Background: The Crohn's Disease Endoscopic Index of Severity (CDEIS) and the Simple Endoscopic Score for Crohn's Disease (SES-CD) are used to assess endoscopic disease severity in Crohn's disease (CD). Central reading has become the standard practice in clinical trials for inclusion and evaluation of endoscopic response to therapy. However, the agreement between severity scores (CDEIS or SES-CD) derived from live local, delayed local video-recorded and central readings has not been studied.
Methods: We conducted a monocentric prospective study between April 2015 and December 2015. Fifty-three CD patients were recruited by three endoscopists trained to endoscopic readings for score calculation (TU, JM and BC). All colonoscopies were recorded on-site and videos were labeled according to the segment of interest: ileum, right colon, transverse colon, left and sigmoid colon, and rectum. Each endoscopist performed immediate readings of his patients and delayed local video-recorded readings of his patients' colonoscopies at least 3 months after the live local reading. Two central readers (JCD and FP) read all videos. CDEIS and SES-CD scores were then computed automatically based on all readings. Intra-class correlation coefficients (ICC) were estimated and Bland and Altman plots were used to assess the agreement between severity scores derived from various readings. In a first step, we studied the agreement between severity scores derived from live local (L) and central (C1 and C2) readings and L and delayed local video-recorded (D) readings.
Results: ICC estimates of CDEIS (n=44) and SES-CD (n=46) scores were respectively 0.89; 95% confidence interval (CI), 0.80–0.94 and 0.94; 95% CI, 0.87–0.97 between L and C1 and 0.80; 95% CI, 0.58–0.90 and 0.85; 95% CI, 0.74–0.91 between L and C2. ICC estimates between L and D were respectively 0.87; 95% CI, 0.78–0.93 and 0.88; 95% CI, 0.79–0.93. An example of Bland and Altman plots derived from L and C1 are shown in figure 1 for CDEIS and figure 2 for SES-CD scores.
Conclusions: Overall, the agreement between severity scores (CDEIS or SES-CD) derived from live local, delayed local video-recorded and central readings is excellent. This data suggests that both local readings by trained endoscopists and central reading could be used in clinical trials.