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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.

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