The following is a summary of “Core Outcome Set for IgE-mediated Food Allergy Clinical Trials and Observational Studies of Interventions: International Delphi Consensus Study ‘COMFA’,” published in the March 2024 issue of Allergy & Immunology by Demidova, et al.

For a study, researchers sought to establish a Core Outcome Set (COS) for IgE-mediated food allergy (FA) clinical trials and observational studies of interventions through the Core Outcome Measures for Food Allergy (COMFA) initiative.

A comprehensive review of published clinical trials, trial protocols, and qualitative literature was conducted to identify outcomes relevant to FA interventions. Outcomes were categorized and classified, informing a two-round online-modified Delphi process and a subsequent hybrid consensus meeting to finalize the COS.

The literature review, taxonomy mapping, and iterative discussions with the COMFA group identified 39 outcomes. This list was reduced to 13 outcomes for formal Delphi voting through iterative online and in-person meetings. Participants suggested an additional outcome after the first Delphi round. A total of 778 participants from 52 countries participated, with 442 participating in both Delphi rounds. None of the outcomes met the pre-established criteria for inclusion, and one outcome was excluded during the Delphi process. About 13 outcomes were brought to the hybrid consensus meeting, with ‘allergic symptoms’ and ‘quality of life’ achieving consensus for inclusion as ‘core’ outcomes.

A Core Outcome Set for FA clinical trials and observational studies was needed to standardize outcome reporting and facilitate intervention comparisons. The Core Outcome Measures for Food Allergy initiative identified ‘allergic symptoms’ and ‘quality of life’ as core outcomes, which should be measured consistently in future FA research. Further efforts would focus on determining the most appropriate methods for measuring these core outcomes.

Reference: onlinelibrary.wiley.com/doi/10.1111/all.16023