CC BY-NC-ND 4.0 · Endosc Int Open 2024; 12(10): E1242-E1250
DOI: 10.1055/a-2435-5445
Original article

Comprehensive audit of gastrointestinal endoscopy adverse events: Emphasizing quality indicators and economic impact with the AIG-AGREE modification

1   Medical Gastroenterology, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
1   Medical Gastroenterology, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
Hardik Rughwani
1   Medical Gastroenterology, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
Nitin Jagtap
1   Medical Gastroenterology, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
Goutham Reddy Katukuri
1   Medical Gastroenterology, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
Shubhankar Godbole
1   Medical Gastroenterology, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
Sara Teles de Campos
2   Gastro-entérologie, Université Libre de Bruxelles, Bruxelles, Belgium (Ringgold ID: RIN26659)
,
Sana Fathima Memon
3   Department of Clinical research, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
Pradev Inavolu
1   Medical Gastroenterology, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
Aniruddha Pratap Singh
1   Medical Gastroenterology, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
Sonam Siddhant Mathur
1   Medical Gastroenterology, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
Aadil Ashraf
1   Medical Gastroenterology, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
Rajendra Patel
1   Medical Gastroenterology, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
Azimudin Haja
1   Medical Gastroenterology, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
1   Medical Gastroenterology, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
Thejesh Katamareddy
4   Anesthesia, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
Rakesh Kalapala
1   Medical Gastroenterology, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
Mohan Ramchandani
1   Medical Gastroenterology, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
1   Medical Gastroenterology, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
Darisetty Santosh
4   Anesthesia, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
,
Nageshwar Reddy
1   Medical Gastroenterology, AIG Hospitals, Hyderabad, India (Ringgold ID: RIN672640)
› Author Affiliations
Clinical Trial: Registration number (trial ID): NCT05228353, Trial registry: Clinical Trials Registry India (http://www.ctri.nic.in/Clinicaltrials), Type of Study: Prospective observational study

Abstract

Background and study aims: This study aimed to conduct a clinical audit of adverse events (AEs) arising from gastrointestinal endoscopy, utilizing the AGREE classification for AEs and establishing its correlation with the ASGE classification. This study further integrated the economic repercussions of AEs into the AGREE classification through the AIG-AGREE modification.

Patients and methods: A prospective observational study was conducted at the Asian Institute of Gastroenterology, Hyderabad, India, from July 1, 2021, to December 31, 2021. The study included all patients who underwent diagnostic or therapeutic endoscopic procedures. AEs were categorized using the American Society of Gastrointestinal Endoscopy (ASGE) and AGREE classifications. A quality indicator questionnaire containing 15 questions was graded based on the latest ASGE and European Society of Gastrointestinal Endoscopy guidelines. The grading scale ranged from 1 to 3 (poor), 4 to 6 (average), 7 to 9 (excellent), to 10 (outstanding). In addition, the AIG-AGREE modification divided the economic impact into five scales (α, β, γ, δ, and ε) based on multiples of the baseline amount. (ClinicalTrials.gov Identifier: NCT05228353)

Results: Over the 6-month study period, a total of 42,471 endoscopic procedures were performed, identifying 220 AEs. Analysis revealed a significant positive correlation (Pearson correlation coefficient = 0.79; P < 0.001) between the grades of AEs in the AGREE and ASGE classifications. The median score for all quality indicators was 8, indicating excellent services based on feedback from 13,042 surveyed patients. Notably, patients with more severe AEs (AGREE III-V) exhibited higher economic impact categories (β, γ, δ, ε) compared with those with less severe AEs (AGREE I-II).

Conclusions: The AIG-AGREE modification stands as a pioneering effort that highlights the importance of considering economic factors in the evaluation of AEs in gastrointestinal endoscopy.

Supplementary Material



Publication History

Received: 22 February 2024

Accepted after revision: 13 September 2024

Accepted Manuscript online:
07 October 2024

Article published online:
28 October 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

