The effect of covariate adjustment for baseline severity in acute stroke clinical trials with responder analysis outcomes

Conclusions: Our results suggest that, under the given treatment effect scenarios, the decision whether or not to adjust for baseline severity when using a responder analysis outcome should be guided by the needs of the study, as type I error rates and power do not appear to vary largely between the methods. These findings are applicable to stroke trials which use the mRS for the primary outcome, but also provide a broader insight into the analysis of binary outcomes that are defined based on baseline prognostic variables.Trial registration: This research is part of the Stroke Hyperglycemia Insulin Network Effort (SHINE) trial, Identification Number NCT01369069.
Source: Trials - Category: Journals (General) Authors: Source Type: research