The Italian Multiple Sclerosis and Related Disorders Register (RISM)

In 2000, the Italian collection of MS clinical data started at different Italian MS centres in the framework of the Italian Multiple Sclerosis Database Network (MSDN). At the end of 2014, the Italian Multiple Sclerosis and Related Disorders Register (RISM) was set up to create a national data source collecting demographic and clinical data on people with multiple sclerosis. Currently, data are collected through a web-based system - the RISM-App - developed ad hoc for the study. Each centre can enter the data after identification through a personalised password. In RISM, each patient is assigned to a specific centre and has a unique valid code identifier, obtained through the patient encrypted fiscal code.

The RISM-App includes 1,475 variables and is organised into sections and subsections. According to the current clinical practice, the following information is requested in the RISM-App: identification/personal data, onset and diagnosis (anamnesis), follow-up visits (EDSS, safety, and relapses), adverse events (clinical events), treatments, non-pharmacological treatments, risk assessment, pregnancies, COVID-19, co-morbidity, familiar anamnesis, tests and scales, laboratory exams, magnetic resonance, liquor, evoked potentials, EEG, ECG, blood pressure, eye examination, optical computerised tomography.

To harmonise data collection, the RISM-App integrates several standardised databases, including FarmaDati, MedDRA, ICD-9-CM, and EUROCAT (for congenital anomalies). Continuous data monitoring is ensured through regular communication with centres, biannual ad hoc reports providing both overall and centre-specific quality and descriptive indicators, data verification requests, and training on standardised data collection procedures. In addition, a set of built-in validation checks - such as consistency between date of birth, diagnosis, first visit, and treatment - is implemented in the RISM-App to prevent conflicting entries.