National Academy Press
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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 competences 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 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 public. In this, the Institute acts under both the Academy’s 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.
Support for this project was provided by the John A. Hartford Foundation of New York City and by the Agency for Policy and Research, U.S. Department of Health and Human Services, under Contract No. 282-90-0018. Additional funds were provided by the Blue Cross and Blue Shield Association, CIGNA Foundation, the Prudential Foundation, and the American College of Cardiology. The views presented are those of the Institute of Medicine Committee on Clinical Practice Guidelines and are not necessarily those of the funding organizations.
Library of Congress Cataloging-in-Publication Data
Institute of Medicine (U.S.). Committee on Clinical Practice Guidelines.
Guidelines for clinical practice : from development to use / Committee on Clinical Practice Guidelines. Division of Health Care Services, Institute of Medicine ; Marilyn J. Field and Kathleen N. Lohr, eds.
Includes bibliographical references and index.
ISBN 0-309-04589-4 (alk. paper)
1. Medical care—Standards—United States. I. Field, Marilyn Jane. II. Lohr, Kathleen N., 1941- . III. Title.
[DNLM: 1. Clinical Medicine—standards—United States. 2. Delivery of Health Care—standards—United States. 3. Quality of Health Care—standards—United States. W 84 AAI I485g]
for Library of Congress 92-8613
Copyright 1992 by the National Academy of Sciences
Printed in the United States of America
The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted a logotype by the Institute of Medicine is based on a relief carving from ancient Greece. now held by the Staatlichemuseen in Berlin.
First Printing, June 1992
Second Printing, January 1994
COMMITTEE ON CLINICAL PRACTICE GUIDELINES
JEROME H. GROSSMAN,* Chair, Chairman & Chief Executive Officer,
New England Medical Center, Inc., Boston, Massachusetts
MARK R. CHASSIN, Senior Vice President,
Value Health Sciences, Inc., Santa Monica, California
SETH B. COWAN,
Practice of Family Medicine, Garland, Texas
ARTHUR J. DONOVAN, Emeritus Professor of Surgery,
University of Southern California, Los Angeles, California
DAVID M. EDDY,* Professor of Health Policy and Management,
Duke University, Jackson, Wyoming
CHARLES K. FRANCIS,* Professor of Clinical Medicine and Director,
Department of Medicine, Harlem Hospital Center, College of Physicians & Surgeons of Columbia University, New York, New York
ALICE G. GOSFIELD, Attorney,
Alice G. Gosfield & Associates, P.C., Philadelphia, Pennsylvania
MICHAEL A. W. HATTWICK,
Practice of Internal Medicine, Annandale, Virginia
ADA SUE HINSHAW,* Director,
National Center for Nursing Research, National Institutes of Health, Bethesda, Maryland
JAMES D. ISBISTER, President,
Pharmavene, Inc., Gaithersburg, Maryland
EDMUND F. KELLY, President,
Employee Benefits Division, Ætna Life and Casualty, Hartford, Connecticut
CLEMENT J. MCDONALD, Professor of Medicine,
Associate Director of Wishard Memorial Hospital and Chief, Medical Information Sciences, Regenstrief Institute, Indianapolis, Indiana
JOHN C. PETERSON III, Director of Medical Affairs,
Professional Review Organization for Washington, Seattle, Washington
JAMES S. ROBERTS, Senior Vice President,
Joint Commission on the Accreditation of Health care Organizations, Oakbrook Terrace, Illinois
LOUISE B. RUSSELL,* Research Professor,
Rutgers University, Institute for Health, New Brunswick, New Jersey
MICHAEL A. STOCKER, Executive Vice President,
U.S. Health care, East Rutherford, New Jersey
JAMES J. STRAIN, Professor and Director,
Division of Behavioral Medicine and Consultation Psychiatry, Mt. Sinai School of Medicine, New York, New York
YVONA TRNKA, Chief of Gastroenterology,
Harvard Community Health Plan, Boston, Massachusetts
LINDA JOHNSON WHITE, Director,
Scientific Policy Department, American College of Physicians, Philadelphia, Pennsylvania
The Committee on Clinical Practice Guidelines and the study staff were assisted by many individuals and groups, most of whom we hope we have acknowledged here. The members of two groups—a health care liaison panel and a specialty society liaison program—are listed in Appendix C. That appendix also lists those who testified at a public hearing in December 1990.
This study benefited from the work of several other IOM projects. In particular, it builds on the work of the Committee to Advise the Public Health Service on Clinical Practice Guidelines, the Committee to Design a Strategy for Quality Review and Assurance in the Medicare Program, and the Committee on Utilization Management in the Private Sector.
The committee commissioned two papers that provided useful background and insights for this report. Gail Povar, M.D., of George Washington University prepared a thoughtful, in-depth examination of ethical issues; Frances Miller, J.D., of Boston University submitted an equally valuable overview of legal issues. The committee's understanding of inconsistencies among guidelines and of ways of identifying them was aided by the work performed by subcontractors Carmi Margolis, M.D., Lawrence Gottlieb, M.D., and their colleagues at the Harvard Community Health Plan and the Ben Gurion University of the Negev.
