The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation

Leila Rooshenas; By-Band-Sleeve study group; CSAW study group; HAND-1 study group; OPTIMA prelim study group; the Romio feasibility study group; Lauren J. Scott; Jane M. Blazeby; Chris A. Rogers; Kate M. Tilling; Samantha Husbands; Carmel Conefrey; Nicola Mills; Chris Metcalfe; Andrew J. Carr; David Beard; Tim Davis; Sangeetha Paramasivan; Marcus Jepson; Kerry Avery; Daisy Elliott; Caroline A  Wilson; Jenny L. Donovan; Iain E Macpherson

doi:10.1016/j.jclinepi.2018.10.004

The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation

Leila Rooshenas^*, By-Band-Sleeve study group, CSAW study group, HAND-1 study group, OPTIMA prelim study group, the Romio feasibility study group, Lauren J. Scott, Jane M. Blazeby, Chris A. Rogers, Kate M. Tilling, Samantha Husbands, Carmel Conefrey, Nicola Mills, Chris Metcalfe, Andrew J. Carr, David Beard, Tim Davis, Sangeetha Paramasivan, Marcus Jepson, Kerry AveryDaisy Elliott, Caroline A Wilson, Jenny L. Donovan, Iain E Macpherson

^*Corresponding author for this work

Research output: Contribution to journal › Article (Academic Journal) › peer-review

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Abstract

Objective: To evaluate the impact of the Quintet Recruitment Intervention (QRI) on recruitment in challenging randomized controlled trials (RCTs) that have applied the intervention. The QRI aims to understand recruitment difficulties, and then implements ‘QRI-actions’ to address these as recruitment proceeds.

Study Design and Setting: A mixed-methods study, comprising: a) before-and-after comparisons of recruitment rates and numbers of patients approached, and b) qualitative case studies, including documentary analysis and interviews with RCT investigators.

Results: Five UK-based publicly-funded RCTs were included in the evaluation. All recruited to target. RCT2 and RCT5 both received up-front pre-recruitment training before the intervention was applied. RCT2 did not encounter recruitment issues and recruited above target from its outset. Recruitment difficulties, particularly communication issues, were identified and addressed through QRI-actions in RCTs 1, 3, 4 and 5. Randomization rates significantly improved post-QRI-action in RCTs 1,3, and 4. QRI-actions addressed issues with approaching eligible patients in RCTs 3 and 5, which both saw significant increases in patients approached. Trial investigators reported that the QRI had unearthed issues they had been unaware of, and reportedly changed their practices post QRI-action.

Conclusion: There is promising evidence to suggest the QRI can support recruitment to difficult RCTs. This needs to be substantiated with future controlled evaluations.

Keywords: Randomized Controlled Trial; Clinical trial; Recruitment; Training healthcare professionals; Qualitative research; Communication.

Original language	English
Pages (from-to)	108-120
Number of pages	13
Journal	Journal of Clinical Epidemiology
Volume	106
Early online date	16 Oct 2018
DOIs	https://doi.org/10.1016/j.jclinepi.2018.10.004
Publication status	Published - 1 Feb 2019

Research Groups and Themes

BTC (Bristol Trials Centre)
Centre for Surgical Research

Keywords

Randomized controlled trial
Clinical Trial
Recruitment
Training healthcare professionals
Qualitative research
Communication

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Rooshenas, L., By-Band-Sleeve study group, CSAW study group, HAND-1 study group, OPTIMA prelim study group, the Romio feasibility study group, Scott, L. J., Blazeby, J. M., Rogers, C. A., Tilling, K. M., Husbands, S., Conefrey, C., Mills, N., Metcalfe, C., Carr, A. J., Beard, D., Davis, T., Paramasivan, S., Jepson, M., ... Macpherson, I. E. (2019). The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation. Journal of Clinical Epidemiology, 106, 108-120. https://doi.org/10.1016/j.jclinepi.2018.10.004

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title = "The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation",

abstract = "Objective: To evaluate the impact of the Quintet Recruitment Intervention (QRI) on recruitment in challenging randomized controlled trials (RCTs) that have applied the intervention. The QRI aims to understand recruitment difficulties, and then implements {\textquoteleft}QRI-actions{\textquoteright} to address these as recruitment proceeds.Study Design and Setting: A mixed-methods study, comprising: a) before-and-after comparisons of recruitment rates and numbers of patients approached, and b) qualitative case studies, including documentary analysis and interviews with RCT investigators.Results: Five UK-based publicly-funded RCTs were included in the evaluation. All recruited to target. RCT2 and RCT5 both received up-front pre-recruitment training before the intervention was applied. RCT2 did not encounter recruitment issues and recruited above target from its outset. Recruitment difficulties, particularly communication issues, were identified and addressed through QRI-actions in RCTs 1, 3, 4 and 5. Randomization rates significantly improved post-QRI-action in RCTs 1,3, and 4. QRI-actions addressed issues with approaching eligible patients in RCTs 3 and 5, which both saw significant increases in patients approached. Trial investigators reported that the QRI had unearthed issues they had been unaware of, and reportedly changed their practices post QRI-action.Conclusion: There is promising evidence to suggest the QRI can support recruitment to difficult RCTs. This needs to be substantiated with future controlled evaluations.Keywords: Randomized Controlled Trial; Clinical trial; Recruitment; Training healthcare professionals; Qualitative research; Communication.",

