P. 1
The Current Evidence-Based Medicine Landscape

The Current Evidence-Based Medicine Landscape

4.5

|Views: 1,789|Likes:
This reference guide identifies and documents all relevant organizations, activities, proposals, and key individuals associated with the evidence movement in the U.S., including anything of note under the rubric of evidence-based medicine (EBM), comparative effectiveness, health (or medical) technology assessment (HTA), etc.
This reference guide identifies and documents all relevant organizations, activities, proposals, and key individuals associated with the evidence movement in the U.S., including anything of note under the rubric of evidence-based medicine (EBM), comparative effectiveness, health (or medical) technology assessment (HTA), etc.

More info:

Published by: National Pharmaceutical Council on Oct 28, 2008
Copyright:Traditional Copyright: All rights reserved

Availability:

Read on Scribd mobile: iPhone, iPad and Android.
download as PDF, TXT or read online from Scribd
See more
See less

05/16/2014

pdf

text

original

Report Prepared for

:
National Pharmaceutical Council
Prepared by:
Bryan R. Luce, PhD, MBA
Rebecca Singer Cohen, MPP
Craig Hunter, MPP, PGDP
Lael Cragin, MPH
Jeanene Johnson, BA
April 2008
THE CURRENT
EVIDENCE-BASED
MEDICINE LANDSCAPE
7101 Wisconsin Avenue
Suite 600
Bethesda, MD 20814
Phone: 1-301-654-9729
Fax: 1-301-654-9864
www.UnitedBioSource.com
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 1
TABLE OF CONTENTS
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
I. GOVERNMENT INITIATIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Agency for Healthcare Research and Quality (AHRQ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
AHRQ Organizational Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
National Advisory Council for Healthcare Research and Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
U.S. Preventive Services Task Force (USPSTF) Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Evidence-Based Practice Center (EPC) Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Effective Health Care (EHC) Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Comparative Effectiveness Reviews (CERs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Centers for Education & Research on Therapeutics (CERT) Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
CMS’s Coverage with Evidence Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Coverage with Appropriateness Determination (CAD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Coverage with Study Participation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Data Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
HHS Value-Driven Health Care Initiative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
Chronic Conditions Data Warehouse (CCW) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
The Department of Defense PharmacoEconomic Center (PEC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Veterans Affairs Technology Assessment Program (VATAP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
National Institutes of Health- Clinical and Translational Science Awards (CTSA) . . . . . . . . . . . . . . . . . . . . . . .28
National Institutes of Health- Antihypertensive and Lipid Lowering Treatment to
Prevent Heart Attack Trial (ALLHAT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
National Institutes of Health- Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) . . . . . . . . .30
Centers for Disease Control and Prevention- Evaluation of Genomic Application
in Practice and Prevention (EGAPP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Oregon Health & Science University Drug Effectiveness Review Project (DERP) . . . . . . . . . . . . . . . . . . . . . . . .31
Medicaid Evidence-Based Decisions Project (MED) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Washington State Health Technology Assessment Program (SHTAP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
II. PROPOSALS FOR COMPARATIVE EFFECTIVENESS CENTERS . . . . . . . . . . . . . . . . . . . . . . . . . .34
Gail Wilensky’s Proposed Center for Comparative Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
Blue Cross and Blue Shield Association Proposed Payer-Funded Center for Comparative Effectiveness . . . . .34
Enhanced Health Care Value for All Act of 2007 (H.R. 2184) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
S.3, Medicare Prescription Drug Price Negotiation Act of 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
H.R. 3162: The Children’s Health and Medicare Protection Act of 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
Baucus/Conrad Senate bill: Introduced and Withdrawn March 4, 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Congressional Budget Office report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
III. PRIVATE INITIATIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
America’s Health Insurance Plans (AHIP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Center for Medical Technology Policy (CMTP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Institute for Clinical and Economic Review (ICER) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 2
IV. INDEPENDENT EVIDENCE-BASED MEDICINE INITIATIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Institute of Medicine (IOM) Roundtable on Evidence-Based Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
The James Lind Alliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
The Cochrane Collaboration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
ECRI Institute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Hayes, Inc. – The Health Technology Assessment Company . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
AcademyHealth Support of Comparative Effectiveness Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Academy of Managed Care Pharmacy’s Format for Formulary Submissions . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
V. CONSUMER-FOCUSED INITIATIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Consumer Reports Best Buy Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
American Association of Retired Persons (AARP) ResearchRx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
Alliance for Better Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
National Working Group on Evidence-Based Healthcare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
US Cochrane Collaboration’s Consumers United for Evidence-based Healthcare (CUE) . . . . . . . . . . . . . . . . .52
VI. MEASURING VALUE IN HEALTH CARE: Standardizing Metrics . . . . . . . . . . . . . . . . . . . . . .54
National Committee for Quality Assurance (NCQA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
The Health Plan Employer Data and Information Set (HEDIS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
Pharmacy Quality Alliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
VII. INTERNATIONAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
U.K.’s National Institute for Health and Clinical Excellence (NICE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
Canadian Agency for Drugs and Technologies in Health (CADTH) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57
Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
The International Network of Agencies for Health Technology Assessment (INAHTA) . . . . . . . . . . . . . . . . . . .58
Health Technology Assessment International (HTAi) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
The OECD Health Care Quality Indicators Project . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
VIII. EVIDENCE-BASED MEDICINE CONGRESSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
October 2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
November 2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61
January 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
February 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
March 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
April 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
May 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
June 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
July 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
August 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
September 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73
October 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74
December 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 3
January 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76
February 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
March 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78
April 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
May 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
June 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
July 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85
September 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86
October 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
November 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
March 2009 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
On-going . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89
APPENDIX A: AHRQ STAFF BIOS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90
APPENDIX B: National Advisory Council for Healthcare Research
and Quality Bios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98
APPENDIX C: U.S. Preventive Services Task Force Bios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .105
APPENDIX D: Evidence–Based Practice Center Bios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .109
APPENDIX E: Effective Health Care Program’s Stakeholder Group Bios . . . . . . . . . . . . . .126
APPENDIX F: Center for Medical Technology Policy Staff Bios . . . . . . . . . . . . . . . . . . . . . . . .135
TABLES AND FIGURES
Table 1. National Advisory Council for Healthcare Research and Quality as of April 2008 . . . . . . . . . . . . . . . .7-9
Table 2. USPSTF Members as of May 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Table 3. EPC Evidence-Based Reports in Progress as of April 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Table 4. Technology Assessments in Progress as of April 2008 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Table 5. EHC Program’s Stakeholder Group (Fall 2007 – Summer 2009) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Table 6. DERP Drug Reviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Table 6. Comparative Effectiveness Reviews (CERPS) by Priority Condition . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Table 7. EHC Programs DEcIDE Research Projects as of May 2007 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Table 7. Center for Medical Technology Policy Staff . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Table 8. AHRQ’s CERT Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Table 8. Consumers Reports Best Buy Drug Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Table 9. Members of Consumers Reports Best Buy Drugs Advisory Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
Table 10. Consumers United for Evidence-based Healthcare: 2007 Member Organizations . . . . . . . . . . . . . . .53
Table 11. Members of Pharmacy Quality Alliance Steering Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
Figure 1. AHRQ Official Organizational Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Figure 2. AHRQ Organizational Structure and Programs Related to EBM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Figure 3. Evidence-based Practice Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Figure 4. Organizational Substructure of AHRQ’s EHC Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 4
INTRODUCTION
This reference guide was developed to identify and document all relevant organizations, activities, proposals
and key individuals associated with the evidence movement in the U.S. This includes anything of note under the
rubric of evidence-based medicine (EBM), comparative effectiveness, health (or medical) technology assessment
(HTA), outcomes research, effectiveness research, etc. This identification process was accomplished via literature
review, Web exploration, word of mouth and, generally, via existing professional contacts.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 5
I. GOVERNMENT INITIATIVES
AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)
The Agency for Healthcare Research and Quality (AHRQ) was established in 1989 as the Agency for
Healthcare Policy and Research. Reauthorizing legislation, passed in November 1999, establishes AHRQ as the
lead Federal agency charged with supporting research designed to improve the quality, safety, efficiency, and
effectiveness of health care for all Americans, reduce its cost, and broaden access to essential services. To achieve
these goals, the Agency conducts and supports a broad base of scientific research and promotion of
improvements in clinical and health systems practices, including the prevention of diseases and other health
conditions. AHRQ sponsors and conducts research that develops and presents evidence-based information on
health care outcomes, quality, patient safety, cost, use and access. Included in AHRQ’s mandate is support of
synthesis and dissemination of available scientific evidence, including dissemination research and analytic
methods or systems for rating the strength of scientific evidence.
AHRQ Organizational Structure
Figure 1 shows the official organizational structure of AHRQ. Figure 2 shows the AHRQ organizational
structure and programs related to EBM.
FIGURE 1. AHRQ Official Organizational Structure
Office of the Director
Carolyn M. Clancy, MD
Director
Kathie Kendrick, RN, MS, C.S.
Deputy Director
Office of Extramural Research,
Education and Priority Populations
Francais D. Chesley, Jr., MD
Director
Directs the scientific review process for grants
and contracts, manages Agency research
training programs, evaluates the scientific
contribution of proposed and ongoing research
and demonstrations; and supports and conducts
health services research on priority populations
Center for Financing, Access,
and Cost Trends
Steven B. Cohen, PhD
Director
Conducts, supports, and manages studies
of the cost and financing of health care,
the access to health care services and
related trends. CFACT also develops
data sets to support policy and
behavioral research and analyses
Office of Communications
and Knowledge Transfer
Allan J. Lazar, MBA
Director
Designs, develops, implements, and
manages programs for disseminating
the results of Agency activites with the
goal of changing audience behavior
Office of Performance Accountability,
Resources and Technology
Jeffrey Toven
Director
Directs and coordinates Agency-wide
program planning and evaluations
activites and administrative operations.
Center for Delivery, Organization,
and Markets
Irene Fraser, PhD
Director
Provides a locus of leadership and expertise for
advances in health care delivery, organization,
and markets through research
Center for Quality Improvement
and Patient Safety
William B. Munier, MD
Director
Works to improve the quality and safety of our
health care system through research and
implementation of evidence
Center for Primary Care, Prevention,
and Clinical Partnerships
David Meyers, MD
Director
Expands the knowledge base for clinical
providers and patients and assures the
translation of new knowledge and systems
improvment into primary care practice
Center for Outcomes and Evidence
Jean R. Slutsky, PA, MSP.H
Director
Conducts and supports research and
assessment of health care, technologies,
processes, and systems
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 6
FIGURE 2. AHRQ Organizational Structure and Programs Related to EBM
Biographies of key AHRQ individuals involved in EBM are provided in Appendix A. The following sections
describe in further detail the EBM programs supported by AHRQ, including their organizational sub-structure
and key individuals.
National Advisory Council for Healthcare Research and Quality
The National Advisory Council for Healthcare Research and Quality provides advice and recommendations
to the Director of AHRQ and to the Secretary, Department of Health and Human Services (HHS), on priorities
for a national health services research agenda.
The 21-member panel is comprised of private-sector experts who contribute a varied perspective on the
health care system and the most important questions that AHRQ’s research should address in order to promote
improvements in the quality, outcomes, and cost-effectiveness of clinical practice. The private-sector members
are appointed by the Secretary, HHS, to serve 3-year terms and represent health care plans, providers, purchasers,
consumers, and researchers.
National Advisory Council for Healthcare
Research & Quality
Evidence-based Practice Centers
(EPC) Program*
Director: Kenneth Fink, MD, MGA, MPH
U.S. Preventive Services Task Force Program
Project Coordinator: Therese Miller, DrPH (AHRQ)
Reviews by: Oregon Evidence-Based Practice Center
Centers for Education & Research on
Therapeutics (CERTs) Program*
Coordination Center:
Duke University Medical Center
Director: Robert M. Califf, MD
AHRQ Program Officer:
Lynn A. Bosco, MD, MPH
U.S. Preventive Services Task Force (USPSTF)
Chair: Bruce N. Calonge, MD, MPH
Vice Chair: Diana B. Petitti, MD, MPH
Effective Health Care
(EHC) Program*
Scientific Resource Center
located at Oregon EPC
Center for Outcomes and Evidence (COE)
Director: Jean R. Slutsky, PA, MSPH
Center for Primary Care, Prevention,
& Clinical Partnerships
Director: Helen Burstin, MD, MPH
Deputy Director: David C. Lanier, MD
Agency for Healthcare Research and Quality (AHRQ)
U.S. Department of Health and Human Services
Office of the Director
Director: Carolyn M. Clancy, MD
Deputy Director: Kathie Kendrick, MS, CS, RN
* Organizational sub-structure of these EBM programs are provided in subsequent sections of report.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 7
Also serving in an ex-officio capacity are principal representatives of seven Federal agencies that address health
care system issues:
1. National Institutes of Health (NIH); the Department of Defense (Health Affairs) (DoD)
2. Centers for Disease Control and Prevention (CDC)
3. Department of Veterans Affairs (VA)
4. Office of Personnel Management (OPM)
5. Food and Drug Administration (FDA)
6. Centers for Medicare & Medicaid Services (CMS)
7. Assistant Secretary for Health
Current Members
(See Appendix B for National Advisory Council biographies.)
T A BLE 1. National Advisory Council for Healthcare Research and Quality as of April 200
Jane F. Barlow, MD,
MPH, MBA (2009)
Vice President Medical
Strategy & Clinical Quality
Medco Health Solutions, Inc.
100 Parsons Pond Drive, Mailstop
F2-16
Franklin Lakes, NJ 07417
Phone: (201) 269-3539
E-mail: jane_barlow@medco.com
Dale W. Bratzler, DO,
MPH (2008)
QIOSC Medical Director
Oklahoma Foundation for Medical
Quality, Inc.
14000 Quail Springs Parkway, Suite
400
Oklahoma City, OK 73134
Phone: (405) 840-2891 X209
Fax: (405) 840-1343
E-mail: dbratzler@okqio.sdps.org
Timothy J. Brei, MD (2009)
Clinical Assistant Professor of
Pediatrics
The James Whitcomb Riley Hospital
for Children
702 Barnhill Drive, Room 1601
Indianapolis, IN 46202-5200
Phone: (317) 274-4846
Fax: (317) 278-0126
E-mail: tbrei@iupui.edu
Patricia Flatley Brennan, PhD, RN,
FAAN, FACMI (2008)
Moehlman Professor of Nursing and
Industrial Engineering
University of Wisconsin-Madison
600 Highland Avenue H6/241
Madison, WI 53792
Phone: (608) 263-5251
Fax: (608) 263-5251
E-mail: pbrennan@engr.wisc.edu
Andrew J. Fishmann, MD, FCCP,
FACP (2009)
Director, Intensive Care Unit
Good Samaritan Hospital
California Lung Associates
1245 Wilshire Boulevard,
Suite 407
Los Angeles, CA 90017
Phone: (213) 977-4979
Fax: (213) 977-0544
E-mail: fish248@aol.com
Robert S. Galvin, MD (2010)
Director, Global Health Care
General Electric
376 Hillside Road
Fairfield, CT 06824
Phone: (203) 373-3435
robert.galvin@ge.com
TABLE 1. National Advisory Council for Healthcare Research and Quality as of April 2008
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 8
M. Carolina Hinestrosa,
M.A., MPH (2009)
Executive Vice President, Programs
and Planning
National Breast Cancer Coalition
1101 17th Street NW
Suite 1300
Washington, DC 20036
Phone: (202) 973-0575
Fax: (202) 265-6854
E-mail:
chinestrosa@stopbreastcancer.or
Ada Sue Hinshaw, PhD,
RN (2008)
2006 Nurse Scholar
National Academy of Sciences
500 Fifth Street NW
Washington, DC 20001
Phone: (202) 334-2000
E-mail: ahinshaw@nas.edu
Carlos Roberto Jaen, MD,
PhD, FAAFP (2008)
Co-Director, Center for Research in
Family Medicine and Primary Care
The Dr. John M Smith, Jr. Professor
& Chairman
Department of Family & Community
Medicine
University of Texas Health Science
Center
7703 Floyd Curl Drive
San Antonio, TX 78229-3900
Phone: (210) 567-4553
Fax: (210) 567-4579
E-mail: jaen@uthscsa.edu
Brent C. James, MD (2008)
Vice President for Medical Research
Executive Director, Institute for
Health Care Delivery Research
Intermountain Health Care
36 South State Street, 16th Floor
Salt Lake City, UT 84111-1486
Phone: (801) 442-3730
Fax: (801) 442-3486
E-mail: bjames@ihc.com
Wishwa N. Kapoor, MD,
MPH (2010)
School of Medicine
University of Pittsburgh
200 Lothrop Street,
Suite 933W-MUH
Pittsburgh, PA 15213
Phone: (412) 692-4821
E-mail: kapoorwn@upmc.edu
Munr Kazmir, MD (2008)
Founder, Direct Meds, Inc.
345 Grand Avenue
Leonia, NJ 07605
Phone: (201) 585-9234
Fax: 9202) 585-7950
E-mail: mkazmir@aol.com
TABLE 1. National Advisory Council for Healthcare Research and Quality as of April 2008
Kathleen Lohr, PhD (2010)
Distinguished Fellow,
Health Services Research
RTI International
PO Box 12194
3040 Cornwallis Road
Research Triangle Park, NC
27709-2194
Phone: (919) 541-6512
E-mail: klohr@rti.org
Thomas P. Miller, JD (2009)
American Enterprise Institute
1150 Seventeenth Street, NW
Washington, DC 20036
Phone: (202) 862-5886
Fax: (202) 828-7177
E-mail: tmiller@aei.org
Neil R. Powe, MD, MPH, MBA
(2009)
Director, Welch Center for
Prevention, Epidemiology &
Clinical Research
Professor of Medicine,
Epidemiology and Health Policy &
Management
The Johns Hopkins University
School of Medicine and Bloomberg
School of Public Health
2024 E. Monument Street,
Suite 2-600
Baltimore, MD 21287-2223
Phone: (410) 955-6953
Fax: (410) 955-0476
E-mail: npowe@jhmi.edu
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 9
U.S. Preventive Services Task Force (USPSTF) Program
The U.S. Preventive Services Task Force (USPSTF), first convened by the U.S. Public Health Service in 1984,
and since 1998 sponsored by the AHRQ, is the leading independent panel of private-sector experts in prevention
and primary care. The USPSTF conducts rigorous, impartial assessments of the scientific evidence for the
effectiveness of a broad range of clinical preventive services, including screening, counseling, and preventive
medications. Its recommendations are considered the “gold standard” for clinical preventive services.
The USPSTF is supported by the Oregon Evidence-Based Practice Center, is a collaboration between the
Oregon Health & Science University Department of Medicine, the Portland Veterans Affairs Medical Center, and
the Kaiser Permanente Center for Health Research. Under contract to AHRQ, the Oregon EPC conducts
systematic reviews of the evidence on specific topics in clinical prevention that serve as the scientific basis for
USPSTF recommendations. The USPSTF, in turn, reviews the evidence, estimates the magnitude of benefits and
harms for each preventive service, reaches consensus about the net benefit for each preventive service, and issues
a recommendation.
The USPSTF comprises primary care clinicians (e.g., internists, pediatricians, family physicians,
gynecologists/obstetricians, and nurses). Individual members’ interests include: decision modeling and
evaluation; effectiveness in clinical preventive medicine; clinical epidemiology; the prevention of high-risk
behaviors in adolescents; geriatrics; and the prevention of disability in the elderly.
AHRQ’s Center for Primary Care, Prevention, and Clinical Partnerships, which is directed by Helen Burstin
MD, MPH, oversees the USPSTF Program. Therese Miller, DrPH, serves as the USPSTF project coordinator.
Their biographies are available in Appendix A.
William Smith, PharmD, MPH,
PhD, FASHP (2010)
Executive Associate Dean
School of Pharmacy
Virginia Commonwealth University
Smith Building
Suite 155
Richmond, VA 23298-0581
Phone: (804) 828-3009
E-mail: wesmith1@vcu.edu
Myrl Weinberg, CAE (2010)
President, National Health Council
1730 M. Street, NW
Suite 500
Washington, DC 20036
Phone: (202) 785-3910
E-mail: mweinberg@nhcouncil.org
Anthony C. Wisniewski,
JD (2009)
Executive Director, Health Policy
U.S. Chamber of Commerce
1615 H Street, NW
Washington, DC 20006
Phone: (202) 463-5500
E-mail: awisniewski@uschamber.com
Michael K. Raymond, MD (2010)
Chief Medical Officer
Rush North Shore Medical Center
9600 Goss Point Road
Skokie, IL 60076
Phone: (847) 933-6007
E-mail: mraymond2@rsh.net
James J. Rohack, MD,
FACC, FACP (2008)
Senior Staff Cardiologist
Medical Director, Scott & White
Health Plan
Scott & White Clinic
2401 South 31st Street
Temple, TX 76508
Phone: (254) 724-4258
Fax: (254) 724-0720
E-mail: jrohack@swmail.sw.org
David L. Shern, PhD (2010)
President and CEO
National Mental Health Association
2600 North Beauregard Street,
6th Floor
Alexandria, VA 22311
Phone: (703) 838-7500
E-mail: dshern@nmha.org
TABLE 1. National Advisory Council for Healthcare Research and Quality as of April 2008
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 10
Current Members
(See Appendix C for USPSTF biographies.)
TABLE 2. USPSTF Members as of May 2007
Lucy N. Marion, PhD, RN
Dean and Professor, School of
Nursing
Medical College of Georgia
Augusta, GA
Bernadette Melnyk, PhD, RN,
CPNP./NPP
Dean and Distinguished Foundation
Professor in Nursing
College of Nursing & Healthcare
Innovation
Arizona State University Phoenix, AZ
Virginia A. Moyer, MD, MPH
Professor, Department of Pediatrics
Director of the Fellowship Program
in Academic General Pediatrics
Baylor College of Medicine,
Houston, TX
Associate Director of Ambulatory
Services
Texas Children’s Hospital Houston,
TX
TABLE 2. USPSTF Members as of May 2007
Bruce N. Calonge, MD,
MPH (Chair)
Chief Medical Officer and
State Epidemiologist
Colorado Department of Public
Health and Environment,
Denver, CO
Diana B. Petitti, MD, MPH (Vice
Chair)
Adjunct Professor
University of Southern California
Los Angeles, CA
Allen J. Dietrich, MD
Professor, Community and Family
Medicine
Dartmouth Medical School
Thomas G. DeWitt, MD
Carl Weihl Professor of Pediatrics
Director of the Division of General
and Community Pediatrics
Department of Pediatrics,
Children’s Hospital Medical Center
Cincinnati, OH
Kimberly D. Gregory, MD, MPH
Director, Maternal-Fetal Medicine
and Women’s Health Services
Research
Cedars-Sinai Medical Center
Los Angeles, CA
David Grossman, MD
Medical Director, Preventive Care
and Senior Investigator, Center for
Health Studies, Group Health
Cooperative
Professor of Health Services and
Adjunct Professor of Pediatrics
University of Washington Seattle,
WA
George Isham, MD, MS
Medical Director and Chief Health
Officer
HealthPartners
Minneapolis, MN
Michael L. LeFevre, MD, MSPH
Professor, Department of Family and
Community Medicine
University of Missouri School of
Medicine
Columbia, MO
Rosanne Leipzig, MD, PhD
Professor, Geriatrics and Adult
Development, Medicine,
Health Policy
Mount Sinai School of Medicine
Judith K. Ockene, PhD, MEd
Professor of Medicine
University of Massachusetts Medical
School
Worcester, MA
George F. Sawaya, MD
Associate Professor
Department of Obstetrics,
Gynecology, and Reproductive
Sciences
Department of Epidemiology and
Biostatistics
University of California
San Francisco. CA
J. Sanford (Sandy) Schwartz, MD
Leon Hess Professor of Medicine,
Health Management, and
Economics
University of Pennsylvania School of
Medicine and Wharton School
Philadelphia, PA
Timothy Wilt, MD, MPH
Professor, Department of Medicine,
Minneapolis VA Medical Center
University of Minnesota
Minneapolis, MN
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 11
These topics are being reviewed by the U.S. Preventive Services Task Force:
• Additional Risk Factors for Intermediate CHD Risk
• Aspirin Use for the Primary Prevention of CHD
• Aspirin Use to Prevent Preeclampsia
• Asymptomatic Bacteriuria
• Breastfeeding
• Breast Cancer Screening
• Cervical Cancer Screening
• Colorectal Cancer Screening
• Counseling to Prevent Sexually Transmitted Infections
• Depression in Adults
• Depression in Children and Adolescents
• Diabetes Mellitus
• Falls in Older Adults
• Folic Acid Supplementation
• Gestational Diabetes
• Hearing Impairment, Older Adults
• Hearing, Newborn
• Lipid Disorders in Adults (Cholesterol Abnormalities, Dyslipidemia)
• Osteoporosis Screening
• Osteoporosis Preventive Medicine
• Ovarian Cancer
• Prostate Cancer Screening
• Skin Cancer Counseling
• Skin Cancer Screening
• Visual Impairment in Older Adults
• Vitamin Supplements to Prevent Cancer and CHD
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 12
Evidence-Based Practice Center (EPC) Program
Under the Evidence-based Practice Center (EPC) Program of AHRQ, launched in 1997 to synthesize existing
scientific literature about important health care topics and promote evidence-based practice and decision-
making, 5-year contracts are awarded to institutions in the United States and Canada to serve as EPCs. The EPCs
develop evidence reports and technology assessments on topics relevant to clinical, social science/behavioral,
economic, and other health care organization and delivery issues — specifically those that are common,
expensive, and/or significant for the Medicare and Medicaid populations. These reports are used for informing
and developing coverage decisions, quality measures, educational materials and tools, guidelines, and research
agendas. Topics are nominated by non-federal partners such as professional societies, health plans, insurers,
employers, and patient groups. The EPCs also conduct research on methodology of systematic reviews.
AHRQ’s Center for Outcomes and Evidence (COE), directed by Jean Slutsky, PA, MSPH, oversees the EPC
Program. Beth Collins Sharp, PhD, RN, serves as Director of the EPC Program. See Appendix A for their
biographies.
The following figure lists the 14 EPCs that comprise AHRQ’s Evidence-Based Practice Center Program as well
as the director(s) of each EPC. See Appendix D for biographies for each of the EPC directors and co-directors,
if applicable.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 13
FIGURE 3. Evidence-based Practice Centers
* Three EPCs (Duke University, ECRI, and Tufts University) focus on technology assessments for CMS.
† The Oregon EPC focuses on evidence reports for the U.S. Preventive Services Task Force (USPSTF).
‡ Three EPCs (Duke University, Johns Hopkins University, and RTI International—University of North Carolina at Chapel Hill) also serve as DEcIDE Research Centers as
part of the Effective Health Care Program, discussed in a subsequent section.
Blue Cross and Blue Shield Association,
Technology Evaluation Center
Director: Naomi Aronson, PhD
Duke University * ‡
Director: David B. Matchar, MD
Head: Douglas McCrory, MD
RTI International —
University of North Carolina at Chapel Hill
††
Co-Director: Kathleen N. Lohr, PhD (RTI)
Co-Director: Timothy S. Carey, MD, MPH (UNC)
Oregon Evidence-Based Practice Center †
(collaboration between OHSU School of Medicine,
the Portland Veterans Affairs Medical Center, and the
Kaiser Permanente Center for Health Research)
Director: Mark Helfand, MD, MS, MPH
University of Connecticut
Co-Director: C. Michael White, PharmD
Co-Director: Craig Coleman, PharmD
Southern California Evidence-Based Practice Center-
RAND
Director: Paul Shekelle, MD, PhD
Vanderbilt University
Director: Katherine E. Hartmann, MD, PhD
Assoc. Director for Methods: Sandra Micucci, MSC
Tufts University — New England Medical Center *
Director: Joseph Lau, MD
University of Minnesota, Minneapolis, MN
Director: Robert L. Kane, MD
McMaster University
Director: Parminder Raina, PhD
ECRI *
Director: Karen Schoelles, MD, SM
Principal Investigator: Vivian H. Coates, MBA
University of Alberta, Canada
Director: Terry P. Klassen, MD, MSc
Associate Director: Brian H. Rowe, MD, MSc
Associate Director: Donna Dryden, PhD
Co-Director: Lisa Hartling, BScPT, MSc
Johns Hopkins University ‡
Director: Eric B. Bass, MD, MPH
Co-Director: Neil R. Powe, MD, MPH, MBA
Co-Director: Karen A. Robinson, MSc
University of Ottawa, Ottawa, Canada
Director: David Moher, PhD
Coordinator: Chantelle Garritty
AHRQ’s Evidence-based Practice Center
(EPC) Program
Director: Kenneth Fink, MD, MGA, MPH
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 14
EPC Evidence-Based Reports
The EPCs develop evidence reports and technology assessments based on rigorous, comprehensive syntheses
and analyses of the scientific literature on topics relevant to clinical, social science/behavioral, economic, and
other health care organization and delivery issues. EPC reports and assessments emphasize explicit and detailed
documentation of methods, rationale, and assumptions. These scientific syntheses may include meta-analyses
and cost analyses. All EPCs collaborate with other medical and research organizations so that a broad range of
experts is included in the development process.
The resulting evidence reports and technology assessments are used by federal and state agencies, private
sector professional societies, health delivery systems, providers, payers, and others committed to evidence-based
health care. In addition, the EPCs undertake methods research, update prior evidence reports, and provide
technical assistance to professional organizations, employers, providers, policymakers, etc. to facilitate translation
of the reports into quality improvement tools, evidence-based curricula, and reimbursement policies.
The following two tables list the evidence-based reports and technology assessments in progress.
Disease Area Evidence-Based Report
Cancer and Blood Disorders HER2 Testing to Manage Patients with Breast or Other Solid Tumors
(mid 2008)
Financing Regulation of Healthcare, Costs (mid 2008)
Heart and Vascular Diseases Erectile Dysfunction, Diagnosis and Treatment (mid 2008)
Information Technology Barriers and Drivers of Health IT Use for the Elderly, Chronically Ill,
and Underserved (late 2008)
Metabolic, Nutritional, and Nutrition (mid 2008)
Endocrine Conditions
Obstetric and Gynecologic Conditions Adverse Maternal & Child Health Outcomes Associated with Maternal
Weight Gain (mid 2008)
Assisted Reproductive Technology, Effectiveness and Efficiency (mid 2008)
Bariatric Surgery in Women of Reproductive Age (mid 2008)
Elective Induction of Labor (mid 2008)
Oral and Gastrointestinal Disorders Management of Chronic Hepatitis B (late 2008)
Pediatric Adverse Maternal & Child Health Outcomes Associated with Maternal
Weight Gain (mid 2008)
Effectiveness of Weight Reduction Programs in Children (mid 2008)
TABLE 3. EPC Evidence-Based Reports in Progress as of April 2008
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 15
Effective Health Care (EHC) Program
The Effective Health Care (EHC) Program is a new program authorized under Section 1013 of the Medicare
Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. The essential goals of the Section
1013 mandate are to develop evidence on the comparative effectiveness of different treatments and appropriate
clinical approaches to difficult health problems. To achieve these goals, AHRQ has begun to support projects
(via the EHC program) that review, synthesize and translate published and unpublished scientific evidence, as
well as identify important issues for which existing scientific evidence is insufficient to inform decisions about
health care.
Supporting the EHC Program as a whole is the Scientific Resource Center. Located at the Oregon EPC (a
collaboration of Oregon Health & Science University—Department of Medical Informatics and Clinical
Epidemiology, the Portland Veterans Affairs Medical Center, and the Kaiser Permanente Center for Health
Research) and directed by Mark Helfand, MD, the Scientific Resource Center has specific responsibilities to:
• Communicate with stakeholders.
• Assist with the development of key questions and research topics.
• Coordinate peer review and public input for comparative effectiveness reviews.
• Support the methodological work of effectiveness reviews and research projects.
The EHC Program’s primary principle is that all stakeholders should have the best available evidence on
which to make decisions about health care items and services. They should be active participants and partners
in these efforts. Therefore, a Stakeholder Group was established to support the program in collaboration with
the Scientific Resource Center. The volunteer group represents several broad constituencies of stakeholders,
including clinicians, researchers, third-party payers, consumers of federal and state beneficiary programs, and
health care industry professionals. The Stakeholder Group’s role is to:
• Provide input on research information gaps for practice and policy and the key research questions
addressing these gaps.
Technology Assessment
• Discharge Planning: Effectiveness of Discharge Planning in Patients with Heart Failure
• Focused Reviews on Selected Gene Tests for Cancer and Noncancer Conditions
• Health and Behavior Assessment/Intervention for the Management of Physical Health Problems — Cancer Pain
• Horizon Scan: Clinical Trials Enrollment and Third Party Payment
• Horizon Scan: Lipoprotein Subfractions for Identifying Patients at Increased Risks for Cardiovascular Diseases
• Peripheral Artery Stenting
• Pulmonary Artery Catheterization
• Quality, Regulation and Clinical Utility of Laboratory-developed Tests
• Spinal Fusion for the Treatment of Low Back Pain Secondary to Lumbar Degenerative Disc Disease
• Targeted Therapies for Cancer
• Use of Bayesian Techniques in Randomized Clinical Trials: A CMS Case Study
TABLE 4. Technology Assessments in Progress as of April 2008
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 16
• Review public input and participate in topic and key question development and refinement in collaboration
with the Scientific Resource Center.
• Provide input on implementation issues for EHC Program reports.
• Provide input on issues of methodology for synthesis, research, and translation of effectiveness evidence.
The following table presents the current members of the Stakeholder Group.* These members serve a two-year
term, Fall 2007 to Summer 2009.
Peter Juhn, MD, MPH
Vice President, Evidence and Regulatory Policy,
Johnson & Johnson
Dick Justman, MD
National Medical Director of United Healthcare
TABLE 5. EHC Program’s Stakeholder Group (Fall 2007 – Summer 2009)
Darrell R. Abernethy, MD, PhD
Chief Science Officer at the United States
Pharmacopeia
Wade M. Aubry, MD
Associate Director of the Center for Medical
Technology Policy and Senior Medical Advisor to the
California Technology Assessment Forum
Jennifer L. Bright, MPA
Executive Director, Society for Healthcare Epidemiology
of America (SHEA) and Founder, National Working
Group on Evidence-Based Healthcare
W. Gary Erwin, PharmD
Senior Vice President, Professional Services, Omnicare,
Inc., and President, Omnicare Senior Health Outcomes
Patricia M. Hart, MD, FACP
Private Practice, Brooklyn, New York
Maria Carolina Hinestrosa, MA, MPH
Executive Vice President for Programs and Planning at
the National Breast Cancer Coalition, and Co-founder
of Nueva Vida
Sharon Levine, MD
Associate Executive Director, The Permanente Medical
Group, Inc.
David B. Lorber, MD
Vice President of Medical Affairs for Caremark
Alan B. Rosenberg, MD
Vice President of Medical Policy, Technology
Assessment and Credentialing Programs for
WellPoint, Inc.
Eric M. Wall, MD, MPH
Senior Medical Director of Qualis Health
Anthony C. Wisniewski, Esq
Executive Director for Health Care at the U.S. Chamber
of Commerce
Doris H. Lotz, MD, MPH
Medicaid Medical Director for the State of New
Hampshire
George Lundberg, MD
Editor in Chief of MedGenMed,
Editor in Chief of Medscape Core,
and Editor in Chief of eMedicine
Newell McElwee, PharmD, MSPH
Vice-President of Evidence-Based Strategies at Pfizer
G. Gregory Raab, MA, PhD
President, Raab & Associates, Inc.
* See Appendix E for EHC’s Stakeholder Group biographies.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 17
The Secretary of HHS has established a list of 10 priority conditions relevant to the Medicare population to
be addressed by the EHC program. These priority conditions were selected by a steering committee comprised
of representatives from AHRQ, the Centers for Medicare & Medicaid Services, the Food and Drug
Administration, and the HHS Office of the Secretary. The priority conditions identified for study are:
• Arthritis and nontraumatic joint disorders (Muscle, bone, and joint conditions)
• Cancer (Cancer)
• Chronic obstructive pulmonary disease and asthma (Breathing conditions)
• Dementia including Alzheimer’s disease (Brain and nerve conditions)
• Depression and other mood disorders (Mental health)
• Diabetes mellitus (Diabetes)
• Ischemic heart disease (Heart and blood vessel conditions)
• Peptic ulcer disease and dyspepsia (Digestive system conditions)
• Pneumonia (Breathing conditions)
• Stroke and hypertension (Heart and blood vessel conditions)
Future reviews will address issues related to Medicaid and the State Children’s Health Insurance Program, in
addition to Medicare.
The organizational sub-structure of AHRQ’s EHC program is presented in the following figure.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 18
FIGURE 4. Organizational Substructure of AHRQ’s EHC Program
Comparative Effectiveness Reviews (CERs)
AHRQ created Evidence-based Practice Centers (EPCs) in 1997 to synthesize existing scientific literature
about important health care topics and promote evidence-based practice and decision-making. The expertise of
the EPCs is now also used for Comparative Effectiveness Reviews (CERs) on medications, devices, and other
relevant interventions. These reviews use a research methodology that systematically and critically appraises
existing research to synthesize knowledge on a particular topic. An important aspect of the Comparative
Effectiveness Reviews is the identification of research gaps, as well as recommendations for studies and
approaches to fill those gaps.
The following table presents studies in progress or completed as of May 2007.
* Refer to Section 2.4 for
a list of AHRQ’s EPCs.
† Three DEcIDE
Research Centers
(Duke University,
Johns Hopkins
University, and
RTI International) also
serves as EPCs.
DEcIDE=Developing
Evidence to Inform
Decisions about
Effectiveness
DEcIDE Research Network
Scientific Resource Center
Location: Oregon EPC
Director: Mark Helfand, MD
Stakeholders Group
Vanderbilt University Medical Center,
Nashville, TN
PI: Marie R. Griffin, MD
Acumen, LLC, Burlingame, CA
PI: Thomas E. MaCurdy, PhD
Brigham and Women’s Hospital, Boston, MA
PI: Sebastian Schneeweiss, MD
Duke University, Durham, NC

