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• Assessing quality of life in children with epilepsy is a highly complex process. • Our results support the reliability and validity of the Spanish version of the QOLCE-55. • This study introduces a version of the QOLCE-55 to evaluate Spanish-speaking children with epilepsy. • The QOLCE-55 is a valid instrument for measuring quality of life across cultures. The aims of the present study were to translate and validate the Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55) into Spanish. A backtranslation procedure was used to translate the English version of QOLCE-55 to Spanish, and subsequently, parents of 88 children (aged four to 12 years), completed the Spanish version of three self-reported questionnaires: the QOLCE-55, the Pediatric Quality-of-Life Inventory (PedsQLTM 4.0), and the Pediatric Sleep Questionnaire (PSQ). Seven to 10 days later, parents completed the questionnaires again under the same conditions. Internal consistency was between 0.669 and 0.968 for the four subscales: cognitive (CF), emotional (EF), social (SF) and physical functioning (PF); and 0.954 for the total score. The test–retest reliability assessed with the intraclass correlation coefficient obtained values from 0.683 for SF to 0.962 for CF. The standard error of measurement for the total score was 5.776, and the minimal detectable change was 16.01. Spearman correlations between the total score of the Spanish version of the QOLCE-55 with the subscales was 0.760 for the CF, 0.776 for the EF, 0.799 for the SF, and 0.682 for the PF (p < 0.001). Convergent validity of QOLCE-55 with the PedsQLTM 4.0 scale was −0.962 (p < 0.001), and the discriminant validity of the QOLCE-55 with PSQ was 0.154 (p = 0.272). This version presented a correlation with maximum lifetime consumption of anti-epileptic drugs (0.500; p < 0.001), and current consumption (0.448; p < 0.001). The Spanish version of the QOLCE-55 has demonstrated adequate psychometric properties, indicating that it can be confidently used to measure the health-related quality-of-life (HRQoL) in children with epilepsy in a Spanish-speaking population. These results corroborate the instrument's cross-cultural validity. [ABSTRACT FROM AUTHOR]

• Both original QOLCE-16 and Spanish version showed similar psychometric properties. • This study should enable to conduct an in-depth study of quality of life in CWE. • This study provides evidence for the use of QOLCE-16 among Spanish speakers. • This work provides an instrument to validly and reliably assess quality of life in CWE. The aim of this study was the translation and cultural adaptation (TCA) of the Spanish version of the16-item Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-16) and an initial assessment of its psychometric properties. The English version of the QOLCE-16 was cross-culturally adapted into Spanish using a back TCA procedure. Subsequently, for the process of validation of the Spanish version of QOLCE-16, the parents of 75 children with epilepsy (CWE) completed the QOLCE-16 questionnaire, the Pediatric Quality-of-Life Inventory (PedsQL™ 4.0), and the Pediatric Sleep Questionnaire (PSQ) twice in an interval of 7–10 days. The psychometric properties of the four domains of functioning (cognitive, emotional, social, and physical functioning subscales) were analyzed, together with the total QOLCE-16 score using Classical Test Theory. The scores of the Spanish version of the QOLCE-16 were obtained (alpha coefficient: 0.882, intraclass coefficient: 0.945). The standard error of measurement for the total score was 4.58, and the minimal detectable change was 13.44. Construct validity was tested using Confirmatory Factor Analysis. The estimates of the loadings for the four factors were higher than 0.35 and significant (α = 0.05). The four-factor model for QOLCE-16 [Chi- squared (p = 0.0540), comparative fit index = 0.985, Tucker–Lewis index = 0.982, root mean square error of approximation = 0.056 (0.000–0.0987), weighted root mean square residual = 0.707] showed good fit to these data. Convergent validity with PedsQL™ 4.0. was 0.791 and the discriminant validity of the QOLCE-16 with PSQ was −0.280. The Spanish version of the QOLCE-16 displays good psychometric properties of validity and reliability. All goodness-of-fit indices represent a good model fit, maintaining the multidimensional Health-related quality-of-life (HRQoL) model of the original English version. The Spanish version of this test can be used reliably to assess HRQoL in CWE in a Spanish-speaking population. [ABSTRACT FROM AUTHOR]