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

作者：J. Mark FitzGerald, Trung N. Tran, Marianna Alacqua, Alan Altraja, Vibeke Backer, Leif Bjermer, Unnur Steina Björnsdóttir, Arnaud Bourdin, Guy Brusselle, Lakmini Bulathsinhala, John Busby, Giorgio Walter Canonica, Victoria Carter, Isha Chaudhry, You Sook Cho, George Christoff, Borja G. Cosío, 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 Siyue Koh, Thao Le, Lauri Lehtimäki, Dóra Lúðvíksdóttir, Anke H. Maitland‐van der Zee, Andrew Menzies‐Gow, Ruth Murray, Nikolaos G. Papadopoulos, Luis Pérez de Llano, Matthew Peters, Paul Pfeffer, Todor A. Popov, Celeste Porsbjerg, Chris Price, Chin Kook Rhee, Mohsen Sadatsafavi, Yuji Tohda, Eileen Wang, Michael E. Wechsler, James Zangrilli, David B. Price · 发表于：BMC Medical Research Methodology · 年份：2020 · DOI：10.1186/s12874-020-01065-0 · 被引用次数：56 · 研究领域：Asthma and respiratory diseases、Delphi Technique in Research、Medication Adherence and Compliance

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, t...