Hammitt Katherine M, Naegeli April N, van den Broek Remon W M, Birt Julie A
Sjögren's Syndrome Foundation, Bethesda, Maryland, USA.
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.
RMD Open. 2017 Sep 17;3(2):e000443. doi: 10.1136/rmdopen-2017-000443. eCollection 2017.
The severity of Sjögren's syndrome has been evaluated using a wide variety of clinical measures and patient-reported outcomes (PROs). This may contribute to the lack of clarity concerning the burden of Sjögren's from the patient perspective.
To perform a comprehensive peer-reviewed literature analysis of the patient aspects of Sjögren's, focusing on PROs, to investigate the complexity underlying the evaluation of the syndrome and to elucidate the discordance between the different measures.
We searched Embase for articles published between January 2005 and September 2015. Research articles, clinical and diagnostic reviews, and validation studies with a focus on patient aspects of Sjögren's were selected as the primary information source.
157 articles met the eligibility criteria. A wide variety of assessment measures used to evaluate glandular, extraglandular and functional domains were observed. Many different, non-validated Visual Analogue Scales, with a wide range of anchor words, were used in the quantification of Sjögren's disease burden, impeding comparisons between studies. Relatively few clinical trials of drug therapies used validated scales: European League Against Rheumatism Sjögren's Syndrome Patient Reported Index was used most often for symptom assessment and 36 Item Short Form Survey for quality of life (QoL).
A wide range and diversity of measures are used to evaluate the patient burden of Sjögren's; most are not validated for use in this disease. PRO endpoints, validated specifically in Sjögren's, that demonstrate improvement are needed. These measures should focus on QoL aspects important to patients and will most likely involve gauging change in function rather than patient-reported symptoms.
干燥综合征的严重程度已通过多种临床指标和患者报告结局（PROs）进行评估。这可能导致从患者角度来看，干燥综合征的负担尚不清楚。
对干燥综合征患者方面进行全面的同行评审文献分析，重点关注PROs，以研究该综合征评估背后的复杂性，并阐明不同指标之间的不一致性。
我们在Embase数据库中检索了2005年1月至2015年9月发表的文章。选取了以干燥综合征患者方面为重点的研究文章、临床和诊断综述以及验证研究作为主要信息来源。
157篇文章符合纳入标准。观察到用于评估腺体、腺体外和功能领域的多种评估指标。在干燥综合征疾病负担的量化中，使用了许多不同的、未经验证的视觉模拟量表，其锚定词范围广泛，这妨碍了研究之间的比较。相对较少的药物治疗临床试验使用了经过验证的量表：欧洲抗风湿病联盟干燥综合征患者报告指数最常用于症状评估，而36项简短问卷调查用于生活质量（QoL）评估。
使用了广泛多样的指标来评估干燥综合征患者的负担；大多数指标未经验证可用于该疾病。需要有专门在干燥综合征中验证过的、能证明病情改善的PRO终点指标。这些指标应关注对患者重要的生活质量方面，很可能涉及衡量功能变化而非患者报告的症状。
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