Back to Search Start Over

Systematic review showed that stepped-wedge cluster randomized trials often did not reach their planned sample size.

Authors :
Eichner FA
Groenwold RHH
Grobbee DE
Oude Rengerink K
Source :
Journal of clinical epidemiology [J Clin Epidemiol] 2019 Mar; Vol. 107, pp. 89-100. Date of Electronic Publication: 2018 Nov 17.
Publication Year :
2019

Abstract

Objective: To determine how often stepped-wedge cluster randomized controlled trials reach their planned sample size, and what reasons are reported for choosing a stepped-wedge trial design.<br />Study Design and Setting: We conducted a PubMed literature search (period 2012 to 2017) and included articles describing the results of a stepped-wedge cluster randomized trial. We calculated the percentage of studies reaching their prespecified number of participants and clusters, and we summarized the reasons for choosing the stepped-wedge trial design as well as difficulties during enrollment.<br />Results: Forty-six individual stepped-wedge studies from a total of 53 articles were included in our review. Of the 35 studies, for which recruitment rate could be calculated, 69% recruited their planned number of participants, with 80% having recruited the planned number of clusters. Ethical reasons were the most common motivation for choosing the stepped-wedge trial design. Most important difficulties during study conduct were dropout of clusters and delayed implementation of the intervention.<br />Conclusion: About half of recently published stepped-wedge trials reached their planned sample size indicating that recruitment is also a major problem in these trials. Still, the stepped-wedge trial design can yield practical, ethical, and methodological advantages.<br /> (Copyright © 2018 Elsevier Inc. All rights reserved.)

Details

Language :
English
ISSN :
1878-5921
Volume :
107
Database :
MEDLINE
Journal :
Journal of clinical epidemiology
Publication Type :
Academic Journal
Accession number :
30458261
Full Text :
https://doi.org/10.1016/j.jclinepi.2018.11.013