PI: David B. Matchar, MD
Outcome Sciences, Cambridge, MA
PI: Richard E. Gliklich, MD
University of Maryland – Baltimore
PI: Bruce C. Stuart, PhD
University of North Carolina at Chapel Hill
PI: Suzanne L. West, PhD
Johns Hopkins University, Baltimore, MD †
PI: Albert W. Wu, MD
RTI International, Research Triangle Park, NC

PI: Kathleen Lohr, PhD
University of Illinois-Chicago
PI: Glen T. Schumock, PharMD
Harvard Pilgrim Health Care,
Harvard Medical School, Boston, MA
PI: Richard Platt, MD
University of Pennsylvania School of Medicine,
Philadelphia, PA
PI: Sean Hennessy, PharmD, PhD
University of Colorado at Denver and Health
Sciences Center, Aurora, CO
PI: John F. Steiner, MD
EPCs*
Comparative Effectiveness
Reviews (CER)
AHRQ’s Effective Health Care Program
John M. Eisenberg Clinical
Decisions & Communications
Science Center
Director: David Hickam, MD
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 19
TABLE 6. Comparative Effectiveness Reviews (CERs) by Priority Condition
Priority Condition Comparative Effectiveness Review Status
Cancer Comparative Effectiveness and Safety of Radiotherapy Treatments In progress
for Head and Neck Cancer
Comparative Effectiveness of Chemotherapy Agents in the Prevention In progress
of Primary Breast Cancer in Women
Comparative Effectiveness of Therapies for Clinically Localized Completed
Prostate Cancer
Core Needle Breast Biopsy and Surgical Excision Biopsy for Diagnosing In progress
Breast Lesions
Comparative Effectiveness of Epoetin and Darbepoetin for Managing Completed
Anemia in Patients Undergoing Cancer Treatment
Effectiveness of Noninvasive Diagnostic Tests for Breast Abnormalities Completed
Technical Brief: Particle Beam Radiation Therapies for Cancer In progress
Diabetes Comparative Effectiveness and Safety of Oral Diabetes Medications Completed
for Adults With Type 2 Diabetes
Comparative Effectiveness, Safety, and Indications of Insulin Analogues In progress
in Premixed Formulations for Adults with Type 2 Diabetes
Digestive system Comparative Effectiveness of Management Strategies for Completed
conditions Gastroesophageal Reflux Disease
Heart and blood Comparative Effectiveness of Combinations of Lipid-Modifying Agents In progress
vessel conditions
Comparative Effectiveness of Medical Therapies for Stable Ischemic In progress
Heart Disease
Comparative Effectiveness of Management Strategies for Completed
Renal Artery Stenosis
Comparative Effectiveness of Percutaneous Coronary Interventions Completed
and Coronary Artery Bypass Grafting for Coronary Artery Disease
Effectiveness and Off-label Use of Recombinant Factor VIIa In progress
Comparative Effectiveness of Angiotensin-Converting Enzyme Completed
Inhibitors (ACEIs) and Angiotensin II Receptor Antagonists (ARBs)
for Treating Essential Hypertension
Effectiveness of Radiofrequency Catheter Ablation (RFA) for Atrial Fibrillation In progress
Mental health Comparative Effectiveness of Second-Generation Antidepressants Completed
in the Pharmacologic Treatment of Adult Depression
Efficacy and Comparative Effectiveness of Off-Label Use of Atypical Completed
Antipsychotics
Muscle, bone, Comparative Effectiveness of Drug Therapy for Rheumatoid Arthritis and Completed
joint conditions Psoriatic Arthritis in Adults
Comparative Effectiveness of Treatments To Prevent Fractures in Men and Completed
Women With Low Bone Density or Osteoporosis
Comparative Effectiveness and Safety of Analgesics for Osteoarthritis Completed
Research DRAFT: Methods Reference Guide for Effectiveness and Comparative In progress
methodology Effectiveness Reviews
TABLE 6. Comparative Effectiveness Reviews (CERs) by Priority Condition as of May 2007
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 20
Developing Evidence to Inform Decisions about Effectiveness: DEcIDE Research Centers
A new network of 13 Developing Evidence to Inform Decisions about Effectiveness research centers (referred
to as DEcIDE) will carry out accelerated studies, including research aimed at filling knowledge gaps about
treatment effectiveness. Operating under strict procedures to guarantee privacy and security, DEcIDE centers
will use de-identified data available through insurers, health plans and other partner organizations to answer
questions about the use, benefits and risks of medications and other therapies. Collectively, the DEcIDE centers
will have access to de-identified medical data for millions of patients, including Medicare’s 42 million
beneficiaries. Initial research focuses on the outcomes of prescription drug use and other interventions for which
randomized controlled trials would not be feasible or timely, or would raise ethical concerns that are difficult to
address. Other DEcIDE network projects may focus on electronic registries, methods for analyzing health
databases, and prospective observational or interventional studies. The following table lists the DEcIDE projects
in progress or completed as of May 2007.
TABLE 6. Comparative Effectiveness Reviews (CERs) by Priority Condition
Priority Condition DEcIDE Research Projects Status
Brain and nerve Methods for Studying Dementia Treatment and Outcomes in In progress
conditions Observational Databases
Breathing Community Pharmacy/Call Center Assessment of Medication In progress
conditions Effectiveness & Safety
Comparative Effectiveness of Anticholinergic Medications in Patients with In progress
Chronic Obstructive Pulmonary Disease (COPD)
Comparative Effects of Classes of Antidepressants on the Risk of In progress
Aspiration Pneumonia in the Aged
Outcomes of COPD Management In progress
Cancer Testing Cancer Quality Measures for End of Life Care In progress
Advancing Research Methodology for Measuring and Monitoring In progress
Patient-Centered Communications in Cancer Care
Diabetes Comparative Effectiveness and Safety of New Therapies for Glucose In progress
Control in Diabetes Mellitus
Digestive system Comparative Safety of NSAIDs with Gastroprotective Therapy In progress
conditions
Heart and blood Comparable Effectiveness of B-Adrenergic Antagonists on the Risk of
vessel conditions Rehospitalization in Adults with Diagnosed Heart Failure In progress
Medical Management of Congestive Heart Failure and the Effectiveness In progress
of Isosorbide Dinitrate and Hydralazine
Treatment of In-Stent Restenosis In progress
Research on Optimal Second-Line Therapy for Hypertension In progress
A Multicenter, Observational Cohort Study to Assess the Cardiovascular In progress
Risks of Medications Prescribed for Attention Deficit Hyperactivity Disorder
A Qualitative Study to Understand Barriers to Conducting Cluster In progress
Randomized Trials
TABLE 7. EHC Program’s DEcIDE Research Projects as of May 2007
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 21
TABLE 6. Comparative Effectiveness Reviews (CERs) by Priority Condition
Heart and blood Development of a Software Tool for Obtaining Doubly Robust Estimate In progress
vessel conditions of Treatment Effects
Development of Statistical Estimators to Address Questions of In progress
Comparative Effectiveness in Elderly Heart Failure Patients
Mental health Comparative Effects of Classes of Antidepressants on the Risk of
Aspiration Pneumonia in the Aged In progress
Comparative Safety of Conventional and Atypical Antipsychotic
Medications: Risk of Death in British Columbia Seniors Completed
A Multicenter, Observational Cohort Study to Assess the Cardiovascular In progress
Risks of Medications Prescribed for Attention Deficit Hyperactivity Disorder
A Qualitative Study to Understand Barriers to Conducting Cluster In progress
Randomized Trials
Muscle, bone, Comparative Safety of NSAIDs with Gastroprotective Therapy In progress
and joint disorders
Assessment of Factors Modulating Treatment Outcomes of In progress
Rheumatoid Arthritis
Adaptation of Data Mining Algorithms Assessing the Comparative In progress
Effectiveness and Safety of NSAIDs
Research Emerging Methods in Comparative Effectiveness and Safety - Completed
methodology Medical Care Supplement
Registries for Evaluating Patient Outcomes: Completed
A User’s Guide
Survey of Medicare Part D Plans’ Medication Therapy Completed
Management Programs
A Qualitative Study to Understand Barriers to Conducting Cluster In progress
Randomized Trials
Adaptation of Data Mining Algorithms Assessing the Comparative In progress
Effectiveness and Safety of NSAIDs
Assessing the Validity of Administrative Data Using Clinical In progress
Medical Records
Community Pharmacy/Call Center Assessment of Medication In progress
Effectiveness & Safety
Data Development for Patient Safety – A Pilot Study using Medicare In progress
Part B Drug Data
Developing a Distributed Research Network to Conduct Population-based In progress
Studies and Safety Surveillance
Development and Validation of Instrumental Variable Methods for In progress
Effectiveness Research
Development of a Software Tool for Obtaining Doubly Robust Estimate In progress
of Treatment Effects
Development of Statistical Estimators to Address Questions of In progress
Comparative Effectiveness in Elderly Heart Failure Patients
Distributed Network for Ambulatory Research in Therapeutics In progress
TABLE 7. EHC Program’s DEcIDE Research Projects as of May 2007
Priority Condition DEcIDE Research Projects Status
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 22
John M. Eisenberg Clinical Decisions and Communications Science Center
The John M. Eisenberg Clinical Decisions and Communications Science Center (Eisenberg Communications
Center), named after the former director of AHRQ, was established on October 1, 2005, and is directed by David
H. Hickam, MD. As scientific evidence about effectiveness is synthesized by the EHC program and generated by
the DEcIDE network, the Eisenberg Communications Center will, in turn, translate the scientific knowledge into
targeted products for all stakeholders — including patients, providers, and policymakers. Stakeholders can use
this knowledge to maximize benefits from their health care, minimize harm, and optimize the use of health care
resources. The Eisenberg Communications Center will take a systematic approach to translate knowledge about
effective health care into understandable, actionable language for all decision-makers. An important function of
the Center is to present the often complex scientific information in a format that stakeholders and the public can
easily understand. It also will conduct its own program of research into effective communication of research
findings in order to improve usability and rapid incorporation of findings into medical practice.
The core staff of the Eisenberg Communications Center is located at Oregon Health & Science University in
Portland, Oregon. Other organizations that participate in the work of the Eisenberg Center include American
Institutes for Research (AIR), Decision Research, Inc., Oregon State University College of Pharmacy, Rhode
Island Hospital, Rochester University, and the University of Oregon.
Centers for Education & Research on Therapeutics (CERT) Program
The Centers for Education and Research on Therapeutics (CERTs) program, established in 1999, is a national
initiative to conduct research and provide education that advances the optimal use of therapeutics (i.e., drugs,
medical devices, and biological products). The program consists of seven research centers and is administered
as a cooperative agreement by AHRQ, in consultation with the U.S. Food and Drug Administration (FDA). Each
center focuses on therapies used in a particular patient population or therapeutic area. These seven centers, a
Coordinating Center, a Steering Committee, and numerous partnerships with public and private organizations
make up the CERTs program. The following table presents the seven centers, their emphasis, and principal
investigators.
TABLE 6. Comparative Effectiveness Reviews (CERs) by Priority Condition
Research Medicare Prescription Drug Data Development: Methods for In progress
methodology Improving Patient Safety and Pharmacovigilance Using Observational Data
Needs Assessment to Establish an Infrastructure for Monitoring the In progress
Utilization and Outcomes of Gene-Based Applications in the
United States Health Care System
Research and Surveillance Methods for Improving Medication Safety In progress
Using Administrative Claims Databases
Testing Cancer Quality Measures for End of Life Care In progress
TABLE 7. EHC Program’s DEcIDE Research Projects as of May 2007
Priority Condition DEcIDE Research Projects Status
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 23
The CERTs receive funds from both public and private sources, with AHRQ providing core financial support.
The research conducted by the CERTs program has three major aims:
1. To increase awareness of both the uses and risks of new drugs and drug combinations, biological products,
and devices, as well as of mechanisms to improve their safe and effective use.
2. To provide clinical information to patients and consumers; health care providers; pharmacists, pharmacy
(HMOs) and health care delivery systems; insurers; and government agencies.
3. To improve quality while reducing cost of care by increasing the appropriate use of drugs, biological
products, and devices and by preventing their adverse effects and the consequences of these effects (such as
unnecessary hospitalizations).
CERT Centers Emphasis Principal Investigators
Duke University Medical * Therapies for disorders of the heart and Eric Peterson, MD, MS
Center blood vessels
HMO Research Network Drug use; safety and effectiveness studies in Richard Platt, MD, MSc
health maintenance organization populations
University of Alabama Therapies for musculoskeletal disorders Kenneth G. Saag, MD,
at Birmingham MSc
University of Arizona Reduction of drug interactions that result in Raymond L. Woosley, MD,
Health Sciences Center harm to women PhD
University of North Carolina Therapies for children Alan D. Stiles, MD
at Chapel Hill
University of Pennsylvania Therapies for infection; antibiotic drug resistance Brian L. Strom, MD, MPH
School of Medicine
Vanderbilt University Prescription drug use in a Medicaid population Wayne A. Ray, PhD
Medical Center
Rutgers, The State University Safe and effective use of treatments for Stephen Crystal, PhD
of New Jersey mental health problems
University of Iowa Safety and effectiveness of medication use Elizabeth A. Chrischilles,
among the elderly MS, PhD
Baylor College of Medicine Consumers and strategies to help patients Maria E. Suarez-Almazor,
take prescription medications appropriately MD, PhD
Weill Cornell Medical Center Medical devices Alvin I. Mushlin, MD, ScM
University of Chicago Clinical and economic issues in hospital settings David Meltzer, MD, PhD
Brigham and Women’s Hospital Health information technology David Bates, MD, MSc
Cincinnati’s Children’s Pediatric therapeutics Carole Lannon, MD, MPH
Hospital Medical Center
University of Illinois at Chicago Tools for optimizing prescribing Bruce L. Lambert, PhD
TABLE 8. AHRQ’s CERT Centers
* The Duke University Medical Center also serves as the Coordinating Center, which is directed by Robert M. Califf, MD
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 24
The CERTs concept grew out of recognition that, while pharmaceuticals and other medical products improve
the lives of many patients, underuse, overuse, adverse events, and medical errors may cause serious impairment
to patient health. The following gaps in knowledge remain:
• Limited comparative information exists on the risks, benefits, and interactions of both new and older agents.
• Health professionals need guidance on the appropriate, cost-effective use of therapeutics that will, in turn,
lead to improved outcomes, error reduction, and prevention of adverse events.
The CERTs Coordinating Center is located at Duke University Medical Center. Directed by Robert M. Califf,
MD, the Coordinating Center helps support the work of the research centers by enhancing cross-center synergy
and disseminating findings from the research conducted by the centers.
A Steering Committee, organized by the Coordinating Center, serves in an advisory capacity to the CERTs
program. Steering Committee members include representatives from each center, the Federal Government
(AHRQ, FDA, and currently the Centers for Medicare & Medicaid Services), the private sector, and consumer
groups. In addition, work groups of representatives from all centers address broad issues related to the CERTs
effort, such as public-private partnerships.
AHRQ’s Center for Outcomes and Evidence oversees the CERTs program and provides technical assistance
and research support. Lynn A. Bosco, MD, MPH, serves as the Program Officer. See Appendix A for her
biography.
CMS’S COVERAGE WITH EVIDENCE DEVELOPMENT
On July 12, 2006, CMS released new guidance entitled “National Coverage Determinations with Data
Collection as a Condition of Coverage: Coverage with Evidence Development”. The guidance describes the
national coverage determinations (NCDs) that include, as a condition of payment, the development and
capture of additional patient data to supplement standard claims data. According to CMS, “The purpose of
CED is to generate data on the utilization and impact of the item or service evaluated in the NCD, so that
Medicare can a) document the appropriateness of use of that item or service in Medicare beneficiaries under
current coverage; b) consider future changes in coverage for the item or service; c) generate clinical information
that will improve the evidence base on which providers base their recommendations to Medicare beneficiaries
regarding the item or service.”
CMS performs evaluations to determine whether they can obtain conclusive answers to assessment questions
specific to the process of the evidence evaluation and whether the investigational item or service will result in
improved patient outcomes. This assessment takes the following three factors into account: 1) the quality of the
individual studies; 2) the relevance of findings from individual studies to the Medicare population; and 3)
overarching conclusions that can be drawn from the body of the evidence about the direction and magnitude of
the risks and benefits of the item or service under investigation. As such, CMS applies coverage with evidence
development in two ways: coverage with appropriateness determination (CAD) and coverage with study
participation (CSP).
Coverage with Appropriateness Determination (CAD)
In the application of CAD, CMS may determine that the evidence for an item or service being evaluated is
adequate to deem it reasonable and necessary, but that additional clinical data is needed that is not routinely
available on claims forms to ensure that the item or service is being provided to appropriate patients in the
manner described in the NCD. The extra data supplements the information that is routinely gathered by
providers through claims. For the most part, providers will submit extra data to databases or registries
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 25
specifically designed for collecting data specified in the NCD in question. CAD will only be invoked when there
is sufficient evidence to determine that the item or service is to be covered. However, when an NCD requires
CAD, only items or services for patients included in the data collection are covered. CMS outlines the following
concerns that may lead to a coverage decision that requires CAD as a condition of coverage:
1. If the newly covered item or service should be restricted to patients with specific conditions and criteria.
2. If the newly covered item or service should be restricted for use by providers with specific training
or credentials.
3. If there is concern among clinical thought leaders that there are substantial opportunities for misuse of
the item or service.
4. If the coverage determination significantly changes how providers manage patients utilizing this newly
covered item or service.
Coverage with Study Participation (CSP)
CSP will allow coverage of certain items or services for which the evidence is not adequate to support coverage
and where additional data gathered in the context of clinical care would further clarify the impact of these items
on the health of patients. CSP allows CMS to determine that an item or service is only reasonable and necessary
when it is provided within a research setting where there are added safety, patient protections, monitoring, and
clinical expertise. The CED/CSP concept considers the item to be reasonable and necessary only while evidence
is being developed. Under section 1142 of the MMA, which describes the authority of the ARHQ, research may
be conducted on the outcomes, effectiveness, and appropriateness of health care services and procedures to
identify the manner in which diseases, disorders, and other health conditions can be prevented, diagnosed,
treated, and managed clinically. In addition, evaluations of the comparative effects, health and functional
capacity; alternative services and procedures utilized in preventing, diagnosing, treating, and clinically managing
diseases, disorders, and other health conditions may be conducted. If the evidence is inadequate to determine
that the item or service is reasonable and necessary, coverage may be extended to patients enrolled in a clinical
research study. The following list includes some of the evidentiary findings that might result in CMS issuing an
NCD for items and services that do not otherwise have sufficient evidence for coverage:
1. Available evidence may be a product of otherwise methodologically rigorous evaluations but may not have
evaluated outcomes that are relevant to Medicare beneficiaries.
2. The available clinical research may have failed to address adequately the risks and benefits to Medicare
beneficiaries for off-label or other unanticipated uses of a drug, biologic, service, or device.
3. Available clinical research studies may not have included specific patient subgroups or patients with
disease characteristics that are highly prevalent in the Medicare population.
4. New applications may exist for diagnostic services and devices that are already on the market, but there
is little or no published research that supports a determination of reasonable and necessary for Medicare
coverage at the time of the request for an NCD.
5. Sufficient evidence about the health benefits of a given item or service to support a reasonable and
necessary determination is available only for a subgroup of Medicare patients with specific clinical criteria
and/or for providers with certain experience or other qualifications. Other patient subgroups or providers
require additional evidence to determine if the item or service is reasonable and necessary.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 26
CSP research may include a broader range of studies than RCTs to include observational studies. In rare
instances, CMS may determine that existing evidence is very preliminary and not reasonable and necessary for
Medicare coverage; however, if the following criteria are met, CSP might be appropriate in these instances:
1. The evidence includes assurances of basic safety;
2. The item or service has a high potential to provide significant benefit to Medicare beneficiaries; and
3. There are significant barriers to conducting clinical trials.
This research, however, must be rigorously designed and meet the standards to be developed in a
reconsideration of the current Clinical Trial Policy established under a 2000 NCD. If the research results are
published in a peer-reviewed journal, the evidence will be used in an NCD reconsideration to determine if a
change in Medicare coverage is appropriate.
Data Sources
CMS may require that data be sent to a centralized database (formal registry). Data collected under CAD will
commonly be submitted to an approved registry and then sent to CMS to ensure that the item or service was
provided in accordance with the NCD, which is payment data. Data submission to a registry may also be
necessary within clinical studies required under CSP. CMS will use the information to meet specific CAD and/or
CSP determinations for Medicare beneficiaries, but the data will also be available to researchers to evaluate
patient safety and health benefits, comparative effectiveness, utilization and diffusion of the item or service, and
variations in outcomes among providers or patients. The data may also be used to evaluate the long-term
outcomes, patient management issues, mortality, and post-coverage utilization of services, or to conduct other
observational studies. The length of data collection will be determined by the requirements of the NCD, and
CMS will use discretion in determining the research that will be funded.
If CMS determines that the evidence for a service or item is inadequate to establish coverage (under section
1862(a) (1) (A)), Medicare may still reimburse for that item or service for beneficiaries enrolled in a research
study that provides data and information to be used to evaluate that item or service, as well as reimburse for the
routine costs incurred by beneficiaries in the study. However, to qualify for reimbursement, the study must be
designed to produce evidence that could be used in a future NCD. In addition, CMS will only provide payment
for clinical research that meets the standards to be outlined in the revision of the Clinical Trial Policy. The length
of data collection will be outlined in the study protocol, and CMS will pay for the clinical costs of patient care for
beneficiaries for which data collection is required.
The following principles govern the application of CED:
1. NCDs requiring CED will occur within the NCD processes, which is transparent and open to
public comment.
2. CED will not be used when other forms of coverage are justified by the available evidence.
3. CED will in general expand access to technologies and treatments for Medicare beneficiaries.
4. CMS expects to use CED infrequently.
5. CED will lead to the production of evidence complementary to existing medical evidence.
6. CED will not duplicate or replace the FDA’s authority in assuring the safety, efficacy, and security of drugs,
biological products, and devices.
7. CED will not assume the NIH’s role in fostering, managing, or prioritizing clinical trials.
8. Any application of CED will be consistent with federal laws, regulations, and patient protections.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 27
HHS VALUE-DRIVEN HEALTH CARE INITIATIVE
On August 22, 2006, President Bush signed Executive Order 13410, committing the federal government to the
“four cornerstones” of value-driven care:
1. Health information technology,
2. Public reporting of provider quality information,
3. Public reporting of cost information, and
4. Incentives for value comparison.
In summary, it is a broad based initiative to collect and publicly report information about the cost and quality
of health care. As noted previously, the premise is that if consumers and other purchasers of health care can
compare cost and quality of health care services, they will choose the best quality for the lowest price. The result
will be a system that will respond with better quality for less money. The goal is to get more transparency into
the system at all levels, including consumers, employer/purchasers, health plans, providers and policymakers.
Less than a year after launching his Value-Driven Health Care Initiative, HHS Secretary Leavitt announced
that more than 100 million Americans are now served by health plans that are committed to providing
consumers with transparent quality and cost information. The federal government; half of the states; about 775
employers, including almost half of the top 200 U.S. corporations; and numerous unions, communities, doctors
and hospitals have joined the movement.
Most plans that are committed to the value-based approach, including all federal agencies that contract with
health plans, will embody the principles of value-driven care in their next contracting cycle. And most enrollees
in these plans are expected to have access to Web-based “report cards” on quality or cost within the next 12
months.
Website: www.hhs.gov/valuedriven
CHRONIC CONDITIONS DATA WAREHOUSE (CCW)
Section 723 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires the
Secretary of the Department of Health and Human Services (DHHS) to make Medicare data readily available to
researchers who are studying chronic illness in the Medicare population. To support this effort, the Office of
Research, Development, and Information (ORDI) of the Centers for Medicare & Medicaid Services (CMS)
contracted with the Iowa Foundation for Medical Care (IFMC) to establish the Chronic Condition Data
Warehouse (CCW).
The CCW is based on the 5 percent national Medicare sample and includes claims, enrollment and assessment
data. The data cover numerous common chronic conditions such as various types of cancer, cardiovascular
disease, and mental illness. The CCW data are considered RIFs, which contain person-specific data on Medicare
providers, beneficiaries, and recipients including individual identifiers that would permit the identity of a
beneficiary or physician to be deduced. The data are, therefore, subject to the Privacy Act, and CMS must
carefully approve data requests to ensure that confidential information is used in accordance with this regulation.
Website: http://www.resdac.umn.edu/CCW/data_available.asp
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 28
THE DEPARTMENT OF DEFENSE PHARMACOECONOMIC CENTER (PEC)
The Department of Defense (DoD) PharmacoEconomic Center (PEC) is a customer oriented Center of
Excellence implementing recognized state of the art pharmacoeconomic analysis for the purpose of improving
readiness by increasing value, quality, and access to medical care and pharmacotherapy within the available
resources of the Military Health System (MHS). In this capacity, PEC monitors drug usage and cost trends and
performs pharmacoeconomic analyses to support DoD formulary management, national pharmaceutical
contracts, and clinical practice guidelines, and also provides extensive administrative and technical support for
the DoD Pharmacy & Therapeutics Committee, which manages the DoD Basic Core Formulary (BCF) and the
Mail Order Pharmacy Formulary. The Pharmacy Operations Center (POC), a component of PEC, supports
users of the Pharmacy Data Transaction Service, a centralized prescription data repository that provides a single,
comprehensive patient drug profile for DoD beneficiaries across the Military Health System. PEC also helps in
the development and management of information systems that support the provision of drug therapy and
evaluation of the pharmacy benefit. The Center also seeks to educate health care providers and other pharmacy
benefit stakeholders about cost-effective drug therapy through the publication of a monthly newsletter and
works with the Defense Supply Center Philadelphia & the VA Pharmacy Benefits Management Strategic Health
Group and National Acquisition Center to establish national pharmaceutical contracts. Finally, the center works
with the VA/DoD Clinical Practice Guideline Workgroup to formulate the drug therapy components of clinical
practice guidelines.
Website: http://www.pec.ha.osd.mil/
VETERANS AFFAIRS TECHNOLOGY ASSESSMENT PROGRAM (VATAP)
The Veterans Affairs Technology Assessment Program (VATAP) is a national program within the Office of
Patient Care Services dedicated to advancing evidence-based decision making in the VA. VATAP helps senior VA
policymakers to determine the effectiveness of health technologies through systematic reviews of the medical
literature. The impartial, peer-reviewed evaluations encompass devices, drugs, procedures, and organizational
and supportive systems used in health care. VATAP’s products include bibliographies, INAHTA briefs,
comprehensive reports, brief overviews, short reports, and e-newsletters, all of which are available to Veterans
Health Administration senior managers. VATAP is a member of both HTAi and INAHTA.
Website: http://www.va.gov/VATAP/index.htm
NATIONAL INSTITUTES OF HEALTH –
CLINICAL AND TRANSLATIONAL SCIENCE AWARDS (CTSA)
The Clinical and Translational Science Awards provide funding to academic institutions pursuing research
in clinical and translational science, which strives to translate innovative advances in medical research into
applicable knowledge and practices that will benefit and improve human health nationwide. The awards
are a response in part to the progress of the NIH Roadmap for Medical Research, as well as extensive
community input.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 29
Grants are awarded to academic institutions with Centers, Departments, or Institutes (C/D/I) that conduct
studies addressing at least one of nine topic areas:
• Development of Novel Clinical and Translational Methodologies
• Pilot and Collaborative Translational and Clinical Studies
• Biomedical Informatics
• Design, Biostatistics, and Clinical Research Ethics
• Regulatory Knowledge and Support
• Participant and Clinical Interactions Resources
• Community Engagement
• Translational Technologies and Resources
• Research, Education, Training and Career Development
In October of 2006, the first 12 Academic Health Centers (AHCs) received funding. The next round of awards
will be announced in September of 2007. The program is anticipated to be fully implemented by 2012 with 60
institutions pursuing research in the discipline of clinical and translational science. The CTSA now acts as a
national consortium of institutions pursuing this research.
Website: http://www.ncrr.nih.gov/clinical_research_resources/clinical_and_translational_science_awards/
NATIONAL INSTITUTES OF HEALTH – ANTIHYPERTENSIVE AND
LIPID LOWERING TREATMENT TO PREVENT HEART ATTACK TRIAL (ALLHAT)
In 1994, the National Heart, Lung, and Blood Institute (part of the National Institutes of Health) began a
major clinical study to analyze the available treatments for high blood pressure (or hypertension) and high
cholesterol, both of which are major risk factors for heart disease. The Antihypertensive and Lipid-Lowering
Treatment to Prevent Heart Attack Trial (ALLHAT) lasted for 8 years, and examined two primary research
prongs: 1) comparing the effects of a diuretic (or a “water” pill) with three newly available and more costly
prescription drugs to lower blood pressure, and 2) comparing the effects of a typical diet alone
1
with a typical
diet aided by a cholesterol-lowering statin drug.
This seminal study provided one of the first large-scale (over 40,000 participants) comparative effectiveness
studies conducted and remains a standard reference for treating high blood pressure and high cholesterol.
Website: http://www.nhlbi.nih.gov/health/allhat/facts.htm
1 A cholesterol lowering drug was added to this “usual care” group when their doctor believed that it was necessary for their health.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 30
NATIONAL INSTITUTES OF HEALTH – CLINICAL ANTIPSYCHOTIC TRIALS
OF INTERVENTION EFFECTIVENESS (CATIE)
The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) is another study examining the
comparative effectiveness of antipsychotic medication intended to treat schizophrenia. The study is funded by
the NIH’s National Institute of Mental Health at $42.6 million.
In 2005, the first iteration of this study involved 1400 people and examined the comparative effectiveness and
side effects of five new and older drugs that were prescribed to treat people with schizophrenia at the time. The
first year’s findings were published in the September 22 issue of JAMA that year.
In December 2006, CATIE published new findings incorporating economic implications of older versus
newer antipsychotic medication juxtaposed with the comparative effectiveness of treatments (American Journal
of Psychiatry). Its primary conclusion was that the older generation of drugs (developed in the 1950s) was less
expensive and no less effective than newer medications.
This study underscores the clinical policy relevance of comparative effectiveness research efforts and in
particular of reconsidering available therapies and medications.
Website: http://www.nimh.nih.gov/press/catie-cost-effectiveness.cfm
CENTERS FOR DISEASE CONTROL AND PREVENTION–EVALUATION
OF GENOMIC APPLICATION IN PRACTICE AND PREVENTION (EGAPP)
The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) began in the fall of 2004 as a
model project of the Office of Genomics and Disease Prevention at the Centers for Disease Control and
Prevention (CDC). The project’s goal is to coordinate the process for evaluating genetic tests and other genomic
applications and facilitate the transfer of this knowledge from research to clinical and public health application.
The EGAPP Working Group is the principal actor in this initiative and is comprised of 13 experts with
multidisciplinary backgrounds such as clinical practice, public health, genomics, epidemiology, evidence-based
review, policy, economics, and health technology assessment. The group focuses on developing understandable
connections from scientific evidence to conclusions and recommendations of research.
Of the four topics currently under review, evidence reviews for three are being conducted by Evidence-based
Practice Centers associated with the Agency for Healthcare Research and Quality. The fourth is undergoing a
more technical review by a private contractor.
Website: http://www.cdc.gov/genomics/gtesting/egapp.htm
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 31
OREGON HEALTH & SCIENCE UNIVERSITY’S
DRUG EFFECTIVENESS REVIEW PROJECT (DERP)
The Drug Effectiveness Review Project (DERP) is a collaboration of organizations that have joined together
to obtain the “best available evidence” on effectiveness and safety comparisons between drugs in the same class,
and to apply the information to public policy and decision-making in local settings. DERP is part of the Center
for Evidence-Based Policy located within the Oregon Health & Sciences University (OHSU) and funded mainly
by a consortium of state Medicaid agencies. The Policy Center contracts with AHRQ’s EPCs around the country
to develop evidence-based drug class reviews for its clients. The DERP product is a series of comprehensive,
updated and formal systematic reviews conducted by Evidence-Based Practice Centers (EPC) with oversight and
coordination from the Oregon EPC. Each participating organization (e.g., each member State Medicaid agency)
contributes an equal amount to the financing of DERP, and guides its operation through a self-governing process
in which each organization is equally represented. The drug classes to be studied are determined through this
self-governance process. The structure of the DERP is summarized graphically:
DERP commenced its reviews in November 2003, with ten member organizations, and has since expanded to
include fourteen participants: thirteen states (Arkansas, Idaho, Kansas, Michigan, Minnesota, Missouri,
Montana, New York, North Carolina, Oregon, Washington, Wisconsin, and Wyoming) and the Canadian Agency
for Drugs and Technologies in Health). Participating organizations have used DERP reports not only for
Medicaid coverage decisions, including setting preferred drug lists (PDLs), but also to inform drug coverage
policy for state employees or other public programs. Notably, Consumers Union (CU) and AARP, although not
DERP members, have begun adapting DERP reviews for consumers. Consumers Union (CU), publisher of
Consumer Reports magazine, has adopted the DERP reports as one critical component of a free public
information project, started in December 2004, on the comparative effectiveness, safety, and cost of prescription
drugs. Drawing on other sources and adding information on drug costs, the Best Buy Drugs Web site
(www.bestbuydrugs.org) chooses Best Buy drugs in each category it evaluates. Similarly, the American
Association for Retired Persons (AARP) has introduced its Web site, www.aarp.org/health/comparedrugs/, which
publishes the DERP reports for members to consult.
The Oregon Evidence-Based Practice Center (Oregon EPC) conducts the reviews and assigns, coordinates and
oversees reviews conducted by other EPCs, updates reviews on a 6-month schedule, and ensures the production
of its reports. The Oregon EPC provides support to the participating organizations in developing key questions
for the reviews, interpreting the reports, and by being available to answer specific questions.
PRIVATE NON-
PROFITS AND STATES
CENTER FOR EVIDENCE-BASED POLICY
COORDINATING EVIDENCE PRACTICE CENTER
OHSU EPC
UNC EPC RAND EPC
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 32
ACE inhibitors Fixed-dose Combination Products: Hyperlipidemia
ADHD Drugs Hepatitis C Drugs
Angiotensin 2 Receptor Antagonists Hormone Replacement Therapy
Antidepressants, 2nd Generation Hypoglycemics, Oral
Antiemetics, Newer Inhaled Corticosteroids
Antiepileptic Drugs Insomnia Drugs, Newer
Antihistamines, 2nd Generation Multiple Sclerosis Drugs
Antiplatelets Neuropathic Pain Drugs
Atypical Antipsychotics Opioids
Alzheimer’s Drugs Overactive Bladder Drugs
Beta Blockers Proton Pump Inhibitors
Calcium Channel Blockers Skeletal Muscle Relaxants
Constipation Drugs Statins
Controller Medications for Asthma Targeted Immune Modulators
COX-2/ NSAIDs Thiazolidinediones
Diabetes Drugs Topical Calcineurin Inhibitors
Fixed-dose Combination Products: Diabetes Triptans
Website: http://www.ohsu.edu/drugeffectiveness
TABLE 6. DERP Drug Reviews
DERP Drug Reviews
The Center for Evidence-based Policy, not to be confused with the Oregon EPC, supports the collaboration
by executing the agreements and contracts required to operate the collaboration, and by staffing the governance
process that directs DERP projects. In addition, the Center for Evidence-based Policy supports communication
between the participating organizations and the EPCs, provides technical assistance to participating
organizations on the understanding and use of systematic reviews, ensures that timelines are met, and manages
communication among the participating organizations, and between pharmaceutical companies and DERP. The
Center for Evidence-based Policy does not participate in the evaluation of the evidence. In addition, the Center
for Evidence-based Policy has other projects that are distinct from DERP and do not involve the EPCs.
According to Neumann (2006), the DERP has drawn criticism from a number of sources, especially the
pharmaceutical industry and some patient advocacy groups. The criticism centers mostly on allegations that the
DERP is merely a cost containment exercise that restricts access to important therapies; the project, some suggest,
gives Medicaid programs and other organizations political cover to justify not paying for expensive new drugs.
Detractors also claim that DERP reviewers favor evidence from RCTs to the exclusion of observational studies
and other sources of data. In addition, there is some criticism that DERP reviews do not promote the true “value”
of drugs in any meaningful sense because they do not consider cost-effectiveness formally. Furthermore, some
contend that the review process lacks transparency and should allow more opportunity for input and feedback.
Finally, drug industry officials have argued that the opportunity for public input during the P&T committee
process is limited.
The following table lists the DERP drug reviews in progress as of April 2008.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 33
MEDICAID EVIDENCE-BASED DECISIONS PROJECT (MED)
The Medicaid Evidence-Based Decisions Project (MED) is a collaboration of state Medicaid programs for
the purpose of making high quality evidence available to states to support benefit design and coverage decisions
made by state programs. MED is a part of the OHSU Center for Evidence-Based Policy and is affiliated with
DERP. This project includes commissioning and access to systematic reviews, technology assessments, a
web-based clearinghouse, and support from research staff at the Center in designing evaluations and applying
the evidence.
Website: http://www.ohsu.edu/med/
WASHINGTON STATE HEALTH TECHNOLOGY ASSESSMENT PROGRAM (SHTAP)
In March 2006, Washington State’s Governor Gregoire signed legislation creating the State Health Technology
Assessment Program (SHTAP). SHTAP is an effort by the state to employ evidence-based medicine principles
into its purchasing of health care. The program will determine which health technologies to evaluate, contract
with an evidence-based practice center or similar entity to conduct the technology assessment, establish, staff and
manage a health technology clinical committee that will then take that technology assessment and make a
coverage recommendation to the state agencies; the efficacy of medical devices, procedures, diagnostic tests, and
services will be evaluated.
Website: http://www.hca.wa.gov/shtap/
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 34
II. PROPOSALS FOR COMPARATIVE –
EFFECTIVENESS CENTERS
GAIL WILENSKY’S PROPOSED CENTER FOR COMPARATIVE EFFECTIVENESS
Gail Wilensky’s paper in Health Affairs has spurred much discussion surrounding the concept of a center for
comparative effectiveness. Her paper assesses the various options regarding the structure, placement, financing,
and functions of an agency devoted to comparative (clinical) effectiveness assessment. Pros and cons of the major
options are presented, along with a judgment about which strategies would be most likely to be acceptable to the
most important stakeholders. A brief discussion of how other countries have handled decisions about the
placement and financing of comparative effectiveness centers is also included.
In summary, the proposed multi-billion dollar center would provide an independent assessment of the
comparative effectiveness of alternative therapies and procedures for use by various payers and provide
supporting information so that both patients and providers can improve their decision making. Such an
assessment would involve systematic reviews of existing research as well as the conduct of prospective trials to
address key questions for which comparative effectiveness evidence was lacking.
The center’s multibillion-dollar size would reflect the need to sponsor new research and produce new data on
comparative clinical effectiveness for the many new and existing technologies that have come on the market over
the past several decades.
Results of each assessment would be made available to the public.
Wilensky GR. Developing a Center for Comparative Effectiveness Information. Health Affairs. 25 (2006):
w572–w585.
BLUE CROSS AND BLUE SHIELD ASSOCIATION’S PROPOSED PAYER –
FUNDED CENTER FOR COMPARATIVE EFFECTIVENESS
On May 7, 2007, the Blue Cross and Blue Shield Association (BCBSA) proposed that Congress enact
legislation to establish a new, independent institute - funded by all health care payers - to provide consumers and
providers with much needed information on which medical treatments work best. This proposal is an important
component of a multi-pronged strategy BCBSA will be announcing in the coming months to improve health care
value and quality for consumers.
Under BCBSA’s proposal, the institute would support research comparing the effectiveness of new and
existing medical procedures, drugs, devices, and biologics. The institute would support a broad range of
research, including much-needed clinical trials, and be governed by a board representing stakeholders in the
government and private sector.
BCBSA proposes funding the institute by assessing all private (insured and self-funded) and public health care
coverage such as Medicare, Medicaid, and other government programs. BCBSA, as a leading provider of health
care coverage to more than 98 million people, is prepared to contribute substantial financial support to the
initiative.
BCBSA recommends that the new comparative information be quickly and efficiently disseminated to
providers, patients, and others, and that the research results be incorporated into clinical practice guidelines
through close collaboration with medical societies.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 35
Another important element of the proposal calls for physicians who rely on practice guidelines established
through the institute’s research to be given safe harbor for non-economic and punitive damages when faced with
claims of medical malpractice.
A summary of the proposal and more information can be found online at:
http://www.bcbs.com/issues/transparency/
To complement this paper, and to increase the relevancy of their position on the issue, the BCBSA released an
update of its commitment to comparative effectiveness research with a five point health care reform plan,
released in January 2008. The plan, entitled, “The Pathway to Covering America: Ensuring Quality, Value and
Access,” states in its first point, “Encourage Research on What Works,” that quality and value must be improved
by “comparing the relative effectiveness of new and existing medical procedures, drugs, devices, and biologics.”
Most notably, the Blue Cross Blue Shield Association endorsed an “Institute” in this plan that very closely
resembles the “Institute” outline in the Senate draft bill by Senator Baucus and Senator Conrad discussed below.
The BCBSA advocates for a broad range and scope of research, entity independence, and stable funding sources
with contributions from stakeholders.
Additionally, the paper recommends that the government take steps to establish incentives for integration and
adoption of new research into clinical practice, as well as acceptance of evidence-based standards to inform
medical malpractice.
BCBSA’s “Pathway to Covering America” health care reform proposal can be found online at:
http://www.bcbs.com/issues/uninsured/pathway-to-covering-america/
ENHANCED HEALTH CARE VALUE FOR ALL ACT OF 2007 (H.R. 2184)
Introduced May 7, 2007, by Rep. Allen (D-ME); co-sponsored by Rep. Emerson (D-MO)
• Amends Section 1013 of the MMA of 2003 “…to expand comparative effectiveness research and to
increase funding for such research to improve the value of health care.”
• Scope to include all “Federal health care programs,” including:

