Inflammatory Bowel Diseases
Conditions
Keywords
Flare, Inflammatory Bowel Diseases, Questionnaire, Internet, Mixed methods
Brief summary
Crohn's disease and ulcerative colitis, the two major forms of inflammatory bowel disease (IBD) are chronic disabling conditions characterized by flares followed by periods of remission. However, IBD patients are seen every 3 to 6 months in the outpatient clinic, and the occurrence of a flare between two outpatient visits is not captured. In the current state of knowledge, there is no validated patient-reported outcome (PRO) tool to measure the phenomenon of flare in IBD. This study aimed to use an innovative methodology to collect messages posted by patients in an Internet forum for developing and validating a PRO measuring flare in IBD. The design involves 1) Engineering sciences for scraping extraction of messages posted in an Internet forum and for Identification of messages related to flare, 2) Qualitative methods for thematic content analyze of the messages posted, for candidate items generation, for items selection (Delphi process) and for items adjustment (think aloud interviews), 3) Quantitative methods for psychometric validation of the PRO.
Interventions
OTHERPsychometric validation of the questionnaire
Delph Process : expert panel will include HCPs and patients. They will evaluate the relevance of items on a Likert scale (HCPs N = 25 ; Patients N = 25 ) Think aloud interviews (N = 10 patients) Psychometric validation ( N = 200 patients)
Sponsors
Association François Aupetit, Paris, France
University of Lorraine
Central Hospital, Nancy, France
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Every patient consulting the gastroenterology unit of Nancy University Hospital with a confirmed IBD diagnosis, regardless of the patient's state or treatment will be considered for inclusion
Exclusion criteria
* patients with a diagnosis \< 3 months. * Protected persons (minors, adults under guardianship, pregnant or breastfeeding women, people living in a public health or social institution, patients in an emergency situation, incarcerated individuals)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scale calibration of the new developped questionnaire | About 30 minutes | Weighing scale calibration |
| Construct validity of the new developped questionnaire | About 30 minutes | Exploratory factor analysis, discriminant validity by Kruskal-Wallis tests |
| Convergence proprieties of the new developped questionnaire | about 30 minutes | Convergence test of Flare-IBD scores with objective biological markers and clinical markers used in routine clinical practice |
| Reproductibility of the new developped questionnaire | Up to 8 days | Investigation of test-retest reliability with a second questionnaire administered 8 days later. |
Contacts
Primary ContactJonathan Epstein, MD, PhD
Backup ContactLaetitia Ricci, PhD
Outcome results
None listed