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.
Inclex A Academic institutions, 58 ACC, see American College of Cardiology ACE, see American College of Physicians ADAMHA, see Alcohol, Drug Abuse, and Mental Health Administration Advocacy, 178-179 Agency for International Development, 38 AHA, see American Hospital Association Alcohol, Drug Abuse, and Mental Health Adminis- tration (ADAMHA), 38, 39, 40, 41, 248 Alcohol treatment demonstration project, 519 Alliance for Engineering in Medicine and Biology, U.S., 232 AMA, see American Medical Association American College of Cardiology (ACC), 2, 32, 54, 261-274 American College of Physicians (ACP), 2, 33, 38, 54, 55, 62, 63, 129, 195, 213, 275-285, 313 American College of Radiology, 2, 33, 54, 55, 195 American College of Surgeons, 2, 33, 103 American Heart Association (AHA), 261-274 American Hospital Association (AHA), 2, 4, 28, 32, 38, 53, 56, 57, 61, 261-274, 286-293 American Medical Association (AMA), 2, 32, 38, 55, 61, 129, 294-300 Army Medical Research and Development Com- mand, U.S., 38, 45 Arteriovenous hemofiltration, continuous (CAVH), 299-300 Arthritis Foundation, 222 Aspirin Myocardial Infarction Study (AMIS),186- 187 Assessment of drugs, see Drug assessment of medical devices, see Medical device assessment technology, see Medical technology assessment B Battelle Columbus Laboratories, 23 Battelle Memorial Institute, 55, 301-307, 334 BCBS, see Blue Cross and Blue Shield Beta-carotene trial, 509 Bias, 80 Blue Cross and Blue Shield (BCBS), 2, 33, 38, 53-54, 194-195, 213, 214, 215, 262, 275, 276, 278, 308-327 Blue Cross and Blue Shield Association, 321-323 Boston Collaborative Drug Project, 122 Boston Elbow, 434-435 British Department of Health and Social Services, 20 British National Perinatal Epidemiology Unit (Oxford), 12 C CAMM, see Commission d'Autorisation de Mise sur le Marche Capital acquisition, 216-217 Cardiac pacemaker implantation, 265-274 Cardiovascular procedures, Task Force on Assess- ment of, 261-274 Care of the Terminally Ill: Mortality and Eco- nomics, The, (article), 338-342 Case-control studies, 117, 118 565
566 Case studies in medical technology assessment, 97-101 from OTA, 99-100 strengthening, 101 strengths of, 100-101 typology of, 98 weaknesses of, 100 CASS, see Coronary Artery Surgery Study Catalog systems, online, 412-423 CAVH, see Continuous arteriovenous hemofiltration CBA, see Cost-benefit analysis CCPDS, see Centralized Cancer Patient Data Sys- tem CDC, see Centers for Disease Control CDP, see Coronary Drug Project CDRH, see Center for Devices and Radiological Health CEA, see Cost-effectiveness analysis CEAP, see Clinical Efficacy Assessment Project Center for Devices and Radiological Health (CDRH), 49 Centers for Disease Control (CDC), 38, 39, 40, 41, 45, 50, 120, 122, 179 Centralized Cancer Patient Data System (CCPDS), 106, 108 Certificate of Need (CoN) programs, 216-217 Chronic obstructive pulmonary disease (COPD), 133 Cimetidine, 456-468 Civilian Health and Medical Program of the Uni- formed Services (CHAMPUS), 555 Clearinghouse, international, 12 Cleveland Clinic, 56 Cleveland Metropolitan General Hospital (METRO), firm trials, 529-533 Clinical Efficacy Assessment Project (CEAP), 129, 213, 275-285 Clinical evaluation, 4, 8-9, 176-207 Clinical situation, 178 Clinical Study Results (summary), 351-354 Clinical trials, 4, 6, 7 basic descriptive material, 495 blinding, 497-498 checklist for comparative, 493-494 comparative, 490-501 compliance, 498 cost-effectiveness model for, 508-509 examples of, 509-510 international, 231-232 national expenditures for, 37-39 NHLBI and, 376 physicians and, 185-187 power, 500 random allocation, 496-497 reporting, 491-500 sample size, 495 selection of patients, 495-496 statistical methods and analysis, 499-500 INDEX tabulation of outcomes, 499 treatment