{"doc_desc":{"title":"Evaluation of hospitalisation for patients with anorexia nervosa: Efficacy of treatment and research predictive outcome factors","idno":"FRESH-PEF60159-en","producers":[{"name":"Nathalie GODART","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60159-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60159"},{"agency":"FReSH","code":"FRESH-PEF60159"}]},"title":"Evaluation of hospitalisation for patients with anorexia nervosa: Efficacy of treatment and research predictive outcome factors","alternate_title":"EVALHOSPITAM OR EVHAN"},"study_authorization":{"agency":[]},"authoring_entity":[{"name":"Nathalie;GODART","firstname":"Nathalie","lastname":"GODART","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"}],"email":"nathalie.godart@fsef.net","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"INSERM - Institut National de Sant\u00e9 et Recherche \/ U669 INSERM TROUBLES DES CONDUITES DE L'ADOLESCENT","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"COMITE SOCIAL ECONOMIQUE INSTITUT MEDICO-CHIRURGICAL MONTSOURIS (CSE IMM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00bea5h57","role":"sponsor id"},{"title":"SIREN","uri":"424729218","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 DE FRANCE","extlink":[{"title":"SIREN","uri":"784314908"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"MINISTERE DE L\u2019ENSEIGNEMENT SUPERIEUR, DE LA RECHERCHE ET DE L\u2019ESPACE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03sjk9a61"},{"title":"SIREN","uri":"110044013"}]},{"name":"MINISTERE DE L'EUROPE ET DES AFFAIRES ETRANGERES","extlink":[{"title":"SIREN","uri":"110006012"}]},{"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":"CNAM"}]},"distribution_statement":{"contact":[{"name":"Nathalie;GODART","lastname":"GODART","firstname":"Nathalie","type":"contact","email":"nathalie.godart@fsef.net","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"clinical outcome"},{"keyword":"Morgan and Russell scale"},{"keyword":"body mass index"},{"keyword":"menstruation"},{"keyword":"somatic complications"},{"keyword":"psychiatric complications"},{"keyword":"social adjustment"},{"keyword":"treatment received"},{"keyword":"Health episodes"},{"keyword":"mortality"}],"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":"Behavioral determinants","vocab":"health determinant"},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Behavioral determinants: Addiction","vocab":"health determinant"}],"purpose":"General objective: to evaluate the impact (efficacy) of five different inpatient treatment modalities for anorexia nervosa. Individual global health outcome (physical, psychiatric, nutritional and social) will be measured on a short-term basis (on discharge), as well as hospital treatment meeting or exceeding statutory charges on a medium term basis (12 months), taking into account confounding factors and recognised prognostic factors. Global health is evaluated using the Morgan and Russell scale as well as secondary criteria for deteriorating health (see evaluation criteria methodology). Secondary objectives: - to determine predictive factors for failures in inpatient treatment, duration of hospitalisation, and treatment costs using clinical epidemiology methodology. - to begin a long-term prospective study to evaluate the psychological, physical, nutritional and social outcome of a homogeneous cohort of subjects suffering from severe anorexia nervosa. - two \"ancillary\" biological sub-projects: - to evaluate the development of depressive and anxiety symptoms in relation to changes in clinical nutritional status and serotonin markers - to evaluate cellular immunity development in relation to changes in clinical nutrition.","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2010-01-01"}],"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\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\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    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients between 8 and 65 years old; - patients hospitalised for anorexia nervosa (who only receive treatment by necessity of somatic condition: rapid weight loss, or significantly underweight with a BMI of less than 15, or their psychological condition), as well as parents of minor and adult patients still living at home; - obtained written consent; - patients not covered by social security health insurance.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['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 event\/mortality"}]},"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\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"180"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational 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":"To be decided if data may be used by academic teams. Data may not be used by industrial teams.","conditions":"","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"01-03-2020","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/tinyurl.com\/Hal-EVALHOSPITAM-EVHAN"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Private non-profit","Public (France)","Public (France)","Public (France)","Public (France)","Public (France)"],"otherFundingAgentType":["","","","","","",""]},"sponsor":{"sponsorType":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Self-administered questionnaire: direct input Interview: direct input Clinical examinations: direct input Biological analysis: direct input","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Multicentric cohort throughout France (11 centres): \u00cele-de-France: 6 centres, Bordeaux: 2 centres, Nantes: 1 centre, Rouen: 1 centre, Saint-\u00c9tienne: 1 centre."},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Type of samples collected: all analysis during hospitalisation (standard protocol), serotonin, tryptophan, CD4\/CD8.","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}