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Appendix F Workshop Agenda LEARNING WHAT WORKS Infrastructure Required to Learn Which Care Is Best A Learning Healthcare System Workshop IOM Roundtable on Evidence-Based Medicine July 30–31, 2008 Lecture Room, The National Academy of Sciences Washington, DC 20001 Issues motivating the discussion 1. Substantial demand for greater insights into the comparative clini- cal effectiveness of clinical interventions and care processes to improve the effectiveness and value of health care. 2. Expanded interest and activity in the work needed—e.g., compara- tive effectiveness research, systematic reviews, innovative research strategies, clinical registries, coverage with evidence development. 3. Currently fragmented and largely uncoordinated selection of stud- ies, study design and conduct, evidence synthesis, methods valida- tion and improvement, and development and dissemination of guidelines. 4. Expanding gap in workforce with skills to develop data sources and systems, design and conduct innovative studies, translate results, and guide application. 5. Opportunities presented by the attention of recent initiatives and the increasing possibility for development of an entity and resources for expanded work on the comparative effectiveness of clinical interventions. 6. Growing appreciation of the importance of assessing the infrastruc- ture needed for this work—e.g., workforce needs, data linkage and 

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2 LEARNING WHAT WORKS improvement, new methodologies, research networks, technical assistance. 7. Desirability of a common venue to identify and characterize the need categories, begin to estimate the shortfalls, consider approaches to addressing the shortfalls, and identify priority next steps. Discussion assumptions: (1) Resources will be available to expand work on the comparative effectiveness of medical interventions, and (2) a designated entity will exist with a formal charge to coordinate the expanded work. Goal: Clarify the elements and nature of the needed capacity, solicit quanti- tative and qualitative assessments of the needs, and characterize in a fashion that will facilitate engagement of the issues by policy makers. DAY ONE 8:00 Welcome and IntroductIons John W. Rowe, Columbia University & IOM Roundtable on Evidence-Based Medicine 8:15 Keynote: a VIsIon for the capacIty to learn What care WorKs Best What are the core elements of a robust and sustainable capacity for comparative effectiveness research? How do they relate to each other as a real infrastructure? What are the priorities and how might we build upon, link, and improve existing public and private system elements? Mark B. McClellan, Brookings Institution & IOM Roundtable on Evidence-Based Medicine 8:45 sessIon 1: the WorK requIred Each presenter will describe the nature of the activity and what is known about the current capacity, suggest an approach to determining the necessary capacity, give an “opening bid” estimate of what that need might be, and offer initial suggestions on policies or activities for progress. Chair: Mark B. McClellan, Brookings Institution & IOM Roundtable on Evidence-Based Medicine

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 APPENDIX F ➢ The Cost and Volume of Current Comparative Effectiveness Research Erin Holve, AcademyHealth ➢ Intervention Studies That Need to Be Conducted Douglas B. Kamerow, RTI International ➢ Clinical Data Sets That Need to Be Mined Jesse A. Berlin, Johnson & Johnson ➢ Knowledge Synthesis and Translation That Need to Be Applied Richard A. Justman, UnitedHealthcare [9:45 – 10:00 BREAK] ➢ Methods That Need to Be Developed Eugene H. Blackstone, Cleveland Clinic ➢ Coordination and Technical Assistance That Need to Be Supported Jean R. Slutsky, Agency for Healthcare Research and Quality OPEN DISCUSSION (60 minutes) 11:30 lunch presentatIon: the potentIal returns eVIdence- from drIVen health care Gail R. Wilensky, Project HOPE 1:00 sessIon 2: the InformatIon netWorKs requIred Each presenter will describe the nature of the systems required to capture and use data for insights on clinical effectiveness and to ensure effective and efficient review and dissemination of those insights. Presenters will also describe what is known about the current capacity, give a rough estimate of the necessary capacity, and offer initial suggestions on policies or activities for progress. Chair: Kathleen A. Buto, Johnson &Johnson ➢ Information Technology Requirements Robert H. Miller, University of California at San Francisco ➢ Data and Information Hub Requirements Carol C. Diamond, The Markle Foundation

