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Clinical Practice Guidelines: Directions for a New
Program
Marilyn J. Field and Kathleen N. Lohr, Editors;
Committee to Advise the Public Health Service on
Clinical Practice Guidelines, Institute of Medicine
ISBN: 0-309-56001-2, 168 pages, 6 x 9, (1990)
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Clinical Practice Guidelines: Directions for a New Program
http://www.nap.edu/catalog/1626.html
i
Clinical Practice
Guidelines
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
Copyright © National Academy of Sciences. All rights reserved.
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Clinical Practice Guidelines: Directions for a New Program
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ii
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 by a Report Review Committee consisting of members of the National Academy of Sci-
ences, 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 pertain-
ing to the health of the public. In this, the Institute acts under both the Academy's 1863 congres-
sional 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.
282-90-0018. 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 book may be reproduced by any mechanical, photographic, or electronic pro-
cess, or in the form of a phonographic recording, nor may it be stored in a retrieval system, transmit-
ted, 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
First Printing, September 1990
Second Printing, November 1991
Third Printing, November 1992
Fourth Printing, January 1994
S-229
Printed in the United States of America
Copyright © National Academy of Sciences. All rights reserved.
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iii
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 Policy and
Management, Duke University, Durham, North Carolina
RICHARD D. FLOYD, Practice of Surgery, Lexington, Kentucky
ALICE G. GOSFIELD, Attorney, Alice G. Gosfield & Associates, P.C.,
Philadelphia, Pennsylvania
MICHAEL A. W. HATTWICK, 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,Office 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
Copyright © National Academy of Sciences. All rights reserved.
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Clinical Practice Guidelines: Directions for a New Program
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iv
WILLIAM B. STASON, Director, Northeast Health Services, Research &
Development Field Program, Veterans Administration Medical Center, West
Roxbury, Massachusetts
MICHAEL A. 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 Policy, American
College of Physicians, Philadelphia, Pennsylvania
CONSTANCE M. WINSLOW, Medical Director, Research and Program
Development, AEtna Life and Casualty, 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
Copyright © National Academy of Sciences. All rights reserved.
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v
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 to 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 A.
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 Schaffarzick, 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 Advancement of Health and
Medical Care of the New England Medical
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vi
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. Greenfield also made a
presentation to the study committee as did Mark R. Chassin of Value Health
Sciences. IOM Scholar-in-Residence Patrick Mattingly 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 operational 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 National Research Council
procedures.
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CONTENTS vii
Contents
Summary 1
1 Introduction and Background 19
2 Definitions of Key Terms 33
3 Attributes of Good Practice Guidelines 52
4 Implementation and Evaluation 78
5 Conclusions and Recommendations 96
Appendix A The Omnibus Budget Reconciliation Act of 1989 107
Appendix B Examples of Practice Guidelines 128
Appendix C Next Steps for the Institute of Medicine 149
Appendix D Biographies of Committee Members 151
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CONTENTS viii
Copyright © National Academy of Sciences. All rights reserved.
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Clinical Practice Guidelines: Directions for a New Program
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SUMMARY 1
Summary
In November 1989, Congress amended the Public Health Service Act to create
the Agency for Health Care Policy and Research (AHCPR). Under the terms of
Public Law 101-239, this agency has broad responsibilities for supporting research,
data development, and other activities that will "enhance the quality,
appropriateness, and effectiveness of health care services. . . ." The needs and
priorities of the Medicare program are an important but not exclusive focus of the
agency.
Many of AHCPR's responsibilities formerly belonged to the National Center
for Health Services Research, which the agency replaced, but the emphasis on
outcomes and effectiveness research is now considerably stronger. Other functions
of the agency are new, in particular those involving a joint public-private enterprise
to develop, disseminate, and evaluate practice guidelines under the sponsorship of
the agency's Forum for Quality and Effectiveness in Health Care.
Shortly after its creation, AHCPR requested advice from the Institute of
Medicine (IOM) on how it might approach these new responsibilities for practice
guidelines. The IOM agreed to appoint a study committee that would work quickly
to provide technical assistance and advice on definition of terms, specification of
key attributes of good guidelines, and certain aspects of planning for
implementation and evaluation. This report largely confines itself to these fairly
specific and limited tasks. It is not a how-to-do-it manual, a methodology text, a
priority-setting exercise, or a primer on guidelines for those seeking an introduction
to the subject. The report does, however, aim to encourage more standardization and
consistency in
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