Power calculation in stepped-wedge cluster randomized trial with reduced intervention sustainability effect

Jing Li, Ying Zhang, Laura J. Myers, Dawn Bravata

Research output: Contribution to journalArticle

Abstract

The stepped-wedge design for pragmatic clinical trials has received increased attention in health service-related research seeking to evaluate the effect of interventions. Compared with the parallel design, the stepped-wedge design is preferred when there is prior knowledge supporting the effectiveness and harmlessness of the intervention, and/or when practical or financial constraints exist such that the intervention can only be implemented sequentially on a fraction of clusters. In some health service studies, the study period may consist of two parts: an active implementation followed by a sustainability phase, where the intervention effect is possibly reduced. There is a gap in current literature of the stepped-wedge design for cluster randomization trials for dealing with this specific scenario. We aim to provide an analytical formula for power analysis under this situation to aid the stepped-wedge design of an ongoing PREVENT trial.

Original languageEnglish (US)
Pages (from-to)663-674
Number of pages12
JournalJournal of biopharmaceutical statistics
Volume29
Issue number4
DOIs
StatePublished - Jan 1 2019

Fingerprint

Pragmatic Clinical Trials
Randomized Trial
Health Services Research
Sustainability
Random Allocation
Wedge
Health Services
Power Analysis
Randomisation
Prior Knowledge
Clinical Trials
Design
Scenarios
Evaluate

Keywords

  • cluster randomized trials
  • power analysis
  • pragmatic clinical trials
  • Stepped-wedge design

ASJC Scopus subject areas

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

Cite this

Power calculation in stepped-wedge cluster randomized trial with reduced intervention sustainability effect. / Li, Jing; Zhang, Ying; Myers, Laura J.; Bravata, Dawn.

In: Journal of biopharmaceutical statistics, Vol. 29, No. 4, 01.01.2019, p. 663-674.

Research output: Contribution to journalArticle

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