Definition of competence standards for optical diagnosis of diminutive colorectal polyps: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement

Abstract

Background The European Society of Gastrointestinal Endoscopy (ESGE) has developed a core curriculum for high quality optical diagnosis training for practice across Europe. The development of easy-to-measure competence standards for optical diagnosis can optimize clinical decision-making in endoscopy. This manuscript represents an official Position Statement of the ESGE aiming to define simple, safe, and easy-to-measure competence standards for endoscopists and artificial intelligence systems performing optical diagnosis of diminutive colorectal polyps (1 – 5 mm).

Methods A panel of European experts in optical diagnosis participated in a modified Delphi process to reach consensus on Simple Optical Diagnosis Accuracy (SODA) competence standards for implementation of the optical diagnosis strategy for diminutive colorectal polyps. In order to assess the clinical benefits and harms of implementing optical diagnosis with different competence standards, a systematic literature search was performed. This was complemented with the results from a recently performed simulation study that provides guidance for setting alternative competence standards for optical diagnosis. Proposed competence standards were based on literature search and simulation study results. Competence standards were accepted if at least 80 % agreement was reached after a maximum of three voting rounds.

Recommendation 1 In order to implement the leave-in-situ strategy for diminutive colorectal lesions (1–5 mm), it is clinically acceptable if, during real-time colonoscopy, at least 90 % sensitivity and 80 % specificity is achieved for high confidence endoscopic characterization of colorectal neoplasia of 1–5 mm in the rectosigmoid. Histopathology is used as the gold standard.

Level of agreement 95 %.

Recommendation 2 In order to implement the resect-and-discard strategy for diminutive colorectal lesions (1–5 mm), it is clinically acceptable if, during real-time colonoscopy, at least 80 % sensitivity and 80 % specificity is achieved for high confidence endoscopic characterization of colorectal neoplasia of 1–5 mm. Histopathology is used as the gold standard.

Level of agreement 100 %.

Conclusion The developed SODA competence standards define diagnostic performance thresholds in relation to clinical consequences, for training and for use when auditing the optical diagnosis of diminutive colorectal polyps.

