Frequently Asked Questions
The International Severe Asthma Registry (ISAR) is the first global severe asthma registry; a joint initiative where national registries (both newly created and pre-existing) retain ownership of their own data but open their borders and share data with ISAR for ethically approved research purposes.
The ISAR initiative is conducted by Optimum Patient Care Global Limited (OPC), with scientific oversight from the ISAR Core Steering Committee (ISC), academic support from the Respiratory Effectiveness Group (REG), ethical governance from the Anonymized Data Ethics & Protocol Committee (ADEPT), co-funding from OPC and AstraZeneca since May 2017.
The biggest strength of ISAR comes from the collection of patient level, anonymous, longitudinal, real-life and standardized, high-quality data (using a core set of variables) from countries all over the world, combined with organizational structure, database experience, inclusivity/openness and expertise. This gives ISAR sufficient statistical power to answer important research questions, sufficient data standardization to compare across countries and regions and the structure and expertise necessary to ensure its continuance, as well as the scientific integrity and clinical applicability of its research. ISAR offers a unique opportunity to implement existing knowledge, generate new knowledge and identify the unknown, so prompting new research.
The ISAR doors are open to new collaborators and partners using the ‘join the registry’ and ‘register your interest’ options on the ISAR home page. Support is available to set up local registries via the provision of standardized variable list and/or a real-life, electronic data capturing system.
Research ideas may be suggested clicking the ‘submit a proposal or research request’ option on the ISAR homepage. All research proposals are reviewed for scientific merit by the ISC and ethical compliance by the ADEPT Committee.
ISAR captures the following information: Demographics, Medical History, Comorbidities, Diagnostics, Hospital Resource Utilization, Biomarkers (Blood and Sputum Eosinophils, IgE, FeNO), Asthma Medication, Allergy Tests, Asthma Control (GINA Assessment for asthma control), Adherence and Clinical Management Plan.
ISAR also collects safety related data across three main events: Cancer, Serious Infections and Anaphylaxis and medication effectiveness data across ten OCS related comorbidities (Osteoporosis, Diabetes, Renal Failure, Anxiety, Depression, Peptic Ulcer, Cataract, Glaucoma, Pneumonia, Cardiovascular Diseases, Obstructive Sleep Apnoea) as well as OCS/ICS doses and reasons for switching from/to/between biologics.
Data are collected by a combination of existing registries and new registries where primary data collection is supported via electronic Case Report Forms (eCRFs). New registries use the electronic data capture system (OpenClinica or REDCaP) specifically designed to collect real-life data.
ISAR international data is hosted at Optimum Patient Care, United Kingdom. Patient-level data is completely anonymized and indexed at the country-level.
OPC or AstraZeneca do not own any data held in the international repository. The country or its contracting body (e.g. severe asthma clinic) owns the data. ISAR’s foundational principle is to only share fully anonymized data for research approved by the ISC and ADEPT.
ISAR adheres to the International Committee of Medical Journal Editors (ICMJE) criteria for authorship. All authors are required to disclose any potential conflicts of interest.