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

By-Band-Sleeve study group; CSAW study group; HAND-1 study group; OPTIMA prelim study group; the Romio feasibility study group; Leila Rooshenas; Lauren J. Scott; Jane M. Blazeby; Chris A. Rogers; Kate M. Tilling; Samantha Husbands; Carmel Conefrey; Nicola Mills; Robert C. Stein; Chris Metcalfe; Andrew J. Carr; David J. Beard; Tim Davis; Sangeetha Paramasivan; Marcus Jepson; Kerry Avery; Daisy Elliott; Caroline Wilson; Jenny L. Donovan; Chris A. Rogers; Robert Andrews; Jane M. Blazeby; James Byrne; Jenny L. Donovan; Jamie Kelly; Graziella Mazza; David Mahon; Hamish Noble; Barnaby C. Reeves; Janice L. Thompson; Sarah Wordsworth; Richard Welbourn; David Beard; Andrew Carr; Jonathan Cook; Jonathan Rees; Wei Tan; Nicola Mills; John Bartlett; Peter Canney; Janet Dunn; Helena Earl; Adele Francis; Peter Hall; Helen Higgins; Louise Hiller; Andrea Marshall; Christopher McCabe; Christopher Poole; Daniel Rea

doi:10.1016/j.jclinepi.2018.10.004

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

By-Band-Sleeve study group, CSAW study group, HAND-1 study group, OPTIMA prelim study group, the Romio feasibility study group, Leila Rooshenas^*, Lauren J. Scott, Jane M. Blazeby, Chris A. Rogers, Kate M. Tilling, Samantha Husbands, Carmel Conefrey, Nicola Mills, Robert C. Stein, Chris Metcalfe, Andrew J. Carr, David J. Beard, Tim Davis, Sangeetha Paramasivan, Marcus JepsonKerry Avery, Daisy Elliott, Caroline Wilson, Jenny L. Donovan, Chris A. Rogers, Robert Andrews, Jane M. Blazeby, James Byrne, Jenny L. Donovan, Jamie Kelly, Graziella Mazza, David Mahon, Hamish Noble, Barnaby C. Reeves, Janice L. Thompson, Sarah Wordsworth, Richard Welbourn, David Beard, Andrew Carr, Jonathan Cook, Jonathan Rees, Wei Tan, Nicola Mills, John Bartlett, Peter Canney, Janet Dunn, Helena Earl, Adele Francis, Peter Hall, Helen Higgins, Louise Hiller, Andrea Marshall, Christopher McCabe, Christopher Poole, Daniel Rea

^*Corresponding author for this work

Cancer Clinical Trials Unit

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

18 Citations (Scopus)

162 Downloads (Pure)

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 (1) before-and-after comparisons of recruitment rates and the numbers of patients approached and (2) 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. Randomized controlled trial 2 and RCT 5 both received up-front prerecruitment training before the intervention was applied. Randomized controlled trial 2 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 after QRI action in RCTs 1, 3, and 4. Quintet Recruitment Intervention actions addressed issues with approaching eligible patients in RCTs 3 and 5, which both saw significant increases in the number of patients approached. Trial investigators reported that the QRI had unearthed issues they had been unaware of and reportedly changed their practices after QRI action.

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

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

Keywords

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

ASJC Scopus subject areas

Epidemiology

Access to Document

10.1016/j.jclinepi.2018.10.004Licence: Creative Commons: Attribution (CC BY)

Leila_Rooshenas_et_al_The_QuinteT_Recruitment_Intervention_Journal_of_Clinical_Epidemiology_2018
Checked for eligibility: 21/12/2018
Final published version, 653 KBLicence: Creative Commons: Attribution (CC BY)

Cite this

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

@article{4625be0ff4e3418782ca5eac85bf888d,

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 “QRI actions” to address these as recruitment proceeds. Study Design and Setting: A mixed-methods study, comprising (1) before-and-after comparisons of recruitment rates and the numbers of patients approached and (2) 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. Randomized controlled trial 2 and RCT 5 both received up-front prerecruitment training before the intervention was applied. Randomized controlled trial 2 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 after QRI action in RCTs 1, 3, and 4. Quintet Recruitment Intervention actions addressed issues with approaching eligible patients in RCTs 3 and 5, which both saw significant increases in the number of patients approached. Trial investigators reported that the QRI had unearthed issues they had been unaware of and reportedly changed their practices after QRI action. Conclusion: There is promising evidence to suggest that the QRI can support recruitment to difficult RCTs. This needs to be substantiated with future controlled evaluations.",

