THE LEARNING HEALTHCARE SYSTEM SERIES

IOM ROUNDTABLE ON EVIDENCE-BASED MEDICINE

LEADERSHIP COMMITMENTS TO IMPROVE VALUE IN HEALTH CARE

Finding Common Ground

Workshop Summary

LeighAnne Olsen, W. Alexander Goolsby, and J. Michael McGinnis

Roundtable on Evidence-Based Medicine

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES

Washington, D.C.
www.nap.edu



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LeighAnne Olsen, W. Alexander Goolsby, and J. Michael McGinnis Roundtable on Evidence-Based Medicine

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 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. This project was supported by the Agency for Healthcare Research and Quality, America’s Health Insurance Plans, AstraZeneca, Blue Shield of California Foundation, Burroughs Wellcome Fund, California Health Care Foundation, Centers for Medicare and Medicaid Services, Charina Endowment Fund, Food and Drug Administration, Johnson & Johnson, sanofi-aventis, Stryker, and U.S. Department of Veterans Affairs. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-11053-2 International Standard Book Number-10: 0-309-11053-X 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. F or more information about the Institute of Medicine, visit the IOM home page at: w ww.iom.edu. Copyright 2009 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). 2009. Leadership Commitments to Improve Value in Health Care: Finding Common Ground: Workshop 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 engineers. 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 Council 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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ROUNDTABLE ON EVIDENCE-BASED MEDICINE1 Denis A. Cortese (Chair), President and Chief Executive Officer, Mayo Clinic Bruce G. Bodaken, Chairman, President, and Chief Executive Officer, Blue Shield of California Adam Bosworth, Founder, President and Chief Executive Officer, Keas, Inc. David R. Brennan, Chief Executive Officer, AstraZeneca PLC Carolyn M. Clancy, Director, Agency for Healthcare Research and Quality Michael J. Critelli, Former Executive Chairman, Pitney Bowes, Inc. Helen Darling, President, National Business Group on Health James A. Guest, President, Consumers Union George C. Halvorson, Chairman and Chief Executive Officer, Kaiser Permanente Carmen Hooker Odom, President, Milbank Memorial Fund Michael M. E. Johns, Chancellor, Emory University Cato T. Laurencin, Vice President for Health Affairs, Dean of the School of Medicine, University of Connecticut Stephen P. MacMillan, President and Chief Executive Officer, Stryker Mark B. McClellan, Director, Engelberg Center for Healthcare Reform, Brookings Institution Elizabeth G. Nabel, Director, National Heart, Lung, and Blood Institute Mary D. Naylor, Professor and Director of Center for Transitions in Health, University of Pennsylvania Peter Neupert, Corporate Vice President, Health Solutions Group, Microsoft Corporation Nancy H. Nielsen, President-Elect, American Medical Association Jonathan B. Perlin, Chief Medical Officer and President, Clinical Services, HCA, Inc. Richard Platt, Professor and Chair, Harvard Medical School and Harvard Pilgrim Health Care John C. Rother, Group Executive Officer, AARP Tim Rothwell, Chairman, Sanofi-Aventis U.S. John W. Rowe, Professor, Mailman School of Public Health, Columbia University Donald M. Steinwachs, Professor, Bloomberg School of Public Health, Johns Hopkins University Andrew L. Stern, President, Service Employees International Union 1 IOM forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteur and the institution. v

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I. Steven Udvarhelyi, Senior Vice President and Chief Medical Officer, Independence Blue Cross Frances M. Visco, President, National Breast Cancer Coalition William C. Weldon, Chairman and Chief Executive Officer, Johnson & Johnson Janet Woodcock, Deputy Commissioner and Chief Medical Officer, Food and Drug Administration Acting Administrator (ex officio), Centers for Medicare and Medicaid Services Undersecretary for Health (ex officio), U.S. Department of Veterans Affairs Roundtable Staff Katharine Bothner, Senior Program Assistant (through July 2008) Andrea Cohen, Financial Associate (through December 2008) Patrick Burke, Financial Associate W. Alexander Goolsby, Program Officer (through August 2008) Kiran Gupta, Research Assistant J. Michael McGinnis, Senior Scholar and Executive Director LeighAnne Olsen, Program Officer Daniel O’Neill, Research Associate (through January 2009) Stephen Pelletier, Consultant Ruth Strommen, Intern Pierre Yong, Program Officer Catherine Zweig, Senior Program Assistant vi

