Evidence-Based Medicine Today:                      -What it is                      -Where Weve Been                     ...
Disclosures• Financial COI:    None• Intellectual COI: Many
What It Is
“Do not ask ‘what is it’….”                                                    -T S Eliot  EB Guidelines            EB Pol...
Where We’ve Been
Where We’ve Been                            Pluses• Tightened methodological conception  – Distinction between risk of bia...
Where We’ve Been                        Early Limitations• Oversimplified equations  –   Therapy = RCTs  –   Diagnosis = P...
Parachutes for Gravitational Challenge                  December 20-27, 2003No randomised controlled trials ofparachute us...
Antibiotics for Septic Shock                                                           Cochrane Library, 2012 Issue 5Selec...
Failure of Dissemination• Coomarasamy A, et al BMJ 2004;329:1017  – Systematic review educational interventions  – EBM tea...
Development of a Research Idea               For Application to Clinical Practice        Bench      Early                 ...
The “Evidence Transfer Gap”RCT   SR                        Clinical                                Practice
The Path From Research to Improved Health Outcomes                                            Glasziou, Haynes ACP Journal...
Concern for Effectiveness and Value• 2003: Medicare Modernization Act  – Empowers AHRQ to develop CER perspective• 2008 IO...
Where We’re Going
Efficacy vs Effectiveness Example Nicotine Replacement Therapy: Efficacy                                           Cochran...
Efficacy vs Effectiveness Example   Nicotine Replacement Therapy: Effectiveness                                           ...
New Standards for Guidelines and Reviews• 2011 IOM paired reports  – Independent importance of observational data  – Engag...
New Approaches to Clinical Trials• Pragmatic versus explanatory trials  – Broader inclusion criteria  – Relaxed monitoring...
Patient Preference• Brewin & Bradley 1989: preference based trials• ‘Participative’ interventions-e.g. counseling• Inheren...
Evidence Based Health Care and    Organizational Process
Closing the Gap ResearchKnowledge        Practice “PUSH” PUSH             “PULL”
The New “Pull” Forms of Evidence    • EHR    • Administrative databases    • Practice based research
The SECI Model of Nonaka                                    To                     Tacit               Explicit       Taci...
Modified SECI Model                              To                     Tacit         Explicit       Tacit      Observatio...
Integration of Internal and External Knowledge     MODE                  CONTENT                         EXCHANGE         ...
Practice Based Evidence• Team based approach to design• Frontline stakeholders select variables• Multiple hypotheses  gene...
Hospital Based HTA•   University of Pennsylvania CEP•   AHRQ EPC with ECRI Institute•   Customized time-lined reviews•   S...
Summary• Need broad definition of ‘EBM’ to address  population, system and patient issues• Traditional EBM contributes met...
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Evidence based medicine today

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  • Objective: provide a framing perspective on EBM in a way that connects to the themes of the conference overall, with emphasis on the evolving concepts of what constitutes evidence and what constitutes quality of evidence
  • Non-academic practitioner X 15 years following graduation (medical school only)Trained in methodology at McMaster X 17 yearsInclined to a practice based orientation to the rigorous lessons of clinepi
  • “EBHC”=the development of concepts, tools and resources to maximally inform clinical guidelines, policy and practice within the health care system
  • These examples illustrate the terms of the traditional debate-emphasis on risk of bias. These debates largely sidestepped deeper issues, such as inherent limitations of randomized trials from the standpoint of real world effectiveness.
  • The concern for effective dissemination went hand and glove with the quest for effectiveness, value and efficiency
  • We are moving into an era characterized by EHR based systems in which new kinds of evidence, paired with new criteria for quality, will transform and expand our concept of evidence based health care
  • More and more, as researchers have accommodated to the pressures of the EBM movement, the methodology of published research has improved and critical appraisal centers on issues of ‘directness’-i.e. applicabilityDIRECTNESS a crucially important quality criterion
  • Not just new kinds of research and evidence---fundamentally new relationships between evidence, research and practice
  • Evidence based medicine today

    1. 1. Evidence-Based Medicine Today: -What it is -Where Weve Been - Where Were Going Peter Wyer MD Chair, NYAM Section on Evidence Based Health Care Associate Clinical Professor of MedicineC Columbia University College of Physicians & Surgeons
    2. 2. Disclosures• Financial COI: None• Intellectual COI: Many
    3. 3. What It Is
    4. 4. “Do not ask ‘what is it’….” -T S Eliot EB Guidelines EB Policy EB Reviews EB MedicineCanadian 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. 5. Where We’ve Been
    6. 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. 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. 8. Parachutes for Gravitational Challenge December 20-27, 2003No randomised controlled trials ofparachute use have been undertaken.The basis for parachute use is purelyobservational, and its apparent efficacycould potentially be explained by a“healthy cohort” effect
    9. 9. Antibiotics for Septic Shock Cochrane Library, 2012 Issue 5Selection criteriaWe planned to include randomized controlled trials of early versus late broad spectrumantibiotics in adult patients with severe sepsisMain resultsWe found no studies that satisfied the inclusion criteria.Authors’ conclusionsBased on this review we are unable to make a recommendation on the early or late use ofbroad 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 trialson the efficacy of early (within one hour) versus late broad spectrum antibiotics in adultsevere sepsis patients.
    10. 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. 11. Development of a Research Idea For Application to Clinical Practice Bench Early Clinical Research human RCT SR PracticeIdeas trials
    12. 12. The “Evidence Transfer Gap”RCT SR Clinical Practice
    13. 13. The Path From Research to Improved Health Outcomes Glasziou, Haynes ACP Journal Club 2005 Haynes ACP Journal Club 2005
    14. 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. 15. Where We’re Going
    16. 16. Efficacy vs Effectiveness Example Nicotine Replacement Therapy: Efficacy Cochrane Library, 2008 Issue 3132 RCTs enrolling > 40,000 subjectsOutcome: at least 6 month abstinenceAll results favored NRTAll 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. 17. Efficacy vs Effectiveness Example Nicotine Replacement Therapy: Effectiveness 2011 Epub ahead of printPopulation based sample of quitters in Massachusetts787 subjects includedOutcome: Association of NRT use and likelihood of relapseNRT use at time of quitting associated with likelihood of relapseExposure to professional counseling did not modify effect
    18. 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. 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. 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. 21. Evidence Based Health Care and Organizational Process
    22. 22. Closing the Gap ResearchKnowledge Practice “PUSH” PUSH “PULL”
    23. 23. The New “Pull” Forms of Evidence • EHR • Administrative databases • Practice based research
    24. 24. The SECI Model of Nonaka To Tacit Explicit Tacit Socialization ExternalizationFrom Explicit Internalization Combination Nonaka, Takeuchi 1995 Oxford U Press
    25. 25. Modified SECI Model To Tacit Explicit Tacit Observation DocumentationFrom Explicit Implementation Analysis Sonka et al 1999 Int Food Agric Mgment Rev
    26. 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. 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. 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. 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

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