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Updated: Sep 25, 2025
Influence of Step-Width Manipulation on Running Biomechanics
Published on: February 28, 2025
Recruitment and implementation challenges were common in stepped-wedge cluster randomized trials: Results from a
Agnes Caille1, Monica Taljaard2, Floriane Le Vilain-Abraham3
1Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpital Pitié-Salpêtrière, Département de Santé Publique, Paris, France; Université de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France; INSERM CIC 1415, CHRU de Tours, Tours, France.
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. A recruitment challenge was defined as a planned number of clusters or participants not achieved or any reported changes made to the design to address recruitment difficulties. An 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%), eight (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 the use of an SW-CRT design. Mitigating strategies should be adopted when planning the trial. More transparent reporting of planned and actual design features is required.
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