BACKGROUND: The heterogeneity and lack of validation of existing severity scores for food allergic reactions limit standardization of case management and research advances. We aimed to develop and validate a severity score for food allergic reactions. METHODS: Following a multidisciplinary experts consensus, it was decided to develop a food allergy severity score (FASS) with ordinal (oFASS) and numerical (nFASS) formats. oFASS with 3 and 5 grades were generated through expert consensus, and nFASS by mathematical modeling. Evaluation was performed in the EuroPrevall outpatient clinic cohort (8232 food reactions) by logistic regression with request of emergency care and medications used as outcomes. Discrimination, classification, and calibration were calculated. Bootstrapping internal validation was followed by external validation (logistic regression) in 5 cohorts (3622 food reactions). Correlation of nFASS with the severity classification done by expert allergy clinicians by Best-Worst Scaling of 32 food reactions was calculated. RESULTS: oFASS and nFASS map consistently, with nFASS having greater granularity. With the outcomes emergency care, adrenaline and critical medical treatment, oFASS and nFASS had a good discrimination (receiver operating characteristic area under the curve [ROC-AUC]>0.80), classification (sensitivity 0.87-0.92, specificity 0.73-0.78), and calibration. Bootstrapping over ROC-AUC showed negligible biases (1.0 × 10-6 -1.23 × 10-3 ). In external validation, nFASS performed best with higher ROC-AUC. nFASS was strongly correlated (R 0.89) to best-worst scoring of 334 expert clinicians. CONCLUSION: FASS is a validated and reliable method to measure severity of food allergic reactions. The ordinal and numerical versions that map onto each other are suitable for use by different stakeholders in different settings.

Allergy Clinic Copenhagen University Hospital at Herlev Gentofte Copenhagen Denmark

Allergy Department 2nd Pediatric Clinic University of Athens Athens Greece

Allergy Department Hospital Clínico San Carlos Facultad de Medicina Universidad Complutense IdISSC ARADyAL Madrid Spain

Allergy Department Hospital Clínico San Carlos IdISSC ARADyAL Madrid Spain

Allergy Department Sotiria Chest Diseases Hospital Athens Greece

Allergy Division Chest Disease Department University Hospital of Strasbourg Strasbourg France

Allergy Dpt 2nd Pediatric clinic University of Athens Athens Greece

Ambulatorio di Allergologia Clinica San Carlo Paderno Dugnano Milan Italy

Chest Diseases Department Strasbourg University Hospital Federation of Translational Medicine University of Strasbourg Strasbourg France

Children's Hospital and Department of Allergy Landspitali University Hospital Reykjavik Iceland

Clinic for Dermatology and Allergology Kantonsspital St Gallen St Gallen Switzerland

Clinic of Allergy and Asthma Medical University in Sofia Sofia Bulgaria

Clinical and Experimental Sciences and Human Development in Health Faculty of Medicine University of Southampton Southampton UK

Clinical and Experimental Sciences Faculty of Medicine University of Southampton Southampton UK

Department of Allergy and Immunology Medical University of Lodz Lodz Poland

Department of Clinical Immunology and Allergy Central Manchester and Manchester Children's University Hospitals NHS Trust Manchester UK

Department of Dermatology University Hospital Zurich Zurich Switzerland

Department of Dietetics Salford Royal NHS Foundation Trust Salford UK

Department of Experimental Immunology and Department of Clinical Epidemiology Biostatistics and Bioinformatics Amsterdam University Medical Center Amsterdam The Netherlands

Department of Pathophysiology and Allergy Research Medical University of Vienna Vienna Austria

Department of Pediatric Respiratory Medicine Immunology and Intensive Care Medicine Charité Universitätsmedizin Berlin Berlin Germany

Departments of Experimental Immunology and of Otorhinoraryngology Amsterdam University Medical Centers Amsterdam The Netherlands

Dept Dermatology Allergology University Medical Center Utrecht Utrecht University Utrecht The Netherlands

Division of Allergy and Immunology Department of Dermatology Venerology and Allergology Charité Universitätsmedizin Berlin Corporate Member of Freie Universität Berlin Humboldt Universität zu Berlin and Berlin Institute of Health Berlin Germany

Division of Infection Immunity and Respiratory Medicine Manchester Academic Health Sciences Centre Manchester Institute of Biotechnology University of Manchester Manchester UK

Division of Infection Immunity and Respiratory Medicine School of Biological Sciences Manchester Academic Health Science Centre NIHR Manchester Biomedical Research Centre and Manchester University NHS Foundation Trust The University of Manchester Manchester UK

Division of Infection Immunity and Respiratory Medicine University of Manchester Manchester UK

Food Allergy Referral Centre Veneto Region Department of Women and Child Health Padua General University Hospital Padua Italy

Grupo de Investigación en Alergia IdISSC Madrid Spain

Institute of Immunity and Transplantation Royal Free Hospital and University College London London UK

Medical Faculty and Faculty Hospital Pilsen Pilsen Czech Republic

Medical Faculty Vilnius University Vilnius Lithuania

National Heart and Lung Institute Imperial College London London UK

NIHR Southampton Biomedical Research Centre University Hospital Southampton NHS Foundation Trust Southampton UK

Preventive Medicine Department Complejo Hospitalario Universitario Santiago de Compostela Santiago de Compostela Spain

Preventive Medicine Department Hospital Clínico San Carlos IdISSC Madrid Spain

Royal College of Surgeons in Ireland Children's Health Ireland at Temple Street Dublin Ireland

Srebrnjak Children's Hospital Zagreb Catholic University of Croatia Zagreb and Medical Faculty Osijek J J Strossmayer University Osijek Croatia

The David Hide Asthma and Allergy Research Centre St Mary's Hospital Isle of Wight UK

Unidad de Apoyo a la Investigación Preventive Medicine Department Hospital Clínico San Carlos IdISSC Universidad Alfonso 10 El Sabio Madrid Spain

University Hospital Sv Ivan Rilski Sofia Bulgaria

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