The Institute for Heart Lung Health, Vancouver, Canada.
AstraZeneca, Gaithersburg, USA.
BMC Med Res Methodol. 2020 Aug 14;20(1):212. doi: 10.1186/s12874-020-01065-0.
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.
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.
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.
重度哮喘给患者和医疗保健带来了不成比例的沉重负担。由于重度哮喘人群存在异质性，许多患者需要进行评估，以了解重度哮喘的临床特征和结局，从而为患者提供个性化和有针对性的治疗。国际重度哮喘注册研究（ISAR）是一个多国家注册研究项目，旨在为此提供帮助。
ISAR 是一个多学科的倡议，得益于 ISAR 指导委员会（ISC）的共同经验（ISC 由 29 个国家的 47 名临床医生和研究人员组成，他们对重度哮喘管理或建立和维护重度哮喘登记处具有特殊兴趣和/或经验），并与数据库管理和沟通方面的科学家和专家合作。将纳入符合 2018 年全球哮喘倡议（GINA）第 5 步定义的治疗方案或第 4 步治疗方案控制不佳的患者（年龄≥18 岁）。将使用 Delphi 方法确定的 95 个核心变量集来收集数据。参与的登记处将同意提供和共享标准化的匿名患者级数据。ISAR 是欧洲药物流行病学和药物警戒网络的注册数据源。ISAR 的合作者包括 Optimum Patient Care、Respiratory Effectiveness Group（REG）和阿斯利康。ISAR 由 ISC、REG、匿名数据伦理和协议透明度委员会以及 ISAR 运营委员会监督，确保进行符合伦理和临床相关的研究，为所有利益相关者带来价值。
ISAR 旨在提供一个真实世界数据的丰富来源，用于科学研究，以了解和改善重度哮喘的疾病负担、治疗模式和患者结局。此外，该登记处将为呼吸医学的研究合作提供一个国际平台，目标是改善全球成年人重度哮喘的初级和二级护理。
