Clinical trial NCT04028232: Influence of Socio-Economic Factor on Net Survival in Patients With Multiple Sclerosis in France ( ECOVIMUS).
Official title: Influence of Socio-Economic Factor on Net Survival in Patients With Multiple Sclerosis in France ( ECOVIMUS).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: C10.114.375.500
Keywords: Multiple Sclerosis
Epidemiology
Socio-Economic Status
Net Survival
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Ecole des Hautes Etudes en Santé Publique
name: Hospices Civils de Lyon
First posted: 2019-07-22
Enrollment: 30000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include all patients registered in 17 selected French OFSEP centres with core dataset with a sufficient level of data (Besançon, Bordeaux, Caen, Clermont-Ferrand, Dijon, Lille, Lyon, Marseille, Nancy, Nice, Rennes, Saint-Etienne, Strasbourg, Toulouse, Montpellier, Nantes, Nîmes). The minimum required data includes: 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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Excess mortality survival
timeFrame: From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016.
Secondary outcomes:
measure: European Deprivation Index (EDI) proxy of Socio-Economic Status
timeFrame: From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016.
measure: Distance to MS expert care center
timeFrame: From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016.
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital Center of CAEN
state: Normandy
city: Besançon
country: France
facility: University Hospital of Besancon
city: Bordeaux
country: France
facility: University Hospital of Bordeaux
city: Caen
country: France
facility: University Hospital Centre of Caen
city: Clermont-Ferrand
country: France
facility: University Hospital of Clermont Ferrand
city: Dijon
country: France
facility: University Hospital of Dijon
city: Lille
country: France
facility: University Hospital of Lille
city: Lyon
country: France
facility: University Hospital of Lyon
city: Marseille
country: France
facility: University Hospital of Marseille
city: Montpellier
country: France
facility: University Hospital of Montpellier
city: Nancy
country: France
facility: University Hospital of Nancy
city: Nantes
country: France
facility: University Hospital of Nantes
city: Nice
country: France
facility: University Hospital of Nice
city: Nîmes
country: France
facility: University hospital Centre of Nîmes
city: Rennes
country: France
facility: University Hospital of Rennes
city: Saint-Étienne
country: France
facility: University Hospital Centre of Saint-Etienne
city: Strasbourg
country: France
facility: University Hospital of Strasbourg
city: Toulouse
country: France
facility: University Hospital Centre of Toulouse
Study officials:
References: