{"doc_desc":{"title":"Cox-2 and tNSAIDs: Description of users","idno":"FRESH-PEF2926-en","producers":[{"name":"C\u00e9cile DROZ-PERROTEAU","affiliation":"UNIVERSITE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF2926-en","IDno":{"metadata_no":[{"agency":"PEF","code":"2926"},{"agency":"FReSH","code":"FRESH-PEF2926"}]},"title":"Cox-2 and tNSAIDs: Description of users","alternate_title":"CADEUS"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Patrick;BLIN","PILabo":"Universit\u00e9 Bordeaux \/ Service de Pharmacologie, CIC-P 0005-INSERM U657- Universit\u00e9 Bordeaux Segalen","affiliationName":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ORCID","uri":"0000-0003-4005-7928","role":"pi id"},{"title":"IdRef","uri":"182433455","role":"pi id"},{"title":"SIREN","uri":"130018351","role":"organisation id"},{"title":"RNSR","uri":"200120110J","role":"labo 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Produits de Sant\u00e9)"},{"keyword":"Cyclo-oxygenase 2"},{"keyword":"coxibs"},{"keyword":"Vioxx"},{"keyword":"use"},{"keyword":"pharmacoepidemiology"},{"keyword":"cohort"},{"keyword":"Department of Pharmacology"},{"keyword":"Bordeaux"}],"topics":[{"topic":"Rheumatology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bfb0bafd-7894-45ba-84fc-ddab5fd6c537"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D012219"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"The objective of this study was to better understand the use of anti-inflammatory drugs, cyclo-oxygenase 2 (COX-2) or coxib (Vioxx\u00ae, Celebrex\u00ae) and traditional anti-inflammatory drugs (tNSAIDs, e.g. Aspirin, Ibuprofen) in France and to describe and assess the risks of adverse events possibly related to treatment.","abstract":"","coll_dates":[{"start":"2003-01-01","end":"2005-01-01"}],"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\": \"Patient randomly selected from the source population using the following criteria: not dead according to the ERASME database, living in France with a valid address, with dispensation of an NSAIDs of interest during the month preceding selection, with at least one healthcare reimbursement within six months preceding the date of dispensation, for whom the contact details of the prescribing physician were available, not previously selected from the source population, not being listed under guardianship or in prison; patient agreeing to participate in the study\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Socio-demographic data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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":""}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"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":"45 217 patients inclus - 45 217 patients included"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":"- Approval of the entire study by the Advisory Committee on Research Information Processing in the Health Field and the National Commission for Data Protection and Liberties (CNIL)."}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"Ownership of study data was the subject of an agreement between the University Bordeaux Segalen and pharmaceutical companies."}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"09-06-2011","lastUpdatedAuto":null,"lastUpdatedManual":"25-06-2012","isContributorPI":"No","contributorName":"C\u00e9cile DROZ-PERROTEAU","contributorAffiliation":"UNIVERSITE DE BORDEAUX","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed?term"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry","Industry"],"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":"A self-administered questionnaire sent to each selected patient and prescriber of the NSAID of interest, has allowed the collection of the information requested by Comit\u00e9 Economique des Produits de Sant\u00e9. For patients agreeing to participate in the study, healthcare reimbursement data for six months before and six months after the reference date (dispensation date of NSAID of interest) were retrieved from the CNAM-TS database. Hospitalizations for cardiovascular events or digestive having occurred between the reference date and the date of questionnaire completion have been documented (retrieval of hospital discharge summaries by a CRA from the prescribing physician or general practitioner with return to the Department of Pharmacology by post). The reason for hospitalization was subsequently validated by a committee blinded to the NSAID of interest and according to predefined diagnostic criteria.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Metropolitan France"},"dataTypes":{"clinicalDataDetails":"","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"}