International Severe Asthma Registry (ISAR): protocol for a global registry

J Mark FitzGerald; Trung N Tran; Marianna  Alacqua; Alan  Altraja; Vibeke Backer; Leif Bjermer; Unnur  Bjornsdottir; Arnaud Bourdin; Guy Brusselle; Lakmini Bulathsinhala; John Busby; Giorgio W. Canonica; Victoria A Carter; Isha Chaudhry; You Sook Cho; George  Christoff; Borja G Cosio; Richard W. Costello; Neva Eleangovan; Peter G Gibson; Liam Heaney; Enrico Heffler; Mark Hew; Naeimeh Hosseini; Takashi  Iwanaga; David J Jackson; Rupert C Jones; Mariko S.  Koh; Thao Le; Lauri Lehtimäki; Dora  Ludviksdottir; Anke H Maitland-van der Zee; Andrew Menzies-Gow; Ruth B Murray; Nikolaos G Papadopoulos; Luis Perez de Llano; Matthew Peters; Paul E Pfeffer; Todor A.  Popov; Celeste Porsbjerg; Chris A.  Price; Chin Kook Rhee; Mohsen  Sadatsafavi; Yuji  Tohda; Wang Eileen; Michael E Wechsler; James Zangrilli; David B Price

doi:10.1186/s12874-020-01065-0

International Severe Asthma Registry (ISAR): protocol for a global registry

J Mark FitzGerald, Trung N Tran, Marianna Alacqua, Alan Altraja, Vibeke Backer, Leif Bjermer, Unnur Bjornsdottir, Arnaud Bourdin, Guy Brusselle, Lakmini Bulathsinhala, John Busby, Giorgio W. Canonica, Victoria A Carter, Isha Chaudhry, You Sook Cho, George Christoff, Borja G Cosio, Richard W. Costello, Neva Eleangovan, Peter G GibsonLiam Heaney, Enrico Heffler, Mark Hew, Naeimeh Hosseini, Takashi Iwanaga, David J Jackson, Rupert C Jones, Mariko S. Koh, Thao Le, Lauri Lehtimäki, Dora Ludviksdottir, Anke H Maitland-van der Zee, Andrew Menzies-Gow, Ruth B Murray, Nikolaos G Papadopoulos, Luis Perez de Llano, Matthew Peters, Paul E Pfeffer, Todor A. Popov, Celeste Porsbjerg, Chris A. Price, Chin Kook Rhee, Mohsen Sadatsafavi, Yuji Tohda, Wang Eileen, Michael E Wechsler, James Zangrilli, David B Price

School of Medicine, Dentistry and Biomedical Sciences

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

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Abstract

Background: Severe asthma exerts a disproportionately heavy burden on patients and health care. Due to the heterogeneity of the severe asthma population, many patients need to be evaluated to understand the clinical features and outcomes of severe asthma in order to facilitate personalised and targeted care. The International Severe Asthma Registry (ISAR) is a multi country registry project initiated to aid in this endeavour. Methods: ISAR is a multi-disciplinary initiative benefitting from the combined experience of the ISAR Steering Committee (ISC; comprising 47 clinicians and researchers across 29 countries, who have a special interest and/or experience in severe asthma management or establishment and maintenance of severe asthma registries) in collaboration with scientists and experts in database management and communication. Patients (≥18 years old) receiving treatment according to the 2018 definitions of the Global Initiative for Asthma (GINA) Step 5 or uncontrolled on GINA Step 4 treatment will be included. Data will be collected on a core set of 95 variables identified using the Delphi method. Participating registries will agree to provide access to and share standardised anonymous patient-level data with ISAR. ISAR is a registered data source on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ISAR’s collaborators include Optimum Patient Care, the Respiratory Effectiveness Group (REG) and AstraZeneca. ISAR is overseen by the ISC, REG, the Anonymised Data Ethics & Protocol Transparency Committee and the ISAR operational committee, ensuring the conduct of ethical, clinically relevant research that brings value to all key stakeholders. Conclusions: ISAR aims to offer a rich source of real-life data for scientific research to understand and improve disease burden, treatment patterns and patient outcomes in severe asthma. Furthermore, the registry will provide an international platform for research collaboration in respiratory medicine, with the overarching aim of improving primary and secondary care of adults with severe asthma globally.

Original language	English
Journal	BMC Medical Research Methodology
Early online date	14 Aug 2020
DOIs	https://doi.org/10.1186/s12874-020-01065-0
Publication status	Early online date - 14 Aug 2020

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International Severe Asthma Registry (ISAR): protocol for a global registry
Copyright 2020 the authors. This is an open access article published under a Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited.
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Mark FitzGerald, J., Tran, T. N., Alacqua, M., Altraja, A., Backer, V., Bjermer, L., Bjornsdottir, U., Bourdin, A., Brusselle, G., Bulathsinhala, L., Busby, J., Canonica, G. W., Carter, V. A., Chaudhry, I., Cho, Y. S., Christoff, G., Cosio, B. G., Costello, R. W., Eleangovan, N., ... Price, D. B. (2020). International Severe Asthma Registry (ISAR): protocol for a global registry. BMC Medical Research Methodology. Advance online publication. https://doi.org/10.1186/s12874-020-01065-0

