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Prehospital Evidence-Based Guidelines

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Title: Prehospital Evidence-Based Guidelines


1
Prehospital Evidence-Based Guidelines
  • Daniel Spaite, MD
  • Professor of Emergency Medicine
  • The University of Arizona

2
History and Development of EBM
  • Historical assumption
  • Medical education, CME, experience, and
    interaction with colleagues are adequate to lead
    to good clinical decisions

3
Early 1970s Three findings destroyed the
assumption
  • 1. Documentation of wide variation in practice
    patterns (Wennberg, 1973)
  • Dramatic procedural variation (RAND)
  • 2. Most medical practice was founded on
    tradition/experience rather than evidence.
  • Cochrane-1972 Many standards of care were found
    to be ineffective, or even dangerous.
  • IOM Report-1985 Estimate Only 15 of medical
    practices based upon solid evidence.

4
Early 1970s Three findings destroyed the
assumption
  • 3. Enormous lag-time from new research findings
    to practice.
  • Dutton-1988 Worse than the Disease Pitfalls
    of Medical Progress.

5
The ever widening gap
  • gt 100 new articles related to EM/day (Medline)

Scientific knowledge (bench)
2008
Practice of Medicine (bedside)
1925
6
TERMINOLOGY A decade into the movement
  • Evidence-Based Guidelines
  • 1990 (Eddy JAMA263 1265)
  • Evidence-Based Medicine
  • 1991 (Guyatt ACP Journal Club, No. 2 A-16).

7
Translating New Knowledge to Patient Care
  • Eddys categorization for EBM
  • Evidence-Based Individual Decision-making (EBID)
  • Brings current knowledge to the bedside in
    real-time.
  • DIRECT use of evidence to impact the care of an
    INDIVIDUAL patient.
  • Evidence-Based Guidelines (EBG)
  • Policies and standards that help guide clinical
    decision-making based upon bring state-of-the-art
    knowledge.
  • INDIRECT use of evidence to change policy,
    practice patterns, regulations, insurance
    coverage, etc.

8
EBID and EBG
  • BOTH are conceptually based upon a hierarchy of
    evidence quality
  • University of Arizona EM EBID ?

9
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10
General Grades of Evidence
  • A
  • B
  • C
  • D

11
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12
EBID
  • Will this EVER be used in prehospital care???
  • Currently not feasible Technical/time
    constraints
  • Physician surrogates Medical decision-making???

13
EBG Around a Long Time
  • Traditional methods
  • Global subjective judgment
  • Preference-based
  • Consensus-based
  • Opinion-based
  • Traditional methods often wrong
  • 1916 Once a C-sectionalways a C-section

14
EBG The Age of Evidence-Based Methods
  • During the 80s, huge advances
  • By the late 90s
  • it is widely accepted that guidelines should be
    based on evidence and the only acceptable use of
    consensus-based methods is when there is
    insufficient evidence to support an
    evidence-based approach. (Eddy)
  • Whats it gonna take in EMS???

15
THE MAGNITUDE OF THE CHALLENGE
  • An overview of the road thats ahead of us

16
Necessary Steps for TRULY Evidence-Based
Guidelines
  • STEP 1 Critical evaluation of the literature
  • EVERY potential clinical condition
  • Comprehensive, systematic literature review.
  • UNC Evidence-based Practice Center (EPC) (Lohr
    Intl J Qual Health Care 2004169-18)
  • 121 different approaches for rating individual
    study quality.
  • Only 19 met standards for proper assessments

17
Necessary Steps
  • STEP 2 Critical evaluation of the CUMMULATIVE
    evidence
  • Must evaluate the quality of the BODY of evidence
  • This is more difficult than rating a single
    investigation.
  • Assess the consistency and heterogeneity of study
    designs
  • Assess the comparability of the Risk Adjustment
    among the studies
  • Weight each study
  • Study size, methodology, quality
  • UNC-EPC (Lohr 2004)
  • 40 methods for rating the strength of a body of
    evidence.
  • 8 met standards for proper assessments

