Adjustment for strong predictors of outcome in traumatic brain injury trials: 25% Reduction in sample size requirements in the IMPACT study

Adrian V. Hernández, Ewout W. Steyerberg, Isabella Butcher, Nino Mushkudiani, Gillian S. Taylor, Gordon D. Murray, Anthony Marmarou, Sung C. Choi, Juan Lu, J. Dik F. Habbema, Andrew I.R. Maas

Resultado de la investigación: Contribución a una revistaArtículorevisión exhaustiva

49 Citas (Scopus)

Resumen

The aim of this study was to quantify the potential reduction in sample size that can be achieved by adjustment for predictors of outcome in traumatic brain injury (TBI) trials. We used individual patient data from seven therapeutic phase III randomized clinical trials (RCTs; n = 6166) in moderate or severe TBI, and three TBI surveys (n = 2238). The primary outcome was the dichotomized Glasgow Outcome Scale at 6 months (favorable/unfavorable). Baseline predictors of outcome considered were age, motor score, pupillary reactivity, computed tomography (CT) classification, traumatic subarachnoid hemorrhage, hyposia, hypotension, glycemia, and hemoglobin. We calculated the potential sample size reduction obtained by adjustment of a hypothetical treatment effect for one to seven predictors with logistic regression models. The distribution of predictors was more heterogeneous in surveys than in trials. Adjustment of the treatment effect for the strongest predictors (age, motor score, and pupillary reactivity) yielded a reduction in sample size of 16-23% in RCTs and 28-35% in surveys. Adjustment for seven predictors yielded a reduction of about 25% in most studies: 20-28% in RCTs and 32-39% in surveys. A major reduction in sample size can be obtained with covariate adjustment In TBI trials. Covariate adjustment for strong predictors should be incorporated in the analysis of future TBI trials.

Idioma originalInglés
Páginas (desde-hasta)1295-1303
Número de páginas9
PublicaciónJournal of Neurotrauma
Volumen23
N.º9
DOI
EstadoPublicada - sep 2006
Publicado de forma externa

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