Statistical methods for continuous outcomes in partially clustered designs

ABSTRACT

We address statistical issues involved in the partially clustered design where clusters are only employed in the intervention arm, but not in the control arm. We develop a cluster adjusted t-test to compare group treatment effects with individual treatment effects for continuous outcomes in which the individual level data are used as the unit of the analysis in both arms, we develop an approach for determining sample sizes using this cluster adjusted t-test, and use simulation to demonstrate the consistent accuracy of the proposed cluster adjusted t-test and power estimation procedures. Two real examples illustrate how to use the proposed methods.

KEYWORDS:

• Behavioral clinical trials
• cluster adjusted t-test
• intraclass correlation
• partially clustered design
• sample size.

MATHEMATICS SUBJECT CLASSIFICATION:

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