Staff training to improve participant recruitment into surgical randomised controlled trials: A feasibility study within a trial (SWAT) across four host trials simultaneously. Issue 1 (January 2023)

• Record Type: Journal Article
• Authors: Parker, Adwoa; Arundel, Catherine; Mills, Nicola; Rooshenas, Leila; Jepson, Marcus; Donovan, Jenny L; Blazeby, Jane M; Coleman, Elizabeth; Clark, Laura; Doherty, Laura; Hewitt, Catherine E; Partha Sarathy, Prasanna; Beard, David; Bower, Peter; Brealey, Stephen; Brocklehurst, Paul; Cooper, Cindy; Croft, Julie; Culliford, Lucy; Dias, Joseph; Devane, Declan; Eldridge, Sandra; Emsley, Richard; Galvin, Sandra; Gemperle-Mannion, Elke; Jayne, David G; Metcalfe, Andrew J; Montgomery, Alan; Rangan, Amar; Sutton, Christopher J; Tharmanathan, Puvanendran; Treweek, Shaun; Torgerson, David;
• Is Part Of: Research methods in medicine & health sciences. Volume 4:Issue 1(2023)
• Page Start: 2
• Page End: 15
• Publication Date: 2023-01
• Subjects: randomised controlled trial -- study within a trial -- recruitment -- staff training -- professional education -- feasibility study -- surgical trials; Medicine -- Research -- Periodicals; Medical sciences -- Research -- Periodicals; 610.7205
• DOI: 10.1177/26320843221106950
• Languages: English
• ISSNs: 2632-0843

Abstract

Objective: 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. Study design and setting: 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. Results: 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; p = 0.002). There was no effect on recruitment rate. Conclusion: 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.