Spondylo-arthritis Screening Tool Among Patient Suffering From Inflammatory Bowel Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Screening questionnaire.
- Who it may be relevant to
- Registry conditions: Spondylarthritis, Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Linguistical Validation of a Spondylo-arthritis Screening Tool for Patients Suffering From Inflammatory Bowel Disease
Overview
The QUESAM study aims to translate into French and validate the traduction of 2 screening questionnaires for spondylo-arthritis among people with inflammatory bowel disease. DETAIL (DETection of Arthritis in Inflammatory boweL diseases) and IBIS-Q (Inflammatory Bowel disease Identification of Spondyloarthritis Questionnaire) questionnaires are built to determine which patients might benefit from a rheumatologic consultation, for a potential rheumatologic inflammatory disease. The investigators will translate the 2 questionnaire in french thanks to an external translation company, from english to french, then back to english to make sure the translation is correct. Then, the main question is: is there a conceptual and semantic equivalence beetween the original english questionnaire and the french-translated one. Participant will answer the 2 screening questionnaire, one initial time during a consultation, and a second time after 1 month.
Detailed description
This is not an actual interventionnal or observationnal study. Investigators will try to provide a statistical validation of 2 questionnaires on people followed in gastro-enterology for an inflammatory bowel disease.
In the first place, investigators will translate the 2 questionnaires
* "The DETection of Arthritis in Inflammatory boweL diseases (DETAIL) questionnaire: development and preliminary testing of a new tool to screen patients with inflammatory bowel disease for the presence of spondyloarthritis, Di Carlo et al (2017)" * "The IBIS-Q \[IBd Identification of Spondyloarthritis Questionnaire\]: A Novel Tool to Detect Both Axial and Peripheral Arthritis in Inflammatory Bowel Disease Patients, Variola et al (2020) From english to french, with a specialized company in scientific translation.
Investigators will then, with the help of 5 patients, determine if the translated final version is easy to understand, and eventually adjust the questionnaires if needed.
If a modification is needed, 5 other patients will be reached to look for any unclear formulation.
If no modification is needed, the questionnaire will be given to eligible patients until 200 answers are reached. People will be recruited during a standard care consultation or a one day-hospitalization for biological treatment
Invistigators will, on top of the questionnaires, be collecting the
* sex * age * study level * type of inflammatory bowel disease * presence of musculoskeletal pain * duration of articulary and bowel disease * previous treatment by biologic * known spondylo-arthritis
At 1 month, participants will be contacted by mail, so that they fill the questionnaires again.
At last, with the answers to the 400 hundreds questionnaires (200 patients, baseline questionnaire + the one month reminder), investigators will be able to make the statistic analyzes required for the statistical validation of the questionnaires, in french.
Outside of the statistical validation, if the questionnaire are in favor of a rheumatologic disease, the gastro-enterologist can address patients to a rheumatology department.
General praticionner will then receive a report of the evaluation.
Interventions
- Other Screening questionnaire
Every patient will answer the 2 screening questionnaires given to them, once at baseline and a second time after 1 month.
Primary outcome measures
- translation and cross-cultural adaptation in french of the questionnaires developped by Di Marco et al (2017) and Variola et al (2020) [Time frame: 13 months]
Secondary outcome measures (6)
- acceptability of the instrument via the proportion of missing data for each item [Time frame: Baseline and one month later]
- Evaluation of the internal consistency assessed by the average inter-item correlation, the average item-result correlation and cronbach's alpha coefficient [Time frame: baseline and one month later]
- evaluation of the reliability of the questionnaire through an intra-rater reliability with the intra-class correlation. [Time frame: Baseline and one month later]
- Comparaison of the acceptability of the instrument via the proportion of missing data for each item [Time frame: 13 months]
- Comparaison of internal consistency of the 2 questionnaires [Time frame: 13 months]
- Comparaison of reliability of the 2 questionnaire [Time frame: 13 months]
Eligibility criteria
Inclusion criteria
- Patient with an inflammatory bowel disease according to gastroenterologist
Exclusion criteria
- No exclusion criteria
- Difficulty for understanding or reading french
- Persons covered by articles L1121-5 to L1121-8 of the French Public Health Code
- Patients with no social security coverage.
- Patients refusing to participate voluntarily.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 1 center
- University Hospital Grenoble — Grenoble
Identifiers
NCT: NCT06998316 · 38RC24.0348