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National Priorities for the Assessment of Clinical Conditions and Meclical Technologies Report of a Pilot Smby Maria Elena Lara and Clifford Goo~nan, editors Priori~-Setting Group Council on Health Care Technology Institute of Medicine NATIONAL ACADEMY PRESS WASHINGTON, D.C. 1990

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N A T 7 O N A L A S S E S S M E N T P R I O R I T ~ E S NOTICE: The project Hat is Be subject of this report was approved by the Govem~ng Board of Be National Research Council, whose members are drawn from Be councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of me 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 man the authors according to procedures approved by a Report Review Committee con- sisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Ins citute of Medicine. The Institute of Medicine was chartered in 1970 by the National Acad- emy of Sciences to enlist distinguished members of the appropriate pro- fessions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's lS63 congressional charter responsibility to be an adviser to the federal govem- ment and its own initiative in identifying issues of medical care, research, and education. Support for this project was provided by the National Center for Heals Services Research and Health Care Technology Assessment, grant num- ber HS 05526. Library of Congress Catalog Number 90-60465 International Standard Book Number ~309 042364 Additional copies of this report are available from: National Academy Puss 2101 Constitution Avenue, N.W Washington, D.C. 20418 Publication lOM-89-14 SIl7 . Printed In He United States of America First Pnnung, April 1990 Second Pnniing, December 1990

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ACKNOWLEDGMENTS The Council on Health Care Technology of the Institute of Medicine wishes to acknowledge the many individuals and organizations who con- tributed to this project. The members of the council's pnonty-setting group generously volun- teered their insight and time to this effort The activities documented in this report built on the previous deliberations of the evaluation pane] of the council. The guidance of George Thibault, chair of the evaluation pane] and of the prionty-seuing group, was adept and invaluable. Our foremost gratitude to the Institute of Medicme DOM) staff recog- nizes the skis and dedication of Maria Elena Lara, who accommodated diverse professional and scientific perspectives in managing this project. Council staff director Clifford Goo~nan was ~nstnunental in shaping the effort and keeping it on course to completion. Ethan Hahn was gready re- sponsible for assembling and documenting the Ascriptions of the 20 priority areas chosen by He priority-setting group. Kathleen Lohr and Richard Rettig provided valuable comments on earlier drafts of the report. Among other lOM staff members who contributed to the review and support of this report are Sharon Baratz, Alastair Conned, Hennan Die- senhaus, Paul Friedman, Annetine Gelijns, Hennck Harwood, Chris Howson, Sam Johnson, Evanson Joseph, Patrick Mauingly, and Robe Weiss. The quality and commitment of Holly Dawkins' logistical support were superb, and deserve special recognition. Others who provided useful infonnation for this report include Pam Cassing and Mike Mably, American College of Radiology; He American Council on Transplantation; Teresa Cryan, American Healthcare Radiol- ogy Adminis=mrs; Susan Manfred, Arthritis Foundation; Rose Conner- ton, Charles Fisher, Mani Happel, Charles Helbing, Roger Keene, B art McCann, Regina McPhillips, and loden Nice, Heal Care Financing Administration; Gauge Gibson, National Osteoporosis Foundation; Diane Murdock, Prospective Payment Assessment Commission; and Steven Woolf, U.S. Preventive Task Force. .

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NATIONAL ASSESSMENT PRIORITIES The following individuals reviewed earlier draft sections of this report: Stanley Baum, University of Pennsylvania School of Medicine; Frank Falkner, University of California at Berkeley; Harvey Fineberg, Harvard School of Public Health; Robert Gifford, Yale University School of Medicine; Edward Krinzman, HaBandale, Florida; Alexander Leaf, Mas- sachusetts General Hospital; Harold Luft, University of California at San Francisco; David Murray, State University of New York Health Sciences Center at Syracuse; Ralph Schaffarzick, Blue Cross and Blue Shield Association, Auburn, Californua; I. Sanford Schwartz, University of Penn- sylvania; William Silen, Harvard Medical School; Richard Smith, Un~- versity of Arkansas; Walter Stark, John Hopkins University; Edward StemmIer, University of Pennsylvania Medical School; John Wennberg, Dartmouth Medical School; Augustus White ITI, Harvard Medical School; and Linda Johnson White, American ColUege of Physicians. The organizations listed in Appendix C provided background informa- tion for the pr~onty-sethng group. However, the 20 priority assessment areas identified in this report were chosen by the p~iority-setting group and do not necessarily represent the preferences or opinions of these source organizations. Funding for this project was provided by grant HS 05526 from the National Center for Health Services Research and Health Care Technol- ogy Assessment, whose support is gratefully acknowledged. WILLIAM N. HUBBARD, JR. Chair Council on Health Care Technology 1V

