High quality colonoscopy: using textbook process as a composite quality measure.

BACKGROUND : High quality colonoscopy is fundamental to good patient outcomes. "Textbook outcome" has proven to be a feasible multidimensional measure for quality assurance between surgical centers. In this study, we sought to establish the "textbook process" (TP) as a new composite measure for the optimal colonoscopy process and assessed how frequently TP was attained in clinical practice and the variation in TP between endoscopists. METHODS : To reach consensus on the definition of TP, international expert endoscopists completed a modified Delphi consensus process. The achievement of TP was then applied to clinical practice. Prospectively collected data in two endoscopy services were retrospectively evaluated. Data on colonoscopies performed for symptoms or surveillance between 1 January 2018 and 1 August 2021 were analyzed. RESULTS : The Delphi consensus process was completed by 20 of 27 invited experts (74.1 %). TP was defined as a colonoscopy fulfilling the following items: explicit colonoscopy indication; successful cecal intubation; adequate bowel preparation; adequate withdrawal time; acceptable patient comfort score; provision of post-polypectomy surveillance recommendations in line with guidelines; and the absence of the use of reversal agents, early adverse events, readmission, and mortality. In the two endoscopy services studied, TP was achieved in 5962/8227 colonoscopies (72.5 %). Of 48 endoscopists performing colonoscopy, attainment of TP varied significantly, ranging per endoscopist from 41.0 % to 89.1 %. CONCLUSION : This study proposes a new composite measure for colonoscopy, namely "textbook process." TP gives a comprehensive summary of performance and demonstrates significant variation between endoscopists, illustrating the potential benefit of TP as a measure in future quality assessment programs.

Impact of sedation on the Performance Indicator of Colonic Intubation.

BACKGROUND: The Performance Indicator of Colonic Intubation (PICI) is a new measure of high-quality colonic intubation. Adequate PICI was defined as cecal intubation without significant discomfort and use of minimal sedation. This study assessed achievement of PICI within the Dutch colorectal cancer (CRC) screening program, and determined the association between PICI and adenoma detection rate (ADR). PICI achievement when using the Dutch median midazolam dose was also assessed. METHODS: This retrospective study was conducted within the Dutch fecal immunochemical test-based CRC screening program. Colonoscopy and pathology data were prospectively collected in a national database. Data between January 2016 through January 2018 were analyzed. Adequate PICI was defined as successful cecal intubation, Gloucester Comfort Scale (GCS) of 1 - 3, and use of ≤ 2.5 mg midazolam. RESULTS: 107 328 colonoscopies were performed during the study period. Adequate PICI was achieved in 49 500 colonoscopies (46.1 %). In colonoscopies with inadequate PICI, inadequacy was due to higher sedation doses in 87.8 %. Adequate PICI was associated with higher ADR (odds ratio 1.16, 95 % confidence interval 1.12 - 1.20). When using a cutoff of 5 mg midazolam, median dose in this Dutch population, adequate PICI was achieved in 95 410 colonoscopies (88.9  %). CONCLUSION: PICI appeared to be heavily dependent on sedation practice. Because of wide variation in sedation practice between individual endoscopists and countries, the benefit of PICI as a quality indicator is limited.

Are adenoma and serrated polyp detection rates correlated with endoscopists' sensitivity of optical diagnosis?

