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The ANNALS of the American Academy of Political and Social Science
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Cluster Randomized Trials of Professional and Organizational Behavior Change Interventions in Health Care Settings

Jeremy Grimshaw

Clinical Epidemiology Program of the Ottawa Health Research Institute; Department of Medicine, University of Ottawa

Martin Eccles

Centre for Health Services Research, School of Population and Health Sciences, University of Newcastle upon Tyne, United Kingdom

Marion Campbell

University of Aberdeen

Diana Elbourne

healthcare evaluation in the Medical Statistics Unit of the London School of Hygiene and Tropical Medicine; EPPI Centre, which is part of the Social Science Research Unit in the Institute of Education, University of London

Individual patient randomized trials are the gold standard for assessing the effects of health care evaluations. However, individual randomization may not be possible for practical, logistical, ethical, or political reasons, for example, when evaluating health care professional and organizational behavior change interventions. Under such circumstances, cluster randomized trials are commonly used. This article discusses the practical and ethical issues in the design, conduct, and analysis of cluster randomized trials of professional behavior and organizational change strategies using examples from two primary studies evaluating health care provider behavior change strategies. Cluster randomized trials are commonly used in health care. They raise distinct ethical and methodological issues that have rarely been adequately addressed in studies to date.

Key Words: cluster randomized trials • implementation research • interventions • dissemination and implementation interventions • COmputerised Guidelines Evaluation in the NorTh of England (COGENT)

The ANNALS of the American Academy of Political and Social Science, Vol. 599, No. 1, 71-93 (2005)
DOI: 10.1177/0002716205274576
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