Agreement of site and central readings of ileocolonoscopic scores in Crohn's disease: comparison using data from the EXTEND trial - 02/06/16
Abstract |
Background and Aims |
Centralized endoscopic scoring may reduce variability, but evidence is lacking in patients with Crohn’s disease. We assessed the agreement of endoscopic scorings between site endoscopists and one central reader by using data from the adalimumab Crohn’s disease clinical trial EXTEND.
Methods |
Agreement between readers for Crohn’s Disease Endoscopic Index of Severity (CDEIS)–scored endoscopies from 6 sites and Simple Endoscopic Score for Crohn’s Disease (SES-CD)–scored endoscopies from 19 sites in EXTEND was evaluated at baseline and weeks 12 and 52. Agreement on total scores was calculated by using intraclass correlation coefficient (ICC). Kappa statistic or Spearman correlation coefficient measured the agreement between readers for each ileocolonic segment on CDEIS variables including deep ulceration, surface involved, and ulcerated surface and SES-CD variables including ulcerated surface, size of ulcers, and affected surface.
Results |
ICCs on mean scores at baseline and weeks 12 and 52 were 0.78, 0.92, and 0.86 (CDEIS), and 0.77, 0.86, and 0.82 (SES-CD), respectively. Site endoscopists consistently reported higher scores. High agreement was observed for most segments and all time points for CDEIS variables and SES-CD large ulcers. Weak agreement occurred for the right side of the colon at all time points for CDEIS deep ulceration and SES-CD large ulcers and at baseline and week 12 for CDEIS ulcerated surface. Fair/moderate agreement occurred for SES-CD ulcerated surface and moderate/high agreement for affected surface for all segments and time points.
Conclusions |
Site and central readers showed high agreement on total CDEIS and SES-CD scores overall, whereas variability for individual segments was observed. Weakest agreement occurred at baseline, with a greater difference for SES-CD than for CDEIS score. (Clinical trial registration number: NCT00348283.)
Le texte complet de cet article est disponible en PDF.Abbreviations : CD, CDAI, CDEIS, EXTEND, SES-CD, UC
Plan
| DISCLOSURES: P. Rutgeerts has received consultancy fees from AbbVie, Bristol-Myers Squibb, Centocor, Merck, Takeda, and UCB Pharma and speaker fees and research support from AbbVie, Centocor, MSD, and UCB Pharma. W. Reinisch has served as a speaker for Abbott Laboratories, AbbVie, Aesca, Aptalis, Centocor, Celltrion, Danone Austria, Elan, Falk Pharma GmbH, Ferring, Immundiagnostik, Mitsubishi Tanabe Pharma Corporation, MSD, Otsuka, PDL, Pharmacosmos, Schering-Plough, Shire, Takeda, Therakos, Vifor, and Yakult; as a consultant for Abbott Laboratories, AbbVie, Aesca, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia, Bioclinica, Biogen Idec, Bristol-Myers Squibb, Cellerix, ChemoCentryx, Celgene, Centocor, Celltrion, Covance, Danone Austria, Elan, Falk Pharma GmbH, Ferring, Galapagos, Genentech, Gilead, Grünenthal, ICON, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millennium, Mitsubishi Tanabe Pharma Corporation, MSD, Nestle, Novartis, Ocera, Otsuka, PDL, Pharmacosmos, Pfizer, Procter & Gamble, Prometheus, Robarts Clinical Trials, Schering-Plough, Setpointmedical, Takeda, Therakos, Tigenix, UCB, Vifor, Zyngenia, and 4SC; as an advisory board member for Abbott Laboratories, AbbVie, Aesca, Amgen, AM Pharma, Astellas, AstraZeneca, Avaxia, Biogen Idec, Bristol-Myers Squibb, Cellerix, ChemoCentryx, Celgene, Centocor, Celltrion, Danone Austria, Elan, Ferring, Galapagos, Genentech, Grünenthal, Inova, Janssen, Johnson & Johnson, Kyowa Hakko Kirin Pharma, Lipid Therapeutics, MedImmune, Millennium, Mitsubishi Tanabe Pharma Corporation, MSD, Nestle, Novartis, Ocera, Otsuka, PDL, Pharmacosmos, Pfizer, Procter & Gamble, Prometheus, Schering-Plough, Setpointmedical, Takeda, Therakos, Tigenix, UCB, Zyngenia, and 4SC; and has received research funding from Abbott Laboratories, AbbVie, Aesca, Centocor, Falk Pharma GmbH, Immundiagnostik, and MSD. J.