The study team would like to acknowledge the patients for their participation and commitment during the study. The authors would like to thank the investigators and contributors from each study site. The authors also thank Valerie AG-014699 nmr Schmitz, Kelli Rotondo, Myra Borsos, Janice Wiggan, Marc Bifano, Amber Griffies, Lori Goebel, Jie Yin, Fei Yu, Joseph Ueland, Dennis Hernandez, and all research staff for their contributions. “
“See Covering the Cover synopsis on page 917. See related article, Turner D et al, on page 1140 in CGH. Endoscopy is extremely valuable for evaluating the efficacy of new treatments for patients with ulcerative

colitis (UC).1 and 2 However, valid endoscopic scoring systems are needed to standardize end points and facilitate meaningful comparisons.3 Interobserver variation in endoscopic Vorinostat clinical trial assessment of disease severity may alter clinical trial outcomes and have a substantial effect on therapeutic or regulatory decisions.4 Several activity indices for UC incorporate endoscopic data, with the Mayo Clinic Index or the Ulcerative Colitis Disease Activity Index commonly used in trials conducted to seek

regulatory approval,1 but these instruments have not undergone appropriate validation or rigorous reliability assessment.1 and 5 To address the need for a highly dependable instrument for assessing the endoscopic severity of UC, we evaluated variations in the overall endoscopic assessment of disease severity, as well as intraindividual and interindividual variations of descriptive terms (“descriptors”),

to create the Ulcerative Colitis Endoscopic Index of Severity (UCEIS).6 The UCEIS was developed in 2 phases: (1) the level of disagreement among investigators and 10 descriptors, each with 3 to 5 levels of severity, was determined and (2) interobserver and intraobserver variability for each descriptor was investigated. A model was then constructed that best represented overall endoscopic severity evaluated on a visual analogue scale (VAS), incorporating 3 descriptors, each with specific definitions: vascular pattern (3 levels), bleeding (4 levels), and erosions and ulcers (4 levels) (Table 1). The worst disease area was scored, Interleukin-2 receptor and the final score represented the sum of the components, with the UCEIS ranging from 3 (normal) to 11 (most severe). The first 2 phases showed very wide variation in endoscopic interpretation of UC disease severity between specialists but that 3 descriptors with 11 separate levels explained 90% of the variance between observers. After the first 2 phases it was concluded that the UCEIS accurately predicted overall assessment of endoscopic severity of UC, but that it should be assessed for reliability and validated before it could be used as an outcome measure in clinical trials or in routine clinical practice.