Brain injury clinical trials: New agents or new statistics?

Abstract

Failure of the vast majority of clinical trials evaluating recovery after severe brain injury from stroke or trauma has triggered interest in novel statistical techniques that are more powerful than conventional dichotomized outcomes. A retrospective analysis of data from a large international trial evaluating high-dose steroids for severe traumatic brain injury found that analysis of a wide range of outcome levels by using an ordinal scale with proportional odds regression or a sliding dichotomy was more likely to detect a treatment effect than the single-dichotomy approach. These techniques may soon become commonplace as critical care research increasingly focuses on patient-centered functional outcomes. © 2011 BioMed Central Ltd.