{"doc_desc":{"title":"Cohorte de patients atteints de schizophr\u00e9nie","idno":"FRESH-PEF73234-fr","producers":[{"name":"Franck SCHURHOFF","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73234-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73234"},{"agency":"FReSH","code":"FRESH-PEF73234"}]},"title":"Cohorte de patients atteints de schizophr\u00e9nie","alternate_title":"FACE-SZ"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Guillaume;FOND","PILabo":"Fondation FondaMental, Inserm, Henri-Mondor university hospitals, AP-HP (Paris Public Hospitals) \/ Inserm, U955, Psychopathology and Psychiatric Disorder Genetics","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0003-3249-2030","role":"pi id"},{"title":"IdRef","uri":"15207127X","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"RNSR","uri":"200919261B","role":"labo id"}],"email":"guillaume.fond@gmail.com","isContact":"Oui"},{"type":"investigator","name":"Franck;SCHURHOFF","PILabo":"Fondation FondaMental, Inserm, Henri-Mondor university hospitals, AP-HP (Paris Public Hospitals) \/ Inserm, U955, Psychopathology and Psychiatric Disorder Genetics","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0002-2732-406X","role":"pi id"},{"title":"IdRef","uri":"078696135","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"RNSR","uri":"200919261B","role":"labo id"}],"email":"franck.schurhoff@inserm.fr","isContact":"Oui"}],"oth_id":[{"name":"EU-GEI project (European Network of National Schizophrenia Networks studying Gene-Environment Interactions), OPTIMISE project (Optimization of Treatment and Management of Schizophrenia in Europe)","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"FONDATION FONDAMENTAL","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rrhf939","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"},{"title":"SIREN","uri":"130002504"}]},{"name":"Fondation FondaMental","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rrhf939"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]}]},"distribution_statement":{"contact":[{"name":"Guillaume;FOND","email":"guillaume.fond@gmail.com","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"}]},{"name":"Franck;SCHURHOFF","email":"franck.schurhoff@inserm.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":"recherche translationnelle"},{"keyword":"schizophr\u00e9nie"},{"keyword":"pr\u00e9vention"},{"keyword":"d\u00e9pistage"},{"keyword":"traitement"},{"keyword":"prise en charge"}],"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":"Schizophr\u00e9nie","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1683919430","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 li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques : Emploi","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Les objectifs sont : -acc\u00e9l\u00e9rer l'acc\u00e8s \u00e0 des sp\u00e9cialistes pour tous les sujets souffrant de schizophr\u00e9nie, ainsi que les sujets \u00e0 risque; -promouvoir une approche de m\u00e9decine personnalis\u00e9e par une enqu\u00eate syst\u00e9matique et approfondie de la schizophr\u00e9nie, pour am\u00e9liorer la d\u00e9tection et la pr\u00e9vention de la comorbidit\u00e9 psychiatrique et somatique, d'offrir des recommandations personnalis\u00e9es pour les soins pharmacologiques, psychosociaux et le mode de vie, d'\u00e9valuer prospectivement l'impact des traitements recommand\u00e9s pour l'individu et d'identifier les facteurs de risque de rechute; -r\u00e9duire les d\u00e9lais entre l'apparition des maladies, un diagnostic pr\u00e9cis et l'introduction d'un traitement appropri\u00e9 -am\u00e9liorer la concordance entre les directives de m\u00e9decine factuelle et la pratique clinique; -Communiquer sur les connaissances et les comp\u00e9tences sur de nouveaux outils de diagnostic et les strat\u00e9gies th\u00e9rapeutiques.","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\": \"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\": \"Patients atteints de schizophr\u00e9nie dans l'un des  10 centres participants\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"603"},"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":"Pour les membres du R\u00e9seau FondaMental qui souhaitent acc\u00e9der aux donn\u00e9es de la base FACE, voici la proc\u00e9dure \u00e0 suivre : 1. Remplir une fiche de demande de sommaire et de th\u00e9saurus de la base FACE et l'envoyer \u00e0 face@fondation-fondamental.org. 2. Suite \u00e0 cet envoi, deux documents vous seront transmis: le th\u00e9saurus FACE (liste de toutes les variables disponibles) et le sommaire FACE (Donn\u00e9es class\u00e9es par grandes th\u00e9matiques) sp\u00e9cifiques \u00e0 la pathologie sp\u00e9cifi\u00e9e. 3. Pour faire une demande d'extraction, le dossier complet \u00e0 fournir comprend 3 \u00e9l\u00e9ments qui sont les suivants: - le formulaire de demande d\u2019extraction de donn\u00e9es de la base FACE (compl\u00e9t\u00e9 et sign\u00e9) - la lettre d'engagement (compl\u00e9t\u00e9e et sign\u00e9e) - le th\u00e9saurus (avec les variables demand\u00e9es coch\u00e9es) Ce dossier est \u00e0 envoyer \u00e0 : face@fondation-fondamental.org","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":"29-09-2015","lastUpdatedAuto":null,"lastUpdatedManual":"20-06-2016","isContributorPI":"Non","contributorName":"Franck SCHURHOFF","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.fondation-fondamental.org\/page_dyn.php?mytabsmenu=4"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Priv\u00e9 \u00e0 but non lucratif","Public (France)"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":"Oui"},"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":"Via l'application e-schizo\u00a9 developp\u00e9e par la fondation FondaMental","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Donn\u00e9es sociod\u00e9mographiques (\u00e2ge, sexe, \u00e9tat matrimonial, le niveau d'\u00e9ducation, nombre d'enfants), donn\u00e9es m\u00e9dico-\u00e9conomique (Global assessment of functioning scale, Quality of life: S-QoL, statut de travail et nombre de jours travaill\u00e9s pendant l'ann\u00e9e pr\u00e9c\u00e9dente, revenus, nombre de consultations durant l'ann\u00e9e autre que spychatrie, nombre de passage aux urgences , soins dentaires, Personal and Social Performance Scale (PSP)), histoire des symptomes et \u00e9volution (Positive And Negative Symptoms Scale (PANSS), nombre et dur\u00e9e des hospitalisions en spychatrie, \u00e2ge et dur\u00e9e de la 1ere hospitalisation, \u00e2ge et dur\u00e9e du 1er traitement antispychotique, comportement agressif, CGI: Clinical Global Impression), humeur (Calgary Depression Score (CDSS heteroquestionnaire), Young Mania Rating Scale (YMRS), suicide), Comorbidit\u00e9 spychatrique et facteurs de risque (anxi\u00e9t\u00e9, troubles alimentaires, histoire familiales, Childhood Trauma Questionnaire (CTQ), obsessions..), addictions (drogue, tabac, alcool, internet, jeux d'argents), comorbidit\u00e9 somatique, donn\u00e9es anthropom\u00e9triques","biologicalDataDetails":"Test sanguins complet, dosage des m\u00e9dicaments, C-reactive protein, enzymes h\u00e9patiques, TG-HDL-LDL, TSH, ionogramme, Ferritine, prolactine","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}