THE LEARNING HEALTH SYSTEM SERIES
ROUNDTABLE ON VALUE and amp; SCIENCE-DRIVEN HEALTH CARE
CLINICAL DATA AS THE BASIC STAPLE OF HEALTH LEARNING
Creating and Protecting a Public Good
Claudia Grossmann, W. Alexander Goolsby, LeighAnne Olsen, and J. Michael McGinnis
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
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 & Medicaid Services, Charina Endowment Fund, Department of Veterans Affairs, Food and Drug Administration, Johnson & Johnson, Moore Foundation, National Institutes of Health, The Peter G. Peterson Foundation, sanofi-aventis, and Stryker. 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: 978-0-309-12060-9
International Standard Book Number-10: 0-309-12060-8
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Suggested citation: IOM (Institute of Medicine). 2010. Clinical data as the basic staple of health learning: Creating and protecting a public good: Workshop Summary. Washington, DC: The National Academies Press.
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
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 Academy 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 engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president 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 Institute 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 Sciences 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.
ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE1
Denis A. Cortese (Chair), Emeritus President and Chief Executive Officer,
Donald Berwick, Administrator,
Centers for Medicare & Medicaid Services (ex officio)
David Blumenthal, National Coordinator,
Office of the National Coordinator for Health IT (ex officio)
Bruce G. Bodaken, Chairman, President, and Chief Executive Officer,
Blue Shield of California
David R. Brennan, Chief Executive Officer,
Paul Chew, Chief Science Officer and CMO,
sanofi-aventis U.S., Inc.
Carolyn M. Clancy, Director,
Agency for Healthcare Research and Quality (ex officio)
Michael J. Critelli, Former Executive Chairman,
Pitney Bowes, Inc.
Helen Darling, President,
National Business Group on Health
Thomas R. Frieden, Director,
Centers for Disease Control and Prevention (designee: Chesley Richards) (ex officio)
Gary L. Gottlieb, President and CEO,
Partners HealthCare System
James A. Guest, President,
George C. Halvorson, Chairman and Chief Executive Officer,
Margaret A. Hamburg, Commissioner,
Food and Drug Administration (ex officio)
Carmen Hooker Odom, President,
Milbank Memorial Fund
Ardis Hoven, Professor of Medicine,
University of Kentucky;
American Medical Association
Brent James, Chief Quality Officer and Executive Director,
Institute for Health Care Delivery Research, Intermountain Healthcare
Michael M. E. Johns, Chancellor,
Craig Jones, Director,
Vermont Blueprint for Health
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,
Mark B. McClellan, Director,
Engelberg Center for Healthcare Reform, The Brookings Institution
Sheri S. McCoy, Worldwide Chairman,
Johnson & Johnson Pharmaceuticals Group
Elizabeth G. Nabel, President,
Brigham and Women’s Hospital
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, Past President,
American Medical Association
William D. Novelli, Former CEO,
Jonathan B. Perlin, Chief Medical Officer and President,
Clinical Services, HCA, Inc.
Robert A. Petzel, Under Secretary,
Veterans Health Administration (ex officio)
Richard Platt, Professor and Chair,
Harvard Medical School and Harvard Pilgrim Health Care
John C. Rother, Group Executive Officer,
John W. Rowe, Professor,
Mailman School of Public Health, Columbia University
Susan Shurin, Acting Director,
National Heart, Lung, and Blood Institute (ex officio)
Mark D. Smith, President and CEO,
California HealthCare Foundation
George P. Taylor, Assistant Secretary for Health Affairs (Acting),
Department of Defense (designee: Michael Dinneen) (ex officio)
Reed D. Tuckson, Executive VP and Chief of Medical Affairs,
Frances M. Visco, President,
National Breast Cancer Coalition
Workshop Planning Committee
Office of the National Coordinator for Health IT (formerly Massachusetts General Hospital, Harvard University)
National Health Council
Kaiser Foundation Hospitals
George Washington University
Johnson & Johnson
Harvard School of Public Health, Harvard University
Christie Bell, Financial Associate
Katharine Bothner, Senior Program Assistant (through July 2008)
Patrick Burke, Financial Associate (until December 2009)
Andrea Cohen, Financial Associate (until December 2008)
W. Alexander Goolsby, Program Officer (through August 2008)
Claudia Grossmann, Program Officer
Kiran Gupta, Research Assistant (until May 2009)
J. Michael McGinnis, Senior Scholar and Executive Director
LeighAnne Olsen, Program Officer
Daniel O’Neill, Research Associate (until December 2008)
Stephen Pelletier, Consultant
Brian Powers, Program Assistant
Ruth Strommen, Intern
Kate Vasconi, Senior Program Assistant
Pierre Yong, Program Officer
Catherine Zweig, Senior Program Assistant
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:
Simon Cohn, Kaiser Permanente
John Lumpkin, Robert Wood Johnson Foundation
Douglas Peddicord, Oldaker, Belair, & Wittie, LLC
Alan Westin, Columbia University
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 Daniel Masys, Vanderbilt University School of Medicine. Appointed by the National Research Council and the Institute of Medicine, Dr. Masys was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.
