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Evidence Based Medicine and Clinical Trials of Amiodarone IV
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  1. Evidence Based Medicine and Clinical Trials of Amiodarone IV Sponsored by DocMD.com

  2. AHA Evidence-based Guidelines • Step 1: gather the evidence • Credible sources • Predetermined criteria (e.g., human studies only, etc.) • Step 2: assess quality of evidence • Power of methodology (level 1-8) • Execution of methodology (excellent, good, fair, poor) • Critical review • Step 3: determine the class recommendation • class I, IIa, IIb, III, indeterminate

  3. Linking AHA Evidence-based Guidelines to ACLS Treatment Recommendations Quality • Excellent • Good • Fair • Poor Recommendation • Class I: definite, excellent level 1 evidence • Class II: acceptable and useful; no harm Class II a: good supportive evidence Class II b: fair supportive evidence • Class III: not acceptable; may be harmful • Indeterminate: insufficient data Evidence • Level 1: large randomized clinical trials • Level 2: smaller randomized clinical trials • Level 3: prospective, controlled, nonrandomized cohort studies • Level 4: historic, nonrandomized cohort or case-control studies • Level 5: case series, no control group • Level 6: animal or mechanical model • Level 7: extrapolations from existing data; theoretical analyses • Level 8: rational conjecture (common sense); common practice

  4. Level of Evidence Level of Evidence 1 2 3 4 5 6 7 8 1 2 3 4 5 6 7 8 Lidocaine in VF/VT Cardiac Arrest Evidence Analysis Excellent Good Fair Supportive Lazzara ’73, ’78Borer ’76Spear ’72Harrison ’63 (12) MI Trials (Lie ’74) Carden ’56 (23) Current Practice Herlitz ’97 (1360) Quality Redding ’68 (105)Vachiery ’90 (18)Chow ’86Anastasiou ’94 (16)Babbs ’79Echt ’89Dorian ’86Kerber ’86 Excellent Good Fair Neutral/Opposing Haynes ’81 (146) VanWalraven ’98 (773) Weaver ’90 (199) Sadowski ’99 (903) MI Metanalyses Olson ’84 (108) Harrison’81 (116) Alexander ’99 (43704) Quality Kudenchuk; AHA National Meeting, Dallas, TX, Feb. 3 2000

  5. Lidocaine in VF/VT Cardiac Arrest Supportive • One “fair” level 4 • One “fair” level 6 • Numerous “fair” level 7 Neutral/Opposing • One “excellent” level 2 • One “good” level 2 • One “fair” level 3 • One “good” level 6 • One “fair” level 8 • Two “good” level 4 • Seven “good” level 6 • Two “good” recent level 7

  6. Level of Evidence Level of Evidence 1 2 3 4 5 6 7 8 1 2 3 4 5 6 7 8 I.V. Amiodarone in VF/VT Cardiac Arrest Evidence Analysis Excellent Good Fair Supportive Kudenchuk ’99 (504) Nalos ’91 (22)Schutzenberger ’89 (26)Helmy ’88 (46)Horowitz (5)Morady (15) Saksena (9)Klein (13)Drexler (14)Ochl (22)Mooss (35) Anastasiou’94 (16)Fain ’87 (12) Kentsch ’89 (20)Kowey ’98 (228) Rosalion ’91 (23) Quality Excellent Good Fair Neutral/Opposing Zhou ’98 (24) Levine ’96 (273)Scheinman ’95 (342) Quality Kudenchuk; AHA National Meeting, Dallas, TX, Feb. 3 2000

  7. I.V. Amiodarone in VF/VT Cardiac Arrest Neutral/Opposing • Two”good” level 2 • One “excellent” level 7 Supportive • One “excellent” level 1 • Two “good” level 2 • Numerous “fair” level 5 • Two “good” level 6 • One “good” level 7