The Inflammatory Bowel Disease Questionnaire in Randomized Controlled Trials of Treatment for Ulcerative Colitis: Systematic Review and Meta-Analysis

Authors

Aaron Yarlas, Optum, Inc.Follow
Stephen Maher, Optum, Inc.Follow
Martha Bayliss, Optum, Inc.Follow
Andrew Lovley, Optum, Inc.Follow
Joseph C. Cappelleri, Pfizer Inc.Follow
Andrew G. Bushmakin, Pfizer Inc.Follow
Marco D. DiBonaventura, Pfizer Inc.Follow

Publication Date

4-27-2020

Keywords

ulcerative colitis, quality of life, meta-analysis, clinical trials, patient questionnaire

Abstract

Purpose: The 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32) is the most frequently used instrument to capture disease-specific quality of life in randomized clinical trials for ulcerative colitis. This review and meta-analysis provides the first synthesis of evidence regarding the sensitivity of IBDQ-32 total and domain scores to treatment efficacy.

Methods: A systematic literature search and risk-of-bias assessment yielded 14 articles that were included in the primary analysis. Treatments were categorized as efficacious if they met the primary efficacy endpoint (which was not the IBDQ-32); otherwise they were categorized as non-efficacious. A continuous measure of treatment efficacy was calculated for each primary efficacy endpoint. Meta-analysis using random-effects models compared standardized mean differences in IBDQ-32 total and domain change scores between target dose and control arms. Meta-regression compared the association between treatment efficacy and these outcomes.

Results: Studies with efficacious treatments showed larger mean improvements relative to controls in IBDQ-32 total scores and all 4 domains (Hedges’ g range: 0.49 to 0.67; P < 0.001 for all). At the same time, patients in studies with non-efficacious treatments showed small and nonsignificant improvements in these outcomes relative to controls (Hedges’ g range: 0.05 to 0.23; P > 0.09 for all). Meta-regression models showed that the magnitude of treatment efficacy was a positive predictor of these same IBDQ-32 outcomes.

Conclusions: These analyses found that IBDQ-32 scores are sensitive to treatment. The results provided here support the use of the IBDQ-32 to capture treatment benefits on quality of life for patients with ulcerative colitis.

Recommended Citation

Yarlas A, Maher S, Bayliss M, Lovley A, Cappelleri JC, Bushmakin AG, DiBonaventura MD. The Inflammatory Bowel Disease Questionnaire in randomized controlled trials of treatment for ulcerative colitis: systematic review and meta-analysis. J Patient Cent Res Rev. 2020;7:189-205. doi: 10.17294/2330-0698.1722