{"doc_desc":{"title":"Etude longitudinale sur des patients anorexiques mentaux pris en charge \u00e0 l'h\u00f4pital","idno":"FRESH-PEF60159-fr","producers":[{"name":"Nathalie GODART","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60159-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60159"},{"agency":"FReSH","code":"FRESH-PEF60159"}]},"title":"Etude longitudinale sur des patients anorexiques mentaux pris en charge \u00e0 l'h\u00f4pital","alternate_title":"EVALHOSPITAM OU EVHAN"},"study_authorization":{"agency":[{"name":"CNIL"}]},"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":"Portail Epid\u00e9miologie France (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":"mesure"},{"keyword":"efficacit\u00e9 des soins"},{"keyword":"facteurs pr\u00e9dictifs de l\u2019\u00e9volution"},{"keyword":"devenir clinique"},{"keyword":"\u00e9chelle de Morgan et Russell"},{"keyword":"indice de masse corporelle"},{"keyword":"r\u00e8gles"},{"keyword":"complications somatiques"},{"keyword":"complications psychiatrique"},{"keyword":"adaptation sociale"},{"keyword":"soins re\u00e7us"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"mortalit\u00e9"}],"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":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Alimentation","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux : Addictions","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : \u00e9valuer l\u2019impact (efficacit\u00e9) de cinq modalit\u00e9s diff\u00e9rentes des prises en charge hospitali\u00e8res de l\u2019anorexie mentale. Cet impact sera mesur\u00e9 \u00e0 court terme (sortie d\u2019hospitalisation) sur l\u2019\u00e9tat de sant\u00e9 global (physique, psychique, nutritionnel et social) des sujets, et \u00e0 moyen terme (\u00e0 12 mois) sur le maintien ou le d\u00e9passement des acquis de l\u2019hospitalisation (en tenant compte des facteurs de confusion et des facteurs pronostics reconnus). L\u2019\u00e9tat de sant\u00e9 global sera \u00e9valu\u00e9 sur le score \u00e0 l\u2019\u00e9chelle de Morgan et Russell et des crit\u00e8res annexes d\u00e9clinant cet \u00e9tat de sant\u00e9 (voir m\u00e9thodologie crit\u00e8res d\u2019\u00e9valuation). Objectifs secondaires : - d\u00e9terminer, \u00e0 partir d\u2019une m\u00e9thodologie relevant de l\u2019\u00e9pid\u00e9miologie clinique, les facteurs pr\u00e9dictifs des \u00e9checs de la prise en charge hospitali\u00e8re, de la dur\u00e9e de l\u2019hospitalisation, du co\u00fbt de ces prises charges. - d\u00e9buter un suivi prospectif \u00e0 long terme d\u2019une cohorte homog\u00e8ne de sujets souffrant d\u2019anorexie mentale grave afin d\u2019\u00e9valuer leur devenir psychique, physique, nutritionnel et social. - deux sous projets biologiques \u00ab ancillaires \u00bb: - \u00e9valuer l\u2019\u00e9volution de la symptomatologie anxieuse et d\u00e9pressive en lien avec l\u2019\u00e9volution de l\u2019\u00e9tat nutritionnel clinique et des marqueurs s\u00e9rotoninergiques - \u00e9valuer l\u2019\u00e9volution de l\u2019\u00e9tat immunitaire cellulaire en lien avec l\u2019\u00e9volution de l\u2019\u00e9tat nutritionnel clinique","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":"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\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\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\": \" patients de 8 \u00e0 65 ans  ; - patients hospitalis\u00e9s pour anorexie mentale (et ne pouvant pas par cons\u00e9quent \u00eatre pris en charge autrement du fait de l\u2019\u00e9tat somatique : maigreur importante BMI inf\u00e9rieur \u00e0 15 ou amaigrissement rapide ou de leur \u00e9tat psychique), ainsi que leurs parents pour les mineurs et les majeurs vivant chez leurs parents ; - consentement \u00e9clair\u00e9 recueilli  ; - personnes non affili\u00e9es \u00e0 la s\u00e9curit\u00e9 sociale.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es biologiques']","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 sujets pour r\u00e9aliser les visites de suivi.R\u00e9alisation d\\'audits de qualit\u00e9 internes par l\\'URC.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"}]},"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\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"180"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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":"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)","Priv\u00e9 \u00e0 but non lucratif","Public (France)","Public (France)","Public (France)","Public (France)","Public (France)"],"otherFundingAgentType":["","","","","","",""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"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":"Auto-questionnaire : saisie directe Entretiens : saisie directe Examens cliniques : saisie directe Examens biologiques : saisie directe","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique (11 centres) Fran\u00e7aise: 6 centres en Ile de France, 2 \u00e0 Bordeaux, 1 \u00e0 Nantes, 1 \u00e0 Rouen, 1 \u00e0 Saint Etienne."},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Type de pr\u00e9l\u00e8vements r\u00e9alis\u00e9s : tous les examens pratiqu\u00e9s pendant l'hospitalisation (protocole standard) et s\u00e9rotonine, tryptophane, 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"}