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

FitzGerald, J. Mark ; Tran, Trung N. ; Alacqua, Marianna ; Altraja, Alan ; Backer, Vibeke ; Bjermer, Leif LU ; Bjornsdottir, Unnur ; Bourdin, Arnaud ; Brusselle, Guy and Bulathsinhala, Lakmini , et al. (2020) In BMC Medical Research Methodology 20(1).
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... (More)

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.

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publishing date
type
Contribution to journal
publication status
published
subject
keywords
Disease registry, Protocol, Real-world, Severe asthma
in
BMC Medical Research Methodology
volume
20
issue
1
article number
212
publisher
BioMed Central (BMC)
external identifiers
  • scopus:85089769760
  • pmid:32819285
ISSN
1471-2288
DOI
10.1186/s12874-020-01065-0
language
English
LU publication?
no
id
f555fa9a-a53a-4c43-aac9-d5d62bf960be
date added to LUP
2020-09-07 16:07:50
date last changed
2024-03-18 12:32:41
@article{f555fa9a-a53a-4c43-aac9-d5d62bf960be,
  abstract     = {{<p>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 &amp; 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.</p>}},
  author       = {{FitzGerald, J. Mark and Tran, Trung N. and Alacqua, Marianna and Altraja, Alan and Backer, Vibeke and Bjermer, Leif and Bjornsdottir, Unnur and Bourdin, Arnaud and Brusselle, Guy and Bulathsinhala, Lakmini and Busby, John and Canonica, Giorgio W. and Carter, Victoria and Chaudhry, Isha and Cho, You Sook and Christoff, George and Cosio, Borja G. and Costello, Richard W. and Eleangovan, Neva and Gibson, Peter G. and Heaney, Liam G. and Heffler, Enrico and Hew, Mark and Hosseini, Naeimeh and Iwanaga, Takashi and Jackson, David J. and Jones, Rupert and Koh, Mariko S. and Le, Thao and Lehtimäki, Lauri and Ludviksdottir, Dora and Maitland-van der Zee, Anke H. and Menzies-Gow, Andrew and Murray, Ruth B. and Papadopoulos, Nikolaos G. and Perez-de-Llano, Luis and Peters, Matthew and Pfeffer, Paul E. and Popov, Todor A. and Porsbjerg, Celeste M. and Price, Chris A. and Rhee, Chin K. and Sadatsafavi, Mohsen and Tohda, Yuji and Wang, Eileen and Wechsler, Michael E. and Zangrilli, James and Price, David B.}},
  issn         = {{1471-2288}},
  keywords     = {{Disease registry; Protocol; Real-world; Severe asthma}},
  language     = {{eng}},
  number       = {{1}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{BMC Medical Research Methodology}},
  title        = {{International severe asthma registry (ISAR) : protocol for a global registry}},
  url          = {{http://dx.doi.org/10.1186/s12874-020-01065-0}},
  doi          = {{10.1186/s12874-020-01065-0}},
  volume       = {{20}},
  year         = {{2020}},
}