title: The Impact of Clinical Information on the Assessment of Endoscopic Activity: Characteristics of the Ulcerative Colitis Endoscopic Index Of Severity [UCEIS].
abstract: OBJECTIVE
  To determine whether clinical information influences endoscopic scoring by central readers using the Ulcerative Colitis Endoscopic Index of Severity [UCEIS; comprising 'vascular pattern', 'bleeding', 'erosions and ulcers'].
  
  
  METHODS
  Forty central readers performed 28 evaluations, including 2 repeats, from a library of 44 video sigmoidoscopies stratified by Mayo Clinic Score. Following training, readers were randomised to scoring with ['unblinded', n = 20, including 4 control videos with misleading information] or without ['blinded', n 20] clinical information. A total of 21 virtual Central Reader Groups [CRGs], of three blinded readers, were created. Agreement criteria were pre-specified. Kappa [κ] statistics quantified intra- and inter-reader variability.
  
  
  RESULTS
  Mean UCEIS scores did not differ between blinded and unblinded readers for any of the 40 main videos. UCEIS standard deviations [SD] were similar [median blinded 0.94, unblinded 0.93; p = 0.97]. Correlation between UCEIS and visual analogue scale [VAS] assessment of overall severity was high [r blinded = 0.90, unblinded = 0.93; p = 0.02]. Scores for control videos were similar [UCEIS: p ≥ 0.55; VAS: p ≥ 0.07]. Intra- [κ 0.47-0.74] and inter-reader [κ 0.40-0.53] variability for items and full UCEIS was 'moderate'-to-'substantial', with no significant differences except for intra-reader variability for erosions and ulcers [κ blinded: 0.47 vs unblinded: 0.74; p 0.047]. The SD of CRGs was lower than for individual central readers [0.54 vs 0.95; p < 0.001]. Correlation between blinded UCEIS and patient-reported symptoms was high [stool frequency: 0.76; rectal bleeding: 0.82; both: 0.81].
  
  
  CONCLUSIONS
  The UCEIS is minimally affected by knowledge of clinical details, strongly correlates with patient-reported symptoms, and is a suitable instrument for trials. CRGs performed better than individuals.
authors.affiliation: Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, UK simon.travis@ndm.ox.ac.uk.
authors.forename: Simon P L
authors.initials: SP
authors.lastname: Travis
authors.affiliation: Middletown, OH, USA.
authors.forename: Dan
authors.initials: D
authors.lastname: Schnell
authors.affiliation: Robarts Research Institute, University of Western Ontario, London, ON, Canada.
authors.forename: Brian G
authors.initials: BG
authors.lastname: Feagan
authors.affiliation: Division of Gastroenterology, University of Miami Leonard M. Miller School of Medicine, Miami, FL, USA.
authors.forename: Maria T
authors.initials: MT
authors.lastname: Abreu
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Altman
authors.affiliation: Digestive Disease Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Hanauer
authors.affiliation: Medpace, Warsaw, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Krzeski
authors.affiliation: Division of Gastroenterology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Gary R
authors.initials: GR
authors.lastname: Lichtenstein
authors.affiliation: AP-HP, Hôpital Lariboisière Medicosurgical Department of Digestive Diseases and University Denis Diderot, Paris, France.
authors.forename: Philippe R
authors.initials: PR
authors.lastname: Marteau
authors.affiliation: INSERM U717 Biostatistics and Clinical Epidemiology, Université Paris Diderot, Paris, France.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Mary
authors.affiliation: Division of Gastroenterology, Department of Medicine, McMaster University, Hamilton, ON, Canada.
authors.forename: Walter
authors.initials: W
authors.lastname: Reinisch
authors.affiliation: Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
authors.forename: Bruce E
authors.initials: BE
authors.lastname: Sands
authors.affiliation: University of Minnesota, Minneapolis, MN, USA.
authors.forename: Patrick
authors.initials: P
authors.lastname: Schnell
authors.affiliation: Division of Digestive Diseases, University of Cincinnati, Cincinnati, OH, USA.
authors.forename: Bruce R
authors.initials: BR
authors.lastname: Yacyshyn
authors.affiliation: Hôpital Claude Huriez, Centre Hospitalier Universitaire de Lille, Lille, France.
authors.forename: Jean-Frédéric
authors.initials: JF
authors.lastname: Colombel
authors.affiliation: Bernhardt Regulatory Consulting, Cincinnati, OH, USA.
authors.forename: Christian A
authors.initials: CA
authors.lastname: Bernhardt
authors.affiliation: Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
mesh_terms: D003093:Colitis, Ulcerative / Q000175:diagnosis*; D006801:Humans; D015588:Observer Variation; D012720:Severity of Illness Index; D012812:Sigmoidoscopy; D016037:Single-Blind Method; D014741:Video Recording
keywords: Endoscopic score; disease activity index; ulcerative colitis