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THE LEARNING HEALTH SYSTEM SERIES
ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE
LEARNING WHA WORKS
T
Infrastructure Required for
Comparative Effectiveness Research
Workshop Summary
LeighAnne Olsen, Claudia Grossmann, and J. Michael McGinnis
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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 Govern-
ing Board of the National Research Council, whose members are drawn from the
councils of the National Academy of Sciences, the National Academy of Engineer-
ing, 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 Founda-
tion, 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, 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: 978-0-309-12068-5
International Standard Book Number-10: 0-309-12068-3
Additional copies of this report are available from the National Academies Press,
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or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.
nap.edu.
For more information about the Institute of Medicine, visit the IOM home page
at: www.iom.edu.
Copyright 2011 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
The serpent has been a symbol of long life, healing, and knowledge among almost
all cultures and religions since the beginning of recorded history. The serpent
adopted as a logotype by the Institute of Medicine is a relief carving from ancient
Greece, now held by the Staatliche Museen in Berlin.
Suggested citation: IOM (Institute of Medicine). 2011. Learning What Works: Infra-
structure Required for Comparative Effectiveness Research: Workshop Summary.
Washington, DC: The National Academies Press.
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“Knowing is not enough; we must apply.
Willing is not enough; we must do.”
— Goethe
Advising the Nation. Improving Health.
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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 Acad-
emy 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 engineer-
ing programs aimed at meeting national needs, encourages education and research,
and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi-
dent 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 Insti-
tute 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 Sci-
ences 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 Coun-
cil 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.
www.national-academies.org
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ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE*
Denis A. Cortese (Chair), Emeritus President and Chief Executive Officer,
Mayo Clinic; Foundation Professor, ASU
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, AstraZeneca PLC
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, Consumers Union
George C. Halvorson, Chairman and Chief Executive Officer, Kaiser
Permanente
Margaret A. Hamburg, Commissioner, Food and Drug Administration
(ex officio)
Carmen Hooker Odom, President, Milbank Memorial Fund Board
Ardis Hoven, Board Chair, American Medical Association
Brent James, Chief Quality Officer and Executive Director, Institute for
Health Care Delivery Research, Intermountain Healthcare
Michael M. E. Johns, Chancellor, Emory University
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, Stryker
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
*Formerly the Roundtable on Evidence-Based Medicine. Institute of Medicine forums and
roundtables do not issue, review, or approve individual documents. The responsibility for the
published workshop summary rests with the workshop rapporteurs and the institution.
v
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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
William D. Novelli, Former CEO, AARP; Professor, Georgetown University
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, AARP
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,
UnitedHealth Group
Frances M. Visco, President, National Breast Cancer Coalition
Workshop 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
Roundtable Staff
Christie Bell, Financial Associate
Patrick Burke, Financial Associate (until December 2009)
Andrea Cohen, Financial Associate (until December 2008)
Claudia Grossmann, Program Officer
Kiran Gupta, Research Assistant (until May 2009)
Katie Jakubs, National Institutes of Health detailee
J. Michael McGinnis, Senior Scholar and Executive Director
vi
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LeighAnne Olsen, Program Officer
Daniel O’Neill, Research Associate (until December 2008)
Stephen Pelletier, Consultant
Brian Powers, Senior Program Assistant
Valerie Rohrbach, Program Assistant
Julia Sanders, Program Assistant
Robert Saunders, Program Officer
Ruth Strommen, Intern
Leigh Stuckhardt, Program Associate
Kate Vasconi, Senior Program Assistant (until January 2011)
Pierre Yong, Program Officer (until May 2010)
Catherine Zweig, Senior Program Assistant (until June 2010)
vii
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Reviewers
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 process. We wish to thank the following individuals for
their review of this report:
Barbara Alving, National Institutes of Health
Meryl Bloomrosen, American Medical Informatics Association
Jean Paul Gagnon, sanofi-aventis
Larry A. Green, University of Colorado at Denver
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 Sam-
uel Nussbaum, Wellpoint, Inc. Appointed by the National Research Council
and the Institute of Medicine, he 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.
ix
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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 effec-
tiveness 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 effec-
tiveness 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 evi-
dence to provide the care most appropriate to each patient, emphasizes preven-
tion 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 perfor-
mance, 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 incen-
1 Formerly the Roundtable on Evidence-Based Medicine.
xi
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xx CONTENTS
Knowledge Synthesis and Translation That Need to
Be Applied, 115
Richard A. Justman
Methods That Need to Be Developed, 123
Eugene H. Blackstone, Douglas B. Lenat, and Hemant Ishwaran
Coordination and Technical Assistance That Need to Be
Supported, 144
Jean R. Slutsky
3 The Information Networks Required 153
Introduction, 153
Electronic Health Records: Needs, Status, and Costs for U.S.