INTRODUCTION : Endoscopists with a high adenoma detection rate (ADR) and proximal serrated polyp detection rate (PSPDR) detect these polyps more frequently, which may be attributable to better recognition of their endoscopic features. Little is known about the association between endoscopic lesion detection and differentiation skills. Therefore, we evaluated the correlation between the ADR, PSPDR, and the sensitivity of optical diagnosis for adenomas and serrated polyps. METHODS: We performed an exploratory post-hoc analysis of the DISCOUNT-2 study, including complete colonoscopies after a positive fecal immunochemical test (FIT) performed by endoscopists who performed ≥ 50 colonoscopies. The correlations between the ADR, PSPDR, and the sensitivity of optical diagnosis were calculated using Pearson's rho correlation coefficient. RESULTS: 24 endoscopists performed ≥ 50 colonoscopies, resulting in a total of 2889 colonoscopies. The overall ADR was 84.5 % (range 71.4 % - 95.3 %) and overall PSPDR was 13.7 % (4.3 % - 29.0 %). The sensitivity of optical diagnosis for adenomas and serrated polyps were 94.5 % (83.3 % - 100 %) and 74.0 % (37.5 % - 94.1 %), respectively. No correlation could be demonstrated between the ADR and the sensitivity of optical diagnosis for adenomas (-0.20; P = 0.35) or between the PSPDR and the sensitivity of optical diagnosis for serrated polyps (-0.12; P = 0.57). CONCLUSIONS: In a homogeneous FIT-positive population, no correlation between the ADR, PSPDR, and the sensitivity of optical diagnosis for adenomas and serrated polyps could be demonstrated. These exploratory results suggest that lesion detection and differentiation require different endoscopic skills. Further prospective studies are needed; until then, monitoring of both performance indicators is important to secure optimal efficacy of FIT-based colorectal cancer screening.

Optical diagnosis of malignant colorectal polyps: is it feasible?

BACKGROUND AND STUDY AIMS: As colorectal cancer screening programs are being implemented worldwide, an increasing number of early (T1) cancers are being diagnosed. These cancers should be recognized during colonoscopy because they require a specific therapeutic approach. Several studies have shown that Asian experts can reliably recognize T1 cancers during colonoscopy. In daily practice, however, accurate endoscopic diagnosis of T1 cancers still seems challenging. We evaluated the performance of optical diagnosis of T1 cancers by European colonoscopy experts, general gastroenterologists and gastrointestinal fellows. PATIENTS AND METHODS: We collected endoscopic images of 43 colonic lesions: 19 T1 cancers (excluding intramucosal carcinoma) and 24 benign polyps ranging from 7 mm to 30 mm in size. Seven colonoscopy experts, 7 general gastroenterologists, and 14 gastrointestinal fellows assessed these images. We calculated sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) and their 95 % confidence intervals for optical diagnosis of T1 cancers. RESULTS: Overall sensitivity for correct diagnosis of T1 cancers was 60 % (95 % CI;45 - 72). Sensitivity was highest for experts (67 %: 95 %CI; 48 - 81), when compared to general gastroenterologists (53 %: 95 %CI; 37 - 69) and gastrointestinal fellows (59 %: 95 %CI;45 - 72). The overall NPV was 75 % (95 %CI;60 - 86); NPV was lowest for general gastroenterologists 72 % (95 %CI;57 - 83) vs 78 % (95 %CI;63 - 89) for experts and 75 % (95 %CI;60 - 85) for gastrointestinal fellows. CONCLUSIONS: In this image-based study, both sensitivity for the optical diagnosis of a T1 cancer and NPV for excluding a T1 cancer were insufficient. Experts performed best with a sensitivity of 67 % and a NPV of 78 %, while the performance of fellows in the last year of training was comparable to that of experts. Our study indicates that training for endoscopic diagnosis for T1 cancers is urgently needed to ensure optimal clinical practice for treatment of these lesions.

Polypectomy skills of gastroenterology fellows: can we improve them?

