The Current Evidence-based Medicine Landscape

THE CURRENT EVIDENCE-BASED MEDICINE LANDSCAPE 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 7101 Wisconsin Avenue Suite 600 Bethesda, MD 20814 Phone: 1-301-654-9729 Fax: 1-301-654-9864 www.UnitedBioSource.com

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

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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

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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

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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.

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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 Extramural Research, Education and Priority Populations

Center for Financing, Access, and Cost Trends

Francais D. Chesley, Jr., MD Director

Steven B. Cohen, PhD 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

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

Center for Outcomes and Evidence Jean R. Slutsky, PA, MSP.H Director

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

Conducts and supports research and assessment of health care, technologies, processes, and systems

Office of the Director Carolyn M. Clancy, MD Director

Office of Performance Accountability, Resources and Technology Jeffrey Toven Director

Kathie Kendrick, RN, MS, C.S. Deputy Director

Center for Primary Care, Prevention, and Clinical Partnerships David Meyers, MD Director

Directs and coordinates Agency-wide program planning and evaluations activites and administrative operations.

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 Delivery, Organization, and Markets

Center for Quality Improvement and Patient Safety

Irene Fraser, PhD Director

William B. Munier, MD Director

Provides a locus of leadership and expertise for advances in health care delivery, organization, and markets through research

Works to improve the quality and safety of our health care system through research and implementation of evidence

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FIGURE 2. AHRQ Organizational Structure and Programs Related to EBM 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

Center for Primary Care, Prevention, & Clinical Partnerships Director: Helen Burstin, MD, MPH Deputy Director: David C. Lanier, MD

National Advisory Council for Healthcare Research & Quality

U.S. Preventive Services Task Force Program Project Coordinator: Therese Miller, DrPH (AHRQ) Reviews by: Oregon Evidence-Based Practice Center Center for Outcomes and Evidence (COE) Director: Jean R. Slutsky, PA, MSPH U.S. Preventive Services Task Force (USPSTF) Chair: Bruce N. Calonge, MD, MPH Vice Chair: Diana B. Petitti, MD, MPH

Evidence-based Practice Centers (EPC) Program* Director: Kenneth Fink, MD, MGA, MPH

*

Effective Health Care (EHC) Program* Scientific Resource Center located at Oregon EPC

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

Organizational sub-structure of these EBM programs are provided in subsequent sections of report.

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.

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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.) TABLE 1. National Advisory Council for Healthcare Research and Quality as of April 2008 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: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

Robert S. Galvin, MD (2010) Director, Global Health Care General Electric 376 Hillside Road Fairfield, CT 06824 Phone: (203) 373-3435 [email protected]

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TABLE 1. National Advisory Council for Healthcare Research and Quality as of April 2008

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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: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

Munr Kazmir, MD (2008) Founder, Direct Meds, Inc. 345 Grand Avenue Leonia, NJ 07605 Phone: (201) 585-9234 Fax: 9202) 585-7950 E-mail: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

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TABLE 1. National Advisory Council for Healthcare Research and Quality as of April 2008 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: [email protected]

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: [email protected]

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: [email protected]

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: [email protected]

Myrl Weinberg, CAE (2010) President, National Health Council 1730 M. Street, NW Suite 500 Washington, DC 20036 Phone: (202) 785-3910 E-mail: [email protected]

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: [email protected]

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.

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Current Members (See Appendix C for USPSTF biographies.) TABLE 2. USPSTF Members as of 2007 TABLE 2. USPSTF Members asMay 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

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

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

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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

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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 decisionmaking, 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.

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FIGURE 3. Evidence-based Practice Centers AHRQ’s Evidence-based Practice Center (EPC) Program Director: Kenneth Fink, MD, MGA, MPH

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

Blue Cross and Blue Shield Association, Technology Evaluation Center Director: Naomi Aronson, PhD

Duke University * ‡ Director: David B. Matchar, MD Head: Douglas McCrory, MD

University of Connecticut Co-Director: C. Michael White, PharmD Co-Director: Craig Coleman, PharmD

ECRI * Director: Karen Schoelles, MD, SM Principal Investigator: Vivian H. Coates, MBA

Johns Hopkins University ‡ Director: Eric B. Bass, MD, MPH Co-Director: Neil R. Powe, MD, MPH, MBA Co-Director: Karen A. Robinson, MSc

RTI International — University of North Carolina at Chapel Hill†† Co-Director: Kathleen N. Lohr, PhD (RTI) Co-Director: Timothy S. Carey, MD, MPH (UNC)

Southern California Evidence-Based Practice CenterRAND Director: Paul Shekelle, MD, PhD

McMaster University Director: Parminder Raina, PhD

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

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 Ottawa, Ottawa, Canada Director: David Moher, PhD Coordinator: Chantelle Garritty

University of Minnesota, Minneapolis, MN Director: Robert L. Kane, MD

* 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.

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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. TABLE 3. EPC Evidence-Based Reports in Progress as of April 2008 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 Endocrine Conditions

Nutrition (mid 2008)

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)

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TABLE 4. Technology Assessments in Progress as of April 2008 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

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.

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• 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. 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

Peter Juhn, MD, MPH Vice President, Evidence and Regulatory Policy, Johnson & Johnson

Dick Justman, MD National Medical Director of United Healthcare

Sharon Levine, MD Associate Executive Director, The Permanente Medical Group, Inc.

David B. Lorber, MD Vice President of Medical Affairs for Caremark

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.

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 * See Appendix E for EHC’s Stakeholder Group biographies.

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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.

