National Academies Press: OpenBook
Suggested Citation:"Front Matter." Institute of Medicine. 2011. Learning What Works: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12214.
×

THE LEARNING HEALTH SYSTEM SERIES

ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE

LEARNING WHAT WORKS

Infrastructure Required for
Comparative Effectiveness Research

Workshop Summary

LeighAnne Olsen, Claudia Grossmann, and J. Michael McGinnis

INSTITUTE OF MEDICINE
           OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Learning What Works: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12214.
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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 Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, 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 Foundation, 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, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 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: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Learning What Works: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12214.
×

Knowing is not enough; we must apply.
Willing is not enough; we must do.
”      

                                                —Goethe

image

INSTITUTE OF MEDICINE
              OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Learning What Works: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12214.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine

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 Academy 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 engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president 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 Institute 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 Sciences 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 Council 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

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Learning What Works: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12214.
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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.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Learning What Works: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12214.
×

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

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Learning What Works: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12214.
×

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)

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Suggested Citation:"Front Matter." Institute of Medicine. 2011. Learning What Works: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12214.
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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 Samuel 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.

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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 effectiveness 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 effectiveness 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 evidence to provide the care most appropriate to each patient, emphasizes prevention 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 performance, 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.

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Learning What Works: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12214.
×

tives, and misplaced patient expectations. Increasingly, it is also a result of our limited capacity for timely generation of evidence on the relative effectiveness, efficiency, and safety of available and emerging interventions. Improving the value of the return on our healthcare investment is a vital imperative that will require much greater capacity to evaluate high priority clinical interventions, stronger links between clinical research and practice, and reorientation of the incentives to apply new insights. We must quicken our efforts to position evidence development and application as natural outgrowths of clinical care—to foster health care that learns.

Approach: The IOM Roundtable on Value & Science-Driven Health Care serves as a forum to facilitate the collaborative assessment and action around issues central to achieving the vision and goal stated. The challenges are myriad and include issues that must be addressed to improve evidence development, evidence application, and the capacity to advance progress on both dimensions. To address these challenges, as leaders in their fields, 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.

Activities include collaborative exploration of new and expedited approaches to assessing the effectiveness of diagnostic and treatment interventions, better use of the patient care experience to generate evidence on effectiveness, identification of assessment priorities, and communication strategies to enhance provider and patient understanding and support for interventions proven to work best and deliver value in health care.

Core concepts and principles: For the purpose of the Roundtable activities, we define science-driven health care broadly to mean that, to the greatest extent possible, the decisions that shape the health and health care of Americans—by patients, providers, payers, and policymakers alike—will be grounded on a reliable evidence base, will account appropriately for individual variation in patient needs, and will support the generation of new insights on clinical effectiveness. Evidence is generally considered to be information from clinical experience that has met some established test of validity, and the appropriate standard is determined according to the requirements of the intervention and clinical circumstance. Processes that involve the development and use of evidence should be accessible and transparent to all stakeholders.

A common commitment to certain principles and priorities guides the activities of the Roundtable and its members, including the commitment to: the right health care for each person; putting the best evidence into practice; establishing the effectiveness, efficiency, and safety of medical care delivered; building constant measurement into our healthcare investments; the establishment of healthcare data as a public good; shared responsibility distributed equitably across stakeholders, both public and private; collaborative stakeholder involvement in priority setting; transparency in the execution of activities and reporting of results; and subjugation of individual political or stakeholder perspectives in favor of the common good.

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Suggested Citation:"Front Matter." Institute of Medicine. 2011. Learning What Works: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12214.
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Foreword

In its role as adviser to the nation to improve health, the Institute of Medicine (IOM) focuses on ensuring that Americans receive care based on the best scientific knowledge—from identifying key opportunities to better support innovation and discovery in basic research to accelerating the translation of biomedical discoveries into clinical practice and providing guidance on developing the systems and workforce to ensure delivery of the care most appropriate to each patient. In several seminal reports, the IOM has highlighted key shortfalls in the safety, quality, and effectiveness of health care delivered—shortfalls compounded by the unsustainable growth of national healthcare expenditures and the recent strains on the national and global economy. Through convening activities and consensus reports, the IOM has also sought solutions to these issues by gathering stakeholder perspectives on key barriers and opportunities for improvement and by developing recommendations for moving toward a healthcare system driven by evidence and focused on delivering care of greater value to patients.

