@article{6040c0fa2e304c1eb6eb9b578e49d531,
title = "Outcomes for clinical trials of food allergy treatments",
abstract = "Objective: Food allergy is a common condition that can have a significant impact on the quality of life of affected individuals and their caregivers. Recent years have witnessed an increased effort to identify new treatments for food allergy. Here, we review the need to identify core outcomes for measurement in clinical trials of food allergy treatments. Data Sources: We reviewed the literature regarding core outcome set development, the important role that these play in prioritizing patient-relevant outcomes, and the potential for core outcomes to accelerate the path to product marketing by allowing prompt and reliable evidence synthesis after trial publication. Study Selections: We reviewed recent clinical trials of food allergy treatments to understand which outcomes have previously been measured, and also reviewed available core outcome set initiatives for other allergic conditions to understand which other outcomes might be explored in future trials. Results: Clinical trials of food allergy treatments have largely focused on outcomes that are relevant to investigators and commercial investors, especially the threshold of reactivity and immunologic changes. Future trials should consider addressing patient-important outcomes and should report the experiences of both adult and child participants and their caregivers. Conclusion: There is a pressing need for core outcome set development for food allergy treatment trials.",
keywords = "Clinical Trials as Topic/standards, Desensitization, Immunologic, Food Hypersensitivity/therapy, Humans, Outcome Assessment, Health Care/standards, Quality of Life, Treatment Outcome",
author = "Kathleen Sim and Dragan Mijakoski and Sasho Stoleski and {del Rio}, {Pablo Rodriguez} and Patrick Sammut and Le, {Thuy My} and Daniel Munblit and Boyle, {Robert J.}",
note = "Funding Information: Disclosures: Dr Boyle has participated as an advisory board member for Prota Therapeutics, DBV Technologies, and ALK Abell{\'o}; has undertaken consultancy for the Dairy Goat Co-operative; and has given expert testimony in relation to infant formula health claims. Dr del Rio received research funding from the Health Research Fund of Carlos III Health Institute, Foundation for Biomedical Research of the Ni{\~n}o Jes{\'u}s University Children's Hospital, and Spanish Society of Allergology and Clinical Immunology Foundation; reports receiving honoraria from the European Cooperation in Science and Technology Cost Action 18227; and received honoraria for consultancy or advisory board or lectures from ALK-Abell{\'o}, HAL Allergy Group, Faes Pharma, LETIPharma, Merck, Aimmune Therapeutics, Allergy Therapeutics, Meda Pharma, and Novartis. Dr Munblit received funding from the 5-100 Russian Academic Excellence Project; was involved in expert activities within the International Life Sciences Institute Europe expert group; and has given paid lectures for Merck Sharp and Dohme, and Bayer. Other authors have no conflicts of interest to report.Funding: The study was funded by the European Cooperation in Science and Technology Cost Action 18227. Funding Information: Funding: The study was funded by the European Cooperation in Science and Technology Cost Action 18227. Publisher Copyright: {\textcopyright} 2020",
year = "2020",
month = nov,
doi = "10.1016/j.anai.2020.06.023",
language = "English",
volume = "125",
pages = "535--542",
journal = "Annals of Allergy, Asthma and Immunology",
issn = "1081-1206",
publisher = "American College of Allergy, Asthma and Immunology",
number = "5",
}