{"doc_desc":{"title":"Longitudinal study in patients aged 0 to 15 years hospitalised for at least 3 days after receiving at least one drug: risk of adverse drug reactions associated with off-label\/unlicensed prescriptions","idno":"FRESH-PEF39007-en","producers":[{"name":"Kim An NGUYEN","affiliation":"UNIVERSITE CLAUDE BERNARD LYON 1"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF39007-en","IDno":{"metadata_no":[{"agency":"PEF","code":"39007"},{"agency":"FReSH","code":"FRESH-PEF39007"}]},"title":"Longitudinal study in patients aged 0 to 15 years hospitalised for at least 3 days after receiving at least one drug: risk of adverse drug reactions associated with off-label\/unlicensed prescriptions","alternate_title":"EREMI"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Behrouz;KASSAI-KOUPAI","PILabo":"Hospices Civils de Lyon (HCL) \/ Clinical Investigation Centre Hospices Civils de Lyon \/Inserm EPICIME (Epidemiology, Pharmacology, Clinical Research and Medical information, Mother and Child) UMR 5558\/CNRS","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"ORCID","uri":"0000-0002-1712-120X","role":"pi id"},{"title":"IdRef","uri":"133741699","role":"pi id"},{"title":"SIREN","uri":"266900273","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"behrouz.kassai-koupai@chu-lyon.fr","isContact":"Yes"}],"oth_id":[{"name":"CIC P\u00e9diatrique - H\u00f4pital Femme-M\u00e8re-Enfant, Hospices Civils de Lyon (HCL) \/ CIC p\u00e9diatrique - H\u00f4pital Robert Debr\u00e9, Assistance publique \u2013 H\u00f4pitaux de Paris (AP-HP)","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"sponsor id"},{"title":"SIREN","uri":"266900273","role":"sponsor id"}],"role":"sponsor"},{"name":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"sponsor id"},{"title":"SIREN","uri":"267500452","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01g80gk13"},{"title":"SIREN","uri":"180036113"}]}]},"distribution_statement":{"contact":[{"name":"Behrouz;KASSAI-KOUPAI","email":"behrouz.kassai-koupai@chu-lyon.fr","type":"contact","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01502ca60","role":"organisation id","title":"ROR"},{"uri":"266900273","role":"organisation id","title":"SIREN"}]},{"name":"Kim An;NGUYEN","email":"kim-an.nguyen@chu-lyon.fr","type":"contact","affiliationName":"UNIVERSITE CLAUDE BERNARD LYON 1","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/029brtt94","role":"organisation id","title":"ROR"},{"uri":"196917744","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"drug"},{"keyword":"ADEs"},{"keyword":"Adverse drug episodes"},{"keyword":"adverse effect"},{"keyword":"market authorisation"},{"keyword":"prescription"},{"keyword":"Hospitalisation"},{"keyword":"MA"},{"keyword":"child"},{"keyword":"adolescent"}],"topics":[{"topic":"Paediatrics","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010372"}]},{"topic":"External causes of morbidity or mortality","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/850137482","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"To compare the probability of occurrence of an adverse drug reaction (ADR) after a licensed prescription drug versus the probability of occurrence of an ADR after prescribing a drug off-label or unlicensed in patients aged 0-15 years hospitalized at least 3 days Secondary objectives: \u2022 Compare the proportion of pediatrics inpatients presenting at least one ADR among inpatients with at least one off-labels or unlicensed prescription drug with the proportion of inpatients presenting at least one ADR among inpatients with all licensed prescription drugs \u2022 To describe, in terms of marketing autorisation and indications, the medicinal products prescribed by paediatric age group. \u2022 Identify the factors influencing the risk of developing ADRs after prescribing a drug \u2022 To estimate the seriousness and avoidability of ADRs","abstract":"","coll_dates":[{"start":"2013-01-01","end":"2016-01-01"}],"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\": \"Infant, Newborn (birth to 28 days)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007231\"\n            }\n        },\n        {\n            \"value\": \"Infant (28 days to 2 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Child, Preschool (2 to 5 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Children from 0 to 15 years old [0 ; 15[ (including term and preterm newborn infants). Hospitalised for at least 3 days. Receiving at least one medication\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Methodology: HCL Paediatric Clinical Investigation Centre; Biostatistics: Biostatistics department of HCL\/UMR CNRS 5558; Management of the database: ClinInfo, Lyon']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.) Population database for statistical purposes']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}"],"research_instrument":"Access on specific project only","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Medico-administrative database"]}],"target_sample_size":"[1000-10000[ individuals","response_rate":"6227"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort 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":"","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":"03-04-2015","lastUpdatedAuto":null,"lastUpdatedManual":"06-09-2020","isContributorPI":"No","contributorName":"Kim An NGUYEN","contributorAffiliation":"UNIVERSITE CLAUDE BERNARD LYON 1","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/adc.bmj.com\/content\/99\/Suppl_2\/A62.2.abstract?sid=0943db08-e27a-4da7-bb7a-909ec1a19723; http:\/\/www.sciencedirect.com\/science\/article\/pii\/S0929693X14719591; http:\/\/www.sciencedirect.com\/science\/article\/pii\/S0929693X1472130X; http:\/\/www.sciencedirect.com\/science\/article\/pii\/S0929693X14721311; http:\/\/www.sciencedirect.com\/science\/article\/pii\/S0929693X14722432"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":"Yes"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"During hospitalisation","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Yes"},"geographicalCoverage":{"geoDetail":"H\u00f4pital Femme-M\u00e8re-Enfant, Hospices Civils de Lyon (HCL) \/ H\u00f4pital Robert Debr\u00e9, Assistance publique \u2013 H\u00f4pitaux de Paris (AP-HP)"},"dataTypes":{"clinicalDataDetails":"Nature and clinical context of ADEs","biologicalDataDetails":"Creatinine level","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}