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

ABSTRACT:

Objective

To study how composite outcomes, which have combined several components into a single measure, are defined, reported, and interpreted.

Design

Systematic review of parallel group randomised clinical trials published in 2008 reporting a binary composite outcome. Two independent observers extracted the data using a standardised data sheet, and two other observers, blinded to the results, selected the most important component.

Results

Of 40 included trials, 29 (73%) were about cardiovascular topics and 24 (60%) were entirely or partly industry funded. Composite outcomes had a median of three components (range 2-9). Death or cardiovascular death was the most important component in 33 trials (83%). Only one trial provided a good rationale for the choice of compone

SUBMITTER: Cordoba G 

PROVIDER: S-EPMC2923692 | biostudies-literature | 2010 Aug

REPOSITORIES: biostudies-literature