{"doc_desc":{"title":"Enqu\u00eate transversale multicentrique de type un jour \u00e9valuant la prise en charge du glaucome \/ hypertension oculaire","idno":"FRESH-PEF101-fr","producers":[{"name":"Sylvie TROY","affiliation":"PFIZER (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF101-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"101"},{"agency":"FReSH","code":"FRESH-PEF101"}]},"title":"Enqu\u00eate transversale multicentrique de type un jour \u00e9valuant la prise en charge du glaucome \/ hypertension oculaire","alternate_title":"e-TUD"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Sylvie;TROY","PILabo":"Pfizer","affiliationName":"PFIZER (FRANCE)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"433623550","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"sylvie.troy@pfizer.com","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"PFIZER (FRANCE)","role":"sponsor","extlink":{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10","role":"sponsor id"}}],"funding_agencies":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10"}}]},"distribution_statement":{"contact":[{"name":"Sylvie;TROY","email":"sylvie.troy@pfizer.com","type":"contact","affiliationName":"PFIZER (FRANCE)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02c9yny10","role":"organisation id","title":"ROR"},{"uri":"433623550","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"prise en charge du glaucome"},{"keyword":"hypertension oculaire"}],"topics":[{"topic":"Ophtalmologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/621ef1ce-2ebd-43d9-a6c7-ecd962d27269"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009885"}]},{"topic":"Glaucome","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/499924848","title":"CIM-11"}]},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Primaire : L\u2019objectif principal de cette enqu\u00eate est de d\u00e9crire la prise en charge diagnostique et th\u00e9rapeutique des glaucomes et\/ou des hypertonies oculaires (d\u00e9finies par une pression intraoculaire \u226521 mm Hg) vus le jour de l\u2019enqu\u00eate. Secondaire : Les objectifs secondaires sont : - La description de la satisfaction et de l\u2019observance per\u00e7ues par les m\u00e9decins en fonction des traitements, - Les techniques diagnostiques utilis\u00e9es : champs visuel, imagerie oculaire et gonioscopie, - Les facteurs de risque des patients dans la pratique courante, - Le mode d\u2019exercice des ophtalmologistes dans la prise en charge du glaucome et\/ou des hypertonies oculaires. - La mise en relation avec les donn\u00e9es de l\u2019enqu\u00eate men\u00e9e en 2003.","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2009-12-31"}],"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\": [\n        \"Patients\"\n    ],\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Tous les patients pr\u00e9sentant un glaucome ou une HTO se pr\u00e9sentant \u00e0 une consultation d\u2019ophtalmologie le jour donn\u00e9 \u00e9taient inclus dans l\u2019enqu\u00eate, s\u2019ils remplissaient les conditions suivantes: - \u00e2ge sup\u00e9rieur ou \u00e9gal \u00e0 18 ans, - diagnostic d\u2019un glaucome, ou d\u2019HTO d\u00e9j\u00e0 \u00e9tablis au moment de la consultation. - a \u00e9t\u00e9 inform\u00e9 sur l\u2019enqu\u00eate et a donn\u00e9 un accord verbal pour l\u2019utilisation de donn\u00e9es le concernant.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques']","quality_statement":{"standards":[{"name":"['Who-Drug']","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Consommation 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 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":"[500-1000[ individus","response_rate":"965"},"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":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"creationDate":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2019","isContributorPI":"Non","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"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":"CRF electronique","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}