Objective: To evaluate the reliability and validity of the Chinese version of the uterine fibroid symptom and health-related quality of life (UFS-QOL) in patients with uterine fibroid. Methods: The original English UFS-QOL was translated into Chinese and linguistically validated following the cross-cultural adaptation of health-related quality of life measures. Patients recruited randomly from Peking Union Medical College Hospital from June 2013 to December 2016 were scheduled for two visits with 2 weeks apart, and they were surveyed through the Chinese version of UFS-QOL and short-form 12-item health survey (SF-12). The reliability and validity of the Chinese version of UFS-QOL were evaluated. Results: A total of 190 uterine fibroid patients who met the criteria participated this study. The Chinese version of UFS-QOL had a high internal consistency (Cronbach's α, uterine fibroid symptom severity scale:0.912, health-related quality of life scale: 0.976) and high test-retest reliability (intraclass correlation coefficient, 0.572-0.951, P<0.01). The symptom severity scores and SF-12 scores were negatively correlated (r=-0.813, P<0.01); the health-related quality of life scores and SF-12 scores were positively correlated (r=0.620, P<0.01). The factor analysis showed good construct validity. Conclusion: Psychometric testing supports the reliability and validity of the Chinese version of UFS-QOL as an disease-specific measure of health-related quality of life.
目的： 引进子宫肌瘤症状及健康相关生命质量问卷（UFS-QOL），对其进行简体中文版本的译制，并评价其在症状性子宫肌瘤患者中应用的信度和效度。 方法： 以"WHO-QOL跨文化生命质量研究问卷翻译法"为标准对UFS-QOL进行简体中文版本的译制。2013年6月—2016年12月在北京协和医院妇产科随机选取符合纳入标准的症状性子宫肌瘤患者190例，对译制的UFS-QOL简体中文版进行中国人群的信度和效度验证。 结果： 190例符合纳入标准的症状性子宫肌瘤患者参与UFS-QOL简体中文版的验证。UFS-QOL简体中文版的子宫肌瘤症状严重程度问卷（UFS8）Cronbach α系数为0.912，子宫肌瘤健康相关生命质量问卷（QOL问卷）Cronbach α系数为0.976，UFS-QOL简体中文版的内部一致性较好。UFS8问卷两次调查结果各题目得分之间的组内相关系数（ICC）为0.572~0.951（P<0.01），QOL问卷的ICC为0.628~0.931（P<0.01），UFS-QOL简体中文版的重测信度好。因子分析结果显示，QOL问卷提取出的因子成分与原版作者的设计相符合，UFS-QOL简体中文版具有极高的结构效度。UFS8问卷得分与中文版健康调查12条简表（SF-12）得分在0.01水平（双侧）显著相关，Spearman相关系数r(1)为－0.813，相关程度高，UFS8问卷得分越高，患者的生命质量越差；QOL问卷得分与中文版SF-12得分在0.01水平（双侧）显著相关，Spearman相关系数r(2)为0.620，相关程度显著，QOL问卷得分越高，患者的生命质量越高。 结论： UFS-QOL简体中文版在中国人群中具有较高的信度和效度，可以作为评价症状性子宫肌瘤患者生命质量的专用问卷。.
Keywords: Leiomyoma; Quality of life; Questionnaires; Reproducibility of results; Sickness impact profile; Uterine neoplasms.