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

By-Band-Sleeve study group, CSAW study group, HAND-1 study group, OPTIMA prelim study group, the Romio feasibility study group, 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 JepsonKerry Avery, Daisy Elliott, Caroline Wilson, Jenny L. Donovan, 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, Jonathan Rees, Wei Tan, Nicola Mills, John Bartlett, Peter Canney, Janet Dunn, Helena Earl, Adele Francis, Peter Hall, Helen Higgins, Louise Hiller, Andrea Marshall, Christopher McCabe, Christopher Poole, Daniel Rea

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

18 Citations (Scopus)
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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 languageEnglish
Pages (from-to)108-120
Number of pages13
JournalJournal of Clinical Epidemiology
Volume106
Early online date16 Oct 2018
DOIs
Publication statusPublished - 1 Feb 2019

Keywords

  • Clinical trial
  • Communication
  • Qualitative research
  • Randomized controlled trial
  • Recruitment
  • Training healthcare professionals

ASJC Scopus subject areas

  • Epidemiology

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