Avedis Donabedian Research Institute (FAD), Universitat Autonòma de Barcelona, Barcelona, Spain.
Institute of General Practice, Goethe University, Frankfurt, Germany.
PLoS One. 2021 Mar 1;16(3):e0247522. doi: 10.1371/journal.pone.0247522. eCollection 2021.
A large body of evidence suggests that self-management interventions (SMIs) may improve outcomes in chronic obstructive pulmonary disease (COPD). However, accurate comparisons of the relative effectiveness of SMIs are challenging, partly due to heterogeneity of outcomes across trials and uncertainty about the importance of these outcomes for patients. We aimed to develop a core set of patient-relevant outcomes (COS) for SMIs trials to enhance comparability of interventions and ensure person-centred care.
We undertook an innovative approach consisting of four interlinked stages: i) Development of an initial catalogue of outcomes from previous EU-funded projects and/or published studies, ii) Scoping review of reviews on patients and caregivers' perspectives to identify outcomes of interest, iii) Two-round Delphi online survey with patients and patient representatives to rate the importance of outcomes, and iv) Face-to-face consensus workshop with patients, patient representatives, health professionals and researchers to develop the COS.
From an initial list of 79 potential outcomes, 16 were included in the COS plus one supplementary outcome relevant to all participants. These were related to patient and caregiver knowledge/competence, self-efficacy, patient activation, self-monitoring, adherence, smoking cessation, COPD symptoms, physical activity, sleep quality, caregiver quality of life, activities of daily living, coping with the disease, participation and decision-making, emergency room visits/admissions and cost effectiveness.
The development of the COPD COS for the evaluation of SMIs will increase consistency in the measurement and reporting of outcomes across trials. It will also contribute to more personalized health care and more informed health decisions in clinical practice as patients' preferences regarding COPD outcomes are more systematically included.
大量证据表明，自我管理干预（SMI）可能改善慢性阻塞性肺疾病（COPD）的结局。然而，由于试验之间结局的异质性以及这些结局对患者的重要性存在不确定性，准确比较 SMI 的相对有效性具有挑战性。我们旨在为 SMI 试验制定一套核心患者相关结局（COS），以增强干预措施的可比性并确保以患者为中心的护理。
我们采用了一种创新方法，包括四个相互关联的阶段：i）从以前的欧盟资助项目和/或已发表的研究中开发出初步的结局目录，ii）对患者和护理人员观点的综述进行范围界定，以确定感兴趣的结局，iii）对患者和患者代表进行两轮在线德尔菲调查，以对结局的重要性进行评分，iv）与患者、患者代表、卫生专业人员和研究人员进行面对面的共识研讨会，以制定 COS。
从最初的 79 个潜在结局列表中，有 16 个被纳入 COS，另外还有一个与所有参与者相关的补充结局。这些结局与患者和护理人员的知识/能力、自我效能、患者激活、自我监测、依从性、戒烟、COPD 症状、身体活动、睡眠质量、护理人员生活质量、日常生活活动、疾病应对、参与和决策、急诊室就诊/入院和成本效益有关。
COPD 的 SMI 评价用 COS 的制定将提高试验之间结局测量和报告的一致性。它还将通过更系统地纳入患者对 COPD 结局的偏好，为临床实践中的个性化医疗保健和更明智的医疗决策做出贡献。