Convened in 2006, the IOM Roundtable on Value & Science-Driven Health Care has contributed to these discussions and articulated a vision for a learning health system, in which evidence is both applied and generated as a natural course of care. The Roundtable has explored key components of such a system though its Learning Health System series of workshops and publications. A central dimension of the Roundtable’s work toward this long-term goal is expanding the capacity to meet the acute, near-term need for evidence of comparative effectiveness information. Such was the focus of the seventh workshop in the Roundtable’s Learning Health System series, Learning What Works: Infrastructure Required for Comparative Effective-

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Learning What Works: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12214.
×

ness Research. Held on July 30–31, 2008, this workshop gathered experts from across disciplines and sectors to explore the nature of the work required to develop insights on the comparative effectiveness of clinical interventions and care processes and to assess the current and needed capacity to expand and improve this work. This publication presents a summary of the workshop presentations and discussions and provides the beginnings of a roadmap for moving forward, especially important in the context of the passage of the American Recovery and Reinvestment Act (ARRA) of 2009. Included in ARRA is $1.1 billion of federal funds to increase national capacity for clinical effectiveness research, underscoring the pressing nature of the demand and the importance of developing coordinated and efficient capacity for the work needed.

I thank the members of the Roundtable staff for facilitation of Roundtable activities, as well as the sponsors, who make this work possible: the Agency for Healthcare Research and Quality, America’s Health Insurance Plans, AstraZeneca, Blue Shield of California Foundation, Burroughs Welcome Fund, California Health Care Foundation, Centers for Medicare & Medicaid Services, Charina Endowment Fund, Commonwealth Fund, Department of Veterans Affairs, Food and Drug Administration, Johnson & Johnson, sanofi-aventis, and Stryker. I would also like to offer my personal thanks to the Roundtable members themselves for their dedication.

Harvey V. Fineberg, M.D., Ph.D.
President, Institute of Medicine  

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Learning What Works: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12214.
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Preface

The Institute of Medicine’s Roundtable on Value & Science-Driven Health Care provides a trusted venue for sustained discussion and collaboration between national experts and health system stakeholders on issues important to improving the generation and application of evidence for healthcare decisions. The Roundtable has set the goal that by 2020, 90 percent of clinical decisions will reflect and be supported by accurate, timely, and up-to-date evidence. Anchoring their work toward this goal is a focus on three dimensions of the challenge:

  1. Accelerating progress toward the long-term vision of a learning health system, in which evidence is both generated and applied as a natural product of the care process.
  2. Expanding the capacity to meet the acute, near-term need for evidence of comparative effectiveness to support medical care that is most effective and produces greatest value.
  3. Improving public understanding of the nature of evidence, the dynamic character of evidence development, and the importance of insisting on medical care that reflects the best evidence.

As illustrated by previous workshops and publications in the Roundtable’s Learning Health System series, the nation’s capacity to develop information on the comparative effectiveness of clinical interventions and care processes falls far short of the need. Evidence development often fails to meet the needs of healthcare decision makers—lacking applicability to the broad patient populations encountered in clinical practice or consid-

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Learning What Works: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12214.
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eration of individual patient variation and preference. Capacity to capture and analyze clinical data relevant to point-of-care decisions is growing but remains fragmented and inefficient, often due to proprietary or privacy concerns. And systems for synthesizing, translating, and applying evidence to clinical practice remain limited.

To explore and assess the infrastructure needed (e.g., skills, workforce, methods, coordination, information networks) to expand the nation’s capacity to develop and apply comparative effectiveness information, the Roundtable convened the workshop, Learning What Works: Infrastructure Required for Comparative Effectiveness Research. Emerging from discussion at the 2-day workshop was the need for coordinated and tailored infrastructure development efforts that engage key healthcare system stakeholders—patients, providers, policy leaders, information technology experts, health services researchers, health economists, and educators, among others. The discussion highlighted key gaps in current and past work, including the fragmentation and redundancy of clinical effectiveness activities; the need to take better advantage of opportunities provided by emerging health information technologies and of established local and international capacities for evidence development, synthesis, and translation; the need to develop study designs and methods that can keep pace with the development of treatments and diagnostics and support dynamic, real-time approaches to learning; and a growing appreciation for comparative effectiveness research as a discipline, with unique workforce training and skills development needs. Also noted was the counter-productivity of the current balkanization of clinical effectiveness research investments and opportunities provided by public–private collaboration. This publication summarizes the presentations and key discussion points and is rich with insights that are important to inform needed infrastructure development.

