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.
Original language | English |
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Pages (from-to) | 108-120 |
Number of pages | 13 |
Journal | Journal of Clinical Epidemiology |
Volume | 106 |
Early online date | 16 Oct 2018 |
DOIs | |
Publication status | Published - 1 Feb 2019 |
Keywords
- Clinical trial
- Communication
- Qualitative research
- Randomized controlled trial
- Recruitment
- Training healthcare professionals
ASJC Scopus subject areas
- Epidemiology