{"doc_desc":{"title":"\u00c9tude transversale sur les \u00e9v\u00e9nements ind\u00e9sirables li\u00e9s aux soins ambulatoires","idno":"FRESH-PEF9027-fr","producers":[{"name":"Philippe MICHEL","affiliation":"COMITE DE COORDINATION DE L&#x27;EVALUATION CLINIQUE ET DE LA QUALITE EN NOUVELLE-AQUITAINE (CCECQA)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF9027-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"9027"},{"agency":"FReSH","code":"FRESH-PEF9027"}]},"title":"\u00c9tude transversale sur les \u00e9v\u00e9nements ind\u00e9sirables li\u00e9s aux soins ambulatoires","alternate_title":"EVISA"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Philippe;MICHEL","PILabo":"Comit\u00e9 de Coordination de l\u2019\u00c9valuation Clinique et de la Qualit\u00e9 en Aquitaine","affiliationName":"COMITE DE COORDINATION DE L'EVALUATION CLINIQUE ET DE LA QUALITE EN NOUVELLE-AQUITAINE (CCECQA)","extlink":[{"title":"ORCID","uri":"0000-0001-8455-8332","role":"pi id"},{"title":"IdRef","uri":"061666300","role":"pi id"},{"title":"SIREN","uri":"409084308","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"philippe.michel@chu-lyon.fr","isContact":"Oui"},{"type":"investigator","name":"Jean-Luc;QUENON","PILabo":"Comit\u00e9 de Coordination de l\u2019\u00c9valuation Clinique et de la Qualit\u00e9 en Aquitaine","affiliationName":"COMITE DE COORDINATION DE L'EVALUATION CLINIQUE ET DE LA QUALITE EN NOUVELLE-AQUITAINE (CCECQA)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"147881935","role":"pi id"},{"title":"SIREN","uri":"409084308","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"jean-luc.quenon@ccecqa.asso.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"ARS NOUVELLE AQUITAINE","extlink":[{"title":"SIREN","uri":"130007867","role":"sponsor id"}],"role":"sponsor"},{"name":"","extlink":[],"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","email":"philippe.michel@chu-lyon.fr","type":"contact","affiliationName":"COMITE DE COORDINATION DE L'EVALUATION CLINIQUE ET DE LA QUALITE EN NOUVELLE-AQUITAINE (CCECQA)","contactPointLabo":"","extlink":[{"uri":"409084308","role":"organisation id","title":"SIREN"}]},{"name":"Jean-Luc;QUENON","email":"jean-luc.quenon@ccecqa.asso.fr","type":"contact","affiliationName":"COMITE DE COORDINATION DE L'EVALUATION CLINIQUE ET DE LA QUALITE EN NOUVELLE-AQUITAINE (CCECQA)","contactPointLabo":"","extlink":[{"uri":"409084308","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"s\u00e9curit\u00e9 des patients"},{"keyword":"iatrog\u00e9n\u00e8se"},{"keyword":"\u00e9v\u00e9nement ind\u00e9sirable li\u00e9 aux soins"},{"keyword":"accidents et incidents m\u00e9dicaux"},{"keyword":"nosocomial"},{"keyword":"soins extra-hospitaliers"},{"keyword":"s\u00e9curit\u00e9 sanitaire"},{"keyword":"risque"}],"topics":[{"topic":"M\u00e9decine d\u2019urgence","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5e1591e2-d02b-436c-8216-6b8912eee467"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D004635"}]}],"purpose":"Estimer la fr\u00e9quence, la gravit\u00e9 et le caract\u00e8re \u00e9vitable des \u00e9v\u00e9nements ind\u00e9sirables graves li\u00e9s aux soins ambulatoires, et \u00e9tudier le contexte et les facteurs contributifs de leur survenue et d\u2019estimer le co\u00fbt de la prise en charge hospitali\u00e8re de ces \u00e9v\u00e9nements.","abstract":"","coll_dates":[{"start":"2008-01-01"}],"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    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" homme et femme - patient hospitalis\u00e9 dans les services de m\u00e9decine et de chirurgie dans les \u00e9tablissements de sant\u00e9 de court s\u00e9jour\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Le contr\u00f4le de la qualit\u00e9 des donn\u00e9es a \u00e9t\u00e9 effectu\u00e9 \u00e0 trois niveaux :- Le CCECQA a r\u00e9alis\u00e9 des contr\u00f4les dans les \u00e9tablissements pour v\u00e9rifier le bon d\u00e9roulement de la collecte des donn\u00e9es, le respect de la m\u00e9thode, l\u2019exhaustivit\u00e9 du recueil et la qualit\u00e9 des donn\u00e9es recueillies.- Les enqu\u00eateurs et l\u2019attach\u00e9e de recherche clinique ont fait le codage des questionnaires et en ont v\u00e9rifi\u00e9 la compl\u00e9tude et la coh\u00e9rence.- Tous les questionnaires ont \u00e9t\u00e9 revus par les m\u00e9thodologistes du CCECQA. Les dossiers \u00e0 probl\u00e8mes (manque de clart\u00e9, incoh\u00e9rences, situation clinique complexe, \u00e9v\u00e9nements ou causes ou cons\u00e9quences de l\u2019\u00e9v\u00e9nement inhabituels, etc.) ont \u00e9t\u00e9 revus par un comit\u00e9 de revue des cas et, si besoin, par des experts du domaine.']"}},"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 non r\u00e9p\u00e9t\u00e9e","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Probability.Stratified\",\"vocab\":\"CESSDA\"},\"value\":\"Probabiliste : stratifi\u00e9\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"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":"47"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","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":"Contacter le responsable scientifique","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":"27-05-2014","lastUpdatedAuto":null,"lastUpdatedManual":"12-05-2015","isContributorPI":"Non","contributorName":"Philippe MICHEL","contributorAffiliation":"COMITE DE COORDINATION DE L'EVALUATION CLINIQUE ET DE LA QUALITE EN NOUVELLE-AQUITAINE (CCECQA)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Non","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"La d\u00e9tection des \u00e9v\u00e9nements ind\u00e9sirables a \u00e9t\u00e9 r\u00e9alis\u00e9e par un m\u00e9decin du service enqu\u00eat\u00e9 \u00e0 partir du questionnaire de d\u00e9tection.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France m\u00e9tropolitaine (7 \u00e9tablissements hospitaliers)"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}