{"doc_desc":{"title":"Measurement of the changes in acceptability of hepatitis B immunization among general practitioners and open-care paediatricians","idno":"FRESH-PEF160-en","producers":[{"name":"Christel LECLERC-ZWIRN","affiliation":"GLAXOSMITHKLINE (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF160-en","IDno":{"metadata_no":[{"agency":"PEF","code":"160"},{"agency":"FReSH","code":"FRESH-PEF160"}]},"title":"Measurement of the changes in acceptability of hepatitis B immunization among general practitioners and open-care paediatricians","alternate_title":"PRALINE"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Christel;LECLERC-ZWIRN","PILabo":"Laboratoire GSK","affiliationName":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"592052146","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"christel.c.leclerc-zwirn@gsk.com","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87","role":"sponsor id"},{"title":"SIREN","uri":"592052146","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87"},{"title":"SIREN","uri":"592052146"}]}]},"distribution_statement":{"contact":[{"name":"Christel;LECLERC-ZWIRN","email":"christel.c.leclerc-zwirn@gsk.com","type":"contact","affiliationName":"GLAXOSMITHKLINE (FRANCE)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00z1h3j87","role":"organisation id","title":"ROR"},{"uri":"592052146","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"vaccine"},{"keyword":"vaccination practice"}],"topics":[{"topic":"Clinical immunology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7a3cf568-46ba-4840-be8f-f22fc030139f"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000486"}]},{"topic":"Infectious disease medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"Hepatitis vaccines","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/396699965","title":"CIM-11"}]}],"purpose":"Measure, in general and pediatric practices, the change in the acceptability of the vaccination against Hepatitis B for children aged 27 months and younger before the reimbursement of InfanrixHexa\u00ae, then during the three following years in France","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2012-01-01"}],"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\": \"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\": \"\u2022 Children from the eligibility registry subjected to the vaccinal policy by the investigator. This criterion will be evaluated using the declarations of the doctors, via 2 questions: 1. \\\"\\\"Have you followed the child since birth? If yes: date of the 1st consultation of the child. If no: did you follow the child the first 6 months? \u00bb 2. \\\"\\\"Are you the doctor in charge of vaccinating this child since birth? \u00bb\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Others"}]},"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 Medical-administrative database (patients, health insurance\/mutual insurance)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}","{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[10000-20000[ individuals","response_rate":"928 practitioners 13920 infants"},"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":"","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":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"07-09-2020","isContributorPI":"No","contributorName":"Christel LECLERC-ZWIRN","contributorAffiliation":"GLAXOSMITHKLINE (FRANCE)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industry"],"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":"The investigating doctor will complete the two eligibility registries. If the vaccination booklet is not available on the day of consultation, the doctor will ask the child's parent to provide the vaccination booklet in the next few days and will then finish filling in the vaccination data in the registry. If the vaccination booklet is not available on the day of consultation, the key information on the vaccination of the child will be completed using the patient's dossier of the doctor, noting the absence of the vaccination booklet.The acceptability questionnaire (paper CRF) will be administered to participating doctors by a clinical research associate, by telephone, during the installation of the center.The data will be collected in the eligibility registry for all of the patients aged 12 to 15 months and 24 to 27 months spontaneously consulting the investigator over the duration of the study","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"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"}