Programs under title XVIII, XIX, or XXI of SSA

Federal employees health benefits program

Dept. of Veteran Affairs

TRICARE

Indian Health Service (IHS)
• Funding

Comes from a newly established Trust Fund

Money comes from fees on each policy written for a cover life (i.e., proportional payments
per covered lives) as an equal percentage of total moneys gathered that year
$100M in FY 2008
$200M in FY 2009
$900M in each FY 2010-2012

Medicare contribution capped at $200M in any given year, regardless of lives covered
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 36
• Forms two independent bodies

Comparative Effectiveness Advisory Board
Primary purpose is to advise Secretary of HHS and Congress on scientific and research issues,
with any funding recommendations

Comprised of
head of AHRQ (currently Carolyn Clancy)
14 other stakeholder representatives including: “…clinicians, patients, researchers, third-party payers,
consumers of Federal and State beneficiary programs, and health care industry professions“

Charged with
Providing input on research priorities
Recommending how to organize research, taking into consideration a “…full range of appropriate
methodologies, including randomized control trials, practical clinical trials, observation studies,
and synthesis of existing research.”
Recommending how findings should be described, presented and disseminated
Creating recommendations within 2 years “…regarding the establishment of one or more
federally-funded research and development centers.”
Define priority areas of research (e.g., chronic care, high cost areas, greatest need, etc.)
Establish a clinical peer-review advisory board for each priority area to advise on appropriate methods
and conduct studies

Drafts 2012 status report with Secretary HHS that includes
ROI evaluation of program
Evaluation of any backlog of unfunded research
Assessment of
– How the program is working
– The governance structure of the program
– Ability of the program to include public comment and patient perspectives in priority setting
– Ability of program to disseminate findings and conclusions

