{"doc_desc":{"title":"Cross-sectional study of deaths related to psychoactive substance abuse","idno":"FRESH-PEF73054-en","producers":[{"name":"Michel MALLARET","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73054-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73054"},{"agency":"FReSH","code":"FRESH-PEF73054"}]},"title":"Cross-sectional study of deaths related to psychoactive substance abuse","alternate_title":"DRAMES"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Michel;MALLARET","PILabo":"Centre R\u00e9gional de Pharmacovigilance et d'information sur les m\u00e9dicaments. Grenoble","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"069721769","role":"pi id"},{"title":"SIREN","uri":"263800302","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"pharmacodependance@chu-grenoble.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/041rhpw39","role":"sponsor id"},{"title":"SIREN","uri":"263800302","role":"sponsor id"}],"role":"sponsor"}],"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"}]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Michel;MALLARET","email":"pharmacodependance@chu-grenoble.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/041rhpw39","role":"organisation id","title":"ROR"},{"uri":"263800302","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"drug dependence"},{"keyword":"narcotics"},{"keyword":"death"},{"keyword":"legal and illegal psychoactive substances"},{"keyword":"medicines"},{"keyword":"drugs"},{"keyword":"toxicology"},{"keyword":"psychoactive"}],"topics":[{"topic":"General medicine","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":"Psychiatry","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3de50dee-da1c-4791-a386-56bca24a5fed"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D011570"}]},{"topic":"Addiction medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/42d645e0-f58d-40ed-9917-5b227ff41a92"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000073316"}]},{"topic":"Behavioral determinants: Addiction","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"This study was set up in order to obtain the most exhaustive data possible regarding cases of death associated with use of psychoactive substances in the setting of abuse or drug dependence. It should allow for: - identification of the substances involved in the deaths of individuals abusing psychoactive substances (medicinal or otherwise). - collection of quantitative data (blood assays) for the substances involved. - more precise estimation of the number of deaths associated with drugs in France, by reducing the underreporting of certain deaths of toxic origin, in particular those occurring in a medical or legal setting not declared to health-care authorities due to the right to confidentiality.","abstract":"","coll_dates":[{"start":"2002-01-01"}],"nation":[{"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\": \"DRAMES includes deaths meeting OEDT's definition A of drug-associated deaths (psychosis due to drugs, dependence, drug abuse without dependence, accidental poisoning caused by taking opioids (if there is a history of abuse), cocaine, psychostimulants, cannabis, hallucinogens or opioid-replacement treatments) and for which toxicology analyses were performed by the toxicologists participating in the study. Deaths due to suicide (voluntary drug overdose), accidental overdose in children (non-dependent), fatal traffic accidents associated with taking one of these products and poorly documented cases were not included in DRAMES\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological data']","quality_statement":{"standards":[{"name":"['DRAMES includes deaths meeting OEDT\\'s definition A of drug-associated deaths (psychosis due to drugs, dependence, drug abuse without dependence, accidental poisoning caused by taking opioids (if there is a history of abuse), cocaine, psychostimulants, cannabis, hallucinogens or opioid-replacement treatments) and for which toxicology analyses were performed by the toxicologists participating in the study']","committee":"","governance":""}],"other_quality_statement":"['Centre R\u00e9gional de Pharmacovigilance et d\\'information sur les m\u00e9dicaments']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/mortality"}]},"method":{"data_collection":{"time_method":"One-time cross-sectional study","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":"[1000-10000[ individuals","response_rate":"2011 (in 2012)"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational 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":"","conditions":"Contact the principal investigator","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":"29-04-2015","lastUpdatedAuto":null,"lastUpdatedManual":"12-09-2017","isContributorPI":"No","contributorName":"Michel MALLARET","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE","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"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"No","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Data collection is performed in an anonymous file, completed by the expert toxicologist","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"13 CEIPs in France"},"dataTypes":{"clinicalDataDetails":"Data collection is performed in an anonymous file, completed by the expert toxicologist. The collected data allow for characterisation of the subjects and description of the circumstances in which the body was found","biologicalDataDetails":"the stage of abuse at the time of death, the autopsy results as well as the identification of the substances at fault and their respective involvement, the quantification of the substances found in the biological samples","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}