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Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Patricia Flatley Brennan, University of Wisconsin-Madison School of Nursing Lynda Bryant-Comstock, GlaxoSmithKline Julianne Howell, Centers for Medicare and Medicaid Services Diana B. Petitti, University of Southern California School of Medicine Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Nancy S. Sung, Burroughs Wellcome Fund. Appointed by the National Research Council and the Institute of Medicine, she was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review com- ments were carefully considered. Responsibility for the final content of this report rests entirely with the editors and the institution. vii

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Institute of Medicine Roundtable on Evidence-Based Medicine Charter and Vision Statement The Institute of Medicine’s Roundtable on Evidence-Based Medicine has been convened to help transform the way evidence on clinical effectiveness is gener- ated and used to improve health and health care. Participants have set a goal that, by the year 2020, 90 percent of clinical decisions will be supported by accurate, timely, and up-to-date clinical information, and will reflect the best available evidence. Roundtable members will work with their colleagues to identify the issues not being adequately addressed, the nature of the barriers and possible solutions, and the priorities for action, and will marshal the resources of the sectors represented on the Roundtable to work for sustained public–private cooperation for change. ****************************************** The Institute of Medicine’s Roundtable on Evidence-Based Medicine has been convened to help transform the way evidence on clinical effectiveness is generated and used to improve health and health care. We seek the develop- ment of a learning healthcare system that is designed to generate and apply the best evidence for the collaborative healthcare choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and to ensure innovation, quality, safety, and value in health care. Vision: Our vision is for a healthcare system that draws on 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. Goal: By the year 2020, 90 percent of clinical decisions will be supported by accurate, timely, and up-to-date clinical information, and will reflect the best available evidence. We feel that this presents a tangible focus for progress toward our vision, that Americans ought to expect at least this level of perfor- mance, that it should be feasible with existing resources and emerging tools, and that measures can be developed to track and stimulate progress. Context: As unprecedented developments in the diagnosis, treatment, and long-term management of disease bring Americans closer than ever to the promise of personalized health care, we are faced with similarly unprecedented challenges to identify and deliver the care most appropriate for individual needs and conditions. Care that is important is often not delivered. Care that is delivered is often not important. In part, this is due to our failure to apply the evidence we have about the medical care that is most effective—a failure related to shortfalls in provider knowledge and accountability, inadequate care coordination and support, lack of insurance, poorly aligned payment incen- ix

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tives, and misplaced patient expectations. Increasingly, it is also a result of our limited capacity for timely generation of evidence on the relative effectiveness, efficiency, and safety of available and emerging interventions. Improving the value of the return on our healthcare investment is a vital imperative that will require much greater capacity to evaluate high-priority clinical interventions, stronger links between clinical research and practice, and reorientation of the incentives to apply new insights. We must quicken our efforts to position evi- dence development and application as natural outgrowths of clinical care—to foster health care that learns. Approach: The IOM Roundtable on Evidence-Based Medicine serves as a forum to facilitate the collaborative assessment and action around issues central to achieving the vision and goal stated. The challenges are myriad and include issues that must be addressed to improve evidence development, evi- dence application, and the capacity to advance progress on both dimensions. To address these challenges, as leaders in their fields, Roundtable members will work with their colleagues to identify the issues not being adequately addressed, the nature of the barriers and possible solutions, and the priorities for action, and will marshal the resources of the sectors represented on the Roundtable to work for sustained public–private cooperation for change. Activities include collaborative exploration of new and expedited approaches to assessing the effectiveness of diagnostic and treatment interven- tions, better use of the patient care experience to generate evidence on effec- tiveness, identification of assessment priorities, and communication strategies to enhance provider and patient understanding and support for interventions proven to work best and deliver value in health care. Core concepts and principles: For the purpose of the Roundtable activi- ties, we define evidence-based medicine broadly to mean that, to the great- est extent possible, the decisions that shape the health and health care of Americans—by patients, providers, payers, and policy makers alike—will be grounded on a reliable evidence base, will account appropriately for individual variation in patient needs, and will support the generation of new insights on clinical effectiveness. Evidence is generally considered to be information from clinical experience that has met some established test of validity, and the appro- priate standard is determined according to the requirements of the intervention and clinical circumstance. Processes that involve the development and use of evidence should be accessible and transparent to all stakeholders. A common commitment to certain principles and priorities guides the activities of the Roundtable and its members, including the commitment to the right health care for each person; putting the best evidence into practice; establishing the effectiveness, efficiency, and safety of medical care delivered; building constant measurement into our healthcare investments; the estab- lishment of healthcare data as a public good; shared responsibility distrib- uted equitably across stakeholders, both public and private; collaborative stakeholder involvement in priority setting; transparency in the execution of activities and reporting of results; and subjugation of individual political or stakeholder perspectives in favor of the common good. x

