; properties assessed; procedure used for the assessment; results; findings or conclusions; limitations of findings; implications of findings for practice; procure- ment/deployment information; where technology is in use. Dissemination: Printed reports, journal articles. Assessment results are published in Health Equipment Information. Each issue is intended to be a "buyer's guide," covering all models which have been evaluated and are still on the market in the United Kingdom. Full reports on any recent models are also includ- ed. Summaries are presented for all models, together with a photograph, current price, country of origin, and a reference to where the reader can find the full report. Reports are available to anyone at their cover price. For details on individual report prices or for subscription information, contact: DHSS Leaflets Unit, PO Box 21, Stanmore, Middlesex, HA7 lAY, United Kingdom. Budget: $3.2 million. Funding source: 100 percent parent organization. Use: Based on feedback from the NHS, equipment manufacturers, and suppliers the assessment reports are widely used by the NHS when selecting equipment for pur- chase. Program evaluation: To ensure that the Programme meets the NHS needs for infor- mation, the DHHS evaluates the Programme on a continuous basis. Centers of Continuous Evaluation Bath Institute of Medical Engineering Equipment category: infusion pumps and controllers, breathing system connectors. Birmingham Dudley Road Hospital Equipment category: humidifiers, C02 expired gas analysers Cardiff Medical Physics Department, South Glamorgan Health Authority Equipment category: surgical diathermy units, baby incubators, infant warmers. 229

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY University of Wales College of Medicine Equipment category: lung ventilators, ventilator alarms, resuscitators. London St. Mary's Hospital, Paddirlgton Equipment category: fetal monitors. Newcastle Regional Engir~eer's Department, Northern Regional Health Authority Equipment category: ECG monitors, automatic non-invasive blood pressure monitors. Oxford Regional Engineer's Department, Oxford Regional Health Authority Equipment category: ECG recorders, ambulatory ECG (Holler) systems. Sheffield University and Health Authority, Department of Medical Physics and Clinical Engi neering Equipment category: dialysis and associated equipment (not dialysers). Completed Reports UA1 United Kingdom Department of Health and So- cial Security, Medical Devices Evaluation Programme. Assessment of Elscint Mam LS3 mammographic unit. 1986 Jan. (Report no. STB6E/86/3) [Epidemiological and other observational methods, Bench testing] UA2 . Assessment of ICE L/U arm angiograph unit.1986 Feb. (Report no. STB/86/7) [Epidemiologi- cal and other observational methods, Bench testing] UA3 . Assessment of Siemens Optilux 57 inten- sifier associated with the Sircam 100mm camera and Polyphos 300E generator. 1986 Jan. (Report no. STB6E/86/4) [Epidemiological and other observa- tional methods, Bench testing] UA4 . Assessment of Wolverson X-ray (Acoma) MXR 102 mammography unit. 1986 Tan. (Report no. STB6E/86/1) [Epidemiological and other observa- tional methods, Bench testing] UA5 . Assessment of medical X-ray supplies (Soredex) Mammex DC mammographic unit. 1986 Jan. (Report no. STB6E/86/2) tEpidemiological and other observational methods, Bench testing] UA6 . Comparison of imaging performance of CT scanners (Issue four). 1986 Mar. (Report no. STB/86/10) [Epidemiological and other observational methods, Bench testing] UA7 . Evaluation of Don Whitley Mark II anaer- obic cabinet/work station. 1986 Mar. (Report no. STB/86/11) [Epidemiological and other observational methods, Bench testing] 230 UA8 . Performance assessment of gamma cam- eras, part four. 1986 Mar. (Report no. STB/86/9) [Epidemiological and other observational methods, Bench testing! UA9 . An evaluation of eight non-invasive elec- tronic KV measuring instruments which are commer- cially available in the UK. 1985 Jun. (Report no. STB6E/85/19) [Epidemiological and other observa- tional methods, Bench testing] UA10 . An evaluation of the Beckman Astra 8 with enzymes. 1985 Jul. (Report no. STB3A/85/32) [Epidemiological and other observational methods, Bench testing] UAl l . An evaluation of the Hamilton Microlab 2100. 1985 Apr. (Report no. STB3A/85/18) [Epide- miological and other observational methods, Bench testing] UA12 . An evaluation of the Kone Process selec- tive chemistry analyser.1985 Jul. (Report no. STB3A/ 85/31) [Epidemiological and other observational methods, Bench testing] UA13 . Assessment of Kodak M8 radiographic film processor. 1985 Jun. (Report no. STB6E/85/24) [Epidemiological and other observational methods, Bench testing] UA14 . Assessment of Lixiscop hand held imager with radioactive source.1985 Sep. (Report no. STB6E/85/33) [Epidemiological and other observa- tional methods, Bench testing]

UNITED KINGDOM DEPARTMENT OF HEALTH AND SOCIAL SECURITY UA15 . Assessment of Philips Medical Systems Saturn 500 and Saturn 850 generators. 1985 Aug. (Report no. STB6E/85/28) tEpidemiological and oth- er observational methods, Bench testing] UA16 . Assessment of Picker Clinix C servo chest unit. 1985 Jun. (Report no. STB6E/85/14) tEpi- demiological and other observational methods, Bench testing] UA17 . Assessment of Picker Modulex T for radiography, tomography and occasional peripheral angiography. 1985 Dec. (Report no. STB6E/85/45) tEpidemiological and other observational methods, Bench testing] UA18 . Assessment of Siemens basic radiological system (BRS) to WHO modified specification. 1985 Sep. (Report no. STB6E/85/34) [Epidemiological and other observational methods, Bench testing] UAl9 . Assessment of Sine Mobil 3N and 3H mobile imaging intensifiers. 1985 Sep. (Report no. STB6E/85/30) [Epidemiological and other observa- tional methods, Bench testing] UA20 . Assessment of Todd Research BRS to WHO modified specification. 1985 Sep. (Report no. STB6A/85/36) tEpidemiological and other observa- tional methods, Bench testing] UA21 . Assessment of Wolverson Mylo X radio- graphic unit, Royal Preston Hospital, North Man- chester. 1985 Apr. (Report no. STB6E/85/8) [Epide- miological and other observational methods, Bench testing] UA22 . Assessment of a Siemens Polydoros 80 X-ray generator. 1985 Aug. (Report no. STB6E/85/ 27) tEpidemiological and other observational meth- ods, Bench testing] UA23 . Comparative evaluation of free thyrox- ine assay kits. 1985 Nov. (Report no. STB3A/85/44) tEpidemiological and other observational methods, Bench testing] UA24 . Comparative evaluation of prostatic acid phosphatase kits. 1985 May. (Report no. STB3A/85/ 21) [Epidemiological and other observational meth- ods, Bench testing] UA25 . Evaluation of Analogue LM3 analyser. 1985 May. (Report no. STB3/85/25) [Epidemiological and other observational methods, Bench testing] UA26 . Evaluation of sickle cell haemoglobin (HBS) screening methods. 1985 Sep. (Report no. STB3A/85/41) [Epidemiological and other observa- tional methods, Bench testing] UA27 . Evaluation of the Autobac IDX. 1985 Dec. (Report no. STB3A/85/46) [Epidemiological and other observational methods, Bench testing] UA28 . Evaluation of the IQ Bio Microlite Flo- teskan system. 1985 Oct. (Report No. STB3A/85/43) tEpidemiological and other observational methods, Bench testing] UA29 . Evaluation of the Matascan. 1985 May. (Report no. STB3A/85/23) tEpidemiological and oth- er observational methods, Bench testing] UA30 . Evaluation of the Syra Advance (summa- ry report). 1985 May. (Report no. STB3A/85/22) tEpidemiological and other observational methods, Bench testing] UA31 . Evaluation of the Syva advance automat- ed fluorescence immuno-assay system. Final report. 1985 Dec. (Report no. STB3A/85/47) tEpidemiologi- cal and other observational methods, Bench testing] UA32 . Introduction to imaging cameras with assessment of Matric HPC 1010/4.1985 Nov. (Report no. STB6E/85/42) tEpidemiological and other obser- vational methods, Bench testing] UA33 . PHLS & DHSS evaluation of five anti- HTLV3/LAV assay kits. 1985 Sep. (Report no. STB3A/85/40) [Epidemiological and other observa- tional methods, Bench testing] UA34 . Physical evaluation of the imaging per- formance of the Agfa Gevaert range of screen film systems. 1985 Aug. (Report no. STB6E/85/26) [Epi- demiological and other observational methods, Bench testing] UA35 . Survey of bench top centrifuges. 1985 May. (Report no. STB3A/85/20) tEpidemiological and other observational methods, Bench testing] 231

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY U.S. Administrators Inc. Professional Policy Committee 5016 North Parkway Calabasas Calabasas, CA 9 ~ 302 800-872-7526, Ext. 173 Contact: Marvin I. Shapiro, M.D., Medical Director. Overview: The U.S. Administrators Inc. is a for-profit corporation that manages self- funded medical care programs of corporations, unions, and government entities. It is sponsered by the Crownx Corporation of Canada and Samuel X. Kaplan and family. The Professional Policy Committee was organized in spring 1983 to obtain timely information on which daily reimbursement decisions could be based. Purpose: To guide reimbursement policies. Primary intended users: Physicians; acute facility administrators; long-term care facili- ty administrators; other care givers; employers; unions and other employee organiza- tions; third party payers; financial analysts, consultants; lawyers. Technologies: Medical or surgical procedure, drug, device, support system, organization- al or administrative system. Any technology is assessed that requires a decision as to whether or not it should be reimbursed and/or under what circumstances it should be reimbursed. Intervention: Treatment, prevention, diagnosis, rehabilitation. Stage: Established or widespread practice, emerging, new, obsolete. As soon as the Committee has knowledge of a new technology not yet released for general use it seeks to develop a policy. Technologies are also evaluated if evidence from claims indicates that there may be misuse of a technology, or a technology may become obsolete. Properties: Effectiveness; safety; efficacy; cost; cost-benefit; cost-effectiveness; system impact; economic implications; ethical, legal, social implications. Technologies are assessed from the perspective of their contribution to patient care. Does a technology contribute significantly to diagnosis or treatment? Does it do a better job than other technologies in that it is more convenient, causing less patient distress, and/or is less expensive? Selection process: Account executives, clients, health benefit coordinators, claims personnel, committee members, the Medical Director, or physician consultants may request that an assessment be conducted. Requests may be either written or oral. Assessment topic priorities are set by the Medical Director. An assessment is performed if a problem with a procedure or a technology is identified. The staff presents the problem and a proposed resolution to the Policy Committee for discussion, evaluation, and final resolution. Methods: Group judgment, information syntheses, expert opinion. 232

U.S. ADMINISTRATORS, INC. The Medical Director and his staff prepare a literature review and an agenda. This material is sent to the Committee members 4 to 6 weeks prior to the meeting. The Committee meets to consider and recommend actions. The Medical Director prepares the minutes, which are reviewed and approved by all Committee members. The results are presented in language suitable for clients and internal personnel and are then circulated in written form. The approximate turnaround time from selection of assess- ment topic to reporting of findings is 6 to 9 months. Assessors: The assessors are physicians with various associations in the medical and academic communities. Assessment reports include: Abstract; the assessment's intended audience; the pur- pose of the assessment; relationship of this assessment to prior or concurrent assess- ments of the technology or other technologies intended for similar purposes; descrip- tion of the technology; stage of life-cycle of technology when assessed; properties assessed; procedure used for the assessment; sources of dataJinformation; methods for collecting data/information; methods for analyzing/synthesizing dataJinformation; re- sults; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, principles; development of the technology; where technology is in use; regulatory agency approval status; coverage/ reimbursement status of the technology. Dissemination: Advisories to members/constituents. The assessment policies are called "Professional Policy Committee Recommendations." The recommendations are sent to all clients and concerned personnel within the organization. Copies of the assessments may be obtained by contacting Marvin I. Shapiro at U.S. Administrators. Budget: $150,000. The approximate cost per assessment is $5,000. Funding source: 100 percent parent organization. Use: The information is used by the parent organization to adjudicate the payment of claims for services. Claims personnel, professional review departments, and physician advisors all make use of the recommendations. Program evaluation: There have been no formal evaluations, but the program is under constant review by the internal personnel who use the recommendations, and by clients. The ongoing review seems to be very positive, since the recommendations have, almost without exception, been accepted, and found helpful in adjudicating claims, dealing with providers, and educating claims personnel of clients as well as employees. Completed Reports UB1 U.S. Administrators, Professional Policy Commit- tee. A.I.D.S. [7/861 [Group judgment] UB2 . Adjuvant chemotherapy for breast can- cer. [7/86] [Group judgment] UB3 . Admission screening hospital. [7/86] [Group judgment] UB4 . Allergy new tests for treatment. [7/86 [Group judgment] UB5 . Alopecia areata. [7/86] [Group judgment] UB6 . Arthritis-diagnostic procedures. t7/86] [Group judgment] 233

MEDICALI~CHNOLOGY ASSESSMENT DIRECTORY UB7 . Arthritis-medical therapy. [7/86] [Group judgment] UB8 . Arthritis surgical intervention. [7/86] [Group judgments UB9 . Arthritis, low-dose methotrexate therapy. [7/86] [Group judgment] UB10 . Arthroscopy of joints other than the knee. t7/86] [Group judgment] UB11 . Arthroscopy of knee. [7/86] [Group judgment] UB12 . B.E.A.M. [7/86] [Group judgment] UB13 . Biofeedback. [7/86] [Group judgment] UB14 . Bone marrow transplantation. [7/86] EGroup judgment] UB15 . Breast imaging. [7/86J EGroup judg ment] UB16 .CT scans-head. [7/86J [Group judg ment] UB17 .CT scans cervical and lumbar spine. [7/ 86] [Group judgment] UB18 . Cardiac rehabilitation programs. t7/86] [Group judgments UB19 . Cardioverter defibrillator, implantable. [7/861 [Group judgment] UB20 . Carotid artery disease. [7/86] [Group judgment] UB21 . Cerebral artery anastomosis, superficial temporal-middle. [Group judgment] UB22 . Cerebral artery anastomosis, superficial temporal-middle. [7/86] EGroup judgment] UB23 . Chemotherapy. [7/86] [Group judg mentJ UB24 . Chest pain~hronic. t7/86] [Group judgment] UB25 . Chiropractic services. [7/86] EGroup judgment] UB26_ . Cholangiography, routine operative. t7/ 86] EGroup judgment] UB27 . Cholecystectomy. [7/86] [Group judg ment] UB28 . Cochlear implants. [7/86] [Group judg ment] UB29 . Coronary arteriography. t7/86] [Group judgment] 234 UB30 . Coronary artery angioplasty. [7/86] [Group judgment] UB31 . Coronary care units, admission to. t7/86J [Group judgmentJ UB32 . Decubitus surgery. [7/86] [Group judg- ment] UB33 . Diabetes mellitus-diagnosis and man- agement. [7/86] [Group judgment] UB34 . Digital subtraction angiography-intra- venous. [7/86] [Group judgment] UB35_ . Dilatation and curettage. [7/861 [Group judgment] UB36 . E.S.W.L. t7/86] [Group judgment] UB37 . Echocardiography in atherosclerotic cor- onary artery disease. [7/86] [Group judgment] UB38 . Emergency rooms. [7/86] [Group judg ment] UB39 . Epikeratophakia grafts. [7/86] [Group judgment] UB40 . Exercise training for chronic obstructive lung disease. t7/86] [Group judgment] UB41 . Eye surgery. [7/86] [Group judgment] UB42 . Fertilization, in vitro. F7/86] EGroup judgment] UB43 . Fetal monitoring-non-stress training. t7/86] [Group judgmentJ UB44 . Gastric bubble, Garren-Edwards. [7/86] [Group judgment] UB45 . Genetic counselling and screening. [7/ 86] [Group judgment] UB46 . Growth hormone human. [7/86] (Group judgment] UB47 . Hodgkin's disease, routine lymphangio- graphy. [7/86] [Group judgment] UB48 . Hodgkin's disease, routine staging lapa- rotomy. [7/86] [Group judgment] UB49 . Holter monitoring. t7/86] [Group judg- ment] UB50 . Hypertension, evaluation and manage- ment. [7/86J [Group judgment] UB51 . Hyperthermia. f7/86] (Groupjudgment] UB52 . Immunoaugmentative therapy. [7/86] [Group judgment]

U.S. ADMINISTRATORS, INC. UB53 . Incentive spirometry. t7/86] [Group judgmentJ UB54 . Intermittent positive pressure breathing. [7/86J [Group judgment] UB55 . Investigations (clinical). [7/86] [Group judgment] UB56 . Kyphoscoliosis surgery. [7/86] [Group judgment] UB57 . Laser therapy. [7/86] [Group judgmentJ UB58 . Linear Pump, Wright. [7/86J [Group judgment] UB59 . Maternity benefits. [7/86] [Group judg ment] UB60 . Metastatic neoplasms. [7/86] [Group judgment] UB61 . Morbid obesity. [7/86] [Group judg ment] UB62 . Multiple views diagnostic radiology. [7/ 86J [Group judgmentJ UB63 . Nail bed transplants. [7/86] [Groupjudg- ment] UB64 . Non-invasive testing lower extremities. [7/861 [Group judgment] UB65 . Non-invasive testing peripheral artery disease. [7/86] [Group judgment] UB66 . Nuclear magnetic resonance imaging. [7/ 86] [Group judgment] UB67 . Organ transplantation. [7/86] [Group judgment] UB68 . Orthoptic training. [7/86] [Group judg ment] UB69 . Pain rehabilitation programs. [7/86] [Group judgment] UB70 . Periodic health screening. [7/86] [Group judgment] UB71 . Peripheral pulmonary lesions. [7/86] [Group judgment] UB72 . Physical therapy. [7/86] [Group judg- ment] UB73. . Preadmission/presurgical screening. [7/ 86] [Group judgment] UB74 . Psychiatric disorders testing. [7/86] [Group judgment] UB75. . Radionuclide scans (post-operative). [7/ 86] [Group judgmentJ UB76 . Radionuclide scans (pre-operative). [7/ 86J [Group judgmentJ UB77 . Research grants investigational. [7/86] [Group judgment] UB78 . . Somatization disorder. [7/86] [Group judgmentJ UB79 . Spinal stenosis. [7/86] [Groupjudgment] UB80. . Streptokinase. [7/86] [Group judgment] UB81 . Stress tests. [7/86] [Group judgment] UB82 . Subcutaneous (subareolar) mastectomy (bilateral). [7/86] [Group judgment] UB83 . Swan Ganz. [7/86] [Group judgment] UB84 . Thallium and/or equilibrium-gated myocardial imaging. [7/86] [Group judgment] UB85 . Therapeutic apheresis (plasmapheresis). [7/86] [Group judgment] UB86 . Transfusion preparation of blood. [7/ 86] [Group judgment] UB87 . Unbundling. [7/86] [Group judgmentJ UB88 . Upper G-I endoscopy. [7/86] [Group judgment] UB89. . Urography (excretory). [7/86J [Group judgment] Ongoing Assessmen~ UB90 . Autologous blood transfusions. Ongo- ing. (Group judgement] UB91 . Bone healing/electromagnetic stimula- tion. Ongoing. [Group judgment] UB92 . Bone marrow transplant reconsidera- tion. Ongoing. [Group judgment] UB93 . CEA testing. Ongoing. [Group judg- mentJ UB94 . Carotid endarterectomy. Ongoing. [Group judgment] UB95 . Chronic backache-diagnosis and thera- py. Ongoing. tGroup judgment] UB96 . Echocardiography/re-evaluation. Ongo- ing. [Group judgment] UB97 . Environmental illness and testing. Ongo- ing. [Group judgmentJ UB98. . Evoked potential monitoring. Ongoing. tGroup judgmentJ 235

