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

Elliott, Daisy; Hamdy, Freddie C.; Leslie, Tom A.; Rosario, Derek; Dudderidge, Tim; Hindley, Richard; Emberton, Mark; Brewster, Simon; Sooriakumaran, Prasanna; Catto, James W.F.; Ahmed, Hashim; Whybrow, Paul; Conte, S; Donovan, Jenny L.

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.

• Journal Article Type: Article
• Acceptance Date: Jun 4, 2018
• Online Publication Date: Jun 11, 2018
• Publication Date: Dec 1, 2018
• Deposit Date: Jul 31, 2018
• Publicly Available Date: Jun 11, 2019
• Journal: BJU International
• Print ISSN: 1464-4096
• Electronic ISSN: 1464-410X
• Publisher: Wiley
• Peer Reviewed: Peer Reviewed
• Volume: 122
• Issue: 6
• Pages: 970-977
• DOI: https://doi.org/10.1111/bju.14432
• Keywords: overcoming difficulties, equipoise, recruitment, randomised controlled trial, partial ablation, radical prostatectomy, unilateral localised, prostate cancer
• Public URL: https://uwe-repository.worktribe.com/output/866768
• Publisher URL: https://doi.org/10.1111/bju.14432
• Related Public URLs: https://onlinelibrary.wiley.com/doi/abs/10.1111/bju.14432
• Additional Information: Additional Information : This is the peer reviewed version of the following article: [Elliott, D., Hamdy, F., Leslie, T., Rosario, D., Dudderidge, T., Hindley, R., Emberton, M., Brewster, S., Sooriakumaran, P., Catto, J., Ahmed, H., Whybrow, P., Conte, S. and Donovan, J. (2018) Overcoming difficulties with equipoise to enable recruitment to a randomised controlled trial of partial ablation versus radical prostatectomy for unilateral localised prostate cancer. BJU International. ISSN 1464-410X], which has been published in final form at https://doi.org/10.1111/bju.14432. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.
• Contract Date: Jul 31, 2018