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

Leila Rooshenas*, By-Band-Sleeve study group, CSAW study group, HAND-1 study group, OPTIMA prelim study group, the Romio feasibility study group, Lauren J. Scott, Jane M. Blazeby, Chris A. Rogers, Kate M. Tilling, Samantha Husbands, Carmel Conefrey, Nicola Mills, Chris Metcalfe, Andrew J. Carr, David Beard, Tim Davis, Sangeetha Paramasivan, Marcus Jepson, Kerry AveryDaisy Elliott, Caroline A Wilson, Jenny L. Donovan, Iain E Macpherson

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)

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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: 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.

Keywords: Randomized Controlled Trial; Clinical trial; Recruitment; Training healthcare professionals; Qualitative research; Communication.
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

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Structured keywords

  • Centre for Surgical Research

Keywords

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

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