{"doc_desc":{"title":"Perspective cohort of patients managed for a venous thromboembolic event (multi-center international study)","idno":"FRESH-PEF60139-en","producers":[{"name":"Laurent BERTOLETTI","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60139-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60139"},{"agency":"FReSH","code":"FRESH-PEF60139"}]},"title":"Perspective cohort of patients managed for a venous thromboembolic event (multi-center international study)","alternate_title":"RIETE"},"study_authorization":{"agency":[]},"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":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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"}],"topics":[{"topic":"Cardiology and vascular medicine","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":"Internal medicine","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":"Pulmonary medicine","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":"Venous thromboembolism","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1197943614","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"Document the epidemiology of the venous thromboembolic disease, demographic and clinical characteristics of patients, as well as caring and 3 months prognosis (incidence of recurrence of symptomatic thromboembolic events (TVP and EP), fatal or not, incidence of hemorrhages, death, complications. Secondary objective : TVP ET","abstract":"","coll_dates":[{"start":"2006-01-01"}],"nation":[{"name":"Spain","abbreviation":"es","extLink":{"vocab":"ISO","vocabURI":"es"}},{"name":"Italy","abbreviation":"it","extLink":{"vocab":"ISO","vocabURI":"it"}},{"name":"Argentina","abbreviation":"ar","extLink":{"vocab":"ISO","vocabURI":"ar"}},{"name":"Israel","abbreviation":"il","extLink":{"vocab":"ISO","vocabURI":"il"}},{"name":"Chile","abbreviation":"cl","extLink":{"vocab":"ISO","vocabURI":"cl"}},{"name":"Greece","abbreviation":"gr","extLink":{"vocab":"ISO","vocabURI":"gr"}},{"name":"United Kingdom","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":"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\": \"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\": \"Patient visited at the hospital for a symptomatic deep venous thrombosis (TVP) of the upper or lower limbs, and\\\/or a symptomatic pulmonary embolism (EP), confirmed by objective examination (i.e phlebography,  venous doppler, plethysmography, MRI on suspicion of TVP, pulmonary angiography, pulmonary scintygraphy ventilation\\\/perfusion or spiral scan for EP suspicion); patient not included in a therapeutically clinical trial; patient allowing a 3 months follow-up\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Coherence request after computer data entry. Missing data asked back to the original file and\/or back to the patient or a third. Surveys about death among city halls. Doctor remainders for follow-up visits. Intern quality audit. Patients are orallyinformed about the use of their data.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":">= 20000 individuals","response_rate":"57 000 in June 2015"},"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":"Possible data utilization by academic teams with contractual access conditions according to publishing rules established by the RIETE scientific committee. Data utilization not available for industry sectors.","conditions":"","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"05-09-2019","isContributorPI":"No","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":"Yes"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Interviews: direct data entry Clinical examinations: hand-written entry Biological examinations: direct data entry","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Spain, Italy, Argentina, Israel, Chili, Greece, United Kingdom, Brazil, France"},"dataTypes":{"clinicalDataDetails":"Clinical examination every 3 months during the follow-up: anticoagulant treatment, vena cava filter, complications (recurrence of thromboeolic events, major or clinically pertinent hemorrhages, death, bone or cutaneous complications, thrombocytopenia)","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}