{"doc_desc":{"title":"Cohorte de traumatis\u00e9s cr\u00e2niens l\u00e9gers et syndrome post-commotionnel. Etude du devenir \u00e0 5 ans.","idno":"FRESH-PEF5187-fr","producers":[{"name":"Emmanuel LAGARDE","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5187-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5187"},{"agency":"FReSH","code":"FRESH-PEF5187"}]},"title":"Cohorte de traumatis\u00e9s cr\u00e2niens l\u00e9gers et syndrome post-commotionnel. Etude du devenir \u00e0 5 ans.","alternate_title":"PERICLES"},"study_authorization":{"agency":[{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Emmanuel;LAGARDE","PILabo":"INSERM - Institut National de la Sant\u00e9 et de la Recherche \/ U897 PR\u00c9VENTION ET PRISE EN CHARGE DES TRAUMATISMES ( Equipe de l'ISPED - Institut de Sant\u00e9 Publique, d'Epid\u00e9miologie et de D\u00e9veloppement)","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0001-8031-7400","role":"pi id"},{"title":"IdRef","uri":"110886413","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"emmanuel.lagarde@u-bordeaux.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"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":"Emmanuel;LAGARDE","email":"emmanuel.lagarde@u-bordeaux.fr","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":"syndrome post commotionnel"},{"keyword":"pr\u00e9valence"},{"keyword":"suivi"},{"keyword":"sympt\u00f4mes"},{"keyword":"facteurs pr\u00e9dictifs"}],"topics":[{"topic":"Orthop\u00e9die et traumatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4538836-ae58-4941-b544-50f53e979e20"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009985"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D014194"}]},{"topic":"Trouble neurocognitif l\u00e9ger","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/195531803","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"Mesurer de mani\u00e8re comparative la pr\u00e9valence \u00e0 5 ans des sympt\u00f4mes du syndrome post commotionnel et en d\u00e9terminer les facteurs pr\u00e9dictifs.","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2008-12-31"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Nouvelle-Aquitaine']","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\": \"Lors de l\u2019admission aux urgences adultes du CHU de Bordeaux, la participation \u00e0 l\u2019\u00e9tude a \u00e9t\u00e9 propos\u00e9e : - \u00e0 l\u2019ensemble des patients atteints d\u2019un traumatisme cr\u00e2nien l\u00e9ger pr\u00e9sentant un ou plusieurs signes de gravit\u00e9 (avec un score de Glasgow de 15, 14 ou 13). - \u00e0 un \u00e9chantillon de patients ayant re\u00e7u un coup sur la t\u00eate sans autres signes de gravit\u00e9. - \u00e0 des t\u00e9moins appari\u00e9s sur le sexe et l\u2019\u00e2ge des cas, choisis parmi les patients se pr\u00e9sentant aux urgences pour des pathologies n\u2019interf\u00e9rant pas avec le traumatisme cr\u00e2niens et ses \u00e9ventuelles cons\u00e9quences.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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\nConsommation de soins\/services de sant\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\":\"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":"3459"},"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":"","conditions":"L'ensemble des donn\u00e9es sont disponibles pour d'autres chercheurs dans le cadre d'un accord \u00e0 passer avec les investigateurs.","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":"21-12-2012","lastUpdatedAuto":null,"lastUpdatedManual":"06-08-2014","isContributorPI":"Non","contributorName":"Emmanuel LAGARDE","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=Head+Trauma+AND+Lagarde+E+[Author]+NOT+22533294+[uid]+NOT+23260691+[uid]+NOT+22355384+[uid]"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"Un examen m\u00e9dical et un scanner c\u00e9r\u00e9bral pour les cas ont \u00e9t\u00e9 conduits dans le cadre habituel de la prise en charge des personnes se pr\u00e9sentant aux urgences.Pendant le s\u00e9jour du patient aux urgences, les participants ont r\u00e9pondu \u00e0 un questionnaire (questionnaire M0) permettant l\u2019\u00e9valuation de la qualit\u00e9 de vie avant l\u2019accident et l\u2019existence de sympt\u00f4mes fonctionnels courants.Les patients ont \u00e9t\u00e9 recontact\u00e9s 3 et 12 mois (M3 et M12) apr\u00e8s l\u2019inclusion. Afin de recueillir des informations quantitatives standardis\u00e9es sur l\u2019\u00e9tat du patient apr\u00e8s son retour au domicile, le questionnaire initial M0 ainsi que les questionnaires M3 et M12 ont \u00e9t\u00e9 pr\u00e9par\u00e9s gr\u00e2ce \u00e0 une adaptation des 3 questionnaires d\u00e9crits ci-apr\u00e8s: le Rivermead post-concussion symptoms questionnaire \u00bb (RSQ), le \u00ab Rivermead head injury follow up questionnaire \u00bb et une partie du \u201cShort Form 36 health questionnaire\u201d (SF36). Une derni\u00e8re partie de ces questionnaires est consacr\u00e9e \u00e0 l\u2019\u00e9valuation du syndrome de stress post-traumatique et des incapacit\u00e9s dans les gestes de la vie quotidienne.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Aquitaine"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}