@article{eb9273cbf7a34c7da4f54d9d6cb2a53a,

title = "International Severe Asthma Registry (ISAR): protocol for a global registry",

abstract = "Background: Severe asthma exerts a disproportionately heavy burden on patients and health care. Due to the heterogeneity of the severe asthma population, many patients need to be evaluated to understand the clinical features and outcomes of severe asthma in order to facilitate personalised and targeted care. The International Severe Asthma Registry (ISAR) is a multi country registry project initiated to aid in this endeavour. Methods: ISAR is a multi-disciplinary initiative benefitting from the combined experience of the ISAR Steering Committee (ISC; comprising 47 clinicians and researchers across 29 countries, who have a special interest and/or experience in severe asthma management or establishment and maintenance of severe asthma registries) in collaboration with scientists and experts in database management and communication. Patients (≥18 years old) receiving treatment according to the 2018 definitions of the Global Initiative for Asthma (GINA) Step 5 or uncontrolled on GINA Step 4 treatment will be included. Data will be collected on a core set of 95 variables identified using the Delphi method. Participating registries will agree to provide access to and share standardised anonymous patient-level data with ISAR. ISAR is a registered data source on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ISAR{\textquoteright}s collaborators include Optimum Patient Care, the Respiratory Effectiveness Group (REG) and AstraZeneca. ISAR is overseen by the ISC, REG, the Anonymised Data Ethics & Protocol Transparency Committee and the ISAR operational committee, ensuring the conduct of ethical, clinically relevant research that brings value to all key stakeholders. Conclusions: ISAR aims to offer a rich source of real-life data for scientific research to understand and improve disease burden, treatment patterns and patient outcomes in severe asthma. Furthermore, the registry will provide an international platform for research collaboration in respiratory medicine, with the overarching aim of improving primary and secondary care of adults with severe asthma globally. ",

author = "{Mark FitzGerald}, J and Tran, {Trung N} and Marianna Alacqua and Alan Altraja and Vibeke Backer and Leif Bjermer and Unnur Bjornsdottir and Arnaud Bourdin and Guy Brusselle and Lakmini Bulathsinhala and John Busby and Canonica, {Giorgio W.} and Carter, {Victoria A} and Isha Chaudhry and Cho, {You Sook} and George Christoff and Cosio, {Borja G} and Costello, {Richard W.} and Neva Eleangovan and Gibson, {Peter G} and Liam Heaney and Enrico Heffler and Mark Hew and Naeimeh Hosseini and Takashi Iwanaga and Jackson, {David J} and Jones, {Rupert C} and Koh, {Mariko S.} and Thao Le and Lauri Lehtim{\"a}ki and Dora Ludviksdottir and {Maitland-van der Zee}, {Anke H} and Andrew Menzies-Gow and Murray, {Ruth B} and Papadopoulos, {Nikolaos G} and {Perez de Llano}, Luis and Matthew Peters and Pfeffer, {Paul E} and Popov, {Todor A.} and Celeste Porsbjerg and Price, {Chris A.} and Rhee, {Chin Kook} and Mohsen Sadatsafavi and Yuji Tohda and Wang Eileen and Wechsler, {Michael E} and James Zangrilli and Price, {David B}",

year = "2020",

month = aug,

day = "14",

doi = "10.1186/s12874-020-01065-0",

language = "English",

journal = "BMC Medical Research Methodology",

issn = "1471-2288",

publisher = "BioMed Central",

}

Mark FitzGerald, J, Tran, TN, Alacqua, M, Altraja, A, Backer, V, Bjermer, L, Bjornsdottir, U, Bourdin, A, Brusselle, G, Bulathsinhala, L, Busby, J, Canonica, GW, Carter, VA, Chaudhry, I, Cho, YS, Christoff, G, Cosio, BG, Costello, RW, Eleangovan, N, Gibson, PG, Heaney, L, Heffler, E, Hew, M, Hosseini, N, Iwanaga, T, Jackson, DJ, Jones, RC, Koh, MS, Le, T, Lehtimäki, L, Ludviksdottir, D, Maitland-van der Zee, AH, Menzies-Gow, A, Murray, RB, Papadopoulos, NG, Perez de Llano, L, Peters, M, Pfeffer, PE, Popov, TA, Porsbjerg, C, Price, CA, Rhee, CK, Sadatsafavi, M, Tohda, Y, Eileen, W, Wechsler, ME, Zangrilli, J & Price, DB 2020, 'International Severe Asthma Registry (ISAR): protocol for a global registry', BMC Medical Research Methodology. https://doi.org/10.1186/s12874-020-01065-0

TY - JOUR

T1 - International Severe Asthma Registry (ISAR): protocol for a global registry

AU - Mark FitzGerald, J

AU - Tran, Trung N

AU - Alacqua, Marianna

AU - Altraja, Alan

AU - Backer, Vibeke

AU - Bjermer, Leif

AU - Bjornsdottir, Unnur

AU - Bourdin, Arnaud

AU - Brusselle, Guy

AU - Bulathsinhala, Lakmini

AU - Busby, John

AU - Canonica, Giorgio W.