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Foreword In its role as adviser to the nation to improve health, the Institute of Medicine (IOM) endeavors to bring individuals with the best scientific expertise together for discussion and deliberation on issues of national importance. Driving change often requires that scientific consensus be linked with leadership and a shared commitment to action. This spirit is embodied in the work of the IOM’s Roundtable on Evidence-Based Medicine. Convened in 2006, the Roundtable comprises senior private- and public-sector leaders representing the key stakeholders shaping health care for Americans. It provides a neutral venue for discussion and collaborative action to transform how evidence is generated and applied to improve the nation’s health. Together, Roundtable members have outlined their vision for a learning healthcare system, as expressed in their charter statement, and a goal by which to mark progress—that by 2020, 90 percent of clini- cal decisions will be supported by accurate, timely, and up-to-date clinical information and will reflect the best available evidence. Through a series of workshops and publications, the Roundtable works to explore the issues and barriers and to identify the key opportunities for collaborative work toward the development of a learning healthcare system. This publication represents the third in the Learning Healthcare System series and is the result of work by each sector represented on the Roundtable—patients, healthcare professionals, healthcare delivery orga- nizations, healthcare product developers, clinical investigators-evaluators, regulators, insurers, employers-employees, and information technology—to identify the key opportunities for individual and collaborative work to fos- ter progress toward the Roundtable’s goal. The results of the work of the xi

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xii FOREWORD Roundtable members were presented at a 2-day workshop entitled, Leader- ship Commitments to Improve Value in Health Care: Finding Common Ground. The sector statements and subsequent workshop discussion are summarized in this volume. Embedded in these pages are insights gleaned from across the spectrum of healthcare stakeholders. Although each sector brought a unique set of challenges, skills, and expertise to its work, many common concerns, issues, and opportunities emerged, including the pressing needs to build more trust and transparency into the system, to identify national priorities and build the necessary capacity, to foster a shared commitment to evidence-driven care, and to build learning into the culture of health care by accelerating advances in medical informatics and engaging the frontline providers in change. Among the opportunities identified, the most essential was that these activities be taken up as a shared endeavor. No one sector, acting alone, can bring about the scope and scale of transformative change neces- sary to develop a system that can consistently and efficiently deliver the safe, effective, and quality care of value that should be our nation’s stan- dard. Stakeholder leadership from the Roundtable and beyond will be vital to success. I would like to offer my personal thanks to Roundtable members for the leadership that they bring to these important issues, to the Roundtable staff for their skill and dedication in coordinating and facilitating the activities, and importantly, to the sponsors who make this work possible: the Agency for Healthcare Research and Quality, America’s Health Insur- ance Plans, AstraZeneca, Blue Shield of California Foundation, Burroughs Wellcome Fund, California Health Care Foundation, Centers for Medicare and Medicaid Services, Charina Endowment Fund, Food and Drug Admin- istration, Johnson & Johnson, sanofi-aventis, Stryker, and U.S. Department of Veterans Affairs. Harvey V. Fineberg, M.D., Ph.D. President, Institute of Medicine

