SBS - Short Bowel Syndrome
Conditions
Brief summary
Today, patients express a very strong need to take into account the consequences of their disease and its treatments in their therapeutic follow-up. It is therefore essential to better understand the needs, expectations and values of patients with SBS in order to better understand the impact of the disease on their lives, and thus improve the conditions for medical, social, psychological and technical care. The clinical expertise of health professionals and meetings with patient associations demonstrate the major gap between the parameters taken into account by physician to evaluate the evolution of the SBS and the day-to-day experience of the disease perceived by the patient. The objective of the ARTEMIS-GC study is to develop and validate an instrument to measure the impact of SBS and its treatments on daily life from the perspective of patients.
Interventions
OTHERExploratory interviews
Exploratory interviews to generate an interview guide
Semi-directive interviews to collect qualitative data that will be used for questionnaire item generation
OTHERDelphi Process
Cotation of newly developed items pertinence on a 4 points likert scale.
OTHERThink aloud interviews
Debriefing session for the newly developed items: final possibility to adjust the tool before validating the psychometric proprieties of the questionnaire.
OTHERPsychometric validation
Psychometric properties study
Sponsors
Beaujon Hospital
Société Francophone Nutrition Clinique et Métabolisme
Central Hospital, Nancy, France
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with SBS defined by a hail length remaining in post-duodenal \< 2 meters * Patients with intestinal insufficiency, i.e. chronic malabsorption requiring energetic and/or hydro-electrolytic intravenous support for more than 6 months * Patients with a period of at least 6 months after the establishment of the SBS * Patients who has already had a return home after the establishment of the SBS for a period of at least 3 months
Exclusion criteria
* Patients with intestinal insufficiency but with a cause other than SBS * Lack of understanding of the study * Not speaking French
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scale calibration of the new developped questionnaire | about 30 minutes | Calibration measure |
| Structure of the new developped questionnaire | about 30 minutes | Structure identification |
| Convergence proprieties of the new developped questionnaire | about 30 minutes | Convergence evaluation |
| Reproducibility of the new developped questionnaire | Up to 8 days | Test of reproducibility |
Countries
France
Contacts
Primary ContactLaetitia Ricci, PhD
Backup ContactFrancisca Joly, MD, PhD
Outcome results
None listed