Developing an instrument to assess the endoscopic severity of ulcerative colitis: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)

被引:424
|
作者
Travis, Simon P. L. [1 ]
Schnell, Dan
Krzeski, Piotr [2 ]
Abreu, Maria T. [3 ]
Altman, Douglas G. [4 ]
Colombel, Jean-Frederic [5 ]
Feagan, Brian G. [6 ]
Hanauer, Stephen B. [7 ]
Lemann, Marc [8 ]
Lichtenstein, Gary R. [9 ]
Marteau, Phillippe R. [10 ,11 ]
Reinisch, Walter [12 ]
Sands, Bruce E. [13 ]
Yacyshyn, Bruce R. [14 ]
Bernhardt, Christian A. [15 ]
Mary, Jean-Yves [16 ]
Sandborn, William J. [17 ]
机构
[1] John Radcliffe Hosp, Translat Gastroenterol Unit, Oxford OX3 9DU, England
[2] Warner Chilcott, Weybridge, Surrey, England
[3] Univ Miami, Leonard M Miller Sch Med, Div Gastroenterol, Miami, FL USA
[4] Univ Oxford, Ctr Stat Med, Oxford, England
[5] CHU Lille, Hop Claude Huriez, F-59037 Lille, France
[6] Univ Western Ontario, Robarts Res Inst, London, ON N6A 3K7, Canada
[7] Univ Chicago, Med Ctr, Sect Gastroenterol & Nutr, Chicago, IL 60637 USA
[8] Univ Paris Diderot, Hop St Louis, Serv Gastroenterol, Paris, France
[9] Univ Penn, Dept Med, Div Gastroenterol, Philadelphia, PA 19104 USA
[10] Hop Lariboisiere, AP HP, Medicosurg Dept Digest Dis, F-75475 Paris, France
[11] Univ Paris 07, Paris, France
[12] Med Univ Vienna, Univ Klin Innere Med 3, Gastroenterol & Hepatol Abt, Vienna, Austria
[13] Mt Sinai Hosp, New York, NY 10029 USA
[14] Univ Cincinnati, Div Digest Dis, Cincinnati, OH USA
[15] Bernhardt Regulatory Consulting, Cincinnati, OH USA
[16] Univ Paris Diderot, INSERM Biostat & Clin Epidemiol U717, Paris, France
[17] Univ Calif San Diego, Div Gastroenterol, La Jolla, CA 92093 USA
关键词
CLINICAL-TRIALS; AGREEMENT;
D O I
10.1136/gutjnl-2011-300486
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background Variability in endoscopic assessment necessitates rigorous investigation of descriptors for scoring severity of ulcerative colitis (UC). Objective To evaluate variation in the overall endoscopic assessment of severity, the intra- and interindividual variation of descriptive terms and to create an Ulcerative Colitis Endoscopic Index of Severity which could be validated. Design A two-phase study used a library of 670 video sigmoidoscopies from patients with Mayo Clinic scores 0-11, supplemented by 10 videos from five people without UC and five hospitalised patients with acute severe UC. In phase 1, each of 10 investigators viewed 16/24 videos to assess agreement on the Baron score with a central reader and agreed definitions of 10 endoscopic descriptors. In phase 2, each of 30 different investigators rated 25/60 different videos for the descriptors and assessed overall severity on a 0-100 visual analogue scale. kappa Statistics tested inter-and intraobserver variability for each descriptor. A general linear mixed regression model based on logit link and beta distribution of variance was used to predict overall endoscopic severity from descriptors. Results There was 76% agreement for 'severe', but 27% agreement for 'normal' appearances between phase I investigators and the central reader. In phase 2, weighted k values ranged from 0.34 to 0.65 and 0.30 to 0.45 within and between observers for the 10 descriptors. The final model incorporated vascular pattern, (normal/patchy/complete obliteration) bleeding (none/mucosal/luminal mild/luminal moderate or severe), erosions and ulcers (none/erosions/superficial/deep), each with precise definitions, which explained 90% of the variance (pR(2), Akaike Information Criterion) in the overall assessment of endoscopic severity, predictions varying from 4 to 93 on a 100-point scale (from normal to worst endoscopic severity). Conclusion The Ulcerative Colitis Endoscopic Index of Severity accurately predicts overall assessment of endoscopic severity of UC. Validity and responsiveness need further testing before it can be applied as an outcome measure in clinical trials or clinical practice.
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收藏
页码:535 / 542
页数:8
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