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

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Title: Overcoming difficulties with equipoise to enable recruitment to a randomised controlled trial of partial ablation versus radical prostatectomy for unilateral localised prostate cancer
Authors: Elliott, D
Hamdy, FC
Leslie, TA
Rosario, D
Dudderidge, T
Hindley, R
Emberton, M
Brewster, S
Sooriakumaran, P
Catto, JWF
Emara, A
Ahmed, H
Whybrow, P
Le Conte, S
Donovan, JL
Item 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.
Issue Date: 1-Dec-2018
Date of Acceptance: 1-Jun-2018
URI: http://hdl.handle.net/10044/1/60738
DOI: https://dx.doi.org/10.1111/bju.14432
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.
Sponsor/Funder: Wellcome Trust
University College London Hospitals Charity
Funder's Grant Number: 204998/Z/16/Z
1348
Keywords: Science & Technology
Life Sciences & Biomedicine
Urology & Nephrology
equipoise
feasibility
qualitative
recruitment
randomised controlled trial
#PCSM
#ProstateCancer
QUALITATIVE RESEARCH
FEASIBILITY
THERAPY
ISSUES
RCT
#PCSM
#ProstateCancer
equipoise
feasibility
qualitative
randomised controlled trial
recruitment
Attitude of Health Personnel
Feasibility Studies
Humans
Male
Patient Selection
Prostatectomy
Prostatic Neoplasms
Qualitative Research
Radiofrequency Ablation
Randomized Controlled Trials as Topic
Research Subjects
Therapeutic Equipoise
Humans
Prostatic Neoplasms
Prostatectomy
Feasibility Studies
Attitude of Health Personnel
Qualitative Research
Patient Selection
Research Subjects
Male
Randomized Controlled Trials as Topic
Therapeutic Equipoise
Radiofrequency Ablation
Equipoise
Feasibility
Prostate cancer
Qualitative
Randomised Controlled Trial
Recruitment
Urology & Nephrology
1103 Clinical Sciences
Publication Status: Published
Conference Place: England
Online Publication Date: 2018-06-11
Appears in Collections:Department of Surgery and Cancer