Rooshenas L
The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation
L, Rooshenas; LJ, Scott; JM, Blazeby; CA, Rogers; KM, Tilling; S, Husbands; C, Conefrey; N, Mills; RC, Stein; C, Metcalfe; AJ, Carr; DJ, Beard; T., Davis; S, Paramasivan; M, Jepson; K, Avery; D, Elliott; C, Wilson; JL, Donovan; Rogers, Chris A.; Andrews, Robert; Blazeby, Jane M.; Byrne, James; Donovan, Jenny L.; Kelly, Jamie; Mazza, Graziella; Mahon, David; Noble, Hamish; Reeves, Barnaby C.; Thompson, Janice L.; Wordsworth, Sarah; Welbourn, Richard; Beard, David; Carr, Andrew; Cook, Jonathan; Cooper, Cushla; Dean, Benjamin; Donovan, Jenny L.; Gray, Alastair; Gwilym, Stephen; Judge, Andrew; Merritt, Naomi; Moser, Jane; Rees, Jonathan; Rombach, Ines; Savulescu, Julian; Tracey, Irene; Wartolowska, Karolina; Tan, Wei; Mills, Nicola; Karantana, Alexia; Sprange, Kirsty; Duley, Lelia; Elliott, Daisy; Blazeby, Jane M.; Hollingworth, William; Montgomery, Alan A.; Davis, Tim; Stein, Rob; Bartlett, John; Cameron, David; Campbell, Amy; Canney, Peter; Donovan, Jenny L.; Dunn, Janet; Earl, Helena; F...
Authors
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
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
Cushla Cooper
Benjamin Dean
Jenny L. Donovan
Alastair Gray
Stephen Gwilym
Andrew Judge
Naomi Merritt
Jane Moser
Jonathan Rees
Ines Rombach
Julian Savulescu
Irene Tracey
Karolina Wartolowska
Wei Tan
Nicola Mills
ALEXIA KARANTANA ALEXIA.KARANTANA@NOTTINGHAM.AC.UK
Clinical Associate Professor in Hand Surgery
KIRSTY SPRANGE KIRSTY.SPRANGE@NOTTINGHAM.AC.UK
Assistant Professor
Lelia Duley
Daisy Elliott
Jane M. Blazeby
William Hollingworth
ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director Nottingham Clinical Trials Unit
Tim Davis
Rob Stein
John Bartlett
David Cameron
Amy Campbell
Peter Canney
Jenny L. Donovan
Janet Dunn
Helena Earl
Mary Falzon
Adele Francis
Peter Hall
Victoria Harmer
Helen Higgins
Louise Hiller
Luke Hughes-Davies
Claire Hulme
Iain Macpherson
Andreas Makris
Andrea Marshall
Christopher McCabe
Adrienne Morgan
Sarah Pinder
Christopher Poole
Elena Provenzano
Daniel Rea
Nigel Stallard
Kerry NL. Avery
C Paul Barham
Richard Berrisford
Jane M. Blazeby
Jenny L. Donovan
Jackie Elliott
Stephen J. Falk
Rob Goldin
George Hanna
Andrew A. Hollowood
Richard Krysztopik
Chris Metcalfe
Sian Noble
Grant Sanders
Christopher G. Streets
Dan R. Titcomb
Tim Wheatley
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.
Citation
L, R., LJ, S., JM, B., CA, R., KM, T., S, H., …Wheatley, T. (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
Journal Article Type | Article |
---|---|
Acceptance Date | Oct 10, 2018 |
Online Publication Date | Oct 16, 2018 |
Publication Date | Feb 1, 2019 |
Deposit Date | Nov 7, 2018 |
Publicly Available Date | Dec 7, 2018 |
Journal | Journal of Clinical Epidemiology |
Print ISSN | 0895-4356 |
Electronic ISSN | 1878-5921 |
Publisher | Elsevier |
Peer Reviewed | Peer Reviewed |
Volume | 106 |
Pages | 108-120 |
DOI | https://doi.org/10.1016/j.jclinepi.2018.10.004 |
Keywords | Randomized Controlled Trial; Clinical trial; Recruitment; Training healthcare professionals; Qualitative research; Communication |
Public URL | https://nottingham-repository.worktribe.com/output/1233541 |
Publisher URL | https://www.sciencedirect.com/science/article/pii/S0895435618306280?via%3Dihub |
Contract Date | Nov 7, 2018 |
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