Development of a Questionnaire Based on Patients' Messages on an Internet Forum for Flare Detection in IBD

Study Overview
=================
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.

Official Title
-----------------
Flare_IBD: Development and Validation of a Questionnaire Based on Patients' Messages on an Internet Forum for Early Detection of Flare in Inflammatory Bowel Disease

Conditions
-----------------
Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Other: Psychometric validation of the questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Validation of the questionnaire<br>Items reduction, ajustment and psychometric validation of the questionnaire | Other: Psychometric validation of the questionnaire<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale calibration of the new developped questionnaire | Weighing scale calibration | About 30 minutes | 
| Construct validity of the new developped questionnaire | Exploratory factor analysis, discriminant validity by Kruskal-Wallis tests | About 30 minutes | 
| Convergence proprieties of the new developped questionnaire | Convergence test of Flare-IBD scores with objective biological markers and clinical markers used in routine clinical practice | about 30 minutes | 
| Reproductibility of the new developped questionnaire | Investigation of test-retest reliability with a second questionnaire administered 8 days later. | Up to 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Flare, Inflammatory Bowel Diseases, Questionnaire, Internet, Mixed methods