The Gastroscopy RAte of Cleanliness Evaluation (GRACE) Scale: an international reliability and validation study

Abstract

Background Mucosal visualization during upper gastrointestinal (UGI) endoscopy can be impaired by the presence of foam, bubbles, and mucus. Some UGI endoscopy visibility scales have been proposed but have not undergone multicenter validation. This study aimed to develop and validate the Gastroscopy RAte of Cleanliness Evaluation (GRACE) scale.

Methods A multicenter, international, cross-sectional study was conducted. The GRACE scale is based on a score from 0 (worst) to 3 (excellent) for esophagus, stomach, and duodenum, for a total ranging from 0 to 9. In phase 1, four expert endoscopists evaluated 60 images twice, with a 2-week interval between rounds; in phase 2, the same 60 images were scored twice by one expert and one nonexpert endoscopist from 27 endoscopy departments worldwide. For reproducibility assessment and real-time validation, the scale was applied to consecutive patients undergoing gastroscopy at each center.

Results On internal validation, interobserver agreement was 0.81 (95 %CI 0.73–0.87) and 0.80 (95 %CI 0.72–0.86), with reliability of 0.73 (95 %CI 0.63–0.82) and 0.72 (95 %CI 0.63–0.81), in the two rounds, respectively. On external validation, overall interobserver agreement was 0.85 (95 %CI 0.82–0.88) and reliability was 0.79 (95 %CI 0.73–0.84). In real-time evaluation, the overall proportion of correct classifications was 0.80 (95 %CI 0.77–0.82).

Conclusions The GRACE scale showed good interobserver agreement, reliability, and validity. The widespread use of this scale could enhance quality and standardize the assessment of mucosal cleanliness during UGI endoscopy, pushing endoscopists to strive for excellent visibility and reducing the risk of missed lesions.

