Development and validation of quality-of-life questionnaire for children with food allergy

Background: Children with food allergies must eliminate allergenic foods from their daily diet and face the risk of accidental ingestion, which can reduce their quality of life (QOL). Objective: This study aimed to develop and validate a Japanese QOL questionnaire consisting of approximately 10 items, specifically designed to align with Japanese cultural and social practices for children with food allergies. Methods: We collected QOL-related events through free-text responses obtained from children aged 9 to 15 years with food allergies and developed a preliminary questionnaire. Based on responses to the primary questionnaire, factor analysis was performed to select items, resulting in a secondary questionnaire comprising 9 items across 3 factors. To validate the secondary questionnaire, we examined its correlation with KINDL, a comprehensive health-related QOL scale for children. Additionally, we compared secondary-questionnaire scores according to the severity of food allergies. Results: A total of 170 children completed the secondary questionnaire, which showed a weak correlation with KINDL ( r = −0.283; P < 0.001). Children who were allergic to 2 or more commonly consumed foods (hen’s eggs, milk, and wheat) scored higher on the questionnaire (≥2 foods vs <2 foods; total score, 0.89 vs 0.56; P = 0.045), indicating lower QOL. However, the secondary questionnaire did not distinguish participants who reported anaphylaxis in the past 3 years. Conclusion: The developed questionnaire demonstrated validity as a QOL instrument for children with food allergies. This tool may improve pediatric food-allergy management, including oral food-challenge tests, oral immunotherapy, and educational programs, contributing to enhanced clinical practice and social support.