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. 2018 Nov 13;40(1):155–165. doi: 10.1007/s10072-018-3610-0

Table 1.

Simplified description of the information collected by the Italian MS Register with indications of the mandatory variables included in the MDS (in bold) and the optional variables (in italic). A detailed description of the MDS variables is reported in Appendix 1

Section Sub-Section Description
Baseline Clinical center Identification
Patient Identification and encryption of personal data
State of Life
Record creation date
Onset MS Date, symptoms, course (including RIS)
Diagnosis Date, Mc Donald Criteria 2010 and 2017 [8, 9]
Follow-up (FU) Visits Date, EDSS, course
Relapses Date, duration, functional systems involved, severity, recovery, steroid treatment
Treatments Start date, end date, dosage, administration routes, disease modifying or symptomatic therapies, discontinuation cause (if applicable)
Adverse events Reporting severe adverse events and adverse events (using MedDRA coding system)
Paraclinical tests Magnetic Resonance Imaging Date, CNS region, presence and number of T2, T1 and, T1 Gd + lesions, McDonald’s Criteria (2017) for space and time dissemination
Cerebrospinal fluid Date, routine, oligoclonal bands (presence/absence)
Evoked potentials Date, visual evoked potentials(VEP), upper and lower somatosensory and motor evoked potentials (SEP and MEP), brainstem auditory evoked potentials (BAEP)
Laboratory tests Date, routine, hematologic, virological, immunological, thyroid function
Clinical events History Family history, pregnancies, comorbidities