Institute of Medicine
Roundtable on Value & Science-Driven Health Care1
Charter and Vision Statement
The Institute of Medicine’s Roundtable on Value & Science-Driven Health Care has been convened to help transform the way evidence on clinical effectiveness is generated 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 Value & Science-Driven Health Care 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 development of a learning health 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 performance, 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 incentives, 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 evidence development and application as natural outgrowths of clinical care—to foster health care that learns.
Approach: The IOM Roundtable on Value & Science-Driven Health Care 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, evidence 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 interventions, better use of the patient care experience to generate evidence on effectiveness, 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 activities, we define science-driven health care broadly to mean that, to the greatest extent possible, the decisions that shape the health and health care of Americans—by patients, providers, payers, and policymakers 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 appropriate 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 establishment of healthcare data as a public good; shared responsibility distributed 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.
The Institute of Medicine (IOM) was established in 1970 as part of the National Academies to serve as the foremost adviser to the nation on issues related to medicine, health, and the biomedical sciences. Essential to fulfilling this role is a commitment to drawing upon the best evidence to guide policy development. Indeed, the capacity to excel, innovate, and advance in any field of inquiry is predicated upon the quality and availability of information—whether to guide decision making, suggest new areas of research, or confirm hypotheses. Clinical data represent an enormous opportunity to improve the quality and efficiency of the nation’s healthcare system. Whether captured as part of research, through delivery processes, or at the point of care, these data will be central to advance our understanding of which medical practices and treatments work best for different patients, and drive continual improvements in the delivery of health care. This potential will only be enhanced as health information technology enables the capture and analysis of vastly larger quantities of data.
While important data are currently collected by a number of healthcare organizations and sectors, their capture and use reflect the fragmentation of the healthcare system, with much of this information siloed in different databases and repositories. In addition, broader sharing, aggregation, and use of these data are often restricted due to proprietary or privacy concerns. Taking better advantage of these resources, while maintaining appropriate privacy protections, requires the engagement of all healthcare sectors in discussions of key challenges and opportunities in a neutral and trusted forum, such as that provided by the IOM Roundtable on Value & Science-Driven Health Care. Established in 2006 as the Roundtable on Evidence-Based
Medicine, the IOM Roundtable is composed of the nation’s top leaders in the public and private sectors who have a keen interest in transforming our nation’s healthcare system. Roundtable members have established a common vision for a learning health system and 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. Since its inception, the Roundtable has convened a series of workshops and publications, as well as initiated a variety of projects and activities to help accelerate progress toward a learning health system.
This publication represents the sixth in the Learning Health System series and summarizes the discussions at the Roundtable’s 2-day workshop titled Clinical Data as the Basic Staple of Health Learning: Creating and Protecting a Public Good. The workshop explored the range of activities that constitute the system of healthcare data in the United States, as well as the challenges and opportunities associated with efficiently leveraging data. Discussion identified many challenges, barriers, and policy issues that must be engaged to move to the next generation of data utility. As reflected by participants’ comments, broader use of health information technology for knowledge development, particularly electronic health records, holds significant potential for healthcare advancement through collaborative data mining and improving transparency of and access to data. Also evident is the central importance of stakeholder leadership, such as that provided by the Roundtable, for maximizing the use of clinical data for continuous learning and improvement in health care.
I would like to offer my personal thanks to the 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: 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 & Medicaid Services, Charina Endowment Fund, Department of Veterans Affairs, Food and Drug Administration, Johnson & Johnson, Moore Foundation, National Institutes of Health, The Peter G. Peterson Foundation, sanofi-aventis, and Stryker.
Harvey V. Fineberg, M.D., Ph.D.
President, Institute of Medicine
The Institute of Medicine convened the Roundtable on Value & Science-Driven Health Care (formerly the Roundtable on Evidence-Based Medicine) in 2006 to provide a trusted forum in which multiple healthcare sectors—including patients, health providers, payers, employees, health product manufacturers, information technology companies, policy makers, and researchers—could share perspectives on key opportunities to help transform how evidence is generated and applied to drive improvements in the efficiency and effectiveness of health care, to guide healthcare decisions, and to improve the nation’s health. An early outcome of the Roundtable activities is a shared vision of a healthcare system that draws on the best available evidence to appropriately tailor care to individual patients and to continuously add to the healthcare knowledge base. Salient topics, addressed through public workshops and collaborative groups, engage critical aspects of concepts essential to achieving this vision and the Roundtable’s goal 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.
