Study type

Study topic

Disease /health condition

Study type

Non-interventional study

Scope of the study

Other

If ‘other’, further details on the scope of the study

Development of a questionnaire for health related quality of life assessment

Data collection methods

Combined primary data collection and secondary use of data
Non-interventional study

Non-interventional study design

Cross-sectional
Study drug and medical condition

Medical condition to be studied

Crohn's disease
Inflammatory bowel disease
Population studied

Short description of the study population

Patients with ulcerative colitis and Crohn’s disease

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)

Special population of interest

Other

Special population of interest, other

Ulcerative colitis and Crohn’s disease patients

Estimated number of subjects

311
Study design details

Main study objective

To elaborate and validate a short quality-of-life questionnaire with the most representative items from the Spanish version of the 36-item Inflammatory Bowel Disease Questionnaire (IBDQ-36) using the Rasch analysis

Data analysis plan

The responses to 311 IBDQ-36 questionnaires from 167 patients with ulcerative colitis (UC) and 144 with Crohn's disease (CD) were analyzed. IBDQ-36 was shortened with successive Rasch analyses until all the remaining items showed acceptable separation and goodness-of-fit properties. Validation of the short questionnaire was studied in a new group of 125 patients by determining its validity and reliability.
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