complications, 499 treatments, 498 withdrawals/loss to follow-up, 498-499 see also Randomized controlled/clinical trials Cluster approach, 128 CME, see Continuing medical education Cohort studies, 117-118 College of American Pathologists, 313 Commission d'Authorisation de Mise sur le Marche (CAMM), 235-236 Commission on Professional Hospital Activities, 182 Communication, channels of, 180-181 Comparative clinical trials, 490-501 Computed tomography (CT), 20-21, 25, 56, 111, 132, 141, 393, 395, 425, 502, 503, 544 Computer knowledge bases, 134-135 CoN (Certificate of Need) programs, 216-217 Consecutive cases, series of, see Series Consensus activities, international, 232 Consensus Development Conferences (NIH), 131- 133 Consensus Development Program (CDP), 61-62, 129, 13O, 180, 194, 377, 382, 386-404 Continuing medical education (CME), 185-186 Continuous arteriovenous hemofiltration (CAVH), 299-300 Contraceptive studies, 519 Controlled trial, randomized, see Randomized controlled/clinical trials Cooperative Studies Program (CSP), 476-489 Coronary Artery Disease (CAD) data bank (Duke University Medical Center), 103 Coronary Artery Surgery Study (CASS), 192, 377, 384-385 Coronary bypass surgery, 483-489 Coronary Drug Project (CDP), 187, 190, 193, 196 Cost-benefit, term, 258 Cost-benefit analysis (CBA), 71, 122, 136-144 capabilities and limitations, 141-143 exampleof, 160-164 recommendations for, 144 strengthening uses of, 143-144 usesof,140-141 Cost-Benefit Studies, Smith Kline & French (SK&F-CBS), 451-468 Cost containment, 9, 10, 214-221 Cost-effectiveness, 58 evaluating, 506-514 model for, 508-509 Cost-effectiveness analysis (CEA),71, 122, 136-144, 508 capabilities and limitations, 141-143 recommendations for, 144 strengtheningusesof, 143-144 usesof, 140-141 Council of Medical Societies (CMS), 277
INDEX Council of Medical Specialty Societies, 33, 276 Council of Subspecialty Societies (CSS), 277 CPT, see Current Procedures Terminology Critical careventilators, 333 Crossover trial, 490-491 Cross-sectional studies, 1 17, 118 CT, see Computed tomography Current Procedures Terminology (CPT), 114 D Data acquisition, 71, 247 Data bases, 101-109 capabilities andlimitations of, 106-109 comparison of registers with, 102 strengthening uses of, 109 usesof, 104-106 Data pooling, 87 DATTA, see Diagnostic and Therapeutic Technol- ogy Assessment Program Decision-making process, 179 Delphi technique, 130-131, 132 DEN, see Device Evaluation Network Department of Commerce, 2, 33, 46 Department of Defense (DOD), 38, 40, 45-46, 49, 554,555 Department of Health and Human Services (DHHS). 2,14,33,38,40,42,55,215,216,228,237, 249,250,306,380,437-450,554 Developing countries, medical technology assessment in, 228-242 Device, see Medical device Device Evaluation Network (DEN),51 DHHS, see Department of Health and Human Ser- v~ces Diagnosis-Belated Groups (DRGs), 10,33,42,57, 88,214-222,224,248,425,438,543,550 Diagnostic and Therapeutic Technology Assessment Program (DATTA), 294-300 Diagnostic tests and technologies, 80-89 Diagnosticxrays,518 Diethylstilbestrol (DES), 118 Diffusion of technology, 8, 177-185 as affected by evaluation, 182-185 determinants of, 178-181 empiricalpatternsof, 184 evidence about effects of evaluation on, 185-195 idealized pattern of, 183 measures of, 181-182 Dimethyl sulfoxide (DMSO), 226 Do-not-admit surgery study, 519 DOD, see Department of Defense DRG, see Diagnosis-Related Group DRMS, see Drug Reaction Monitoring System Drug(s) assessment, 47-49 in different countries, l l-12,234-237 expenditures for, 48-49 567 industry, 46-49 expenditures, 3-4 R&D, 46-47 postmarketing surveillance of, 240-241 term, 256 treatment for hypertension, 21-22, 25 Drug Price Competition and Patient Restoration Act of 1984,49 Drug Reaction Monitoring System (DRMS), 105 Dyspepsia, endoscopy in, 