Validation of the Generic Version of China Health Related Outcomes Measures (CHROME-G) among individuals with type 2 diabetes in China.
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OBJECTIVE: The Generic Version of China Health Related Outcomes Measures (CHROME-G) was a new preference-based health-related quality of life (HRQoL) instrument designed specifically for the Chinese population. This study aimed to validate and compare measurement properties of CHROME-G with EuroQol-5 Dimensions-5 Levels (EQ-5D-5L), Short Form-6 Dimensions version 2 (SF-6Dv2), and Diabetes-Specific Quality of Life (DSQL) scales among the elderly Chinese population with type 2 diabetes. METHODS: A representative sample population was recruited across the country. Internal consistency was assessed using Cronbach's alpha. Hypotheses testing including convergent validity and known-groups validity were evaluated using Spearman's rank correlation and effect sizes, respectively. Sensitivity was examined using relative efficiency and receiver operating characteristic curve. RESULTS: A total of 131 individuals with type 2 diabetes (54.20% male; mean age 69.03 years) were enrolled. Cronbach's alpha was 0.94 for DSQL, 0.93 for CHROME-G, 0.87 for EQ-5D-5L, and 0.88 for SF-6Dv2. For the convergent validity of CHROME-G, 24/29 (82.76%) correlations met the predefined hypotheses, with Spearman's rank correlation coefficients ranging from 0.51 to 0.96. Among the different health subgroups, the effect sizes for CHROME-G, DSQL, EQ-5D-5L, and SF-6Dv2 were 0.19-1.26, 0.36-1.62, 0.22-1.06, and 0.49-0.87, respectively. CHROME-G, DSQL, and SF-6Dv2 had higher efficiency compared with EQ-5D-5L in detecting differences in self-reported health status, with relative efficiency of 3.18 and 1.76, 4.38 and 6.52, and 1.56 and 2.09, respectively. CONCLUSIONS: CHROME-G demonstrates relatively good measurement properties compared with EQ-5D-5L and SF-6Dv2 for measuring the HRQoL among the elderly Chinese population with type 2 diabetes. The sensitivity of DSQL appears to be better than that of the three generic instruments.