Peer-Reviewed Journal Details
Mandatory Fields
Demidova A;Drewitz KP;Kimkool P;Banjanin N;Barzylovich V;Botjes E;Capper I;Castor MAR;Comberiati P;Cook EE;Costa J;Chu DK;Epstein MM;Galvin AD;Giovannini M;Girard F;Golding MA;Greenhawt M;Ierodiakonou D;Jones CJ;Khaleva E;Knibb RC;Macit-Çelebi MS;Mack DP;Mafra I;Marchisotto MJ;Mijakoski D;Nekliudov N;Özdemir C;Patel N;Pazukhina E;Protudjer JLP;Rodríguez Del Rio P;Roomet J;Sammut P;Schoos AM;Schopfer AF;Schultz F;Seylanova N;Skypala I;Sřrensen M;Stoleski S;Stylianou E;Upton J;van de Veen W;Genuneit J;Boyle RJ;Apfelbacher C;Munblit D; ;
2024
April
Allergy
Core Outcome Set for IgE-mediated food allergy clinical trials and observational studies of interventions: International Delphi consensus study 'COMFA'.
Validated
()
Optional Fields
79
4
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. 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. 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. 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.
1398-9995
10.1111/all.16023
Grant Details