Overcoming difficulties with equipoise to enable recruitment to a randomised controlled trial of partial ablation vs radical prostatectomy for unilateral localised prostate cancer

Daisy Elliott, Freddie Hamdy, Tom Leslie, Derek Rosario, Tim Dudderidge, Richard Hindley, Mark Emberton, Simon Brewster, Prasanna Sooriakumaran, James Catto, Hashim Ahmed, Paul Whybrow, Steffi le Conte, Jenny Donovan

Research output: Contribution to journalArticle (Academic Journal)peer-review

6 Citations (Scopus)
209 Downloads (Pure)

Abstract

Objective
To describe how clinicians conceptualised equipoise in the PART (Partial prostate Ablation vs Radical prosTatectomy in intermediate‐risk unilateral clinically localised prostate cancer) feasibility study and how this affected recruitment.
Subjects and Methods
PART included a QuinteT Recruitment Intervention (QRI) to optimise recruitment. Phase I aimed to understand recruitment, and included: scrutinising recruitment data, interviewing the trial management group and recruiters (n = 13), and audio‐recording recruitment consultations (n = 64). Data were analysed using qualitative content and thematic analysis methods. In Phase II, strategies to improve recruitment were developed and delivered.

Results
Initially many recruiters found it difficult to maintain a position of equipoise and held preconceptions about which treatment was best for particular patients. They did not feel comfortable about approaching all eligible patients, and when the study was discussed, biases were conveyed through the use of terminology, poorly balanced information, and direct treatment recommendations. Individual and group feedback led to presentations to patients becoming clearer and enabled recruiters to reconsider their sense of equipoise. Although the precise impact of the QRI alone cannot be determined, recruitment increased (from a mean [range] of 1.4 [0–4] to 4.5 [0–12] patients/month) and the feasibility study reached its recruitment target.

Conclusion
Although clinicians find it challenging to recruit patients to a trial comparing different contemporary treatments for prostate cancer, training and support can enable recruiters to become more comfortable with conveying equipoise and providing clearer information to patients.
Original languageEnglish
Number of pages8
JournalBJU International
Early online date11 Jun 2018
DOIs
Publication statusE-pub ahead of print - 11 Jun 2018

Structured keywords

  • Centre for Surgical Research

Keywords

  • equipose
  • feasibility
  • qualitative
  • randomised control trial
  • recruitment
  • #PCSM
  • #ProstateCancer

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