282-285 E ECRI,2, 4, 5, 33, 34, 38, 53, 57, 61, 62, 63, 328-333 Effect sizes, 125 Effectiveness, term, 71, 258 Efficacy, term, 71, 258 EFM, see Electronic fetal monitoring EIES, see Electronic information exchange system E1 Camino Hospital, 23-24 Electro Spinal Orthosis (ESO), 351-354 Electronic fetal monitoring (EFM), 19-20, 25 Electronic information exchange system (EIES), 135 Eleventh Congress of European Dialysis and Trans- plant Association, 234 Emergency Care Research Institute, see ECRI Employer contributions for hearth, 59 End-stage renal disease (ESRD), 155-156, 234, 344-346, 518-519 Endoscopy in dyspepsia, 282-285 Environmental constraints and incentives, 179 Environmental Protection Agency (EPA), 306 Epidemiologic methods, 116-120 capabilities and limitations of, 119 strenghening uses of, 119-120 uses of, 117-118 ESO, see Electro Spinal Orthosis ESRD, see End-stage renal disease Ethical issues, 154-159 experience in addressing, 157-158 term, 258 Ethics of investigation, 158-159 European Economic Community, 234, 235 European Free Trade Association, 234 Evaluation, 176-177 diagnostic technologies and, 80-89 diffusion as affected by, 182-185 evidence about effects of, on diffusion, 185-195 of medical and social experiments, 506-513 medical practices and, 193-194 methods of, 80-89, 179-180 physicians and, 185-195 primary, physicians and, 185 regulation and, 195-196 studies, 198-207
568 synthetic, 194-195 types of, 176 Expenditures, national, 37-39 F FDA, see Food and Drug Administration Federal government, 39-46 expenditures, 3 payers for health care, 28-29, 554-564 Federalism, new, in technology assessment, 542-553 Federation of County Councils, 12, 229 Fetal monitoring, electronic (EFM), 19-20 Food, Drug, and Cosmetic Act, 4, 49, 52, 60, 234, 545 Food and Drug Administration (E;DA), 4, 11, 13, 18, 27, 38-41, 47-52, 56, 59-62, 105, 121-122, 177, 179, 195-196, 213, 224-225, 229, 237, 244, 306, 321, 349-350, 359-360, 454, 481, 507, 545, 561-562 Freedom of Information Act, 108 G General Accounting Office, U.S., 2, 42, 312, 428 Georgetown University, 334 Government, federal, see Federal government Grab samples, 96 Group Health Association of America, 56 Group Health of Puget Sound (GHC), 56, 57, 521- 524 Group judgment methods, 129-136 designed for health issues, 131-135 formal, 130-131 strengthening, 135-136 Group practice, prepaid, 515-524 randomized controlled trial with, 525-528 H Hartford Foundation, 278 Harvard Community Health Plan, 56, 57, 520-521 Hastings Center, 38, 55, 63, 334-342 Hawthorne effect, 532-533 HCA, see Hospital Corporation of America HCFA, see Health Care Financing Administration HCT, see Historically controlled trial HDP, see Health Devices Program Health and Population Study Center (Battelle Memorial Institute), 302, 305 Health and Public Policy Committee (ACP), 277- 278 Health care government payers for, 554-564 of the terminally ill, 338-342 values and preferences in delivery of, 535-541 Health Care Financing Administration (HCFA), 5-7, 10, 38-43, 58-6O, 63-64, 72-73, 112- 114, 179-180, 196, 212-214, 218, 222-223, INDEX 250-251, 287-288, 302-308, 321, 355-363, 377, 554, 556-557, 560-563 Health care systems in different countries, 237-239 Health Devices Program (HDP), 328-333 Health information, international, 239 Health Insurance Plan of Greater New York (HIP), 147 Health Interview Survey, 182 Health maintenance organizations (HMOs), 27-28, 38, 56, 57, S9, 119, 453, 470, 515 Health Policy Research Group (Hastings Center), 335 Health Program (OTA), 424-436 Health Promotion and Disease Prevention Amend- ments of 1984, 44 Health registers, see Registers Health Resources and Services Administration (HRSA), 38, 40 Health Services Research, Division of, 343-346 Hemofiltration, continuous arteriovenous (CAVH) 299-300 Hepatitis Knowledge Base, 135, 