{"doc_desc":{"title":"Cohorte du r\u00e9seau national d'Etude des facteurs pr\u00e9dictifs et de la Pr\u00e9vention des Morts Soudaines inattendues dans les Epilepsies partielles pharmaco r\u00e9sistantes","idno":"FRESH-PEF60180-fr","producers":[{"name":"Philippe RYVLIN","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60180-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60180"},{"agency":"FReSH","code":"FRESH-PEF60180"}]},"title":"Cohorte du r\u00e9seau national d'Etude des facteurs pr\u00e9dictifs et de la Pr\u00e9vention des Morts Soudaines inattendues dans les Epilepsies partielles pharmaco r\u00e9sistantes","alternate_title":"REPO2MSE"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Philippe;RYVLIN","PILabo":"Inserm \/ INSERM U821 (DYNAMIQUE C\u00c9R\u00c9BRALE ET COGNITION) et CTRS-INSERM COGNITIVE DEVELOPMENT IN EPILEPSY UNIVERSIT\u00c9 CLAUDE BERNARD LYON 1","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0001-7775-6576","role":"pi id"},{"title":"IdRef","uri":"060148381","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"philippe.ryvlin@chuv.ch","isContact":"Oui"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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"}],"funding_agencies":[{"name":"EISAI SAS","extlink":[{"title":"SIREN","uri":"403459639"}]},{"name":"LIGUE FRANCAISE CONTRE L EPILEPSIE (LFCE)","extlink":[{"title":"SIREN","uri":"391270006"}]},{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Philippe;RYVLIN","email":"philippe.ryvlin@chuv.ch","type":"contact","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"mort soudaine inattendue dans l'\u00e9pilepsie (Sudep)"},{"keyword":"accident provoqu\u00e9 par une crise d'\u00e9pilepsie"},{"keyword":"\u00e9tat de mal \u00e9pileptique"},{"keyword":"gu\u00e9rison"},{"keyword":"stabilit\u00e9"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"d\u00e9c\u00e8s"},{"keyword":"comorbidit\u00e9s"},{"keyword":"suicide"},{"keyword":"\u00e9volution"},{"keyword":"am\u00e9lioration"},{"keyword":"aggravation"},{"keyword":"sujets hospitalis\u00e9s"},{"keyword":"syst\u00e8me de sant\u00e9"}],"topics":[{"topic":"Neurologie","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"}]}],"purpose":"Objectif g\u00e9n\u00e9ral : d\u00e9terminer les facteurs de risque principaux de mort soudaine inattendue dans l'\u00e9pilepsie (SUDEP), et \u00e9valuer en particulier l\u2019impact de la survenue d\u2019apn\u00e9es critiques et post-critiques, et de la zone d\u2019origine des crises d\u2019\u00e9pilepsie. Objectif secondaire : Obtenir des donn\u00e9es syst\u00e9matiques relatives : - aux modalit\u00e9s de prise en charge des patients admis en monitoring vid\u00e9o-EGG ; - au suivi \u00e0 long terme de ces patients sur le plan m\u00e9dical et m\u00e9dico-\u00e9conomique ; - aux r\u00e9sultats de la chirurgie de l\u2019\u00e9pilepsie ; - aux comorbidit\u00e9s graves associ\u00e9es aux \u00e9pilepsies (incluant la surmortalit\u00e9) ; - aux facteurs de susceptibilit\u00e9 g\u00e9n\u00e9tique (g\u00e9notypage syst\u00e9matique).","abstract":"","coll_dates":[{"start":"2010-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\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\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients souffrant d'\u00e9pilepsie r\u00e9fractaire admis en unit\u00e9 de monitoring vid\u00e9o-EEG en vue de la caract\u00e9risation de leurs crises d'\u00e9pilepsie (dans l'optique d'un traitement chirurgical de leur \u00e9pilepsie ou d'une meilleure identification du syndrome \u00e9pileptique)\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie','Donn\u00e9es paracliniques (hors biologiques) : Exploration fonctionnelle']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques.Gestion des donn\u00e9es manquantes par retour au dossier source.Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi. Relance des sujets pour r\u00e9aliser les visites de suivi.Audits internes tous les 3 mois.Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"933 (juillet 2013)"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques Utilisation non possible des donn\u00e9es par des industriels","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"25-07-2014","isContributorPI":"Non","contributorName":"Philippe RYVLIN","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.lfce.fr\/Publication_a80.html"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie","Priv\u00e9 \u00e0 but non lucratif","Public (France)","Public (France)"],"otherFundingAgentType":["","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Auto-questionnaire : saisie \u00e0 partir d\u2019un questionnaire papier (saisie manuelle) Entretiens : saisie \u00e0 partir d\u2019un questionnaire papier (saisie manuelle) Examens cliniques : \u00e9tape manuscrite (saisie manuelle) Examens biologiques : \u00e9tape manuscrite (saisie manuelle)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique fran\u00e7aise (14 centres). Les 14 centres participant \u00e0 l'\u00e9tude repr\u00e9sentent l'essentiel des structures b\u00e9n\u00e9ficiant de monitoring vid\u00e9o-eeg de longue dur\u00e9e prenant en charge les patients r\u00e9pondant aux crit\u00e8res d'inclusion"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi tous les deux ansInformations recueillies lors de l'examen clinique : examen neurologique complet, description des crises d'\u00e9pilepsie, de leur fr\u00e9quence, de leur retentissement","biologicalDataDetails":"Type de pr\u00e9l\u00e8vements r\u00e9alis\u00e9s : prise de sang","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}