Initial directions for both this and the earlier project on guidelines were provided by a planning committee that met in November 1989. The meeting was chaired by Jerome H. Grossman, M.D.; the participants were Peter Bouxsein, J.D.; J. Jarrett Clinton, M.D.; Arthur J. Donovan, M.D.; David
M. Eddy, M.D., Ph.D.; Sheldon Greenfield, M.D.; Clark C. Havighurst, J.D.; Neil Hollander; Carmault B. Jackson, Jr., M.D.; John Kelly, M.D.; Marie Michnich, Dr.P.H., R.N.; Joel E. Miller; William H. Moncreif, Jr., M.D.; Charles E. Phelps, Ph.D.; William L. Roper, M.D.; Ralph Schaffarzick, M.D.; Richard S. Sharpe; Linda Johnson White; and Sally Hart Wilson, J.D.
Some of the substantive groundwork for the report's recommendation of attributes for review criteria 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, M.D.; Arthur J. Donovan, M.D.; Leonard S. Driefus, M.D.; David M. Eddy, M.D., Ph.D.; Lesley Fishelman, M.D.; Sheldon Greenfield, M.D.; Robert J. Marder, M.D.; Jane L. Neumann, M.D.; Bruce Perry, M.D.; and Ralph Schaffarzick, M.D.
Among the many who provided the committee with important insights into the challenges of using practice guidelines are Brent James, M.D., and Alan Morris, M.D., of InterMountain Health Care; William Minogue, M.D., Elaine Campbell, Mark Smith, M.D., Jack Zimmerman, M.D., Stanley Deutsch, M.D., Robert Sherrick, M.D., and others at the George Washington University Hospital; Joanne Lynn, M.D., Rebecca Elon, M.D., Monica Koshuta, Mollie Sabol-Spencer, and others at the Washington Home and Hospice; Rob Johnson and James Herbert of Eastman Chemicals Company; James Mortimer of Midwest Business Group on Health; Dean Anderson of the Heritage National Health Plan; Paul Perlman, M.D., of Kingsport IPA; Paul Bishop, Ken Unger, Penny Romeo, Carol Gilreath, and others at Holston Valley Community Hospital and Indian Path Hospital in Kingsport, Tennessee; Sheldon Greenfield, M.D., Thomas Smith, M.D., Michael Goldberg, M.D., Deirdre Bigalow, Elizabeth Kantz, R.N., Tina Shapleigh, M.D., Karyl Woldrum, R.N., Paul Drew, M.D., and Cynthia Taft of the New England Medical Center; Dale Benson, M.D., and William Van Osdol, M.D., of the Community Health Network and Methodist Hospital of Indiana; Harvey Feigenbaum, M.D., at University Hospital of the Indiana University School of Medicine; and A. Alan Fischer, M.D., Indiana University School of Medicine.
Not known to us by name are the pediatricians and general surgeons in two focus groups organized for us under subcontract by Mathew Greenwald and Associates. We were assisted with the focus group of pediatricians by the American Academy of Pediatrics, in particular by Robert Sebring, Ph.D., and we discussed the other focus group with Paul Ebert, M.D., of the American College of Surgeons. In addition, to expand the insights available to us, we consulted with the American College of Physicians in developing formats that could be used both for this project's focus groups and for those the College was conducting as part of its evaluation of its Clinical Efficacy Assessment Project.
At the Agency for Health Care Policy and Research, many individuals helped keep us abreast of the activities and thinking of the organization: Kathleen McCormick, Ph.D., R.N.; Stephen King, M.D.; Kathleen Hastings, J.D.; Linda Demlo, Ph.D.; Margaret VanAmringe; Elaine Corrigan; and others. Project staff also attended the retreat organized by the agency to consider lessons learned from the first year of work on guidelines and participated in discussions of guidelines at conferences on medical liability and directions for health services research. Members of the IOM study committee were also in touch with members of the expert panels developing guidelines under AHCPR sponsorship. Marjorie Cahn of the new Center for Health Services Research Information at the National Library of Medicine helped in describing how the NLM will support the dissemination of guidelines.
Arnold Rosoff, J.D., and Eleanor Kinney, J.D., helped in sorting out the complexities of medical malpractice, and Edward David, M.D., J.D., answered many questions about the Maine Medical Liability Demonstration Project. At the American Medical Association, John Kelly, M.D., Margaret Toepp, Shirley Dodd, J.D., and others were unfailingly helpful. George Hripcsak, M.D., Robert Nease, Ph.D., and Douglas Owens, M.D., provided helpful discussions of ways of formatting practice guidelines. Robert Hayward, M.D., at the Johns Hopkins University, contributed a variety of insights into how medical schools might incorporate guidelines into the educational process. Harold Sox, Jr., M.D., and other members of the Clinical Efficacy Assessment Project of the American College of Physicians allowed us to see their process at work. Staff participation in the Harvard Community Health Plan seminar on guidelines development also provided important insights into the challenges of developing and formatting guidelines.
Very substantial assistance was provided to this project by several individuals who, at the request of specialty societies participating in our liaison program, reviewed the Provisional Instrument for Assessing Clinical Practice Guidelines. Some reviews were provided anonymously, but we can acknowledge the contributions of Hannan Bell, Ph.D.; Michael Greenberg, M.D.; Lester Rosen, M.D.; Thomas Harbin, M.D.; Andrew Schachat, M.D.; Harold Pincus, M.D.; Irene Feurer, M.S.Ed.; Richard A. Deyo, M.D.; David Hickham, M.D.; and William Golden, M.D. Betty King of the Internal Medicine Center to Advance Research and Education (IMCARE) secured more than 60 responses from an IMCARE task force. Anne-Marie Audet, M.D., contributed substantially to the initial draft of the instrument.