Should we rely on trials with disease- rather than patient-oriented endpoints?

Should I change practice on the basis of this study [ 1 ]? Which primary endpoint should I choose to compute the sample size of my trial [ 2 , 3 ]? Answering these questions requires a critical appraisal of study endpoints by both researchers and clinicians. In this report, we analyze the use of disease-oriented endpoints (such as organ dysfunction scores) in intensive care (IC) trials, and we briefly review the pitfalls of extrapolating disease-oriented endpoints to real patient benefit.