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Matching the Research Design to the Study Question
 

Matching the Research Design to the Study Question

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  • Agenda: http://www.cmtpnet.org/cer-institute-1/agenda
  • http://www.ahrq.gov/workingforquality/nqs/

Matching the Research Design to the Study Question Matching the Research Design to the Study Question Presentation Transcript

  • Matching the Research Design to the Study Question
    • Lisa Simpson, MD, MPH
    • July 25, 2011
  • Overview
    • Overview of AcademyHealth
    • Matching the research to the need
    • Matching the design to the question
    • Implications for the CER enterprise
  • AcademyHealth: Improving Health & Health Care
    • As the professional society for health services researchers and health policy analysts, our mission is three-fold:
      • Support the development of health services research
      • Facilitate the use of the best available research and information
      • Assist health policy and practice leaders in addressing major health challenges
    • We work to both “push” the production of research and promote the “pull” by decision makers
  • In Other Words…
    • We help build the knowledge base
    • AND
    • move knowledge into action
    • through programs and services for research producers and research users.
  • Overview
    • Overview of AcademyHealth
    • Matching the Research to the Need
        • National Quality Strategy
  • National Quality Strategy
    • Secretary of HHS mandated by Affordable Care Act to develop a National Strategy for Quality Improvement in Health
    • Requires strategic plan and implementation metrics for national, state, and local efforts to improve health care quality on common aims, priorities and goals
  • National Quality Strategy: Three Aims
    • Better Care: Improve the overall quality, by making health care more patient-centered, reliable, accessible, and safe.
    • Healthy People/Healthy Communities: Improve the health of the U.S. population by supporting proven interventions to address behavioral, social and, environmental determinants of health in addition to delivering higher-quality care.
    • Affordable Care: Reduce the cost of quality health care for individuals, families, employers, and government.
  • National Quality Strategy: Six Priorities
    • Safer care
    • Effective care coordination
    • Person and family centered care
    • Prevention and treatment of leading causes of mortality
    • Supporting better health in communities
    • Making care more affordable
  • NQS and IOM: Priorities in Sync
    • Safer care
    • Effective care coordination
    • Person and family centered care
    • Prevention and treatment of leading causes of mortality
    • Supporting better health in communities
    • Making care more affordable
    • Methods to eradicate MRSA and reduce HAI
    • Effectiveness of comprehensive care programs
    • None explicitly “patient-centered”
    • Primary prevention methods vs. clinical interventions
    • Effectiveness of dissemination and translation techniques
    • Reduce healthcare disparities including literacy
    • Localized prostate cancer management strategies
  • NQS and FCC CER
    • Safer care
    • Effective care coordination
    • Person and family centered care
    • Prevention and treatment of leading causes of mortality
    • Supporting better health in communities
    • Making care more affordable
    • None explicitly on safety
    • Decision support tools
    • Focusing on immediate, specific patient needs; family as surrogate decision makers
    • Prevention
    • Focus on priority populations
    • Delivery system strategies, including community-based models
  • National Quality Strategy Principles
    • 1. Person-centeredness and family engagement
    • 2. Specific health considerations
    • 3. Eliminating disparities in care
    • 4. Aligning the efforts of public and private sectors
    • 5. Quality improvement
    6. Consistent national standards 7. Primary care will become a bigger focus 8. Coordination will be enhanced 9. Integration of care delivery 10. Providing clear information CER focused at the individual level, responsive to patient needs CER examining discrete &/or complex comorbid conditions Importance of sub group analyses, examination of context, & within group heterogeneity Enterprise dependent on public & private sources Examination of system level effectiveness and co-occurring interventions Methodologic standards for priority setting, engaging patients & research Focus on real world setting and heterogeneous patient populations as well as practice variations Implementation and Dissemination CER Importance of system level studies
  • So is this…
  • A brief (& Selected) History of Time… 1989 AHCPR PCORI Public/Private Funding Priority Questions Methods & Standards Stakeholder input 1999 AHRQ 2003 MMA 2009 ARRA 2009 ACA Outcomes PORTS Outcomes CERTS Quality & Safety AHRQ EHC Program Priority Conditions Payer focus Public input CER enterprise Priority Questions Methods & Standards Stakeholder input
  • Over That Time…
    • A more than tripling of the NIH budget in 20 years
