SAPPHIRE, Department of Health Sciences, University of Leicester, Leicester, UK
Digestive Diseases Unit, Kettering General Hospital, Kettering, UK.
BMJ Open. 2023 Jan 6;13(1):e064117. doi: 10.1136/bmjopen-2022-064117.
Strong recruitment and retention into randomised controlled trials involving invasive therapies is a matter of priority to ensure better achievement of trial aims. The BRIDE (Barrett's Randomised Intervention for Dysplasia by Endoscopy) Study investigated the feasibility of undertaking a multicentre randomised controlled trial comparing argon plasma coagulation and radiofrequency ablation, following endoscopic resection, for the management of early Barrett's neoplasia. This paper aims to identify factors influencing patients' participation in the BRIDE Study and determine their views regarding acceptability of a potential future trial comparing surgery with endotherapy.
A semistructured telephone interview study was performed, including both patients who accepted and declined to participate in the BRIDE trial. Interview data were analysed using the constant comparison approach to identify recurring themes.
Interview participants were recruited from across six UK tertiary centres where the BRIDE trial was conducted.
We interviewed 18 participants, including 11 participants in the BRIDE trial and 7 who declined.
Four themes were identified centred around interviewees' decision to accept or decline participation in the BRIDE trial and a potential future trial comparing endotherapy with surgery: (1) influence of the recruitment process and participant-recruiter relationship; (2) participants' views of the design and aim of the study; (3) conditional altruism as a determining factor and (4) participants' perceptions of surgical risks versus less invasive treatments.
We identified four main influences to optimising recruitment and retention to a randomised controlled trial comparing endotherapies in patients with early Barrett's-related neoplasia. These findings highlight the importance of qualitative research to inform the design of larger randomised controlled trials.
强有力的招募和保留参与涉及侵袭性治疗的随机对照试验是当务之急，以确保更好地实现试验目标。BRIDE（Barrett's 随机干预性内镜下治疗异型增生）研究调查了开展一项多中心随机对照试验的可行性，比较内镜下切除后氩等离子凝固和射频消融治疗早期 Barrett 肿瘤的疗效。本文旨在确定影响患者参与 BRIDE 研究的因素，并确定他们对未来比较手术与内镜治疗的潜在试验的可接受性的看法。
采用半结构化电话访谈研究，包括接受和拒绝参与 BRIDE 试验的患者。使用恒比法分析访谈数据，以确定反复出现的主题。
BRIDE 试验在英国六家三级中心进行，访谈参与者来自这些中心。
我们共采访了 18 名参与者，其中 11 名参加了 BRIDE 试验，7 名拒绝参加。
确定了四个主题，围绕着参与者接受或拒绝参与 BRIDE 试验以及未来比较内镜治疗与手术的潜在试验的决定：（1）招募过程和参与者-招募者关系的影响；（2）参与者对研究设计和目的的看法；（3）条件利他主义是一个决定因素；（4）参与者对手术风险与非侵入性治疗的看法。
我们确定了优化比较早期 Barrett 相关异型增生患者的内镜治疗的随机对照试验招募和保留率的四个主要影响因素。这些发现强调了定性研究对指导更大规模随机对照试验设计的重要性。