 
  • References

  • 1 Bisschops R, Areia M, Coron E. et al. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) quality improvement initiative. Endoscopy 2016; 48: 843-864
  • 2 Ben-Menachem T, Decker GA, Early DS. et al. Adverse events of upper GI endoscopy. Gastrointest Endosc 2012; 76: 707-718
  • 3 Kaminski MF, Thomas-Gibson S, Bugajski M. et al. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) quality improvement initiative. Endoscopy 2017; 49: 378-397
  • 4 Reumkens A, Rondagh EJ, Bakker MC. et al. Post-colonoscopy complications: a systematic review, time trends, and meta-analysis of population-based studies. Am J Gastroenterol 2016; 111: 1092-1101
  • 5 Fisher DA, Maple JT, Ben-Menachem T. et al. Complications of colonoscopy. Gastrointest Endosc 2011; 74: 745-752
  • 6 Kim SY, Kim H-S, Park HJ. Adverse events related to colonoscopy: Global trends and future challenges. World J Gastroenterol 2019; 25: 190
  • 7 Clavien PA, Barkun J, De Oliveira ML. et al. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg 2009; 250: 187-196
  • 8 Dindo D, Demartines N, Clavien P-A. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004; 240: 205-213
  • 9 Nass KJ, Zwager LW, van der Vlugt M. et al. Novel classification for adverse events in GI endoscopy: the AGREE classification. Gastrointest Endosc 2022; 95: 1078-1085 e1078
  • 10 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
  • 11 Day LW, Cohen J. ASGE Endoscopy Unit Quality Indicator Taskforce. et al. Quality indicators for gastrointestinal endoscopy units. VideoGIE 2017; 2: 119-140
  • 12 Valori R, Cortas G, De Lange T. et al. Performance measures for endoscopy services: a European Society of Gastrointestinal Endoscopy (ESGE) quality improvement initiative. Endoscopy 2018; 50: 1186-1204
  • 13 Cotton PB, Elmunzer BJ. Adverse events: definitions, avoidance, and management. ERCP: The Fundamentals 2020; 2020: 357-384
  • 14 Guda NM, Freeman ML. Overview of ERCP complications: prevention and management. ERCP and EUS: A case-based approach. ERCP EUS 2015; 2015: 37-56
  • 15 Wang P, Li Z-S, Liu F. et al. Risk factors for ERCP-related complications: a prospective multicenter study. Am J Gastroenterol 2009; 104: 31-40
  • 16 Elmunzer BJ. Reducing the risk of post-endoscopic retrograde cholangiopancreatography pancreatitis. Digest Endosc 2017; 29: 749-757
  • 17 Nabi Z, Ramchandani M, Chavan R. et al. Peroral endoscopic myotomy in treatment-naïve achalasia patients versus prior treatment failure cases. Endoscopy 2018; 50: 358-370
  • 18 Inoue H, Sato H, Ikeda H. et al. Per-oral endoscopic myotomy: a series of 500 patients. J Am Coll Surg 2015; 221: 256-264
  • 19 Haito-Chavez Y, Inoue H, Beard KW. et al. Comprehensive analysis of adverse events associated with per oral endoscopic myotomy in 1826 patients: an international multicenter study. Am J Gastroenterol 2017; 112: 1267-1276
  • 20 Von Renteln D, Fuchs KH, Fockens P. et al. Peroral endoscopic myotomy for the treatment of achalasia: an international prospective multicenter study. Gastroenterology 2013; 145: 309-311.e303
  • 21 Zhang X-C, Li Q-L, Xu M-D. et al. Major perioperative adverse events of peroral endoscopic myotomy: a systematic 5-year analysis. Endoscopy 2016; 48: 967-978
  • 22 Werner YB, von Renteln D, Noder T. et al. Early adverse events of per-oral endoscopic myotomy. Gastrointest Endosc 2017; 85: 708-718.e702
  • 23 de Brito Nunes M, Knecht M, Wiest R. et al. Predictors and management of post-banding ulcer bleeding in cirrhosis: A systematic review and meta-analysis. Liver Int 2023; 43: 1644-1653
  • 24 Bambha K, Kim WR, Pedersen R. et al. Predictors of early re-bleeding and mortality after acute variceal haemorrhage in patients with cirrhosis. Gut 2008; 57: 814-820
  • 25 Ramchandani M, Rughwani H, Inavolu P. et al. Diagnostic yield and therapeutic impact of novel motorized spiral enteroscopy in small-bowel disorders: a single-center, real-world experience from a tertiary care hospital (with video). Gastrointest Endosc 2021; 93: 616-626
  • 26 Rughwani H, Singh AP, Ramchandani M. et al. A randomized, controlled trial, comparing the total enteroscopy rate and diagnostic efficacy of novel motorized spiral enteroscopy and single balloon enteroscopy in patients with small-bowel disorders-THE MOTOR TRIAL (NCT 05548140). Am J Gastroenterol 2022; 10: 14309
  • 27 Pal P, Rebala P, Nabi Z. et al. Small-bowel transection after peroral motorized spiral enteroscopy. iGIE 2023; 2: 271-272
  • 28 Papaefthymiou A, Ramai D, Maida M. et al. Performance and safety of motorized spiral enteroscopy: a systematic review and meta-analysis. Gastrointest Endosc 2023; 97: 849-858.e845
  • 29 Bjorkman DJ, Popp Jr JW. Measuring the quality of endoscopy. Gastrointest Endosc 2006; 101: 864-865
  • 30 Faigel DO, Pike IM, Baron TH. et al. Quality indicators for gastrointestinal endoscopic procedures: an introduction. Gastrointest Endosc 2006; 101: 866-872
  • 31 Zagari RM, Frazzoni L, Fuccio L. et al. Adherence to European Society of Gastrointestinal Endoscopy quality performance measures for upper and lower gastrointestinal endoscopy: a nationwide survey from the Italian Society of Digestive Endoscopy. Front Med 2022; 9: 868449