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

      research-article
      1 , 2 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 10 , 10 , 14 , 15 , 16 , 17 , 10 , 18 , 19 , 20 , 12 , 13 , 21 , 10 , 22 , 23 , 24 , 25 , 10 , 26 , 27 , 28 , 29 , 10 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 10 , 37 , 38 , 22 , 39 , 40 , 2 , 10 , 41 , 42 ,
      BMC Medical Research Methodology
      BioMed Central
      Disease registry, Protocol, Real-world, Severe asthma

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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.

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          Most cited references19

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          The Delphi method as a research tool: an example, design considerations and applications

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            The prevalence of severe refractory asthma.

            Severe asthma is characterized by difficulty to achieve disease control despite high-intensity treatment. However, prevalence figures of severe asthma are lacking, whereas longstanding estimates vary between 5% and 10% of all asthmatic patients. Knowing the exact prevalence of severe refractory asthma as opposed to difficult-to-control asthma is important for clinical decision making, drug development, and reimbursement policies by health authorities.
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              Sputum neutrophil counts are associated with more severe asthma phenotypes using cluster analysis.

              Clinical cluster analysis from the Severe Asthma Research Program (SARP) identified 5 asthma subphenotypes that represent the severity spectrum of early-onset allergic asthma, late-onset severe asthma, and severe asthma with chronic obstructive pulmonary disease characteristics. Analysis of induced sputum from a subset of SARP subjects showed 4 sputum inflammatory cellular patterns. Subjects with concurrent increases in eosinophil (≥2%) and neutrophil (≥40%) percentages had characteristics of very severe asthma.
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                Author and article information

