Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Valdemar Hansens vej 1-13, 2600 Glostrup, Denmark.
Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Valdemar Hansens vej 1-13, 2600 Glostrup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, Denmark.
Semin Arthritis Rheum. 2022 Jun;54:151995. doi: 10.1016/j.semarthrit.2022.151995. Epub 2022 Mar 16.
Evaluating the effect of self-management interventions targeting people with inflammatory arthritis (IA) is a challenge because self-management interventions are complex and consensus on important outcomes is lacking. The aim is to identify, and map applied outcome domains and outcome measurement instruments from previous trials measuring the effect of self-management interventions targeting people with IA.
We performed an informative systematic literature review following guidance from the 'Outcome Measures in Rheumatology' (OMERACT) and 'Core Outcome Measures in Effectiveness Trials' (COMET) initiatives. Trials describing their experimental intervention as "self-management" applied in people diagnosed with any IA were included. Information on outcome domains and the corresponding measurement instruments were extracted, sorted, and categorized in domains and sub-domains.
From a total of 2,502 records, we included 38 trials published between 1988 and 2021. We identified 12 different outcome domains, covering 39 subdomains, collected with 119 different measurement instruments. The most frequently applied outcome domains were self-efficacy, pain, physical functioning/disability, anxiety and depression, quality of life, fatigue, global assessment/disease activity and coping. The applied measurement instruments varied within each outcome domain and were predominantly patient-reported outcomes.
The outcome domains and measurement instruments used in self-management trials were widely diverse and differ from the current general OMERACT Core Outcome Sets (COS) for IA conditions. Further steps towards the establishment of a COS to be reported in all self-management intervention trials will enhance the relevance and the subsequent impact on the body of evidence from these trials.
评估针对炎症性关节炎（IA）患者的自我管理干预效果具有挑战性，因为自我管理干预措施较为复杂，并且缺乏对重要结局的共识。本研究旨在确定并绘制既往针对 IA 患者的自我管理干预效果评估试验中应用的结局领域和结局测量工具，并进行分类。
我们按照“风湿病结局测量（OMERACT）”和“疗效试验核心结局测量（COMET）”倡议的指导进行了一项信息丰富的系统文献回顾。纳入的试验需将其实验性干预描述为“自我管理”，并应用于确诊为任何类型 IA 的患者。我们提取、分类和整理了结局领域和相应测量工具的信息。
在总共 2502 条记录中，我们纳入了 1988 年至 2021 年期间发表的 38 项试验。我们确定了 12 个不同的结局领域，涵盖 39 个子领域，使用了 119 种不同的测量工具。应用最广泛的结局领域包括自我效能、疼痛、身体功能/残疾、焦虑和抑郁、生活质量、疲劳、总体评估/疾病活动度和应对能力。在每个结局领域中应用的测量工具各不相同，主要是患者报告的结局。
自我管理试验中使用的结局领域和测量工具广泛多样，与当前 IA 疾病的一般 OMERACT 核心结局集（COS）不同。进一步朝着为所有自我管理干预试验报告建立 COS 的方向努力，将提高这些试验证据的相关性和后续影响力。
