{"doc_desc":{"title":"Observatoire National sur la prise en charge th\u00e9rapeutique en m\u00e9decine de ville des patients de 65 ans et plus, pr\u00e9sentant un diab\u00e8te de type 2, une douleur chronique ou une fibrillation auriculaire","idno":"FRESH-PEF90-fr","producers":[{"name":"Franck VIGNAL","affiliation":"SANOFI (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF90-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"90"},{"agency":"FReSH","code":"FRESH-PEF90"}]},"title":"Observatoire National sur la prise en charge th\u00e9rapeutique en m\u00e9decine de ville des patients de 65 ans et plus, pr\u00e9sentant un diab\u00e8te de type 2, une douleur chronique ou une fibrillation auriculaire","alternate_title":"Les S.AGES"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"type":"investigator","name":"Franck;VIGNAL","PILabo":"Sanofi Aventis","affiliationName":"SANOFI (FRANCE)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"395030844","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"franck.vignal@sanofi.com","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"SANOFI (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02n6c9837","role":"sponsor id"},{"title":"SIREN","uri":"395030844","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02n6c9837"},{"title":"SIREN","uri":"395030844"}]}]},"distribution_statement":{"contact":[{"name":"Franck;VIGNAL","email":"franck.vignal@sanofi.com","type":"contact","affiliationName":"SANOFI (FRANCE)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02n6c9837","role":"organisation id","title":"ROR"},{"uri":"395030844","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Observatoires sujets \u00e2g\u00e9s"}],"topics":[{"topic":"Diab\u00e8te sucr\u00e9 de type 2","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/119724091","title":"CIM-11"}]},{"topic":"Fibrillation atriale","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/171698302","title":"CIM-11"}]},{"topic":"Douleur chronique","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1581976053","title":"CIM-11"}]}],"purpose":"D\u00e9crire la prise en charge th\u00e9rapeutique en m\u00e9decine g\u00e9n\u00e9rale des patients de 65 ans et plus pr\u00e9sentant un diab\u00e8te de type 2, une douleur chronique ou une fibrillation auriculaire.","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2014-01-01"}],"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\": \"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\": \"\u25aaHomme ou femme \u00e2g\u00e9(e) de 65 ans et plus r\u00e9sidant en France m\u00e9tropolitaine  \u25aaAffili\u00e9 \u00e0 un r\u00e9gime de s\u00e9curit\u00e9 sociale ou b\u00e9n\u00e9ficiaire d\u2019un r\u00e9gime \u00e9quivalent \u25aaAcceptant de participer \u00e0 l\u2019\u00e9tude et ayant sign\u00e9 le formulaire de consentement  \u25aaPr\u00e9sentant un diab\u00e8te de type 2 trait\u00e9 par antidiab\u00e9tiques oraux et\\\/ou antidiab\u00e9tiques injectables (pour l'observatoire Diab\u00e8te) \u25aaPr\u00e9sentant ou ayant pr\u00e9sent\u00e9 dans les 12 mois pr\u00e9c\u00e9dant l\u2019inclusion, une fibrillation auriculaire (FA) document\u00e9e (par ECG ou Holter ECG) quel que soit le rythme le jour de l\u2019inclusion (pour l'observatoire Fibrillation Auriculaire) \u25aaPr\u00e9sentant une douleur \u00e9voluant depuis plus de 3 mois, n\u00e9cessitant une prise en charge (pour l'observatoire Douleur Chronique)\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es paracliniques (hors biologiques) : Autre']","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\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation de soins\/services de sant\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral 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":"in progress"},"method_notes":"Etude observationnelle","study_class":"Inconnu","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":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"18-01-2013","isContributorPI":"Non","contributorName":"Franck VIGNAL","contributorAffiliation":"SANOFI (FRANCE)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Recueil des donn\u00e9es pour chacune des visites, par le m\u00e9decin g\u00e9n\u00e9raliste, sur un site internet d\u00e9di\u00e9 \u00e0 chacun des observatoires.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"- Cr\u00e9atin\u00e9mie - HBA1C pour l'observation Diab\u00e8te","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}