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Prehospital Evidence-Based Guidelines

Prehospital Evidence-Based Guidelines. Daniel Spaite, MD Professor of Emergency Medicine The University of Arizona. History and Development of EBM. Historical assumption: Medical education, CME, experience, and interaction with colleagues are adequate to lead to good clinical decisions.

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Prehospital Evidence-Based Guidelines

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  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 1970’s: 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 1970’s: 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 > 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: JAMA:263; 1265) “Evidence-Based Medicine: 1991 (Guyatt: ACP Journal Club, No. 2: A-16).

  7. Translating New Knowledge to Patient Care Eddy’s 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. General Grades of Evidence A = B = C = D =

  10. EBID Will this EVER be used in prehospital care??? Currently not feasible: Technical/time constraints Physician surrogates: Medical decision-making???

  11. EBG: Around a Long Time Traditional methods: “Global subjective judgment” “Preference-based” “Consensus-based” “Opinion-based” Traditional methods often wrong: 1916: “Once a C-section…always a C-section”

  12. EBG: The Age of “Evidence-Based” Methods During the 80’s, huge advances: By the late 90’s: “…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) What’s it gonna take in EMS???

  13. THE MAGNITUDE OF THE CHALLENGE An overview of the road that’s ahead of us

  14. 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: 2004;16:9-18) 121 different approaches for rating individual study quality. Only 19 met standards for proper assessments

  15. 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

  16. 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

  17. 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: BMJ;315:1997) The “Real World”  EFFICACY vs. EFFECTIVENESS

  18. 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 Urgent…but not emergent interventions

  19. 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

  20. 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 exists…and 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?

  21. Necessary Steps STEP #7: Plan for recurrent, future evaluations of evidence and revisions of the guidelines If there’s a lack of commitment to future changes based upon new evidence…is 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 it’s use: No statistical benefit but significant harm (vaginal cancer, breast cancer, etc.)

  22. HUGE QUESTIONS Are we SURE we mean EVIDENCE-based guidelines…OR…do we REALLY mean CONSENSUS-based guidelines??? Will protocols be developed and supported where the only “evidence” is opinion and theory?

  23. Steering Committee’s “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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