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ASSESSI
No
MEDICAL
I ~ ~ ~ ~ war ~ ~
Committee for Evaluating Medical Technologies
in Clinical Use
Division of Health Sciences Policy
Division of Health Promotion and Disease Prevention
INSTITUTE OF MEDICINE
NATIONAL ACADEMY PRESS
Washington, D. C. 1985
E,~
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National Academy Press · 2101 Constitution Avenue, NW · Washington, DC 20418
NOTICE: The project that is the subject of this report was approved by the Governing Board of the National
Research Council, whose members are drawn from the councils of the National Academy of Sciences, the Na-
tional Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the
report were chosen for their special competencies and with regard for appropriate balance.
This report has been reviewed by a group other than the authors according to the procedures approved by a
Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of
Engineering, and the Institute of Medicine.
The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished
members of the appropriate professions in the examination of policy matters pertaining to the health of the pub-
lic. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an advisor
to the federal government and its own initiative in identifying issues of medical care, research, and education.
This study was supported by the Henry J. Kaiser Family Foundation, Kaiser Foundation Hospitals, the Na-
tional Research Council Fund, and by the Office of Medical Applications of Research, National Institutes of
Health, Contract No. ASU000001-03.
The National Research Council Fund is a pool of private, discretionary, nonfederal funds that is used to support
a program of academy-initiated studies of national issues in which science and technology figure significantly.
Library of Congress Cataloging-in-Publication Data
Institute of Medicine (U.S.). Division of Health
Science Policy.
Assessing medical technologies.
Outgrowth of a conference held by the Institute of
Medicine in 1980.
Prepared by the Committee for Evaluating Medical
Technologies in Clinical Use.
Includes bibliographies and index.
1. Medical care—United States. 2. Technology
assessment—United States.
United States—Evaluation.
3. Medical technology—
4. Medical care. 5. Tech-
nology assessment. 6. Medical technology—Evaluation.
I. Institute of Medicine (U.S.~. Division of Health
Promotion and Disease Prevention. II. Institute of
Committee for Evaluating Medical
III. Title. fDNLM:
Medicine (U. S. ) .
Technologies in Clinical Use.
1. Evaluation Studies. 2. Technology Assessment,
Biomedical. 3. Technology, Medical—standards.
WE 365 I59a]
RA445.I58 1985 610'.28 85-15284
ISBN 0-309-03583-X
Copyright (D 1985 by the National Academy of Sciences
No part of this book may be reproduced by any mechanical,
photographic, or electronic process or in the form of a
phonographic recording, nor may it be stored in a retrieval
system, transmitted, or otherwise copied for public or pri-
vate use, without written permission from the publisher,
except for the purposes of official use by the United States
Government.
Printed in the United States of America
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Committee for Evaluating
Medical Technologies in Clinical Use
FREDERICK MOSTELLER
Roger I. Lee Professor,
Harvard School of Public Health,
Boston, Massachusetts (Chairman)
H. DAVID BANTA
Deputy Director, Pan American Health
Organization, Washington, D.C.
STUART BONDURANT
Professor of Medicine and Dean,
University of North Carolina School of
Medicine, Chapel Hill, North Carolina
MORRIS F. COLLEN
Former Director, Technology Assessment,
Department of Medical Methods
Research, Kaiser Permanente Medical
Care Program, Oakland, California
JOANNE E. FINLEY
Fellow, Department of Psychiatry,
University of Pennsylvania Graduate
Hospital Division (Former New Jersey
State Commissioner of Health)
BARBARA I. McNEIL
Professor of Radiology and Clinical
Epidemiology, Harvard Medical School,
and Director, Center for Cost-Effective
Care, Brigham and Womens Hospital
Boston, Massachusetts
LAWRENCE C. MORRIS, JR.
Senior Vice President, Health Benefits
Management, Blue Cross and Blue Shield
Association, Chicago, Illinois
LINCOLN E. MOSES
Professor of Statistics, Stanford
University, Stanford, California
· · .
SEYMOUR PERRY
Senior Fellow and Deputy Director,
Institute for Health Policy Analysis
Georgetown Medical Center,
Washington, D.C.
