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The ANNALS of the American Academy of Political and Social Science, Vol. 599, No. 1, 94-114 (2005)
DOI: 10.1177/0002716205274742

Cluster Randomized Trials for the Evaluation of Strategies Designed to Promote Evidence-Based Practice in Perinatal and Neonatal Medicine

Laura C. Leviton

faculty of the University of Pittsburgh School of Public Health

Jeffrey D. Horbar

University of Vermont, College of Medicine

This article makes a case for cluster-randomized trials to encourage evidence-based practice in medical care. The case rests on theoretical, empirical, and methodological grounds. To illustrate, we describe two recent studies. The first trial, with participation by 27 tertiary care hospitals, concerned methods to encourage a relatively simple, low-cost therapy for women in premature labor. A significant effect was seen in intervention hospitals on the primary outcome variable: increase in the proportion of eligible patients receiving antenatal corticosteroid therapy. The second trial, with participation by 114 neonatal intensive care units, aimed to close the gap between evidence and practice in the use of early and prophylactic surfactant therapy for premature infants. It achieved one of the largest effects seen in the literature on changing medical care practices. Using the two illustrations, the authors discuss some of the theoretical, methodological, and practical issues when using cluster randomized designs in this field of inquiry.

Key Words: cluster randomized trials • evidence-based practice • antenatal • neonatal • therapeutic interventions • multilevel analysis


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