1. The American Recovery and Reinvestment Act: AHRQ's Role in Comparative Effectiveness Research Carolyn M. Clancy, MD, Director Jean Slutsky, Director, Center for Outcomes and Evidence Agency for Healthcare Research and Quality Bethesda – September 14, 2009

2. Current Challenges Concerns about health spending – about $2.3 trillion per year in the U.S. and growing Concerns about health spending – about $2.3 trillion per year in the U.S. and growing Large variations in clinical care Large variations in clinical care A lot of uncertainty about best practices involving treatments and technologies A lot of uncertainty about best practices involving treatments and technologies Pervasive problems with the quality of care that people receive Pervasive problems with the quality of care that people receive Translating scientific advances into actual clinical practice Translating scientific advances into actual clinical practice Translating scientific advances into usable information for clinicians and patients Translating scientific advances into usable information for clinicians and patients

3. Huge Geographic Variations: Higher Prices Don’t Always Mean Better Care New York Times, September 8, 2009

4. AHRQ: New Resources, Ongoing Priorities AHRQ: New Resources, Ongoing Priorities Redefining Health Care Delivery Redefining Health Care Delivery ARRA: Translating Science into Real-World Applications ARRA: Translating Science into Real-World Applications Q & A Q & A ARRA: AHRQ's Role in Comparative Effectiveness Research

5. AHRQ 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

6. AHRQ 2009: New Resources, Ongoing Priorities $372 million for AHRQ in FY ‘09 budget $372 million for AHRQ in FY ‘09 budget – $37 million more than FY 2008 – $46 million more than Administration request FY 2009 appropriation includes: FY 2009 appropriation includes: – $50 million for comparative effectiveness research, $20 million more than FY 2008 – $49 million for patient safety activities – $45 million for health IT

7. AHRQ’s Role in Comparative Effectiveness Using Information to Drive Improvement: Scientific Infrastructure to Support Reform Lead federal funding Engage private sector Aggregate best evidence to inform complex learning and implementation challenges Increase knowledge base to spur high-value care 21 st Century Health Care

8. Comparative Effectiveness: AHRQ Effective Health Care Program Created in 2005, authorized by Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 Created in 2005, authorized by Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 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

9. AHRQ Comparative Effectiveness Research http://effectivehealthcare.ahrq.gov

10. Outputs of CER at AHRQ Peer reviewed manuscripts in journals Peer reviewed manuscripts in journals Systematic reviews published by AHRQ Systematic reviews published by AHRQ Translation products Translation products Processes and procedures Processes and procedures – Methods guides – Processes for topic selection – Disposition of comments – Reading room

11. Defining/Refining Health Care Delivery Fostering more precise application of biomedical discoveries Fostering more precise application of biomedical discoveries – Substantial variations in care – ‘cost without benefit’? – Pervasive disparities – Care delivery: platform for discovery and rapid translation – An “Abundance of Riches”

12. Comparative Effectiveness and the Recovery Act The American Recovery and Reinvestment Act of 2009 includes $1.1 billion for comparative effectiveness research: The American Recovery and Reinvestment Act of 2009 includes $1.1 billion for comparative effectiveness research: – AHRQ: $300 million – NIH: $400 million (appropriated to AHRQ and transferred to NIH) – Office of the Secretary: $400 million (allocated at the Secretary’s discretion) Federal Coordinating Council appointed to coordinate comparative effectiveness research across the federal government

13. FCC Framework and IOM Human & Scientific Capital Research Data Infrastructure Dissemination and Translation Priority Populations Priority Conditions Types of Interventions Crosscutting Priority Themes Specific CER funding priorities outlinedGeneral Considerations only Legend

14. Definition: Federal Coordinating Council CER is the conduct and synthesis of research comparing the benefits and harms of various interventions and strategies for preventing, diagnosing, treating, and monitoring health conditions in real-world settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence- based information to patients, clinicians, and other decision makers about which interventions are most effective for which patients under specific circumstances. CER is the conduct and synthesis of research comparing the benefits and harms of various interventions and strategies for preventing, diagnosing, treating, and monitoring health conditions in real-world settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence- based information to patients, clinicians, and other decision makers about which interventions are most effective for which patients under specific circumstances.

15. Definition: IOM Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers and policy makers to make informed decisions that will improve health care at both the individual and population levels. Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers and policy makers to make informed decisions that will improve health care at both the individual and population levels. National Priorities for Comparative Effectiveness Research Institute of Medicine Report Brief June 2009

16. Conceptual Framework Dissemination & Translation Horizon Scanning Evidence Need Identification Evidence Synthesis Evidence Generation Career Development Research Training Stakeholder Input & Involvement

