{"doc_desc":{"title":"Cohorte de patients souffrant d'arthrose symptomatique douloureuse du genou : prise en charge th\u00e9rapeutique au long cours en m\u00e9decine g\u00e9n\u00e9rale","idno":"FRESH-PEF121-fr","producers":[{"name":"Catherine PAYEN-CHAMPENOIS","affiliation":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF121-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"121"},{"agency":"FReSH","code":"FRESH-PEF121"}]},"title":"Cohorte de patients souffrant d'arthrose symptomatique douloureuse du genou : prise en charge th\u00e9rapeutique au long cours en m\u00e9decine g\u00e9n\u00e9rale","alternate_title":"ATLANTIS"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Catherine;PAYEN-CHAMPENOIS","PILabo":"Bristol-Myers Squibb","affiliationName":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"380059956","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"catherine_payen-champenois@vrtx.com","isContact":"Oui"},{"type":"investigator","name":"Nathalie;SCHMIDELY","PILabo":"Bristol-Myers Squibb","affiliationName":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"380059956","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"","isContact":"Non"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/013b57229","role":"sponsor id"},{"title":"SIREN","uri":"380059956","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE POINTE-A-PITRE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/013b57229"},{"title":"SIREN","uri":"380059956"}]}]},"distribution_statement":{"contact":[{"name":"Catherine;PAYEN-CHAMPENOIS","email":"catherine_payen-champenois@vrtx.com","type":"contact","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":"parac\u00e9tamol"},{"keyword":"PRO"},{"keyword":"prise en charge"}],"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":"Arthrose du genou","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1685726407","title":"CIM-11"}]},{"topic":"Arthrose","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/558562409","title":"CIM-11"}]}],"purpose":"Evaluer, chez le m\u00e9decin g\u00e9n\u00e9raliste, l'\u00e9volution de la strat\u00e9gie th\u00e9rapeutique de premi\u00e8re intention chez les patients souffrant d'arthrose douloureuse du genou, sur une p\u00e9riode d'un an, en particulier: - Evaluer le pourcentage de patients trait\u00e9s par chaque modalit\u00e9 th\u00e9rapeutique \u00e0 la fin de la p\u00e9riode d'observation d'un an. - D\u00e9crire les modifications apport\u00e9es dans la prise en charge th\u00e9rapeutique et identifier les raisons justifiant ces modifications.","abstract":"","coll_dates":[{"start":"2003-01-01","end":"2006-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Espagne","abbreviation":"es","extLink":{"vocab":"ISO","vocabURI":"es"}}],"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\": \"1. Hommes ou femmes  50 ans ou plus souffrant d'arthrose symptomatique douloureuse du genou  2. Non trait\u00e9s au cours des 6 derniers mois pour cette pathologie (seront autoris\u00e9s les traitements non pharmacologiques, l\u2019autom\u00e9dication par antalgiques ou AINS \u00e0 faibles doses). 3. Pour lesquels le m\u00e9decin aura d\u00e9cid\u00e9 d'initier un traitement de premi\u00e8re intention conforme aux recommandations de l'EULAR 2000-2003 (parac\u00e9tamol - en prises syst\u00e9matiques \u00e0 une dose de 3 \u00e0 4g\\\/j - en monoth\u00e9rapie pharmacologique en association avec des traitements non pharmacologiques).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','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":"Consommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Probability.Cluster\",\"vocab\":\"CESSDA\"},\"value\":\"Probabiliste : grappe\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral']"}},"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":"1114 (586 in France, 528 in Spain)"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"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":"","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":"05-09-2017","isContributorPI":"Non","contributorName":"Catherine PAYEN-CHAMPENOIS","contributorAffiliation":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","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":"cahier d'observation papier","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France et Espagne"},"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"}