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; 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 Dias; Declan 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

doi:10.1177/26320843221106950

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 journal › Article › peer-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 language	English
Pages (from-to)	2-15
Number of pages	14
Journal	Research Methods in Medicine & Health Sciences
Volume	4
Issue number	1
Early online date	15 Jun 2022
DOIs	https://doi.org/10.1177/26320843221106950
Publication status	Published - 1 Jan 2023

Keywords

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

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Parker, A., Arundel, C., Mills, N., Rooshenas, L., Jepson, M. A., Donovan, J. L., Blazeby, J. M., Coleman, E., Clark, L., Doherty, L., Hewitt, C. A., Partha Sarathy , P., Beard, D. J., Bower, P., Brealey, S., Brocklehurst, P., Cooper, C., Crofts, J., Culliford, L., ... Torgerson, D. (2023). Staff training to improve participant recruitment into surgical randomised controlled trials: A feasibility study within a trial (SWAT) across four host trials simultaneously. Research Methods in Medicine & Health Sciences, 4(1), 2-15. https://doi.org/10.1177/26320843221106950

Staff training to improve participant recruitment into surgical randomised controlled trials : A feasibility study within a trial (SWAT) across four host trials simultaneously. / Parker, A (Corresponding Author); Arundel, Catherine; Mills, Nicola et al.

In: Research Methods in Medicine & Health Sciences, Vol. 4, No. 1, 01.01.2023, p. 2-15.

Research output: Contribution to journal › Article › peer-review

Parker, A, Arundel, C, Mills, N, Rooshenas, L, Jepson, MA, Donovan, JL, Blazeby, JM, Coleman, E, Clark, L, Doherty, L, Hewitt, CA, Partha Sarathy , P, Beard, DJ, Bower, P, Brealey, S, Brocklehurst, P, Cooper, C, Crofts, J, Culliford, L, Dias, J, Devane, D, eldridge, S, Emsley, R, Galvin, S, Gemperle-Mannion, E, Jayne, D, Metcalfe, A, Montgomery, A, Rangan, A, Sutton, C, Tharmanathan , P, Treweek, S & Torgerson, D 2023, 'Staff training to improve participant recruitment into surgical randomised controlled trials: A feasibility study within a trial (SWAT) across four host trials simultaneously', Research Methods in Medicine & Health Sciences, vol. 4, no. 1, pp. 2-15. https://doi.org/10.1177/26320843221106950

@article{ef0d0a6bb29e417d9c72404e23ebe028,

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

abstract = "ObjectiveTo 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 settingTwelve 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. ResultsFour 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. ConclusionIt 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. ",

keywords = "randomised controlled trial (RCT), Study within a trial (SWAT), recruitment, staff training, professional education, feasibility study, surgical trials",

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

note = "The PROMoting THE Use of SWATs (PROMETHEUS) programme was funded by the Medical Research Council (MRC) [grant number MR/R013748/1]. The DISC host trial is funded by the Health Technology Assessment Programme (Grant Ref: 15/102/04). IntAct is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership (Grant Ref: 14/150/62). The EME Programme is funded by the MRC and NIHR, with contributions from the CSO in Scotland and Health and Care Research Wales and the HSC R&D Division, Public Health Agency in Northern Ireland. PROFHER-2 is funded by the Health Technology Assessment Programme (Grant Ref: 16/73/03). START: REACTS is funded by the NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/61/18. The development of the training intervention was funded by the MRC Network of Hubs for Trials Methodology Research (MR/L004933/1- R53) and supported by the MRC ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomized controlled Trials In Invasive procedures - MR/K025643/1). The online version of the training intervention was funded by the NIHR and is hosted on the NIHR Learn platform (https://learn.nihr.ac.uk/course/view.php?id=385). It is based on the face-to face GRANULE training course funded by the Bowel Disease Research Foundation in collaboration with the University of Birmingham, University of Bristol and former MRC ConDuCT-II Hub. This work was part-funded by the Wellcome Trust [ref: 204829] through the Centre for Future Health (CFH) at the University of York. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, the MRC or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the article. ",

year = "2023",

month = jan,

day = "1",

doi = "10.1177/26320843221106950",

language = "English",

volume = "4",

pages = "2--15",

journal = "Research Methods in Medicine & Health Sciences",

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TY - JOUR

T1 - Staff training to improve participant recruitment into surgical randomised controlled trials

T2 - A feasibility study within a trial (SWAT) across four host trials simultaneously

AU - Parker, A

AU - Arundel, Catherine

AU - Mills, Nicola

AU - Rooshenas, Leila

AU - Jepson, M A

AU - Donovan, J. L.

AU - Blazeby, Jane M

AU - Coleman, Elizabeth

AU - Clark, L

AU - Doherty, Laura

AU - Hewitt, Catherine A

AU - Partha Sarathy , P

AU - Beard, David J

AU - Bower, Peter

AU - Brealey, S

AU - Brocklehurst, P.

AU - Cooper, C

AU - Crofts, J

AU - Culliford, L

AU - Dias, J

AU - Devane, Declan

AU - eldridge, sandra

AU - Emsley, Richard

AU - Galvin, S

AU - Gemperle-Mannion, E

AU - Jayne, D

AU - Metcalfe, A

AU - Montgomery, A

AU - Rangan, A

AU - Sutton, C

AU - Tharmanathan , P

AU - Treweek, Shaun

AU - Torgerson, D

N1 - The PROMoting THE Use of SWATs (PROMETHEUS) programme was funded by the Medical Research Council (MRC) [grant number MR/R013748/1]. The DISC host trial is funded by the Health Technology Assessment Programme (Grant Ref: 15/102/04). IntAct is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership (Grant Ref: 14/150/62). The EME Programme is funded by the MRC and NIHR, with contributions from the CSO in Scotland and Health and Care Research Wales and the HSC R&D Division, Public Health Agency in Northern Ireland. PROFHER-2 is funded by the Health Technology Assessment Programme (Grant Ref: 16/73/03). START: REACTS is funded by the NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/61/18. The development of the training intervention was funded by the MRC Network of Hubs for Trials Methodology Research (MR/L004933/1- R53) and supported by the MRC ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomized controlled Trials In Invasive procedures - MR/K025643/1). The online version of the training intervention was funded by the NIHR and is hosted on the NIHR Learn platform (https://learn.nihr.ac.uk/course/view.php?id=385). It is based on the face-to face GRANULE training course funded by the Bowel Disease Research Foundation in collaboration with the University of Birmingham, University of Bristol and former MRC ConDuCT-II Hub. This work was part-funded by the Wellcome Trust [ref: 204829] through the Centre for Future Health (CFH) at the University of York. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, the MRC or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the article.

PY - 2023/1/1

Y1 - 2023/1/1

N2 - ObjectiveTo 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 settingTwelve 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. ResultsFour 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. ConclusionIt 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.

AB - ObjectiveTo 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 settingTwelve 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. ResultsFour 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. ConclusionIt 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.

KW - randomised controlled trial (RCT)

KW - Study within a trial (SWAT)

KW - recruitment

KW - staff training

KW - professional education

KW - feasibility study

KW - surgical trials

U2 - 10.1177/26320843221106950

DO - 10.1177/26320843221106950

M3 - Article

VL - 4

SP - 2

EP - 15

JO - Research Methods in Medicine & Health Sciences

JF - Research Methods in Medicine & Health Sciences

SN - 2632-0843

IS - 1

ER -

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

Abstract

Keywords

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