BACKGROUND AND AIMS: Currently, most training programs for gastroenterology (GI) fellows lack systematic training in polypectomy. Systematic education and direct feedback with the direct observational polypectomy skills (DOPyS) method is a simple and inexpensive way to train GI fellows in practical endoscopy. Our primary aim was to evaluate whether a lecture-based training course could improve the polypectomy skills of GI fellows. As a secondary aim, the interobserver agreement among the three assessors was evaluated. PARTICIPANTS AND METHODS: We invited GI fellows to record five polypectomies, after which they attended a training course consisting of three lectures on polyps and polypectomy methods given by expert endoscopists. After training, the fellows recorded five polypectomies again. All videos were blindly assessed by three expert endoscopists, who used the DOPyS method. RESULTS: Eight GI fellows participated in this study. There was no significant difference in the median overall competency scores before and after training; before training, 25 % (10/40) of the polypectomies were scored as "pass," compared with 37.5 % (15/40) after training (P = 0.56). The interobserver agreement among the experts was fair (intraclass correlation coefficient [ICC] 0.34, 95 % confidence interval [CI] 0.14 - 0.52). CONCLUSIONS: Our lecture-based training course did not result in an improvement in overall competency scores for the polypectomy skills of GI fellows. Besides, the overall quality of the polypectomy techniques of the fellows was considered low. To optimize polypectomy training and competency, we believe that direct feedback in the endoscopy suite and hands-on training by dedicated teachers are essential.

Evaluation of an assay for methylated BCAT1 and IKZF1 in plasma for detection of colorectal neoplasia.

BACKGROUND: Specific genes, such as BCAT1 and IKZF1, are methylated with high frequency in colorectal cancer (CRC) tissue compared to normal colon tissue specimens. Such DNA may leak into blood and be present as cell-free circulating DNA. We have evaluated the accuracy of a novel blood test for these two markers across the spectrum of benign and neoplastic conditions encountered in the colon and rectum. METHODS: Circulating DNA was extracted from plasma obtained from volunteers scheduled for colonoscopy for any reason, or for colonic surgery, at Australian and Dutch hospitals. The extracted DNA was bisulphite converted and analysed by methylation specific real-time quantitative PCR (qPCR). A specimen was deemed positive if one or more qPCR replicates were positive for either methylated BCAT1 or IKZF1 DNA. Sensitivity and specificity for CRC were estimated as the primary outcome measures. RESULTS: Plasma samples were collected from 2105 enrolled volunteers (mean age 62 years, 54 % male), including 26 additional samples taken after surgical removal of cancers. The two-marker blood test was run successfully on 2127 samples. The test identified 85 of 129 CRC cases (sensitivity of 66 %, 95 % CI: 57-74). For CRC stages I-IV, respective positivity rates were 38 % (95 % CI: 21-58), 69 % (95 % CI: 53-82), 73 % (95 % CI: 56-85) and 94 % (95 % CI: 70-100). A positive trend was observed between positivity rate and degree of invasiveness. The colonic location of cancer did not influence assay positivity rates. Gender, age, smoking and family history were not significant predictors of marker positivity. Twelve methylation-positive cancer cases with paired pre- and post-surgery plasma showed reduction in methylation signal after surgery, with complete disappearance of signal in 10 subjects. Sensitivity for advanced adenoma (n = 338) was 6 % (95 % CI: 4-9). Specificity was 94 % (95 % CI: 92-95) in all 838 non-neoplastic pathology cases and 95 % (95 % CI: 92-97) in those with no colonic pathology detected (n = 450). CONCLUSIONS: The sensitivity for cancer of this two-marker blood test justifies prospective evaluation in a true screening population relative to a proven screening test. Given the high rate of marker disappearance after cancer resection, this blood test might also be useful to monitor tumour recurrence. TRIAL REGISTRATION: ACTRN12611000318987 .

Fecal immunochemical testing results and characteristics of colonic lesions.

