Development and Validation of the Japanese Version of Quality of Life Assessment of Spina Bifida in Children (QUALAS-C-J).

BACKGROUND

We previously developed the Japanese version of The Quality of Life Assessment of Spina Bifida in Teenagers, a health-related quality-of-life instrument specific to children aged 13-17 years with spina bifida (SB). The Quality of Life Assessment of Spina Bifida in Children is a version of this questionnaire for children aged 8-12 years. The purpose of this study was to develop a Japanese version of the Quality of Life Assessment of Spina Bifida in Children (QUALAS-C-J) and verify its reliability and validity.

METHODS

Three urologists specializing in SB, 2 nurses, and 1 statistician developed the QUALAS-C-J and conducted a pilot and main survey. Participants included children with SB and non-disabled (ND) children. Participants completed the QUALAS-C-J and the Japanese version of KIDSCREEN-27 (J-KIDSCREEN) without parental help.

RESULTS

Five children with SB participated in the pilot study and provided face and content validity. Sixty-three children with SB and 40 age- and sex-matched ND children participated in the main survey. The intraclass correlation coefficient in the retest was 0.80, and Cronbach's alpha in each domain was 0.73. The validity was verified by factor analysis, convergent / divergent validity, and known-groups validity. Factor analysis converged to the same two-factor structure as the original version. The correlation between QUALAS-C-J and J-KIDSCREEN-27 was weak (r=-0.06-0.30). The scores of both groups for the two domains of the QUALAS-C-J were significantly lower in SB than ND children.

CONCLUSIONS

QUALAS-C-J is easy to answer, suitable for Japanese children with SB, reliable, and valid. It can be a communication tool for children with SB, medical staff, families, communities, and school teachers.