{"doc_desc":{"title":"\u00c9tude \u00e9pid\u00e9miologique descriptive de la prise de d\u00e9cision th\u00e9rapeutique lors de la prise en charge de la polyarthrite rhumato\u00efde : crit\u00e8res des m\u00e9decins et opinions des patients","idno":"FRESH-PEF74131-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74131-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74131"},{"agency":"FReSH","code":"FRESH-PEF74131"}]},"title":"\u00c9tude \u00e9pid\u00e9miologique descriptive de la prise de d\u00e9cision th\u00e9rapeutique lors de la prise en charge de la polyarthrite rhumato\u00efde : crit\u00e8res des m\u00e9decins et opinions des patients","alternate_title":"DUO"},"study_authorization":{"agency":[{"name":"Autre"}]},"authoring_entity":[],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":";Medical data center","lastname":"Medical data center","firstname":"","type":"contact","email":"data_sharing.france@roche.com","affiliationName":"F. HOFFMANN-LA ROCHE AG","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01mqmer16","role":"organisation id","title":"ROR"},{"uri":"775752140","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Tocilizumab"}],"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":"Arthropathies inflammatoires","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/396939646","title":"CIM-11"}]},{"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":"Objectifs principaux : D\u00e9crire les crit\u00e8res utilis\u00e9s pour la prise de d\u00e9cision th\u00e9rapeutique pour les patients atteints de polyarthrite rhumato\u00efde : - donn\u00e9es cliniques, biologiques et radiologiques, impact de la polyarthrite rhumato\u00efde sur la vie des patients selon les m\u00e9decins ; - impact de la polyarthrite rhumato\u00efde sur la vie des patients selon les patients ; - caract\u00e9ristiques des m\u00e9decins. Objectifs secondaires : - D\u00e9crire les caract\u00e9ristiques de la population de patients inclus en fonction des modifications de traitement apr\u00e8s la visite d'inclusion.","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\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Crit\u00e8res d'inclusion : - Adulte (\u00e2g\u00e9 de >= 18 ans) ; - Trait\u00e9 pour la polyarthrite rhumato\u00efde ; - Vouloir et pouvoir remplir l'auto-questionnaire en fran\u00e7ais sur l'impact de la polyarthrite rhumato\u00efde pendant la visite ; - Avoir \u00e9t\u00e9 inform\u00e9 de l'\u00e9tude oralement et par \u00e9crit et ne pas s'opposer au traitement de ses donn\u00e9es.  \",\n    \"clusion_E\": \"Les patients participant \u00e0 une autre \u00e9tude clinique \u00e9valuant le traitement de la polyarthrite rhumato\u00efde au moment de l'inclusion\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"['CDISC']","committee":"","governance":""}],"other_quality_statement":"['Bonnes pratiques cliniques\/Bonnes Pratiques de Pharmacovigilance (GCP\/GVP)']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nConsommation 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\":\"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\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1115"},"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":"23-06-2022","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","isContributorPI":false,"contributorName":"Camille BACHOT","contributorAffiliation":"F. HOFFMANN-LA ROCHE AG","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"papier","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Date de la visite d'inclusion - Information du patient sur l'\u00e9tude - Donn\u00e9es g\u00e9n\u00e9rales : \u00e2ge, sexe, poids, taille - Date du diagnostic initial - Caract\u00e9ristiques de la maladie - Traitement symptomatique en cours ou corticost\u00e9ro\u00efdes (dose) - DMARDs pass\u00e9s et actuels : noms des mol\u00e9cules (m\u00e9thotrexate, hydroxychloroquine, sulfasalazine, sels d'or, l\u00e9flunomide, D-p\u00e9nicillamine, azathioprine, ciclosporine, infliximab, \u00e9tanercept, adalimumab, abatacept, rituximab, anakinra, autres), sch\u00e9mas th\u00e9rapeutiques en cours, voie d'administration et date de mise en \u0153uvre du m\u00e9thotrexate (le cas \u00e9ch\u00e9ant), date de la derni\u00e8re perfusion de rituximab (le cas \u00e9ch\u00e9ant) - S\u00e9curit\u00e9 : tout effet ind\u00e9sirable ou inconfort ressenti par le patient, selon le m\u00e9decin - Entretien avec le patient : Activit\u00e9 globale de la polyarthrite rhumato\u00efde \u00e9valu\u00e9e par l\u2019\u00e9chelle visuelle analogique (EVA), degr\u00e9 d'asth\u00e9nie, intensit\u00e9 de la douleur, dur\u00e9e de la raideur matinale, r\u00e9veils nocturnes li\u00e9s \u00e0 la polyarthrite rhumato\u00efde - Examen clinique : localisation des articulations sensibles et des articulations gonfl\u00e9es (sur 28) - Examen biologique (dernier disponible pour 2009) : dates et valeurs de la vitesse de s\u00e9dimentation des \u00e9rythrocytes (1\u02b3\u1d49 heure), de la prot\u00e9ine C-r\u00e9active et de la concentration en h\u00e9moglobine \u2013 Indice d\u2019activit\u00e9 de la maladie DAS 28 (Disease Activity Score \u00e9valuant 28 articulations, si calcul\u00e9), bas\u00e9 sur la vitesse de s\u00e9dimentation des \u00e9rythrocytes ou la prot\u00e9ine C-r\u00e9active pour le calcul. - Traitement prescrit \u00e0 la fin de la visite (traitement modifi\u00e9 ou non) - Conditions dans lesquelles l'auto-questionnaire du patient a \u00e9t\u00e9 rempli : avant la visite\/pendant la visite mais avant que la d\u00e9cision th\u00e9rapeutique ne soit prise, autre (\u00e0 pr\u00e9ciser).","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}