{"study_desc":{"title_statement":{"idno":"FRESH-PEF2849-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"2849"},{"agency":"FReSH","code":"FRESH-PEF2849"}]},"title":"Etude longitudinale sur des patients atteints d\u2019un psoriasis chronique en plaques, localis\u00e9 aux endroits difficiles \u00e0 traiter","alternate_title":"PSOLEMEE : PSOriasis Localis\u00e9 : Evaluation MEdico-Economique"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Nicholas;MOORE","firstname":"Nicholas","lastname":"MOORE","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"organisation id"},{"title":"SIREN","uri":"130018351","role":"organisation id"},{"uri":"0000-0003-1212-2817","role":"pi id","title":"ORCID"},{"uri":"077852877","role":"pi id","title":"IdRef"}],"email":"nicholas.moore@u-bordeaux.fr","affiliationName":"UNIVERSITE DE BORDEAUX","PILabo":"Universit\u00e9 Bordeaux \/ Service de Pharmacologie, CIC-P 0005-INSERM U657- Universit\u00e9 Bordeaux Segalen","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"sponsor id"},{"title":"SIREN","uri":"130018351","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"IBSA PHARMA SAS","extlink":[{"title":"SIREN","uri":"341264570"}]}]},"distribution_statement":{"contact":[{"name":"Nicholas;MOORE","lastname":"MOORE","firstname":"Nicholas","type":"contact","email":"nicholas.moore@u-bordeaux.fr","affiliationName":"UNIVERSITE DE BORDEAUX","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/057qpr032","role":"organisation id","title":"ROR"},{"uri":"130018351","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Psoriasis"},{"keyword":"co\u00fbt de la pathologie"},{"keyword":"\u00e9tude m\u00e9dico-\u00e9conomique"},{"keyword":"qualit\u00e9 de vie"},{"keyword":"cohorte"},{"keyword":"pharmaco-\u00e9pid\u00e9miologie"},{"keyword":"d\u00e9partement de pharmacologie"},{"keyword":"Bordeaux"}],"topics":[{"topic":"Dermatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5375c411-6db9-40ed-a854-6554102a587b"},{"title":"MeSH","uri":"D003880"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"L\u2019objectif de cette \u00e9tude \u00e9tait d\u2019\u00e9valuer le co\u00fbt de la prise en charge globale du psoriasis des patients correspondant \u00e0 la population cible du Betesil\u00ae, c\u2019est-\u00e0-dire atteint d\u2019un psoriasis chronique en plaques, localis\u00e9 aux endroits difficiles \u00e0 traiter (genoux, coudes, face ant\u00e9rieure du tibia, sur une surface ne d\u00e9passant pas 5% de la surface corporelle).","abstract":"","coll_dates":[{"start":"2009-01-01","end":"2010-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Masculin\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"F\u00e9minin\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Adulte (19 \u00e0 24 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adulte (25 \u00e0 44 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Adulte (45 \u00e0 64 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}},{\"value\":\"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}},{\"value\":\"Grand \u00e2ge (80 ans et plus)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000369\"}}],\"level_type_clusion_I\":\"Patients\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"Patient \u00e2g\u00e9 de 18 ans et plus ;  Patient atteint d\u2019un psoriasis chronique en plaques ;  Patient dont les plaques sont localis\u00e9es aux endroits difficiles \u00e0 traiter (genoux, coudes et face ant\u00e9rieure du tibia, sur une surface ne d\u00e9passant pas 5% de la surface corporelle) ;  Patient apte \u00e0 comprendre ou \u00e0 compl\u00e9ter les questionnaires de l\u2019\u00e9tude ;  Patient pouvant \u00eatre suivi durant la p\u00e9riode de l\u2019\u00e9tude, soit 6 mois ;  Patient acceptant de participer \u00e0 l\u2019\u00e9tude.\",\"clusion_E\":\"\"}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es de sant\u00e9 rapport\u00e9es par les participants de l'\u00e9tude']","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 des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)','Via les professionnels de sant\u00e9 d'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":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"475"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}","notes":"La propri\u00e9t\u00e9 des donn\u00e9es de l'\u00e9tude a fait l'objet d'une convention entre l'Universit\u00e9 Bordeaux Segalen et le laboratoire."},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"Import\u00e9e","creationDate":"30-05-2011","lastUpdatedManual":"05-09-2017","isContributorPI":"","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"A l'inclusion, les donn\u00e9es \u00e9taient recueillies par les m\u00e9decins traitants ou dermatologues (questionnaire m\u00e9dical), par les patients (autoquestionnaire) et par un ARC (questionnaire t\u00e9l\u00e9phonique avec les patients). Lors du suivi \u00e0 3 et 6 mois, les donn\u00e9es \u00e9taient recueillies par les patients (autoquestionnaire) et par un ARC (questionnaire t\u00e9l\u00e9phonique aupr\u00e8s des patients).","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"M\u00e9decins g\u00e9n\u00e9ralistes et dermatologues lib\u00e9raux et hospitaliers en France m\u00e9tropolitaine"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}