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Sample size calculation for cluster randomization trials with a time-to-event endpoint.

Publication ,  Journal Article
Li, J; Jung, S-H
Published in: Stat Med
November 10, 2020

Cluster randomization trials randomize groups (called clusters) of subjects (called subunits) between intervention arms, and observations are collected from each subject. In this case, subunits within each cluster share common frailties, so that the observations from subunits of each cluster tend to be correlated. Oftentimes, the outcome of a cluster randomization trial is a time-to-event endpoint with censoring. In this article, we propose a closed form sample size formula for weighted rank tests to compare the marginal survival distributions between intervention arms under cluster randomization with possibly variable cluster sizes. Extensive simulation studies are conducted to evaluate the performance of our sample size formula under various design settings. Real study examples are taken to demonstrate our method.

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Published In

Stat Med

DOI

EISSN

1097-0258

Publication Date

November 10, 2020

Volume

39

Issue

25

Start / End Page

3608 / 3623

Location

England

Related Subject Headings

  • Statistics & Probability
  • Sample Size
  • Research Design
  • Randomized Controlled Trials as Topic
  • Random Allocation
  • Humans
  • Computer Simulation
  • Cluster Analysis
  • 4905 Statistics
  • 4202 Epidemiology
 

Citation

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Li, J., & Jung, S.-H. (2020). Sample size calculation for cluster randomization trials with a time-to-event endpoint. Stat Med, 39(25), 3608–3623. https://doi.org/10.1002/sim.8683
Li, Jianghao, and Sin-Ho Jung. “Sample size calculation for cluster randomization trials with a time-to-event endpoint.Stat Med 39, no. 25 (November 10, 2020): 3608–23. https://doi.org/10.1002/sim.8683.
Li, Jianghao, and Sin-Ho Jung. “Sample size calculation for cluster randomization trials with a time-to-event endpoint.Stat Med, vol. 39, no. 25, Nov. 2020, pp. 3608–23. Pubmed, doi:10.1002/sim.8683.
Li J, Jung S-H. Sample size calculation for cluster randomization trials with a time-to-event endpoint. Stat Med. 2020 Nov 10;39(25):3608–3623.
Journal cover image

Published In

Stat Med

DOI

EISSN

1097-0258

Publication Date

November 10, 2020

Volume

39

Issue

25

Start / End Page

3608 / 3623

Location

England

Related Subject Headings

  • Statistics & Probability
  • Sample Size
  • Research Design
  • Randomized Controlled Trials as Topic
  • Random Allocation
  • Humans
  • Computer Simulation
  • Cluster Analysis
  • 4905 Statistics
  • 4202 Epidemiology