{"doc_desc":{"title":"Cohorte de patients atteints de maladies rhumatismales: observation des pratiques et usages","idno":"FRESH-PEF60035-fr","producers":[{"name":"Francis GUILLEMIN","affiliation":"chu"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60035-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60035"},{"agency":"FReSH","code":"FRESH-PEF60035"}]},"title":"Cohorte de patients atteints de maladies rhumatismales: observation des pratiques et usages","alternate_title":"CORPUS"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Francis;GUILLEMIN","PILabo":"CHU \/ CIC-EC NANCY","affiliationName":"chu","extlink":[{"title":"ORCID","uri":"0000-0002-9860-7024","role":"pi id"},{"title":"IdRef","uri":"068536569","role":"pi id"},{"title":"SIREN","uri":"200042166","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"francis.guillemin@univ-lorraine.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/016ncsr12","role":"sponsor id"},{"title":"SIREN","uri":"200042166","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ABBOTT FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05wz8pk64"},{"title":"SIREN","uri":"602950206"}]},{"name":"MERCK SANTE","extlink":[{"title":"SIREN","uri":"572028033"}]},{"name":"PFIZER (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10"},{"title":"SIREN","uri":"433623550"}]}]},"distribution_statement":{"contact":[{"name":"Francis;GUILLEMIN","email":"francis.guillemin@univ-lorraine.fr","type":"contact","affiliationName":"chu","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/016ncsr12","role":"organisation id","title":"ROR"},{"uri":"200042166","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"\u00e9tat de sant\u00e9"},{"keyword":"recours au soins"},{"keyword":"reprise d'activit\u00e9"},{"keyword":"traitement par bioth\u00e9rapie"},{"keyword":"switch"},{"keyword":"effets ind\u00e9sirables"},{"keyword":"qualit\u00e9 de vie"}],"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":"Spondylarthrite inflammatoire","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1848981072","title":"CIM-11"}]},{"topic":"Arthrite juv\u00e9nile idiopathique","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1322678686","title":"CIM-11"}]}],"purpose":"Objectif g\u00e9n\u00e9ral : d\u00e9terminer l'impact de la prescription du traitement de fond avec ou sans prescription de bioth\u00e9rapies et plus particuli\u00e8rement l'impact des changements de bioth\u00e9rapies au cours du temps. Enregistrement \u00e9pid\u00e9miologique de la survenue d'\u00e9v\u00e9nements ind\u00e9sirables \u00e0 long terme. Objectif secondaire : d\u00e9terminer la place des bioth\u00e9rapies dans l'ensemble de la prise en charge de ces patients, en termes de position dans l'ordre des prescriptions au cours du temps dans leurs s\u00e9quences th\u00e9rapeutiques.","abstract":"","coll_dates":[{"start":"2007-01-01","end":"2012-01-01"}],"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 (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\": \"Tous les patients n'ayant jamais re\u00e7u de bioth\u00e9rapie, suivis dans l'un des centre participant : - avec une polyarthrite rhumato\u00efde active (avec ou sans prescriptions), avec un score DAS 28 sup\u00e9rieur \u00e0 3.2, quelquesoit l'\u00e2ge du d\u00e9but de la maladie, disposant d'une radiographie de moins de 3 mois de mains et de pieds - avec une arthrite juvenile (AJI) idiopathique active (avec ou sans prescription), apres \u00e9chec ou intol\u00e9rance au methrexate, disposant d'une radiographie de moins de 3 mois - avec une spondylarthropathie (SPA) (ankylosante ou rhumatisme psoriasique) active (avec ou sans prescription), quelque soit l'\u00e2ge du d\u00e9but de la maladie, disposant d'une radiographie de moins de 3 mois de bassin et de rachis, ou de mains et de pieds selon la forme axiale ou p\u00e9ripherique\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques Appels de t\u00e9l\u00e9monitoring trimestriels \u00e0 l\\'investigateur pour r\u00e9soudre les incoh\u00e9rences et compl\u00e9ter les donn\u00e9es manquantes. Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi R\u00e9alisation d\\'audits internes de qualit\u00e9Fr\u00e9quence audit interne : tous les ans 10% des investigateurs sont audit\u00e9s sur les donn\u00e9es des patients recueilles dans l\\'ann\u00e9e de l\\'auditLes patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Qualit\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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"640 (407 PAR, 192 SPA, 41 AJI)"},"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 aux seules m\u00e9tadonn\u00e9es\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_14cb\"}]}"},"dataset_use":{"restrictions":"Utilisation non possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques. Utilisation non possible des donn\u00e9es par des industriels.","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"05-09-2017","isContributorPI":"Non","contributorName":"Francis GUILLEMIN","contributorAffiliation":"CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/tinyurl.com\/PUBMED-CORPUS"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie","Industrie","Industrie"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"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":"Auto-questionnaire : saisie optique \u00e0 partir d\u2019un questionnaire papier Examens cliniques : saisie optique \u00e0 partir d\u2019un formulaireExamens biologiques : saisie optique \u00e0 partir d\u2019un formulaire papier","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique (133 centres) Fran\u00e7aise"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi tous les ansInformations recueillies lors de l'examen clinique : historique de la maladie, historique des radiologies, autres techniques d'imageries, donn\u00e9es biologiques, prise en charge pass\u00e9e : chirurgie, ergoth\u00e9rapie, kin\u00e9sith\u00e9rapie, \u00e9valuation \u00e9conomique, signes associ\u00e9s \u00e0 la maladie, traitement","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"}