{"doc_desc":{"title":"Etude transversale sur des patients suivis en m\u00e9decine de ville, usagers de substances actives illicites ou de m\u00e9dicaments d\u00e9tourn\u00e9s de leur usage th\u00e9rapeutique ou sous traitement de substitution de la d\u00e9pendance aux opiac\u00e9s","idno":"FRESH-PEF73301-fr","producers":[{"name":"Xavier THIRION","affiliation":"UNIVERSITE D'AIX MARSEILLE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73301-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73301"},{"agency":"FReSH","code":"FRESH-PEF73301"}]},"title":"Etude transversale sur des patients suivis en m\u00e9decine de ville, usagers de substances actives illicites ou de m\u00e9dicaments d\u00e9tourn\u00e9s de leur usage th\u00e9rapeutique ou sous traitement de substitution de la d\u00e9pendance aux opiac\u00e9s","alternate_title":"OPEMA : Observation des pharmacod\u00e9pendances en m\u00e9decine ambulatoire"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Elisabeth;FRAUGER","firstname":"Elisabeth","lastname":"FRAUGER","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/002cp4060","role":"organisation id"},{"title":"SIREN","uri":"261300081","role":"organisation id"}],"email":"elisabeth.frauger@ap-hm.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","PILabo":"CEIP Marseille","isContact":true},{"name":"Jo\u00eblle;MICALLEF","firstname":"Jo\u00eblle","lastname":"MICALLEF","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/002cp4060","role":"organisation id"},{"title":"SIREN","uri":"261300081","role":"organisation id"}],"email":"joelle.micallef@ap-hm.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","PILabo":"CEIP Marseille","isContact":true},{"name":"Samira;MILOUDI","firstname":"Samira","lastname":"MILOUDI","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/035xkbk20","role":"organisation id"},{"title":"SIREN","uri":"130015332","role":"organisation id"}],"email":"","affiliationName":"UNIVERSITE D'AIX MARSEILLE","PILabo":"Centre associated with CEIP-Addictovigilance PACA-Corsica, Public Health Laboratory, Faculty of Medicine, Aix-Marseille Universit\u00e9 \/ EA 3279","isContact":false},{"name":"Veronica;ORLEANS","firstname":"Veronica","lastname":"ORLEANS","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/035xkbk20","role":"organisation id"},{"title":"SIREN","uri":"130015332","role":"organisation id"}],"email":"","affiliationName":"UNIVERSITE D'AIX MARSEILLE","PILabo":"Centre associated with CEIP-Addictovigilance PACA-Corsica, Public Health Laboratory, Faculty of Medicine, Aix-Marseille Universit\u00e9 \/ EA 3279","isContact":false},{"name":"Xavier;THIRION","firstname":"Xavier","lastname":"THIRION","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/035xkbk20","role":"organisation id"},{"title":"SIREN","uri":"130015332","role":"organisation id"}],"email":"xavier.thirion@ap-hm.fr","affiliationName":"UNIVERSITE D'AIX MARSEILLE","PILabo":"Centre associated with CEIP-Addictovigilance PACA-Corsica, Public Health Laboratory, Faculty of Medicine, Aix-Marseille Universit\u00e9 \/ EA 3279","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":""}],"funding_agencies":[{"name":"AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01g80gk13"},{"title":"SIREN","uri":"180036113"}]}]},"distribution_statement":{"contact":[{"name":"Elisabeth;FRAUGER","lastname":"FRAUGER","firstname":"Elisabeth","type":"contact","email":"elisabeth.frauger@ap-hm.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/002cp4060","role":"organisation id","title":"ROR"},{"uri":"261300081","role":"organisation id","title":"SIREN"}]},{"name":"Jo\u00eblle;MICALLEF","lastname":"MICALLEF","firstname":"Jo\u00eblle","type":"contact","email":"joelle.micallef@ap-hm.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/002cp4060","role":"organisation id","title":"ROR"},{"uri":"261300081","role":"organisation id","title":"SIREN"}]},{"name":"Xavier;THIRION","lastname":"THIRION","firstname":"Xavier","type":"contact","email":"xavier.thirion@ap-hm.fr","affiliationName":"UNIVERSITE D'AIX MARSEILLE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/035xkbk20","role":"organisation id","title":"ROR"},{"uri":"130015332","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"pharmaco-\u00e9pid\u00e9miologie \/ consommations de substances psychoactives \/ m\u00e9decins g\u00e9n\u00e9ralistes"}],"topics":[{"topic":"M\u00e9decine g\u00e9n\u00e9rale","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4b9f8efb-68dd-45a1-b04c-d23d457d6898"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D058006"}]},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Son objectif principal est de recueillir des informations sur les caract\u00e9ristiques socio d\u00e9mographiques, les consommations de produits et l'\u00e9tat de sant\u00e9 des patients suivis en m\u00e9decine de ville, usagers de substances actives illicites ou de m\u00e9dicaments d\u00e9tourn\u00e9s de leur usage th\u00e9rapeutique ou sous traitement de substitution de la d\u00e9pendance aux opiac\u00e9s.","abstract":"","coll_dates":[{"start":"2008-01-01"}],"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            \"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\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients volontaires et consultant chez un m\u00e9decin g\u00e9n\u00e9raliste recrut\u00e9 et anim\u00e9 par les CEIP\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es socio-d\u00e9mographiques']","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\nConsommation de soins\/services de sant\u00e9"}]},"method":{"data_collection":{"time_method":"Etude transversale r\u00e9p\u00e9t\u00e9e","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"Pas d\u2019acc\u00e8s","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"418 (2008), 628 (2009), 1385 (2010), 1516 (2011)"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s aux seules m\u00e9tadonn\u00e9es\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_14cb\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contacter le responsable scientifique","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":"05-01-2016","lastUpdatedAuto":null,"lastUpdatedManual":"19-10-2017","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/ansm.sante.fr\/Declarer-un-effet-indesirable\/Pharmacodependance-Addictovigilance\/Outils-de-surveillance-et-d-evaluation-Resultats-d-enquetes\/%28offset%29\/3#paragraph_54413"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":[],"otherSponsorType":[]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Par les m\u00e9decins g\u00e9n\u00e9ralistes","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"\u00c9tat de sant\u00e9 et leur consommation actuelle de substances psychoactives","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}