Simple sample size calculation for cluster-randomized trials

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Simple sample size calculation for cluster-randomized trials.

BACKGROUND Cluster-randomized trials, in which health interventions are allocated randomly to intact clusters or communities rather than to individual subjects, are increasingly being used to evaluate disease control strategies both in industrialized and in developing countries. Sample size computations for such trials need to take into account between-cluster variation, but field epidemiologis...

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Methods for sample size determination in cluster randomized trials

BACKGROUND The use of cluster randomized trials (CRTs) is increasing, along with the variety in their design and analysis. The simplest approach for their sample size calculation is to calculate the sample size assuming individual randomization and inflate this by a design effect to account for randomization by cluster. The assumptions of a simple design effect may not always be met; alternativ...

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Most informed consent documents for randomized controlled trials implicitly or explicitly promise the prospective participant that the trial has a reasonable chance of answering a medically important question. The medical literature, however, is replete with descriptions of trials that provided equivocal answers to the questions they addressed. Papers describing the results of such studies may ...

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Sample size and robust marginal methods for cluster-randomized trials with censored event times.

In cluster-randomized trials, intervention effects are often formulated by specifying marginal models, fitting them under a working independence assumption, and using robust variance estimates to address the association in the responses within clusters. We develop sample size criteria within this framework, with analyses based on semiparametric Cox regression models fitted with event times subj...

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ژورنال

عنوان ژورنال: International Journal of Epidemiology

سال: 1999

ISSN: 0300-5771,1464-3685

DOI: 10.1093/ije/28.2.319