Reliability and validity of the 15-item Chronic Oral Mucosal Disease Questionnaire in China: A short-form instrument to measure quality of life

Background Chronic oral mucosal diseases have been a common problem, which affected individuals' health and social functions seriously. Although there has been a rigorous Chinese version of the Chronic Mucosal Diseases Questionnaire (COMDQ-26) to measure the quality of life of patients with chronic oral mucosal diseases, 26 items were so redundant to be a burden for patients. It was necessary to make a brief, practical, and easy-to-use tool in China. This study aimed to test the validity and reliability of the Chinese version of the short-form Chronic Mucosal Diseases Questionnaire (COMDQ-15). Methods A total of 165 respondents from a tertiary stomatological hospital were recruited in this study from July to December, 2020. Internal consistency, test-retest reliability, criterion validity, confirmatory factor analysis, and exploratory factor analysis were used to evaluate the reliability and validity of the Chinese version of Chronic Mucosal Diseases Questionnaire-15. Results The total Cronbach's alpha of 0.841 and subscale ranging from 0.736 to 0.965 revealed good internal consistency of the reliability. The intraclass correlation coefficients exceeded 0.80 indicated excellent test-retest reliability. Compared with the Oral Health Impact Profile-14, the criterion validity was 0.549. The confirmatory factor analysis results supported acceptable validity of the Chinese version of Chronic Mucosal Diseases Questionnaire-15, and the exploratory factor analysis demonstrated that the 15 items were classified into four domains, with a cumulative proportion of 71.52%. Conclusion The Chinese version of Chronic Mucosal Diseases Questionnaire-15 is a brief and low-burden tool, and has been proved reliable and valid to assess the quality of life of patients with chronic oral mucosal diseases in China (the Chinese Clinical Trial Registry (no. ChiCTR2000031607).