The Italian multiple sclerosis register

Abstract

The past decade has seen extraordinary increase in worldwide availability of and access to several large multiple sclerosis (MS) databases and registries. MS registries represent powerful tools to provide meaningful information on the burden, natural history, and long-term safety and effectiveness of treatments. Moreover, patients, physicians, industry, and policy makers have an active interest in real-world observational studies based on register data, as they have the potential to answer the questions that are most relevant to daily treatment decision-making. In 2014, the Italian MS Foundation, in collaboration with the Italian MS clinical centers, promoted and funded the creation of the Italian MS Register, a project in continuity with the existing Italian MS Database Network set up from 2001. Main objective of the Italian MS Register is to create an organized multicenter structure to collect data of all MS patients for better defining the disease epidemiology, improving quality of care, and promoting research projects in high-priority areas. The aim of this article is to present the current framework and network of the Italian MS register, including the methodology used to improve the quality of data collection and to facilitate the exchange of data and the collaboration among national and international groups.Electronic supplementary materialThe online version of this article (10.1007/s10072-018-3610-0) contains supplementary material, which is available to authorized users.

Multiple Sclerosis in the Campania Region (South Italy): Algorithm Validation and 2015–2017 Prevalence

“…We extracted individuals with a diagnosis of MS and resident in the Campania Region from the clinical registry of the MS Clinical Care and Research Centre, at the "Federico II" University of Naples, Italy, from 2015 to 2017 (n = 1460). This cohort is part of the Italian MS Registry [7] and has already been used for a number of cohort studies [22,23]. Of note, a recent meta-analysis defined this cohort at moderate risk of bias, compared with the serious risk of other similar cohorts [24,25].…”

“…In the past decades, fifteen disease-modifying therapies (DMTs) for MS have been developed within randomised controlled trials (RCTs), directly comparing different DMTs (or placebo) in a short time frame (24-36 months), and for specific clinical outcome measures (e.g., relapses, disability) [3,4]. In the meanwhile, worldwide MS centres have developed MS registries to provide meaningful information on the natural history of MS, and on the long-term safety and effectiveness of DMTs in the real-life [5][6][7]. However, RCTs and MS registries do not include overall healthcare resource utilisation [6,[8][9][10], and, not least, hold potential risks from patient selection (e.g., with earlier and more educated patients being more likely to visit MS centres and participate into research), and follow-up (e.g., with patients doing poorly being more likely to be lost to follow-up) [11,12].…”

Disease-Modifying Drugs and Family Planning in People with Multiple Sclerosis: A Consensus Narrative Review from the Gulf Region

“…Glatiramer acetate This treatment has no teratogenic effects, according to data from national registries. In the Italian Multiple Sclerosis Register, analysis of data from 427 pregnancies in mothers with MS from 21 centres found no additional risk of spontaneous abortion or other adverse maternal or foetal outcomes [ 28 , 29 ]. A total of 151 women with MS in Germany had been taking glatiramer acetate before the pregnancy, of whom 148 discontinued treatment in the first trimester and 3 discontinued treatment in the second trimester; 95 pregnancies unexposed to DMDs served as a control group [ 30 ].…”

Pregnancy and the Postpartum Period in Women With Relapsing-Remitting Multiple Sclerosis Treated With Old and New Disease-Modifying Treatments: A Real-World Multicenter Experience

“…In this cross-sectional multicenter study, women with RRMS were identified from three large tertiary MS centers in Italy. The data entry used iMed © software (iMed, Merck Serono SA; Geneva), and a rigorous quality assurance procedure was ensured regularly and locally by the treatment clinics using patient health records while coordinating with the iMed © software data coordinators (22).…”