Persistent, refractory, and biphasic anaphylaxis: A multidisciplinary Delphi study

Timothy E. Dribin; Hugh A. Sampson; Carlos A. Camargo; David C. Brousseau; Jonathan M. Spergel; Mark I. Neuman; Marcus Shaker; Ronna L. Campbell; Kenneth A. Michelson; Susan A. Rudders; Amal H. Assa'ad; Kimberly A. Risma; Mariana Castells; Lynda C. Schneider; Julie Wang; Juhee Lee; Rakesh D. Mistry; David Vyles; Lisa M. Vaughn; Daniel J. Schumacher; John K. Witry; Shiv Viswanathan; Erica M. Page; David Schnadower

doi:10.1016/j.jaci.2020.08.015

Persistent, refractory, and biphasic anaphylaxis: A multidisciplinary Delphi study

Timothy E. Dribin^*, Hugh A. Sampson, Carlos A. Camargo, David C. Brousseau, Jonathan M. Spergel, Mark I. Neuman, Marcus Shaker, Ronna L. Campbell, Kenneth A. Michelson, Susan A. Rudders, Amal H. Assa'ad, Kimberly A. Risma, Mariana Castells, Lynda C. Schneider, Julie Wang, Juhee Lee, Rakesh D. Mistry, David Vyles, Lisa M. Vaughn, Daniel J. SchumacherJohn K. Witry, Shiv Viswanathan, Erica M. Page, David Schnadower

^*Corresponding author for this work

Pediatrics

Research output: Contribution to journal › Article › peer-review

71 Scopus citations

Abstract

Background: The use of inconsistent definitions for anaphylaxis outcomes limits our understanding of the natural history and epidemiology of anaphylaxis, hindering clinical practice and research efforts. Objective: Our aim was to develop consensus definitions for clinically relevant anaphylaxis outcomes by utilizing a multidisciplinary group of clinical and research experts in anaphylaxis. Methods: Using Delphi methodology, we developed agenda topics and drafted questions to review during monthly conference calls. Through online surveys, a 19-member panel consisting of experts in allergy and/or immunology and emergency medicine rated their level of agreement with the appropriateness of statements on a scale of 1 to 9. A median value of 1.0 to 3.4 was considered inappropriate, a median value of 3.5 to 6.9 was considered uncertain, and a median value of 7.0 to 9.0 was considered appropriate. A disagreement index was then calculated, with values less than 1.0 categorized as “consensus reached.” If consensus was not reached after the initial survey, subsequent surveys incorporating the aggregate de-identified responses from prior surveys were sent to panel members. This process was repeated until consensus was reached or 4 survey rounds had been completed, after which the question was categorized as “no consensus reached.” Results: The panel developed outcome definitions for persistent, refractory, and biphasic anaphylaxis, as well as for persistent and biphasic nonanaphylactic reactions. There was also consensus among panel members regarding the need to develop an anaphylaxis severity grading system. Conclusion: Dissemination and application of these definitions in clinical care and research will help standardize the terminology used to describe anaphylaxis outcomes and serve as the foundation for future research, including research aimed at development of an anaphylaxis severity grading system.

Original language	English (US)
Pages (from-to)	1089-1096
Number of pages	8
Journal	Journal of Allergy and Clinical Immunology
Volume	146
Issue number	5
DOIs	https://doi.org/10.1016/j.jaci.2020.08.015
State	Published - Nov 2020

Funding

Disclosure of potential conflict of interest: H. A. Sampson receives funding to his institution for grants from the National Institutes of Health (NIH)/National Institute of Allergy and Infectious Diseases (NIAID) and is employed part-time by and has received stock options from DBV Technologies. C. A. Camargo has consulted for Bryn Pharma and Kaleo. D. C. Brousseau receives funding from the NIH and Maternal and Child Health Bureau. J. M. Spergel has grant support from DBV Technology, AImmune, and NIH; he has consulted for Kaleo. M. Shaker has a brother who is chief executive officer of Altrix Medical. He is a member of the Joint Task Force on Practice Parameters and serves as an editorial board member for the Journal of Allergy and Clinical Immunology In Practice, Annals of Allergy, Asthma, and Immunology, and Journal of Food Allergy. R. L. Campbell has been a peer reviewer for EB Medicine and an author for UpToDate. K. A. Michelson receives funding from Agency for Healthcare Research and Quality. A. H. Assa’ad has research grants from NIH, Aimmune, DBV Technologies, Astellas, AbbVie, and Sanofi. M. Castells is the Brigham and Women's Hospital principal investigator for the PIONEER BluPrint Clinical trial for Indolent Systemic Mastocytosis. L. C. Schneider has received research support from Regeneron Pharmaceuticals, DBV Technologies, Pfizer, and Genentech; in addition, he has consulted for Aimmune Therapeutics and is on the Medical Advisory Board of FARE (Food Allergy Research and Education). J. Wang receives research support from NIAID, Aimmune, DBV Technologies, and Regeneron, as well as consultancy fees from Aimmune, ALK-Abelló, DBV Technologies, and Genentech. R. Mistry receives funding from the NIAID. D. Schnadower receives funding from the NIH. The rest of the authors declare that they have no relevant conflicts of interest. Supported by the Division of Emergency Medicine , Cincinnati Children's Hospital Medical Center .

