2007 IOM ANNUAL MEETING SUMMARY

EVIDENCE-BASED MEDICINE AND THE CHANGING NATURE OF HEALTH CARE

Mark B. McClellan, J. Michael McGinnis, Elizabeth G. Nabel, and LeighAnne M. Olsen

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

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Mark B. McClellan, J. Michael McGinnis, Elizabeth G. Nabel, and LeighAnne M. Olsen

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 International Standard Book Number 13: 978-0-309-11369-4 International Standard Book Number 10: 0-309-11369-5 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2008 by the National Academy of Sciences. All rights reserved. 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 serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Suggested citation: IOM (Institute of Medicine). 2008. Evidence-based medicine and the changing nature of health care: 2007 IOM annual meeting summary. Washington, DC: The National Academies Press.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” — Goethe Advising the Nation. Improving Health.

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Acad- emy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding en- gineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Insti- tute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sci- ences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Coun- cil is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Foreword Evidence-based medicine (EBM) has been famously characterized by David Sackett as the “conscientious, explicit, and judicious use of cur- rent best evidence in making decisions about individual care.” The central notion in EBM of the importance of integrating individual clinical expertise with the best available external evidence provides a helpful framework for providers navigating the uncertainty inherent in patient care. The selection of EBM as a topic for the 2007 Annual Meeting of the Institute of Medicine (IOM) signals its potential as a key driver toward greater value and effi- ciency in medical care. Technological and scientific innovations continue to expand the universe of medical interventions, treatments, and approaches to care, ushering in an era rich with potential for improving the quality of health care but also rife with increased uncertainty about what works best for whom. That uncertainty can—and does—lead to the delivery of services that may be unnecessary, unproven, and sometimes harmful. This publication, Evidence-Based Medicine and the Changing Nature of Health Care, documents the content of the 2007 IOM Annual Meeting. In the years ahead, demographic, epidemiologic, and technologic develop- ments will foist change on health care. Reforms will be necessary to remedy existing shortfalls in access to care as well as to take better advantage of the opportunities provided by innovation, information technology, and broader stakeholder engagement. At this time in our nation’s history, a host of health policy issues dominate the headlines, from the safety of imported drugs to children’s healthcare coverage. Amid the cacophony surrounding each debate, the IOM strives to voice objective, independent, evidence-based counsel and v

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vi FOREWORD recommendations on critical questions. We know from experience that as- cendancy and importance of healthcare access, cost, and quality challenges are no guarantees of action. The IOM’s mission is to draw attention to issues and options that lay the groundwork for policy. We work to engage the field, facilitate needed discussion and debate, and develop sound policy recommendations. The last 2 years have seen a burgeoning interest in convening activities at the IOM: the forums and roundtables that bring together individuals from government, academia, business, and the public at large for collec- tive consideration and action around common problems. The Roundtable on Evidence-Based Medicine draws upon the many perspectives within the healthcare field, informs the debate, and provides an opportunity for dialogue among key stakeholders. The Roundtable’s overview publication, The Learning Healthcare System, outlines a number of opportunities to transform the development and use of evidence to improve health care. The subsequent workshops and meetings in the Learning Healthcare System series delineate research methods, assess data availability, and describe ways to improve research on the effectiveness of healthcare delivery. The 2007 IOM Annual Meeting drew upon the Roundtable membership for planning and execution and builds upon some of the work of the Roundtable. This publication is the second in the Learning Healthcare System series. I would like to offer my personal thanks to Roundtable participants, particularly Mark McClellan, Betsy Nabel, and Michael McGinnis, for their contributions as part of the planning committee. Harvey V. Fineberg, M.D., Ph.D. President, Institute of Medicine

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Preface The creative and innovative ethic of American medicine is legend and has contributed fundamentally to the breadth, depth, and pace of advances in our capacity for diagnosis and treatment of disease and injury. Indeed, the number of new pharmaceuticals, biologics, medical devices, and health- care services introduced into American healthcare settings and market- places substantially exceeds the capacity to know the circumstances under which a particular intervention is best applied. The consequences of this gap between assessment capacity and available services include increasing uncertainty about what constitutes “best care,” a steady expansion in the national and personal cost of medical care, and a substantial growth in con- cern and distrust among physicians and patients alike. The need is acute for better evidence to guide the decisions of patients and their caregivers on the approaches most appropriate to individual circumstances and preferences. This need for a more systematic approach to evidence development and application, as well as the prospect of new ways of meeting the need, provides the back-drop for the discussions at the 37th Annual Meeting of the Institute of Medicine (IOM). Entitled Evidence-Based Medicine and the Changing Nature of Health Care, this meeting was held on October 8, 2007, and focused on the potential of evidence-based medicine to help deliver the promise of scientific discovery and technological innovation and provide the right care for the right patient at the right time. The annual meeting was structured to bring together many of the na- tion’s leading authorities on various aspects of the issues—both challenges and opportunities—to present their perspectives and engage in discussion with the IOM membership. Included in the presentations, and documented vii

