{"doc_desc":{"title":"Programme d'\u00e9tudes 3A-P\u00e9gase (Pharmaco-Epid\u00e9miologie de la Gonarthrose et de la coxArthoSE)","idno":"FRESH-PEF2611-en","producers":[{"name":"Elodie AUBRUN","affiliation":"L.A. SANTE EPIDEMIOLOGIE EVALUATION RECH"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF2611-en","IDno":{"metadata_no":[{"agency":"PEF","code":"2611"},{"agency":"FReSH","code":"FRESH-PEF2611"}]},"title":"Programme d'\u00e9tudes 3A-P\u00e9gase (Pharmaco-Epid\u00e9miologie de la Gonarthrose et de la coxArthoSE)","alternate_title":"3A-P\u00e9gase"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Lamiae;GRIMALDI-BENSOUDA","PILabo":"LA-SER","affiliationName":"L.A. SANTE EPIDEMIOLOGIE EVALUATION RECH","extlink":[{"title":"ORCID","uri":"0000-0003-1952-5467","role":"pi id"},{"title":"IdRef","uri":"077296125","role":"pi id"},{"title":"SIREN","uri":"450195979","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"lamiae.grimaldi@aphp.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"L.A. SANTE EPIDEMIOLOGIE EVALUATION RECH","extlink":[{"title":"SIREN","uri":"450195979","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"EXPANSCIENCE","extlink":[{"title":"SIREN","uri":"317586808"}]},{"name":"IBSA PHARMA SAS","extlink":[{"title":"SIREN","uri":"341264570"}]},{"name":"NEGMA","extlink":[{"title":"SIREN","uri":"402542492"}]},{"name":"NOVARTIS PHARMA SAS","extlink":[{"title":"SIREN","uri":"410349070"}]},{"name":"PIERRE FABRE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04hdhz511"}]},{"name":"ROTTAPHARM","extlink":[{"title":"SIREN","uri":"379127780"}]}]},"distribution_statement":{"contact":[{"name":"Lamiae;GRIMALDI-BENSOUDA","email":"lamiae.grimaldi@aphp.fr","type":"contact","affiliationName":"L.A. SANTE EPIDEMIOLOGIE EVALUATION RECH","contactPointLabo":"","extlink":[{"uri":"450195979","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Symptomatic slow-acting anti-arthritics"},{"keyword":"intake of NSAIDs"}],"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":"Osteoarthritis of knee","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1685726407","title":"CIM-11"}]},{"topic":"Osteoarthritis of hip","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/20048211","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"Evaluate the impact (benefit and risk) of osteoarthritis treatments in terms of public health.","abstract":"","coll_dates":[{"start":"2010-01-01"}],"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\": \"Men or women, aged 18 years or older, having painful gonarthrosis and\\\/or coxarthrosis, non-treated or treated with a symptomatic slow-acting anti-arthritic for less than 3 months.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through independent healthcare practitioners']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1900 patients"},"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":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"08-04-2011","lastUpdatedAuto":null,"lastUpdatedManual":"13-07-2012","isContributorPI":"No","contributorName":"Elodie AUBRUN","contributorAffiliation":"L.A. SANTE EPIDEMIOLOGIE EVALUATION RECH","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry","Industry","Industry","Industry","Industry","Industry"],"otherFundingAgentType":["","","","","",""]},"sponsor":{"sponsorType":["Industry"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"The data is collected using medical questionnaires and during standardized telephone interviews with the patient included. The telephone interviews are conducted after sending an interview guide beforehand (visual support).","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"}