Sample size requirements to detect an intervention by time interaction in longitudinal cluster randomized clinical trials

Moonseong Heo, Andrew C. Leon

Research output: Contribution to journalArticle

40 Citations (Scopus)

Abstract

In designing a longitudinal cluster randomized clinical trial (cluster-RCT), the interventions are randomly assigned to clusters such as clinics. Subjects within the same clinic will receive the identical intervention. Each will be assessed repeatedly over the course of the study. A mixed-effects linear regression model can be applied in a cluster-RCT with three-level data to test the hypothesis that the intervention groups differ in the course of outcome over time. Using a test statistic based on maximum likelihood estimates, we derived closed-form formulae for statistical power to detect the intervention by time interaction and the sample size requirements for each level. Importantly, the sample size does not depend on correlations among second-level data units and the statistical power function depends on the number of second- and third-level data units through their product. A simulation study confirmed that theoretical power estimates based on the derived formulae are nearly identical to empirical estimates.

Original languageEnglish (US)
Pages (from-to)1017-1027
Number of pages11
JournalStatistics in Medicine
Volume28
Issue number6
DOIs
StatePublished - Mar 15 2009

Fingerprint

Randomized Clinical Trial
Sample Size
Linear Models
Randomized Controlled Trials
Likelihood Functions
Statistical Power
Requirements
Interaction
Theoretical Models
Mixed Effects
Unit
Power Function
Maximum Likelihood Estimate
Linear Regression Model
Estimate
Test Statistic
Closed-form
Simulation Study

Keywords

  • Effect size
  • Intervention by time interaction
  • Longitudinal cluster-RCT
  • Power
  • Sample size
  • Three-level data

ASJC Scopus subject areas

  • Epidemiology
  • Statistics and Probability

Cite this

Sample size requirements to detect an intervention by time interaction in longitudinal cluster randomized clinical trials. / Heo, Moonseong; Leon, Andrew C.

In: Statistics in Medicine, Vol. 28, No. 6, 15.03.2009, p. 1017-1027.

Research output: Contribution to journalArticle

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