{"doc_desc":{"title":"Cohorte sur les douleurs neuropathiques postop\u00e9ratoires","idno":"FRESH-PEF60123-fr","producers":[{"name":"Christian DUALE","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60123-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60123"},{"agency":"FReSH","code":"FRESH-PEF60123"}]},"title":"Cohorte sur les douleurs neuropathiques postop\u00e9ratoires","alternate_title":"EDONIS"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Christian;DUALE","PILabo":"INSERM CIC \/ CPC-CIC","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0002-2333-7357","role":"pi id"},{"title":"IdRef","uri":"095640088","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"cduale@chu-clermontferrand.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE CLERMONT-FERRAND","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02tcf7a68","role":"sponsor id"},{"title":"SIREN","uri":"266307464","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE CLERMONT-FERRAND","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02tcf7a68"},{"title":"SIREN","uri":"266307461"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]},{"name":"PFIZER (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10"},{"title":"SIREN","uri":"433623550"}]}]},"distribution_statement":{"contact":[{"name":"Christian;DUALE","email":"cduale@chu-clermontferrand.fr","type":"contact","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"douleur chronique"},{"keyword":"consultations"},{"keyword":"type de chirurgie"},{"keyword":"caract\u00e9ristiques neuropathiques"},{"keyword":"outils sp\u00e9cifiques"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"\u00e9valuation"},{"keyword":"traitement"},{"keyword":"douleur"},{"keyword":"pr\u00e9valence"}],"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":"D\u00e9terminants biologiques : Pr\u00e9dispositions g\u00e9n\u00e9tiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants biologiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : Le projet EDONIS (PHRC national 2005), pilot\u00e9 par le CIC de Clermont-Ferrand, est une \u00e9tude \u00e9pid\u00e9miologique multicentrique nationale dont l\u2019objectif principal est de conna\u00eetre la pr\u00e9valence des douleurs neuropathiques 3 et 6 mois apr\u00e8s une intervention chirurgicale programm\u00e9e. Il s\u2019agit de la premi\u00e8re \u00e9tude prospective de cette envergure portant sur les douleurs chroniques post-chirurgicales, qui sont un probl\u00e8me de sant\u00e9 publique motivant pr\u00e8s de 15% des nouvelles consultations dans les structures sp\u00e9cialis\u00e9es dans la prise en charge de la douleur Objectif secondaire : Edonis a aussi pour but d\u2019identifier des facteurs de risque pr\u00e9- et p\u00e9ri-op\u00e9ratoires de la douleur, et de caract\u00e9riser ses m\u00e9canismes, notamment neuropathiques. huit types de chirurgie conventionnelle avaient \u00e9t\u00e9 retenus, soit (a) car elles \u00e9taient d\u00e9j\u00e0 connues comme pourvoyeuses de douleur neuropathique (thoracotomie, mastectomie, herniorraphie inguinale), (b) car elles sont fr\u00e9quemment pratiqu\u00e9es en france et des cas de douleur chronique leur sont attribu\u00e9s (sternotomie, c\u00e9sarienne, chol\u00e9cystectomie, saph\u00e8nectomie), ou (c) l\u2019abord chirurgical laissait suspecter un risque de l\u00e9sion nerveuse (arthroscopie de genou). Une \u00e9tude ancillaire g\u00e9nomique est \u00e9galement associ\u00e9e.","abstract":"","coll_dates":[{"start":"2006-01-01","end":"2010-01-01"}],"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\": 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biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Autoquestionnaire : Saisie \u00e0 partir d\u2019un questionnaire papier (Saisie manuelle) avec double saisie Examens cliniques : Etape manuscrite (Saisie manuelle) Gestion des donn\u00e9es manquantes par retour vers le patient Relance des m\u00e9decins pour r\u00e9aliser les visites de suiviRelance des sujets pour r\u00e9aliser les visites de suivi R\u00e9alisation d\\'audits internes de qualit\u00e9 bimestrielsLes patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\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)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\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":"[1000-10000[ individus","response_rate":"3330"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study 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