Patient-Reported Outcomes in Clinical Trials of Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis.
Jurij Hanzel, Yuhong Yuan, Shane W Goodwin et al.
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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.