Abstract
ObjectiveTo 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 SettingA 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. ResultsFive 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. ConclusionThere is promising evidence to suggest that the QRI can support recruitment to difficult RCTs. This needs to be substantiated with future controlled evaluations.
Highlights
High-quality evidence about treatment effectiveness is crucial for improving patient outcomes and promoting judicial use of resources
Thirty Randomized controlled trial (RCT) were considered for inclusion, with start dates spanning 2005-2017
The timing of the first QuinteT Recruitment Intervention (QRI) action ranged from month 3 to month 14 of the RCT’s recruitment period
Summary
The QRI is designed to be integrated with an RCT’s recruitment plans. It aims to rapidly understand recruitment issues and implement solutions to address these while recruitment is underway. This is achieved through two iterative phases [13]. In brief: Phase 1 is a rapid investigation of the RCT’s recruitment processes using four core data collection processes: (1) audio-recording appointments where recruiters discuss the trial with potential participants; (2) interviews with recruiters and trial management group (TMG) members; (3) mapping eligibility and recruitment pathways; and (4) scrutinizing trial documentation.
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