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FIGURE 4. Organizational Substructure of AHRQ’s EHC Program AHRQ’s Effective Health Care Program

Scientific Resource Center Location: Oregon EPC Director: Mark Helfand, MD

Stakeholders Group

EPCs* Comparative Effectiveness Reviews (CER)

DEcIDE Research Network

Acumen, LLC, Burlingame, CA PI: Thomas E. MaCurdy, PhD

University of Colorado at Denver and Health Sciences Center, Aurora, CO PI: John F. Steiner, MD

Brigham and Women’s Hospital, Boston, MA PI: Sebastian Schneeweiss, MD

Duke University, Durham, NC † PI: David B. Matchar, MD

* 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

John M. Eisenberg Clinical Decisions & Communications Science Center Director: David Hickam, MD

University of Illinois-Chicago PI: Glen T. Schumock, PharMD

University of Maryland – Baltimore PI: Bruce C. Stuart, PhD

Harvard Pilgrim Health Care, Harvard Medical School, Boston, MA PI: Richard Platt, MD

University of North Carolina at Chapel Hill PI: Suzanne L. West, PhD

Johns Hopkins University, Baltimore, MD † PI: Albert W. Wu, MD

University of Pennsylvania School of Medicine, Philadelphia, PA PI: Sean Hennessy, PharmD, PhD

Outcome Sciences, Cambridge, MA PI: Richard E. Gliklich, MD RTI International, Research Triangle Park, NC PI: Kathleen Lohr, PhD

†

Vanderbilt University Medical Center, Nashville, TN PI: Marie R. Griffin, MD

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.

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TABLE TABLE6.6.Comparative ComparativeEffectiveness EffectivenessReviews Reviews(CERs) (CERs)bybyPriority PriorityCondition Condition as of May 2007 Priority Condition Cancer

Comparative Effectiveness Review

Status

Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer

In progress

Comparative Effectiveness of Chemotherapy Agents in the Prevention of Primary Breast Cancer in Women

In progress

Comparative Effectiveness of Therapies for Clinically Localized Prostate Cancer

Completed

Core Needle Breast Biopsy and Surgical Excision Biopsy for Diagnosing Breast Lesions

In progress

Comparative Effectiveness of Epoetin and Darbepoetin for Managing Anemia in Patients Undergoing Cancer Treatment

Completed

Effectiveness of Noninvasive Diagnostic Tests for Breast Abnormalities

Completed

Technical Brief: Particle Beam Radiation Therapies for Cancer

In progress

Comparative Effectiveness and Safety of Oral Diabetes Medications for Adults With Type 2 Diabetes

Completed

Comparative Effectiveness, Safety, and Indications of Insulin Analogues in Premixed Formulations for Adults with Type 2 Diabetes

In progress

Digestive system conditions

Comparative Effectiveness of Management Strategies for Gastroesophageal Reflux Disease

Completed

Heart and blood vessel conditions

Comparative Effectiveness of Combinations of Lipid-Modifying Agents

In progress

Comparative Effectiveness of Medical Therapies for Stable Ischemic Heart Disease

In progress

Comparative Effectiveness of Management Strategies for Renal Artery Stenosis

Completed

Comparative Effectiveness of Percutaneous Coronary Interventions and Coronary Artery Bypass Grafting for Coronary Artery Disease

Completed

Effectiveness and Off-label Use of Recombinant Factor VIIa

In progress

Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin II Receptor Antagonists (ARBs) for Treating Essential Hypertension

Completed

Effectiveness of Radiofrequency Catheter Ablation (RFA) for Atrial Fibrillation

In progress

Comparative Effectiveness of Second-Generation Antidepressants in the Pharmacologic Treatment of Adult Depression

Completed

Efficacy and Comparative Effectiveness of Off-Label Use of Atypical Antipsychotics

Completed

Comparative Effectiveness of Drug Therapy for Rheumatoid Arthritis and Psoriatic Arthritis in Adults

Completed

Comparative Effectiveness of Treatments To Prevent Fractures in Men and Women With Low Bone Density or Osteoporosis

Completed

Comparative Effectiveness and Safety of Analgesics for Osteoarthritis

Completed

DRAFT: Methods Reference Guide for Effectiveness and Comparative Effectiveness Reviews

In progress

Diabetes

Mental health

Muscle, bone, joint conditions

Research methodology

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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 Effectiveness ReviewsProjects (CERs) by Priority Condition TABLE6.7.Comparative EHC Program’s DEcIDE Research as of May 2007 Priority Condition

DEcIDE Research Projects

Status

Brain and nerve conditions

Methods for Studying Dementia Treatment and Outcomes in Observational Databases

In progress

Breathing conditions

Community Pharmacy/Call Center Assessment of Medication Effectiveness & Safety

In progress

Comparative Effectiveness of Anticholinergic Medications in Patients with Chronic Obstructive Pulmonary Disease (COPD)

In progress

Comparative Effects of Classes of Antidepressants on the Risk of Aspiration Pneumonia in the Aged

In progress

Outcomes of COPD Management

In progress

Testing Cancer Quality Measures for End of Life Care

In progress

Advancing Research Methodology for Measuring and Monitoring Patient-Centered Communications in Cancer Care

In progress

Comparative Effectiveness and Safety of New Therapies for Glucose Control in Diabetes Mellitus

In progress

Digestive system conditions

Comparative Safety of NSAIDs with Gastroprotective Therapy

In progress

Heart and blood vessel conditions

Comparable Effectiveness of B-Adrenergic Antagonists on the Risk of Rehospitalization in Adults with Diagnosed Heart Failure

In progress

Cancer

Diabetes

20

Medical Management of Congestive Heart Failure and the Effectiveness of Isosorbide Dinitrate and Hydralazine

In progress

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 Risks of Medications Prescribed for Attention Deficit Hyperactivity Disorder

In progress

A Qualitative Study to Understand Barriers to Conducting Cluster Randomized Trials

In progress

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TABLE Effectiveness Reviews (CERs) as byof Priority Condition TABLE6.7. Comparative EHC Program’s DEcIDE Research Projects May 2007 Priority Condition Heart and blood vessel conditions

Mental health

Muscle, bone, and joint disorders

Research methodology

DEcIDE Research Projects

Status

Development of a Software Tool for Obtaining Doubly Robust Estimate of Treatment Effects

In progress

Development of Statistical Estimators to Address Questions of Comparative Effectiveness in Elderly Heart Failure Patients

In progress

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 Risks of Medications Prescribed for Attention Deficit Hyperactivity Disorder

In progress

A Qualitative Study to Understand Barriers to Conducting Cluster Randomized Trials