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

author = "{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 Leila Rooshenas 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 Stein, {Robert C.} and Chris Metcalfe and Carr, {Andrew J.} and Beard, {David J.} and Tim Davis and Sangeetha Paramasivan and Marcus Jepson and Kerry Avery and Daisy Elliott and Caroline Wilson and Donovan, {Jenny L.} and Rogers, {Chris A.} and Robert Andrews and Blazeby, {Jane M.} and James Byrne and Donovan, {Jenny L.} and Jamie Kelly and Graziella Mazza and David Mahon and Hamish Noble and Reeves, {Barnaby C.} and Thompson, {Janice L.} and Sarah Wordsworth and Richard Welbourn and David Beard and Andrew Carr and Jonathan Cook and Jonathan Rees and Wei Tan and Nicola Mills and John Bartlett and Peter Canney and Janet Dunn and Helena Earl and Adele Francis and Peter Hall and Helen Higgins and Louise Hiller and Andrea Marshall and Christopher McCabe and Christopher Poole and Daniel Rea",

year = "2019",

month = feb,

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",

}

By-Band-Sleeve study group, CSAW study group, HAND-1 study group, OPTIMA prelim study group, the Romio feasibility study group, Rooshenas, L, Scott, LJ, Blazeby, JM, Rogers, CA, Tilling, KM, Husbands, S, Conefrey, C, Mills, N, Stein, RC, Metcalfe, C, Carr, AJ, Beard, DJ, Davis, T, Paramasivan, S, Jepson, M, Avery, K, Elliott, D, Wilson, C, Donovan, JL, Rogers, CA, Andrews, R, Blazeby, JM, Byrne, J, Donovan, JL, Kelly, J, Mazza, G, Mahon, D, Noble, H, Reeves, BC, Thompson, JL, Wordsworth, S, Welbourn, R, Beard, D, Carr, A, Cook, J, Rees, J, Tan, W, Mills, N, Bartlett, J, Canney, P, Dunn, J, Earl, H, Francis, A, Hall, P, Higgins, H, Hiller, L, Marshall, A, McCabe, C, Poole, C & Rea, D 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 - 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 - Rooshenas, Leila

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 - Stein, Robert C.

AU - Metcalfe, Chris

AU - Carr, Andrew J.

AU - Beard, David J.

AU - Davis, Tim

AU - Paramasivan, Sangeetha

AU - Jepson, Marcus

AU - Avery, Kerry

AU - Elliott, Daisy

AU - Wilson, Caroline

AU - Donovan, Jenny L.

AU - Rogers, Chris A.

AU - Andrews, Robert

AU - Blazeby, Jane M.

AU - Byrne, James

AU - Donovan, Jenny L.

AU - Kelly, Jamie

AU - Mazza, Graziella

AU - Mahon, David

AU - Noble, Hamish

AU - Reeves, Barnaby C.

AU - Thompson, Janice L.

AU - Wordsworth, Sarah

AU - Welbourn, Richard

AU - Beard, David

AU - Carr, Andrew

AU - Cook, Jonathan

AU - Rees, Jonathan

AU - Tan, Wei

AU - Mills, Nicola

AU - Bartlett, John

AU - Canney, Peter

AU - Dunn, Janet

AU - Earl, Helena

AU - Francis, Adele

AU - Hall, Peter

AU - Higgins, Helen

AU - Hiller, Louise

AU - Marshall, Andrea

AU - McCabe, Christopher

AU - Poole, Christopher

AU - Rea, Daniel

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 (1) before-and-after comparisons of recruitment rates and the numbers of patients approached and (2) 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. Randomized controlled trial 2 and RCT 5 both received up-front prerecruitment training before the intervention was applied. Randomized controlled trial 2 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 after QRI action in RCTs 1, 3, and 4. Quintet Recruitment Intervention actions addressed issues with approaching eligible patients in RCTs 3 and 5, which both saw significant increases in the number of patients approached. Trial investigators reported that the QRI had unearthed issues they had been unaware of and reportedly changed their practices after QRI action. Conclusion: There is promising evidence to suggest that the QRI can support recruitment to difficult RCTs. This needs to be substantiated with future controlled evaluations.

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 (1) before-and-after comparisons of recruitment rates and the numbers of patients approached and (2) 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. Randomized controlled trial 2 and RCT 5 both received up-front prerecruitment training before the intervention was applied. Randomized controlled trial 2 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 after QRI action in RCTs 1, 3, and 4. Quintet Recruitment Intervention actions addressed issues with approaching eligible patients in RCTs 3 and 5, which both saw significant increases in the number of patients approached. Trial investigators reported that the QRI had unearthed issues they had been unaware of and reportedly changed their practices after QRI action. Conclusion: There is promising evidence to suggest that the QRI can support recruitment to difficult RCTs. This needs to be substantiated with future controlled evaluations.

KW - Clinical trial

KW - Communication

KW - Qualitative research

KW - Randomized controlled trial

KW - Recruitment

KW - Training healthcare professionals

UR - http://www.scopus.com/inward/record.url?scp=85056893849&partnerID=8YFLogxK

U2 - 10.1016/j.jclinepi.2018.10.004

DO - 10.1016/j.jclinepi.2018.10.004

M3 - Article

AN - SCOPUS:85056893849

SN - 0895-4356

VL - 106

SP - 108

EP - 120

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

ER -

By-Band-Sleeve study group, CSAW study group, HAND-1 study group, OPTIMA prelim study group, the Romio feasibility study group, Rooshenas L 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

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Fingerprint

Cite this