@article{def057494c1d46af9ab907262ec66069,
title = "Reliability of histologic assessment in patients with eosinophilic oesophagitis",
abstract = "Background: The validity of the eosinophilic oesophagitis (EoE) histologic scoring system (EoEHSS) has been demonstrated, but only preliminary reliability data exist. Aim: Formally assess the reliability of the EoEHSS and additional histologic features. Methods: Four expert gastrointestinal pathologists independently reviewed slides from adult patients with EoE (N = 45) twice, in random order, using standardised training materials and scoring conventions for the EoEHSS and additional histologic features agreed upon during a modified Delphi process. Intra- and inter-rater reliability for scoring the EoEHSS, a visual analogue scale (VAS) of overall histopathologic disease severity, and additional histologic features were assessed using intra-class correlation coefficients (ICCs). Results: Almost perfect intra-rater reliability was observed for the composite EoEHSS scores and the VAS. Inter-rater reliability was also almost perfect for the composite EoEHSS scores and substantial for the VAS. Of the EoEHSS items, eosinophilic inflammation was associated with the highest ICC estimates and consistent with almost perfect intra- and inter-rater reliability. With the exception of dyskeratotic epithelial cells and surface epithelial alteration, ICC estimates for the remaining EoEHSS items were above the benchmarks for substantial intra-rater, and moderate inter-rater reliability. Estimation of peak eosinophil count and number of lamina propria eosinophils were associated with the highest ICC estimates among the exploratory items. Conclusion: The composite EoEHSS and most component items are associated with substantial reliability when assessed by central pathologists. Future studies should assess responsiveness of the score to change after a therapeutic intervention to facilitate its use in clinical trials.",
author = "Warners, {M. J.} and Ambarus, {C. A.} and Bredenoord, {A. J.} and J. Verheij and Lauwers, {G. Y.} and Walsh, {J. C.} and Katzka, {D. A.} and S. Nelson and {van Viegen}, T. and Furuta, {G. T.} and Gupta, {S. K.} and L. Stitt and G. Zou and Parker, {C. E.} and Shackelton, {L. M.} and D'Haens, {G. R.} and Sandborn, {W. J.} and Dellon, {E. S.} and Feagan, {B. G.} and Collins, {M. H.} and V. Jairath and Pai, {R. K.}",
note = "Funding Information: Declaration of personal interests: MJW has no competing interests. CAA has no competing interests. AJB has received research funding from Endostim and Danone and received speaker and/or consulting fees from MMS, Astellas, AstraZeneca, Almirall and Allergan. JV has no competing interests. GYL has no competing interests. JCW has no competing interests. DAK has no competing interests. SN is an employee of Robarts Clinical Trials. TvV is an employee of Robarts Clinical Trials. GTF has no competing interests. SKG has received consulting fees from Abbott, Allakos, Celgene, QOL and research support from Shire. LS is an employee of Robarts Clinical Trials. GYZ has no competing interests. CEP is an employee of Robarts Clinical Trials. LMS has no competing interests. GRD{\textquoteright}H has received consulting and/ or lecture fees from AbbVie, ActoGeniX, AIM, Boehringer Ingelheim GmbH, Centocor, Chemo Centryx, Cosmo Technologies, Elan Pharmaceuticals, enGene, Dr Falk Pharma, Ferring, Galapagos, Giuliani SpA, Given Imaging, GlaxoSmithKline, Janssen Biologics, MSD, Neovacs, Novo Nordisk, Otsuka, PDL BioPharma, Pfizer, Receptos, Salix, SetPoint, Shire Pharmaceuticals, Schering-Plough, Takeda, Tillotts Pharma, UCB Pharma, Versant, and Vifor Pharma; research grants from AbbVie, Janssen, Given Imaging, MSD, Dr Falk Pharma, and PhotoPill; and speaking honoraria from AbbVie, Tillotts, Tramedico, Ferring, MSD, UCB Pharma, Norgine, and Shire. WJS has served as a consultant to: AbbVie Inc., ActoGeniX NV, AGI Therapeutics, Inc., Alba Therapeutics Corporation, Albireo, Alfa Wasserman, Amgen, AM-Pharma BV, Anaphore, Astellas Pharma, Athersys, Inc., Atlantic Healthcare Limited, Axcan Pharma (now Aptalis), BioBalance Corporation, Boehringer-Ingelheim Inc, Bristol Meyers Squibb, Celgene, Celek