BACKGROUND AND STUDY AIMS: Fecal immunochemical tests (FIT) are used to detect blood in feces, which might indicate the presence of colorectal neoplasia. The aim of this study was to investigate whether FIT results vary depending on the characteristics of colonic lesions. PATIENTS AND METHODS: This was a retrospective analysis of lesions detected in a cohort of asymptomatic individuals (aged 50 - 75 years) who were invited to participate in a FIT-based screening pilot in The Netherlands. The mean FIT result was compared across subgroups of individuals defined by histopathology of the most advanced lesion detected. In addition, the results were compared with data from a primary colonoscopy screening trial, in which participants also completed a FIT. RESULTS: In three rounds of FIT-based screening, a total of 877 FIT-positive individuals underwent colonoscopy. Higher mean FIT results (hemoglobin [Hb]/g feces) were observed in individuals with carcinomas (199 µg Hb/g) and advanced adenomas (87 µg Hb/g) compared with participants with nonadvanced adenomas (50 µg Hb/g) or those with serrated lesions (46 µg Hb/g) (P < 0.001). In the primary colonoscopy trial, 1256 participants completed a FIT test and underwent colonoscopy. The number of participants with nonadvanced adenomas as the most advanced lesion was comparable between this group and the FIT-based screening group (20 % vs. 22 %). CONCLUSION: In FIT-based screening, the mean FIT results varied depending on the characteristics of the most advanced colonic lesion. The proportion of participants with a nonadvanced adenoma as the most advanced lesion was similar in the FIT-based screening group and in the primary colonoscopy screening group, suggesting that these lesions are coincidental findings rather than FIT-detected findings. CLINICAL TRIAL REGISTRATION: www.trialregister.nl number NTR2755.

The proximal serrated polyp detection rate is an easy-to-measure proxy for the detection rate of clinically relevant serrated polyps.

BACKGROUND AND AIMS: The adenoma detection rate (ADR) is the most important surrogate quality parameter for colorectal cancer (CRC) prevention. However, serrated polyps also are precursors of CRC. Large, prospective studies comparing the detection rate of serrated polyps among endoscopists in an era of awareness about the malignant potential of serrated polyps have not yet been performed. We aimed to compare the proximal serrated polyp (PSP) detection rate and the clinically relevant serrated polyp (RSP) detection rate among endoscopists and to analyze the association between these parameters and the ADR. METHODS: Colonoscopy data were retrieved in one expert center between January 2011 and July 2014 by using a structured reporting system, enabling prospective and automatic quality assessment. Endoscopists who performed at least 50 colonoscopies within the timeframe were included for analysis. Multivariate logistic regression was used to compare the ADR, PSP detection rate, and RSP detection rate among endoscopists. The association among these parameters was calculated by using the Pearson r correlation coefficient. All lesions were assessed by an expert pathologist. RESULTS: In total, 16 endoscopists and 2088 colonoscopies were included for analysis. The PSP detection rate ranged from 2.9% to 18.6% (mean 10.4%) among endoscopists. Corrected for confounders, the odds ratio to detect ≥1 PSP, compared with endoscopists with the highest detection rate, ranged from 0.79 (95% confidence interval [CI], 0.41-1.52) to 0.12 (95% CI, 0.03-0.55). The PSP detection rate was highly correlated with the RSP detection rate (ρ 0.94; P < .001), ranging from 4.3% to 20.9% (mean 13.9%). The PSP detection rate moderately correlated with the ADR (0.55; P = .03), which ranged from 23.2% to 49.2% (mean 35.2%). CONCLUSIONS: The PSP detection rate is widely variable among endoscopists, strongly correlated with the RSP detection rate, and moderately correlated with the ADR. These results suggest a high miss rate of RSPs among endoscopists with low rates of PSP detection. Future research should determine the association between endoscopists' PSP detection rates and the risk of interval cancer.

Adenoma detection rate varies greatly during colonoscopy training.

