Table Of Contenti
Assessing Medical Technologies
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
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ii
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 mem-
bers are drawn from the councils of the National Academy of Sciences, the National 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 appropri-
ate professions in the examination of policy matters pertaining to the health of the public. 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 National 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. 3. Medical technology— United States—Evaluation. 4. Med-
ical care. 5. Technology assessment. 6. Medical technology—Evaluation. I. Institute of Medicine (U.S.). Division of Health Promotion and
Disease Prevention. II. Institute of Medicine (U.S.). Committee for Evaluating Medical Technologies in Clinical Use. III. Title. [DNLM: 1.
Evaluation Studies. 2. Technology Assessment, Biomedical. 3. Technology, Medical—standards. WB 365 I59a]
RA445.I58 1985 610`.28 85-15284
ISBN 0-309-03583-X
Copyright © 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 private use, without written permission from the pub-
lisher, except for the purposes of official use by the United States Government.
Printed in the United States of America
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iii
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 J. 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
DONALD 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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iv
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ACKNOWLEDGMENTS v
Acknowledgments
As with many reports issued by the Institute of Medicine (IOM), this report represents the collaborative efforts of the
committee, a number of IOM members, the project staff, and many persons outside the IOM. The individuals listed below
drafted sections of the report, wrote background papers for committee consideration, reviewed drafts, submitted suggestions
for improving technology assessment, 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 furthering 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 B. 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 IOM member
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ACKNOWLEDGMENTS vi
*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 IOM member
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PREFACE vii
Preface
Twentieth century advances in scientific knowledge have been responsible for profound improvements in human health.
Many diseases have been eradicated and others now can be successfully treated or prevented. However, new technologies and
procedures have developed 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 consequences has lagged
far behind. This situation does not serve the patient, the physician, or our society well, and there is an increasing conviction
that we need a coordinated system for medical technology assessment and a national program of support for it.
This study 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
technologies and for applying the information obtained to physician education, clinical practice, resource allocation, quality
assurance, and reimbursement. They also considered such issues as the funding of evaluative research and translating
research findings on safety, efficacy, and cost-effectiveness into policy and 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 and 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.
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PREFACE viii
• How does knowledge from technology assessment translate into better clinical 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 doing it, how much they are spending on it, and for what purposes. These considerations
are carried further in Chapters 6 and 7.
• Who should pay for technology assessment? The stage for this important question is set in Chapters 2 and 5. The
question is also examined in Chapter 7, along with the recommendations of the study committee.
PROCEDURE FOR THE STUDY
Primary responsibility for conducting the study was vested in a committee of 12 experts in the fields of technology
assessment, biostatistics, epidemiology, public health policy, clinical practice, and third-party payment mechanisms.
Committee members defined the task more precisely in preliminary meetings and then enrolled the assistance of outside
experts in drafting materials for their review and incorporation into the report. Committee members, staff, and outside experts
worked collaboratively to complete the report.
Dr. Enriqueta Bond led the staff, organized much of the committee's work, and tirelessly wrote parts of and contributed
to the editing of the report. Clifford Goodman contributed much beyond the sections signed by him and wrote Appendix A to
this book, which gives basic systematic information about many of the institutions performing technology assessment.
Wallace Waterfall aided the committee enormously by editing a massive manuscript flowing from many hands. Without the
excellent secretarial assistance of Naomi Hudson and Linda DePugh, the book would 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 reader's choosing his or her own path through the text, each chapter is intended to include enough information
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 students and educators. Second, researchers and funding agencies can find a research agenda
developed throughout the book, but especially in Chapters 3, 4, and 7. Next, those who carry out and 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, and
Appendix A. Finally, the book should serve as a resource to the Institute of
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PREFACE ix
Medicine in its efforts to contribute to the nation's system for technology assessment by the establishment of a Council for
Technology as defined by P.L. 98-551.
Recommendations in this report are of three types. Most of the individual chapters 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 highlighted in boldface type as contributions to a research agenda for
technology assessment.
Appendix B of this report presents a selection from among the many papers prepared for the committee. Paper titles and
authors are as follows: Guide to Comparative Clinical Trials, by Clifford S. Goodman; Information Needs for Technology
Assessment, by Morris F. Collen; Toward Evaluating Cost-Effectiveness of Medical and Social Experiments, by Frederick
Mosteller and Milton C. Weinstein; Technology Assessment in Prepaid Group Practice, by Morris F. Collen; A Randomized
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 Randomized Clinical Trials, by David I.
Cohen and Duncan Neuhauser; Values and Preferences in the Delivery of Health Care, by Barbara J. McNeil; New
Federalism and State Support of Technology Assessment, by George D. Greenberg and Penny H. Feldman; and Government
Payers for Health Care, by Donald A. Young.
FREDERICK MOSTELLER
CHAIRMAN
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