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY UB99 . Guidelines for reimbursement policies for inpatient and outpatient therapy for alcoholism and psychiatric disorders. Ongoing. [Group judg- ment] UB100 . Guidelines of appropriate indications for "oscopies". Ongoing. [Group judgment] UB101 . Hospice care/Alzheimer's. Ongoing. [Group judgment] UB102 . Hyperbaric oxygen therapy. Ongoing. tGroup judgment] UB103 . Intrapartum fetal monitoring. Ongo- ing. tGroup judgment] UB104_ . Intrauterine fetal shunts. Ongoing. [Group judgment! UB105 . Lithotripsy-reconsideration re ex- panded indications. Ongoing. [Group judgment] UB106 . Liver/spleen scans. Ongoing. [Group judgment] University of California, San Francisco Institute for Health Policy Studies 1326 Third Avenue San Francisco, CA 94143 415-476-4921 UB107 . Pain clinics. Ongoing. [Group judg ment] UB108 . Penile implants. Ongoing. [Group judgment] UB109 . Programmed electronic stimulation post-myocardial infarct. Ongoing. [Group judgment] UB110 . Protocol for use of multiple EKG's and chest X-rays in CCUs and ICUs. Ongoing. [Group judgment] UB111 . Radiation therapy for lung carcinoma. Ongoing. [Group judgment] UB112 . Relaxation therapy for hypertension. Ongoing. [Group judgment] UB113 . Sclerosing therapy for esophageal vari- ces. Ongoing. [Group judgment] UB114 . Screening tests for osteoporosis. Ongo- ing. [Group judgment] UB115 . Sleep testing and therapy of sleep ap- nea. Ongoing. [Group judgment] Contact: Jonathan Showstack, Associate Professor of Health Policy; or Phyllis Fetto, Program Administrator. Overview: The Institute for Health Policy Studies (IMPS) is an academic and research unit of the University of California, San Francisco (UCSF). It was established in 1972 as the Health Policy Program. In 1982, the name officially changed to the IHPS when it was formally designated an Organized Research Unit within the School of Medicine, UCSF. Purpose: The IHPS has a threefold purpose. First, IHPS provides education and training programs for students and practitioners in the health professions; for students and faculty in other disciplines; and for policy-makers, program managers, and others in the health field. Second, the IHPS faculty conduct health services research and policy analysis projects. Third, the IHPS gives advice on effective and efficient health care delivery systems to federal and state governments and other policy-making bodies. Primary intended users: Physicians, third party payers, government regulators, public policy-makers, legislators, policy research organizations. Technologies: Medical or surgical procedure, device, support system, organizational or . . . at ministrative system. 236

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO In recent years, IMPS's priorities in research and policy analysis have been health maintenance organizations and other organized health care delivery systems, cost containment, impact of medical technology on health care, ethical issues in health care, reproductive health, the aged, child health, prescription drugs, health manpower, health planning, health promotion and disease prevention, and health care for disad- vantaged persons. Intervention: Treatment, diagnosis. Stage: Established or widespread practice, new. Properties: Cost-effectiveness; efficacy; effectiveness; cost; cost-benefit; service require- ments; acceptance/adoption level; system impact; economic implications; ethical, legal, social implications. 1 , Selection process: Faculty and staff members generally select assessment topics. Pro- jects must be within a faculty/staff member's area of interest; consistent with the purposes of IMPS; and subject to university policies regarding grants, contracts, and other arrangements with outside parties. Methods: Cost analyses, information syntheses, expert opinion, groupjudgment, model- ing, epidemiological and other observational methods. Through its formal relationships with other university institutions, IHPS has access to clinical data. The turnaround time from selection of assessment topic to reporting of findings varies according to the type of study conducted or other assistance provided. For instance, the case studies on various technologies conducted for the Congressional Office of Technology Assessment took approximately 6 months to complete. Respons- es to requests for technical assistance may take 1 day to several weeks and formal health services research projects are often 2 to 3 years long. Assessors: The IHPS has approximately 30 faculty members and 28 affiliated faculty, over 20 full-time research staff, 40 predoctoral and postdoctoral fellows and visiting scholars, and approximately 20 full-time support staff. This multidisciplinary staff represents the fields of law, pharmacology, philosophy and ethics, medicine, econom- ics, public policy and administration, planning, statistics, sociology, epidemiology, polit- ical science, medical anthropology, and medical information sciences. Assessment reports include: Abstract; the purpose of the assessment; who sponsored/ commissioned/supported the assessment; who conducted the assessment, description of the technology; stage of life-cycle of technology when assessed; properties assessed; procedure used for the assessment; source of data/information; methods for collecting data/information; methods for analyzing/synthesizing data/information; results; find- ings or conclusions; limitations of findings; implications of findings for practice; recom- mendations for practice, future assessments, technology development, research; how the technology works, including theory, principles; development of the technology; regulatory agency approval status; coverage/reimbursement status of the technology. Dissemination: Printed reports; journal articles; press conferences/news releases, TV/ radio broadcasts, video products. 237

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY A comprehensive dissemination program exists to communicate information on health policy issues and research findings to four major audiences: federal, state and local policy-makers; the health services research and health policy research communities; representatives of not-for-profit and for mrnI;t mr<r~r~i~t;r`~c that ~`r;rl~ Hell A ices; and the general public. ~4 ~4 5~AAA=~A~],.l,6 ~L~11 ~! ~ V 1 ~1l~l~ll Amp V Faculty and research staff place a high priority on the development of publications including books, monographs, discussion papers, book chapters, and journal articles. There are three internal publication series: a discussion paper series; a monograph . . . series; anc a reprint series. The Institute's semiannual newsletter IHPS Report, is designed to communicate Insti- tute research findings. The Institute's Center for Population and Reproductive Health Policy produces the semiannual newsletter Research Highlights. Institute faculty and research staff organize conferences on national, state, and local health policy issues. The conferences bring selected groups together to share research findings and to analyze the implications of these findings for key policy questions. Budget: Research, $1,500,000, technology assessment, $750,000. Funding sources: 50 percent government grants/contracts, 50 percent foundations, other private grants. Use: It is difficult to measure directly the impact of IHPS activities, because IHPS acts as an analytic and advisory body, not a policy-making body. Results of health services research and policy analyses projects have had wide circulation through publication in peer-reviewed journals and are often cited by other investigators. Technical assistance and policy analyses provided by IHPS have been used in augmenting and guiding legislative efforts and various policy changes. From 1977 through 1983, IHPS faculty and research staffresponded to approximately 800 requests for technical assistance. Over 50 percent of the requests were from federal policy-makers and staff. The primary users have been Congress and Congressional offices, the Executive Office of the President, the Department of Health and Human Services, and the Federal Trade Commission. For these and other federal agencies, IHPS analyses have contrib- uted to research agendas and policy options in such areas as prescription drugs, health manpower, health promotion and disease prevention, and health planning and regula- t~on. For the state of California, IHPS provided analyses of MediCal reform options, the impact of prepaid medical care plans, health and social service policy options in long- term care, the cost-effectiveness of prenatal care, and other areas. The health provider community-individual providers, institutions, and service programs have benefited from IHPS technical assistance, information, and educational programs. The expansion of IHPS research and analyses activities has augmented its role in education and training. IHPS faculty have developed some 20 courses in health policy and related areas for students on the UCSF and University of California, Berkeley campuses. IHPS has been instrumental in several major developments in academic programs at UCSF, including the establishment of the Division of General Internal Medicine; the Division of Medical Ethics; the Aging Health Policy Center; and postgraduate pro- grams in health policy research, health policy management, and clinical epidemiology. 238 .

UNIVERSITY OF CALIFORNIA, SAN FRANCISCO The IHPS is described in Institute of Medicine, Committee on Evaluating Medical Technologies in Clinical Use. Assessing medical technologies. Washington, DC: National Academy Press, 1985. Completed Reports UF1 Showstack ~A, Hughes Stone M, Schroeder SA. [University of California, San Francisco, Institute for Health Policy Studies] The role of changing clinical practices in the rising costs of hospital care. N Engl Med 1985;313:1201-1207. UF? Korenbrot CC, Aalto LH, Laros RK. "University of California, San Francisco, Institute for Health Policy Studies] The cost effectiveness of stopping preterm labor with beta-adrenerg~c treatment. N Engl J Med 1984;310:691-696. UF3 Nevitt MD, Epstein WV, Masem M, Murray WR. Universe of California, San Francisco, Institute for Health Policy Studies] Work disability before and af- ter total hip arthroplasty: assessment of effectiveness in reducing disability. Arthritis Rheum 1984;27:410- 421. UF4 Schroeder SA, Myers LP, McPhee S}, et al. tUni- versity of California, San Francisco, Institute for Health Policy Studies] The failure of physician educa- tion as a cost containment strategy: report of a pro- spect~ve controlled trial at a university hospital. JAMA 1984;252:225-230. UF5 Budetti P. McManus P. University of California, San Francisco, Institute for Health Policy Studies] Assessing the effectiveness of neonatal intensive care. Med Care 1982;20: 1027-1039. UFO McPhee Sl, Myers LP, Schroeder SA. [University of California, San Francisco, Institute for Health Poli- cy Studies] The costs and risks of medical care. An annotated bibliography for clinicians and educators. West J Med 1982;137(2):145-161. UF7 Showstack JA, Schroeder SA, Matsumoto ME. "University of California, San Francisco, Institute for Health Policy Studies] Changes in the use of medical technologies, 1972-1977. A study of 10 in-patient di- agnoses. N Engl J Med 1982;306:706-712. UFO Simborg DW, Whiting-O'Keefe QE. [University of California, San Francisco, Institute for Health Policy Studies] Evaluation methodology for ambulatory care information systems. Med Care 1982;20:255-265. UF9 Myers LP, Schroeder SA. "University of California, San Francisco, Institute for Health Policy Studies] Physician use of services for the hospitalized patient: a review, with implications for cost containment. Mil- bank Mem Fund Q 1981 ;59~4~:481-507. UF10 Showstack ~A, Schroeder SA, Steinberg HR. [University of California, San Francisco, Institute for Health Policy Studies] Evaluating the costs and bene- fits of a diagnostic technology: the case of upper gas- trointestinal endoscopy. Med Care 1981;19:498-508. University of Lausanne Institute of Social and Preventive Medicine Evaluation of the Efficacy anti Safety of Chorionic Villi Sampling 17 r. Bugnon 1005 Lausanne, Switzerland (41-2 1 ) 4 1-28-66 Contact: R. Chrzanowski, M.D., M.PH; or G. Pesia, Professor, Department of Human Genetics, University Hospital (CHUV) 1011 Lausanne, Switzerland. Overview: The Evaluation of the Efficacy and Safety of Chorionic Villi Sampling (CVS) is a randomized clinical trial sponsored by the Institute of Social and Preventive Medicine, University of Lausanne. The CVS registry and trial began January 20, 1986. By October 1, 1986, the pilot stage of the study had ended and a 3-year grant was awarded. 239

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Purpose: To evaluate the efficacy and safety of prenatal diagnostic tests for genetic disease. Primary intended users: Patients, physicians, health/medical professional associations, consumer associations, third party payers, government regulators. Technologies: Medical or surgical procedure. Specifically, chorionic villi sampling (CVS) and amniotic liquid sampling (ALS) are assessed. Intervention: Diagnosis. Stage: New, established or widespread practice. Properties: Efficacy; safety; effectiveness; cost-benefit; cost-effectiveness; acceptance/ adoption level; system impact; ethical, legal, social implications. Selection process: Physicians, health/medical associations, third party payers, and government regulators can request that an assessment be conducted. An interdisciplin- ary research group at the direction of the Institute sets assessment topic priorities. Methods: Clinical trials, expert opinion, modeling, cost analyses, epidemiological and other observational methods. The assessment project consists of a questionnaire, registry (computerized database), followup, intermediary analysis and report, and a final statistical analysis and report. Project presentations are made to the Directory Committee, the Ethical Committee, and the Expert Committee. The CVS assessment will be completed in 1989. Assessors: Assessors have expertise in the areas of community medicine, epidemiol- ogy, human genetics, gynecology, and biostatistics. Assessment reports include: The purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/supported the assess- ment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; properties assessed; procedure used for the assessment; sources of data/information; methods for collecting data/information; methods for analyzing/synthesizing data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how the technology works, including theory, principles. Dissemination: Printed reports, journal articles, advisories to members/constituents. Copies of publications and the final report are available from the Institute. Budget: $60,000. Funding source: 100 percent parent organization. Use: Third party payers and the federal insurance agency have asked to be informed about the project results. Related activities: Project staff participate in international conference on CVS. 240

UNIVERSITY OF LAUSANNE Completed Reports UL1 Gutzwiller F. Grob PI, Boppart I, Marguerat PH, eds. "University of Lausanne, Institute of Social and Preventive Medicine] Swiss alpha-foetoprotein screening working group: results of the collaborative study of early detection of neural tube defects. 1985. tEpidemiolog~cal and other observational methods] University of Pennsylvania Leonard Davis Institute of Health Economics 3641 Locust Walk Philadelphia, PA ~ 9 ~ 04 2 15-898-60 1 1 Contact: Joanne Levy, Assistant Director. Ongoing Assessments UL2 [University of Lausanne, Institute of Social and Preventive Medicine] Evaluation of efficacy and safe- ty of chorionic villi sampling (CVS). Ongoing F(:lini- cal trials] Overview: The Leonard Davis Institute of Health Economics is a not-for-profit re- search institute that emphasizes an interdisciplinary approach to health services re- search. Allied principally with the Wharton School and the University of Pennsylvania's medical school, the Institute is perhaps the earliest effort to build formal partnerships within the same university among the clinical, management, and social sciences. The Institute assesses impact and cost-effectiveness of various health policy practices. Projects in the area of medical technology examine patterns of technology adoption, diffusion, and use, particularly as they relate to management decision-making. Purpose: To promote an interdisciplinary approach to health services research and education in the organization, financing, and delivery of health care. Primary intended users: Providers, generally; physicians; acute facility administrators; long- term care facility administrators; health product manufacturers; health industry associations; government regulators; public policy-makers, legislators. Technologies: Organizational or administrative system, device, medical or surgical proce- dure, support system. Inte~vendon: Prevention, diagnosis, rehabilitation. Stage: Nell', emerging, established or widespread practice. The Institute focuses on health policies that are just coming into practice. Properties: Cost-effectiveness, economic implications, efficacy, effectiveness, cost, cost-bene- fit, acceptance/adoption level, system impact. Selection process: Assessments are initiated by senior fellows of the Institute, individ- ually or jointly, based on their interests, the availability of data, and availability of funding. Investigators respond to requests for proposals or submit unsolicited grant 1 0 ~O O ~ 241

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY proposals to government agencies, foundations, corporations, university funding sources, and providers. Assessment topic priorities are set by the Institute's national advisory council, its governing board, and its executive committee. Followup studies are undertaken when interest persists and funding is available. Methods: Cost analyses, modeling, information syntheses, expert opinion, group judg- ment, epidemiological and other observational methods. Specifically, methods include interviews, on-site observations, and computer modeling and simulation. Medical management models are developed to improve the screening, diagnostic, and treatment decisions of clinicians and to understand resource allocation decisions at a societal level. Descriptive studies examine the actual decision processes used by clinicians when recommending the use of alternative technologies, procedures, and pharmaceuticals. The average project is completed in 18 months although the range is from 4 months to 5 years. Assessors: The Institute draws upon health services researchers in the university community and faculty from a variety of disciplines, including management, insur- ance, medicine, economics, decision sciences, dentistry, law, psychology, nursing, and sociology. Assessment reports include: Abstract; the assessment's intended audience; the pur- pose of the assessment; relationship of this assessment to prior or concurrent assess- ments of the technology or other technologies intended for similar purposes; who sponsored/commissioned/supported the assessment; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; proper- ties assessed; procedure used for the assessment; sources of data/information; methods for collecting data/information; methods for analyzing/synthesizing data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research; how much the assessment cost; how the technology works, including theory, principles; coverage/reimbursement status of the technology. Dissemination: Journal articles; printed reports; advisories to members/constituents; press conferences/news releases, TV/radio broadcasts, video products. Research results are disseminated through published articles in the academic, profes- sional, and popular press; press releases; books; and book chapters. In addition, senior fellows are frequent lecturers at universities, professional conferences, and association meetings. The Institute also has its own publication series. To obtain publications, contact Jennifer Conway, Editor and Manager of Information Services, Leonard Davis Institute of Health Economics, 215-898-4750. Budget: $1,723,300. Funding for current and recent projects has ranged from $3,000 to $612,000 with scope and length of the project being the determining factors. Funding sources: 2 percent parent organization; 42 percent government grants/con- tracts; 56 percent foundations, other private grants. 242

UNIVERSITY OF PENNSYLVANIA Use: The Institute's studies are used primarily by policy-makers, researchers, and practitionersjudging from citations in the literature, speaking invitations, and followup work. Related activities: The Institute conducted a two-part conference on Medicare re- search and policy in 1986 and 1987. Two books will contain the conference papers and presentations. In addition, the Institute sponsors advanced education programs and a seminar series on health services research topics. Completed Reports UP1 University of Pennsylvania, Leonard Davis Insti- tute of Health Economics. A study of voluntary hospi- tal governance. 1986 Sep. (Study for the Robert Wood Johnson Foundation) UP: . Antecedents and consequences of con- tract management. 1986 Feb. (Final report to Nation- al Center for Health Services Research, DHHS) UPS . Cost of generic vs. branded ethical drugs. 1986 fun. (Final report to Ayerst Laboratories) UP4 . Financing options for health care for un- insured poor. 1986 Dec. (Study for North Carolina Hospital Foundation, Inc) UPS . Hospital contract management: structure, process, and outcome. 1986 Apr. (Final report to the Hospital Corporation of America) UPS . Magnetic resonance imaging. 1986 Dec. (Pilot study for University of Pennsylvania) UP7 . Designing and evaluating incentives for ambulatory surgery: a nationwide study. 1986 Dec. (Study for Robert Wood Johnson Foundation) UPS . Adjustment artifacts in DRG-based Medi- care reimbursement. 1985 Aug. (Final report to the National Center for Health Services Research, DHHS) UP9 . DRG's disease staging, and variance re- duction. 1985 Jul. (Final Report to the National Cen- ter for Health Services Research, DHHS) UP10 . The effect of telemetry on advanced life support care. 1984 Apr. (Final Report to the National Center for Health Services Research, DHHS) UPll . Vertically-integrated systems: a prelimi- nary study. 1984 Jul. (Final report to the Center for the Study of Aging, University of Pennsylvania) UP12 . Cost benefit, cost effectiveness, and other decision making techniques in health care resource allocation. 1983. (Proceedings of a Regional Sympo- sium, November 4-6, 1982, funded by Smith Kline and French Laboratories) UP13 . Cost of medical education in West Vir- ginia: policy research and analysis. 1983 Dec. (Final report to the Claude Worthington Benedum Founda- tion) UP14 . The spatial distribution of hospital utili- zation. 1983 May. (Final report submitted to the Na- tional Center for Health Services Research, DHHS) UP15 . A review of the economic benefits of selected health education and promotion activities. 1982 May. (Interim report submitted to Johnson and Johnson Live for Life Program) UP16 . Cost-benefit and cost-effectiveness analy- sis in policymaking: cimetidine as an example. 1982. (Proceedings of an International Symposium, No- vember 22-24, 1981, funded by Smith Kline and French Laboratories) UP17 . Hospital services coordination: a com- parative case study of triad and care program man- agement systems. 1982 May. (A final report to the National Center for Health Services Research, DHHS) UP18 . Methodological limitations of hospital case-mix measures (Task III). 1982 Aug. (Final re- port to the Hospital Research and Educational Trust of New Jersey) UPl9 . Indentifying hospital variables that might improve the incentives in New Jersey's pro- spective hospital reimbursement program (Task II). 1981 Oct. (Final report to the Hospital Research and Educational Trust of New Jersey) UP20 . National conference monograph: evalu- ating the performance of multi institutional systems. 1981 Sep. (Final report to the National Center for Health Services Research, DHHS) UP21 . The causes and significance of clinically inappropriate patient assignments. 1981 Oct. (Final report to the Hospital Research and Educational Trust of New Jersey) 243

