{"doc_desc":{"title":"Etude transversale Nationale sur les \u00c9v\u00e8nements Ind\u00e9sirables graves associ\u00e9s aux Soins, observ\u00e9s en \u00e9tablissement de sant\u00e9","idno":"FRESH-PEF73176-fr","producers":[{"name":"Philippe MICHEL","affiliation":"HOSPICES CIVILS DE LYON (HCL)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73176-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73176"},{"agency":"FReSH","code":"FRESH-PEF73176"}]},"title":"Etude transversale Nationale sur les \u00c9v\u00e8nements Ind\u00e9sirables graves associ\u00e9s aux Soins, observ\u00e9s en \u00e9tablissement de sant\u00e9","alternate_title":"ENEIS"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Philippe;MICHEL","firstname":"Philippe","lastname":"MICHEL","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"organisation id"},{"title":"SIREN","uri":"266900273","role":"organisation id"}],"email":"philippe.michel@chu-lyon.fr","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","PILabo":"Hospices Civils de Lyon","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315","role":"sponsor id"},{"title":"SIREN","uri":"130016546","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Philippe;MICHEL","lastname":"MICHEL","firstname":"Philippe","type":"contact","email":"philippe.michel@chu-lyon.fr","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01502ca60","role":"organisation id","title":"ROR"},{"uri":"266900273","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"\u00e9v\u00e8nements ind\u00e9sirables graves"},{"keyword":"s\u00e9curit\u00e9 du patient"}],"topics":[{"topic":"Allergologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/af65e2bf-afc5-45e8-a0fc-364dfb48f0a4"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000486"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"L'objectif principal de l'enqu\u00eate est d'estimer l'incidence des \u00e9v\u00e9nements ind\u00e9sirables graves observ\u00e9s en milieu hospitalier et leur caract\u00e8re \u00e9vitable, pour les \u00e9v\u00e9nements \u00e0 l'origine d'une admission dans les unit\u00e9s de m\u00e9decine et chirurgie des \u00e9tablissements de sant\u00e9 ou survenant dans de telles unit\u00e9s au cours d'une hospitalisation. Les objectifs secondaires sont : 1) d'estimer la gravit\u00e9 et la part \u00e9vitable de ces \u00e9v\u00e9nements ; 2) de d\u00e9crire les causes imm\u00e9diates de survenue de ces \u00e9v\u00e9nements li\u00e9s aux soins.","abstract":"","coll_dates":[{"start":"2004-01-01","end":"2009-01-01"}],"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\": \"Nouveau-n\u00e9 (naissance \u00e0 28j)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Petite enfance (2 \u00e0 5 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\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            \"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\": \"Tous les s\u00e9jours de patients pr\u00e9sents pendant l'enqu\u00eate (une semaine par unit\u00e9) en unit\u00e9 de m\u00e9decine et chirurgie de court s\u00e9jour.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es socio-d\u00e9mographiques']","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\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9"}]},"method":{"data_collection":{"time_method":"Etude transversale r\u00e9p\u00e9t\u00e9e","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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"L'objectif est de disposer d'un \u00e9chantillon minimum de 800 s\u00e9jours ou fractions de s\u00e9jours dans chacun des domaines d'analyse d\u00e9finis ci-dessous. L'analyse est r\u00e9alis\u00e9e selon deux axes :1) le type d'unit\u00e9 de soins : chirurgie ou m\u00e9decine2) le type d'\u00e9tablissement : Centres hospitaliers universitaires ou r\u00e9gionaux (CHU\/CHR), autres \u00e9tablissements publics et \u00e9tablissements priv\u00e9s \u00e0 but non lucratif, \u00e9tablissements priv\u00e9s \u00e0 but lucratif. Soit six strates d'analyse.Au total 8000 s\u00e9jours environ constituent l'\u00e9chantillon. L'\u00e9chantillon permet de r\u00e9aliser des estimations nationales."},"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":"","conditions":"La base de donn\u00e9es anonymis\u00e9e peut \u00eatre mise \u00e0 disposition de chercheurs sous r\u00e9serve d'une demande motiv\u00e9e (examen par un comit\u00e9 scientifique).","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"Les \u00e9tablissements participants sont destinataires des restitutions les concernant en d\u00e9cembre de l'ann\u00e9e de la collecte."}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"22-07-2015","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2019","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.drees.sante.gouv.fr\/l-enquete-nationale-sur-les-evenements-indesirables-lies,6507.html"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"Le recueil se fait en deux temps par des enqu\u00eateurs externes \u00e0 l'\u00e9tablissement. Un enqu\u00eateur-infirmier passe, sur une semaine, tous les deux ou trois jours et d\u00e9tecte les patients susceptibles de pr\u00e9senter un \u00e9v\u00e9nement ind\u00e9sirable \u00e0 l'aide d'une grille de 17 crit\u00e8res de d\u00e9tection. La d\u00e9tection est faite avec le cadre de soins et s'appuie sur le dossier du patient.Une \u00e0 deux semaines apr\u00e8s, un enqu\u00eateurm\u00e9decin se rend dans l'unit\u00e9 pour confirmer ou infirmer la pr\u00e9sence d'\u00e9v\u00e9nement ind\u00e9sirable pour les patients d\u00e9tect\u00e9s. De plus, il appr\u00e9cie le caract\u00e8re \u00e9vitable des \u00e9v\u00e9nements survenus pendant l'hospitalisation. Pour cela, il rencontre le m\u00e9decin en charge du patient et consulte \u00e9galement avec lui le dossier du patient.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France m\u00e9tropolitaine (plusieurs r\u00e9gions et plusieurs d\u00e9partements)"},"dataTypes":{"clinicalDataDetails":"","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"}