{"doc_desc":{"title":"Etude longitudinale en population g\u00e9n\u00e9rale : d\u00e9termination de l'\u00c9pid\u00e9miologie de la FIbromyalgie","idno":"FRESH-PEF112-fr","producers":[{"name":"Isabelle PITHOIS-MERLI","affiliation":"PFIZER (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF112-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"112"},{"agency":"FReSH","code":"FRESH-PEF112"}]},"title":"Etude longitudinale en population g\u00e9n\u00e9rale : d\u00e9termination de l'\u00c9pid\u00e9miologie de la FIbromyalgie","alternate_title":"DEFI"},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"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":[{"keyword":"pr\u00e9valence fibromyalgie"}],"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 diffuse chronique","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/849253504","title":"CIM-11"}]}],"purpose":"Principal : - \u00c9valuer la pr\u00e9valence de la fibromyalgie en population g\u00e9n\u00e9rale, dans cinq \u00ab r\u00e9gions fran\u00e7aise \u00bb, en identifiant : \u2022 dans un premier temps, par t\u00e9l\u00e9phone, les patients fibromyalgiques potentiels ou av\u00e9r\u00e9s, \u2022 puis dans un second temps, parmi ces patients, ceux pr\u00e9sentant une fibromyalgie valid\u00e9e par un rhumatologue. Secondaires : - D\u00e9crire les caract\u00e9ristiques des patients avec un diagnostic de fibromyalgie valid\u00e9 par un rhumatologue. - D\u00e9crire les caract\u00e9ristiques des patients pour qui ce diagnostic n\u2019a pas \u00e9t\u00e9 valid\u00e9 par le rhumatologue. - Comparer les caract\u00e9ristiques de ces deux groupes de patients entre eux et chacune d\u2019elles avec les caract\u00e9ristiques de la population g\u00e9n\u00e9rale de l\u2019\u00e9tude.","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2009-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Auvergne Rh\u00f4ne-Alpes','Bretagne','Ile-de-France','Occitanie','Hauts-de-France']","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\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" Patients \u00e2g\u00e9s de 18 ans ou plus. - Patients jug\u00e9s aptes \u00e0 r\u00e9pondre aux questions. - Patients s\u00e9lectionn\u00e9s al\u00e9atoirement acceptant de participer \u00e0 l\u2019enqu\u00eate (en cas de refus, la personne s\u00e9lectionn\u00e9 n\u2019\u00e9tait pas remplac\u00e9e au sein du foyer, ni dans l\u2019\u00e9tude).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant 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"}]},"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) Base de population \u00e0 finalit\u00e9 statistique']"}},"coll_mode":["{\"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":"[1000-10000[ individus","response_rate":"2849"},"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\":[]}"},"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":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2019","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":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"T\u00e9l\u00e9phonique et papier","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"les agglom\u00e9rations de Lille, Grenoble, Toulouse et les d\u00e9partements du Val-de-Marne et de l\u2019Ille-et-Vilaine"},"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"}