keywords = "Randomized controlled trial, Clinical Trial, Recruitment, Training healthcare professionals, Qualitative research, Communication",

author = "Leila Rooshenas and {By-Band-Sleeve study group} and {CSAW study group} and {HAND-1 study group} and {OPTIMA prelim study group} and {the Romio feasibility study group} and Scott, {Lauren J.} and Blazeby, {Jane M.} and Rogers, {Chris A.} and Tilling, {Kate M.} and Samantha Husbands and Carmel Conefrey and Nicola Mills and Chris Metcalfe and Carr, {Andrew J.} and David Beard and Tim Davis and Sangeetha Paramasivan and Marcus Jepson and Kerry Avery and Daisy Elliott and Wilson, {Caroline A} and Donovan, {Jenny L.} and Rogers, {Chris A.} and Robert Andrews and Blazeby, {Jane M.} and James Byrne and Donovan, {Jenny L.} and Graziella Mazza and David Mahon and Reeves, {Barnaby C.} and Thompson, {Janice L.} and Richard Welbourn and David Beard and Carr, {Andrew J.} and Donovan, {Jenny L.} and Andrew Judge and Jonathan Rees and Nicola Mills and Daisy Elliott and Blazeby, {Jane M.} and William Hollingworth and Montgomery, {Alan A.} and Tim Davis and John Bartlett and Donovan, {Jenny L.} and Helen Higgins and Macpherson, {Iain E} and Kerry Avery and Barham, {C. Paul} and Blazeby, {Jane M.} and Donovan, {Jenny L.} and Falk, {Stephen J.} and Hollowood, {Andrew A.} and Richard Krysztopik and Chris Metcalfe and Sian Noble and Streets, {Christopher G.}",

year = "2019",

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day = "1",

doi = "10.1016/j.jclinepi.2018.10.004",

language = "English",

volume = "106",

pages = "108--120",

journal = "Journal of Clinical Epidemiology",

issn = "0895-4356",

publisher = "Elsevier Inc.",

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Rooshenas, L, By-Band-Sleeve study group, CSAW study group, HAND-1 study group, OPTIMA prelim study group, the Romio feasibility study group, Scott, LJ , Blazeby, JM , Rogers, CA , Tilling, KM , Husbands, S , Conefrey, C , Mills, N , Metcalfe, C, Carr, AJ, Beard, D, Davis, T, Paramasivan, S , Jepson, M , Avery, K , Elliott, D, Wilson, CA, Donovan, JL & Macpherson, IE 2019, 'The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation', Journal of Clinical Epidemiology, vol. 106, pp. 108-120. https://doi.org/10.1016/j.jclinepi.2018.10.004

TY - JOUR

T1 - The QuinteT Recruitment Intervention supported five randomized trials to recruit to target

T2 - a mixed-methods evaluation

AU - Rooshenas, Leila

AU - By-Band-Sleeve study group

AU - CSAW study group

AU - HAND-1 study group

AU - OPTIMA prelim study group

AU - the Romio feasibility study group

AU - Scott, Lauren J.

AU - Blazeby, Jane M.

AU - Rogers, Chris A.

AU - Tilling, Kate M.

AU - Husbands, Samantha

AU - Conefrey, Carmel

AU - Mills, Nicola

AU - Metcalfe, Chris

AU - Carr, Andrew J.

AU - Beard, David

AU - Davis, Tim

AU - Paramasivan, Sangeetha

AU - Jepson, Marcus

AU - Avery, Kerry

AU - Elliott, Daisy

AU - Wilson, Caroline A

AU - Donovan, Jenny L.

AU - Rogers, Chris A.

AU - Andrews, Robert

AU - Blazeby, Jane M.

AU - Byrne, James

AU - Donovan, Jenny L.

AU - Mazza, Graziella

AU - Mahon, David

AU - Reeves, Barnaby C.

AU - Thompson, Janice L.

AU - Welbourn, Richard

AU - Beard, David

AU - Carr, Andrew J.