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Preface The essence of this publication, Leadership Commitments to Improve Value in Health Care: Finding Common Ground, reflects the motivations and driving forces behind the Roundtable on Evidence-Based Medicine. That is, that no one sector can effect the transformation needed in health care and that collaborative work and action are vital to developing the learning healthcare system that provides care of the best possible value to all of our citizens. By value, we mean the full value equation—the best outcomes, safety, and service for the best price. The Institute of Medicine (IOM) Roundtable is made up of stakeholders with often different perspec- tives and incentives, but we are all stakeholders committed to obtaining better results and better value from the health care that we deliver and we receive. Outlined in this volume are exciting and important opportunities to collectively move toward our vision and goal. This publication represents just one component of the Roundtable’s work to help transform how evidence is both generated and used to improve health and health care. Our charter statement articulates a collective vision for a 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 deliv- ery of care, and leads to improvements in the nation’s health.” Our goal is that by 2020, 90 percent of clinical decisions will be supported by accurate, timely, and up-to-date clinical information and will reflect the best available evidence. Although it is ambitious, this goal presents a tangible focus for progress and should be achievable given our nation’s substantial investment in health care. xiii

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xiv PREFACE The guiding framework for the Roundtable’s work is its focus on fos- tering the development of a learning healthcare system. Because our current system is so fragmented, achieving this aim will require the extraordinary creativity and energy discussed at the workshop and in this publication. Our initial workshop and resulting publication, The Learning Healthcare System, characterized the system that we seek, one that is designed to generate the best evidence and to apply that evidence to the healthcare choices that each patient and provider make in collaboration; to drive the process of discovery as a natural outgrowth of patient care; and to ensure innovation, quality, safety, and value in health care. The key characteristics of a learning healthcare system include adaptation to the pace of change; strong systemwide synergy and synchrony; a culture of shared responsibil- ity; a practical clinical research paradigm in play; evidence standards that are consistent and tailored; clinical decision support systems that are fully applied; universal electronic health records; the establishment of clinical data as a public good; databases that are linked, mined in real time, and used; incentives that are aligned for practice-based evidence; patients who are engaged as evidence proponents; and a trusted scientific broker of needed guidance. The Learning Healthcare System workshop series is designed to explore in greater detail these component issues. None is more important in this respect than the mutual commitment of the stakeholders discussed here. To identify the greatest opportunities and to begin the process of inter- sectoral collaboration, on July 24-25, 2007, the Roundtable convened a 2-day workshop titled Leadership Commitments to Improve Value in Health Care: Finding Common Ground. The third in the Learning Health- care System series, this workshop convened representatives from a variety of sectors—patients, healthcare professionals, healthcare delivery organi- zations, healthcare product developers, clinical investigators-evaluators, regulators, insurers, employers-employees, and information technology professionals—to discuss the ways that each sector, individually and collab- oratively, can contribute to the transformative change necessary to achieve the Roundtable’s goal. Workshop presentations resulted from several months of work by Roundtable members to develop, in cooperation with other participants recruited from their respective arenas, statements that laid out the issues and opportunities from the perspectives of each of the sectors. These statements detailed the important characteristics and activities of each sec- tor with respect to evidence development and application and advanced some key opportunities and specific initiatives for individual and cross- sectoral work to bring about transformative change. These statements were presented over the course of the 2-day workshop and set the stage for rich discussion and debate. This publication includes the sectoral

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xv PREFACE statements, a summary of the workshop proceedings, and identification of the common themes. Among the participants, several important foundation stones were considered vital to progress. Common ground could be forged by building trust between the many stakeholders and fostering a shared commitment to evidence-driven care. Also needed are efforts to consistently build learning into the culture of health care and the establishment of a common focal point or trusted source to coordinate the development and dissemination of evidence. The greatest transformational opportunities identified include the clarification of core concepts, beginning with a sharper focus on the value proposition and the establishment of transparent principles and processes for evidence interpretation and use; identifying a set of national priorities around unused evidence and unavailable evidence and strengthening the national capacity for evidence development and guidance; reorienting the healthcare system to produce the evidence for today’s decisions, with tomorrow in view; encouraging rapid progress in medical informatics; and engaging healthcare providers in establishing interdisciplinary evidence- driven team care as standard care. Above all, stakeholder leadership will be essential to encourage and promote the needed change. We would like to acknowledge the many individuals and organiza- tions that donated their valuable time to the development of this workshop summary. In particular, we acknowledge the contributors to this volume for their presence at the workshop and their efforts to further develop their presentations into the chapters contained within this summary. We would also like to acknowledge those who provided counsel during the planning stages of this workshop, including Patrick Anderson (Stryker), Helen Darling (National Business Group on Health), Michael Johns (Emory University), and Carmen Hooker Odom (Milbank Memorial Fund).1 A number of IOM staff were instrumental in the preparation and conduct of the 2-day workshop in July 2007, including Rachel Passman, Kristina Shulkin, and Jamie Skipper. Roundtable staff, including Katharine Bothner, Alex Goolsby, LeighAnne Olsen, and Daniel O’Neill, helped to translate the workshop proceedings and discussion into this workshop summary. Stephen Pelletier also contributed substantially to publication development. We would also like to thank Michele de la Menardiere, Bronwyn Schrecker, Vilija Teel, and Jackie Turner for helping to coordinate the various aspects of review, production, and publication. As illustrated in this publication, a shared commitment to evidence- driven care offers a means to define common goals, set priorities, and 1 IOM planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteur and the institution.

