NCT04150302

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• SBS - Short Bowel Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-01-01
• Primary completion: 2020-01-01
• Completion: 2021-06-01
• First posted: 2019-11-04
• Last updated: 2019-11-04

Locations

1 site across 1 country: France