BSACI guidance for the implementation of Palforzia® peanut oral immunotherapy in the United Kingdom: a Delphi consensus study

Background: Palforzia® enables the safe and effective desensitisation of children with peanut allergy. The treatment pathway requires multiple visits for dose escalation, up-dosing, monitoring of patients taking maintenance therapy and conversion onto daily real-world peanut consumption. The demand...

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Main Authors: Marrs, Tom, Patel, Nandinee, Burrell, Sarah, Rampersad, Anjali, Minshall, Eleanor, Leech, Susan, Chandratilleke, Dinusha, Dempsey, Justine, Ludman, Sian, Roberts, Graham, Michaelis, Louise Jane, Brough, Helen A., Karanam, Surendra, Batt, Rebecca, Moulsdale, Phoebe, Steifel, Gary, Tiwana, Kiran, Smith, Helen, Knight, Katherine, Vazquez-Ortiz, Marta, Vyas, Deepan, Turner, Paul J., Makwana, Nick
Other Authors: Lee Kong Chian School of Medicine (LKCMedicine)
Format: Journal Article
Language:English
Published: 2024
Subjects:
Online Access:https://hdl.handle.net/10356/181911
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author Marrs, Tom
Patel, Nandinee
Burrell, Sarah
Rampersad, Anjali
Minshall, Eleanor
Leech, Susan
Chandratilleke, Dinusha
Dempsey, Justine
Ludman, Sian
Roberts, Graham
Michaelis, Louise Jane
Brough, Helen A.
Karanam, Surendra
Batt, Rebecca
Moulsdale, Phoebe
Steifel, Gary
Tiwana, Kiran
Smith, Helen
Knight, Katherine
Vazquez-Ortiz, Marta
Vyas, Deepan
Turner, Paul J.
Makwana, Nick
author2 Lee Kong Chian School of Medicine (LKCMedicine)
author_facet Lee Kong Chian School of Medicine (LKCMedicine)
Marrs, Tom
Patel, Nandinee
Burrell, Sarah
Rampersad, Anjali
Minshall, Eleanor
Leech, Susan
Chandratilleke, Dinusha
Dempsey, Justine
Ludman, Sian
Roberts, Graham
Michaelis, Louise Jane
Brough, Helen A.
Karanam, Surendra
Batt, Rebecca
Moulsdale, Phoebe
Steifel, Gary
Tiwana, Kiran
Smith, Helen
Knight, Katherine
Vazquez-Ortiz, Marta
Vyas, Deepan
Turner, Paul J.
Makwana, Nick
author_sort Marrs, Tom
collection NTU
description Background: Palforzia® enables the safe and effective desensitisation of children with peanut allergy. The treatment pathway requires multiple visits for dose escalation, up-dosing, monitoring of patients taking maintenance therapy and conversion onto daily real-world peanut consumption. The demand for peanut immunotherapy outstrips current National Health Service (NHS) capacity and requires services to develop a national consensus on how best to offer Palforzia® in a safe and equitable manner. We undertook a Delphi consensus exercise to determine guidance statements for the implementation of Palforzia®-based immunotherapy in the NHS. Methods: We undertook focus groups with children and young people who had received peanut immunotherapy to assess what was important for them and their carers. Common themes from patients formed the basis of creating draft statements. A panel of 18 multi-disciplinary professionals engaged in two rounds of anonymised voting to adapt the statements and score their importance. A final consensus workshop consolidated any variation in comments and scores to develop the final guidance statements. Results: The panel achieved consensus on 91% (29/32) of guidance statements, demonstrating strong consensus around pragmatic principles for assuring the integrity of consent, safety and conversion from Palforzia® to real-world peanut products. The greatest amount of feedback was generated from three broad issues; (i) whether eligibility assessment should include compulsory peanut challenges and whether these should be designed to assess the threshold at which patients react to peanut, (ii) the governance processes to best ensure that patients' interests are prioritised and (iii) how to safely transition young people to other services, or discharge them, while they are taking daily peanut. Conclusions: This consensus highlights the urgent need for the NHS to increase capacity for undertaking diagnostic food challenges as well as developing Palforzia® immunotherapy pathways. The voting panel agreed that families of peanut allergic children should be made aware of immunotherapy, that eligibility assessment should include how co-morbid conditions are managed and that services should monitor for adverse effects. The finalised statements are now published online for clinical practice in the UK. These guidance statements will be adapted in the coming years as more evidence is published and as the international experience of peanut immunotherapy evolves.
