{"doc_desc":{"title":"Longitudinal Study on Patients with Irritable Bowel Syndrome: Epidemiological Monitoring and Cost","idno":"FRESH-PEF8715-en","producers":[{"name":"Jean-Marc SABATE","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8715-en","IDno":{"metadata_no":[{"agency":"PEF","code":"8715"},{"agency":"FReSH","code":"FRESH-PEF8715"}]},"title":"Longitudinal Study on Patients with Irritable Bowel Syndrome: Epidemiological Monitoring and Cost","alternate_title":"SECSII"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Jean-Marc;SABATE","PILabo":"APHP \/ H\u00f4pital Louis MourierService d\u2019h\u00e9pato-gastroent\u00e9rologie","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0001-5591-3489","role":"pi id"},{"title":"IdRef","uri":"06969141X","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"jean-marc.sabate@aphp.fr","isContact":"Yes"}],"oth_id":[{"name":"E-cost European project; GENIEUR (www.genieur.eu)","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"ASSOCIATION NATIONALE DES HEPATO-GASTROENTEROLOGUES DES HOPITAUX GENERAUX DE FRANCE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0269vww35","role":"sponsor id"}],"role":"sponsor"},{"name":"ASS DES PATIENTS SOUFFRANTS DU SYNDROME DE L INTESTIN IRRITABLE (APSSII)","extlink":[{"title":"SIREN","uri":"533148680","role":"sponsor id"}],"role":"sponsor"},{"name":"GROUPE FRANCAIS DE NEURO-GASTRO-ENTEROLOGIE (GFNG)","extlink":[{"title":"SIREN","uri":"791608334","role":"sponsor id"}],"role":"sponsor"},{"name":"CLUB REFLEXION GROUPES DE GASTRO ENTEROL (CREGG)","extlink":[{"title":"SIREN","uri":"342104460","role":"sponsor id"}],"role":"sponsor"},{"name":"SOCIETE NATIONALE FRAN\u00c7AISE DE GASTRO-ENTEROLOGIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04c6sc363","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"SOCIETE NATIONALE FRAN\u00c7AISE DE GASTRO-ENTEROLOGIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04c6sc363"}]}]},"distribution_statement":{"contact":[{"name":"Jean-Marc;SABATE","email":"jean-marc.sabate@aphp.fr","type":"contact","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"irritable bowel syndrome"},{"keyword":"abdominal pain"},{"keyword":"altered bowel habits"},{"keyword":"direct cost"},{"keyword":"indirect cost"},{"keyword":"severity"},{"keyword":"diagnosis"},{"keyword":"treatment"}],"topics":[{"topic":"Gastroenterology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/a3898340-a42d-4f5e-a822-1de204a9a867"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D005762"}]},{"topic":"Irritable bowel syndrome","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1158238623","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"}],"purpose":"Irritable bowel syndrome (IBS), which involves abdominal pain and altered bowel habits, is a common disease that affects 5% of the population. There is no diagnostic test provided and the treatments used are often ineffective. IBS may significantly reduce quality of life and impact daily activities and work. All of these factors can contribute to increased consultations and treatment and, as such, the overall cost of the disease in France for which there is no recent data. The aim of this cohort is to describe the actual overall cost of IBS by assessing direct costs (examinations, consultations, hospitalisations, reimbursed or non-reimbursed treatment, self-medication, alternative treatments), and indirect costs (work disruption, reduced productivity), assessing the role of factors linked to the disease (IBS type, severity, disease history) and the treatment type (centres of expertise, hospital, practice). This is a multicentric French cohort of IBS patients for carrying out health economics and epidemiological analyses (increased knowledge of prognostic demographic factors, history, comorbidities, predominant symptoms, type of treatment).","abstract":"","coll_dates":[{"start":"2014-01-01","end":"2018-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\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    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Aged 18 to 75 years old; - Suffering from IBS (ROME-II criteria); - Normal digestive examinations (total colonoscopy and\\\/or normal barium enema for subjects aged 50 or over, proctosigmoidoscopy and\\\/or normal barium enema in people under 50 years old). These examinations should be carried out 5 years prior to enrolment for patients over 50 years old. There is no time limit for patients under 50 years of age. - Satisfactory level of French language comprehension and expression. - Internet access or agreement to send questionnaires by post.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Real-time monitoring with CRA.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth care consumption and services\r\nQuality 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":""}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"500"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the scientist in charge for further information.","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":"28-04-2014","lastUpdatedAuto":null,"lastUpdatedManual":"11-05-2015","isContributorPI":"No","contributorName":"Jean-Marc SABATE","contributorAffiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Private non-profit"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Private non-profit","Private non-profit","Private non-profit","Private non-profit","Private non-profit"],"otherSponsorType":["","","","",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Yes"},"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":"Data are collected through a secure internet site that was specifically developed for this study and approved by the CNIL (French National Data Processing and Liberties Commission).","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"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"}