DOROTHY P. RICE
Regent's Lecturer, Department of Social
and Behavioral Sciences, School of
Nursing, University of California, San
Francisco, California
HERMAN A. TYROLER
Alumni Distinguished Professor,
Department of Epidemiology, School of
Public Health, University of North
Carolina, Chapel Hill, North Carolina
DONALI) A. YOUNG
Executive [Director' Prospective Payment
Assessment Commission, Washington,
D.C.
Study Staff
ENRIQUETA C. BOND, Study
Director and Director, Division of
Health Promotion and Disease
Prevention
BARBARA FILNER, Director, Division
of Health Sciences Policy
CAREN CARNEY, Research Assistant
CLIFFORD GOODMAN, National
Research Council Fellow
LINDA DePUGH, Administrative
Secretary
NAOMI HUDSON, Administrative
Secretary
WALLACE K. WATERFALL, Editor
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Acknowlecigments
As with many reports issued by the Institute of Medicine (IOM), this report rep-
resents the collaborative efforts of the committee, a number of TOM members, the
project staff, anti many persons outside the TOM. The individuals listen] below
drafted sections of the report, wrote background] papers for committee consider-
ation, reviewed (lrafts, submitted suggestions for improving technology assess-
ment, and, in general, gave their active assistance and collaboration. In Appendix
B are collected a number of papers written or contributed to the project as further-
ing our undertaking of technology assessment. We wish especially to express our
gratitude to National Research Council Fellow, Clifford Goodman, who has
worked closely with the committee for the past 2 years. The major contributors to
each chapter are further identified in appropriate sections of the report.
John Bailar, Harvard School of Public Health
John Ball, American College of Physicians
Benjamin Barnes, Harvard School of Public Health
*Jeremiah A. Barondess, Cornell University Medical College
*Lionel M. Bernstein, Knowledge Systems, Inc.
Jonathan Brown, Harvard School of Public Health
*Thomas C. Chalmers, Mount Sinai Medical Center
David Cohen, Cleveland Metropolitan General Hospital
*Jerome R. Cox, Jr., St. Louis School of Engineering and Applied Sciences,
Washington University
Betty L. Dooley, Center for Health Policy Studies
Jack Dunn, Employee Benefit Specialist, Ford Motor Company
* Denotes TOM member
v
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*David Eddy, Duke University
*Richard H. Egdahl, Boston University Medical Center
Penny H. Feldman, Harvard School of Public Health
*Harvey V. Fineberg, Harvard School of Public Health
G.D. Friedman, The Permanente Medical Group
Clifton R. Gaus, Foundation for Health Services Research
George Greenberg, U.S. Department of Health and Human Services
Paul F. Griner, The Henry J. Kaiser Family Foundation
*Ruth S. Hanft, Consultant
Richard J. Havlik, National Heart, Lung, and Blood Institute
Paul Jones, Case Western Reserve University School of Medicine
*Albert R. Jonsen, University of California, San Francisco
Edward H. Kass, Harvard Medical School
Jeffrey P. Koplan, Centers for Disease Control
John Laszlo, Duke University Medical Center
*Robert H. Moser, American College of Physicians
*Duncan B. Neuhauser, Case Western Reserve University School of Medicine
Joel J. Nobel, ECRI (formerly the Emergency Care Research Institute)
*Gerald T. Perkoff, University of Missouri-Columbia School of Medicine
Michael R. Reich, Harvard School of Public Health
Janet Reis, Northwestern University Center for Health Services and Policy
Research
Stanley J. Reiser, The University of Texas Health Science Center at Houston
Pierre F. Renault, National Institutes of Health
J. Sanford Schwartz, University of Pennsylvania
*Sam Shapiro, The Johns Hopkins University
Donald Shepard, Harvard School of Public Health
Herbert Sherman, Harvard School of Public Health
Jonathan Showstack, University of California, San Francisco
*Reuel A. Stallones, University of Texas Health Science Center at Houston
C. Frank Starmer, St. Louis School of Engineering and Applied Sciences,
Washington University
Seymour Sudman, University of Illinois
Bruce Vladeck, United Hospital Fund of New York
Milton C. Weinstein, Harvard School of Public Health
*Frank Young, Food and Drug Administration
$ Denotes TOM member
V1
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Preface
Twentieth century advances in scientific knowledge have been responsible for
profound improvements in human health. Many diseases have been eradicates!
and others now can be successfully treated or prevented. However, new technolo-
gies ant] procedures have cleveloped so rapidly—and there are such economic and
social incentives to use them that the evaluation of their safety, efficacy, and
cost-effectiveness as well as the consideration of their social and ethical conse-
quences has lagger] far behincl. This situation does not serve the patient, the physi-
cian, or our society well, and there is an increasing conviction that we need a coor-
dinatecI system for medical technology assessment and a national program of
support for it.
