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

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  4. The "RCT augmentation": a novel simulation method to add patient heterogeneity into phase III trials

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  3. Agreement Between Transcutaneous Monitoring and Arterial Blood Gases During COPD Exacerbation

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  4. Unique Aspects of Asthma in Women

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  • 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
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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 and 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 languageEnglish
Article number212
JournalBMC Medical Research Methodology
Volume20
Issue number1
Pages (from-to)212
ISSN1471-2288
DOIs
Publication statusPublished - 14 Aug 2020

    Research areas

  • Disease registry, Protocol, Real-world, Severe asthma

ID: 60804841