• References

• 1 Areia M, Dinis-Ribeiro M, Rocha Goncalves F. Cost-utility analysis of endoscopic surveillance of patients with gastric premalignant conditions. Helicobacter 2014; 19: 425-436
• 2 Areia M, Pimentel-Nunes P, Marcos-Pinto R. et al. Gastric cancer: an opportunity for prevention. Acta Med Port 2013; 26: 627-629
• 3 Marques-Silva L, Areia M, Elvas L. et al. Prevalence of gastric precancerous conditions: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol 2014; 26: 378-387
• 4 Pimentel-Nunes P, Libanio D, Marcos-Pinto R. et al. Management of epithelial precancerous conditions and lesions in the stomach (MAPS II): European Society of Gastrointestinal Endoscopy (ESGE), European Helicobacter and Microbiota Study Group (EHMSG), European Society of Pathology (ESP), and Sociedade Portuguesa de Endoscopia Digestiva (SPED) guideline update 2019. Endoscopy 2019; 51: 365-388
• 5 Pimentel-Nunes P, Libanio D, Lage J. et al. A multicenter prospective study of the real-time use of narrow-band imaging in the diagnosis of premalignant gastric conditions and lesions. Endoscopy 2016; 48: 723-730
• 6 Castro R, Rodriguez M, Libanio D. et al. Reliability and accuracy of blue light imaging for staging of intestinal metaplasia in the stomach. Scand J Gastroenterol 2019; 54: 1301-1305
• 7 Rodriguez-Carrasco M, Esposito G, Libanio D. et al. Image-enhanced endoscopy for gastric preneoplastic conditions and neoplastic lesions: a systematic review and meta-analysis. Endoscopy 2020; 52: 1048-1065
• 8 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
• 9 Pimenta-Melo AR, Monteiro-Soares M, Libanio D. et al. Missing rate for gastric cancer during upper gastrointestinal endoscopy: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol 2016; 28: 1041-1049
• 10 Lai EJ, Calderwood AH, Doros G. et al. The Boston Bowel Preparation Scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc 2009; 69: 620-625
• 11 Asl SM, Sivandzadeh GR. Efficacy of premedication with activated dimethicone or N-acetylcysteine in improving visibility during upper endoscopy. World J Gastroenterol 2011; 17: 4213-4217
• 12 Chen MJ, Wang HY, Chang CW. et al. The add-on N-acetylcysteine is more effective than dimethicone alone to eliminate mucus during narrow-band imaging endoscopy: a double-blind, randomized controlled trial. Scand J Gastroenterol 2013; 48: 241-245
• 13 Bhandari P, Green S, Hamanaka H. et al. Use of Gascon and Pronase either as a pre-endoscopic drink or as targeted endoscopic flushes to improve visibility during gastroscopy: a prospective, randomized, controlled, blinded trial. Scand J Gastroenterol 2010; 45: 357-361
• 14 Chang CC, Chen SH, Lin CP. et al. Premedication with pronase or N-acetylcysteine improves visibility during gastroendoscopy: an endoscopist-blinded, prospective, randomized study. World J Gastroenterol 2007; 13: 444-447
• 15 Chang WK, Yeh MK, Hsu HC. et al. Efficacy of simethicone and N-acetylcysteine as premedication in improving visibility during upper endoscopy. J Gastroenterol Hepatol 2014; 29: 769-774
• 16 Elvas L, Areia M, Brito D. et al. Premedication with simethicone and N-acetylcysteine in improving visibility during upper endoscopy: a double-blind randomized trial. Endoscopy 2017; 49: 139-145
• 17 Bertoni G, Gumina C, Conigliaro R. et al. Randomized placebo-controlled trial of oral liquid simethicone prior to upper gastrointestinal endoscopy. Endoscopy 1992; 24: 268-270
• 18 McNally PR, Maydonovitch CL, Wong RK. The effectiveness of simethicone in improving visibility during colonoscopy: a double-blind randomized study. Gastrointest Endosc 1988; 34: 255-258
• 19 Kuo CH, Sheu BS, Kao AW. et al. A defoaming agent should be used with pronase premedication to improve visibility in upper gastrointestinal endoscopy. Endoscopy 2002; 34: 531-534
• 20 Basford PJ, Brown J, Gadeke L. et al. A randomized controlled trial of pre-procedure simethicone and N-acetylcysteine to improve mucosal visibility during gastroscopy – NICEVIS. Endosc Int Open 2016; 4: E1197-E1202
• 21 Manfredi G, Berte R, Iiritano E. et al. Premedication with simethicone and N-acetylcysteine for improving mucosal visibility during upper gastrointestinal endoscopy in a Western population. Endosc Int Open 2021; 9: E190-E194
• 22 Khan R, Gimpaya N, Vargas JI. et al. The Toronto Upper Gastrointestinal Cleaning Score: a prospective validation study. Endoscopy 2023; 55: 121-128
• 23 Romanczyk M, Ostrowski B, Kozlowska-Petriczko K. et al. Scoring system assessing mucosal visibility of upper gastrointestinal tract: The POLPREP scale. J Gastroenterol Hepatol 2022; 37: 164-168
• 24 Kottner J, Audige L, Brorson S. et al. Guidelines for Reporting Reliability and Agreement Studies (GRRAS) were proposed. J Clin Epidemiol 2011; 64: 96-106
• 25 Cohen J. A coefficient of agreement for nominal scales. Educ Psychol Meas 1960; 20: 37-46
• 26 Hripcsak G, Heitjan DF. Measuring agreement in medical informatics reliability studies. J Biomed Inform 2002; 35: 99-110
• 27 Romanczyk M, Ostrowski B, Lesinska M. et al. The prospective validation of a scoring system to assess mucosal cleanliness during EGD. Gastrointest Endosc 2024; 100: 27-35
• 28 Cordova H, Barreiro-Alonso E, Castillo-Regalado E. et al. Applicability of the Barcelona scale to assess the quality of cleanliness of mucosa at esophagogastroduodenoscopy. Gastroenterol Hepatol 2024; 47: 246-252