1. Evidence-Based Medicine Today:
-What it is
-Where We've Been
- Where We're Going
Peter Wyer MD
Chair, NYAM Section on Evidence Based Health Care
Associate Clinical Professor of Medicine
C Columbia University College of Physicians & Surgeons

2. Disclosures
• Financial COI: None
• Intellectual COI: Many

3. What It Is

4. “Do not ask ‘what is it’….”
-T S Eliot
EB Guidelines EB Policy EB Reviews EB Medicine
Canadian screening Variations research Cochrane–RCTs Clinical epidemiology
1979 1973 1972 1968
David Eddy 1990 Gordon Guyatt 1990
GRADE 2003
Health Care Delivery
Knowledge Translation
“EVIDENCE BASED HEALTH CARE“

5. Where We’ve Been

6. Where We’ve Been
Pluses
• Tightened methodological conception
– Distinction between risk of bias and random error
– Emphasis on patient-important outcomes
– Clinically and policy relevant formatting of results
• Filtered databases
– Cochrane
– Centre for Review and Dissemination
– National Guidelines Clearinghouse
– ACP Journal Club

7. Where We’ve Been
Early Limitations
• Oversimplified equations
– Therapy = RCTs
– Diagnosis = Performance accuracy
– Prognosis = Cohort studies
– Etiology = Case-control designs
• Linear hierarchies
– RCT
– Observational studies
– Pathophysiological investigations
– Practitioner opinion

8. Parachutes for Gravitational Challenge
December 20-27, 2003
No randomised controlled trials of
parachute use have been undertaken.
The basis for parachute use is purely
observational, and its apparent efficacy
could potentially be explained by a
“healthy cohort” effect

9. Antibiotics for Septic Shock
Cochrane Library, 2012 Issue 5
Selection criteria
We planned to include randomized controlled trials of early versus late broad spectrum
antibiotics in adult patients with severe sepsis
Main results
We found no studies that satisfied the inclusion criteria.
Authors’ conclusions
Based on this review we are unable to make a recommendation on the early or late use of
broad spectrum antibiotics in adult patients with severe sepsis in the ED pre-ICU admission.
There is a need to do large prospective double blinded randomized controlled trials
on the efficacy of early (within one hour) versus late broad spectrum antibiotics in adult
severe sepsis patients.

10. Failure of Dissemination
• Coomarasamy A, et al BMJ 2004;329:1017
– Systematic review educational interventions
– EBM teaching does not affect practitioner behavior
• McGlynn EA, et al N Engl J Med 2003;348:2365
– Large survey of adults with a range of health
conditions
– Only 55% receiving recommended care
• Greenhalgh T, et al Soc Sci Med 2005
– EBM/KT based on flawed, rationalist premises

11. Development of a Research Idea
For Application to Clinical Practice
Bench Early Clinical
Research human RCT SR Practice
Ideas trials

12. The “Evidence Transfer Gap”
RCT SR Clinical
Practice

13. The Path From Research to Improved Health Outcomes
Glasziou, Haynes ACP Journal Club 2005
Haynes ACP Journal Club 2005

14. Concern for Effectiveness and Value
• 2003: Medicare Modernization Act
– Empowers AHRQ to develop CER perspective
• 2008 IOM: “Knowing what works in health care”
– Calls for increased US capacity to use evidence to
guide health care decisions
• 2009 IOM: “Initial national priorities for CER”
– Recognizes need to draw on multiple sources of
information
• 2011 IOM: New standards for guidelines and SRs

15. Where We’re Going

16. Efficacy vs Effectiveness Example
Nicotine Replacement Therapy: Efficacy
Cochrane Library, 2008 Issue 3
132 RCTs enrolling > 40,000 subjects
Outcome: at least 6 month abstinence
All results favored NRT
All trials: RR 1.58 (95% CI 1.50-1.66)
3 trials simulating OTC: RR 1.98 (95% CI 1.40-2.79)
Level of professional counseling did not modify effect

17. Efficacy vs Effectiveness Example
Nicotine Replacement Therapy: Effectiveness
2011 Epub ahead of print
Population based sample of quitters in Massachusetts
787 subjects included
Outcome: Association of NRT use and likelihood of relapse
NRT use at time of quitting associated with likelihood of relapse
Exposure to professional counseling did not modify effect

18. New Standards for Guidelines and Reviews
• 2011 IOM paired reports
– Independent importance of observational data
– Engagement of stakeholders including patients
– Transparency
• GRADE system: Criteria for evidence quality
– Methodology (allows for observational evidence)
– Directness
– Precision
– Consistency
– Reporting bias

19. New Approaches to Clinical Trials
• Pragmatic versus explanatory trials
– Broader inclusion criteria
– Relaxed monitoring
– Active treatment to all patients
– Real world conditions
– Patient centered outcomes
• Preference based trials
– Screen initially for patient/practitioner preferences
– Limit randomization to neutral subjects

20. Patient Preference
• Brewin & Bradley 1989: preference based trials
• ‘Participative’ interventions-e.g. counseling
• Inherently require patient motivation for effectiveness
• Study of effectiveness incompatible with
randomization, concealment, blinding
• Concept of ‘efficacy’ clinically meaningless
Brewin & Bradley BMJ 1989;299:313

21. Evidence Based Health Care and
Organizational Process

22. Closing the Gap
Research
Knowledge Practice
“PUSH”
PUSH “PULL”

23. The New “Pull” Forms of Evidence
• EHR
• Administrative databases
• Practice based research

24. The SECI Model of Nonaka
To
Tacit Explicit
Tacit Socialization Externalization
From
Explicit Internalization Combination
Nonaka, Takeuchi 1995 Oxford U Press

25. Modified SECI Model
To
Tacit Explicit
Tacit Observation Documentation
From
Explicit Implementation Analysis
Sonka et al 1999 Int Food Agric Mgment Rev

26. Integration of Internal and External Knowledge
MODE CONTENT EXCHANGE
Process Outcomes
Quality Improvement/TQM (Error reduction Internal Knowledge
Variation decrease)
Clinical Outcomes
External Knowledge
(Adoption of innovation
Knowledge Translation
‘De-adoption’ of unnecessary
care)

27. Practice Based Evidence
• Team based approach to design
• Frontline stakeholders select variables
• Multiple hypotheses
generated, verified, explored
• Externally generated research relevant to process
Horn et al Arch Phys Med Rehab 2012;93 (Supl): S127

28. Hospital Based HTA
• University of Pennsylvania CEP
• AHRQ EPC with ECRI Institute
• Customized time-lined reviews
• Services Penn Health system
• Integrate external evidence with local data
• CDS applications emerge from process
Umscheid et al. J Gen Intern Med 2010;25:1352

29. Summary
• Need broad definition of ‘EBM’ to address
population, system and patient issues
• Traditional EBM contributes methodological rigor
and filtered electronic databases
• Traditional EBM reflects incomplete model of
dissemination and diffusion
• Effective health care requires multiple kinds of
evidence, including evidence generated from
within practice settings
• ‘Quality’ is co-defined by methdological rigor and
practical applicability