{"doc_desc":{"title":"Monitoring a cohort with anal incontinence in the Rh\u00f4ne-Alpes area","idno":"FRESH-PEF60104-en","producers":[{"name":"Henri DAMON","affiliation":"HOSPICES CIVILS DE LYON (HCL)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60104-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60104"},{"agency":"FReSH","code":"FRESH-PEF60104"}]},"title":"Monitoring a cohort with anal incontinence in the Rh\u00f4ne-Alpes area","alternate_title":"ORALIA"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Henri;DAMON","PILabo":"SERVICE EXPLORATIONS FONCTIONNELLES DIGESTIVES HOPITAL EDOUARD HERRIOT- HOSPICES CIVILS DE LYON","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"166662771","role":"pi id"},{"title":"SIREN","uri":"266900273","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"damon.henri.heh.2014@gmail.com","isContact":"Yes"},{"type":"investigator","name":"Fran\u00e7ois;MION","PILabo":"SERVICE EXPLORATIONS FONCTIONNELLES DIGESTIVES \u2013 HOPITAL EDOUARD HERRIOT","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"ORCID","uri":"0000-0002-2908-1591","role":"pi id"},{"title":"IdRef","uri":"080107966","role":"pi id"},{"title":"SIREN","uri":"266900273","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"francois.mion@chu-lyon.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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","email":"damon.henri.heh.2014@gmail.com","type":"contact","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","email":"francois.mion@chu-lyon.fr","type":"contact","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":"Medical treatment"},{"keyword":"surgical treatment"},{"keyword":"perineal re-education"},{"keyword":"additional diagnostic examinations"},{"keyword":"absence from work"}],"topics":[{"topic":"Andrology and urology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7341b8bd-fcb0-44c1-9ca9-8752b542ed59"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d90d8dbf-c4b3-46c0-bf2c-55a4a3d9ba8b"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D033441"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D014572"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"To assess treatment outcome (by medical, surgical and physiotherapy treatment) for patients with anal incontinence included in the ORALIA cohort and to measure any observed improvement to symptoms and quality of life. Secondary objectives: - to study the development of associated perineal disorders: constipation, urinary incontinence, sexual issues, - to estimate treatment costs proposed to patients based on their measured impact.","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Anal incontinence: Wexner score greater than 5\\\/20\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Paraclinical data (non-biological) : Imaging','Paraclinical data (non-biological) : Function testing']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Quality of life\/health perception"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[500-1000[ individuals","response_rate":"621"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Metadata-only access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_14cb\"}]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"05-08-2014","isContributorPI":"No","contributorName":"Henri DAMON","contributorAffiliation":"HOSPICES CIVILS DE LYON (HCL)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=%28Damon+H[author]+OR+Mion+F[author]%29+AND+ORALIA"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Self-administered questionnaire: entry from a paper questionnaire; Interviews: entry from a paper questionnaire; Clinical examinations: handwritten.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Rh\u00f4ne Alpes"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}