Development and Validation of a Questionnaire to Measure the Impact of SBS and Its Treatments on Patients' Lives

Study Overview
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Brief Summary
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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.

Official Title
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Development and Validation of a Questionnaire to Measure the Impact of Short Bowel Syndrome (SBS) and Its Treatments on Patients' Lives

Conditions
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SBS - Short Bowel Syndrome

Intervention / Treatment
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* Other: Exploratory interviews
* Other: Semi-directive interviews
* Other: Delphi Process
* Other: Think aloud interviews
* Other: Psychometric validation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Exploratory interviews|Exploratory interviews to generate an interview guide|
|Other: Semi-directive interviews|Semi-directive interviews to collect qualitative data that will be used for questionnaire item generation|
|Other: Delphi Process|Cotation of newly developed items pertinence on a 4 points likert scale.|
|Other: Think aloud interviews|Debriefing session for the newly developed items: final possibility to adjust the tool before validating the psychometric proprieties of the questionnaire.|
|Other: Psychometric validation|Psychometric properties study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale calibration of the new developped questionnaire | Calibration measure | about 30 minutes | 
| Structure of the new developped questionnaire | Structure identification | about 30 minutes | 
| Convergence proprieties of the new developped questionnaire | Convergence evaluation | about 30 minutes | 
| Reproducibility of the new developped questionnaire | Test of reproducibility | Up to 8 days |