Chronic Inflammatory Bowel Diseases
Conditions
Keywords
Psychometric properties, Patient-Reported Outcomes
Brief summary
Validating two questionnaires for measuring relapse in IBD (Crohn's / UC)
Detailed description
IBD (Chronic Inflammatory Bowel Diseases) includes Crohn's disease and ulcerative colitis (UC). In France, an estimated 300,000 people suffer from IBD (source afa Crohn RCH France). To our knowledge, there are no Patient Reported Outcomes (PROs) validated in French to measure the relapse phenomenon in IBD. Such an instrument would complement the available indicators and enable clinicians to detect treatment response at an early stage, as well as failure to respond to treatment, as manifested by the resumption or increased frequency of relapses, and thus enable rapid adjustment of the proposed therapeutic strategy. Two questionnaires have been developed, their psychometric properties need to be studied. The project's deliverable will therefore be two validated questionnaires for measuring relapse from the patient's perspective in IBD for routine use. For this reason, the questionnaires will be short, simple to use, easy to interpret and designed to integrate online applications for patient self-monitoring of IBD disease activity.
Interventions
None listed
Sponsors
EPSTEIN Jonathan
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient member of the AFA Crohn RCH, and registered in the mailing list * Person having received full information on the organization of the research and not having objected to his/her participation and to the use of his/her data.
Exclusion criteria
\- There were no non-inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Structural validity evaluated by a confirmatory factor analysis, thresholds: comparative fit index (CFI)>0.90, Tucker-Lewis index (TLI)>0.90, root mean square error of approximation (RMSEA)<0.08 | day 0 | Psychometric properties measurable in a cross-sectional study as described by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), using classical test theory and item response theory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility evaluated by answers to respondents' questions according to declared status corresponding to current absence of relapse. Measured by intraclass correlation coefficient (ICC), a value above 0.70 is expected for acceptable reproducibility | day 15 | Reproductibility |
Contacts
Primary ContactANDREIA CARVALHO DE FREITAS
Outcome results
None listed