Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada Department of Medicine, University of Western Ontario, London, Ontario, Canada.
Robarts Clinical Trials, Robarts Research Institute, University of Western Ontario, London, Ontario, Canada Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada.
Gut. 2016 Jul;65(7):1119-25. doi: 10.1136/gutjnl-2014-308973. Epub 2015 May 2.
The Crohn's Disease Endoscopic Index of Severity (CDEIS) and Simple Endoscopic Score for Crohn's Disease (SES-CD) are commonly used to assess Crohn's disease (CD) activity; however, neither instrument has been fully validated. We assessed intra-rater and inter-rater reliability of these indices.
Video recordings of colonoscopies obtained from 50 patients with CD who participated in an induction trial of a biological therapy were triplicated and reviewed in random order by four central readers. Data were used to assess intra-rater and inter-rater reliability for CDEIS, SES-CD and a global evaluation of lesion severity (GELS). Subsequently, readers participated in a consensus process that identified common sources of disagreement.
Intraclass correlation coefficients (ICCs) for intra-rater reliability for CDEIS, SES-CD and GELS (95% CIs) were 0.89 (0.86 to 0.93), 0.91 (0.89 to 0.95) and 0.81 (0.77 to 0.89), respectively, with standard error of measurement (SEM) of 2.10, 2.42 and 1.15. The corresponding ICCs for inter-rater reliability were 0.71 (0.63 to 0.76), 0.83 (0.75 to 0.88) and 0.62 (0.52 to 0.70), with SEM of 3.42, 3.07 and 1.63, respectively. Correlation between CDEIS and GELS was 0.75, between SES-CD and GELS was 0.74 and between CDEIS and SES-CD was 0.92. The most common sources of disagreement were interpretation of superficial ulceration, definition of disease site at the ileocolonic anastomosis, assessment of anorectal lesions and grading severity of stenosis.
Central reading of CDEIS and SES-CD had 'substantial' to 'almost perfect' intra-rater and inter-rater reliability; however, the responsiveness of these instruments is yet to be determined.
Clinicaltrials.gov NCT01466374.
克罗恩病内镜严重程度指数（CDEIS）和简单克罗恩病内镜评分（SES-CD）常用于评估克罗恩病（CD）的活动度；然而，这两种方法都尚未得到充分验证。本研究旨在评估这两种方法的观察者内和观察者间可靠性。
对参加生物治疗诱导试验的 50 例 CD 患者的结肠镜录像进行了三次复制，并由 4 位中心读者随机进行了回顾性评估。数据用于评估 CDEIS、SES-CD 和病变严重程度的整体评估（GELS）的观察者内和观察者间可靠性。随后，读者参与了一个共识过程，确定了常见的意见分歧来源。
CDEIS、SES-CD 和 GELS 的观察者内可靠性的组内相关系数（ICC）（95%CI）分别为 0.89（0.86 至 0.93）、0.91（0.89 至 0.95）和 0.81（0.77 至 0.89），测量误差（SEM）分别为 2.10、2.42 和 1.15。观察者间可靠性的相应 ICC 分别为 0.71（0.63 至 0.76）、0.83（0.75 至 0.88）和 0.62（0.52 至 0.70），SEM 分别为 3.42、3.07 和 1.63。CDEIS 与 GELS 之间的相关性为 0.75，SES-CD 与 GELS 之间的相关性为 0.74，CDEIS 与 SES-CD 之间的相关性为 0.92。最常见的意见分歧来源是对表浅性溃疡的解释、回肠结肠吻合口处疾病部位的定义、肛直肠病变的评估和狭窄严重程度的分级。
CDEIS 和 SES-CD 的中心读取具有“高度”至“几乎完美”的观察者内和观察者间可靠性；然而，这些工具的反应性尚待确定。
Clinicaltrials.gov NCT01466374。
