Psychometric evaluation of the Spanish version of the Pediatric Quality of Life Eosinophilic Esophagitis Questionnaire (Peds QL-EoE Module ™).

BACKGROUND: The Paediatric Eosinophilic Oesophagitis Module (PedsQL-EoE) was developed in English as a valid and reliable questionnaire to assess health-related quality of life (HRQoL) in children with EoE. The aim of this study was to evaluate the validity and reliability of the PedsQL-EoE that was previously adapted to Spanish by our group. METHODS: This cross-sectional multicentre study was conducted in 36 paediatric gastroenterology units. Groups with and without dietary restrictions were studied separately. The PedsQL-EoE consists of 33 items divided into seven factors. Age-specific versions of the PedsQL-EoE were sent by e-mail to children and parents. Statistical analysis was used to study the questionnaire structure by means of exploratory factor analysis and interitem correlations. Confirmatory factor analysis (CFA) was applied to verify the proposed model as well as its psychometric properties through SMSR (standardized root mean square), outer loadings and R-square. To study construct validity and reliability, Cronbach´s alpha coefficient, convergent validity (AVE), discriminant validity (HTMT) and intraclass correlation coefficients (ICC) were used. RESULTS: A total of 341 children and 394 parents participated with 307 matched answers. The median age was 12 years, and 75% were male. The questionnaire structure explained 68% and 66% of the total variance for parents and children, respectively. Five items showed negative correlations and were removed from the questionnaire. CFA applied to the new model supported the following construct: SMRS was less than 0.08, outer loadings measured above 0.5, and R2 explained more than 89% of the total variance. Once the modifications were performed, good internal consistency was demonstrated, with Cronbach's alpha values > 0.7, AVE values > 0.5 and HTMT < 0.9 with good child/parent agreement (ICC = 0.80). The most robust model of the PedsQL-EoE module was formed by seven factors: Symptoms I (6 items), Symptoms II (4 items), Treatment (4 items), Worries (3 items), Communication (5 items), Food and Eating (3 items) and Food Feelings (3 items). CONCLUSIONS: The final PedsQL-EoE Module version, after the removal of five items, is a valid and reliable tool to be used in children with EoE. The Spanish validated version appears to be a useful instrument for measuring the impact of EoE on Spanish children´s quality of life.

Respuesta de los autores: Estandarización, adaptación y validación de pruebas psicométricas: diferencias necesarias / Authors reply: Standardization, adaptation and validation of psychometric tests: Necessary differences

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Adaptación transcultural del cuestionario Pediatric Eosinophilic Esophagitis Quality of Life Module / Transcultural adaptation of the Pediatric Eosinophilic Esophagitis Quality of Life Module Questionnaire

INTRODUCCIÓN: La esofagitis eosinofílica (EoE) afecta a la calidad de vida (CVRS) de los pacientes y sus familias. Los cuestionarios de calidad de vida específicos permiten evaluar la CVRS para esa enfermedad concreta y realizar cambios diagnósticos o terapéuticos para mejorarla. OBJETIVO: Realizar la adaptación transcultural de la versión inglesa original del cuestionario Pediatric Eosinophilic Esophagitis Quality of Life Module (Peds QL EoE Module) a lengua española. MÉTODOS: El cuestionario Peds QL EoE Module consta de 3 versiones para padres y niños de 5-7, 8-12 y 13-18 años y una para padres de niños de 2-4 años. Se siguió la metodología internacionalmente consensuada, realizando 2 traducciones independientes de la versión original inglesa al español, versión española de consenso, traducción inversa al inglés, versión final preliminar, entrevista cognitiva a 5 padres y niños de cada grupo de edad para evaluar la comprensión del cuestionario y crear, una vez resueltas las dificultades encontradas, la versión final. RESULTADOS: En la entrevista cognitiva respondieron la totalidad de las preguntas 15 niños y 20 padres; el tiempo empleado en contestar el cuestionario les pareció adecuado y el test, de fácil comprensión. El grupo de niños de 5 a 7 años fue el que más tiempo tardó en responder y el que presentó mayor dificultad en su comprensión. La satisfacción global fue alta y la encuesta les pareció una herramienta útil. CONCLUSIONES: La adaptación transcultural al español del cuestionario Peds QL EoE Module permitirá, tras su validación, su aplicación para el estudio de la CVRS de los niños españoles con EoE

INTRODUCTION: Eosinophilic oesophagitis (EoE) affects the quality of life (QoL) of the patients and their families. Specific quality of life questionnaires help to evaluate the QoL for this particular disease, as well as to make diagnostic or therapeutic changes in order to improve it. OBJECTIVE: To make a transcultural adaptation of the original English version of the Pediatric Eosinophilic Esophagitis Quality of Life Module (Peds QL EoE Module) into the Spanish language. METHODS: The PedsQL EoE Module questionnaire consists of 3 versions for parents and children from 5-7, 8-12, and 13-18 years, and one for parents of children from 2-4 years. It follows the international consensus methodology, consisting of performing independent translations of the original English version to Spanish, a consensus Spanish version, a back-translation into English, preliminary final version, as well as a cognitive interview with 5 parents and children of each age group in order to evaluate the comprehension of the questionnaire, and once the difficulties found are resolved, the final version. RESULTS: In the cognitive interview, 15 children and 20 parents responded to all the questions. The time taken to complete the questionnaire seemed adequate to them, and the comprehension test was easy. The 5 to 7 years children group took the longest in responding and that had more difficulty in understanding it. The overall satisfaction was high, and the questionnaire seemed to be a useful tool for them. CONCLUSIONS: After it validation, the transcultural adaptation to Spanish of the Peds QL EoE Module questionnaire can be applied in order to study the QoL of Spanish children with EoE

[Transcultural adaptation of the Pediatric Eosinophilic Esophagitis Quality of Life Module Questionnaire]. / Adaptación transcultural del cuestionario Pediatric Eosinophilic Esophagitis Quality of Life Module.

INTRODUCTION: Eosinophilic oesophagitis (EoE) affects the quality of life (QoL) of the patients and their families. Specific quality of life questionnaires help to evaluate the QoL for this particular disease, as well as to make diagnostic or therapeutic changes in order to improve it. OBJECTIVE: To make a transcultural adaptation of the original English version of the Pediatric Eosinophilic Esophagitis Quality of Life Module (Peds QL EoE Module) into the Spanish language. METHODS: The PedsQL EoE Module questionnaire consists of 3 versions for parents and children from 5-7, 8-12, and 13-18 years, and one for parents of children from 2-4 years. It follows the international consensus methodology, consisting of performing independent translations of the original English version to Spanish, a consensus Spanish version, a back-translation into English, preliminary final version, as well as a cognitive interview with 5 parents and children of each age group in order to evaluate the comprehension of the questionnaire, and once the difficulties found are resolved, the final version. RESULTS: In the cognitive interview, 15 children and 20 parents responded to all the questions. The time taken to complete the questionnaire seemed adequate to them, and the comprehension test was easy. The 5 to 7 years children group took the longest in responding and that had more difficulty in understanding it. The overall satisfaction was high, and the questionnaire seemed to be a useful tool for them. CONCLUSIONS: After it validation, the transcultural adaptation to Spanish of the Peds QL EoE Module questionnaire can be applied in order to study the QoL of Spanish children with EoE.