MEDICAL TECHNOLOGY AssEssMENr DIRECTORY UP22 . Vertical integration of care for cancer patients: a Markovian approach. 1981 May. (Final report to the Cancer Center, Hospitals of the Univer- sity of Pennsylvania) Ongoing Assessments UP23 . Adoption and diffusion of magnetic res- onance imaging under DRGs. Ongoing. (Study for the National Center for Health Services Research, DHHS) UP24 . Adverse selection in multiple-opi~on group insurance. Ongoing. (Study for National Cen- ter for Health Services Research, DHHS) UP25 . Evaluation of the DEW National Dental Education Program. Ongoing. (Study for the Glen- mede Trust Co) UP26 . Heur~sucs and biases in diagnostic deci- sions. Ongoing. (Study for the National Science Foun- dai~on and the National Library of Medicine) Veterans Administration Cooperative Studies Program (151 I) Veterans Administration Medical Center 150 South Huntington Avenue Boston, MA 02130 617-739-3479 UP27 . Policy implications of hospital contract management. Ongoing. (Project for the Common- wealth Fund) Planned Assessments UP28 . Evaluation of magnetic resonance imag- ing. Planned. (Submitted to Riverside Methodist Hos- pital, Columbus, OH). UP29 . Full Medicare capitation for ESRD bene- ficiar~es: design, implementation, and evaluation of a controlled nationwide demonstration. Planned. (Sub- mitted to the Health Care Financing Administration). UP30 . The cost-quality tradeoff for trauma pa- nents treated in a non-designated trauma hospital. Planned. (Submitted to University of Pennsylvania) Contact: Daniel Deykin, M.D., Chief; or Ping C. Huang, Ph.D., Staff Assistant, Cooper- ative Studies Program, Veterans Administration, 810 Vermont Ave. NW. Washington. DC 20420, 202-872-1 151. Overview: The Veterans Administration (VA) extends to eligible veterans free or highly subsidized health care services, including hospital, ambulatory, and nursing home care. Most of these services are provided at its 172 hospital centers. The VA annually assists about 3 million veteran patients, including about 1.4 million inpatients. The VA also has three major research and development services: the Medical Research Service, the Rehabilitation Research and Development Service, and the Health Services Research and Development Service. The Coonerative Studies Prooram its in the Merli _ _ 1 ~ _ 1 ~· art ~· · ~. _ _ . 1 ~ cat Kesearcn Service. one Program In its present form was instituted in 1972 in recognition of the growing number of multi-hospital studies in the VA medical system. The VA is an especially useful environment for multicenter study because it has a relatively uniform and large patient base under one management. Purpose: To provide coordination and support for multiple medical centers to study collectively a selected medical problem in a uniform manner, using a common protocol. 244

VA/COOPERATIVE STUDIES PROGRAM Primary intended users: Providers, generally; physicians; acute facility administrators; long-term facility administrators; other care rivers: regulators: biomerlicn1 recf`~rrherc public policy-makers. Technologies: Drug, device, medical or surgical procedure, support system. If drugs or devices used in a study require approval from the Food and Drug Adminis- tration, an investigational new drug application or investigational device exemption must be filed with the FDA before the study can begin. Intervention: Diagnosis, treatment, rehabilitation. Stage: Emerging, new, established or widespread practice. Properties: Safe), efficacy, effectiveness, cost-benefit, cost-effectiveness. Selection process: Any eligible (more than 5/8 time) researcher-physician or medical investigator in the VA system can request the support to undertake a cooperative study, by sending a proposal to the Chief of the Program. The Chief may encourage studies in certain areas of special interest to the VA. Proposals are reviewed by experts in the area of the study and then either assigned to a coordinating center for planning, returned to the requester for revision, or rejected. This process culminates in the development of a final protocol that is reviewed by the Cooperative Studies Evaluation Committee, a group of medical and biostatistical experts who serve 3-year terms. The Committee's recommendations are reviewed by the Director of the Medical Research Service. Reassessments are initiated in the same way. Methods: Clinical trials, cost analyses, epidemiological and other observational meth- ods. The majority of VA cooperative studies are randomized clinical trials. A few have been nonrandomized trials and observational studies. Cost analyses are included when appropriate. Five groups share the responsibility for conducting or monitoring a cooperative study: a study group, an executive committee, an operations committee, the cooperative studies coordinating center human rights committee, and the cooperative studies evaluation committee. In general, the study group, executive committee, and opera- tions committee meet prior to patient intake for organizational, information, and training purposes; again 9 months after patient intake; and annually for the duration of the study. The human rights committee meets with the operations committee at least once a year for the course of the study. All cooperative studies undergo an in-depth review by the cooperative studies evaluation committee at 3-year intervals during their active phase. The approximate turnaround time from selection of assessment topic to reporting of findings may range from 1 to 7 years. Assessors: Assessors include physicians and other health care providers, biostatisti- cians, clinical pharmacists, and other experts in the subject matter of the study. 245

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Assessment reports include: Abstract; the purpose of the assessment; relationship of the assessment to prior or concurrent assessments of the technology or other technol- og~es intended for similar purposes; who sponsored/commissioned/supported the as- sessment; who conducted the assessment; description of the technology; properties assessed; procedure used for the assessment; sources of data/information; methods for collecting dataJinformation; methods for analyzing/synthesizing data/information; re- sults; findings or conclusions; limitations of findings; implications of findings for practice; recommendations for practice, future assessments, technology development, research. ~ Dissemination: Journal articles; press conferences/news releases, TV/radio broadcasts, video products. All VA medical centers conducting medical research report regularly to the VA Medi- cal Research Service which maintains an R&D Information System database. An annual report to Congress on medical research in the VA includes summaries of cooperative studies. Results are also presented at scientific meetings and published in refereed journals. Reprints of articles may be requested from the author or through the Pro- gram office. Budget: $14,000,000. The average cost for a clinical trial is $2-2.5 million. Funding sources: 86 percent parent organization; 7 percent government grants/contracts (inter- agency agreements); 7 percent foundations, other private grants. Use: Citations in the published literature to the Program include the following: Institute of Medicine, Committee on Evaluating Medical Technologies in Clinical Use. Assessing medical technologies. Washington, DC: National Academy Press, 1985. fames KE. A model for the development, conduct, and monitoring of multicenter clinical trials in the Veterans Administration. Controlled Clin Trials 1980;1:193-207. Henderson WG. Some operational aspects of the Veterans Administration Cooperative Studies Program from 1972 to 1970 ~r)n.t.rr)~/P~ blip Trip 1 An 1 9na 99~ ~vv~ ~ TV ~ TV v ^ ~ vow ~ ~ ~ ~ ~ ~ · ~ ~ ~ ~ w. Kathe BA, et al. Patients rights and welfare in the VA Cooperative Studies Program. Controlled Clin Trials 1981;4:267-274. Program evaluation: To review the progress and future direction of certain aspects of the Program, evaluations have been made from time to time, as requested by the Director of the Medical Research Service and the Chief of the Program. Congress also has asked the Government Accounting Office to evaluate VA medical research, includ- ing the Cooperative Studies Program. In 1983, evaluations were performed for the Program as a whole and for its cost- effectiveness analysis activities. An ad hoc advisory committee of experts was appointed to conduct site visits, interviews, and group discussions. The committee's recommenda- tions were adopted whenever feasible. Completed Reports VC1 Veterans Administration, Cooperative Studies Program. A randomized clinical trial of total paren- teral nutrition in malnourished surgical patients. Pending. "Clinical trials] 246 VC2 . Anticoagulants in the Rx of CA (RA-233~. Pending. (Clinical trials] VC3 . Bactrim in leukopenia with non-lvmohn- cytic leukemia. Pending. [Clinical trials] ,

VAJCOOPERATIVE STUDIES PROGRAM VC4 . Effects of reduction in drugs or dosage after long term control of hypertension. Pending. [Clinical trials] VC5 . Evaluations of corticosteroid therapy in gram negative sepsis. Pending. [Clinical trialsJ VC6 . Surgical shunt vs. medical treatment in alcoholic cirrhosis ascites. Pending. EClinical trials] VC7 . Treatment of mild hypertension in the aged. Antihypertensive effectiveness and patients' tol eration of different regimens. Pending. [Clinical tri alsJ VC8 . A comparison of hospital and home treat ment programs for aphasic patients. [1980] [Clinical trials] VC9 . Alcoholic hepatitis (steroid therapy). t1980] [Clinical trials] VC10 . Antabuse in the treatment of alcoholics on methadone maintenance. [1980] [Clinical trials] VCll . Anticoagulants in RX of CA (warfarin). [1980] [Clinical trials] VC12 . Clinical studies on captopril: evaluation of low doses, twice daily doses and addition of hydro chlorothiazide. t1980] [Clinical trials] VC13 . Community vs. VA nursing home care vs. hospitalization in psychiatric patients. [1980] EClin ical trials] VC14 . Comparison of propranolol with hydro chlorothiazide for the "step 1" treatment of hyperten sion. [1980] [Clinical trials] VC15 . Disulfiram (antabuse) in the treatment of alcoholism. [1980] [Clinical trials] VC16 . Efficacy of low doses of reserpine plus chlorthalidone in comparison with standard dosage of reserpine plus chlorthalidone in hypertension. cat trials] t1980] [Clinical trials] VC17 . Evaluation of anti-epileptic drugs (phen obarb vs. phenytoin vs. primidone vs. carbamaze pine). [1980] [Clinical trials] VC18 . Evaluation of nadolol in treatment of hypertension. [19801. [Clinical trials] VCl9 . Hepatitis and dentistry. t19801. EClinical trials] VC20 . Nafcillin therapy of staphylococcal bac teremia. [19801. [Clinical trials] VC21 . Oxprenolol vs. propranolol in hyperten sion. t19801. EClinical trials] VC22 . Platelet aggregation in diabetes (use of ASA & persantine). t19801. "Clinical trials] VC23 . Pneumococcal capsular vaccine immuni- ty in high risk patients. [19801. [Clinical trials] VC24 . Prazosin vs. hydralazine in hypertension. t1980] [Clinical trials] VC25 . Renal failure self-care dialysis (hemo vs. peritoneal dialysis). [19801. [Clinical trials] VC26 _ . Treatment and prevention of infection- induced urinary stones in spinal cord injuries. t19801. [Clinical trials] VC27 . Vasodilators used in chronic heart fail- ure (CSP 1534. [19803. [Clinical trials] VC28 . Vasodilators used in chronic heart fail- ure (CSP 191. [1980J. [Clinical trials] Ongoing Assessments VC29 . A five year clinical evaluation of alterna- tive crown and bridge systems (NIDR). Ongoing. EClinical trials] VC30 . A new strategy to preserve the larynx in treatment of advanced laryngeal cancer. Ongoing. [Clinical trials] VC31 . A prospective randomized cooperative study of cochlear implants. Ongoing. EClinical trials] VC32 . A prospective randomized trial of medi- cal and surgical therapies for gastroesophageal reflux disease. Ongoing. "Clinical trials] VC33 . A randomized study of prostatic surgery for moderately symptomatic benign prostatic hyper- plasia in elderly men. Ongoing. [Clinical trialsJ VC34 . Antiplatelet therapy after coronary ar- tery by-pass .araft (CABG) surgery-I. Ongoing. fClini VC35 . Antiplatelet therapy after coronary ar- tery bypass graft (CABG) surgery-II. Ongoing. [Clini- cal trialsJ VC36 . Asymptomatic carotoid stenosis etiologi- cal importance in development of stroke. Ongoing. fClinical trials] VC37 . Clinical comparison of base metal alloys vs. a gold alloy used in the fabrication of fixed (crown and bridge) restorations. Ongoing. [Clinical trials] VC38 . Clinical studies of biphasic calcium phos- phate ceramic in peridontal osseous defects. EClinical trials] 247

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY VC39 . Comparative efficacy of vascular by-pass graft materials in lower extremity revascularization. Ongoing. EClinical trials] VC40 . Cooperative clinical trial of sclerotherapy for esophageal varices in alcoholic liver disease. On- going. [Clinical trials] VC41 . Coronary artery surgery I: stable angina (vein by-pass). Ongoing. [Clinical trials] VC42 . Coronary artery surgery II: unstable an VC50 . Percutaneous transluminal coronary an- gioplasty (PTCA). Ongoing. [Clinical trials] VC51 . Prognosis and outcome following heart valve replacement (non-biological vs. tissue). Ongo- ing. [Clinical trialsJ VC52 . Prospective evaluation of the efficacy & tolerance of oral trimethoprim sulfamethoxazole pro- phylaxis in granulocytopenic parents with acute non- lymphocytic leukemia. Ongoing. [Clinical trials] gina (vein by-pass). Ongoing. [Clinical teals]VC53 . Protein-calorie therapy in combination with anabolic steroids in alcoholic hepatitis. Ongoing. VC43 . Dental Implants (removable vs. perma-. . nent dentures). Ongoing. [Clinical trials][Clinical trials] VC54 . Randomized clinical trial of total paren teral nutrition in malnourished surgical patients. On VC44 . Detection and treatment of influenza A infections in high risk ambulatory care patients. On- going. EClinical trials1 VC45 . Efficacy and toxicity of carbamazepine vs. valproic acid for partial seizures. Ongoing. [Clini- cal trials] VC46 . Evaluations of corticosteroid therapy in severe sepsis. Ongoing. [Clinical trials] VC47 . Lithium treatment in alcohol depend- ence. EClinical trials] VC48 . Monotherapy of hypertension. Ongoing. [Clinical trials] VC49 . Percutaneous transluminal ang~oplasty in the lower extremity. Ongoing. [Clinical trials] Veterans Administration Health Services Research and Development Service (152) ~10 Vermont Avenue NW Washington, DC 20420 In collaboration with: Special Projects Office VA Medical Center (152) Perry Point, MD 21902 301-642-241 1 Contact: Prakash L. Grover, Ph.D., Chief, Special Projects Office. going. [Clinical trials] VC55 . Spontaneous pneumothorax. Ongoing. [Clinical trials] VC56 . Stroke prevention in non-valvular atrial fibrillation. Ongoing. "Clinical trials] VC57 . Treatment of AIDS and AIDS related complex. Ongoing. [Clinical trials] VC58 . Treatment of multiple myeloma directed by in vitro chemosensitivity testing. Ongoing. [Clinical trials1 VC59 . Vasodilators used in chronic heart fail- ure-II. Ongoing. [Clinical trials1 Overview: The Veterans Administration Health Services Research and Development Service (VA-HSR&D) works to improve the health care of veterans by supporting research on the planning, organization, management, delivery, utilization, and evalua- tion of health care. The overall purpose is to generate information and to improve 248

VA/HEALTH SERVICES RESEARCH AND DEVELOPMENT SERVICE understanding of how health services may be provided more effectively, efficiently, and at lower cost without compromising quality of care. The Special Projects Office (SPO) was created in August 1984 to provide scientific, educational, and administrative support to the VA-HSR&D system through the VA Central Office, Washington, DC. The SPO was fully staffed in March 1985, plans for a technology assessment system were developed during the spring 1985, and activities began in June 1985. Purpose: To monitor and evaluate emerging and new health care technologies and to provide information needed by policy-makers and managers regarding adoption and acquisition of such technologies in the VA health care system; and to identify emerging or new technologies that may be useful for improving the health care of veterans. Primary Intended users: Physicians, acute facility administrators, long-term care facili- ty administrators, government regulators, public policy-makers, legislators. Technologies: Device, medical or surgical procedure, support system, organizational or . · . . aummlstratlve system. The SPO assesses any discrete and identifiable regimen or modality used to diagnose and treat illness, prevent disease, maintain patient health and quality of life, or facilitate the provision of health care services. It examines processes of health care delivery aimed at achieving outcomes such as improved health, improved quality of life, optimal use of resources, lower costs, and rational use of health services. Intervention: Diagnosis, prevention, treatment, rehabilitation. Stage: New, emerging. Properties: Cost-e~ectiveness, safety, efficacy, effectiveness, cost, service requirements, · . . . economic Imp 1catlons. Assessments primarily focus on the technical characteristics, established and potential clinical applications, cost-effectiveness, and capital costs of a medical technology. There is some attention to the safety, efficacy, service requirements, and system impact (i.e.,on the VA health care system). When appropriate, modeling is conducted to determine levels of potential utilization and application in veteran populations. Selection process: System level managers in the VA Central Office request that an assessment be conducted. Requests are made to the SPO through the HSR&D in the Office of the Assistant Chief Medical Director, Research and Development. Senior managers in the VA Central Office set assessment topic priorities depending on the projected needs of the VA health care system and financial considerations. Highest priority is given to the assessment of tangible technologies (e.g., diagnostic imaging equipment) that have costs expected to (1) exceed $100,000 per unit, (2) in the aggre- gate exceed $1,000,000 per year, or (3) result in annual use costs Chit in the Rant exceed $10,000,000. ~ At, ~ ~ Methods: Information syntheses, expert opinion, modeling, cost analyses, epidemiological and other observational methods. 249

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY The SPO normally synthesizes existing knowledge from the medical, health services, and health policy literature with the assistance of expert consultants. The staff identi- fies and works with an expert panel of consultants, identifies and reviews published and unpublished literature, solicits expert opinion, analyzes and synthesizes this informa- tion, and develops a draft final report. The draft report is reviewed by VA Central Office managers and expert VA and non-VA consultants. No consensus of expert opinion is developed for the content or findings of the report. The final report generally concerns the technical attributes of the technology, clinical effectiveness, capital acquisition, operational costs, cost-effectiveness, and a summary of findings. The average turnaround time from selection of assessment topic to reporting of findings is 9 months with a range from 6 to 15 months. The amount of time and the resources needed to conduct an assessment vary, depending on the amount of available information and whether it is necessary to collect and analyze primary data. Assessors: The SPO has a staff of three permanent health science specialists that spend some portion of their time in technology assessment activity. Areas of expertise include health care, social science, statistics, public health, and evaluation. Outside consultants are contracted to conduct review and draft reports. Consultants are recruited from universities, private research organizations, and the government. Assessment reports include: Abstract; the purpose of the assessment; relationship of this assessment to prior or concurrent assessments of the technology or other technol- ogies intended for similar purposes; who conducted the assessment; description of the technology; stage of life-cycle of technology when assessed; properties assessed; proce- dure used for the assessment; sources of data/information; methods for collecting data/ information; methods for analyzing/synthesizing data/information; results; findings or conclusions; limitations of findings; implications of findings for practice; recommenda- tions for practice, future assessments, technology development, research. Two types of reports have been developed: a technology assessment information synthesis and a technology assessment. The information synthesis reports are more narrowly focused on new and emerging medical technologies or specific issues in technology assessment. A technology assessment involves a more comprehensive evalu- ation of the performance standards; safety; efficacy; clinical effectiveness; cost-effec- tiveness; the immediate and long-term social, economic, and organizational conse- quences of the new medical technology; and guidance on policy questions regarding its acquisition and use. The information synthesis report usually covers one or more of the issues within a technology assessment. Dissemination: Printed reports, journal articles. Following approval by the VA Central Office, the SPO disseminates reports to the VA Central Office managers and VA medical center clinicians and administrators. On request, the reports are transmitted to other government agencies, universities, profes- sional associations, and private organizations. Copies of the reports may be obtained by contacting the SPO at 301-642-2411 Ext. 5442 or the Director, HSR&D, VA Central Office (1523, 810 Vermont Ave. NW, Washington, DC 20420, 202-233-2666. Budget: $100,000. The approximate cost per assessment is $30,000 to $50,000. Fund- ing source: 100 percent parent organization. 250

