title: Agreement of site and central readings of ileocolonoscopic scores in Crohn's disease: comparison using data from the EXTEND trial.
abstract: OBJECTIVE
  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. (
  
  
  BACKGROUND
  NCT00348283.).
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Catholic University of Leuven, Leuven, Belgium.
authors.forename: Paul
authors.initials: P
authors.lastname: Rutgeerts
authors.affiliation: Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Walter
authors.initials: W
authors.lastname: Reinisch
authors.affiliation: Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
authors.forename: Jean-Frederic
authors.initials: JF
authors.lastname: Colombel
authors.affiliation: Division of Gastroenterology, University of California San Diego, La Jolla, California, USA.
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.affiliation: Department of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands and Imelda GI Clinical Research Center, Bonheiden, Belgium.
authors.forename: Geert
authors.initials: G
authors.lastname: D'Haens
authors.affiliation: Global Medical Affairs Gastroenterology, AbbVie Inc., North Chicago, Illinois, USA.
authors.forename: Joel
authors.initials: J
authors.lastname: Petersson
authors.affiliation: Data and Statistical Sciences, AbbVie Inc., North Chicago, Illinois, USA.
authors.forename: Qian
authors.initials: Q
authors.lastname: Zhou
authors.affiliation: Global Medical Affairs Gastroenterology, AbbVie Inc, Rungis, France.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Iezzi
authors.affiliation: Global Medical Affairs Gastroenterology, AbbVie Inc., North Chicago, Illinois, USA.
authors.forename: Roopal B
authors.initials: RB
authors.lastname: Thakkar
mesh_terms: D003106:Colon / Q000473:pathology*; D003113:Colonoscopy; D003424:Crohn Disease / Q000175:diagnosis*; D016099:Endoscopy, Gastrointestinal; D006801:Humans; D007082:Ileum / Q000473:pathology*; D007413:Intestinal Mucosa / Q000473:pathology*; D015588:Observer Variation; D016032:Randomized Controlled Trials as Topic; D012007:Rectum / Q000473:pathology*; D014456:Ulcer / Q000175:diagnosis*