TY - JOUR
T1 - Core Outcome Set for IgE ‐mediated food allergy clinical trials and observational studies of interventions: International Delphi consensus study ‘ COMFA ’
AU - Demidova, Anastasia
AU - Drewitz, Karl Philipp
AU - Kimkool, Parisut
AU - Banjanin, Nikolina
AU - Barzylovich, Vladyslava
AU - Botjes, Erna
AU - Capper, India
AU - Castor, Mary Anne R.
AU - Comberiati, Pasquale
AU - Cook, Emma E.
AU - Costa, Joana
AU - Chu, Derek K.
AU - Epstein, Michelle M.
AU - Galvin, Audrey Dunn
AU - Giovannini, Mattia
AU - Girard, Frédéric
AU - Golding, Michael A.
AU - Greenhawt, Matthew
AU - Ierodiakonou, Despo
AU - Jones, Christina J.
AU - Khaleva, Ekaterina
AU - Knibb, Rebecca C.
AU - Macit‐Çelebi, Melahat Sedanur
AU - Mack, Douglas P.
AU - Mafra, Isabel
AU - Marchisotto, Mary Jane
AU - Mijakoski, Dragan
AU - Nekliudov, Nikita
AU - Özdemir, Cevdet
AU - Patel, Nandinee
AU - Pazukhina, Ekaterina
AU - Protudjer, Jennifer L. P.
AU - Rodríguez del Rio, Pablo
AU - Roomet, Jelena
AU - Sammut, Patrick
AU - Schoos, Ann‐Marie Malby
AU - Schopfer, Anita Fossaluzza
AU - Schultz, Fallon
AU - Seylanova, Nina
AU - Skypala, Isabel
AU - Sørensen, Martin
AU - Stoleski, Sasho
AU - Stylianou, Eva
AU - Upton, Julia
AU - van de Veen, Willem
AU - Genuneit, Jon
AU - Boyle, Robert J.
AU - Apfelbacher, Christian
AU - Munblit, Daniel
AU - Adel‐Patient, Karine
N1 - 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 (https://creativecommons.org/licenses/by-nc/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
PY - 2024/4
Y1 - 2024/4
N2 - 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.
AB - 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.
KW - allergic symptoms
KW - core outcome set
KW - quality of life
KW - outcome assessment
KW - food allergy
UR - https://onlinelibrary.wiley.com/doi/10.1111/all.16023
UR - http://www.scopus.com/inward/record.url?scp=85186941669&partnerID=8YFLogxK
U2 - 10.1111/all.16023
DO - 10.1111/all.16023
M3 - Article
SN - 0105-4538
VL - 79
SP - 977
EP - 989
JO - Allergy
JF - Allergy
IS - 4
ER -