Transcript Evolution of Decision Making in Health Care

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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Evolution of medicine and evidencebased medicine (EBM)
The EBM approach and evidencebased decision making
Translating research into practice and
practice into research
Evolution of Evidence-based Medicine
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Early 20th Century
• Flexner Report led to dominance of biomedical
model of medical care
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Mid-Late 20th Century
• Rapid growth in biomedical science and new
technologies
• Physicians primary decision makers
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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 20th Century:
Health Care Costs Explode
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International response
• Australia and Ontario introduce Cost Effectiveness
as a criterion in formulary decisions
• UK establishes NICE
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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
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Treatment Guidelines, Preferred Drug Lists/Formularies
Early 21st Century – US
Application of EBM and HECON to coverage decisions by
States (Medicaid) and Federal Government (Medicare)
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Medicare Modernization Act (MMA)
• Comparative effectiveness (e.g., EBM) – Section 1013 (AHRQ)
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Center for Medicare and Medicaid Services (CMS)
• CMS endorsement of health economics in MMA formulary design
• National Coverage Decisions
 Coverage with Evidence Development
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Drug Effectiveness Review Project – (DERP, 17 State
Consortium - Medicaid)
• Evidence-based Drug Class Reviews
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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)
The Evidence-Based Approach
Evidence-based . . . .
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Evidence-based Medicine (EBM)
• Patient care based on evidence from the best available
studies
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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
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Comparative Effectiveness
• Subset of EBM which assesses alternative therapies
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
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Address a specific problem
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Examine highest quality studies
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Apply tools critical appraisal to assess
studies
Summarize implications of the evidence
Contrast with Expert Reviews
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Subject to biased selection of studies
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Subject to biased interpretations
Goals of Explicit,
Evidence-based Approach
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Credibility
Transparency
• People can understand what you did
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Systematic
Reproducibility, limit bias
• Different people would get same result
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Identify gaps in evidence
• Highlight where we need better evidence
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Reduce the chance of “getting it wrong”
Explicit, Evidence-based
Process Specifies:
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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
Economic
Information
Studies
Evidence Review
and Synthesis
(Formulary Committee Staff,
EPCs, DERP)
Framing
Key Questions
Rigor Required
Budget
Constraints
1
Evidence-Based
Decision Making
2
(Formulary Committee
of PBM, Private Payer,
States)
Evidence
Review
Acceptability
3
Teutsch S, Berger M, Evidence Synthesis and
Evidence-based Decision Making: Related But
Distinct Processes.
Medical Decision Making 2005;25:487-9.
Decisions
If we want more evidence-based
practice, we need more practice-based
evidence.
Larry Green (www.lgreen.net)
Integrating Evidence into
Practice and Research
that Informs Real-World
Practice
Integration of Evidence-Based
Processes into Practice
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Efficacy vs. Effectiveness
Decision oriented
Post-marketing surveillance
Quasi-experimental methods
Learning networks (voluntary, selforganizing)
Rapid cycle from problem identification to
hypothesis testing
Integration of evidence into practice
Quality improvement and measurement
The Two Faces of “TRIP”
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Funding research on transferring
research into practice
versus
Embedding the transfer of research
into practice within the culture of
universities, health care
organizations and research funders
Efficacy vs. Effectiveness
Clinical Trials
Efficacy
Clinical Practice
Effectiveness
Single diagnosis
High-risk patients with
co-morbid conditions
Drug vs. placebo
Multiple drug choices and
alternatives
Exclusions of user groups Use is generally
e.g., elderly
unlimited
Clinical endpoints,
Death, disability, QoL
biomarkers
Genetics/biology
Sociology/psychology
“Artificial” settings
Real world clinics
Effectiveness Trials
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Trials for which the hypothesis and
study design are formulated based
on information to make a decision.
Tunis et al., 2003
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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
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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
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Guidelines and standards based on
evidence
System change to assure delivery of
services
• EHR
• Disease management
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Performance metrics and incentives
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Service
McGlynn E, et al. NEJM 2003
Translating Research into Practice
Study systems for quality improvement
• Organization and structure of care
• Reimbursement and incentives
• Information systems
• Community and patient engagement
• Training
Policy
EBM / HECON
Decisions
Model
Biomedical
Model
Consequences of EBM Paradigm
Basic Science
Clinical Research
EBM Literature
Synthesis
Comparative Effectiveness
Inform R&D Needs
Relative Value (Cost Effectiveness)
Evidence-based Guidelines
Reimbursement, Coverage
and Incentives
Determine Access
to Services
Determine
Appropriate Care
Quality Improvement
Determine Outcomes
Of Care
Thanks!
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