This stucly was the outgrowth of a 1980 Institute of Medicine conference on
linking the clinical use of biomedical technologies and the collection of evaluative
data. * The conferees considered] several methods for evaluating biomedical tech-
nologies and for applying the information obtained to physician eclucation, clini-
cal practice, resource allocation, quality assurance, and reimbursement. They also
consiclered such issues as the funding of evaluative research and translating re-
search findings on safety, efficacy, and cost-effectiveness into policy ant} practice.
This study was undertaken to address in greater detail the following questions
raised at the conference:
· What are the strengths and limits of methods for technology assessment ant]
how can it be improved? This question is primarily considered in Chapter 3 of the
report. Useful methods do exist for assessing medical technologies.
* Supported by the Charles H. Revson Foundation.
· ~
V11
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·..
V111
PREFACE
· How does knowledge from technology assessment translate into better clini-
cal care? This issue is discussed in Chapter 4, which indicates that we have much
to learn in this area.
· What gaps exist in the current system for technology assessment? Chapter 2
explores the terrain of technology assessment, identifying who is cloing it, how
much they are spending on it, ant! for what purposes. These considerations are
carrier] further in Chapters 6 and 7.
· Who shouIc3 pay for technology assessment? The stage for this important
question is set in Chapters 2 ant! 5. The question is also examined in Chapter 7,
along with the recommendations of the study committee.
PROCEDURE FOR THE STUDY
Primary responsibility for conclucting the stucly was vested in a committee of 12
experts in the fields of technology assessment, biostatistics, epidemiology, public
health policy, clinical practice, and thir(l-party payment mechanisms. Committee
members defined the task more precisely in preliminary meetings and then en-
rollec] the assistance of outside experts in crafting materials for their review ant]
incorporation into the report. Committee members, staff, ant] outside experts
worked collaboratively to complete the report.
Dr. Enriqueta Bond lee] the staff, organized much of the committee's work, and
tirelessly wrote parts of ant} contributes] to the editing of the report. Clifforc]
Goodman contributed much beyond the sections signed by him and wrote Appen-
clix A to this book, which gives basic systematic information about many of the
institutions performing technology assessment. Wallace Waterfall aided the com-
mittee enormously by editing a massive manuscript flowing from many hands.
Without the excellent secretarial assistance of Naomi Hudson and Linda DePugh,
the book wouIcI never have been completed.
AUDIENCE FOR THE STUDY
Various chapters of the report are expected to be of particular interest to one or
another segment of the total audience. To facilitate the reacler's choosing his or her
own path through the text, each chapter is intended to include enough informa-
tion from the others to keep at hand the context of the whole. First, the book is a
terrain map of medical technology assessment that can serve as a textbook for stu-
dents and educators. Second, researchers and funding agencies can find a research
agenda cleveloped throughout the book, but especially in Chapters 3, 4, and 7.
Next, those who carry out ant] use the results of technology assessment will find
value in the scope of technology assessment described in Chapter 2 and Appendix
A, the methods identified in Chapter 3, and recommendations for developing a
better system of technology assessment outlined in Chapter 7. Policymakers will
also be interested in these recommendations as well as the Summary, Chapter 2,
ant] Appendix A. Finally, the book should serve as a resource to the Institute of
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PREFACE
i:
Medicine in its efforts to contribute to the nation's system for technology assess-
ment by the establishment of a Council for Technology as definer! by P.~. 98-551 .
Recommendations in this report are of three types. Most of the individual chap-
ters include recommendations very specific to the chapter topics. Chapter 7 has
recommendations pertinent to establishing a system of technology assessment. And
the text in several chapters has sentences that are highlighter] in boiciface type as
contributions to a research agenda for technology assessment.
