Standardizing outcomes in food allergy research: aligning clinical trials with patient priorities

This review explores the clinical outcomes used in immunoglobulin E (IgE)-mediated food allergy (FA) intervention studies, emphasizing unmet need for patient-centred outcomes. Standardizing outcome measurement is critical as research into FA treatments, particularly food immunotherapy, expands. Here we discuss how outcomes should reflect the multidimensional impact of FA on people's lives.

Current evidence reveals a discrepancy between clinical trial outcomes and those most valued by patients and carers. While trials often prioritize changes in reactivity thresholds or immunological markers, patients and carers emphasize need in reducing severe reactions, improving quality of life, and enhancing confidence in disease management. This disparity highlights importance of harmonization efforts to guide FA research.The Core Outcome Measures for Food Allergy (COMFA) initiative recently identified two core outcomes - 'allergic symptoms' and 'quality of life' - through an international consensus process involving patients, caregivers, clinicians, and researchers. Outcomes like 'desensitization' and 'remission/sustained unresponsiveness' were considered important but were not seen as the most critical.

Developing and implementing a COS for FA intervention studies is essential to align research with patient priorities, ensuring meaningful improvements in routine clinical care. Standardized outcome measurement will generate robust evidence, inform clinical practice, and empower patients and caregivers in decision-making about FA management.