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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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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
Vis graf over relationer

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.

OriginalsprogEngelsk
TidsskriftBMC Medical Research Methodology
Vol/bind20
Udgave nummer1
Sider (fra-til)212
ISSN1471-2288
DOI
StatusUdgivet - 14 aug. 2020

ID: 60804841