In progress

Comparative Safety of NSAIDs with Gastroprotective Therapy

In progress

Assessment of Factors Modulating Treatment Outcomes of Rheumatoid Arthritis

In progress

Adaptation of Data Mining Algorithms Assessing the Comparative Effectiveness and Safety of NSAIDs

In progress

Emerging Methods in Comparative Effectiveness and Safety Medical Care Supplement

Completed

Registries for Evaluating Patient Outcomes: A User’s Guide

Completed

Survey of Medicare Part D Plans’ Medication Therapy Management Programs

Completed

A Qualitative Study to Understand Barriers to Conducting Cluster Randomized Trials

In progress

Adaptation of Data Mining Algorithms Assessing the Comparative Effectiveness and Safety of NSAIDs

In progress

Assessing the Validity of Administrative Data Using Clinical Medical Records

In progress

Community Pharmacy/Call Center Assessment of Medication Effectiveness & Safety

In progress

Data Development for Patient Safety – A Pilot Study using Medicare Part B Drug Data

In progress

Developing a Distributed Research Network to Conduct Population-based Studies and Safety Surveillance

In progress

Development and Validation of Instrumental Variable Methods for Effectiveness Research

In progress

Development of a Software Tool for Obtaining Doubly Robust Estimate of Treatment Effects

In progress

Development of Statistical Estimators to Address Questions of Comparative Effectiveness in Elderly Heart Failure Patients

In progress

Distributed Network for Ambulatory Research in Therapeutics

In progress

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TABLE Effectiveness Reviews (CERs) as byof Priority Condition TABLE6.7. Comparative EHC Program’s DEcIDE Research Projects May 2007 Priority Condition Research methodology

DEcIDE Research Projects

Status

Medicare Prescription Drug Data Development: Methods for Improving Patient Safety and Pharmacovigilance Using Observational Data

In progress

Needs Assessment to Establish an Infrastructure for Monitoring the Utilization and Outcomes of Gene-Based Applications in the United States Health Care System

In progress

Research and Surveillance Methods for Improving Medication Safety Using Administrative Claims Databases

In progress

Testing Cancer Quality Measures for End of Life Care

In progress

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.

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TABLE 8. AHRQ’s CERT Centers CERT Centers

Emphasis

Principal Investigators

Duke University Medical * Center

Therapies for disorders of the heart and blood vessels

Eric Peterson, MD, MS

HMO Research Network

Drug use; safety and effectiveness studies in health maintenance organization populations

Richard Platt, MD, MSc

University of Alabama at Birmingham

Therapies for musculoskeletal disorders

Kenneth G. Saag, MD, MSc

University of Arizona Health Sciences Center

Reduction of drug interactions that result in harm to women

Raymond L. Woosley, MD, PhD

University of North Carolina at Chapel Hill

Therapies for children

Alan D. Stiles, MD

University of Pennsylvania School of Medicine

Therapies for infection; antibiotic drug resistance

Brian L. Strom, MD, MPH

Vanderbilt University Medical Center

Prescription drug use in a Medicaid population

Wayne A. Ray, PhD

Rutgers, The State University of New Jersey

Safe and effective use of treatments for mental health problems

Stephen Crystal, PhD

University of Iowa

Safety and effectiveness of medication use among the elderly

Elizabeth A. Chrischilles, MS, PhD

Baylor College of Medicine

Consumers and strategies to help patients take prescription medications appropriately

Maria E. Suarez-Almazor, 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 Hospital Medical Center

Pediatric therapeutics

Carole Lannon, MD, MPH

University of Illinois at Chicago

Tools for optimizing prescribing

Bruce L. Lambert, PhD

* The Duke University Medical Center also serves as the Coordinating Center, which is directed by Robert M. Califf, MD

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).

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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

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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.

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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. 26

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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

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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.

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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 alone1 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.

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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

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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:

PRIVATE NONPROFITS AND STATES CENTER FOR EVIDENCE-BASED POLICY COORDINATING EVIDENCE PRACTICE CENTER OHSU EPC

UNC EPC

RAND EPC

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.

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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. TABLE 6. DERP Drug Reviews DERP Drug Reviews 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

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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/

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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.

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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

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• 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

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 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

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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.

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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.“

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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 Fundconnected 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.

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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 middlemanagers. 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

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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. TABLE 7. Center for Medical Technology Policy Staff Center for Medical Technology Policy Staff* Sean Tunis, MD, MSc Founder and Director

Gail Wilensky, PhD Senior Policy Advisor

Wade Aubry, MD Associate Director

Molly Coye, MD Senior Advisor

Linda Bergthold, PhD Senior Advisor

Steven Pearson, MD, MSc Senior Advisor

Rita Redberg, MD, MSc, FACC Clinical Advisor

* Staff biographies are included in Appendix F.

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• 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/

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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?

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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.

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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.)

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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 publicprivate 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.

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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. 48

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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. TABLE 8. Consumers Reports Best Buy Drug Report Consumer Reports Best Buy Drug Reports 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, and Stroke – Antiplatelets

Angina, High Blood Pressure – Calcium Channel Blockers

Drugs for Heartburn, Acid Reflux Disease – The PPIs

Opioids – Treating Chronic Pain

Treating Bipolar Disorder, Nerve Pain and Fibromyalgia – The Anticonvulsants

Treating Type 2 Diabetes – The Oral Diabetes Drugs

* Staff biographies are included in Appendix F.

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

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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. TABLE 9. Members of Consumers Reports Best Buy Drugs Advisory Board Member of Consumer Reports Best Buy Drugs Advisory Board Nancy Wilson Ashbach, MD, MBA Family Physician-Former Member Board of Directors American Academy of Family Physicians

Sharlea Leatherwood, PD President National Community Pharmacists Association

Jerry Avorn, MD Associate Professor of Medicine Harvard Medical School

Jay Bhatt President American Medical Students Association

Georges C. Benjamin, MD Executive Director American Public Health Association

Lisa Schwartz, MD, MS Associate Professor of Medicine VA Outcomes Group Dartmouth Medical School

Roger Herdman, MD Senior Scholar Institute of Medicine National Academy of Sciences

Steven Woloshin, MD, MS Associate Professor of Medicine VA Outcomes Group Dartmouth Medical School

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

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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 Evidencebased 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 statefocused 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

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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.