AU - Donovan, Jenny L.

AU - Judge, Andrew

AU - Rees, Jonathan

AU - Mills, Nicola

AU - Elliott, Daisy

AU - Blazeby, Jane M.

AU - Hollingworth, William

AU - Montgomery, Alan A.

AU - Davis, Tim

AU - Bartlett, John

AU - Donovan, Jenny L.

AU - Higgins, Helen

AU - Macpherson, Iain E

AU - Avery, Kerry

AU - Barham, C. Paul

AU - Blazeby, Jane M.

AU - Donovan, Jenny L.

AU - Falk, Stephen J.

AU - Hollowood, Andrew A.

AU - Krysztopik, Richard

AU - Metcalfe, Chris

AU - Noble, Sian

AU - Streets, Christopher G.

PY - 2019/2/1

Y1 - 2019/2/1

N2 - Objective: To evaluate the impact of the Quintet Recruitment Intervention (QRI) on recruitment in challenging randomized controlled trials (RCTs) that have applied the intervention. The QRI aims to understand recruitment difficulties, and then implements ‘QRI-actions’ to address these as recruitment proceeds.Study Design and Setting: A mixed-methods study, comprising: a) before-and-after comparisons of recruitment rates and numbers of patients approached, and b) qualitative case studies, including documentary analysis and interviews with RCT investigators.Results: Five UK-based publicly-funded RCTs were included in the evaluation. All recruited to target. RCT2 and RCT5 both received up-front pre-recruitment training before the intervention was applied. RCT2 did not encounter recruitment issues and recruited above target from its outset. Recruitment difficulties, particularly communication issues, were identified and addressed through QRI-actions in RCTs 1, 3, 4 and 5. Randomization rates significantly improved post-QRI-action in RCTs 1,3, and 4. QRI-actions addressed issues with approaching eligible patients in RCTs 3 and 5, which both saw significant increases in patients approached. Trial investigators reported that the QRI had unearthed issues they had been unaware of, and reportedly changed their practices post QRI-action.Conclusion: There is promising evidence to suggest the QRI can support recruitment to difficult RCTs. This needs to be substantiated with future controlled evaluations.Keywords: Randomized Controlled Trial; Clinical trial; Recruitment; Training healthcare professionals; Qualitative research; Communication.

AB - Objective: To evaluate the impact of the Quintet Recruitment Intervention (QRI) on recruitment in challenging randomized controlled trials (RCTs) that have applied the intervention. The QRI aims to understand recruitment difficulties, and then implements ‘QRI-actions’ to address these as recruitment proceeds.Study Design and Setting: A mixed-methods study, comprising: a) before-and-after comparisons of recruitment rates and numbers of patients approached, and b) qualitative case studies, including documentary analysis and interviews with RCT investigators.Results: Five UK-based publicly-funded RCTs were included in the evaluation. All recruited to target. RCT2 and RCT5 both received up-front pre-recruitment training before the intervention was applied. RCT2 did not encounter recruitment issues and recruited above target from its outset. Recruitment difficulties, particularly communication issues, were identified and addressed through QRI-actions in RCTs 1, 3, 4 and 5. Randomization rates significantly improved post-QRI-action in RCTs 1,3, and 4. QRI-actions addressed issues with approaching eligible patients in RCTs 3 and 5, which both saw significant increases in patients approached. Trial investigators reported that the QRI had unearthed issues they had been unaware of, and reportedly changed their practices post QRI-action.Conclusion: There is promising evidence to suggest the QRI can support recruitment to difficult RCTs. This needs to be substantiated with future controlled evaluations.Keywords: Randomized Controlled Trial; Clinical trial; Recruitment; Training healthcare professionals; Qualitative research; Communication.

KW - Randomized controlled trial

KW - Clinical Trial

KW - Recruitment

KW - Training healthcare professionals

KW - Qualitative research

KW - Communication

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U2 - 10.1016/j.jclinepi.2018.10.004

DO - 10.1016/j.jclinepi.2018.10.004

M3 - Article (Academic Journal)

C2 - 30339938

AN - SCOPUS:85056893849

SN - 0895-4356

VL - 106

SP - 108

EP - 120

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

ER -

Rooshenas L, By-Band-Sleeve study group, CSAW study group, HAND-1 study group, OPTIMA prelim study group, the Romio feasibility study group et al. The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation. Journal of Clinical Epidemiology. 2019 Feb 1;106:108-120. Epub 2018 Oct 16. doi: 10.1016/j.jclinepi.2018.10.004

The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation

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Dr Kerry N L Avery

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The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation

Abstract

Research Groups and Themes

Keywords

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Dr Kerry N L Avery

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Dr Nicola J Mills

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