Data collection
Any patient with MS or a related disease monitored by an OFSEP-participant neurologist can be included in the OFSEP cohort.
During a consultation or hospital visit, the neurologist proposes participation in OFSEP to the patient: the project is explained; an information document and a consent form are provided. The patient is free to accept or refuse to participate in all or part of the project, without having to justify his decision and without fearing any change in his treatment.
Once a patient has given his consent, clinical data, biological samples and MRIs are collected and supply the OFSEP cohort. Collection is continued as long as the patient is receiving care from a neurologist participating in the OFSEP project.
Clinical data must be collected as routine protocol and are limited to the data on the OFSEP minimal form (OMF). These data, defined by the clinical group, include the description of the patients, their diseases and their therapeutic care (socio-demographic characteristics, neurological episodes, disability, treatment, serious adverse events, etc.). All patients having consulted or been hospitalized since 15 June 2013 are concerned by the OMF.
The data collected are entered in the EDMUS database (computerized medical file specialized in MS patient care) of each center.
The biological samples (serum, urine, CSF, stools) come from left-over samples taken for medical purposes. Only samples from patient populations with specific characteristics (called OFSEP biological cohorts) are stored and processed, conform to standardized procedures, in compliance with biology group recommendations. Data concerning these samples are entered into a single centralized TK® database (biological sample management software), constituting a virtual BRC.
MRIs prescribed as part of the care protocol are carried out according to standardized acquisition protocols, defined by the imaging group. Nominative data is deleted from the MRIs before transfer and storage on the Shanoir platform (Sharing NeurOImagingResources).
Twice a year, data from the EDMUS database, TK and Shanoir are re-compiled to constitute the common OFSEP database. At every stage of the process, data transfer and storage guarantees confidentiality and conforms to applicable regulations. The common database is a valuable source for research projects
The OFSEP quality strategy
OFSEP has implemented a strategy to ensure the quality of the data and samples collected.
- Neurologists use the data collected for medical purposes (clinical data entered in EDMUS, MRI acquisition protocol optimized for care and research, biological samples collected as part of the care process), so it is in their interest to ensure the validity of the data collected and entered, which enhances the quality of the database.
- The EDMUS software has an integrated data verification tool to identify missing or incoherent data. If such errors are of a medical nature, a neurologist validates or corrects them.
- Every time the common database is updated, the OFSEP National coordination center (NCC) is provided with the list of incoherent data entries (internal to the clinical, imaging, biological databases and inter-databases), which enables processing advice to be proposed to the centers.
- The NCC provides a number of tools for the centers: information documents, data quality indicators and their evolution over time, training sessions and audits.
