Evaluation and interpretation of Hawthorne and other trial-related effects in Celiac Disease: A systematic review and meta-analysis.
Dorina Pjetraj, Elena Lionetti, Alfredo Pulvirenti et al.
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In 30 seconds
This systematic review and meta-analysis evaluated the Hawthorne effect in celiac disease (CeD) by analyzing histological changes in patients on a gluten-free diet. The study included ten qualitative studies and three studies with histological data from 168 participants. The meta-analysis revealed a significant increase in the villous height-crypt depth (Vh/Cd) ratio of +0.25, indicating that observation may influence outcomes.
Key findings
- Placebo or control groups showed improvements in symptoms and mucosal morphology.
- Meta-analysis indicated a significant increase in Vh/Cd ratio of +0.25 (95% CI 0.11-0.39; p < 0.001).
- Low heterogeneity was observed in the meta-analysis results.
Why it matters
Understanding the Hawthorne effect is crucial for interpreting clinical trial outcomes in celiac disease, as it highlights the impact of observation on patient-reported and histological improvements.