{"doc_desc":{"title":"Etude transversale de patients suivis pour douleurs neuropathiques p\u00e9riph\u00e9riques (DNP) : comorbidit\u00e9s associ\u00e9es","idno":"FRESH-PEF111-fr","producers":[{"name":"Isabelle PITHOIS-MERLI","affiliation":"PFIZER (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF111-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"111"},{"agency":"FReSH","code":"FRESH-PEF111"}]},"title":"Etude transversale de patients suivis pour douleurs neuropathiques p\u00e9riph\u00e9riques (DNP) : comorbidit\u00e9s associ\u00e9es","alternate_title":"ORBIT"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"V\u00e9ronique;MILLET","firstname":"V\u00e9ronique","lastname":"MILLET","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10","role":"organisation id"},{"title":"SIREN","uri":"433623550","role":"organisation id"}],"email":"veronique.millet@pfizer.com","affiliationName":"PFIZER (FRANCE)","PILabo":"Pfizer","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"PFIZER (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10","role":"sponsor id"},{"title":"SIREN","uri":"433623550","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10"},{"title":"SIREN","uri":"433623550"}]}]},"distribution_statement":{"contact":[{"name":"V\u00e9ronique;MILLET","lastname":"MILLET","firstname":"V\u00e9ronique","type":"contact","email":"veronique.millet@pfizer.com","affiliationName":"PFIZER (FRANCE)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02c9yny10","role":"organisation id","title":"ROR"},{"uri":"433623550","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[],"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":"Douleur neuropathique p\u00e9riph\u00e9rique chronique","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/425464783","title":"CIM-11"}]}],"purpose":"Primaire : - Evaluer la fr\u00e9quence des troubles anxieux et des troubles de l\u2019humeur et le degr\u00e9 des troubles de sommeil chez les patients suivis pour DNP Secondaire : - D\u00e9crire les liens entre les composantes de la DNP et l\u2019existence de troubles anxieux, de troubles de l\u2019humeur et le degr\u00e9 de troubles de sommeil, - D\u00e9crire les relations entre les composantes de la DNP, les troubles anxieux, les troubles de sommeil, les troubles de l\u2019humeur d\u2019une part et la qualit\u00e9 de vie de l\u2019autre, - D\u00e9crire la relation entre les composantes de la DNP, l\u2019existence de troubles anxieux et de troubles de l\u2019humeur, le degr\u00e9 des troubles de sommeil d\u2019une part et la prise en charge m\u00e9dicamenteuse actuelle des patients de l\u2019autre.","abstract":"","coll_dates":[{"start":"2006-01-01","end":"2008-01-01"}],"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 (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\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\": \" Patients adultes - Douleur neuropathique p\u00e9riph\u00e9rique (en relation avec une l\u00e9sion du syst\u00e8me nerveux p\u00e9riph\u00e9rique). - Intensit\u00e9 de la douleur sup \u00e0 3 sur l\u2019EVN,  - Une radiculalgie sans lombalgie ou bien avec une lombalgie dont l\u2019intensit\u00e9 de la douleur est inf \u00e0 3 sur l\u2019EVN (intensit\u00e9 de la lombalgie de 0 \u00e0 2), - En neurologie de ville : patient consultant pour sa DNP ou pour l\u2019\u00e9tiologie de cette DNP, - En CAD : patient consultant pour une DNP en 1\u00e8re ou 2\u00e8me consultation.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\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"}]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","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)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"195"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contacter le responsable scientifique","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":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2018","isContributorPI":false,"contributorName":"V\u00e9ronique MILLET","contributorAffiliation":"PFIZER (FRANCE)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"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":"CRF papier","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"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"}