P295 VALIDation of the IBD-Disk instrument for assessing disability in inflammatory bowel diseases in a population-based cohort: The VALIDate study

C. Le Berre1, A. Bourreille1, M. Flamant1, G. Bouguen2, L. Siproudhis2, M. Dewitte2, N. Dib3, E. Cesbron-Metivier3, T. Goronflot4, P.A. Gourraud4, E. Kerdreux5, A. Poinas6, C. Trang-Poisson1

1Department of Gastroenterology, CHU Hotel Dieu, Nantes Cedex 1, France, 2Department of Gastroenterology, CHU de Rennes, Rennes, France, 3Department of Gastroenterology, CHU d’Angers, Angers, France, 4Department of Biostatistics, CHU Hotel Dieu, Nantes Cedex 1, France, 5Centre d’Investigation Clinique, CHU Hotel Dieu, Nantes Cedex 1, France, 6Direction de la Recherche Clinique, CHU Hotel Dieu, Nantes Cedex 1, France

Background

Inflammatory bowel diseases (IBD) are disabling disorders. The IBD-Disability Index (IBD-DI) was developed for quantifying disability in IBD patients but is difficult to use. The IBD-Disk is a shortened and visual adaptation of the IBD-DI. It has not been validated yet. The main objectives were to validate the IBD-Disk in a large cohort of IBD patients and to assess its variability over time.

Methods

From March 2018 to July 2019, IBD patients from three university-affiliated hospitals responded twice to both IBD-Disk and IBD-DI at 3–12 months intervals (NCT03590639). Validation included concurrent validity, reproducibility, internal consistency, and evaluation of IBD-Disk correlation with IBD activity. Variability was assessed by comparing scores between baseline and follow-up visits.

Results

A total of 559 patients (73% Crohn’s disease, 27% ulcerative colitis) were included and 389 were followed up (Table 1). There was a good correlation between IBD-Disk and IBD-DI scores (r = 0.75, p < 0.001) (Figure 1). The IBD-Disk was significantly higher in patients with active disease according to Physician/Patient Global Assessment (Figure 2), clinical scores (Figure 3), and biomarkers levels, compared with patients with inactive disease. Reproducibility was excellent (intra-class correlation coefficient = 0.90), as well as internal consistency (Cronbach’s α = 0.89). The IBD-Disk score significantly decreased in patients becoming inactive over time.

Table 1. Clinical characteristics of the study population (n = 559).

Gender, n (%)
Female313 (56)
Age at baseline, mean (SD)40.1 (14.1)
Age at diagnosis, mean (SD)28.1 (12.5)
Disease location (CD / UC), n (%)
L1 / E1114 (28) / 32 (22)
L2 / E2103 (25) / 52 (35)
L3 / E3187 (46) / 62 (42)
L4 / Pouchitis38 (9) / 3 (2)
Disease behaviour in CD, n (%)
B1219 (54)
B2130 (32)
B358 (14)
Perineal location in CD, n (%)
Never295 (72)
Past84 (21)
Active28 (7)
Extra-intestinal manifestation, n (%)123 (22)
Intestinal resection, n (%)172 (31)
Stoma, n (%)25 (4)
Perianal surgery, n (%)85 (15)
Seton, n (%)7 (1)

Figure 1. Correlation between total scores of IBD-Disk and IBD-DI at baseline (n = 418).

Figure 2. Distribution of IBD-Disk scores at baseline according to (A) Patient Global Assessment (n = 513), (B) Physician Global Assessment (n = 514).

Figure 3. Distribution of IBD-Disk scores at baseline according to (A) HBI score (CD), (B) Mayo sub-score (UC).

Conclusion

This is the first study to validate the IBD-Disk in a large cohort of IBD patients, demonstrating that it is a valid and reliable tool for quantifying disability in clinical practice. Further studies are warranted to assess its correlation with endoscopic activity, to explore its responsiveness to change, and to evaluate the factors associated with disability.