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

A Parker* (Corresponding Author), Catherine Arundel, Nicola Mills, Leila Rooshenas, M A Jepson, J. L. Donovan, Jane M Blazeby, Elizabeth Coleman, L Clark, Laura Doherty, Catherine A Hewitt, P Partha Sarathy , David J Beard, Peter Bower, S Brealey, P. Brocklehurst, C Cooper, J Crofts, L Culliford, J DiasDeclan Devane, sandra eldridge, Richard Emsley, S Galvin, E Gemperle-Mannion, D Jayne, A Metcalfe, A Montgomery, A Rangan, C Sutton, P Tharmanathan , Shaun Treweek, D Torgerson

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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.
Original languageEnglish
JournalResearch Methods in Medicine & Health Sciences
Early online date15 Jun 2022
DOIs
Publication statusE-pub ahead of print - 15 Jun 2022

Keywords

  • randomised controlled trial (RCT)
  • Study within a trial (SWAT)
  • recruitment
  • staff training
  • professional education
  • feasibility study
  • surgical trials

Fingerprint

Dive into the research topics of 'Staff training to improve participant recruitment into surgical randomised controlled trials: A feasibility study within a trial (SWAT) across four host trials simultaneously'. Together they form a unique fingerprint.

Cite this