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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...


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

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

Clinical Associate Professor in Hand Surgery

Lelia Duley

Daisy Elliott

Jane M. Blazeby

William Hollingworth

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


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.

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.

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


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.

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
Keywords Randomized Controlled Trial; Clinical trial; Recruitment; Training healthcare professionals; Qualitative research; Communication
Public URL
Publisher URL


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