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© 1990 Oxford University Press

review-article

A Methodological Review of Non-Therapeutic Intervention Trials Employing Cluster Randomization, 1979–1989

ALLAN DONNER*, K STEPHEN BROWN{dagger} and PENNY BRASHER*

*Department of Epidemiology and Biostatistics, University of Western Ontario Canada
{dagger}Department of Statistics and Actuarial Sciences, University of Waterloo Canada

A methodological review is presented of 16 non-therapeutic intervention trials published over the last decade which have randomized intact clusters rather than individuals in treatment groups. Each of the trials was surveyed as to the information supplied on six methodological criteria. Although there is increasing recongnition of the methodological issues associated with cluster randomization, many investigators are still not aware of the impact of this design on sample size requirements and analysis considerations. Investigators are urged to publish the cluster-specific event rates observed in their trials as a guide for the planning of future studies.

Received 1 June 1990


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