Reliability and Initial Validation of the Ulcerative Colitis Endoscopic Index of Severity

被引:379
作者
Travis, Simon P. L. [1 ]
Schnell, Dan [2 ]
Krzeski, Piotr [3 ]
Abreu, Maria T. [4 ]
Altman, Douglas G. [5 ]
Colombel, Jean-Frederic [6 ]
Feagan, Brian G. [7 ]
Hanauer, Stephen B. [8 ]
Lichtenstein, Gary R. [9 ]
Marteau, Philippe R. [10 ,11 ]
Reinisch, Walter [12 ]
Sands, Bruce E. [13 ]
Yacyshyn, Bruce R. [14 ]
Schnell, Patrick [15 ]
Bernhardt, Christian A. [16 ]
Mary, Jean-Yves [17 ]
Sandborn, William J.
机构
[1] John Radcliffe Hosp, Translat Gastroenterol Unit, Oxford OX3 9DU, England
[2] Stat Consultant, Middletown, OH USA
[3] Medpace, Warsaw, Poland
[4] Univ Miami, Leonard M Miller Sch Med, Div Gastroenterol, Miami, FL USA
[5] Univ Oxford, Ctr Stat Med, Oxford, England
[6] Ctr Hosp Univ Lille, Hop Claude Huriez, Lille, France
[7] Univ Western Ontario, Robarts Res Inst, Robarts Clin Trials, London, ON, Canada
[8] Univ Chicago, Med Ctr, Sect Gastroenterol & Nutr, Chicago, IL 60637 USA
[9] Univ Penn, Dept Med, Div Gastroenterol, Philadelphia, PA 19104 USA
[10] AP HP, Hop Lariboisiere Medicosurg, Dept Digest Dis, Paris, France
[11] Univ Paris 07, Paris, France
[12] Med Univ Vienna, Universitatsklin Innere Med 3, Gastroenterol & Hepatol Abt, Vienna, Austria
[13] Icahn Sch Med Mt Sinai, Dr Henry D Janowitz Div Gastroenterol, New York, NY USA
[14] Univ Cincinnati, Div Digest Dis, Cincinnati, OH USA
[15] Ohio State Univ, Dept Math, Columbus, OH 43210 USA
[16] Bernhardt Regulatory Consulting, Cincinnati, OH USA
[17] Univ Paris Diderot, INSERM, Unit Biostat & Clin Epidemiol 717, Paris, France
关键词
Endoscopic Score; Endoscopic Severity; Inflammatory; Bowel Disease; Disease Activity; DISEASE-ACTIVITY; CLINICAL-TRIALS; AGREEMENT; THERAPY;
D O I
10.1053/j.gastro.2013.07.024
中图分类号
R57 [消化系及腹部疾病];
学科分类号
100201 [内科学];
摘要
BACKGROUND & AIMS: We studied the reliability of the previously described Ulcerative Colitis Endoscopic Index of Severity (UCEIS) and validated it with an independent cohort of investigators. METHODS: We created a new library of 57 videos of flexible sigmoidoscopy and stratified them based on disease severity. Twenty-five investigators were each randomly assigned to assess 28 videos (which included 4 duplicates to assess intraobserver reliability). Investigators were blinded to clinical details except for 2 of 4 duplicated videos (to assess the impact of knowledge of symptoms on assessment). Three descriptors (" vascular pattern", " bleeding", and " erosions and ulcers") comprising the UCEIS were scored with a visual analogue scale (VAS) to assess overall severity. Intrainvestigator and interinvestigator agreement was characterized by k statistical analysis; reliability ratios were used to compare VAS and UCEIS scores. RESULTS: There was a high level of correlation between UCEIS scores and overall assessment of severity (correlation coefficient, 0.93). Internal consistency (Cronbach a analysis) was 0.86. Intrainvestigator and interinvestigator reliability ratios for UCEIS scores were 0.96 and 0.88, respectively. Intrainvestigator agreement in determination of the UCEIS score was good (k = 0.72), with individual descriptors ranging from a k of 0.47 (for bleeding) to 0.87 (for vascular pattern). Interinvestigator agreement in determination of UCEIS scores was moderate (k = 0.50), with descriptors ranging from a k of 0.48 (for bleeding) to 0.54 (for vascular pattern). Intrainvestigator variability in determining UCEIS scores did not change appreciably when a video was presented with clinical details. CONCLUSIONS: The UCEIS and its components show satisfactory intrainvestigator and interinvestigator reliability. Among investigators, the UCEIS accounted for a median of 86% of the variability in evaluation of overall severity on the VAS when assessing the endoscopic severity of UC and was unaffected by knowledge of clinical details.
引用
收藏
页码:987 / 995
页数:9
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