Chances and challenges of a long-term data repository in multiple sclerosis: 20th birthday of the German MS registry

Abstract

In 2001, the German Multiple Sclerosis Society, facing lack of data, founded the German MS Registry (GMSR) as a long-term data repository for MS healthcare research. By the establishment of a network of participating neurological centres of different healthcare sectors across Germany, GMSR provides observational real-world data on long-term disease progression, sociodemographic factors, treatment and the healthcare status of people with MS. This paper aims to illustrate the framework of the GMSR. Structure, design and data quality processes as well as collaborations of the GMSR are presented. The registry’s dataset, status and results are discussed. As of 08 January 2021, 187 centres from different healthcare sectors participate in the GMSR. Following its infrastructure and dataset specification upgrades in 2014, more than 196,000 visits have been recorded relating to more than 33,000 persons with MS (PwMS). The GMSR enables monitoring of PwMS in Germany, supports scientific research projects, and collaborates with national and international MS data repositories and initiatives. With its recent pharmacovigilance extension, it aligns with EMA recommendations and helps to ensure early detection of therapy-related safety signals.

Therapy Switches in Fingolimod-Treated Patients with Multiple Sclerosis: Long-Term Experience from the German MS Registry

“…Furthermore, only limited data were available on drug safety related to treatment switches, such as infection rates or lymphocyte numbers. Data on pharmacovigilance comprising adverse events, pregnancy, body mass, and medical history as well as data on the reasons for switching are only reported by the GMSR since 2019 [ 13 ]. Consequently, data on those reasons were limited during the observation period.…”

“…The aim was to collect comprehensive and comparable clinical, sociodemographic, and therapeutic data on PwMS in Germany and to support MS research [ 13 ]. In 2014, the GMSR underwent technical revisions to include more comprehensive data on DMDs, including treatment duration, DMD type, and reasons for DMD discontinuation/switch [ 13 ]. The structure, data basis, and methods of data collection and management of the GMSR are described comprehensively in a paper by Ohle et al [ 13 ].…”

“…In 2014, the GMSR underwent technical revisions to include more comprehensive data on DMDs, including treatment duration, DMD type, and reasons for DMD discontinuation/switch [ 13 ]. The structure, data basis, and methods of data collection and management of the GMSR are described comprehensively in a paper by Ohle et al [ 13 ]. Since 2014 and up to 17 October 2021, data on 35,932 PwMS have been entered into the database.…”

Characteristics of secondary progressive multiple sclerosis: Disease activity and provision of care in Germany – A registry-based/multicentric cohort study

“…The GMSR was initiated in 2001 under the auspices of the German MS Society (DMSG), Bundesverband e.V., to collect nationwide data from patients with MS. A detailed description of the methodology is provided elsewhere (Ohle et al, 2021) (www.msregister.de/en). In brief, the GMSR is aimed at collecting both epidemiological data and data related to disease course, healthcare, and the social situation of MS patients.…”

How is and how should healthcare for people with multiple sclerosis in Germany be designed?–The rationale and protocol for the mixed-methods study Multiple Sclerosis–Patient-Oriented Care in Lower Saxony (MS-PoV)

“…This data source comprises clinical information regarding the medical history, socio-demographics and initial symptoms, in addition to the follow-up data and information on symptoms, therapy, care, medication and relapses. The German MS Registry is described in more detail by Ohle et al [ 57 ].…”