{"doc_desc":{"title":"Int\u00e9r\u00eat, en m\u00e9decine g\u00e9n\u00e9rale, de l'utilisation de nouveaux concepts pour l'\u00e9valuation de la r\u00e9ponse au traitement antalgique,chez les patients atteints d'arthrose des membres inf\u00e9rieurs.","idno":"FRESH-PEF93-fr","producers":[{"name":"Franck VIGNAL","affiliation":"SANOFI (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF93-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"93"},{"agency":"FReSH","code":"FRESH-PEF93"}]},"title":"Int\u00e9r\u00eat, en m\u00e9decine g\u00e9n\u00e9rale, de l'utilisation de nouveaux concepts pour l'\u00e9valuation de la r\u00e9ponse au traitement antalgique,chez les patients atteints d'arthrose des membres inf\u00e9rieurs.","alternate_title":"PASS-ARTHROSE"},"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":"\u00e9valuation de la douleur et r\u00e9ponse au traitement antalgique"},{"keyword":"PASS"},{"keyword":"Minimal Clinically Important Improvement (MCII)"}],"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","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/558562409","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"D\u00e9terminer, chez les patients souffrant d\u2019arthrose des membres inf\u00e9rieurs, le pourcentage de patients trouvant leur douleur \u00ab acceptable \u00bb au repos et au mouvement, apr\u00e8s une semaine de traitement, selon le concept du PASS ( Patient Acceptable Symptomatic State).","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2010-01-01"}],"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\": \"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\": \"Les patients doivent : \u2022 \u00eatre ambulatoires, \u2022 \u00eatre \u00e2g\u00e9s de 50 ans et plus, \u2022 consulter pour une gonarthrose et\\\/ou une coxarthrose d\u00e9finie selon les crit\u00e8res cliniques ou radiologiques de l\u2019American College of Rheumatology,  \u2022 \u00eatre symptomatiques avec une douleur sup\u00e9rieure ou \u00e9gale \u00e0 3 sur une \u00e9chelle num\u00e9rique de douleur de 0 \u00e0 10, au repos ou au mouvement, dans les 24 heures pr\u00e9c\u00e9dant l\u2019entr\u00e9e dans l\u2019\u00e9tude, \u2022 n\u00e9cessiter la prise d\u2019un traitement antalgique pendant une dur\u00e9e d\u2019au moins une semaine, \u2022 \u00eatre capables et accepter de compl\u00e9ter un questionnaire d\u2019auto-\u00e9valuation, \u2022 accepter de participer \u00e0 l\u2019\u00e9tude.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es socio-d\u00e9mographiques']","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":"Etude transversale non r\u00e9p\u00e9t\u00e9e","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral Base m\u00e9dico-administrative (de patients, Assurance Maladie\/Mutuelle) Registre de maladies, de d\u00e9c\u00e8s']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"3329"},"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,"status":"imported","creationDate":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2020","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":"Non","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"m\u00e9decine g\u00e9n\u00e9rale, \u00e9valuation de la douleur et r\u00e9ponse au traitement antalgique, arthrose MI Questionnaire m\u00e9decin autoquestionnaire patient","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Territoire fran\u00e7ais (France+DOM)"},"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"}