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

Parker, Adwoa orcid.org/0000-0002-2880-3935, Arundel, Catherine Ellen orcid.org/0000-0003-0512-4339, Mills, N et al. (30 more authors) (2022) 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. Research Methods in Medicine & Health Sciences. ISSN 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. 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) Keywords: Randomised controlled trial (RCT), Study Within A Trial (SWAT), recruitment, staff training, professional education, feasibility study, surgical trials

Metadata

Item Type:	Article
Authors/Creators:	Parker, Adwoa https://orcid.org/0000-0002-2880-3935 Arundel, Catherine Ellen https://orcid.org/0000-0003-0512-4339 Mills, N Rooshenas, L Jepson, M Donovan, JL Blazeby, JM Coleman, Elizabeth https://orcid.org/0000-0003-4210-1865 Clark, Laura Kate https://orcid.org/0000-0001-9227-5447 Doherty, Laura Hewitt, Catherine Elizabeth https://orcid.org/0000-0002-0415-3536 Partha Sarathy, P Beard, D Bower, P Brealey, Stephen Derek https://orcid.org/0000-0001-9749-7014 Brocklehurst, P Cooper, C Croft, J Culliford, L Dias, Joseph Devane, D Eldridge, S Emsley, Richard Galvin, Sandra Gemperle-Mannion, E Jayne, D Metcalfe, A Montgomery, Alan Rangan, Amar (amar.rangan@york.ac.uk) Sutton, C Tharmanathan, Puvanendran https://orcid.org/0000-0001-9196-0207 Treweek, Shaun Torgerson, David John https://orcid.org/0000-0002-1667-4275
Copyright, Publisher and Additional Information:	© The Author(s) 2022
Dates:	Accepted: 8 June 2022 Published (online): 15 June 2022
Institution:	The University of York
Academic Units:	The University of York > Faculty of Sciences (York) > Health Sciences (York)
Depositing User:	Pure (York)
Date Deposited:	22 Jun 2022 09:20
Last Modified:	10 Apr 2025 23:32
Published Version:	https://doi.org/10.1177%2F26320843221106950
Status:	Published online
Refereed:	Yes
Identification Number:	10.1177/26320843221106950
Open Archives Initiative ID (OAI ID):	oai:eprints.whiterose.ac.uk:188215

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

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