Reliability among central readers in the evaluation of endoscopic disease activity in pouchitis - 16/07/18
Doi : 10.1016/j.gie.2018.04.2330
Mark A. Samaan, MD 1, 2, Bo Shen, MD 3, Mahmoud H. Mosli, MD 4, Guangyong Zou, PhD 2, 5, William J. Sandborn, MD 2, 6, Lisa M. Shackelton, PhD 2, Sigrid Nelson, MS 2, Larry Stitt, MS 2, Stuart Bloom, MD 7, Darrell S. Pardi, MD 8, Paolo Gionchetti, MD, PhD 9, James Lindsay, MD 10, Simon Travis, MD, PhD 11, Ailsa Hart, MD, PhD 12, Mark S. Silverberg, MD, PhD 13, Brian G. Feagan, MD 2, 5, 14, Geert R. D’Haens, MD, PhD 15, Vipul Jairath, MD, PhD 2, 5, 14, ⁎
1 Department of Gastroenterology, Guy’s & St. Thomas’ Hospital, London, United Kingdom
2 Robarts Clinical Trials Inc, London, Ontario, Canada
3 Center for Inflammatory Bowel Diseases, Digestive Disease Institute, The Cleveland Clinic Foundation, Cleveland, Ohio, USA
4 Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia
5 Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada
14 Department of Medicine, University of Western Ontario, London, Ontario, Canada
6 Division of Gastroenterology, University of California San Diego, La Jolla, California, USA
7 Department of Gastroenterology, University College London Hospital, NHS Trust, London, United Kingdom
8 Division of Gastroenterology and Hepatology, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA
9 Department of Medical and Surgical Sciences (DIMEC), University of Bologna-Italy, Bologna, Italy
10 Bart’s Health NHS Trust, The Royal London Hospital, London, United Kingdom
11 Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, United Kingdom
12 St. Mark’s Hospital Inflammatory Bowel Disease Unit, Imperial College, London, United Kingdom
13 Division of Gastroenterology, Mount Sinai Hospital Inflammatory Bowel Disease Centre, Toronto, Ontario, Canada
15 Department of Gastroenterology, Academic Medical Center, Amsterdam, Netherlands
∗Reprint requests: Vipul Jairath, MBChB DPhil, University of Western Ontario, London, Ontario, Canada, OX3 9DU.University of Western OntarioLondonOntarioOX3 9DUCanada
Abstract |
Background and Aims |
Pouchitis is a common adverse event after proctocolectomy with ileal pouch anal anastomosis for ulcerative colitis. Evaluation of pouchitis disease activity and response to treatment requires use of validated indices. We assessed the reliability of items evaluating endoscopic pouchitis disease activity.
Methods |
Twelve panelists used a modified RAND appropriateness methodology to rate the appropriateness of items evaluating endoscopic pouchitis disease activity derived from a systematic review and also identified additional potential endoscopic items based on expert opinion. Four central readers then evaluated 50 pouchoscopy videos in triplicate, in random order. Intra- and inter-rater reliability for each item was assessed by calculating and comparing intraclass correlation coefficients (ICCs). A Delphi process identified common sources of disagreement among the readers.
Results |
Ten existing endoscopic items were identified from the systematic review and an additional 7 exploratory items from the panelists. ICCs for inter-rater reliability were highest for the existing item of pouch ulceration (.72; 95% confidence interval [CI], .60-.82) and for the exploratory item of ulcerated surface in the pouch body (.67; 95% CI, .53-.75). Inter-rater reliability for all other existing and exploratory items was “moderate” (ICC < .60). The item “ulcerated surface in the pouch body” demonstrated the best correlation with a global evaluation of lesion severity (r = .80; 95% CI, .73-.85).
Conclusion |
Substantial reliability was observed only for the endoscopic items of ulceration and ulcerated surface in the pouch body. Future studies should assess responsiveness to treatment in the next stage toward development of an endoscopic pouchitis disease activity index.