-F. Colombel has received consulting and/or lecture fees from AbbVie, ActoGeniX, Albireo Pharma, Amgen, AstraZeneca, Bayer AG, Biogen Idec, Boehringer Ingelheim GmbH, Bristol-Myers Squibb, Cellerix, Centocor, ChemoCentryx, Cosmo Technologies, Danone Research, Elan Pharmaceuticals, Genentech, Giuliani SPA, Given Imaging, GlaxoSmithKline, Hutchison MediPharma, MSD, Neovacs, Ocera Therapeutics, Otsuka America Pharmaceutical, Pfizer, Prometheus Laboratories, Sanofi-Aventis, Schering-Plough, Shire, Synta Pharmaceuticals, Takeda, Teva, Therakos, Tillotts Pharma, UCB Pharma, and Wyeth and has stock ownership in Intestinal Biotech Development, Lille, France. W. Sandborn has received consulting fees from AbbVie, ActoGeniX NV, AGI Therapeutics, Alaven Pharmaceuticals, Alba Therapeutics, Albireo, Alfa Wasserman, Amgen, AM-Pharma BV, Anaphore, Astellas, Athersys, Atlantic Healthcare, Axcan Pharma, BioBalance, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celek Pharmaceuticals, Cellerix SL, Centocor, Cerimon Pharmaceuticals, ChemoCentryx, CoMentis, Cosmo Technologies, Coronado Biosciences, Cytokine Pharmasciences, Eagle Pharmaceuticals, Eisai Medical Research, Elan, EnGene, Eli Lilly, Enteromedics, Exagen Diagnostics, Ferring, Flexion Therapeutics, Funxional Therapeutics, Genzyme, Genentech, Gilead Sciences, Given Imaging, GlaxoSmithKline, Human Genome Sciences, Ironwood Pharmaceuticals, KaloBios Pharmaceuticals, Lexicon Pharmaceuticals, Lycera, Merck Research Laboratories, MerckSerono, Millennium, Nisshin Kyorin Pharmaceuticals, Novo Nordisk, NPS Pharmaceuticals, Optimer Pharmaceuticals, Orexigen Therapeutics, PDL Biopharma, Pfizer, Procter & Gamble, Prometheus Laboratories, ProtAb Limited, Purgenesis Technologies, Receptos, Relypsa Inc, Salient Pharmaceuticals, Salix Pharmaceuticals, Santarus, Schering-Plough, Shire Pharmaceuticals, Sigmoid Pharma, Sirtris Pharmaceuticals, SLA Pharma (UK), Targacept, Teva Pharmaceuticals, Therakos, Tillotts Pharma AG, TxCell SA, UCB Pharma, Viamet Pharmaceuticals, Vascular Biogenics, Warner Chilcott, and Wyeth; lecture fees from AbbVie, Bristol-Myers Squibb, and Janssen and research support from AbbVie, Bristol-Myers Squibb, Genentech, GlaxoSmithKline, Janssen, Millennium, Novartis, Pfizer, Procter & Gamble, Shire, and UCB Pharma. G. D’Haens has received consulting and/or lecture fees from AbbVie, ActoGeniX, AIM, Boehringer Ingelheim GmbH, Centocor, ChemoCentryx, 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. J. Petersson, Q. Zhou, A. Iezzi, and R. Thakkar are AbbVie employees and shareholders in AbbVie Inc. |
Vol 83 - N° 1
P. 188 - janvier 2016 Retour au numéro
Article précédent
- Prediction of patency capsule retention in known Crohn's disease patients by using magnetic resonance imaging
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- Toward reducing bias in clinical trials: central readers for endoscopic endpoints
- Sunanda V. Kane, Ashwin N. Ananthakrishnan
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