Validation of the Disease-Specific Components of the Kidney Disease Quality of Life-36 (KDQOL-36) in Chinese Patients Undergoing Maintenance Dialysis.

AIM: The aim of this study was to evaluate the validity, reliability and sensitivity of the disease-specific items of the Kidney Disease Quality of Life-36 (KDQOL-36) in Chinese patients undergoing maintenance dialysis.

METHODS: The content validity was assessed by content validity index (CVI) in ten subjects. 356 subjects were recruited for pilot psychometric testing. The internal construct validity was assessed by corrected item-subscale total correlation. Confirmatory factor analysis (CFA) was used to confirm the factor structure. The convergent validity was assessed by Pearson's correlation test between the disease specific subscale scores and SF-12 version 2 Health Survey (SF-12 v2) scores. The reliability was assessed by the internal consistency (Cronbach's Alpha coefficient) and 2-week test-retest reliability (intraclass correlation coefficient (ICC)). The sensitivity was determined by performing known group comparisons by independent t-test.

RESULTS: The CVI on clarity and relevance was ≥ 0.9 for all items. Corrected item- total correlation scores were ≥0.4 for all, except an item related to problems with access site. CFA confirmed the 3-factor structure of the disease-specific component of the KDQOL-36. The correlation coefficients between the disease-specific domain scores and the SF-12 v2 physical and mental component summary scores ranged from 0.328 to 0.492. The reliability was good (Cronbach's alpha coefficients ranged from 0.810 to 0.931, ICC ranged from 0.792 to 0.924). Only the effect subscale was sensitive in detecting differences in HRQOL between haemodialysis and peritoneal dialysis patients, with effect size = 0.68.

CONCLUSION: The disease-specific items of the KDQOL-36 are a valid, reliable and sensitive measure to assess the health-related quality of life of Chinese patients on maintenance dialysis.