{"doc_desc":{"title":"Long term observational study on the therapeutic management of knee osteoarthritis by general practitioners","idno":"FRESH-PEF121-en","producers":[{"name":"Catherine PAYEN-CHAMPENOIS","affiliation":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF121-en","IDno":{"metadata_no":[{"agency":"PEF","code":"121"},{"agency":"FReSH","code":"FRESH-PEF121"}]},"title":"Long term observational study on the therapeutic management of knee osteoarthritis by general practitioners","alternate_title":"ATLANTIS"},"study_authorization":{"agency":[]},"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":"Yes"},{"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":"No"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"therapeutic management"},{"keyword":"paracetamol"},{"keyword":"patient reported outcomes"}],"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","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/558562409","title":"CIM-11"}]}],"purpose":"Evaluate, in general practice, the change in the first-line therapeutic strategy in patients suffering from knee osteoarthritis, over one year, specially: - Evaluate the percentage of patients treated with each therapeutic modality at the end of the one year observation period. - Describe the modifications implemented in the therapeutic management and identify the reasons justifying these modifications.","abstract":"","coll_dates":[{"start":"2003-01-01","end":"2006-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Spain","abbreviation":"es","extLink":{"vocab":"ISO","vocabURI":"es"}}],"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\": \"1. Males or females 50 years or older suffering from symptomatic osteoarthritis of the knee  2. Not treated over the last 6 months for this pathology (non-pharmaceutical treatments and self-medication by analgesics or NSAIDs at low doses will be allowed). 3. For whom the physician will have decided to initiate a first-line treatment in line with the recommendations of EULAR 2000-2003 (paracetamol - systematically taken at a dose of 3 to 4g\\\/d - as pharmacological monotherapy in combination with non-pharmaceutical treatments).\",\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 care consumption and services\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Probability.Cluster\",\"vocab\":\"CESSDA\"},\"value\":\"Probability: Cluster\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through independent healthcare practitioners']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1114 (586 in France, 528 in Spain)"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"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":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"05-09-2017","isContributorPI":"No","contributorName":"Catherine PAYEN-CHAMPENOIS","contributorAffiliation":"BRISTOL MYERS SQUIBB PHARMA FRANCE S.A","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["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":"paper case report form","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France and Spain"},"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"}