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Influence of Socio-Economic Factor on Net Survival in Patients With Multiple Sclerosis in France ( ECOVIMUS). (ECOVIMUS)
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.
| Condition or disease |
|---|
| C10.114.375.500 |
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 30000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Target Follow-Up Duration: | 2 Years |
| Official Title: | Influence of Socio-Economic Factor on Net Survival in Patients With Multiple Sclerosis in France ( ECOVIMUS). |
| Actual Study Start Date : | July 10, 2019 |
| Estimated Primary Completion Date : | April 30, 2020 |
| Estimated Study Completion Date : | December 31, 2020 |
- Excess mortality survival [ Time Frame: From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016. ]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.
- European Deprivation Index (EDI) proxy of Socio-Economic Status [ Time Frame: From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016. ]
The EDI Score is a combination of weighted ecological variates and is available for each 'IRIS area' (Ilots regroupés pour l'Information Statistique). An IRIS area represents the smallest geographical entity for which census data are available in France.
The geolocation of each individual address, according to latitude and longitude coordinates, is performed with the system of geographical information (SGI) ARGIS® 10.5. This point of geolocation is correlated to the IRIS area and then an EDI score can be attributed to patients registered in the database. The EDI score can be categorized into quintiles.
- Distance to MS expert care center [ Time Frame: From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016. ]Distance in kilometer by road transport from residence place to MS expert care center
| Ages Eligible for Study: | 1 Year to 100 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
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.
| Contact: Gilles-Louis DEFER, Professor | 0033231064617 | defer-gi@chu-caen.fr | |
| Contact: Floriane CALOCER, PharmD/PhD Student | 0033231064617 | calocer-fl@chu-caen.fr |
Show 18 study locations
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 19, 2019 | ||||||||
| First Posted Date | July 22, 2019 | ||||||||
| Last Update Posted Date | January 23, 2020 | ||||||||
| Actual Study Start Date | July 10, 2019 | ||||||||
| Estimated Primary Completion Date | April 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Excess mortality survival [ Time Frame: From date of MS onset to the date of patients death or to study cut-off date on 1st January 2016. ] 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.
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | 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). | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Other |
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| Target Follow-Up Duration | 2 Years | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. | ||||||||
| Condition | C10.114.375.500 | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
30000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2020 | ||||||||
| Estimated Primary Completion Date | April 30, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 1 Year to 100 Years (Child, Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
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| Listed Location Countries | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04028232 | ||||||||
| Other Study ID Numbers | 18512 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | University Hospital, Caen | ||||||||
| Study Sponsor | University Hospital, Caen | ||||||||
| Collaborators |
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| Investigators | Not Provided | ||||||||
| PRS Account | University Hospital, Caen | ||||||||
| Verification Date | January 2020 | ||||||||