Pharmaceuticals, Cellerix SL, Cerimon Pharmaceuticals, ChemoCentryx, CoMentis, Cosmo Technologies, Coronado Biosciences, Cytokine Pharmasciences, Eagle Pharmaceuticals, Eisai Medical Research Inc., Elan Pharmaceuticals, EnGene, Inc., Eli Lilly, Enteromedics, Exagen Diagnostics, Inc., Ferring Pharmaceuticals, Flexion Therapeutics, Inc., Funxional Therapeutics Limited, Genzyme Corporation, Genentech (now Roche), Gilead Sciences, Given Imaging, Glaxo Smith Kline, Human Genome Sciences, Ironwood Pharmaceuticals (previously Microbia Inc.), Janssen (previously Centocor), KaloBios Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Lycera Corporation, Meda Pharmaceuticals (previously Alaven Pharmaceuticals), Merck Research Laboratories, MerckSerono, Millennium Pharmaceuticals (subsequently merged with Takeda), Nisshin Kyorin Pharmaceuticals Co., Ltd., Novo Nordisk A/S, NPS Pharmaceuticals, Optimer Pharmaceuticals, Orexigen Therapeutics, Inc., PDL Biopharma, Pfizer, Procter and Gamble, Prometheus Laboratories, ProtAb Limited, Purgenesis Technologies, Inc., Receptos, Relypsa, Inc., Salient Pharmaceuticals, Salix Pharmaceuticals, Inc., Santarus, Schering Plough Corporation (acquired by Merck), Shire Pharmaceuticals, Sigmoid Pharma Limited, Sirtris Pharmaceuticals, Inc. (a GSK company), S.L.A. Pharma (UK) Limited, Targacept, Teva Pharmaceuticals, Therakos, Tillotts Pharma AG (acquired by Zeria Pharmaceutical Co., Ltd), TxCell SA, UCB Pharma, Via-met Pharmaceuticals, Vascular Biogenics Limited (VBL), Warner Chilcott UK Limited; has received speaker{\textquoteright}s fees from: AbbVie Inc., Bristol Meyers Squibb, and Janssen (previously Centocor); and financial support for research from: AbbVie Inc., Bristol Meyers Squibb, Genentech, Glaxo Smith Kline, Janssen (previously Centocor), Millennium Pharmaceuticals (now Takeda), Novartis, Pfizer, Procter and Gamble Pharmaceuticals, Shire Pharmaceuticals, and UCB Pharma.ESD has no competing interests. BGF has received grant/research support from Millennium Pharmaceuticals, Merck, Tillotts Pharma AG, AbbVie, Novartis Pharmaceuticals, Centocor Inc., Elan/Biogen, UCB Pharma, Bristol-Myers Squibb, Genentech, ActoGenix, and Wyeth Pharmaceuticals Inc.; consulting fees from Millennium Pharmaceuticals, Merck, Centocor Inc., Elan/Biogen, Janssen-Ortho, Teva Pharmaceuticals, Bristol-Myers Squibb, Celgene, UCB Pharma, AbbVie, Astra Zeneca, Serono, Genentech, Tillotts Pharma AG, Unity Pharmaceuticals, Albireo Pharma, Given Imaging Inc., Salix Pharmaceuticals, Novonor-disk, GSK, Actogenix, Prometheus Therapeutics and Diagnostics, Athersys, Axcan, Gilead, Pfizer, Shire, Wyeth, Zealand Pharma, Zynge-nia, GiCare Pharma Inc., and Sigmoid Pharma; and speakers bureaux fees from UCB, AbbVie, and J&J/Janssen. MHC has received research funding from Shire, Regeneron and Receptos; honoraria from Regen-eron; is a consultant with Adare; is Chairperson of the Medical Advisory Panel of the American Partnership for Eosinophilic Disorders (APFED); is a member of The International Gastrointestinal Researchers (TIGERS). VJ has received scientific advisory board fees from Abb-Vie, Takeda, Janssen, Merck and Sandoz; speakers fees from Takeda, Janssen, Abbvie, Ferring. RKP has received consulting fees from Genentech. Robarts Clinical Trials began in 1986 as an academic research unit within the Robarts Research Institute which is affiliated with University Hospital and the University of Western Ontario. A subsequent international (United States of America and Netherlands) expansion in 2012 necessitated establishment of a corporate entity to meet international federal/taxation regulations. All profits from Robarts Clinical Trials, Inc. are directed towards academic research. The University of Western Ontario is the sole shareholder of Robarts Clinical Trials Inc. None of the authors with affiliation to Robarts Clinical Trials, Inc. have an equity position or any shares in the corporation. Declaration of funding interests: None.",
year = "2018",
month = apr,
doi = "10.1111/apt.14559",
language = "English (US)",
volume = "47",
pages = "940--950",
journal = "Alimentary Pharmacology and Therapeutics",
issn = "0269-2813",
publisher = "Wiley-Blackwell",
number = "7",
}