A suitable health literacy assessment instrument for patients with chronic pain (HLCP) in China with good instrument's psychometric properties is required. A theoretical framework for the HLCP was developed by adopting the hierarchical model of health literacy proposed by Nutbeam. The reliability and validity of the HLCP were tested in a cross-sectional survey of 237 chronic pain patients from three pain clinics and wards of Grade-3A hospitals in Zhejiang Province, China. The discriminant degree method, correlation analysis method, factor analysis method (exploratory factor analysis), half reliability, and other methods were utilized to screen items for inclusion in the final version of HLCP, and the fitness of the model was subsequently evaluated by confirmatory factor analysis. Cronbach's alpha value and test-retest with two-week intervals were used to test the internal consistency and retest reliability of the HLCP. In the exploratory factor analysis, three domains, functional health literacy (10 items), interactive health literacy (14 items), and critical health literacy (7 items), comprising 31 items in total, were finally loaded; the model was determined to explain 70.9% of the total variance. HLCP's effective assessment of the health literacy level of patients with chronic pain and its acceptable reliability and validity were revealed through the results.
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