{"doc_desc":{"title":"Cross-Sectional Study on Adverse Events Linked to Ambulatory Care","idno":"FRESH-PEF9027-en","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-en","IDno":{"metadata_no":[{"agency":"PEF","code":"9027"},{"agency":"FReSH","code":"FRESH-PEF9027"}]},"title":"Cross-Sectional Study on Adverse Events Linked to Ambulatory Care","alternate_title":"EVISA"},"study_authorization":{"agency":[]},"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":"Yes"},{"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":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"iatrogenesis"},{"keyword":"treatment-related adverse event"},{"keyword":"medical accidents and incidents"},{"keyword":"outpatient care"},{"keyword":"patient safety"},{"keyword":"nosocomial"},{"keyword":"health safety"},{"keyword":"risk"}],"topics":[{"topic":"Emergency medicine","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":"To estimate the frequency, severity and preventability of adverse events linked to ambulatory care, as well as investigate the context and contributing factors on the occurrence of these events and to estimate the hospital treatment costs.","abstract":"","coll_dates":[{"start":"2008-01-01"}],"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    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Male and female; - Patients hospitalised in medical and surgical departments in short-stay healthcare institutions.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Participant-reported health data']","quality_statement":{"standards":[{"name":"['Data quality control was carried out in three stages:']","committee":"","governance":""}],"other_quality_statement":"['- The CCECQA (Coordination Committee for Clinical Evaluation and Quality in Aquitaine) carried out checks in institutions to verify proper data collection conduct, adherence to the method, as well as the completeness and quality of collected data. - Researchers and research associates coded questionnaires and checked for completeness and consistency. - All questionnaires were reviewed by CCECQA methodologists. Problematic records (unclear; inconsistent; complex clinical situation; episodes, causes or impact of an unusual event, etc.) were reviewed by a case review committee and, if required, by field experts.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality"}]},"method":{"data_collection":{"time_method":"One-time cross-sectional study","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Probability.Stratified\",\"vocab\":\"CESSDA\"},\"value\":\"Probability: Stratified\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"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":"47"},"method_notes":"Observational Study","study_class":"Completed study","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":"","conditions":"Contact the principal investigator","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":"27-05-2014","lastUpdatedAuto":null,"lastUpdatedManual":"12-05-2015","isContributorPI":"No","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":"No","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Adverse events were detected by a physician in the surveyed department from a detection questionnaire.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Metropolitan France (7 hospitals)."},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}