Abstract / Summary
Abstract Background Preventing and managing diabetic kidney disease (DKD) requires people with diabetes to understand disease-specific information, obtain information from different sources, communicate with healthcare professionals, appraise information quality and personal relevance, and use recommendations in health-related decisions. Existing general and kidney-specific health-literacy measures do not specifically assess this combined set of DKD-related information-use and decision-making competencies. This study aimed to develop and preliminarily evaluate the Diabetic Kidney Disease Prevention and Control Literacy Questionnaire (DKD-PCLQ). Methods This multisite, multiphase instrument-development and psychometric evaluation study was conducted in Fuzhou, China, in 2025. The DKD-PCLQ was developed and administered in Chinese. Candidate items were generated from a literature review and semi-structured interviews with people with diabetes and refined through two rounds of expert consultation and two rounds of cognitive interviewing. Item analysis was conducted in 266 participants. Psychometric properties were evaluated in 422 participants randomly divided into exploratory (n = 212) and confirmatory (n = 210) subsamples. Test-retest reliability was assessed in 20 participants after 14 days. Results The preliminary DKD-PCLQ contained 35 items. Eight items were removed during item analysis and one further item because of substantial cross-loadings, resulting in a 26-item questionnaire across functional, interactive, and critical health-literacy domains. Principal component analysis identified a three-component structure, and confirmatory factor analysis showed acceptable fit after limited model modification (chi-square/df = 1.839; CFI = 0.925; RMSEA = 0.063). Internal consistency was good for the total score (Cronbach's alpha = 0.898) and all domains (alpha = 0.866–0.912). Content validity was high (S-CVI/Ave = 0.979), and the total-score test-retest ICC was 0.96 (95% CI 0.91–0.98). Conclusions The Chinese-language DKD-PCLQ demonstrated good internal consistency and content validity, with preliminary evidence of structural validity and test-retest reliability. By integrating DKD-specific knowledge with competencies for health-information access, communication, appraisal, application, and decision-making, it may help identify needs for tailored education and decision support. External validation, measurement-error assessment, responsiveness, interpretability, measurement invariance, and electronic-mode equivalence should be examined before routine clinical or digital implementation.