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

Elizabeth L. Turner, Pablo Perel, Tim Clayton, Phil Edwards, Adrian V. Hernández, Ian Roberts, Haleema Shakur, Ewout W. Steyerberg

Resultado de la investigación: Contribución a una revistaArtículorevisión exhaustiva

33 Citas (Scopus)


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.

Idioma originalInglés
Páginas (desde-hasta)474-481
Número de páginas8
PublicaciónJournal of Clinical Epidemiology
EstadoPublicada - may 2012
Publicado de forma externa


Profundice en los temas de investigación de 'Covariate adjustment increased power in randomized controlled trials: An example in traumatic brain injury'. En conjunto forman una huella única.

Citar esto