Healthcare Delivery Organizations, 155
Robert H. Miller
Data and Information Hub Requirements, 163
Carol C. Diamond
Integrative Vehicles Required for Evidence Review and
Dissemination, 172
Lorne A. Becker
4 The Talent Required 191
Introduction, 191
Comparative Effectiveness Workforce—
Framework and Assessment, 192
William R. Hersh, Timothy S. Carey, Thomas Ricketts,
Mark Helfand, Nicole Floyd, Richard N. Shiffman, and
David H. Hickam
Toward an Integrated Enterprise—The Ontario, Canada, Case, 221
Danielle Whicher, Kalipso Chalkidou, Irfan Dhalla, Leslie Levin,
and Sean R. Tunis
5 Implementation Priorities 241
Introduction, 241
Information Technology Platform Requirements, 242
Mark E. Frisse
Data Resource Development and Analysis Improvement, 248
T. Bruce Ferguson, Jr., and Ansar Hassan
Practical Challenges and Infrastructure Priorities for Comparative
Effectiveness Research, 266
Daniel E. Ford
Transforming Health Professions Education, 272
Benjamin K. Chu
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xxi
CONTENTS
Building the Training Capacity for a Health Research Workforce of
the Future, 280
Steven A. Wartman and Claire Pomeroy
Public–Private Partnerships, 293
Carmella A. Bocchino, Rachel E. Behrman, and William Z. Potter
6 Moving Forward 315
Introduction, 315
The Roadmap—Policies, Priorities, Strategies, and Sequencing, 316
Common Themes in Workshop Discussions, 318
Key Factors and Needs, 323
Quick Hits—Things That Can Be Done Now, 325
Appendixes*
A Learning What Works Best: The Nation’s Need for Evidence on
Comparative Effectiveness in Health Care 333
B Comparative Effectiveness Studies Inventory Project 439
C Comparative Effectiveness Research Priorities: IOM
Recommendations (2009) 469
D Comparative Effectiveness Research Priorities: FCCCER
Recommendations (2009) 511
E Affordable Care Act (ACA) (2010) Provisions for the
Patient-Centered Outcomes Research Institute (PCORI) 519
F Workshop Agenda 541
G Biographical Sketches of Workshop Participants 549
H Workshop Attendee List 569
*Appendixes A-E are not printed in this book. They are available online at http://www.nap.
edu/catalog.php?record_id=12214.
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Abbreviations and Acronyms
AAAS American Association for the Advancement of Science
AAP American Academy of Pediatrics
AASHTO American Association of State Highway and
Transportation Officials
ACA Affordable Care Act (2010)
ACC American College of Cardiology
ACOG American Congress of Obstetricians and Gynecologists
ADHD attention deficit hyperactivity disorder
ADNI Alzheimer’s Disease Neuroimaging Initiative
AF atrial fibrillation
AHA American Heart Association or American Hospital
Association
AHC academic health center
AHIP America’s Health Insurance Plans
AHRQ Agency for Healthcare Research and Quality
AIDS acquired immunodeficiency syndrome
ALS amyotrophic lateral sclerosis
AMA American Medical Association
AMCP Academy of Managed Care Pharmacy
AMD age-related macular degeneration
AMI acute myocardial infarction
AQA Ambulatory Care Quality Alliance
ARRA American Recovery and Reinvestment Act
ASC active surveillance culturing
xxiii
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xxiv ABBREVIATIONS AND ACRONYMS
BC Biomarkers Consortium
BMI biomedical informatics
BMS bare-metal stent
CABG coronary artery bypass graft
CADTH Canadian Agency for Drugs and Technologies in Health
CARE ICDJ Querying Author about Definition
CATIE Clinical Antipsychotic Trials in Intervention Effectiveness
CCN Cardiac Care Network (Ontario)
CCR Center for Cancer Research
CDC Centers for Disease Control and Prevention
CDMS chronic disease management system
CDR Common Drug Review (Canada)
CDRH Center for Devices and Radiological Health
CDSR Cochrane Database of Systematic Reviews
CE comparative effectiveness
CEAP Committee for Assessment of Diagnostic and Therapeutic
Procedures (France)
CED coverage with evidence development
CENTRAL Cochrane Central Register of Controlled Trials
