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Some aspects of the design and analysis of cluster randomization trials
Author(s) -
Donner Allan
Publication year - 1998
Publication title -
journal of the royal statistical society: series c (applied statistics)
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.205
H-Index - 72
eISSN - 1467-9876
pISSN - 0035-9254
DOI - 10.1111/1467-9876.00100
Subject(s) - psychological intervention , clinical trial , research design , clinical study design , sample size determination , cluster randomised controlled trial , randomization , cluster (spacecraft) , health care , psychology , management science , medical education , medicine , family medicine , nursing , computer science , sociology , political science , social science , engineering , pathology , statistics , mathematics , law , programming language
Trials which randomize intact social groups, or clusters, to different interventions are becoming increasingly widespread. Although statistically less efficient than trials which randomize individuals, such designs are often preferred from a practical or ethical point of view, particularly in the evaluation of health care or educational strategies. We discuss selected issues that arise in the conduct of such trials, including the choice of design, ethical implications, sample size estimation and approaches to the analysis. The discussion is closely tied to methodological issues that have arisen in a recent evaluation trial of a new antenatal care programme, as sponsored by the Special Programme of Research, Development and Research Training in Human Reproduction of the World Health Organization.