Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Jan;40(1):155-165.
doi: 10.1007/s10072-018-3610-0. Epub 2018 Nov 13.

The Italian multiple sclerosis register

Maria Trojano  1 , Roberto Bergamaschi  2 , Maria Pia Amato  3 , Giancarlo Comi  4 , Angelo Ghezzi  5 , Vito Lepore  6   7 , Maria Giovanna Marrosu  8 , Paola Mosconi  7 , Francesco Patti  9 , Michela Ponzio  10 , Paola Zaratin  10 , Mario Alberto Battaglia  11   12 ; Italian Multiple Sclerosis Register Centers Group
Collaborators, Affiliations

The Italian multiple sclerosis register

Maria Trojano et al. Neurol Sci. 2019 Jan.

Erratum in

  • Correction to: The Italian multiple sclerosis register.
    Trojano M, Bergamaschi R, Amato MP, Comi G, Ghezzi A, Lepore V, Marrosu MG, Mosconi P, Patti F, Ponzio M, Zaratin P, Battaglia MA; Italian Multiple Sclerosis Register Centers Group. Trojano M, et al. Neurol Sci. 2019 Apr;40(4):907. doi: 10.1007/s10072-019-03772-z. Neurol Sci. 2019. PMID: 30815752 Free PMC article.

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.

Keywords: Epidemiology; Multiple sclerosis; Quality of care; Register.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest

These authors declare the following: Amato MP has received research grants honoraria as a speaker and member of Advisory Boards from Biogen, Bayer, Novartis, Roche, Teva, Sanofi-Genzyme, Merck. Ghezzi A received honoraria for speaking and consultancy by Novartis, Genzyme, Roche, Merck Serono, Teva, Mylan. Bergamaschi R received honoraria for speaking from Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi-Aventis, Teva; research grants from Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi-Aventis, Teva; congress and travel/accommodation expenses funded by Almirall, Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Roche, Sanofi-Aventis, Teva. Comi G received personal compensation for consulting services and/or speaking activities from Novartis, Teva, Sanofi-Genzyme, Merck, Biogen, Roche, Almirall, Celgene, Forward Pharma, Medday, Excemed. Patti F received personal compensation for consulting services and/or speaking activities by Adienne, Bayer, Biogen, Celgene, Merck, Novartis, Roche, Sanofi, Teva. Trojano MT has served on scientific Advisory Boards for Biogen, Novartis, Roche and Sanofi-Genzyme; has received speaker honoraria from Biogen, Sanofi-Genzyme, Merck Serono,Teva and Novartis; and has received research grants for her Institution from Biogen, Merck Serono and Novartis. Mario Alberto Battaglia, Maria Giovanna Marrosu, Paola Mosconi, Michela Ponzio, Vito Lepore, and Paola Zaratin declared no conflict.

Figures

Fig. 1
Fig. 1
Distribution of the 140 centers participants (black circle) to Italian MS Register and of 72 centers (white circle) with actual data transfer to the central database
Fig. 2
Fig. 2
Cumulative recruitment of patients per year of entry into the cohort in relation to follow-up (FU) duration (in years) (Appendix 2 data in detail)
Fig. 3
Fig. 3
Quality of data collected. Legend (see also Table 2 for more details). Score_UPDATE means adherence to periodic central database update; Score_N._Pts_year means sample size by center; Score:_Pts_with FUP ≥ 5 years means sample size by center with prospective clinical follow-up ≥5 years; Score:_active Pts means patients in active status, i.e., at least one visit and/or contact with the center in the last 2 years; Score:_VISIT every 6 months means semi-annual visit rates; Score:_EDSS every 6 months means semi-annual EDSS assessment rates; Score:_I°visit_within_I° yr from onset means first visit within 2 year of the disease onset.
See this image and copyright information in PMC

References

    1. Gliklich RE, Leavy MB. Registries for evaluating patient outcomes: a User's Guide. 3. Rockville: Agency for Healthcare Research and Quality (US); 2014. - PubMed
    1. Trojano M, Tintore M, Montalban X, Hillert J, Kalincik T, Iaffaldano P, Spelman T, Sormani MP, Butzkueven H. Treatment decisions in multiple sclerosis—insights from real-world observational studies. Nat Rev Neurol. 2017;13:105–118. doi: 10.1038/nrneurol.2016.188. - DOI - PubMed
    1. De Groot S, van der Linden N, Franken MG, et al. Balancing the optimal and the feasible: a practical guide for setting up patient registries for the collection of real-world data for health care decision making based on Dutch experiences. Value Health. 2017;20:627–636. doi: 10.1016/j.jval.2016.02.007. - DOI - PubMed
    1. Flachenecker P, Buckow K, Pugliatti M, Kes VB, Battaglia MA, Boyko A, Confavreux C, Ellenberger D, Eskic D, Ford D, Friede T, Fuge J, Glaser A, Hillert J, Holloway E, Ioannidou E, Kappos L, Kasilingam E, Koch-Henriksen N, Kuhle J, Lepore V, Middleton R, Myhr KM, Orologas A, Otero S, Pitschnau-Michel D, Rienhoff O, Sastre-Garriga J, Schyns-Liharska T, Sutovic D, Thalheim C, Trojano M, Vlasov YV, Yaldizli Ö, for the EUReMS Consortium* Consortium EU. Multiple sclerosis registries in Europe—results of a systematic survey. Mult Scler. 2014;20(11):1523–1532. doi: 10.1177/1352458514528760. - DOI - PubMed
    1. Trojano M, Granieri E, Rosati G et al (2003) In: abstracts from the 19th congress of the European Committee for Treatment and Research in Multiple Sclerosis, Milan, Italy - PubMed