Kim Myoung-Hee, Cho Young-Shin, Uhm Wan-Sik, Kim Sehyun, Bae Sang-Cheol
Department of Preventive Medicine, Eulji University School of Medicine, Daejeon, Republic of Korea.
Qual Life Res. 2005 Jun;14(5):1401-6. doi: 10.1007/s11136-004-5681-z.
This study aimed to determine the cross-cultural adaptation and validation of the Korean version of the EQ-5D in rheumatic conditions.
Translation, back-translation and cognitive debriefing were performed according to the EuroQol group's guidelines. For validity, 508 patients were recruited and administered the EQ-5D, Short-Form 36 and condition-specific measures. Construct validity and sensitivity were evaluated by testing a-priori hypotheses. For reliability, another 57 patients repeated the EQ-5D at 1-week interval, and intra-class correlations (ICC) and kappa statistics were estimated. For responsiveness, another 60 patients repeated it at 12-week interval within the context of clinical trial, and standardized response mean(SRM) were calculated.
The cross-cultural adaptation produced no major modifications in the scale. The associations of the EQ-5D with the generic- and condition-specific measures were observed as expected in hypotheses: the higher EQ-5Dindex and EQ-5D(VAS) scores, the better health status by generic- or condition-specific measures, and the better functional class. The ICCs were 0.751 and 0.767, respectively, and kappa ranged from 0.455 to 0.772. The SRM were 0.649 and 0.410, respectively.
The Korean EQ-5D exhibits good validity and sensitivity in various rheumatic conditions. Although its reliability and responsiveness were not excellent, it seems acceptable if condition-specific measures are applied together.
本研究旨在确定EQ-5D韩文版在风湿性疾病中的跨文化适应性及有效性。
按照欧洲生活质量研究组的指南进行翻译、回译及认知反馈。为评估有效性,招募了508名患者并对其进行EQ-5D、简短健康调查问卷36项(Short-Form 36)及疾病特异性测量。通过检验先验假设评估结构效度和敏感性。为评估信度,另外57名患者每隔1周重复进行EQ-5D测量,并估算组内相关系数(ICC)和kappa统计量。为评估反应度,另外60名患者在临床试验背景下每隔12周重复进行测量,并计算标准化反应均值(SRM)。
跨文化适应过程中量表未作重大修改。EQ-5D与通用及疾病特异性测量之间的关联如假设中预期的那样:EQ-5D指数和EQ-5D(视觉模拟量表)得分越高,通过通用或疾病特异性测量得出的健康状况越好,功能分级也越好。ICC分别为0.751和0.767,kappa值在0.455至0.772之间。SRM分别为0.649和0.410。
韩文版EQ-5D在各种风湿性疾病中表现出良好的有效性和敏感性。虽然其信度和反应度并非极佳,但如果同时应用疾病特异性测量,似乎是可以接受的。