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Comparative Effectiveness: Concepts and Strategies

Comparative Effectiveness: Concepts and Strategies. Sean Tunis MD, MSc October 24, 2008. Calls for New “Comparative Effectiveness” Entity. MMA Section 1013 (2003) Gail Wilenksy, Health Affairs (11/06) AHIP, BCBSA proposals (early 2007) MedPAC report (6/07) CBO final report (12/07)

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Comparative Effectiveness: Concepts and Strategies

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  1. Comparative Effectiveness:Concepts and Strategies Sean Tunis MD, MSc October 24, 2008

  2. Calls for New “Comparative Effectiveness” Entity • MMA Section 1013 (2003) • Gail Wilenksy, Health Affairs (11/06) • AHIP, BCBSA proposals (early 2007) • MedPAC report (6/07) • CBO final report (12/07) • Commonwealth Fund report (12/07) • Several presidential candidates • AMA, ACP, and many others

  3. Typical CER Definition • “Research evaluating and comparing the implications and outcomes of 2 or more health care strategies to address a particular medical condition” • Primary focus on drugs, devices, procedures, diagnostics “and any other processes or items used in the treatment or diagnosis of patients” • More expanded view includes benefit design, provider payment mechanisms, etc

  4. Methods • Systematic reviews (traditional HTA) • Retrospective studies • with claims and/or EMR data • Modeling (+/- cost data) • Prospective observational or experimental studies • Registries • Pragmatic trials, Cluster RCTs • Bayesian / adaptive methods

  5. Finding Out What Works - History • OTA (Congress, 1972) • NCHCT (DHHS, 1980) • CHCT (IOM, 1985) • AHCPR (1989) • NICE (1999) • Why are we here 20 years later trying to create something new?

  6. Critical Knowledge Gaps • “Available evidence is limited or poor quality” • Despite 12,000 RCTs published every year • Evidence producers • NIH: discovery and proof of concept • Industry: FDA and market focus • AHRQ: modest budget, broad portfolio • DERP / /BCBSA / Cochrane: reviews • Decision makers have no significant influence in what evidence is created

  7. Potential Success Factors • Meaningful involvement of decision makers • Researchers should execute, not control • Balance transparency with speed • Priority setting will require effort • Judicious use of observational methods • Judicious use of systematic reviews • Faster, cheaper, simpler prospective studies • Start with a narrower, not broader scope

  8. Contact Info • sean.tunis@cmtpnet.org • www.cmptnet.org • 443-759-3116 (D) • 410-963-8876 (M)

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