Composite outcomes that combine a number of individual outcomes (such as types of
morbidity) are frequently used as primary outcomes in obstetrical trials. The main
argument for their use is to ensure that trials can answer important clinical questions
in a timely fashion, without needing huge sample sizes. Arguments against their use
are that composite outcomes may be difficult to use and interpret, leading to errors
in sample size estimation, possible contradictory trial results, and difficulty in
interpreting findings. Such problems may reduce the credibility of the research, and
may impact on the implementation of findings. Composite outcomes are an attractive
solution to help to overcome the problem of limited available resources for clinical
trials. However, future studies should carefully consider both the advantages and
disadvantages before using composite outcomes. Rigorous development and reporting
of composite outcomes is essential if the research is to be useful.
Key words
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Article Info
Publication History
Accepted:
October 25,
2006
Received in revised form:
August 9,
2006
Received:
May 31,
2006
Footnotes
Reprints not available from the authors.
Cite this article as: Ross S. Composite outcomes in randomized clinical trials: arguments for and against. Am J Obstet Gynecol 2007;196:119.e1-119.e6.
Identification
Copyright
© 2007 Mosby, Inc. Published by Elsevier Inc. All rights reserved.