                Contributors
                dprice@opri.sg
                Journal
                BMC Med Res Methodol
                BMC Med Res Methodol
                BMC Medical Research Methodology
                BioMed Central (London )
                1471-2288
                14 August 2020
                14 August 2020
                2020
                : 20
                : 212
                Affiliations
                [1 ]The Institute for Heart Lung Health, Vancouver, Canada
                [2 ]GRID grid.418152.b, AstraZeneca, ; Gaithersburg, USA
                [3 ]GRID grid.412269.a, ISNI 0000 0001 0585 7044, Department of Pulmonary Medicine, , University of Tartu and Lung Clinic, Tartu University Hospital, ; Tartu, Estonia
                [4 ]GRID grid.5254.6, ISNI 0000 0001 0674 042X, Center of Physical Activity Research, , Rigshospitalet and Copenhagen University, ; Copenhagen, Denmark
                [5 ]GRID grid.411843.b, ISNI 0000 0004 0623 9987, Department of Respiratory Medicine & Allergology, , Skåne University Hospital, ; Lund, Sweden
                [6 ]GRID grid.14013.37, ISNI 0000 0004 0640 0021, Faculty of Medicine, , University of Iceland, ; Reykjavik, Iceland
                [7 ]Department of Respiratory Diseases, Montpellier University Hospitals, Hopital Arnaud de Villeneuve and PhyMed Exp (INSERM U 1046, CNRS UMR9214), Universite de Montpellier, Montpellier, France
                [8 ]GRID grid.410566.0, ISNI 0000 0004 0626 3303, Department of Respiratory Medicine, , Ghent University Hospital, ; Ghent, Belgium
                [9 ]GRID grid.5645.2, ISNI 000000040459992X, Departments of Epidemiology and Respiratory Medicine, , Erasmus Medical Center Rotterdam, ; Rotterdam, The Netherlands
                [10 ]Optimum Patient Care, Cambridge, UK
                [11 ]GRID grid.4777.3, ISNI 0000 0004 0374 7521, Centre for Public Health, , Queen’s University Belfast, ; Belfast, UK
                [12 ]Personalized Medicine Asthma & Allergy Clinic, Humanitas University & Research Hospital, Milan, Italy
                [13 ]SANI-Severe Asthma Network Italy, Milan, Italy
                [14 ]GRID grid.413967.e, ISNI 0000 0001 0842 2126, Division of Allergy, Department of Medicine, , Asan Medical Center, College of Medicine, University of Ulsan, ; Seoul, South Korea
                [15 ]GRID grid.410563.5, ISNI 0000 0004 0621 0092, Faculty of Public Health, , Medical University – Sofia, ; Sofia, Bulgaria
                [16 ]GRID grid.411164.7, ISNI 0000 0004 1796 5984, Son Espases University Hospital-IdISBa-Ciberes, ; Mallorca, Spain
                [17 ]GRID grid.4912.e, ISNI 0000 0004 0488 7120, Clinical Research Centre, , Smurfit Building Beaumont Hospital and Department of Respiratory Medicine, RCSI, ; Dublin, Ireland
                [18 ]GRID grid.266842.c, ISNI 0000 0000 8831 109X, Australasian Severe Asthma Network, Priority Research Centre for Healthy Lungs, , University of Newcastle, ; Newcastle, Australia
                [19 ]GRID grid.414724.0, ISNI 0000 0004 0577 6676, Department of Respiratory and Sleep Medicine, , Hunter Medical Research Institute, John Hunter Hospital, ; New Lambton Heights, Australia
                [20 ]GRID grid.4777.3, ISNI 0000 0004 0374 7521, Centre for Experimental Medicine, , Queen’s University Belfast, ; Belfast, UK
                [21 ]GRID grid.267362.4, ISNI 0000 0004 0432 5259, Alfred Health & Monash University, ; Melbourne, Australia
                [22 ]GRID grid.413111.7, ISNI 0000 0004 0466 7515, Department of Respiratory Medicine & Allergology, Faculty of Medicine, , Kindai University Hospital, ; Ōsakasayama, Japan
                [23 ]GRID grid.420545.2, Guy’s & St Thomas’ NHS Trust and King’s College London, ; London, UK
                [24 ]GRID grid.11201.33, ISNI 0000 0001 2219 0747, Faculty of Medicine & Dentistry, , University of Plymouth, ; Plymouth, UK
                [25 ]GRID grid.163555.1, ISNI 0000 0000 9486 5048, Department of Respiratory & Critical Care Medicine, , Singapore General Hospital and Duke-National University Singapore Medical School, ; Singapore, Singapore
                [26 ]GRID grid.412330.7, ISNI 0000 0004 0628 2985, Allergy Centre, , Tampere University Hospital and Tampere University, ; Tampere, Finland
                [27 ]GRID grid.410540.4, ISNI 0000 0000 9894 0842, Department of Respiratory Medicine, Faculty of Medicine, , Landspitali University Hospital and University of Iceland, ; Reykjavik, Iceland
                [28 ]GRID grid.7177.6, ISNI 0000000084992262, University of Amsterdam, ; Amsterdam, The Netherlands
                [29 ]GRID grid.421662.5, ISNI 0000 0000 9216 5443, Royal Brompton & Harefield NHS Foundation Trust, ; London, UK
                [30 ]GRID grid.5216.0, ISNI 0000 0001 2155 0800, University of Athens, ; Athens, Greece
                [31 ]GRID grid.5379.8, ISNI 0000000121662407, University of Manchester, ; Manchester, UK
                [32 ]GRID grid.414792.d, ISNI 0000 0004 0579 2350, Pneumology Service, , Hospital Universitario Lucus Augusti, ; Lugo, Spain
                [33 ]GRID grid.1013.3, ISNI 0000 0004 1936 834X, University of Sydney Medical School, ; Sydney, Australia
                [34 ]GRID grid.4868.2, ISNI 0000 0001 2171 1133, UK Severe Asthma Network, , Barts Health NHS Trust and Queen Mary University of London, ; London, UK
                [35 ]University Hospital “Sv. Ivan Rilski”, Sofia, Bulgaria
                [36 ]Bispebjerg Hospital, Copenhagen University, Copenhagen, Denmark
                [37 ]GRID grid.411947.e, ISNI 0000 0004 0470 4224, The Catholic University of Korea, ; Seoul, South Korea
                [38 ]GRID grid.17091.3e, ISNI 0000 0001 2288 9830, Faculty of Pharmaceutical Sciences, , University of British Columbia, ; Vancouver, Canada
                [39 ]GRID grid.413085.b, ISNI 0000 0000 9908 7089, 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, ; Denver and Aurora, CO USA
                [40 ]GRID grid.240341.0, ISNI 0000 0004 0396 0728, Division of Pulmonary, Critical Care and Sleep Medicine, Asthma Program, National Jewish Health, ; Denver, USA
                [41 ]GRID grid.500407.6, Observational and Pragmatic Research Institute, ; Singapore, Singapore
                [42 ]GRID grid.7107.1, ISNI 0000 0004 1936 7291, Academic Primary Care, Division of Applied Health Sciences, , University of Aberdeen, ; Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD UK
                Article
                1065
                10.1186/s12874-020-01065-0
                7439682
                32819285
                23ba5214-c47b-4c6a-81ff-7c2a7590752d
                © The Author(s) 2020

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 11 December 2019
                : 26 June 2020
                Funding
                Funded by: AstraZeneca
                Funded by: Optimum Patient Care
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2020

                Medicine
                disease registry,protocol,real-world,severe asthma
                Medicine
                disease registry, protocol, real-world, severe asthma

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