VA/HEALTH SERVICES RESEARCH AND DEVELOPMENT SERVICE Use: The Chief Medical Director of the VA recently commissioned a task force to develop policy options on technology assessment, including those focusing on formaliz- ing ways to use the products of assessment in planning the acquisition and location of new medical technology for the VA. Completed Reports VH1 Health Systems Research and Development Divi- sion. [Veterans Administration] Management of tech- nology assessment. Perry Point, MD: Special Projects Office, Health Systems Research and Development Division, Veterans Administration, in preparation, expected 1987. VH2 Health Systems Research and Development Divi- sion. [Veterans Administration] Technology assess- ment of magnetoencephalography (MEG). Perry Point, MD: Special Projects Office, Health Systems Research and Development Division, Veterans Ad- ministration, in preparation, expected August 1987. VH3 Goldschmidt PG. [Veterans Administration] Health services research and development: the Veter- ans Administration program. Health Serv Res 1986;20~6~:Part II 789-824. VH4 Health Services Research and Development Serv- ice. "Veterans Administration] Nuclear magnetic res- onance imaging: information synthesis on clinical ap- plications and cost considerations. Perry Point, MD: Special Projects Office, Health Services Research and Development, Veterans Administration, April 1986. VH5 Health Services Research and Development Serv- ice. "Veterans Administration] Technology assess- ment of extracorporeal shock wave lithotripsy (ESWL). Perry Point, MD: Special Projects Office, Health Services Research and Development, Veter- ans Administration, 1986. VH6 Health Services Research and Development Serv- ice. [Veterans Administration] The cost-effectiveness of lithotripsy: an information synthesis. Perry Point, MD: Special Projects Office, Health Services Research and Development, Veterans Administration, 1986. 251

MEDICAL TEC~OLOGY ASSESSMENT DIRECTORY ASSESSMENT REPORT CODE PREFIXES The assessment report citations listed in Part 1 are grouped by sponsoring assessment program. Each citation has been assigned a unique code consisting of a prefix designat- ing the sponsoring program and a sequential report number. This list contains all the report code prefixes and the corresponding program. The prefixes are arranged alphabetically; the first letter of the prefix is the first initial of a program's name. The Index to Assessment Report Citations guides the user to a specific report code. Prefix Program Name AA - American Academy of Neurology, Prac- tice Committee AB - American Academy of Ophthalmology, Ophthalmic Procedures Assessment Program AC - American Academy of Pediatrics AD - American College of Cardiology/Ameri- can Heart Association Task Force on Assessment of Diagnostic and Thera- peutic Cardiovascular Procedures AE - American College of Obstetricians and Gynecologists, Committee Opinions AF - American College of Obstetricians and Gynecologists, Committee on Techni- cal Bulletins AG - American College of Physicians, Clinical Efficacy Assessment Project AH - American College of Radiology, Task Force on Breast Cancer A] - American Dental Association, Council on Dental Materials, Instruments, and Equipment AK - American Dental Association, Council on Dental Therapeutics AL - American Diabetes Association AM - American Gastroenterological Associa- tion, Patient Care Committee AN - American Hospital Association, Hospital Technology Series Program AO - American Medical Association, Council on Scientific Affairs 252 Prefix Program Name AP - American Medical Association, Diagnos- tic and Therapeutic Technology As- sessment AQ - American Medical Association, Drug Evaluations AS - American Society for Gastrointestinal Endoscopy BA - Battelle Memorial Institute BC - Blue Cross and Blue Shield Association, Medical Necessity Program BS - Blue Cross and Blue Shield Association, Technology Evaluation and Coverage Program CA BU - Brandeis University Health Policy Center - California Medical Association CB - Centraal Begeleidingsorgaan voor de In- tercollegiale Toetsing,-National Orga- nization for Quality Assurance in Hos- pitals CP - College of American Pathologists CU - Congress of the United States, Office of Technology Assessment DC - Duke University, Center for Health Poli- cy Research and Educating EH - ECRI Health Devices Program ET - ECRI Technology Assessment Program FA - Food and Drug Administration, Center for Devices and Radiological Health ID - Food and Drug Administration, Center for Drugs and Biologics

INDEX TO REPORT CITATIONS Prefix Program Name GU - Georgetown University Medical Center, NH Institute for Health Policy Analysis HA - Harvard School of Public Health, NK Institute for Health Research HC - Hastings Center HE - Health Care Financing Administration, Office of Research and Demonstra tions HN - Health Council of The Netherlands HW - Health and Welfare Canada PA OH - Johns Hopkins Program for Medical PH Technology and Practice Assessment pp KE - Kings Fund Centre for Service Develop- ment LE - Lewin and Associates, Inc. LU - Linkoping University, Center for Medi- cal Technology Assessment MG - McGill University, Department of Epide- miology and Biostatistics MM - McMaster University, Department of Clinical Epidemiology and Biostatistics MR - Medical Research Council, Canada MT - Medical Technology and Practice Pat- terns Institute NA - National Center for Health Services Re- search and Health Care Technology Assessment, Division of Extramural Research NC - National Center for Health Services Re- search and Health Care Technology, Office of Health Technology Assess- ment ND - National Health Research and Develop- ment Program (Canada) Prefix Program Name - National Heart, Lung, and Blood Insti- tute - National Institute of Child Health and Human Development NL - National Institutes of Health, Consensus Development Program NM - National Library of Medicine NS - Netherlands Organization for Applied Scientific Research - Policy Analysis, Inc. - Project HOPE - Prospective Payment Assessment Com- mission SC - Steering Committee on Future Health Scenarios SP - Swedish Planning and Rationalization In- stitute of the Health Services - United Kingdom Department of Health and Social Security - U.S. Administrators, Inc. - University of California, San Francisco, Institute for Health Policy Studies UL - University of Lausanne, Institute of So- cial and Preventive Medicine UP - University of Pennsylvania, Leonard Da- vis Institute of Health Economics VC - Veterans Administration, Cooperative Studies Program VH - Veterans Administration, Health Serv- ices Research and Development Serv- ~ce UA UB UP 253

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY INDEX TO REPORT CITATIONS Abortion AC94, AF34, HC3 Abortion, Missed AF33 Absorptiometry NC126 Absorptiometry- Dual photon BS1, BS2, ET3, ET50, NC5 Absorptiometry Single photon BS2, NC12 Accident prevention CU25, HF161 Accidental falls HF161 Acetaminophen FD101, MR37 Acetohydroxamic acid FD1 Acidulated phosphate fluoride MG2 Acne AC58, HA3 Acoustic impedance tests CA12 Acquired immunodeficiency syndrome AC14, AO33, CU27, HN23, HN34, UB1, VC57 Actinomycosis AG72, NC64 Activities of daily living AC8, ND95, ND146 Acupuncture AA35, AO60 Acute Physiology and Chronic Health Evaluation see APACHE 254 Acyclovir D56 Adaptation, Psychological ND8, ND23, ND43, ND170, ND172, ND198 Adenoidectomy NL57 Adhesives AJ37 Administration, Cutaneous ET71 Administrative personnel NA41 Admission testing, Routine BC37, BC38, UB3, UB73 Adolescence AC14, AC51, AC66, AC76, AC83, AC109, DC14, HW5, ND178, ND184 Adolescent medicine HW13, ND81, ND174 Adolescent psychiatry HW16 Adrenal cortex hormones NH78, VC5, VC46 Adrenal gland neoplasms HA1 Aerosol therapy BC42 Affective disorders NL23 Aged AO42, CU9, DC5, DCl9, HF66, HF93, HF117, HF159, HF161, HF179, HW20, NA60, NA87, NA110, NA129, NDll, NDl9, ND28, ND61, ND118, ND181, ND182, NH4, NH16, NH21, NH71, NH76, NH81, NL62, VC7, VC33

INDEX TO REPORT CrrATIONS Agranulocytosis VCS2 Aid to Families with Dependent Children HF5, HF43 AIDS-related complex VC57 Airway obstruction AC5, AO37 Alberta ND166 Albuterol FD57 Alclometasone FD31 Alcohol drinking AO44 Alcoholic beverages AO51 Alcoholism AC46, AG3, CA3, CA41, CU47, DC3, HF7, HF8, HF9, HF10, HF11, HF12, HF86, NC61, NC99, NC132, ND25, ND55, ND141, UB99, VC10, VC15, VC40, VC47 Allopurinol FD2, FD3 Alopecia areata UB5 Alpha fetoprotein assays FA95, FA107, FA131, FA135, FA159, FA164, FA214, FA215 Alprazolam FD58 Alprostadil FD59 Alternative medicine CU4, HN36 Aluminum NC10, ND83 Alzheimer's disease ND83, UB101 Amantadine NL44 Ambulances AC2 Ambulatory care AA24, AA30, AD4, AG32, HF88, HF113, NA34, NA56, NA82, NC13, NC30, NC63, ND33, ND104, ND109, ND133, ND139, ND174 Ambulatory care facilities HF54, HF206, HN21, NA7, NA121, NC127 Ambulatory care information systems UFO Amcinonide FD60 American Association of Retired Persons HF14 Amiloride FD61, FD62 Amino acids FD55 Aminocaproic acids FD32 Aminoglutethimide FD126 Aminophylline FD63 AMIS see Aspirin Myocardial Infarction Study Amoxicillin FD127 Amputees ND131, ND192 255

MEDICAL TEC~OLOGY ASSESSMENT DIRECTORY Amyotrophic lateral sclerosis AA15, AA19 Analgesics NL18 Androgens MR40 Anemia, Aplastic NC14 Anemia, Sickle cell NL54 Anesthesia AC22, AF23, CA96, ET32, ET41, HN7, ND29 Anesthesia- Epidural BS17 Anesthesiology HC10, HN29 . Anglna pectoris LU16, NH146, NH150, NH153, VC41, VC42 Angiographic injectors FA193 Angiography ADO, BCl 9, UA2 Angiomas AS3 Angioplasty UB30 Ankle joint ND88, ND106 Anorexia nervosa HN37, ND47 Anoxemia NH74, NH141, NH142 An thelmin tics AC98 256 A. . ntlanxlety agents AO69 Anti-arrhythmics MR25 Antibiotics AFT, HN31, NA38, NA39, NA40, NA100 Antibiotics Intravenous LE1 Antibiotics Prophylactic AC40, AC41, AE9 Antibody formation AG66 Anticholinergics CA13, NA87 Anticoagulants BC16, VC2 Anticonvulsants AC21, AC84, AE10, NA86 Antidepressants AO69, ND153 Antihypertensives NH1, NH14, NH22, NH32, NH48, NH53, NH73 Anti-inhibitor coagulant complex NC112 Antilymphocyte serum AG61 Antenatal steroid administration see AST Antineoplastics handling AO17 Antiplatelet therapy VC34, VC35 A ntlpyresls MG16

INDEX TO REPORT CITATIONS Anxiety AP32, NA20, ND25, ND175 Aorta, Thoracic NC49 APACHE NA80, NA81 Aphakia NC121 Aphasia AA18, VC8 Apheresis AA3, AA4, AA7, AA36, AG22, AG34, CU49, ET44, HN17, NC2, NC15, NC31, NC32, NC55, NC76,NC97,NC117,UB85 Apnea CA2, CA10, NC4, NK1, UB115 Apnea monitoring APl 9, BS33, NK1, NL8 Apnea monitors FA326 Appropriateness Evaluation Protocol HF26, HF1 73 Apraxia ND120 Arizona HF83 Arm ND131, ND192, PP9 Arousal ND56 Arrhythmia MR25, NH3, NH31, NH79 Arrhythmia monitors AN26, EH11, EH38 Arterial occlusive diseases DC1, VC36 Arteries BC2, UB65 Arteriography NH71, UB29 Arteriosclerosis ND182 Arteriovenous fistula NC48 Arteriovenous malformations CA33 Arthritis AG14, AG73, CA95, NC85, NC113, UB7, UB9 Arthritis, Rheumatoid AG34, CA36, CA37, CA84, CA90, CA99, LUll, NC102, NC111, NC115, NC116, NC117, ND4, ND186 Arthroscopy CA39, ET75, UB10, UB11 Artificial heart CU61 Artificial pancreas MR1 Artificial procreation HN4 Artificial sweeteners AL2 Ascites VC6 Aspartame AO12 Asphyxia MR8 . . Asplrln AC72, MM17, NHl 9, NH123, NH124, NH125, NH128 257

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Aspirin Myocardial Infarction Study NH30, NH36, NH46, NH123, NH124, NH125 Assertiveness NDS1 AST NH13, NH41, NH111 Asthma AC110, MG14, ND86 Atenolol FD128 Atherosclerosis ET38, NC103, ND74, ND182, NH8, NH9, NH63, NH87, UB37 Atopic syndrome CB1 Atrial fibrillation VC56 Attention deficit disorder with hyperactivity HN22, HN54, ND65, ND140, NL32 Audio-visual aids ND93, NM6, NM12 Audiometry tests ND142 Autoimmune diseases MR38 Automated microbiology systems ET27, ET28, FA85 Automatic data processing AN12, HF6, HF129, HF130, NA24, NA49, NA82 Automation NA28 Automobile passenger restraints AF17, CU54 Autopsy AA8, AO13 258 Autotransfusion units AN23 Aversion therapy AG3, CA41, NC99, NC132 Azatadine FD64 Azathioprine FD129, MG17 Azlocillin FD65 Bacampicillin FD66 Back CA57, CB19 Backache AP38, CA51, HA15, ND105, UB95 Bacterial antigens CA108 Bacterial infections VC5, VC46 Bacterial vaccines AC29, VC23 Balance training devices ND36 Balloon dilatation catheters FA4, FA67, FA280 Barbiturates CA59 Barium enema with sigmoidoscopy ND58 Batteries, Electric EH12 BCG immunotherapy AP4

INDEX TO REPORT CITATIONS BCG vaccine ND94 Beclomethasone FD130 Bed conversion HF76 Beds, Electric EH4 13ehavior ND103 Behavior therapy NK9 Behavioral medicine ND21, ND82, ND165 Behavioral sciences NMS, NM10 Bendien's test NC77 Bendroflumethiazide FD45 Benoxaprofen FD67 Bentonite flocculation test AG62, NC102, NC115 Benzyl alcohol AC56, AC61 Beta-Blocker Heart Attack Trial NH2, NH3, NHl l, NH12, NH30, NH31, NH39, NH44, NH45, NH62, NH70, NH72, NH79, NH105, NH106, NH115, NH126 Beta blockers NH2, NH57, NH70, UF2 Beta-carotene NH19 Betamethasone FD4, FD5, FD6, FD33 Bethanidine FD131 BHAT see Beta-Block~r Heart Attack Trzal Bibliographic information bases NM11 Bibliographic information bases- Training NM18 Bibliography NM5, NM17 Bile acids and salts NC28 Biliary tract diseases ND53 Bilio-pancreatic bypass CA60 Bilirubin ND155 Bilirubinometers ET65 Biochemical analyzers UA10, UA25, UA28 Biochemical profiles BC3 Biocompatible materials NL31 Bioethics HC4, HC5, HC6, HC7, HCl l, HN78 Biofeedback AA10, AA25, AA44, AG23, AG24, AG25, AG26, AP29, CA61, ND86, ND151, UB13 Biomechanics MR45 Biometry NA30 259

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Biopsy AG28, CA42 Biopsy Endometrial AE8 Biopsy Fetal blood AF41 Biopsy Renal MG18 Biotechnology HN38, SC2 Bipolar disorder MR10, ND1 Birth weight MG8 Blacks NH42, PA2 Bladder neoplasms AP4 Blindness ND136 Blood ND111 Blood banks CU20 Blood cell count BC8, CP10 Blood chemistry analysis NA28 Blood chemistry analyzers CU66, HA20, UA12 Blood coagulation factors NC112 Blood cultures BC4 260 Blood donors ND111 Blood gas monitoring BC2, BC39, MT7 Blood gas monitors EH1, EH29, EH35, ET70, ET88, FA66, FA208, FA260, FA273, FA289, FA303, FA311, FA314 Blood glucose control devices NC57 Blood glucose monitoring AG46, AL1, AL6 Blood glucose monitors CA106, NC84 Blood platelets ND114 Blood pressure NH110 Blood pressure monitoring AG17, AG67, BS5, CA85, GU5, JH9, MT1 NA85, NC7, NC63, NC75, NL47 Blood pressure monitors AN21, EH9, ET73, NS10 Blood substitutes ET74 Blood transfusion CB20, CP6, NL54, UB86 Blood transfusion-Autologous UB9O Blood urea concentration BC5 Blood warmers EH20, NS5 Blue light AJ5 Body weight MM3, ND9, NH50

INDEX TO REPORT CITATIONS Bolen's test NC78 Bone cements FA54, FA175, FA176, MR21 Bone growth stimulation BS14, UB91 Bone growth stimulators ET83, FA7, FA12 Bone mineral studies AG12, CA81, NC79 Bone neoplasms BC33, NL21 Bone prosthesis FA327 Boston elbow CU37 Bottle feeding AC104 Botulinum toxin AB8 Brachial plexus AP8 Brain MR4 Brain death HN25 Brain diseases NK3, NL62 Brain edema AA2 Brain electrical activity mapping UB12 . . . . Braln 1ngurles · AP15,CB16 Brain scan BC34 Breast diseases AF21, AH5, NC153 Breast feeding AC73, AC79, AC88, AC105, AC112, AE16, HN40 Breast imaging BC30, UB15 Breast neoplasms AE15, AH4, AH6, AO29, AP7, AP22, DC11, KF1, MR36, NC73, ND170, ND180, ND198, NH88, NL13, NL36, NL51, NL52, SP16, UB2 Breath tests AG43, AG44, AG45, AG51, AG59, NC28, NC29, NC67, NC68 Breech presentation AF6 British Columbia ND109, ND180 Bromocriptine AE1, FD132 Bronchi BS31 Bronchial spasm ND86 Bulimia HN37, MR15, ND47 Bumetanide FD8, Fug Bupivacaine FD68 Buprenorphine FD69 Burn units HW4, NA68 261

