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

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

Timing of allergenic food introduction and risk of IgE-mediated food allergy: systematic review and meta-analysis

Importance: Earlier egg and peanut introduction probably reduce risk of egg or peanut allergy, but it is uncertain whether food allergy as a whole can be prevented using earlier allergenic food introduction.Objective: This study is a systematic review on timing of allergenic food introduction to the infant diet and risk of food allergy.Data Sources: Medline, Embase and CENTRAL were searched to December 2022.Study Selection: Randomized controlled trials evaluating timing of allergenic food introduction during infancy were included.Data Extraction and Synthesis: Data were extracted in duplicate and synthesized using a random-effects model. GRADE was used to assess certainty of evidence.Main Outcomes and Measures: Primary outcomes were risk of allergy to any food and withdrawal from the intervention. Secondary outcomes included allergy to specific foods.Results: Of 9283 titles screened, data were extracted from 23 eligible trials (56 reports, 13749 randomized participants). There was moderate-certainty evidence from 4 trials (3295 participants) that earlier introduction of multiple allergenic foods at 2 to 12 months (median 3 to 4 months) was associated with reduced food allergy (risk ratio [RR], 0.49; 95% CI, 0.33-0.74; I2=49%). Absolute risk reduction for a population with 5% incidence of food allergy was 26 cases (95% CI, 13-34 cases) per 1000 population. There was moderate-certainty evidence from 5 trials (4703 participants) that earlier introduction of multiple allergenic foods at 2 to 12 months was associated with increased withdrawal from the intervention ([RR], 2.29; 95% CI, 1.45-3.63; I2=89%). Absolute risk difference for a population with 20% withdrawal from the intervention was 258 cases (95% CI, 90-526 cases) per 1000 population. There was high-certainty evidence from 9 trials (4811 participants) that earlier introduction of egg at 3 to 6 months was associated with reduced egg allergy (RR, 0.60; 95% CI, 0.46-0.77; I2=0%); and high-certainty evidence from 4 trials (3796 participants) that earlier introduction of peanut at 3 to 10 months was associated with reduced peanut allergy (RR, 0.31; 95% CI, 0.19-0.51; I2=21%). Evidence for timing of introduction of cow's milk and risk of milk allergy was very low certainty.Conclusions and Relevance: Earlier introduction of multiple allergenic foods was associated with lower risk of developing food allergy, but a high rate of withdrawal from the intervention