Maeve M Kelleher1, Nicola Jay2, Michael R Perkin3, Rachel H Haines4, Rebecca Batt5, Lucy E Bradshaw4, Alan A Montgomery4, Joanne R Chalmers6, Hywel C Williams6, Robert J Boyle1,6. 1. Section of Inflammation, Repair & Development, National Heart & Lung Institute, Imperial College London, London, UK. 2. Children's Allergy Dept., Sheffield Children's NHS Foundation Trust, Sheffield, UK. 3. Population Health Research Institute, St George's University of London, London, UK. 4. Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK. 5. Children's Allergy Service, Evelina Children's Hospital London, London, UK. 6. Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.
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.
RCT Entities:
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.
Authors: Maeve M Kelleher; Suzie Cro; Victoria Cornelius; Karin C Lodrup Carlsen; Håvard O Skjerven; Eva M Rehbinder; Adrian J Lowe; Eishika Dissanayake; Naoki Shimojo; Kaori Yonezawa; Yukihiro Ohya; Kiwako Yamamoto-Hanada; Kumiko Morita; Emma Axon; Christian Surber; Michael Cork; Alison Cooke; Lien Tran; Eleanor Van Vogt; Jochen Schmitt; Stephan Weidinger; Danielle McClanahan; Eric Simpson; Lelia Duley; Lisa M Askie; Joanne R Chalmers; Hywel C Williams; Robert J Boyle Journal: Cochrane Database Syst Rev Date: 2021-02-05
Authors: Joanne R Chalmers; Rachel H Haines; Lucy E Bradshaw; Alan A Montgomery; Kim S Thomas; Sara J Brown; Matthew J Ridd; Sandra Lawton; Eric L Simpson; Michael J Cork; Tracey H Sach; Carsten Flohr; Eleanor J Mitchell; Richard Swinden; Stella Tarr; Susan Davies-Jones; Nicola Jay; Maeve M Kelleher; Michael R Perkin; Robert J Boyle; Hywel C Williams Journal: Lancet Date: 2020-02-19 Impact factor: 202.731