Permanent council
Purpose is to assist the relevant offices and agencies in coordinating the conduct or support of
health services research and work to set national strategic goals and plans; more “big picture” than
advisory council
Comprised of 20 members, including:
Director of AHRQ, who in-turn selects other members
One senior official from each of the following
– VA
– Dept of Defense Military Health Care
– CDC
– NCHS
– NIH
– CMS
– Federal Employees Health Benefits Program
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 37
4 senior leaders from major national philanthropic foundations that fund and use health services
research
8 stakeholder members “…in health services research, including private purchasers, health plans,
hospitals and other health facilities, and health consumer groups.”
Members serve lifetime appointments
Secretary of HHS designates chair and co-chair once all members selected
Duties of the council are to examine:
major infrastructural challenges facing the field of health services research
the field’s research priorities over the next 5 years
the current portfolio of health services research being funded
ways to stimulate innovation in the field
goals for transformation by 2020
Tasked with creating a strategic plan within 2 years that addresses each of the topics of examination
on the national level
S.3, MEDICARE PRESCRIPTION DRUG PRICE NEGOTIATION ACT OF 2007
Introduced January 4, 2007, by Baucus.
Section 4: Prioritizing Studies of Comparative Clinical Effectiveness of Covered Part D Drugs
I. Priority: The Secretary of HHS, “…shall develop a comprehensive prioritized list of comparative clinical
effectiveness studies that are most critical to building the evidence needed to advance value-based purchasing
of covered part D drugs….”
II. Prioritized list will:
a. specify items and services to be evaluated;
b. include the methodology to use in each identified study “…taking into account the full range of
mythologies available, from systematic reviews to clinical trials;” and
c. be delivered in draft form to the Congress within 1 year of enactment with final version delivered following
a 60-day public comment period.
III.Development of prioritized list will take into consideration:
a. work already completed by AHRQ, including areas in which AHRQ has deemed evidence as insufficient;
b. priority medical conditions developed for section 1013;
c. “areas where patients and doctors are most lacking the information needed to make the best decision
regarding covered Part D drugs, such as the areas where there is a large gap in knowledge of drug therapies
and areas that involve the most widely prescribed covered part D drugs;” and
i. “…areas where patients and doctors…” part of this section leaves an open door to consider anything
ii. latter half of this part encourages CE applied to most prescribed part D drugs, but does not mandate it
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 38
d. advice from a new advisory committee
i. made-up of a “…diverse range of public and private clinical experts, stakeholders, and interests
from the following groups” with no majority membership from any one group:
1. medical and health industries
2. patients and representatives of patients
3. researchers
4. government
ii. all advice given by committee to be made public
iii. committee will accept oral or written comments prior to any advisement
IV. Rule of Construction
a. gives Secretary of HHS ability to prioritize and conduct comparative clinical effectiveness research as
deemed appropriate by the secretary
b. meant as a catch-all clause, but could be used to circumvent procedure laid out within the bill (e.g.,
undertake non-prioritized research)
H.R. 3162: THE CHILDREN’S HEALTH AND MEDICARE PROTECTION ACT OF 2007
The debate around comparative effectiveness research in the House last summer was folded in to the larger
health care debate on children’s health insurance that intensified with the impending expiration of the SCHIP
authorization in September of 2007. This bill, nicknamed the “CHAMP” bill (for the Children’s Health and
Medicare Protection Act) incorporated language closely derived from H.R. 2184 (see above) and established a
Center for Comparative Effectiveness under AHRQ to “conduct, support, and synthesize research with respect to
the outcomes, effectiveness, and appropriateness of health care services and procedures.”
Funding for this center would begin with $300 million from 2008 to 2010 and $375 million per year thereafter,
originating with the Medicare trust funds, and transfer over time to insurance companies. This contribution
would be calculated as a per capita amount multiplied by the average number of lives per policy.
The Center would be overseen by two governing bodies. The first, entitled a Comparative Effectiveness
Research Commission, would be comprised of major stakeholders in government and the private sector and
monitor the quality of research conducted at the Center. Manufacturing stakeholders are not explicitly listed in
the bill as potential appointees, but are similarly not excluded from playing this kind of role. The second, a
Council for Health Services Research, would be comprised of a larger proportion of research- focused
government stakeholders with the intention of advising the Secretary on health services research priorities and
agenda setting.
Due in part to the political jostling around the reauthorization of SCHIP, the CHAMP bill was not passed into
law. However, the CHAMP bill represents the current position and perspective of the House of Representatives
on comparative effectiveness, and further debate will likely use this language as a starting point. As we anticipated
in the previous report in August 2007, this remains the primary vehicle in the House for the establishment of a
comparative effectiveness research entity.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 39
Introduced July 24, 2007, by Congressman John Dingell.
H.R. 3162, Title IX, Section 904: Comparative Effectiveness Research
Amends Part A of title XVIII of the Social Security Act
I. Center for Comparative Research Established
i. conduct, support, and synthesize research relevant to the comparative clinical effectiveness of the full
spectrum of health care treatments including systematic reviews and RCT and observational clinical
research
II. Oversight by Comparative Effectiveness Research Commission
a) Duties
i. Oversee and evaluate the activities carried out by the Center and ensure highly credible and relevant
research projects
ii. Establish national research priorities, ensure appropriate use of funds from the CERTF, engage in and
oversee comparative effectiveness research activities across government agencies
b) Structure
i. Director of AHRQ (currently Dr. Carolyn Clancy)
ii. Chief Medical Officer of CMS
iii. Up to 15 other stakeholders including “clinicians, patients, researchers, third-party payers, consumers of
Federal and State beneficiary programs,” and
iv. At least one member of the Commission must represent clinical researchers “who conduct research on
behalf of pharmaceutical or device manufacturers.“
III.Coordinating Council for Health Services Research
a) Duties
i. Coordinate health services research across all federal departments and agencies
ii. Advise the Congress and President on national health services research agenda, infrastructure needs,
expenditures.
b) Comprised of 20 members including
i. Director of AHRQ
ii. VA
iii. DoD Military Health Care System
iv. CDC
v. National Center for Health Statistics
vi. NIH
vii. CMS
viii. FEHB Program
ix. 4 senior leaders from major national, philanthropic foundations that fund and use health
services research
x. Remaining members are stakeholders including “private purchasers, health plans, hospitals and
other health facilities, and health consumer groups.“
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 40
IV. Establishment of Comparative Effectiveness Research Trust Fund
a) Funding for FY2008- FY2011 will be $90-110 million per year from Medicare trust funds, specifically the
trust fund established for Medicare Part D
b) Beginning in 2011, a tax is established on all health insurance plans, including self insured plans, according
to a “fair share per capita” amount, a government established fee multiplied by the number of covered lives.
This total contribution amount is set at $375,000,000 in 2011.
BAUCUS/CONRAD SENATE BILL:
INTRODUCED AND WITHDRAWN MARCH 4, 2008
In early March of 2008, Senator Baucus and Senator Conrad introduced, and several hours later withdrew, the
Senate’s response to the House comparative effectiveness legislation. Although the provisions closely resembled
those in the House bill, there were a few major differences that represented both the Senate’s commitment and
thoughtfulness.
As in the CHAMP bill, the Baucus/Conrad bill establishes a new entity for Comparative Effectiveness
Research, entitled a “Healthcare Comparative Effectiveness Research Institute,” with a Medicare Trust Fund-
connected funding stream and governance that involves wide stakeholder representation.
However, the Senate bill departs from the House bill in several major ways. First, the bill specifies a stakeholder
role for industry on the Board of Governors, identifying pharmaceutical, device, and technology manufacturers.
This Board of Governors, which oversees the research priority setting for the Institute, would be appointed by
the Comptroller General of the Government Accountability Office (GAO). The bill connects the Center with
AHRQ only so far as a contracting relationship for literature reviews.
The bill establishes a funding stream from annual appropriations and the Medicare Trust Fund, beginning
with $400 million over the first 5 years and increasing to $200 million by the fifth year.
The bill was withdrawn due to jurisdictional issues. At this time, the bill has not yet been reintroduced, and it
is unclear whether these jurisdictional issues will be resolved successfully, or whether other Senators will
collaborate to consider related legislation this spring.
CONGRESSIONAL BUDGET OFFICE REPORT
In December 2007, the Congressional Budget Office released a major report entitled, “Research on the
Comparative Effectiveness of Medical Treatments: Issues and Options for an Expanded Federal Role.”This report
was prepared in response to requests from the Senate Budget and Finance Committee and presented the case that
comparative effectiveness research can improve health care quality and simultaneously help to reduce spending
on health care.
The report reflected the most comprehensive review to date of current activity in comparative effectiveness,
federal investment in generating and reviewing evidence, options for comparing the effectiveness of treatments,
and available opportunities for the federal government to support these options. Although no new
groundbreaking information was presented, the fact that this report was prepared and disseminated widely is
illustrative of the increasing traction of comparative effectiveness proposals and the intent of Congress to pass
legislation.
Notably, Dr. Peter Orszag, director of the CBO, has been very public in giving speeches about the importance
and necessity of investing in CER, citing CBO forecasts that over an extended period CER will generate a positive
return on investments.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 41
III.PRIVATE INITIATIVES
AMERICA’S HEALTH INSURANCE PLANS (AHIP)
AHIP is the national association representing nearly 1,300 member companies providing health insurance
coverage to more than 200 million Americans. The organization’s principal purpose is to represent the interests
of its members on legislative and regulatory issues at the federal and state levels, and with the media, consumers
and employers. AHIP is involved in advocacy around issues such as creating standards for portable personal
health records, rewarding quality performance in health care, regulatory reform to improve access and efficiency,
and initiatives to make evidence-based medicine the standard for health care.
The AHIP Foundation is the non-profit, educational, scientific and research arm of AHIP. The Foundation
seeks to create, support, and enhance programs in health insurance plans which will improve quality,
effectiveness, and value in health care through research, education, information sharing, and other activities
which strengthen and reward exemplary practices by individuals and organizations. As such, the Foundation
offers leadership training programs for health insurance plan executives, medical directors and middle-
managers. Through its programs, AHIP works to ensure that the best health care practices are understood and
disseminated to a wide audience.
For 2008, AcademyHealth has identified “Broad based and Adequate funding for Comparative Effectiveness
Research” as one of its top public policy priorities.
Website: http://www.ahip.org/default.aspx
CENTER FOR MEDICAL TECHNOLOGY POLICY
Founded in January 2006 by former chief medical officer and director of the Office of Clinical Standards and
Quality at CMS, Dr. Sean Tunis, the Center for Medical Technology Policy (CMTP) is a private, non-profit
organization (operated and managed under the auspices of the Health Technology Center (San Francisco) that
provides a neutral forum in which patients, clinicians, payers, manufacturers and researchers can work together
to design and implement prospective, real world studies to inform health care decisions. The primary goal of
CMTP is to improve the process for generating reliable and credible information about the real world risks,
benefits and costs of promising new medical technologies. By developing a center focused on the real-world
questions asked by health care decision makers, the CMTP intends to address:
• Comparative effectiveness of new technologies against current standards of care
• Studies of procedures or technologies not regulated by the FDA (such as surgical procedures and some
pharmacogenomic tests)
• Outcomes not typically measured in regulatory trials, such as quality of life and health care utilization
• Drug/device complication rates/side effects in real world settings
• Risks/benefits of common off-label uses
• Risks/benefits to important patient subgroups or those excluded from trials
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 42
The specific objectives of the CMTP are to:
• Fully incorporate the perspectives of health care decision makers in research priorities and study design.
• Ensure the rapid development and adoption of valuable technologies, and the efficient and appropriate use
of these technologies.
• Limit the adoption and use of technologies of limited or uncertain benefit.
• Maintain incentives for innovators and investors to develop new high value technologies.
• Develop a collaborative model of health care research for other organizations interested in expanding the
supply of relevant and reliable evidence for decision makers.
CMTP’s primary activities during the development phase are to design and begin implementation of clinical
studies for three pilot project topics. As part of this process, CMTP will develop methods for priority setting
among potential high value new technologies. CMTP will also create a robust organizational structure of
advisory committees to support its work. Lastly, steps will be taken to develop a sustainable long-term funding
model to support the CMTP and its designed study protocols. Initial funding for CMTP has been provided by
the California HealthCare Foundation and the Blue Shield of California Foundation.
In May of 2006, CMTP held the first meeting of its steering committee, which led to the selection of five
potential pilot project topics, based on specific pre-established criteria. The topics selected were: 1) radiation
therapy for prostate cancer, 2) delivery of ICU care through telemedicine, 3) minimally-invasive bariatric surgery,
4) gene expression profiling tests for early stage breast cancer, and 5) CT angiography for diagnosis of coronary
artery disease.
CMTP is also:
• Working with several patient advocacy organizations and physician groups to explore collaborative
mechanisms for priority setting.
• Convening a series of in-person and conference-call meetings of organizations working in the area of
evidence-based technology policy: the Technology Policy Collaborative, a forum for communication and
collaboration among a group of leaders currently focused on evidence-based health technology policy.
Sean Tunis, MD, MSc
Founder and Director
Wade Aubry, MD
Associate Director
Linda Bergthold, PhD
Senior Advisor
Gail Wilensky, PhD
Senior Policy Advisor
Molly Coye, MD
Senior Advisor
Steven Pearson, MD, MSc
Senior Advisor
Rita Redberg, MD, MSc, FACC
Clinical Advisor
* Staff biographies are included in Appendix F.
TABLE 7. Center for Medical Technology Policy Staff
Center for Medical Technology Policy Staff*
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 43
• Convening a workshop focused on pragmatic clinical trials, cluster-randomized trials, quasi-experimental
designs and other methods intended to increase the speed and affordability of prospective clinical studies.
• Drafting a 5-year strategic plan, including options for medium and long term funding.
In addition, CMTP has developed active working relationships with key regional and national decision
makers, stakeholders and experts. CMTP has also established links with other organizations focused on
technology policy and evidence development, including the National Institutes of Health (NIH), the Food and
Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), the Institute of Medicine
(IOM), the New England Healthcare Institute (NEHI), the HMO Research Network (HMORN), the Integrated
Healthcare Association (IHA), the Institute for Clinical and Economic Research (ICER), the Critical Path
Institute (C-PATH) and others.
INSTITUTE FOR CLINICAL AND ECONOMIC REVIEW (ICER)
In June 2006, Dr. Steven Pearson was awarded a grant from the Blue Shield Foundation of California to launch
the Institute for Clinical and Economic Review (ICER) to develop and test new methods of technology appraisal
for US decision-makers. ICER produces appraisals of the clinical effectiveness and cost effectiveness of medical
innovations, with the goal of providing new information to decision makers intent on improving the value of
health care services.
Pearson has also recently received grant support to develop and test a new format for technology assessment
that can integrate clinical and cost-effectiveness reviews. The use of cost-effectiveness in policy decision making
has raised many ethical and political issues in the past, and Pearson’s project is an explicit attempt to forge a new
method that can overcome these difficulties and provide decision makers with the information on health care
value that can support a more equitable and sustainable health care system.
The mission of the Institute for Clinical and Economic Review (ICER) is to be the most trusted source of
information to help fill this evidence gap for the benefit of all stakeholders in health and the health care system.
ICER produces rigorous assessments of new medical interventions, and translates its findings into integrated
ratings specifically formatted to support value-based insurance benefit designs, coverage and reimbursement
policy, and patient-clinician decision support tools.
Website: http://www.icer-review.org/
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 44
IV. INDEPENDENT EVIDENCE-BASED
MEDICINE INITIATIVES
INSTITUTE OF MEDICINE’S (IOM) ROUNDTABLE ON EVIDENCE-BASED MEDICINE
Chartered in 1970 as a component of the National Academy of Sciences, the Institute of Medicine (IOM) is a
nonprofit organization specifically created for the purpose of providing unbiased, evidence-based, and
authoritative information and advice concerning health and science policy to policy-makers, professionals,
leaders in every sector of society, and the public at large. Operating outside the framework of government to
ensure scientifically informed analysis and independent guidance, the IOM’s mission is to serve as adviser to the
nation to improve health.
Roundtables are a specific type of convening activity of The National Academies intended to enable dialogue
and discussion among key leaders and representatives in a particular field. Roundtables are prohibited by the
National Academies from producing reports that provide advice or recommendations.
The IOM Roundtable on Evidence-Based Medicine brings together key stakeholders from multiple sectors —
patients, health providers, payers, employers, manufacturers, policy makers, and researchers — for cooperative
consideration of the ways that evidence can be better developed and applied to drive improvements in the
effectiveness and efficiency of medical care in the United States. The objectives of the IOM Roundtable include
both finding ways to generate better evidence on which to base clinical decisions, and prompting stronger public
and provider commitment to putting evidence into practice. Specific issues and agenda topics will span a broad
range of issues in research, medical care, and health policy. Examples include:
• Assessment priorities. Which interventions do stakeholders feel are the highest priorities for evaluation? By
what criteria? How can they best be assessed? How can coordination be improved for assessment activities.
• Assessment approaches. What criteria should guide choices among various assessment tools — e.g. registries,
other observational data (natural experiments), randomized clinical trials, practical clinical trials, modeling?
How can these methods be improved and the lessons shared? What decision criteria should guide
determinations on the sufficiency of evidence?
• Data issues. What are the constraints, issues and opportunities to advancing the public good aspect of health
data? How should the protection requirements mandated under HIPAA (the Health Insurance Portability
and Accountability Act) be engaged to expedite collection of evidence on medical effectiveness? What is
needed for electronic health records to generate real-time evaluative information? Can an interoperable
network of integrated health system data be developed to expedite assessment of new interventions?
• Policy issues. How can policies on coverage and regulation better foster evidence generation? How can the
ethical and confidentiality issues be best addressed? How can sustained support be developed for studies
needed on comparative effectiveness of diagnostics and treatment interventions?
• Translation strategies. What are the most promising opportunities to accelerate the application of proven
interventions in health care? What communication strategies might be most effective in translating to the
public the nature of evolving science and medicine?
• Cooperative arrangements. What mechanisms might facilitate cooperative pooling of resources and
information to generate better evidence on which to base clinical decisions?
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 45
To address these issues, the Roundtable will work over the next three years in formal meetings, expert panels,
workshops, and symposia. There are four working groups, with 5–7 members each, focusing on the following
four main areas: (1) evidence development; (2) sustainable capacity; (3) evidence applications; and (4) vision.
The Roundtable’s first event was a workshop entitled “The Learning Healthcare System.” This workshop was
the first in a series and considered how health care is structured to develop and to apply evidence – from health
professions training and infrastructure development to advances in research methodology, patient engagement,
payment schemes, and measurement – and highlighted opportunities for the creation of a sustainable, learning
health care system that gets the right care to people when they need it and then captures the results for
improvement. The most pressing needs for change identified in The Learning Healthcare System are those
related to:
• Adaptation to the pace of change
• Stronger synchrony of efforts
• New clinical research paradigm
• Clinical decision support systems
• Tools for database linkage, mining, and use
• Notion of clinical data as a public good
• Incentives aligned for practice-based evidence
• Public engagement
• Trusted scientific broker
• Leadership
The second workshop in the Learning Healthcare System series, titled Judging the Evidence: Standards for
Determining Clinical Effectiveness, was held on February 5, 2007 and involved discussions surrounding
inconsistencies in evidence standards, variations in the evidence threshold in certain situations, and new forms
of evidence that have recently appeared on the horizon and how they can be applied clinically.
The third workshop in the Learning Healthcare System series, titled Leadership Commitments to Improve Value
in Health Care: Toward Common Ground took place on July 23 and 24, 2007. The workshop provided a setting
for a rich exchange of ideas about how various stakeholder sectors can work, both individually and
collaboratively, to foster the development of a learning health care system.
The fourth workshop in the Learning Healthcare System series, titled Redesigning the Clinical Effectiveness
Research Paradigm: Innovation and Practice-Based Approaches, was held on December 12-13, 2007. Participants
examined the role of innovative research designs and tools that can expedite the development of evidence on
clinical effectiveness by streamlining approaches and bringing research and practice closer together. In the
context of existing evidence gaps and a need for a substantially improved understanding of comparative clinical
effectiveness of health care interventions, this workshop explored opportunities presented by emerging research
networks and data resources, innovative study designs, and new methods of analysis and modeling that will
address the existing evidence gap and the need for a substantially improved understanding of comparative
clinical effectiveness of health care interventions. Presentations and discussion focused on how these tools and
methods can be engaged in a new generation of studies that better address current challenges in clinical
effectiveness research.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 46
The fifth workshop in the Learning Healthcare System series, titled Clinical Data as the Basic Staple of Health
Learning, took place on February 28-29, 2008, and explored the transformational opportunities that could be
available by evolving large and potentially interoperable clinical and administrative data sets, held in multiple
activities and many institutions.
The sixth workshop, entitled Engineering a Learning Healthcare System: A Look at the Future, took place on
April 28-29, 2008, and focused on how to engineer the development of a learning health care system to be
structured in a way to keep the patient constantly in focus, while continuously improving quality, safety,
knowledge, and value in health care.
The seventh workshop, scheduled for July 29-30, is titled Learning What Works: Infrastructure and Clinical
Priorities for Learning Which Care is Best. This workshop will discuss what infrastructure is needed to expand the
scope of current comparative effectiveness research. Specifically, this will involve clarifying the “nature of the
work; assess future capacity needs related to workforce, research method innovation, data linkage and
improvement, and coordination of efforts.”
In January 2008, the IOM published a report entitled, “Knowing what works in health care: A roadmap for
the nation.”
2
In this comprehensive review, the IOM-convened Committee on Reviewing Evidence to Identify
Highly Effective Clinical Services provides a guide for how the United States can “assess the effectiveness of
clinical services and to provide credible, unbiased information about what really works in health care.“
THE JAMES LIND ALLIANCE
The James Lind Alliance was started by Sir Iain Chalmers, founder of the Cochrane Collaboration, in order
to bring physicians and patients together to identify gaps of evidence in health services research for effectiveness
of treatments. The purpose is to both “identify and prioritize the unanswered [research] questions” as well as to
contribute perspectives and critical research needs from patients and physicians.
The Alliance utilizes a Database of Uncertainty about the Effectiveness of Treatments (DUETs) to “identify
and publish uncertainties reflected in patients’ and clinicians’ questions about the effects of treatments which
cannot be answered by referring to up-to-date systematic reviews of existing research evidence.” This database is
being developed in partnership with Oxford University and is funded by the UK Medical Research Council and
the UK Department of Health.
http://www.lindalliance.org
THE COCHRANE COLLABORATION
The Cochrane Collaboration, founded in 1993, is an international non-profit and independent organization,
dedicated to making up-to-date, accurate information about the effects of health care readily available
worldwide. It produces and disseminates systematic reviews of health care interventions and promotes the search
for evidence in the form of clinical trials and other studies of interventions. It is now the largest organization in
the world engaged in the production and maintenance of systematic reviews. The major product of the
Collaboration is the Cochrane Database of Systematic Reviews, which is published quarterly as part of The
Cochrane Library.
Those who prepare the reviews are mostly health care professionals who volunteer to work in one of the many
Cochrane Review Groups, with editorial teams overseeing the preparation and maintenance of the reviews, as
well as application of the rigorous quality standards for which Cochrane Reviews have become known. The
2 Footnote: Institute of Medicine (IOM). 2008. Knowing what works in health care: A roadmapfor the nation. Washington, DC: The National Academies Press.)
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 47
Cochrane Collaboration is supported by hundreds of organizations from around the world, including health
service providers, research funding agencies, departments of health, international organizations and universities.
There are currently more than 10,000 people contributing to the work of The Cochrane Collaboration from over
80 countries, and this involvement continues to grow.
ECRI INSTITUTE
ECRI Institute (formerly the Emergency Care Research Institute) is a nonprofit health services research
agency and a Collaborating Center of the World Health Organization (WHO). In addition, it is designated as an
Evidence-based Practice Center (EPC) by AHRQ. ECRI’s mission is to promote high standards of safety, quality,
and cost-effectiveness in health care to benefit patient care through research, publishing, education and
consulting. Its focus is health care technology, health care risk and quality management, patient safety
improvement and health care environmental management. ECRI provides information services and technical
assistance to more than 5,000 hospitals, health care organizations, ministries of health, government and planning
agencies, voluntary sector organizations, associations, and accrediting agencies worldwide. It offers more than
30 databases, publications, information services, and technical assistance services.
ECRI’s services alert readers to health care system and technology-related hazards with strategies to correct
them; disseminate the results of medical product evaluations and health technology assessments; provide expert
advice on technology acquisitions, staffing, and management; report on hazardous materials management policy
and practices; and supply authoritative information on risk control in health care facilities and clinical practice
guidelines and standards.
ECRI has served as an AHRQ-designated EPC since 1997. While most EPCs are located within academic
institutions, ECRI’s evidence-based medicine and health technology assessment activities are funded in a public-
private cooperative model that relies on a variety of Federal and State government funding, as well as commercial
sales of ECRI’s evidence-based health policy resources, available through its Health Technology Assessment
Information Service (HTAIS). The resources of ECRI’s technology assessment work are used by a wide variety
of constituencies, including public and private payers, providers, clinical specialty societies, regulators, industry,
and patients and their families.
In addition to its capabilities in traditional health technology assessment methodology, the staff of the ECRI
EPC also has expertise in research design and evaluation, outcomes data analysis and modeling, horizon
scanning, and health policy analysis.
ECRI’s other activities include such diverse areas as:
• Methodology support for clinical practice guideline development.
• Development of evidence-based information for patients and their families.
• Patient safety program development.
• Adverse event reporting systems.
• Health technology planning and engineering evaluation.
• Technology acquisition and procurement assistance.
• Accident and forensic investigation.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 48
HAYES, INC. – THE HEALTH TECHNOLOGY ASSESSMENT COMPANY
Hayes, Inc. is an independent health technology assessment organization that specializes in robust, clinically
focused health technology assessment reports for health care organizations, including health plans, managed care
companies, hospitals, and health networks. Hayes’ medical research analysts assess such technologies as medical
and surgical procedures, drugs, biologics, diagnostic and screening tests, medical devices and equipment, and
complementary and alternative therapies. Hayes offers several professional health technology assessment
products including a tool for monitoring emerging medical technologies; a service focused on medical literature
database searches with brief reports; health technology briefs for decision makers; and a directory containing
over 350 reports assessing a variety of new and emerging medical technologies.
Website: http://www.hayesinc.com/
ACADEMYHEALTH SUPPORT OF COMPARATIVE EFFECTIVENESS RESEARCH
On May 15, 2007, AcademyHealth issued a press release that expressed the organization’s support of H.R.
2184 (see above). According to that statement, “AcademyHealth believes increased funding for comparative
effectiveness research will provide evidenced-based and data-driven solutions to our most pressing health policy
challenges.” This expression of support is directly in-line with AcademyHealth’s 2007 vision and priorities for
health services research policy, which states: “Congress should increase and expand the sources of funding for
conducting and coordinating a wide spectrum of comparative effectiveness research, including systematic
reviews of existing literature, analysis of administrative data and clinical registries, and pragmatic, prospective,
head-to-head trials. Doing so would ultimately help patients, providers, payers, and policymakers make rational
choices about new and existing health services. Since the findings of the research would benefit all people, its
sources of funding should be broad based. Independence and scientific integrity should be emphasized.”
AcademyHealth is essentially supporting a broad range of health services research methodologies as they
relate to the larger comparative effectiveness discussion that is taking place in the US. By keeping its focus on
improving both the health of patients as well as the system of health services through the application of a wide
range of methodologies (as opposed to just head-to-head clinical trials), AcademyHealth has positioned itself
firmly on the side of best scientific practice within the larger debate while avoiding any support for a specific
institute or organization to carry out that research.
Website: http://www.academyhealth.org/index.htm
ACADEMY OF MANAGED CARE PHARMACY’S FORMAT
FOR FORMULARY SUBMISSIONS
In October of 2000, AMCP developed the Format for Formulary Submissions to help ensure that the
utilization of pharmaceutical drugs and vaccines were appropriate, and that information was available on the
relative effectiveness and cost-effectiveness of newer drugs introduced to the market. The drug dossiers that are
developed according to the Format are intended to be transparent and credible, and document research
protocols, study designs, modeling, and results analysis.
The Format has become an industry standard for reporting economic and clinical evidence on efficacy, safety,
and comparative economic value. It seeks to provide pharmacy and therapeutics committees with the necessary
information in a digestible standard format to evaluate the value of a drug and its potential economic impact to
the health care organization. To date, the Format has been used by government agencies such as the Department
of Defense, Medicaid programs, pharmacy benefit managers, health plans, and hospitals as the adopted standard
for policy documentation and determinations.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 49
V. CONSUMER – FOCUSED INITIATIVES
CONSUMER REPORTS BEST BUY DRUGS
Launched in December 2004, Consumer Reports Best Buy Drugs is a public education project of Consumers
Union, the publisher of Consumer Reports. The organization produces drug reports that combine an expert
review of the scientific evidence on prescription drugs with their prices. Evaluations are based on reviews by
the aforementioned Oregon Health & Science University-based Drug Effectiveness Review Project (DERP). The
project’s overriding purpose is to translate the DERP’s findings for consumers and, combining that with drug
price and cost data, to produce an independent and unbiased resource on the comparative effectiveness and
value of prescription drugs (Findlay, 2006). The reports compare and contrast prescription drugs by category
– that is, drugs in the same class that are used to treat a specific condition or illness such as high blood pressure,
high cholesterol, allergies, coronary-artery disease, heartburn, or depression. Physicians and pharmaceutical
experts serve as professional peer reviewers of the drug reports. The following table presents a list of reports
currently available.
The Consumers Union emphasizes that their findings are intended to assist consumers in discussing with
their doctors which medicines are best for them. Best Buy picks are based on assessments of all the drugs in a
class, and a comparison of the drugs in that class to each other. The main criteria used are a drug’s effectiveness,
it’s safety, the side effects it may cause, it’s convenience of use (for example, how many pills you have to take each
day), its track record in studies and actual use, and of course how much it costs relative to others drugs. There is
no set formula for choosing Best Buys. The factors differ in each category, and some of those factors are quite
subtle. However, in general, Best Buys are chosen because they are: (a) as effective as all the other drugs in the
category, or more so; (b) as safe and cause no more - and usually fewer - side effects than other drugs in the
category; and (c) cost less on average than other drugs in the category. That is not always true, though. Several of
High Blood Pressure, Heart Failure – The ACE Inhibitors Asthma and Lung Disease – Inhaled Steroids
Attention Deficit Hyperactivity Disorder Drugs Sleeping Pills for Insomnia
Alzheimer’s Disease Drugs Migraine Headache Drugs – The Triptans
Schizophrenia, Bipolar Disorder Osteoarthritis, Pain – The NSAIDs
Antidepressants Overactive Bladder
High Cholesterol, Heart Disease – The Statins Menopause – Female Hormones
Allergies, Hay Fever, and Hives – Antihistamines Heart Disease and High Blood Pressure – Beta Blockers
Treating Heart Disease, Heart Attacks, Angina, High Blood Pressure – Calcium Channel Blockers
and Stroke – Antiplatelets
Drugs for Heartburn, Acid Reflux Disease – The PPIs Opioids – Treating Chronic Pain
Treating Bipolar Disorder, Nerve Pain Treating Type 2 Diabetes – The Oral Diabetes Drugs
and Fibromyalgia – The Anticonvulsants
* Staff biographies are included in Appendix F.
TABLE 8. Consumers Reports Best Buy Drug Report
Consumer Reports Best Buy Drug Reports
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 50
the Best Buys have been chosen because of their superior effectiveness or safety profile even though they cost
more. Overall, a drug’s effectiveness is the most important criteria in choosing Best Buys.
The project is funded by grants from the Engelberg Foundation and the National Library of Medicine and seeks
guidance from members of its advisory board, who are listed in the following table.
According to their website, the project is aimed at helping the uninsured, seniors without any drug coverage,
insured people with high co-pays, employers, insurance companies, unions and anyone interested in getting a
better value for their health-care dollar. As such, multiple organizations have partnered with the Consumers
Union to educate their members about the Best Buy Drugs project and include:
• AFL-CIO
• Alliance for Retired Americans
• American Federation of State, County and Municipal Employees
• American Public Health Association
• American Medical Student Association
• Common Cause
• Consumer Federation of America
• Families USA
• National Committee to Preserve Social Security and Medicare
• National Education Association
• U.S. Public Interest Research Group
Nancy Wilson Ashbach, MD, MBA
Family Physician-Former Member
Board of Directors
American Academy of Family Physicians
Jerry Avorn, MD
Associate Professor of Medicine
Harvard Medical School
Georges C. Benjamin, MD
Executive Director
American Public Health Association
Roger Herdman, MD
Senior Scholar
Institute of Medicine
National Academy of Sciences
Sharlea Leatherwood, PD
President
National Community Pharmacists Association
Jay Bhatt
President
American Medical Students Association
Lisa Schwartz, MD, MS
Associate Professor of Medicine
VA Outcomes Group
Dartmouth Medical School
Steven Woloshin, MD, MS
Associate Professor of Medicine
VA Outcomes Group
Dartmouth Medical School
TABLE 9. Members of Consumers Reports Best Buy Drugs Advisory Board
Member of Consumer Reports Best Buy Drugs Advisory Board
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 51
AMERICAN ASSOCIATION OF RETIRED PERSONS (AARP) RESEARCHRX
AARP now offers an online consumer guide that provides comparative information about the effectiveness
and safety of brand-name and generic drugs within nine prescription drug classes. AARP’s conclusions found
on the site are based on an independent review and assessment of the available medical evidence undertaken
by the Drug Effectiveness Review Project of Oregon Health & Science University’s Center for Evidence-
based Policy.
Website: http://www.aarp.org/health/comparedrugs/
ALLIANCE FOR BETTER MEDICINE
The Alliance for Better Medicine (ABM) is a California-based coalition of patient advocacy groups, physician
experts and ethnic health care organizations working together to make sure patients receive appropriate,
individualized medical care. ABM’s most urgent priority is to ensure that the evolving concept of evidence-based
medicine, or EBM, is defined and implemented in a way that protects the most appropriate treatment for the
individual patient or consumer.
The mission of ABM is to “Educate policymakers and the public to achieve the best and most cost effective
outcomes in health care utilizing the best available science and information developed in consultation with
researchers, practitioners and recipients of care, that considers the differences in responses to specific
medications or procedures, based upon factors such as age, sex, race, ethnicity and co-occurring disorders.” To
achieve this mission, ABM promotes the use of analyses that focus on disease management and that consider the
total costs of treatment. The Alliance is wary of analyses that examine particular procedures, treatments, or
classes of medicine without considering their impact on other costs and services. It is opposed to the notion that
EBM should be used to justify limited access to medications and restrictive policies which do not consider the
specific needs of the individual patient or clinical experience of the physician.
ABM hosted an Educational Summit on Evidence-Based Medicine in August 2005 in order to engage groups
and individuals to discuss the best ways to use evidence to improve health outcomes. The group has submitted
public comments to the Oregon Evidence-Based Practice Center’s DERP questioning the methodology of its
drug review reports and to CMS and the Consumers Union questioning the applicability of the “Best Buy Drug”
reports to the Medicare population. ABM’s other activities include the proposed California Healthcare
Accountability Center (CHAC) and Governor Schwarzenegger’s California Health Reform.
Member organizations of ABM include numerous national health associations and California chapters of
national health organizations such as the Alzheimer’s Association, the Asthma and Allergy Foundation of
America, Epilepsy Foundation, and many others. The 18-member Steering Committee consists of physicians,
academics, and representatives of health and patient advocacy organizations. (For a complete list of Steering
Committee members, please see: http://www.allianceforbettermedicine.org/members/steering.html.)
Website: http://www.allianceforbettermedicine.org/
NATIONAL WORKING GROUP ON EVIDENCE-BASED HEALTHCARE
In January 2006, Mental Health America (MHA) convened the National Working Group on Evidence-Based
Health Care to help ensure greater patient-focused, consumer knowledge and involvement in national and state-
focused initiatives seeking to promote a better quality of care. The group functions as an education and advocacy
organization that represents consumers, caregivers, practitioners and researchers committed to promoting
accurate and appropriate evidence-based policies and practices that improve the quality of health care services in
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 52
the U.S. A core activity of many of the group’s initiatives is the review, interpretation, and dissemination of
information about scientific research.
The four major categories of the EBM initiatives on which the Working Group focuses include: measuring
value in health care; payer adoption of EBM principles; generation of medical information and evidence; and
defining clinical research priorities. The group was formed with the objective of addressing challenges and
raising concerns associated with evidence-based health care (EBH) initiatives and serves as a centralized
information resource and forum for consumers, voluntary health organizations, providers, researchers and other
interested stakeholders. Its most recent activities included hosting a public forum on the central role patients
should play in EBH featuring patients and expert panelists who discussed trends and approaches for including
patients in health care decision making. The group also drafted a letter to Health Affairs in August 2006 giving a
consumer’s perspective on DERP and making tangible recommendations for improving the development and
use of DERP reports.
Members of the Working Group include over 30 organizations such as the Alliance for Better Medicine,
American Psychiatric Association, Easter Seals, and the FDA Office of Special Health Issues. A complete list of
member organizations can be found at the following address:
http://www.evidencebasedhealthcare.org/index.cfm?objectid=7FBE8DB3-1372-4D20-C8E764D83B9A1A61
Website: http://www.evidencebasedhealthcare.org/index.cfm
U.S. COCHRANE COLLABORATION’S CONSUMERS UNITED
FOR EVIDENCE-BASED HEALTHCARE (CUE)
Initial funding from the Agency for Healthcare Research and Quality (AHRQ), has enabled the United States
Cochrane Center (USCC) to develop Consumers United for Evidence-based Healthcare (CUE). CUE is a
pioneering effort to improve consumers’ ability to engage in and demand high quality health care. CUE started
in 2003 as a partnership between consumer health advocacy groups and scientists involved in evidence-based
health care (EBHC). CUE is a national coalition of health and consumer advocacy organizations and represents
a consumer advocate-scientist partnership.
The mission of CUE is to promote the health of populations and the quality of individual health care by
empowering consumers, public health policy makers, and health care providers to make informed decisions
based on the best current evidence through research, education, and advocacy. As key stakeholders in health
and health care decision making, consumers need access to high quality health information and critical
appraisal tools.
• Consumers are bombarded with health care information from the print media, TV, radio, Internet and their
health care providers.
• Interpreting the accuracy and validity of information is often difficult, as reports can be conflicting and
evidence may seem to change over time.
• Consumers and consumer advocates need the tools to interpret, analyze, and understand this influx of
information.
United by a common interest in integrating understanding and interpretation of EBHC into their advocacy
activities, the 27 CUE member-organizations work to strengthen the voice of consumers and provide leadership
in health care research. A list of the participating organizations for 2007 is provided in the following table.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 53
TABLE 10. Consumers United for Evidence-based Healthcare: 2007 Member Organizations*
Consumers United for Evidence-based Healthcare: 2007 Member Organizations
Annie Appleseed Project
http://www.annieappleseedproject.org/
National Coalition for Lesbian, Gay,
Bisexual and Transgender Health
http://www.lgbthealth.net/
* Note: a list of updated 2008 Member Organizations has not been posted to their website.
Marianne Hamilton, MPA, serves as the US Cochrane Center’s Consumer Coordinator.
Black Women’s Health Imperative
http://www.blackwomenshealth.org/
National Consumers League
http://www.nclnet.org/
Center for Medical Consumers
http://www.medicalconsumers.org/
National Council on Aging
http://www.ncoa.org/
National Breast Cancer Coalition
http://www.natlbcc.org/
National Center for Transgender Equality
http://www.nctequality.org/
Young Survival Coalition
http://www.youngsurvival.org/
Center for Science in the Public Interest
http://www.cspinet.org/
National Environmental Education &
Training Foundation
http://www.neetf.org/
Cherab Foundation
http://www.cherab.org/
National Mental Health Consumers’
Self-Help Clearinghouse
http://www.mhselfhelp.org/
Childbirth Connection
http://www.childbirthconnection.org/
National Partnership for Women & Families
http://www.nationalpartnership.org/
Citizens for Health
http://www.citizens.org/
National Vaccine Information Center
http://www.909shot.com/
Citizens Health Alliance for Truth
http://www.chatdc.org/
National Women’s Health Network
http://www.nwhn.org/
Consumers Union
http://www.consumersunion.org/
Our Bodies Ourselves
http://www.ourbodiesourselves.org/
Faces and Voices of Recovery
http://www.facesandvoicesofrecovery.org/
Rhode Island Breast Cancer Coalition
1-800-216-1040
Lamaze International
http://www.lamaze.org/
SafeMinds
http://www.safeminds.org/
Mautner Project, the National Lesbian
Health Organization
http://www.mautnerproject.org
TMJ Association, Ltd.
http://www.tmj.org/
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 54
VI.MEASURING VALUE IN HEALTH CARE:
STANDARDIZING METRICS
NATIONAL COMMITTEE FOR QUALITY ASSURANCE (NCQA)
The National Committee for Quality Assurance is a nonprofit organization dedicated to improving health
care quality. The organization is frequently referred to as a watchdog for the managed care industry, but NCQA