• References

• 1 Bisschops R, Dekker E, East JE. et al. European Society of Gastrointestinal Endoscopy (ESGE) curricula development for postgraduate training in advanced endoscopic procedures: rationale and methodology. Endoscopy 2019; 51: 976-979
• 2 Dekker E, Houwen B, Puig I. et al. Curriculum for optical diagnosis training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy 2020; 52: 899-923
• 3 Pickhardt PJ, Kim DH. Colorectal cancer screening with CT colonography: key concepts regarding polyp prevalence, size, histology, morphology, and natural history. AJR Am J Roentgenol 2009; 193: 40-46
• 4 Vleugels JLA, Hassan C, Senore C. et al. Diminutive polyps with advanced histologic features do not increase risk for metachronous advanced colon neoplasia. Gastroenterology 2019; 156: 623-634.e623
• 5 Ignjatovic A, East JE, Suzuki N. et al. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol 2009; 10: 1171-1178
• 6 Hassan C, Pickhardt PJ, Kim DH. et al. Systematic review: distribution of advanced neoplasia according to polyp size at screening colonoscopy. Aliment Pharmacol Ther 2010; 31: 210-217
• 7 Vleugels JLA, Hazewinkel Y, Fockens P. et al. Natural history of diminutive and small colorectal polyps: a systematic literature review. Gastrointest Endosc 2017; 85: 1169-1176.e1161
• 8 Hassan C, Pickhardt PJ, Rex DK. A resect and discard strategy would improve cost-effectiveness of colorectal cancer screening. Clin Gastroenterol Hepatol 2010; 8: 865-869 .e861–e863
• 9 Vleugels JLA, Greuter MJE, Hazewinkel Y. et al. Implementation of an optical diagnosis strategy saves costs and does not impair clinical outcomes of a fecal immunochemical test-based colorectal cancer screening program. Endosc Int Open 2017; 5: E1197-E1207
• 10 National Institute for Health and Care Excellence. Virtual chromoendoscopy to assess colorectal polyps during colonoscopy. Diagnostics guidance [DG28]. 2017 Available from (Accessed 13.10.2021): https://www.nice.org.uk/guidance/dg28
• 11 Bisschops R, East JE, Hassan C. et al. Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline – Update 2019. Endoscopy 2019; 51: 1155-1179
• 12 Rutter MD, East J, Rees CJ. et al. British Society of Gastroenterology/Association of Coloproctology of Great Britain and Ireland/Public Health England post-polypectomy and post-colorectal cancer resection surveillance guidelines. Gut 2020; 69: 201-223
• 13 Jones J, Hunter D. Consensus methods for medical and health services research. BMJ 1995; 311: 376
• 14 Boulkedid R, Abdoul H, Loustau M. et al. Using and reporting the Delphi method for selecting healthcare quality indicators: a systematic review. PloS One 2011; 6: e20476
• 15 Humphrey-Murto S, de Wit M. The Delphi method—more research please. J Clin Epidemiol 2019; 106: 136-139
• 16 Houwen BBSL, Greuter MJ, Vleugels JLA. et al. Guidance for setting easy-to-adopt competence criteria for optical diagnosis of diminutive colorectal polyps: a simulation approach. Gastrointest Endosc 2021; 94: 812-822.e4
• 17 Houwen BBSL, Hassan C, Hazewinkel Y. et al. Methodological framework for the development of standards for optical diagnosis in gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy 2021;
• 18 Stoop EM, de Haan MC, de Wijkerslooth TR. et al. Participation and yield of colonoscopy versus non-cathartic CT colonography in population-based screening for colorectal cancer: a randomised controlled trial. Lancet Oncol 2012; 13: 55-64
• 19 Vleugels JLA, Dijkgraaf MGW, Hazewinkel Y. et al. Effects of training and feedback on accuracy of predicting rectosigmoid neoplastic lesions and selection of surveillance intervals by endoscopists performing optical diagnosis of diminutive polyps. Gastroenterology 2018; 154: 1682-1693.e1681
• 20 Toes-Zoutendijk E, van Leerdam ME, Dekker E. et al. Real-time monitoring of results during first year of Dutch Colorectal Cancer Screening Program and optimization by altering fecal immunochemical test cut-off levels. Gastroenterology 2017; 152: 767-775.e762
• 21 Jass JR. Classification of colorectal cancer based on correlation of clinical, morphological and molecular features. Histopathology 2007; 50: 113-130
• 22 Toyota M, Ahuja N, Ohe-Toyota M. et al. CpG island methylator phenotype in colorectal cancer. Proc Natl Acad Sci USA 1999; 96: 8681-8686
• 23 Bleijenberg AGC, van Leerdam ME, Bargeman M. et al. Substantial and sustained improvement of serrated polyp detection after a simple educational intervention: results from a prospective controlled trial. Gut 2020; 69: 2150-2158
• 24 Picot J, Rose M, Cooper K. et al. Virtual chromoendoscopy for the real-time assessment of colorectal polyps in vivo: a systematic review and economic evaluation. Health Technol Assess 2017; 21: 1-308
• 25 Kessler WR, Imperiale TF, Klein RW. et al. A quantitative assessment of the risks and cost savings of forgoing histologic examination of diminutive polyps. Endoscopy 2011; 43: 683-691
• 26 Rex DK, Patel NJ, Vemulapalli KC. A survey of patient acceptance of resect and discard for diminutive polyps. Gastrointest Endosc 2015; 82: 376-380.e371
• 27 Sekiguchi M, Otake Y, Kakugawa Y. et al. Incidence of advanced colorectal neoplasia in individuals with untreated diminutive colorectal adenomas diagnosed by magnifying image-enhanced endoscopy. Am J Gastroenterol 2019; 114: 964-973
• 28 Ninomiya Y, Oka S, Tanaka S. et al. Clinical impact of surveillance colonoscopy using magnification without diminutive polyp removal. Dig Endosc 2017; 29: 773-781
• 29 Oka S, Tanaka S, Nakadoi K. et al. Endoscopic features and management of diminutive colorectal submucosal invasive carcinoma. Dig Endosc 2014; 26 (Suppl. 02) 78-83
• 30 Payne SR, Church TR, Wandell M. et al. Endoscopic detection of proximal serrated lesions and pathologic identification of sessile serrated adenomas/polyps vary on the basis of center. Clin Gastroenterol Hepatol 2014; 12: 1119-1126
• 31 Schachschal G, Sehner S, Choschzick M. et al. Impact of reassessment of colonic hyperplastic polyps by expert GI pathologists. Int J Colorectal Dis 2016; 31: 675-683
• 32 Mahajan D, Downs-Kelly E, Liu X. et al. Reproducibility of the villous component and high-grade dysplasia in colorectal adenomas <1 cm: implications for endoscopic surveillance. Am J Surg Pathol 2013; 37: 427-433
• 33 Wang LM, East JE. Diminutive polyp cancers and the DISCARD strategy: Much ado about nothing or the end of the affair?. Gastrointest Endosc 2015; 82: 385-388
• 34 Willems P, Djinbachian R, Ditisheim S. et al. Uptake and barriers for implementation of the resect and discard strategy: an international survey. Endosc Int Open 2020; 8: E684-E692
• 35 Gellad ZF, Voils CI, Lin L. et al. Clinical practice variation in the management of diminutive colorectal polyps: results of a national survey of gastroenterologists. Am J Gastroenterol 2013; 108: 873-878
• 36 von Renteln D, Bouin M, Barkun AN. et al. Patients' willingness to defer resection of diminutive polyps: results of a multicenter survey. Endoscopy 2018; 50: 221-229
• 37 Gupta S, Lieberman D, Anderson JC. et al. Recommendations for follow-up after colonoscopy and polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology 2020; 158: 1131-1153.e5
• 38 Hassan C, Antonelli G, Dumonceau JM. et al. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) Guideline – Update 2020. Endoscopy 2020; 52: 687-700
• 39 Kaltenbach T, Rastogi A, Rouse RV. et al. Real-time optical diagnosis for diminutive colorectal polyps using narrow-band imaging: the VALID randomised clinical trial. Gut 2015; 64: 1569-1577
• 40 Soudagar AS, Nguyen M, Bhatia A. et al. Are gastroenterologists willing to implement the "predict, resect, and discard" management strategy for diminutive colorectal polyps? Results from a national survey. J Clin Gastroenterol 2016; 50: e45-e49
• 41 Vu HT, Sayuk GS, Gupta N. et al. Patient preferences of a resect and discard paradigm. Gastrointest Endosc 2015; 82: 381-384.e381