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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/

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/

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 Breast Cancer Coalition http://www.natlbcc.org/

Young Survival Coalition http://www.youngsurvival.org/

National Center for Transgender Equality http://www.nctequality.org/

* 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.

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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.

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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.

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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. TABLE 11. Members of Pharmacy Quality Alliance Steering Committee Members of Pharmacy Quality Alliance Steering Committee Judith Cahill Executive Director Academy of Managed Care Pharmacy

Jack Mahoney, MD Corporate Medical Director Pitney Bowes

Carolyn Clancy, MD Director Agency for Healthcare Research and Quality

Mark McClellan, MD, PhD Visiting Senior Fellow AEI Brookings Joint Center

John Gans, PharmD Executive Vice President and CEO American Pharmacists Association

Edmond Weisbart, MD Chief Medical Officer Express Scripts, Inc.

N. Lee Rucker, MSPH Strategic Policy Advisor, Public Policy Institute, AARP

Bruce Roberts, RPh Executive Vice President and CEO National Community Pharmacists Association (NCPA)

Karen Ignagni President and CEO America’s Health Insurance Plans

Rebecca Snead, RPh Executive Vice President and CEO National Alliance of State Pharmacy Associations

Steven Anderson President and CEO National Association of Chain Drug Stores

John Feather Executive Director & CEO American Society of Consultant Pharmacists

John L. Fish, Vice President Channel Management & Pharmacy Solutions GlaxoSmithKline

Jeffrey Kelman, MD Center for Beneficiary Choices Centers for Medicare and Medicaid Services

David Marshall Vice President, Commercial Operations Teva Pharmaceuticals USA

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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 costeffectiveness 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 costeffectiveness information in decision making among health care providers and consumers. Website: http://www.cadth.ca/index.php/en/home The Current Evidence - Based Medicine Landscape

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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.

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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.

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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 Organization: Event:

The Health Industry Forum, Brandeis University Coverage Policy in an Era of Personalized Medicine: Evaluating and Paying for Genetic Testing Services

Date:

October 12, 2006

Location:

Washington, D.C.

Description: Website:

N/A – see agenda at link below http://healthforum.brandeis.edu/meetings.htm http://healthforum.brandeis.edu/October%2012,%202006/Agenda_Web%2010.12.06.pdf

Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description:

Website:

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Society for Medical Decision Making The 28th Annual Meeting of the Society for Medical Decision Making October 15-18, 2006 Boston, MA N/A http://smdm.confex.com/smdm/2006ma/techprogram/MEETING.HTM

The Chochrane Collaboration 14th Cochrane Colloquium October 22-26, 2006 Dublin, Ireland 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. http://www.cochrane.co.uk/colloquium/welcome.htm

National Pharmaceutical Council

The Current Evidence - Based Medicine Landscape

OCTOBER 2006 continued Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description: Website:

International Society for Pharmacoeconomics and Outcomes Research (ISPOR) ISPOR 9th Annual European Congress October 28-31, 2006 Copenhagen, Denmark N/A – see agenda at link below http://www.ispor.org/congresses/denmark1006/CongressProgram.pdf

Organized in conjunction with ISPOR Regional Conference on Cost-Effective Healthcare 2006 October 28-31, 2006 Singapore N/A http://www.cehealth2006.com/

NOVEMBER 2006 Organization: Event: Date: Location: Description:

Website:

The Health Industry Forum, Brandeis University Comparative Effectiveness Forum November 30, 2006 Washington, D.C. 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. http://healthforum.brandeis.edu/meetings.htm http://healthforum.brandeis.edu/NOVEMBER%20HTA%2030,%202006/ ExecBriefCompEffectiveForum113006.pdf

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JANUARY 2007 Organization: Event:

University of Queensland 4th Queensland Biohumanities Conference: Evidence-Based Medicine

Date:

January 8-9, 2007

Location:

Brisbane, Australia

Description: Website:

N/A http://www.representinggenes.org/biohumanities/podcasts/4QBC_podcast.htm

FEBRUARY 2007 Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description: Website:

Massachusetts Health Data Consortium 2007 Healthcare Information Technology Conference February 2, 2007 Burlington, MA N/A – please see agenda at link below http://www.mahealthdata.org/forums/events/2007/HIT_0202/registration.html

Asia Pacific Center for Evidence-Based Medicine 5th Asia Pacific Evidence-Based Medicine Workshop & Conference February 4-7, 2007 Singapore N/A – please see agenda at link below http://www.nuh.com.sg/nuh_apebm/5th%20APEBM_Home.html http://www.nuh.com.sg/nuh_apebm/5th%20APEBM_WorkshopInformation(2).html#Programme

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MARCH 2007 Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description:

Website:

Organization: Event: Date: Location: Description: Website:

National Council for Community Behavioral Healthcare 37th Annual National Council Conference March 26-28, 2007 Las Vegas, NV Session of interest: Evidence-Based Depression Treatment: Making an IMPACT (03/27-28) http://conference.nccbh.org/

Avalere Health Audio Conference on Presenting Comparative Treatment Information to Consumers: Impact on Patients and Manufacturers March 28, 2007 Audio conference The Agency for Healthcare Research and Quality (AHRQ) recently began producing consumeroriented 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. http://www.avalerehealth.net/conferences/effective_health_care.html

Old Dominion University/Center for Medicine in the Public Interest Improving Healthcare Quality and Value: The Role of Comparative Effectiveness Research March 29, 2007 Washington, D.C. (National Press Club) N/A http://hs.odu.edu/hs/newsevents/nfhkm_agenda.pdf

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APRIL 2007 Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description: Website:

64

The Health Industry Forum, Brandeis University Developing an Effective Long Term Strategy for Post-Marketing Surveillance of Medical Products April 11, 2007 Washington, D.C. N/A – see agenda at link below http://healthforum.brandeis.edu/meetings.htm