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Burns NA103, ND172, NL60, PP1 Bypass graft materials VC39 Caerulein FD73 Caffeine Cannabis AO65, AO74 Capitation payment HF13, HF33, HF51, HF79, HF133, PH13, UP29 Capsules AG70 AO26 Capsulotomy BS30 Calcium channel blockers AO36 Calcium chloride FD70 California HF31 Camphor AC97 ~ . ~amplng AC49 Campylobacter ND188 Canada MR4 Cancer screening AE17 Cancer screening Breast AG31, DC6, DCl 9, ET45, HN67, ND84, NL63 Cancer screening- Cervical AF13, CU62, DC7, DC28, ND15 Cancer screening Colorectal CU72, DC8, DC15, DC27, NL58 Cancer screening Lung CAl9, DC10, ND14, NL59 Cancer staging AF37 262 Captopril FD133, VC12 Carbamazepine FD71,MR15,VC17,VC45 Carbon dioxide ET41, FA208, HN1, MT7 Carcinoembryonic antigen assays BC6, FA60, FA130, FA157, NL37, UB93 Carcinogens CU5, CU74, ND149 Caranoma AFl l, AF12, AFl 9, CA72 Cardiac catheterization AG32, BCl 9, NC127, ND85 Cardiac enzyme assays BC7 Cardiac monitors FA183, FA196, NC150, NS7 Cardiac pacemakers AD3, AO23, BC24, CA43, EH31, ET22, ET80, ET81, FA25, FA68, FA70, FA71, FA78, FA87, FA92, FA169, FA199, FA200, FA205, FA242, FA259, FA2 66, FA2 76, FA299, FA323, GU4, NS9, PH6, PP2 Cardiac rehabilitatior1 AGl l, AO68, AP5, BC23, NC128, ND92, UB18

INDEX TO REPORT CITATIONS Cardiokymography AG18, AP21, BC18, ET4, NC25, NC56, NC130 Cardiology HA9, HA16 Cardiovascular surgery SC6 Carmustine AA26, CA87 Carotid arteries AG55 Carotid artery AGO Carotid artery disease UB20 Carotid body resection NC17 Carotid endarterectomy NC131, UB94 Case management HF35, HF72 CASS see Coronary Artery Surgery Study Cataract MR43, ND108 Cataract extraction AB5,CA14,DC20,PH11 Catheters FA249, FA250, FA2 75, UB83 Cefotaxime FD1 74 Cell counters FA185 Cell counts CA65 Centrifuges UA35 Cephradine FD72 Cerebral artery anastomosis UB21, UB22 Cerebral ischemia MM4 Cerebral palsy AA27, AA33, ND97, ND106 Cerebrospinal fluid shunt valves FA181 Cerebrovascular disorders AA1, BC28, CU30, LU10, MG23, MM17, NC147, ND36, ND64, NH91, SP2, VC36, VC56 Certification NA41 Cervical cap ND73 Cervical dilators FA57, FA235 Cervical vertebrae CA18 Cervix dysplasia AE5 Cervix neoplasms AF19 Cesarean section AF23, NK5, NL39 Challenge food testing CA50, CA54, CA82, CA84, NC110 Charcot-Marie disease CA25 Chelation therapy AO27, ND83 263

MEDICAL TEC~OLOGY ASSESSMENr DIRECTORY Chelation therapy EDTA AP31, NC103 Chelation therapy Penicillamine ND22 CHEMLINE NM8, NM9 Chemonucleolysis ET61 Chemotherapy Cancer MR36, NC66, NC140, NC142, NL13, NL36, PP5, UB2, UB23 Chest pain ND21, UB24 Child AC5, AC8, ACll, AC14, AC18, AC22, AC23, AC29, AC30, AC31, AC33, AC39, AC40, AC60, AC65, AC66, AC68, AC71, AC76, AC91, AC103, AC109, AF17, AO3, AP20, BC31, CA2, CA7, HW5, MG14, MR22, NA120, ND56, ND67, ND101, ND127, ND133, ND134, ND140, ND165, ND184, ND Child abuse AC9, AO11, AO50 Child behavior disorders ND7 Child care ND171 Chiropractic UB25 Chlamydia infections AF8 Chlorhexidine FD134 Chlorpheniramine FD135, FD164 Chlorthalidone NH17,NH18,NH21,VC16 Cholangiography AM2, UB26 Cholangiopancreatography AG36 Cholecystectomy UB27 Cholecystography FA116 Cholelithiasis AO48, ND196 Cholesterol AC10, NA120, ND169, NH10, NH56, NH129, NL22, PA5 Cholestryamine NH38, NH54, PA1 Child health services Chorionic villi sampling ACl9, CU10, CU12, HF97, HF124, HW13 BS9, CA16, ET5, ND57, UL2 Child, Hospitalized AC3, AC27, NA9, ND62 Child r~utrition AC10, AC64, AC77, AC80, AC87 Child, Preschool AC115, ND44, ND179, ND183 Chile DC17, DC21 264 Chromatogenesis assist devices FA147 Chromosome abnormalities ND78 Chronic disease ACl9, NA63, NA64, ND101 Chymopapain FD34, HN41

INDEX TO REPORT CITATIONS Ciclopirix olamine FD35 Cimetidine CU64, HA18, LU2, UP16 Cine-CT AN4 C i n gu lo to my AA14, AP18, NC26 Circumcision AC114 Classification AJ12, =9, HF38 Clinical laboratory information systems AN25, NA36 Clinical Study of Intermittent Positive Pressure Breathing NH77, NH114 Clinical trials CU48, MG29, MR44, NA4, NA51, NA115, NH30, NH84, NH93, NH149, UB55 Clinical trials Randomized NA3 Clonidine FD10 Clorazepate dipotassium FD136 C lo trim azole FD11 Cluster headache AA17 Coagulation assays CP2, CP8 Cochlear implantation MT3 Cochlear implants AO38, CA97, ET15, ET69, FA156, MT4, NC3, UB28, VC31 Cochleostomy AA29 Codeine AC103 Cognition ND34, ND145 Cognitive therapy ND21, ND47 Colitis, Ulcerative AS20, ND89 Collagen implants BS10, CA62, ET62 Colonic neoplasms AS6 Colonic polyps AS19 Colonoscopy AG27, AS6, AS13, ASl9, AS20, ND58 Colorectal neoplasms AG27, CB2, ND166 Coma CA59, ND134 Combined modality therapy AO28, ND105 Communicable diseases CA35, CA70 Communication AF38 Communication aids for the handicapped CU43, CU57, ND95 Community health aides HF52 265

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Community health centers NA66 Community health services HF50, HF75, HF78, HF88, HF189, HF192, HF202, HF206, ND129 Community mental health services ND152 Competition AO40, CU55, HF46, HF84, HF137, HF185, HF209 Competitive bidding HF48, HF49, HF69 Computed tomography AG16, AO72, CA44, CU79, ET23, HAT, HAll, HA22, HA23, HA26, HA32, HW17, SP13 Computed tomography Bone mineral assess ments ET3, NC125 Contact lens lubricants Computed tomography HeadFA81, FA281, FA294 AP15, BC28, BC31, HA35, MG28, NL34, UB16 Contact lens markers Computed tomography-Liver and spleen FA252 UB106 Computed tomography-Pancreas HA21, HA24 Computed tomography-Spine CA63, UB17 Computed tomography scanners AN13, CU71, CU88, ET36, HA36, ~H10, UA6, UA17 Computer-aided design ND35 Computer-assisted diagnosis ND9O Computer communication networks NA117 Computer simulation LU18, NA25, NA72, NA92, NA125 266 Computer software HF184, ND87 Computers AC34, CU86, NA15, NA18, NA85 Connecticut HF11 Consumer participation HF44, HF45 Consumer satisfaction HF2 Contact lens cleaners FA5, FA9, FA13, FA15, FA16, FA17, FA18, FA20, FA36, FA37, FA38, FA43, FA75, FA79, FA80, FA82, FA90, FA102, FA103, FA105, FA145, FA162, FA216, FA217, FA218, FA221, FA222, FA226, FA227, FA229, FA231, FA232, FA233, FA241, FA246, FA253, FA257, FA258, FA261 Contact lenses ABl l, CU38, FAT, FA2, FA23, FA24, FA40, FA41, FA74, FA91, FA97, FA98, FA104, FA126, FA128, FA129, FA132, FA152, FA153, FA154, FA160, FA168, FA170, FA198, FA207, FA210, FA228, FA238, FA243, FA251, FA254, FA263, FA267, FA310, FA321, FA325, GU10 Contact lenses, Hydrophilic FA14, FAl9, FA21, FA22, FA29, FA30, FA64, FA65, FA72, FA83, FA94, FA96, FA101, FA133, FA141, FA143, FA144, FA146, FA148, FA150, FA155, FA161, FA173, FA197, FA202, FA203, FA211, FA213, FA234, FA239, FA245, FA264, FA2 79, FA288, FA290, FA296, FA300, FA313, FA329 Continuous ambulatory peritoneal dialysis AO52, CU31, FA248, HA7, MG30

INDEX TO REPORT CITATIONS Continuous passive motion devices BS12, EH2, ET31 Continuous passive motion therapy CA64 Continuous positive airway pressure BS28 Contraception AC79, AC83, AE6, AE16, ND178 Contract services HF197, UP2, UP5, UP27 Contralateral breast surgery CA6 Convulsions, Febrile NL42 Cooperative Study of Factor VIII Inhibitors NH139 Copper AJ27 Corneal diseases AB11 Corneal endothelial cell microscopy BS13, DC20 Corneal grafts ND13 Coronary Drug Project NH112, NH128, NH129 Coronary arteriosclerosis NH38, NH84 Coronary artery bypass grafting AG1, HA17, HA37, KF2, NA51, NA52, ND43, NH16, NH34, NH40, NH64, NH65, NH66, NH67, NH68, NH69, NH71, NH80, NH96, NH104, NH109, NH117, NH119, NH134, NL40, VC41, VC42 Coronary Artery Surgery Study NH16, NH34, NH40, NH64, NH65, NH66, NH67, NH68, NH69, NH71, NH75, NH80, NH89, NH95, NH96, NH101, NH104, NH108, NH109, NH113, NH117, NH119, NH133, NH134 Coronary care units BC22, UB31, UB110 Coronary disease HA13, NA8, NA22, NA31, NA48, NA70, NA71, NA91, NA133, NA134, ND42, ND80, NH15, NH16, NH33, NH36, NH51, NH54, NH55, NH56, NH67, NH80, NH89, NH96, NH101, NH108, NH109, NH112, NH113, NH128, PA1, PA5 Coronary Primary Prevention Trial NH35, NH55, NH56, NH58, NH93, NH135, NH145 Coronary stenosis NA133 Coronary vessels ET43 Cost benefit analysis BA2, CP3, CU62, CU65, CU66, CU67, CU81, CU83, DCl9, HA3, HA12, HA13, HA16, HA17, HA18, HA20, HA30, HA33, HA34, LE1, LU4, LU5, LU14, LU18, LU20, MG5, MGll, NA34, NA48, NA54, NA58, NA113, NA125, NA128, ND24, ND121, PA1, PA2, PA3, PA4, PA5, PA6, PH12, SP1, UP16 Cost control GU4, HA2, HF2, HF44, HF52, HF63, HF83, HF173, HF180, HF184, HF199, NA77, PH4, UF4, UF9 Costs and cost analysis BA1, CU34, CU47, CU62, CU63, DC24, HA5, HA7, HA14, HA29, HA34, HC5, HF18, HF39, HF42, HF46, HF66, HF107, HF117, HF123, HF152, HF201, ~H7, LU6, LU7, LU8, LU10, LU12, LU17, NA43, NA66, NA74, NA101, NA103, NA112, UP13, UP30, VH4 267

MEDICAL TEC~OLOGY AssEssMENr DIRECTORY Cough AC103 Counseling AC52, AC94, ND4, ND101 Creatinine concentration, Serum BC5 Critical care NA111, NA112, NA116, NA122, NL25 Cross infection AF40, HN33, HN64, ND54 Cryometers FA186 Cryopreservation MR39, ND78 Cryosurgery AE5 Cryptorchism CB9 Cushions ND19 Cyanoacrylates AB10 Cyclophosphamide CA17 Cyclothiazide FD137 Cystic fibrosis ND72 Cytotoxic food testing AG69, CA46, NC101 DTPA FD102 Dacarbazine FD138 268 Data banks HF135, MR44, NH95 Data collection ND7, ND53 Databases NA89 Day care HW12, HW20, HW23 Deafness CA97, ND136 Death ET32, NA93, NH46 Death, Sudden NH6 Debridement NC18 Decision making HA9, HAl9, HF14, HF115, LE2, NA5, NAll, NA84? NA86, NA99, NL1, UP12, UP26 Decision making, Computer-assisted FA182, MR7, NAT, NA104, NA119 Decubitus surgery UB32 Decubitus ulcer AG49, CB10, CB13, NC74, NC104, NC122, ND19 Deferoxamine NC10 Defibrillation NA26, NA62 Defibrillators BS6, EH30, ET2, FA106, FA179, ~H6, NC20, NS3, NS4, PP4, UB19 Deglutition disorders NC134

INDEX TO REPORT CITA=ONS Delivery AC99, MR8 Dementia AO15, BC28, NL2 Demography NH47, NH152 Dental alloys AJ7, AJ12, AJ25, AJ27, AJ36, AJ40, AJ46, VC37 Dental amalgam AJ21, AJ27, AJ39, AK1 Dental amalgamators AJ22 Dental anesthesia HN6, NL14 Dental bonding AJ1, AJ17, AJ18, AJ29 Dental bridges VC29, VC37 Dental care NA60 Dental caries AC104, AK10, MR12, NA13, NL26 Dental caries removal systems FA73 Dental cements AJ16 Dental ceramics VC38 Dental crowns AJ6, AJ7, VC29, VC37 Dental facilities AKS Dental implants AJ2, AJ10, AJ44, LU8, LU12, NL56, VC43 Dental insurance NA60 Dental materials AJ6, AJI O. AJ32, AJ34, FASO, FA265 Dental plaque AK3 Dental porcelain AJ36 Dental radiography AJ15, AJ26, AJ41, FA47, FA117 Dental resins AJ3, AJ4, AJ18, AJ23, AJ31 Dental scaling and stain-removal devices AJ8 Dental sealants AJ20, NL26 Dental sterilization devices AJ38 Dental visible light-curing units AJ9, AJ33 Dentin sensitivity AK4, MG1 Dentistry AJ13, AJ14, AJ42, AK9, HN7, NA3, NA4, VC19 Denture cleansers AJ19 Denture, Partial AJ7, AJ45 Dentures VC43, AJ34 Depression AP32, CA82, ND147 Depressive disorder SP9 269

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Desensitization, Immunologic AG75 Desoximetasone FD75 Developing countries CU3, DC23 Developmental disabilities screening AC7, ND185 D exam e th as o ne NH13, NH41, NH111 Dexamethasone suppression test AG60 Dextromethorphan AC103, FD36 Diabetes mellitus AF3, AG52, AG53, AG54, AL3, AL4, AL7, AL9, CBl l, HW23, MG6, NC37, ND17, ND99, ND154, UB33 Diabetes mellitus, Non-insulin-dependent AO71, NL6 Diagnosis AL9, UP26 Diagnosis, Cardiovascular HA13 Diagnosis, Differential NL2 Diagnosis, Laboratory NC11 Diagnostic errors UP21 Diagnostic services CU2, HF49 Diagnostic tests, Routine BC10, BCl l, CP1, CU2, NA74, NA75, NA97 270 Dialysis HNS, HN43, MG3, MG4, MG6, MG1S, MTS, MT6, NCl l, ND6 Diarrhea NL17 Diathermy AP33, FA125, NC59, NC108 Diazepam FD139, NA10 Diet ND65, NH143, NL6 Diet fads AC108 Diet therapy AO39, HF67, MM3, NC91, ND67, NH27, NH50 NH61, NH144, NL32 Diet, Sodium-restricted NH52, NH82 Dietary fats AC10 Dietary fiber AC80 Dietary Intervention Study of Hypertension NH27, NH50, NH52, NH61, NH82, NH102 Diethylpropion FD37 Dietitians HF1 74 Diffuse fibrotic lung disease NH78 Diffusion of innovation LUl 9, MG22, NA45, PH15 Diflunisal FD76

INDEX TO REPORT CITATIONS Digital imaging ET60, SC3 Digital subtraction angiography AN27, CU30, ET33, SP6, UB34 Digitalis NHl l, NH80 Digoxin FD77, ND143, NH5 Dihydroergotamine FD141 Dilatation AS5 Dilatation and curettage UB35 Diltiazem FD38 Dimethyl sulfoxide AC57, AO53, CA98 Direct service costs CUl l, NA43 Disability evaluation ND9O Discography CA18 Disease staging NA27, UP9 Disodium cromoglycate FD74 Disopyramide FD78 Dissolution therapy ND196 Disulfiram DC3, VC10, VC15 Diuretics NA46, NH26, NH60, NH82 DNA AG66 DNA, Recombinant ND49 Doman-Delacato treatment AC68 Dopamine FD12, FD13, FD140 Doping in sports AO1, AO16 DRGs CU44, HF34, HF36, HF38, HF47, HF54, HF55, HF57, HF58, HF59, HF60, HF61, HF62, HF64, HF90, HF92, HF113, HF116, HF123, HF132, HF142, HF151, HF169, HF178, HF186, HF200, PHI, PH5, PH6, PH7, PH10, PH14, PP1, PP5, PP7, PP9, UP8, UP9, UP18, UP23 Drug costs UP3 Drug information services NA94 Drug interactions NA83, NA109 Drug labeling AC102, AO26, CU3 Drug ordering AC111, AO32, GU9, NA10, NA12, NA39, NA40, NA55, NA65, NA73, NA87, NA100, NA105, NA107, NA118 Drug packaging FD103, FD114, FD125, FD157 Drug preparation AC20, AC55 Drug regulation LU7 271

MEDICAL TEC~OLOGY ASSESSMENT DIRECTORY Drug therapy AK3, AO39, CA87, DCll, LU16, NA77, NA84, NL23, NL27, PH7, VC4 Drugs AC45, AC99, AC102, NA53, UP3 Drugs, Generic UP3 Drugs, Non-prescription NL55 Drugs, Prescription CU56 Dual-energy scanned projection radiography ET76 Dyskinesia, Drug-induced MR9 Dysmenorrhea AF20 Dysuria BC15 Echocardiography AN14, BC20, BC27, ET24, ET47, UB37, UB96 Econazole FD39 Economics, Hospital HF60, HF62, HF140, HF143, HF146, HF168, HF169, HF173, HF180, UF1 Economics, Medical HF20 Economics, Nursing HF57 Edema NC40 Edinburgh Masker AA16 Education, Dental UP25 272 Education, Medical AS18, CU86, ND24, NM3, NM4, NM6, NM19, UF4, UP13 Education, Medical, Continuing ND69 Education, Special ND136 Educational measurement CU86 Elbow joint CU37 Electrical stimulation Cardiac AG37, MT8, NC34, UB109 Electrical stimulation- Cerebellar AA27, AA28 Electrical stimulation- Cerebral palsy MR22 Electrical stimulation Cranial AP32, CA45 Electrical stimulation- Facial nerve palsy AA39, AA40, NC35, NC81 Electrical stimulation Muscular CA75 Electrical stimulation Neural AA38, BS16, CA29 Electrical stimulation Neuromuscular NC46 Electrical stimulation Scoliosis AP26 Electrical stimulation Spinal AA33, AA48, BS15 Electrical stimulators FA69, FA140, FA201, FA247, FA285 Electrocardiographs BC21, EH22, EH45, FA184, NSI I, NS12

