{"doc_desc":{"title":"Etude cas\/t\u00e9moin sur l'\u00e9valuation de l\u2019atteinte de la coh\u00e9rence centrale dans l\u2019anorexie mentale restrictive : \u00e9tude monocentrique cas\/t\u00e9moin","idno":"FRESH-PEF73274-fr","producers":[{"name":"Jennyfer CHOLET","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73274-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73274"},{"agency":"FReSH","code":"FRESH-PEF73274"}]},"title":"Etude cas\/t\u00e9moin sur l'\u00e9valuation de l\u2019atteinte de la coh\u00e9rence centrale dans l\u2019anorexie mentale restrictive : \u00e9tude monocentrique cas\/t\u00e9moin","alternate_title":"CoCA"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"ANSM"},{"name":"CPP"}]},"authoring_entity":[{"name":"Jennyfer;CHOLET","firstname":"Jennyfer","lastname":"CHOLET","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05c1qsg97","role":"organisation id"},{"title":"SIREN","uri":"264400136","role":"organisation id"}],"email":"jennyfer.cholet@ch-gdaumezon.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","PILabo":"CHU de Nantes \/ Service d\u2019Addictologie et de Psychiatrie de Liaison \/ UIC 18 (CHU de Nantes) \"Addictions Comportementales et Troubles de l'Humeur Complexes\" \/ EA 4275 SPHERE \"Biostatistique, Pharmaco\u00e9pid\u00e9miologie et Mesures Subjectives en Sant\u00e9\"","isContact":true}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05c1qsg97","role":"sponsor id"},{"title":"SIREN","uri":"264400136","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"FONDATION DE FRANCE","extlink":[{"title":"SIREN","uri":"784314908"}]}]},"distribution_statement":{"contact":[{"name":"Jennyfer;CHOLET","lastname":"CHOLET","firstname":"Jennyfer","type":"contact","email":"jennyfer.cholet@ch-gdaumezon.fr","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05c1qsg97","role":"organisation id","title":"ROR"},{"uri":"264400136","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[],"topics":[{"topic":"Psychiatrie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3de50dee-da1c-4791-a386-56bca24a5fed"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D011570"}]},{"topic":"Addictologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/42d645e0-f58d-40ed-9917-5b227ff41a92"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000073316"}]},{"topic":"Anorexie mentale","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/263852475","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"}],"purpose":"","abstract":"","coll_dates":[{"start":"2015-01-01","end":"2017-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Pays de la Loire']","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\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Cas : Femmes,  \u00e2g\u00e9e de plus de 15 ans et 3 mois, suivie dans le service d\u2019addictologie et de psychiatrie de liaison du CHU de Nantes (consultations et\\\/ou hospitalisations) pour une anorexie mentale restrictive, maitrisant la langue fran\u00e7aise et ayant sign\u00e9 le consentement si elles sont majeures sinon que le repr\u00e9sentant l\u00e9gal ait sign\u00e9 le consentement (pour les mineures).  T\u00e9moins : Femmes,  \u00e2g\u00e9e de plus de 15 ans et 3 mois, maitrisant la langue fran\u00e7aise et ayant sign\u00e9 le consentement si elles sont majeures sinon que le repr\u00e9sentant l\u00e9gal ait sign\u00e9 le consentement (pour les mineures). Appariement sur l'\u00e2ge avec les cas. Ne seront pas incluses les femmes avec des troubles du comportement alimentaire actuels ou pass\u00e9s. \",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Cotation par deux \u00e9valuateurs en aveugle pour figure de Rey et test de Hayling. Saisie de l\\'auto\u00e9valuation et de l\\'h\u00e9t\u00e9ro\u00e9valuation sur e-CRF. Lors de la saisie sur l\\'eCRF des tests de coh\u00e9rence sont effectu\u00e9s.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation de soins\/services de sant\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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"120 : 60 cas (cases) - 60 t\u00e9moins (controls)"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Etude cas-t\u00e9moins"]}]},"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":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques \u00e0 d\u00e9terminer. 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":"18-11-2015","lastUpdatedAuto":null,"lastUpdatedManual":"26-09-2017","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["","",""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.sphere-nantes.fr\/"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":false},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Recueil sur CRf papier : autoquestionnaires papiers compl\u00e9t\u00e9s pr\u00e9alablement \u00e0 l'h\u00e9t\u00e9ro\u00e9valuation en face \u00e0 face, h\u00e9t\u00e9ro\u00e9valuation compl\u00e9t\u00e9e sur CRF papier lors de l'\u00e9valuation en face \u00e0 face, cotation des tests neuropsychologiques \u00e0 post\u00e9riori","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Patientes et t\u00e9moins en provenance de Nantes et de la r\u00e9gion pays de la loire principalement"},"dataTypes":{"clinicalDataDetails":"Diagnostic de TCA actuel (crit\u00e8res DSM), Diagnostics de TCA pass\u00e9s (crit\u00e8res DSM), v\u00e9rifications des crit\u00e8res d'inclusions et de non inclusions par le m\u00e9decin r\u00e9f\u00e9rent de la prise en charge pour les cas. Mesures staturopond\u00e9rales avec l'\u00e9valuateur lors de l'entretien en face \u00e0 face pour les cas et les t\u00e9moins","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"}