评估 IgG4 相关疾病（IgG4-RD）患者报告的症状和痛苦：IgG4-RD 症状严重程度指数的制定、临床验证和内容验证。
Assessment of patient-reported symptoms and distress in IgG4-related disease (IgG4-RD): Development, clinical validation, and content validation of the IgG4-RD Symptom Severity Index.
机构信息
Clinical Epidemiology Program, Mongan Institute, Massachusetts General Hospital, USA; Rheumatology Unit, Division of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, USA; Harvard Medical School, USA.
Clinical Epidemiology Program, Mongan Institute, Massachusetts General Hospital, USA; Rheumatology Unit, Division of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, USA.
出版信息
Semin Arthritis Rheum. 2023 Dec;63:152253. doi: 10.1016/j.semarthrit.2023.152253. Epub 2023 Aug 18.
OBJECTIVE
IgG4-related disease (IgG4-RD), a multi-organ autoimmune disease, causes diverse manifestations that can lead to symptoms and distress. We developed and validated the Symptom Severity Index (SSI) to assess symptom burden.
METHODS
A pilot SSI was tested in n = 5; several gaps were identified. Twenty semi-structured qualitative interviews were performed to expand the item set and identify missing symptoms. Subsequent changes resulted in the current SSI; it was administered with quality of life (QOL) measures to n = 136. We assessed symptom burden and the construct validity of the SSI. A distress score for each symptom is calculated by multiplying symptom frequency ("Never" [0 points] to "Every Day" [3 points]) by associated distress ("None" [0 points] to "Very Much" [4 points]). Each distress score is summed to calculate a total SSI score.
RESULTS
The SSI assesses the frequency and distress of 24 symptoms. Among n = 136 with ≥ 1 SSI, 90% experienced ≥ 1 symptom and 88% had distress. The median SSI score was 6.5 (IQR 3.0, 18.0). Fear of more severe disease was observed in 49%. The SSI inversely correlated with the SF-36 (r= - 0.51, p<0.001), the feeling thermometer (r= - 0.28, p<0.001), and the EQ-5D (r= - 0.28, p<0.001). The median SSI score was higher during active vs non-active disease among n = 52 who completed >1 SSI (15 [6, 26] vs. 3 [2, 14], p = 0.008).
CONCLUSIONS
Symptoms and distress are common in IgG4-RD and associated with worse health-related QOL. The SSI has face, content, and construct validity; it corresponds with QOL measures.
目的
IgG4 相关疾病（IgG4-RD）是一种多器官自身免疫性疾病，其临床表现多样，可导致症状和痛苦。我们开发并验证了症状严重程度指数（SSI）来评估症状负担。
方法
在 n=5 中测试了试点 SSI；发现了几个差距。进行了 20 次半结构化定性访谈，以扩展项目集并确定缺失的症状。随后的变化导致了当前的 SSI；它与生活质量（QOL）措施一起用于 n=136。我们评估了 SSI 的症状负担和结构效度。通过将症状频率乘以相关痛苦（从不[0 分]到非常多[4 分]），为每个症状计算痛苦得分。每个痛苦得分相加得到总的 SSI 得分。
结果
SSI 评估了 24 个症状的频率和痛苦。在 n=136 个≥1 SSI 的患者中，90%的患者有≥1个症状，88%的患者有痛苦。SSI 的中位数为 6.5（IQR 3.0，18.0）。有 49%的人担心疾病更严重。SSI 与 SF-36（r=-0.51，p<0.001）、感觉温度计（r=-0.28，p<0.001）和 EQ-5D（r=-0.28，p<0.001）呈负相关。在 n=52 名完成≥1 次 SSI 的患者中，活动期与非活动期相比，SSI 中位数更高（15[6,26]vs.3[2,14]，p=0.008）。
结论
在 IgG4-RD 中，症状和痛苦很常见，与健康相关的 QOL 更差相关。SSI 具有表面效度、内容效度和结构效度；它与 QOL 测量相对应。
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