TY - JOUR T1 - Responsiveness of histological disease activity indices in ulcerative colitis: a post hoc analysis using data from the TOUCHSTONE randomised controlled trial JF - Gut JO - Gut SP - 1162 LP - 1168 DO - 10.1136/gutjnl-2018-316702 VL - 68 IS - 7 AU - Vipul Jairath AU - Laurent Peyrin-Biroulet AU - Guangyong Zou AU - Mahmoud Mosli AU - Niels Vande Casteele AU - Reetesh K Pai AU - Mark A Valasek AU - Aude Marchal-Bressenot AU - Larry W Stitt AU - Lisa M Shackelton AU - Reena Khanna AU - Geert R D’Haens AU - William J Sandborn AU - Allan Olson AU - Brian G Feagan AU - Rish K Pai Y1 - 2019/07/01 UR - http://gut.bmj.com/content/68/7/1162.abstract N2 - Objective We evaluated the reliability and responsiveness of available but incompletely validated UC histological disease activity indices using standardised rules for centralised assessment.Design Disease activity was assessed in biopsies collected in a phase II placebo-controlled ozanimod trial by four blinded pathologists using the Geboes (GS) and modified Riley (MRS) scores, the Robarts Histopathology (RHI) and Nancy Histological (NHI) indices and a Visual Analogue Scale. Reliability was assessed with intraclass correlation coefficients (ICCs). Index responsiveness was evaluated by assessing longitudinal validity (Pearson correlations of changes in index scores and other disease measures), and effect size estimates (standardised effect size (SES)) using two criteria for change (treatment assignment and >2 point decrease in total Mayo Clinic score). Area under the receiver operating characteristic (AUROC) curve estimates evaluated the probability of the indices to discriminate between treatment and placebo.Results Inter-rater reliability of the histological indices was substantial to almost perfect (ICC>0.61), and responsiveness was moderate to large (SES estimates>0.5); 0.81 (0.52, 1.10), 0.87 (0.58, 1.17), 0.57 (0.30, 0.84) and 0.81 (0.52, 1.09) when treatment assignment was the criterion for change and 1.05 (0.80, 1.31), 1.13 (0.87, 1.39), 0.88 (0.64, 1.12) and 1.06 (0.80, 1.31) for the change in Mayo score criterion for the GS, MRS, RHI and NHI, respectively. The indices had similar drisciminative ability based on AUROC estimates (range 0.608–0.649).Conclusion All four existing histological indices were similarly reliable and responsive based on this dataset. ER -