An algorithm for diagnosing IgE-mediated food allergy in study participants who do not undergo food challenge.
atopic dermatitis
diagnosis
food allergy
oral food challenge
paediatrics
Journal
Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology
ISSN: 1365-2222
Titre abrégé: Clin Exp Allergy
Pays: England
ID NLM: 8906443
Informations de publication
Date de publication:
03 2020
03 2020
Historique:
received:
06
11
2019
revised:
11
01
2020
accepted:
27
01
2020
pubmed:
31
1
2020
medline:
10
6
2021
entrez:
31
1
2020
Statut:
ppublish
Résumé
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. To design and evaluate an algorithm for detecting IgE-mediated food allergy in clinical study participants who do not undergo OFC. 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. 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. We describe a new algorithm with high sensitivity for IgE-mediated food allergy in clinical study participants who do not undergo OFC. This may be a useful tool for excluding food allergy in future clinical studies where OFC is not conducted.
Sections du résumé
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.
Substances chimiques
Immunoglobulin E
37341-29-0
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
334-342Subventions
Organisme : Department of Health
ID : 12/67/12
Pays : United Kingdom
Organisme : Department of Health
ID : PB-PG-0317-20028
Pays : United Kingdom
Organisme : Department of Health
ID : TRF-2017-10-003
Pays : United Kingdom
Informations de copyright
© 2020 The Authors. Clinical & Experimental Allergy published by John Wiley & Sons Ltd.
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