Validation of China Health-Related Outcomes Measures-Cardiovascular Disease.

Objectives: China Health -Related Outcomes Measures (CHROME) was an initiative aimed at developing a system of preference -based health -related quality of life instruments for China. CHROME -cardiovascular disease (CVD) is a CVD-specific instrument with 14 items developed under this initiative. This study aimed to test the psychometric properties of CHROME-CVD. Methods: This validation study was conducted using cross-sectional questionnaire survey in China. Eligible patients with CVD were recruited and asked to complete the CHROME-CVD, the EQ-5D-5L, and a CVD-specific nonpreference-based healthrelated quality of life instrument selected according to the confirmed diagnosis of the patients. Item evaluation, internal consistency, measurement invariance, test -retest reliability, structural validity, and construct validity were tested using classic test theory. Item response theory was used to evaluate item -level performance. Results: A total of 444 patients with CVD (coronary artery disease, n = 276, heart failure, n = 104, angina, n = 33, and atrial fibrillation, n =16) from 6 provinces in China were enrolled for the validation. Exploratory factor analysis identified 4 factors: chest pain, other symptoms, physical health, and mental and social health. Cronbach 's alpha and intraclass correlation coefficient were .0.8. A total of 20 of 26 (76.9%), and 90 of 95 (94.7%) predefined hypotheses were met for convergent and discriminant validities, respectively. No important difference was identified between subgroups of gender and residency. Response options of 10 items were found overlapped based on categorical response curves, which led to modification to 4 -level response options. Wording of 3 items were modified by referring wordings of reference instruments. Conclusion: The validation of the CHROME-CVD demonstrated generally good psychometric properties. Further validation on the modified CHROME-CVD is needed.