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 Carter; Isha Chaudhry; You Sook Cho; George Christoff; Borja G. Cosio; Richard W. Costello; Neva Eleangovan; Peter G.  Gibson; Liam G. Heaney; Enrico Heffler; Mark Hew; Naeimeh Hosseini; Takashi Iwanaga; David J. Jackson; Rupert Jones; Mariko S. Koh; Thao Le; Lauri Lehtimäki; Dora Ludviksdottir; Anke Hilse 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 M. Porsbjerg; Chris A. Price; Chin K. Rhee; Mohsen Sadatsafavi; Yuji Tohda; Wang Eileen; Michael E. Wechsler; James Zangrilli; David 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 Carter, Isha Chaudhry, You Sook Cho, George Christoff, Borja G. Cosio, Richard W. Costello, Neva Eleangovan, Peter G. GibsonLiam G. Heaney, Enrico Heffler, Mark Hew, Naeimeh Hosseini, Takashi Iwanaga, David J. Jackson, Rupert Jones, Mariko S. Koh, Thao Le, Lauri Lehtimäki, Dora Ludviksdottir, Anke Hilse 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 M. Porsbjerg, Chris A. Price, Chin K. Rhee, Mohsen Sadatsafavi, Yuji Tohda, Wang Eileen, Michael E. Wechsler, James Zangrilli, David Price^* (Corresponding Author)

^*Corresponding author for this work

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
Article number	212
Number of pages	14
Journal	BMC Medical Research Methodology
Volume	20
DOIs	https://doi.org/10.1186/s12874-020-01065-0
Publication status	Published - 14 Aug 2020

Bibliographical note

Acknowledgements
The authors thank the following individuals who contributed to the initial set-up of ISAR, provided input to the development of the protocol and/or were involved in local implementation of ISAR: Elisabeth Bel, Roland Buhl, Sverre Lehmann, Stelios Loukidis, Richard Martin, Juno Pak, Pearlanne Zelar ney, Joy Zimmer, Christena Kolakowski, Margo Brown, Jessica Cummings, Jennifer Brandorff, Seth Skelton, John Upham, Philip Bardin, Paul Reynolds, David Langton, Peter Middleton, Belinda Cochrane, Katya Vasileva Noleva, Plamen Hristov Yakovliev, Sonya Metodieva Genova, Violina Milchova Vasi leva, Darina Petrova Dimova, Nadezhda K Takovska, Cvetantka Hristova Odz hakova, Eleonora M Stamenova, Diana X Hristova, Vincente Plaza, Ian Hirsch, Cekomir Vodenicharov, Alexandrina Vodenicharova and Magdalena Alexandrova. Medical writing support was provided by Michelle Rebello, PhD, and Liam Gillies, PhD, of Cactus Communications (Mumbai, India).

Funding
The International Severe Asthma Registry is conducted by Optimum Patient Care Global Limited, and co-funded by Optimum Patient Care Global Limited and AstraZeneca. ISAR is supported by grants from AstraZeneca and Optimum
Patient Care (OPC) Global (a not-for-profit social enterprise). The ISAR steering
committee (ISC) was involved in the development of the protocol and is responsible for approving research proposals via a democratic voting process. In
addition to 47 clinicians and researchers with an interest and experience in severe asthma, the ISC also includes members of OPC and four medical experts
from AstraZeneca. AstraZeneca reviewed the draft before submission; however,
decision to submit was made by the authors. Medical writing support was funded by AstraZeneca in accordance with Good Publication Practice (GPP3)
guidelines (http://www.ismpp.org/gpp3).