Keywords

Anaphylaxis
Delphi
biphasic anaphylaxis
biphasic nonanaphylactic reactions
emergency department
persistent anaphylaxis
persistent nonanaphylactic reactions
refractory anaphylaxis

ASJC Scopus subject areas

Immunology and Allergy
Immunology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.jaci.2020.08.015

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Dribin, T. E., Sampson, H. A., Camargo, C. A., Brousseau, D. C., Spergel, J. M., Neuman, M. I., Shaker, M., Campbell, R. L., Michelson, K. A., Rudders, S. A., Assa'ad, A. H., Risma, K. A., Castells, M., Schneider, L. C., Wang, J., Lee, J., Mistry, R. D., Vyles, D., Vaughn, L. M., ... Schnadower, D. (2020). Persistent, refractory, and biphasic anaphylaxis: A multidisciplinary Delphi study. Journal of Allergy and Clinical Immunology, 146(5), 1089-1096. https://doi.org/10.1016/j.jaci.2020.08.015

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title = "Persistent, refractory, and biphasic anaphylaxis: A multidisciplinary Delphi study",

abstract = "Background: The use of inconsistent definitions for anaphylaxis outcomes limits our understanding of the natural history and epidemiology of anaphylaxis, hindering clinical practice and research efforts. Objective: Our aim was to develop consensus definitions for clinically relevant anaphylaxis outcomes by utilizing a multidisciplinary group of clinical and research experts in anaphylaxis. Methods: Using Delphi methodology, we developed agenda topics and drafted questions to review during monthly conference calls. Through online surveys, a 19-member panel consisting of experts in allergy and/or immunology and emergency medicine rated their level of agreement with the appropriateness of statements on a scale of 1 to 9. A median value of 1.0 to 3.4 was considered inappropriate, a median value of 3.5 to 6.9 was considered uncertain, and a median value of 7.0 to 9.0 was considered appropriate. A disagreement index was then calculated, with values less than 1.0 categorized as “consensus reached.” If consensus was not reached after the initial survey, subsequent surveys incorporating the aggregate de-identified responses from prior surveys were sent to panel members. This process was repeated until consensus was reached or 4 survey rounds had been completed, after which the question was categorized as “no consensus reached.” Results: The panel developed outcome definitions for persistent, refractory, and biphasic anaphylaxis, as well as for persistent and biphasic nonanaphylactic reactions. There was also consensus among panel members regarding the need to develop an anaphylaxis severity grading system. Conclusion: Dissemination and application of these definitions in clinical care and research will help standardize the terminology used to describe anaphylaxis outcomes and serve as the foundation for future research, including research aimed at development of an anaphylaxis severity grading system.",

keywords = "Anaphylaxis, Delphi, biphasic anaphylaxis, biphasic nonanaphylactic reactions, emergency department, persistent anaphylaxis, persistent nonanaphylactic reactions, refractory anaphylaxis",

author = "Dribin, \{Timothy E.\} and Sampson, \{Hugh A.\} and Camargo, \{Carlos A.\} and Brousseau, \{David C.\} and Spergel, \{Jonathan M.\} and Neuman, \{Mark I.\} and Marcus Shaker and Campbell, \{Ronna L.\} and Michelson, \{Kenneth A.\} and Rudders, \{Susan A.\} and Assa'ad, \{Amal H.\} and Risma, \{Kimberly A.\} and Mariana Castells and Schneider, \{Lynda C.\} and Julie Wang and Juhee Lee and Mistry, \{Rakesh D.\} and David Vyles and Vaughn, \{Lisa M.\} and Schumacher, \{Daniel J.\} and Witry, \{John K.\} and Shiv Viswanathan and Page, \{Erica M.\} and David Schnadower",

note = "Publisher Copyright: {\textcopyright} 2020 American Academy of Allergy, Asthma \& Immunology",

year = "2020",

month = nov,

doi = "10.1016/j.jaci.2020.08.015",

language = "English (US)",

volume = "146",

pages = "1089--1096",

journal = "Journal of Allergy and Clinical Immunology",

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Dribin, TE, Sampson, HA, Camargo, CA, Brousseau, DC, Spergel, JM, Neuman, MI, Shaker, M, Campbell, RL, Michelson, KA, Rudders, SA, Assa'ad, AH, Risma, KA, Castells, M, Schneider, LC, Wang, J, Lee, J, Mistry, RD, Vyles, D, Vaughn, LM, Schumacher, DJ, Witry, JK, Viswanathan, S, Page, EM & Schnadower, D 2020, 'Persistent, refractory, and biphasic anaphylaxis: A multidisciplinary Delphi study', Journal of Allergy and Clinical Immunology, vol. 146, no. 5, pp. 1089-1096. https://doi.org/10.1016/j.jaci.2020.08.015

TY - JOUR

T1 - Persistent, refractory, and biphasic anaphylaxis

T2 - A multidisciplinary Delphi study

AU - Dribin, Timothy E.