Appendix B of this report presents a selection from among the many papers pre-
parec] for the committee. Paper titles and authors are as follows: Guicle to Com-
parative Clinical Trials, by Clifford S. Goodman; Information Needs for Technol-
ogy Assessment, by Morris F. Collen; Towarc! Evaluating Cost-Effectiveness of
Medical and Social Experiments, by Frederick Mosteller and Milton C. Weinstein;
Technology Assessment in Prepaic] Group Practice, by Morris F. Collen; A Ran-
domizec] Controlled Trial to Evaluate the Effects of an Experimental Prepaid
Group Practice on Medical Care Utilization and Cost, by Gerald T. Perkoff; The
Metro Firm Trials: An Innovative Approach to Ongoing Ranclomizecl Clinical
Trials, by David I. Cohen and Duncan Neuhauser; Values and Preferences in the
Delivery of Health Care, by Barbara J. McNeil; New Fecleralism and State Sup-
port of Technology Assessment, by George D. Greenberg ant! Penny H. Feldman;
ant] Government Payers for Health Care, by Donald A. Young.
FREDER~cK Most
Chairman
.x
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Contents
SUMMARY ....................................
The Scope of U.S. Medical Technology Assessment, 2
Varieties and Expense of Assessment, 3
Federal Government, 3; Drug Industry, 3; Medical Device
Industry, 4; Other Private Sector Assessment Activities, 4
Lags in Assessment, 5
Recommendations, 6
MethocIs of Medical Technology Assessment, 6
Effects of Evaluation on Diffusion of Technology,
Diffusion and Its Determinants, 3
Types of Evaluation That Precede Accepted Medical Practice,
Recommendations, 9
Reimbursement and Technology Assessment, 9
Assessment in the New Era of Cost Containment, 10
Paying for Technology Assessment, ~ O
Recommendations, TI
Medical Technology Assessment AbroacI, IT
Recommendations, 12
Conclusions ant] Recommendations, 13
The Challenge, 13
Key Functions for Assessment, 13
Builcling a System, 14
Financing, 14
Recommendations, 14
X1
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· ~
X11
1. INTRODUCTION
Polio, 17
Surgical Procedure, 17
Examples of Technology Assessment, 19
Electronic Fetal Monitoring, 19
Computed Tomography Scanning, 20
Drug Treatment for Hypertension, 21
Hysterectomy, 22
Medical Information System, 23
Some Lessons from the Examples, 24
Comprehensive Technology Assessment, 25
Different Parties, Different Aims in Assessments, 26
References, 30
2. THE SCOPE OF U.S. MEDICAL TECHNOLOGY ASSESSMENT
An Overview, 32
Varieties of Medical Technology Assessment, 34
National Expenditures for Health Research and Development,
Clinical Trials, and Technology Assessment, 37
Federal Government, 39
National Institutes of Health, 40
Office of Medical Applications of Research, 41
Food and Drug Administration, 41
Office of Technology Assessment, 41
Prospective Payment Assessment Commission, 42
Health Care Financing Administration, 42
National Center for Health Services Research and Health
Care Technology Assessment, 43
Office of Health Technology Assessment, 44
National Center for Health Statistics, 44
Veterans Administration, 45
Centers for Disease Control, 45
Department of Defense, 45
Drug Inclustry, 46
Drug Industry Research and Development, 46
Assessment of Drugs, 47
Expenditures for Drug Assessment, 43
Medical Device Industry, 49
Medical Device Industry Research and Development, 49
Assessment of Medical Devices, 50
Expenditures for Medical Device Assessment, 52
Other Private Sector Assessment Activities, 53
Insurers, 53
Medical Associations, 54
CONTENTS
. . . . . .16
.32
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CONTENTS
Policy Research Groups, 55
Industry Associations, 55
Provider Institutions, 56
Academic Institutions, 58
Employers, 59
Conclusions, 59
Recommendations, 61
Assessment Concerns, 61
Coordination of Assessment Information, 61
Responsibility for Conduct of Assessments, 61