409, 410 High blood pressure, see Hypertension Historical control groups, 491 Historically controlled trial (HCT), 75-76 HMOs, see Health maintenance organizations Hospital computer system, S19 Hospital Corporation of America (HCA), 57-58 Hospital Discharge Survey, 182 Hospital stay for myocardial infarction, 191-192 Hospital Technology Series Program, 286-293 HRSA, see Health Resources and Services Adminis- tration Human Affairs Research Centers (Battelle Memorial Institute) (HARC), 301-307 Hypertension, drug treatment for, 21-22, 25 Hypertension Detection and Follow-up Program (HDFP), 186, 188, 194 Hysterectomy, 22-23, 25 ~, I ICD, see International Classification of Diseases IDE, see Investigational device exemption IHCE, see Institute of Health Care Evaluation IMPS, see Institute for Health Policy Studies IND, see Investigational new drug Industry associations, 55-56 Information combining, 125, 247 dissemination of, 247 monitoring and acquisition, 246-247 needs for technology assessment, 502-505 system, medical, 23-24 Innovations, 178 Institute for Health Policy Studies (IHPS), 469-475 Institute of Health Care Evaluation (IHCE), 222- 223
INDEX Institute of Medicine (IOM), 1, 12, 33, 154, 157, 223, 242 Institute of Society, Ethics and the Life Sciences, 334-342 Insurance, private, 10 Insurers, 53-54 Intensive care units, 432-434 International Classification of Diseases (ICD), 114-115 International clearinghouse, 12 International health information, 239 International organizations, 239-241 International pharmaceutical firms, 239 Investigational device exemption (IDE), 51 new drug (IND), 47 IOM, see Institute of Medicine J Joint American College of Cardiology/American Heart Association Task Force on Assessment of Cardiovascular Procedures, 261-274 Joint Commission on Prescription Drug Use, 124 Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure, 186 K Kaiser-Permanente Medical Care Program (KPMCP), 56-57, 96, 105, 343-346, 517-520 Kennedy Institute of Ethics, 334 L Legal considerations, 224-226 Lister Hill National Center for Biomedical Com- munications (NML), 406-408 Liver transplantation, 397-404 M Mammary artery ligation, internal, 17-18 Manpower for technology assessment, 248 Massachusetts Hospital Association (MHA), 54 Mathematical modeling, 144-154 background of, 145 example of, 146, 164-166 limitations of, 150-152 role of, 146-147 strengthening, 152-153 types of, 148-149 uses of, 147-148 validation of, 149-150 Matching, 491 Mayo Clinic, 56, 96 MDR, see Medical device reporting Medicaid, 43, 113, 214, 215, 221, 543, 544, 550, 554-564 Medical and social experiment, evaluation of cost- effectiveness of, 506-513 569 Medical associations, 54-55. See also specific assoc'- ations. Medical Care Group of Washington University (MCG), 525-528 Medical Device Amendments of 1976, 4, 50-51, 52, 60 Medical devices assessment, 4, 50-53 expenditures for, 4, 52-53 industry, 49-53 reporting (MDR), 51 term, 256-257 Medical information system, 23-24 Medical Literature Analysis and Retrieval System (MEDLARS), 239, 406, 410 Medical Methods Research (MMR), Division of, 343-346, 517-518 Medical Necessity Program, 195, 213, 262, 275, 276, 278, 309-318 Medical Practice Information Project, 133-134 Medical practices, evaluation and, 193-194 Medical procedure, term, 257 Medical technology application of, 258-259 assessment, 1-2 abroad, 11-12 alternative, 503 case studies in, 97-101 comprehensive, 25-26 comprehensiveness of U.S., 36 conclusions and recommendations, 13-15, 244-254 coordination of, 61 costs of, 502-503 definition of type of, 502 in developed countries, 228-242 different aims in, 26-30 dollar level of effort in, 3 effects of clinical evaluation on diffusion of technology, 8-9, 176-210 in era of retrospective payments, 212-214 examples of, 19-25 financial support for, 6, 62-64, 252-253 functional specifications for, 502 information needs for, 246-247, 502-505 institutional arangements for, 249-251 introduction, 16-31 key functions for, 13-14, 246-249 lags in, 5 manpower for, 248 mathematical modeling and, 144-154 methods of, 6-8, 70-166, 259 need for, 214-221 in new era of cost containment, 10, 214-221 new federalism and state support for, 542-553 paying for, 10-11, 221-223 in prepaid group practice, 515-524
