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    ‘What’ and ‘How’ to Measure in Allergy and Clinical Immunology: A Systematic Review of Core Outcome Sets and Outcome Harmonisation Processes
    (Wiley, 2026-04-13)
    Demidova, Anastasia
    ;
    Kiknavelidze, Nata
    ;
    Purtskhvanidze, Kristine
    ;
    Alieva, Elvina
    ;
    Ebrahimnejad, Mehrshad
    Background Heterogeneity in outcome reporting and inconsistent use of outcome measurement instruments in allergy and clinical immunology research affects the comparability, synthesis, and clinical applicability of study findings. Harmonisation efforts, particularly Core Outcome Set (COS) development, aim to address these challenges by establishing standardised, evidence‐based and consensus‐driven outcome recommendations. This systematic review aims to map available COS and other harmonisation processes (HP) in allergy and clinical immunology, evaluate their methodological approaches, and assess their alignment with established development standards. Methods We systematically searched MEDLINE, EMBASE, and the COMET Initiative database until June 7, 2024 to identify COS and HP. We included studies if they provided recommendations on ‘core’ outcomes and/or outcome measurement instruments. Data extraction included disease focus, methodological approach, stakeholder involvement, and adherence to the Core Outcome Set‐STAndards for Development criteria. We synthesised the data at the initiative (process) level rather than the publication level because harmonisation initiatives are frequently iterative and reported across multiple papers (e.g., protocol, Delphi rounds, consensus statement, and subsequent instrument‐selection outputs). Results A total of 15,612 records were identified, with 44 studies (representing 22 initiatives both finished and in development) meeting inclusion criteria. The majority of initiatives focused on asthma ( n  = 9), followed by eczema (atopic dermatitis n= 2; hand eczema = 1; eczema = 1), urticaria ( n= 2), allergic rhinitis ( n= 2), chronic rhinosinusitis ( n = 1), celiac disease ( n  = 1), Immunoglobulin E (IgE)—mediated food allergy ( n = 1), eosinophilic esophagitis ( n = 1), and hereditary angioedema ( n= 1). No COS or HP addressed drug allergy, anaphylaxis, or other immune‐mediated allergic conditions. ‘Quality of life’ was consistently included in all COS with ‘signs and symptoms’, ‘exacerbations’ and ‘disease control’ frequently selected as well. Methodological approaches to COS development varied widely, with most employing Delphi surveys, consensus meetings, and stakeholder involvement, though levels of engagement differed. COS developers inconsistently adhered to Core Outcome Set‐STAndards for Development criteria, with some initiatives demonstrating rigorous methodology while others lacked transparency in key developmental steps. Conclusion This review highlights growing efforts to harmonise outcome assessment in allergy and clinical immunology. Major gaps remain in coverage and methodological rigour. Quality of life and patient‐reported symptoms are frequently recommended outcomes, yet definitions and measurement tools are inconsistent. Strengthening methodological consistency and expanding COS development to neglected areas are critical next steps to improve outcome reliability and comparability in the field.
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    Core Outcome Set for IgE-mediated food allergy clinical trials and observational studies of interventions: International Delphi consensus study 'COMFA'
    (Wiley, 2024-03-03)
    Demidova, Anastasia
    ;
    Drewitz, Karl Philipp
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    Kimkool, Parisut
    ;
    Banjanin, Nikolina
    ;
    Barzylovich, Vladyslava
    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.
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    Immunological Outcomes of Allergen-Specific Immunotherapy in Food Allergy
    (Frontiers Media SA, 2020)
    Schoos, Ann-Marie Malby
    ;
    Bullens, Dominique
    ;
    Chawes, Bo Lund
    ;
    Costa, Joana
    ;
    De Vlieger, Liselot
    IgE-mediated food allergies are caused by adverse immunologic responses to food proteins. Allergic reactions may present locally in different tissues such as skin, gastrointestinal and respiratory tract and may result is systemic life-threatening reactions. During the last decades, the prevalence of food allergies has significantly increased throughout the world, and considerable efforts have been made to develop curative therapies. Food allergen immunotherapy is a promising therapeutic approach for food allergies that is based on the administration of increasing doses of culprit food extracts, or purified, and sometime modified food allergens. Different routes of administration for food allergen immunotherapy including oral, sublingual, epicutaneous and subcutaneous regimens are being evaluated. Although a wealth of data from clinical food allergen immunotherapy trials has been obtained, a lack of consistency in assessed clinical and immunological outcome measures presents a major hurdle for evaluating these new treatments. Coordinated efforts are needed to establish standardized outcome measures to be applied in food allergy immunotherapy studies, allowing for better harmonization of data and setting the standards for the future research. Several immunological parameters have been measured in food allergen immunotherapy, including allergen-specific immunoglobulin levels, basophil activation, cytokines, and other soluble biomarkers, T cell and B cell responses and skin prick tests. In this review we discuss different immunological parameters and assess their applicability as potential outcome measures for food allergen immunotherapy that may be included in such a standardized set of outcome measures.