{"study_desc":{"title_statement":{"idno":"FRESH-PEF7596-en","IDno":{"metadata_no":[{"agency":"PEF","code":"7596"},{"agency":"FReSH","code":"FRESH-PEF7596"}]},"title":"National Survey on Lead Poisoning Prevalence and Infectious Disease Seroprevalence in Children Between 6 Months and 6 Years Old (Lead Poisoning Component and Biobank)","alternate_title":"Saturn-Inf 2008-2009 Survey (Enqu\u00eate Saturn-Inf 2008-2009)"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"ANSM"}]},"authoring_entity":[],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58","role":"sponsor id"},{"title":"SIREN","uri":"130022338","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"SANTE PUBLIQUE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00dfw9p58"},{"title":"SIREN","uri":"130022338"}]}]},"distribution_statement":{"contact":[{"name":";Invs-DSE","lastname":"Invs-DSE","firstname":"","type":"contact","email":"DSE-infosan@invs.sante.fr","affiliationName":"SANTE PUBLIQUE FRANCE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00dfw9p58","role":"organisation id","title":"ROR"},{"uri":"130022338","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"blood lead level"},{"keyword":"exposure"},{"keyword":"lead poisoning"},{"keyword":"prevalence"},{"keyword":"children"}],"topics":[{"topic":"Paediatrics","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"D010372"}]},{"topic":"Harmful effects of or exposure to noxious substances, chiefly nonmedicinal as to source, not elsewhere classified","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1119330136","title":"CIM-11"}]},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"}],"purpose":"- To estimate the national prevalence of lead poisoning in children between 6 months and 6 years old; - To determine the blood lead level distribution of children between 6 months and 6 years old by administrative region; - To update knowledge of factors that determine blood lead level; - To validate indicators that characterise at-risk areas.","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2009-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Male\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"Female\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Infant (28 days to 2 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D007223\"}},{\"value\":\"Child, Preschool (2 to 5 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D002675\"}},{\"value\":\"Child (6 to 12 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D002648\"}},{\"value\":\"Adolescent (13 to 18 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000293\"}}],\"level_type_clusion_I\":\"General population\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"Children between 6 months and 6 years old; - Covered by social security health insurance; - Inpatient or outpatient hospital stay during study period; - Where a blood sample was prescribed as part of treatment or where a sampling system (catheter) is already in place; - Residing in France at the time of enrolment.\",\"clusion_E\":\"\"}","data_kind":"['Biological data','Socio-demographic data','Participant-reported health data']","quality_statement":{"standards":[{"name":"['Dictionary of variables.']","committee":"","governance":""}],"other_quality_statement":"['Checks for duplicated, missing, outlier and inconsistent data.']"}},"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":"","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"3,800"},"method_notes":"Observational Study","study_class":"Completed study","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"individual anonymised data.","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}","notes":""},"dataset_use":{"restrictions":"","conditions":"Data access procedure generated and held by InVS.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"en","originLang":"en","autoTranslation":false,"status":"Imported","creationDate":"18-10-2013","lastUpdatedManual":"01-01-2019","isContributorPI":"","contributorName":"Anne DOUSSIN","contributorAffiliation":"SANTE PUBLIQUE FRANCE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":["",""]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/opac.invs.sante.fr\/doc_num.php?explnum_id"}],"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":"Face-to-face questionnaire with parents recorded by hospital staff. Two blood samples collected for blood lead level assay and Biobank. Collection managed by service provider.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Blood lead level","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}