also recognizes individual doctors and medical groups. It also provides information to employers and consumers
to help them make more informed health care choices.
NCQA’s programs and services reflect a straightforward formula for improvement: Measure. Analyze.
Improve. Repeat. NCQA makes this process possible in health care by developing quality standards and
performance measures for a broad range of health care entities. These measures and standards are the tools that
organizations and individuals can use to identify opportunities for improvement. The annual reporting of
performance against such measures has become a focal point for the media, consumers, and health plans, which
use these results to set their improvement agendas for the following year.
NCQA began accrediting managed care organizations (MCOs) in 1991 in response to the need for
standardized, objective information about the quality of these organizations. Although the MCO accreditation
program is voluntary and rigorous, it has been well received by the managed care industry. More than half the
HMOs in the nation, covering three-quarters of all HMO enrollees, have been reviewed by NCQA. Many large
employers will not do business with a health plan that has not earned NCQA’s seal of approval. Thirty states
recognize NCQA Accreditation as meeting certain regulatory requirements for health plans, eliminating the need
for a separate state review. For an organization to become accredited by NCQA, it must undergo a rigorous
survey and meet certain standards designed to evaluate the health plan’s clinical and administrative systems. In
particular, NCQA evaluates health plans in the areas of patient safety, confidentiality, consumer protection,
access, service and continuous improvement.
During a survey, plans are reviewed against more than 60 different standards, each of which focuses on an
important aspect of the health plan. These standards fall into five broad categories:
• Access and Service – Do health plan members have access to the care and service they need?
Does the health plan resolve grievances quickly and fairly?
• Qualified Providers – Does the health plan thoroughly check the credentials of all of its providers?
• Staying Healthy – Does the health plan help people maintain good health and avoid illness?
• Getting Better – How well does the plan care for people when they become sick?
• Living with Illness – How well does the help people manage chronic illnesses?
Accreditation surveys are conducted by teams of physicians and other experts. The process is rigorous; a
health plan must be aggressively managing quality to achieve NCQA Accreditation.
Since 1997, NCQA has produced an annual State of Health Care Quality report, an overall assessment of the
performance of the health care system. The report is issued right before the annual “open enrollment” season,
when most Americans choose their health plan for the following year. Consequently, the report generates an
enormous amount of media attention.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 55
The Health Plan Employer Data and Information Set (HEDIS)
NCQA also sponsors, supports, and maintains The Health Plan Employer Data and Information Set
(HEDIS), a tool used by nearly all health plans to measure performance on important dimensions of care and
service. HEDIS is a set of standardized performance measures designed to ensure that purchasers and consumers
have the information they need to reliably compare the performance of managed health care plans. The
performance measures in HEDIS are related to many significant public health issues such as cancer, heart disease,
smoking, asthma and diabetes. HEDIS also includes a standardized survey of consumers’ experiences that
evaluates plan performance in areas such as customer service, access to care and claims processing. Altogether,
there are more than 60 different measures in HEDIS. Because HEDIS data are collected by such a large portion
of the market, and because the measures are so specifically defined, HEDIS makes it possible to compare the
performance of managed health care plans on an “apples-to-apples” basis. Health plans also use HEDIS results
themselves to see where they need to focus their improvement efforts.
PHARMACY QUALITY ALLIANCE
Formed in April 2006 and officially launched in April 2007, the Pharmacy Quality Alliance (PQA) is an
unprecedented collaborative effort among the pharmacy community, health plans, government, employers,
physicians, and consumer groups aimed at improving health care quality and patient safety in pharmacy practice.
Founding members include the National Community Pharmacists Association (NCPA), the National
Association of Chain Drug Stores, America’s Health Insurance Plans, and CMS.
The mission of the Pharmacy Quality Alliance is to improve health care quality and patient safety through a
collaborative process in which key stakeholders agree on a strategy for measuring performance at the pharmacy
level; collecting data in the least burdensome way; and reporting meaningful information to consumers,
pharmacists, employers, health insurance plans, and other health care decision-makers to help make informed
choices, improve outcomes, and stimulate the development of new payment models. The approach being
utilized by PQA is similar to the AQA and the Hospital Quality Alliance that have involved a broad array of
stakeholders with the goal of producing a standardized set of measures to improve the quality of health care.
Interest in pharmacy quality measures has grown accordingly in recent years, with employers and
policymakers leading the call for a means to measure and compare pharmacy quality. Most notably, Congress
enacted the Medicare Modernization Act in 2003, which created the Medicare Part D drug benefit and expanded
access to needed medications for the nation’s 43 million Medicare beneficiaries. The legislation also called for
development of quality standards and measures.
In November 2006, PQA, in collaboration with a broad array of stakeholders, approved a starter set of 35 key
areas for quality measurement for pharmacies and pharmacists practicing in a variety of settings. The starter set
of defined areas is intended to provide pharmacists and pharmacies with a set of indicators that may be utilized
for quality improvement, public reporting and pay-for-performance programs. The uniform starter set
comprises several key areas for measurement that include: 14 cardiovascular disease measures, 3 measures in
diabetes, 2 measures in hyperlipidemia, 4 measures in the area of respiratory disorders, 9 measures in the area of
patient safety and 3 measures in the generic efficiency area. Areas designated for measurement include
medication adherence and persistence, generic efficiency measures, and safe, efficient and appropriate
medication use. This effort will lead to a uniform set of measures for pharmacy care that can focus quality efforts
and give consumers data they need to make more informed health care decisions. In March 2007, PQA
announced the selection of the National Committee for Quality Assurance (NCQA) to further develop and test
these performance measures in alpha and beta testing as well as validation through pilot testing within
pharmacies.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 56
In addition to approving the initial set of measures, the PQA also endorsed two sets of principles put forth by
the PQA Reporting Workgroup: The PQA Principles for Public Reports, and The PQA Principles for Reporting to
Pharmacists and Pharmacy Practices. The next steps for the Reporting Workgroup will be to develop draft
reporting templates and also pilot test reports for use by pharmacies, pharmacists and consumers. Both sets of
principles are posted on the PQA website.
The PQA is guided by a Steering Committee committed to improving health care quality and patient safety and
pharmacy practice, and appointed to a three-year term of service, whose members are listed in the following
table.
Judith Cahill
Executive Director
Academy of Managed Care Pharmacy
Carolyn Clancy, MD
Director
Agency for Healthcare Research and Quality
John Gans, PharmD
Executive Vice President and CEO
American Pharmacists Association
N. Lee Rucker, MSPH
Strategic Policy Advisor,
Public Policy Institute,
AARP
Karen Ignagni
President and CEO
America’s Health Insurance Plans
Steven Anderson
President and CEO
National Association of Chain Drug Stores
John L. Fish, Vice President
Channel Management & Pharmacy Solutions
GlaxoSmithKline
David Marshall
Vice President, Commercial Operations
Teva Pharmaceuticals USA
Jack Mahoney, MD
Corporate Medical Director
Pitney Bowes
Mark McClellan, MD, PhD
Visiting Senior Fellow
AEI Brookings Joint Center
Edmond Weisbart, MD
Chief Medical Officer
Express Scripts, Inc.
Bruce Roberts, RPh
Executive Vice President and CEO
National Community Pharmacists
Association (NCPA)
Rebecca Snead, RPh
Executive Vice President and CEO
National Alliance of State Pharmacy Associations
John Feather
Executive Director & CEO
American Society of Consultant Pharmacists
Jeffrey Kelman, MD
Center for Beneficiary Choices
Centers for Medicare and Medicaid Services
TABLE 11. Members of Pharmacy Quality Alliance Steering Committee
Members of Pharmacy Quality Alliance Steering Committee
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 57
VII. INTERNATIONAL
U.K.’S NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE (NICE)
Established as a part of the British National Health Service in 1999, NICE reviews all types of medical
technologies, including drugs, that are likely to have a sizable health or budgetary impact or otherwise to be
controversial, and provides guidance to the NHS on the use of new and existing technologies. The actual
evaluation and assessment of the technology is done by a technical committee called the Technology Appraisal
Committee (TAC), which includes a large group of academic experts, clinicians, patient advocates, and industry
representatives. An academic group does the actual assessment; the TAC reviews it and publishes a
recommendation, which can be appealed. The recommendation is then submitted to NICE. The NICE appraisal
process has been estimated to take a year or more. NICE is not bound by the TAC’s recommendations; however,
drugs recommended by NICE are required to be funded by the government. NICE’s Citizens Council helps to
integrate broad social values judgments of the general public into the guidance NICE prepares.
Website: http://www.nice.org.uk/
CANADIAN AGENCY FOR DRUGS AND TECHNOLOGIES IN HEALTH (CADTH)
The Canadian Agency for Drugs and Technologies in Health (CADTH) is an independent, not-for-profit
agency funded by Canadian federal, provincial, and territorial governments to provide credible, impartial advice
and evidence-based information about the effectiveness of drugs and other health technologies to Canadian
health care decision makers. Activities include:
• Assessing drugs and health technologies: Health Technology Assessment (HTA)
HTA provides high-quality information about the clinical effectiveness, cost-effectiveness, and broader
impact of drugs, medical technologies, and health systems. The impartial, rigorous, and comprehensive
assessments examine four questions: (1) How will this health technology affect the health of Canadians? (2)
How does it compare with alternatives? (3) Does it provide value for the investment? (4) Are there other
health service implications to consider?
• Reviewing clinical evidence on new drugs: Common Drug Review (CDR)
In 2003, Canada introduced a coordinated process for reviewing drug coverage applications, the Common
Drug Review (CDR). The CDR reviews only new chemical entities and new combination products. The
reviews, which are not binding, are done for government drug plans in all provinces other than Quebec. An
advisory committee of experts, appointed by the deputy ministers of health from each province, makes
recommendations to the CDR based on assessments by reviewers, who can be either internal or external to
the CDR. The advisory committee sends the initial recommendation to the manufacturer, which can appeal
the decision. A summary of the recommendation and the rationale is posted, although neither the data nor
the assessment is made public.
• Identifying and promoting best practices in drug prescribing and use: Canadian Optimal Medication
Prescribing and Utilization Service (COMPUS)
Through its COMPUS program, CADTH identifies and promotes evidence-based, clinical and cost-
effectiveness information on optimal drug prescribing and use and is focused on improving health outcomes.
Strategies, tools, and services are provided to encourage the use of evidence-based clinical and cost-
effectiveness information in decision making among health care providers and consumers.
Website: http://www.cadth.ca/index.php/en/home
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 58
AUSTRALIA’S PHARMACEUTICAL BENEFITS ADVISORY COMMITTEE (PBAC)
PBAC is an independent statutory body established on 12 May 1954 under section 101 of the National Health
Act 1953 to make recommendations and give advice to the Minister about which drugs and medicinal
preparations should be made available as pharmaceutical benefits based on data and economic analyses
submitted by drug companies. PBAC is required by the Act to consider the effectiveness and cost of a proposed
benefit compared to alternative therapies. In making its recommendations PBAC, on the basis of community
usage, recommends maximum quantities and repeats and may also recommend restrictions as to the indications
where Pharmaceutical Benefits Scheme (PBS) subsidy is available. When recommending listings, the Committee
provides advice to the Pharmaceutical Benefits Pricing Authority (PBPA) regarding comparison with alternatives
or their cost effectiveness.
No new drug may be made available as a pharmaceutical benefit unless PBAC has so recommended. The final
decision is made public, but not the rationale for the decision or the relevant clinical or cost-effectiveness data.
There is no formal process for appeal.
GERMANY’S INSTITUTE FOR QUALITY AND EFFICIENCY
IN HEALTH CARE (IQWIG)
The Institute for Quality and Efficiency in Health Care is an independent scientific institute that evaluates
the quality and efficiency of health care. The Institute investigates what therapeutic and diagnostic services
are feasible and valuable, and communicates its findings to the health care professions, patients and the
general public.
On 1 June 2004, the Institute was established as part of Germany’s Health Care Reform overhaul as an
institution of the Foundation for Quality and Efficiency in Health Care in order to undertake commissions from
the Federal Joint Committee and the Federal Ministry of Health. Institute is financed by a tax on inpatient and
outpatient health care services, which are mainly reimbursed by the statutory health insurance (SHI) funds.
The Institute’s tasks include the evaluation of pharmaceuticals, surgical procedures, diagnostic tests, clinical
practice guidelines and aspects of disease management programs, following the principles of evidence-based
medicine. It also publishes health information for patients and the general public. The Institute’s primary goal is
to contribute to improvements in health care in Germany.
The Institute currently has eight departments. Professor Dr. Peter T. Sawicki, who assumed office
on 1 September 2004, is the Institute’s Director.
THE INTERNATIONAL NETWORK OF AGENCIES
FOR HEALTH TECHNOLOGY ASSESSMENT (INAHTA)
The International Network of Agencies for Health Technology Assessment (INAHTA) was established in
1993 and has grown to 45 member agencies linked to national and regional governments from 23 countries
including North and Latin America, Europe, Australia, and New Zealand. All members are non-profit
organizations who produce health technology assessments. INAHTA’s mission is to provide a forum for the
identification and pursuit of interests common to health technology agencies in order to facilitate exchange
and collaboration among agencies, promote information sharing and comparison, and prevent unnecessary
duplication of activities.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 59
The INAHTA membership meets yearly (in conjunction with the HTAi conference) and participates in
various working groups throughout the year. The organization’s website serves as its key form of
communication, where its reports, briefs, newsletter and other projects are available. In addition, INAHTA
participates in international conferences, workshops, exhibitions, educational activities and seminars to
disseminate its work. Currently, INAHTA’s individual working groups are collaborating on external partnerships
with such organizations as WHO, HTAi, OECD, and PAHO, as well as such issues as industry relations, quality
assurance, education and training, among others. The group plans to continue to enhance its function through
more systematic exchange of work among its members, more training opportunities, and by improving its
collaboration with other organizations.
Website: http://www.inahta.org/inahta_web/index.asp
HEALTH TECHNOLOGY ASSESSMENT INTERNATIONAL (HTAI)
HTAi is an international membership organization that focuses uniquely on health technology assessment
(HTA). HTAi seeks to support the development, communication, understanding and use of HTA around the
world as a means of promoting the introduction of effective innovations and effective use of resources in health
care. The group serves as a forum for individuals from the worlds of health care, academia, and business who
are interested in the science, development and application of HTA. HTAi’s activities include publication of the
quarterly International Journal of Technology Assessment in Health Care (IJTAHC) and an annual conference.
Website: http://www.htai.org/index.php?id=121
THE OECD HEALTH CARE QUALITY INDICATORS PROJECT
Run by the Organization for Economic Cooperation and Development (OECD), the HCQI Project is the only
international, multicondition project examining quality measurement and improvement issues. AHRQ has
provided ongoing technical guidance and leadership on this effort since 2001.
The OECD brought together a group of international leaders in the field of quality measurement to guide
development of a conceptual framework for the HCQI Project as well as develop a set of 85 indicators across 5
priority condition areas. This framework and these indicators will serve as the basis for the Project’s work on
improving data systems and tracking quality of care for many years. The supplement concludes with a look
forward at improving international quality measurement and reporting over the long term.
Ongoing support for the HCQI Project is provided by the European Commission and the Commonwealth
Fund, a national, private foundation based in New York City that supports independent research on health and
social issues. Technical and project leadership by AHRQ and these partners has helped ensure a solid foundation
for the HCQI Project and its goal of developing indicators and data systems that can be used to raise questions
on quality of care internationally.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 60
Organization: The Health Industry Forum, Brandeis University
Event: Coverage Policy in an Era of Personalized Medicine: Evaluating and Paying for
Genetic Testing Services
Date: October 12, 2006
Location: Washington, D.C.
Description: N/A – see agenda at link below
Website: http://healthforum.brandeis.edu/meetings.htm
http://healthforum.brandeis.edu/October%2012,%202006/Agenda_Web%2010.12.06.pdf
Organization: Society for Medical Decision Making
Event: The 28th Annual Meeting of the Society for Medical Decision Making
Date: October 15-18, 2006
Location: Boston, MA
Description: N/A
Website: http://smdm.confex.com/smdm/2006ma/techprogram/MEETING.HTM
Organization: The Chochrane Collaboration
Event: 14th Cochrane Colloquium
Date: October 22-26, 2006
Location: Dublin, Ireland
Description: As we approach the 3000th full Cochrane review, the challenges of making their findings more
accessible are ever increasing. This session will describe initiatives to help meet these challenges.
We will hear about ways to distil the information in Cochrane reviews into shorter summaries and
to combine multiple reviews into new, umbrella reviews. Other means of dissemination are also
important. There will be talks from the perspective of a long-standing print journal keen to help
make the message in Cochrane reviews more available and about an initiative between The
Cochrane Collaboration and Wiley to produce a new journal based heavily on Cochrane reviews.
Website: http://www.cochrane.co.uk/colloquium/welcome.htm
VIII. EVIDENCE-BASED MEDICINE CONGRESSES
A search was conducted to develop a comprehensive list of recently completed and upcoming meetings and
conferences being held on issues related to health technology assessment (HTA), evidence-based medicine
(EBM), and/or comparative effectiveness (CE), including conferences which may only have specific sessions
concentrated in one or both of these areas. The search included meetings and conferences that have occurred or
are scheduled to occur within the next year within North America, Europe, and elsewhere.
The results are included below.
OCTOBER 2006
NOVEMBER 2006
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 61
Organization: The Health Industry Forum, Brandeis University
Event: Comparative Effectiveness Forum
Date: November 30, 2006
Location: Washington, D.C.
Description: The Comparative Effectiveness Forum, held in Washington, D.C. on November 30, 2006,
brought together leading thinkers from academia, industry, and government to examine in
very practical terms how to make broadly available comparative effectiveness research a
reality in the U.S. This report summarizes the Forum’s four discussion sessions, highlighting
key points from each. Note: The Forum convenes small leadership conferences focusing on
innovative strategies for improving the quality and effectiveness of health care. Participation
is by invitation only.
Website: http://healthforum.brandeis.edu/meetings.htm
http://healthforum.brandeis.edu/NOVEMBER%20HTA%2030,%202006/
ExecBriefCompEffectiveForum113006.pdf
Organization: International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
Event: ISPOR 9th Annual European Congress
Date: October 28-31, 2006
Location: Copenhagen, Denmark
Description: N/A – see agenda at link below
Website: http://www.ispor.org/congresses/denmark1006/CongressProgram.pdf
Organization: Organized in conjunction with ISPOR
Event: Regional Conference on Cost-Effective Healthcare 2006
Date: October 28-31, 2006
Location: Singapore
Description: N/A
Website: http://www.cehealth2006.com/
OCTOBER 2006 continued
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 62
FEBRUARY 2007
Organization: University of Queensland
Event: 4th Queensland Biohumanities Conference: Evidence-Based Medicine
Date: January 8-9, 2007
Location: Brisbane, Australia
Description: N/A
Website: http://www.representinggenes.org/biohumanities/podcasts/4QBC_podcast.htm
JANUARY 2007
Organization: Massachusetts Health Data Consortium
Event: 2007 Healthcare Information Technology Conference
Date: February 2, 2007
Location: Burlington, MA
Description: N/A – please see agenda at link below
Website: http://www.mahealthdata.org/forums/events/2007/HIT_0202/registration.html
Organization: Asia Pacific Center for Evidence-Based Medicine
Event: 5th Asia Pacific Evidence-Based Medicine Workshop & Conference
Date: February 4-7, 2007
Location: Singapore
Description: N/A – please see agenda at link below
Website: http://www.nuh.com.sg/nuh_apebm/5th%20APEBM_Home.html
http://www.nuh.com.sg/nuh_apebm/5th%20APEBM_WorkshopInformation(2).html#Programme
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 63
MARCH 2007
Organization: National Council for Community Behavioral Healthcare
Event: 37th Annual National Council Conference
Date: March 26-28, 2007
Location: Las Vegas, NV
Description: Session of interest: Evidence-Based Depression Treatment: Making an IMPACT (03/27-28)
Website: http://conference.nccbh.org/
Organization: Avalere Health
Event: Audio Conference on Presenting Comparative Treatment Information to Consumers:
Impact on Patients and Manufacturers
Date: March 28, 2007
Location: Audio conference
Description: The Agency for Healthcare Research and Quality (AHRQ) recently began producing consumer-
oriented versions of its evidence-based comparative effectiveness research reports; the guides
publish costs of various over-the-counter and prescription drugs in addition to other decision-making
information. Audio conference participants learned how these guides were developed, how they
have impacted the physician-patient relationship, and talked about the government’s role in
influencing decision-making at the patient level.
Website: http://www.avalerehealth.net/conferences/effective_health_care.html
Organization: Old Dominion University/Center for Medicine in the Public Interest
Event: Improving Healthcare Quality and Value: The Role of Comparative Effectiveness Research
Date: March 29, 2007
Location: Washington, D.C. (National Press Club)
Description: N/A
Website: http://hs.odu.edu/hs/newsevents/nfhkm_agenda.pdf
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 64
APRIL 2007
Organization: The Health Industry Forum, Brandeis University
Event: Developing an Effective Long Term Strategy for Post-Marketing Surveillance
of Medical Products
Date: April 11, 2007
Location: Washington, D.C.
Description: N/A – see agenda at link below
Website: http://healthforum.brandeis.edu/meetings.htm
Organization: National Working Group on Evidence-Based Health Care
Event: Public forum on the central role patients should play in evidence-based health care
Date: April 19, 2007
Location: Webcast
Description: N/A – see agenda at link below
Website: http://healthforum.brandeis.edu/meetings.htm
Organization: Canadian Agency for Drugs and Technologies in Health (CADTH)
Event: 2007 CADTH Symposium - Informing Policy, Influencing Practice, Improving Health
Date: April 22-24, 2007
Location: Ottawa, Ontario
Description: Multiple relevant sessions on HTA and EBM — see event program for full descriptions.
Website: http://www.cadth.ca/index.php/en/events/sympos-2007
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 65
MAY 2007
Organization: BIO® Biotechnology Industry Organization
Event: BIO International Convention
Date: May 6-9, 2007
Location: Boston, MA
Description: Sessions of interest - Science for Payment: A Payer Perspective of Technology Assessment (05/07);
The Cost of Effective Care for Rare Diseases (05/07); The Value of Innovation: A Patient-Centered
Agenda in Pricing & Reimbursement? (05/08); The Fourth Reimbursement Hurdle: Cost-
Effectiveness; Safe or Effective? FDA’s, the Industry’s and the Patient’s Regulatory Dilemma.
Website: http://www.bio2007.org/
Organization: Blue Cross and Blue Shield Association
Event: Luncheon Briefing: BCBSA Announces New Initiative For Comparative
Effectiveness Research
Date: May 7, 2007
Location: Washington, D.C. (National Press Club)
Description: Blue Cross and Blue Shield Association announces a proposal for a new, independent entity to
explore the effectiveness of new and existing medical procedures, drugs, devices, and biologics.
Website: http://www.bcbs.com/news/press/luncheon-briefing-bcbsa.htm
Organization: Jefferson Medical College
Event: The Disease Management Colloquium
Date: May 7-9, 2007
Location: Philadelphia, PA
Description: Session of interest: Evidence-Based Medicine and Disease Management (05/07).
Website: http://www.dmconferences.com/
Organization: European Science Foundation (ESF)
Event: The International Regulation of New Medical Technology, Germany
Date: May 7-11, 2007
Location: Philadelphia, PA
Description: Salzau Castle, Salzau (near Kiel), Germany
Website: http://www.esf.org/conferences/07237
Organization: National Health Service (NHS)
Event: Service Delivery and Organization R&D Programme (SDO) –
Sixth National SDO Conference: Delivering Better Health Services
Date: May 9, 2007
Location: London, UK
Description: A one day conference for all those concerned with the delivery and management of effective,
evidence-based health care – service users, health service managers, health professionals,
researchers and policy makers.
Website: http://www.healthcareevents.co.uk/tabid/63/Default.aspx/?conferenceId=99
MAY 2007 continued
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 66
Organization: National Quality Forum (NQF)
Event: NQF Spring Meetings
Date: May 9-11, 2007
Location: Chicago, IL
Description: The demand for reporting quality-related data to increase the transparency and accountability
of health care is growing, and the NQF is convening its 2007 Healthcare Quality Implementation
Conference to support providers in overcoming the challenges of performance measurement and
reporting. A vanguard of users of NQF-endorsed TM consensus standards is proving that it can
be done. Their stories demonstrate that consensus standards can be implemented successfully,
to the ultimate benefit of patients.
Website: http://www.qualityforum.org/about/meetings/spring_meeting07.asp
http://www.qualityforum.org/pdf/meetings/ag04-18-07.pdf
Organization: American Psychiatric Association
Event: APA 160th Annual Meeting
Date: May 19, 2007
Location: San Diego, CA
Description: Sessions of interest: Evidence-Based and Guideline Approaches to Psychiatric Treatments (05/22);
Uneasy Partners: The Pharmaceutical Industry and the Psychiatric Profession (05/22); several other
discussions on evidence-based practices in particular areas of psychiatry.
Website: http://www.psych.org/edu/ann_mtgs/am/07/index.cfm
Organization: International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
Event: ISPOR 12th Annual International Meeting
Date: May 19-23, 2007
Location: Arlington, VA
Description: New Tools, New Audiences for Health Outcomes Research – Sessions of interest: Health Care
Comparative Effectiveness in the United States Symposium (05/20); Raising the Bar in the U.S.:
The Impact of Heightened Awareness of the Need for Health-Economic Data in the Absence of
a Regulatory Mandate (05/21); Do Physicians Use Cost-Effectiveness Research? Should They?
(05/22); Health Technology Assessment in Evidence-Based Reimbursement (05/22); What is
Uncertainty in Cost-Effectiveness Analysis? How Should We Characterize It? (05/22); numerous
posters and podium presentations.
Website: http://www.ispor.org/Events/Index.aspx?eventId=11
MAY 2007 continued
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 67
Organization: Avalere Health
Event: Evidence-Based Medicine: Set Your Sights
Date: May 22, 2007
Location: Washington, D.C.
Description: Recent developments in evidence-based medicine are generating a wave of transformation in health
care – are you ready to take it on? Join experts from government, industry, and academia to discuss
the latest trends in value-based purchasing, comparative effectiveness, and insurance coverage
decision-making. Find out how developments in EBM may further influence product
commercialization strategy, how to engage in the redefinition of the clinical research enterprise, and
whether payment reform will include paying for quality improvement.
Website: http://www.avalerehealth.net/conferences/evidence2007.html
Organization: Institute of Medicine (IOM) Forum on the Science of Health Care Quality
Improvement and Implementation
Event: Workshop on Conduct of Healthcare Quality Improvement Research
Date: May 24-25, 2007
Location: Irvine, CA
Description: N/A – see agenda at links below
Website: http://www.iom.edu/CMS/3809/38607/42075.aspx
http://www.iom.edu/Object.File/Master/42/842/Draft%20Public%20Agenda%20
Workshop%202-%205%203%2007.pdf
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 68
JUNE 2007
Organization: AcademyHealth
Event: Annual Research Meeting 2007
Date: June 3-5, 2007
Location: Orlando, FL
Description: AcademyHealth’s Annual Research Meeting brings together health services researchers, providers,
and key decision makers to address the critical challenges confronting the health care delivery
system. The meeting provides opportunities to present and hear about cutting-edge research,
debate timely policy issues, and learn about new methods and funding sources. Sessions of
interest: Expanding the Capacity for Comparative Effectiveness Research in the United States
(06/03); Gift Horse or Trojan Horse: The Increasing Controversy Surrounding Evidence-Based
Medicine (06/04); Issues in Cost-Effectiveness Analysis (06/05).
Website: http://www.academyhealth.org/arm/index.htm
Organization: Canadian College of Health Service Executives (CCHSE)/
Canadian Association for Health Services and Policy Research (CAHSPR)
Event: National Healthcare Leadership Conference/2007 Annual CAHSPR Conference
Date: June 11-12, 2007
Location: Toronto, Canada
Description: N/A – see agenda at link below
Website: http://www.healthcareleadershipconference.ca/default1.asp
Organization: University of York Centre for Health Economics
Event: York Expert Workshops in the Socio Economic Evaluation of Medicines 2007
Date: June 13-15/18-22/25-27, 2007
Location: York, UK
Description: Session of interest: Meeting Decision-Makers’ Requirements: Advanced Methods for
Cost Effectiveness Analysis (06/18-22).
Website: http://www.york.ac.uk/inst/che/training/expert.htm
Organization: The European League Against Rheumatism (EULAR)
Event: EULAR Congress 2007
Date: June 13-16, 2007
Location: Barcelona, Spain
Description: The EULAR congress is the venue for scientific presentation of basic, clinical and translational
research. Hopefully, new knowledge can be translated into improved prevention of the rheumatic
diseases and into better treatment and rehabilitation of patients with these disorders. The congress
is also a meeting point for rheumatologists, health professionals and patients where they come
together, exchange ideas, and develop plans for future collaborative research or educational
activities. Sessions of interest: Evidence-Based Practice in Non-Pharmacological Care – from Vision
to Reality (06/13)
Website: http://www.eular.org/scientificprogramme/
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 69
JUNE 2007 continued
Organization: Asia Pacific Center for Evidence-Based Medicine
Event: Annual Evidence-Based Medicine Workshop: How to Practice and Teach
Evidence-Based Medicine
Date: June 14-17, 2007
Location: Antipolo City, Philippines
Description: N/A – see agenda at link below
Website: http://www.apebm.com/
Organization: Health Technology Assessment International (HTAi)
Event: HTAi 2007: HTA For Evidence-Based Public Health
Date: June 17-20, 2007
Location: Barcelona, Spain
Description: The International Regulation of New Medical Technology: Health Technology Adoption in the
European Union, the US, East Asia and in the Developing World - Our conference comprises five
thematic sessions with invited presentations and additional short talks and poster viewing sessions.
(1) Theory and Policy Issues, (2) Health Technology Adoption and Regulation in the European Union,
(3) Health Technology Adoption and Regulation in North America, (4) Health Technology Adoption
and Regulation in East Asia, (5) Health Technology Adoption and Regulation in Low and Middle
Income Countries.
Website: http://www.esf.org/conferences/07237
Organization: Drug Information Association (DIA)
Event: 43rd Annual Meeting
Date: June 17-21, 2007
Location: Atlanta, GA
Description: The DIA Annual Meeting is the event of the year for the pharmaceutical and related industries. No
other industry event can rival the breadth and depth of experience that this meeting delivers. With
more than 1,000 speakers from the FDA, EMEA, and other regulatory agencies, 27 content-area
tracks, and nearly 400 sessions, the presentations are geared to attendees of all experience and
functional levels. The DIA Annual Meeting, above all others, offers valuable professional cross-
functional learning, continuing education credits, and networking experiences. Sessions of interest:
Personalized Medicine: A Perspective Beyond Science (06/18); The Emergent Role of the Medical
Scientist in the Evidence-based Payer Environment: A Fundamental Source for Qualitative and
Quantitative Information (06/20); Defining the Value of Pharmaceuticals (06/20).
Website: http://www.diahome.org/DIAHome/FlagshipMeetings/home.aspx?meetingid=11362
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 70
JUNE 2007 continued
Organization: America’s Health Insurance Plans (AHIP)
Event: AHIP Institute 2007
Date: June 20-22, 2007
Location: Las Vegas, NV
Description: Institute, AHIP’s Annual Meeting offers attendees from all arenas within the health insurance
industry and stakeholders in health care the opportunity to explore the latest cutting-edge
technologies, marketplace changes, new models of delivery and care, and other leading challenges
and opportunities facing the health care industry. Thousands of leaders attend the Institute each
year, including Presidents and CEOs, COOs, CFOs, CIOs, CMOs/Medical Directors, Vice Presidents,
Medical Program Managers, Product and Plan Design Professionals, Account Managers, and
Consultants. Session of interest: Translating Comparative Effectiveness Into Value-Based Benefit and
Reimbursement Designs (06/20).
Website: http://www.ahip.org/links/institute2007/
Organization: The NHS Confederation
Event: Annual Conference and Exhibition 2007
Date: June 20-22, 2007
Location: London, UK
Description: The NHS Confederation’s annual conference and exhibition bridges the gap between day-to-day
reality and the politicians’ vision for the future. Themed this year around serving patients and the
community, the event will deliver a programme that is relevant to every sector and stakeholder in
the health service. Session of interest: quality and efficiency strand.
Website: http://www.nhsconfed.org/about/about-2405.cfm
Organization: Faculty of Public Health
Event: The Faculty of Public Health Annual Conference 2007
Date: June 26-28, 2007
Location: Eastbourne, UK
Description: N/A - see agenda at link below
Website: http://www.publichealthconferences.org.uk/annual/
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 71
JULY 2007
Organization: International Health Economics Association (iHEA)
Event: iHEA 6th World Congress: Explorations in Health
Date: July 8-11, 2007
Location: Copenhagen, Denmark
Description: Sessions of interest: Coverage of new health care technologies in the US: an investigation of
principles, processes and the use of cost-effectiveness information (07/09); The ACE (Assessing Cost
Effectiveness) Approach to Priority Setting (07/09); The research-policy interface: better evidence for
better health policies in Europe (07/09); From Best Evidence to Best Practice - Effect of Guidelines-
Based Practice on Patient Outcomes and Health Care Utilization (07/09); Systematic reviews and
economic evaluations in technology appraisals conducted for NICE in the UK: A game of two halves?
(07/10); Expected value of information and decision making in HTA (07/11).
Website: http://www.healtheconomics.org/congress/2007/
Organization: Advanced Medical Technology Association (AdvaMed)
Event: Medical Technology Reimbursement Specialist Workshop
Date: July 10-13, 2007
Location: Washington, D.C.
Description: N/A – see agenda at link below
Website: http://www.advamedmtli.org/mtli/mtg07-21.cfm
Organization: The Cochrane Collaboration
Event: Summer Institute for Evidence-Based Practice: Quality and Safety
Date: July 12-14, 2007
Location: San Antonio, TX
Description: N/A – see agenda at link below
Website: http://news.cochrane.org/view/item/review_one.jsp?j=754
http://www.acestar.uthscsa.edu/institute/su07/agenda.html
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 72
AUGUST 2007
Organization: The Department of Preventive Medicine and the
Rocky Mountain Prevention Research Center
Event: 9th Rocky Mountain Workshop on How to Practice Evidence-Based Health Care
Date: August 5-9, 2007
Location: Colorado Springs, CO
Description: This five-day, hands-on workshop is held annually in the summer at one of the beautiful resorts in
the Rocky Mountains. It features a cadre of world-renowned teachers, practitioners and researchers
from the arena of evidence-based health care. Funded in part by a grant from AHRQ, this five-day
workshop will focus on teaching the basics of, and developing further insights into, the
conscientious use of current best evidence in making decisions about the care of individual patients
or the delivery of health services.
Website: http://news.cochrane.org/view/item/review_one.jsp?j=810
Organization: Strategic Research Institute
Event: 5th Annual Disease Management Conference
Date: August 6-7, 2007
Location: Boston, MA
Description: Mark your calendars for a state-of-the-industry featuring various key issues, challenges, new
developments and implications for major stakeholders. The sessions will cover the following major
areas and offer timely and practical advice to practitioners and key health care players. Implications
and developments relating to: employers, managed care organizations, consumer-driven health care,
new technologies, disease management vendors, government agencies, evidence and outcomes
research, public and private consumer engagement strategies.
Website: http://www.srinstitute.com/conf_page.cfm?instance_id=27&web_id=913&pid=520
Organization: São Paulo Center for Health Economics at the Federal University of São Paulo
(Centro Paulista de Economia da Saúde – CPES)
Event: 7th International Symposium on Health Economics - Health Technology Assessment:
Challenges for a Responsible Decision
Date: August 15-17, 2007
Location: São Paulo, Brazil
Description: N/A
Website: http://www.ispor.org/meetings/other/7simposio_ingles.pdf
http://cpes.org.br/
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 73
SEPTEMBER 2007
Organization: International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
Event: ISPOR 1st Latin America Conference
Date: September 9-11, 2007
Location: Cartagena, Colombia
Description: Session of interest: 2nd Plenary Session: Health Care Technology Assessment: Developing &
Using the Evidence in Health Care Decisions (09/11)
Website: http://www.ispor.org/Events/Index.aspx?eventId=23
Organization: International Society for Quality in Health Care (ISQua)
Event: 24th Conference for the International Society for Quality in Health Care (ISQua)
Date: September 30 – October 3, 2007
Location: Boston, MA
Description: The International Society for Quality in Health Care conference focus is on the methodologies that
facilitate safe, quality health care. From invited plenary presentations, selected panels, oral and
poster presentations, participants will have opportunities to explore collaborative approaches to
quality improvement among users, providers and funders, and to examine new systems and ideas.
With the theme of Transforming Healthcare in the Electronic Age, this multidisciplinary quality health
care program will be of value to all health policy makers, planners, professionals, administrators,
researchers, educators and their representatives.
Website: http://www.isqua.org/isquaPages/boston07.html
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 74
Organization: Advanced Medical Technology Association (AdvaMed)
Event: 2007 Med Tech Conference
Date: October 1-3, 2007
Location: Washington, D.C.
Description: N/A – TBD
Website: http://www.advamed2007.com/
Organization: Institute of Medicine (IOM)
Event: 37th Annual Members Meeting
Date: October 8, 2007
Location: Washington, D.C.
Description: Theme: Evidence-Based Medicine and the Changing Nature of Health Care.
Website: http://www.iom.edu/
Organization: Institute of Medicine (IOM)
Event: Joint conference on comparative effectiveness (ECRI/Milbank/Kaiser/EBRI/Health Affairs)
Date: October 17-18, 2007
Location: N/A
Description: N/A
Website: http://www.iom.edu/CMS/2957.aspx
Organization: Society for Medical Decision Making
Event: The 29th Annual Meeting of the Society for Medical Decision Making
Date: October 21-24, 2007
Location: Pittsburgh, PA
Description: N/A
Website: http://www.smdm.org/
Organization: International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
Event: ISPOR 10th Annual European Congress
Date: October 20-23, 2007
Location: Dublin, Ireland
Description: Expanding European Horizons for Pharmacoeconomics and Outcomes Research –
Sessions of interest: First Plenary Session: Is Small Beautiful? Challenges Facing Ireland in
Adopting the “Fourth Hurdle” (10/21); Second Plenary Session: Patient Reported Outcomes:
A European Perspective (10/22).
Website: http://www.ispor.org/Events/Index.aspx?eventId=21
OCTOBER 2007
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 75
OCTOBER 2007 continued
Organization: America’s Health Insurance Plans (AHIP)
Event: 2007 Medical Leadership Forum: Evidence-based Solutions to Health Care’s Challenge
Date: October 22-24, 2007
Location: Phoenix, AZ
Description: This year’s Forum offers a unique opportunity to discuss key health issues that challenge the
delivery and financing of care with nationally recognized leaders.
Website: http://www.ahip.org/links/medmgt2007/
Organization: Q1 Productions
Event: Evidence-Based Medicine Conference: Examining the Best Practices in Data Analysis,
Review and Collection to Support Labeling and Reimbursement Claims through Strategic
Evidence-Based Medicine Practices
Date: October 22-23, 2007
Location: Baltimore, MD
Description: Through addressing a range of topics related to the best practices in evidence-based medicine, this
conference program will provide attendees with the need to know information related to health
economics and outcomes research within the pharmaceutical and biotechnologies industry. Building
upon early Q1 successes including the PRO 2006 conference as well as the Phase IV Clinical
Research and Patient Registries conferences, this program will be a meeting of the minds and will
address both strategic and tactical questions related to improving overall health quality of life
through evidence-based medicine.
Website: http://www.q1productions.com/events_EvidenceBasedMedicine.htm
Organization: The Cochrane Collaboration
Event: 15th Cochrane Colloquium: Evidence-based health care for all
Date: October 23-27, 2007
Location: São Paulo, Brazil
Description: Over the past fifteen years, the Cochrane Collaboration has grown rapidly and Colloquia (the
annual international conferences of the Cochrane Collaboration) are evolving to meet needs of an
expanding spectrum of participants. The Cochrane Library now includes a breadth of knowledge
that is relevant to a wide range of different types of health professionals, policy makers and
consumers. It is important that we continue to develop the quality and quantity of this evidence
and ensure that it is accessible to decision makers to support “evidence-based health care for all“-
the theme of this year’s Colloquium.
Website: http://www.colloquiumbrasil.info/php/index.php
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 76
JANUARY 2008
DECEMBER 2007
Organization: The National Institute for Health and Clinical Excellence (NICE)
Event: NICE 2007 Annual Conference and Exhibition: Evidence into Practice
Date: December 5-6, 2007
Location: Manchester, UK
Description: NICE 2007 will address how NICE uses expert advice and evidence to develop guidance, and will
offer practical and realistic examples for those working in the NHS and wider public health
community on the best ways to turn recommendations into reality.
Website: http://www.nice2007.co.uk/
Organization: Health Economists’ Study Group (HESG)
Event: 72nd Meeting of the Health Economists’ Study Group
Date: January 9-11, 2008
Location: Norwich, UK
Description: N/A
Website: http://www.hesg.org.uk/news.php?PHPSESSID=00649792cbf58669454fa9d0eb4117b1
Organization: University of Birmingham
Event: Methodological Basis of HTA
Date: January 21-25, 2008
Location: Birmingham, UK
Description: This two-week course provides a detailed overview of the methodological basis of undertaking a
systematic review/health technology assessment. Technologies considered include interventions,
clinical, diagnostic test accuracy and other types of HTA. Areas that will be covered include:
scoping/focusing of questions, literature searching methods, publication and related biases, quality
assessment of studies, approaches to data extraction, interpretation of results, data synthesis and
analysis methods including meta-analysis. The course is practically based and participants will have
the opportunity to work with example data sets including their own.
Website: http://www.pcpoh.bham.ac.uk/publichealth/programmes/hta/short-courses.htm
Organization: The Institut D’Economie Industrielle
Event: Health Economics and the Pharmaceutical Industry
Date: January 25-26, 2008
Location: Toulouse, France
Description: Industry Regulation and Consequences; Industrial organization of the drug industry (and of other
parts of the health sector); Health System Reform, with a special emphasis on European health
systems; Economics and Value of Health
Website: http://www.irdes.fr/EspaceDoc/Documents/CalendrierDesColloques
/ConfHealthEconomics25janv08.pdf
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 77
FEBRUARY 2008
Organization: AcademyHealth
Event: 2008 National Health Policy Conference
Date: February 4-5, 2008
Location: Washington, D.C.
Description: Get perspective on 2008 policy priorities directly from the policymakers.
Website: http://www.academyhealth.org/nhpc/agenda.htm
Organization: World Congress
Event: The World Congress Leadership Summit on Evidence-Based Medicine
Date: February 11-12, 2008
Location: Alexandria, VA
Description: The Evidence-Based Medicine Summit will convene senior level executives from health plans,
health systems, hospitals, government agencies and academia to discuss the utilization of
evidence-based medicine to develop a clinical guideline policy. Thought leaders will share best
practices in using the guidelines to improve cost and quality of care and the tools and techniques
required to assess the validity of the data. The issues of coverage and reimbursement models will
also be discussed as health care moves towards value based medicine.
Website: http://www.worldcongress.com/events/HL08007/index.cfm?print=true&TheConfCode=HL08007
Organization: AdvaMed
Event: Medical Technology Reimbursement Specialist Workshop
Date: February 19-22, 2008
Location: Las Vegas, NV
Description: Session of note: Technology Assessments
Website: http://www.advamedmtli.org/go.cfm?do=Page.View&pid=50
Organization: National University Hospital of Singapore, Asia Pacific Centre for
Evidence-Based Medicine
Event: 6th Asia Pacific Evidence-Based Medicine/Nursing Workshop and Conference
Date: February 26-29, 2008
Location: Singapore
Description: Conference highlight: Post-conference symposium for heads of departments:
“Why Bother with Evidence-Based Medicine?“
Website: http://www.nuh.com.sg/nuh_ebm/ebm_apebm.htm
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 78
MARCH 2008
Organization: America’s Health Insurance Plans (AHIP)
Event: National Policy Forum
Date: March 4-6, 2008
Location: Washington, D.C.
Description: N/A
Website: http://www.ahip.org
Organization: The Cochrane Collaboration
Event: 2008 Canadian Cochrane Symposium
Date: March 6-7, 2008
Location: Edmonton, AB, Canada
Description: N/A
Website: http://news.cochrane.org/view/item/review_one.jsp?j=948
Organization: National Quality Forum (NQF)
Event: Leadership Colloquium and Quality Award Gala; Board of Directors Meeting
Date: March 14-15, 2008
Location: Washington, D.C.
Description: N/A
Website: http://www.qualityforum.org/
Organization: National Quality Forum (NQF)
Event: Spring Membership Meeting and Implementation Conference on Care Coordination;
Board of Directors Meeting
Date: March 26-28, 2008