Le texte complet de cet article est disponible en PDF.Abbreviations : CI, GELS, ICC, PDAI
Plan
| DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: M.A. Samaan: Advisory fee recipient from Hospira; speaker for Hospira, Takeda, MSD, Falk, and Janssen. W.J. Sandborn: Consultant for AbbVie, ActoGeniX NV, AGI Therapeutics, Alba Therapeutics Corporation, Albireo, Alfa Wasserman, Amgen, AM-Pharma BV, Anaphore, Astellas Pharma, Athersys, Atlantic Healthcare Limited, Axcan Pharma (now Aptalis), BioBalance Corporation, Boehringer-Ingelheim, Bristol Meyers Squibb, Celgene, Celek Pharmaceuticals, Cellerix SL, Cerimon Pharmaceuticals, ChemoCentryx, CoMentis, Cosmo Technologies, Coronado Biosciences, Cytokine Pharmasciences, Eagle Pharmaceuticals, Eisai Medical Research, Elan Pharmaceuticals, EnGene, Eli Lilly, Enteromedics, Exagen Diagnostics, Ferring Pharmaceuticals, Flexion Therapeutics, Funxional Therapeutics Limited, Genzyme Corporation, Genentech (now Roche), Gilead Sciences, Given Imaging, Glaxo Smith Kline, Human Genome Sciences, Ironwood Pharmaceuticals (previously Microbia), Janssen (previously Centocor), KaloBios Pharmaceuticals, Lexicon Pharmaceuticals, Lycera Corporation, Meda Pharmaceuticals (previously Alaven Pharmaceuticals), Merck Research Laboratories, MerckSerono, Millennium Pharmaceuticals (subsequently merged with Takeda), Nisshin Kyorin Pharmaceuticals, Novo Nordisk A/S, NPS Pharmaceuticals, Optimer Pharmaceuticals, Orexigen Therapeutics, PDL Biopharma, Pfizer, Procter and Gamble, Prometheus Laboratories, ProtAb Limited, Purgenesis Technologies, Receptos, Relypsa, Salient Pharmaceuticals, Salix Pharmaceuticals, Santarus, Schering Plough Corporation (acquired by Merck), Shire Pharmaceuticals, Sigmoid Pharma Limited, Sirtris Pharmaceuticals (a GSK company), S.L.A. Pharma (UK) Limited, Targacept, Teva Pharmaceuticals, Therakos, Tillotts Pharma AG (acquired by Zeria Pharmaceutical), TxCell SA, UCB Pharma, Viamet Pharmaceuticals, Vascular Biogenics Limited (VBL), Warner Chilcott UK Limited; speaker for AbbVie, Bristol Meyers Squibb, and Janssen (previously Centocor); research support recipient from AbbVie, 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. S. Nelson, L. Stitt: Employees of Robarts Clinical Trials. S. Bloom: Advisory board member for Takeda, Janssen, MSD, Abbvie, Falk, Pfizer, Ferring, Pharmacosmos, and Vifor. D. S. Pardi: Research grant recipient from Atlantic, Janssen, Merck, Pfizer, Rebiotix, Salix, Seres, Takeda, and Crestovo; consultant for Assembly Bioscience, C3 Jian, Casdin Capital, Cowen Group, Ferring, Janssen, Nestle, Merck, Otsuka, Salix, Seres, Gilead, and Pfizer. S. Travis: Advisor, speaker, and research support recipient from AbbVie, Allergan, Amgen, Asahi, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Chemocentryx, Cosmo, Enterome, Ferring, Giuliani SpA, GlaxoSmithKline, Genentech, Immunocore, Immunometabolism, Janssen, Lilly, MSD, Neovacs, NovoNordisk, Novartis, NPS Pharmaceuticals, Pfizer, Proximagen, Receptos, Roche, Shire, Sigmoid Pharma, Takeda, Topivert, UCB, VHsquared, and Vifor. B.G. Feagan: Received support recipient from Millennium Pharmaceuticals, Merck, Tillotts Pharma AG, AbbVie, Novartis Pharmaceuticals, Centocor, Elan/Biogen, UCB Pharma, Bristol-Myers Squibb, Genentech, ActoGenix, and Wyeth Pharmaceuticals; consultant for Millennium Pharmaceuticals, Merck, Centocor, 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, Salix Pharmaceuticals, Novonordisk, GSK, Actogenix, Prometheus Therapeutics and Diagnostics, Athersys, Axcan, Gilead, Pfizer, Shire, Wyeth, Zealand Pharma, Zyngenia, GiCare Pharma, and Sigmoid Pharma; speaker for UCB, AbbVie, and J&J/Janssen. G.R. D’Haens: Consultant and/or lecturer for 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 grant recipient from AbbVie, Janssen, Given Imaging, MSD, Dr Falk Pharma, and PhotoPill; speaker for AbbVie, Tillotts, Tramedico, Ferring, MSD, UCB Pharma, Norgine, and Shire. V. Jairath: Scientific advisory board member for AbbVie, Takeda, Janssen, Merck, and Sandoz; speaker for Takeda, Janssen, Abbvie, and Ferring. All other authors disclosed no financial relationships relevant to this publication. |
© 2018
American Society for Gastrointestinal Endoscopy. Publié par Elsevier Masson SAS. Tous droits réservés.
Vol 88 - N° 2
P. 360 - août 2018 Retour au numéro
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