Patient-Reported Outcomes in Clinical Trials of Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis.

Clin Gastroenterol HepatolMay 28, 2026 (epub)
Clinical ResearchGastroenterology

Jurij Hanzel, Yuhong Yuan, Shane W Goodwin et al.

✦ AI-curated · Sources linked

In 30 seconds

This systematic review and meta-analysis examined patient-reported outcome measures (PROMs) in 132 randomized controlled trials for inflammatory bowel disease, including Crohn's disease and ulcerative colitis. The study found pooled placebo outcome rates ranging from 25.2% to 43.6%, with effect sizes for PROMs being smaller than primary endpoints, highlighting significant heterogeneity in reporting and validation of these measures.

Key findings

  • Pooled placebo outcome rates for PROMs ranged from 25.2% to 43.6%.
  • Effect sizes for PROMs were smaller compared to primary endpoints in the same trials.
  • Only a minority of PROMs underwent extensive validation, including IBD Control and IBD Questionnaire.
  • Outcome definitions and reporting formats were highly heterogeneous across trials.

Why it matters

Understanding the variability and validation of patient-reported outcomes is crucial for interpreting clinical trial results in inflammatory bowel disease. This knowledge can inform clinicians about the reliability of these measures in assessing treatment efficacy.

Source

PubMed · PMID 42214800

Published in Clin Gastroenterol Hepatol. This summary was written by xxcode from the publication's abstract and metadata. It is not peer reviewed and is not a substitute for the original article. For clinical decisions, review the original publication.

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