{"doc_desc":{"title":"Registre prospectif des patients pris en charge pour un \u00e9v\u00e8nement thromboembolique (\u00e9tude internationale multicentrique)","idno":"FRESH-PEF60139-fr","producers":[{"name":"Laurent BERTOLETTI","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60139-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60139"},{"agency":"FReSH","code":"FRESH-PEF60139"}]},"title":"Registre prospectif des patients pris en charge pour un \u00e9v\u00e8nement thromboembolique (\u00e9tude internationale multicentrique)","alternate_title":"RIETE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Laurent;BERTOLETTI","PILabo":"CHU Saint-Etienne \/ INSERM CENTRE D\u2019INVESTIGATION CLINIQUE \u2013 EPIDEMIOLOGIE CLINIQUE (CIE3) - UMR 1059 SAINBIOSE -CHU DE SAINT ETIENNE","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","extlink":[{"title":"ORCID","uri":"0000-0001-8214-3010","role":"pi id"},{"title":"IdRef","uri":"116915854","role":"pi id"},{"title":"SIREN","uri":"264200304","role":"organisation id"},{"title":"RNSR","uri":"200320132Z","role":"labo id"}],"email":"laurent.bertoletti@chu-st-etienne.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04pn6vp43","role":"sponsor id"},{"title":"SIREN","uri":"264200304","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ACTIVITE UNIVERSITAIRE DU SERVICE","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Laurent;BERTOLETTI","email":"laurent.bertoletti@chu-st-etienne.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04pn6vp43","role":"organisation id","title":"ROR"},{"uri":"264200304","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"prevention."},{"keyword":"tol\u00e9rance aux traitements"},{"keyword":"antiplatelet treatment"}],"topics":[{"topic":"Cardiologie et m\u00e9decine vasculaire","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4455c187-2f2f-4cd1-a4dd-449f59d73b39"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D002309"}]},{"topic":"M\u00e9decine interne","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/0d45044a-74d5-4bd7-b920-b92af3388576"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f0844378-9f30-4873-b19b-5bff8c184a36"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D007388"}]},{"topic":"Pneumologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f6e18c52-6087-4662-904c-5c4b8174e40e"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D015272"}]},{"topic":"Thromboembolie veineuse","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1197943614","title":"CIM-11"}]},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Documenter l\u2019\u00e9pid\u00e9miologie de la maladie veineuse thromboembolique, tant sur les caract\u00e9ristiques d\u00e9mographiques et cliniques des patients que sur la prise en charge et le pronostic \u00e0 3 mois (incidence des r\u00e9cidives d\u2019\u00e9v\u00e9nements thromboemboliques (TVP et EP) symptomatiques, fatals ou non, incidence des h\u00e9morragies, d\u00e9c\u00e8s, complications)","abstract":"","coll_dates":[{"start":"2006-01-01"}],"nation":[{"name":"Espagne","abbreviation":"es","extLink":{"vocab":"ISO","vocabURI":"es"}},{"name":"Italie","abbreviation":"it","extLink":{"vocab":"ISO","vocabURI":"it"}},{"name":"Argentine","abbreviation":"ar","extLink":{"vocab":"ISO","vocabURI":"ar"}},{"name":"Israel","abbreviation":"il","extLink":{"vocab":"ISO","vocabURI":"il"}},{"name":"Chili","abbreviation":"cl","extLink":{"vocab":"ISO","vocabURI":"cl"}},{"name":"Gr\u00e8ce","abbreviation":"gr","extLink":{"vocab":"ISO","vocabURI":"gr"}},{"name":"Royaume-Uni","abbreviation":"gb","extLink":{"vocab":"ISO","vocabURI":"gb"}},{"name":"Belize","abbreviation":"bz","extLink":{"vocab":"ISO","vocabURI":"bz"}},{"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            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" patient vu \u00e0 l\u2019h\u00f4pital pour une thrombose veineuse profonde (TVP) symptomatique des membres sup\u00e9rieurs ou inf\u00e9rieurs et\\\/ou une embolie pulmonaire (EP) symptomatique, confirm\u00e9es par des examens objectifs (i.e phl\u00e9bographie, doppler veineux, pl\u00e9thysmographie, IRM pour suspicion de TVP, angiographie pulmonaire, scintigraphie pulmonaire ventilation\\\/perfusion ou scanner spirale pour suspicion d\u2019EP) ; - patient non inclus dans un essai clinique th\u00e9rapeutique ; - patient dont le suivi \u00e0 trois mois est possible\",\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']","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 et\/ou par retour vers le patient ou vers un tiers- Enqu\u00eates aupr\u00e8s des mairies pour les d\u00e9c\u00e8s - Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi- R\u00e9alisation d\\'audit qualit\u00e9 interne selon les inclusions- Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es par orale']"}},"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"}]},"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":">= 20000 individus","response_rate":"57 000 - juin 2015"},"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 avec acc\u00e8s de fa\u00e7on contractuelles selon les r\u00e8gles de publication \u00e9tablies par le comit\u00e9 scientifique de RIETE Utilisation impossible 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":"05-09-2019","isContributorPI":"Non","contributorName":"Laurent BERTOLETTI","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"List of publications in HAL","link":"http:\/\/www.hal.inserm.fr\/RIETE"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"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":"Entretiens : saisie directe Examens cliniques : saisie manuscrite Examens biologiques : Saisie directe","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Espagne, Italie, Argentine, Isra\u00ebl, Chili, Gr\u00e8ce, Royaume-Uni, Br\u00e9sil, France"},"dataTypes":{"clinicalDataDetails":"Examen clinique au cours du suivi tous les 3 mois : traitement anticoagulant, filtre cave, complications (r\u00e9cidives thromboemboliques, h\u00e9morragies majeures ou cliniquement pertinentes, d\u00e9c\u00e8s, complications osseuse ou cutan\u00e9es, thrombop\u00e9nies)","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}