570 primary purpose of, 9 principal technologies in programs, 35-36 program profiles, 255-489 recommendations on, 6, 11, 61-64, 252-253 reimbursement and, 9-11, 211-226 research and development for, 37-39, 230-232, 248-249 responsibility for conduct of, 61-62 scope of U.S., 2-6, 32-69 selected attributes of, 34 social and ethical issues in, 154-159 summary, 1-15 systematic approach to, 18-19 technical specifications of, 502 trends in, in developed countries, 229-230 types of, 8-9 varieties and expense of, 3-5 varieties of, 34-36 in different countries, 232-234 stage of, 258 Medicare, 7, 10, 29, 32-33, 43, 56, 57, 63, 113-114, 196, 211, 212, 214-216, 220-221, 224, 251, 305, 321, 356, 363, 437, 438, 543, 544, 554- 564 Medicare prospective payment system (PPS), 437- 450 Medicare Statistical System, 113-114 MEDLARS, see Medical Literature Analysis and Retrieval System Medtronic, Inc., 347-354 Mental models, 146 Meta-analysis, 125-129 Metro Firm trials, 529-534 Mild hypertension trial, 509-510 Modeling, simulation by, 7 Morbidity and Mortality Weekly Report (MMWR), 120 Multiphasic health testing, 519 Myocardial infarction, hospital stay for, 191-192 N National Ambulatory Medical Care Survey (NAMCS), 110, 111 National Cancer Institute (NCI), 40, 104, 373, 382 National Burn Demonstration Project, 395 National Center for Health Care Technology (NCHCT), 14, 64, 110, 196, 212, 249, 250, 306, 543 National Center for Health Services Research and Health Care Technology Assessment (NCHSRHCTA), 33, 38, 39, 40, 43-44, 59, 62, 105, 212, 248, 250, 252, 253, 355-363, 387, 517 National Center for Health Statistics (NCHS), 40, 182 sample surveys, 110-114 statistics, 44-45 INDEX National Commission for the Protection of Human Subjects (NCPHS), 157-158 National Committee on Vital and Health Statistics, 115 National Disease and Therapeutic Index, 182 National expenditures, 37-39 National Eye Institute (NEI), 361 National Health Interview Survey (NHIS), 110 National Health Service (NHS), 237-238 National Health Survey Act of 1956, 110 National Heart, Lung, and Blood Institute (NHLBI), 59, 60, 61, 64, 103, 186, 187, 262, 306, 373-385 National Heart Transplantation Study, 302, 304, 305, 306 National Hospital Discharge Survey (NHDS), 110- 111, 115 National Implant Registry, 104 National Institute for Handicapped Research (NIHR), 50 National Institutes of Health (NIH), 2, 3, 5, 18, 32, 38-44, 50, 58-62, 129-133, 180, 194, 222, 232, 252, 373, 382, 386-404, 506-507. see also Consensus Development Conferences; and specific institutes National Kidney Dialysis and Kidney Transplanta- tion Study, 303, 304 National Library of Medicine (NLM), 134, 239, 331, 405-423 National Medical Care Utilization and Expenditure Survey (NMCUES), 112-113 National Mortality Survey, 112 National Multiple Sclerosis Society, 222 National Natality Survey, 112, 114 National Science Foundation (NSF), 37 National Society of Hospital Pharmacists, 111 National Survey of Family Growth, 122 Navy Medical Research and Development Com- mand, U.S., 45 NCHCT, see National Center for Health Care Tech- nology NCHS, see National Center for Health Statistics NCHSRHCTA, see National Center for Health Ser- vices Research and Health Care Technology Assessment NCI, see National Cancer Institute Negative trials, 492-493 New drug application (NDA), 47 NOT see Nominal group technique NHDS, see National Hospital Discharge Survey NHLBI, see National Heart, Lung, and Blood Institute NHS, see National Health Service NIH, see National Institutes of Health NIHR, see National Institute for Handicapped Research NLM, see National Library of Medicine
