Development and Validation of a Questionnaire to Assess the Quality of Life in Patients with Inflammatory Bowel Disease in Mainland China.

Abstract

Inflammatory bowel disease (IBD) affects the quality of patients' life in many ways. The aim of this study was to develop and validate a mainland Chinese version of IBD quality-of-life questionnaire for ulcerative colitis (UC) and Crohn's disease (CD). A draft questionnaire containing 30 items was generated from a descriptive qualitative study, literature review and consulting with IBD patients and experts. The validity, discriminant ability, reliability, and sensitivity to change were validated in 336 patients with IBD. A 22-item IBD quality-of-life questionnaire (IBDQOL-22) with 4 domains was developed. The 4 domain scores of the IBDQOL-22 correlated well with the related SF-36 (36-Item Short Form Health Survey) dimensional scores in UC (r = 0.42-0.75) and CD (r = 0.41-0.66). The total scores of the IBDQOL-22 correlated well with the physical component summary scores of the SF-36 in UC (r = 0.74) and CD (r = 0.74), the mental component summary scores of the SF-36 in UC (r = 0.77) and CD (r = 0.71), the colitis activity index in UC (r = -0.61) and the CD activity index (r = -0.53). It was able to discriminate between patients with active and inactive disease. Cronbach's alpha for the 4 domains of the IBDQOL-22 ranged from 0.77 to 0.90 in UC and from 0.76 to 0.89 in CD. Test-retest reliability was excellent (intraclass correlation coefficient was 0.88-0.95 in UC and 0.72-0.90 in CD). The 3 domains of the IBDQOL-22 (emotional function, symptoms and discomfort, bowel symptoms and its influences) were able to detect changes in patients whose clinical activity index changed more than one point. The IBDQOL-22 is a valid, reliable, and responsive instrument for assessing disease-specific quality-of-life in patients with IBD in Mainland China.