{"doc_desc":{"title":"Cohorte de patients de plus de 50 ans : fardeau du zona et des douleurs post-zost\u00e9riennes","idno":"FRESH-PEF73317-fr","producers":[{"name":"Christel LECLERC-ZWIRN","affiliation":"GLAXOSMITHKLINE (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73317-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73317"},{"agency":"FReSH","code":"FRESH-PEF73317"}]},"title":"Cohorte de patients de plus de 50 ans : fardeau du zona et des douleurs post-zost\u00e9riennes","alternate_title":"POSTHER"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Laetitia;ROUSTAND","PILabo":"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":"laetitia.m.roustand@gsk.com","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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":""}]},"distribution_statement":{"contact":[{"name":"Laetitia;ROUSTAND","email":"laetitia.m.roustand@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":"Zona"},{"keyword":"virus varicelle-zona"},{"keyword":"VZV"},{"keyword":"vaccination"}],"topics":[{"topic":"Neurologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009462"}]},{"topic":"Dermatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5375c411-6db9-40ed-a854-6554102a587b"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D003880"}]},{"topic":"Zona","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/523481501","title":"CIM-11"}]},{"topic":"Autre","vocab":"health determinant"}],"purpose":"Objectif de la recherche : Evaluer le fardeau du zona et des NPZ parmi les patients \u2265 50 ans, en termes de soins m\u00e9dicaux, de co\u00fbts m\u00e9dicaux directs et de co\u00fbts indirects, ainsi que de s\u00e9v\u00e9rit\u00e9 des douleurs et la qualit\u00e9 de vie des patients. Objectif principal - Evaluer les co\u00fbts m\u00e9dicaux directs et les couts indirect li\u00e9s \u00e0 la prise en charge du zona et des NPZ pendant 9 mois (au global, par sexe et par classe d\u2019\u00e2ge). Objectifs secondaires - D\u00e9crire la s\u00e9v\u00e9rit\u00e9 des douleurs zost\u00e9riennes pendant 9 mois (au global, par sexe et par classe d\u2019\u00e2ge), - Evaluer l\u2019impact du zona et des NPZ sur la qualit\u00e9 de vie des patients pendant 9 mois (au global, par sexe et par classe d\u2019\u00e2ge","abstract":"","coll_dates":[{"start":"2016-01-01","end":"2016-12-31"}],"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 (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Crit\u00e8res d\u2019inclusion-exclusion de la cohorte Zona -Patient avec une 1\u00e8re visite pour le diagnostic d\u2019un zona et qui consulte moins de 2 semaines apr\u00e8s l\u2019apparition des 1er sympt\u00f4mes du zona (d\u00e9fini par des douleurs unilat\u00e9rales accompagn\u00e9es d'une \u00e9ruption unilat\u00e9rale sans  diagnostic alternatif)-Patient \u2265 50 ans sans ant\u00e9c\u00e9dent de zona,-Patient acceptant de participer \u00e0 l\u2019\u00e9tude et ayant sign\u00e9 un consentement \u00e9clair\u00e9,-Patient capable de comprendre l\u2019\u00e9tude, de compl\u00e9ter un auto-questionnaire (seul ou avec l\u2019aide d\u2019un parent) et de r\u00e9pondre aux interviews t\u00e9l\u00e9phoniques.Crit\u00e8res d\u2019inclusion-exclusion de la cohorte NPZ -Patient de la cohorte Zona pr\u00e9sentant des NPZ, 3 mois apr\u00e8s l\u2019apparition de l\u2019\u00e9ruption cutan\u00e9e (d\u00e9finies par la pr\u00e9sence de douleurs s\u00e9v\u00e8res associ\u00e9es au zona : douleur \u2265 3 pour la douleur \u00ab la plus intense \u00bb du questionnaire ZBPI).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es \u00e9conomiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"","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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Pas d\u2019acc\u00e8s","sources":[],"target_sample_size":"< 500 individus","response_rate":"- 250 zona - 40 NPZ"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","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":"19-02-2016","lastUpdatedAuto":null,"lastUpdatedManual":"29-10-2020","isContributorPI":"Non","contributorName":"Christel LECLERC-ZWIRN","contributorAffiliation":"GLAXOSMITHKLINE (FRANCE)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"par questionnaires papier, auto-questionnaires papier et t\u00e9l\u00e9phone","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France enti\u00e8re"},"dataTypes":{"clinicalDataDetails":"Questions relatives \u00e0 l'\u00e9pisode de zona et aux comorbidit\u00e9s existantes","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"}