The perspectives, themes, and insights from each workshop are disseminated through the Learning Health System series of publications. The Clinical Data as a Basic Staple of Health Learning: Creating and Protecting a Public Good publication is a summary of the proceedings of the sixth workshop in the Learning Health System series. Held on February 12–13, 2008, this workshop was designed to explore leading perspectives on clinical data as a transformative agent in health care, as well as possible strategies for their implementation in the delivery of evidence-based care. Issues motivating the discussion include:
Discovering what works best in medical care—including for whom and under what circumstances—requires that clinical data be carefully nurtured as a resource for continuous learning.
Transformational opportunities are presented by evolving large and potentially interoperable clinical and administrative datasets.
Clinical data are recorded and held in multiple activities and many institutions, including medical records, administrative and claims records, and research studies.
Public policy and public awareness lag behind the technical, organizational, and legal capacity for reliable safeguarding of individual privacy and data security in mining clinical data for new knowledge.
A significant challenge to progress resides in the barriers and restrictions that derive from the treatment of medical care data as a proprietary commodity by the organizations involved.
Even clinical research and medical care data developed with public funds are often not available for broader analysis and insights.
Broader access and use of healthcare data for new insights require not only fostering data system reliability and interoperability but also addressing the matter of individual data ownership and the extent to which data central to progress in health and health care should constitute a public good.
During the 2-day workshop, participants explored a variety of relevant technical, economic, legal, and policy issues important to addressing these issues. Invited speakers and panelists highlighted opportunities to advance elements of clinical data and identified areas in need of greater attention and focus. The following pages summarize the workshop discussion, including the review of characteristics of clinical data, the marketplace for healthcare data, legal issues related to data access and use, and the role of privacy and security concerns. Throughout the workshop, participants identified specific policy issues in need of engagement to move to the next generation of data utility. The need for broader public engagement was also discussed, as participants noted that public policy and awareness often lag behind the technical, organizational, and legal capacity for reliable safeguarding of individual privacy and data security. Key opportunities identified included realigning incentives to promote real-time use of clinical data in evidence development, correcting the market failure for expanding electronic health records, and greater engagement of the public in shaping evidence development strategies.
We wish to acknowledge the individuals and organizations who offered their time and guidance in the development and execution of the workshop and summary. Individuals presenting at the workshop and authoring
manuscripts for the summary are acknowledged in particular. Also vital to the success of the workshop were the planning committee members, representing a cross-section of stakeholders and thought leaders in clinical data issues: David Blumenthal (Massachusetts General Hospital), Mary Durham (Kaiser Permanente), Lynn Etheredge (George Washington University), George Isham (HealthPartners, Inc.), Peter Juhn (Johnson & Johnson), and Alexander Walker (Harvard University). Roundtable staff members, including Katharine Bothner, Alexander Goolsby, Claudia Grossmann, Kiran Gupta, LeighAnne Olsen, Daniel O’Neill, Kate Vasconi, Pierre Yong, and Catherine Zweig, were instrumental to workshop coordination and summary production. We also wish to acknowledge the Roundtable members for their guidance and the sponsors of Roundtable activities: Agency for Healthcare Research and Quality, America’s Health Insurance Plans, Astra-Zeneca, Blue Shield of California Foundation, Burroughs Wellcome Fund, California Health Care Foundation, Centers for Medicare & Medicaid Services, Charina Endowment Fund, Department of Veterans Affairs, Food and Drug Administration, Johnson & Johnson, Moore Foundation, National Institutes of Health, The Peter G. Peterson Foundation, sanofi-aventis, and Stryker.
Denis A. Cortese, M.D.
Roundtable on Value & Science-Driven Health Care
J. Michael McGinnis, M.D., M.P.P.
Roundtable on Value & Science-Driven Health Care
Current Healthcare Data Profile,
Data Primarily Collected for New Insights,
Health Product Marketing Data,
Networked Data-Sharing and Standardized Reporting Initiatives,
Large Health Database Aggregation,
Legal Issues Related to Data Access, Pooling, and Use,
HIPAA Implications and Issues,
Examples from Other Sectors,
Building on Collaborative Models,
Technical and Operational Challenges,
Economic Incentives and Legal Issues,
Generating Public Interest in a Public Good,
Implications of “Patients Like Me” Databases,
Implications of Personal Health Records,