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 LEARNING WHAT WORKS ➢ Integrative Vehicles Required for Evidence Review and Dissemination Lorne A. Becker, Cochrane Collaboration OPEN DISCUSSION (45 minutes) 2:30 sessIon 3: the talent requIred Session Three will review the competencies and workforce necessary to carry out comparative effectiveness work, including the presentation of initial estimates of the workforce needed in key areas, comments on the estimates from end users of such research, and insights on the implications for training programs. Chair: Donald M. Steinwachs, Johns Hopkins University Bloomberg School of Public Health & IOM Roundtable on Evidence-Based Medicine ➢ Comparative Effectiveness Workforce—Framework and Assessment William R. Hersh, Oregon Health and Science University • Reactor Panel Jean Paul Gagnon, sanofi-aventis Bruce Bruce H. Hamory, Geisinger Health System Steve E. Phurrough, Centers for Medicare & Medicaid Services Robert J. Temple, Food and Drug Administration OPEN DISCUSSION (30 minutes) ➢ Panel Discussion: Training and Education Needs • linical Epidemiology and Research—Eric B. Bass, C Johns Hopkins University • ealth Services Research— Timothy S. Carey, H University of North Carolina at Chapel Hill • nformatics—Don E. Detmer, American Medical I Informatics Association • uideline Development— Richard N. Shiffman, G Yale University • nowledge Translation—David H. Hickam, Eisenberg K Center

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 APPENDIX F OPEN DISCUSSION (30 minutes) ➢ Toward an Integrated Enterprise—An International Case Study Sean R. Tunis, Center for Medical Technology and Policy OPEN DISCUSSION (20 minutes) 5:15 hIghlIghts of day’s dIscussIon John W. Rowe, Columbia University & Roundtable on Evidence-Based Medicine 5:30 RECEPTION DAY TWO 8:00 Welcome and recap of the fIrst day J. Michael McGinnis, Institute of Medicine 8:15 sessIon 4: next steps—prIorItIes for ImplementatIon In this discussion of priorities, strategies, staging, and policies, each participant will offer comments that reflect on the nature (quantitative and qualitative) of the need in the relevant area, how to clarify the understanding on that count, and the possible approaches to ramping up. Specific consideration of how to take best advantage of existing manufacturer and related private sector capacity will also be discussed. Ten minutes of comments on each of the following areas, followed by open discussion. Chair: Nancy H. Nielsen, American Medical Association & IOM Roundtable on Evidence-Based Medicine ➢ Information Technology Platform Requirements Mark E. Frisse, Vanderbilt University ➢ Data Resource Development and Analysis Improvement T. Bruce Ferguson, East Carolina Heart Institute ➢ Research Infrastructure Improvement Daniel E. Ford, Johns Hopkins University ➢ Transforming Health Professions Education Benjamin K. Chu, Kaiser Foundation Health Plan and Hospitals

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 LEARNING WHAT WORKS ➢ Building the Training Capacity Steven A. Wartman, Association of Academic Health Centers PANEL & OPEN DISCUSSION (50 minutes) [10:00 – 10:15 BREAK] 10:15 sessIon 5: puBlIc–prIVate partnershIps Session panelists will address the following questions: How might better advantage be taken of capacity in the private sector? What existing or planned efforts might best inform the development of needed infrastructure for comparative analyses and research (e.g., biomarkers consortium, data aggregation efforts, Food and Drug Administration Sentinel Network)? Chair: W. David Helms, AcademyHealth ➢ Carmella A. Bocchino, America’s Health Insurance Plans ➢ Rachel E. Behrman, Food and Drug Association ➢ William Z. Potter, Merck Research Laboratories PANEL & OPEN DISCUSSION (45 minutes) 11:15 sessIon 6: gettIng started This final session will be a facilitated open discussion of the priorities and strategies for building the needed infrastructure. There will be 30-45 minutes each on the following. Chair: John W. Rowe, Columbia University & Roundtable on Evidence-Based Medicine ➢ The Roadmap—Policies, Priorities, Strategies, and Sequencing Stuart Guterman, The Commonwealth Fund ➢ Quick Hits—Things That Can Be Done Now W. David Helms, AcademyHealth ➢ Building Support Mary Woolley, Research!America 12:45 concludIng summary remarKs and adJournment J. Michael McGinnis, Institute of Medicine

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 APPENDIX F Planning Committee: John W. Rowe (Chair), Mailman School of Public Health, Columbia University Stuart H. Altman, Brandeis University Kathleen A. Buto, Johnson & Johnson Carolyn M. Clancy, Agency for Healthcare Research and Quality W. David Helms, AcademyHealth Mark B. McClellan, Brookings Institution Peter R. Orszag, Congressional Budget Office

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