Overcoming difficulties with equipoise to enable recruitment to a randomised controlled trial of partial ablation versus radical prostatectomy for unilateral localised prostate cancer
File(s)Elliott_et_al-2018-BJU_International.pdf (182.42 KB)
Published version
Author(s)
Type
Journal Article
Abstract
OBJECTIVE: To describe how clinicians conceptualised equipoise in the PART (Partial prostate Ablation versus 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 mean 1.4 (range=0-4) to 4.5 (range=0-12) patients per month) and the feasibility study reached its recruitment target. CONCLUSION: Although clinicians find it challenging to recruit participants 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.
Date Issued
2018-12-01
Date Acceptance
2018-06-01
Citation
BJU International, 2018, 122 (6), pp.970-977
ISSN
1464-4096
Publisher
Wiley
Start Page
970
End Page
977
Journal / Book Title
BJU International
Volume
122
Issue
6
Copyright Statement
© 2018 The Authors BJU International published by John Wiley & Sons Ltd on behalf of BJU International
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
Sponsor
Wellcome Trust
University College London Hospitals Charity
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/29888845
Grant Number
204998/Z/16/Z
1348
Subjects
Equipoise
Feasibility
Prostate cancer
Qualitative
Randomised Controlled Trial
Recruitment
Publication Status
Published
Coverage Spatial
England
Date Publish Online
2018-06-11