Review

. 2024 Apr;79(4):977-989.

doi: 10.1111/all.16023. Epub 2024 Mar 3.

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

Anastasia Demidova¹, Karl Philipp Drewitz², Parisut Kimkool³, Nikolina Banjanin⁴, Vladyslava Barzylovich⁵, Erna Botjes⁶, India Capper⁷, Mary Anne R Castor⁸, Pasquale Comberiati⁹, Emma E Cook¹⁰, Joana Costa¹¹, Derek K Chu¹², Michelle M Epstein¹³, Audrey Dunn Galvin¹⁴, Mattia Giovannini^{15

16}, Frédéric Girard¹⁷, Michael A Golding¹⁸, Matthew Greenhawt¹⁹, Despo Ierodiakonou²⁰, Christina J Jones²¹, Ekaterina Khaleva^{22

23}, Rebecca C Knibb²⁴, Melahat Sedanur Macit-Çelebi²⁵, Douglas P Mack²⁶, Isabel Mafra¹¹, Mary Jane Marchisotto²⁷, Dragan Mijakoski^{28

29}, Nikita Nekliudov³⁰, Cevdet Özdemir³¹, Nandinee Patel³, Ekaterina Pazukhina³², Jennifer L P Protudjer^{18

33}, Pablo Rodríguez Del Rio³⁴, Jelena Roomet³⁵, Patrick Sammut³⁶, Ann-Marie Malby Schoos^{37

38}, Anita Fossaluzza Schopfer³⁹, Fallon Schultz⁴⁰, Nina Seylanova⁴¹, Isabel Skypala⁴², Martin Sørensen⁴³, Sasho Stoleski^{28

29}, Eva Stylianou⁴⁴, Julia Upton⁴⁵, Willem van de Veen⁴⁶, Jon Genuneit⁴⁷, Robert J Boyle³, Christian Apfelbacher², Daniel Munblit^{48

49}; COMFA Consortium

Collaborators, Affiliations

Collaborators

COMFA Consortium:
Karine Adel-Patient, Flore Amat, Anna Andrałojć, Corina Bocsan, Helen A Brough, Dominique M A Bullens, Dianne Campbell, Ozlem Ceylan, Joanne R Chalmers, Bo Chawes, Costas A Christophi, Alice Coimbra, Piotr Dąbrowiecki, Amandine Divaret-Chauveau, Сintia Falck, Gillian Dunn Galvin, Gennadiy Novik, Alessandro Fiocchi, Johan Garssen, Jennifer D Gerdts, Christiane Hilger, Tatjana Jakjovska, Carla Jones, Sahar Kazemi, Annette Kuehn, Michael Levin, Melanie Lloyd, Bryan Martin, Sergei Masalsky, Karen Matvienko-Sikar, Vildan Mevsim, Clare Mills, Blanca Maria Morfin-Maciel, Aigun Mursalova, Maria Novitskaya, Diego Peroni, Marcia Podestà, Graham Roberts, Sabine Schnadt, Ahmed Seri, Naoki Shimojo, Yuri Smolkin, Sophie Spitters, Hania Szajewska, Mimi L K Tang, Mirjana Turkalj, Paul J Turner, Carina Venter, Kitty Verhoeckx, Christina West

Affiliations

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.

PMID: 38433402
DOI: 10.1111/all.16023

Review

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

Anastasia Demidova et al. Allergy. 2024 Apr.

. 2024 Apr;79(4):977-989.

doi: 10.1111/all.16023. Epub 2024 Mar 3.

Authors

Collaborators

COMFA Consortium:
Karine Adel-Patient, Flore Amat, Anna Andrałojć, Corina Bocsan, Helen A Brough, Dominique M A Bullens, Dianne Campbell, Ozlem Ceylan, Joanne R Chalmers, Bo Chawes, Costas A Christophi, Alice Coimbra, Piotr Dąbrowiecki, Amandine Divaret-Chauveau, Сintia Falck, Gillian Dunn Galvin, Gennadiy Novik, Alessandro Fiocchi, Johan Garssen, Jennifer D Gerdts, Christiane Hilger, Tatjana Jakjovska, Carla Jones, Sahar Kazemi, Annette Kuehn, Michael Levin, Melanie Lloyd, Bryan Martin, Sergei Masalsky, Karen Matvienko-Sikar, Vildan Mevsim, Clare Mills, Blanca Maria Morfin-Maciel, Aigun Mursalova, Maria Novitskaya, Diego Peroni, Marcia Podestà, Graham Roberts, Sabine Schnadt, Ahmed Seri, Naoki Shimojo, Yuri Smolkin, Sophie Spitters, Hania Szajewska, Mimi L K Tang, Mirjana Turkalj, Paul J Turner, Carina Venter, Kitty Verhoeckx, Christina West

Affiliations

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.

PMID: 38433402
DOI: 10.1111/all.16023

Abstract

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.

Keywords: allergic symptoms; core outcome set; food allergy; outcome assessment; quality of life.

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References

REFERENCES

1. Warren C, Dyer A, Lombard L, Dunn‐Galvin A, Gupta R. The psychosocial burden of food allergy among adults: A US population‐based study. J Allergy Clin Immunol Pract. 2021;9(6):2452‐2460.e3.
1. Sindher SB, Long A, Chin AR, et al. Food allergy, mechanisms, diagnosis and treatment: Innovation through a multi‐targeted approach. Allergy. 2022;77(10):2937‐2948.
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Core Outcome Set for IgE-mediated food allergy clinical trials and observational studies of interventions: International Delphi consensus study 'COMFA'

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

References

REFERENCES

Publication types

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous