Staff training to improve participant recruitment into surgical randomised controlled trials: A feasibility study within a trial (SWAT) across four host trials simultaneously

<p><strong>Objective</strong> To test the feasibility of undertaking a simultaneous Study Within A Trial (SWAT) to train staff who recruit participants into surgical randomised controlled trials (RCTs), by assessing key uncertainties around recruitment, randomisation, intervention...

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Bibliographic Details
Main Authors: Parker, A, Arundel, C, Mills, N, Rooshenas, L, Jepson, M, Donovan, JL, Blazeby, JM, Coleman, E, Clark, L, Doherty, L, Hewitt, CE, Partha Sarathy, P, Beard, D, Bower, P, Brealey, S, Brocklehurst, P, Cooper, C, Croft, J, Culliford, L, Dias, J, Devane, D, Eldridge, S, Emsley, R, Galvin, S, Gemperle-Mannion, E, Jayne, DG, Metcalfe, AJ, Montgomery, A, Rangan, A, Sutton, CJ, Tharmanathan, P, Treweek, S, Torgerson, D
Format: Journal article
Language:English
Published: SAGE Publications 2022
Description
Summary:<p><strong>Objective</strong> To test the feasibility of undertaking a simultaneous Study Within A Trial (SWAT) to train staff who recruit participants into surgical randomised controlled trials (RCTs), by assessing key uncertainties around recruitment, randomisation, intervention delivery and data collection.</p> <p><strong>Study design and setting</strong> Twelve surgical RCTs were eligible. Interested sites (clusters) were randomised 1:1, with recruiting staff (surgeons and nurses) offered training or no training. The primary outcome was the feasibility of recruiting sites across multiple surgical trials simultaneously. Secondary outcomes included numbers/types of staff enrolled, attendance at training, training acceptability, confidence in recruiting and participant recruitment rates six months later.</p> <p><strong>Results</strong> Four RCTs (33%) comprising 91 sites participated. Of these, 29 sites agreed to participate (32%) and were randomised to intervention (15 sites, 29 staff) or control (14 sites, 29 staff). Research nurses attended and found the training to be acceptable; no surgeons attended. In the intervention group, there was evidence of increased confidence when pre- and post- training scores were compared (mean difference in change 1.42; 95% CI 0.56, 2.27; <i>p</i> = 0.002). There was no effect on recruitment rate.</p> <p><strong>Conclusion</strong> It was feasible to randomise sites across four surgical RCTs in a simultaneous SWAT design. However, as small numbers of trials and sites participated, and no surgeons attended training, strategies to improve these aspects are needed for future evaluations.</p>