1. Making Comparative Effectiveness More than a Dream Carolyn M. Clancy, MD Director Agency for Healthcare Research and Quality AcademyHealths 2008 National Health Policy Conference Washington, DC – February 4, 2008

2. Excellence & Mediocrity Excellence & Mediocrity Turning Evidence Into Action Turning Evidence Into Action 21 st Century Health Care 21 st Century Health Care Comparative Effectiveness

3. Excellence & Mediocrity A society which scorns excellence in plumbing simply because it is plumbing, but rewards mediocre philosophy simply because it is philosophy will soon become a society in which neither its pipes nor its theories will hold water. John W. Gardner (1961) John W. Gardner (1961)

4. Scope of the Opportunity in Health Care Major challenges in 21 st Century health care include evaluating all of the innovations and determining which: Major challenges in 21 st Century health care include evaluating all of the innovations and determining which: – Represent added value – Offer minimal enhancements over existing choices – Fail to reach their potential – Work for some patients and not for others

5. Improving Evidence about Benefits and Risks Comparative effectiveness research addresses issues including: Comparative effectiveness research addresses issues including: – Relevancy – Timeliness – Impact on priority populations – Disproportionate impact on subpopulations – The ability to impact treatment decisions

6. AHRQ FY 2008 Priorities Effective Health Care Program Medical Expenditure Panel Surveys Ambulatory Patient Safety Patient Safety Patient Safety Health IT Patient Safety Organizations New Patient Safety Grants Comparative Effectiveness Reviews Comparative Effectiveness Research Clear Findings for Multiple Audiences Quality & Cost-Effectiveness, e.g. Prevention and Pharmaceutical Outcomes U.S. Preventive Services Task Force MRSA/HAIs Visit-Level Information on Medical Expenditures Annual Quality & Disparities Reports Safety & Quality Measures, Drug Management and Patient-Centered Care Patient Safety Improvement Corps Other Research & Dissemination Activities

7. AHRQ FY 2008 Funding $334.6 million $334.6 million – FY 2008 Request – $329.6 million – FY 2007 Appropriation – $318.7 million FY 2008 appropriation includes: FY 2008 appropriation includes: – $30 million for comparative effectiveness research Double the $15 million designated in FY 2007 Double the $15 million designated in FY 2007 – $5 million for research and activities to reduce Methicillin Resistant Staphylococcus aureus (MRSA) and related infections The first such federal grant to AHRQ for MRSA/HAIs The first such federal grant to AHRQ for MRSA/HAIs Congress also encouraged AHRQ to: Congress also encouraged AHRQ to: – Consider proposals to detect medical errors and preemptively control injury via compact medical devices – Investigate the feasibility of an open-source, no-cost license computer model capable of predicting the effects of health care policy alternatives to improve quality and cost-effectiveness

8. AHRQ Comparative Effectiveness Research The additional funding for comparative effectiveness will help ARHQ generate a wealth of new products and tools: The additional funding for comparative effectiveness will help ARHQ generate a wealth of new products and tools: – The number of comparative effectiveness reviews and technical briefs will double – New research initiated will include studies on surgery, prescription drugs, biologics and vaccines for Medicare beneficiaries in priority condition areas – A new series of technical reports will establish a foundation for guiding the evaluation of gene-based test performance – The number of products designed to help patients and clinicians make informed decisions will increase

9. Program Enhancements Two reports will be commissioned for use by AHRQ to: Two reports will be commissioned for use by AHRQ to: – Enhance the Effective Health Care Programs infrastructure and growth needs – Begin assessing the Programs impact Money from the initial funding will be used for awards to develop and enhance individual scientist research and methodological capacities for conducting future comparative effectiveness research Money from the initial funding will be used for awards to develop and enhance individual scientist research and methodological capacities for conducting future comparative effectiveness research

10. The Promise of Genomics: Recent Activities AHRQ is funding a Randomized Control Trial to clarify the added value of genetic testing to improve warfarin dosing. AHRQ is funding a Randomized Control Trial to clarify the added value of genetic testing to improve warfarin dosing. AHRQ and CDC are co-funding a DEcIDE project to review databases focusing on utilization and outcomes of gene-based tests and therapies AHRQ and CDC are co-funding a DEcIDE project to review databases focusing on utilization and outcomes of gene-based tests and therapies EPC Reports: EPC Reports: – Genomic testing in ovarian cancer (completed) – CYP450 testing in depression (completed) – HNPCC testing in colorectal patients (completed) – Horizon scan on cancer genetic tests for CMS (completed) – BRCA testing in breast and ovarian cancers (w/USPSTF recommendation) – HER-2-Neu testing in breast cancer (ongoing) – Expression profile tests in breast cancer (completed) – Family history in breast, ovarian, colorectal and prostate cancers (completed) – Screening for hemochromatosis (w/USPSTF recommendation)

11. Comparative Effectiveness: Effective Health Care Program Uses current, unbiased evidence in making head-to-head comparisons to show which health interventions: Uses current, unbiased evidence in making head-to-head comparisons to show which health interventions: – Add Value – Offer minimal benefit above current choices – Fail to reach their potential – Work for some patients, but not others Builds on years of experience gained through AHRQs Evidence-Based Practice centers Builds on years of experience gained through AHRQs Evidence-Based Practice centers Goal: To develop and disseminate better evidence about benefits and risks of alternative choices

12. Effective Health Care Program A. Evidence synthesis (EPC program) – Systematically reviewing, synthesizing, comparing existing evidence on treatment effectiveness – Identifying relevant knowledge gaps B. Evidence generation (DEcIDE, CERTs) – Development of new scientific knowledge to address knowledge gaps. – Accelerate practical studies C. Evidence communication/translation (Eisenberg Center) – Translate evidence into improvements – Communication of scientific information in plain language to policymakers, patients, and providers

13. 21 st Century Health Care Improving quality by promoting a culture of safety through Value-Driven Health Care 21 st Century Health Care Information-rich, patient- focused enterprises Information and evidence transform interactions from reactive to proactive (benefits and harms) Evidence is continually refined as a by-product of care delivery Actionable information available – to clinicians AND patients – just in time

14. The Social Case: Potential lives saved through quality improvement Woolf and Johnson,

15. How Can We Enhance Our Efforts? The Evolution of Translational Research

16. Making Better Decisions Many decisions in healthcare require different types of evidence Many decisions in healthcare require different types of evidence The demand side is as important as the production of evidence The demand side is as important as the production of evidence Wise and prudent use of resources and opportunities to advance effective health care is imperative Wise and prudent use of resources and opportunities to advance effective health care is imperative AHRQs Effective Health Care Program is the model for how this can be achieved AHRQs Effective Health Care Program is the model for how this can be achievedwww.effectivehealthcare.ahrq.gov

17. Comparative Effectiveness Research typically will focus on realistic decisions confronting patients and their clinicians in actual practice…. Because of this focus on effectiveness as opposed to efficacy, these investigations will likely rely on both prospective trials and observational data to determine relative value in real-world settings. IOM Roundtable on Evidence-Based MedicineComparative Effectiveness Research typically will focus on realistic decisions confronting patients and their clinicians in actual practice…. Because of this focus on effectiveness as opposed to efficacy, these investigations will likely rely on both prospective trials and observational data to determine relative value in real-world settings. IOM Roundtable on Evidence-Based Medicine