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Evidence Based Medicine and Clinical Trials of Amiodarone IV Sponsored by DocMD.com
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Step 1: gather the evidence Step 1: gather the evidence - Credible sources - Predetermined criteria (e.g., human studies only, etc.) Step 2: assess quality of evidence 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 Step 3: determine the class recommendation - class I, IIa, IIb, III, indeterminate AHA Evidence-based Guidelines
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Evidence Level 1: large randomized clinical trials Level 1: large randomized clinical trials Level 2: smaller randomized clinical trials Level 2: smaller randomized clinical trials Level 3: prospective, controlled, nonrandomized cohort studies Level 3: prospective, controlled, nonrandomized cohort studies Level 4: historic, nonrandomized cohort or case-control studies Level 4: historic, nonrandomized cohort or case-control studies Level 5: case series, no control group Level 5: case series, no control group Level 6: animal or mechanical model Level 6: animal or mechanical model Level 7: extrapolations from existing data; theoretical analyses Level 7: extrapolations from existing data; theoretical analyses Level 8: rational conjecture (common sense); common practice Level 8: rational conjecture (common sense); common practice Linking AHA Evidence-based Guidelines to ACLS Treatment Recommendations Quality Excellent Excellent Good Good Fair Fair Poor PoorRecommendation Class I: definite, excellent level 1 evidence Class I: definite, excellent level 1 evidence Class II: acceptable and useful; no harm Class II: acceptable and useful; no harm Class II a: good supportive Class II a: good supportive evidence evidence Class II b: fair supportive Class II b: fair supportive evidence evidence Class III: not acceptable; may be harmful Class III: not acceptable; may be harmful Indeterminate: insufficient data Indeterminate: insufficient data
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Lidocaine in VF/VT Cardiac Arrest Evidence Analysis Lazzara ’73, ’78 Borer ’76 Spear ’72 Harrison ’63 (12) MI Trials (Lie ’74) Herlitz ’97 (1360) Carden ’56 (23) Current Practice Haynes ’81 (146) Olson ’84 (108) Harrison ’81 (116) VanWalraven ’98 (773) Weaver ’90 (199) Redding ’68 (105) Vachiery ’90 (18) Chow ’86 Anastasiou ’94 (16) Babbs ’79 Echt ’89 Dorian ’86 Kerber ’86 Sadowski ’99 (903) MI Metanalyses ExcellentGoodFair Kudenchuk; AHA National Meeting, Dallas, TX, Feb. 3 2000 Quality Quality 1 2 3 4 5 6 7 8 Level of Evidence ExcellentGoodFair 1 2 3 4 5 6 7 8 Level of Evidence Alexander ’99 (43704) Supportive Neutral/Opposing
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Supportive One “fair” level 4 One “fair” level 4 One “fair” level 6 One “fair” level 6 Numerous “fair” level 7 Numerous “fair” level 7 Lidocaine in VF/VT Cardiac Arrest Neutral/Opposing One “excellent” level 2 One “excellent” level 2 One “good” level 2 One “good” level 2 One “fair” level 3 One “fair” level 3 One “good” level 6 One “good” level 6 One “fair” level 8 One “fair” level 8 Two “good” level 4 Two “good” level 4 Seven “good” level 6 Seven “good” level 6 Two “good” recent level 7 Two “good” recent level 7
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I.V. Amiodarone in VF/VT Cardiac Arrest Evidence Analysis ExcellentGoodFair Kudenchuk; AHA National Meeting, Dallas, TX, Feb. 3 2000 Quality Quality 1 2 3 4 5 6 7 8 Level of Evidence ExcellentGoodFair 1 2 3 4 5 6 7 8 Level of Evidence Nalos ’91 (22) Schutzenberger ’89 (26) Helmy ’88 (46) Horowitz (5) Morady (15) Saksena (9) Klein (13) Drexler (14) Ochl (22) Mooss (35) Zhou ’98 (24) Kudenchuk ’99 (504) Anastasiou’94 (16) Fain ’87 (12) Levine ’96 (273) Scheinman ’95 (342) Kentsch ’89 (20) Kowey ’98 (228) Rosalion ’91 (23) Supportive Neutral/Opposing
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Supportive One “excellent” level 1 One “excellent” level 1 Two “good” level 2 Two “good” level 2 Numerous “fair” level 5 Numerous “fair” level 5 Two “good” level 6 Two “good” level 6 One “good” level 7 One “good” level 7 I.V. Amiodarone in VF/VT Cardiac Arrest Neutral/Opposing Two”good” level 2 Two”good” level 2 One “excellent” level 7 One “excellent” level 7
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