结肠胶囊内镜检查中的肠道清洁质量评估：参考标准是什么？
Bowel cleansing quality evaluation in colon capsule endoscopy: what is the reference standard?
作者信息
Schelde-Olesen Benedicte, Koulaouzidis Anastasios, Deding Ulrik, Toth Ervin, Dabos Konstantinos John, Eliakim Abraham, Carretero Cristina, González-Suárez Begoña, Dray Xavier, de Lange Thomas, Beaumont Hanneke, Rondonotti Emanuele, Kopylov Uri, Ellul Pierre, Pérez-Cuadrado-Robles Enrique, Robertson Alexander, Stenfors Irene, Bojorquez Alejandro, Piccirelli Stefania, Raabe Gitte Grunnet, Margalit-Yehuda Reuma, Barba Isabel, Scardino Giulia, Ouazana Salome, Bjørsum-Meyer Thomas
机构信息
Department of Surgery, Odense University Hospital, Svendborg, Baagoes Alle 31, Svendborg 5700, Denmark.
Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
出版信息
Therap Adv Gastroenterol. 2024 Oct 23;17:17562848241290256. doi: 10.1177/17562848241290256. eCollection 2024.
BACKGROUND
The diagnostic accuracy of colon capsule endoscopy (CCE) depends on a well-cleansed bowel. Evaluating the cleansing quality can be difficult with a substantial interobserver variation.
OBJECTIVES
Our primary aim was to establish a standard of agreement for bowel cleansing in CCE based on evaluations by expert readers. Then, we aimed to investigate the interobserver agreement on bowel cleansing.
DESIGN
We conducted an interobserver agreement study on bowel cleansing quality.
METHODS
Readers with different experience levels in CCE and colonoscopy evaluated bowel cleansing quality on the Leighton-Rex scale and Colon Capsule CLEansing Assessment and Report (CC-CLEAR), respectively. All evaluations were reported on an image level. A total of 24 readers rated 500 images on each scale.
RESULTS
An expert opinion-based agreement standard could be set for poor and excellent cleansing but not for the spectrum in between, as the experts agreed on only a limited number of images representing fair and good cleansing. The overall interobserver agreement on the Leighton-Rex full scale was good (intraclass correlation coefficient (ICC) 0.84, 95% CI (0.82-0.85)) and remained good when stratified by experience level. On the full CC-CLEAR scale, the overall agreement was moderate (ICC 0.62, 95% CI (0.59-0.65)) and remained so when stratified by experience level.
CONCLUSION
The interobserver agreement was good for the Leighton-Rex scale and moderate for CC-CLEAR, irrespective of the reader's experience level. It was not possible to establish an expert-opinion standard of agreement for cleansing quality in CCE images. Dedicated training in using the scales may improve agreement and enable future algorithm calibration for artificial intelligence supported cleansing evaluation.
TRIAL REGISTRATION
All included images were derived from the CAREforCOLON 2015 trial (Registered with The Regional Health Research Ethics Committee (Registration number: S-20190100), the Danish data protection agency (Ref. 19/29858), and ClinicalTrials.gov (registration number: NCT04049357)).
背景
结肠胶囊内镜检查（CCE）的诊断准确性取决于肠道的良好清洁。评估清洁质量可能具有挑战性，因为观察者之间存在很大差异。
目的
我们的主要目的是基于专家读者的评估建立CCE肠道清洁的一致性标准。然后，我们旨在研究观察者之间在肠道清洁方面的一致性。
设计
我们进行了一项关于肠道清洁质量的观察者间一致性研究。
方法
在CCE和结肠镜检查方面具有不同经验水平的读者分别根据Leighton-Rex量表和结肠胶囊清洁评估与报告（CC-CLEAR）对肠道清洁质量进行评估。所有评估均在图像层面进行报告。共有24位读者对每种量表的500张图像进行评分。
结果
可以为清洁不佳和清洁良好设定基于专家意见的一致性标准，但无法为两者之间的范围设定标准，因为专家们仅对代表清洁一般和良好的有限数量图像达成一致。Leighton-Rex全量表的总体观察者间一致性良好（组内相关系数（ICC）0.84，95%置信区间（0.82 - 0.85）），按经验水平分层时仍保持良好。在完整的CC-CLEAR量表上，总体一致性为中等（ICC 0.62，95%置信区间（0.59 - 0.65）），按经验水平分层时也是如此。
结论
无论读者的经验水平如何，观察者间一致性在Leighton-Rex量表上良好，在CC-CLEAR量表上中等。无法为CCE图像的清洁质量建立基于专家意见的一致性标准。专门的量表使用培训可能会提高一致性，并为人工智能支持的清洁评估的未来算法校准提供可能。
试验注册
所有纳入的图像均来自2015年CAREforCOLON试验（已在地区健康研究伦理委员会注册（注册号：S - 20190100）、丹麦数据保护机构（参考号：19/29858）以及ClinicalTrials.gov（注册号：NCT0404935））。
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