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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Algorithms validation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  4500

Study design details

• Main study objective:
  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.
• Data analysis plan:
  The statistical analysis will be performed using the SAS software (latest current version), following a detailed statistical analysis plan. The following analyses will be performed: - a description of patient selection, - a description of initial patient characteristics, - for each algorithm (relapses, motor disability, disability specific to sphincter impairment): an estimate of the algorithm's sensitivity and diagnostic performance