Responsiveness of histological disease activity indices in ulcerative colitis: A post hoc analysis using data from the TOUCHSTONE randomised controlled trial

Vipul Jairath, Laurent Peyrin-Biroulet, Guangyong Zou, Mahmoud Mosli, Niels Vande Casteele, Reetesh K. Pai, Mark A. Valasek, Aude Marchal-Bressenot, Larry W. Stitt, Lisa M. Shackelton, Reena Khanna, Geert R. D'Haens, William J. Sandborn, Allan Olson, Brian G. Feagan, Rish Pai

Research output: Contribution to journalArticle

13 Scopus citations

Abstract

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.

Original languageEnglish (US)
JournalGut
DOIs
StateAccepted/In press - Jan 1 2018

Keywords

  • histopathology
  • ulcerative colitis

ASJC Scopus subject areas

  • Gastroenterology

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    Jairath, V., Peyrin-Biroulet, L., Zou, G., Mosli, M., Vande Casteele, N., Pai, R. K., Valasek, M. A., Marchal-Bressenot, A., Stitt, L. W., Shackelton, L. M., Khanna, R., D'Haens, G. R., Sandborn, W. J., Olson, A., Feagan, B. G., & Pai, R. (Accepted/In press). Responsiveness of histological disease activity indices in ulcerative colitis: A post hoc analysis using data from the TOUCHSTONE randomised controlled trial. Gut. https://doi.org/10.1136/gutjnl-2018-316702