OFSEP - French registry on Multiple Sclerosis
Head :
Vukusic Sandra, Service de Neurologie A, Centre de Coordination et Fondation EDMUS contre la Sclérose en PlaquesInserm U1028
Last update : 09/05/2019 | Version : 7 | ID : 3138
| General | |
| Identification | |
| Detailed name | French registry on Multiple Sclerosis |
| Sign or acronym | OFSEP |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL 914066v2 |
| General Aspects | |
| Medical area |
Neurology |
| Pathology (details) | Multiple sclerosis |
| Keywords | Pharmacoepidemiology |
| Scientific investigator(s) (Contact) | |
| Name of the director | Vukusic |
| Surname | Sandra |
| Address | Hôpital Neurologique Pierre Wertheimer - 59 boulevard Pinel - 69677 BRON cedex |
| Phone | +33 (0)4 72 68 13 10 |
| sandra.vukusic@chu-lyon.fr | |
| Unit | Service de Neurologie A, Centre de Coordination et Fondation EDMUS contre la Sclérose en PlaquesInserm U1028 |
| Organization | Université Claude Bernard Lyon 1, Hospices Civils de Lyon, Fondation Eugène Devic |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | Projet Big MS Data gathering European registers |
| Funding | |
| Funding status |
Public |
| Details | ANR "Investissements d'avenir" |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Université Claude Bernard Lyon 1 |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Hospices Civils de Lyon (HCL) |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Fondation Eugène Devic EDMUS |
| Organisation status |
Private |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Name of the contact | Casey |
| Surname | Romain |
| Address | Hôpital Neurologique Pierre Wertheimer - 59 boulevard Pinel - 69677 BRON cedex |
| Phone | 04 72 12 96 41 |
| romain.casey@chu-lyon.fr | |
| Unit | OFSEP |
| Organization | Fondation EDMUS |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Cohort open to all French neurologists willing to participate. The medical care of French MS patients is provided by two specialized, complementary and closely interconnected networks : the 28 university hospital neurology departments (expert centres) and the 18 regional health care networks dedicated to MS. This organization ensures a dense and homogeneous nationwide coverage. |
| Database objective | |
| Main objective |
- Maintain and develop the national cohort of MS patients (currently more than 40,000 patients) registered at the EDMUS format (database that can be used as an electronic medical record, specifically designed to process the data of MS patients) and enrich the clinical data currently available with biological samples, MRI data and socio-economic data.
- Provide a continuously updated "photograph" of MS in France, thus allowing a better understanding of the personal, professional and social consequences of the disease, and of the effect of disease modifying treatments (DMTs) in MS care in France. It is ideally suited for nationwide epidemiological studies on MS. - Maintain and develop existing nested cohorts ("historical" Lyon cohort on the natural history of MS, KIDMUS cohort on MS with childhood onset, TYSEDMUS cohort on patients treated with Tysabri, etc.) and implement new ones, addressing specific issues such as pharmaco-epidemiology of recently introduced DMTs and their cost effectiveness. To develop the new OFSEP-HD cohort |
| Inclusion criteria | MS patients treated by any neurologist involved in the OFSEP project |
| Population type | |
| Age |
Infant (28 days to 2 years) Early childhood (2 to 5 years) Childhood (6 to 13 years) Adolescence (13 to 18 years) Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Pathology | G35 - Multiple sclerosis |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Metropolitan France and French overseas departments and territories |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 1992 |
| Size of the database | |
| Size of the database (number of individuals) |
Greater than 20 000 individuals |
| Details of the number of individuals | 62 000 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Neurological episodes, handicap scale, MRI (results and pictures), disease modifying treatments, medical history, etc. |
| Declarative data (detail) |
Face to face interview |
| Paraclinical data (detail) | 1. Results of additional tests for the diagnosis and during routine follow-up (brain and spinal cord MRI, evoked potentials...) registered in the EDMUS software. 2. Electronic storage of brain and spinal cord images on the Shanoir Platform (http://shanoir.org). A common and feasible brain and spinal cord acquisition protocol has been defined by the MRI Work Group and the major MRI manufacturers have agreed to provide the dedicated collection of sequences as an “OFSEP box” with every software upgrade or new MRI machine in order to guarantee the standardisation of data. |