17. AHRQ’s Priority Conditions for the Effective Health Care Program Arthritis and non- traumatic joint disorders Arthritis and non- traumatic joint disorders Cancer Cancer Cardiovascular disease, including stroke and hypertension Cardiovascular disease, including stroke and hypertension Dementia, including Alzheimer Disease Dementia, including Alzheimer Disease Depression and other mental health disorders Depression and other mental health disorders Developmental delays, attention-deficit hyperactivity disorder and autism Developmental delays, attention-deficit hyperactivity disorder and autism Diabetes Mellitus Diabetes Mellitus Functional limitations and disability Functional limitations and disability Infectious diseases including HIV/AIDS Infectious diseases including HIV/AIDS Obesity Obesity Peptic ulcer disease and dyspepsia Peptic ulcer disease and dyspepsia Pregnancy including pre-term birth Pregnancy including pre-term birth Pulmonary disease/Asthma Pulmonary disease/Asthma Substance abuse Substance abuse

18. IOM’s 100 Priority Topics Initial National Priorities for Comparative Effectiveness Research (June 20, 2009) Initial National Priorities for Comparative Effectiveness Research (June 20, 2009) Topics in 4 quartiles; groups of 25. Topics in 4 quartiles; groups of 25. First quartile is highest priority. Included in first quartile: First quartile is highest priority. Included in first quartile: – Treatment strategies for atrial fibrillation, including surgery, ablation and drugs – Treatments for hearing loss in children and adults – Primary prevention methods, such as exercise and balance training, vs. clinical treatments in preventing falls in older adults Report Brief Available At http://www.iom.edu http://www.iom.edu

19. AHRQ Operating Plan for Recovery Act’s CER Funding Stakeholder Input and Involvement: To occur throughout the program Stakeholder Input and Involvement: To occur throughout the program Horizon Scanning: Identifying promising interventions Horizon Scanning: Identifying promising interventions Evidence Synthesis: Review of current research Evidence Synthesis: Review of current research Evidence Generation: New research with a focus on under-represented populations Evidence Generation: New research with a focus on under-represented populations Research Training and Career Development: Support for training, research and careers Research Training and Career Development: Support for training, research and careers

20. Translating the Science into Real-World Applications Examples of Recovery Act-funded Evidence Generation projects: Examples of Recovery Act-funded Evidence Generation projects: – Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE): First coordinated national effort to establish a series of pragmatic clinical comparative effectiveness studies ($100M) – Request for Registries: Up to five awards for the creation or enhancement of national patient registries, with a primary focus on the 14 priority conditions ($48M) – DEcIDE Consortium Support: Expansion of multi-center research system and funding for distributed data network models that use clinically rich data from electronic health records ($24M)

21. Additional Proposed Investments Supporting AHRQ’s long-term commitment to bridging the gap between research and practice: Supporting AHRQ’s long-term commitment to bridging the gap between research and practice: – Dissemination and Translation Between 20 and 25 two-three-year grants ($29.5M) Between 20 and 25 two-three-year grants ($29.5M) Eisenberg Center modifications (3 years, $5M) Eisenberg Center modifications (3 years, $5M) – Citizen Forum on Effective Health Care Formally engages stakeholders in the entire Effective Health Care enterprise Formally engages stakeholders in the entire Effective Health Care enterprise A Workgroup on Comparative Effectiveness will be convened to provide formal advice and guidance ($10M) A Workgroup on Comparative Effectiveness will be convened to provide formal advice and guidance ($10M)

25. Emerging Methods in Comparative Effectiveness, EBM & Safety Variation in methods among systematic reviews undercuts transparency Variation in methods among systematic reviews undercuts transparency Poorly done new research can be misleading Poorly done new research can be misleading Methods must continue to evolve and not remain stagnant Methods must continue to evolve and not remain stagnant AHRQ has and will continue to make investments in improving methods, esp. in understanding clinical heterogeneity. AHRQ has and will continue to make investments in improving methods, esp. in understanding clinical heterogeneity.

26. CER and Innovation CER will enhance the best and most innovative strategies CER will enhance the best and most innovative strategies Can open up new populations for which something can be useful in Can open up new populations for which something can be useful in Can bring early attention to potential issues Can bring early attention to potential issues

27. Comparative Effectiveness Challenges/Opportunities Anticipating downstream effects of policy applications Anticipating downstream effects of policy applications Making sure that comparative effectiveness is "descriptive, not prescriptive” Making sure that comparative effectiveness is "descriptive, not prescriptive” Creating a level playing field among all stakeholders, including patients and consumers Creating a level playing field among all stakeholders, including patients and consumers Using research to address concerns of patients and clinicians Using research to address concerns of patients and clinicians

28. Where to From Here? Timing: Significant support for and interest in comparative effectiveness research Timing: Significant support for and interest in comparative effectiveness research The mission: Address gaps in quality and resolve conflicting or lack of evidence about most effective treatment approaches The mission: Address gaps in quality and resolve conflicting or lack of evidence about most effective treatment approaches Words of wisdom: “In theory, there is no difference between theory and practice. In practice, there is.” – Yogi Berra Words of wisdom: “In theory, there is no difference between theory and practice. In practice, there is.” – Yogi Berra

29. Questions? http://www.ahrq.gov http://www.hhs.gov/recovery