{"doc_desc":{"title":"Utilisation d'Instanyl rapport\u00e9e par les patients","idno":"FRESH-PEF2943-fr","producers":[{"name":"C\u00e9cile DROZ-PERROTEAU","affiliation":"UNIVERSITE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF2943-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"2943"},{"agency":"FReSH","code":"FRESH-PEF2943"}]},"title":"Utilisation d'Instanyl rapport\u00e9e par les patients","alternate_title":"PIUS"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CESREES"}]},"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 id"}],"email":"patrick.blin@u-bordeaux.fr","isContact":"Oui"},{"type":"investigator","name":"Nicholas;MOORE","PILabo":"Universit\u00e9 Bordeaux \/ Service de Pharmacologie, CIC-P 0005-INSERM U657- Universit\u00e9 Bordeaux Segalen","affiliationName":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ORCID","uri":"0000-0003-1212-2817","role":"pi id"},{"title":"IdRef","uri":"077852877","role":"pi id"},{"title":"SIREN","uri":"130018351","role":"organisation id"},{"title":"RNSR","uri":"200120110J","role":"labo id"}],"email":"nicholas.moore@u-bordeaux.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"sponsor id"},{"title":"SIREN","uri":"130018351","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"TAKEDA FRANCE SAS","extlink":[{"title":"SIREN","uri":"785750266"}]}]},"distribution_statement":{"contact":[{"name":"Patrick;BLIN","email":"patrick.blin@u-bordeaux.fr","type":"contact","affiliationName":"UNIVERSITE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/057qpr032","role":"organisation id","title":"ROR"},{"uri":"130018351","role":"organisation id","title":"SIREN"}]},{"name":"Nicholas;MOORE","email":"nicholas.moore@u-bordeaux.fr","type":"contact","affiliationName":"UNIVERSITE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/057qpr032","role":"organisation id","title":"ROR"},{"uri":"130018351","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Instanyl\u00ae"},{"keyword":"fentanyl"},{"keyword":"opio\u00efde"},{"keyword":"acc\u00e8s douloureux paroxystiques"},{"keyword":"d\u00e9tournement d'utilisation"},{"keyword":"abus"},{"keyword":"m\u00e9susage"},{"keyword":"plan de gestion de risques"},{"keyword":"cancer"},{"keyword":"pharmaco-\u00e9pid\u00e9miologie"},{"keyword":"d\u00e9partement de pharmacologie"},{"keyword":"Bordeaux"}],"topics":[{"topic":"Oncologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D008495"}]},{"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":"L\u2019objectif est d\u2019\u00e9valuer le m\u00e9susage, le d\u00e9tournement d\u2019utilisation et l\u2019abus d\u2019Instanyl\u00ae report\u00e9s par les patients en vie r\u00e9elle. Les donn\u00e9es sur les prescriptions hors indication permettront de compl\u00e9ter les donn\u00e9es de l\u2019\u00e9tude r\u00e9alis\u00e9e dans les cinq pays du Nord de l\u2019Europe (\u00e9tude LINUS, record Linkage INstanyl Use Study).","abstract":"","coll_dates":[{"start":"2011-01-01","end":"2012-01-01"}],"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\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patient ayant re\u00e7u une d\u00e9livrance d\u2019Instanyl\u00ae dans une pharmacie non hospitali\u00e8re\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","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 non 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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"600 patients inclus - 600 patients included"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"La propri\u00e9t\u00e9 des donn\u00e9es de l'\u00e9tude a fait l'objet d'une convention entre l'Universit\u00e9 Bordeaux Segalen et le laboratoire."}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"17-06-2011","lastUpdatedAuto":null,"lastUpdatedManual":"26-10-2017","isContributorPI":"Non","contributorName":"C\u00e9cile DROZ-PERROTEAU","contributorAffiliation":"UNIVERSITE DE BORDEAUX","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Non","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Les patients acceptant de participer compl\u00e8tent un questionnaire strictement anonyme.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Pharmacies non hospitali\u00e8res en France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"","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"}