| Biological data (detail) | 1. Results of additional tests for the diagnosis and during routine follow-up (lumbar puncture, blood tests...) registered in the EDMUS software. 2. Biological samples (blood, cerebrospinal fluid, urine...) stored in specific (REFGENSEP for genetics) or generic ("MS collection") Biological Ressources Centres. Treatment and conservation of biological samples have been standardised. The groups of patients to be followed are defined according to research projects. |
| Administrative data (detail) | Medico-economic data : 1. Places of birth and residence 2. Domestic status (lives alone/with spouse or partner/with another family member/in health institution) 3. Education level. |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Plasma Fluids (saliva, urine, amniotic fluid, …) Cell lines DNA DNAc/RNAm Others |
| Details of biobank content | - Minimum samples : serum, plasma EDTA, DNA, PBMC, urine. - Additional samples : cerebrospinal fluid and feces |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception Others |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | 1/ Clinical data. Data are collected using the EDMUS software. According to the physician's convenience, medical data can be restricted to minimum data (specified by the community of EDMUS users) or be comprehensive, thus constituting a real electronic medical record. Clinical symptoms are deliberately described from a functional angle first, then from an objective examination angle if necessary. This ensures a homogeneous integration of information, either restrospective or prospective, from the patients, their family circle, their GP or neurologist. Only crude data are also deliberately recorded in the system. All inferred data, such as the level of diagnostic ascertainment or classification of disease course (recurring-remitting, secondary progressive, primary progressive) are automatically generated with algorithms integrated in the software. This approach has many advantages : time-saving, uniform classification, automatic update of classifications each time new data are entered in a patient's record. Changes in the classifications that may be decided by the medical and scientific community can also be taken into consideration by changing the algorithms. Data can be entered directly using the software or using the standardized form called "OFSEP minimal data". 2/ MRI. MRI (realized according to OFSEP standard during the clinical follow-up of the patient) are uploaded on Shanoir platform from PACS or CD of patients. 3/ Biological samples. Biological samples are collected during clinical follow-up of patients. They are stored locally by CBR participating to the OFSEP project. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Inclusion of a patient in the OFSEP cohort does not mean any change in his/her routine follow-up. Data are collected during the visits and hospitalizations required for the patient's follow-up, usually at least twice a year for patients receiving an immuno-active treatment, once a year for other patients. Additional tests may be done according to clinical requirements. The samples stored in the biological ressources centers are surpluses from these routine tests. However, in the OFSEP project, a minimum clinical, biological and MR follow-up will be recommended for all patients in the cohort. For nested cohorts (particularly for the monitoring of immuno-active treatments), a specific follow-up included in the routine follow-up will be proposed. |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | CNAM-TS systematic agreement for the interconnection with individual reimbursement data collected by health insurance systems(SNIIR-AM). Definition of practical and regulatory terms on going. |
| Promotion and access | |
| Promotion | |
| Link to the document | OFSEP_Dissemination des résultats_2019-09-04_VF.pdf |
| Link to the document | http://www.hal.inserm.fr/OFSEP |
| Description | List of publications in HAL |
| Link to the document | http://tinyurl.com/Publi-Pubmed-OFSEP |
| Description | List of publications in Pubmed |
| Link to the document | OFSEP_Access to a powerful epidemiological tool_V1.0_2019-07-19.pdf |
| Access | |
| Presence of document that lists variables and coding procedures |
Yes |
| Terms of data access (charter for data provision, format of data, availability delay) | Access to the OFSEP cohort data is made available to outer institutions (academic or industrial, public or private, French or foreign). Requests should be made to the OFSEP National Coordination Centre (request form available on the OFSEP web site http://www.ofsep.org/en/data-access or on request at contact@ofsep.org). Projects are assessed by the OFSEP Scientific Committee and the National Coordination Centre on the basis of their scientific rationale, quality of the protocol and feasibility. Compliance with good practices, ethical aspects and compliance with the current regulations will also be taken into consideration. Decisions are approved by the OFSEP Steering Committee. A signed data transfer agreement between OFSEP and the applicant is required before any transfer of data. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