Evaluation of Assessment Programs, 62
Financial Support for Medical Technology Assessment, 62
Amount of Support, 62; Sources of Support, 64; A Worthy
Investment, 64
Notes, 64
References, 66
3. METHODS OF TECHNOLOGY ASSESSMENT
Randomizec! Clinical Trials, 73
Practical Problems of Comparing Treatments, 74
The Protocol, 74
Random Assignment to Treatment, 75
Limitations of RCTs, 76
Strengthening RCTs, 78
A Final Remark, 79
Evaluating Diagnostic Technologies, 80
Present Evaluation Methods, 80
Limitations of Present Evaluation Methods, 85
Strengthening the Method, 87
Summary, 88
The Series of Consecutive Cases as a Device for Assessing
Outcomes of Intervention, 89
Description of a Series, 90
Needed Information, 90
Adjustment for Interfering Variables, 90
Capabilities and Limitations, 91
Interpretation of Series, 92
Integrity of Counting, 92; Consequences of No Protocol, 92;
Consequences of No Randomization, 93
What About the Clear-Cut Series?, 94
Some Additional Issues, 95
Subgroups, 95; Temporal Drift, 96; Grab Samples, 96
Strengthening the Method, 97
· · ~
x~t
.70
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XIV
CONTENTS
The Case Study as a Too! for Meclical Technology Assessment, 97
What Is a Case Study?, 97
Case Studies from the Office of Technology Assessment, 99
Weaknesses of Case Studies, 100
Strengths of Case Studies, 100
Strengthening Case Studies, 101
Conclusions, 101
Registers and Data Bases, 101
Uses of Registers and Data Bases, 104
Capabilities and Limitations of Registers and Data Bases, ~ 06
Strengthening Uses of Registers and Data Bases, 109
Sample Surveys, 109
Uses of Sample Surveys, Il0
NCHS Surveys, Il0
Health Care Financing Administration Data, ~13
Capabilities ant! Limitations of Sample Surveys, Il4
Strengthening Uses of Sample Surveys, Il5
Epiclemiologic Methods, Il6
Uses of Epidemiologic Methods, Il7
Cohort Studies, 117; Case-Control Studies, 118; Cross-Sectional
Studies, 118
Capabilities and Limitations of Epidemiologic Methods, Il9
Strengthening Uses of Epidemiologic Methods, Il9
Surveillance, 120
Uses of Surveillance, 121
Capabilities and Limitations of Surveillance, 123
Strengthening Uses of Surveillance, 124
Quantitative Synthesis Methods Meta-Analysis, 125
Voting Methods, 126
Cumulation of Significance Levels (p-Values), 127
Other Statistical Synthesis Procedures, 127
Example of Synthesis, 128
Group Judgment Methods, 129
Formal Group Methods, 130
Delphi Technique, 130; Nominal Group Technique, 131
Group Methods Designed for Health Issues, 131
NIH Consensus Development Conferences, 131; State-of-the-Art Diagnosis
and Care of COPD, 133; Medical Practice Information Project, 133;
Rand-UCLA Health Services Utilization, 134; Computer
Knowledge Bases, 134
Strengthening Group Judgment Efforts, 135
Cost-Effectiveness and Cost-Benefit Analyses, 136
Uses of CEA/CBA, 140
Capabilities and Limitations, 141
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CONTENTS
Strengthening Use of CEA/CBA, 143
Recommendations, 144
Technology Assessment: The Role of Mathematical Modeling, 144
Background, 145
An Example, 146
The Role of Moclels, 146
Mental Models, 146; Mathematical Models, 147
Uses of Mathematical Models in Technology Assessment, 147
Estimating Outcomes, 147; Additional Uses, 148
Types of Mathematical Models, 148
Validation of Mathematical Models, 149
Limitations, 150
Strengthening the Technique, 152
Conclusion, 153
Social ant] Ethical Issues in Technology Assessment
Experience in Aciciressing Ethical Issues, 157
Ethics of Investigation, 158
Initiation, 158; Conduct, 158; Termination, 158
.,
154
Conclusions and Recommendations, 159
Appendix 3-A: Example of Cost-Benefit Analysis, 160
Appendix 3-B: An Example of a Mathematical Moclel of Medical
Technology, 164
References, 166
4. EFFECTS OF CLINICAL EVALUATION ON THE
DIFFUSION OF MEDICAL TECHNOLOGY.......