National Working Group on Evidence-Based Health Care Public forum on the central role patients should play in evidence-based health care April 19, 2007 Webcast N/A – see agenda at link below http://healthforum.brandeis.edu/meetings.htm

Canadian Agency for Drugs and Technologies in Health (CADTH) 2007 CADTH Symposium - Informing Policy, Influencing Practice, Improving Health April 22-24, 2007 Ottawa, Ontario Multiple relevant sessions on HTA and EBM — see event program for full descriptions. http://www.cadth.ca/index.php/en/events/sympos-2007

National Pharmaceutical Council

The Current Evidence - Based Medicine Landscape

MAY 2007 Organization: Event: Date: Location: Description:

Website:

Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description: Website:

Organization: Event:

BIO® Biotechnology Industry Organization BIO International Convention May 6-9, 2007 Boston, MA 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: CostEffectiveness; Safe or Effective? FDA’s, the Industry’s and the Patient’s Regulatory Dilemma. http://www.bio2007.org/

Blue Cross and Blue Shield Association Luncheon Briefing: BCBSA Announces New Initiative For Comparative Effectiveness Research May 7, 2007 Washington, D.C. (National Press Club) 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. http://www.bcbs.com/news/press/luncheon-briefing-bcbsa.htm

Jefferson Medical College The Disease Management Colloquium May 7-9, 2007 Philadelphia, PA Session of interest: Evidence-Based Medicine and Disease Management (05/07). http://www.dmconferences.com/

European Science Foundation (ESF) The International Regulation of New Medical Technology, Germany

Date:

May 7-11, 2007

Location:

Philadelphia, PA

Description: Website:

Organization: Event: Date: Location: Description:

Website:

Salzau Castle, Salzau (near Kiel), Germany http://www.esf.org/conferences/07237

National Health Service (NHS) Service Delivery and Organization R&D Programme (SDO) – Sixth National SDO Conference: Delivering Better Health Services May 9, 2007 London, UK 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. http://www.healthcareevents.co.uk/tabid/63/Default.aspx/?conferenceId=99

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MAY 2007 continued Organization: Event: Date: Location: Description:

Website:

National Quality Forum (NQF) NQF Spring Meetings May 9-11, 2007 Chicago, IL 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. http://www.qualityforum.org/about/meetings/spring_meeting07.asp http://www.qualityforum.org/pdf/meetings/ag04-18-07.pdf

Organization: Event:

APA 160th Annual Meeting

Date:

May 19, 2007

Location:

San Diego, CA

Description:

Website:

Organization: Event: Date: Location: Description:

Website:

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American Psychiatric Association

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. http://www.psych.org/edu/ann_mtgs/am/07/index.cfm

International Society for Pharmacoeconomics and Outcomes Research (ISPOR) ISPOR 12th Annual International Meeting May 19-23, 2007 Arlington, VA 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. http://www.ispor.org/Events/Index.aspx?eventId=11

National Pharmaceutical Council

The Current Evidence - Based Medicine Landscape

MAY 2007 continued Organization: Event: Date: Location: Description:

Website:

Organization:

Event: Date: Location: Description: Website:

Avalere Health Evidence-Based Medicine: Set Your Sights May 22, 2007 Washington, D.C. 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. http://www.avalerehealth.net/conferences/evidence2007.html

Institute of Medicine (IOM) Forum on the Science of Health Care Quality Improvement and Implementation Workshop on Conduct of Healthcare Quality Improvement Research May 24-25, 2007 Irvine, CA N/A – see agenda at links below 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

The Current Evidence - Based Medicine Landscape

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JUNE 2007 Organization: Event: Date: Location: Description:

Website:

AcademyHealth Annual Research Meeting 2007 June 3-5, 2007 Orlando, FL 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). 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: Location: Description: Website:

Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description:

Website:

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June 11-12, 2007 Toronto, Canada N/A – see agenda at link below http://www.healthcareleadershipconference.ca/default1.asp

University of York Centre for Health Economics York Expert Workshops in the Socio Economic Evaluation of Medicines 2007 June 13-15/18-22/25-27, 2007 York, UK Session of interest: Meeting Decision-Makers’ Requirements: Advanced Methods for Cost Effectiveness Analysis (06/18-22). http://www.york.ac.uk/inst/che/training/expert.htm

The European League Against Rheumatism (EULAR) EULAR Congress 2007 June 13-16, 2007 Barcelona, Spain 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) http://www.eular.org/scientificprogramme/

National Pharmaceutical Council

The Current Evidence - Based Medicine Landscape

JUNE 2007 continued Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description:

Website:

Organization: Event: Date: Location: Description:

Website:

Asia Pacific Center for Evidence-Based Medicine Annual Evidence-Based Medicine Workshop: How to Practice and Teach Evidence-Based Medicine June 14-17, 2007 Antipolo City, Philippines N/A – see agenda at link below http://www.apebm.com/

Health Technology Assessment International (HTAi) HTAi 2007: HTA For Evidence-Based Public Health June 17-20, 2007 Barcelona, Spain 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. http://www.esf.org/conferences/07237

Drug Information Association (DIA) 43rd Annual Meeting June 17-21, 2007 Atlanta, GA 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 crossfunctional 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). http://www.diahome.org/DIAHome/FlagshipMeetings/home.aspx?meetingid=11362

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JUNE 2007 continued Organization: Event: Date: Location: Description:

Website:

Organization: Event: Date: Location: Description:

Website:

Organization: Event: Date: Location: Description: Website:

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America’s Health Insurance Plans (AHIP) AHIP Institute 2007 June 20-22, 2007 Las Vegas, NV 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). http://www.ahip.org/links/institute2007/

The NHS Confederation Annual Conference and Exhibition 2007 June 20-22, 2007 London, UK 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. http://www.nhsconfed.org/about/about-2405.cfm

Faculty of Public Health The Faculty of Public Health Annual Conference 2007 June 26-28, 2007 Eastbourne, UK N/A - see agenda at link below http://www.publichealthconferences.org.uk/annual/