BACKGROUND: The adenoma detection rate (ADR) is considered the most important quality indicator for colonoscopy and varies widely among colonoscopists. It is unknown whether the ADR of gastroenterology consultants can already be predicted during their colonoscopy training. OBJECTIVE: To evaluate the ADR of fellows in gastroenterology and evaluate whether this predicts their ADR as gastroenterology consultants. DESIGN: Retrospective observational study. SETTING: Academic and regional centers. PATIENTS: Symptomatic patients undergoing colonoscopy. MAIN OUTCOME MEASUREMENTS: The variance in ADR among 7 gastroenterology fellows during their training (between May 2004 and March 2012) and of the same fellows after they registered as consultants (between October 2011 and April 2014) was evaluated. Multivariate logistic regression was performed to compare the highest detector (endoscopist with highest ADR) with the individual fellows and to evaluate whether an ADR of 20% or higher during the training was predictive of a high ADR as a consultant. RESULTS: During training, ADRs ranged from 14% to 36% (P < .001). Compared with the highest detector, the OR for detecting an adenoma ranged from 0.64 (95% CI, 0.40-1.03) to 0.29 (95% CI, 0.17-0.48). After registration, ADR ranged from 19.8% to 40.2% (P = .066). Compared with the highest detector during consultancy, the OR ranged from 0.64 (95% CI, 0.34-1.21) to 0.26 (95% CI, 0.13-0.52). Only 2 fellows significantly improved their ADR after completing their training. An ADR lower than 20% during training was associated with a lower ADR as a consultant (OR 0.51; 95% CI, 0.30-0.87). LIMITATIONS: Retrospective study. CONCLUSIONS: Variance in ADR is already present during the endoscopy training of gastroenterology fellows. Most fellows do not improve their ADR after completing their training. These findings suggest that the ADR can be predicted during colonoscopy training, and we suggest that feedback and benchmarking should be implemented early during training of fellows in an effort to improve ADR in future daily practice as a consultant.

Quality of colonoscopy and advances in detection of colorectal lesions: a current overview.

Colonoscopy is the gold standard for the detection of colorectal cancer and its precursors. Nevertheless multiple studies have demonstrated a significant miss-rate for polyps and, more importantly, demonstrated the occurrence of interval cancers in the years after colonoscopy. This imperfect protection against colorectal cancer can be explained by multiple factors related to both the endoscopist and the equipment. To ensure the quality of colonoscopy, several quality indicators have been described. These include bowel preparation, cecal intubation rate, withdrawal time, adenoma detection rate and complication rate. Measurement of these quality indicators, followed by awareness, benchmarking and additional training will hopefully optimize daily practice. If these basic quality parameters are well taken care of, advanced colonoscopic techniques will aim at further increasing the detection and differentiation of colonic lesions. In this review, the authors discuss the literature on quality indicators for colonoscopy and give a comprehensive overview of the advanced colonoscopic techniques currently available.

Polyp morphology: an interobserver evaluation for the Paris classification among international experts.

OBJECTIVES: The Paris classification is an international classification system for describing polyp morphology. Thus far, the validity and reproducibility of this classification have not been assessed. We aimed to determine the interobserver agreement for the Paris classification among seven Western expert endoscopists. METHODS: A total of 85 short endoscopic video clips depicting polyps were created and assessed by seven expert endoscopists according to the Paris classification. After a digital training module, the same 85 polyps were assessed again. We calculated the interobserver agreement with a Fleiss kappa and as the proportion of pairwise agreement. RESULTS: The interobserver agreement of the Paris classification among seven experts was moderate with a Fleiss kappa of 0.42 and a mean pairwise agreement of 67%. The proportion of lesions assessed as "flat" by the experts ranged between 13 and 40% (P<0.001). After the digital training, the interobserver agreement did not change (kappa 0.38, pairwise agreement 60%). CONCLUSIONS: Our study is the first to validate the Paris classification for polyp morphology. We demonstrated only a moderate interobserver agreement among international Western experts for this classification system. Our data suggest that, in its current version, the use of this classification system in daily practice is questionable and it is unsuitable for comparative endoscopic research. We therefore suggest introduction of a simplification of the classification system.

A novel colonoscopy reporting system enabling quality assurance.

