Luo Nan, Chew Ling-Huo, Fong Kok-Yong, Koh Dow-Rhoon, Ng Swee-Cheng, Yoon Kam-Hon, Vasoo Sheila, Li Shu-Chuen, Thumboo Julian
Department of Medicine, National University of Singapore, Singapore.
Health Qual Life Outcomes. 2003 Apr 17;1:7. doi: 10.1186/1477-7525-1-7.
BACKGROUND: Although multiple language versions of health-related quality of life instruments are often used interchangeably in clinical research, the measurement equivalence of these versions (especially using alphabet vs pictogram-based languages) has rarely been assessed. We therefore investigated the measurement equivalence of English and Chinese versions of the EQ-5D, a widely used utility-based outcome instrument. METHODS: In a cross-sectional study, either EQ-5D version was administered to consecutive outpatients with rheumatic diseases. Measurement equivalence of EQ-5D item responses and utility and visual analog scale (EQ-VAS) scores between these versions was assessed using multiple regression models (with and without adjusting for potential confounding variables), by comparing the 95% confidence interval (95%CI) of score differences between these versions with pre-defined equivalence margins. An equivalence margin defined a magnitude of score differences (10% and 5% of entire score ranges for item responses and utility/EQ-VAS scores, respectively) which was felt to be clinically unimportant. RESULTS: Sixty-six subjects completed the English and 48 subjects the Chinese EQ-5D. The 95%CI of the score differences between these versions overlapped with but did not fall completely within pre-defined equivalence margins for 4 EQ-5D items, utility and EQ-VAS scores. For example, the 95%CI of the adjusted score difference between these EQ-5D versions was -0.14 to +0.03 points for utility scores and -11.6 to +3.3 points for EQ-VAS scores (equivalence margins of -0.05 to +0.05 and -5.0 to +5.0 respectively). CONCLUSION: These data provide promising evidence for the measurement equivalence of English and Chinese EQ-5D versions.
背景:尽管与健康相关的生活质量工具的多种语言版本在临床研究中经常互换使用,但这些版本的测量等效性(尤其是基于字母语言与基于象形图语言之间)很少得到评估。因此,我们研究了广泛使用的基于效用的结局工具EQ-5D的英文和中文版本的测量等效性。 方法:在一项横断面研究中,向连续就诊的风湿性疾病门诊患者发放EQ-5D的任一版本。通过比较这些版本之间得分差异的95%置信区间(95%CI)与预先定义的等效界值,使用多元回归模型(有和没有调整潜在混杂变量)评估这些版本之间EQ-5D条目反应、效用和视觉模拟量表(EQ-VAS)得分的测量等效性。等效界值定义了得分差异的幅度(条目反应和效用/EQ-VAS得分分别为整个得分范围的10%和5%),认为该幅度在临床上不重要。 结果:66名受试者完成了英文EQ-5D,48名受试者完成了中文EQ-5D。这些版本之间得分差异的95%CI与4个EQ-5D条目、效用和EQ-VAS得分的预先定义等效界值重叠,但未完全落在其中。例如,这些EQ-5D版本之间调整后得分差异的95%CI,效用得分是-0.14至+0.03分,EQ-VAS得分是-11.6至+3.3分(等效界值分别为-0.05至+0.05和-5.0至+5.0)。 结论:这些数据为英文和中文EQ-5D版本的测量等效性提供了有前景的证据。
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