S84 Systematic Literature Review of the Ability of the IBDQ-32 to Detect Meaningful Change in Ulcerative Colitis Health Indicators

Abstract

Background: The 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32), a measure of IBD-specific health-related quality of life (HRQoL), with scores ranging from 32-224 and higher scores indicating better HRQoL, has been shown to be reliable and valid in patients with ulcerative colitis (UC). Previous reviews produced weak evidence to support its responsiveness or ability to detect changes in UC health indicators. Given the need for accurate assessment in clinical trials, this review and meta-analysis provide an updated synthesis of the literature on IBDQ-32 responsiveness. Methods: A systematic literature review using the PubMed, Embase, and CENTRAL databases identified articles published since the IBDQ-32’s inception through 2021 that either 1) linked change in IBDQ-32 to change in UC health indicators in adults, or 2) reported IBDQ-32 responder analyses in randomized control trials (RCTs) of adults with UC. Studies that fit criteria 1 were summarized in a narrative review. Studies that fit criteria 2 were included in a random effects meta-analysis that compared the proportions of patients who showed a response on the IBDQ-32 (typically ≥16 points) between active treatment and placebo arms. A moderator analysis (Cochran’s Q-test, significance level = 0.10) compared the proportion of IBDQ-32 responders between efficacious treatments (those that met the primary endpoint) and non-efficacious treatments (those that did not meet the primary endpoint). A linear meta-regression examined the association between a continuous predictor of treatment efficacy (primary endpoint odds ratios) and proportions of IBDQ-32 responders in active treatment compared with placebo groups. Results: This review identified 15 articles that linked changes in IBDQ-32 to change in UC health. Change in IBDQ-32 total scores showed consistent moderate-to-strong correlations in the expected direction with change in other UC health measures. Change in IBDQ-32 total scores were correlated with changes in patient-reported symptoms (correlations: r = 0.57, ρ = -0.64), clinical response/remission on disease activity indices (e.g., partial Mayo score; correlations: ρ = -0.53, -0.59), and remission/mucosal healing on endoscopic activity indices (correlations: ρ = -0.37, -0.50). Further, changes in patient-reported symptoms or disease activity indices were linked to clinically meaningful (>16 points) mean changes in IBDQ-32 total scores (ranging from 22.3 to 50.1 points). Patients achieving clinical remission (based on disease activity indices) or mucosal healing (based on Mayo endoscopic sub-scores) experienced significantly larger mean changes in IBDQ-32 total scores than those who did not achieve remission or mucosal healing (p. Conclusion(s): Evidence supports the ability of the IBDQ-32 to detect change and response to treatment among patients with UC, supporting the use of the IBDQ-32 in clinical trials. Future research should examine IBDQ-32 responsiveness in the context of real-world evidence studies.