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spelling ntu-10356/1819112025-01-05T15:39:30Z BSACI guidance for the implementation of Palforzia® peanut oral immunotherapy in the United Kingdom: a Delphi consensus study Marrs, Tom Patel, Nandinee Burrell, Sarah Rampersad, Anjali Minshall, Eleanor Leech, Susan Chandratilleke, Dinusha Dempsey, Justine Ludman, Sian Roberts, Graham Michaelis, Louise Jane Brough, Helen A. Karanam, Surendra Batt, Rebecca Moulsdale, Phoebe Steifel, Gary Tiwana, Kiran Smith, Helen Knight, Katherine Vazquez-Ortiz, Marta Vyas, Deepan Turner, Paul J. Makwana, Nick Lee Kong Chian School of Medicine (LKCMedicine) Medicine, Health and Life Sciences Delphi study Drug safety Background: Palforzia® enables the safe and effective desensitisation of children with peanut allergy. The treatment pathway requires multiple visits for dose escalation, up-dosing, monitoring of patients taking maintenance therapy and conversion onto daily real-world peanut consumption. The demand for peanut immunotherapy outstrips current National Health Service (NHS) capacity and requires services to develop a national consensus on how best to offer Palforzia® in a safe and equitable manner. We undertook a Delphi consensus exercise to determine guidance statements for the implementation of Palforzia®-based immunotherapy in the NHS. Methods: We undertook focus groups with children and young people who had received peanut immunotherapy to assess what was important for them and their carers. Common themes from patients formed the basis of creating draft statements. A panel of 18 multi-disciplinary professionals engaged in two rounds of anonymised voting to adapt the statements and score their importance. A final consensus workshop consolidated any variation in comments and scores to develop the final guidance statements. Results: The panel achieved consensus on 91% (29/32) of guidance statements, demonstrating strong consensus around pragmatic principles for assuring the integrity of consent, safety and conversion from Palforzia® to real-world peanut products. The greatest amount of feedback was generated from three broad issues; (i) whether eligibility assessment should include compulsory peanut challenges and whether these should be designed to assess the threshold at which patients react to peanut, (ii) the governance processes to best ensure that patients' interests are prioritised and (iii) how to safely transition young people to other services, or discharge them, while they are taking daily peanut. Conclusions: This consensus highlights the urgent need for the NHS to increase capacity for undertaking diagnostic food challenges as well as developing Palforzia® immunotherapy pathways. The voting panel agreed that families of peanut allergic children should be made aware of immunotherapy, that eligibility assessment should include how co-morbid conditions are managed and that services should monitor for adverse effects. The finalised statements are now published online for clinical practice in the UK. These guidance statements will be adapted in the coming years as more evidence is published and as the international experience of peanut immunotherapy evolves. Published version 2024-12-30T08:09:38Z 2024-12-30T08:09:38Z 2024 Journal Article Marrs, T., Patel, N., Burrell, S., Rampersad, A., Minshall, E., Leech, S., Chandratilleke, D., Dempsey, J., Ludman, S., Roberts, G., Michaelis, L. J., Brough, H. A., Karanam, S., Batt, R., Moulsdale, P., Steifel, G., Tiwana, K., Smith, H., Knight, K., ...Makwana, N. (2024). BSACI guidance for the implementation of Palforzia® peanut oral immunotherapy in the United Kingdom: a Delphi consensus study. Clinical and Experimental Allergy, 54(7), 459-469. https://dx.doi.org/10.1111/cea.14491 0954-7894 https://hdl.handle.net/10356/181911 10.1111/cea.14491 2-s2.0-85196784191 7 54 459 469 en Clinical and Experimental Allergy © 2024 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, which permits use, distribution and reproduction in any medium, provided the original work is properly cited application/pdf
spellingShingle Medicine, Health and Life Sciences
Delphi study
Drug safety
Marrs, Tom
Patel, Nandinee
Burrell, Sarah
Rampersad, Anjali
Minshall, Eleanor
Leech, Susan
Chandratilleke, Dinusha
Dempsey, Justine
Ludman, Sian
Roberts, Graham
Michaelis, Louise Jane
Brough, Helen A.
Karanam, Surendra
Batt, Rebecca
Moulsdale, Phoebe
Steifel, Gary
Tiwana, Kiran
Smith, Helen
Knight, Katherine
Vazquez-Ortiz, Marta
Vyas, Deepan
Turner, Paul J.
Makwana, Nick
BSACI guidance for the implementation of Palforzia® peanut oral immunotherapy in the United Kingdom: a Delphi consensus study
title BSACI guidance for the implementation of Palforzia® peanut oral immunotherapy in the United Kingdom: a Delphi consensus study
title_full BSACI guidance for the implementation of Palforzia® peanut oral immunotherapy in the United Kingdom: a Delphi consensus study
title_fullStr BSACI guidance for the implementation of Palforzia® peanut oral immunotherapy in the United Kingdom: a Delphi consensus study
title_full_unstemmed BSACI guidance for the implementation of Palforzia® peanut oral immunotherapy in the United Kingdom: a Delphi consensus study
title_short BSACI guidance for the implementation of Palforzia® peanut oral immunotherapy in the United Kingdom: a Delphi consensus study
title_sort bsaci guidance for the implementation of palforzia r peanut oral immunotherapy in the united kingdom a delphi consensus study
topic Medicine, Health and Life Sciences
Delphi study
Drug safety
url https://hdl.handle.net/10356/181911
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