Responsiveness of histological disease activity indices in ulcerative colitis: a post hoc analysis using data from the TOUCHSTONE randomised contro...

A new interesting article has been published in Gut. 2019 Jul;68(7):1162-1168. doi: 10.1136/gutjnl-2018-316702. Epub 2018 Aug 3. Clinical Trial, Phase II; Randomized Controlled Trial; Research Support, Non-U.S. Gov’t and titled:

Responsiveness of histological disease activity indices in ulcerative colitis: a post hoc analysis using data from the TOUCHSTONE randomised contro…

Authors of this article are:

Jairath V, Peyrin-Biroulet L, Zou G, Mosli M, Vande Casteele N, Pai RK, Valasek MA, Marchal-Bressenot A, Stitt LW, Shackelton LM, Khanna R, D’Haens GR, Sandborn WJ, Olson A, Feagan BG, Pai RK.

A summary of the article is shown below:

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.© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.

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[link-preview url=https://www.ncbi.nlm.nih.gov/pubmed/30076171 forceshot=true]

This article is a good source of information and a good way to become familiar with topics such as: Biopsy;Colitis, Ulcerative;Female;Humans;Indans;Male;Middle Aged;Oxadiazoles;ROC Curve;Reproducibility of Results;Severity of Illness Index;Visual Analog Scale.

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