Department of Palliative Medicine, University Hospital, LMU Munich, Munich, Germany
Department of Palliative Medicine, Albert Ludwig University of Freiburg, Freiburg im Breisgau, Germany.
BMJ Open. 2021 Jun 1;11(6):e042266. doi: 10.1136/bmjopen-2020-042266.
Over the last decades, patient-reported outcome (PRO) measures have been developed to better understand the patient's perspective and enable patient-centred care. In palliative care, the Integrated Palliative care Outcome Scale (IPOS) is recommended as a PRO tool. Its implementation in specialised palliative home care (SPHC) would benefit from an electronic version validated for the setting.Following the Medical Research Council (MRC) guidance, the study Palli-MONITOR is developing (phase 1) and testing the feasibility (phase 2) of implementing the electronic version of IPOS (eIPOS) in the SPHC setting to inform a cluster-randomised phase 3 trial.
Palli-MONITOR is a multicentre, sequential mixed-methods, two-phase development and feasibility study. The study consists of four substudies. In phase 1 (MRC development phase), qualitative patient interviews and focus groups with SPHC professionals are used to identify barriers and facilitators of eIPOS (substudy I). Substudy II tests the equivalence of eIPOS and IPOS in a crossover randomised controlled trial. Phase 2 (MRC feasibility/piloting phase) includes a quasi-experimental study with two control groups (substudy III), and qualitative interviews as well as focus groups to explore the feasibility and acceptability of the developed intervention (substudy IV).Qualitative data will be analysed with thematic analysis following the framework approach. Quantitative analysis uses a two-way intraclass correlation coefficients model for the equivalence testing. Quantitative analysis of the quasi-experimental study will focus on the primary outcomes, recruitment rates and completeness of eIPOS. Secondary outcomes will include intraindividual change in palliative symptoms and concerns, quality of life and symptom burden.
Approval of the ethics committee of the Ludwig Maximilian University Munich was received for all study parts. Results and experiences will be presented at congresses and in written form. Additionally, participating SPHC teams will receive summarised results.
NCT03879668.
在过去的几十年中，人们开发了患者报告结局（PRO）测量方法，以更好地了解患者的观点并实现以患者为中心的护理。在姑息治疗中，建议将综合姑息治疗结局量表（IPOS）作为 PRO 工具。如果在专门的姑息治疗家庭护理（SPHC）中实施，该量表的电子版本将受益于经过验证的版本。根据医学研究委员会（MRC）的指导，研究 Palli-MONITOR 正在开发（第 1 阶段）并测试（第 2 阶段）在 SPHC 环境中实施 IPOS 电子版本（eIPOS）的可行性，以便为一项集群随机临床试验提供信息。
Palli-MONITOR 是一项多中心、顺序混合方法、两阶段开发和可行性研究。该研究由四项子研究组成。在第 1 阶段（MRC 开发阶段）中，对 SPHC 专业人员进行定性患者访谈和焦点小组讨论，以确定 eIPOS 的障碍和促进因素（子研究 I）。子研究 II 在交叉随机对照试验中测试 eIPOS 和 IPOS 的等效性。第 2 阶段（MRC 可行性/试验阶段）包括一项具有两个对照组的准实验研究（子研究 III），以及定性访谈和焦点小组，以探索开发干预措施的可行性和可接受性（子研究 IV）。定性数据将按照框架方法进行主题分析。定量分析使用双向内类相关系数模型进行等效性测试。准实验研究的定量分析将侧重于主要结局、招募率和 eIPOS 的完整性。次要结局将包括姑息症状和关注点、生活质量和症状负担的个体内变化。
所有研究部分均获得了慕尼黑路德维希马克西米利安大学伦理委员会的批准。结果和经验将在会议上和书面形式呈现。此外，参与 SPHC 团队将收到总结的结果。
NCT03879668。