INDEX NMCUES, see National Medical Care Utilization and Expenditure Survey NMR, see Nuclear magnetic resonance Nominal group technique (NOT), 131 Northern California, technology assessment in, 517-519 Northern California Kaiser Foundation Health Plan (KFHP), 345-346 NSF, see National Science Foundation Nuclear magnetic resonance (NMR), 21, 289-293, 431-432 o GASH, see Office of the Assistant Secretary for Health OASPE, see Office of the Assistant Secretary for Planning and Evaluation Observational studies, 491 Occupational Safety and Health Administration (OSHA), 41, 306 Office of Health Research Statistics and Technology, 95 Office of Health Technology Assessment (OHTA), 5,7,38,39,40,41,44,59,72,73,212,244, 287, 355-363, 377, 387 Office of Medical Applications of Research (OMAR), 41, 132, 232, 377-380, 386-404 Office of Research and Demonstrations (ORD), 43 Office of Technology Assessment (OTA), 1-2, 5, 14, 25-26, 33, 38-42, 59, 72, 99-100, 110, 115, 136-143, 155-156, 160, 193, 196, 215, 217, 223, 244, 249-250, 256, 334, 424-436, 442, 472-473, 515, 544 Office of the Assistant Secretary for Health, 40, 355, 356 Office of the Assistant Secretary for Planning and Evaluation (OASPE), 43 OHTA, see Office of Health Technology Assessment OMAR, see Office of Medical Applications of Research Online catalog systems, 412-423 ORD, see Office of Research and Demonstrations Oregon, technology assessment in, 519-520 Organization of Economic Cooperation and Devel- opment, 12, 230 Organizational/administrative system, term, 257 Organizations, selected, 35-36 Orphan Drug Act of 1983, 49 OSHA, see Occupational Safety and Health Admin- istration OTA, see Office of Technology Assessment p p-values, 127 Pacemaker implantation, cardiac, 265-274 Pap smear, 164-166 571 Paralytic poliomyelitis, 17 Patient information, 503-504 Peer Review Organizations (PROs), 221 Peptic ulcer disease, 456-468 Percutaneous transluminal angioplasty (PTA), 364- 372 Permanente Medical Group, The (TPMG), 343-346 Pharmaceutical firms, international, 235, 239 Pharmaceutical Manufacturers Association (PMA), 3-4, 37-38, 46, 47, 56, 61 Phase IV studies, 48 Physicians clinical trials and, 185-187 evaluation and, 185-195 primary evaluation impact on, 185 RCTs and, 187-193 PMA, see Pharmaceutical Manufacturers Association PMAA, see Premarket approval application Policy research groups, 55 Poliomyelitis, paralytic, 17 Population information, 503-504 Postmarketing studies, 4, 48 Postmarketing surveillance of drugs, 240-241 Potential adopter, 179 Practice setting, 179 Predictive value positive and predictive value nega- tive, 82-83 Premarket approval application (PMAA),4,51,52 Premarketing studies' 4, 47-48 Prepaid group practice, 515-524, 525-528 President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 157-158 Prevailing theory, 178 Prevalence of disease, 83 Priority setting, 247-248 Private insurance, 10, 224-226 Private-public body, 249-250 Private sector assessment activities, 4-5, 53-59 Product Reporting Program (PRP), 51 Profile narratives, 256 Program profiles, 255-489 Prospective Payment Assessment Commission (ProPAC), 33, 40, 42, 62, 63, 218, 220, 223, 425, 437-450, 543 Protocol, 74-75, 79, 92-93 Provider information, 503-504 Provider institutions, 56-58 PRP, see Product Reporting Program PTA, see Percutaneous transluminal angioplasty Public Health Service (PHS), 61, 62, 63, 195, 196, 212, 306, 355, 356, 361 Public Health Services Act, 28 Q Quantitative synthesis methods, 125-129
