evidence based medicine and clinical trials of amiodarone iv sponsored by docmd.com
DESCRIPTION
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 dataTRANSCRIPT
Evidence Based Evidence Based Medicine and Clinical Medicine and Clinical
Trials of Amiodarone IVTrials of Amiodarone IV
Sponsored by DocMD.comSponsored by DocMD.com
• Step 1: gather the evidenceStep 1: gather the evidence- Credible sourcesCredible sources- Predetermined criteria (e.g., human studies Predetermined criteria (e.g., human studies
only, etc.)only, etc.)
• Step 2: assess quality of evidenceStep 2: assess quality of evidence- Power of methodology (level 1-8)Power of methodology (level 1-8)- Execution of methodology (excellent, good, fair, Execution of methodology (excellent, good, fair,
poor)poor)- Critical reviewCritical review
• Step 3: determine the class recommendationStep 3: determine the class recommendation- class I, IIa, IIb, III, indeterminateclass I, IIa, IIb, III, indeterminate
AHA Evidence-based AHA Evidence-based GuidelinesGuidelines
EvidenceEvidence• Level 1: large randomized Level 1: large randomized
clinical trialsclinical trials
• Level 2: smaller randomized Level 2: smaller randomized clinical trialsclinical trials
• Level 3: prospective, controlled, Level 3: prospective, controlled, nonrandomized cohort studiesnonrandomized cohort studies
• Level 4: historic, nonrandomized cohort or Level 4: historic, nonrandomized cohort or case-control studiescase-control studies
• Level 5: case series, no control groupLevel 5: case series, no control group
• Level 6: animal or mechanical modelLevel 6: animal or mechanical model
• Level 7: extrapolations from existing data; Level 7: extrapolations from existing data; theoretical analysestheoretical analyses
• Level 8: rational conjecture (common Level 8: rational conjecture (common sense); common practicesense); common practice
Linking AHA Evidence-based Guidelines Linking AHA Evidence-based Guidelines to ACLS Treatment Recommendationsto ACLS Treatment Recommendations
QualityQuality• ExcellentExcellent
• GoodGood
• FairFair
• PoorPoor
RecommendationRecommendation• Class I: definite, excellent Class I: definite, excellent
level 1 evidencelevel 1 evidence
• Class II: acceptable and Class II: acceptable and useful; no harmuseful; no harm
Class II a: good supportiveClass II a: good supportive evidenceevidence
Class II b: fair supportive Class II b: fair supportive evidenceevidence
• Class III: not acceptable; may Class III: not acceptable; may be harmfulbe harmful
• Indeterminate: insufficient Indeterminate: insufficient datadata
Lidocaine in VF/VT Cardiac Arrest Lidocaine in VF/VT Cardiac Arrest Evidence AnalysisEvidence Analysis
Lazzara ’73, ’78Borer ’76Spear ’72Harrison ’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 ’86Anastasiou ’94 (16)Babbs ’79Echt ’89Dorian ’86Kerber ’86
Sadowski ’99 (903) MI Metanalyses
ExcellentExcellent
GoodGood
FairFair
Kudenchuk; AHA National Meeting, Dallas, TX, Feb. 3 2000Kudenchuk; AHA National Meeting, Dallas, TX, Feb. 3 2000
Qu a
l ity
Qu a
l ity
Qu a
l ity
Qu a
l ity
1 1 2 2 3 3 4 4 5 5 6 6 7 7 8 8Level of EvidenceLevel of Evidence
ExcellentExcellent
GoodGood
FairFair
1 1 2 2 3 3 4 4 5 5 6 6 7 7 8 8Level of EvidenceLevel of Evidence
Alexander ’99 (43704)
Supportive
Neutral/Opposing
SupportiveSupportive
• One “fair” level 4One “fair” level 4
• One “fair” level 6One “fair” level 6
• Numerous “fair” level 7Numerous “fair” level 7
Lidocaine in VF/VT Cardiac ArrestLidocaine in VF/VT Cardiac Arrest
Neutral/Neutral/OpposingOpposing
• One “excellent” level 2One “excellent” level 2
• One “good” level 2One “good” level 2
• One “fair” level 3One “fair” level 3
• One “good” level 6One “good” level 6
• One “fair” level 8One “fair” level 8
• Two “good” level 4Two “good” level 4
• Seven “good” level 6Seven “good” level 6
• Two “good” recent level 7Two “good” recent level 7
I.V. Amiodarone in VF/VT Cardiac Arrest I.V. Amiodarone in VF/VT Cardiac Arrest Evidence AnalysisEvidence Analysis
ExcellentExcellent
GoodGood
FairFair
Kudenchuk; AHA National Meeting, Dallas, TX, Feb. 3 2000Kudenchuk; AHA National Meeting, Dallas, TX, Feb. 3 2000
Qu a
l ity
Qu a
l ity
Qu a
l ity
Qu a
l ity
1 1 2 2 3 3 4 4 5 5 6 6 7 7 8 8Level of EvidenceLevel of Evidence
ExcellentExcellent
GoodGood
FairFair
1 1 2 2 3 3 4 4 5 5 6 6 7 7 8 8Level of EvidenceLevel 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
SupportiveSupportive
• One “excellent” level 1One “excellent” level 1
• Two “good” level 2Two “good” level 2
• Numerous “fair” level 5Numerous “fair” level 5
• Two “good” level 6Two “good” level 6
• One “good” level 7One “good” level 7
I.V. Amiodarone in VF/VT Cardiac ArrestI.V. Amiodarone in VF/VT Cardiac ArrestNeutral/Neutral/OpposingOpposing
• Two”good” Two”good” level 2level 2
• One “excellent” One “excellent” level 7level 7