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

Authors
  • FitzGerald, J. Mark1
  • Tran, Trung N.2
  • Alacqua, Marianna2
  • Altraja, Alan3
  • Backer, Vibeke4
  • Bjermer, Leif5
  • Bjornsdottir, Unnur6
  • Bourdin, Arnaud7
  • Brusselle, Guy8, 9
  • Bulathsinhala, Lakmini10
  • Busby, John11
  • Canonica, Giorgio W.12, 13
  • Carter, Victoria10
  • Chaudhry, Isha10
  • Cho, You Sook14
  • Christoff, George15
  • Cosio, Borja G.16
  • Costello, Richard W.17
  • Eleangovan, Neva10
  • Gibson, Peter G.18, 19
  • And 28 more
  • 1 The Institute for Heart Lung Health, Vancouver, Canada , Vancouver (Canada)
  • 2 AstraZeneca, Gaithersburg, USA , Gaithersburg (United States)
  • 3 University of Tartu and Lung Clinic, Tartu University Hospital, Tartu, Estonia , Tartu (Estonia)
  • 4 Rigshospitalet and Copenhagen University, Copenhagen, Denmark , Copenhagen (Denmark)
  • 5 Skåne University Hospital, Lund, Sweden , Lund (Sweden)
  • 6 University of Iceland, Reykjavik, Iceland , Reykjavik (Iceland)
  • 7 Montpellier University Hospitals, Hopital Arnaud de Villeneuve and PhyMed Exp (INSERM U 1046, CNRS UMR9214), Universite de Montpellier, Montpellier, France , Montpellier (France)
  • 8 Ghent University Hospital, Ghent, Belgium , Ghent (Belgium)
  • 9 Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands , Rotterdam (Netherlands)
  • 10 Optimum Patient Care, Cambridge, UK , Cambridge (United Kingdom)
  • 11 Queen’s University Belfast, Belfast, UK , Belfast (United Kingdom)
  • 12 Humanitas University & Research Hospital, Milan, Italy , Milan (Italy)
  • 13 SANI-Severe Asthma Network Italy, Milan, Italy , Milan (Italy)
  • 14 Asan Medical Center, College of Medicine, University of Ulsan, Seoul, South Korea , Seoul (South Korea)
  • 15 Medical University – Sofia, Sofia, Bulgaria , Sofia (Bulgaria)
  • 16 Son Espases University Hospital-IdISBa-Ciberes, Mallorca, Spain , Mallorca (Spain)
  • 17 Smurfit Building Beaumont Hospital and Department of Respiratory Medicine, RCSI, Dublin, Ireland , Dublin (Ireland)
  • 18 University of Newcastle, Newcastle, Australia , Newcastle (Australia)
  • 19 Hunter Medical Research Institute, John Hunter Hospital, New Lambton Heights, Australia , New Lambton Heights (Australia)
  • 20 Alfred Health & Monash University, Melbourne, Australia , Melbourne (Australia)
  • 21 Kindai University Hospital, Ōsakasayama, Japan , Ōsakasayama (Japan)
  • 22 Guy’s & St Thomas’ NHS Trust and King’s College London, London, UK , London (United Kingdom)
  • 23 University of Plymouth, Plymouth, UK , Plymouth (United Kingdom)
  • 24 Singapore General Hospital and Duke-National University Singapore Medical School, Singapore, Singapore , Singapore (Singapore)
  • 25 Tampere University Hospital and Tampere University, Tampere, Finland , Tampere (Finland)
  • 26 Landspitali University Hospital and University of Iceland, Reykjavik, Iceland , Reykjavik (Iceland)
  • 27 University of Amsterdam, Amsterdam, The Netherlands , Amsterdam (Netherlands)
  • 28 Royal Brompton & Harefield NHS Foundation Trust, London, UK , London (United Kingdom)
  • 29 University of Athens, Athens, Greece , Athens (Greece)
  • 30 University of Manchester, Manchester, UK , Manchester (United Kingdom)
  • 31 Hospital Universitario Lucus Augusti, Lugo, Spain , Lugo (Spain)
  • 32 University of Sydney Medical School, Sydney, Australia , Sydney (Australia)
  • 33 Barts Health NHS Trust and Queen Mary University of London, London, UK , London (United Kingdom)
  • 34 University Hospital “Sv. Ivan Rilski”, Sofia, Bulgaria , Sofia (Bulgaria)
  • 35 Bispebjerg Hospital, Copenhagen University, Copenhagen, Denmark , Copenhagen (Denmark)
  • 36 The Catholic University of Korea, Seoul, South Korea , Seoul (South Korea)
  • 37 University of British Columbia, Vancouver, Canada , Vancouver (Canada)
  • 38 University of Colorado Hospital, Denver and Aurora, CO, USA , Denver and Aurora (United States)
  • 39 Division of Pulmonary, Critical Care and Sleep Medicine, Asthma Program, National Jewish Health, Denver, USA , Denver (United States)
  • 40 Observational and Pragmatic Research Institute, Singapore, Singapore , Singapore (Singapore)
  • 41 University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK , Aberdeen (United Kingdom)
Type
Published Article
Journal
BMC Medical Research Methodology
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Aug 14, 2020
Volume
20
Issue
1
Identifiers
DOI: 10.1186/s12874-020-01065-0
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundSevere 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.MethodsISAR 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.ConclusionsISAR 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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