18
Necessary Steps
  • STEP 3 Critical evaluation of the CHAINS of
    evidence
  • RARE to find a body of knowledge that writes the
    guideline for you.
  • Requires explicit cognitive steps that translates
    DIRECT evidence into guideline through
    INFERENCES.
  • Example Animal studies ? Human studies ?
    Guideline applied across a broad population in
    potentially dramatically different settings.
  • Inevitably requires judgment, inference, and
    opinion

19
Necessary Steps
  • STEP 4 Critical evaluation of the PREHOSPITAL
    implications of the body of evidence
  • Strong evidence for EFFICACY of an intervention
    does not mean that it will be EFFECTIVE in the
    field.
  • Lack of prehospital studies must be taken into
    account even with strong positive evidence in
    other settings.
  • Medicine-Based Evidence A Prerequisite for
    Evidence-based Medicine. (Knottnerus
    BMJ3151997)
  • The Real World ? EFFICACY vs. EFFECTIVENESS

20
Necessary Steps
  • STEP 5 Critical evaluation of other pertinent
    issues
  • Systems-related factors. Effectiveness may vary
    with
  • Rural vs. urban settings
  • Demography
  • e.g. Is a separate pediatric guideline needed?
  • Operations (e.g. response/transport intervals)
  • Patient populations
  • e.g. Cost-effectiveness varies with prevalence
  • Socioeconomics At-risk populations
  • Impact of delaying an intervention Does it have
    to be done?
  • Extremes are easy Cardiac arrest Tinea pedis
  • Urgentbut not emergent interventions

21
Necessary Steps
  • STEP 5 (Continued) Critical evaluation of
    other pertinent issues
  • Risk for harm
  • Cost
  • Feasibility and practicality
  • Value-judgments Individual, religious, cultural
    variation
  • Example Life vs. profound morbidity
  • Confidence of benefit vs. magnitude of benefit
  • Confidence of benefit vs. significance of benefit
  • Related specialty-based guidelines if they exist
    (AHA CPR/ACLS)
  • Evaluation of current guidelines/protocols
  • This alone is an enormous undertaking

22
Necessary Steps
  • STEP 6 Evaluation of whether a guideline is
    appropriate at all
  • What if all evidence is WEAK?
  • When should a stand be taken that clearly states
    that insufficient evidence existsand that a
    guideline is inappropriate?
  • What if there are already LOTS of guidelines out
    there?
  • Are there commonly used interventions that should
    be trashed and NOT recommended for use in EMS?
  • If CONSENSUS is the basis for a guideline, how is
    this distinguishable from EVIDENCE-based
    guidelines?
  • What are the implications of having these
    guidelines LOOK equally authoritative when they
    make it to the street?

23
Necessary Steps
  • STEP 7 Plan for recurrent, future evaluations
    of evidence and revisions of the guidelines
  • If theres a lack of commitment to future changes
    based upon new evidenceis it best not to start
    in the first place?
  • Guidelines are NOT harmless!!!
  • Guidelines hang around a LONG time!!!
  • Example
  • Diethylstilbestrol (DES)
  • 1938 1971 Recommended by expert consensus
    guideline to prevent miscarriage
  • 4.8 million pregnant women received it
  • 1971 FDA halted its use No statistical benefit
    but significant harm (vaginal cancer, breast
    cancer, etc.)

24
HUGE QUESTIONS
  • Are we SURE we mean EVIDENCE-based
    guidelinesORdo we REALLY mean CONSENSUS-based
    guidelines???
  • Will protocols be developed and supported where
    the only evidence is opinion and theory?

25
Steering Committees Consensus
  • A high threshold for requiring solid evidence
    for a guideline to be recommended.
  • When in doubt, err on the side of requiring
    strong evidence before propagating guidelines.
  • The HOT topic
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