logo ecco
Portal

ECCO'24 Abstracts

ECCO'24 Abstracts on the JCC Website

ECCO'24 Abstract Book PDF Version

ECCO'24 Abstracts COI Disclosure

Poster presentations: Clinical: Diagnosis and Outcome 2020

P267 Validation of the short inflammatory bowel disease questionnaire as an outcome measure in Crohn’s disease patients

S. Reggev1, G. Goran1, O. Sarid1, D. Schwartz2, R. Sergienko3, V. Slonim-Nevo1, M. Friger3, A. Nemirovsky4, E. Vinogradov4, A. Monsonego4, D. Greenberg5, S. Odes6

1Ben-Gurion University of the Negev, Social Work, Beer Sheva, Israel, 2Soroka Medical center, Gastroenterology, Beer Sheva, Israel, 3Ben-Gurion University of the Negev, Public Health, Beer Sheva, Israel, 4Ben-Gurion University of the Negev, Microbiology and Immunology, Beer Sheva, Israel, 5Ben-Gurion University of the Negev, Health Systems Management, Beer Sheva, Israel, 6Ben-Gurion University of the Negev, Health Sciences, Metar, Israel

Background

Health-related quality-of-life by the self-report, disease-specific Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is increasingly used as an outcome measure in Crohn`s disease (CD) patients in clinical trials. Higher SIBDQ scores indicate better quality-of-life; the range is 10 to 70. However, the construct validity of SIBDQ and its responsiveness to change of disease status require validation.

Methods

Adult (≥18 years) CD patients (n = 108) with Harvey–Bradshaw Index (HBI) >4 and <16 prospectively filled in the SIBDQ at two time-points (T1, T2) 3 months apart. Medical data at T1 and T2 were collected, and recorded by their physicians in the HBI. Biomarkers of disease activity included Calprotectin and C-reaction protein (CRP), measured at T1 and T2. The construct validity of SIBDQ in relation to biomarkers and HBI was determined by Pearson correlations and group comparisons using Student`s t-test. Statistical significance was taken as p < 0.05. Patients’ medications were prescribed without regard to the study protocol.

Results

Demographic and medical characteristics (median, %) of the cohort were: age 30 years; females 65%, married/partner 48%; higher education 83%; BMI 22; non-smokers/past-smokers 92%; disease duration 5 years; past Crohn’s disease-related surgery 17%; Montreal classification A2 89%, L2+L3 89%, B1+B2 89%, perianal disease 18%; medications: corticosteroids 4%, 5-ASA 5%, immunomodulators 21%, biologicals 43%. HBI and SIBDQ median scores at T1 and T2 were: HBI: 9 and 4 (p < 0.001); SIBDQ: 43 and 49 (p < 0.001). SIBDQ scores correlated inversely with Calprotectin (r = −0.395, p = .002), CRP (r = −0.208, p = .046), and HBI (r = −0.345, p < 0.001). Baseline HBI scores were used to divide the cohort into two groups for comparison: mild disease (5–7) vs. moderate disease (8–16). Mild disease patients reported higher SIBDQ scores than those with moderate disease (42.7 vs. 39.7, t = 1.96, p = 0.05). Regarding sensitivity of SIBDQ to clinical changes between T1 and T2, we found that change in SIBDQ correlated significantly with change in CRP across these two administrations (r = −0.232, p = 0.042). Finally, defining clinical response in CD as a decrease from baseline HBI score by ≥3 points, SIBDQ change scores were significantly larger in treatment responders (n = 51, M = 6.25) than non-responders (n = 30, M = 1.13, t = −3.042, p = 0.003).

Conclusion

The SIBDQ measure is a valid assessment of quality-of-life in CD, correlating with biomarkers and sensitive to change of disease activity, with potential for use as a patient-reported outcome in both clinical practice and as a primary end-point in clinical trials.