The Austrian MS Database and the Austrian MS Cohort: a national effort towards data harmonization and prospective data collection

BackgroundA variety of disease-modifying therapies (DMTs) are now available for multiple sclerosis (MS), each with distinct efficacy and risk profiles. However, the clinical course of MS varies significantly both within and between individuals, and the optimal treatment strategy remains uncertain at the group and individual levels. Addressing questions about treatment strategies through traditional randomized controlled trials is unrealistic due to the large sample sizes and high costs required. Instead, large-scale multicenter registries and well-characterized prospective observational cohorts offer a feasible approach to generating meaningful insights. For valid results, such registries and cohorts require harmonization across centers to support comprehensive, standardized, user-friendly data collection while meeting data protection standards and ensuring quality control. ObjectiveThis project aims to establish standardized, nationwide MS data collection in Austria. MethodsThe project consists of five key components: i) harmonization of data collection, ii) creation of infrastructure for data sharing, iii) retrospective harmonized data collection (Austrian MS Database, AMSD), iv) prospective harmonized data collection (Austrian MS Cohort, AMSC), and v) aggregated analyses. ResultsA comprehensive set of harmonized common data elements (CDE) comprising clinical and paraclinical data was developed and a common data collection infrastructure was generated using the web-based Research, Documentation, and Analysis platform (webRDA), an innovative data capture, processing, and analysis system provided by the Medical University of Vienna offering pseudonymized storage of data supported by a robust permissions system sufficing legal data protection and ethical requirements. The AMSC is set up as a standardized prospective collection of demographic, clinical, epidemiological, psycho-socio-economic, MRI, and OCT data as well as body fluids. ConclusionThe AMSD and AMSC will facilitate the evidence-based development of prognostic biomarkers, individualized therapy strategies and treatment sequences based on a high-quality, population-based dataset of more than 8,000 people with MS.