Definition and validation of algorithms for the identification of specific clinical markers of multiple sclerosis using SNDS data (DIONISOS)

Study identification

• EU PAS number:
  EUPAS104596
• Study ID:
  104597
• Official title and acronym:
  Definition and validation of algorithms for the identification of specific clinical markers of multiple sclerosis using SNDS data (DIONISOS)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Multiple sclerosis (MS) is an incapacitating, progressive, chronic neurological disorder that involves a selective, chronic inflammation and demyelination of the central nervous system. The severity of the disease varies from mildly forms to severe disabilities within a few years. Relapsing-remitting MS forms (RRMS) are the most common, and are characterized by the presence of relapses without disability progression between relapses. A complex algorithm for identifying MS relapses has been developed using SNDS data SNDS, and has been validated within the database using the sequence of patient care consumption in the SNDS. This is an original method that would benefit from external validation using clinical data. In this context, a validation study comparing clinical data of MS patients registered in the OFSEP database between 2010 and 2019 linked to the SNDS via probabilistic matching will be performed. The main objective is to evaluate and improve the diagnostic performance of an MS relapse identification algorithm developed from SNDS data using OFSEP clinical data linked to SNDS data as an external data source. Secondary objectives are to: - Develop and validate an SNDS algorithm to identify the level of MS-related motor disability and its evolution, - Develop and validate an SNDS algorithm to identify the level of disability specific to sphincter impairment and its evolution.
• Study status:
  Planned

Research institutions and networks

Institutions

University of Bordeaux

France

Study timelines

Date when funding contract was signed

Actual:23/03/2023

Study start date

Planned:15/09/2023

Date of final study report

Planned:31/12/2023

Sources of funding

Other

More details on funding

Health Data Hub

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable