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. 2025 Aug 22;18(9):101105.
doi: 10.1016/j.waojou.2025.101105. eCollection 2025 Sep.

Methodology of the international cross-sectional prevalence and severity study of pediatric and adult IgE-mediated food allergies (ASSESS FA)

Ruchi Gupta  1   2 , Tarek Mnif  3 , Suzanne Reed  3 , Mira Hleyhel  3 , Stefani Dritsa  3 , Perrine LeCalvé  3 , Alissar Moussallem  3 , Paolo Tassinari  4 , Jessica Marvel  5 , Alessandro Fiocchi  6
Affiliations

Methodology of the international cross-sectional prevalence and severity study of pediatric and adult IgE-mediated food allergies (ASSESS FA)

Ruchi Gupta et al. World Allergy Organ J. .

Abstract

Background: The burden and prevalence of food allergy (FA), a condition known to negatively impact the quality of life (QoL) of patients and their families, vary across countries due to cultural habits and clinical practices and have been assessed differently among previous studies. To date, no validated scale exists to measure FA severity risk.

Objective: The study objectives were to develop a standardized methodology to estimate FA point prevalence in children and adults in 9 countries, to assess FA impact on QoL, and to construct a framework to define FA severity risk based on QoL and FA clinical severity.

Methods: This was a cross-sectional, international study that collected self-reported data through an online quantitative survey. Participants were recruited from general population panels: parents/caregivers of children aged 6 months-17 years, and adults aged 18-65 years. The survey instrument was developed by a panel of clinical FA experts and epidemiologists.

Results: Weighted prevalence rates were calculated for the 4 generated case definitions of FA (self-reported, physician-diagnosed, symptom-convincing, and confirmed FA). Several validated scales, including the Food Allergy Quality of Life Questionnaire (FAQLQ) and the Food Allergy Independent Measure (FAIM), were used to assess FA impact on QoL in patients with symptom-convincing FA. Four FA severity risk profiles were generated: non-severe, at-risk, highly impacted QoL, and severe patients.

Conclusion: The ASSESS FA study developed a methodology to estimate the prevalence of FA and its impact on QoL consistently across countries, age groups, and food allergens. The severity risk framework was based on both the clinical severity and impact on QoL aspects of FA.

Keywords: Allergy and immunology; Cross-sectional studies; Epidemiology; Food hypersensitivity; Immunoglobulin E; Methods.

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Conflict of interest statement

Ruchi Gupta receives research support from the National Institutes of Health (NIH) (R21 ID # AI135705, R01 ID # AI130348, U01 ID # AI138907), Food Allergy Research & Education (FARE), Melchiorre Family Foundation, Sunshine Charitable Foundation, The Walder Foundation, UnitedHealth Group, Thermo Fisher Scientific, Novartis, and Genentech. She serves as a medical consultant/advisor for Genentech, Novartis, Aimmune LLC, Allergenis LLC, and Food Allergy Research & Education (FARE). Dr. Gupta has ownership interest in Yobee Care, Inc. She is currently employed by Ann & Robert H. Lurie Children's Hospital of Chicago and is a Professor of Pediatrics & Medicine at Northwestern University Feinberg School of Medicine. Alessandro Fiocchi declares the receipt of honoraria or consulting fees by the following companies – Danone, Abbott, Aimmune, Ferrero, Novartis, Sanofi, Stallergenes. Tarek Mnif, Stefani Dritsa, Suzanne Reed, Mira Hleyhel, Perrine Le Calvé, Alissar Moussallem: Oracle Life Sciences, France (a company that received research funds from Novartis Pharma AG. during the conduct of the study) – employees. Paolo Tassinari, Jessica Marvel: Novartis Pharma AG – employees, may hold stock and/or stock options in the company.

Figures

Fig. 1
Fig. 1
Flow chart of the criteria for the 4 types of evidence of FA (self-reported, physician-diagnosed, symptom-convincing, and confirmed). Note: Self-reported FA: Self-report of current FA to 1 or more allergens. Physician-diagnosed FA: Self-report of a current FA to 1 or more allergens with a physician diagnosis (regardless of the presence of symptoms indicative of FA). Symptom-convincing FA: Self-report of a current FA to 1 or more allergens with symptoms indicative of FA (regardless of the presence of a physician diagnosis). Confirmed FA: Self-report of current FA to 1 or more allergens with symptoms indicative of FA and with a physician diagnosis. Oral allergy syndrome (AOS) is excluded from the definition of the symptom-convincing FA and the confirmed FA, but it is included in the definition of self-reported and physician-diagnosed FA due to the absence of symptom-based FA confirmation.
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