Goodsall Thomas M, An Yoon-Kyo, Andrews Jane M, Begun Jakob, Friedman Antony B, Lee Andrew, Lewindon Peter J, Spizzo Paul, Rodgers Nick, Taylor Kirstin M, White Lauren S, Wilkens Rune, Wright Emily K, Zou Lily, Maguire Bryan R, Parker Claire E, Rémillard Julie, Novak Kerri L, Panaccione Remo, Feagan Brian G, Jairath Vipul, Ma Christopher, Bryant Robert V
IBD Service, Department of Gastroenterology, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia; Faculty of Health Sciences, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.
Mater Hospital Brisbane, University of Queensland, Brisbane, Queensland, Australia; Mater Research Institute, University of Queensland, Brisbane, Queensland, Australia.
Clin Gastroenterol Hepatol. 2024 Aug 28. doi: 10.1016/j.cgh.2024.08.007.
BACKGROUND & AIMS: Intestinal ultrasound (IUS) is increasingly used to assess Crohn's disease (CD) activity in clinical practice. However, application in clinical trials has been limited by heterogeneous scoring methods and concerns about reliability. We aimed to determine the inter- and intra-rater reliability of locally and centrally read IUS parameters for evaluating CD using prospectively performed scans.
Twenty-four participants with CD and 6 gastroenterologists participated in a 2-day workshop where each participant underwent 6 IUS scans in total. Eight IUS parameters (bowel wall thickness [BWT], bowel wall stratification [BWS], color Doppler signal [CDS], inflammatory mesenteric fat [i-fat], submucosal prominence, submucosal layer thickness, haustra coli/peristalsis, and affected segment length) and an overall measure of sonographic disease activity were blindly assessed by the 6 local readers and 4 central gastroenterologist-sonographers. Reliability was quantified using intraclass correlation coefficients (ICCs). Institutional review board approval was granted for this study (12938).
Five IUS parameters demonstrated at least moderate (ICC ≥0.41) inter- and intra-rater reliability when local and central reading was performed (BWT, CDS, i-fat, submucosal prominence, and affected segment length). Reliability was generally better with central, in distinction to local, reading. ICCs for BWS and i-fat were highest when evaluated as binary outcomes. Sensitivity analyses demonstrated that IUS parameters are most reliable when evaluated in the worst affected segment. Fair reliability was observed when local readers identified the worst affected segment.
Local and central reading of IUS demonstrated at least moderate inter- and intra-rater reliability for several parameters. This study supports refining existing activity indices and incorporating IUS central reading into clinical trials.
在临床实践中，肠道超声（IUS）越来越多地用于评估克罗恩病（CD）的活动情况。然而，由于评分方法的异质性以及对可靠性的担忧，其在临床试验中的应用受到了限制。我们旨在通过前瞻性扫描，确定本地和集中阅片的IUS参数在评估CD时的评分者间和评分者内可靠性。
24名CD患者和6名胃肠病学家参加了一个为期2天的研讨会，每位参与者总共接受6次IUS扫描。6名本地阅片者和4名集中阅片的胃肠病学家-超声医师对8个IUS参数（肠壁厚度[BWT]、肠壁分层[BWS]、彩色多普勒信号[CDS]、炎性肠系膜脂肪[i-脂肪]、黏膜下隆起、黏膜下层厚度、结肠袋/蠕动以及受累节段长度）以及超声疾病活动的总体指标进行了盲法评估。使用组内相关系数（ICC）对可靠性进行量化。本研究获得了机构审查委员会的批准（12938）。
在进行本地和集中阅片时，5个IUS参数显示出至少中等程度（ICC≥0.41）的评分者间和评分者内可靠性（BWT、CDS、i-脂肪、黏膜下隆起和受累节段长度）。与本地阅片相比，集中阅片时的可靠性总体上更好。当将BWS和i-脂肪评估为二元结果时，其ICC最高。敏感性分析表明，在受影响最严重的节段进行评估时，IUS参数最为可靠。当本地阅片者识别出受影响最严重的节段时，观察到的可靠性一般。
IUS的本地和集中阅片在几个参数上显示出至少中等程度的评分者间和评分者内可靠性。本研究支持完善现有的活动指数，并将IUS集中阅片纳入临床试验。
