Identification of outcome domains in primary Sjögren's disease: A scoping review by the OMERACT Sjögren disease working group,Seminars in Arthritis and Rheumatism |
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Identification of outcome domains in primary Sjögren's disease: A scoping review by the OMERACT Sjögren disease working group,Seminars in Arthritis and Rheumatism
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Sjögren's disease (SjD) is a heterogenous disease with a wide range of manifestations, ranging from symptoms of dryness, fatigue, and pain, to systemic involvement. Considerable advances have been made to evaluate systemic activity or patient-reported outcomes, but most of the instruments were not able to assess all domains of this multifaceted disease. The aim of this scoping review was to generate domains that have been assessed in randomized controlled trials, as the first phase of the Outcome Measures in Rheumatology (OMERACT) process of core domain set development. We systematically searched Medline (Pubmed) and EMBASE between 2002 and March 2023 to identify all randomized controlled trials assessing relevant domains, using both a manual approach and an artificial intelligence software (BIBOT) that applies natural language processing to automatically identify relevant abstracts. Domains were mapped to core areas, as suggested by the OMERACT 2.1 Filter. Among the 5,420 references, we included 60 randomized controlled trials, focusing either on overall disease manifestations (53%) or on a single organ/symptom: dry eyes (17%), xerostomia (15%), fatigue (12%), or pulmonary function (3%). The most frequently assessed domains were perceived dryness (52% for overall dryness), fatigue (57%), pain (52%), systemic disease activity (45%), lacrimal gland function (47%) and salivary function (55%), B-cell activation (60%), and health-related quality of life (40%). Our scoping review highlighted the heterogeneity of SjD, in the study designs and domains. This will inform the OMERACT SjD working group to select the most appropriate core domains to be used in SjD clinical trials and to guide the future agenda for outcome measure research in SjD
中文翻译：
干燥病 (SjD) 是一种异质性疾病，具有多种表现形式，从干燥、疲劳和疼痛症状到全身受累。在评估系统活动或患者报告的结果方面已经取得了相当大的进展，但大多数仪器无法评估这种多方面疾病的所有领域。本次范围界定审查的目的是生成已在随机对照试验中评估的领域，作为风湿病结果测量 (OMERACT) 核心领域集开发过程的第一阶段。我们在 2002 年至 2023 年 3 月期间系统地检索了 Medline (Pubmed) 和 EMBASE，以识别评估相关领域的所有随机对照试验，使用手动方法和应用自然语言处理自动识别相关摘要的人工智能软件 (BIBOT)。根据 OMERACT 2.1 过滤器的建议，域被映射到核心区域。在 5,420 份参考文献中，我们纳入了 60 项随机对照试验，重点关注总体疾病表现 (53%) 或单一器官/症状：干眼症 (17%)、口干症 (15%)、疲劳 (12%) 或肺功能（3%）。最常评估的领域是感知干燥（整体干燥为 52%）、疲劳（57%）、疼痛（52%）、全身性疾病活动（45%）、泪腺功能（47%）和唾液功能（55%） 、B 细胞激活 (60%) 和健康相关的生活质量 (40%)。我们的范围审查强调了 SjD 在研究设计和领域中的异质性。这将为 OMERACT SjD 工作组选择用于 SjD 临床试验的最合适的核心领域提供信息，并指导 SjD 结果测量研究的未来议程 |
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