Patient-reported Outcomes in Clinical Trials of Inflammatory Bowel Disease: A Systematic Review and Meta-analysis - PubMed
an hour ago
- #clinical trials
- #inflammatory bowel disease
- #patient-reported outcomes
- Patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs) are increasingly important in clinical trials for inflammatory bowel disease (IBD).
- A systematic review and meta-analysis of 132 randomized controlled trials (RCTs) identified 29 PROMs, with IBD Questionnaire, PRO-2, Euro QoL survey, and 36-item Short Form being most common.
- PROM reporting shows substantial heterogeneity in outcome definitions and formats.
- Pooled placebo outcome rates for PROMs range from 25.2% to 43.6%, with smaller effect sizes compared to primary endpoints.
- Only a minority of 78 PROMs were extensively validated, including IBD Control, IBD Disability Index, and IBDQ; none followed regulatory recommendations.