Department of Health Technology Assessment, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Health Policy and Management Research Center, Department of Health Services Management, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Diabetes Metab Syndr. 2021 Jan-Feb;15(1):319-324. doi: 10.1016/j.dsx.2021.01.009. Epub 2021 Jan 14.
BACKGROUND AND AIMS: The psychometric properties of the EQ-5D-3L (a generic preference-based instrument used for calculating quality-adjusted Life -years) have not been known for any type of disease in Iran. This study aimed to assess its validity and reliability in patients with type 2 diabetes. METHODS: Data of 579 patients were collected from the Diabetes Research Center and Clinics in Yazd using EQ-5D-3L, SF-36, and DQoL instruments. The ceiling effects were computed for the EQ-5D-3L index and EQ VAS. The construct validity was assessed by using convergent validity, discriminant validity, and known-groups validity. Reliability was assessed using Cohen's kappa value, Cronbach's alpha, and intra-class correlation coefficient. RESULTS: The ceiling effects of EQ-5D-3L and EQ VAS were 20.18% and 15.33%, respectively. The highest degree of correlation was found between the pain/discomfort of EQ-5D and the BP scale of the SF-36 (0.55). Higher scores of all scales of the DQoL were associated with patients reporting no problems in each EQ-5D dimension. The mean of EQ-5D-3L index and EQ VAS scores were significantly higher in the male, married, and employed patients, and they did not have retinopathy, nephropathy, IHD, hypertension, DFU. The range of kappa values was from 0.39 to 0.71, and value of ICC for the EQ-5D-3L index and EQ VAS was 0.76 and 0.64, respectively. Cronbach's alpha was 0.87 for EQ-5D-3L and 0.74 for EQ VAS. CONCLUSIONS: Our findings demonstrated good construct validity and moderate to good levels of reliability of the EQ-5D-3L for using in the patients with diabetes, and it can be used in research or clinical practice in Iran and other regions of the Middle East.
背景与目的:EQ-5D-3L(一种用于计算质量调整生命年的通用偏好量表)在伊朗的任何疾病类型中都没有经过信度和效度验证。本研究旨在评估其在 2 型糖尿病患者中的信度和效度。
方法:采用 EQ-5D-3L、SF-36 和 DQoL 量表,从亚兹德糖尿病研究中心和诊所收集了 579 名患者的数据。计算了 EQ-5D-3L 指数和 EQ VAS 的天花板效应。通过收敛效度、判别效度和已知组效度评估结构效度。采用 Cohen's kappa 值、Cronbach's alpha 和组内相关系数评估信度。
结果:EQ-5D-3L 和 EQ VAS 的天花板效应分别为 20.18%和 15.33%。EQ-5D 中疼痛/不适与 SF-36 的 BP 量表之间的相关性最高(0.55)。DQoL 所有量表的评分较高与报告 EQ-5D 各维度无问题的患者相关。EQ-5D-3L 指数和 EQ VAS 评分在男性、已婚和就业患者中均较高,且他们没有视网膜病变、肾病、冠心病、高血压、DFU。kappa 值的范围为 0.39 至 0.71,EQ-5D-3L 指数和 EQ VAS 的 ICC 值分别为 0.76 和 0.64。EQ-5D-3L 的 Cronbach's alpha 为 0.87,EQ VAS 的 Cronbach's alpha 为 0.74。
结论:我们的研究结果表明,EQ-5D-3L 在伊朗和中东其他地区的研究或临床实践中具有良好的结构效度和中高度的信度,可用于糖尿病患者。
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