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viii PREFACE in this publication, are summaries of the rapidly changing nature of the science base and tool chest for medical practice; the implications for the costs, quality, and effectiveness of health care; the challenges to individual practitioners; possible means of accelerating the necessary assessment of the appropriateness, effectiveness, and value of medical care; and the policy changes necessary to improve the efficiency and outcomes of the American healthcare system. Organization of this meeting was facilitated by the experience and com- mitment of the IOM’s Roundtable on Evidence-Based Medicine, in which we are participants. Convened in 2006, the IOM Roundtable is comprised of about two dozen members representing national leadership from the various stakeholder sectors important to progress in health care: patients and the public, providers, service delivery organizations, health researchers, government agencies, employers, insurers, health product manufacturers, and information technology organizations. The Roundtable’s vision is for a learning healthcare system that “draws upon the best evidence to provide the care most appropriate to each patient, emphasizes prevention and health promotion, delivers the most value, adds to learning throughout the delivery of care, and leads to improvements in the nation’s health.” In effect, the learning healthcare system is one which enlists organizations, providers, and patients in driving the process of discovery as a natural outgrowth of patient care, and ensures innovation, quality, safety, and value in health cares. As a tangible focus for progress towards this vision, the Roundtable has set the goal that by 2020, 90 per- cent of clinical decisions will be supported by accurate, timely, and up-to- date clinical information, and will reflect the best available evidence. While ambitious, this goal ought to be achievable, given the nation’s commitment of more that one out of every six dollars to the delivery of health care. We are pleased to have had the opportunity to present some of the key perspectives motivating the Roundtable’s work over the last 2 years to the distinguished IOM membership, in serving as the planning committee members for the Annual Meeting and as authors of this publication.1 We would like to also acknowledge our Roundtable colleagues who served as discussion moderators, and, in particular, the individual contributors who donated their valuable time and insights to the scientific program through their presentations and through their efforts to further develop the content into the manuscripts contained in this summary. A number of IOM staff were instrumental in the preparation and conduct of the meeting, including Afrah Ali, Sandra Amamoo-Kakra, Bryn 1 The responsibility for the published annual meeting summary rests with the authors and the institution. IOM forums and roundtables do not issue, review, or approve individual documents.

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ix PREFACE Bird, Allison Brantley, Sarah Bronko, Thelma Cox, Donna Duncan, Patrick Egan, Amy Haas, Geraldine Kennedo, Adam Rose, Autumn Rose, Sara Sairitupa, Judith Shamir, Kristina Shulkin, and Jovett Solomon. The re- sponsibility for assembling the volume from the meeting was carried out by Roundtable staff under the direction of LeighAnne Olsen and included the work of Katharine Bothner, Molly Galvin, and Daniel O’Neill. We would also like to thank Lara Andersen, Michele de la Menardiere, and Bronwyn Schrecker for helping to coordinate the various aspects of review, produc- tion, and publication. As illustrated in this publication, the challenges facing the nation’s healthcare system are great, as is its promise. We look forward to expand- ing the sphere of engagement and action in the field to capture the substan- tial opportunities identified in this publication and the vision we all share for the health and productivity of Americans. Mark B. McClellan, M.D., Ph.D. IOM Annual Meeting Co-Chair Director, Engelberg Center for Health Care Reform, Leonard D. Schaeffer Chair in Health Policy Studies The Brookings Institution Elizabeth G. Nabel, M.D. IOM Annual Meeting Co-Chair Director, National Heart, Lung, and Blood Institute J. Michael McGinnis, M.D. M.P.P. Executive Director, Roundtable on Evidence-Based Medicine

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Contents Summary 1 1 The Changing Nature of Health Care 33 Introduction, 33 Evidence-based medicine and the IOM, 35 Common themes from the 2007 IOM Annual Meeting, 44 References, 46 2 The Need for Better Medical Evidence 49 Introduction, 49 Health care and the evidence base, Elliott S. Fisher, 50 The high price of the lack of evidence, Peter R. Orszag, 62 References, 68 3 Circumstances Accelerating the Need 71 Introduction, 71 New healthcare product introduction, Molly J. Coye, 72 Rapidly developing insights into genetic variation, David M. Altshuler, 84 References, 90 4 Contending with the Changes 93 Introduction, 93 Beyond expert-based practice, William W. Stead and John M. Starmer, 94 xi

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xii CONTENTS The partnership imperative in an evidence-driven environment, Marc Boutin, 105 References, 107 5 The Promise of Information Technology 109 Introduction, 109 Information technology tools to support best practices in health care, Robert Hayward, 110 Information technology tools that inform and empower patients, Peter M. Neupert, 115 Reference, 125 6 Transforming the Speed and Reliability of New Evidence 127 Introduction, 127 Electronic medical records and the prospect of real-time evidence development, George C. Halvorson, 128 Research methods to speed the development of better evidence— the registries example, Eric D. Peterson, 132 Product innovation—the tailored therapies example, Steven M. Paul, Eiry W. Roberts, and Christine Gathers, 142 References, 151 7 Policy Changes to Improve the Value We Need from Health Care 155 Introduction, 155 Regulatory and healthcare financing reforms, Donna E. Shalala, 156 Defining and introducing value in health care, Michael E. Porter, 161 References, 172 Appendixes A Meeting Agenda 173 B Biographical Sketches of Principals 177 C IOM Roundtable on Evidence-Based Medicine Roster and Background 187