CEPP Committee for Assessment of Devices and Health
Technologies (France)
CER comparative effectiveness research
CEVG Cochrane Eyes and Vision Group
CHD coronary heart disease
CI confidence interval
CIHR Canadian Institutes of Health Research
CIS clinical information system
CMS Centers for Medicare & Medicaid Services
CMTP Center for Medical Technology Policy
CNS central nervous system
COE Center for Outcomes and Evidence
COMPUS Canadian Optimal Medication Prescribing and Utilization
Service
COPD chronic obstructive pulmonary disease
COPR Council of Public Representatives
COX cyclo oxygenase
CPI Critical Path Initiative
CPOE computerized physician order entry
CPR computer-based patient record
CPSC Consumer Product Safety Commission
CRG Cochrane HIV/AIDS review group
CRN Cancer Research Network
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xxv
ABBREVIATIONS AND ACRONYMS
CS computer science
CT computed tomography
CTSA Clinical and Translational Science Awards
CTSC Clinical and Translational Science Center
DAG directed acyclic graph
DBS deep brain stimulation
DCRI Duke Clinical Research Institute
DEcIDE Developing Evidence to Inform Decisions about
Effectiveness
DERP Drug Effectiveness Review Project
DES drug-eluting stent
DHS Department of Homeland Security
DNA deoxyribonucleic acid
DOD Department of Defense
DOE Department of Energy
DSM Diagnostic and Statistical Manual of Mental Disorders
EBM evidence-based medicine
EC executive committee
ECG electrocardiogram
EHR electronic health record
EMEA European Medicines Agency
EMR electronic medical record
EPC evidence-based practice center
EUnetHTA European Network for Health Technology Assessment
FDA Food and Drug Administration
FDAAA FDA Amendments Act of 2007
FFRDC federally funded research and development center
FNIH Foundation for the National Institutes of Health
FOMC Federal Open Market Committee
FTC Federal Trade Commission
FTE full-time equivalent
FY fiscal year
G-BA Federal Joint Committee (Germany)
GBS Guillain-Barré Syndrome
GCGH Grand Challenges in Global Health
GERD gastroesophageal reflux disease
GIN Guidelines International Network
GKS gamma knife surgery
GPRD General Practices Research Data (United Kingdom)
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xxvi ABBREVIATIONS AND ACRONYMS
GRADE Grading of Recommendations Assessment, Development,
and Evaluation Working Group
HAI hospital acquired infection
HAS Haute Autorité de Santé (France)
HCDS health care delivery system
HECS highly effective clinical services
HEI Health Effects Institute
HER2 human epidermal growth factor receptor 2
HHS Department of Health and Human Services
HIMSS Health Information Management Systems Society
HIPAA Health Insurance Portability and Accountability Act
HIT health information technology
HIV human immunodeficiency virus
HMO health maintenance organization
HMORN HMO Research Network
HQA Hospital Quality Alliance
HR hazard ratio
HRT hormone-replacement therapy
HSI Homeland Security Institute
HSR health services research
HSRProj Health Services Research Projects in Progress
HTA health technology assessment
HVI Heart and Vascular Institute
IC institute and center
ICD implantable cardiac defibrillator
ICER Institute for Clinical and Economic Review
ICES Institute for Clinical Evaluative Sciences
IDA Institute for Defense Analyses
IH international health
ILI influenza-like-illness
INHATA International Network of Agencies for Health Technology
Assessment
IOM Institute of Medicine
IQWiG Institute for Quality and Efficiency (Germany)
IRB institutional review board
ISO independent scientific organization
IT information technology
JHU Johns Hopkins University
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xxvii
ABBREVIATIONS AND ACRONYMS
LLNL Lawrence Livermore National Laboratory
LVEF left ventricular ejection fraction
MAS Medical Advisory Secretariat
MCV meningococcal conjugate vaccine
MEDCAC Medicare Evidence Development and Coverage Advisory