National Pharmaceutical Council

The Current Evidence - Based Medicine Landscape

JULY 2007 Organization: Event: Date: Location: Description:

Website:

Organization: Event: Date: Location: Description: Website:

Organization: Event:

International Health Economics Association (iHEA) iHEA 6th World Congress: Explorations in Health July 8-11, 2007 Copenhagen, Denmark 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 GuidelinesBased 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). http://www.healtheconomics.org/congress/2007/

Advanced Medical Technology Association (AdvaMed) Medical Technology Reimbursement Specialist Workshop July 10-13, 2007 Washington, D.C. N/A – see agenda at link below http://www.advamedmtli.org/mtli/mtg07-21.cfm

The Cochrane Collaboration Summer Institute for Evidence-Based Practice: Quality and Safety

Date:

July 12-14, 2007

Location:

San Antonio, TX

Description: Website:

N/A – see agenda at link below http://news.cochrane.org/view/item/review_one.jsp?j=754 http://www.acestar.uthscsa.edu/institute/su07/agenda.html

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AUGUST 2007 Organization:

Event: Date: Location: Description:

Website:

Organization: Event: Date: Location: Description:

Website:

Organization:

Event: Date: Location: Description: Website:

The Department of Preventive Medicine and the Rocky Mountain Prevention Research Center 9th Rocky Mountain Workshop on How to Practice Evidence-Based Health Care August 5-9, 2007 Colorado Springs, CO 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. http://news.cochrane.org/view/item/review_one.jsp?j=810

Strategic Research Institute 5th Annual Disease Management Conference August 6-7, 2007 Boston, MA 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. http://www.srinstitute.com/conf_page.cfm?instance_id=27&web_id=913&pid=520

São Paulo Center for Health Economics at the Federal University of São Paulo (Centro Paulista de Economia da Saúde – CPES) 7th International Symposium on Health Economics - Health Technology Assessment: Challenges for a Responsible Decision August 15-17, 2007 São Paulo, Brazil N/A http://www.ispor.org/meetings/other/7simposio_ingles.pdf http://cpes.org.br/

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SEPTEMBER 2007 Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description:

Website:

International Society for Pharmacoeconomics and Outcomes Research (ISPOR) ISPOR 1st Latin America Conference September 9-11, 2007 Cartagena, Colombia Session of interest: 2nd Plenary Session: Health Care Technology Assessment: Developing & Using the Evidence in Health Care Decisions (09/11) http://www.ispor.org/Events/Index.aspx?eventId=23

International Society for Quality in Health Care (ISQua) 24th Conference for the International Society for Quality in Health Care (ISQua) September 30 – October 3, 2007 Boston, MA 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. http://www.isqua.org/isquaPages/boston07.html

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OCTOBER 2007 Organization: Event: Date: Location: Description:

Advanced Medical Technology Association (AdvaMed) 2007 Med Tech Conference October 1-3, 2007 Washington, D.C. N/A – TBD

Website:

http://www.advamed2007.com/

Organization:

Institute of Medicine (IOM)

Event: Date: Location: Description: Website:

Organization: Event: Date:

October 8, 2007 Washington, D.C. Theme: Evidence-Based Medicine and the Changing Nature of Health Care. http://www.iom.edu/

Institute of Medicine (IOM) Joint conference on comparative effectiveness (ECRI/Milbank/Kaiser/EBRI/Health Affairs) October 17-18, 2007

Location:

N/A

Description:

N/A

Website:

Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description:

Website:

74

37th Annual Members Meeting

http://www.iom.edu/CMS/2957.aspx

Society for Medical Decision Making The 29th Annual Meeting of the Society for Medical Decision Making October 21-24, 2007 Pittsburgh, PA N/A http://www.smdm.org/

International Society for Pharmacoeconomics and Outcomes Research (ISPOR) ISPOR 10th Annual European Congress October 20-23, 2007 Dublin, Ireland 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). http://www.ispor.org/Events/Index.aspx?eventId=21

National Pharmaceutical Council

The Current Evidence - Based Medicine Landscape

OCTOBER 2007 continued Organization: Event: Date: Location: Description: Website:

Organization: Event:

Date: Location: Description:

Website:

America’s Health Insurance Plans (AHIP) 2007 Medical Leadership Forum: Evidence-based Solutions to Health Care’s Challenge October 22-24, 2007 Phoenix, AZ 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. http://www.ahip.org/links/medmgt2007/

Q1 Productions 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 October 22-23, 2007 Baltimore, MD 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. http://www.q1productions.com/events_EvidenceBasedMedicine.htm

Organization: Event: Date: Location: Description:

Website:

The Cochrane Collaboration 15th Cochrane Colloquium: Evidence-based health care for all October 23-27, 2007 São Paulo, Brazil 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. http://www.colloquiumbrasil.info/php/index.php

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DECEMBER 2007 Organization:

The National Institute for Health and Clinical Excellence (NICE)

Event:

NICE 2007 Annual Conference and Exhibition: Evidence into Practice

Date: Location: Description:

Website:

December 5-6, 2007 Manchester, UK 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. http://www.nice2007.co.uk/

JANUARY 2008 Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description:

Website:

Organization: Event: Date: Location: Description:

Website:

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Health Economists’ Study Group (HESG) 72nd Meeting of the Health Economists’ Study Group January 9-11, 2008 Norwich, UK N/A http://www.hesg.org.uk/news.php?PHPSESSID=00649792cbf58669454fa9d0eb4117b1

University of Birmingham Methodological Basis of HTA January 21-25, 2008 Birmingham, UK 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. http://www.pcpoh.bham.ac.uk/publichealth/programmes/hta/short-courses.htm

The Institut D’Economie Industrielle Health Economics and the Pharmaceutical Industry January 25-26, 2008 Toulouse, France 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 http://www.irdes.fr/EspaceDoc/Documents/CalendrierDesColloques /ConfHealthEconomics25janv08.pdf

National Pharmaceutical Council

The Current Evidence - Based Medicine Landscape

FEBRUARY 2008 Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description:

Website:

Organization: Event: Date: Location: Description: Website:

