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Responsiveness of histological disease activity indices in ulcerative colitis: a post hoc analysis using data from
Vipul Jairath1, Laurent Peyrin-Biroulet2, Guangyong Zou1
1Robarts Clinical Trials Inc., London, Ontario, Canada.
Four histological indices for ulcerative colitis (UC) disease activity showed similar reliability and responsiveness in a clinical trial. These validated tools aid in assessing treatment effectiveness for UC patients.
Area of Science:
- Gastroenterology
- Histopathology
- Clinical Trial Analysis
Background:
- Accurate histological assessment of ulcerative colitis (UC) disease activity is crucial for treatment evaluation.
- Existing histological indices require validation for standardized, centralized assessment.
Purpose of the Study:
- To evaluate the reliability and responsiveness of four validated histological disease activity indices in UC.
- To assess the performance of Geboes (GS), modified Riley (MRS), Robarts Histopathology (RHI), and Nancy Histological (NHI) indices.
Main Methods:
- Four blinded pathologists assessed UC disease activity using GS, MRS, RHI, NHI, and a Visual Analogue Scale in a phase II ozanimod trial.
- Reliability was measured using intraclass correlation coefficients (ICCs).
- Responsiveness was evaluated using longitudinal validity, standardized effect size (SES), and receiver operating characteristic (AUROC) curves.
Main Results:
- Inter-rater reliability for all histological indices was substantial to almost perfect (ICC > 0.61).
- Responsiveness was moderate to large (SES estimates > 0.5), with similar discriminative ability (AUROC range: 0.608–0.649).
- Specific SES estimates varied based on the criterion for change (treatment assignment or Mayo score decrease).
Conclusions:
- All four evaluated histological indices demonstrated comparable reliability and responsiveness.
- These validated indices can be effectively used for centralized assessment of UC disease activity.
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