[NDEX TO REPORT CITATIONS Electrocardiography AD4, AP35, BCll, BC26, BS34, ET64, NA32, NA135, NC42, NC129, ND33, NH24, NH25, NH32, NH33, NH48, UB110 Electrocoagulation APl l, AP13, AS4, AS8, NC6 Electroconvulsive therapy ND77, NL15 Electrodes FA184 Electrodes, Implanted BS15 Electroencephalographs EH3, ND139, NS6 Electroencephalography AA9, AA24, AA30, AA31, AA37, AA45, AP28, AP36, CA58, ET7, ET64, NC30, NC60, ND133 Electrolytes BC12, FD125, FD162 Electromyography AA10, ND151 Electronics, Medical EH39 Electronystagmography AA11 Electrophysiology AD5 Electrosurgery FA188 Electrosurgical devices EH5, EH13 Electroversion therapy NC61 ELISA ND144 Emergency communication systems ET18, NA90, NA110, NA128, NA129 Emergency kits AK15 Emergency medical services AC1, AC47, HW7, NA104, NA107, NA125, NA130, UP30 Emergency medical technicians NA26, NA62, NA132 Emergency service, Hospital HF34, UB38 Enalapril FD14 Encephalomyelitis, Equine ND144 Endocarditis, Bacterial AK8 Endocardium NC34 Endometriosis AF9 Endometrium AF11 Endorphins ND82 Endoscopes FA180 Endoscopy AS9, AS18, AS22, AS23, AS24, AS25, HN44, NC6, UBIOO Endothelial cell photography NC82 Enteral nutrition ND97 Enteral nutrition pumps EH23 273

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Enter~t~s AC33 Enuresis AC92 Environmental exposure NDl9O Environmental health UB97 Environmental monitoring NDl 9O Enzyme-albumin polymers MR34 Enzymes CP5 Ephedrine FD135 Epikeratophakia AB1, BS18, CA7 Epilepsy AA9, AC66 Epilepsy, Focal NC109, VC45 Equilibrium ND36 Equipment and supplies AN24, BA2, CU22, CU32, CU33, HF48, HN53, ND111, ND116, PH8 Equipment and supplies, Hospital AN15, JH3 Equipment failure AN10, FA124 Equipment safety FA248 Ergonovine provocative testing AG38 274 Ericsson sex selection method CA66 Erythrocyte membrane ND1 Erythrocyte sedimentation rate BC9 Erythromycin FD142 Esophageal and gastric varices AS12, UB113, VC40 Esophageal neoplasms AS2 Esophageal stenosis AS1 Esophagogastroduodenoscopy AG29 Esophagoscopy CA9 Esophagus AS14, NC13 Esterine CA99 Estramustine FD79 Estrogens AF2, AO41, MR40, NL46 Ethanol AC39 Ethics, Medical AC113, HC9, HC10, LU13 Ethinyl estradiol FD80, FD100 Ethylene oxide EH40

INDEX TO REPORT CITATIONS Ethynodiol diacetate FD80 Etomidate FD40, FD81 Evaluation studies HF124, HF125, HF126, UFO, UP20 Evoked potentials AA22, AA37, AA43, ET84, UB98 Exercise test AD2, AO64, BC17, NA135, NC129, NH33 NH113, UB81 Exercise therapy AO42, AO68, ND163, NL6, UB40 Exertion NL6 Expert systems FA182, MR7, ND139, NL53, NM22 Extracorporeal membrane oxygenation ET8 Extracranial-intracranial arterial bypass AA1, BSl9, MM4, NC147 Extremities AC91, FA118, NA57, NA88, NC39 Eye SP8 Eye diseases AB8 Eyeglasses AJ5, NC121 Facial paralysis AA39, AA40, NC35, NC81 Factor VIII ND112, NH139 False positive reactions NA21 Family HF65 Family practice ND119 Fasting NC91 Fat emulsions, Intravenous FD88, FD150 Fees and charges HF15, HF45 Fees, Medical HF4, HF21, HF22, HF90, HF106 Femoral artery AG57, DC1 Fetal death AF33 Fetal diseases AF30 Fetal monitoring AE7, AF39, AF45, AO61, HA4, HAl9, HA31 MTll,UB43,UB103 Fetal monitors EH41 Fetal shunts UB104 Fetoscopy AE12 Fetus AC44, AC113, HC1, I]C2, HN42 Fibrinogen scanning MM14 Filtration NC72 Financing, Personal HF181 275

MEDICAL TEC~OLOGY ASSESSMENT DIRECTORY ~- rlres AO6 First aid AC5 Fish oils CU39 Flocculation tests AG62 Florida HF187 Fluoride varnishes MG2, MR12 Fluoroscopy BC36, BS36, ET63, ET89 Follow-up studies AC67, CB2, HF167, ND12, ND172 Food additives ND164 Food diaries ND28, NH143 Food, Formulated AC62, ACI 12 Food, Fortified AO76 Food hypersensitivity CA46, CA50, CA54, CA82, CA83, CA84, NC101, NC106, NCI I O Food irradiation HN46 Foot diseases CBl l, HF91 Foreign bodies AS14 Formaldehyde ND2 276 Fructose AL10 Furosemide FD144, FD145 Gait assessment ND106, ND197 Gallbladder AG7 Gamma cameras UA8 Gamma globulins AG64, NCllI Gas scavengers AJ43, EH28 Gastric acidity determination AG70 Gastric bubble APO, BS20, CAB, ET9, FA115, MT12, UB44 Gastric freezing HA25, NC83 Gastroesophageal antireflux prosthesis AP2, BS4, ET26, NC1, NC54 Gastroesophageal reflux VC32 Gastro-ileal bypass CA101 Gastrointestinal diseases AG23 Gastrointestinal endoscopy AP14, ASll, AS14, AS15, AS17, AS21, CU76, NL41, UB88, UF10 Gastrointestinal system AS3, AS25, BC36, FA116 Gastrostomy AS9

~DEX TO REPORT CITATIONS Gemfibrozil FD82 Generators, Electric UA15 Genetic complementation test ND52 Genetic counseling AF43, AO55, UB45 Genetic engineering AC17 Genetic screening CUI9, HN68, ND147, NK6, NK8, NL45, SC4, UB45 Genetics HN78 Genital disease, Female AFI Genital neoplasms, Female AP30 Genitourinary fistula AF7 Geriatric medicine NA54 Geriatric nursing HF32 Geriatric psychiatry HN65, ND77 Geriatrics MG19 G. . . . nglvltls AK3 Glaucoma screening DC9, DC26, MR35 Glaucoma, Open-angle AB14, MR35, NC43 Glioblastoma multiforme AA26 Glomerulonephritis ND16 Glomerulonephrotides, Membranous prolifera tive NC55 Gl u coco rti co id s AO2 Glucose FD106, FD122, FD123, FD124 Glutathione disulfides FD106 Glyceryl trinitrate ET71, FD163 Glycocholic acid AG43, AG44 Gonorrhea AC60, AF8 Goodpasture's syndrome NCS5 Gorgas Memorial Laboratory CU45 Governing board UPI Graft survival ND13 Granulocyte Transfusion Study NH120, NH121 Growth ND98 Guanabenz FD41 Guanadrel sulfate FD42 277

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Guillain-Barre syndrome AA3, NC15 Hair analysis HN47 Halazepam FD146 Hand ND71 Handicapped AC8, AC18, CU59, HF101, HF118, HF182, HF207, ND39, ND51, ND87, ND136 Handicapped child ND8 Head NC33 Head injuries ND137, ND145 Headache AA25, AG24, AP29, BC28 Health Care Financing Administration (U.S.) CU21 Health care delivery UP22 Health education AC13, AC36, AC46, ND48, ND129, ND179 UP15 Health examination AC15, AO45, DC29, MG20, MG21, UB70 Health food AC108 Health insurance HF14, HF22, HF47, HF64, HF114, HF115, HF156, HF199, UP8, UP24, UB99, UP4 Health insurance reimbursement AL4, HF47, HF54, HF64, HF91, HFl l l . HF113, HF150, HF178, NA80 278 Health maintenance organizations HF2, HF51, HF70, HF74, HF79, HF80, HF81, HF82, HF94, HF114, HF138, HF163, HF188 Health manpower HF106 Health policy CU5, CU20, CU33, CU48, CU69, CU71, CU88, CU90, HA26, HA28, HC12 Health promotion LU5, LU20, PH16, UP15 Health resources NA7, UP12 Health services CU14, LU6, ND20 Health services accessibility HF77, ND20 Health services for the aged HF28, HF122, HW20 Health services needs and demand AO56, HF98, HF107, HF162, HF177, LUl l, NA72, ND118, ND174 Health services research VH3 Health status HF95, ND2, ND11 Health status indicators AC49, LU21, NH51, NH97 Hearing aids FA142, ND46, ND60, ND184 Hearing disorders CU57, ND27, ND59 NA123, NA132 Heart diseases NA113, NA120, NL22

INDEX TO REPORT CITATIONS Heart failure, Congestive NC143, VC27, VC28, VC59 Heart rate FA196 Heart rate, Fetal AE7, AF45, MT11 Heart valve implantation VC51 Heart valve prosthesis FA10, FA138, FA190, FA191, FA192, FA274, FA312 Heart ventricle NC42, NH22, NH25, NH43 Heat exhaustion AC48 Heimlich maneuver AO9, AO37 Hematologic tests NA46 Hemiplegia ND151, ND163 Hemochromatosis NC10 Hemodialysis AG81, CU32, HF176, NA124, VC25 Hemodialysis, Home MGl l, NA124 Hemodynamics NC36 Hemofiltration AP9, BSl l, NC9 Hemoglobin A, Glycosylated AG35 Hemoglobinopathies screening NL5, UA26 Hemoperfusion NC10 Hemophilia CB3, NC112, ND112, NH139 Hemophilus influenza type B vaccine HN74 Hemorrhage, Gastrointestinal APl l, AP12, AP13, AP14, AS4, AS7, AS8, AS10, AS23, AS24, NC6, NC146, ND58 Hemostatic materials FA42, FA59, FA134, FA225, FA2 78, FA283, FA306 Heparin AG39, MM13, NC41, NC62 Hepatitis VC19 Hepatitis, Alcoholic VC9, VC53 Hepatitis B AC16, HN26, MG7 Hepatitis B core antigens FA89 Hepatitis B tests FA77, FA158 Hepatitis Knowledge Base System NM14 Herpes simplex AK9, AO3, CB5 Herpes simplex infection screening, Neonatal ND121 Heterozygote detection AF43, CU19 Hexachlorophene FD147, FD148 279

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Hip fractures HF117 Hip joint replacement NL33, UF3 Hip prosthesis CB7, ET48, FA244, FA320, NAl9, SP11 Histamine AG76 Histamine therapy AA17, AA41 Histapenia AG77 HISTLINE NM7 HIV detection assays ND161,NL7,UA33 HLA antigens ND162 Hodgkin's disease MG13, UB47, UB48 Holter monitoring UB49 Home care AA32, AC25, AG46, BS21, CP1, GUll, HF24, HF32, HF42, HF52, HF56, HF99, HF100, HF112, HF172, HF174, HF192, HF198, HF202, HN76, LET, NC84, ND66, ND68, ND72, NKI, PH12, SC5, VC8, VC13 Homosexuality AO56 Hormone therapy MR42 Hospice HF102, HF145, HF205, UBIOI Hospital bed capacity CU26 z80 Hospital planning AN5, CU26, ND70 . Hospitalization HF26, ND26, UP14, VC13 Hospitals AG32, AL6, AN16, AO47, CPI, HW10, HW12, HW13, NA89, NA117, UP5, UP17, UP27 Hospitals, Community AN5, HF119, NA122 Hospitals, Municipal HF75 Hospitals, Rural HF76 Hospitals, Satellite ND6 Hospitals, Special ND109 Hospitals, Teaching MGI9, NA18 Hospitals, University NA122 Hostel HW24 Hubbard method CA3 Human growth hormone AC54, HN81, UB46 Human milk HN40 Human milk banking AC89 HF152. HF158, HF203, Humidifiers EH32 Hyaluronidase NH57

INDEX TO REPORT CrrATIONS Hybrid cells ND156, ND195 Hybridomas MR38 Hydralazine VC24 Hydrochloride FD83 Hydrochlorothiazide FD23, FD62, FD115, VC12, VC14 Hydrocortisone FD44, FD84 Hydrogen AG44, AG51, AG59 Hydrogen-ion concentration NC13 Hydromorphone FD15 Hydrotherapy NC104 Hydroxycholecalciferol level AG68 Hyperbaric oxygen therapy AA2, AG47, AG48, AG49, AG50, AG72, AG73, AG74, CA67, ET77, NC38, NC39, NC40, NC64, NC65, NC85, NC86, NC87, NC88, NC89, UB102 Hypercholesterolemia CB4, NH8 Hyperkinesis AA10 Hyperlipidemia NH7, NH9, NH85 Hyperlipoproteinemia type IV NL30 Hyperopia AB1 Hypersensitivity AJl l, AJ16, CA107, ND164, UB4 Hypertension AG25, BA1, HN28, MM1, MM3, MM6, MM7, MM9, MMll, MM12, MM16, MM18, NA50, NA85, NC7, NC63, NC75, ND182, NH4, NH21, NH27, NH32, NH47, NH50, NH52, NH60, NH61, NH76, NH81, NH82, NH91, NH92, NH102, NH127, NH130, NH147, NH148, NH151, NH152, PA2, UB50, UB112, Hypertension Detection Followup Program NH1, NH14, NH22, NH23, NH47, NH48, NH49, NH51, NH73, NH88, NH91, NH92, NH99, NH100, NH127, NH130, NH131, NH137, NH147, NH148, NH151, NH152 Hypertension, Portal MR33 Hyperthermia systems FA109, FA166, FA167 Hyperthermia therapy AG83, AP25, BS22, CA68, ET35, MR31, NC445 UB51 Hypertrophy NH22 Hypnosis AO22, CA96 Hypnotic drugs AC22, AO63 Hypothermia AC96 Hypothyroidism AC101 Hypothyroidism screening, Neonatal AC75 Hysterectomy AE9, CU68, HA6, NA58 281

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Hysteroscopy AE4 Ibuprofen FD16, FD17, FD85, FD149 Ileal bypass NH7, NH8, NH9, NH10, NH63, NH86, NH87, NH140 Iliac artery AG57 Illinois HF7 Imaging centers ET34 Immune system CA88 Immunization AC29, AC30, AC31, AF25, MG27 Immunoassay systems, Fluorescence UA30, UA31 Immunocompetence ND11 Immunologic diagnostic tests CP4, ND159 Immunologic tests CP9 Immunology AG2, AG4 Immunoradiometric assay with monoclonal anti bodies ND113 Immunoradiometric assays FA6, FA61 Immunosuppressants AO10, CU41 Immunotherapy AO10, CUB, CU41, UB52 z82 Immunotherapy Cancer AG63, CA48, CA49 Implants, Artificial AA28 Impotence MR23, NC136, NC137, NC156, NC159, NC160 Impotence diagnosis MR24, NC135 Impotence treatment NC157, NC158 In vitro chemosensitivity testing VC58 In vitro fertilization AE13, BS24, CA22, HC6, HN48, UB42 incentive spirometry BC43, UB53 Incontinent pads EH33 Incubators EH42, EH43, NS8 Incubators, Infant NA79 India DC18, DC22 Indian Health Service (U.S.) CU6 Indians, North American CU14, ND20, ND102 Indomethacin FD86, FD87 Induction of labor AF35 Industry DC24

INDEX TO REPORT CITATIONS Infant AC67, AC77, HC1, HC9, HF195, ND132, ND189 Infant foods AC62, AC90, AC104, AC112 Infant, Low birth weight AC32 Infant, Newborn AC86, AC99, AF28 CB5, EH24, HA31, ND94, ND142, ND155, NH13, NH41, NH111, NL5, NL8 Infant nutrition AC32, AC50, AC81, AO57, AO73 Infant, Premature MR26, NA79, ND12, ND45, ND75 Infection AK5 Infertility CA28, ND18 Infertility, Male AP17 Influenza NL44, VC44 Influenza vaccine AO59, CU67, HN75 Information systems AN10, AN18, CU21, CU90, HA9, LU14, NA2, NA24, NA61, NA64, NA106, ND133, ND160, NH28, NH89, NH94, NH138 Informed consent NH115 Infusion pumps AG39, AG52, AL8, AN22, AP34, EH14, EH25, EH44, ET78, ET86, ET87, FA307, NC41, NC139, NC141, NC143, NC144, NC145, ND99, NS2, NS13, SP1 Infusion pumps-External AG53, NC37, NC62, NC138, NC140 Infusion pumps Implantable BS23, NC66, NC142 Infusions, Intra-arterial AA26 Infusions, Parenteral NH78 Injections AG82, FD162, NC123 Injections, Intra-arterial CA87 Inpatients CUl l, HF90, HF103, MT21 Insect bites and stings NL55 Insomnia AO63, NL27 Insulin FD48, FD143, FD166, FD167, FD168 . . . . Insulln 1nJectlon CA89 Insulin, Isophane FD43, FD153, FD154 Insurance benefits UB59 Intensive care AC28, AN29, CU34, HC8, HW21, NA17, NA101, NA102, NA119, UB110 Intensive care systems, Mobile HF149, NA47, NA126 Interferons CA69, CA70, MR27, MR28 Interlibrary loans NM2, NM13 Intermittent positive pressure breathing BC44, CA102, NC148, NH77, NH114, UB54 283

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Intestinal diseases NC68 Intra-aortic balloon pumps ET79 Intracranial pressure monitoring NC105 Intracranial pressure monitors AA46, FA209, FA319 Intracutaneous t~trat~on CA53 Intraocular lens implantation NL48, PP13, SP15 Intraocular lenses FA3, FA31, FA32, FA34, FA35, FA62, FA76, FA137, FA151, FA219, FA220, FA236, FA237, FA240, FA255, FA256, FA2 70, FA293, FA295, FA298, FA315, FA316 Intraoperative care AA31, AA45, ET7, NC42 Intraosseous pressure measurement CA24 Iodide therapy ACl10 Iodoxamate meglumine FD151 Iontophoresis BS25 Iridology AO62 Iron-dextran complex FD152 Ischemia AG47, NC65 Isosulfan blue FD155 284 I. . sotret~no~n FD89 Jaundice AM3 Jaundice, Neonatal BS21 Jejunostomy AS9 Joint prosthesis CU37, CU65 Keratoconus AB1 Keratomileusis AB6 Keratophakia AB6 Ketoconazole FD156 Keyes technique CU70 Kidney AG61 Kidney calculi AP16, AP23, AP27, ET67, HN72, NCl9, NC23, NC27, NC154 Kidney diseases NL18 Kidney failure, Chronic CU69, HC9, HF29, HF33, HF41, HF46, HF67, HF68, HF69, HF116, HF147, HF176, HF187, HW18, MG6, MGl l, MT5, MT6, NA72, NC10, NCl l, UP29 Kinetic therapy CA51 Knee joint ND88, UB11

INDEX TO REPORT CITATIONS Knee prosthesis FA112, FA113, NA23 Kunkel test AG64, NC111 Labetalol PA2 Labor AC99, AE7, NK2 Labor, Premature CA5, UF2 Laboratories ETl 9, HN20, HW15, NA41, NA69 Lactates BS27 Lactation AC69, AC82 Lactose NC67 Lactulose AG51, NC68 Language development disorders ND12 Laparotomy UB48 Laryngeal neoplasms VC30 Laser angioplasty ET38 Laser iridotomy CA80 Laser photocoagulation AP12, AS7, BS29, NC146 Laser radiation therapy CA25, CA72, ET53 Laser surgery AS2, CA26, NC45, SC6 Laser surgery Carbon dioxide AB9, AP30, BS31, NC33, NC80 Laser surgery Nd:YAG BS30, CA38 Laser trabeculoplasty AB14, NC43 Lasers AN5, AO4, AS6, ET38, FA88, FA136, HN50 HN77, UB57 Lasers Carbon dioxide AE11 Lasers Nd:YAG AB13, FA26, FA33, FA44, FA56, FA63, FA108, FA110, FA139, FA163, FA171, FA172 Lead screening HA12 Learning ND103 Learning disorders AC115, CU46, ND34, ND56 Leg CA57, NC107, ND90, UB64, VC39, VC49 Leisure skills training ND64 Length of stay CUSO Leukemia AP20, NC14, NH121, PH7, PP5, VC3, VC52 Leukemia, Myelocytic NH120 Leukocyte count BC8 285