BACKGROUND AND STUDY AIMS: The quality of colonoscopy can only be measured if colonoscopy reports include all key quality indicators. In daily practice, reporting is often incomplete and not standardized. This study describes a novel, structured colonoscopy reporting system, which aims to generate standardized and complete reports and to facilitate the automatic analysis of colonoscopy quality indicators. METHODS: A new colonoscopy reporting system (EndoALPHA) was developed. The system reports all colonoscopy quality indicators, as well as pathological findings, in a systematic manner using structured terminology. All essential items carry specific codes, which enables statistical analysis and the automatic generation of reports of all quality indicators. The EndoALPHA reporting system was tested with regard to completeness of reporting and evaluation of quality indicators both for individual endoscopists and the endoscopy unit. RESULTS: In 2012, all 810 colonoscopies performed at one colonoscopy center were documented using EndoALPHA. Overall, 94 % of performed colonoscopies were reported completely using the encoded terminology. Individual unadjusted cecal intubation rates were above 90 % for all endoscopists (mean 96.7 %), and the adenoma detection rate was above 20 % for all endoscopists (35.4 % for the unit). CONCLUSION: The novel EndoALPHA reporting system enables automatic quality assessment on two levels: the completeness of reporting can be evaluated, and if this is adequate, the quality of the colonoscopies can also be assessed. Integrated with feedback, benchmarking and training, the reporting system may facilitate quality improvement for colonoscopy services.

The accuracy of polyp assessment during colonoscopy in FIT-screening is not acceptable on a routine basis.

BACKGROUND: During colonoscopy, correct assessment of polyps is important. Recognition of early carcinomas is needed for tailor-made treatment and avoidance of unnecessary complications. Moreover, accurate diagnosis of diminutive lesions could result in a safe resect and discard strategy. We assessed the accuracy of polyp assessment by general endoscopists without specific training or experience in image-enhanced endoscopy during routine colonoscopies within a fecal immunochemical test (FIT)-based screening program. METHODS: Data were collected in the third round of a FIT-based colorectal cancer screening pilot program. Patients diagnosed as FIT-positive (318) underwent colonoscopy using Olympus (160 and 180 series) endoscopes without magnification or routine use of (virtual) chromoendoscopy. Endoscopists received no special training. They made an on-site evaluation and classified detected polyps as hyperplastic, adenoma, carcinoma. Samples of resected lesions were sent for histopathology. Sensitivity and specificity were calculated. We differentiated for fellows and consultants. RESULTS: In the 318 patients with a positive FIT-screening result, 683 lesions were detected; 564 lesions were included in the analyses. The pathologist classified these lesions as 141 hyperplastic polyps, 349 adenomas, 16 carcinomas, and 58 other. Sensitivity for diagnosis of adenomas was 88 % (95 %CI 84 - 91); specificity 49 % (95 %CI 42 - 55). Of the 16 colorectal carcinomas, endoscopists diagnosed four incorrectly (sensitivity 75 % [95 %CI 44 - 89]; specificity 99 % [95 %CI 98 - 100]), including three stage I cancers and one stage III cancer. There were no differences in accuracy of diagnosis that related to different sizes of lesions or the experience of the endoscopist. CONCLUSION: In a routine FIT-based screening setting and without specific training or routine use of (digital) chromoendoscopy, endoscopic prediction of the histopathology of colonic lesions is inaccurate when the procedure is performed by general endoscopists.

Retrospective comparison of magnetic resonance imaging features and histopathology in Crohn's disease patients.

PURPOSE: To retrospectively compare histopathological findings of surgically resected bowel segments with magnetic resonance imaging (MRI) findings on Crohn's disease activity. MATERIALS AND METHODS: Patients who underwent a MR enterography or enteroclysis before surgery were included after informed consent. MRI features (T1-enhancement, T1 and T2 stratification, T2 signal intensity, bowel wall thickness, presence of ulcerations, comb sign, creeping fat, and disease activity) were assessed by three experienced abdominal radiologists. An acute inflammatory score based on histopathology (parameters: mucosal ulceration, edema, depth and degree of neutrophils) was calculated. Interobserver variability for subjective MRI features was also assessed. RESULTS: Thirty-nine segments in 25 patients (mean age 38 years) were included. Of the MRI features, disease activity per segment and bowel wall thickness had a positive association with the acute inflammatory score (p<0.05). T1-enhancement had a positive correlation with disease chronicity. All other MRI features did not have an association with the acute inflammatory score. Interobserver agreement between the three observers was weak to moderate. CONCLUSION: MR features bowel wall thickness and disease activity per-segment reflect disease activity in Crohn's disease patients.