Location: Atlanta, GA
Description: N/A
Website: http://www.qualityforum.org/
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 79
APRIL 2008
Organization: Centre for Evidence-Based Medicine
Event: 3-Day Workshop on Evidence-Based Practice
Date: April 7-9, 2008
Location: Oxford, UK
Description: This workshop is aimed at clinicians and other health care professionals, including those involved
in mental health, who want to gain knowledge of critical appraisal and experience in the
practice of evidence-based health care. The workshop is intended to serve as an introduction to
evidence-based medicine itself.
Website: http://www.cebm.net/index.aspx?o=1475
Organization: Institute of Medicine
Event: Roundtable on Evidence-Based Medicine Workshop on Engineering a
Learning Healthcare System
Date: April 28-29, 2008
Location: Washington, D.C.
Description: Increasing complexity in health care is likely to accentuate current problems unless reform efforts
go far beyond financing, to foster significant changes in the culture, practice, and delivery of
health care. If the effectiveness of health care is to keep pace with the opportunity of diagnostic
and treatment innovation, system design and information technology must be structured to assure
application of the best evidence, continuous learning, and research insights as a natural by-
product of the care process. In effect, the nation needs to engineer the development of a learning
health care system—one structured to keep the patient constantly in focus, while continuously
improving quality, safety, knowledge, and value in health care. Striking transformations have
occurred through systems and process engineering in service and manufacturing sectors—
e.g., banking, airline safety, and automobile manufacturing. Despite the obvious differences that
exist in the dynamics of mechanical versus biological and social systems, the current challenges
in health care compel an entirely fresh view of the organization, structure, and function of the
delivery and monitoring processes in health care.
Website: http://www.iom.edu/CMS/28312/RT-EBM/52747.aspx
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 80
MAY 2008
Organization: National Council for Community Behavioral Healthcare
Event: 38th National Council Conference
Date: May 1-3, 2008
Location: Boston, MA
Description: From scientific advances to leadership training, we’re planning a robust curriculum featuring
an array of tools and insights to help community behavioral health providers enhance business
operations and revenue and improve clinical outcomes. Attendees also benefit from engaging
presentations from world-renowned motivational speakers, incomparable opportunities for
personal and career growth, and more — all wrapped in a spirit of
community, camaraderie, and caring.
Website: http://www.thenationalcouncil.org/cs/boston
Organization: International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
Event: ISPOR 13th Annual International Meeting
Date: May 3-7, 2008
Location: Toronto, ON, Canada
Description: Vive la Différence - Enhancing/Expanding Outcomes Research One Country at a Time
Website: http://www.ispor.org/Events/Index.aspx?eventId=24
Organization: American Psychiatric Association
Event: 2008 APA Annual Meeting
Date: May 3-8, 2008
Location: Washington, D.C.
Description: Our Voice in Action: Advancing Science, Care, and the Profession
Website: http://www.psych.org/edu/ann_mtgs/am/08/index.cfm
Organization: National and Gulf Center for Evidence-Based Medicine
Event: 4th Saudi Annual Workshop; Systematic Review Workshop; 4th Saudi Annual Conference
Date: May 7-8, 2008
Location: Riyadh, Saudi Arabia
Description: N/A
Website: http://www.ngha.med.sa/ebm/Events/2008/index.htm?L2ID=2004
Organization: The Cochrane Collaboration
Event: 8th Annual International C2 Colloquium
Date: May 12-14, 2008
Location: Vancouver, BC, Canada
Description: N/A
Website: http://www.campbellcolloquium.org
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 81
MAY 2008 continued
Organization: Jefferson Medical College
Event: 8th Disease Management Colloquium at Jefferson
Date: May 19-21, 2008
Location: Philadelphia, PA
Description: The Colloquium seeks to better educate government agencies, the health care industry
(including health plans and providers), employers, and the general public about the important
role disease management programs play in improving health care quality and outcomes for
persons subject to chronic conditions.
Website: http://www.dmconferences.com/overview.html
Organization: Geneva Health Forum
Event: Strengthening Health Systems and the Global Health Workforce
Date: May 25-28, 2008
Location: Geneva, Switzerland
Description: N/A
Website: http://www.genevahealthforum.org/
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 82
JUNE 2008
Organization: Society for Medical Decision Making
Event: SMDM Europe 2008
Date: June 1-4, 2008
Location: Engleberg, Switzerland
Description: The conference will bring together researchers and practitioners in a variety of areas within
medical decision-making. Participants will be exposed to theoretical developments, applications,
and implementation in practice.
Website: http://www.smdmeurope2008.com
Organization: Canadian Healthcare Association, Canadian College of Health Service Executives
Event: National Healthcare Leadership Conference
Date: June 2-3, 2008
Location: Saskatoon, Saskatchewan, Canada
Description: Regionalization: Lessons Learned or Lessons Lost?
Website: http://www.healthcareleadershipconference.ca/default1.asp
Organization: AcademyHealth
Event: Annual Research Meeting
Date: June 8-10, 2008
Location: Washington, D.C.
Description: AcademyHealth’s Annual Research Meeting (ARM) has brought together health services
researchers, providers, and key decision makers to address the critical challenges confronting
the nation’s health care delivery system.
Website: http://www.academyhealth.org/arm/themes.htm
Organization: Biotechnology Industry Organization
Event: BIO International Convention 2008
Date: June 17-20, 2008
Location: San Diego, CA
Description: N/A
Website: http://bio2007.org/
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 83
JUNE 2008 continued
Organization: America’s Health Insurance Plans (AHIP)
Event: Institute 2008 – AHIP’s Annual Meeting
Date: June 18-20, 2008
Location: San Francisco, CA
Description: N/A
Website: http://www.ahip.org
Organization: The National Health Service (NHS) Confederation
Event: Annual Conference and Exhibition
Date: June 18-20, 2008
Location: Manchester, UK
Description: A major program of work with members and partners in advance of the conference will look
ahead to anticipate what will be different in the future and what the opportunities for progress
will be. The thinking from this work will be discussed at the conference with a number of
provocative questions debated in the plenary and strand sessions. We expect to address
challenges of consumerism and user empowerment, health improvement and community
development, productivity, compassion in care, a new relationship between the medical
profession and management, clinical futures and the future workforce.
Website: http://www.nhsconfed.org/issues/about-2801.cfm
Organization: American Society of Health Economists
Event: 2nd Biennial Conference
Date: June 22-25, 2008
Location: Durham, NC
Description: Equity and Efficiency in Health and Healthcare
Website: http://www.healtheconomics.us/conference/
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 84
JUNE 2008 continued
Organization: The University of York Centre for Health Economics
Event: York Expert Workshops in the Socioeconomic Evaluation of Medicines 2008
Module 1: Foundations of Economic Evaluation in Health Care
Date: June 23-27, 2008
Location: York, UK
Description: N/A
Website: http://www.york.ac.uk/inst/che/training/expert.htm
Organization: European Health Management Association (EHMA)
Event: 2008 EHMA Annual Conference
Date: June 25-27, 2008
Location: Athens, Greece
Description: N/A
Website: http://www.ehma.org/annual_conference/default.asp?NCID=83
Organization: The University of York Centre for Health Economics
Event: York Expert Workshops in the Socioeconomic Evaluation of Medicines 2008
Module 2: Meeting Decision-makers’ Requirements: Advanced Methods for
Cost-Effectiveness Analysis
Date: June 30 – July 5, 2008
Location: York, UK
Description: N/A
Website: http://www.york.ac.uk/inst/che/training/expert.htm
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 85
JULY 2008
Organization: Health Technology Assessment International (HTAi)
Event: Fifth Annual Meeting of HTAi
Date: July 6-9, 2008
Location: Montreal, Canada
Description: Supporting decision making in health systems is the raison d’être of HTA. The conference will
develop the theme Health Technology Assessment in Context by focusing specifically on the links
between governance and HTA, the role of HTA in hospitals, and the role of HTA in enabling the
introduction of promising technologies. This first Annual Meeting of HTAi in North America,
birthplace of HTA, will provide a unique forum for researchers, practitioners and decision makers
to share experiences and knowledge on best practice in HTA for decision making for health.
Website: http://www.htai2008.org/en_home.phtml
Organization: The University of York Centre for Health Economics
Event: York Expert Workshops in the Socioeconomic Evaluation of Medicines 2008
Module 3: Quality of Life
Date: July 7-9, 2008
Location: York, UK
Description: N/A
Website: http://www.york.ac.uk/inst/che/training/expert.htm
Organization: Athens Institute for Education and Research
Event: 7th International Conference on Health Economics, Management, and Policy
Date: July 10-13, 2008
Location: Athens, Greece
Description: N/A
Website: http://www.atiner.gr/docs/Health.htm
Organization: European Congress on Health Economics (ECHE)
Event: 7th European Conference on Health Economics
Date: July 23-26, 2008
Location: Rome, Italy
Description: The theme chosen for the ECHE Roma 2008 Conference raises the hope that health economics
becomes the centre of a global process of renewal based on development stemming from new
knowledge in the scientific field but also paying due attention to the experience and knowledge
previously accumulated.
Website: http://www.echeroma2008.eu/home/
SEPTEMBER 2008
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 86
Organization: International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
Event: ISPOR 3rd Asia-Pacific Conference
Date: September 7-9, 2008
Location: Seoul, South Korea
Description: Evidence-Based Health Care Decision Making in Asia Pacific: The Application of
Pharmacoeconomics and Outcomes Research
Website: http://www.ispor.org/Events/Index.aspx?eventId=26
Organization: Centre for Evidence-Based Medicine
Event: 5-Day Workshop on Teaching Evidence-Based Practice
Date: September 8-12, 2008
Location: Oxford, UK
Description: This workshop is aimed at clinicians and other health care professionals, including those involved in
mental health, who already have some knowledge of critical appraisal and experience in the
practice of evidence-based health care and who want to explore issues around teaching evidence-
based medicine. The workshop is NOT intended to serve as an introduction to evidence-based
medicine itself.
Website: http://www.cebm.net/index.aspx?o=1080
Organization: AdvaMed
Event: The MedTech Conference 2008
Date: September 21-28, 2008
Location: Washington, D.C.
Description: N/A
Website: http://www.advamed2008.com
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 87
OCTOBER 2008
Organization: The Cochrane Collaboration
Event: 16th Cochrane Colloquium: Evidence in the area of globalisation
Date: October 3-7, 2008
Location: Freiburg, Germany
Description: The Cochrane Colloquium 2008 offers an outstanding opportunity to interact with central
players active in evidence-based health care, global knowledge management and systematic
reviews. Catch up on current international developments and perspectives and attend workshops
to delve further into individual topics.
Website: http://www.cochrane.de/en/colloquium2008.htm
Organization: Institute of Medicine (IOM)
Event: 2008 IOM Annual Meeting
Date: October 12-13, 2008
Location: Washington, D.C
Description: N/A
Website: http://www.iom.edu/CMS/2951/16671/16689.aspx
Organization: National Quality Forum (NQF)
Event: 2008 Annual Meeting and Policy Conference on Quality; Board of Directors Meeting
Date: October 15-17, 2008
Location: Washington, D.C., Arlington, VA
Description: N/A
Website: http://www.qualityforum.org/
Organization: International Society for Quality of Life Research (ISOQOL)
Event: 15th Annual Scientific Meeting
Date: October 22-25, 2008
Location: Montevideo, Uruguay
Description: N/A
Website: http://www.isoqol.org
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 88
NOVEMBER 2008
Organization: European Network for Health Technology Assessment (EUnetHTA)
Event: EUnetHTA Conference 2008: HTA’s Future in Europe
Date: November 20, 2008
Location: Paris, France
Description: N/A
Website: http://www.eunethta.net/
MARCH 2009
Organization: National Quality Forum (NQF)
Event: 2009 Spring Membership Meeting and Implementation Conference;
Board of Directors Meeting
Date: March 27-29, 2008
Location: Cleveland, OH
Description: N/A
Website: http://www.qualityforum.org/
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 89
ON-GOING
Organization: Institute of Medicine (IOM) Roundtable on Evidence-Based Medicine
Event: Project meetings and workshops
Date: Various
Location: Washington, D.C.
Description: The IOM Roundtable on Evidence-Based Medicine brings together key stakeholders from multiple
sectors — patients, health providers, payers, employers, manufacturers, policy makers, and
researchers — for cooperative consideration of the ways that evidence can be better developed
and applied to drive improvements in the effectiveness and efficiency of medical care in the United
States. Recent session: Judging the Evidence: Standards for Determining Clinical Effectiveness
(02/05/07). Others: Leadership Commitments to Improve Value in Health Care - workshop (07/24);
Roundtable meeting (09/24); Practice-Based Research: Redesigning the clinical effectiveness
research paradigm – workshop (12/12-13); Creating a Public Good: Clinical data as the basic
staple of health care improvement – workshop (02/28-29/2008)
Website: http://www.iom.edu/CMS/28312/RT-EBM.aspx
Organization: Institute of Medicine (IOM)
Event: Ongoing project: Reviewing Evidence to Identify Highly Effective Clinical Services
Date: Various
Location: Washington, D.C.
Description: The Robert Wood Johnson Foundation has funded this study to address problems in our system for
evaluating clinical evidence and to propose changes in the way we marshal evidence and apply it to
endorse the most effective clinical interventions. The IOM committee is specifically charged with
recommending a sustainable, replicable approach to identifying and evaluating the clinical services
that have the highest potential effectiveness.
Website: http://www8.nationalacademies.org/cp/projectview.aspx?key=HCSX-H-05-09-A
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 90
APPENDIX A: AHRQ Staff Bios
Carolyn M. Clancy, MD
Director
Agency for Healthcare Research and Quality (AHRQ)
Department of Health and Human Services
Contact information:
Agency for Healthcare Research and Quality
540 Gaither Road, 3rd Floor
Rockville, MD 20850
Phone: 301–427–1200
Fax: 301–427–1201
Email: carolyn.clancy@ahrq.hhs.gov
Background: Carolyn M. Clancy, MD, who is a general internist and health services researcher, was appointed
Director of the Agency for Healthcare Research and Quality (AHRQ) on February 5, 2003. Prior to her
appointment, Dr. Clancy had served as AHRQ’s Acting Director since March 2002 and previously was Director
of the Agency’s Center for Outcomes and Effectiveness Research (COER). Before joining AHRQ in 1990, she was
also an assistant professor in the Department of Internal Medicine at the Medical College of Virginia in
Richmond. Her medical specialties include primary care medicine and women’s health.
Dr. Clancy holds an academic appointment at George Washington University School of Medicine (Clinical
Associate Professor, Department of Medicine) and serves as Senior Associate Editor, Health Services Research.
Dr. Clancy has served on multiple editorial boards (currently Annals of Family Medicine, American Journal of
Medical Quality, and Medical Care Research and Review; formerly Journal of General Internal Medicine,
American Journal of Public Health, and Journal of Evaluation in Clinical Practice.)
Dr. Clancy has published widely in peer-reviewed journals and has edited or contributed to seven books. In
addition, she has presented multiple research papers at academic conferences and spoken to diverse audiences
and the media on health care issues. Dr. Clancy was elected a Master of the American College of Physicians in
2004 and is an elected member of the National Academy of Social Insurance. She has also held leadership
positions in multiple other professional organizations, including the Society of General Internal Medicine. She is
a member of the Institute of Medicine.
Education: Dr. Clancy holds a bachelor’s of science (BS), magna cum laude, in math and chemistry from Boston
College (1975) and a doctorate of medicine (MD) from the University of Massachusetts School of Medicine
(1979).
Her postdoctoral training includes: the Kennedy Institute of Bioethics Intensive Course at Georgetown
University in 1989; the Stanford Faculty Development Program in Clinical Teaching in 1988; and, the Henry
Kaiser Family Foundation Fellow in General Internal Medicine from 1982–84 at the Hospital of the University
of Pennsylvania.
Research interests: Her major research interests include various dimensions of health care quality and patient,
including women’s health, primary care, access to care services, and the impact of financial incentives on
physicians’ decisions.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 91
Kathie Kendrick, MS, CS, RN
Deputy Director
Agency for Healthcare Research and Quality (AHRQ)
Department of Health and Human Services
Contact information:
Agency for Healthcare Research and Quality
540 Gaither Road, 4th Floor
Rockville, MD 20850
Phone: 301–427–1700
Fax: 301–427–1639
Email: kathie.kendrick@ahrq.hhs.gov
Background: Ms. Kendrick joined AHRQ in 2000 as the Director of Planning, Evaluation, and Program
Development where she is actively involved in developing and guiding AHRQ’s strategic planning processes and
program development and evaluation activities. She now serves as deputy director of AHRQ. Prior to joining
the AHRQ staff, she was a Senior Health Policy Analyst in the General Accounting Office (GAO) Health Care
Issue area. Ms. Kendrick has over 25 years experience in Health Care Administration, most recently as the Chief,
Mental Health Outpatient Programs at the VA Medical Center in Washington, DC.
Education: Ms. Kendrick received a BS in Nursing from Keuka College and a MS in Child and Adolescent Mental
Health from the University of Maryland. She is currently a PhD candidate in program evaluation at the
University of Maryland.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 92
Helen R. Burstin, MD
Center for Primary Care, Prevention, & Clinical Partnerships, Director
Agency for Healthcare Research and Quality (AHRQ)
Department of Health and Human Services
Contact information:
Agency for Healthcare Research and Quality
540 Gaither Road, 4th Floor
Rockville, MD 20850
Phone: 301–427–1500
Fax: 301–427–1595
Email: helen.burstin@ahrq.hhs.gov
Background: Dr. Burstin, MD, MPH, has served as the Director of the Center for Primary Care, Prevention, and
Clinical Partnerships at the Agency for Healthcare Research and Quality (AHRQ) since January 2000. Prior to
her appointment at AHRQ, Dr. Burstin was an Assistant Professor at Harvard Medical School and Director of
Quality Measurement at Brigham and Women’s Hospital.
Dr. Burstin is the author of over 60 articles and book chapters and is board certified in Internal Medicine. She
is a deputy editor of the Journal of General Internal Medicine. She is President of the American Medical Student
Association (AMSA) Foundation Board of Directors and a member of the Board of Directors of La Clinica del
Pueblo, a free Latino clinic in Washington, DC, where she is a volunteer staff physician.
Education: Dr. Burstin is a graduate of the State University of New York at Upstate College of Medicine and the
Harvard School of Public Health. Dr. Burstin completed a residency in primary care internal medicine at Boston
City Hospital. After residency, she completed AHRQ-funded fellowship training in General Internal Medicine
and Health Services Research at Brigham and Women’s Hospital and Harvard Medical School.
Research Interests: Dr. Burstin’s research focuses on primary care topics such as patient-provider
communication; disparities in access and quality for vulnerable populations; and safety and quality of
ambulatory care.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 93
David C. Lanier, MD
Center for Primary Care, Prevention, & Clinical Partnerships, Deputy Director
Agency for Healthcare Research and Quality (AHRQ)
Department of Health and Human Services
Contact information:
Agency for Healthcare Research and Quality
540 Gaither Road, 4th Floor
Rockville, MD 20850
Phone: 301–427–1567
Fax: 301–427–1597
Email: DLanier@ahrq.gov
Background: David Lanier, MD, is the Associate Director of the Center for Primary Care, Prevention, and
Clinical Partnerships (CP3). In addition to assisting the Director in planning, developing, and managing all
Center activities, Dr. Lanier heads CP3’s extramural research program and also directs the Center’s initiative
supporting primary care practice-based research networks (PBRNs).
Prior to joining AHRQ (then named the Agency for Health Care Policy and Research) in 1993, Dr. Lanier was
on the family practice faculty of the University of California at Irvine and then was named residency director and
chief of the division of family medicine at Georgetown University. From 1993 to 1995, he worked in the Agency’s
Forum for Quality and Effectiveness in Health Care before joining the staff of the Center for Primary Care
Research. In 1996, he led a special research initiative on referrals from primary to specialty care. From September
1998 to January 2000, he served as the Center’s Acting Director, and since 2003 has served as Associate Director
of the Center for Primary Care, Prevention, and Clinical Partnerships (CP3).
Dr. Lanier directs the Agency’s initiative on primary care practice-based research networks (PBRNs), which
has provided funding for over 45 networks across the country, and also serves as the director of extramural
research for CP3. He has completed research and published articles on numerous subjects, including low back
pain, the ecology of medical care, and physician accountability. Dr. Lanier provides medical care to HIV-infected
patients one half-day per week as a volunteer physician at the Whitman-Walker Clinic.
Education: A graduate of the medical school of the University of North Carolina at Chapel Hill, Dr. Lanier
completed residency training in family medicine in the University of Rochester (NY)/Highland Hospital
program and later completed fellowship training in academic family medicine at Baylor University.
Research interests: Dr. Lanier has been working actively with leaders of AHRQ-funded primary care practice-
based research networks to analyze data descriptive of the practice of primary care across the United States. The
PRImary care Network Survey (PRINS) is a NAMCS-like database including demographic information for
almost 1,000 primary care providers/practices as well as data describing over 20,000 patient encounters.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 94
Therese Miller, DrPH
Project Coordinator, USPSTF
Center for Primary Care, Prevention, & Clinical Partnerships
Agency for Healthcare Research and Quality (AHRQ)
Contact information:
Center for Primary Care, Prevention, & Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Phone: 301–427–1585
Fax: 301–427–1597
Email: TMiller@ahrq.gov
Background: Tess Miller began her career at a New York City advertising agency as a Media Specialist. However,
her interest eventually turned to social marketing and public health. She has over 10 years experience managing
public health projects including the Hospital-Based Rural Health Care Program, Pathways to Adulthood: A Three
Generation Urban Study, and the National Evaluation of The Healthy Steps for Young Children Program.
Education: She attended the Johns Hopkins University Bloomberg School of Public Health, earning a doctoral
degree in Public Health and a Certificate in Health Communications.
Research interests: Adolescent reproductive health, child development, community-level interventions, and
behavior change.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 95
Jean R. Slutsky, MS, CS, RN
Center for Outcomes and Evidence (COE), Director
Agency for Healthcare Research and Quality (AHRQ)
Department of Health and Human Services
Contact information:
Agency for Healthcare Research and Quality
540 Gaither Road, 6th Floor
Rockville, MD 20850
Phone: 301–427–1600
Fax: 301–427–1639
Email: jean.slutsky@ahrq.hhs.gov
Background: Ms. Slutsky has directed the Center for Outcomes and Evidence (COE), AHRQ, US Department
of Health and Human Services since June 2003. Prior to Ms. Slutsky’s appointment as director of COE, she served
as acting director of the Center for Practice and Technology Assessment at AHRQ. She oversees the Evidence-
based Practice Center program; Technology Assessment Program; extramural and intramural research portfolios
concerning translating research into practice, outcomes and effectiveness research, including pharmaceutical
outcomes, and cost-effectiveness analyses; and the National Guideline, Quality Measures and Quality Tools
Clearinghouses.
Prior to becoming acting director of the Center for Practice and Technology Assessment, Ms. Slutsky directed
the development of the National Guideline Clearinghouse (NGC) Project. The NGC is an Internet-based
repository (www.guideline.gov) for comparative information on evidence-based clinical practice guidelines. In
addition, Ms. Slutsky served as project director of the U.S. Preventive Services Task Force, an internationally
recognized panel of experts who make evidence-based recommendations on clinical preventive services. In
addition, she is a member of the executive board of the Guidelines International Network and a Society for
Medical Decision Making Advisory Task Force Member.
Education: Ms. Slutsky received her BS at the University of Iowa, a MS in Public Health (Health Policy and
Administration) from the University of North Carolina at Chapel Hill, and trained as a Physician Assistant at the
University of Southern California.
Research interests: Ms. Slutsky is particularly interested in the translation of complex scientific information for
health care decision-makers. Most recently, she has been implementing a comparative effectiveness research
program that includes evidence synthesis, evidence generation and evidence communication.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 96
Beth Collins Sharp, PhD, RN
Acting Director, Evidence-Based Practice Centers (EPC) Program
Center for Outcomes and Evidence (COE)
Agency for Healthcare Research and Quality (AHRQ)
Contact information:
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road, Suite 6000
Rockville, MD 20850
Phone: (301) 427-1503
Fax: (301) 427-1520
E-mail: Beth.Collinssharp@ahrq.hhs.gov
[Bio not available.]
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 97
Lynn A. Bosco, MD, MPH
Program Officer, Centers for Education and Research on Therapeutics
Director, Pharmaceutical Studies
Contact information:
Director, Pharmaceutical Studies
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
540 Gaither Road, 6th Floor
Rockville, MD 20850
Phone: 301–427–1600
Fax: 301–427–1520
E-mail: LBosco@ahrq.gov
Background: Lynn A. Bosco, MD, MPH, is Director, Pharmaceutical Studies, and Program Officer for the
Centers for Education and Research on Therapeutics (CERTs). Dr. Bosco represents AHRQ to the U.S.
Pharmacopeia (USP). She holds an academic appointment at the University of Maryland School of Medicine
(Adjunct Associate Professor, Department of Epidemiology and Prevention). Before working at AHRQ, Dr.
Bosco was a Section Chief, Epidemiology Branch, in the Center for Drug Evaluation and Research, Food and
Drug Administration (FDA). While in that position, she headed a group responsible for research, of adverse drug
reaction and drug utilization information. Dr. Bosco has been a commissioned officer in the U.S. Public Health
Service since 1984 and holds the rank of Captain. She represents AHRQ on the Physicians’ Professional Advisor
Committee (PPAC) which advises the Surgeon General on issues related to government physicians. She is an
active member of the Commissioned Corps Readiness Force (CCRF).
Education: Dr. Bosco received a BA in psychology from the University of Illinois and an MD from Rush Medical
College, in Chicago. She interned at the Los Angeles County Hospital and completed a residency in preventive
medicine within the Department of Epidemiology, at the Johns Hopkins School of Hygiene and Public Health,
where she also received an MPH Dr. Bosco is Board Certified in Preventive Medicine and in Clinical
Pharmacology.
Research interests: Her research interests are focused in the area of pharmacoepidemiology, and have resulted in
peer-reviewed publications using both Medicaid and drug marketing data.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 98
APPENDIX B:
National Advisory Council for Healthcare Research
and Quality Bios
Jane F. Barlow, MD, MPH, MBA (2009)
Dr. Barlow is responsible for the delivery of health care for over 600,000 employee, retirees and dependents in the
U.S. at a cost of over $1.7 billion annually. She has an extensive background in creating and implementing health
care benefits and health program for employees and is a strong advocate for patient centered care. Previously Dr.
Barlow served as Federal Aviation Administration (FAA) Senior Aviation Medical Examiner for the Texas
Rehabilitation Commission, Medical Director for the Family Health Center in Del Rio, Texas, Director of
Occupational and Environmental Health at the Department of Veterans Affairs Medical Center and flight
surgeon at Beal Air Force Base California. She currently co-chairs the National Committee on Evidence-based
Benefit Design, National Business Group on Health. She has published frequently on keeping healthy in the
workplace and is a national speaker on patient-centered care.
Dale W. Bratzler, DO, MPH (2008)
Dale W. Bratzler is QIOSC Medical Director, Oklahoma Foundation for Medical Quality and Adjunct Associate
Professor, Department of Health Administration and Policy, College of Public Health, Oklahoma University
Health Sciences Center. Dr. Bratzler currently serves as Chair of both the Health Care Information Advisory
Committee and the Hospital Advisory Committee of the Oklahoma State Department of Health. Dr. Bratzler is
immediate past President of the American Health Quality Association (AHQA). He is the recipient of the 2002
Excellence in Physician Leadership Award presented by the James Q. Cannon Memorial Endowment, and the
American College of Osteopathic Internists Researcher of the Year. He is also currently working with the
Medicare National Pneumonia Quality Improvement Project and the CMS/CDC National Surgical Site Infection
Project. Dr. Bratzler graduated summa cum laude with a B.S. in Biology from Central Missouri State University;
received his doctor of osteopathy at the College of Osteopathic Medicine (1st in class), University of Health
Sciences, Kansas City, Missouri; and, received his MPH with a 4.0 GPA at the University of Oklahoma.
Timothy J. Brei, MD (2009)
Dr. Brei, a recognized expert on diagnosing and treating children with disabilities, has written and presented
extensively on the subject. Dr. Brei himself has Spina Bifida and serves on the Board of many national, regional
and local committees, including DAMAR Homes, Inc., for children and adolescents with severe disabilities and
behavior disorders, and the Spina Bifida Association of America. He is a Fellow of the American Academy of
Pediatrics and the American Academy of Cerebral Palsy and Developmental Medicine.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 99
Patricia Flatley Brennan, PhD, RN, FAA, FACMI (2008)
Patricia Flatley Brennan is the Moehlman Bascom Professor of Nursing and Industrial Engineering, School of
Nursing and College of Engineering, University Wisconsin-Madison. Dr. Brennan’s area of expertise is the nexus
of engineering principles and health care. Dr. Brennan has been a recipient of many awards and honors. In 2001,
she was elected to the Institute of Medicine in 2002, she was named distinguished nurse researcher by the
National Institute of Nursing Research. During 2005, she is Distinguished Lecturer, University of Missouri-St.
Louis, and Lazerow Lecturer, University of Minnesota. Dr. Brennan serves as associate editor of the Journal of the
American Medical Informatics Association and reviewer for many other publications. She serves on the Markel
Foundations Personal Health Technology Council and the Robert Wood John Foundation Personal Health
System. Dr. Brennan has been a guest lecturer for health care informatics internationally and she has published
numerous articles on health care and informatics. Dr. Brennan is an in-demand consultant with hospitals
nationwide. She received a BS in nursing from the University of Delaware; an MS in Nursing from the University
of Pennsylvania; and an MS and PhD in Industrial Engineering from the University of Wisconsin-Madison.
Andrew J. Fishmann, MD, FCCP, FAC (2009)
Dr. Fishmann is an experienced hospitalist, as well as, co-founder and Board Member of Cogent Healthcare, Inc.
In addition, Dr. Fishmann is the Director of the Intensive Care Unit, Good Samaritan Hospital in Los Angeles,
and is in private practice with California Lung Associates. Dr. Fishmann received his BA in Biology from Franklin
and Marshall College and his MD from the Temple University Medical School, and his Pulmonary/Critical Care
Fellowship from the University of California, San Diego.
Robert S. Galvin, MD (2010)
Board certified in internal medicine, Dr. Glavin is responsible for medical services internationally of 225 clinics,
750 physicians and nurses and 1.5 million patient visits including oversight of wellness and disease management
programs and occupations medicine programs. He is also adjunct professor at Yale University School of
Medicine. Among his many accomplishments, Dr. Glavin co-funded the Leapfrog Group and Bridges to
Excellence. He is a member of the National Commission on Quality Accreditation. He served on the Department
of Defense (DoD) Task Force on the future of Military Health Care, and the Commonwealth Fund Commission
on a Highly Effective Health Care Systems. He has been a member of the Institute of Medicine (IOM)
Committees and has reviewed IOM Reports. He has been asked to testify and present on the issues of health care
costs and quality before both Congress and Secretaries of Executive Departments. Dr. Galvin received his MD at
the University of Pennsylvania and his MBA at the Boston University School of Management.
M. Carolina Hinestrosa, MA, MPH (2009)
Ms. Hinestrosa is a leader in representing cancer patients and cancer survivors. Her expertise has been called
upon by the Institute of Medicine, the National Quality Forum, and the National Cancer Institute, to serve on a
variety of committees involving detection and treatment of cancer. Previously, she founded and was executive
director of Nueva Vida, Inc., a non profit organization delivering comprehensive support to Latinas with breast
and cervical cancer. Ms. Hinestrosa also coordinated the development of the Latina Health Radio Network that
broadcast a daily Spanish language program on health promotion and disease prevention and is a well known
speaker at the World Conferences on Breast Cancer Advocacy.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 100
Ada Sue Hinshaw, PhD, RN (2008)
Ada Sue Hinshaw is Dean and Professor, University of Michigan, School of Nursing, Ann Arbor. Dr. Hinshaw is
a health services educator and researcher who has received many academic awards and honors in the fields of
clinical nursing and nursing administration as well as in the development and testing of health evaluation and
cost models. Dr. Hinshaw is a member of Sigma Theta Tau, Honorary Nursing Society at the Universities of
Kansas, Arizona and Michigan; Sigma Xi and the Scientific Research Society of North America. She is a member
of the Institute of Medicine and the National Academies of Practice. She has been a Visiting Professor in both in
the US and internationally, most recently at Peking and Tanjin Universities. Dr. Hinshaw was recognized in a 2004
book by Houser, B.P. and Player, K.N., Pivotal Moments in Nursing: Leaders Who Changed the Path of a
Profession, and in 2005, received an Honorary Doctor of Science from Binghamton, University. She received a
B.S. in Nursing from the University of Kansas; a MSN. from Yale University; and an MA and PhD in Sociology
from the University of Arizona. Dr. Hinshaw previously served on the National Advisory Council in 1997.
Carlos Roberto Jaen, MD, PhD (2008)
Dr. Jaen is Professor and Chairman, Department of Family and Community Medicine, University of Texas
Health Science Center—San Antonio, TX. He also holds the Dr. M. Smith Professorship. Dr. Jaen’s research
interests are in behavioral health counseling, Latino health issues, primary care, and smoking cessation. He has
authored numerous abstracts, book chapters, and journal articles on these subjects. In 2004 he was honored by
Who’s Who Among America’s Teachers; received the Unsung Hero Presidential Award from the Texas Academy
of Family Physicians; awarded the degree of Fellow from the American Academy of Family Physicians; and was
named in the Best Doctor’s in America. His research has been supported by the Robert Wood Johnson
Foundation, The National Board of Medicine Examiners, and the American Cancer Society. Dr. Jaen serves as a
reviewer for a number of medical publications including the Annals of Family Medicine, the American Journal
of Public Health, and JAMA. He is a member of the America Family Medicine Organizations Committee on
Research Capacity and of the Society of Teachers of Family Medicine Research Committee. Dr. Jaen received a
BS (cum laude) in Biology and an MS in Oncology from Niagara University, a PhD in Epidemiology and
Community Health, and his MD at the State University of New York.
Brent James, MD (2008)
Dr. James is the Executive Director, Institute for Health Care Delivery Research and Vice President, Medical
Research and Executive Director of its Institute for Health Care Delivery Research which leads IHC’s clinical
improvement efforts. An interest in cancer led him to spend several years with the American College of Surgeons
where he helped support the Commission on Cancer and designed and staffed the College’s first in-house
mainframe computer system. He later served as a biostatistician in the Eastern Cooperative Oncology Group
while an assistant professor in the Department of Biostatistics at the Harvard School of Public Health. Dr. James
received an undergraduate degree in Computer Science, a Master of Statistics degree, an MD degree, and training
in general surgery from the University of Utah.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 101
Wishwa N. Kapoor, MD, MPH (2010)
Dr. Kapoor is an expert in health services research, most recently examining the outcomes and evaluation of
syncope, and outcomes, cost, and quality of pneumonia. As the Director of the Center for Research on Health
Care, he has developed the Clinical Research Training Program and teaches research methodology courses in the
program. Dr. Kapoor has extensive experience in mentoring fellows and junior faculty. He is a member of the
American Society for Clinical Investigation, an American Academy of Pediatrics, Past President of Society of
General Internal Medicine (SGIM) and recipient for the Robert J. Glaser award for Exceptional Achievement in
Teaching and Research. Dr. Kapoor has been a member of the grant review committee for the National Heart
Lung and Blood Institute (NHLBI) and has testified before Congress on Residency Programs. He has published
hundreds of research papers in peer reviewed professional and scientific publications and is on the editorial
boards of the Journal of Medicine and the Journal of International Medicine. Dr. Kapoor received his BS in
Chemical Engineering, and his MD at Washington University, St. Louis, and his MPH in Epidemiology at the
University of Pittsburgh.
Munr Kazmir, MD (2008)
Dr. Kazmir is founder and CEO of Direct Meds, Inc. in Leonia, New Jersey. Direct Meds, Inc. is a company
licensed to provide prescription medicines thought the United States. He is also the founder and CEO of Quality
Home Care, a company that serves over 200,000 patients in the diverse New York, New Jersey metropolitan area
to ensure that indigents, homeless, HIV patients and children of neglect receive appropriate medical care. Dr.
Kazmir is the recipient of many international humanitarian awards. The State of New Jersey Child Protection
Commission and Children’s Trust Fund honored him for his fundraising efforts to combat Juvenile diabetes.
Keren-Or, an organization in Jerusalem devoted to the care and rehabilitation of multi-handicapped blind
children, awarded Dr. Kazmir the Maimonides Award in recognition of his generous support. Dr. Kazmir was
born in Pakistan and graduated from the University of Punjab in LaHore where he received his MBBS/MD. He
completed a one-year internship at the Mayo Hospital in LaHore and a two year residency at Holy Family
Hospital in Rawalpindi, Pakistan. Upon arriving in the United States, Dr. Kazmir successfully completed his
internal medicine internship at the White Plains Hospital — Montefiore Medical Center and pursued additional
medical studies at the Methodist Hospital in Houston. He completed his third year residency at SUNY
Department of Medicine. Dr. Kazmir speaks six languages.
Kathleen Lohr, PhD (2010)
Dr Lohr is also Research Professor at the School of Public Health, University of North Carolina, Chapel Hill.
Previously, Dr. Lohr’s served as the director for the Division of Health Care Services for the Institute of Medicine,
Technical Information Specialist in the Bureau of Health Professions, Department of Health Education and
Welfare, and was a researcher at the Johns Hopkins School of Medicine and School of Hygiene and Public Health.
She has published countless, articles, monographs and books and is in demand as a member of diverse advisory
panels for both the public and private sector. She is the 2005 recipient of the Avedis Donabedian Outcomes
Research Lifetime Achievement Award, given by the International Society of Pharmacoeconomics and Outcomes
Research, and a Fellow of the Association for Health Services Research. Dr. Lohr received her B.A. and M.A. from
Stanford University, and her PhD from RAND Graduate Institute, Santa Monica, CA.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 102
Thomas P. Miller, JD (2009)
Mr. Miller is a senior policy professional with 30 years experience in economic and regulatory policy,
communication and legal issues in health policy, among other expertise. He has participated in health care
forums including consumer driven health care, insurance deductibles and Health Savings Accounts (HSAs), the
uninsured and long term care. He directed health policy studies at the CATO Institute and has been a journalist
in both broadcast and print media. He graduated Phi Beta Kappa from New York University and received his JD
degree from Duke Law School.
Neil R. Powe, MD, MPH, MBA (2009)
Dr. Powe is Professor of Medicine in the Department of Medicine at the Johns Hopkins University School of
Medicine and Director of the Welch Center for Prevention, Epidemiology and Clinical Research, a
multidisciplinary research and training center at Johns Hopkins focused on clinical and population-based
research. He also is Professor of Epidemiology and Health Policy and Management at Hopkins’ Bloomberg
School of Public Health. He directs the Clinical Research Scholars Program, the Predoctoral Clinical Research
Training Program and the Clinical Epidemiology Program at Hopkins which has trained a cadre of physicians
and population scientists in clinical research. He has published over 270 articles on the prevention, diagnosis and
treatment of diseases, value of health care technologies, and the effectiveness of the health care system. His major
areas of interest and expertise are kidney and cardiovascular diseases; effectiveness and outcomes research and;
economic evaluations in health care. He has studied physician decision making and other determinants of use of
medical practices including payers’ decisions about insurance coverage for new medical technologies, the effect
of financial incentives on the use of technology, efficiency and outcomes in for-profit versus non-profit health
care institutions, and the relation between hospital volume, technology and outcomes. Dr. Powe is author of
more than 270 articles and among his many honors are membership in the Institute of Medicine, the John M.
Eisenberg National Award for Career Achievement in Research from the Society of General Internal Medicine
and the Distinguished Educator Award from the Association of Clinical Research Training.
Michael K. Raymond, MD (2010)
As CMO for the Rush North Shore Medical Center, Dr. Raymond implemented a quality improvement paradigm
that established an effective process for collecting measures and reporting performance and encouraging
employee feedback. Previously, Dr. Raymond served as Medical Director of the Physicians Hospital Organization
(PHO) of the Rush North Shore Medical Center. In that capacity he managed all aspects of care, including
contracting, utilization management, and pay-for-performance initiatives and outcomes measurement. During
his tenure, PHO has consistently exceeded its performance targets. Under his leadership the Rush North Shore
PHO became one of the first integrated delivery systems in Illinois to implement a Clinical Integration program
using physician profiles and report indicators of performance. Dr. Raymond is also an expert in the key
performance indicators (KPI) from Medicare commercial payors and other external review agencies. Dr.
Raymond received his B.S. from Bradley University, and his MD, from the Universidad Autonomo De Ciudad,
Juarez, Mexico.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 103
James J. Rohack, MD, FACC, FACP (2008)
Dr. Rohack is a senior staff cardiologist with the Scott & White Clinic and Professor of Medicine at Texas A&M
Health Science Center (TAMRHSC) College of Medicine. He serves as Medical Director for System Improvement
for the Scott & White Health Plan, a nonprofit community based health plan with a national recognition for
quality medical care delivery as well as the Director for the Center for Healthcare Policy at Scott and White. He
is chair of the American Medical Association Board of Trustees as well as being Secretary of the Board of
Commissioners of the Joint Commission on Accreditation of Healthcare Organizations.
Dr. Rohack has had a long involvement with medical education and accreditation standards. He service
includes the Council on Medical Education of both the Texas Medical Association and American Medical
Association; the National Board of Medical Examiners; the Accreditation Council on Continuing Medical
Education; the Liaison Committee on Specialty Boards and the Liaison Committee on Medical Education which
accredits programs leading to the MD degree in the U.S. and Canada. He is a nationally recognized speaker on
medical education and the financing and delivery of health care. He has served on External Advisory committees
for the George Bush School of Public Policy and the MD Anderson Cancer Center, and currently serves on the
TAMUHSC School of Rural Public Health. He is the recipient of numerous awards and recognition including
Who’s Who in Medicine and Health Care, America and the World, and the Golden Nugget Distinguished
Alumnus Award from the College of Liberal Arts at the University of Texas El Paso (UTEP).
Dr. Rohack attended the UTEP as a Stevens Scholar and graduated with highest honors. He obtained his
medical degree (M.D) with honors from the University of Texas Medical Branch (UTMB). He continued his
training at UTMB with a residency in Internal Medicine, an additional year as Chief Resident, and a clinical
fellowship in Cardiology.
David L. Shern, PhD (2010)
Dr. Shern is Professor and Dean of the Louis de la Parte Florida Mental Health Institute, University of South
Florida. He is a member, Steering committee, Annapolis Coalition on Behavioral Health Workforce, National
Institutes of Health Reviews Reserve — Ad Hoc Reviewer, Ad Hoc Grant Reviewer, Veterans Administration,
Robert Wood Johnson Foundation, National Advisory Board, Boston University Center for Psychiatric
Rehabilitation. Many consultative positions including University of South Carolina Program on Research on
Public Psychiatry, Missouri Institute of Mental Health. He is a member of the Governor’s Task Force on Suicide
Prevention and Who’s Who in America (2002-Present). Dr. Shern has written and published technical reports,
papers, articles, chapters, and newsletters for professional and trade journals. He serves on the editorial board of
Administration and Policy in Mental Health and Mental Health Services Research. Dr. Shern received his BA,
MA, and PhD from the University of Colorado, Boulder.
William Smith, PharmD, MPH, PhD, FASHP (2010)
Dr. Smith has been Professor of Pharmacy and Executive Associate Dean for the past 10 years. He serves as a
member of the Virginia Commonwealth University (VCU) School of Pharmacy Executive Committee, Non-
traditional PharmD Program and Curriculum Committee, as well as a member of the Research Grants Program
Selection Plan of the American Society of Hospital-base Pharmacists (AHSP). In his previous positions, Dr.
Smith served as Vice President, Research Administration, where he was responsible for administrations of
research programs and Assistant Dean for the Long Beach Memorial Medical Center. He was also Chair,
Department of Pharmacy Practice, Bouve College of Pharmacy and Health Science, Northeastern University. Dr.
Smith received his PharmD from the University of California, San Francisco, and his PhD in Pharmaceutical
Science from Auburn University.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 104
Myrl Weinberg, CAE (2010)
Ms. Weinberg is president of the National Health Council, an umbrella organization whose members are 50 of
the leading voluntary health agencies committed to quality health care, and representing over 100 million
individuals with chronic disease and /or disabilities. For over 30 years Ms. Weinberg’s career has focused on
health, medical research, and long-term care and she has held managerial and leadership positions in many
different health care organizations including, the American Diabetes Association and the Joseph P. Kennedy, Jr.
Foundation. She was selected to serve on the congressionally mandated Institute of Medicine (IOM) Committee
to assess how research priorities are established at the National Institutes of Health (NIH), and has served on
numerous boards. Ms. Weinberg pursued advanced graduate study at Purdue University, holds an MA in Special
Education from Georgia Peabody College, Nashville, Tennessee, and holds a BA in Psychology from the
