Equipoise Across the Patient Population: Optimising the Timing of Recruitment to a Randomized Controlled Trial

Paul Whybrow, Robert Pickard, Susan Hrisos, Tim Rapley

Research output: Contribution to journalArticle (Academic Journal)

171 Downloads (Pure)

Abstract

Background
This paper proposes a novel perspective on the value of qualitative research for improving trial design and optimising recruitment. We report findings from a qualitative study set within the OPEN trial, a surgical randomised controlled trial (RCT) comparing two interventions for recurrent bulbar urethral stricture, a common cause of urinary problems in men.

Methods
Interviews were conducted with men meeting trial eligibility criteria (n = 19) to explore reasons for accepting or declining participation and with operating urologists (n = 15) to explore trial acceptability.

Results
Patients expressed various preferences and understood these in the context of relative severity and tolerability of their symptoms. Accounts suggest a common trajectory of worsening symptoms with a particular window within which either treatment arm would be considered acceptable. Interviews with clinician recruiters found that uncertainty varied between general and specialist sites, which reflect clinicians’ relative exposure to different proportions of the patient population.

Conclusion
Recruitment post referral, at specialist sites, was challenging due to patient (and clinician) expectations. Trial design, particularly where there are fixed points for recruitment along the care pathway, can enable or constrain the possibilities for effective accrual depending on how it aligns with the optimum point of patient equipoise. Qualitative recruitment investigations, often focussed on information provision and patient engagement, may also look to better understand the target patient population in order to optimise the point at which patients are approached.
Original languageEnglish
Article number140
Number of pages12
JournalTrials
Volume18
Issue number1
DOIs
Publication statusPublished - 27 Mar 2017

Keywords

  • Trials
  • Recruitment
  • Qualitative
  • Multicentre
  • Trial design
  • Surgical trial
  • Equipoise
  • Patient preferences

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