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The Learning Healthcare System: Workshop Summary Appendix A Workshop Agenda THE LEARNING HEALTHCARE SYSTEM A WORKSHOP OF THE IOM ROUNDTABLE ON EVIDENCE-BASED MEDICINE THE KECK CENTER OF THE NATIONAL ACADEMIES WASHINGTON, DC 20001 JULY 20-21, 2006 MEETING AGENDA OBJECTIVE: To characterize the key features of the Learning Healthcare System, to identify the most important hindrances to its evolution, and to posit some remedies. DAY 1: THE LEARNING HEALTHCARE SYSTEM 8:30 WELCOME AND OPENING REMARKS Harvey Fineberg, Institute of Medicine Darrell Kirch, Association of American Medical Colleges What would be the features of a healthcare system designed not to learn—how might it be corrected? 9:00 SESSION 1: HINTS OF A DIFFERENT WAY—LEARNING FROM EXPERIENCE CASE STUDIES IN PRACTICE-BASED EVIDENCE DEVELOPMENT CHAIR: Carolyn Clancy, Agency for Healthcare Research and Quality (AHRQ) and EBM Roundtable Member What “best practices” might be spotlighted to illustrate ways to use the health care experience as a practical means of both generating and applying evidence for health care? Are there lessons from certain examples that can help identify the most promising approaches?
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The Learning Healthcare System: Workshop Summary 15-minute presentations followed by discussion session Peter Bach, Centers for Medicare & Medicaid Services (CMS) Coverage with evidence development: Lung volume reduction surgery Jed Weissberg, Permanente Federation Use of large system databases: Cyclooxygenase-2 (COX-2) inhibitors Stephen Soumerai, Harvard Pilgrim Health Care Potential of quasi-experimental designs for evaluating health policy Sean Tunis, Health Technology Center Practical clinical trials Alan Morris, Latter Day Saints Hospital and University of Utah Computerized protocols to assist clinical research* 10:30 SESSION 2: THE EVOLVING EVIDENCE BASE—METHODOLOGIC AND POLICY CHALLENGES CHAIR: Don Steinwachs, Johns Hopkins University and EBM Roundtable Member What challenges confront methodologically rigorous learning from experience? How can alternatives to randomized controlled trials (RCTs) and innovative approaches to generating evidence be used to confront emerging challenges: broader post-marketing surveillance; linking Phase III and coverage requirements; increasingly complex patterns of comorbidity; subgroup analysis, and heterogeneity in treatment outcomes? How might learning that is more nimble also foster innovation and discovery? 15-minute presentations followed by discussion session Robert Califf, Duke Clinical Research Institute Alternatives to large RCTs David Goldstein, Duke Institute for Genome Sciences and Policy Engaging the implications of subgroup heterogeneity— prospects for pharmacogenetics Harlan Weisman, Johnson & Johnson Broader post-marketing surveillance for insights on risk and effectiveness Telba Irony, Food and Drug Administration (FDA) Evaluating interventions in a rapid state of flux David Eddy, Archimedes Inc. Mathematical models to fill the gaps in evidence*
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The Learning Healthcare System: Workshop Summary Sheldon Greenfield, University of California at Irvine Heterogeneity of treatment effects: subgroup analysis* Steve Teutsch, Merck & Co. Inc. Adjusting evidence generation to the scale of effects* Janlori Goldman, Health Privacy Project Protecting privacy while linking patient records* 12:00 Lunch 1:00 SESSION 3: NARROWING THE RESEARCH-PRACTICE DIVIDE—SYSTEM CONSIDERATIONS CHAIR: Cato Laurencin, University of Virginia and EBM Roundtable Member What system changes are needed for the healthcare delivery environment to facilitate the generation and application of better evidence? What are the needs and implications for structuring “built-in” study designs, managing the data burden, and defining appropriate levels of evidence needed? What is needed to turn clinical data into an “epidemiologic utility,” a public good? 15-minute presentations followed by discussion session Brent James, Intermountain Healthcare Feedback loops to expedite study timeliness and relevance Walter Stewart, Geisinger Health System Clinical data system structure and management for better learning Steven Pearson, America’s Health Insurance Plans Implications for standards of evidence Robert Galvin, General Electric Implications for innovation acceleration 2:30 SESSION 4: PANEL DISCUSSION—KEY BARRIERS AND PRIORITIES FOR ACTION CHAIR: Denis Cortese, Mayo Clinic and EBM Roundtable Member Members of the Roundtable on Evidence-Based Medicine