AU - Sampson, Hugh A.

AU - Camargo, Carlos A.

AU - Brousseau, David C.

AU - Spergel, Jonathan M.

AU - Neuman, Mark I.

AU - Shaker, Marcus

AU - Campbell, Ronna L.

AU - Michelson, Kenneth A.

AU - Rudders, Susan A.

AU - Assa'ad, Amal H.

AU - Risma, Kimberly A.

AU - Castells, Mariana

AU - Schneider, Lynda C.

AU - Wang, Julie

AU - Lee, Juhee

AU - Mistry, Rakesh D.

AU - Vyles, David

AU - Vaughn, Lisa M.

AU - Schumacher, Daniel J.

AU - Witry, John K.

AU - Viswanathan, Shiv

AU - Page, Erica M.

AU - Schnadower, David

PY - 2020/11

Y1 - 2020/11

N2 - Background: The use of inconsistent definitions for anaphylaxis outcomes limits our understanding of the natural history and epidemiology of anaphylaxis, hindering clinical practice and research efforts. Objective: Our aim was to develop consensus definitions for clinically relevant anaphylaxis outcomes by utilizing a multidisciplinary group of clinical and research experts in anaphylaxis. Methods: Using Delphi methodology, we developed agenda topics and drafted questions to review during monthly conference calls. Through online surveys, a 19-member panel consisting of experts in allergy and/or immunology and emergency medicine rated their level of agreement with the appropriateness of statements on a scale of 1 to 9. A median value of 1.0 to 3.4 was considered inappropriate, a median value of 3.5 to 6.9 was considered uncertain, and a median value of 7.0 to 9.0 was considered appropriate. A disagreement index was then calculated, with values less than 1.0 categorized as “consensus reached.” If consensus was not reached after the initial survey, subsequent surveys incorporating the aggregate de-identified responses from prior surveys were sent to panel members. This process was repeated until consensus was reached or 4 survey rounds had been completed, after which the question was categorized as “no consensus reached.” Results: The panel developed outcome definitions for persistent, refractory, and biphasic anaphylaxis, as well as for persistent and biphasic nonanaphylactic reactions. There was also consensus among panel members regarding the need to develop an anaphylaxis severity grading system. Conclusion: Dissemination and application of these definitions in clinical care and research will help standardize the terminology used to describe anaphylaxis outcomes and serve as the foundation for future research, including research aimed at development of an anaphylaxis severity grading system.

AB - Background: The use of inconsistent definitions for anaphylaxis outcomes limits our understanding of the natural history and epidemiology of anaphylaxis, hindering clinical practice and research efforts. Objective: Our aim was to develop consensus definitions for clinically relevant anaphylaxis outcomes by utilizing a multidisciplinary group of clinical and research experts in anaphylaxis. Methods: Using Delphi methodology, we developed agenda topics and drafted questions to review during monthly conference calls. Through online surveys, a 19-member panel consisting of experts in allergy and/or immunology and emergency medicine rated their level of agreement with the appropriateness of statements on a scale of 1 to 9. A median value of 1.0 to 3.4 was considered inappropriate, a median value of 3.5 to 6.9 was considered uncertain, and a median value of 7.0 to 9.0 was considered appropriate. A disagreement index was then calculated, with values less than 1.0 categorized as “consensus reached.” If consensus was not reached after the initial survey, subsequent surveys incorporating the aggregate de-identified responses from prior surveys were sent to panel members. This process was repeated until consensus was reached or 4 survey rounds had been completed, after which the question was categorized as “no consensus reached.” Results: The panel developed outcome definitions for persistent, refractory, and biphasic anaphylaxis, as well as for persistent and biphasic nonanaphylactic reactions. There was also consensus among panel members regarding the need to develop an anaphylaxis severity grading system. Conclusion: Dissemination and application of these definitions in clinical care and research will help standardize the terminology used to describe anaphylaxis outcomes and serve as the foundation for future research, including research aimed at development of an anaphylaxis severity grading system.

KW - Anaphylaxis

KW - Delphi

KW - biphasic anaphylaxis

KW - biphasic nonanaphylactic reactions

KW - emergency department

KW - persistent anaphylaxis

KW - persistent nonanaphylactic reactions

KW - refractory anaphylaxis

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U2 - 10.1016/j.jaci.2020.08.015

DO - 10.1016/j.jaci.2020.08.015

M3 - Article

C2 - 32853640

AN - SCOPUS:85091614972

SN - 0091-6749

VL - 146

SP - 1089

EP - 1096

JO - Journal of Allergy and Clinical Immunology

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IS - 5

ER -

Persistent, refractory, and biphasic anaphylaxis: A multidisciplinary Delphi study

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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