Ulcerative Colitis Clinical Trial
Official title:
Development and Validation of a Self-reported Objective Index of Work Disability in Inflammatory Bowel Disease
Background theme Crohn's disease (CD) and ulcerative colitis (UC) are chronic diseases that
alternate flares of active inflammation with periods of clinical remission. The working
capacity of patients may be affected both by disease activity and by the aggressive treatment
or surgical intervention required for the management of the disease and its complications.
Work disability and impairment are especially important in patients with inflammatory bowel
disease (IBD) because the disease affects young individuals who are generally employed and
fully active.
Although there are several indexes in the literature that assess the degree of work
disability due to IBD, all have a high degree of subjectivity, so none can be used to request
disability pensions.
Experience of the research group on the subject Our group has developed a line of research on
work disability associated with IBD.
Initially the investigators have studied the parameters that condition the granting of
disability pensions of Spanish courts.
Subsequently, a population study of the prevalence of work disability in Spain has been
carried out.
Finally, the investigators develop and validated a disability index for CD (published in its
extensive and reduced form) and for UC (currently under review).
Hypothesis The IBD generates a work disability that can be measured objectively. Establishing
the parameters related to disability is essential to promote equity in administrative and
judicial decisions related to the granting of disability pensions to patients with IBD.
Objective Development and validation of an objective index to measure the degree of
disability in IBD.
Material and methods:
Study 1:
A self-reported and objective questionnaire of disability will be developed based on the data
of the population survey already carried out by our group.
Patients from a previous study (n 293) will be included. The relationship of different
objective variables and disability outcomes will be analyzed with a univariate and a
subsequent multivariate analysis. Alternative work disability scores will be developed.
Study 2: for the validation of the questionnaire a new online interview will be performed,
patients from patients' assocations will be asked to participate. Data Collection: patients
will answer a online survey administered with the SurveyMonkey © platform.
Participant will answer questions about demographics, disease activity, treatment and
complications and data regarding disability. Patients will also complete the SCDWDQ (Short
Crohn's Disease Work Disability Questionnaire), Work Productivity and Activity Index (WPAI),
IBDQ-9, the EuroQol and IBD-DI (IBD disability index).
Statistical analysis: psychometric properties of the index will be evaluated:
1. Convergent validity: the Spearman correlation will be used to correlate the objective
disability score with IBD-DI and SCDWDQ.
2. Discriminant validity: it will be measured by the t-test among patients with different
degrees of disability (inactive-active, hospitalization-no hospitalization, surgery-no
surgery).
n/a
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