{"doc_desc":{"title":"French registry on Multiple Sclerosis","idno":"FRESH-PEF3138-en","producers":[{"name":"Anne-C\u00e9cile DE GIACOMONI","affiliation":"UNIVERSITE CLAUDE BERNARD LYON 1"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3138-en","IDno":{"metadata_no":[{"agency":"PEF","code":"3138"},{"agency":"FReSH","code":"FRESH-PEF3138"}]},"title":"French registry on Multiple Sclerosis","alternate_title":"OFSEP"},"study_authorization":{"agency":[]},"authoring_entity":[{"name":"Sandra;VUKUSIC","firstname":"Sandra","lastname":"VUKUSIC","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/029brtt94","role":"organisation id"},{"title":"SIREN","uri":"196917744","role":"organisation id"}],"email":"","affiliationName":"UNIVERSITE CLAUDE BERNARD LYON 1","PILabo":"Universit\u00e9 Claude Bernard Lyon 1, Hospices Civils de Lyon, Fondation Eug\u00e8ne Devic \/ Service de Neurologie A, Centre de Coordination et Fondation EDMUS contre la Scl\u00e9rose en PlaquesInserm U1028","isContact":false}],"oth_id":[{"name":"Projet Big MS Data gathering European registers","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"sponsor id"},{"title":"SIREN","uri":"266900273","role":"sponsor id"}],"role":"sponsor"},{"name":"UNIVERSITE CLAUDE BERNARD LYON 1","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/029brtt94","role":"sponsor id"},{"title":"SIREN","uri":"196917744","role":"sponsor id"}],"role":"sponsor"},{"name":"","role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"},{"title":"SIREN","uri":"130002504"}]}]},"distribution_statement":{"contact":[{"name":"Romain;CASEY","lastname":"CASEY","firstname":"Romain","type":"contact","email":"romain.casey@chu-lyon.fr","affiliationName":"FONDATION EUGENE DEVIC EDMUS CONTRE LA SCLEROSE EN PLAQUES","contactPointLabo":"","extlink":[{"uri":"527754154","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Pharmacoepidemiology"}],"topics":[{"topic":"Neurology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009462"}]},{"topic":"Multiple sclerosis","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1298865187","title":"CIM-11"}]}],"purpose":"- 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","abstract":"","coll_dates":[{"start":"1992-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Infant (28 days to 2 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Child, Preschool (2 to 5 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"MS patients treated by any neurologist involved in the OFSEP project\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data','Paraclinical data (non-biological) : Imaging']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services\r\nQuality of life\/health perception\r\nOthers"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through independent healthcare practitioners Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":">= 20000 individuals","response_rate":"62 000"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"L'acc\u00e8s aux donn\u00e9es et \u00e9chantillons biologiques de la cohorte OFSEP est ouvert aux entit\u00e9s ext\u00e9rieures (acad\u00e9miques ou industrielles, publiques ou priv\u00e9es, fran\u00e7aises ou \u00e9trang\u00e8res). Les demandes d'acc\u00e8s aux donn\u00e9es doivent \u00eatre adress\u00e9es au Centre de coordination national de l'OFSEP (fichier disponible sur le site de l'OFSEP http:\/\/www.ofsep.org\/fr\/acces-aux-donnees ou sur demande \u00e0 l'adresse contact@ofsep.org). Les projets seront \u00e9valu\u00e9s par le Comit\u00e9 scientifique de l'OFSEP et par le Centre de coordination national sur leur rationnel scientifique, la qualit\u00e9 du protocole et la faisabilit\u00e9. Le respect des r\u00e8gles de bonnes pratiques, les aspects \u00e9thiques et la conformation \u00e0 la r\u00e9glementation en vigueur pour l'utilisation des donn\u00e9es seront \u00e9galement consid\u00e9r\u00e9s. Le Comit\u00e9 de Pilotage de l'OFSEP validera les d\u00e9cisions. La cession des donn\u00e9es engendrera la signature d'une convention de mise \u00e0 disposition entre l'OFSEP et l'entit\u00e9 ext\u00e9rieure.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"29-02-2012","lastUpdatedAuto":null,"lastUpdatedManual":"02-06-2025","isContributorPI":false,"contributorName":"Anne-C\u00e9cile DE GIACOMONI","contributorAffiliation":"UNIVERSITE CLAUDE BERNARD LYON 1","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)","Public (France)","Private non-profit"],"otherSponsorType":["","",""]},"governance":{"committee":true},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"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.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Metropolitan France and French overseas departments and territories"},"dataTypes":{"clinicalDataDetails":"Neurological episodes, handicap scale, MRI (results and pictures), disease modifying treatments, medical history, etc.","biologicalDataDetails":"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.","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}