Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review

摘要

STUDY QUESTION Are composite outcomes, which have combined several components into a single measure, appropriately defined, reported, and interpreted? SUMMARY ANSWER No. The use of composite outcomes in clinical trials is highly problematic, with components often unreasonably combined, inconsistently defined, and inadequately reported. WHAT IS KNOWN AND WHATTHIS PAPER ADDS Composite outcomes in clinical trials are theoretically attractive, as they reduce sample size requirement costs, and time. However, they should generally be avoided, as their use leads to much confusion and bias.