What type of cluster randomized trial for which setting?

Karla Hemming*, Andrew Copas, Andrew Forbes, Jessica Kasza

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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Abstract

The cluster randomized trial allows a randomized evaluation when it is either not possible to randomize the individual or randomizing individuals would put the trial at high risk of contamination across treatment arms. There are many variations of the cluster randomized design, including the parallel design with or without baseline measures, the cluster randomized cross-over design, the stepped-wedge cluster randomized design, and more recently-developed variants such as the batched stepped-wedge design and the staircase design. Once it has been clearly established that there is a need for cluster randomization, one ever important question is which form the cluster design should take. If a design in which time is split into multiple trial periods is to be adopted (e.g. as in a stepped-wedge), researchers must decide whether the same participants should be measured in multiple trial periods (cohort sampling); or if different participants should be measured in each period (continual recruitment or cross-sectional sampling). Here we outline the different possible options and weigh up the pros and cons of the different design choices, which revolve around statistical efficiency, study logistics and the assumptions required.

Original languageEnglish
Article number202195
JournalJournal of epidemiology and population health
Volume72
Issue number1
DOIs
Publication statusPublished - 20 Feb 2024

Bibliographical note

Copyright © 2024 The Author(s)

Keywords

  • Humans
  • Cross-Sectional Studies
  • Longitudinal Studies
  • Research Design
  • Randomized Controlled Trials as Topic

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