Background: IBDs are disabling conditions that negatively affect physical, psychological, familial and social dimensions of life. Thus, specific tools have been used to assess the impact of disease and its treatment options on relevant end-points such as health-related quality of life (HRQL), measured by the IBD-Questionnaire (IBD-Q). Recently, the IBD-Disability Index (IBD-DI) has been developed to evaluate the entire spectrum of limitations in functioning in patients (pt) with IBD. This index is inspired to the ICF. The aim of the present study was to assess the relationship between the IBD-DI, clinical characteristics and HRQoL in a cohort of Sicilian pt with ulcerative colitis (UC).
Methods: IBD-Q and IBD-DI questionnaires were administered to consecutive UC adults outpatients from July to November 2016. The IBD-DI consists of 28 items that evaluate the 4 domains of body functions, activity and participation, body structures and environmental factors. A higher score indicating a greater level of disability. IBD-Q consists of 32 questions grouped into 4 dimensions: bowel, systemic, social, emotional. Scores range from 1 to 7 with higher scores indicating better QoL. Disease activity was assessed by partial Mayo score. The mean differences of DI score in relation to dichotomic clinical variables were performed by Student's t test. By linear regression analysis we assessed also the relationship between DI and IBD-Q. Differences were reported as statistically significant if the pvalue was<0.05.
Results: 49 UC patients (69% males, median age 47 years) were enrolled; 24% were smokers. 75% had inactive or mild disease, 12 (25%) moderate disease. None of the recruited pt had severe disease. Concomitant medications at the time of the interview were conventional therapy in 32 pt (65%) or immunosuppressants in 12 pt (24%). 4 pt took no medications and 1 patients was on topical therapy. The mean IBD-DI score was 25.49±19.83; 59% of patients had low DI≤25 while 14% had high DI (>50. No correlations were found between IBD-DI and gender, disease duration, disease extension (Montreal Classification) and extraintestinal manifestations. IBD-DI was related to clinical disease activity (p=0.006) and immunosuppressive therapy (p=0.060). By linear regression analysis, IBD-DI was significantly associated with IBD-Q (R2 0.693; p<0.001.Interestingly, 8% (n=4) of patients with inactive or mild disease had severe disability (>50) and 6% (n=3) with active disease had low disability (<25).
Conclusions: Our preliminary results show that the IBD-DI is a reliable tool to measure functional status and disability in UC; it correlates with disease activity, need of immunosuppressive therapy and HR-QoL. This novel index should be adopted as a primary endpoint in disease modification trials.