Format

Send to

Choose Destination
Am J Public Health. 2004 Mar;94(3):416-22.

Pitfalls of and controversies in cluster randomization trials.

Author information

1
Department of Epidemiology and Biostatistics, University of Western Ontario, London, Canada. donner@biostats.uwo.ca

Abstract

It is now well known that standard statistical procedures become invalidated when applied to cluster randomized trials in which the unit of inference is the individual. A resulting consequence is that researchers conducting such trials are faced with a multitude of design choices, including selection of the primary unit of inference, the degree to which clusters should be matched or stratified by prognostic factors at baseline, and decisions related to cluster subsampling. Moreover, application of ethical principles developed for individually randomized trials may also require modification. We discuss several topics related to these issues, with emphasis on the choices that must be made in the planning stages of a trial and on some potential pitfalls to be avoided.

PMID:
14998805
PMCID:
PMC1448267
DOI:
10.2105/ajph.94.3.416
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Atypon Icon for PubMed Central
Loading ...
Support Center