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Influence of Socio-Economic Factor on Net Survival in Patients With Multiple Sclerosis in France ( ECOVIMUS).

C

Caen University Hospital

Status

Unknown

Conditions

C10.114.375.500

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

Background: In comparison to general population, persons with Multiple Sclerosis have a higher risk to premature death with an estimate reduced life expectancy from 7 to 14 years. However, risk factors of mortality in MS are not well identified and well known. Following the example of studies carry on cancers survival, socioeconomic status (SES) may have an influence on survival in MS.

Objective: The main objective of ECOVIMUS is to estimate net survival according to SES using the European Deprivation Index as a proxy and other major covariates (gender, initial clinical phase and years of disease onset).

Methods: In order to answer to our main objective, we will use a retrospective cohort of MS patients with a medical follow-up in one of the 18 centers included in SURVIMUS II, with a MS onset between 1960 and 2015 and with an informed vital at the date of December 31st, 2015.

The ecological score of deprivation EDI will be used as a proxy of the socioeconomic status and will be attributed from the geolocalisation to patient's residence address. Net survival is directly associated to the notion of "mortality in excess". This mortality will be estimated comparing the observed mortality in MS patients to mortality in the general population. The advantage of this methodological approach is that cause of death is not needed.

Statistical analysis: The influence of socioeconomic status on the excess of mortality will be estimated thanks to a parametric multivariate model of excess rate mortality. This model will be adjusted on other major covariates (gender, age at disease onset, and initial clinical phase) and will include potential complex effects as non-linearity, non-proportionality and interactions.

Expected results: We expect to highlight some differences of net survival in MS patients according to socioeconomic group as it was already shown in cancers. This study will complete information on factors of mortality excess in MS and knowledge on socioeconomic inequalities encountered all along MS disease course.

Enrollment

30,000 estimated patients

Sex

All

Ages

1 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • all patients registered in 17 selected French OFSEP centres with core dataset with a sufficient level of data
  • Diagnosis a of definite or probably MS according to Poser or McDonald criteria. With an MS onset date between January 1st, 1960 and December 31st, 2015.
  • With a postal residence address well informed in the OFSEP database.

Exclusion criteria

  • MS patients with less than one year's disease duration by the study end will be excluded.

Trial contacts and locations

18

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Central trial contact

Gilles-Louis DEFER, Professor; Floriane CALOCER, PharmD/PhD Student

Data sourced from clinicaltrials.gov

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