Keywords

disease registry
protocol
real-world
severe asthma
Disease registry
Real-world
Severe asthma
Protocol
DEFINITION
DESIGN
MEPOLIZUMAB
SAFETY
PHENOTYPES
TO-TREAT ASTHMA
COSTS
EXACERBATIONS
HEALTH-CARE
OUTCOMES

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FitzGerald, J. M., 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., Chaudhry, I., Cho, Y. S., Christoff, G., Cosio, B. G., Costello, R. W., Eleangovan, N., ... Price, D. (2020). International severe asthma registry (ISAR): protocol for a global registry. BMC Medical Research Methodology, 20, Article 212. https://doi.org/10.1186/s12874-020-01065-0

FitzGerald, JM, Tran, TN, Alacqua, M, Altraja, A, Backer, V, Bjermer, L, Bjornsdottir, U, Bourdin, A, Brusselle, G, Bulathsinhala, L, Busby, J, Canonica, GW, Carter, V, Chaudhry, I, Cho, YS, Christoff, G, Cosio, BG, Costello, RW, Eleangovan, N, Gibson, PG, Heaney, LG, Heffler, E, Hew, M, Hosseini, N, Iwanaga, T, Jackson, DJ, Jones, R, 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, CM, Price, CA, Rhee, CK, Sadatsafavi, M, Tohda, Y, Eileen, W, Wechsler, ME, Zangrilli, J & Price, D 2020, 'International severe asthma registry (ISAR): protocol for a global registry', BMC Medical Research Methodology, vol. 20, 212. https://doi.org/10.1186/s12874-020-01065-0

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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.",

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author = "FitzGerald, {J. Mark} 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 Victoria Carter 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 Heaney, {Liam G.} and Enrico Heffler and Mark Hew and Naeimeh Hosseini and Takashi Iwanaga and Jackson, {David J.} and Rupert Jones and Koh, {Mariko S.} and Thao Le and Lauri Lehtim{\"a}ki and Dora Ludviksdottir and {Maitland-van der Zee}, {Anke Hilse} and Andrew Menzies-Gow and Murray, {Ruth B.} and Papadopoulos, {Nikolaos G.} and Luis Perez-de-Llano and Matthew Peters and Pfeffer, {Paul E.} and Popov, {Todor A.} and Porsbjerg, {Celeste M.} and Price, {Chris A.} and Rhee, {Chin K.} and Mohsen Sadatsafavi and Yuji Tohda and Wang Eileen and Wechsler, {Michael E.} and James Zangrilli and David Price",

note = "Acknowledgements The authors thank the following individuals who contributed to the initial set-up of ISAR, provided input to the development of the protocol and/or were involved in local implementation of ISAR: Elisabeth Bel, Roland Buhl, Sverre Lehmann, Stelios Loukidis, Richard Martin, Juno Pak, Pearlanne Zelar ney, Joy Zimmer, Christena Kolakowski, Margo Brown, Jessica Cummings, Jennifer Brandorff, Seth Skelton, John Upham, Philip Bardin, Paul Reynolds, David Langton, Peter Middleton, Belinda Cochrane, Katya Vasileva Noleva, Plamen Hristov Yakovliev, Sonya Metodieva Genova, Violina Milchova Vasi leva, Darina Petrova Dimova, Nadezhda K Takovska, Cvetantka Hristova Odz hakova, Eleonora M Stamenova, Diana X Hristova, Vincente Plaza, Ian Hirsch, Cekomir Vodenicharov, Alexandrina Vodenicharova and Magdalena Alexandrova. Medical writing support was provided by Michelle Rebello, PhD, and Liam Gillies, PhD, of Cactus Communications (Mumbai, India). Funding The International Severe Asthma Registry is conducted by Optimum Patient Care Global Limited, and co-funded by Optimum Patient Care Global Limited and AstraZeneca. ISAR is supported by grants from AstraZeneca and Optimum Patient Care (OPC) Global (a not-for-profit social enterprise). The ISAR steering committee (ISC) was involved in the development of the protocol and is responsible for approving research proposals via a democratic voting process. In addition to 47 clinicians and researchers with an interest and experience in severe asthma, the ISC also includes members of OPC and four medical experts from AstraZeneca. AstraZeneca reviewed the draft before submission; however, decision to submit was made by the authors. Medical writing support was funded by AstraZeneca in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).",

year = "2020",

month = aug,

day = "14",

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

language = "English",

volume = "20",

journal = "BMC Medical Research Methodology",

issn = "1471-2288",

publisher = "BioMed Central",

}

TY - JOUR

T1 - International severe asthma registry (ISAR)

T2 - protocol for a global registry

AU - FitzGerald, J. Mark

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

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 G.

