BMC Medical Research Methodology (Aug 2020)
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 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 M. Porsbjerg,
- Chris A. Price,
- Chin K. Rhee,
- Mohsen Sadatsafavi,
- Yuji Tohda,
- Eileen Wang,
- Michael E. Wechsler,
- James Zangrilli,
- David B. Price
Affiliations
- J. Mark FitzGerald
- The Institute for Heart Lung Health
- Trung N. Tran
- AstraZeneca
- Marianna Alacqua
- AstraZeneca
- Alan Altraja
- Department of Pulmonary Medicine, University of Tartu and Lung Clinic, Tartu University Hospital
- Vibeke Backer
- Center of Physical Activity Research, Rigshospitalet and Copenhagen University
- Leif Bjermer
- Department of Respiratory Medicine & Allergology, Skåne University Hospital
- Unnur Bjornsdottir
- Faculty of Medicine, University of Iceland
- Arnaud Bourdin
- Department of Respiratory Diseases, Montpellier University Hospitals, Hopital Arnaud de Villeneuve and PhyMed Exp (INSERM U 1046, CNRS UMR9214), Universite de Montpellier
- Guy Brusselle
- Department of Respiratory Medicine, Ghent University Hospital
- Lakmini Bulathsinhala
- Optimum Patient Care
- John Busby
- Centre for Public Health, Queen’s University Belfast
- Giorgio W. Canonica
- Personalized Medicine Asthma & Allergy Clinic, Humanitas University & Research Hospital
- Victoria Carter
- Optimum Patient Care
- Isha Chaudhry
- Optimum Patient Care
- You Sook Cho
- Division of Allergy, Department of Medicine, Asan Medical Center, College of Medicine, University of Ulsan
- George Christoff
- Faculty of Public Health, Medical University – Sofia
- Borja G. Cosio
- Son Espases University Hospital-IdISBa-Ciberes
- Richard W. Costello
- Clinical Research Centre, Smurfit Building Beaumont Hospital and Department of Respiratory Medicine, RCSI
- Neva Eleangovan
- Optimum Patient Care
- Peter G. Gibson
- Australasian Severe Asthma Network, Priority Research Centre for Healthy Lungs, University of Newcastle
- Liam G. Heaney
- Centre for Experimental Medicine, Queen’s University Belfast
- Enrico Heffler
- Personalized Medicine Asthma & Allergy Clinic, Humanitas University & Research Hospital
- Mark Hew
- Alfred Health & Monash University
- Naeimeh Hosseini
- Optimum Patient Care
- Takashi Iwanaga
- Department of Respiratory Medicine & Allergology, Faculty of Medicine, Kindai University Hospital
- David J. Jackson
- Guy’s & St Thomas’ NHS Trust and King’s College London
- Rupert Jones
- Faculty of Medicine & Dentistry, University of Plymouth
- Mariko S. Koh
- Department of Respiratory & Critical Care Medicine, Singapore General Hospital and Duke-National University Singapore Medical School
- Thao Le
- Optimum Patient Care
- Lauri Lehtimäki
- Allergy Centre, Tampere University Hospital and Tampere University
- Dora Ludviksdottir
- Department of Respiratory Medicine, Faculty of Medicine, Landspitali University Hospital and University of Iceland
- Anke H. Maitland-van der Zee
- University of Amsterdam
- Andrew Menzies-Gow
- Royal Brompton & Harefield NHS Foundation Trust
- Ruth B. Murray
- Optimum Patient Care
- Nikolaos G. Papadopoulos
- University of Athens
- Luis Perez-de-Llano
- Pneumology Service, Hospital Universitario Lucus Augusti
- Matthew Peters
- University of Sydney Medical School
- Paul E. Pfeffer
- UK Severe Asthma Network, Barts Health NHS Trust and Queen Mary University of London
- Todor A. Popov
- University Hospital “Sv. Ivan Rilski”
- Celeste M. Porsbjerg
- Bispebjerg Hospital, Copenhagen University
- Chris A. Price
- Optimum Patient Care
- Chin K. Rhee
- The Catholic University of Korea
- Mohsen Sadatsafavi
- Faculty of Pharmaceutical Sciences, University of British Columbia
- Yuji Tohda
- Department of Respiratory Medicine & Allergology, Faculty of Medicine, Kindai University Hospital
- Eileen Wang
- Division of Allergy & Clinical Immunology, Department of Medicine, National Jewish Health and Division of Allergy & Clinical Immunology, Department of Internal Medicine, University of Colorado Hospital
- Michael E. Wechsler
- Division of Pulmonary, Critical Care and Sleep Medicine, Asthma Program, National Jewish Health
- James Zangrilli
- AstraZeneca
- David B. Price
- Optimum Patient Care
- DOI
- https://doi.org/10.1186/s12874-020-01065-0
- Journal volume & issue
-
Vol. 20,
no. 1
pp. 1 – 14
Abstract
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.
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