TRANSLATION AND VALIDATION OF THE BRAZILIAN VERSION OF THE “QUALITY OF LIFE ASSESSMENT IN SPINA BIFIDA” QUESTIONNAIRE FOR CHILDREN AND TEENAGERS

ABSTRACT Objective: To assess the reliability and validity of the Quality of Life Assessment in Spina Bifida (QUALAS), children and teenager’s versions (QUALAS C and T, respectively). This is the first self-applicable quality of life assessment tool for patients under 13 years of age, which also addresses the issue of urinary and fecal incontinence. Methods: Two urologists performed the translation of both QUALAS versions. A commission produced a consensus version (Version 2), which was applied as a pilot study to define Version 3. It was then backtranslated into English and compared with the original version for equivalence of concepts. Internal consistency with Cronbach’s alpha and the intraclass correlation coefficient (ICC) reproducibility was analyzed after two assessments with an interval from two to four weeks. Convergent and divergent validities between the QUALAS and a generic health-related quality of life questionnaire, the KIDSCREEN-27, were studied through Pearson’s correlation. Results: The reliability analysis showed good internal consistency for QUALAS-C (α=0.73) and QUALAS-T (α=0.79) and good reproducibility in both questionnaires (QUALAS-C - ICC=0.86; QUALAS-T - ICC=0.92). For QUALAS-C convergent validity, there was a low correlation between its items (r=0.35). In addition, a low correlation was also found in the divergent validity analysis, when compared to the KIDSCREEN-27 (r≤0.33). Convergent and divergent validities of the QUALAS-T questionnaire had similar results: r=0.46 and r≤0.49, respectively. Conclusions: After the adaptation and validation process, QUALAS-C and QUALAS-T questionnaires showed to be reliable and valid instruments for measuring the health-related quality of life of children and teenagers with spina bifida aged 8 years or older.

摘要 目的：评估脊柱裂生活质量评估量表（Quality of Life Assessment in Spina Bifida, QUALAS）儿童版与青少年版（分别记为QUALAS C与QUALAS T）的信度与效度。该量表是首款适用于13岁以下患者的自评式健康相关生活质量评估工具，同时覆盖尿失禁与粪失禁相关临床问题。
方法：由两名泌尿外科医师完成两款QUALAS量表的翻译工作。专家组达成共识形成第二版（Version 2），并通过预实验确定第三版（Version 3）。随后将第三版量表回译为英文，并与原版进行概念等效性比对。在间隔2至4周的两次评估后，采用克朗巴赫α系数（Cronbach’s alpha）分析内部一致性，以组内相关系数（intraclass correlation coefficient, ICC）评估重测信度。通过皮尔逊相关分析，探究QUALAS与通用健康相关生活质量问卷KIDSCREEN-27之间的会聚效度与区分效度。
结果：信度分析结果显示，QUALAS-C（α=0.73）与QUALAS-T（α=0.79）均具备良好的内部一致性，两款量表均表现出优异的重测信度（QUALAS-C：ICC=0.86；QUALAS-T：ICC=0.92）。针对QUALAS-C的会聚效度分析，其各条目间相关性较低（r=0.35）；与KIDSCREEN-27的区分效度分析亦显示低相关性（r≤0.33）。QUALAS-T的会聚效度与区分效度结果与之相似，分别为r=0.46与r≤0.49。
结论：经过适配与验证流程后，QUALAS-C与QUALAS-T量表可作为可靠且有效的评估工具，用于测量8岁及以上脊柱裂患儿与青少年的健康相关生活质量。