Staff training to improve participant recruitment into surgical randomised controlled trials: a feasibility Study Within A Trial (SWAT) across four host randomised controlled trials simultaneously

Adwoa Parker, Catherine Ellen Arundel, N Mills, L Rooshenas, M Jepson, JL Donovan, JM Blazeby, Elizabeth Coleman, Laura Kate Clark, Laura Doherty, Catherine Elizabeth Hewitt, P Partha Sarathy, D Beard, P Bower, Stephen Derek Brealey, P Brocklehurst, C Cooper, J Croft, L Culliford, Joseph DiasD Devane, S Eldridge, Richard Emsley, Sandra Galvin, E Gemperle-Mannion, D Jayne, A Metcalfe, Alan Montgomery, Amar Rangan, C Sutton, Puvanendran Tharmanathan, Shaun Treweek, David John Torgerson

Research output: Contribution to journalArticlepeer-review


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.

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.

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.

Trial registration
ISRCTN registry: DISC (ISRCTN18254597), registered on 4th April 2017; PROFHER 2 (ISRCTN76296703), registered on 5th April 2018; IntAct (ISRCTN13334746), registered on 10th April 2017; and START:REACTS (ISRCTN17825590), registered on 5th March 2018. The training SWAT has been submitted to the MRC SWAT repository (SWAT111)

Randomised controlled trial (RCT), Study Within A Trial (SWAT), recruitment, staff training, professional education, feasibility study, surgical trials
Original languageEnglish
Number of pages14
JournalResearch Methods in Medicine & Health Sciences
Early online date15 Jun 2022
Publication statusE-pub ahead of print - 15 Jun 2022

Bibliographical note

© The Author(s) 2022

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