{"doc_desc":{"title":"Etude transversale en Soins PRImaires sur les \u00e9v\u00e9nemenTs ind\u00e9sirables","idno":"FRESH-PEF9015-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-PEF9015-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"9015"},{"agency":"FReSH","code":"FRESH-PEF9015"}]},"title":"Etude transversale en Soins PRImaires sur les \u00e9v\u00e9nemenTs ind\u00e9sirables","alternate_title":"ESPRIT"},"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"}],"oth_id":[{"name":"Partenariat avec Open Romehttp:\/\/esprit.openrome.org\/documents\/Rapport_ESPRIT_final.pdf","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"COMITE DE COORDINATION DE L'EVALUATION CLINIQUE ET DE LA QUALITE EN NOUVELLE-AQUITAINE (CCECQA)","extlink":[{"title":"SIREN","uri":"409084308","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","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"}]}]},"study_info":{"keywords":[{"keyword":"Fr\u00e9quence"},{"keyword":"\u00e9v\u00e9nements ind\u00e9sirables"},{"keyword":"gestion des risques"}],"topics":[{"topic":"M\u00e9decine g\u00e9n\u00e9rale","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4b9f8efb-68dd-45a1-b04c-d23d457d6898"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D058006"}]},{"topic":"Syst\u00e8mes de soins et acc\u00e8s aux soins","vocab":"health determinant"}],"purpose":"Estimer en France l\u2019incidence des \u00e9v\u00e9nements ind\u00e9sirables associ\u00e9s aux soins (EIAS) \u00e9vitables en m\u00e9decine g\u00e9n\u00e9rale et d\u2019en d\u00e9crire la typologie.","abstract":"","coll_dates":[{"start":"2012-01-01","end":"2013-01-01"}],"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\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" homme et femme - patients vus ou contact\u00e9s par les m\u00e9decins g\u00e9n\u00e9ralistes volontaires de l'\u00e9tude\",\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":"['La compl\u00e9tude des donn\u00e9es sera suivie:\u2010 en temps r\u00e9el pour les fiches saisies en ligne,\u2010 \u00e0 l\u2019arriv\u00e9e \u00e0 la coordination Open Rome pour les fiches envoy\u00e9es par la Poste.Un retour au m\u00e9decin sera fait au fur et \u00e0 mesure par la coordination, si n\u00e9cessaire, pour compl\u00e9ter les donn\u00e9es ou ajuster le recueil. La qualit\u00e9 de la saisie et la coh\u00e9rence des donn\u00e9es seront valid\u00e9s par les responsables de la base de donn\u00e9es selon leurs proc\u00e9dures habituelles.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d&#x27;exercice lib\u00e9ral']"}},"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":"475"},"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":"23-05-2014","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":[{"type":"","title":"","link":"http:\/\/www.invs.sante.fr\/beh\/2014\/24-25\/2014_24-25_1.html"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Oui"},"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":"Le recueil sera r\u00e9alis\u00e9 sur une semaine tir\u00e9e au sort parmi celles de la p\u00e9riode de collecte qui seront d\u00e9finies au pr\u00e9alable avec chaque m\u00e9decin g\u00e9n\u00e9raliste,en fonction de sa disponibilit\u00e9. L\u2019ensemble des donn\u00e9es est collect\u00e9 sur un site internet s\u00e9curis\u00e9 et h\u00e9berg\u00e9 par Open Rome, sauf pour les m\u00e9decins g\u00e9n\u00e9ralistes pr\u00e9f\u00e9rant adresser les questionnaires sous version papier \u00e0 Open Rome qui se chargeait de la saisie.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"19 r\u00e9gions de France m\u00e9tropolitaine"},"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"}