RESUMO
Summary: Background. Food allergy (FA) negatively affects health-related quality of life (HR-QoL) of children and caregivers. To date, no questionnaire self-compiling assessing the HR-QoL in pre-school children with FA is available. The aim of this study is to develop and validate a self-administered, rapid and easy questionnaire to evaluate the HR-QoL in children ≥ 7 years with IgE-mediated FA. Methods. A two-center prospective study was conducted including children aged 4-7 years with IgE-mediated FA. The Vitulia questionnaire was administered to study participants at the baseline (T0) and after one month (T1). To assess the feasibility and reliability, the Vitulia questionnaire was compared with other two pre-existing questionnaires: FAQLQ-PF and the KiddyKindl, which were also tested at both T0 and T1. The validation phase aimed to assess the following psychometric properties: convergent validity, internal consistency, discriminant validity and sensitivity to change. Results. One hundred patients (62% male, mean age 5.4 ± 1.2 years) were enrolled. The Vitulia questionnaire showed a good internal consistency along with an excellent reliability and repeatability of the measure. Another noteworthy feature of the questionnaire was its discriminant validity as demonstrated by the ability to provide different scores in subgroups, which have differences in terms of quality of life. On the other hand, the questionnaire seems not be sensitive to changes in health status over time. Conclusions. The Vitulia questionnaire represents a valid tool, quick and easy to interpret, which can be used to assess the quality of life in preschool children with IgE-mediated FA.