Covariate adjustment increased power in randomized controlled trials: an example in traumatic brain injury.

Elizabeth L Turner; Pablo Perel ORCID logo; Tim Clayton ORCID logo; Phil Edwards ORCID logo; Adrian V Hernández; Ian Roberts ORCID logo; Haleema Shakur ORCID logo; Ewout W Steyerberg; CRASH trial collaborators; (2012) Covariate adjustment increased power in randomized controlled trials: an example in traumatic brain injury. Journal of clinical epidemiology, 65 (5). pp. 474-481. ISSN 0895-4356 DOI: 10.1016/j.jclinepi.2011.08.012
Copy

OBJECTIVE: We aimed to determine to what extent covariate adjustment could affect power in a randomized controlled trial (RCT) of a heterogeneous population with traumatic brain injury (TBI). STUDY DESIGN AND SETTING: We analyzed 14-day mortality in 9,497 participants in the Corticosteroid Randomization After Significant Head Injury (CRASH) RCT of corticosteroid vs. placebo. Adjustment was made using logistic regression for baseline covariates of two validated risk models derived from external data (International Mission on Prognosis and Analysis of Clinical Trials in Traumatic Brain Injury [IMPACT]) and from the CRASH data. The relative sample size (RESS) measure, defined as the ratio of the sample size required by an adjusted analysis to attain the same power as the unadjusted reference analysis, was used to assess the impact of adjustment. RESULTS: Corticosteroid was associated with higher mortality compared with placebo (odds ratio=1.25, 95% confidence interval=1.13-1.39). RESS of 0.79 and 0.73 were obtained by adjustment using the IMPACT and CRASH models, respectively, which, for example, implies an increase from 80% to 88% and 91% power, respectively. CONCLUSION: Moderate gains in power may be obtained using covariate adjustment from logistic regression in heterogeneous conditions such as TBI. Although analyses of RCTs might consider covariate adjustment to improve power, we caution against this approach in the planning of RCTs.

Full text not available from this repository.

Atom BibTeX OpenURL ContextObject in Span Multiline CSV OpenURL ContextObject Dublin Core Dublin Core MPEG-21 DIDL EndNote HTML Citation JSON MARC (ASCII) MARC (ISO 2709) METS MODS RDF+N3 RDF+N-Triples RDF+XML RIOXX2 XML Reference Manager Refer Simple Metadata ASCII Citation EP3 XML
Export

Downloads