We would like to acknowledge those individuals and organizations that donated valuable time toward the development of this workshop summary, including all present at the workshop and the workshop presenters, who not only offered valuable comments but also further developed their presentations into the manuscripts contained within this summary. We would also like to thank those who provided their counsel by serving on the planning committee for this workshop, including Stuart Altman, Ph.D. (Brandeis University); Kathy Buto, M.P.A. (Johnson & Johnson); Carolyn Clancy, M.D. (Agency for Healthcare Research and Quality); David Helms, Ph.D. (AcademyHealth); Mark McClellan, M.D., Ph.D. (Brookings Institution); Peter Orszag, Ph.D. (at the time of the workshop, Congressional Budget Office; currently, Office of Management and Budget); and John Rowe, M.D.

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(Chair) (Mailman School of Public Health, Columbia University).1 Roundtable staff, including Katharine Bothner, Lori Burns, Alex Goolsby, Kiran Gupta, Katie Jakubs, LeighAnne Olsen, Daniel O’Neill, Kate Sharaf, Ruth Strommen, and Catherine Zweig, were instrumental in coordinating the 2-day workshop in July 2008 and translating the workshop proceedings and discussion into this workshop summary. We would also like to thank Greta Gorman, Michele de la Menardiere, Abbey Meltzer, Robert Pool, Bronwyn Schrecker, Vilija Teel, Jackie Turner, and Jordan Wyndelts for helping to coordinate the various aspects of review, production, and publication.

The need to improve the effectiveness and value of health care is all the more pressing as economic disparities increase within the United States and globally. The development of methods to reduce costly system inefficiencies and waste and improve outcomes for each individual patient is integral to the sustainability of our healthcare system, and the implementation of infrastructure to support comparative clinical effectiveness research will provide a solid foundation.

 

Denis A. Cortese, M.D.

Chair, Roundtable on Value & Science-Driven Health Care

 

John W. Rowe, M.D.

Member, Roundtable on Value & Science-Driven Health Care, and Chair, Workshop Planning Committee

 

J. Michael McGinnis, M.D., M.P.P.

Executive Director, Roundtable on Value & Science-Driven Health Care

_______________

1 Institute of Medicine planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

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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

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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

Suggested Citation:"Front Matter." Institute of Medicine. 2011. Learning What Works: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12214.
×

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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×

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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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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Suggested Citation:"Front Matter." Institute of Medicine. 2011. Learning What Works: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12214.
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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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Suggested Citation:"Front Matter." Institute of Medicine. 2011. Learning What Works: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12214.
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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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It is essential for patients and clinicians to have the resources needed to make informed, collaborative care decisions. Despite this need, only a small fraction of health-related expenditures in the United States have been devoted to comparative effectiveness research (CER). To improve the effectiveness and value of the care delivered, the nation needs to build its capacity for ongoing study and monitoring of the relative effectiveness of clinical interventions and care processes through expanded trials and studies, systematic reviews, innovative research strategies, and clinical registries, as well as improving its ability to apply what is learned from such study through the translation and provision of information and decision support.

As part of its Learning Health System series of workshops, the Institute of Medicine's (IOM's) Roundtable on Value & Science-Driven Health Care hosted a workshop to discuss capacity priorities to build the evidence base necessary for care that is more effective and delivers higher value for patients. Learning What Works summarizes the proceedings of the seventh workshop in the Learning Health System series. This workshop focused on the infrastructure needs--including methods, coordination capacities, data resources and linkages, and workforce--for developing an expanded and efficient national capacity for CER. Learning What Works also assesses the current and needed capacity to expand and improve this work, and identifies priority next steps.

Learning What Works is a valuable resource for health care professionals, as well as health care policy makers.

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