University of Arkansas.
Anthony C. Wisniewski, JD (2009)
As Executive Director for Health Policy for the U.S. Chamber of Commerce, Mr. Wisniewski is responsible for
health policy issues pending before the U.S. Congress and federal agencies. Previously, he served as head of public
policy for the biotechnology company MedImmune, Inc. Mr. Wisniewski received his JD from Notre Dame
University and his BA from the Catholic University of America.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 105
APPENDIX C:
U.S. Preventive Services Task Force Bios
Bruce Nedrow (Ned) Calonge, MD, MPH (Chair)
Dr. Calonge, the Chief Medical Officer of the Colorado Department of Public Health and Environment, is also
the State Epidemiologist and the Executive Director of State Bioterrorism Preparedness. He is an Associate
Professor of Family Medicine and of Preventive Medicine and Biometrics at the University of Colorado Health
Sciences Center. Dr. Calonge is also the President of the Colorado Board of Medical Examiners, which licenses
and provides regulatory oversight for physicians and physician assistants. Dr. Calonge serves on the Board of
Directors for the Colorado Academy of Family Practice (President), the Colorado Foundation for Medical Care
(Board Chair), and the Colorado Prevention Center. At the Colorado Medical Society, he chairs the Health Affairs
Committee. He is a member of the Colorado Patient Safety Coalition.
Diana B. Petitti, MD, MPH (Vice Chair)
Dr. Petitti is Senior Scientific Advisor for Health Policy and Medicine at Kaiser Permanente Southern CA,
Pasadena, CA. She is a member of the American Public Health Association, the Society for Epidemiologic
Research and the American Epidemiologic Society and is a Fellow of the American Heart Association Council on
Epidemiology. Dr. Petitti serves on the editorial board of Epidemiology, American Journal of Preventive
Medicine, and American Journal of Medicine. She is also currently a member of the Institute of Medicine, New
Approaches to Early Detection of Breast Cancer; the California Office of Statewide Planning on Health, Technical
Advisory Committee; and the Kaiser Permanente National Research Council, Kaiser Permanente.
Allen J. Dietrich, MD
Dr. Dietrich, a board-certified family physician, is a professor of community and family medicine at Dartmouth
Medical School and a member of the Institute of Medicine of the National Academy of Sciences. He is also
associate director for population sciences at the Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical
Center and serves as chair of the John D. and Catherine T. MacArthur Foundation Initiative on Depression and
Primary Care.
Thomas G. DeWitt, MD
Thomas G. DeWitt, MD is the Carl Weihl Professor of Pediatrics, Director of the Division of General and
Community Pediatrics, and Associate Chair for Primary Care, in the Department of Pediatrics, at the Children’s
Hospital Medical Center, Cincinnati, Ohio. Since the mid-1980s, he has served as the Project Director for the
Bureau of Health Professions (BHPr) grants in General Pediatrics Residency Training and Faculty Development,
both at Children’s Hospital Medical Center Cincinnati and at the University of Massachusetts Medical Center.
For 10 years, Dr. DeWitt served on the Board of Directors of the Ambulatory Pediatric Association (APA), serving
as president from 1993–1994. He was instrumental in the APA’s role in developing BHPr supported educational
guidelines in general pediatrics for both medical students and residents. In 1996, Dr. DeWitt also served as Chair
of the Planning Committee for the first national conference on faculty development, jointly sponsored by the
BHPr and the American Association of Medical Colleges. He has published and presented extensively on the
subject of community-based education and faculty development for community preceptors.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 106
Kimberly D. Gregory, MD, MPH
Dr. Gregory is Director of Maternal-Fetal Medicine and Director of Women’s Health Services Research at Cedars-
Sinai Medical Center, Los Angeles, CA. She is an Associate Professor at the David Geffen School of Medicine at
UCLA, Department of Obstetrics & Gynecology and at the UCLA School of Public Health Department of
Community Health Sciences. She is President of the Perinatal Advisory Council, Los Angeles Communities and
has served on numerous advisory boards, including the Office of Statewide Health Planning and Development
— California Health Policy and Data Advisory Commission on Lowering Cesarean Sections; the Department
Health Services Maternal & Child Health Branch; Department of Health Services Office of Women’s Health; the
California Perinatal Quality Care Collaborative; and the March of Dimes. Dr. Gregory is a member of many
professional organizations, including the American College of Obstetrics and Gynecology where she is currently
on the OB Practice Committee and ACOG District IX Legislative Committee.
David Grossman, MD
Dr. Grossman, a board-certified pediatrician recognized for his research on injury prevention and Native
American health, is medical director of preventive care at Group Health Cooperative in Seattle. He is also a senior
investigator at the Group Health Center for Health Studies and a professor of health services and adjunct
professor of pediatrics at the University of Washington. He serves on the Secretary’s Advisory Committee on
Injury Prevention and Control for the Centers for Disease Control and Prevention. In 2007, the American
Academy of Pediatrics awarded Dr. Grossman the Native American Child Health Advocacy Award.
George J. Isham, MD
Dr. Isham is Medical Director and Chief Health Officer for HealthPartners, a large health care organization in
Minnesota, representing nearly 800,000 members. Dr. Isham is responsible for quality, utilization management,
health promotion and disease management, research, and health professionals’ education at HealthPartners. He
is active in strategic planning and policy issues. He is an experienced primary care clinician and was chair of the
Institute of Medicine committee that produced the report, Priority Areas for National Action: Transforming Health
Care Quality.
Michael L. LeFevre, MD, MSPH
Dr. LeFevre is a Professor in the Department of Family and Community Medicine at the University of Missouri
School of Medicine, Columbia, Missouri. He is the Medical Director for Family Medicine at Missouri University
Health Care; is Director of the Missouri University Health Care Electronic Medical Record project; Chair of the
Credentialing Committee for the Department of Family Medicine; and Director of Clinical Services at the
Department of Family Medicine. He has served on the Commission on Clinical Policies and Research of the
American Academy of Family Physicians. Dr. LeFevre is a researcher, a published author and consultant, and has
been invited to give many presentations across the country.
Rosanne Leipzig, MD, PhD
Dr. Leipzig, a board-certified internist and geriatrician is a professor in the departments of Geriatrics and Adult
Development, Medicine, and Health Policy at Mount Sinai School of Medicine in New York. She also serves as
vice chair of Education in the Departments of Education and Geriatrics and Adult Development at Mount Sinai.
She has been a recipient of the American College of Physicians Richard and Hinda Rosenthal award, given for
the notable contribution her work in evidence-based medicine has made to improve clinical care in internal
medicine.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 107
Lucy N. Marion, PhD, RN
Dr. Marion is the new Dean and Professor at the Medical College of Georgia School of Nursing in Augusta,
Georgia, after several years as Associate Dean for Academic Nursing Practice at the University of Illinois at
Chicago College of Nursing. As a researcher, clinician (family nurse practitioner), published author, and
international consultant, Dr. Marion has received numerous honors and awards. She has served on state and
national advisory groups concerning mental health care, environmental risks to children, the genetics workforce,
and the practice doctorate for nurses, and belongs to several professional organizations. Her NIH-funded
translational research focuses on sexual risk reduction interventions for high risk minority populations. In
Chicago, she developed a nurse-managed system in partnership with Thresholds Psychosocial Rehabilitation
Agency for the delivery of integrated primary and mental health care for people with severe and persistent mental
illness.
Bernadette Melnyk, PhD, RN, CPNP/NPP
Dr. Melnyk is dean and distinguished foundation professor in nursing at the Arizona State University College of
Nursing & Healthcare Innovation. She is a pediatric and psychiatric nurse practitioner whose research focuses on
improving mental health outcomes in children, teens, and parents. She directs the National Association of
Pediatric Nurse Practitioners’ KySS mental health promotion program. She served on the American Academy of
Pediatrics Mental Health Task Force in 2006 and the Institute of Medicine’s working committee on evidence-
based practice in 2007. For her dedication to innovative programming leading to health care solutions, the
American Academy of Nursing named her a 2006 Edge Runner.
Virginia A. Moyer, MD, MPH
Dr. Moyer is Professor of Pediatrics and Internal Medicine at the University of Texas—Houston Medical School
and is the Associate Director of the Center for Clinical Research and Evidence-Based Medicine at the UT Health
Science Center. She is a member of the Evidence-Based Medicine Working Group, which has produced the
Journal of the American Medical Association “Users’ Guides to the Medical Literature” series, a member of the
Executive Committee of the AAP Section on Epidemiology, and is on the International Advisory Board for the
Cochrane Child Health Field. Dr. Moyer is Editor in Chief of the recently published book, Evidence-Based
Pediatrics and Child Health. She is Editor in Chief of Current Problems in Pediatrics and is on the editorial
boards of The Journal of Pediatrics and AAP Journal Club.
Judith K. Ockene, PhD, MEd
Dr. Ockene is a clinical psychologist with an appointment as Professor of Medicine at the University of
Massachusetts Medical School, where she is also the Barbara Helen Smith Chair, Chief, and founder of the
Division of Preventive and Behavioral Medicine. Dr. Ockene has extensive experience in both research and
evaluation of evidence-based methods in the area of disease prevention and health promotion. Dr. Ockene has
served on numerous advisory panels and review groups, has served as scientific editor on two Surgeon General
Reports on smoking, and is president-elect of the Society of Behavioral Medicine. She has over 140 publications
in preventive and behavioral medicine and serves as a reviewer for several journals, including Journal of the
American Medical Association, New England Journal of Medicine, Archives of Internal Medicine, Health
Psychology, and Preventive Medicine.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 108
George F. Sawaya, MD
Dr. Sawaya is an Associate Professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences and
the Department of Epidemiology and Biostatistics at the University of California, San Francisco (UCSF). Dr.
Sawaya has received many honors and awards; is an active researcher and lecturer; is a published author; and
currently serves on two Expert Panels for the Centers for Disease Control and Prevention focusing on detection
of ovarian, breast, and cervical cancers. He developed and teaches the required curriculum in evidence-based
medicine and clinical decision making at UCSF. Dr. Sawaya serves as a peer reviewer for several journals,
including the New England Journal of Medicine, Journal of the American Medical Association, Annals of Internal
Medicine, and Obstetrics and Gynecology.
J. Sanford (Sandy) Schwartz, MD
Dr. Schwartz, a board-certified internal medicine specialist, is the Leon Hess Professor of Medicine, Health
Management, and Economics at the University of Pennsylvania School of Medicine and Wharton School. He is
past president of the American Federation of Clinical Research and the Society for Medical Decision Making,
former Executive Director of the Leonard Davis Institute of Health Economics, and past Editor of the American
Journal of Managed Care. An expert in the evaluation of medical practices and guidelines, Dr. Schwartz has
served on the National Institutes of Health and Institute of Medicine committees in these areas. He is a member
of the Centers for Medicare and Medicaid Services Medical Care Advisory Committee and the Blue Cross and
Blue Shield Associations Medical Advisory Panel.
Timothy Wilt, MD, MPH
Dr. Wilt, a board-certified internal medicine specialist, is a professor in the Department of Medicine at the
University of Minnesota and the Minneapolis VA Medical Center. As an investigator in the Minneapolis VA
Health Services Research and Development Center for Chronic Disease Outcomes Research, his research interests
include evidence-based chronic disease prevention and management. Dr. Wilt served on the Outcomes Research
& Epidemiology Task Force in 1997 and currently sits on the editorial board of the American Journal of Medicine.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 109
APPENDIX D:
Evidence – Based Practice Centers Bios
Blue Cross and Blue Shield Association, Technology Evaluation Center
Naomi Aronson, PhD
Director, BC/BS Evidence-based Practice Center
Executive Director, Technology Evaluation Center
Blue Cross Blue Shield Association
225 North Michigan Avenue
Chicago, IL 60601
Phone: (312) 297-5530
Fax: (312) 297-6827
E-mail: naomi.aronson@bcbsa.com
Dr. Aronson is the Executive Director of the Blue Cross and Blue Shield Association Technology Evaluation
Center (TEC). She has overseen TEC’s development as a nationally recognized technology assessment program
and an Evidence-based Practice Center (EPC) of the Agency for Healthcare Research and Quality (AHRQ). Dr.
Aronson has directed over 300 technology assessments and 10 evidence reports for AHRQ. She has published
articles in Annals of Internal Medicine, Journal of the National Cancer Institute, Cancer, Journal of the American
College of Surgeons, Academic Radiology, Journal of Family Practice, and Gastrointestinal Endoscopy. She
represented the private sector on a US Agency for International Development team providing technical assistance
to the Hungarian government on building evidence-based medicine capacity in the national health insurance
system. She is a member of the Institute of Medicine Forum on Drug Discovery Translation and Development,
and the Steering Committee of the Chicago-Area DEcIDE Research Center and the National Business Group on
Health Committee on Evidence-Based Benefit Design.
Previously, Dr. Aronson was a member of Northwestern University faculty, specializing in sociology of science
and medicine. She was also a post-doctoral fellow in the Science, Technology and Society Program at the
Massachusetts Institute of Technology and received research awards from the National Science Foundation and
the American Council of Learned Societies. Dr. Aronson’s academic research focused on how the organization
of scientific specialties in biomedical and clinical research affects the process of scientific discovery.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 110
Duke University
David B. Matchar, MD
Director and Professor of Medicine
Duke Center for Clinical Health Policy Research
2200 W. Main Street, Suite 220 Tower
Durham, NC 27705
E-mail: match001@mc.duke.edu
Dr. Matchar’s research relates to clinical practice improvement — from the development of clinical policies to
their implementation in real world clinical settings, and most recently, cerebrovascular disease, disabling
neurological conditions, cardiovascular disease, and cancer prevention.
Dr. Matchar served as principal investigator for the Stroke Prevention Patient Outcome Research Team
(PORT). Funded by the AHCPR, the PORT involved 35 investigators at 13 institutions. The Stroke PORT has
been highly productive and has led to a stroke prevention project funded as a public/private partnership by the
AHCPR and DuPont Pharma, the Managing Anticoagulation Services Trial (MAST). MAST is a practice
improvement trial in 6 managed care organizations, focusing on optimizing anticoagulation for individuals with
atrial fibrillation.
Dr. Matchar also serves as consultant in the general area of analytic strategies for clinical policy development,
as well as for specific projects related to stroke (e.g., acute stroke treatment, management of atrial fibrillation, and
use of carotid endarterectomy.) Dr. Matchar has worked with AHCPR (now AHRQ), ACP, AHA, AAN, Robert
Wood Johnson Foundation, NSA, WHO, and several pharmaceutical companies.
Research interests: clinical policy development and implementation, evidence synthesis, disease modeling, health
economics, practice improvement trials.
Douglas C. McCrory, MD, MHSc
Head, Evidence-based Practice Center and Associate Professor
Duke Center for Clinical Health Policy Research
2200 W. Main Street, Suite 220 Tower
Durham, NC 27705
E-mail: mccro002@mc.duke.edu
Dr. McCrory has also worked in health care policy development, working with professional and other
organizations translate evidence into clinical recommendations. Such projects include the RAND carotid
endarterectomy appropriateness project, the American College of Physicians’ Clinical Efficacy Assessment
Project recommendations for medical treatment for stroke prevention and a joint ACP-ASIM/ACCP guideline
development on management of acute exacerbation of COPD.
Research interests: meta-analysis, clinical practice guideline development, systematic review methodology.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 111
John W. Williams Jr., MD
Professor of Medicine & Psychiatry
Scientific Editor, NC Medical Journal
Duke University and Durham VA Medical Center
2424 Erwin Road
Suite 1105, Hock Plaza
Durham, NC 27705
Phone: (919) 668-0300
Fax: (919) 668-1300
E-mail: jw.williams@duke.edu
Dr. William’s is a Professor in the Department of Medicine and an Associate Professor in the Department of
Psychiatry at Duke University. His research interests include implementing best practices, mental illness in
primary care with a focus on depression and dementia, quality indicators, systematic reviews, and effectiveness
trials.
ECRI
Karen Schoelles, MD, SM
Director, ECRI Evidence-based Practice Center
ECRI
5200 Butler Pike
Plymouth Meeting, PA 19462
Phone: (610) 825-6000, ext. 5337
Fax: (610) 834-1275
E-mail: kschoelles@ecri.org
Vivian H. Coates, MBA
Vice President for Information Services and Technology Assessment
Principal Investigator
ECRI
5200 Butler Pike
Plymouth Meeting, PA 19462-1298
Phone: (610) 825-6000
Fax: (610) 834-1275
E-mail: vcoates@ecri.org
Vivian H. Coates, MBA, is ECRI’s vice president of information services and technology assessment. Ms. Coates
developed and directs ECRI’s technology assessment program and works to enhance the program’s contribution
to the health care community. She initiates and fosters relationships with the users of technology assessment
information to promote the use of evidence-based medicine in health care delivery, coverage, and clinical practice
guideline development. She directs the translation and dissemination of technology assessments into forms that
can be used by constituents throughout the health care community, including policy makers, consumer
advocates, and patients and their families. Ms. Coates oversees ECRI’s Evidence-based Practice Center (EPC),
which conducts technology assessments and develops evidence reports for the Agency for Healthcare Research
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 112
and Quality (AHRQ). She also is responsible for ECRI’s technology assessment contract with TRICARE
Management Activity, the Department of Defense agency that administers the health benefits for the U.S. Armed
Services personnel and their families, reservists, and retirees.
Ms. Coates has developed a number of health care and health technology-related information resources,
including ECRI’s Healthcare Standards print directory database, and TARGET, a searchable Web-deployed
database of evidence reports on emerging medical technologies. Ms. Coates is project director for ECRI’s contract
with AHRQ to develop, implement, and maintain the National Guideline Clearinghouse™, an Internet-accessible
database of summaries of clinical practice guidelines and related documents. She also directs ECRI’s contract
with AHRQ to develop, implement, and maintain the National Quality Measures Clearinghouse™, a database of
health care quality measures and supporting documentation.
Ms. Coates is responsible for the continuous development and promulgation of ECRI’s Universal Medical
Device Nomenclature System™ (UMDNS™), a controlled vocabulary and coding system for classifying medical
products and indexing clinical, regulatory, and technical information. It has been adopted by many nations and
by the European Union as the interim standard for medical devices in support of the Medical Devices Directives.
Ms. Coates was a member of the Project Council for the European Union project to develop the Global Medical
Device Nomenclature.
Since 1991, she has directed ECRI’s work with the National Library of Medicine (NLM) to index unique
health services research literature for NLM’s bibliographic databases and to incorporate UMDNS into NLM’s
Unified Medical Language System. She represents ECRI on several international medical informatics standards
committees, such as ISO TC 210 and CEN TC 257, and has been a member of the Global Harmonization Task
Force Study Group 2 on Vigilance and Postmarket Surveillance.
Johns Hopkins University
Eric B. Bass, MD, MPH
Director, Johns Hopkins Evidence-based Practice Center
Associate Professor of Medicine and Health Policy &Management
The Johns Hopkins Medical Institutions
1830 Building, Suite 8068
Baltimore, MD 21205
Phone: (410) 955-9871
Fax: (410) 955-0825
E-mail: ebass@jhmi.edu
Karen A. Robinson, MSc
Co-Director, EPC
Email: krobin@jhmi.edu
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 113
Jonathan M. Samet, MD, MS
Co-Chair of Scientific Advisory Committee
Phone: (410) 955-3286
Email: jsamet@jhsph.edu
Dr. Jonathan Samet is one of the world’s leading scientific experts on the health effects of active and passive
smoking. He has been contributed to many of the Surgeon General’s reports in the US and is the senior scientific
editor for the 2004 and 2006 reports on active and passive smoking respectively. He was also responsible for the
first surveillance efforts to track the tobacco epidemic in China.
Neil R. Powe, MD, MPH, MBA
Co-Director, EPC and Co-Chair of Scientific Advisory Committee
Director, Welch Center for Prevention, Epidemiology and Clinical Research
2024 E. Monument St.
Suite 2-600
Phone: (410) 955-6953
Fax: (410) 955-0476
Email: npowe@jhsph.edu
Education: BA, Princeton University, 1976; MD, Harvard Medical School, 1981; MPH, Harvard School of Public
Health, 1981; MBA, The Wharton School, University of Pennsylvania, 1986
Research and Professional Experience: Dr. Powe’s research involves prevention and screening, clinical
epidemiology, patient outcomes research, technology assessment, and cost-effectiveness analysis. He has
worked on many important diseases with substantial morbidity including kidney disease, cardiovascular
disease, diabetes, thyroid disease, depression, and eye disease. He has also conducted projects on health
disparities, managed care, access to care, and quality of care. His research has used prospective methods of
randomized controlled trials and cohort studies, cost-effectiveness analysis, meta-analysis, retrospective
analyses of administrative databases, and survey research.
Dr. Powe has studied the relation between volume, technology, and outcomes of patients with myocardial
infarction, thrombolytic therapy in the elderly, and ethnic differences in cardiovascular procedure use in patients
with chronic kidney disease. Dr. Powe is principal investigator of the CHOICE study, a study of the outcomes of
end-stage renal disease patients funded by the agency for Healthcare Research and Quality (AHRQ) and the
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). This is a national study of patient
outcomes in chronic kidney disease. He has extensive experience in developing and measuring outcomes in this
population using data from prospective studies, the United States Renal Data System (USRDS), Medicare
records, and patient surveys.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 114
Steven N. Goodman, MD, MHS, PhD
Co-Director, EPC
Depart of Oncology
Division of Biostatistics
John Hopkins School of Medicine
1103 550 Building
Phone: (410) 955-4596
Fax: (410) 614-2325
Email: sgoodman@welchlink.welch.jhu.edu
Steven N. Goodman, MD, MHS, PhD, is an Associate Professor of Oncology in the Division of Biostatistics of the
Johns Hopkins Kimmel Cancer Center, with appointments in the Departments of Pediatrics, Biostatistics and
Epidemiology in the Johns Hopkins Schools of Medicine and Public Health. Dr. Goodman received a BA from
Harvard, MD from NYU, trained in Pediatrics at Washington University in St. Louis, and received an MHS. in
Biostatistics and PhD in Epidemiology from Johns Hopkins School of Public Health. In the Oncology Center he
directs the Biostatistics cores of the SPORE grants in GI and Head and Neck Cancer and consults on numerous
clinical research projects. As part of the Head and Neck SPORE, he is overseeing the production of HAND (Head
And Neck Database), which will integrate clinical, pathologic, molecular, genetic and epidemiologic information
on all patients with these types of cancer seen at Johns Hopkins. This is being designed to conform to cross-
institutional standards developed within the EDRN - Early Detection Research Network.
In addition to his activities in oncology, Dr. Goodman is an active leader and teacher in a variety of
departments and programs within the Johns Hopkins Medical Institutions. He is co-director of the PhD program
in the Department of Epidemiology and of the Johns Hopkins Evidence-Based Practice Center, and is on the core
faculties of the Johns Hopkins Bioethics Institute, the Center for Clinical Trials, and the Graduate Training
Program in Clinical Investigation (GTPCI). He directs Project ImpACT (Important Achievements of Clinical
Trials), a project to identify, compile and profile the 100 most important clinical trials ever performed, across all
disciplines of medicine and public health. He runs a yearlong doctoral seminar for all epidemiology PhD
students, teaches a course on Meta-analysis in the Epidemiology department, and is a director of the 2 week
Methods in Clinical Research course taught every summer under the auspices of the GCRC (General Clinical
Research Center) and GTPCI. He is a regular lecturer in several courses on research ethics and research methods
given throughout the year. He chairs the Department of Epidemiology curriculum committee and serves as a
statistician for the pediatric clinical research unit of the GCRC.
Dr. Goodman is very active outside of Johns Hopkins in a variety of editorial and advisory capacities. He is
the Editor-in-chief of Clinical Trials: Journal of the Society for Clinical Trials, and has been Statistical Editor of
the Annals of Internal Medicine since 1987. He has served on a wide variety of national panels, including the
Institute of Medicine’s Committee on Veterans and Agent Orange, Committee on Immunization Safety, the
Medicare Coverage Advisory Commission, and the Surgeon General’s committees to write the 2001 and 2002
reports on Smoking and Health. He served as a consultant to the President’s Advisory Commission on Human
Radiation Experiments. He chairs a national panel on the health outcomes of children born using assisted
reproductive technologies, sponsored by the American Academy of Pediatrics and the American Society for
Reproductive Medicine. He represents the American Academy of Pediatrics on the Medical Advisory Panel of the
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 115
National Blue Cross/Blue Shield Technology Evaluation program, and was recently appointed to succeed Dr.
David Eddy as scientific advisor to the group. He is on the Board of Directors of the Society for Clinical Trials
and was co-director of the Baltimore Cochrane Center from 1994-1998. He writes and teaches extensively on
evidence synthesis, and inferential, methodological and ethical issues in epidemiology and clinical trials.
Education: PhD, Johns Hopkins University; MD, New York University; MHS, Johns Hopkins University
American Academy of Pediatrics Appointee to the Blue Cross and Blue Shield Association Medical Advisory
Panel
Member of several IOM panels (Agent Orange, Immunization Safety) and committees for Surgeon General’s
reports (2001, 2002)
Member of Medicare Coverage Advisory Committee (MCAC)
Research and teaching focus on inferential and ethical issues in clinical research, peer review, meta-analysis
Board-certified by the American Board of Pediatrics
Co-Scientific Advisor to the Association’s Medical Advisory Panel
McMaster University
Dr. Parminder Raina, PhD
Director, McMaster Evidence-based Practice Center
Associate Professor, Department of Clinical Epidemiology & Biostatistics
McMaster University
1280 Main Street West, Courthouse T-27, 3rd floor
Hamilton, Ontario, Canada L8S 4L8
Phone: (905) 525-9140, ext. 22197
Fax: (905) 546-7681
E-mail: praina@mcmaster.ca
In addition to his appointments at McMaster University, Parminder Raina has an appointment at the Institute of
Population Health at Hamilton General Hospital. Dr. Raina also holds joint faculty appointments in the
Department Health Care and Epidemiology at UBC, and Centre for Community Child Health Research
(CCCHR), BC Children’s Hospital.
Dr. Raina received his undergraduate degree from the University of Saskatchewan, Canada in 1989. He moved
to University of Guelph, Ontario to start his PhD program in epidemiology in 1991. He completed his PhD in
1995. After completing his PhD, he was appointed as an Assistant Professor (part-time) in the Department of
Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University. In Guelph and
Hamilton he was involved in the investigation of social support and health care use among seniors, epidemiology
of dementia, health of caregivers of dementia patients, SES and health of seniors, injuries among seniors
disability among seniors and development of motor growth curves among children with cerebral palsy. During
his time at McMaster, he was also involved in methodological studies related to the presentation of meta-analysis
data, framing of effects sizes and quality of primary studies used in M-A.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 116
In 1997, Dr. Raina took a faculty position at UBC and CCCHR. During his stay (1997-2001) in Vancouver, he
developed a research agenda in population health and injuries and directed BC Injury Research and Prevention
Unit. He continues to hold the position of Director of BC Injury Research and Prevention Unit. His focus on
injury research is to initiate the implementation of an emergency room surveillance system in British Columbia,
as well as examining the determinants of injuries in children and youth and older populations. In 1999, he was
also awarded a 5-year CIHR/NHRDP Investigator Award in the area of population health and injuries, and in
2003 he has been awarded a CIHR Investigator Award in the area of Healthy Aging.
Since moving to Hamilton in 2001, he has continued to work in the area of geriatric epidemiology, injuries
and methods related to M-A, systematic reviews, and knowledge transfer. He is also co-leading the development
of the Canadian Longitudinal Study on Aging. The overall aim of the CLSA is to examine aging as a dynamic
process. This study will investigate the inter-relationship among intrinsic and extrinsic factors from mid life to
older age, capturing transitions and trajectories that will allow us to clarify the concept of healthy aging. Once in
place, the CLSA will provide infrastructure and build capacity for the ongoing conduct of high quality research
on aging in Canada.
Oregon Health & Science University
Mark Helfand, MD, MS, MPH
Oregon Evidence-based Practice Center, Director
Professor of Medicine and Medical Informatics & Clinical Epidemiology, OHSU
Assistant Professor, School of Medicine
Division of Medical Informatics and Outcomes Research
3181 SW Sam Jackson Park Road
Portland, OR 97201-3098
Phone: (503) 494-4277
Fax: (503) 494-4551
E-mail: helfand@ohsu.edu
As Oregon Evidence-based Practice Center (EPC) Director, Dr. Helfand is responsible for the quality and
scientific integrity of all aspects of producing Oregon EPC reports. The Oregon EPC conducts systematic reviews
of health care topics for federal and state agencies and private foundations. These reviews report the evidence
from clinical research studies and the quality of that evidence for use by policy makers in decisions on guidelines
and coverage issues.
Education:
1990 MS in Health Services Research, Stanford University
1984 MD, University of Illinois at Chicago
1984 MPH in Health Resources Management, University of Illinois at Chicago
1979 BA, English Language and Literature, Stanford University
1979 BS, Biology, Stanford University
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 117
Evelyn P. Whitlock, MD, MPH
Oregon Evidence-based Practice Center, Co-Director & Liaison to Kaiser Permanente
Senior Investigator and Director for Research-Health Care Integration, KPCHR
Clinical Associate Professor of Public Health and Preventive Medicine, OHSU
Oregon Health & Science University
Oregon Evidence-based Practice Center
3181 SW Sam Jackson Park Road
Mail code: BICC
Portland, Oregon 97239-3098
Phone: (503) 418-5409
Fax: (503) 418-3332
E-mail: Evelyn.Whitlock@kpchr.org
Dr. Whitlock is a Senior Investigator at Center for Health Research, a board-certified preventive medicine
physician, and the Director of Research-Healthcare Integration. As Director of Research-Healthcare Integration,
she oversees translational research collaborations between CHR and Kaiser Permanente Northwest, particularly
those focused on evidence-based medicine. Dr. Whitlock is also an active member of CHR’s Leadership Team.
Dr. Whitlock is Associate Director of the Oregon Evidence-based Practice Center (EPC), a multi-institute
collaboration between CHR, Oregon Health & Science University (OHSU), and the Portland Veterans Affairs
Medical Center. The Oregon EPC is under a multi-year contract to the Agency for Healthcare Research and
Quality (AHRQ) to produce evidence syntheses based on systematic reviews, lead methodological development
for systematic reviews, and support the increased application of systematic reviews and other evidence-based
products into policy and practice. Dr. Whitlock serves as the Principal Investigator for the United States
Preventive Services Task Force (USPSTF), an EPC program that systematically reviews the evidence for a given
preventive service, so the USPSTF can develop recommendations for clinical preventive services.
She is also co-Principal Investigator of AHRQ’s Scientific Resource Center for its Effective Healthcare
Program and leads the Topic Nomination group, which generates topics for systematic evaluation. Dr. Whitlock
is a member of the senior faculty of the Oregon Clinical and Translational Research Institute (OCTRI), one of 12
NIH-funded awards for Clinical and Translational Sciences, and has helped develop and direct OCTRI’s
Translation of Research into Policy and Practice Program. She serves as the Portland Clinical Site Medical
Director, medical adjudicator, and co-investigator for the Women’s Health Initiative. Dr. Whitlock has significant
experience conducting epidemiological studies and health-services research using large observational datasets,
survey data, and administrative datasets. Other recent research includes collaboration with the CDC that created
and validated an algorithm to determine pregnancy episodes and their outcomes within Kaiser Permanente
Northwest, with ongoing work investigating important public health issues during pregnancy.
In addition to her appointment at CHR, Dr. Whitlock is an adjunct associate professor in OHSU’s
Department of Medical Informatics and Clinical Epidemiology. She also serves as a clinical associate professor in
the Department of Health and Preventive Medicine at OHSU, where she directed the Residency Program from
1993-1997.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 118
Roger Chou, MD
Scientific Director, Oregon Evidence-based Practice Center
Internal Medicine & Geriatrics
Sam Jackson Hall, 3rd Floor
3181 S.W. Sam Jackson Park Road
Portland, OR 97239
Phone: (503) 494-8562
Dr. Chou received his medical degree from Northwestern University Medical School and completed an internal
medicine residency at OHSU. He is board certified in internal medicine. Chou’s research interests include
development of evidence-based guidelines for health screening and management of pain conditions. He has led
research for the U.S. Preventive Services Task Force, the Drug Effectiveness Review Project, the American Pain
Society and the Agency for Healthcare Research and Quality’s Comparative Effectiveness Program. In his free
time, he enjoys rock climbing, mountaineering, hiking and photography.
Professional Education:
Degree(s): MD Northwestern University, Chicago, 1995
Residency: Oregon Health & Science University, Portland
Fellowships: General Internal Medicine-Veterans Affairs Medical Center, Portland
RTI International – University of North Carolina
Kathleen N. Lohr, PhD
Director, EPC
Director, Health Services and Policy Research
RTI International
3040 Cornwallis Road, P.O. Box 12194
Research Triangle Park, NC 27709-2194
Phone: (919) 541-6512 or (919) 541-7480
Fax: (919) 990-8454
E-mail: klohr@rti.org
Expertise: Quality of Care and Clinical Practice Guidelines; Evidence-Based Practice and Methods; Health Status
and Quality of Life Assessment
Education: PhD, Public Policy Analysis, RAND Graduate Institute; MA, Education, Stanford University; BA,
Sociology, Stanford University.
Background: Dr. Lohr has more than 30 years of experience in health care services and health policy research.
She also directs the RTI International-University of North Carolina Evidence-based Practice Center. In 2000, she
was named a Chief Scientist at RTI after four years of directing a broad program of health services research and
policy analysis. In addition, Dr. Lohr holds the rank of Research Professor, Health Policy and Administration,
UNC School of Public Health; Senior Investigator, UNC Program on Health Outcomes; and Senior Research
Fellow at the UNC Cecil G. Sheps Center for Health Services Research. Dr. Lohr spent nine years at the Institute
of Medicine, National Academy of Sciences, where she directed the Division of Health Care Services portfolio of
studies. During 12 years at The RAND Corporation, she led or worked on numerous health care studies,
including the RAND Health Insurance Experiment. She has written or edited dozens of reports and nearly 100
peer-reviewed articles.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 119
Meera Viswanathan, PhD
Director, RTI-UNC Evidence-based Practice Center
RTI International
3040 Cornwallis Road
P.O. Box 12194
Research Triangle Park, NC 27709-2194
Phone: (919) 316-3930
Fax: (919) 541-7384
E-mail: viswanathan@rti.org
Timothy S. Carey, MD, MPH
Professor of Medicine
Director, Cecil G. Sheps Center for Health Services Research
Deputy Director, UNC Program on Health Outcomes
University of North Carolina at Chapel Hill
725 Airport Road, Campus Box 7590
Chapel Hill, NC 27599-7590
Phone: (919) 966-7101
Fax: (919) 966-5764
E-mail: tim_carey@unc.edu
Southern California
Paul Shekelle, MD, PhD
Director, Southern California EPC-RAND
1700 Main Street
Santa Monica, CA 90401
Phone: (310) 393-0411, ext. 6669
Fax: (310) 451-6917
E-mail: paul_shekelle@rand.org
Expertise: Complementary and alternative medicine, quality of care
Education: MD, Duke University; PhD, University of California, Los Angeles
Background: Currently an Associate Professor of Medicine at the UCLA School of Medicine, and a staff physician
at the VA Medical Center in West Los Angeles. Research focus has been in the application of innovative methods
to the assessment and improvement of the quality of care. Co-directs the Assessing Care of the Vulnerable Elderly
project, which seeks to develop a comprehensive set of quality tools to assess care for this population. As an
Atlantic Fellow in Public Policy, studied how quality of care was being assessed in the National Health Service in
the United Kingdom.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 120
Tufts University – New England Medical Center
Joseph Lau, MD
Director, Principal Investigator
Center for Clinical Evidence Synthesis
Division of Clinical Care Research
Tufts-New England Medical Center
750 Washington Street, Box 63
Boston, MA 02111
Phone: (617) 636-7670
Fax: (617) 636-8628
E-mail: jlau1@tufts-nemc.org
Dr. Lau is Professor of Medicine at the Division of Clinical Care Research at the Tufts-New England Medical
Center. He is the Director of one of AHRQ Evidence-based Practice Centers (EPC) and the Director of the New
England Cochrane Center (Boston Office). He also heads an AHRQ funded program to train “Evidence-Based
Practitioners.” He has published extensively on the methodologies and clinical applications of meta-analysis. He
has given many lectures and short courses on meta-analysis nationally and internationally. He is a member of the
editorial board of Clinical Evidence. His earlier work in cumulative meta-analysis of acute myocardial infarction
treatment trials has won the distinction of being included in a proposed 27-articles core-canon of the western
medical literature by the editor of the Lancet in 1997.
University of Alberta
Terry P. Klassen, MD, MSc, FRCPC
Director, ARCHE/EPC
Professor and Chair, Department of Pediatrics
Phone: (780) 407-7084
Fax: (780) 407-8538
E-mail: terry.klassen@ualberta.ca
Dr. Terry Klassen founded the Alberta Research Center for Child Health Evidence (ARCHE) out of an eagerness
to generate evidence and expand the knowledge base for decisions in child health. Dr. Klassen’s interest in
evidence-based practice developed while working in the pediatric emergency department at the Children’s
Hospital of Eastern Ontario and trying to determine what was the best management for the acutely ill and
injured children he was assessing. This led him to actively research emerging issues through randomized trials
and systematic reviews. Dr. Klassen’s two major research interests have been in the areas of acute respiratory
disease and injury prevention and control.
Recognizing the limitations of single centre research, he was the founding member of Pediatric Emergency
Research of Canada (PERC). This organization, which involves all the pediatric emergency departments across
Canada, aims to foster collaborative research addressing the major health issues in pediatric emergency medicine.
It also has a major emphasis on mentoring young investigators in this field. This vibrant research group has major
funding from the Canadian Institutes of Health Research (CIHR) and has published in the major medical
journals, including British Medical Journal (BMJ), the Journal of the American Medical Association (JAMA), and
the New England Journal of Medicine (NEJM).
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 121
In keeping with his enthusiasm for evidence-based practice, Dr. Klassen led the Child Health Field of the
Cochrane Collaboration into existence in 1999. The Cochrane Collaboration is an international organization
that aims to synthesize all the available evidence in health. The mandate of the Child Health Field is to ensure
that the child health area is addressed in a comprehensive and relevant way within the collaboration.
As part of a collaborative effort, involving key researchers from the University of Alberta and Capital Health,
he is currently the Director of the University of Alberta Evidence-based Practice Center (U of A EPC). This center
has been involved with evidence reports regarding Biventricular Pacing for Congestive Heart Failure, Melatonin
for Sleep Disorders, and Occupational Asthma.
Since 1999, Dr. Klassen has been the Professor and Chair of the Department of Pediatrics at the University of
Alberta and Clinical Leader for the Child Health Program of Capital Health, which is home for the Stollery
Children’s Hospital. In 2003, in recognition for his lifetime achievement in research in pediatrics, he was awarded
the Research Award from the Ambulatory Pediatric Association.
Brian H. Rowe, MD, MSc, CCFP(EM), FCCP
Associate Director, University of Alberta EPC
Research Director, Division of Emergency Medicine
Professor, University of Alberta
Room 1G1.43 WMC
University of Alberta Hospital
8440-112th Street
Edmonton, Alberta, Canada T6G 2B7
Tel: (780) 407-6707
Fax: (780) 407-3982
Email: Brian.Rowe@ualberta.ca
Lisa Hartling, BScPT, MSc
Administrative Director, EPC
Administrative Director
University of Alberta Evidence-based Practice Center
Department of Pediatrics
University of Alberta
Aberhart Centre One, Room 9424
11402 University Avenue
Edmonton, Alberta
Canada T6G 2J3
Phone: (780) 492-6124
Fax: (780) 407-6435
E-mail: hartling@ualberta.ca
Lisa Hartling is the co-director of ARCHE and the University of Alberta Evidence-based Practice Center. Her
responsibilities include: overseeing the activities of the ARCHE/EPC group, participating in systematic reviews,
and assisting clinicians and other professionals in conducting systematic reviews.
Through her education in epidemiology (MSc Community Health and Epidemiology, Queen’s University,
1995) and her clinical experience as a physiotherapist (BScPT, University of Alberta, 1990), Lisa developed an
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 122
acute awareness of the need for quality research to justify and support health care activities. Lisa is interested in
research at all levels from designing studies and implementing research protocols to analyzing and interpreting
results and making these available in a form that is meaningful to the intended audience. Her specific research
interests include injury epidemiology, methodological issues, surveillance and child health.
Donna Dryden, PhD
Associate Director, EPC
Phone: (780) 492-1273
Fax: (780) 407-6435
E-mail: ddryden@ualberta.ca
Dr. Dryden is the Associate Director of the University of Alberta/Capital Health Evidence-based Practice Center.
Donna received her Masters and PhD in Medical Sciences — Public Health Sciences (Epidemiology) from the
University of Alberta. Her doctoral research was an examination of spinal cord injury in Alberta, including the
epidemiology, utilization of health services and direct health care costs. She recently (July 2005) completed a Post
Doc with the British Columbia Rural and Remote Health Research Institute at the University of Northern British
Columbia. Donna’s primary research interests are injury epidemiology and the use of administrative data to
explore health outcomes and patterns of health service utilization for specific illnesses and injuries. She is the
author of a number of peer-reviewed papers and published abstracts. As a researcher, she has conducted several
systematic reviews and has also been involved in teaching critical appraisal and evidence-based medicine. Prior
to becoming an epidemiologist, Donna was a health sciences librarian.
University of Connecticut
C. Michael White, PharmD
Associate Professor of Pharmacy Practice
University of Connecticut
School of Pharmacy, Room 342
69 North Eagleville Road, Unit 3092
Storrs, Connecticut 06269-3092
Phone: (860) 486-4697
Fax: (860) 545-2415
E-mail: cmwhite@harthosp.org
C. Michael White earned his BS and PharmD at the Albany College of Pharmacy in Albany, NY, and served a
fellowship at the UConn School of Pharmacy/Hartford Hospital in 1998. His professional interests include
arrhythmia detection, prevention, and treatment; the impact of drugs, herbs, and natural products on
implantable cardiac devices and electrophysiology; and pleiotrophic effects of antihyperlipidemic agents.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 123
Craig Coleman, PharmD
Assistant Professor of Pharmacy Practice
University of Connecticut
School of Pharmacy, Room 346
69 North Eagleville Road, Unit 3092
Storrs, Connecticut 06269-3092
Phone: (860)545-2096
Fax: (860)486-1553
E-mail: ccolema@harthosp.org
Craig Coleman earned a BS in Biology from Clark University, and a BS in Pharmacy Studies along with his
PharmD from the University of Connecticut. His professional interests include: assessment of the clinical and
pharmacoeconomic outcomes of cardiovascular drugs including drugs used in the diagnosis and evaluation of
coronary artery disease and to prevent atrial fibrillation after cardiothoracic surgery; evaluation and modeling of
the cardiovascular effects of non-cardiovascular drugs; pharmacoeconomic evaluations of programs, devices,
and interventions designed to increase the appropriate and safe use of medications; and teaching outcomes
assessment and internal medicine pharmacotherapy to students, residents, and research fellows.
University of Ottawa
David Moher, PhD
Director, UO-EPC
Chalmers Research Group
Children’s Hospital of Eastern Ontario Research Institute
401 Smyth Road
Ottawa, Ontario
Canada K1H 8L1
Phone: (613) 738-3591
Fax: (613) 738-4800
E-mail: dmoher@uottawa.ca
The CRG team is led by David Moher, Director of Clinical Research at CHEO. Dr. Moher founded the Thomas
C. Chalmers Centre for Systematic Reviews in January 1998 and he has established an international reputation
regarding the methodology of systematic reviews and meta-analysis. His leadership led to the development of the
CONSORT standard for reporting randomized controlled trials, adopted by approximately 500 health care
journals internationally. David Moher has spearheaded over 30 systematic reviews, receiving national and
international funding. He has over 100 scientific papers in respected health care journals such as The Lancet and
JAMA. He is an Assistant Professor of Pediatrics, Medicine, and Epidemiology and Community Medicine, at the
University of Ottawa. David Moher is on the editorial board of several medical journals.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 124
Chantelle Garritty
UO-EPC Coordinator, CRG Systematic Reviews Manager
Chalmers Research Group
Children’s Hospital of Eastern Ontario Research Institute
401 Smyth Road
Ottawa, Ontario
Canada K1H 8L1
Phone: (613) 737-7600, ext. 4117
Fax: (613) 738-4800
E-mail: cgarritty@cheo.on.ca
University of Minnesota
Robert L. Kane, MD
Principal Investigator
Minnesota Chair in Long-Term Care and Aging
University of Minnesota School of Public Health
Mayo Mail Code 197
Minneapolis, MN 55455
Phone: (612) 624-1185
Fax: (612) 624-8448
E-mail: kanex001@umn.edu
Robert Kane, MD, Co-Director, is a physician with a background in preventive medicine, health services research,
and geriatrics, is a professor in the Division of Health Services Research and Policy and holds an endowed chair
in Long-term Care and Aging. Dr. Kane combines experience in aging and long-term care with expertise in policy
analysis and outcomes measurement. He has directed numerous large-scale research and evaluation projects in
a variety of fields related to health services research and directs the University’s Center on Aging.
Most recently, his larger efforts have examined the outcomes of Medicare patients discharged from hospitals
to assess the role of both hospital care and post-hospital care. He directed a study to examine the quality of home
