SECSII - Longitudinal Study on Patients with Irritable Bowel Syndrome: Epidemiological Monitoring and Cost

Head :
Sabaté Jean-Marc, Hôpital Louis MourierService d’hépato-gastroentérologie

Last update : 07/07/2015 | Version : 1 | ID : 8715

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Longitudinal Study on Patients with Irritable Bowel Syndrome: Epidemiological Monitoring and Cost
Sign or acronym SECSII
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL approval DR-2014-07 (authorisation request no. 913409); 01 April 2014 CEERB North Paris: No. 13-065: Irritable Bowel Syndrome : an economic and [...]
General Aspects
Medical area Gastroenterology et hepatology
Health determinants Iatrogenic
Medicine
Nutrition
Social and psychosocial factors
Keywords irritable bowel syndrome, abdominal pain, altered bowel habits, direct cost, indirect cost, severity, diagnosis, treatment
Scientific investigator(s) (Contact)
Name of the director Sabaté
Surname Jean-Marc
Address 178, rue des Renouillers 92700 Colombes
Phone +33 (0)1 47 60 67 21
Email jean-marc.sabate@lmr.aphp.fr
Unit Hôpital Louis MourierService d’hépato-gastroentérologie
Organization APHP
Collaborations
Participation in projects, networks and consortia Yes
Details E-cost European project; GENIEUR (www.genieur.eu)
Funding
Funding status Private
Details National French Society of Gastroenterology
Governance of the database
Sponsor(s) or organisation(s) responsible Groupe Français de Neuro-Gastroentérologie (GFNG)
Organisation status Private
Sponsor(s) or organisation(s) responsible Société Nationale Française de Gastro-Entérologie (SNFGE)
Organisation status Private
Sponsor(s) or organisation(s) responsible Association National des Hépato-Gastroentérologues des Hôpitaux Généraux (ANGH)
Organisation status Private
Sponsor(s) or organisation(s) responsible Club de Réflexion des Cabinets et Groupes d’Hépato-Gastroentérologie (CREGG)
Organisation status Private
Sponsor(s) or organisation(s) responsible Association des Patients Souffrant du Syndrome de l’Intestin Irritable (APSSII)
Organisation status Private
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Longitudinal study (except cohorts)
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Patients attending consultation.
Database objective
Main objective 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).
Inclusion criteria - 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.
Population type
Age Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area France
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2014
Date of last collection (YYYY or MM/YYYY) 2018
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 500
Data
Database activity Current data collection
Type of data collected Clinical data
Declarative data
Clinical data (detail) Direct physical measures
Medical registration
Details of collected clinical data --
Declarative data (detail) Paper self-questionnaire
Details of collected declarative data Patient self-administered questionnaire on quality of life, anxiety, depression, work presenteeism and disruption, as well as healthcare consumption.
Presence of a biobank No
Health parameters studied Health event/morbidity
Health care consumption and services
Quality of life/health perception
Care consumption (detail) Hospitalization
Medical/paramedical consultation
Medicines consumption
Procedures
Data collection method 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).
Quality procedure(s) used Real-time monitoring with CRA.
Participant monitoring Yes
Details on monitoring of participants Frequency of visits (physician): baseline, 6 months and one year. Frequency of self-administered questionnaires (patient): baseline, 3 months, 6 months, 9 months and 1 year.
Links to administrative sources No
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) Through publications. Contact the scientist in charge for further information.
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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