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

Nina Steinemann, Jens Kuhle, Pasquale Calabrese, Jürg Kesselring, Giulio Disanto, Doron Merkler, Caroline Pot, Vladeta Ajdacic-Gross, Stephanie Rodgers, Milo Alan Puhan, Viktor von Wyl, Swiss Multiple Sclerosis Registry, Bernd Anderseck, Pasquale Calabrese, Andrew Chan, Giulio Disanto, Britta Engelhardt, Claudio Gobbi, Roger Häussler, Christian P Kamm, Susanne Kägi, Jürg Kesselring, Jens Kuhle, Roland Kurmann, Christoph Lotter, Kurt Luyckx, Doron Merkler, Patricia Monin, Stephanie Müller, Krassen Nedeltchev, Caroline Pot, Milo A Puhan, Irene Rapold, Anke Salmen, Sven Schippling, Claude Vaney, Viktor von Wyl, Nina Steinemann, Jens Kuhle, Pasquale Calabrese, Jürg Kesselring, Giulio Disanto, Doron Merkler, Caroline Pot, Vladeta Ajdacic-Gross, Stephanie Rodgers, Milo Alan Puhan, Viktor von Wyl, Swiss Multiple Sclerosis Registry, Bernd Anderseck, Pasquale Calabrese, Andrew Chan, Giulio Disanto, Britta Engelhardt, Claudio Gobbi, Roger Häussler, Christian P Kamm, Susanne Kägi, Jürg Kesselring, Jens Kuhle, Roland Kurmann, Christoph Lotter, Kurt Luyckx, Doron Merkler, Patricia Monin, Stephanie Müller, Krassen Nedeltchev, Caroline Pot, Milo A Puhan, Irene Rapold, Anke Salmen, Sven Schippling, Claude Vaney, Viktor von Wyl

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov NCT02980640 ; December 6, 2016; retrospectively registered.

Keywords: Epidemiology; Health-related quality of life; Multiple sclerosis; Patient-reported outcomes; Switzerland.

Conflict of interest statement

The Swiss Multiple Sclerosis Registry was approved by the Ethics Committee of the Canton of Zurich, Switzerland (Study number PB-2016-00894). Informed consent is obtained from all study participants.

The authors declare that they have no competing interests.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study design of the Swiss Multiple Sclerosis Registry (SMSR)
Fig. 2
Fig. 2
Holistic ascertainment of determinants of health outcomes in individuals affected by MS

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