The Learning Healthcare System

A Workshop of the IOM Roundtable on Evidence-Based Medicine

Keck Center of the National Academies

Room 100

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 & 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 & Quality & 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?

15 minute presentations followed by discussion session

Peter Bach, Centers for Medicare & Medicaid Services
Coverage with evidence development: Lung volume reduction surgery

Jed Weissberg, Permanente Federation
Use of large system databases: 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

10:30             Session 2: The Evolving Evidence Base—Methodologic and Policy Challenges

Chair:  Don Steinwachs, Johns Hopkins University & EBM Roundtable Member

What challenges confront methodologically rigorous learning from experience? How can alternatives to RCTs and innovative approaches to generating evidence be used to confront emerging challenges: broader post marketing surveillance; linking phase 3 and coverage requirements; increasingly complex patterns of co-morbidity; 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 & 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
Evaluating interventions in a rapid state of flux

12:00             Lunch

1:00               Session 3: Narrowing the Research-Practice Divide—System Considerations

Chair:  Cato Laurencin, University of Virginia & 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 & EBM Roundtable MemberMembers of IOM Roundtable on Evidence-Based Medicine

The Learning Healthcare System

July 20-21, 2006

Meeting Agenda

DAY 2:  Accelerating The Progress

8:30               Opening Remarks

Denis Cortese, Mayo Clinic & 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 & EBM Roundtable Member

What experiences of healthcare systems highlight the opportunities and challenges in integrating the generation and application 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 VA

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 & 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 Roadmap initiatives use of integrated delivery systems

Cynthia Palmer, Agency for Healthcare Research & Quality
Turning research to ACTION through delivery systems

Eric Larson, Group Health Cooperative
HMO Research Network-developing the T(B)EST bed

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 & 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

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 & EBM Roundtable Member

What are the educational needs for the health professional in the Learning Healthcare System? How must qualification exams and CE 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

2:40               Session 9: Structuring the Incentives for Change                       

Chair:  John Rother, AARP & 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 & 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 & EBM Roundtable Chair

J. Michael McGinnis, Institute of Medicine

4:30               Adjourn