572 R R&D, see Research and development Rand Corporation, 55, 130, 132, 395 Rand-UCLA Health Serviees Utilization, 134 Randomized eontrolled/clinical trials (RCTs), 6, 8, 21, 121, 123, 128-129, 145, 147, 177, 178, 196, 507 electronic monitoring and, 19-20 innovative approach to ongoing, 529-534 lack of, 93-94 limitation of, 76-78 physicians and, 185-193 prepaid group practice and, 525-528 protocol of, 74-75, 79 strengthening use of, 78-79 treatments and, 74, 75-76 uses of, 490-491 Receiver operating characteristic (ROC) curve, 83- 88 Reference standard, 86-87 Registers, 101-109 approximate costs of, 108 capabilities and limitations of, 106-109 comparison of data bases with, 102 strengthening uses of, 109 uses of, 104-106 Regulation, evaluation and, 195-196 Regulatory authority, 251-252 Reimbursement, technology assessment and, 211-226 Renal disease, end-stage (ESRD), 155-156 Replicability, term, 80 Research, identification of gaps in knowledge that require, 247 Research and development (R&D), 3, 4, 5, 58, 59- 60 in developed countries, 230-232 for drug industry, 4, 46-47 for health, 37-53 for medical device industry, 49-50 of methods for assessment, 248-249 ROC, see Receiver operating characteristic S Safety, term, 258 Sample surveys, 109-116 capabilities and limitations of, 114-115 NCHS, 110-113 strengthening uses of, 115-116 uses of, 110 SEER, see Survival, Epidemiology, and End- Results) Program Sensitivity, term, 82 Sensory evoked potential (SEP), 324-327 Series capabilities and limitations of, 91-92 clear-cut, 94-95 INDEX of consecutive eases, 90, 92-94 description of, 90 grab samples and, 96 integrity of counting, 92 interfering variables and, 90-91 interpretation of, 90, 92-94 leek of randomization and, 93-94 protocol and, 92-93 subgroups and, 95 temporal drift and, 96 Serum alpha-fetoprotein, 518 Significance levels, 125 cumulation of, 127 Smith Kline & French Cost-Benefit Studies (SK&F-CBS), 451-468 Soeial issues, 154-159 Soeial Seeurity Aet, 212 Soeial Seeurity Aet Amendments, 212, 221, 250 Soeial Seeurity Administration, 355 Soeial Seeurity Reform Aet of 1983, 10, 42, 215 Southern California, technology assessment in, 520 Specificity, term, 82 Speech impairments, 430-431 SPRI, see Swedish Planning and Rationalization Institute of Health Serviees Standard error (SE) for the mean, 95 Standard minimum data set, recommendation for, 505 State-of-the-art diagnosis, 133 State support for technology assessment, 542-553 Stevenson-Wydler Technology Innovation Aet, 2, 33 Stratified trial, 491 Summaries of studies, 198-207 Support system, term, 257 Surgical procedure, 17, 25, 257 Surveillance, 120-124 capabilities and limitations of, 123-124 of drugs, 240-241 strengthening uses of, 124 uses of, 121-123 Surveys, see Sample surveys Survival, Epidemiology, and End-Results (SEER) Program, 104, 107 Swedish Medieal Research Council, 232 Swedish Planning and Rationalization Institute of Health Serviees (SPRI), 11-12, 229-230 Synthesis example of, 128-129 methods, quantitative, 125-129 T Tax Equity and Fiscal Responsibility Act (TEFRA), 215, 217 Team primary care, 519 Teehnieon Medieal Information System (TMIS), 23-24
INDEX Technology assessment, medical, see Medical tech- nology assessment Technology diffusion, see Diffusion of technology Technology Evaluation and Coverage Program (TEC), 312, 319-327 Technology transfer, international, 232 Television, and community health, 519-520 Temporal drift, 96 TMIS, see Technicon Medical Information System U Uniform Hospital Discharge Systems (UHDDS), 221 Uniform Medical Policy, 321-327 University Group Diabetes Program (UGDP), 159, 187-188, 189-190 573 V VA, see Veterans Administration Ventilators, critical care, 333 Veterans Administration (VA), 2, 21, 33, 38, 39, 45, 50, 51, 57, 96, 425, 47~489, 555-556 Voting methods, 126-127 W Wheelchairs, 435-436 World Health Organization (WHO), 11, 12, 121, 122, 124, 193, 196, 229, 234, 235, 236, 240- 241, 242
