The impact of clinical information on the assessment of endoscopic activity: Characteristics of the ulcerative colitis endoscopic index of severity [UCEIS]

Simon P.L. Travis, Dan Schnell, Brian G. Feagan, Maria T. Abreu, Douglas G. Altman, Stephen B. Hanauer, Piotr Krzeski, Gary R. Lichtenstein, Philippe R. Marteau, Jean Yves Mary, Walter Reinisch, Bruce E. Sands, Patrick Schnell, Bruce R. Yacyshyn, Jean Frédéric Colombel, Christian A. Bernhardt, William J. Sandborn

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29 Scopus citations

Abstract

Background and Aims: 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.

Original languageEnglish (US)
Pages (from-to)607-616
Number of pages10
JournalJournal of Crohn's and Colitis
Volume9
Issue number8
DOIs
StatePublished - 2015

Keywords

  • Disease activity index
  • Endoscopic score
  • Ulcerative colitis

ASJC Scopus subject areas

  • Gastroenterology

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    Travis, S. P. L., Schnell, D., Feagan, B. G., Abreu, M. T., Altman, D. G., Hanauer, S. B., Krzeski, P., Lichtenstein, G. R., Marteau, P. R., Mary, J. Y., Reinisch, W., Sands, B. E., Schnell, P., Yacyshyn, B. R., Colombel, J. F., Bernhardt, C. A., & Sandborn, W. J. (2015). The impact of clinical information on the assessment of endoscopic activity: Characteristics of the ulcerative colitis endoscopic index of severity [UCEIS]. Journal of Crohn's and Colitis, 9(8), 607-616. https://doi.org/10.1093/ecco-jcc/jjv077