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

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, By-Band-Sleeve study group, CSAW study group, HAND-1 study group, Optima prelim study group, Romio feasibility study group, 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, Eleanor Harrison, Wei Tan, Nicola Mills, Alexia Karantana, Kirsty Sprange, Lelia Duley, Daisy Elliott, Jane M Blazeby, William Hollingworth, Alan A Montgomery, 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 N L 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, 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, By-Band-Sleeve study group, CSAW study group, HAND-1 study group, Optima prelim study group, Romio feasibility study group, 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, Eleanor Harrison, Wei Tan, Nicola Mills, Alexia Karantana, Kirsty Sprange, Lelia Duley, Daisy Elliott, Jane M Blazeby, William Hollingworth, Alan A Montgomery, 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 N L 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 (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.

Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Figures

Fig. 1
Fig. 1
Timeline of RCTs, with points of QRI integration and point at which QRI actions were implemented. RCT, Randomized controlled trial; QRI, QuinteT Recruitment Intervention.
Fig. 2
Fig. 2
Results of analysis 1 (change in randomization success, preintervention and postintervention) and analysis 2 (changes in the numbers of patients approached, preintervention and postintervention). Panel A: Odds ratio of randomization success after the first QRI action, shown for individual trials. Panel B: Incident rate ratios (IRR) of eligible and approached (E&A) patients after the first QRI action, shown for individual trials. RCT, Randomized controlled trial; QRI, QuinteT Recruitment Intervention.

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