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Council on Health Care Technology Chair WILLIAM N. HUBBARD, JR. Fonner President, Lee Upjohn Company Co-Chair JEREMIAH A. BARONDESS William T. Foley Distinguished Professor in Clinical Medicine, Cornell University Medical College HERBERT L. ABRAMS Professor of Radiology, Stanford University School of Medicine RICHARD E. BEHRMAN Managing Director, Center for He I;ut~e of Children, The David and Lucite Packard Foundation 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 BEN L. HOLMES Vice President/General Wager, Medical Products Group, Hewlett-Packard Company GERALD D. LAUBACH President, Pfizer, Inc. WALTER B. MAHER Director, Federal Relations, Human Resources Office, Chrysler Motors Corporation WAYNE R. MOON Executive Vice President and Operations Manager, Kaiser Foundation Health Plan, Inc. LAWRENCE C. MORRIS, JR. Consultant in Health Care Financing and Fonner Senior Vice President, Health Benefits Management, Blue Cross and Blue Shield Association FREDERICK MOSTELLER Roger I. Lee Professor Emeritus of Mathematical Statistics and Director, Technology Assessment Group, Harvard University School of Public Health MARY 0. MUND1NGER Dean, School of Nursing, Columbia University ANNE A. SCIU)VSKY Chief, Health Economics Department, Palo Alto Medical Foundation GAIL L. WARDEN President and Chief Executive Off~cer,Henry Ford Health Systems v

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Council on Health Care Technology Priority-Setting Group Chair GEORGE THIBAULT Chief of the Medical Service. West Roxbury Veterans Administration Medical Center CHERYL F. AUSTEIN Director, Division of Science and Public Health Policy, Office of the Assistant Secretary for Planning and Evaluation, Department of Health and Human Services JEREMIAH A. BARONDESS William T. Foley Distinguished Professor in Clinical Medicine, Cornell University Medical College RICHARD E. BEHRMAN Managing Director, Center for the Future of Children, The David and Lucile Packard Foundation DAVID M. EDDY Professor of Health Policy and Management, Duke University PAUL S. ENTMACBR Senior Vice President and Chief Medical Director, Metropolitan Life Insurance Company MELVIN A. GLASSER Director, Health Security Action Council V1 ROGER HEADMAN Assistant Director, Division of Health and Life Sciences, Office of Technology Assessment, United States Congress BEN L. HOLMES Vice President/General Manager, Medical Products Group, Hewlett-Packard Company G. MAX K. HUGHES Vice President, Systems and Communications, Pfizer, Inc. GERALD D. LAUBACH President, Pfizer, Inc. WAYNE R. MOON Executive Vice President and Operations Manager, Kaiser Foundation Health Plan, Inc. LAWRENCE C. MORRIS, JR. Consultant in Health Care Financing and Former Senior Vice President, Health Benefits Management, Blue Cross and Blue Shield Association MARY 0. MUNDINGER Dean, School of Nursing, Columbia University SEYMOUR PERRY Professor and Interim Chair, Department of Community and Family Medicine, Georgetown University School of Medicine

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CHARLES E. PULPS Professor and Chairman, Deparanent of Community and Preventive Medicine, and Professor of Political Science and Economics, University of Rochester MICHAEL F. ROIZEN Professor and Chairperson, Department of Anesthesia and Critical Care, University of Chicago ANNE A. SCITOVSKY Chief, Health Economics Department, Palo Alto Medical Foundation HAROLD C. SOX, JR. Professor and Chair, Department of Medicine, Daranouth-Hitchcock Medical Center EARL P. STEINBERG Associate Professor, Division of Internal Medicine, Johns Hopkins University School of Medicine ELEANOR TRAVERS Chair, Task Force on Technology Assessment, Veterans Administration DONALD A. YOUNG Executive Director, Prospective Payment Assessment Commission Institute of Medicine SAMUEL O. THEIR President ENRIQUETA C. BOND Executive Officer Project Stay CLIFFORD GOODMAN Director, Council on Health Care Technology MARIA ELENA LARA Project Director ETHAN A. HALM Research Associate HOLLY DAWNS Project Assistant EVANSON H. JOSEPH Project Assistant ~ V11