      • ~$10 million in 1991 to $31 billion
    • Growing understanding of the many gaps in quality, outcomes
    • Pervasive disparities
    • The “inexorable cost curve”
    • Increasing demand for research ROI
      • For identified needs to drive funding
      • Improved methods for seeking public, user input
    • Increasing emphasis on priority setting
    • Focus on comparisons
    • Expansion beyond discrete clinical comparisons
    • Focus on methodologic standards
  • It is still wine, but…
  • CER Defining Characteristics
    • Objective of directly informing clinical or health policy decision
    • Compares at least 2 alternatives
    • Results at population and subgroup level
    Tunis, 2009
  • “ 70 Kilo White Male”
  • CER Defining Characteristics
    • Objective of directly informing clinical or health policy decision
    • Compares at least 2 alternatives
    • Results at population and subgroup level
    • Measures outcomes important to patients
    • Methods and data sources appropriate for the decision of interest
    • Conducted in real world settings
    Tunis, 2009
  • CER vs PCOR: is there a difference? Not comparative Patient reported outcomes Subgroups Patient-Centered Outcomes Research Comparative Effectiveness Research Comparisons No patient reported data
    • So before we can match the study design to the question, we have to match the question to the need.
    • And that need varies depending on who you ask and how you ask.
  • Overview
    • Overview of AcademyHealth
    • Matching the research to the need
    • Matching the design to the question
  • Who is asking the question? Why?
    • Policymakers
      • Coverage, delivery system regulations, payment, quality
    • Payers
      • Coverage, payment, quality
    • Industry
      • Regulatory requirements, impact on innovation
    • Providers
      • Health care choices
    • Consumers/Patients
      • Health care choices
  • The design depends on who is asking the question
    • Constructing relationships
    • Constructing questions
    • Constructing answers
    • Constructing messages
      • (Translation)
    Source: Zerzan, JT et al. “Improving State Medicaid Policies with Comparative Effectiveness Research: A Key Role for Academic Health Centers.” Academic Medicine, Vol. 86, No. 6. June 2011. Pgs 695-700.
  • Categories of CER Methods
    • Systematic reviews of existing research
    • Decision modeling, with or without cost information
    • Retrospective analysis of existing clinical or administrative data
      • Significant new investments in data infrastructure
    • Prospective non-experimental studies, including registries
    • Experimental studies, including randomized clinical trials (RCTs)
    Tunis, 2009
  • The skeptical, “purist” view...
    • […] “if American medicine is to avoid the mistakes of high-dose chemotherapy, hormone therapy, antiarrhythmic agents, and numerous other failed interventions, that our profession adopted on the basis of inferior evidence.”
    Source: Lauer, MS. “Will Academia Embrace Comparative Effectiveness Research?” Academic Medicine, Vol. 86, No. 6. June 2011. Pgs 671-673.
  • Matching the Designs Source: Thorpe KE et al, Journal of Clinical Epidemiology, 2009
  • Matching the Designs
    • Pediatric quality demonstrations
    • 10 grants, 18 states, 47 projects
    • Multiple stakeholders
      • CMS
      • State policymakers
      • Health plans
      • Providers
      • Patients & families
  • Considerations
    • Degree of harm
      • Individual morbidity & mortality, versus population outcomes
    • Amount of existing evidence
      • System level decisions even more “evidence free”
    • Market entry vs prevalent practice
    • Measuring the fidelity &/ adaptation of the intervention
    • Opportunity to reconsider the choice
      • Mid course corrections
      • Coverage with evidence development
      • Lifecycle approach to evidence development
  • Matching the Design to the Question Observational Studies RCTs Balance Rigor Relevance Timeliness
  • All methods have a role
    • Inevitable tradeoff between internal validity and feasibility, generalizability, cost, time
    • The nature of the research question, and the decision maker will influence best practices
    • Experimental studies will have a crucial role in CER, and there is need for improving design and implementation
    • Non-experimental methods hold great promise, particularly as methods are refined and data infrastructure is improved
    Tunis, 2009
  • Overview
    • Overview of AcademyHealth
    • Matching the research to the need
    • Matching the design to the question
    • Implications for the CER enterprise
    • An approach that advances a balanced portfolio of activities including:
      • Variety of study designs
        • Evidence generation
        • Evidence translation
      • Methodologic research
      • Infrastructure enhancements
        • Data
        • Workforce(s)
    • An approach that builds in “meta-learning”
      • A high performing evidence system
    Source: Adapted from Van Lare, Conway & Sox, NEJM, 2010
  • Questions? Lisa Simpson, MB, BCh, MPH, FAAP President and CEO