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xvi PREFACE identify practical ways to initiate action. However, collaboration is more than just a tool. Given the transformative change needed in health care, it is an imperative. The Roundtable looks forward to expanding the sphere of sector involvement, collaboration, and action in the field to build upon the substantial opportunities identified in this publication. Denis A. Cortese, M.D. Chair, Roundtable on Evidence-Based Medicine J. Michael McGinnis, M.D., M.P.P. Executive Director, Roundtable on Evidence-Based Medicine

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Contents Summary 1 PART ONE: Finding Value in Common Ground 1 Guiding Perspective: The Learning Healthcare System 39 Overview, 39 The Learning Healthcare System, 40 The Sectoral Strategies Process, 42 Patients, Providers, and Stewardship of the Evidence, 43 References, 58 2 Foundation Stones in the Common Ground 59 Building Trust: Transparency and Value, 60 Shared Commitment to Evidence-Driven Care, 62 Building Learning into the Culture of Health Care, 63 Common Focal Point and Trusted Source, 64 Stakeholder Leadership for Change, 64 3 Transformational Opportunities 67 Focus on the Value Proposition, 68 Transparent Principles and Processes for Evidence Interpretation and Use, 69 National Priorities: Challenges of Unused and Unavailable Evidence, 70 xvii

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xviii CONTENTS Producing the Evidence for Today’s Decisions with Tomorrow in View, 72 Medical Informatics: The Nerve Center of a Learning Healthcare System, 76 Interdisciplinary Evidence-Driven Team Care as Standard Care, 77 4 Moving Forward 79 Overview, 79 Building on Common Ground, 80 Priorities for Collaboration, 80 Concluding Comments and Next Steps, 86 PART TWO: Leadership Commitments to Improve Health Care 5 Patients 97 Sector Overview, 97 Activity Categories, 102 Leadership Commitments and Initiatives, 111 Next Steps, 113 References, 114 6 Healthcare Professionals 117 Sector Overview, 117 Activity Categories, 133 Leadership Commitments and Initiatives, 135 Next Steps, 141 References, 143 7 Healthcare Delivery Organizations 149 Sector Overview, 149 Activity Categories, 155 Leadership Commitments and Initiatives, 173 Next Steps, 178 References, 183 8 Healthcare Product Developers 187 Sector Overview, 187 Activity Categories, 199 Leadership Commitments and Initiatives, 211 Next Steps, 212 References, 215

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xix CONTENTS 9 Clinical Investigators and Evaluators 217 Sector Overview, 217 Activity Categories, 221 Leadership Commitments and Initiatives, 224 Next Steps, 233 References, 235 10 Regulators 237 Sector Overview, 237 Activity Categories, 244 Leadership Commitments and Initiatives, 256 Next Steps, 264 References, 267 11 Insurers 269 Sector Overview, 269 Activity Categories, 273 Leadership Commitments and Initiatives, 281 Next Steps, 290 References, 292 12 Employers and Employees 297 Sector Overview, 297 Activity Categories, 299 Leadership Commitments and Initiatives, 304 Next Steps, 306 References, 307 13 Information Technology 309 Sector Overview, 309 Activity Categories, 310 Leadership Commitments and Initiatives, 313 Next Steps, 316 APPENDIXES A Sectoral Strategies Process 323 B Workshop Agenda 327 C Biographical Sketches of Participants 331 D Workshop Attendees 339

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