{"doc_desc":{"title":"Cross-Sectional Study on Primary Care for Adverse Events","idno":"FRESH-PEF9015-en","producers":[{"name":"Philippe MICHEL","affiliation":"COMITE DE COORDINATION DE L'EVALUATION CLINIQUE ET DE LA QUALITE EN NOUVELLE-AQUITAINE (CCECQA)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF9015-en","IDno":{"metadata_no":[{"agency":"PEF","code":"9015"},{"agency":"FReSH","code":"FRESH-PEF9015"}]},"title":"Cross-Sectional Study on Primary Care for Adverse Events","alternate_title":"ESPRIT"},"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"}],"oth_id":[{"name":"Partnership with Open Rome http:\/\/esprit.openrome.org\/documents\/Rapport_ESPRIT_final.pdf","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"risk management"},{"keyword":"frequency"},{"keyword":"adverse events"}],"topics":[{"topic":"General medicine","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"}]}],"purpose":"To estimate the incidence of avoidable treatment-related adverse effects in general medicine and to describe the typology.","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":"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\": \"General population\",\n \"level_type_clusion_other\": \"\",\n \"clusion_I\": \"Male and female; - Patients seen or contacted by voluntary general practitioners from the study.\",\n \"clusion_E\": \"\"\n}","data_kind":"['Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Data completeness will be monitored: \u2010 in real time, - when files arrive to Open Rome by post. If required, the organisation will contact to the physician again to adjust or supplement data collection. The quality of data recording and consistency will be checked by those in charge of the database in accordance with regular procedures']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"One-time cross-sectional study","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through independent healthcare practitioners']"}},"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":"475"},"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":"23-05-2014","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":[{"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":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Yes"},"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":"Collection will be carried out over a randomly selected week during the data collection period that is scheduled beforehand with all general practitioners, according to availability. All data is collected on a secure website hosted by Open Rome, except for general practitioners who choose to send questionnaires in paper format to Open Rome, who are in charge of recording.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"19 regions throughout metropolitan France."},"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"}