MICAS ~CHNOL~Y ASSESS DI~CIO~ Leukocyte di~rentia1 counters Levodopa ~3, ~9 . . . . LlabUl~ 1nsu~nce ~2 ~ . . . uccalne #~< ~7~ Lid change events ~2 . ~ Lag support care ~70 Lifestyle ~747, ~749 Ligament prosthesis ^700 nmb son Linear pumps ~ . ., ClplOS ~707, ~73>, ~7~) . . . . Lipoprotein evaluation 60) Lipoproteins ~,~740 Lithium ~6 I, ~7 . . . tnotclpsy ~C ~7^ ~ Lkhothpsy-Extracorporea1 shock wave C ~t CU! Id, [^ ~ ~? ~% I, ~C ~ Lkhothpsy- Percutaneous 286 Lithotripsy - (ansurethra1 ^754 Lkhothpters-Extracorporea1 shock wave ~7,^774,~7 ~ . salver Liver cirrhosis, Alcoholic ~ . . salver c .lseases ~< ^) I, ~0 Liver neoplasms ^6d, ~ . . . Scope If, ~74 Long COT syndrome Long term care ~,~( !AF76, /LF77 7, FAF77 6, f6F7~6, /LF737, [AF73d, !LF7~7, !LF7d2, [LF772, 'NF7 76, 'AFT 66, !AF7 69, !AF7 96, !LF20O,77~y),77~P77, }~4726, )~D70, }~7 Lumbar vertebrae Carp Cam, C47~< E/67 Lung Lung dGeases 46776 CB77 Lung diseases, Obstructive AV774, A~777, A6777V, AV7777, AVY7 42, CB40 Lung neoplasms ~777 Lupus erythematosus, Systems ^4,\= Lymph nodes

INDEX TO REPORT CrrATIONS Lymphangiography UB47 Lymphoma PH7 Magnesium NH26 Magnesium chloride FD70 Magnesium sulfate FD97 Mammographic devices UA1, UA4, UA5 Mammography AE18,AHl,AH2,AH3,AH7,AH8,AP7, CB18, CU9, DC4, DC5, DCl9, FA50, FA119, SP16 Mandelic acids ND61 Manitoba ND15, ND118, ND123 Manometry CA24 Magnetic resonance imaging AA13, AG13, AN8, AN20, CA27, CU36, ET40, Maule sYrun urine disease screenin~ HA8, HN57, MR2, MR6, MT16, MT17, NC21, NC133, ND91, ND103, NL3, PP6, SP4, UB66, UP6, UP23, UP28, VH4 --r - - - ~ - --r DC12 Marketing of health services NA53 Magnetic resonance imaging-Lung injury MR17 Magnetic resonance imaging-Multiple sclerosis MR29, MR30 Magnetic resonance imaging- Neoplasms ND135 Magnetic resonance imaging systems FA84, FA93, FA127, FA149, FA174, FA177, FA206, FA212 Magnetic resonance spectroscopy HN8 Magnetoencephalography VH2 Maine HF120, HF202 Malabsorption syndromes NC28, NC29, NC67 Malathion FD9O Malpractice HF121, NK2 ~ _ _ ~ AA_ ^~ Maryland HF1 68 Mass spectroscopy ET6 Massachusetts HF72, HF111, HF180 Mastectomy ND170, UB82 Maternal behavior MG29, ND76 Maternal serum alpha fetoprotein monitoring AO58, ET56, NA20, UL1 Maternal welfare HC2 Measles-mumps-rubella vaccine ND148 287

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Medicaid AC6, HFS, HF6, HF7, HF8, HF9, HF10, HF27, HF31, HF43, HF63, HF73, HF83, HF96, HF97, HF112, HF120, HF124, HF125, HF126, HF127, HF128, HF129, HF130, HF131, HF134, HF140, HF144, HF156, HF160, HF182, HF190, HF191, ~F192, HF195, HF202, HF208 Medical history taking DC13 Medical indigency AO66, UP4 Medical informatics NA36, NA64, NA78, NA127, NA131, NL53, NM3, NM4 Medical record linkage ND1 68 Medical record systems NA24, NA49, NA56, NA76, NA82, NA104, ND148 Medicare ANl 9, AN30, AN31, CU18, CU35, CU44, ET14, HF1, HF7, HF8, HF9, HF10, HFl l, HF12, HF13, HF15, HF18, HF27, HF37, HF51, HF70, HF74, HF84, HF85, HF104, HF114, HF121, HF133, HF134, HF135, HF136, HF137, HF138, HF139, HF140, HF175, HF177, HF185, HF193, HF194, HF197, HF201, HF205, HF207, HF208, HF209, JH8, LE2, NA80, PH6, PHl l, UP29 Medigap HF141 MEDLARS CU53 MEDLINE NM1 MEDLINE-Optical disk NM21 Medroxyprogesterone AC85 288 Melanoma CA48, CB15, NL29 Melodic intonation therapy AA18, NC9O Meniere's disease AA29, AA41 Meningomyelocele AC9S Menopause AO41, MR40, NL46 Mental disorders AP18, UB74, UB99 Mental health services CU10, HF85, HN9 Mental retardation AA9, AC78, DC12, HF202, NK9 Mercury A]l l, AJ14, AJ35 Metabolic diseases AF28 Metabolism MR40 Metatarsalgia ND186 Methacholine compounds ND86 Methadone VC10 Methaqualone AO46 Methotrexate AG14, UB9 Methoxsalen FD91

INDEX TO REPORT CITATIONS Methyldopa FD159 Methylethylketone CA88 Methylphenidate ND140 Metoclopramide FD92, ND61 Metolazone FD160 Metoprolol LU9 Metronidazole CA36, FD93 Metropolitan Comprehensive Care Program HF143 Me zlocill in FD161 Michigan HF8 Miconazole FD94, FD95 Microbiological testing systems FA165, FA230, FA328 Microbiology CP3, CP7 Microbiology equipment UA7, UAll, UA27, UA29 Microcomputers AN16, NA1 Micronucleus test ND149 Microsurgery AE14, AP8, CA28, CA109, MR13 Microwaves FA125, MR43, ND150 Migraine AA44, ND81 Migration inhibition test ND164 Milk AC43, AC50 Minerals AC87, AG41 MINERVA NA59 Missouri HF144 Minnesota Q-Qs codes NH24, NH25 Mitral valve prolapse ND21 Mobility aids ND183 Moire topography ND157, ND193, ND194 Molar, Third NL50 Monitoring, Physiologic NC13 Monoclonal antibodies HN10, HNll, HN55, ND162, SC7 Morphine NC141, NC144, NC145 Mortality HA31, HF159, HF204, MG3, MG4, NA14, NA27, NA123, NA132, NA134, ND118, NH15, NH23, NH40, NH47, NH48, NH65, NH67, NH68, NH73, NH96, NH109, NH117, NH127, NH129, NH131, NH134, NH147, NH151 Mother-child relations MG29 289

MEDICAL TEC~OLOGY ASSESSMENT DIRECTORY Mothers ND75 Motor activity ND9O Motor skills ND189 Mouth neoplasms DC23 Mouth protectors AJ13 Movement ND71 Movement notation system ND96 Moxalactam FD96 Multicenter Investigation of Limitation of Infarct S. 1ze NH5, NH6, NH43, NH57, NH59 Multi-institutional systems UPll, UP20 Multiple myeloma VC58 Multiple Risk Factor Intervention Trial NH15, NH17, NH18, NH26, NH32, NH33, NH42, NH53, NH60, NH90, NH97, NH98, NH103, NH107, NH110, NH116, NH118, NH122, NH132, NH136, NH143, NH144 Multiple sclerosis AA2, AA20, AA36, AA48, AA49, CA17, CA104, MR27, MR28, NC76, NC87 Muscle spasticity AA12 Muscular atrophy CA75, NC46 Musculoskeletal diseases AP33 290 Mutagenicity tests ND50 Mutation ND156, ND195 Myasthenia gravis AA21 Mycoplasma complement fixation tests NC116 Myocardial infarction AG9, AG33, BC7, BC16, CA71, MR25, NA32, NA37, NA98, NC50, ND92, NH2, NH3, NH5, NH6, NHl l, NH20, NH24, NH25, NH40, NH43, NH45, NH46, NH49, NH51, NH57, NH59, NH62, NH70, NH72, NH105, NH123, NH124, NH125, NH136, NH154, SP10, UB109 Myocardium MR18, NH104 Myoelectric prostheses ND130, ND132, ND138 Myopia AB1, AB4, AP37, CA31 NHLBI Type II Coronary Intervention Study NH38, NH54, NH83 Nadolol FD45, VC18 Nafcillin VC20 Nail diseases NC18 Naloxone AC86, FD46, MR8 National Dental Education Program UP25 National Hospice Study HF109, HF145 National Hospital Rate-Setting Study HF146

INDEX TO REPORT CITATIONS National Institutes of Health (U.S.) CU60 National Library of Medicine NM2, NMl O National Medical Care Utilization and Expendi- ture HF19 Nebulizers and vaporizers FD7 Neck CA57, CB6, NC33 Needle aspiration cytology AE15 Negative pressure respirators AA32, NC70 Neonatal intensive care AC24, AC35, AC53, CU77, HA14, HN27, HW22, UF5 Neonatal monitors FA39 Neoplasm metastasis BC33, UB60 Neoplasms AC12, AG71, AG83, AP25, CA68, CA69, CU4, CU89, DC17, DC18, DC21, DC22, DC24, DC29, ET35, ET53, HF186, MG13, MG24, MG25, MR31, MR38, NA27, NC44, NC77, NC78, NC144, ND23, ND31, ND124, ND146, UB51, UP22 Nephrolithotomy AP23, AP27 Nephrostomy ET52 Nerve crush NC65 Nervous system diseases AC68, NL12 Neural tube defects AF26, MR46, UL1 Neurologic examination ND32 Neuromuscular diseases AA32, AG26 Neuropharmacology ND181 Neurosciences SC1 Neurotoxins AA15, AA19 Neutralization therapy Food allergies NC106, NC1 10 New Jersey HF9, HF149, HF169, UP19 New York HF10, HF110, HF150, HF151, HF156 Nickel AJ1 1, AJ25 Niclosamide FD98 CA13 Nicotine gum AO30, PA6 Nifedipine FD99 Nissen fundoplication CA74 Nitroprusside FD1 73 Nitrous oxide AJ43 291

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Nocturnal Oxygen Therapy Trial NH74, NH141, NH142 Noncardiac pain diagnosis AM4 Nonionizing radiation measurement devices FA187 Nonverbal communication ND87 Norethindrone FD100 Normaline kit FA223, FA284 Nova Scotia ND196 Nuclear medicine AN17, FA122, FA301, NA6 Nurse anesthetists HF155 Nurse midwives CU15 Nurse practitioners CU15, CU78, HF32, MG12 Nurseries, Hospital AC56, AC61 Nursing care HF58, ND31 Nursing homes HF3, HF35, HF42, HF66, HF72, HF89, HF110, HF120, HF190, HF196, VC13 Nutrition AC82, AL3, HC4, HN18, ND97, NH132 Nutrition disorders ND26, VC1, VC54 Nutritional counseling ND11 292 Nutritional requirements ND98 Nutritional status ND11 Nutritive value AC108 Obesity AC77, CA60, NC91, ND39, ND67, ND165, NL16 Obesity, Morbid APO, CAB, CA74, CA101, MT12, NL61, UB61 Obstetrics HF77 Obstetrics and gynecology department, Hospital AF40 Occult blood DC13 Occupational diseases CU25 Occupational health PH16 Occupational health services MM16 Oklahoma HF12 Oral contraceptives AF42, NK10 Oral health AC9 Oral rehydration therapy AC33, NC139 Oregon HF13 Organ donors BUT, HC1

INDEX TO REPORT CrrATIONS Organ preservation MR5, MR16 Organ procurement AO67, B U2, B U3, ~ U4, B U5, B U6, HCl 2, HF53, HF154 Organization and administration ND126, UP2, UP5, UP17, VH1 Orphan products GU12 Orthodontic appliances AJ30, MR20 Orthomolecular therapy AC78 Orthomyxoviruses type A VC44 Orthoptics UB68 Orthotic devices ND41, ND157 Osteomyelitis AG74, NC86 Osteonecrosis AO2 Osteoporosis AF22, BS1, CBl2, HN59, NL24 Osteoporosis screening DC2, UBl14 Osteoradionecrosis NC89 Osteotomy ND88 Otitis media HN12, HN60 Otosclerosis CA78 Outcome and process assessment (Health care) CU50, HF3, HF39, HF46, HF56, HF63, HF66, HF102, HF153, NAl9, NA134, ND100, ND104, VC51 Outpatients AL4, BC23, HF54, HF150, MT4, MT6, MT10, MT17, MT22, NA10, NA12, NA40, NA46, VC44 Ovarian neoplasms AF18, ND159 Oximeters ET20 Oximetry MT20 Oxprenolol VC21 Oxygen analyzers EH34 Oxygen therapy BC41 Oxygen therapy- Topical NC74 Oxygen-air proportioners EH15 Pain AA12, AA23, CA57, NC141, NC145, ND82, NL49 Pain, Intractable NC144 Pain measurement ND82 Pain, Postoperative AA38, NC119 Pain rehabilitation UB69 Pain therapy ET42, HN13, HN62, NL9, UB107 293

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Palatopharyngoplasty CA76 Pancreatic neoplasms HA21 Panic disorder BS27 Pap smear NL38 Papaverine NC136, NC159 Paraformaldehyde AK1 Parenteral nutrition PEEP valves AC63, AG15, AM1, MT21, MT22, VC1, VC54 EH17 Parkinson disease MR3, ND176 Parkinson disease, Symptomatic MR9 Partial thromboplastin time BC1 Paternity AO18 Pathology, Surgical ND187 Patient admission CA9 Patient care planning EH7, ND10 Patient compliance Patlent partlapat~on ET42, NH30 Patient readmission HF175 Patient selection NA88 Patients NAT, ND111, UP22 Pattern recognition ND139 Pediatrics AC12, AC28, AC38, AC4l, AC52, AC74, HN63 Peer group ND4 Pelvic neoplasms AF37 Penile artery bypass NC160 Penile prosthesis ET66, NC156, PP8, UB108 Pentazocine FD46, FD101 Pentetates see DTPA Peptic ulcer AS22, CU64, HA18, LU2, NC83 Percussion MM2, MM6, MM18, NA40, ND184, NH99, ND72 NH100, NH129, NH143 Patient discharge AC67, HF95, NA37, NA98, ND167 Patient education AL4, MT4, ND23, ND62, ND75, ND85 294 Percutaneous balloon valvuloplasty ET16 Percutaneous transluminal angioplasty AA5, AG55, AG57, AG58, AO31, DC1, ET68, NC48, NC49, NC93, NC107, VC49

INDEX TO REPORT CITATIONS Percutaneous transluminal coronary angioplasty AD7, AG1, AG56, CA32, ET17, FAl l, JH4, MTl9, NC22, NC92, NC149, NH75, NH133 PP14, VC50 Perimetry AB12, NC58 Perinatology MG29, NK3 Periodontal diseases CU70 Periodontal ligament injection AJ24 Peritoneal dialysis FA248, FD103, VC25 Peritoneal dialysis cyclers EH8 Permanent eyeliner CA30 Persantine VC22 Personnel staffing and scheduling CU6 Personnel, Hospital CA56 Pertussis vaccine AC42, HA27 Pharmacy service, Hospital ND126 Pharyngitis BC14 Phenobarbital VC17 Phenylketonuria AC37 Phenylketonuria screening AC75 Phenylpropanolamine AO5, FD164 Phenytoin VC17 Phlebography MM14, MM15 Phobic disorders ND25 Phonetics ND59 Phonocardiography AG65 Photokymography NC71 Phototherapy AC25, BS21 Physical therapy ND66, ND163, ND189, UB72 Physician-patient relations AF38 Physicians HF92, HF104, HF166, ND24 Physician assistants CU15 Physicians' offices CP1, ET19 Physician's practice patterns AC102, HF27,JH10, NA75, NA94, NA105, UF1, UF7, UF9 Physiologic monitoring systems EH16, EH46 Picture archiving and communication systems ANSI, ET10, ET49 Pindolol FD104 295

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Piperacillin FD108 Piroxicam FD105 Plasma ND110, ND116 Plasma exchange ND110, ND115, ND191 Plasma exchange devices FA86, FA2 68, FA292 Plasma filters FA55 Plasma, Prozen NL20 Plasma perfusion NC72 Plasma separation systems FA204, FA224, FA277 Plasmapheresis AA20, AA21, AF10, AO14, CA90, CA91, CA104 ET90, NC95, ND16, NL12 Plasticizers ND111, ND116 Plastics FD103, FD114, FD125, FD157 Platelet aggregation VC22 Platelet transfusion CB17, NL10 Plethysmography ET55, MM14, NC94, NC137 Pleura AG28 Pneumococcal vaccine AC30, AC31, AG20, AO59, CU42 296 Pneumothorax VC55 Policy making UP16 Polydextrose AL5 Polyneuropathy, Chronic inflammatory demye . . 1natlng AG22 Polyneuropathy, Chronic relapsing AA7, NC31 Polypectomy AS13 Polyradiculoneuritis AA3 Polyurethane tubing FA124 Popliteal artery AG57, DC1 Population surveillance CA56 rosltlve pressure respiration NC4 Positron emission tomography ANT, HN14, HN61, MR41 Postmarketing surveillance CU56, HN79, MG9, MG10 Postnatal care ND68 Postoperative care AA31 Postural drainage BC45, ND72

INDEX TO REPORT CITATIONS Posture ND158 Posture control devices ND39, ND158 Potassium NA46, ND98 Potassium chloride FD18, FDl9, FD20, FD70, FD97, FD165 Potassium citrate FD21 Potassium phosphate FD97 Praziquantel FD47 Prazosin VC24 Precancerous conditions AS25 Predictive value of tests MG18, NA22, ND7, ND17, ND156 Pre-eclampsia AF5 Pregnancy AC69, AC84, AC94, AE10, AF3, AF17, AF25, AF31, AF32, NA20, NL54 Pregnancy trimester, Second AF34 Prenatal care HC2, HF5, HF160, ND68, NK3, NK7 Prenatal diagnosis AC93, AF26, BS9, HA28, NK8 Prenatal education MG8 Prenatal exposure delayed effects ND29, ND44 Preoperative care AC71, AP35, BC10, BCll, BC38, HA30, NA33 Pressure transducers EH21 Prevention of Neonatal Respiratory Distress Syndrome with Antenatal Steroid Administra t~on see AST Preventive health services DC24, HF1, HF170, HF201, LU5, LU20 Preventive medicine MG24, MG25, NA16, NA42, NH112, PA3, PA4 Preventive psychiatry ND8 Primadone VC17 Primary care NA65, NA74 Primary health care HF96, LU15, MG24, MG25 Problem solving ND137 Professional practice AC34 Progestin receptor assays FA262 Prognosis NAB, NA22, NA32, NA71, NA133 Program of Surgical Control of the Hyperlipid em~as NH7, NH8, NH9, NH10, NH24, NH25, NH28, NH29, NH63, NH84, NH85, NH86, NH87, NH94, NH138, NH140 Pro l o th e rap y AA42 297

