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(clinical ~ I - ~ BUT Directions for a New Program Committee to Advise the Public Health Service on Clinical Practice Guidelines Institute of Medicine Marilyn J. Field and Kathleen N. Lohr, editors NATIONAL ACADEMY PRESS Washington, D.C. 1990

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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 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 procedures approved ~ 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 membem of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academies 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. This project was supported by the Department of Health and Human Services, Contract No. 2~-90 0018. The views presented are those of the Institute of Medicine Committee to Advise the Public Health Service on Clinical Practice Guidelines and are not necessarily those of the funding organization. The Andrew W. Mellon Foundation contribution to independent Institute of Medicine funds was also used to support the project. Library of Congress Catalog Card Number 90 062881 International Standard Book Number 0-309 04346-8 Publication IOM-90 08 No part of this boolc 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 publisher, except for the purpose of official use By the U.S. Government. Additional copies of this report are available from: National Academy Press 2101 Constitution Avenue, N.W. Washington, DC 20418 S-229 Printed in the United States of America First Printing, September 1990 Second Printing, November 1991 Third Printing, November 1992 Fourth Painting, January 1994

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COMMITTEE TO ADVISE THE PUBLIC HEALTH SERVICE ON CLINICAL PRACTICE GUIDELINES JEROME H. GROSSMAN,* Chair, Chairman and Chief Executive Officer, New England Medical Center, Inc., Boston, Massachusetts HUGH P. H. BOWER, Family Practice, Bradford, Vermont ROBERT H. BROOK,* Deputy Director, Health Program, The RAND Corporation, Santa Monica, California ARTHUR J. DONOVAN, Professor and Chairman, Department of Surgery, University of Southern California, Los Angeles, California DAVID M. EDDY,$ J. Alexander McMahon Professor of Health Poligy and Management, Duke University, Durham, North Carolina RICHARD D. FLOYD, Practice of Surgery, Lexington, Kentucly ALICE G. GOSFIELD, Attorney, Alice G. Gosfield & Associates, P.C., Philadelphia, Pennsylvania MICHAEL ~ W. HA11WICK, Practice of Internal Medicine, Annandale, Virginia CLARK C. HAVIGHURST,* William Neal Reynolds Professor of Law, Duke University, Durham, North Carolina ADA SUE HINSHAW,* Director, National Center for Nursing Research, National Institutes of Health, Bethesda, Maryland JOHN T. KELLY, Director, Once of Quality Assurance, American Medical Association, Chicago, Illinois DONALD G. LANGSLEY, Executive Vice President, American Board of Medical Specialties, Evanston, Illinois LAWRENCE C. MORRIS, Consultant in Health Care Finance, Wilmette, Illinois JOACHIM L. OPITZ, Department of Physician Medicine and Rehabilitation, Mayo Clinic, Rochester, Minnesota JOHN C. PETERSON III, Director of Medical Affairs, Professional Review Organization for Washington, Seattle, Washington ELLISON C. PIERCE, JR., Chairman, Department of Anaesthesia, New England Deaconess Hospital, Boston, Massachusetts BRENDA RICHARDSON, President, Massachusetts Peer Review Organization, Boston, Massachusetts LOUISE B. RUSSELL,$ Research Professor of Economics, Rutgers University, New Brunswick, New Jersey * Institute of Medicine member . . . 111

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WILLIAM B. STASON, Director, Northeast Health Services, Research & Development Field Program, Veterans Administration Medical Center, West Roxbu~y, Massachusetts MICHAEL ~ STOCKER, Executive Vice President, U.S. Healthcare, Paramus, New Jersey JAMES J. STRAIN, Professor and Director, Division of Behavioral Medicine and Consultation Psychiatry, Mt. Sinai School of Medicine, New York, New York LINDA JOHNSON WHITE, Director, Department of Scientific Polipy, American College of Physicians, Philadelphia, Pennsylvania CONSTANCE M. WINSLOW, Medical Director, Research and Program Development, AEtna Life and Casually, Hartford, Connecticut STUDY STAFF KARL D. YORDY, Director, Division of Health Care Services MARILYN J. FIELD, Study Co-Director KATHLEEN N. LOHR, Study Co-Director MOLLA S. DONALDSON, Senior Staff Officer THELMA COX, Project Secretary DONALD TILLER, Administrative Assistant 1V

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Acknowledgments This project was shaped by the work of two earlier Institute of Medicine committees: the Committee on Utilization Management by Third Parties and the Committee lo Design a Strategy for Quality Review and Assurance in Medicare. The report of the first committee was issued in October 1989 and the report of the second, in March 1990. Some of the substantive groundwork for this report was laid by an expert panel convened for the quality assurance project to consider desirable characteristics of quality of care indicators. That panel consisted of William ~ Causey, Arthur J. Donovan, Leonard S. Dreifus, David M. Eddy, Lesley Fishelman, Sheldon Greenfield, Robert J. Marder, Jane L. Neumann, Bruce Perry, and Ralph Schaffarzick Both the utilization management and quality assurance committees made recommendations for further work on the development and use of clinical practice guidelines that led to a project planning meeting in November 1989. The meeting was chaired by Jerome H. Grossman, and the participants were Peter Bouxsein, J. Jarrett Clinton, Arthur J. Donovan, David M. Eddy, Sheldon Greenfield, Clark C. Havighurst, Neil Hollander, Carmault B. Jackson, Jr., John T. Kelly, Marie Michnich, Joel E. Miller, William H. Moncreif, Jr., Charles E. Phelps, William L. Roper, Ralph Schaflarzick, Richard S. Sharpe, Linda Johnson White, and Sally Hart Wilson. As background for the planning meeting and the study committee, Anne-Marie Audet and Sheldon Greenfield of the Institute for the Ad- vancement of Health and Medical Care of the New England Medical

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Center, Inc., conducted a focused survey of prototypical initiatives on clinical practice guidelines. Marilyn Field, study co-director, prepared a background case study of mammography screening guidelines. Dr. Green- field also made a presentation to the study committee as did Mark R. Chassin of Value Health Sciences. IOM Scholar-in-Residence Patrick Mat- tingly and Robert Wood Johnson Fellow Philip Goodman provided useful suggestions and information. Stephen King, director of the Forum for Quality and Effectiveness in Health Care, Agency for Health Care Policy and Research, was always helpful in providing necessary information on the agency. In addition, he briefed the study committee at its February and April meetings. From January through March 1990, Don Tiller kept the study oper- ational by overseeing the work of a series of temporary secretaries until Suzanna Gilbert began work in April. Marilyn Field and Kathleen Lohr had primary responsibility for writing the report with assistance from Molla Donaldson, who also prepared two sets of examples of practice guidelines for the committee's examination. Leah Mazade copyedited the report. The editors also acknowledge the constructive comments of those who reviewed the report under Nanona1 Research Council procedures. vi

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Contents SUMMARY 1 INTRODUCTION AD BACKGROUND DEFINITIONS OF KEY TERMS 1 19 33 3 ATTRIBUTES OF GOOD PRACTICE GUIDELINES 52 4 IMPLEMENTATION AND EVALUATION 5 CONCLUSIONS AND RECOMMENDATIONS APPENDICES A THE OMNIBUS BUDGET RECONCILIATION ACT OF 1989 B EXAMPLES OF PRACTICE GUIDELINES C 78 96 107 128 NEXT STEPS FOR THE INSTITUTE OF MEDICINE 149 D BIOGRAPHIES OF COMMITTEE MEMBERS . . V11 151

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