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Randomized Controlled Trial
. 2020 Mar;50(3):334-342.
doi: 10.1111/cea.13577. Epub 2020 Feb 13.

An algorithm for diagnosing IgE-mediated food allergy in study participants who do not undergo food challenge

Maeve M Kelleher  1 , Nicola Jay  2 , Michael R Perkin  3 , Rachel H Haines  4 , Rebecca Batt  5 , Lucy E Bradshaw  4 , Alan A Montgomery  4 , Joanne R Chalmers  6 , Hywel C Williams  6 , Robert J Boyle  1   6
Affiliations
Randomized Controlled Trial

An algorithm for diagnosing IgE-mediated food allergy in study participants who do not undergo food challenge

Maeve M Kelleher et al. Clin Exp Allergy. 2020 Mar.

Abstract

Background: Food allergy diagnosis in clinical studies can be challenging. Oral food challenges (OFC) are time-consuming, carry some risk and may, therefore, not be acceptable to all study participants.

Objective: To design and evaluate an algorithm for detecting IgE-mediated food allergy in clinical study participants who do not undergo OFC.

Methods: An algorithm for trial participants in the Barrier Enhancement for Eczema Prevention (BEEP) study who were unwilling or unable to attend OFC was developed. BEEP is a pragmatic, multi-centre, randomized-controlled trial of daily emollient for the first year of life for primary prevention of eczema and food allergy in high-risk infants (ISRCTN21528841). We built on the European iFAAM consensus guidance to develop a novel food allergy diagnosis algorithm using available information on previous allergenic food ingestion, food reaction(s) and sensitization status. This was implemented by a panel of food allergy experts blind to treatment allocation and OFC outcome. We then evaluated the algorithm's performance in both BEEP and Enquiring About Tolerance (EAT) study participants who did undergo OFC.

Results: In 31/69 (45%) BEEP and 44/55 (80%) EAT study control group participants who had an OFC the panel felt confident enough to categorize children as "probable food allergy" or "probable no food allergy". Algorithm-derived panel decisions showed high sensitivity 94% (95%CI 68, 100) BEEP; 90% (95%CI 72, 97) EAT and moderate specificity 67% (95%CI 39, 87) BEEP; 67% (95%CI 39, 87) EAT. Sensitivity and specificity were similar when all BEEP and EAT participants with OFC outcome were included.

Conclusion: We describe a new algorithm with high sensitivity for IgE-mediated food allergy in clinical study participants who do not undergo OFC.

Clinical relevance: This may be a useful tool for excluding food allergy in future clinical studies where OFC is not conducted.

Keywords: atopic dermatitis; diagnosis; food allergy; oral food challenge; paediatrics.

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References

REFERENCES

    1. Cummings AJ, Knibb RC, King RM, Lucas JS. The psychosocial impact of food allergy and food hypersensitivity in children, adolescents and their families: a review. Allergy. 2010;65(8):933-945.
    1. Gupta R, Sheikh A, Strachan DP, Anderson HR. Burden of allergic disease in the UK: secondary analyses of national databases. Clin Exp Allergy. 2004;34(4):520-526.
    1. Burks AW, Tang M, Sicherer S, et al. ICON: food allergy. J Allergy Clin Immunol. 2012;129(4):906-920.
    1. Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, et al. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012;130(6):1260-1274.
    1. Osborne NJ, Koplin JJ, Martin PE, et al. Prevalence of challenge-proven IgE-mediated food allergy using population-based sampling and predetermined challenge criteria in infants. J Allergy Clin Immunol. 2011;127(3): 668-676.e2.

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