EvidenceBased Medicine: Can It Work in the Real World

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Evidence-Based MedicineCan It Work in the Real
World?

• Mark C. Wilson, M.D., M.P.H.
• Wake Forest University School of Medicine

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• Where is the wisdom we have lost in knowledge,
• and where is the knowledge we have lost in
  information.
• T S Eliot

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Whats Irritating AboutEvidence-Based
Medicine?
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Why EBM Chafes

• Arrogant Posture
• to publish the gold that intellectually intense
  processes will mine from the ore of 100 of the
  worlds top journals
• Elitism
• how dare you insinuate Im a bad doc
• Unfamiliar Trendy Terminology
• Threatens the Art of Medicine
• Best Evidence Frequently Incomplete/Contradictory

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Todays Road Map

• Evolution of EBM
• Patients Clarify EBMs Place
• EBM An Imperfect Label
• Attempts to Implement Evidence-Based Practice
• EBM as Added Value

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EBM Its a Paradigm Shift

• When defects in an existing paradigm accumulate
  to the extent that the paradigm is no longer
  tenable, the paradigm is challenged and replaced
  by a new way of looking at the world
• A new paradigm for medical practice is emerging
• Evidence-based medicine requires new skills of
  the physician
• JAMA 1992 2682420-5

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Evidence Based Medicine

• Clinical intuition, unsystematic experience,
  pathophysiologic rationale

Evidence from clinical research
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Reason for Healthy Skepticism
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Users Guides Series in JAMAEvidence-Based
Medicine Working Group

• Are the Results Valid?
• Are the Results Important?
• Will the Results Help Me Care for My Patients?

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Irreverent EBM Descriptors

• Evangelism
• By
• Messiah

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EBM A Hierarchy of Evidence

• N-of-1 Trials
• Meta-Analysis of Homogeneous RCTs
• Single RCT
• Cohort Study
• Case-Control Study
• Case Series
• Individual Clinical Experience

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Remember ...

• Whenever You Get Confused,
• Start Back with the Patient

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Patients with New Proximal DVTs

• What Are Your Current Practice Patterns
• or the Predominate Patterns at Your Various
  Sites?

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Ahh The Best Evidence

• RCT at 15 Centers in Canada
• 500 patients with acute proximal DVT
• Enoxaparin 1mg/kg SQ bid versus Standard
  continuous heparin infusion
• Equal rates of recurrent VTE (5-6) and major
  bleeding rare (1-2)
• 50 of LMWH group never hospitalized
• Levine, et al. NEJM 1996 334677-81

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How Would You Treat These Patients With Newly
Diagnosed DVT?

• 43 y/o truck driver whose husband is a nurse
• 68 y/o man 3 weeks s/p TKR who was participating
  in rehab program 3X/week
• 75 y/o woman with metastatic ovarian cancer who
  is non-communicative after CVA 2 yrs ago and has
  no advance directives

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So We Discovered That ...

• Evidence Alone
• Never
• Makes Clinical Decisions

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Determinants of Decision-Making

• Evidence
• clinical evidence from patient
• external evidence ... the best available
• systematic research
• pathophysiology
• local experts
• Values
• your patients
• your own

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Lots of Decisions Are Lacedwith Uncertainty ...
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EBM What it is

• Evidence-Based Medicine is the conscientious,
  explicit, and judicious use of current best
  evidence in making decisions about the care of
  individual patients.
• Practice of evidence-based medicine means
  integrating individual clinical expertise with
  the best available external clinical evidence
  from systematic research.
• EBM What it is and what it isnt. Br Med J
  1996 31271-72

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EBM What it is

• Evidence-Based Medicine is the conscientious,
  explicit, and judicious use of current best
  evidence in making decisions about the care of
  individual patients.
• Practice of evidence-based medicine means
  integrating individual clinical expertise with
  the best available external clinical evidence
  from systematic research.
• EBM What it is and what it isnt. Br Med J
  1996 31271-72

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EBM What it is

• Evidence-Based Medicine is the conscientious,
  explicit, and judicious use of current best
  evidence in making decisions about the care of
  individual patients.
• Practice of evidence-based medicine means
  integrating individual clinical expertise with
  the best available external clinical evidence
  from systematic research.
• EBM What it is and what it isnt. Br Med J
  1996 31271-72

