Core Outcome Set for IgE-Mediated Food Allergy Clinical Trials and Observational Studies of Interventions: International Delphi Consensus Study ‘COMFA’

To establish a Core Outcome Set (COS) for IgE-mediated food allergy clinical trials and observational studies based upon stakeholder consensus among international researchers (RS), health care professionals (HCP), and patients or caregivers of those with food allergies less than 18 years of age (PFA).Delphi round 1 consisted of 778 participants (25% RS, 18% HCP, 57% PFA) from 52 countries and 6 continents, Delphi round 2 was attended by 422 participants (32% RS, 19% HCP, 49% PFA), and the consensus meeting was completed among 30 participants (37% RS, 43% HCP, 20% PFA).Original study and comprehensive review of published food allergy clinical trials, trial protocols, and qualitative literature with outcome list generation and subclassification. A 2-round Delphi process with a validated scoring system among international stakeholder groups was used and followed by a consensus meeting to establish the COS. To be included in the COS, 80% of participants in each of the stakeholder groups were required to consider the outcome to be “critically important” to research in the field.Of the 39 outcomes included in the preliminary list, 13 outcomes among 3 domains (physiologic or clinical, functioning and resource use) were considered in the final consensus meeting. Of those, only “allergic symptoms” (100% RS, 100% HCP, 83% PFA) and “quality of life” (91% RS, 100% HCP, 83% PFA) met criteria for inclusion in the COS.The results of this study suggest that ‘allergic symptoms’ and ‘quality of life’ should be considered key outcomes in the design and implementation of future clinical trials and observation studies regarding IgE-mediated food allergy, and specifically when evaluating emerging interventions and therapeutics.In a time of therapeutic breakthroughs and the rapid development of biologic therapies, this study highlights the importance of patient-centered outcomes in IgE-mediated food allergy research. Pediatricians caring for children with food allergies should not rely solely upon approval by regulating bodies to make clinical recommendations, but should critically evaluate the evidence base behind developing interventions to ensure the provision of comprehensive patient-centered care.