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

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 multidisciplinary 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.

Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma

“…Because of the crossdisciplinary global nature of ISAR, its structured and uniform data collection, and its premise of inclusivity and the expertise of the individuals of the ISC, this collaboration provides an appropriate platform to address essential research questions in severe asthma. [11][12][13][14]…”

Eosinophilic and Noneosinophilic Asthma

“…A full description of how ISAR works has been published previously. 20 Details on compliance with local and international codes and regulations are provided in e-Appendix 1.…”

Serious fungal diseases in Democratic Republic of Congo – Incidence and prevalence estimates

“…Data about severe asthma deaths are scarce. 77,78 SAFS is uncertain as this disease has been recently described, it was conservatively estimated that 30% of patients with severe asthma have or develop SAFS in the world. In Africa the highest burden was described in Egypt (176,661) and the lowest is Kenya (23,359).…”