Organization:

Event: Date: Location: Description: Website:

AcademyHealth 2008 National Health Policy Conference February 4-5, 2008 Washington, D.C. Get perspective on 2008 policy priorities directly from the policymakers. http://www.academyhealth.org/nhpc/agenda.htm

World Congress The World Congress Leadership Summit on Evidence-Based Medicine February 11-12, 2008 Alexandria, VA 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. http://www.worldcongress.com/events/HL08007/index.cfm?print=true&TheConfCode=HL08007

AdvaMed Medical Technology Reimbursement Specialist Workshop February 19-22, 2008 Las Vegas, NV Session of note: Technology Assessments http://www.advamedmtli.org/go.cfm?do=Page.View&pid=50

National University Hospital of Singapore, Asia Pacific Centre for Evidence-Based Medicine 6th Asia Pacific Evidence-Based Medicine/Nursing Workshop and Conference February 26-29, 2008 Singapore Conference highlight: Post-conference symposium for heads of departments: “Why Bother with Evidence-Based Medicine?“ http://www.nuh.com.sg/nuh_ebm/ebm_apebm.htm

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MARCH 2008 Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description: Website:

78

America’s Health Insurance Plans (AHIP) National Policy Forum March 4-6, 2008 Washington, D.C. N/A http://www.ahip.org

The Cochrane Collaboration 2008 Canadian Cochrane Symposium March 6-7, 2008 Edmonton, AB, Canada N/A http://news.cochrane.org/view/item/review_one.jsp?j=948

National Quality Forum (NQF) Leadership Colloquium and Quality Award Gala; Board of Directors Meeting March 14-15, 2008 Washington, D.C. N/A http://www.qualityforum.org/

National Quality Forum (NQF) Spring Membership Meeting and Implementation Conference on Care Coordination; Board of Directors Meeting March 26-28, 2008 Atlanta, GA N/A http://www.qualityforum.org/

National Pharmaceutical Council

The Current Evidence - Based Medicine Landscape

APRIL 2008 Organization: Event: Date: Location: Description:

Website:

Organization: Event:

Centre for Evidence-Based Medicine 3-Day Workshop on Evidence-Based Practice April 7-9, 2008 Oxford, UK 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. http://www.cebm.net/index.aspx?o=1475

Institute of Medicine Roundtable on Evidence-Based Medicine Workshop on Engineering a Learning Healthcare System

Date:

April 28-29, 2008

Location:

Washington, D.C.

Description:

Website:

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 byproduct 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. http://www.iom.edu/CMS/28312/RT-EBM/52747.aspx

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MAY 2008 Organization: Event: Date: Location: Description:

Website:

Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description: Website:

Organization: Event: Date: Location: Description: Website:

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National Council for Community Behavioral Healthcare 38th National Council Conference May 1-3, 2008 Boston, MA 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. http://www.thenationalcouncil.org/cs/boston

International Society for Pharmacoeconomics and Outcomes Research (ISPOR) ISPOR 13th Annual International Meeting May 3-7, 2008 Toronto, ON, Canada Vive la Différence - Enhancing/Expanding Outcomes Research One Country at a Time http://www.ispor.org/Events/Index.aspx?eventId=24

American Psychiatric Association 2008 APA Annual Meeting May 3-8, 2008 Washington, D.C. Our Voice in Action: Advancing Science, Care, and the Profession http://www.psych.org/edu/ann_mtgs/am/08/index.cfm

National and Gulf Center for Evidence-Based Medicine 4th Saudi Annual Workshop; Systematic Review Workshop; 4th Saudi Annual Conference May 7-8, 2008 Riyadh, Saudi Arabia N/A http://www.ngha.med.sa/ebm/Events/2008/index.htm?L2ID=2004

The Cochrane Collaboration 8th Annual International C2 Colloquium May 12-14, 2008 Vancouver, BC, Canada N/A http://www.campbellcolloquium.org

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MAY 2008 continued Organization: Event: Date: Location: Description:

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Jefferson Medical College 8th Disease Management Colloquium at Jefferson May 19-21, 2008 Philadelphia, PA 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. http://www.dmconferences.com/overview.html

Geneva Health Forum Strengthening Health Systems and the Global Health Workforce May 25-28, 2008 Geneva, Switzerland N/A http://www.genevahealthforum.org/

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JUNE 2008 Organization: Event: Date: Location: Description:

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Society for Medical Decision Making SMDM Europe 2008 June 1-4, 2008 Engleberg, Switzerland 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. http://www.smdmeurope2008.com

Canadian Healthcare Association, Canadian College of Health Service Executives National Healthcare Leadership Conference June 2-3, 2008 Saskatoon, Saskatchewan, Canada Regionalization: Lessons Learned or Lessons Lost? http://www.healthcareleadershipconference.ca/default1.asp

AcademyHealth Annual Research Meeting June 8-10, 2008 Washington, D.C. 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. http://www.academyhealth.org/arm/themes.htm

Biotechnology Industry Organization BIO International Convention 2008 June 17-20, 2008 San Diego, CA N/A http://bio2007.org/

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JUNE 2008 continued Organization: Event:

America’s Health Insurance Plans (AHIP) Institute 2008 – AHIP’s Annual Meeting

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June 18-20, 2008

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San Francisco, CA

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N/A http://www.ahip.org

The National Health Service (NHS) Confederation Annual Conference and Exhibition June 18-20, 2008 Manchester, UK 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. http://www.nhsconfed.org/issues/about-2801.cfm

American Society of Health Economists 2nd Biennial Conference June 22-25, 2008 Durham, NC Equity and Efficiency in Health and Healthcare http://www.healtheconomics.us/conference/

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JUNE 2008 continued Organization: Event:

The University of York Centre for Health Economics York Expert Workshops in the Socioeconomic Evaluation of Medicines 2008 Module 1: Foundations of Economic Evaluation in Health Care

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June 23-27, 2008 York, UK N/A http://www.york.ac.uk/inst/che/training/expert.htm

European Health Management Association (EHMA) 2008 EHMA Annual Conference June 25-27, 2008 Athens, Greece N/A http://www.ehma.org/annual_conference/default.asp?NCID=83

