TY - JOUR
T1 - Core Outcome Set for IgE-mediated food allergy clinical trials and observational studies of interventions
T2 - International Delphi consensus study 'COMFA'
AU - COMFA Consortium
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
N1 - Funding Information:
DMu is a Co‐Chair of International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) Global Paediatric Long COVID Working Group, member of ISARIC working group on long‐term follow‐up in adults and lead of PC‐COS project. CA reports grants or contracts from Dr Wolff Group and Bionorica. He also acknowledges consulting fees from the Dr Wolff Group, Bionorica, Sanofi and LEO Pharma. He serves as a Co‐Chair Harmonising Outcome Measures for Eczema (HOME) initiative and Co‐Chair Hand Eczema Core Outcome Set (HECOS) initiative and is the core principal investigator of the KUNOKids Health Study (Regensburg, Germany). JG is the project manager of unrestricted research grants from Danone Nutricia Research to Leipzig University for research into human milk composition within the Ulm Birth Cohort Studies. This work is not related to the present publication. RJB declares consultancy payment from Cochrane, Wiley and the British Society for Allergy and Clinical Immunology for editorial work, and payment for expert witness work in cases involving food anaphylaxis and a disputed infant formula health claim. KPD is part‐time employed by the IVDK, which systematically collects and analyses data on contact allergies from over 50 partner healthcare facilities. It is partly sponsored by the cosmetic industry or associations as well as by public funds. DPM has provided consultation and speaker services for DBV, ALK, and Alladapt, and is an investigator for DBV and ALK‐Abello. JLPP is Section Head, Allied Health; and Co‐Lead, Research Pillar for the Canadian Society of Allergy and Clinical Immunology, and is on the steering comittee for Canada's National Food Allergy Action Plan. She reports consulting from Ajonomoto Cambrooke, Novartia, Nutricia and ALK Abelló. EEC is on the board of the patient organization NPO Atopicco Chikyu no Ko Nettowa‐ku which deals with allergic disease in Japan. She is a patient representative on Novartis' Global Food Allergy Patient Council. EK is an author of the EAACI guideline: Preventing development of food allergy in infants and young children (2020 update) and Managing food allergy: GA2LEN 2022. RK's work involves the development of psychometric scales for allergy and asthma, and she has published a number of psychometric scales in the field. PRR reports research grants from FAES and Aimmune Therapeutics; speaker honoraria from DBV, GSK, FAES, Novartis, ALK‐Abelló, LETI Pharma, Aimmune Therapeutics, Sanofi, Stallergenes; and conslutant fees from FAES, Miravo outside the submitted work. AMMS is on the advisory board for ALK and a paid speaker for Thermo Fisher Scientific. MS reports being a speker at seminars arranged by Thermo Fisher Scientific. JU is an associate editor of AACI and she is on the board of directors of CSACI.
Funding Information:
We thank the chair of COMET Initiative Paula Williamson for her invaluable advice in conducting the COS. We also express our appreciation to the following organizations for their assistance in disseminating information about the Delphi survey: the World Allergy Organization, The Canadian Society of Allergy and Clinical Immunology, The British Society for Allergy and Clinical Immunology, European Academy of Allergy and Clinical Immunology Patient Organization Committee, the American College of Allergy Asthma and Immunology, and the American Academy of Allergy, Asthma and Immunology. We are grateful to Angelo Basteris, Dominique Vandekerchove, Tania Gonzalez‐Ovin, Sara Silvestre and Matthew Borg for their valuable assistance and kind support. We also thank all the volunteers who helped with meetings organization (Imelda Gerry, Nabeela Bhaloo, Joseph Withers Green, Anna Quayle, Carla Teixeira, Caterina Villa, Maria Araujo and Isabel Ferreira). Additionally, Ekaterina Khaleva was supported by the National Institute for Health Research through the NIHR Southampton Biomedical Research Centre and Southampton Academy of Research. Finally, we extend our gratitude to everyone who contributed to the project at various stages, including Teresa Bachhuber, Tanja Cirkovic Velickovic, Ramona Grzeschik, Veronika Kauert, Daria Levina, Ruslan Sharifullin, Sabine Puhlfuerst, Martina Pusch, María Otal Buesa, Maureen Smith. These collective efforts have been instrumental in the success of this project. During the preparation of this work the authors used ChatGPT in order to improve the grammatical structure and readability. After using this tool, the authors reviewed and edited the content as neededand take full responsibility for the content of the publication.
Publisher Copyright:
© 2024 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.
PY - 2024/3/3
Y1 - 2024/3/3
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.
UR - http://www.scopus.com/inward/record.url?scp=85186941669&partnerID=8YFLogxK
U2 - 10.1111/all.16023
DO - 10.1111/all.16023
M3 - Article
C2 - 38433402
SN - 0105-4538
VL - 79
SP - 977
EP - 989
JO - Allergy
JF - Allergy
IS - 4
ER -