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在临床实践中管理的慢性自发性荨麻疹患者中,一日一次荨麻疹活动评分(UAS)的西班牙语版本的心理测量特性(EVALUAS 研究)。

Psychometric properties of the Spanish version of the once-daily Urticaria Activity Score (UAS) in patients with chronic spontaneous urticaria managed in clinical practice (the EVALUAS study).

机构信息

Allergy Department, Hospital Universitario Basurto, Bilbao, Spain.

Dermatology Department, Hospital del Mar, Parc de Salut Mar, Universitat Autonoma Barcelona, Barcelona, Spain.

出版信息

Health Qual Life Outcomes. 2019 Jan 31;17(1):23. doi: 10.1186/s12955-019-1087-z.

Abstract

BACKGROUND

The daily diary Urticaria Activity Score (UAS) and its weekly score (UAS7) are widely used to assess signs and symptoms in patients with chronic spontaneous urticaria (CSU). The objective of this study was to assess the psychometric properties of a Spanish version of the once-daily UAS.

METHODS

Observational study in patients ≥18 years old receiving usual care for CSU (daily or almost daily occurrence of generalized hives or angioedema for ≥6 weeks). Patients were included consecutively and completed the UAS, EQ-5D, and the Chronic Urticaria Quality of Life scale (CU-QoL) at two study visits 6 weeks apart. On each occasion, the UAS was completed once-daily for 7 consecutive days to be able to calculate the UAS7 score. Psychometric properties of reliability, construct validity, and responsiveness were assessed. The Minimal Important Difference (MID) was estimated for the UAS7 using anchor- and distribution-based approaches.

RESULTS

Data from 166 patients was available for analysis (mean age 49 years, 65.7% female). Floor (5.4% of patients with the lowest possible score) and ceiling (1.2%) effects were low; 15% of patients had missing values. Internal consistency and test-retest reliability were good (Cronbach's alpha of 0.83 and an ICC of 0.84, respectively). Convergent validity was demonstrated through the pattern of correlations with the EQ-5D and CU-QoL and known groups' validity was demonstrated by the instrument's ability to discriminate between patients with different overall levels of urticaria severity, with between-group effect-sizes (ES) ranging from 0.36 to 1.19. The UAS7 proved responsive to change with effect sizes ranging from 0.3 to 1.52 in patients reporting improvement or deterioration in overall urticaria status. The MID for the UAS7 score was estimated at 7-8 points, on a scale of 0-42.

CONCLUSIONS

The Spanish version of the UAS score has demonstrated a robust psychometric performance in patients with CSU managed in conditions of usual care. It can therefore be considered a suitable instrument to assess disease activity in clinical practice in Spanish-speaking patients. The Spanish version's reliability and validity are similar to those reported for other language versions of the once- and twice-daily variants of the UAS.

摘要

背景

每日日记荨麻疹活动评分(UAS)及其每周评分(UAS7)被广泛用于评估慢性自发性荨麻疹(CSU)患者的体征和症状。本研究的目的是评估单次 UAS 的西班牙版本的心理测量特性。

方法

在接受 CSU 常规护理的年龄≥18 岁的患者中进行观察性研究(全身性荨麻疹或血管性水肿每天或几乎每天发生≥6 周)。连续纳入患者,并在两次相隔 6 周的研究访问中完成 UAS、EQ-5D 和慢性荨麻疹生活质量量表(CU-QoL)。每次都要在连续 7 天内每天完成一次 UAS,以计算 UAS7 评分。评估了可靠性、结构有效性和反应性的心理测量特性。使用基于锚点和分布的方法估计 UAS7 的最小重要差异(MID)。

结果

166 名患者的数据可用于分析(平均年龄 49 岁,65.7%为女性)。地板(最低可能评分的 5.4%的患者)和天花板(1.2%)效应较低;15%的患者有缺失值。内部一致性和重测信度良好(Cronbach 的 alpha 为 0.83,ICC 为 0.84)。通过与 EQ-5D 和 CU-QoL 的相关性模式以及已知群体的有效性证明了收敛效度,该工具能够区分不同总体荨麻疹严重程度的患者,组间效应大小(ES)范围为 0.36 至 1.19。UAS7 对变化具有反应性,在报告总体荨麻疹状况改善或恶化的患者中,其效果大小在 0.3 至 1.52 之间。UAS7 评分的 MID 估计为 7-8 分,范围为 0-42。

结论

在常规护理条件下管理的 CSU 患者中,UAS 评分的西班牙版本表现出了强大的心理计量性能。因此,它可以被认为是评估西班牙语患者临床实践中疾病活动的合适工具。西班牙版本的可靠性和有效性与其他语言版本的单次和两次 UAS 报告的相似。

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