BACKGROUND Chronic urticaria is defined as the appearance of urticarial lesions and/or angioedema during a period of more than six weeks. We aimed at developing the Portuguese version of the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) and at testing its reliability and the content, construct and criterion validity. METHODS The forward-backward approach to a linguistic equivalence was followed, after which a clinical review and a cognitive debriefing with patients were performed. The intraclass correlation coefficient checked test-retest reliability with patients filling the same questionnaire with one week apart and the Cronbach's alpha indicator assessed the internal consistency. Construct validity was tested by an exploratory factor analysis and by hypothesis tests involving sociodemographic and clinical patient characteristics, including the urticaria control test (UCT). On the other hand, criterion validity was tested through correlations with the Short-Form Health Survey SF-36, EQ-5D-5 L, and the Dermatology Quality of Life Index (DLQI). RESULTS A total of 162 patients from seven hospital units were included. The mean (standard deviation) age was 42.6 (13.3) and 81.6% were female. CU-Q2oL was entirely filled by all respondents. Internal consistency was 0.947 for the overall score, ranging from 0.661 (limits) to 0.899 (sleep problems) and the corresponding reproducibility indicator was 0.910, based on 23 patients and ranging from 0.711 (swelling) and 0.957 (looks). Exploratory factor analysis in general confirmed the original structure originally obtained by the authors. All CU-Q2oL dimensions were highly correlated with DLQI Index and differentiated well between males and females, and between different levels of wheals and pruritus. In addition, moderate negative correlations were found between Cu-Q2oL scores and the dimensions from SF-36 and EQ-5D-5 L. CONCLUSIONS The satisfactory metric properties confirmed the cultural adaptation and validity of CU-Q2oL into Portuguese population, providing the clinicians with a valid tool to evaluate the impact of chronic urticaria on patient's QoL and therefore adjust their treatment. TRIAL REGISTRATION NUMBER Not applicable.

中文翻译：

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葡萄牙语版本的慢性荨麻疹生活质量调查表（CU-Q2oL）的心理测量特性。

背景技术慢性荨麻疹定义为在超过六周的时间内出现荨麻疹病变和/或血管性水肿。我们旨在开发葡萄牙语版本的《慢性荨麻疹生活质量调查表》（CU-Q2oL），并测试其可靠性以及内容，结构和标准的有效性。方法采用前后对等的语言对等方法，然后进行临床复查并与患者进行认知汇报。组内相关系数通过间隔一周填写同一份问卷的患者来检验重测信度，Cronbach'sα指标评估内部一致性。通过探索性因素分析以及涉及社会人口统计学和临床​​患者特征的假设检验（包括荨麻疹对照检验（UCT））来检验构建体的有效性。另一方面，通过与简短健康调查表SF-36，EQ-5D-5 L和皮肤病生活质量指数（DLQI）的相关性，对标准的有效性进行了测试。结果总共包括来自七个医院单位的162名患者。平均年龄（标准差）为42.6（13.3），女性为81.6％。CU-Q2oL完全由所有受访者填写。基于23位患者的总体评分，内部一致性为0.947，范围为0.661（极限）至0.899（睡眠问题），相应的可重复性指标为0.910，范围为0.711（肿胀）和0.957（外观）。探索性因素分析通常证实了作者最初获得的原始结构。所有CU-Q2oL尺寸均与DLQI指数高度相关，并且在男女之间以及不同水平的风疹和瘙痒之间有很好的区分。此外，在Cu-Q2oL得分与SF-36和EQ-5D-5 L的尺寸之间发现中等程度的负相关。结论令人满意的度量标准特性证实了CU-Q2oL在葡萄牙人群中的文化适应性和有效性，为临床医生提供了便利。评估慢性荨麻疹对患者生活质量的影响的有效工具，从而调整其治疗方法。试用注册号不适用。所有CU-Q2oL尺寸均与DLQI指数高度相关，并且在男女之间以及不同水平的风疹和瘙痒之间有很好的区分。此外，在Cu-Q2oL得分与SF-36和EQ-5D-5 L的尺寸之间发现中等程度的负相关。结论令人满意的度量标准特性证实了CU-Q2oL在葡萄牙人群中的文化适应性和有效性，为临床医生提供了便利。评估慢性荨麻疹对患者生活质量的影响的有效工具，从而调整其治疗方法。试用注册号不适用。所有CU-Q2oL尺寸均与DLQI指数高度相关，并且在男女之间以及不同水平的风疹和瘙痒之间有很好的区分。此外，在Cu-Q2oL得分与SF-36和EQ-5D-5 L的尺寸之间发现中等程度的负相关。结论令人满意的度量标准特性证实了CU-Q2oL在葡萄牙人群中的文化适应性和有效性，为临床医生提供了便利。评估慢性荨麻疹对患者生活质量的影响的有效工具，从而调整其治疗方法。试用注册号不适用。结论令人满意的度量标准特性证实了CU-Q2oL在葡萄牙人群中的文化适应性和有效性，为临床医生提供了评估慢性荨麻疹对患者QoL影响的有效工具，因此可以调整其治疗方法。试用注册号不适用。结论令人满意的度量标准特性证实了CU-Q2oL在葡萄牙人群中的文化适应性和有效性，为临床医生提供了评估慢性荨麻疹对患者QoL影响的有效工具，因此可以调整其治疗方法。试用注册号不适用。