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...

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., C, C., N, M., RC, S., C, M., AJ, C., DJ, B., T., D., S, P., M, J., K, A., D, E., C, W., JL, D., Rogers, C. A., …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