{"study_desc":{"title_statement":{"idno":"FRESH-PEF60104-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60104"},{"agency":"FReSH","code":"FRESH-PEF60104"}]},"title":"Etude longitudinale sur les patients de l\u2019observatoire Rh\u00f4ne-Alpes de l\u2019incontinence anale","alternate_title":"ORALIA"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Henri;DAMON","firstname":"Henri","lastname":"DAMON","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"organisation id"},{"title":"SIREN","uri":"266900273","role":"organisation id"},{"uri":"166662771","role":"pi id","title":"IdRef"}],"email":"damon.henri.heh.2014@gmail.com","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","PILabo":"SERVICE EXPLORATIONS FONCTIONNELLES DIGESTIVES HOPITAL EDOUARD HERRIOT- HOSPICES CIVILS DE LYON","isContact":true},{"name":"Fran\u00e7ois;MION","firstname":"Fran\u00e7ois","lastname":"MION","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"organisation id"},{"title":"SIREN","uri":"266900273","role":"organisation id"},{"uri":"0000-0002-2908-1591","role":"pi id","title":"ORCID"},{"uri":"080107966","role":"pi id","title":"IdRef"}],"email":"francois.mion@chu-lyon.fr","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","PILabo":"SERVICE EXPLORATIONS FONCTIONNELLES DIGESTIVES \u2013 HOPITAL EDOUARD HERRIOT","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"sponsor id"},{"title":"SIREN","uri":"266900273","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Henri;DAMON","lastname":"DAMON","firstname":"Henri","type":"contact","email":"damon.henri.heh.2014@gmail.com","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01502ca60","role":"organisation id","title":"ROR"},{"uri":"266900273","role":"organisation id","title":"SIREN"}]},{"name":"Fran\u00e7ois;MION","lastname":"MION","firstname":"Fran\u00e7ois","type":"contact","email":"francois.mion@chu-lyon.fr","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01502ca60","role":"organisation id","title":"ROR"},{"uri":"266900273","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"traitements m\u00e9dicaux"},{"keyword":"traitements chirurgicaux"},{"keyword":"r\u00e9\u00e9ducation p\u00e9rin\u00e9ale"},{"keyword":"examens compl\u00e9mentaires diagnostiqu\u00e9s"},{"keyword":"arr\u00eats de travail"}],"topics":[{"topic":"Andrologie et urologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7341b8bd-fcb0-44c1-9ca9-8752b542ed59 | http:\/\/data.europa.eu\/8mn\/euroscivoc\/d90d8dbf-c4b3-46c0-bf2c-55a4a3d9ba8b"},{"title":"MeSH","uri":"D033441 | D014572"}]},{"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":"Mesurer l\u2019impact de la prise en charge (par th\u00e9rapeutique : m\u00e9dicale, chirurgicale et kin\u00e9sith\u00e9rapie) des patients atteints d\u2019incontinence anale de la cohorte ORALIA et quantifier l\u2019am\u00e9lioration observ\u00e9e sur les sympt\u00f4mes et sur la qualit\u00e9 de vie. Objectifs secondaires : - \u00c9valuer l\u2019\u00e9volution des pathologies p\u00e9rin\u00e9ales associ\u00e9es : constipation, incontinence urinaire, perturbation de la sexualit\u00e9 ; - \u00c9valuer le co\u00fbt des th\u00e9rapeutiques propos\u00e9es aux patients en fonction de leur impact mesur\u00e9.","abstract":"","coll_dates":[{"start":"2002-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Auvergne Rh\u00f4ne-Alpes']","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 (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\":\"Incontinence anale : score de Wexner sup\u00e9rieur \u00e0 5\/20\",\"clusion_E\":\"\"}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques (hors biologiques)','Donn\u00e9es paracliniques (hors biologiques) : Imagerie','Donn\u00e9es paracliniques (hors biologiques) : Exploration fonctionnelle','Donn\u00e9es de sant\u00e9 rapport\u00e9es par les participants de l'\u00e9tude']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques.Gestion des donn\u00e9es manquantes par retour au dossier source et\/ou par retour vers le patient.R\u00e9alisation d'audit qualit\u00e9 interne 1 fois par an.Les patients sont inform\u00e9s de l'utilisation de leur donn\u00e9es.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Qualit\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)']"}},"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":"[500-1000[ individus","response_rate":"621"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s aux seules m\u00e9tadonn\u00e9es\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_14cb\"}]}","notes":""},"dataset_use":{"restrictions":"Utilisation impossible des donn\u00e9es par des \u00e9quipes acad\u00e9miques ou des industriels.","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":"08-03-2013","lastUpdatedManual":"05-08-2014","isContributorPI":"","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications 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