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Recruitment and implementation challenges were common in stepped-wedge cluster randomized trials: results from a methodological review

Caille, Agnes; Taljaard, Monica; Le Vilain-Abraham, Floriane; Le Moigne, Alexis; Copas, Andrew J; Tubach, Florence; Dechartres, Agnes; (2022) Recruitment and implementation challenges were common in stepped-wedge cluster randomized trials: results from a methodological review. Journal of Clinical Epidemiology , 148 pp. 93-103. 10.1016/j.jclinepi.2022.04.024. Green open access

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Abstract

OBJECTIVE: To explore challenges in recruitment and intervention implementation in recent stepped-wedge cluster randomized trials (SW-CRTs). STUDY DESIGN AND SETTING: We searched PubMed to identify primary reports of SW-CRTs (2019-2020). Two reviewers independently screened studies and extracted data from each report. Recruitment challenge was defined as planned number of clusters or participants not achieved, or any reported changes made to the design to address recruitment difficulties. Implementation challenge was defined as early, late or no implementation of the intervention in at least one cluster. RESULTS: Of 55 SW-CRTs, 18 (33%) had a recruitment challenge, 23 (42%) had none, and for 14 (26%) it was impossible to judge. At least one implementation challenge was present in 24 (44%), 8 (15%) had none, and for 23 (42%) it was impossible to judge. Of the 35 (64%) trials with recruitment or implementation challenges, 18 (72%) had one or more modifications of their design, most often a modification of the trial duration. CONCLUSION: Investigators must be aware of the risks of recruitment or implementation challenges when considering use of a SW-CRT design. Mitigating strategies should be adopted when planning the trial. More transparent reporting of planned and actual design features is required.

Type: Article
Title: Recruitment and implementation challenges were common in stepped-wedge cluster randomized trials: results from a methodological review
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.jclinepi.2022.04.024
Publisher version: https://doi.org/10.1016/j.jclinepi.2022.04.024
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Stepped-wedge cluster randomized trial, design, implementation, methodological review, recruitment, reporting
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health > Infection and Population Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
URI: https://discovery.ucl.ac.uk/id/eprint/10147960
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