The American Recovery and Reinvestment Act: AHRQ's Role in Comparative Effectiveness Research

On September 14, 2009, Directors Carolyn M. Clancy, MD, and Jean Slutsky of the Center for Outcomes and Evidence made this presentation at the 2009 Annual Conference. Select to access the PowerPoint® presentation (3.7 MB) (Plugin Software Help).

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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

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Current Challenges

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

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Huge Geographic Variations: Higher Prices Don't Always Mean Better Care

Image: An image of the Medicare spending per beneficiary, 2006 (according to the Dartmouth Atlas of Health Care is shown.

New York Times, September 8, 2009

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ARRA: AHRQ's Role in Comparative Effectiveness Research

• AHRQ: New Resources, Ongoing Priorities
• Redefining Health Care Delivery
• ARRA: Translating Science into Real-World Applications
• Q & A

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AHRQ Priorities

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

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AHRQ 2009: New Resources, Ongoing Priorities

• $372 million for AHRQ in FY '09 budget
  • $37 million more than FY 2008
  • $46 million more than Administration request
• 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

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AHRQ's Role in Comparative Effectiveness

21st Century Health Care

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

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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
• 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

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AHRQ Comparative Effectiveness Research

A screen shot is http//:effectivehealthcare.ahrq.gov is shown.

http//:effectivehealthcare.ahrq.gov

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Outputs of CER at AHRQ

• Peer reviewed manuscripts in journals
• Systematic reviews published by AHRQ
• Translation products
• Processes and procedures
  • Methods guides
  • Processes for topic selection
  • Disposition of comments
  • Reading room

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Defining/Refining Health Care Delivery

• 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"

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Comparative Effectiveness and the Recovery Act

Federal Coordinating Council appointed to coordinate comparative effectiveness research across the federal government

• 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

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FCC Framework and IOM

• Research (Specific CER funding priorities outlined)
• Human & Scientific Capital (General Considerations only)
• Data Infrastructure (General Considerations only)
• Dissemination and Translation (General Considerations only)

• Crosscutting Priority Theme

• Priority Populations
• Priority Conditions
• Types of Interventions

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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.

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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.

National Priorities for Comparative Effectiveness Research
Institute of Medicine Report Brief
June 2009

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Conceptual Framework

Stakeholder Input & Involvement

Research Training

Evidence Need Identification

• Horizon Scanning
• Evidence Generation
• Dissemination & Translation
• Evidence Synthesis

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AHRQ's Priority Conditions for the Effective Health Care Program

• Arthritis and non-traumatic joint disorders
• Cancer
• Cardiovascular disease, including stroke and hypertension
• Dementia, including Alzheimer Disease
• Depression and other mental health disorders
• Developmental delays, attention-deficit hyperactivity disorder and autism
• Diabetes Mellitus
• Functional limitations and disability
• Infectious diseases including HIV/AIDS
• Obesity
• Peptic ulcer disease and dyspepsia
• Pregnancy including pre-term birth
• Pulmonary disease/Asthma
• Substance abuse

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IOM's 100 Priority Topics

• Initial National Priorities for Comparative Effectiveness Research (June 20, 2009)
• Topics in 4 quartiles; groups of 25.
• 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

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AHRQ Operating Plan for Recovery Act's CER Funding

• Stakeholder Input and Involvement: To occur throughout the program
• Horizon Scanning: Identifying promising interventions
• Evidence Synthesis: Review of current research
• Evidence Generation: New research with a focus on under-represented populations
• Research Training and Career Development: Support for training, research and careers

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Translating the Science into Real-World Applications

• 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)

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Additional Proposed Investments

• 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)
    • Eisenberg Center modifications (3 years, $5M)
  • Citizen Forum on Effective Health Care
    • 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)

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An image of the CME Metrics Report cover is shown.

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An article titled "Clinical Effectiveness of Coronary Stents in Elderly Persons" is shown.

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An article titled "Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation" is shown.

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Emerging Methods in Comparative Effectiveness, EBM & Safety

• Variation in methods among systematic reviews undercuts transparency
• Poorly done new research can be misleading
• 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.

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CER and Innovation

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

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Comparative Effectiveness Challenges/Opportunities

• Anticipating downstream effects of policy applications
• Making sure that comparative effectiveness is "descriptive, not prescriptive"
• Creating a level playing field among all stakeholders, including patients and consumers
• Using research to address concerns of patients and clinicians

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Where to From Here?

• 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
• Words of wisdom: "In theory, there is no difference between theory and practice. In practice, there is." - Yogi Berra

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Questions?

www.ahrq.gov
www.hhs.gov/recovery