Core Outcome Set for IgE ‐mediated food allergy clinical trials and observational studies of interventions: International Delphi consensus study ‘ COMFA ’

Anastasia Demidova, Karl Philipp Drewitz, Parisut Kimkool, Nikolina Banjanin, Vladyslava Barzylovich, Erna Botjes, India Capper, Mary Anne R. Castor, Pasquale Comberiati, Emma E. Cook, Joana Costa, Derek K. Chu, Michelle M. Epstein, Audrey Dunn Galvin, Mattia Giovannini, Frédéric Girard, Michael A. Golding, Matthew Greenhawt, Despo Ierodiakonou, Christina J. JonesEkaterina Khaleva, Rebecca C. Knibb, Melahat Sedanur Macit‐Çelebi, Douglas P. Mack, Isabel Mafra, Mary Jane Marchisotto, Dragan Mijakoski, Nikita Nekliudov, Cevdet Özdemir, Nandinee Patel, Ekaterina Pazukhina, Jennifer L. P. Protudjer, Pablo Rodríguez del Rio, Jelena Roomet, Patrick Sammut, Ann‐Marie Malby Schoos, Anita Fossaluzza Schopfer, Fallon Schultz, Nina Seylanova, Isabel Skypala, Martin Sørensen, Sasho Stoleski, Eva Stylianou, Julia Upton, Willem van de Veen, Jon Genuneit, Robert J. Boyle, Christian Apfelbacher, Daniel Munblit*, Karine Adel‐Patient

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


Background: IgE‐mediated food allergy (FA) is a global health concern with substantial individual and societal implications. While diverse intervention strategies have been researched, inconsistencies in reported outcomes limit evaluations of FA treatments. To streamline evaluations and promote consistent reporting, the Core Outcome Measures for Food Allergy (COMFA) initiative aimed to establish a Core Outcome Set (COS) for FA clinical trials and observational studies of interventions. Methods: The project involved a review of published clinical trials, trial protocols and qualitative literature. Outcomes found as a result of review were categorized and classified, informing a two‐round online‐modified Delphi process followed by hybrid consensus meeting to finalize the COS. Results: The literature review, taxonomy mapping and iterative discussions with diverse COMFA group yielded an initial list of 39 outcomes. The iterative online and in‐person meetings reduced the list to 13 outcomes for voting in the formal Delphi process. One more outcome was added based on participant suggestions after the first Delphi round. A total of 778 participants from 52 countries participated, with 442 participating in both Delphi rounds. No outcome met a priori criteria for inclusion, and one was excluded as a result of the Delphi. Thirteen outcomes were brought to the hybrid consensus meeting as a result of Delphi and two outcomes, ‘allergic symptoms’ and ‘quality of life’ achieved consensus for inclusion as ‘core’ outcomes. Conclusion: In addition to the mandatory reporting of adverse events for FA clinical trials or observational studies of interventions, allergic symptoms and quality of life should be measured as core outcomes. Future work by COMFA will define how best to measure these core outcomes.
Original languageEnglish
Pages (from-to)977-989
Number of pages13
Issue number4
Early online date3 Mar 2024
Publication statusPublished - Apr 2024

Bibliographical note

Copyright © 2024 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License (, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.


  • allergic symptoms
  • core outcome set
  • quality of life
  • outcome assessment
  • food allergy


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