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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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