{"doc_desc":{"title":"Cohorte de jeunes atteints de maladies inflammatoires\/rhumatologie p\u00e9diatrique","idno":"FRESH-PEF60138-fr","producers":[{"name":"Pierre QUARTIER-DIT-MAIRE","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60138-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60138"},{"agency":"FReSH","code":"FRESH-PEF60138"}]},"title":"Cohorte de jeunes atteints de maladies inflammatoires\/rhumatologie p\u00e9diatrique","alternate_title":"CEMARA"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Pierre;QUARTIER-DIT-MAIRE","PILabo":"UIH) ET INSERM U768 HOPITAL NECKER-ENFANTS MALADES \/ UNITE D\u2019IMMUNO-HEMATOLOGIE PEDIATRIQUE","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0002-1769-549X","role":"pi id"},{"title":"IdRef","uri":"139645683","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"pierre.quartier@aphp.fr","isContact":"Oui"}],"oth_id":[{"name":"Implication dans un r\u00e9seau de cohorte : PLATEFORME CEMARA PARTAGEE PAR 32 CENTRES DE REFERENCE MALADIES RARES Inclusion dans un projet europ\u00e9en : PARTICIPATION AU REGISTRE EUROFEVER POUR PLUSIEURS MALADIES INFLAMMATOIRES DONT LA FORMES SYSTEMIQUE D\u2019ARTHRITE JUVENILE IDIOPATHIQUE, L\u2019OSTEOMYELITE MULTIFOCALE PROGRESSIVE, LES GRANULOMATOSES SYSTEMIQUES PEDIATRIQUES, LES SYNDROMES CINCA\/MUCKLE-WELLS, \u2026","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"},{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"sponsor id"},{"title":"SIREN","uri":"267500452","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Pierre;QUARTIER-DIT-MAIRE","email":"pierre.quartier@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"pronostic vital"},{"keyword":"atteinte embryonaire\/foetale"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"\u00e9v\u00e9nements ind\u00e9sirables"},{"keyword":"d\u00e9c\u00e8s"},{"keyword":"hospitalisation"},{"keyword":"s\u00e9quelles"},{"keyword":"n\u00e9oplasies"}],"topics":[{"topic":"P\u00e9diatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"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":"M\u00e9nopause","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1965418440","title":"CIM-11"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : \u00c9valuer le risque de survenue d\u2019\u00e9v\u00e9nements ind\u00e9sirables graves sous ou apr\u00e8s exposition \u00e0 des bioth\u00e9rapies prescrites en rhumatologie p\u00e9diatrique. La population \u00e9tudi\u00e9e comporte une proportion croissante de patients expos\u00e9e d\u00e8s l\u2019enfance \u00e0 des bioth\u00e9rapies d\u2019introduction r\u00e9cente (antagonistes du TNFalpha, de l\u2019IL-1, de l\u2019IL-6, anti-CD20, CTLA-4IG, \u2026) parfois en association \u00e0 des immunosuppresseurs Objectifs secondaires : 1\/ \u00c9valuer parall\u00e8lement \u00e0 l\u2019objectif principal le risque de survenue d\u2019\u00e9v\u00e9nements ind\u00e9sirables graves (EIG) en l\u2019absence de bioth\u00e9rapie dans l\u2019ensemble de la cohorte de rhumatologie p\u00e9diatrique . 2\/ \u00c9valuer le risque d\u2019EIG en pr\u00e9sence ou en l\u2019absence de bioth\u00e9rapie pour nos principales sous-cohortes : arthrites juv\u00e9niles idiopathiques, maladies auto-inflammatoires p\u00e9diatriques, vascularites syst\u00e9miques et connectivit\u00e9s de l\u2019enfant dont le lupus . 3\/ Description plus pr\u00e9cise des caract\u00e9ristiques \u00e9volutives et de la prise en charge de ces patients. 4\/ Incr\u00e9menter des \u00e9tudes \u00e9pid\u00e9miologiques, cliniques et fondamentales via notamment la constitution d\u2019une bioth\u00e8que et des liens avec d\u2019autres cohortes et registres . 5\/ Favoriser l\u2019\u00e9valuation des pratiques m\u00e9dicales et de l\u2019application des recommandations des protocoles nationaux de diagnostic et de soin.","abstract":"","coll_dates":[{"start":"2007-01-01"}],"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\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients inclus dans la base Cemara avec un diagnostic relevant du label du centre de r\u00e9f\u00e9rence maladies rares \u00ab arthrites juv\u00e9niles \u00bb = maladies inflammatoires de rhumatologie p\u00e9diatrique recens\u00e9es dans le thesaurus Cemara (et le thesaurus Orphanet) entrant dans l\u2019une des 4 cat\u00e9gories suivantes : arthrites juv\u00e9niles idiopathiques, autres arthrites juv\u00e9niles, maladies auto-inflammatoires p\u00e9diatriques, maladies syst\u00e9miques et vascularit\u00e9s p\u00e9diatriques\",\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 Gestion des donn\u00e9es manquantes par retour au dossier source Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi Relance des sujets pour r\u00e9aliser les visites de suivi R\u00e9alisation d\\'audits de qualit\u00e9 internes et externes Fr\u00e9quence audit interne : 1\/AN Fr\u00e9quence audit externe : 1\/3 ANS Autre(s) proc\u00e9dure(s) qualit\u00e9 : CONTROLE PAR ECHANTILLONAGE Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9"}]},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"1068"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational 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