AU - Carter, Victoria A

AU - Chaudhry, Isha

AU - Cho, You Sook

AU - Christoff, George

AU - Cosio, Borja G

AU - Costello, Richard W.

AU - Eleangovan, Neva

AU - Gibson, Peter G

AU - Heaney, Liam

AU - Heffler, Enrico

AU - Hew, Mark

AU - Hosseini, Naeimeh

AU - Iwanaga, Takashi

AU - Jackson, David J

AU - Jones, Rupert C

AU - Koh, Mariko S.

AU - Le, Thao

AU - Lehtimäki, Lauri

AU - Ludviksdottir, Dora

AU - Maitland-van der Zee, Anke H

AU - Menzies-Gow, Andrew

AU - Murray, Ruth B

AU - Papadopoulos, Nikolaos G

AU - Perez de Llano, Luis

AU - Peters, Matthew

AU - Pfeffer, Paul E

AU - Popov, Todor A.

AU - Porsbjerg, Celeste

AU - Price, Chris A.

AU - Rhee, Chin Kook

AU - Sadatsafavi, Mohsen

AU - Tohda, Yuji

AU - Eileen, Wang

AU - Wechsler, Michael E

AU - Zangrilli, James

AU - Price, David B

PY - 2020/8/14

Y1 - 2020/8/14

N2 - Background: Severe asthma exerts a disproportionately heavy burden on patients and health care. Due to the heterogeneity of the severe asthma population, many patients need to be evaluated to understand the clinical features and outcomes of severe asthma in order to facilitate personalised and targeted care. The International Severe Asthma Registry (ISAR) is a multi country registry project initiated to aid in this endeavour. Methods: ISAR is a multi-disciplinary initiative benefitting from the combined experience of the ISAR Steering Committee (ISC; comprising 47 clinicians and researchers across 29 countries, who have a special interest and/or experience in severe asthma management or establishment and maintenance of severe asthma registries) in collaboration with scientists and experts in database management and communication. Patients (≥18 years old) receiving treatment according to the 2018 definitions of the Global Initiative for Asthma (GINA) Step 5 or uncontrolled on GINA Step 4 treatment will be included. Data will be collected on a core set of 95 variables identified using the Delphi method. Participating registries will agree to provide access to and share standardised anonymous patient-level data with ISAR. ISAR is a registered data source on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ISAR’s collaborators include Optimum Patient Care, the Respiratory Effectiveness Group (REG) and AstraZeneca. ISAR is overseen by the ISC, REG, the Anonymised Data Ethics & Protocol Transparency Committee and the ISAR operational committee, ensuring the conduct of ethical, clinically relevant research that brings value to all key stakeholders. Conclusions: ISAR aims to offer a rich source of real-life data for scientific research to understand and improve disease burden, treatment patterns and patient outcomes in severe asthma. Furthermore, the registry will provide an international platform for research collaboration in respiratory medicine, with the overarching aim of improving primary and secondary care of adults with severe asthma globally.

AB - Background: Severe asthma exerts a disproportionately heavy burden on patients and health care. Due to the heterogeneity of the severe asthma population, many patients need to be evaluated to understand the clinical features and outcomes of severe asthma in order to facilitate personalised and targeted care. The International Severe Asthma Registry (ISAR) is a multi country registry project initiated to aid in this endeavour. Methods: ISAR is a multi-disciplinary initiative benefitting from the combined experience of the ISAR Steering Committee (ISC; comprising 47 clinicians and researchers across 29 countries, who have a special interest and/or experience in severe asthma management or establishment and maintenance of severe asthma registries) in collaboration with scientists and experts in database management and communication. Patients (≥18 years old) receiving treatment according to the 2018 definitions of the Global Initiative for Asthma (GINA) Step 5 or uncontrolled on GINA Step 4 treatment will be included. Data will be collected on a core set of 95 variables identified using the Delphi method. Participating registries will agree to provide access to and share standardised anonymous patient-level data with ISAR. ISAR is a registered data source on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ISAR’s collaborators include Optimum Patient Care, the Respiratory Effectiveness Group (REG) and AstraZeneca. ISAR is overseen by the ISC, REG, the Anonymised Data Ethics & Protocol Transparency Committee and the ISAR operational committee, ensuring the conduct of ethical, clinically relevant research that brings value to all key stakeholders. Conclusions: ISAR aims to offer a rich source of real-life data for scientific research to understand and improve disease burden, treatment patterns and patient outcomes in severe asthma. Furthermore, the registry will provide an international platform for research collaboration in respiratory medicine, with the overarching aim of improving primary and secondary care of adults with severe asthma globally.

U2 - 10.1186/s12874-020-01065-0

DO - 10.1186/s12874-020-01065-0

M3 - Article

SN - 1471-2288

JO - BMC Medical Research Methodology

JF - BMC Medical Research Methodology

ER -

International Severe Asthma Registry (ISAR): protocol for a global registry

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