The Swiss Multiple Sclerosis Registry (SMSR): study protocol of a participatory, nationwide registry to promote epidemiological and patient-centered MS research

• Published in: BMC neurology 2018-08, Vol.18 (1), p.111-10, Article 111
• Main Authors: Steinemann, Nina, Kuhle, Jens, Calabrese, Pasquale, Kesselring, Jürg, Disanto, Giulio, Merkler, Doron, Pot, Caroline, Ajdacic-Gross, Vladeta, Rodgers, Stephanie, Puhan, Milo Alan, von Wyl, Viktor
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Analysis; Biomedical Research - methods; Care and treatment; Chronic illnesses; Clinical Protocols; Complications and side effects; Computer simulation; Data collection; Disability; Epidemiology; Health-related quality of life; Humans; Medical research; Multiple sclerosis; Multiple Sclerosis - epidemiology; Multiple Sclerosis - therapy; Patient Participation; Patient-Centered Care; Patient-reported outcomes; Patients; Population studies; Prevalence studies (Epidemiology); Prospective Studies; Public health; Quality of life; Registries; Research Design; Study Protocol; Surveys and Questionnaires; Switzerland; Switzerland - epidemiology; Trends; Young Adult
• ISSN: 1471-2377; 1471-2377
• DOI: 10.1186/s12883-018-1118-0

Multiple sclerosis (MS) is one of the most frequently observed neurological conditions in Switzerland, but data sources for country-wide epidemiological trend monitoring are lacking. Moreover, while clinical and laboratory MS research are generally well established, there is a gap in patient-centered MS research to inform care management, or treatment decisions and policy making not only in Switzerland but worldwide. In light of these research gaps, the Swiss Multiple Sclerosis Society initiated and funded the Swiss Multiple Sclerosis Registry (SMSR) an open-ended, longitudinal and prospective, nationwide, patient-centered study. The SMSR recruits adult persons with a suspected or confirmed MS diagnosis who reside or receive care in Switzerland. The SMSR has established a governance structure with clear rules and guidelines. It follows a citizen-science approach with direct involvement of persons with MS (PwMS), who contribute actively to registry development, operations, and research. Main scientific goals entail the study of MS epidemiology in Switzerland, health care access and provision, as well as life circumstances and wellbeing of persons with MS. The innovative study design ("layer model") offers several participation options with different time commitments. Data collection is by means of regular surveys and medical record abstraction. Survey participation is offered in different modes (web, paper & pencil) and in the three main national languages (German, French, Italian). Participants also receive regular data feedbacks for personal use and self-monitoring, contextualized in the whole population of study participants. Data feedbacks are also used to solicit data corrections of key variables from participants. The SMSR combines the advantages of traditional and novel research methods in medical research and has recruited over 1600 PwMS in its first year. The future-oriented design and technology will enable a response not only to future technological innovations and research trends, but also to challenges in health care provision for MS. ClinicalTrials.gov   NCT02980640 ; December 6, 2016; retrospectively registered.