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EBM What it is

• Evidence-Based Medicine is the conscientious,
  explicit, and judicious use of current best
  evidence in making decisions about the care of
  individual patients.
• Practice of evidence-based medicine means
  integrating individual clinical expertise with
  the best available external clinical evidence
  from systematic research.
• EBM What it is and what it isnt. Br Med J
  1996 31271-72

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Problems in the Evidence of EBM

• Major Constraints in Best Available Evidence to
  Help Care for Individual Patients
• Implying that a Specific Collection of Evidence
  is the Best Available Sets Stage for Abuses by
  Guideline Makers and Health Systems
• EBM Places Excess Emphasis on Gathering RCTs and
  Doing Meta-analyses
• EBM Advocates De-emphasize Soft Data
• Feinstein, Am J Med 1997 103529-35

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Is Life Too Short For EBM?

• YES!
• Excessively Emphasizes Biomedical Model of
  Decision-Making
• Insufficient to Explain All that Occurs in a
  Doctor-Patient Relationship
• Editorial, Internal Medicine News, 10/98

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Is Life Too Short For EBM?

• NO!
• Its Empowering
• Its a Challenging Form of Self-Directed Learning
  
• Its Fun
• Editorial, Internal Medicine News 10/98

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Perhaps EBM is a Concept or Paradigm with an
Imperfect Label

• Consider the Perspectives of the 3 Blind Men
  Encountering the Elephant of Individualized
  Clinical Decision Making
• Theres No Better Name at Present
• So we should just get on with our work of
  seeking to integrate external evidence with our
  other professional tools

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EBM Attempts to

• Inspire Us to Conscientiously Pursue Best
  Available Evidence
• Help Us Explicitly Acknowledge the Strengths
  Limitations of Evidence that Influence Our
  Decisions
• Motivate Us to Tackle the Difficult Judgements
  for Individual Patients that We Must Make
• Empower Us to Keep Up-to-Date and Maintain Our
  Autonomy

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Much Work Still to Do

• EBM is Still in its Infancy
• EBM is Not a Panacea

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Much Work Still to Do

• EBM is Still in its Infancy
• EBM is Not a Panacea
• But the process of EBM is quite appealing on
  multiple levels

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Evidence-Based Health Care
Best External Evidence
Patient Preferences
Flexible Management Strategies
Establishing Effective Physician-Patient Communica
tion
Patients Clinical Problems
Co-Morbidities
Social Support
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Is Evidence-Based Practice Advantageous for
Healthcare Systems?

• Implementation of Clinical Practice Guidelines
• Systematic Review of CPGs (n13) Did Not Improve
  Patient Outcomes in Primary Care
• Worrall, CMAJ 1997 1561705-12
• Nonrandomized Multicenter Intervention Study of
  CPGs for Hip/Knee Surgery Can Decrease L.O.S.
• Weingarten, Am J Med 1998 10533-40

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Is Evidence-Based Practice Advantageous for
Healthcare Systems?

• Implementation of Disease Management
• Emergence of Evidence-Based Disease Management
  Lingo Cites a Few Cost Triumphs
• Ellrodt, JAMA 1997 2781687-92
• Recently Implemented Disease Management Model for
  Pediatric Asthma in Atlanta
• Richman, Pediatric Annals 1998 27563-8

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Assessing the Impact of CQI on Practice

• Systematic Review of Literature (1991-97)
• Settings Inpatient (44) gt Outpatient (11)
• Single-Site (42) gt Multi-Site (13)
• Problems Addressed
• Misuse (30) gt Overuse (15) gt Underuse
• Study Design
• Pre/post Observation (52) most pos.
• Randomized Trial (3) all neg.
• Shortell, Milbank Quarterly 1998 76593-624

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EBM as Added Value forYour Clinicians

• Provide Them with Capacity for Just-in-Time
  Informatics
• Cultivate the EBM Skills of Local Opinion Leaders
• Focus clear clinical questions
• Efficiently search for evidence
• Critically appraise evidence
• Make judgements about applicability
• When Ready to Launch CQI, Consider Choosing an
  Issue that Addresses a Problem of Underuse
• Gain credibility for the process
• Avoid perception of only a cost-control activity

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• Where is the wisdom we have lost in knowledge,
  and where is the knowledge we have lost in
  information.
• T S Eliot

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EBM Will It Really Ever Matter?