An analysis of randomized controlled trials underpinning ST-elevation myocardial infarction management guidelines.
Practice guideline
Randomized controlled trials
Research methodology
ST-elevation myocardial infarction
STEMI
Statistics
Journal
The American journal of emergency medicine
ISSN: 1532-8171
Titre abrégé: Am J Emerg Med
Pays: United States
ID NLM: 8309942
Informations de publication
Date de publication:
12 2019
12 2019
Historique:
received:
31
01
2019
revised:
23
03
2019
accepted:
25
03
2019
pubmed:
4
4
2019
medline:
14
4
2020
entrez:
4
4
2019
Statut:
ppublish
Résumé
The fragility index (FI) is calculated by iteratively changing one outcome "event" to a "non-event" within a trial until the associated p-value exceeds 0.05. To investigate the FI and fragility quotient (FQ) of trial endpoints referenced in the ACCF/AHA/SCAI guidelines in the management of ST-elevation myocardial infarctions. Secondarily, we assess the post-hoc power and risk of bias for these specific outcomes and whether differences exist between adequately and inadequately powered studies on fragility measures. All citations referenced in the guideline were screened for inclusion criteria. The FI and FQ for all included trials were then calculated. The Cochrane 'risk of bias' Tool 2.0 was used to evaluate the likelihood and sources of bias in the included trials. Forty-two randomized controlled trials were included for assessment. The median FI was 10 with a FQ of 0.0055. Seven trials were at a high risk of bias, all due to bias in the randomization process. Fifteen trials were found to be underpowered. Adequately powered studies had higher FIs and FQs compared to underpowered studies. Our findings support the use of FI and FQ analyses with power analyses in future methodology of randomized control trials. With understanding and reporting of FI and FQ, evidence of studies can be readily available and quickly eliminate some readers' concern for possible study limitations.
Sections du résumé
BACKGROUND
The fragility index (FI) is calculated by iteratively changing one outcome "event" to a "non-event" within a trial until the associated p-value exceeds 0.05.
PURPOSE
To investigate the FI and fragility quotient (FQ) of trial endpoints referenced in the ACCF/AHA/SCAI guidelines in the management of ST-elevation myocardial infarctions. Secondarily, we assess the post-hoc power and risk of bias for these specific outcomes and whether differences exist between adequately and inadequately powered studies on fragility measures.
BASIC PROCEDURES
All citations referenced in the guideline were screened for inclusion criteria. The FI and FQ for all included trials were then calculated. The Cochrane 'risk of bias' Tool 2.0 was used to evaluate the likelihood and sources of bias in the included trials.
MAIN FINDINGS
Forty-two randomized controlled trials were included for assessment. The median FI was 10 with a FQ of 0.0055. Seven trials were at a high risk of bias, all due to bias in the randomization process. Fifteen trials were found to be underpowered. Adequately powered studies had higher FIs and FQs compared to underpowered studies.
PRINCIPAL CONCLUSIONS
Our findings support the use of FI and FQ analyses with power analyses in future methodology of randomized control trials. With understanding and reporting of FI and FQ, evidence of studies can be readily available and quickly eliminate some readers' concern for possible study limitations.
Identifiants
pubmed: 30940409
pii: S0735-6757(19)30188-3
doi: 10.1016/j.ajem.2019.03.038
pii:
doi:
Types de publication
Journal Article
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
2229-2238Informations de copyright
Copyright © 2019 Elsevier Inc. All rights reserved.