Institute of Medical Science, University of Toronto-St George Campus, Toronto, Ontario, Canada
Multi-organ Transplant, UHN, Toronto, Ontario, Canada.
BMJ Open. 2024 Jan 30;14(1):e080712. doi: 10.1136/bmjopen-2023-080712.
Patients with kidney failure experience symptoms that are often under-recognised and undermanaged. These symptoms negatively impact health-related quality of life and are associated with adverse clinical outcomes. Regular symptom assessment, using electronic patient reported outcomes measure (ePROMs) linked to systematic symptom management, could improve such outcomes. Clinical implementation of ePROMs have been successful in routine oncology care, but not used for patients on dialysis. In this study, we describe a pilot study of ePROM-based systematic symptom monitoring and management intervention in patients treated with in-centre haemodialysis.
This is a parallel-arm, controlled pilot of adult patients receiving in-centre maintenance haemodialysis. Participants in the intervention arm will complete ePROMs once a month for 6 months. ePROMs will be scored real time and the results will be shared with participants and with the clinical team. Moderate-severe symptoms will be flagged using established cut-off scores. Referral options for those symptoms will be shared with the clinical team, and additional symptom management resources will also be provided for both participants and clinicians. Participants in the control arm will be recruited at a different dialysis unit, to prevent contamination. They will receive usual care, except that they will complete ePROMs without the presentation of results to participants of the clinical team. The primary objectives of the pilot are to assess (1) the feasibility of a larger, randomised clinical effectiveness trial and (2) the acceptability of the intervention. Interviews conducted with participants and staff will be assessed using a content analysis approach.
Ethical approval for this study was obtained from the University Health Network (REB#21-5199) and the William Osler Health System (#23-0005). All study procedures will be conducted in accordance with the standards of University Health Network research ethics board and with the 1964 Helsinki declaration and its later amendments. Results of this study will be shared with participants, patients on dialysis and other stakeholders using lay language summaries, oral presentations to patients and nephrology professionals. We will also be publishing the results in a peer-reviewed journal and at scientific meetings.
4 (16 November 2022).
NCT05515991.
肾衰竭患者会出现经常被忽视和处理不当的症状。这些症状会对健康相关的生活质量产生负面影响，并与不良的临床结局相关。使用与系统症状管理相关的电子患者报告结局测量工具（ePROMs）定期进行症状评估，可以改善这些结局。ePROMs 在常规肿瘤学护理中的临床应用已取得成功，但尚未用于透析患者。在这项研究中，我们描述了一项针对中心血液透析患者的基于 ePROM 的系统症状监测和管理干预的试点研究。
这是一项接受中心维持性血液透析的成年患者的平行臂对照性试点研究。干预组的参与者将每月完成一次 ePROMs，为期 6 个月。ePROMs 将实时评分，结果将与参与者和临床团队共享。使用既定的截断分数标记中度至重度症状。对于这些症状，将共享转诊选项给临床团队，还将为参与者和临床医生提供额外的症状管理资源。对照组的参与者将在另一个透析单位招募，以防止交叉污染。他们将接受常规护理，但他们将在不向临床团队的参与者展示结果的情况下完成 ePROMs。该试点的主要目标是评估（1）更大规模的随机临床有效性试验的可行性，（2）干预的可接受性。对参与者和工作人员进行的访谈将使用内容分析方法进行评估。
这项研究获得了大学健康网络（REB#21-5199）和威廉·奥瑟尔健康系统（#23-0005）的伦理批准。所有研究程序将按照大学健康网络研究伦理委员会的标准以及 1964 年赫尔辛基宣言及其后修正案进行。这项研究的结果将以通俗易懂的摘要、向患者和肾病学专业人员的口头报告以及同行评议的期刊和科学会议上的发表等方式与参与者、透析患者和其他利益相关者分享。
4（2022 年 11 月 16 日）。
NCT05515991。
