Abstract
PURPOSE: The study aimed to cross-culturally adapt and psychometrically test the Mandarin version of the Chinese Health Literacy Scale for Diabetes (M-CHLSD). PATIENTS AND METHODS: A cross-sectional study was conducted in Beijing with 221 adults diagnosed with type 2 diabetes. The adaptation followed a rigorous five-step process: forward translation, synthesis, back translation, expert review (utilizing a two-round Delphi method), and cognitive interviews using the Questionnaire Appraisal System. Psychometric properties of the M-CHLSD were evaluated using reliability, content validity, and construct validity. Criterion validity was assessed by correlating the scale with glycemic measures and conducting group comparisons using the Mann-Whitney U-test. RESULTS: The Delphi review highlighted the need for linguistic refinement, clinical accuracy, and contextual adaptation, leading to revisions aligned with Mainland China's healthcare system. Pilot testing with 15 patients confirmed comprehensibility. Confirmatory Factor Analysis indicated a good model fit (Comparative Fit Index = 0.93, Tucker-Lewis Index = 0.91, Root Mean Square Error of Approximation = 0.064). The scale demonstrated excellent internal consistency (Cronbach's α=0.884) and test-retest reliability (Intraclass Correlation Coefficient=0.82-0.91). The M-CHLSD showed moderate correlations with fasting plasma glucose (ρ = -0.36) and 2-hour postprandial glucose (ρ = -0.39). The scale successfully distinguished between individuals with good versus poor glycemic control (Cohen's d = 0.54-0.56). A mild ceiling effect (15.1%) was observed. CONCLUSION: The M-CHLSD is a robust, reliable, and clinically relevant tool for assessing health literacy in Mandarin-speakers with diabetes. Its rigorous methodology, including Delphi, cognitive interviews, and comprehensive psychometric testing, makes it superior to other adapted tools. The scale's strong clinical correlations and ability to stratify patients based on glycemic control ensure its utility in personalized education and follow-up care pathways.