care and another to develop an information system to examine the outcomes of mental health care in managed
behavioral care. These projects demonstrate not only his background in outcomes research but also his ability to
design and direct large scale, multi-site, longitudinal research efforts.
With regard to managed care, he also developed a process to assess the quality of care for PACE, which offers
capitated care to high risk older persons and he directs the team that is providing the technical assistance to
establish the second generation of Social HMOs. As part of the second generation SHMO demonstration, Dr.
Kane has been instrumental in designing the geriatric intervention for the demonstration and developing
screeners and triggers to be used in care management of the elderly SHMO enrollees. Dr. Kane is well known for
his abilities to design and carry out large-scale projects and for his general expertise in long-term care financing
and delivery and in quality of care. He is the editor of Understanding Health Care Outcomes (Aspen, 1997).
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 125
Vanderbilt University
Katherine E. Hartmann, MD, PhD
Director, Vanderbilt University Evidence-based Practice Center
Deputy Director, Institute for Medicine and Public Health
Vanderbilt University
Sixth Floor, Suite 600
2525 West End Avenue
Nashville, TN 37203
Phone: (615)936-8320
Fax: 615-936-8290
E-mail: katherine.hartmann@vanderbilt.edu
Dr. Hartmann is the Director of the Vanderbilt University EPC. She is also the Deputy Director of the Institute
for Medicine and Public Health at Vanderbilt University Medical Center (VUMC), where she serves as Director
of Women’s Health Research, and as the Lucius M. Burch Vice Chair of Research in Obstetrics and Gynecology.
Dr. Hartmann is a health care and reproductive epidemiologist. She received her medical training as well as her
a master’s degree in science writing from Johns Hopkins University. She completed her residency and doctoral
training in epidemiology at the University of North Carolina. She was the founding director of the Center for
Women’s Health Research at the University of North Carolina before joining the faculty of Vanderbilt University
in 2006.
Melissa McPheeters, MPH, PhD
Dr. McPheeters is the Associate Director for Operations. She is an Assistant Professor in the Departments of
Obstetrics and Gynecology and General Medicine and Public Health. She is also the Deputy Director for
Women’s Health Research at Vanderbilt and Director of Communications at the Institute for Medicine and
Public Health. She is trained in scientific writing and research, with a bachelor’s degree in professional writing,
an MPH in maternal and child health, and a PhD in Epidemiology. Dr. McPheeters has more than a decade of
experience managing proposal teams, conducting research and communicating complex concepts to a range of
audiences, including clinicians, policy makers, and the public.
Sandra Micucci, MSC
Ms. Micucci is the Associate Director for Methods. She holds an undergraduate degree in industrial relations and
economics, as well as a master’s in Health Research Methodology, and is currently completing a PhD in medical
geography. Her expertise crosses numerous methodological lines, including quantitative, evidence-based,
qualitative, mixed, geographical and economic methods of research. In her role with the Effective Public Health
Practice Project, a joint McMaster University and City of Hamilton project, she oversaw multiple reviews
simultaneously, integrating content experts and research staff from numerous locations. She has authored or co-
authored nine systematic review in public health and two systematic reviews in cancer care.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 126
APPENDIX E:
Effective Health Care Program’s
Stakeholder Group Bios
Darrell R. Abernethy, MD, PhD
Chief Science Officer at the United States Pharmacopeia
Dr. Abernethy assumed the position of Chief Science Officer at the United States Pharmacopeia in June, 2007.
Dr. Abernethy received his MD (AOA) and PhD (Pharmacology) degrees from the University of Kansas School
of Medicine in 1976. Further clinical training was in Internal Medicine at Jackson Memorial Hospital/University
of Miami through Board Certification in Internal Medicine. He then did post-doctoral fellowship training in
Clinical Pharmacology at the Massachusetts General Hospital. Dr. Abernethy joined the faculty at Tufts
University School of Medicine as Assistant Professor of Psychiatry and Medicine in 1981. He moved to Baylor
College of Medicine in 1983 where he advanced to Associate Professor of Medicine in the Division of
Hypertension and Clinical Pharmacology. In 1986 he moved to Brown University School of Medicine as Chief of
the Division of Clinical Pharmacology. He was subsequently promoted to Professor of Medicine at Brown. In
1994 Dr. Abernethy became the Francis Cabell Brown Professor and Director of the Division of Clinical
Pharmacology at Georgetown University School of Medicine, where he served until 1999. He then moved to
become Chief of the Laboratory of Clinical Investigation at the National Institute on Aging and was at this post
until June, 2007, at which time he assumed his current post.
Dr. Abernethy has contributed to understanding of mechanisms of peripheral distribution of drugs
and drug disposition and effect in obesity. He also has contributed to the knowledge base in
pharmacokinetic/pharmacodynamic relationships of cardiovascular drugs in aging and has advanced the
concept that the pathophysiology of aging must be considered when interpreting drug effects in the aged patient.
Currently Dr. Abernethy is studying the role of genetic polymorphisms of drug effectors that effect responses to
cardiovascular drugs. These studies include both phenotypic changes and genotypic changes which contribute to
altered phenotype and nongenotypic splice variant transcriptional changes which result in phenotypic changes.
Presently these studies are focusing on endothelial nitric oxide synthase and the L-type calcium channel.
These efforts have resulted in 187 publications of original research and over 50 book chapters and reviews.
Dr. Abernethy has participated in, and continues to participate actively in service and organizational activities
which promote the safe and effective use of medications in aged patients. As an extramural investigator, he served
on the NIGMS Pharmacological Sciences study section (1988-1992), the FDA generic drugs (1990-1992)
and cardiorenal (1992-1996) advisory committees, and served as chair of the VA merit review Geriatrics
subcommittee (1998-2000). As an educator, he served on the National Board of Medical Examiners
Pharmacology Test Committee (1992-1996), was chair of the NBME (now called USMLE) Applied
Pharmacology Committee (1997-2000), the Step 1 Test Committee (2006) and presently serves on the USMLE
biostatistics task force. Editorial activities include membership on the editorial boards of Clinical Pharmacology
and Therapeutics, the Journal of Clinical Psychopharmacology, Drugs, as Associate Editor of the Journal of
Pharmacology and Experimental Therapeutics, and he served as Editor-in-Chief of Pharmacological Reviews
(2001-2006). Organizational and public service have included serving as President of the American Society of
Clinical Pharmacology and Therapeutics (1991-1992) and on the Gerontology Committee of the United States
Pharmacoepia (1990-2005) that he subsequently chaired (1999-2005). He also served on the USP Medicare
Medication Guidelines committee, a group designated by the US Congress to establish the basis for the Medicare
Prescription Drug Benefit (2004-2005). In 2005 he was elected President of the USP Convention for the 2005-
2010 cycle.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 127
Wade M. Aubry, MD
Associate Director of the Center for Medical Technology Policy and Senior Medical Advisor
to the California Technology Assessment Forum
Dr. Aubry is Associate Director of the Center for Medical Technology Policy and Senior Medical Advisor to
the California Technology Assessment Forum. CMTP is a new nonprofit organization based in San Francisco
whose mission is to generate new evidence on important technologies to meet the needs of decision makers. He
has an extensive background in technology assessment and coverage decision making as former Senior Vice
President and Chief Medical Officer for Blue Shield of California and former Chairman of the Blue Cross Blue
Shield Association’s TEC Medical Advisory Panel. Dr. Aubry has also been a Medicare Part B Carrier Medical
Director for Northern California and has served two terms on the CMS Medicare Evidence Development and
Coverage Advisory Panel. He has been a member of numerous national advisory committees related to medical
technology, clinical research, and evidence-based medicine for the IOM, NIH, NCQA, ACRIN, and others. He
also has experience in health care consulting as a former Vice President for the Lewin Group.
Dr. Aubry received his B.S. degree from Stanford University and his MD degree from the UCLA School of
Medicine. Trained as an internist and endocrinologist at Cedars-Sinai Medical Center in Los Angeles, he practices
medicine at Saint Francis Memorial Hospital in San Francisco, where he is Chairman of the hospital’s
Institutional Review Board. He is also Associate Clinical Professor of Medicine at the UCSF Institute for Health
Policy Studies, where he serves on the faculty task force for the California Health Benefits Review Program and
teaches in clinical medicine and health policy. He is co-author of “False Hope: Bone Marrow Transplantation for
Breast Cancer”, which details the rise and fall of a controversial procedure that continues to have an impact on
policies related to the dissemination of new medical technology.
Jennifer L. Bright, MPA
Executive Director, Society for Healthcare Epidemiology of America (SHEA) and Founder, National Working Group
on Evidence-Based Healthcare
Ms. Bright leads the efforts of the National Working Group on Evidence-Based Healthcare, a group founded
in January 2006 that represents patient organizations, caregivers, physicians and consumers who are committed
to educating stakeholders, facilitating engagement in evidence-based health care initiatives and dialogue and
promoting inclusion of patient/consumer and caregiver contributions and perspectives in all aspects of evidence
generation, translation, dissemination and implementation to the practice of medical care.
Ms. Bright is currently the Executive Director for the Society for Healthcare Epidemiology of America
(SHEA), a professional society of clinical experts in hospital infection control and epidemiology. From 2000 to
2007, Ms. Bright was Vice President at Mental Health America, where she oversaw policy initiatives affecting
patients/consumers and families for over six years. This work included extensive review of comparative
effectiveness research conducted by OHSU’s Drug Effectiveness Review Project as well as the AHRQ Effective
Healthcare program. Ms. Bright’s past career experience in state government relations and consulting with
Stateside Associates and Booz-Allen & Hamilton has focused on a variety of health policy issues including
information privacy, screening, adverse event reporting, FDA reform, Medicaid and Medicare, mental health,
insurance reform, health IT, and scope of practice.
Ms. Bright earned a bachelor’s degree in Political Science from Trinity College, Washington, D.C., and a
Masters of Public Administration from The George Washington University.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 128
W. Gary Erwin, PharmD
Senior Vice President, Professional Services, Omnicare, Inc., and President, Omnicare Senior Health Outcomes
Dr. Erwin’s responsibilities include development, management and measurement of clinical programs for
Omnicare Senior Pharmacy services; business development in the areas of clinical initiatives for retiree
populations; and performance of outcomes studies and database reporting.
Dr. Erwin received his B.S. Pharmacy degree from Auburn University in 1976 and his Doctor of Pharmacy
degree from the University of Kentucky in 1981. He also completed a hospital pharmacy residency at the
University of Kentucky Medical Center in 1981. Prior to joining Omnicare, Dr. Erwin served as Vice President
for Professional Programs, and Professor of Clinical Pharmacy, Philadelphia College of Pharmacy and Science.
In addition, he was on the faculty at the University of Georgia, where he specialized in geriatric pharmacotherapy
and long-term care.
Omnicare, Inc., a Fortune 500 company based in Covington, Kentucky, is a leading provider of
pharmaceutical care for the elderly. Omnicare serves residents in long-term care facilities and other chronic care
settings comprising approximately 1,419,000 beds in 47 states, the District of Columbia and Canada. Omnicare
is the largest U.S. provider of professional pharmacy, related consulting and data management services for skilled
nursing, assisted living and other institutional health care providers as well as for hospice patients in homecare
and other settings. Omnicare’s pharmacy services also include distribution and patient assistance services for
specialty pharmaceuticals. Omnicare offers clinical research services for the pharmaceutical and biotechnology
industries in 30 countries worldwide.
Patricia M. Hart, MD, FACP
Private Practice, Brooklyn, New York
Patricia M. Hart, MD is board certified in both Internal medicine and Nephrology. In addition to practicing
medicine in a private medical practice, Dr. Hart is recognized for her expertise in innovative health strategies and
policies specifically involving minority health.
Dr. Hart received her BA in Biology from Fordham University. She received her medical doctorate from the
State University of New York at Buffalo. Dr. Hart completed her internship and residency training at the Harlem
Hospital Center in New York City. She completed a fellowship in Nephrology also at the Harlem Hospital Center.
Dr. Hart is a Fellow of the American College of Physicians.
Dr. Hart has not limited her career to clinical practice but rather is an advocate for improved health care and
has worked tirelessly within organized medicine. She has been appointed and elected to several local and national
positions of the National Medical Association including membership on the Board of Trustees. She has also
served on committees of the American College of Physicians and is a member of the Association of Black
Cardiologists and the Association of Minority Nephrologists. Dr. Hart is also involved with and supports several
nonprofit foundations and organizations.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 129
Maria Carolina Hinestrosa, MA, MPH
Executive Vice President for Programs and Planning at the National Breast Cancer Coalition, and
Co-founder of Nueva Vida
Carolina Hinestrosa is the Executive Vice President for Programs and Planning at the National Breast Cancer
Coalition, and co-founder of Nueva Vida, a support network for Latinas with cancer in the Washington
metropolitan area. A two-time breast cancer survivor, Ms. Hinestrosa is a member and former Chair of the
Integration Panel of the Department of Defense Breast Cancer Research Program. She has served on various
national committees at the National Cancer Institute, the Institute of Medicine, National Quality Forum, the
Ethical Force of the American Medical Association, among others. She is a sought-after speaker on breast cancer
advocacy in research, access and quality care. Born in Bogotá, Colombia, Ms. Hinestrosa came to the United
States in 1985 as a Fulbright scholar. She holds graduate degrees in economics and public health. She has broad
experience in strategic planning and nonprofit management in Colombia, New Zealand and the United States.
Peter Juhn, MD, MPH
Vice President, Evidence and Regulatory Policy, Johnson & Johnson
Peter Juhn is responsible for shaping evidence-based medicine policies at the J&J Corporate level, especially
as payers use evidence-based medicine as a basis for decisions on reimbursement and coverage of
pharmaceuticals and medical devices. He works with the various J&J operating companies on a global basis to
anticipate the methods and types of evidence needed in this evolving payer and regulatory environment. He also
provides policy coverage for developments in the Health Information Technology initiatives as well as quality-
based “pay-for-performance” activities. He serves as the industry representative to the Medicare Evidence
Development and Coverage Advisory Committee at CMS and is the coordinator of the manufacturer sector at
the IOM Roundtable on Evidence-based Medicine.
Most recently, he was Vice President, Health Improvement Resources, at WellPoint Health Networks, where
he managed the disease management programs for all the operating units. He also held senior positions at Kaiser
Permanente, including founding Executive Director, Care Management Institute, which is Kaiser’s corporate
disease management and clinical policy entity, and President and CEO of CareTouch, Inc., an e-health start-up
venture. He has a BA from the University of Chicago, an MD from Harvard, and an MPH from the University of
Washington, where he was a Robert Wood Johnson Clinical Scholar. He completed his Internal Medicine
residency at the University of Pennsylvania.
Dick Justman, MD
National Medical Director of UnitedHealthcare
Dick Justman is national medical director of UnitedHealthcare, a national health service delivery company.
He works in the Clinical Advancement division. Dick is accountable for medical technology assessment, clinical
support of pharmacy programs and clinical support of benefit administration. He has been with
UnitedHealthcare since 1993. Dick received his bachelor’s degree from Cornell University and his MD degree
from the State University of New York at Buffalo. He is board-certified in pediatrics, and received his
postgraduate training at The University of Chicago Hospitals and Clinics and the Johns Hopkins Hospital. Dick
practiced pediatrics in Minneapolis, Minnesota for fifteen years before joining UnitedHealthcare.
He has served on the Institute of Medicine Forum on Drug Discovery, Development and Translation; the
Institute of Medicine Committee to Identify Highly Effective Clinical Services; the American Medical Association
CPT-5 Project; the American Medical Association Initiative to Transform Medical Education (ITME); and an
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 130
expert panel developing an Evidence Report on diabetes education for children with type I diabetes,
commissioned by the Agency for Healthcare Research and Quality (AHRQ).
Sharon Levine, MD
Associate Executive Director, The Permanente Medical Group, Inc.
Sharon Levine, MD, is a nationally respected expert and frequent speaker on issues of health policy, drug use
management, and the design and delivery of health care services. As Associate Executive Director for The
Permanente Medical Group of Northern California since 1991- the largest medical group in the country – Dr.
Levine has responsibility for the recruitment, compensation, clinical education, management training and
leadership development for the group’s physicians; government and community relations, health policy and
external affairs; and pharmacy policy and drug use management
A board certified (American Board of Pediatrics) pediatrician, Dr Levine has practiced with The Permanente
Medical Group since 1977. During that time she has held multiple leadership roles within the Medical Group,
including Chief of Pediatrics, Chief of Quality, and Physician in Charge of the Fremont Medical Center.
Dr. Levine began her medical career at the Montgomery-Georgetown Pediatric Comprehensive Care Clinic,
and Georgetown University Community Health Plan. In addition, she has held academic appointments at Tufts
University School of Medicine and Georgetown University School of Medicine, and spent two years as a Clinical
Associate at the National Institutes of Health, Institute of Child Health and Human Development, doing research
on infant nutrition.
Dr. Levine is a member of the American College of Physician Executives, California Medical Association, and
American Medical Association. She serves on the Boards of Directors of the Integrated Healthcare Association,
The California Association of Physician Groups, The California Hospital Association, The Public Heath Institute
of California, and the Women’s Foundation of California.
A native of Boston, Dr. Levine received her undergraduate degree from Radcliffe College at Harvard
University, and her MD degree from Tufts University School of Medicine. Dr. Levine is married and lives in Palo
Alto, Ca.
Kaiser Permanente is America’s leading integrated health plan. Founded in 1945, it is a not-for-profit, group
practice prepayment program with headquarters in Oakland, California. Kaiser Permanente serves the health
care needs of over 8.2 million members in 9 states and the District of Columbia. Today it encompasses the not-
for-profit Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals and their subsidiaries, and the for-
profit Permanente Medical Groups, as well as an affiliation with Group Health Cooperative based in Seattle.
Nationwide, Kaiser Permanente includes approximately 136,000 technical, administrative and clerical employees
and over 11,000 physicians representing all specialties.
David B. Lorber, MD
Vice President of Medical Affairs for Caremark
David Lorber, MD, is Vice President of Medical Affairs for Caremark. He has been with the Company since
2000. Dr. Lorber is responsible for clinical oversight of Caremark programs, focusing on clinical product
development and eBusiness initiatives. In addition, he provides clinical support to account management teams
and for Medicare Part D initiatives.
Prior to joining Caremark, Dr. Lorber was Medical Director at Blue Cross Blue Shield of New Mexico in
Albuquerque. His responsibilities included utilization management, disease management, provider profiling,
pharmacy and therapeutics committee, credentialing and liaison to the State Medical Society and New Mexico
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 131
Department of Health. In addition, he served as the medical director for the Indian Health Service Contract
Health Services, a national entity managed by Blue Cross Blue Shield of New Mexico.
Before that, Dr. Lorber was a private practitioner in pulmonary, critical care and internal medicine and held
numerous positions in community leadership and professional organizations including President of the New
Mexico Chapter of the American Thoracic Society. He has held faculty appointments as Assistant Clinical
Professor of Medicine with the University of New Mexico School of Medicine, and as Assistant Professor with the
University of Arizona Medical Center in Tucson and the Tucson VA Hospital.
In addition, Dr. Lorber serves on both the Pulmonology Expert Committee and the Therapeutic Decision
Making Expert Committee of United States Pharmacopeia.
He received a Bachelor of Arts with distinction in biology from the University of Virginia and earned a Doctor
of Medicine degree from the Virginia Commonwealth University, Medical College of Virginia. He is board
certified in internal medicine, pulmonary disease. He is a Fellow of the American College of Chest Physicians and
a member of the American College of Emergency Physicians.
Caremark is a leading pharmaceutical services company that provides, through its affiliates, comprehensive
drug benefit services to more than 2,000 health plan sponsors and their plan participants throughout the
United States.
Doris H. Lotz, MD, MPH
Medicaid Medical Director for the State of New Hampshire
Since July 2002, Dr. Lotz has been the Medicaid Medical Director for the State of New Hampshire. She
provides clinical guidance for policy and program development and strategic planning. She is the program
director for the NH Medicaid disease management program provides plenary and implementation leadership to
the State’s Enhanced Care Coordination program. Additionally, she provides oversight to the program’s $80
million pharmacy program and directs the development and maintenance of the state’s preferred drug list. Dr.
Lotz has been responsible for the development, procurement and contracting of the State’s Medicaid Pharmacy
Benefits Management program, Outpatient Diagnostic Imaging Prior Authorization initiative and Independent
Review Organization program. She provided clinical leadership to the State’s selective contracting initiative in the
development of preferred network of Medicaid providers. She has become the Medicaid program’s resource for
“pay-for-performance” and quality measurement. Dr. Lotz is the State of New Hampshire’s lead contact for three
AHRQ initiatives on Quality Based Purchasing, Medicaid Care Management and the Medicaid Medical Director
Network. As a part of the Quality Based Purchasing initiative, Dr. Lotz is developing a Medicaid Report Card and
a provider incentive program. As well, she is the State’s contact for a CHCS Medicaid Value Program on Diabetes
Education. Dr. Lotz remains actively engaged Medicaid quality improvement and in maintaining balance
between clinical and business priorities.
Doris Lotz, MD completed her medical degree at Ohio State University in 1986, her Emergency Medicine
internship and residency at Harbor-UCLA Medical Center in Torrance, California in 1989 and a Masters in
Public Health from Johns Hopkins Bloomberg School of Public Health in 2005. She has worked clinically in both
private practice and managed care settings in both southern and northern California and Atlanta, Georgia while
remaining active in quality related issues. In 1998, Dr. Lotz became the Associate Medical Director for a large
managed care company in New Hampshire where she was primarily responsible for inpatient utilization
management, case management, predictive modeling, local disease management and quality issues. Dr. Lotz was
subsequently promoted to the regional position of New England Quality Medical Director for CIGNA Health
Care with oversight of clinical programs, including regional disease management, operations and accreditation
for a 5 state New England region.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 132
George Lundberg, MD
Editor in Chief of MedGenMed, Editor in Chief of Medscape Core, and Editor in Chief of eMedicine
A 1995 “pioneer” of the medical internet, Dr. Lundberg was born in Florida, grew up in rural southern
Alabama and holds earned and honorary degrees from North Park College, Baylor University, the University of
Alabama (Birmingham and Tuscaloosa), the State University of New York, Syracuse, Thomas Jefferson University
and the Medical College of Ohio. He completed a clinical internship in Hawaii and a pathology residency in San
Antonio. He served in the US Army during the Vietnam War in San Francisco and El Paso, leaving as a lieutenant
colonel after 11 years. Dr. Lundberg was then Professor of Pathology and Associate Director of Laboratories at
the Los Angeles County/USC Medical Center for 10 years, and for five years was Professor and Chair of Pathology
at the University of California-Davis.
Dr. Lundberg has worked in tropical medicine in Central America and Forensic Medicine in New York,
Sweden and England. His major professional interests are toxicology, violence, communication, physician
behavior, strategic management and health system reform. He is past President of the American Society of
Clinical Pathologists. From 1982 to 1999, Dr. Lundberg was at the American Medical Association as Editor in
Chief, Scientific Information and Multimedia with editorial responsibility for its 39 medical journals, American
Medical News, and various Internet products, and the Editor of JAMA.
In 1999 Dr. Lundberg became Editor in Chief of Medscape, the leading source of online health information
and education for physicians and health care professionals and the founding Editor in Chief of both Medscape
General Medicine and CBS HealthWatch.com. In 2002, Dr. Lundberg became Special Healthcare Advisor to the
Chairman and CEO of WebMD. Today, he serves as the Editor in Chief of MedGenMed www.medgenmed.com,
the original open access general medical journal, on Medline/PubMed since 2000, available exclusively on the
www.Medscape.com publishing platform. Dr Lundberg also serves as Editor in Chief of Medscape Core, and,
beginning in 2006, Editor in Chief of eMedicine, the original open access comprehensive medical textbook. A
frequent lecturer, radio and television guest and host in the past, and current webcasting moderator, host and
editorialist, and a member of the Institute of Medicine of the National Academy of Sciences, Dr. Lundberg holds
academic appointments as a professor at Stanford and Harvard. In 2000, the Industry Standard dubbed Dr.
Lundberg “Online Health Care’s Medicine Man”.
Newell McElwee, PharmD, MSPH
Vice-President of Evidence-Based Strategies at Pfizer
Newell McElwee is Vice-President of Evidence-Based Strategies at Pfizer where he leads a group of scientists
focused on Evidence-Based Medicine, Health Technology Assessment, the use of observational data for assessing
clinical effectiveness, and the application of evidence to coverage decisions. He has worked in the pharmaceutical
industry since 1992 following a career in academia. His educational background is in pharmacy (BS, University
of Louisiana; PharmD, Mercer University) and epidemiology (MSPH, University of Utah). Newell also completed
a clinical pharmacy residency and a research fellowship in clinical pharmacology and toxicology. His experience
has spanned the evidence continuum, from identification and prioritization of research topics to generation of
evidence to answer specific research questions to application of evidence in practice. He believes that in order to
improve the effectiveness and efficiency of our health care system, there must be a shared responsibility among
all stakeholders and decision-makers. To that end, Newell’s breadth of experience allows him to understand the
unique needs of public and private payers, clinicians, patients, researchers, policy decision-makers, and
developers of new technologies so that collectively they can address the challenges facing our health care system.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 133
G. Gregory Raab, MA, PhD
President, Raab & Associates, Inc.
Greg Raab is an independent consultant specializing in technology innovation, reimbursement requirements,
and health policy. His clients include medical technology associations and groups, as well as medical technology
companies.
Before beginning his consulting practice in 2000, Dr. Raab held senior government affairs and health policy
positions at AdvaMed, the Advanced Medical Technology Association, for more than seven years, and at
Medtronic, Inc. for close to ten years. From 1981 to 1983, Dr. Raab staffed Senator Max Baucus (D-MT) in his
role as the Ranking Democratic Member of the Senate Finance Committee’s Health Subcommittee,
concentrating on Medicare policies and hospital reimbursement reform. He also worked for several years at
HCFA (now the Centers for Medicare and Medicaid Services) on a wide range of legislative and policy matters,
as well as the U.S. Public Health Service. He earned his M.A. and PhD. from the University of Virginia.
Alan B. Rosenberg, MD
Vice President of Medical Policy, Technology Assessment and Credentialing Programs for WellPoint, Inc.
Alan B Rosenberg, MD is the Vice President of Medical Policy, Technology Assessment and Credentialing
Programs for WellPoint, Inc. Among his responsibilities, Dr. Rosenberg leads WellPoint’s program (across all of
its affiliated Brands) for medical policy, technology assessment, credentialing, and Clinical Health Policy training.
He is also President of Anthem UM Services, Inc. and of Anthem Credentialing Services Inc. Prior to his current
position, he has served as Chief Medical Officer for Rush Prudential Health Plans; Director in Healthcare
Business Consulting for Arthur Andersen; and Vice President of Medical Affairs and Medical Director for Aetna
US Healthcare of the Midwest, Inc.
Dr. Rosenberg received his undergraduate training from Columbia University in New York and received his
medical degree from New York University Medical School. He completed his residency in Internal Medicine at
the University of Chicago, Michael Reese Hospital.
Dr. Rosenberg is a Fellow of the Institute of Medicine of Chicago, serves as a Board Member of American
Association of Preferred Provider Organizations (AAPPO), member of the Blue Cross Association TEC Medical
Advisory Panel and Medical Policy Panel, several America’s Health Insurance Plan (AHIP) committees, and the
Agency for Healthcare Research and Quality Effective Healthcare Program Stakeholder Group.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 134
Eric M. Wall, MD, MPH
Senior Medical Director of Qualis Health
Eric M. Wall, MD, MPH is recently appointed Senior Medical Director of Qualis Health, a private, nonprofit
health care quality improvement organization based in Seattle, WA. He is responsible for supervision of the
Medical Services Department and implementing key strategic goals of the organization. Prior to his current
position, Dr. Wall was the Regional Medical Director for LifeWise Health Plan of Oregon and Premera Blue Cross
in Alaska for 8 years. Dr. Wall is a practicing family physician who taught at the Oregon Health & Sciences
University for 22 years with appointments in the Department of Family Medicine, Public Health and Preventive
Medicine, and the School of Nursing. He was Associate Professor and the first Director of Research in the OSHU
Family Medicine department between 1985 and 1995.
Dr. Wall received his MD degree from the Catholic University of Louvain in Belgium and completed his family
medicine residency at the University of Miami-Jackson Memorial Hospital. He completed his Masters in Public
Health at the University of Washington. His research interests have been in the areas of clinical decision-making,
development and implementation of clinical practice guidelines, and evidence-based maternity care.
Dr. Wall served as the Chair of the American Academy of Family Physician’s Commission on Science from
2005-2007. He currently serves on the American Medical Association’s Performance Measures and Evaluation
Subcommittee. He has participated on numerous guideline development panels and most recently worked on the
American Pain Society/American College of Physicians Low Back Pain Guideline Advisory Panel.
Anthony C. Wisniewski, Esq.
Executive Director for Health Care at the U.S. Chamber of Commerce
Anthony C. Wisniewski is executive director for health care at the U.S. Chamber of Commerce, where he is
primarily responsible for developing Chamber policy on health and life sciences and advocating those policies
before Congress and the federal agencies.
He joined the Chamber in September 2006 from biotechnology company MedImmune, Inc., where he served
as head of public policy and policy counsel, overseeing the development and implementation of policy strategies
for federal, state, and international government affairs matters.
Prior to MedImmune, Wisniewski served as senior director of state policy for the Pharmaceutical Research
and Manufacturers of America (PhRMA), managing state policy operations for several regions across the United
States. Before that, Wisniewski was in private legal practice, most recently with Tydings & Rosenberg LLP in
Baltimore, Maryland. His practice focused on commercial business transactions as well as government affairs on
local, state, and federal levels.
Wisniewski is admitted to the bars of both Maryland and the District of Columbia. He received his Juris
Doctorate from the University of Notre Dame and a Bachelor of Arts from the Catholic University of America,
majoring in politics, with minors in philosophy and history.
Wisniewski was appointed by President George W. Bush to the Christopher Columbus Fellowship Foundation
Board of Trustees as well as by U.S. Secretary of Health and Human Services Michael O. Leavitt to the Agency for
Healthcare Research and Quality (AHRQ) National Advisory Council. Currently, Wisniewski also serves the
University of Maryland Biotechnology Institute Board of Visitors, the Quality Alliance Steering Committee, and
the Hospital Quality Alliance. He is a former gubernatorial appointee to the board of the Maryland Technology
Development Corporation.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 135
APPENDIX F:
Center for Medical Technology Policy Staff Bios
Sean S. Tunis, MD, MSc
Founder and Director of Center for Medical Technology Policy; CHP/PCOR Adjunct Associate
Contact information:
Center for Medical Technology Policy
4712 Keswick Rd
Baltimore, MD 21210
(410) 963-8873
sean.tunis@netzero.net
Sean Tunis, MD, MSc. is the Founder and Director of the Center for Medical Technology Policy in San
Francisco, where he is working with health care decision makers and stakeholders to support the rapid evaluation
and effective use of new medical technologies. He is also a Principal at Rubix Health, which consults with early-
stage life sciences companies on reimbursement strategy deigned around developing reliable evidence of product
value.
Through September of 2005, Dr. Tunis was the Director of the Office of Clinical Standards and Quality and
Chief Medical Officer at the Centers for Medicare and Medicaid Services (CMS). In this role, he had lead
responsibility for clinical policy and quality for the Medicare and Medicaid programs, which provide health
coverage to over 100 million US citizens. Dr. Tunis supervised the development of national coverage policies,
quality standards for Medicare and Medicaid providers; quality measurement and public reporting initiatives,
and the Quality Improvement Organization program. As Chief Medical Officer, Dr. Tunis served as the senior
advisor to the CMS Administrator on clinical and scientific policy. He also co-chaired the CMS Council on
Technology and Innovation
Dr. Tunis joined CMS in 2000 as the Director of the Coverage and Analysis Group. Before joining CMS, Dr.
Tunis was a senior research scientist with the Lewin Group, where his focus was on the design and
implementation of prospective comparative effectiveness trials and clinical registries. Dr. Tunis also served as the
Director of the Health Program at the Congressional Office of Technology Assessment and as a health policy
advisor to the U.S. Senate Committee on Labor and Human Resources, where he participated in policy
development regarding pharmaceutical and device regulation.
He received a BS degree in History of Science from Cornell University, and a medical degree and masters in
Health Services Research from the Stanford University School of Medicine. Dr. Tunis did his residency training
at UCLA and the University of Maryland in Emergency Medicine and Internal Medicine. He is board certified in
Internal Medicine and holds adjunct faculty positions at Johns Hopkins and Stanford University School of
Medicine.
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 136
Wade Aubry, MD
Associate Director, Center for Medical Technology Policy
wade.aubry@cmtpnet.org
Wade M. Aubry, MD is a medical technology consultant, health policy researcher, and clinician based in San
Francisco. He is Senior Advisor for the Health Technology Center (HealthTech), where his work involves
forecasting the impact of emerging technologies on the health care system. He is responsible for HealthTech’s
methodology committee, health plan initiatives program, and federal liaison work, as well as for overseeing the
production and updating of technology forecast reports. He is also Associate Director of the Center for Medical
Technology Policy. Dr. Aubry has extensive experience with the Blue Cross Blue Shield system and Medicare,
especially in technology assessment, coverage decisions, CPT coding, and quality initiatives. He is currently an
advisor to the Blue Shield of California Foundation’s California Technology Assessment Forum and to the Blue
Cross Blue Shield Association on CPT coding issues. He is Associate Clinical Professor of Medicine at the UCSF
Institute for Health Policy Studies and a practicing endocrinologist at Saint Francis Hospital in San Francisco,
where he chairs the hospital’s Institutional Review Board. Previously, he was Vice President of the Lewin Group,
a health care consulting firm, Senior Vice President and Chief Medical Officer for Blue Shield of California,
Medicare Part B Medical Director for Northern California, and National Medical Consultant for the BCBSA,
where he chaired its Technology Evaluation Center’s national Medical Advisory Panel for 6 years.
Dr. Aubry received his BS degree Phi Beta Kappa from Stanford University, his MD degree from the UCLA
School of Medicine, and his postgraduate training at Cedars-Sinai Medical Center in Los Angeles. He has served
as a member of the AMA’s committee overseeing the revision of the CPT procedure coding system, NIH
committees related to clinical trials and managed care, the IOM Committee on Technologies for the Early
Detection of Breast Cancer (reported 2001), and the IOM Committee on Establishing a National Cord Blood
Stem Cell Program (reported 2005). Currently, he is a member of the CMS Medicare Coverage Advisory
Committee, the American College of Radiology Imaging Network (ACRIN) Advisory Panel, and the National
Committee for Quality Assurance (NCQA) Geriatrics Measurement Advisory Panel, where he recently helped
develop a new national performance measure for physical activity in Medicare health plans. His research interests
are in medical technology assessment and coverage decision making. Currently, he is a member of the UCSF
Effectiveness Center for the California Health Benefits Review Program (CHBRP), which produces evidence
reports on proposed health insurance mandates in California. He has lectured internationally and published
numerous articles on medical technology and managed care topics. He is co-author of a comprehensive case
study on bone marrow transplants for breast cancer which will be published in 2006 by Oxford University Press
entitled False Hope vs. Evidence-Based Medicine: Bone Marrow Transplantation for Breast Cancer.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 137
Linda Bergthold, PhD
Linda Bergthold is a senior advisor to the Center on Medical Technology Policy. Linda has more than 20 years
of experience in health care consulting and research to public and private purchasers and providers.
Prior to establishing her own consulting and research practice, she was a senior consultant and national
thought leader for the health care practice in the Los Angeles office of Watson Wyatt Worldwide, focusing on
evidence-based benefit design for large employers.
She has also been a vice president and head of the California office of The Lewin Group, a national health
policy consulting firm. At Lewin, she focused on strategic planning, benefit design and technology assessment,
and a principal with the William M. Mercer human resources consulting firm as the leader of their Western
Region managed care practice and national coordinator for health reform. She has been an Adjunct Professor at
the Center for Health Policy at Stanford University doing research on medical necessity and coverage issues in
managed care.
Linda worked on the benefit package for the Health Security Act as co-chair of the Benefits Working Group
for the White House Health Care Reform Task Force in 1993. She currently serves as a consumer representative
on the Medicare Evidence Development and Coverage Advisory Committee in Washington, D.C. She is a board
member of the California Technology Assessment Forum and the National Partnership for Women and Families
and has represented Watson Wyatt on the Integrated Healthcare Association board and the National Business
Group on Health’s Evidence-based Benefit Design Committee in Washington D.C.
Linda holds a BA from the University of California at Los Angeles, and an MA and PhD in Sociology from
the University of California. She was a Pew Health Policy Doctoral Fellow at the Institute for Health Policy, UCSF.
She is a widely published author on benefit design, medical necessity and purchasing strategies, including
“Medical Necessity: Do We Need It?” in Health Affairs 1995. Her book, Purchasing Power in Health was
published by Rutgers Press in 1990.
Molly J. Coye, MD, MPH
Founder and CEO, HealthTech
Dr. Molly J. Coye is founder and CEO of the Health Technology Center (HealthTech), a non-profit education
and research organization established in 2000 to advance the use of beneficial technologies in promoting
healthier people and communities.
Today HealthTech provides objective technology forecasts, innovative decision-making tools, and expert
learning networks for 45 Partner organizations. Partners include nearly 25 percent of the nation’s hospitals, as
well as the country’s leading health plans and the Centers for Medicare and Medicaid, which together cover more
than half of all insured Americans.
Dr. Coye has extensive experience in both the public and private sectors. She served as Commissioner of
Health for the State of New Jersey and Director of the California Department of Health Services, in addition to
heading the Division of Public Health at the Johns Hopkins School of Hygiene and Public Health, leading
marketing and product development for interactive health communication and disease management at
HealthDesk Corp, serving as Executive Vice President for the Good Samaritan Health System, and directing The
Lewin Group’s West Coast office.
As a member of the Institute of Medicine, Dr. Coye co-authored the reports To Err is Human and Crossing
the Quality Chasm, chaired the Committee on Access to Insurance for Children, and co-chaired the Committee
on Patient Safety Data Standards.
Dr. Coye is on the Board of Trustees of the American Hospital Association and the Program for Appropriate
Technology in Health (PATH), one of the largest and most creative nonprofit organizations working in
National Pharmaceutical Council The Current Evidence- Based Medicine Landscape 138
international health. She was a founding board member of The California Endowment, the largest private health
care philanthropy in California.
Dr. Coye has her MD and MPH degrees from Johns Hopkins University and is board certified by the
American College of Preventive Medicine. In 2005, she was selected one of the 100 most influential leaders in
health care - and the 25 most influential women in health care - by Modern Healthcare magazine.
Steven Pearson, MD, MSc, FRCP
Steven D. Pearson, MD, MSc, FRCP is a general internist and Associate Professor of Ambulatory Care and
Prevention at Harvard Medical School. Dr. Pearson received his BA from Stanford University and his MD from
the University of California at San Francisco. He was a medical intern and resident at Brigham and Women’s
Hospital in Boston, following which he completed a fellowship in health services research and received a Masters
of Science in Health Policy and Management from the Harvard School of Public Health.
Dr. Pearson’s work examines the scientific and ethical foundations of evidence-based policy making in health
care. His published work includes the book No Margin, No Mission: Health Care Organizations and the Quest
for Ethical Excellence, published in 2003 by Oxford University Press. Dr. Pearson serves on the management
committee of the International Society for Priority Setting in Health Care, and in 2004 he was awarded an
Atlantic Fellowship to pursue policy studies at the National Institute for Clinical Excellence in London, England.
He returned to the US to serve from 2005-2006 as Special Advisor, Technology and Coverage Policy, at the
Centers for Medicare and Medicaid Services.
In June, 2006 he was named Senior Fellow at America’s Health Insurance Plans (AHIP) to perform research
and policy analysis on issues related to evidence-based medicine. In 2006, Dr. Pearson also received grant
funding to support the Institute for Clinical and Economic Review (ICER). ICER is a new initiative, created to
integrate appraisals of the clinical effectiveness and cost-effectiveness of medical innovations, with the goal of
providing new information to decision makers’ intent on improving the value of health care services.
Gail Wilensky, PhD
Gail Wilensky, an economist, and a Senior Fellow at Project HOPE (an international health education
foundation) analyzes and develops policies relating to health care reform and to ongoing changes in the health
care environment.
Dr. Wilensky is a Commissioner on the President’s Commission on Care for America’s Returning Wounded
Warriors, the WHO’s Commission on the Social Determinants of Health, is co-chair of the Department of
Defense task force on the Future of Military Health Care, is Vice Chair of the Maryland Health Care Commission
and serves as a trustee of the Combined Benefits Fund of the United Mineworkers of America and the National
Opinion Research Center. She is an elected member of the Institute of Medicine and has served two terms on its
governing council. She is a former chair of the board of directors of Academy Health, a former trustee of the
American Heart Association and a current or former director on numerous other organizations. She is also a
director on several corporate boards.
From 1990 - 1992, she was Administrator of the Health Care Financing Administration, directing the
Medicare and Medicaid programs. She also served as Deputy Assistant to President (GHW) Bush for Policy
Development, advising him on health and welfare issues from 1992 to 1993.
The Current Evidence- Based Medicine Landscape National Pharmaceutical Council 139
From 1997 to 2001, she chaired the Medicare Payment Advisory Commission, which advises Congress on
payment and other issues relating to Medicare, and from 1995 to 1997, she chaired the Physician Payment Review
Commission. From 2001 to 2003, she co-chaired the President's Task Force to Improve Health Care Delivery for
Our Nation's Veterans, which covered health care for both veterans and military retirees.
Dr. Wilensky testifies frequently before Congressional committees, acts as an advisor to members of Congress
and other elected officials, and speaks nationally and internationally before professional, business and consumer
groups. She received a bachelor's degree in psychology and a PhD in economics at the University of Michigan
Rita Redberg, FACC, MD, MSc
Director, Women's Cardiovascular Services
Contact information:
UCSF Medical Center
Division of Cardiology
505 Parnassus Avenue
San Francisco, CA 94143-0124
Telephone/Fax/Email:
Phone: (415) 476-6874
Fax: (415) 502-8627
Email: redberg@medicine.ucsf.edu
Dr. Rita Redberg is a cardiologist specializing in heart disease in women. She earned her medical degree from
the University of Pennsylvania School of Medicine, in Philadelphia. She completed her residency at Columbia-
Presbyterian Medical Center in New York, where she went on to complete a fellowship in cardiology. Then she
completed a fellowship in non-invasive cardiology at Mount Sinai Medical Center, also in New York. In addition,
Redberg has a masters of science in health policy and administration from the London School of Economics in
England. Also she is currently a Robert Wood Johnson health policy fellow.
Redberg has written, edited and contributed to many books, including You Can Be a Woman Cardiologist,
Heart Healthy: The Step-by-Step Guide to Preventing and Healing Heart Disease and Coronary Disease in
Women: Evidence-Based Diagnosis and Treatment.

You're Reading a Free Preview

Download
scribd
/*********** DO NOT ALTER ANYTHING BELOW THIS LINE ! ************/ var s_code=s.t();if(s_code)document.write(s_code)//-->