1. AHRQ’s Role in Comparative Effectiveness Carolyn M. Clancy, MD Director Agency for Healthcare Research and Quality Alliance for Health Reform Briefing April 4, 2008

2. Comparative Effectiveness: Effective Health Care Program To improve the quality, effectiveness, and efficiency of health care delivered through Medicare, Medicaid, and S-CHIP programs. To improve the quality, effectiveness, and efficiency of health care delivered through Medicare, Medicaid, and S-CHIP programs. – Focus is on what is known now: ensuring programs benefit from past investments in research and what research gaps are critical to fill – Focus is on clinical effectiveness

3. Key Program Attributes Infrastructure Infrastructure – Connected to AHRQ Health IT investments – Builds on AHRQ connections with providers and consumers Unbiased Unbiased Responsive Responsive Trusted Trusted

4. Transparency Public Comment Public Comment – Priority areas – Nomination of topics for research – Comment on draft research questions – Comment on draft reports No “Black Box” No “Black Box” – Systematic Reviews include details on review methodology and topic considerations

5. AHRQ Center for Outcomes & Evidence GrantsContracts Intramural Research

6. Program Outputs Research Reports Systematic Reviews Consumer Guides

8. What Have We Learned Often, there are no clear winners and losers Often, there are no clear winners and losers Need to think of questions years in advance of decision makers asking Need to think of questions years in advance of decision makers asking It is amazing what we don’t know about common and ubiquitous treatments It is amazing what we don’t know about common and ubiquitous treatments

9. AHRQ Comparative Effectiveness Research The additional funding for comparative effectiveness will help AHRQ generate a wealth of new products and tools: The additional funding for comparative effectiveness will help AHRQ 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

10. Emerging Methods in Comparative Effectiveness & Safety A series of 23 articles by AHRQ researchers on new approaches in comparative effectiveness methods are compiled in a special October edition of Medical Care A series of 23 articles by AHRQ researchers on new approaches in comparative effectiveness methods are compiled in a special October edition of Medical Care A valuable new resource for scientists committed to advancing the comparative effectiveness and safety research A valuable new resource for scientists committed to advancing the comparative effectiveness and safety research All articles available for free download on AHRQ’s website or from AHRQ’s Clearinghouse (Pub. No. OM07-0085) All articles available for free download on AHRQ’s website or from AHRQ’s Clearinghouse (Pub. No. OM07-0085) http://effectivehealthcare.ahrq.gov/reports/med-care-report.cfm

11. From Research to High-Value Health Care Increased overlap between researchers / product developers and health care leaders  ‘embed’ findings in clinical strategies, electronic and personal health records Increased overlap between researchers / product developers and health care leaders  ‘embed’ findings in clinical strategies, electronic and personal health records Distributed leadership Distributed leadership Clear path for feedback from care delivery to research enterprise at multiple points Clear path for feedback from care delivery to research enterprise at multiple points From ‘stand-alone’ registries to those that are are used both locally and regionally / nationally From ‘stand-alone’ registries to those that are are used both locally and regionally / nationally Transparency in production and use of CE information Transparency in production and use of CE information

12. “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 Medicine