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Monograph of the Council: on
Heals Care Technology
Assessment of
Diagnostic Technology
in Health Care
Rationale, Methods,
Problems, and Directions
Harold Sox, Susan Stern,
Douglas Owens, and
Herbert L. Abrams
Institute of Medicine
NATIONAL ACADEMY PRESS · WASHINGTON, D.C. · 1989
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THE INSTITUTE OF MEDICINE was chartered in 1970 by the National
Academy of Sciences to enlist distinguished members of appropriate professions
in the examination of policy matters pertaining to the health of the public. In this,
the Institute acts under both the Academy's 1X63 congressional charter responsi-
bility to be an adviser to the federal government, and its own initiative in
identifying issues of medical care, research, and education.
THE COUNCIL ON HEALTH CARE TECHNOLOGY was established in
1986 by the Institute of Medicine of the National Academy of Sciences as a
pu~ic-pnvate entity to address issues of health care technology and technology
assessment. The council is committed to the well-being of patients as the
fundamental purpose of technology assessment. In pursuing Hat goal, the council
draws on the services of the nation's experts in medicine, health policy, science,
engineering, and industry.
This monograph was supported in part by a grant to the Council on Health
Care Technology of the Institute of Medicine from He National Center for Health
Services Research of the U.S. Deparunent of Health and Human Services (grant 5
R09 HS055 26 02~. The opinions and conclusions expressed here are those of the
authors and do not necessarily represent the views of the Department of Health
and Human Services, the National Academy of Sciences, or any of their constitu-
ent parts.
Library of Congress Catalog Card Number 89-62666
International Standard Book Number 309-04099-X
Additional copies of this report are available from:
National Academy Press
2101 Constitution Avenue, NW
Washington, DC 20418
Printed in the United States of America
S033
First Printing, November 1989
Second Printing, September 1990
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Council on
Health Care Technology
Chairman
WILLIAM N. HUBBARD, JR.
Former President
The Upjohn Company
Co~hairman
JEREMIAH A. BARONDESS
Irene F. and I. Roy Psaty Distinguished
Professor of Clinical Medicine
Cornell University Medical College
Members
HERBERT L. ABRAMS
Professor of Radiology
Stanford University School of Medicine
RICHARD E. BEHRMAN
Dean, School of Medicine
Case Western Reserve University
PAUL A. EBERT
Director
American College of Surgeons
PAUL S. ENTMACHER
Senior Vice-President and
Chief Medical Director
Metropolitan Life Insurance Company
MELVIN A. GLASSER
Director
Health Security Action Council
BENJAMIN L. HOLMES
Vice-President and General Manager,
Medical Products Group
Hewlett-Packard Company
GERALD D. LAUBACH
President
Pfizer Inc.
WALTER B. MAKER
Director, Employee Benefits and
Health Services
Chrysler Corporation
WAYNE R. MOON
Executive Vice-President and
Operations Manager
Kaiser Foundation Health Plan, Inc.
LAWRENCE C. MORRIS
Senior Vice-President,
Health Benefits Management
Blue Cross and Blue Shield
Association
FREDERICK MOSTELLER
Roger I. Lee Professor (Emeritus)
Howard School of Public Health
MARY 0. MUNDINGER
Dean, School of Nursing
Columbia University
ANNE A. SCITOVSKY
Chief, Health Economics
Department
Palo Alto Medical Foundation
GAIL L. WARDEN
Chief Executive Officer
Group Health Cooperative of
Puget Sound
· · .
111
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PREFACE
In the recent past the interests of different groups concerned with
health care have focused on the use of medical technologies~heir ~m-
pacts on safety, efficacy, and effectiveness; cost-effectiveness and cost-
benefit; quality; and their social, legal, and ethical implications. The sum
of these varied interests is the field of health care technology assessment.
The Council on Health Care Technology was created to promote the
development and application of technology assessment in health care and
the review of health care technologies for their appropn ate use. The
council was established as a public-pr~vate enter se at the Institute of
Medicine, a component of the National Academy of Sciences, through the
Health Promotion and Disease Prevention Amendments of 1984 (P.L. 98-
551, later amended by P.L. 99-1171. In 1987 the U.S. Congress extended
support for the council as a public-private venture for an additional three
years (by P.~. 100-1771.
The goals and objectives of the council, as stated in the report of its first
two years of operations, are "to promote the development and application
of technology assessment in medicine and to review medical technologies
for their appropn ate use. The council is guided in its efforts by the belief
that the fundamental purpose of technology assessment is to improve
well-being and the quality of care." In pursuing these goals, the council
seeks to improve the use of medical technology by developing and evalu-
ating the measurement criteria and the methods used for assessment, to
promote education and training in assessment methods, and to provide
technical assistance In the use of data from published assessments.
The council conducts its activities through several working and liaison
panels. Members of these panels reflect a broad set of interested constitu-
encie~physicians and other heady professionals, patients and their fami-
lies, payers for care, biomedical and health services researchers, manufac-
turers of health-related products, managers and administrators throughout
the health care system, and public policymakers. In addition, it carries out
councilwide activities that utilize the specific assignments of more than
one panel.
This monograph contributes to the series of occasional publications
produced by the council in carrying out its several missions. It examines
two issues of special concern to the council~ollection of primary data
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CONTENTS
Introduction
Herbert L. Abrams
I. Rationale for Assessment of Diagnostic Technology
2. The Use of Diagnostic Tests: A Probabilistic Approach
3. Assessment: Problems and Proposed Solutions.........
4. Primary Assessment of Diagnostic Tests: Bamers to
Implementation
5. Costs and Sources of Funding.........
· · .
6. A National Program for Assessing Diagnostic Technology
7. Problems of Multi-Institutional Studies
The Authors ...................
· ~
V11
8
. . . 23
5s
73
107
..... 120
· —
. 129
....... 143
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