The University of York Centre for Health Economics York Expert Workshops in the Socioeconomic Evaluation of Medicines 2008 Module 2: Meeting Decision-makers’ Requirements: Advanced Methods for Cost-Effectiveness Analysis

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June 30 – July 5, 2008 York, UK N/A http://www.york.ac.uk/inst/che/training/expert.htm

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Health Technology Assessment International (HTAi) Fifth Annual Meeting of HTAi July 6-9, 2008 Montreal, Canada 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. http://www.htai2008.org/en_home.phtml

The University of York Centre for Health Economics York Expert Workshops in the Socioeconomic Evaluation of Medicines 2008 Module 3: Quality of Life

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July 7-9, 2008 York, UK N/A http://www.york.ac.uk/inst/che/training/expert.htm

Athens Institute for Education and Research 7th International Conference on Health Economics, Management, and Policy July 10-13, 2008 Athens, Greece N/A http://www.atiner.gr/docs/Health.htm

European Congress on Health Economics (ECHE) 7th European Conference on Health Economics July 23-26, 2008 Rome, Italy 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. http://www.echeroma2008.eu/home/

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SEPTEMBER 2008 Organization: Event: Date: Location: Description: Website:

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International Society for Pharmacoeconomics and Outcomes Research (ISPOR) ISPOR 3rd Asia-Pacific Conference September 7-9, 2008 Seoul, South Korea Evidence-Based Health Care Decision Making in Asia Pacific: The Application of Pharmacoeconomics and Outcomes Research http://www.ispor.org/Events/Index.aspx?eventId=26

Centre for Evidence-Based Medicine 5-Day Workshop on Teaching Evidence-Based Practice September 8-12, 2008 Oxford, UK 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 evidencebased medicine. The workshop is NOT intended to serve as an introduction to evidence-based medicine itself. http://www.cebm.net/index.aspx?o=1080

AdvaMed The MedTech Conference 2008 September 21-28, 2008 Washington, D.C. N/A http://www.advamed2008.com

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OCTOBER 2008 Organization: Event:

The Cochrane Collaboration 16th Cochrane Colloquium: Evidence in the area of globalisation

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October 3-7, 2008

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Freiburg, Germany

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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. http://www.cochrane.de/en/colloquium2008.htm

Institute of Medicine (IOM) 2008 IOM Annual Meeting October 12-13, 2008 Washington, D.C N/A http://www.iom.edu/CMS/2951/16671/16689.aspx

National Quality Forum (NQF) 2008 Annual Meeting and Policy Conference on Quality; Board of Directors Meeting October 15-17, 2008 Washington, D.C., Arlington, VA N/A http://www.qualityforum.org/

International Society for Quality of Life Research (ISOQOL) 15th Annual Scientific Meeting

Date:

October 22-25, 2008

Location:

Montevideo, Uruguay

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N/A http://www.isoqol.org

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NOVEMBER 2008 Organization: Event: Date: Location: Description: Website:

European Network for Health Technology Assessment (EUnetHTA) EUnetHTA Conference 2008: HTA’s Future in Europe November 20, 2008 Paris, France N/A http://www.eunethta.net/

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National Quality Forum (NQF) 2009 Spring Membership Meeting and Implementation Conference; Board of Directors Meeting March 27-29, 2008 Cleveland, OH N/A http://www.qualityforum.org/

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ON-GOING Organization: Event: Date: Location: Description:

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Institute of Medicine (IOM) Roundtable on Evidence-Based Medicine Project meetings and workshops Various Washington, D.C. 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) http://www.iom.edu/CMS/28312/RT-EBM.aspx

Institute of Medicine (IOM) Ongoing project: Reviewing Evidence to Identify Highly Effective Clinical Services Various Washington, D.C. 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. http://www8.nationalacademies.org/cp/projectview.aspx?key=HCSX-H-05-09-A

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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: [email protected] 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.

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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: [email protected] 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.

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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: [email protected] 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.

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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: [email protected] 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 practicebased 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.

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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: [email protected] 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.

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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: [email protected] 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 Evidencebased 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.

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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: [email protected] [Bio not available.]

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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: [email protected] 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.

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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.

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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.

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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.

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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.

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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.

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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, Nontraditional 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.

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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.

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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.

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Kimberly D. Gregory, MD, MPH Dr. Gregory is Director of Maternal-Fetal Medicine and Director of Women’s Health Services Research at CedarsSinai 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.

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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 evidencebased 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.

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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.

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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: [email protected] 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.

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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: [email protected] 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: [email protected] 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.

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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: [email protected] 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: [email protected] 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: [email protected] 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

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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: [email protected] Karen A. Robinson, MSc Co-Director, EPC Email: [email protected]

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Jonathan M. Samet, MD, MS Co-Chair of Scientific Advisory Committee Phone: (410) 955-3286 Email: [email protected] 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: [email protected] 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.

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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: [email protected] 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 crossinstitutional 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

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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: [email protected] 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.

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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: [email protected] 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

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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: [email protected] 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.

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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: [email protected] 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.

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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: [email protected] 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: [email protected] 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: [email protected] 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.

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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: [email protected] 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: [email protected] 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).

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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: [email protected] 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: [email protected] 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

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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: [email protected] 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: [email protected] 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.

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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: [email protected] 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: [email protected] 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.

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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: [email protected] 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: [email protected] 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).

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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: [email protected] 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 coauthored nine systematic review in public health and two systematic reviews in cancer care.

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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 20052010 cycle.

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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.

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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.

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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 qualitybased “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

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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 notfor-profit Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals and their subsidiaries, and the forprofit 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

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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.

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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.

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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.

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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.

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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 [email protected] 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 earlystage 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.

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Wade Aubry, MD Associate Director, Center for Medical Technology Policy [email protected] 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.

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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

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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.

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The Current Evidence - Based Medicine Landscape

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: [email protected] 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 ColumbiaPresbyterian 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.

The Current Evidence - Based Medicine Landscape

National Pharmaceutical Council

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