{"doc_desc":{"title":"Etude longitudinale sur des jeunes adultes trait\u00e9s pour hypothyro\u00efdie cong\u00e9nitale depuis la p\u00e9riode n\u00e9onatale : \u00e9tat de sant\u00e9, fertilit\u00e9, d\u00e9roulement de la grossesse et \u00e9tat de sant\u00e9 de leur enfant","idno":"FRESH-PEF5664-fr","producers":[{"name":"Juliane LEGER","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5664-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5664"},{"agency":"FReSH","code":"FRESH-PEF5664"}]},"title":"Etude longitudinale sur des jeunes adultes trait\u00e9s pour hypothyro\u00efdie cong\u00e9nitale depuis la p\u00e9riode n\u00e9onatale : \u00e9tat de sant\u00e9, fertilit\u00e9, d\u00e9roulement de la grossesse et \u00e9tat de sant\u00e9 de leur enfant","alternate_title":"HYPOTHYRO\u00cfDIE CONG\u00c9NITALE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Juliane;LEGER","firstname":"Juliane","lastname":"LEGER","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id"},{"title":"SIREN","uri":"267500452","role":"organisation id"}],"email":"juliane.leger@aphp.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","PILabo":"AP-HP \/ CENTRE DE R\u00c9F\u00c9RENCE MALADIES ENDOCRINIENNES RARES DE LA CROISSANCE H\u00d4PITAL ROBERT DEBR\u00c9 AP-HP","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"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":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]},{"name":"PFIZER (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10"},{"title":"SIREN","uri":"433623550"}]}]},"distribution_statement":{"contact":[{"name":"Juliane;LEGER","lastname":"LEGER","firstname":"Juliane","type":"contact","email":"juliane.leger@aphp.fr","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":"statut vital"},{"keyword":"insertion socio-professionnelle"},{"keyword":"fertilit\u00e9"},{"keyword":"descendance"},{"keyword":"Ev\u00e9nements de sant\u00e9"},{"keyword":"traitement"},{"keyword":"qualit\u00e9 de vie"},{"keyword":"morbidit\u00e9"},{"keyword":"grossesse"},{"keyword":"environnement"}],"topics":[{"topic":"Endocrinologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D004704"}]},{"topic":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : analyser le devenir \u00e0 l\u2019\u00e2ge adulte des sujets trait\u00e9s depuis la p\u00e9riode n\u00e9onatale pour hypothyro\u00efdie cong\u00e9nitale (HC), gr\u00e2ce \u00e0 l'action de d\u00e9pistage syst\u00e9matique institu\u00e9e en France depuis 1978. Objectifs secondaires : - \u00e9valuer l\u2019\u00e9tat de sant\u00e9 \u00e0 l\u2019\u00e2ge adulte, de la qualit\u00e9 de vie et de l\u2019insertion socio-professionnelle, de la fertilit\u00e9 et de l\u2019\u00e9tat de sant\u00e9 de leur descendance c'est-\u00e0-dire des enfant des sujets trait\u00e9s pour HC, avec la recherche d\u2019anomalie de d\u00e9veloppement de la thyro\u00efde ainsi que le d\u00e9veloppement g\u00e9n\u00e9ral lors de la premi\u00e8re ann\u00e9e de vie. - identifier selon le ph\u00e9notype des sous groupes de patients candidats \u00e0 une \u00e9tude g\u00e9n\u00e9tique. L\u2019\u00e9tude des femmes trait\u00e9es pour hc comprend \u00e9galement l\u2019analyse du d\u00e9roulement et de l\u2019issue de la grossesse ainsi que des besoins en thyroxine pendant la grossesse . - am\u00e9liorer les strat\u00e9gies de prise en charge (enfant, adolescents, adultes, femmes enceintes).","abstract":"","coll_dates":[{"start":"1978-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"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\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": 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\"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\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\": \"D\u00e9pist\u00e9s pour hypothyro\u00efdie en p\u00e9riode n\u00e9onatale entre 1978 et 1988\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude']","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 ou retour vers le patient ou retour vers un tiers Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi Relance des sujets pour r\u00e9aliser les visites de suivi 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\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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet 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