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
| 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 |
| 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 |