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FOREWORD There is a growing realization in the public and private sectors of the need to evaluate medical practice. Increased recognition of He ~mpor- tance of me clinical evaluative sciences, such as clinical and health services research, health technology assessment, and health status assess- ment, has set He stage for new national research programs. Evidence of this new emphasis includes the Medical Treatment Effectiveness Program of the Department of Health and Human Services, which grew out of work begun at the Health Care Financing Administration and the National Center for Heath Services Research, and the establishment of a new Agency for Health Care Policy and Research as mandated by Congress in legislation enacted in late 1989. The Institute of Medicine welcomes the recognition mat better organ- ized and funded clinical evaluative efforts are needed to improve the nations capacity to guide improvements in health care delivery for the 1990s and beyond. The financial and hwnan resources available for medical practice and technology assessment are limited. To permit me greatest return on me investment of these resources, He capability of focusing them on questions of highest priority is required. The report of this pilot effort descnbes a broad-based process, using explicit cntena, for sewing national-level assessment pnondes. The 20 national priority assessment areas and He pnonty-seuing proc- ess descnbed in this report respond ~ the congressional charge to the Council on Health Care Technology to "identify needs in He assessment of heath care technology." Early in its deliberations, He council recog- n~zed that an appropn ate process for national pnonty-setting would re- quire activities beyond those explicitly requested by Congress. Lee na- tional pnonty-seuing process described here reflects an expanded charge at Tree levels. First, the clinical context in which medical technologies and practices are used, and padent needs and charactenshcs, Could be taken exE'1icidy into account in setting pnonties. Use of clinical conditions to focus the evaluation of medical practice as employed in this report is favors over He approach implied by the original congressional charge, which would have focused Unmanly on medical technologies. The council recogruzes, however, that needs may arise for He assessment of specific medical tech- 1X

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NATIONAL ASSESSMENT PRIORITIES nologies. Accordingly, although most of the 20 priority areas identified in this report are clinical conditions, certain areas in which the assessment of medical technology per se deserves national attention are also specified. Second, setting national priorities for medical practice and technology assessment calls for an accountable approach that involves a broad range of interests. As a public-private partnership coordinated by the Institute of Medicine, the Council on Health Care Technology was well positioned to develop explicit criteria for national prior~ty-setting. The members of the group that chose He 20 prorate assessment areas identified in this report, as well as the many individuals and organizations that provided background information for this project, are broadly representative of the different parties involved in health care. Third, despite the need for national pnonty-setting, adequate primary data and widely accepted pnonty-sefflng methodologies to address this need are lacking. Given these limitations, He council opted for a two- stage strategy to address its congressional charge to set national assess- ment pr~onties. The first, pilot effort documented in this report needs to be improved, validated, and expanded through an ongoing process. Though this report, the Institute of Medicine intends to call attention to this first set of priorities and underscore the need for an ongoing national pr~or~ty-setting process for the evaluation of medical practice. We look forward to continued cooperation with He private and public sector participants in these endeavors. SAMUEL O. THIER President Institute of Medicine x

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CONTENTS Summary 1. In~oductione.eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee.eeee.e. 9 2. A Pilot Process for Serdng National Assessment Prionties e e e e e 15 3e Twenty Pr~or~ty Assessment Areas e e e e e; e e e e e e e e ~ ~ e e e e e e e e 27 4. Next Steps e e e e e e e e e e e ~ e e e e e e e e e e e e e e e e e e e ~ e e e e e e e e e e ~ 55 5. Conclusions end Recommendations e e ~ e ~ 57 Appendixes A C1inical Conditions and Medica] Technolog~es Considered by the Prionty-Sefflng Group .. . ... 6 B Companson of Prionty-Sefflng Criterla .... e e e ~ ~ e e e e e e e e e e 77 C Orgaruzations Providing Backg~und Info~mation Bibliography GIossaly e ~ e e ~ e e ~ e ~ e e e e ~ ~ ~ ~ ~ e e ~ e e e e e e ~ ~ e e e e e e ~ ^__ 83 89 X1

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