{"doc_desc":{"title":"Etude transversale sur la prise en charge th\u00e9rapeutique de la Polyarthrite Rhumato\u00efde en France en 2006","idno":"FRESH-PEF122-fr","producers":[{"name":"Bruno BREGMAN","affiliation":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF122-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"122"},{"agency":"FReSH","code":"FRESH-PEF122"}]},"title":"Etude transversale sur la prise en charge th\u00e9rapeutique de la Polyarthrite Rhumato\u00efde en France en 2006","alternate_title":"OPALE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Bruno;BREGMAN","firstname":"Bruno","lastname":"BREGMAN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/013b57229","role":"organisation id"},{"title":"SIREN","uri":"380059956","role":"organisation id"}],"email":"bruno.bregman@bms.com","affiliationName":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","PILabo":"Bristol-Myers 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POINTE-A-PITRE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/013b57229"},{"title":"SIREN","uri":"380059956"}]}]},"distribution_statement":{"contact":[{"name":"Bruno;BREGMAN","lastname":"BREGMAN","firstname":"Bruno","type":"contact","email":"bruno.bregman@bms.com","affiliationName":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/013b57229","role":"organisation id","title":"ROR"},{"uri":"380059956","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"prise en charge"},{"keyword":"traitements"},{"keyword":"caract\u00e9ristiques"}],"topics":[{"topic":"Rhumatologie","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":"Polyarthrite rhumato\u00efde","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/576319925","title":"CIM-11"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"D\u00e9crire les modalit\u00e9s de prise en charge des patients souffrant de polyarthrite rhumato\u00efde ainsi que des types d'associations de traitements prescrits par les praticiens en France, de fa\u00e7on globale et en fonction des principales caract\u00e9ristiques des patients et de la maladie.","abstract":"","coll_dates":[{"start":"2006-01-01","end":"2006-12-31"}],"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\": \"Partie Registre: H\\\/F adultes, souffrant de polyarthrite rhumato\u00efde l\u00e9g\u00e8re \u00e0 s\u00e9v\u00e8re trait\u00e9e ou non, vus en consultation de rhumatologie. Partie Etude: patients du registre recevant ou initiant un traitement de fond (biologique ou non biologique) au moment de l'inclusion dans l'\u00e9tude\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","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"}]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Probability.Cluster\",\"vocab\":\"CESSDA\"},\"value\":\"Probabiliste : grappe\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1600"},"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\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"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":"31-01-2011","lastUpdatedAuto":null,"lastUpdatedManual":"05-09-2017","isContributorPI":false,"contributorName":"Bruno BREGMAN","contributorAffiliation":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/tinyurl.com\/PUBMED-OPALE"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"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":"Fomulaire papier ou electronique","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"VS, CRP, Facteur rhumato\u00efde, HLA DR4, Anti CCP","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}