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

Kelleher, MM; Jay, N; Perkin, MR; Haines, RH; Batt, R; Bradshaw, LE; Montgomery, AA; Chalmers, JR; Williams, HC; Boyle, RJ (2020) An algorithm for diagnosing IgE-mediated food allergy in study participants who do not undergo food challenge. Clin Exp Allergy, 50 (3). pp. 334-342. ISSN 1365-2222 https://doi.org/10.1111/cea.13577
SGUL Authors: Perkin, Michael Richard

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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.

Item Type: Article
Additional Information: © 2020 The Authors. Clinical & Experimental Allergy published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
Keywords: atopic dermatitis, diagnosis, food allergy, oral food challenge, paediatrics, atopic dermatitis, diagnosis, food allergy, oral food challenge, paediatrics, 1107 Immunology, 1117 Public Health and Health Services, Allergy
SGUL Research Institute / Research Centre: Academic Structure > Population Health Research Institute (INPH)
Journal or Publication Title: Clin Exp Allergy
ISSN: 1365-2222
Language: eng
Dates:
DateEvent
27 February 2020Published
13 February 2020Published Online
27 January 2020Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
12/67/12Health Technology Assessment programmehttp://dx.doi.org/10.13039/501100000664
TRF-2017-10-003Research Trainees Coordinating Centrehttp://dx.doi.org/10.13039/501100000659
UNSPECIFIEDGoldman Sachs Group, Inc.http://dx.doi.org/10.13039/100004354
PubMed ID: 31999862
Web of Science ID: WOS:000513158700001
Go to PubMed abstract
URI: http://openaccess.sgul.ac.uk/id/eprint/111709
Publisher's version: https://doi.org/10.1111/cea.13577

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