{"doc_desc":{"title":"Cohort of Patients with Schizophrenia","idno":"FRESH-PEF73234-en","producers":[{"name":"Franck SCHURHOFF","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73234-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73234"},{"agency":"FReSH","code":"FRESH-PEF73234"}]},"title":"Cohort of Patients with Schizophrenia","alternate_title":"FACE-SZ"},"study_authorization":{"agency":[]},"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":"Yes"},{"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":"Yes"}],"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":"Epidemiology France Portal (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":"translational research"},{"keyword":"schizophrenia"},{"keyword":"prevention"},{"keyword":"screening"},{"keyword":"treatment"},{"keyword":"care"}],"topics":[{"topic":"Psychiatry","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":"Addiction medicine","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":"Schizophrenia","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1683919430","title":"CIM-11"}]},{"topic":"Behavioral determinants: Addiction","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants: Employment","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"Aims are: \u2013 to accelerate access to specialists for patients with schizophrenia as well as those at risk; \u2013 to foster a personalised medical approach through a systematic and thorough investigation of schizophrenia in order to improve detection and to prevent psychiatric and somatic comorbidity; to provide personalised care recommendations from a pharmacological, psychosocial and lifestyle standpoint; to prospectively assess the impact of treatments recommended to the individual and to identify relapse risk factors; \u2013 to reduce the time periods between the onset of disorders, accurate diagnoses and the introduction of suitable treatment; \u2013 to improve consistency between evidence-based medical guidelines and clinical practice; \u2013 to communicate expertise and skills using new diagnostic tools and treatment strategies.","abstract":"","coll_dates":[{"start":"2007-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients with schizophrenia in one of 10 participating centres.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth care consumption and services\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[500-1000[ individuals","response_rate":"603"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Procedure for FondaMental network members who wish to access the FACE database: 1. Complete a summary FACE database request form and lexicon and send to face@fondation-fondamental.org. 2. After this submission, two documents will be sent: FACE lexicon (list of all available items) and FACE summary (data classified by main themes) regarding the specific illness. 3. The file to complete for retrieval requests consists of the following 3 items: \u2013 FACE database retrieval request form (completed and signed) \u2013 Letter of engagement (completed and signed) \u2013 Lexicon (with requested items checked) This form shall be sent to: face@fondation-fondamental.org","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"29-09-2015","lastUpdatedAuto":null,"lastUpdatedManual":"20-06-2016","isContributorPI":"No","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)","Private non-profit","Public (France)"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":"Yes"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Through e-schizo\u00a9 application developed by the Fondation FondaMental","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Social and demographic data (age, sex, marital status, education level, number of children), economic and medical data (Global Assessment of Functioning Scale, Quality of Life: S-QoL, work status and number of days worked in the last year, income, number of consultations during the year excluding psychiatric, number of emergency admissions, dental care, Personal and Social Performance Scale (PSP)), symptom history and progression (Positive And Negative Symptoms Scale (PANSS), number and duration of psychiatric hospital admissions, age and duration of first admission, age and duration of initial psychiatric treatment, aggressive behaviour, CGI: Clinical Global Impression), mood (Calgary Depression Score (CDSS hetero-questionnaires), Young Mania Rating Scale (YMRS), suicide), psychiatric comorbidity and risk factors (anxiety, eating disorders, family history, Childhood Trauma Questionnaire (CTQ), compulsions, etc.), addictions (drugs, tobacco, alcohol, internet, gambling), somatic comorbidity and anthropometric data.","biologicalDataDetails":"Full blood test; medication dosage; C-reactive protein; liver enzymes; TG-HDL-LDL; TSH; electrolytes; ferritin and prolactin levels","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}