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The Learning Healthcare System: Workshop Summary DAY 2: ACCELERATING THE PROGRESS 8:30 OPENING REMARKS Denis Cortese, Mayo Clinic and EBM Roundtable Chair What are some of the key challenges and opportunities if the development of a sustainable capacity for real-time learning is to be accelerated? 9:00 SESSION 5: HINTS OF A DIFFERENT WAY—LEARNING SYSTEMS IN PROGRESS CHAIR: Jonathan Perlin, Department of Veterans Affairs and EBM Roundtable Member What experiences of healthcare systems highlight the opportunities and challenges in integrating the generation and application of evidence for improved care? What’s needed to take to scale? 15-minute presentations followed by discussion session Joel Kupersmith, Veterans Health Administration Implementation of evidence-based practice in the Veterans Administration George Isham, HealthPartners AQA (Ambulatory Care Quality Alliance) Robert Phillips, Robert Graham Center Practice-Based Research Networks Lynn Etheredge, George Washington University A rapid learning health system 10:30 SESSION 6: DEVELOPING THE TEST BED: LINKING INTEGRATED DELIVERY SYSTEMS CHAIR: Helen Darling, National Business Group on Health and EBM Roundtable Member How can integrated healthcare delivery systems be better engaged for structured real-time learning? How can the organizational, logistical, data system, reimbursement and regulatory issues be addressed? 15-minute presentations followed by discussion session Stephen Katz, National Institutes of Health (NIH) NIH Roadmap initiatives use of integrated delivery systems Cynthia Palmer, Agency for Healthcare Research and Quality Turning research to ACTION through delivery systems
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The Learning Healthcare System: Workshop Summary Eric Larson, Group Health Cooperative Health Maintenance Organization Research Network (HMORN) Michael Mustille, Permanente Federation Council of Accountable Physician Practices 12:00 LUNCH 12:30 SESSION 7: THE PATIENT AS A CATALYST FOR CHANGE CHAIR: Andrew Stern, Service Employees International Union and EBM Roundtable Member What is the changing role of the patient in an age of the Internet and the personal health record? Reengineering a system focused on patient needs and built around best care requires improved communication of evidence. How does patient preference fit into evidence development? 15-minute presentations followed by discussion session Janet Marchibroda, eHealth Initiative The Internet, eHealth, and patient empowerment Andrew Barbash, Apractis Solutions Joint patient-provider management of the electronic health record (EHR) James Weinstein, Dartmouth-Hitchcock Medical Center Evidence and shared decision making 1:35 SESSION 8: TRAINING THE LEARNING HEALTH PROFESSIONAL CHAIR: Nancy Nielsen, American Medical Association and EBM Roundtable Member What are the educational needs for the health professional in the Learning Healthcare System? How must qualification exams and continuing education be adjusted? What approaches can bring the processes of learning and application into seamless alignment? 15-minute presentations followed by discussion session Mary Mundinger, Columbia University School of Nursing Health professions education and teaching about evidence William Stead, Vanderbilt University Providers and the electronic health record as a learning tool Mark Williams, Emory University School of Medicine Redefining continuing education around evolving evidence
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The Learning Healthcare System: Workshop Summary 2:40 SESSION 9: STRUCTURING THE INCENTIVES FOR CHANGE CHAIR: John Rother, AARP and EBM Roundtable Member What policies can provide the incentives for the developments necessary to build learning—evidence development and application—into every healthcare encounter? 15-minute presentations followed by discussion session Alan Rosenberg, WellPoint Opportunities for private insurers Steve Phurrough, Centers for Medicare and Medicaid Services Opportunities for CMS Wayne Rosencrans, Jr., AstraZeneca Opportunities for manufacturers Margaret O’Kane, National Care Quality Alliance Opportunities for standards organizations 4:00 CONCLUDING SUMMARY REMARKS Denis Cortese, Mayo Clinic and EBM Roundtable Chair J. Michael McGinnis, Institute of Medicine 4:30 ADJOURN *Presentation included in workshop materials, but not delivered.
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