Consensus on DEfinition of Food Allergy SEverity (DEFASE) an integrated mixed methods systematic review.

BACKGROUND AND AIMS

The term "Food Allergy" refers to a complex global health problem with a wide spectrum of severity. However, a uniform definition of severe food allergy is currently missing. This systematic review is the preliminary step towards a state-of-the-art synopsis of the current evidence relating to the severity of IgE-mediated food allergy; it will inform attempts to develop a consensus to define food allergy severity by clinicians and other stakeholders.

METHODS

We undertook a mixed-methods systematic review, which involved searching 11 international biomedical databases for published studies from inception to 31 December 2019. Studies were independently screened against pre-defined eligibility criteria and critically appraised by established instruments. The substantial heterogeneity of included studies precluded meta-analyses and, therefore, narrative synthesis of quantitative and qualitative data was performed.

RESULTS

We found 23 studies providing eligible primary data on symptom-specific severity of food allergic reactions, and 31 previously published symptom-severity scoring systems referred to food allergic reactions. There were seven studies which assessed quality-of-life measures in patients (and family members) with different food allergy severity and two studies that investigated the economic burden of food allergy severity. Overall, the quality and the global rating of all included studies were judged as being moderate.

CONCLUSIONS

There is heterogeneity among severity scoring systems used and even outcomes considered in the context of severity of food allergy. No score has been validated. Our results will be used to inform the development of an international consensus to define the severity of food allergy.

SYSTEMATIC REVIEW REGISTRATION

A protocol was prospectively registered with the International Prospective Register of Systematic Reviews (PROSPERO) database with the registration number CRD42020183103 (https://www.crd.york.ac.uk/prospero/#recordDetails).

Informations de copyright

© 2021 The Authors.

Déclaration de conflit d'intérêts

The following authors declared no potential interests: Ignacio J Ansotegui; Stefania Arasi; Shahd Daher; Alessandro Fiocchi; Ulugbek Nurmatov; Stavros Petrou; Graham Roberts; Mario Sánchez-Borges; Luciana Kase Tanno; Marta Vazquez Ortiz; Gary Wing-Kin Wong. Some of the authors have professional affiliations related to the content of the systematic review as set out below: Audrey Dunn-Galvin: consultancy fee from Aimmune and DBV; Paul J Turner: grants from UK 10.13039/501100000265Medical Research Council, 10.13039/501100013342NIHR/Imperial BRC, JM Charitable Foundation and UK 10.13039/501100000354Food Standards Agency; personal fees from UK Food Standards Agency, DBV Technologies, ILSI Europe and Allergenis, non-financial support from Aimmune Therapeutics; Sayantani B Sindher: supported by 10.13039/100000002NIH grants. Involved in clinical trials with Regeneron, Aimmune Therapeutics, DBV Technologies, Adare Pharmaceuticals, Sanofi, Novartis; Ruchi Gupta: grants from The 10.13039/100000002National Institute of Health (NIH) (R21 ID # AI135705, R01 ID# AI130348, U01 ID # AI138907), Rho Inc., Stanford Sean N. Parker Center for Allergy Research, UnitedHealth Group, Thermo Fisher Scientific, Genentech, and the National Confectioners Association (NCA); is employed by Ann & Robert H. Lurie Children's Hospital of Chicago; is a Professor of Pediatrics at Northwestern University; and serves as a medical consultant/advisor for Before Brands, Kaléo Inc., Genentech, ICER, FARE, Aimmune Therapeutics, and DBV Technologies; Philippe Eigenmann: Research grants and support: Ulrich Muller Gierock Foundation, 10.13039/100011033ThermoFisher Scientific; Consultant: DBV technologies, Nesté, Danone, Novartis, Abbott; Speaking engagements: ThermoFisher Scientific, ALK, Abbott; Stock options: DBV technologies; Anna Nowak-Wegrzyn: Grant/Research/Clinical Trial Support: DBV Technologies; ITN/NIAID; 10.13039/100004324Astellas Pharmaceutical; 10.13039/100004339Sanofi-Aventis [Future therapies for food allergy]. International FPIES Association [FPIES, unpaid advisor]. Consultant/Advisory Boards: Gerber Nutrition Institute; Merck. Speaking engagements: Nestle, Thermofisher Scientific; Montserrat Fernandez-Rivas: research grants from the Spanish Government (10.13039/501100003329MINECO, ISCIII) for the project SOLMILK, ARADyAL network and PI19/01095; consultancy fees from Aimmune, DBV, Novartis, SPRIM; lecture fees from ALK, Allergy Therapeutics, Diater, GSK, HAL Allergy, Thermofisher Scientific; Brian P Vickery: Employment: Pediatric Institute of Emory University + Children's Healthcare of Atlant; Consultant/Advisor: Aimmune Therapeutics; AllerGenis, LLC; Food Allergy Research and Education (FARE); Reacta Biosciences; Grant support: NIH-NIAID; 10.13039/100006423FARE; 10.13039/100004328Genentech; Clinical investigator: Aimmune; DBV Technologies; Regeneron; Motohiro Ebisawa: lecture fees: DBV technologies and Mylan.