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Development and validation of the Food Allergy Severity Score

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  • Montserrat Fernández-Rivas
  • Ismael Gómez García
  • Alejandro Gonzalo-Fernández
  • Manuel Fuentes Ferrer
  • Sabine Dölle-Bierke
  • Guadalupe Marco-Martín
  • Barbara K. Ballmer-Weber
  • Riccardo Asero
  • Simona Belohlavkova
  • Kirsten Beyer
  • Frédéric de Blay
  • Michael Clausen
  • Mareen R. Datema
  • Ruta Dubakiene
  • Kate E.C. Grimshaw
  • Karin Hoffmann-Sommergruber
  • Jonathan O.B. Hourihane
  • Monika Jedrzejczak-Czechowicz
  • André C. Knulst
  • Tanya Kralimarkova
  • Thuy My Le
  • Nikolaos G. Papadopoulos
  • Todor A. Popov
  • Lars K. Poulsen
  • Ashok Purohit
  • Suranjith L. Seneviratne
  • Angela Simpson
  • Atanasios Sinaniotis
  • Mirjana Turkalji
  • Sonia Vázquez-Cortés
  • Rosialzira N. Vera-Berrios
  • Antonella Muraro
  • Margitta Worm
  • Graham Roberts
  • Ronald van Ree
  • Cristina Fernández-Pérez
  • Paul J. Turner
  • Elizabeth N.Clare Mills
Vis graf over relationer

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.

OriginalsprogEngelsk
TidsskriftAllergy: European Journal of Allergy and Clinical Immunology
Vol/bind77
Udgave nummer5
Sider (fra-til)1545-1558
Antal sider14
ISSN0105-4538
DOI
StatusUdgivet - maj 2022

Bibliografisk note

Funding Information:
Dr Fernández‐Rivas reports research grant to her institution from EU FP7 for the iFAAM project related to the work reported in this manuscript; research grants to her institution from Spanish Government (MINECO, ISCIII), and Aimmune Therapeutics and Diater, consultancy fees from Aimmune Therapeutics, Novartis and SPRIM, fees for participation in DSMB from DBV, lecture fees from Aimmune Therapeutics, ALK, Allergy Therapeutics, Diater, GSK, HAL Allergy and Thermo Fisher Scientific, outside the submitted work. Dr. Beyer reports grants/research supports from Aimmune Therapeutics, Danone/Nutricia/Milupa, DBV, Hipp, Hycor, Infectopharm and honoraria or consultation fees from Aimmune Therapeutics, Bencard, Danone/Nutricia/Milupa, DBV, Hipp, Hycor, Infectopharm, Jenapharma, Mylan/Meda, Nestle, Novartis, Thermo Fisher outside of the submitted work. Dr de Blay reports advisory board membership of Aimmune Therapeutics, Stallergènes Greer, Mundipharma, Novartis, Regeneron, DVB, Sanofi, ALK, Boehringer, and AstraZeneca, outside the submitted work. Dr Hourihane reports research funding from Aimmune Therapeutics, DBV Technologies, Johnson&Johnson, Dublin Skin and Cancer Hospital Charity, National Children's Research Centre, Dublin, Ireland, Temple St Hospital Foundation Charity and Clemens von Pirquet Foundation; advisory board membership of Aimmune Therapeutics; speaker bureaux of Aimmune Therapeutics, DBV Technologies and Danone‐Nutricia, outside the submitted work. Dr Papadopoulos reports research Support from Gerolymatos Int, Capricare, Nutricia, Vian; Speaker/Chairperson fees from HAL, Menarini/Faes Farma, MSD, Biomay, Novartis, Nutricia, Sanofi, Boehringer Ingelheim, Mylan/Meda, Asit Biotech; Advisory board fees from HAL, Menarini/Faes Farma, Novartis, Nutricia, GSK, AstraZeneca, Mylan/Meda, outside the submitted work. Prof. Worm declares the receipt of honoraria or consultation fees by the following companies: ALK‐Abelló Arzneimittel GmbH, Mylan Germany GmbH, Leo Pharma GmbH, Sanofi‐Aventis Deutschland GmbH, Regeneron Pharmaceuticals, DBV Technologies S.A, Stallergenes GmbH, HAL Allergie GmbH, Allergopharma GmbH & Co.KG, Bencard Allergie GmbH, Aimmune Therapeutics UK Limited, Actelion Pharmaceuticals Deutschland GmbH, Novartis AG, Biotest AG., AbbVie Deutschland GmbH & Co. KG and Lilly Deutschland GmbH, outside the submitted work. Prof. Roberts reports funding to his institution by the European Commission and the UK Food Standards Agency to undertake research as part of iFAAM, for the reported work in this manuscript. Dr van Ree reports research grant from EU FP7 for the iFAAM Project for the reported work in this manuscript; research grants from EU FP7, Dutch Science Foundation, and Health Holland, a research contract from Agany Inc., consulting fees from HAL Allergy BV, Citeq BV, Angany Inc., lecture fees from HAL Allergy BV, ALK and Thermo Fisher Scientific, support for attending meetings from HAL Allergy BV, advisory board fees from HAL Allergy BV and Agany Inc., stock options from Agany Inc., outside the submitted work. Dr Turner reports grants from European Commission H2020 iFAAM collaboration for the reported work in this manuscript; grants from UK Medical Research Council, NIHR/Imperial BRC, and UK Food Standards Agency; advisory board fees from ILSI Europe, Aimmune Therapeutics, and AllerGenis, outside the submitted work. Dr. Mills owns founder shares in Reacta Biotech Ltd, a company developing oral food challenge diagnostics for food allergy. Funding for research and consultancy is received from the company through the University of Manchester. All other authors declare no conflicts of interest.

Funding Information:
The authors wish to thank Prof. Marek L. Kowalski (deceased June 22nd, 2021) for his contribution in the EuroPrevall and iFAAM projects; Audrey DunnGalvin, Lynn Regent, Angel Sánchez, and Sabine Schnadt for their participation in the discussions on severity scoring within the iFAAM project, and Irene Serrano for the technical review of the FASS tool. The development and evaluation of FASS were undertaken as part of the European Union funded project iFAAM (312147), and the subsequent validation was done within the ARADyAL Research Network (RD16/0006/0009) and the BIOGRIAL‐SEVERAL (PI19/01095) project cofounded by the Instituto de Salud Carlos III, Ministry of Science of the Spanish Government and FEDER (European Regional Development Fund).

Publisher Copyright:
© 2021 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.

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