Influence of Socio-Economic Factor on Net Survival in Patients With Multiple Sclerosis in France ( ECOVIMUS).
ECOVIMUS
1 other identifier
observational
30,000
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2019
CompletedFirst Submitted
Initial submission to the registry
July 19, 2019
CompletedFirst Posted
Study publicly available on registry
July 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJanuary 23, 2020
January 1, 2020
10 months
July 19, 2019
January 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Excess mortality survival
Net survival is defined as the probability of death in a hypothetical setting where the cause of interest (in our case MS) would be the only possible cause of death. It is directly linked to the concept of the "excess mortality due to the studied disease". Net survival can be calculated according to two settings, either the estimator of survival can be calculated from death due to MS while cause of death are known, either it can be calculated from the excess of mortality due to MS compared to the mortality of the general population obtained from mortality table of the generable population.
From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016.
Secondary Outcomes (2)
European Deprivation Index (EDI) proxy of Socio-Economic Status
From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016.
Distance to MS expert care center
From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- MS patients with less than one year's disease duration by the study end will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Caenlead
- Ecole des Hautes Etudes en Santé Publiquecollaborator
- Hospices Civils de Lyoncollaborator
Study Sites (18)
University Hospital Center of CAEN
Caen, Normandy, 14033, France
University Hospital of Besancon
Besançon, France
University Hospital of Bordeaux
Bordeaux, France
University Hospital Centre of Caen
Caen, France
University Hospital of Clermont Ferrand
Clermont-Ferrand, France
University Hospital of Dijon
Dijon, France
University Hospital of Lille
Lille, France
University Hospital of Lyon
Lyon, France
University Hospital of Marseille
Marseille, France
University Hospital of Montpellier
Montpellier, France
University Hospital of Nancy
Nancy, France
University Hospital of Nantes
Nantes, France
University Hospital of Nice
Nice, France
University hospital Centre of Nîmes
Nîmes, France
University Hospital of Rennes
Rennes, France
University Hospital Centre of Saint-Etienne
Saint-Etienne, France
University Hospital of Strasbourg
Strasbourg, France
University Hospital Centre of Toulouse
Toulouse, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2019
First Posted
July 22, 2019
Study Start
July 10, 2019
Primary Completion
April 30, 2020
Study Completion
December 31, 2020
Last Updated
January 23, 2020
Record last verified: 2020-01