Coyle David, Ormandy Paula, Fernandes da Silva Nancy, Davies Simon
NIHR Devices for Dignity, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
School of Health and Society, University of Salford, Manchester, UK.
Health Technol Assess. 2025 Jan 29:1-18. doi: 10.3310/DOTR5903.
For people receiving haemodialysis, a balance has to be struck between removing sufficient but not too much fluid during a treatment session and maintaining any remaining kidney function they might have. In the BISTRO trial, this study sought to establish if getting the balance right might be improved by the additional use of bioimpedance, a device that measures body fluid composition to help decide how much fluid to remove during dialysis. Designing and executing this trial, which incorporated complex and repeated trial procedures that would be dependent on participant engagement, presented challenges that demanded effective public and patient involvement.
This study aimed to develop an effective public and patient involvement participation model, ensuring that the patient voice was heard by the Trial Management Group, with a Patient Advisory Group undertaking coproduction of all participant-facing documents and communications, including dissemination of the trial results, with the main purpose of maximising participant engagement in the study.
An open-label randomised controlled trial in which 439 participants from 34 centres were allocated for regular assessments of their bodily fluid content with or without the use of bioimpedance measurements.
Development of an effective public and patient involvement working model that was represented within the Trial Management Group, contributing to protocol design, selection of bioimpedance device, and coproduction of all participant-facing communications including dissemination of trial findings.
Public and patient involvement contribution prior to trial initiation, description of the participant-facing communications, adherence to trial materials, dropout and dissemination of trial findings. Post-trial evaluation by research teams, Patient Advisory Group and co-applicants.
An effective working model was developed which relied on remuneration of the public and patient involvement patient lead and use of social media (e.g. WhatsApp) to maximise inclusivity. The Patient Advisory Group coproduced with the Trial Management Group a series of communication postcards and newsletters and a web page to support the participants and disseminate the trial results that were highly rated by research teams, but not always passed on to trial participants. Participant adherence to the main trial outcomes was excellent (113.6% urine collections obtained). Potentially avoidable dropout was 14.4%, with 3.6% being clearly attributable to inability or unwillingness to comply with the trial procedures. Reflections by the Patient Advisory Group indicated that they felt valued, involved and listened to but anticipated more direct involvement with the trial participants, recommending that barriers to this be addressed during the trial design and set-up.
Evaluation of public and patient involvement was retrospective and there was a lack of real-time assessment of the impact of public and patient involvement that might have supported a causative link between public and patient involvement interventions and the successful delivery of the trial.
Public and patient involvement played an important role in the design, delivery and dissemination of the BISTRO trial. Key to this success was the close relationship between the Patient Advisory Group and the Trial Management Group. Given the complexity of the intervention, dropout was reasonably low and did not compromise trial findings, but reasons were not always clear. Prospective gathering of data to capture the impact of public and patient involvement is recommended and direct support for participants facilitated.
This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 14/216/01.
对于接受血液透析的患者而言，在一次治疗过程中，必须在充分清除但不过多清除液体与维持其可能尚存的任何残余肾功能之间取得平衡。在BISTRO试验中，本研究旨在确定额外使用生物电阻抗（一种测量体液成分以帮助确定透析期间清除多少液体的设备）是否可能改善这种平衡的把握。设计和实施该试验面临诸多挑战，该试验纳入了复杂且重复的试验程序，而这些程序依赖于参与者的参与，这就需要有效的公众和患者参与。
本研究旨在建立一个有效的公众和患者参与模式，确保试验管理小组能够听取患者的意见，由患者咨询小组共同制作所有面向参与者的文件和沟通材料，包括试验结果的传播，主要目的是最大限度地提高参与者对研究的参与度。
一项开放标签随机对照试验，来自34个中心的439名参与者被分配接受有无生物电阻抗测量的定期体液含量评估。
建立一个有效的公众和患者参与工作模式，该模式在试验管理小组中有代表，为方案设计、生物电阻抗设备的选择以及所有面向参与者的沟通材料（包括试验结果的传播）的共同制作做出贡献。
试验启动前公众和患者参与的贡献、面向参与者的沟通材料的描述、对试验材料的依从性、退出情况以及试验结果的传播。研究团队、患者咨询小组和共同申请人进行试验后评估。
开发了一个有效的工作模式，该模式依赖于对公众和患者参与患者负责人的报酬以及使用社交媒体（如WhatsApp）以最大限度地提高包容性。患者咨询小组与试验管理小组共同制作了一系列沟通明信片、时事通讯和一个网页，以支持参与者并传播试验结果，这些材料得到了研究团队的高度评价，但并非总是传达给试验参与者。参与者对主要试验结局的依从性极佳（尿液收集率达113.6%）。潜在可避免的退出率为14.4%，其中3.6%显然归因于无法或不愿遵守试验程序。患者咨询小组的反思表明，他们感到自己受到重视、参与其中且意见得到倾听，但期望能更多地直接参与试验参与者的事务，并建议在试验设计和筹备期间解决这方面的障碍。
对公众和患者参与的评估是回顾性的，缺乏对公众和患者参与影响的实时评估，而这种评估可能有助于支持公众和患者参与干预措施与试验成功实施之间的因果关系。
公众和患者参与在BISTRO试验的设计、实施和传播中发挥了重要作用。这一成功的关键在于患者咨询小组与试验管理小组之间的密切关系。鉴于干预措施的复杂性，退出率相当低且未影响试验结果，但原因并不总是清晰明确。建议前瞻性收集数据以了解公众和患者参与的影响，并为参与者提供直接支持。
本文介绍了由英国国家卫生与保健研究所（NIHR）卫生技术评估计划资助的独立研究，资助编号为14/216/01。
