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Evidence-Based Medicine: Implications for Coverage, Practice, and Research. Nuts and Bolts Research Methods Symposium UT College of Medicine Chattanooga September 29, 2006 Steven Teutsch, MD, MPH, Executive Director Outcomes Research, Merck. Agenda.

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evidence based medicine implications for coverage practice and research

Evidence-Based Medicine: Implications for Coverage, Practice, and Research

Nuts and BoltsResearch Methods Symposium

UT College of Medicine Chattanooga

September 29, 2006

Steven Teutsch, MD, MPH, Executive Director

Outcomes Research, Merck

  • Evolution of medicine and evidence-based medicine (EBM)
  • The EBM approach and evidence-based decision making
  • Translating research into practice and practice into research
evolution of evidence based medicine
Evolution of Evidence-based Medicine
  • Early 20th Century
    • Flexner Report led to dominance of biomedical model of medical care
  • Mid-Late 20th Century
    • Rapid growth in biomedical science and new technologies
    • Physicians primary decision makers
      • Lack of coherent synthesis of knowledge enables practice variation (Wennberg)
    • Emergence of Evidence-based Medicine
    • Appearance of Practice Guidelines and Performance Metrics
        • Consensus-based (Professional Societies)
        • Evidence-based (USPSTF, AHCPR, ACP)
        • NCQA (e.g., HEDIS), Pay-for-Performance
end of 20 th century health care costs explode
End of 20th Century:Health Care Costs Explode
  • International response
    • Australia and Ontario introduce Cost Effectiveness as a criterion in formulary decisions
    • UK establishes NICE
      • Employs EBM and cost effectiveness to control access to new treatments
      • Increases credibility of these processes
      • Recommends, but does not enforce implementation
  • US response
    • Rise of Managed Care and Consolidation of Payers
      • Treatment Guidelines, Preferred Drug Lists/Formularies
Early 21st Century – USApplication of EBM and HECON to coverage decisions by States (Medicaid) and Federal Government (Medicare)
  • Medicare Modernization Act (MMA)
    • Comparative effectiveness (e.g., EBM) – Section 1013 (AHRQ)
  • Center for Medicare and Medicaid Services (CMS)
    • CMS endorsement of health economics in MMA formulary design
    • National Coverage Decisions
      • Coverage with Evidence Development
  • Drug Effectiveness Review Project – (DERP, 17 State Consortium - Medicaid)
    • Evidence-based Drug Class Reviews
  • Agency for Healthcare Research and Quality (AHRQ )
    • Centers for Research & Education in Therapeutics (CERTs)
    • Evidence-based Practice Centers (EPCs)
    • Effectiveness Health Care Program
      • Comparative Effectiveness (EPCs)
      • Network of Research Centers (DEcIDE)
      • Eisenberg Center for Clinical Decisions and Communications (Oregon)
evidence based
Evidence-based . . . .
  • Evidence-based Medicine (EBM)
    • Patient care based on evidence from the best available studies
  • Evidence-based Decision Making
    • EBM extended to include population-based decision making in the form of guidelines and formulary decisions using formal evidence criteria and deliberative processes
  • Comparative Effectiveness
    • Subset of EBM which assesses alternative therapies
what is evidence based medicine
What is Evidence-Based Medicine?

“The process of finding relevant information in the medical literature to address a specific clinical problem; the application of simple rules of science and common sense to determine the validity of the information; the application of the information to the clinical question. In short, patient care based on evidence derived from the best available (“gold standard”) studies.”

John Last, A Dictionary of Epidemiology, Oxford, 1995

systematic evidence reviews
Systematic Evidence Reviews
  • Address a specific problem
  • Examine highest quality studies
  • Apply tools critical appraisal to assess studies
  • Summarize implications of the evidence
contrast with expert reviews
Contrast with Expert Reviews
  • Subject to biased selection of studies
  • Subject to biased interpretations
goals of explicit evidence based approach
Goals of Explicit,Evidence-based Approach
  • Credibility
  • Transparency
    • People can understand what you did
  • Systematic
  • Reproducibility, limit bias
    • Different people would get same result
  • Identify gaps in evidence
    • Highlight where we need better evidence
  • Reduce the chance of “getting it wrong”
explicit evidence based process specifies
Explicit, Evidence-based Process Specifies:
  • Key questions to be answered
  • Consistent process for identifying and critically reviewing evidence
  • Procedures to reduce bias and conflict of interest

Dynamic Relationship Between Evidence Review & Synthesis and Evidence-based Decision Making



Key Questions

Rigor Required

  • Evidence Review
  • and Synthesis
  • (Formulary Committee Staff,
  • EPCs, DERP)


Decision Making

(Formulary Committee

of PBM, Private Payer,












Teutsch S, Berger M, Evidence Synthesis and

Evidence-based Decision Making: Related But

Distinct Processes.

Medical Decision Making2005;25:487-9.

If we want more evidence-based practice, we need more practice-based evidence.

Larry Green (www.lgreen.net)

integration of evidence based processes into practice
Integration of Evidence-Based Processes into Practice
  • Efficacy vs. Effectiveness
  • Decision oriented
  • Post-marketing surveillance
  • Quasi-experimental methods
  • Learning networks (voluntary, self-organizing)
  • Rapid cycle from problem identification to hypothesis testing
  • Integration of evidence into practice
  • Quality improvement and measurement
the two faces of trip
The Two Faces of “TRIP”
  • Funding research on transferring research into practice


  • Embedding the transfer of research into practice within the culture of universities, health care organizations and research funders
effectiveness trials
Effectiveness Trials
  • Trials for which the hypothesis and study design are formulated based on information to make a decision.

Tunis et al., 2003

  • Focus is gathering information of maximum interest to clinicians and other decision-makers.

March et al., 2005

explanatory pragmatic domains for practical clinical trials practihc workgroup
Explanatory-Pragmatic Domains for Practical Clinical TrialsPRaCTIHC workgroup
  • Eligibility criteria
  • Flexibility of the intervention
  • Practitioner expertise
  • Follow-up intensity
  • Follow-up duration
  • Participant compliance
  • Practitioner adherence to protocol and intervention
  • Primary analysis scope and specification
quality improvement
Quality Improvement
  • Guidelines and standards based on evidence
  • System change to assure delivery of services
    • EHR
    • Disease management
  • Performance metrics and incentives
adherence to quality indicators overall and by type of care and function
Adherence to Quality Indicators, Overall and by Type of Care and Function

McGlynn E, et al. NEJM 2003

translating research into practice
Translating Research into Practice

Study systems for quality improvement

  • Organization and structure of care
  • Reimbursement and incentives
  • Information systems
  • Community and patient engagement
  • Training
consequences of ebm paradigm
Consequences of EBM Paradigm

Basic Science



Clinical Research

Comparative Effectiveness

Inform R&D Needs

Relative Value (Cost Effectiveness)

EBM Literature





Appropriate Care

Evidence-based Guidelines



Reimbursement, Coverage

and Incentives

Quality Improvement

Determine Outcomes

Of Care

Determine Access

to Services