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Background: This study examined the reliability and validity of the Japanese versions of the DISABKIDS-37 generic modules, a tool for assessing the health-related quality of life (HRQOL) of children and adolescents with a chronic condition., Methods: The study was conducted using a sample of 123 children/adolescents with a chronic medical condition, aged 8-18 years, and their parents. Focus interviews were performed to ensure content validity after translation. The classical psychometric tests were used to assess reliability and scale intercorrelations. The factor structure was examined with confirmatory factor analysis (CFA). Convergent validity was assessed by the correlation between the total score and the sub-scales of DISABKIDS-37 as well as the total score of KIDSCREEN-10., Results: Both the children/adolescent and parent versions of the score showed good to high internal consistency, and the test-retest reliability correlations were r = 0.91 or above. The CFA revealed that the modified models for all domains were better fit than the original 37 item scale model for both self-report and proxy-report. Moderate to high positive correlations were found for the associations within DISABKIDS-37 sub-scales and between the subscales and total score, except for the treatment sub-scale, which correlated weakly with the remaining sub-scales. The total score of the child-reported version of KIDSCREEN-10 correlated significantly and positively with the total score and all the sub-scales of the child-reported version of DISABKIDS-37 except the Treatment sub-scale in adolescents., Conclusions: The modified models of Japanese version of DISABKIDS generic module were psychometrically robust enough to assess the HRQOL of children with a chronic condition.

Background: Although there is an increasing need to investigate the health-related quality of life (HRQOL) of children and adolescents with chronic conditions in Japan, there is currently no standardized measure in which young children can directly answer questions about their HRQOL. The DISABKIDS Smiley measure uses face emoticons to measure HRQOL and distress caused by illness and related treatments among young children. We tested the reliability and validity of the DISABKIDS Smiley measure in a sample of young Japanese children., Methods: After translating the child and parent questionnaires into Japanese, a pre-test was performed to test the content validity in accordance with guidelines from the DISABKIDS Group. In total, 60 child-parent pairs were recruited to participate in the survey. We measured internal consistency of the scales using Cronbach's alpha as well as Guttman split-half, test-retest reliability using intraclass correlation coefficients (ICCs) at a two-week interval, and ICCs between child- and parent-reported scores. Convergent validity of the scale was also examined against the Kiddy-KINDL scale., Results: Both child-reported and parent-reported scales showed good internal consistency and split-half reliability. Test-retest reliability of the child-reported version (ICC = 0.53, p = 0.004) was lower than that of the parent-reported version (ICC = 0.80, p < 0.001). Moderate to good agreement between child- and parent- reported scales was observed in both the first (ICC = 0.75, p < 0.001) and second administration (ICC = 0.71, p < 0.001). Moderate to very strong positive correlations were observed with the total score of the Kiddy-KINDL child-reported version (r = 0.51, p < 0.001), and facets of the Kiddy-KINDL parent-reported version (ranging from r = 0.364 to r = 0.60, p < 0.001) and total score (r = 0.71, p < 0.001)., Conclusions: The psychometric property of the instrument showed that the Japanese version of the DISABKIDS Smiley can be applied to assess the HRQOL of Japanese children with chronic conditions. Further investigation will be needed to explore the reliability and validity for repeated use of the instrument in clinical practice as an indicator of clinical significance.