Guidelines for Clinical Practice

FROM DEVELOPMENT TO USE

MARILYN J. FIELD AND KATHLEEN N. LOHR, Editors

Committee on Clinical Practice Guidelines

Division of Health Care Services

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, D.C.
1992



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page R1
Guidelines for Clinical Practice: From Development to Use Guidelines for Clinical Practice FROM DEVELOPMENT TO USE MARILYN J. FIELD AND KATHLEEN N. LOHR, Editors Committee on Clinical Practice Guidelines Division of Health Care Services INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. 1992

OCR for page R1
Guidelines for Clinical Practice: From Development to Use National Academy Press 2101 Constitution Avenue, N.W. Washington, D.C. 20418 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. p. cm. 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] RA399.A3I56 1992 362.1'021873—dc20 DNLM/DLC for Library of Congress 92-8613 CIP 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

OCR for page R1
Guidelines for Clinical Practice: From Development to Use 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 *   Member, Institute of Medicine

OCR for page R1
Guidelines for Clinical Practice: From Development to Use Study Staff HOLLY DAWKINS, Research Assistant MOLLA S. DONALDSON, Senior Staff Officer MARILYN J. FIELD, Study Director KATHLEEN N. LOHR, Deputy Director, Division of Health Care Services DONNA D. THOMPSON, Senior Project Assistant KARL D. YORDY, Director, Division of Health Care Services

OCR for page R1
Guidelines for Clinical Practice: From Development to Use Acknowledgments 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

OCR for page R1
Guidelines for Clinical Practice: From Development to Use 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.

OCR for page R1
Guidelines for Clinical Practice: From Development to Use 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.

OCR for page R1
Guidelines for Clinical Practice: From Development to Use This page in the original is blank.

OCR for page R1
Guidelines for Clinical Practice: From Development to Use Contents     SUMMARY     1   INTRODUCTION   23     Purpose of the Report,   25     What Are Practice Guidelines?,   26     Why Are Policy makers Interested in Guidelines?,   36     Who Uses Guidelines and for What?,   40     Basic Propositions,   42     Report Organization,   43     Summary,   44 2   DEVELOPING CLINICAL PRACTICE GUIDELINES   45     Pluralism and Diversity in Guidelines Development,   46     Professional Societies and Related Entities,   47     Public Agencies,   52     Private Research, Payer, Provider, and Other Groups,   59     Costs of Guideline Development,   62     Summary,   63 3   IMPLEMENTING GUIDELINES: OVERVIEW AND ILLUSTRATIVE CASES   65     Guidelines and the Real World,   66     Case Studies,   68     General Issues in Implementation,   77     Summary,   81

OCR for page R1
Guidelines for Clinical Practice: From Development to Use 4   IMPLEMENTING GUIDELINES: CONDITIONS AND STRATEGIES   83     Context, Philosophies, and Strategies,   84     Education,   86     Information and Decision Support Systems,   90     Summary,   98 5   IMPLEMENTATION: QUALITY, COST, AND RISK MANAGEMENT   99     Quality Assurance and Improvement,   100     Cost Management,   111     Risk Management, Medical Liability, and Practice Guidelines,   123     Summary,   134 6   THE INESCAPABLE COMPLEXITY OF DECISION MAKING: ETHICS, COSTS, AND INFORMED CHOICES   135     An Ethical Context,   136     Guidelines, Costs, and Decisions,   140     The Patient as Decision maker: What Is Informed Choice?,   146     The Physician as Decision maker: What Care Is Required?,   153     Summary,   161 7   EVOLUTION IN PROCEDURES AND METHODS FOR DEVELOPING PRACTICE GUIDELINES   163     General Structures and Procedures,   164     Persistent Questions for the Development Process,   170     Areas for Methods Research and Development,   174     Issues at the Interface of Development and Implementation,   183     Summary,   194 8   A FRAMEWORK FOR THE FUTURE   196     Working Assumptions and Principles,   196     General Strengths and Weaknesses of Current Practice Guidelines Activities,   197     Improving the Development of Guidelines,   199     Ensuring the Use of Good Guidelines,   205     A Critical Need: Means to Assess the Soundness of Guidelines,   208     Research Agenda,   215     Final Note: Guidelines and Health Care Reform,   217

OCR for page R1
Guidelines for Clinical Practice: From Development to Use     REFERENCES   220     APPENDIXES         A Examples of Clinical Practice Guidelines and Related Materials,   243     B A Provisional Instrument for Assessing Clinical Practice Guidelines,   346     C Rosters,   411     INDEX   417

OCR for page R1
Guidelines for Clinical Practice: From Development to Use This page in the original is blank.

OCR for page R1
Guidelines for Clinical Practice: From Development to Use Guidelines for Clinical Practice

OCR for page R1
Guidelines for Clinical Practice: From Development to Use This page in the original is blank.