Committee
MedPAC Medicare Payment Advisory Commission
MI myocardial infarction
MIS management information systems
MIT Massachusetts Institute of Technology
MMA Medicare Prescription Drug, Improvement, and
Modernization Act
MOHLTC Ministry of Health and Long-Term Care (Ontario)
MRI magnetic resonance imaging
MRSA methicillin-resistant Staphylococcus aureus
MSAC Medical Services Advisory Committee (Australia)
NAE National Academy of Engineering
NANSAID non-aspirin, non-steroidal anti-inflammatory drug
NAS National Academy of Sciences
NC2D National Consortium of Clinical Databases
NCCN National Cancer Care Network
NCHRP National Cooperative Highway Research Program
NCHS National Center for Health Statistics
NCI National Cancer Institute
NDAI National Data Aggregation Initiative
NGO nongovernmental organization
NHLBI National Heart, Lung, and Blood Institute
NHS National Health Service (United Kingdom)
NICE National Institute for Health and Clinical Excellence
(United Kingdom)
NIH National Institutes of Health
NMCES National Medical Care Expenditure Survey
NNSA National Nuclear Security Administration
NRC National Research Council
NRT nicotine replacement therapy
NSAID non-steroidal anti-inflammatory drug
NSF National Science Foundation
NYHA New York Heart Association
NYU New York University
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xxviii ABBREVIATIONS AND ACRONYMS
OAI Osteoarthritis Initiative
ODE-I Office of Drug Evaluation I
OFPP Office of Federal Procurement Policy
OHSU Oregon Health and Science University
OHTAC Ontario Health Technology Assessment Committee
OS Office of the Secretary
OSD Office of the Secretary of Defense
OSTP Office of Science and Technology Policy
OTA Office of Technology Assessment
OTC over-the-counter
PACS Picture Archiving and Communication System
PATH Program for the Assessment of Technology in Health
PBAC Pharmaceutical Benefits Advisory Committee (Australia)
PCI percutaneous coronary intervention
PCORI Patient-Centered Outcomes Research Institute
PCR polymerase chain reaction
PDUFA Prescription Drug Use Fee Act
PET positron emission tomography
POC point of care
PPP public–private partnership
PSA prostate-specific antigen
PSAC Priority Setting Advisory Committee
PTSD post-traumatic stress disorder
QI quality improvement
QIO quality improvement organization
R&D research and development
RCT randomized controlled trial or randomized clinical trial
RNI radionuclide imaging
RWJF Robert Wood Johnson Foundation
S&T science and technology
SBU Swedish Council on Technology Assessment in Health
Care
SEER Surveillance, Epidemiology and End Results
SES socioeconomic status
SHRPII Strategic Highway Research Programs II
SNOMED Systematized Nomenclature of Medicine
SPARQL SPARQL Protocol and RDF Query Language
SSNDI Social Security National Death Index
SSRI selective serotonin reuptake inhibitor
STEMI ST-segment elevation myocardial infarction
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xxix
ABBREVIATIONS AND ACRONYMS
STPI Science and Technology Policy Institute
STS Society of Thoracic Surgeons
SUNY State University of New York
TAB Technology Assessment Board
TAPP transabdominal pre-peritoneal
TCA tricyclic antidepressant
TEC Technology Evaluation Center
TEP totally extraperitoneal
TGA Therapeutic Goods Administration (Australia)
THETA Toronto Health Economics and Technology Assessment
Collaboration
tPA tissue plasminogen activator
TRB Transportation Research Board
UAB University of Alabama at Birmingham
UC University of California
UMLS unified medical language system
UNC University of North Carolina
URI upper respiratory infection
USPSTF U.S. Preventive Services Task Force
USQA U.S. Quality Algorithms
USRDS U.S. Renal Data System
VA Department of Veterans Affairs
VATAP VA Technology Assessment Program
VBID value-based insurance design
VHA Veterans Health Administration
VSD Vaccine Safety Datalink
WHO World Health Organization
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