Chen Guo, Yang Baoqi, Zhang Zhaoxia, Yang Qing, Yan Xiaoxiao, Murrell Dédée F, Zhang Furen
Department of Dermatology, School of Medicine and Life Sciences, University of Jinan-Shandong Academy of Medical Sciences; Department of Dermatology, Shandong Provincial Institute of Dermatology and Venereology, Shandong Academy of Medical Sciences; Department of Dermatology, Shandong Provincial Hospital for Skin Diseases, Jinan; Department of Dermatology, Laiwu Institute of Dermatology, Laiwu, Shandong, China.
Department of Dermatology, School of Medicine and Life Sciences, University of Jinan-Shandong Academy of Medical Sciences; Department of Dermatology, Shandong Provincial Institute of Dermatology and Venereology, Shandong Academy of Medical Sciences; Department of Dermatology, Shandong Provincial Hospital for Skin Diseases, Jinan, China.
Indian J Dermatol Venereol Leprol. 2018 Jul-Aug;84(4):431-436. doi: 10.4103/ijdvl.IJDVL_538_16.
Treatments for autoimmune blistering disease carry significant risks of medical complications and can affect the patient's quality of life. Recently, the Treatment of Autoimmune Bullous Disease Quality of Life questionnaire was developed in Australia.
The objective of this study was to evaluate the reliability and validity of the Chinese version of the Treatment of Autoimmune Bullous Disease Quality of Life questionnaire in Chinese patients with autoimmune blistering diseases.
The Chinese version of the Treatment of Autoimmune Bullous Disease Quality of Life questionnaire was produced by forward-backward translation and cross-cultural adaptation of the original English version. Autoimmune blistering disease patients recruited in the study self-administered the Chinese Treatment of Autoimmune Bullous Disease Quality of Life questionnaire, the Dermatology Life Quality Index and the 36-item Short-Form Health Survey. Reliability of the Chinese Treatment of Autoimmune Bullous Disease Quality of Life was evaluated using internal consistency and test-retest (days 0 and 7) methods. Validity was analyzed by face, content, construct, convergent and discriminant validity measures.
A total of 86 autoimmune blistering disease patients were recruited for the study. Cronbach's alpha coefficient was 0.883 and the intraclass correlation coefficient was 0.871. Face and content validities were satisfactory. Convergent validity testing revealed correlation coefficients of 0.664 for the Treatment of Autoimmune Bullous Disease Quality of Life and Dermatology Life Quality Index and -0.577 for the Treatment of Autoimmune Bullous Disease Quality of Life and 36-item Short-Form Health Survey. With respect to discriminant validity, no significant differences were observed in the Treatment of Autoimmune Bullous Disease Quality of Life scores of men and women (t = 0.251, P = 0.802), inpatients and outpatients (t = 0.447, P = 0.656), patients on steroids and steroid-sparing medications (t = 0.672, P = 0.503) and patients with different autoimmune blistering disease subtypes (F = 0.030, P = 0.971).
Illiterate patients were excluded from the study. The patients were from a single hospital and most of their conditions were in a relatively stable status.
The Chinese version of the Treatment of Autoimmune Bullous Disease Quality of Life questionnaire is a reliable and valid instrument to measure treatment burden and to serve as an end point in clinical trials in Chinese autoimmune blistering disease patients.
自身免疫性水疱病的治疗存在重大医疗并发症风险，且会影响患者生活质量。最近，澳大利亚开发了自身免疫性大疱病生活质量治疗问卷。
本研究旨在评估自身免疫性大疱病生活质量治疗问卷中文版在中国自身免疫性水疱病患者中的信度和效度。
自身免疫性大疱病生活质量治疗问卷中文版通过对原始英文版进行正向-反向翻译和跨文化调适得出。研究中招募的自身免疫性水疱病患者自行填写中文版自身免疫性大疱病生活质量治疗问卷、皮肤病生活质量指数和36项简短健康调查问卷。采用内部一致性和重测法（第0天和第7天）评估中文版自身免疫性大疱病生活质量治疗问卷的信度。通过表面效度、内容效度、结构效度、收敛效度和区分效度测量分析效度。
共招募了86例自身免疫性水疱病患者参与研究。克朗巴哈α系数为0.883，组内相关系数为0.871。表面效度和内容效度令人满意。收敛效度测试显示，自身免疫性大疱病生活质量治疗问卷与皮肤病生活质量指数的相关系数为0.664，自身免疫性大疱病生活质量治疗问卷与36项简短健康调查问卷的相关系数为-0.577。在区分效度方面，男性和女性、住院患者和门诊患者、使用类固醇和不使用类固醇药物的患者以及不同自身免疫性水疱病亚型患者的自身免疫性大疱病生活质量治疗问卷得分均无显著差异（t = 0.251，P = 0.802；t = 0.447，P = 0.656；t = 0.672，P = 0.503；F = 0.030，P = 0.971）。
文盲患者被排除在研究之外。患者来自单一医院，且大多数病情处于相对稳定状态。
自身免疫性大疱病生活质量治疗问卷中文版是一种可靠且有效的工具，可用于衡量中国自身免疫性水疱病患者的治疗负担，并作为临床试验的终点指标。