AU - Heffler, Enrico

AU - Hew, Mark

AU - Hosseini, Naeimeh

AU - Iwanaga, Takashi

AU - Jackson, David J.

AU - Jones, Rupert

AU - Koh, Mariko S.

AU - Le, Thao

AU - Lehtimäki, Lauri

AU - Ludviksdottir, Dora

AU - Maitland-van der Zee, Anke Hilse

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 M.

AU - Price, Chris A.

AU - Rhee, Chin K.

AU - Sadatsafavi, Mohsen

AU - Tohda, Yuji

AU - Eileen, Wang

AU - Wechsler, Michael E.

AU - Zangrilli, James

AU - Price, David

N1 - Acknowledgements The authors thank the following individuals who contributed to the initial set-up of ISAR, provided input to the development of the protocol and/or were involved in local implementation of ISAR: Elisabeth Bel, Roland Buhl, Sverre Lehmann, Stelios Loukidis, Richard Martin, Juno Pak, Pearlanne Zelar ney, Joy Zimmer, Christena Kolakowski, Margo Brown, Jessica Cummings, Jennifer Brandorff, Seth Skelton, John Upham, Philip Bardin, Paul Reynolds, David Langton, Peter Middleton, Belinda Cochrane, Katya Vasileva Noleva, Plamen Hristov Yakovliev, Sonya Metodieva Genova, Violina Milchova Vasi leva, Darina Petrova Dimova, Nadezhda K Takovska, Cvetantka Hristova Odz hakova, Eleonora M Stamenova, Diana X Hristova, Vincente Plaza, Ian Hirsch, Cekomir Vodenicharov, Alexandrina Vodenicharova and Magdalena Alexandrova. Medical writing support was provided by Michelle Rebello, PhD, and Liam Gillies, PhD, of Cactus Communications (Mumbai, India). Funding The International Severe Asthma Registry is conducted by Optimum Patient Care Global Limited, and co-funded by Optimum Patient Care Global Limited and AstraZeneca. ISAR is supported by grants from AstraZeneca and Optimum Patient Care (OPC) Global (a not-for-profit social enterprise). The ISAR steering committee (ISC) was involved in the development of the protocol and is responsible for approving research proposals via a democratic voting process. In addition to 47 clinicians and researchers with an interest and experience in severe asthma, the ISC also includes members of OPC and four medical experts from AstraZeneca. AstraZeneca reviewed the draft before submission; however, decision to submit was made by the authors. Medical writing support was funded by AstraZeneca in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).

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.

KW - disease registry

KW - protocol

KW - real-world

KW - severe asthma

KW - Disease registry

KW - Real-world

KW - Severe asthma

KW - Protocol

KW - DEFINITION

KW - DESIGN

KW - MEPOLIZUMAB

KW - SAFETY

KW - PHENOTYPES

KW - TO-TREAT ASTHMA

KW - COSTS

KW - EXACERBATIONS

KW - HEALTH-CARE

KW - OUTCOMES

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U2 - 10.1186/s12874-020-01065-0

DO - 10.1186/s12874-020-01065-0

M3 - Article

C2 - 32819285

SN - 1471-2288

VL - 20

JO - BMC Medical Research Methodology

JF - BMC Medical Research Methodology

M1 - 212

ER -

International severe asthma registry (ISAR): protocol for a global registry

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Bibliographical note

Keywords

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