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Propranolol FD22, FD23, FD24, NH3, NH31, NH45, NH59, NH62, NH72, NH79, NH105, PA2, VC14, VC21 Prospective payment system AN15, CU16, CU23, CU24, HF25, HF71, HF99, HF103, HF105, HF108, HF109, HF111, HF120, HF142, HF151, HF155, HF164, HF165, HF166, HF167, HF168, HF169, HF183, PH2, PH3, PH8, PH9, PH15, PP10, PPll, PP12, PP15, PP16 Prostatic acid phosphatase kits UA24 Prostatic neoplasms LU17, MR42, NL4 Prostheses ND40, ND122 Prosthesis design ND60, ND130, ND192 Protein calorie therapy with anabolic steroids VC53 Prothrombin time BC1 Prothrombin-complex concentrate NH139 Provocation tests CA83, NC106 Pruritis NC72 Pseudophakia NC121 Psoralens BS32 Psoriasis HA2 Psychiatric department, Hospital HW16, HW19 298 Psychiatry VC13 Psychoactive drugs AC69 Psychomotor performance ND71 Psychosexual dysfunctions MR40 Psychosurgery HN66, NC26 Psychotherapy CU82, ND100 Public health NL7 Public opinion ND152 Public policy GU1, HC4 Pulmonary embolism CA79, MM8, NL11 Pulmonary fibrosis NH78 Pulmonary function tests AG10, BC40 Punctal occlusion AB2 Purchasing, Hospital AN15, HF48, HF49, JH3 Purpura, Thrombotic thrombocytopenic NC95, ND110 PUVA therapy AC100, BS32, HA2 Pyrimethamine FD111

INDEX TO REPORT CITATIONS Quality assurance programs CP1, FA122, FA178, FA301, NA114 Quality assurance, Health care CP4, HF89, HF110, HF171, HF197, NA50, NA69, ND187 Quality control FA121, HF171, NA3, NA4, UP9 Quality of health care AC3, CUT, HC5, HF42, HF102, HF103, HF108, HF170, HF196, ~H3, ND10, ND69, ND123, PH13, UP30 Quality of life HF41, HF172, LU1, LUl l, LU16, LU21, NA51, ND124, NH64 RX Project NA106 Radial keratotomy AB4, AP37, CA31, ET82 Radiant warmers EH24 Radiation HN80 Radiation dosage FA119 Radiation effects AJ26 Radiation injuries NC89 Radiation measurement FA48, FA50, FA51, FA53, FA117, ND150 Radiation protection FA49, FA120, FA123, HN21 Radiation therapy AN2, CA33, UB111 Radiation, Ionizing AO34 Radioactivity AO7 Radioallergosorbent test AG78, CA52, CA103 Radiographic contrast dyes AC107, ET13, ~H1, ~H2, ~H5 Radiographic darkrooms AJ28 Radiographic equipment UA3, UA9, UA16, UA18, UAl9, UA20, UA21, UA22, UA32 Radiographic film UA34 Radiographic film processors EH50, UA13 Radiographic image enhancements ET63 Radiography AC71, AC91, AC106, AGO, AG41, BC29, CU51, FA116, FA118, HA15, HA30, MR14, MR32, NA57, NA88, ND128, SP5, UB62, UB110 Radioisotopes HN20 Radioligand assay ND63 Radiology FA178 Radiology department, Hospital HN21 Radionuclide angiography NA70, NA71, NA91 Radionuclide imaging AD1, BC32, BC33, BC34, CU52, HA16, NC129, UB75, UB76 Radionuclide laboratories HW6 299

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Radiopaque plastics AJ42 Radiopharmaceuticals MR41 Radiotherapy NDlSO Radiowaves FA125 Ranitidine FD25, FD26 Rape AC51 Reading ND27 Reagent kits, Diagnostic SC7 Recall AO22, ND28 Receptors, Dopamine ND63 Receptors, Endogenous substances ND14 Receptors, Steroid NL51 Rectal mucosal replacement CA77 Referral and consultation HF87, NA130 Regent kits, Diagnostic AG46 Reg~onal Renal Failure Program (Canada) HW18 Registries MG27 3OO Regression analysis NA91, NA95 Rehabilitation HFS5, HW1, ND4, ND31, ND36, ND176 Rehabilitation centers HF165 Rehabilitation programs Spinal cord injury HW2 Rehabilitation programs-Stroke HW3 Rehfuss test NC96 Keimbursement UB99 Reimbursement, Incentive HF66, HF111, HF112, UP19 Reimbursement mechan~sms HF33, HF96, HF196 . Relaxation therapy ND86, UB112 Reminder systems MG26, ND119 Renal artery AG58, NC93 Research AC44, NA3, NA4, NA113 Research design FA52, FA183, HF17, H~ F56, LU14, LU21, MG4, NA3, NA11, NH12, NH39, NH57, NH69, NH83, NH106, NH123, NH126, NH137, NM5, NM1 7, NM22 Research support UB77 Reserpine NH88, VC16

INDEX TO REPORT CITATIONS Residential mobility NH130 Residential treatment HF16, HF118, HF172, HF181 Respiratory distress syndrome ET8, NH13, NH41, NH111 Respiratory hypersensitivity CA53, CA108 Respiratory system NA79 Respiratory therapy CU63, HF100, MR19 Respiratory therapy department, Hospital HW25 Respiratory tract diseases CA83 Respiratory tract infections ND1 77 Respite care HF1 79 Resuscitation AC13, NA17, NA96 Resuscitation Mouth-to-mouth CA35 Resuscitators FA194 Retinopathy of prematurity AC26 Reuse of disposables FA184, GU1, GU2, GU3, GU6, GU7, GU8, HW9, NC8 Reye's syndrome AC72, NL35 Rh isoimmunization AF4, AF14, ND191 Rheumatology tests UB6 Rhinoplasty CA40 Ringer's irrigation FD1 69 Risk AC76, AM2, FA248, HN80, NA58, NA102, UFO, VC23 Rubella AF29, FA52 Rubella vaccine ND49 Rubidium MR11 Running AC76 Saccharin AO21, CU89 Safety LE1 Salicylates ND164 . . . Salplngltls ND5 Saralasin FD1 70 Satellite communication AN6, NM15, NM16 Scales, Patient EH26 Schizophrenia AG81, MRl l, ND63, ND127 School health services AC45, AC47 3

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Schools AC13, AC14, AC15, AC36, AC46, AC48, AO3 CA12 Scintiphotography Heart NH43 Scintiphotography Joint NC113 Sclerotherapy AG42, AS12, CA57, UB113, VC40 Scoliosis AP26, FA69, FA120, FA123, ND38, ND193 ND194, UB56 S. creenlng AH4, AP22, CA12, ND179 Secretin FD1 71 S. elzures AP28 Selenium sulfide FD49 Self administration ND81 Self care ~F184 Semen preservation ND78 Senility AA2, AG50, NC88 Sensory aids ND46 Seromucoid assay NC98 Severity of illness index HF59, HF60, HF61, HF142, HF186, HF187, NA67, NA108, NA116 302 Sex disorders AF38 Sex hormones CA37 Sexually transmitted diseases AF36, AO49, HN15, ND79 Shape sensor ND37 Shock, Hemorrhagic AF16 Shock, Septic AF15 Shoe insoles ND186 Shoulder dislocation CA1 Siccakeratitis AB3 Sigmoidoscopy AS16 Silver sulfadiazine FD107 Singer-Blom valve operation CA105 . . . Slsomlan FD1 72 Sleep disorders CA92 Slow virus diseases AA8 Smell AA34

INDEX TO REPORT CITATIONS Smoke detectors AO6 Smoking AF32, AO30, AO47, NH98, NH116, PA6 Snoring CA76 Social adjustment ND43, ND101, ND125, ND172, ND198 Social behavior ND146 Social support HF65, ND89, ND101 Social work HF136 Socioeconomic factors MM12, ND32 Socket prosthesis ND30, ND35 Sodium AC81 Sodium cellulose phosphate FD27 Sodium chloride FA8, FD70, FD97, FD120, FD121, FD123, FD124 Sodium phosphate FD97 Soft tissue neoplasms NL21 Somatoform disorders UB78 Sorbitol AL10 South Carolina HF189 SPECT imaging ET21 Speech disorders CU43 Speech pathology BS36, NC134 Sperm penetration assay API 7, BS35 Sphincterotomy AG36, AS11 Spinal cord FA140 ~ . . . . ~plna1 corcl 1nJurles VC26 Spinal puncture AG21 Spinal stenosis UB79 Spine CA93, MR45, ND157 Spondylitis, Ankylosing ND66 Sporicidin AK14 Sports AC66, AJ13 Sprinklers AO6 Standardized Medreview Instrument HF1 7, HF26 Stapedectomy CA78 Staphylococcal infections VC20 303

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Stereotaxic depth electrode implantation NC109 Stereotaxic neurosurgery, Computed tomogra phy-assisted ET30 Stereotaxic technics AA14, AP18, CA33, NC26 Stereotyping MM10, MM11 Sterilizers AK6, AN28, EH40 Steroids AE2, VC9 Stomach AS14 Stool guaiac HA38 Streptococcal infections BC14, ND102 Streptococcus pyogenesis ND102 Streptokinase CA71, ET43, JH4, NC50, NH20, UB80 Streptozocin FD109 Stress (Psychology) HN69 Stuttering AA16 Subclavian artery AG55 Substance abuse AC52, AO32, AO54 Substance dependence HW10 304 Sucralfate FD110 Suction equipment EH18, EHl9, EH36 Suction lipectomy CA34 Sudden infant death syndrome AP19, BS33 Suicide DC14, HN16, HN70 Sulfadoxine FD111 Sulfamethoxazole FD176, VC52 Sulfinpyrazone MM17 Suloctidil MM5 Sunlamps FA121 Surgery AC40, AC41, HA33, HA34, HF87, HF159, HF175, HF204, HN63, NA9, NA14, NA45, NA99, ND29, ND117, NH85, PA4, SP8 Surgery-Ambulatory HW14, JH7, UP7 Surgery Arthritis UB8 Surgery Breast CU73 Surgery-Eye UB41 Surgery Fetal AO43, HN45 Surgery-Heart HN24, HN32, NC60

INDEX TO REPORT CITATIONS Surgery Impotence NC155 Surgery-Morbid obesity AP24, DC25, ET57, NL61 Surgery Prostate VC33 Surgery Scoliosis MR45, UB56 Surgery department, Hospital CU26 Surgical aids Ophthalmic FA27, FA28, FA2 69, FA271 Surgical case carts EH47, EH48 Surgical drapes EH10 Surgical gloves EH37 Surgical shunt VC6 Surgical stapling CA1 Survival NA116 Sutures FA45, FA99, FA111, FA305 Swan Ganz heart catheter UB83 Syphilis tests BC13 ~ . ~yrlnge pumps NS1 Systeme International units AO20, AO75 Systems analysis NA61 Systolic Hypertension in the Elderly Program NH4, NH21, NH76, NH81 T. ~ amoxlien DC1 1 Tars NDl9O Taste disorders AA34 Tay-Sachs disease AF43 Team care MG23 Technetium 99M oxidronate FD1 77 Technetium Tc 99m aggregated albumin FD50 Technetium Tc 99m disofenin FD1 13 Technetium Tc 99m medronate FD178 Technetium Tc 99m pryprophophates NH43 Technetium Tc 99m pertechnetate NC113 Technetium Tc 99m succimer FD1 12 Technology CU59 Technology assessment, Biomedical ANl 9, AN30, AN31, AO35, AO70, CU58, CU87, CU91, HA5, LE2, LU13, MG22, NA29, NA35, NA63, NA78, SP7, SP12, VH1 3o5

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Technology, Medical CU12, CU35, CU55, CU60, CU81, CU83, CU84, GU4, GUll, GU13, HA26, HA29, HC3, HC5, HN49, LU15, NA44, PH4, SC1, UF7 Telecommunications CU57 Telemetry UP10 Temazepam FD1 79 Temperature NA79 Temporomandibular joint AK1 1 Temporomandibular joint procedure CA55 Tendon transfer ND106 Teratogens AE2 Terminal care HF193 Test interpretation ET11 Tetratogens AC59 Texas HF200 Thalassemia MG5 Thallium AG5 Thallium imaging UB84 Theophylline FD114, MG14 306 Therapeutic drug monitoring ET58 Therapeutic embolization ET59 Therapeutic equivalency CU92 Therapy, Computer-assisted FA182, HF184, NL53 Thermography AH6, AP38, CA93, NC152 Thermography-Breast ET45, NC73 Thermometers EH39, FA189 T. . nlamlne AO51 Tho race n tes is AGl 9, AG28 Thoracic neoplasms AG16 Throat cultures BC14 Thrombocytopenia ND115 Thromboembolism MM5 Thrombolysis in Myocardial Infarction Trial NH20, NH37, NH154 Thrombolytic therapy AG33, CA79, NL43 Thrombophlebitis CB8, ET55, MM13, MM14, MM15, PA3, PA4 Thrombosis NL43

INDEX TO REPORT CITATIONS Thrombosis, Venous NL11 Thymoxamine AB7 Thyroid neoplasms CB14 Thyroxine assays UA23 T·1 ' ola ND88 Timolol FD1 15 Tinnitus maskers NC118 Tioconazole FD51 Tissue banks MR4 T. . . . ssue plasmlnogen act~vators DC16, ET54, JH4, NH154 T. . ssue preservation MR18, ND114 Tobacco smoke pollution CU17 Tobacco, Smokeless AC23 Tobramycin FD116 Tocodynamometry BS3, CA5, CU7 Tomography, Standard AG16 Tongue neoplasms DC23 Tonometry DC26 Tonsillectomy CA23, NL57 Tooth extraction NL50 Toothpaste AK2, AK7, AK12, AK13, MG1 Topographic brain mapping AA6, AN3, CA4 Tourniquets EH27 TOXLINE NM20 Trace elements ND45 Tranquilizing agents, Major MR9 Transcutaneous electrical nerve stimulation AA23, CA94, NC51, NC119 Transfer factor AA49 Transillumination Breast AP22, NC52, NC153, ND3 Transplantation AG61, AO10, AO25, CU41, HN2, HN71, MG17, UB67 Transplantation-Bone marrow AP20, CU75, ET29, HN39, MT2, UB14, UB92 Transplantation Bone marrow, Allogenic BS7,HNl9,NC14 Transplantation-Bone marrow, Autologous AP3, BS8, NC16, NC151 Transplantation-Cornea UB39 307

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Transplantation-Heart CA100, HF194, MT13, PH9 Transplantation Heart-lung CA47 Transplantation Kidney HF39, HF176, HN5, MG4, MG6, MG7, MGl l, MG15, NC32 Transplantation Liver AO8, CA73, HN52, MT15, NC69, NC124, NL28 Transplantation Nail bed UB63 Transplantation Pancreas AG54, NC53 Transsexual surgery NC120 Transsexualism HN30 Trazodone FD117 Tr~amterene FD28 Triazolam FD52 Trimethoprim FD118, FD176, FD180, VC3, VC52 T. . rloctanoln AG44 Triolein AG44 Trophoblastic tumor AF30 Tropical medicine CU28 Tryptophan MR10 308 Tubal ligation CA15 Tuberculosis NC77 Tuberculosis screening CA56 Tumor markers ET46 Tumor stem cell assay AG71, CA86, NC114 Type A score NH36 Ulcer AS4, AS7, AS10 Ultrasonography AH5 Ultrasonography-Arteries AA50, AG79, AG80, NC100 Ultrasonography-Follicular growth AE3 Ultrasonography-Head BC31, MR26 Ultrasonography Pancreas HA24 Ultrasonography Pregnancy NK4, NL19 Ultrasonography-Prostate ET72 Ultrasonography Sinuses CA20 Ultrasound AA47, HN3, HN73 Ultrasound Cardiac output NC47

INDEX TO REPORT CITATIONS Ultrasound Intraoperative AP10 Ultrasound-Obstetrics and gynecology AF27 Ultrasound-Obstetrics and gynecology Pelvi metry BC35 Ultrasound equipment-Diagnostic HW8 Ultrasound equipment-Therapeutic FA46, NS14 Ultraviolet rays AO19, NC121 Ultraviolet therapy NC122 Unbundling JH8, UB87 Unstable Angina Pectoris Trial NH146, NH150, NH153 Ureteroscopy NC27, NC154 Urinalysis BC15, ET25 Urinary calculi LU3, VC26 Urinary catheterization ND54 Urinary incontinence AF44, CU29, EH33, HF93, SP3 Urinary sphincter, Artificial ET1 Urinary tract infections AF40, ND54, ND128 Urination disorders CA29, ND181 Urine AG82, BC15, NC123 Urography AC92, UB89 Urologic disease screening AC1 09 Urticaria ND164 Uterine hemorrhage AF24 Utilization review HF119 Vaccination policy CU80, CU85, HN58 Vaccines CA95, HN35, SC2 Valproate AC59, AC70, VC45 Vascular access ports ET37, FA302 Vasculitis NC97 Vasodilators VC27, VC28, VC59 Vegetarianism AC1 08 Venous insufficiency AG48, NC38 Ventilation-perfusion lung scans MM8 Ventilators ANl l, EH6, EH49, ET85, FA195 Ventricular assist devices MT14 309

MEDICAL TECHNOLOGY ASSESSMENT DIRECTORY Ventricular fibrillation NA62 Verapamil FD29, FD30, FD119, FD181 Vertebral artery AG55 Vertebral artery surgery CA11 Veterans Administration CUl l, CU22, VC13, VH3 Vidarabine FD53 Video recording NM13 Viral antibodies FA52 Viral hepatitis vaccine AG40, AO59, LU4, NH149 Vision SP8 Vision screening AC4, AC11 Vitamin B 12 ND1 73 Vitamin E AC26, MR43, ND108 Vitamins AC87, AO24 Vulvar neoplasms AF12 Warfarin MM13, VC11 Warts CA26 310 Water, Sterile FD1 75 West Virginia UP13 Wheelchairs CU40, HA10, ND95, ND107 Wolff-Parkinson-White syndrome API Women AE17,AF17,AF37,AF44,AO44,AO69,BC15 Work AF31 Wounds and injuries AC65, CBl 9, NA57, NA67 Xenon FD54 Xylitol AL10 Xylose AG45 Yohimbine MR23 Znc ND98 Zomepirac sodium FD182

Next: Part 2: Assessment Report Citations Listed by Technology »
Medical Technology Assessment Directory: A Pilot Reference to Organizations, Assessments, and Information Resources Get This Book
×
Buy Hardback | $250.00
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

For the first time, a single reference identifies medical technology assessment programs. A valuable guide to the field, this directory contains more than 60 profiles of programs that conduct and report on medical technology assessments. Each profile includes a listing of report citations for that program, and all the reports are indexed under major subject headings. Also included is a cross-listing of technology assessment report citations arranged by type of technology headings, brief descriptions of approximately 70 information sources of potential interest to technology assessors, and addresses and descriptions of 70 organizations with memberships, activities, publications, and other functions relevant to the medical technology assessment community.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  6. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  7. ×

    View our suggested citation for this chapter.

    « Back Next »
  8. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!