The Impact of Clinical Information on the Assessment of Endoscopic Activity: Characteristics of the Ulcerative Colitis Endoscopic Index Of Severity [UCEIS]

• Published in: Journal of Crohn's and colitis 2015-08, Vol.9 (8), p.607-616
• Main Authors: Travis, Simon P. L., Schnell, Dan, Feagan, Brian G., Abreu, Maria T., Altman, Douglas G., Hanauer, Stephen B., Krzeski, Piotr, Lichtenstein, Gary R., Marteau, Philippe R., Mary, Jean-Yves, Reinisch, Walter, Sands, Bruce E., Schnell, Patrick, Yacyshyn, Bruce R., Colombel, Jean-Frédéric, Bernhardt, Christian A., Sandborn, William J.
• Format: Article
• Language: English
• Subjects: Colitis, Ulcerative - diagnosis; Humans; Observer Variation; Original; Severity of Illness Index; Sigmoidoscopy; Single-Blind Method
• ISSN: 1873-9946; 1876-4479
• DOI: 10.1093/ecco-jcc/jjv077

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.