Novel classification for adverse events in GI endoscopy: the AGREE classification.

ABSTRACT

BACKGROUND AND AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.