Evaluation, 176
Diffusion, 177
Determinants of Diffusion, 178
Prevailing Theory, 178; The Innovation, 178; The Clinical
Situation, 178; Advocacy, 178; The Potential Adopter, 179;
The Practice Setting, 179; The Decision-Making Process, 179;
Environmental Constraints and Incentives, 179; Evaluation and
Methods of Evaluation, 179; Channels of Communication, 180
Measures of Diffusion and Sources of Data, 181
Diffusion as Affected by Evaluation, 182
Evidence About the Effects of Evaluation on Diffusion, 185
Evaluation and Physician Behavior, 185
The Impact of Primary Evaluations on Physicians, 185; Effects of
Clinical Trials on Physician Awareness, 185; Effects of RCTs on
Physician Practices, 187; Types of Evaluation That Precede
Accepted Medical Practices, 193; The Impact of Synthetic
Evaluations, 194
Evaluation and Policy on Regulation and Reimbursement, 195
Conclusions and Recommendations, 196
xv
. ... ...176
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XVI
Appendix 4-A: Summaries of Studies, 198
References, 207
REIMBURSEMENT AND TECHNOLOGY ASSESSMENT
Assessment in the Era of Retrospective Payments, 212
The Need for Assessment in the New Era of Cost Containment, 214
Leverage of the Reimbursement System over Institutions, 215
Capital Acquisition, 216
Stimulus for Technology Assessment in Reimbursement Policy, 217
DRG Price Development and Technology Assessment, 217
Cost-Containment Information: Feedback for Change, 219
Mechanisms to Promote Appropriate Use of Technology, 220
Paying for Technology Assessment, 221
Conclusions and Recommendations, 224
Appendix 5-A: Legal Considerations in Private Health Insurer's
Identification and Exclusion of Unnecessary, Incompetent,
and Unproved Services, 224
References, 226
6. MEDICAL TECHNOLOGY ASSESSMENT
IN DEVELOPED COUNTRIES:
TRENDS AND OPPORTUNITIES FOR COLLABORATION
Trends in Assessment and Regulation, 229
Research and Development, 230
Clinical Trials, 231
Consensus Activities, 232
Use of Technology in Different Countries, 232
Assessment of Drugs in Different Countries, 234
France, 235
West Germany, 236
Health Care Systems in Different Countries, 237
Britain, 237
Japan, 238
International Organizations, 239
International Pharmaceutical Firms, 239
International Health Information, 239
World Health Organization Network on Technology
Assessment, 240
Postmarketing SurveilIanee of Drugs, 240
Conclusions and Recommendations, 241
References, 242
CONTENTS
.211
.228
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CONTENTS
7. CONCLUSIONS AND RECOMMENDATIONS
The Challenge, 246
Key Functions Needing Improvement, 246
:Information Monitoring ant] Acquisition, 246
Combining Information from Different Sources, 247
Dissemination of Tnformation, 247
Identification of Gaps in Knowledge That Require Research, 247
Data and Tnformation Acquisition, 247
Priority Setting, 247
Manpower for Technology Assessment, 248
Research ant] Development of Methods for Assessment, 248
Builcling a System, 249
Advantages and Disadvantages of Various Institutional
Arrangements, 249
Private-Public Body, 249
Reestablish the NCHCT, 250
Development of a System by the DHHS Secretary, 250
A Separate Federal Agency, 250
Not the Regulatory Approach, 251
Financing, 252
Recommendations, 252
Closing Comment, 253
References, 254
APPENDIX A
Profiles of 20 Technology Assessment Programs
APPENDIX B Selected Papers ........
Guicle to Comparative Clinical Trials, 490
Tnformation Needs for Technology Assessment, 502
Toward Evaluating Cost-Effectiveness of Medical ant] Social
Experiments, 506
Technology Assessment in Prepaic} Group Practice, 515
A Randomized Controller] Trial to Evaluate the Effects of an
Experimental Prepaic] Group Practice on Meclical Care Utilization
and Cost, 525
The Metro Firm Trials: An Innovative Approach to Ongoing
Randomized Clinical Trials, 529
Values and Preferences in the Delivery of Health Care, 535
New Federalism ant] State Support for Technology Assessment, 542
Government Payers for Health Care, 554
INDEX .
· ~
XV11
.244
.255
490
.565
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