Equipoise across the patient population: optimising recruitment to a randomised controlled trial

Whybrow, Paul; Pickard, Robert; Hrisos, Susan; Rapley, Tim

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.

Citation

Whybrow, P., Pickard, R., Hrisos, S., & Rapley, T. (2017). Equipoise across the patient population: optimising recruitment to a randomised controlled trial. Trials, 18(1), Article 140. https://doi.org/10.1186/s13063-016-1711-8

• Journal Article Type: Article
• Acceptance Date: Nov 16, 2016
• Online Publication Date: Mar 27, 2017
• Publication Date: 2017-12
• Deposit Date: Mar 20, 2021
• Publicly Available Date: Mar 29, 2021
• Journal: Trials
• Print ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 18
• Issue: 1
• Article Number: 140
• DOI: https://doi.org/10.1186/s13063-016-1711-8
• Keywords: Trials; Recruitment; Qualitative; Multicentre; Trial design; Surgical trial; Equipoise; Patient preferences
• Public URL: https://hull-repository.worktribe.com/output/3742940