Department of Gastroenterology and Hepatology, Research Institute Amsterdam Gastroenterology & Metabolism, Amsterdam University Medical Center, Amsterdam, the Netherlands.
Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Center, Amsterdam, the Netherlands.
Gastrointest Endosc. 2022 Jun;95(6):1078-1085.e8. doi: 10.1016/j.gie.2021.11.038. Epub 2021 Dec 8.
Standardized registration and evaluation of adverse events (AEs) are essential to assess the safety of endoscopic procedures. We propose a novel classification system, named adverse events in GI endoscopy (AGREE), adapted from a widely accepted surgical tool.
The Clavien-Dindo classification for surgical AEs was adapted for endoscopy. To validate the novel classification, we assessed if the severity of AEs, as perceived by 10 endoscopists, 10 endoscopy nurses, and 10 patients, corresponded with the severity grading used in the AGREE classification in 10 pairwise comparisons. We additionally assessed the correlation between the AGREE classification and the American Society for Gastrointestinal Endoscopy (ASGE) classification. The acceptability of the AGREE classification was evaluated through an international questionnaire.
The perception of endoscopists, endoscopy nurses, and patients corresponded with the severity grading of the AGREE classification in 80% of cases (238/299). The AGREE classification significantly correlated with the ASGE classification (ρ = .760). Fifty-seven of 84 experts (68%) completed a questionnaire regarding the acceptability of the AGREE classification. The experts consulted considered the AGREE classification as simple (86%), reproducible (98%), logical (98%), and useful (96%). Most case presentations (84%) were correctly graded according to the AGREE classification.
The AGREE classification provides a standardized and reproducible approach to the assessment of AEs in diagnostic and therapeutic GI endoscopy. Broad implementation of the AGREE classification may facilitate the evaluation of AEs across different endoscopists, disciplines, endoscopy services, and regions. This standardization of AE reporting will support improved quality assurance in GI endoscopy.
标准化登记和评估不良事件（AE）对于评估内镜操作的安全性至关重要。我们提出了一种新的分类系统，命名为胃肠道内镜不良事件（AGREE），该系统源自广泛接受的外科工具。
我们对用于外科 AE 的 Clavien-Dindo 分类进行了内镜改编。为了验证新分类，我们评估了 10 名内镜医生、10 名内镜护士和 10 名患者对 AE 严重程度的感知是否与 AGREE 分类中使用的严重程度分级相对应，在 10 对比较中进行了评估。我们还评估了 AGREE 分类与美国胃肠内镜学会（ASGE）分类之间的相关性。通过国际问卷调查评估了 AGREE 分类的可接受性。
在 80%的情况下（238/299），内镜医生、内镜护士和患者的感知与 AGREE 分类的严重程度分级相对应。AGREE 分类与 ASGE 分类显著相关（ρ=0.760）。84 名专家中的 57 名（68%）完成了一份关于 AGREE 分类可接受性的问卷。咨询的专家认为 AGREE 分类简单（86%）、可重现（98%）、逻辑（98%）和有用（96%）。根据 AGREE 分类，大多数病例呈现（84%）被正确分级。
AGREE 分类为诊断和治疗性胃肠道内镜中 AE 的评估提供了一种标准化和可重现的方法。AGREE 分类的广泛实施可能有助于不同内镜医生、学科、内镜服务和地区之间对 AE 的评估。这种 AE 报告的标准化将支持胃肠道内镜的质量保证改进。
