Sample size and power calculations for open cohort longitudinal cluster randomized trials

Statistics in Medicine
Jessica KaszaAndrew B Forbes

Abstract

When calculating sample size or power for stepped wedge or other types of longitudinal cluster randomized trials, it is critical that the planned sampling structure be accurately specified. One common assumption is that participants will provide measurements in each trial period, that is, a closed cohort, and another is that each participant provides only one measurement during the course of the trial. However some studies have an "open cohort" sampling structure, where participants may provide measurements in variable numbers of periods. To date, sample size calculations for longitudinal cluster randomized trials have not accommodated open cohorts. Feldman and McKinlay (1994) provided some guidance, stating that the participant-level autocorrelation could be varied to account for the degree of overlap in different periods of the study, but did not indicate precisely how to do so. We present sample size and power formulas that allow for open cohorts and discuss the impact of the degree of "openness" on sample size and power. We consider designs where the number of participants in each cluster will be maintained throughout the trial, but individual participants may provide differing numbers of measurements. Our results are a uni...Continue Reading

References

Jul 11, 2006·Contemporary Clinical Trials·Michael A Hussey, James P Hughes
Jun 29, 2016·Statistics in Medicine·Richard HooperSandra Eldridge
Aug 9, 2017·Statistics in Medicine·J N S Matthews, A B Forbes
Nov 21, 2018·Journal of Clinical Epidemiology·Felizitas A EichnerKatrien Oude Rengerink
Jan 22, 2019·Statistics in Medicine·Kelsey L GranthamAndrew B Forbes
Jul 6, 2019·Journal of Clinical Epidemiology·Richard Hooper, Andrew Copas

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Citations

Jun 6, 2021·Clinical Trials : Journal of the Society for Clinical Trials·Elizabeth KorevaarAndrew B Forbes

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