Core Outcome Set for <scp>IgE</scp>‐mediated food allergy clinical trials and observational studies of interventions: International Delphi consensus study ‘<scp>COMFA</scp>’-Reference-Cited by-同舟云学术

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

Published:2024-03-03 Issue:4 Volume:79 Page:977-989
ISSN:0105-4538
Container-title:Allergy
language:en
Short-container-title:Allergy

Author:

Demidova Anastasia¹^ORCID,Drewitz Karl Philipp²^ORCID,Kimkool Parisut³^ORCID,Banjanin Nikolina⁴^ORCID,Barzylovich Vladyslava⁵^ORCID,Botjes Erna⁶,Capper India⁷,Castor Mary Anne R.⁸^ORCID,Comberiati Pasquale⁹^ORCID,Cook Emma E.¹⁰^ORCID,Costa Joana¹¹^ORCID,Chu Derek K.¹²^ORCID,Epstein Michelle M.¹³^ORCID,Galvin Audrey Dunn¹⁴^ORCID,Giovannini Mattia¹⁵¹⁶^ORCID,Girard Frédéric¹⁷,Golding Michael A.¹⁸^ORCID,Greenhawt Matthew¹⁹^ORCID,Ierodiakonou Despo²⁰^ORCID,Jones Christina J.²¹^ORCID,Khaleva Ekaterina²²²³^ORCID,Knibb Rebecca C.²⁴^ORCID,Macit‐Çelebi Melahat Sedanur²⁵^ORCID,Mack Douglas P.²⁶^ORCID,Mafra Isabel¹¹^ORCID,Marchisotto Mary Jane²⁷^ORCID,Mijakoski Dragan²⁸²⁹^ORCID,Nekliudov Nikita³⁰^ORCID,Özdemir Cevdet³¹^ORCID,Patel Nandinee³^ORCID,Pazukhina Ekaterina³²^ORCID,Protudjer Jennifer L. P.¹⁸³³^ORCID,Rodríguez del Rio Pablo³⁴^ORCID,Roomet Jelena³⁵,Sammut Patrick³⁶,Schoos Ann‐Marie Malby³⁷³⁸^ORCID,Schopfer Anita Fossaluzza³⁹,Schultz Fallon⁴⁰^ORCID,Seylanova Nina⁴¹^ORCID,Skypala Isabel⁴²^ORCID,Sørensen Martin⁴³^ORCID,Stoleski Sasho²⁸²⁹^ORCID,Stylianou Eva⁴⁴^ORCID,Upton Julia⁴⁵^ORCID,van de Veen Willem⁴⁶^ORCID,Genuneit Jon⁴⁷^ORCID,Boyle Robert J.³^ORCID,Apfelbacher Christian²^ORCID,Munblit Daniel⁴⁸⁴⁹^ORCID,

Affiliation:

1. Independent Researcher Limassol Cyprus

2. Institute of Social Medicine and Health Systems Research, Medical Faculty Otto von Guericke University Magdeburg Germany

3. Department of Pediatric Allergy Imperial College Healthcare NHS Trust London UK

4. Institute of Hygiene and Medical Ecology, Faculty of Medicine University of Belgrade Belgrade Serbia

5. Department of Pediatrics National Medical University named after O.O. Bogomolets Kyiv Ukraine

6. Dutch Food Allergy SVA Nijkerk The Netherlands

7. University of Nottingham Nottingham UK

8. Division of Allergy and Immunology, Department of Pediatrics, College of Medicine—Philippine General Hospital University of the Philippines Manila Manila Philippines

9. Department of Clinical and Experimental Medicine, Section of Pediatrics University of Pisa Pisa Italy

10. Modern Japanese Studies Program, Graduate School of Media and Communication Hokkaido University Sapporo Japan

11. REQUIMTE‐LAQV, Faculdade de Farmácia Universidade do Porto Porto Portugal

12. Department of Health Research Methods, Evidence, and Impact McMaster University Hamilton Ontario Canada

13. Experimental Allergy Laboratory, Department of Dermatology Medical University of Vienna Vienna Austria

14. School of Applied Psychology University College Cork Cork Ireland

15. Allergy Unit Meyer Children's Hospital IRCCS Florence Italy

16. Department of Health Sciences University of Florence Florence Italy

17. DBV Technologies Montrouge France

18. The Children's Hospital Research Institute of Manitoba, Department of Pediatrics and Child Health University of Manitoba Winnipeg Manitoba Canada

19. Department of Pediatrics, Section of Allergy and Immunology, Children's Hospital Colorado University of Colorado School of Medicine Aurora Colorado USA

20. Department of Primary Care and Population Health University of Nicosia Medical School Nicosia Cyprus

21. School of Psychology University of Surrey Guildford UK

22. Clinical and Experimental Sciences and Human Development and Health, Faculty of Medicine University of Southampton Southampton UK

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

24. School of Psychology, Aston Institute of Health and Neurodevelopment Aston University Birmingham UK

25. Department of Nutrition and Dietetics, Faculty of Health Sciences Ondokuz Mayis University Samsun Turkey

26. Department of Pediatrics McMaster University Hamilton Ontario Canada

27. MJM Advisory, LLC New York New York USA

28. Department for Allergic Diseases Institute of Occupational Health of R.N. Macedonia, WHO Collaborating Center Skopje North Macedonia

29. Department of Occupational Medicine, Faculty of Medicine, Ss. Cyril and Methodius University in Skopje Skopje North Macedonia

30. Institute for Health Metrics and Evaluation University of Washington Seattle Washington USA

31. Department of Pediatric Basic Sciences, Institute of Child Health Istanbul University Istanbul Turkey

32. Heybeliada Istanbul Turkey

33. Department of Pediatrics and Child Health University of Manitoba Winnipeg Manitoba Canada

34. Allergy department Hospital Universitario Infantil Niño Jesus Madrid Spain

35. Centre for Allergology and Immunology East Tallinn Central Hospital Tallinn Estonia

36. Department of Paediatrics Mater Dei Hospital Msida Malta

37. COPSAC, Copenhagen Prospective Studies on Asthma in Childhood Copenhagen University Hospital—Herlev and Gentofte Gentofte Denmark

38. Department of Pediatrics Slagelse Sygehus Slagelse Denmark

39. Allergissima Association Crissier Switzerland

40. International FPIES Association (IFPIES) Point Pleasant Beach New Jersey USA

41. Independent Researcher London UK

42. Department of Inflammation and Repair Imperial College London London UK

43. Regional center for asthma, allergy and hypersensitivity University Hospital of North Norway Tromsø Norway

44. Department of Pulmonary Medicine, Regional Centre for Asthma, Allergy and Hypersensitivity Oslo University Hospital Oslo Norway

45. The Hospital for Sick Children, Divison of Immunology and Allergy, Department of Pediatrics, Faculty of Medicine University of Toronto Toronto Ontario Canada

46. Swiss Institute of Allergy and Asthma Research (SIAF) University of Zürich Davos Switzerland

47. Pediatric Epidemiology, Department of Pediatrics, Medical Faculty Leipzig University Leipzig Germany

48. Care for Long Term Conditions Division, Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care King's College London London UK

49. Department of Paediatrics and Paediatric Infectious Diseases Institute of Child’s Health, Sechenov First Moscow State Medical University (Sechenov University) Moscow Russia

Abstract

AbstractBackgroundIgE‐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.MethodsThe 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.ResultsThe 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.ConclusionIn 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.

Publisher

Wiley

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/all.16023

Reference21 articles.

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2. Food allergy, mechanisms, diagnosis and treatment: Innovation through a multi‐targeted approach

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