Nationally Automated Colonoscopy Performance Feedback Increases Polyp Detection: the NED APRIQOT Randomised Controlled Trial.

BACKGROUND AND AIMS: Post-colonoscopy colorectal cancer incidence and mortality rates are higher for endoscopists with low polyp detection rates. Using the UK's National Endoscopy Database (NED), which automatically captures real-time data, we assessed if providing feedback of case-mix-adjusted Mean Number of Polyps (aMNP), as a key performance indicator, improved endoscopists' performance. Feedback was delivered via a theory-informed evidence-based audit and feedback intervention. METHODS: This multicentre, prospective, NED Automated Performance Reports to Improve Quality Outcomes Trial (NED-APRIQOT) randomised NHS endoscopy centres to intervention or control. Intervention-arm endoscopists were emailed tailored monthly reports automatically generated within NED, informed by qualitative interviews and behaviour change theory. The primary outcome was endoscopists' aMNP during the 9-month intervention. RESULTS: From November 2020-July 2021, 541 endoscopists across 36 centres (19 intervention; 17 control) performed 54,770 procedures during the intervention, and 15,960 procedures during the 3-months post-intervention period. Comparing intervention-arm to control-arm endoscopists during the intervention period: aMNP was non-significantly higher (7%, 95% confidence interval (CI) -1% to 14%; p=0·08). Unadjusted MNP (10%, 95%CI 1-20%) and polyp detection rate (PDR) (10%, 95%CI 4-16%) were significantly higher. Differences were not maintained in the post-intervention period. In the intervention-arm, endoscopists accessing NED-APRIQOT webpages had higher aMNP than those who did not (118 vs 102 aMNP, p=0.03). CONCLUSION: Although our automated feedback intervention did not increase aMNP significantly in the intervention period; MNP and PDR did significantly improve. Engaged endoscopists benefited most and improvements were not maintained post-intervention; future work should address engagement in feedback and consider the effectiveness of continuous feedback. www.isrctn.org ISRCTN11126923.

Colonoscopic cancer detection rate: a new performance measure - is it FIT for purpose?

Introduction: Gastrointestinal symptoms correlate poorly with cancer diagnosis. A faecal immunochemical test (FIT) result of ≥10 µg has high sensitivity and negative predictive value for colorectal cancer (CRC) detection. An FIT-based diagnostic pathway may lead to more effective resource utilisation. We aimed to use National Endoscopy Database (NED) data to create a new colonoscopy performance measure, cancer detection rate (CDR) to assess the appropriate identification of target populations for colonoscopy; then to use CDR to assess the impact of implementing an FIT-based referral pathway locally. Methods: NED data were analysed to compare local diagnostic colonoscopic CDR in 2019 (prepathway revision) and 2021 (postpathway revision), benchmarked against overall national CDR for the same time frames. Results: 1, 123, 624 NED diagnostic colonoscopies were analysed. Locally, there was a significant increase in CDR between 2019 and 2021, from 3.01% (2.45%-3.47%) to 4.32% (3.69%-4.95%), p=0.003. The CDR increase was due to both a 10% increase in the number of CRCs detected and a 25% reduction in the number of diagnostic colonoscopies performed. Nationally, there was a smaller, but significant, increase in CDR from 2.02% (1.99%-2.07%) to 2.33% (2.29%-2.37%), p<0.001. The rate of increase in CDR% between 2019 and 2021 was significantly different locally compared with nationally. Conclusion: Our study indicates that the introduction of a robustly vetted FIT-based algorithm to determine whether diagnostic colonoscopy is required, is effective in increasing the colonoscopic CDR. Moreover, CDR appears to be a meaningful performance metric that can be automatically calculated through NED, enabling monitoring of the quality of referral and vetting pathways.

Umbrella systematic review of potential quality indicators for the detection of dysplasia and cancer at upper gastrointestinal endoscopy.

Background and study aims Upper gastrointestinal (UGI) endoscopy lacks established quality indicators. We conducted an umbrella systematic review of potential quality indicators for the detection of UGI cancer and dysplasia. Methods Bibliographic databases were searched up to December 2021 for systematic reviews and primary studies. Studies reporting diagnostic accuracy, detection rates or the association of endoscopy or endoscopist-related factors with UGI cancer or dysplasia detection were included. AMSTAR2 and JBI checklists were used to assess systematic review and primary study quality. Clinical heterogeneity precluded meta-analysis and findings are summarized narratively. Results Eight systematic reviews and nine primary studies were included. Image enhancement, especially narrow band imaging, had high diagnostic accuracy for dysplasia and early gastric cancer (pooled sensitivity 0.87 (95% CI 0.84-0.89) and specificity 0.97 (0.97-0.98)). Higher detection rates with longer endoscopy examination times were reported in three studies, but no difference was observed in one study. Endoscopist biopsy rate was associated with increased gastric cancer detection (odds ratio 2.5; 95% confidence interval [CI] 2.1-2.9). Early esophageal cancer (0.17% vs 0.14%, P =0.04) and gastric cancer (0.16% vs 0.12%, P =0.02) detection rates were higher with propofol sedation compared to no sedation. Endoscopies performed by trained endoscopists on dedicated Barrett's surveillance lists had higher detection rates (8% vs 3%, P <0.001). The neoplasia detection rate during diagnostic endoscopies for Barrett's esophagus was 7% (95% CI 4%-10%). Conclusions Image enhancement use, longer examination times, biopsy rate and propofol sedation are potential quality indicators for UGI endoscopy. Neoplasia detection rate and dedicated endoscopy lists are additional potential quality indicators for Barrett's esophagus.

UK ERCP sedation practices, patient comfort and endoscopist characteristics: National Endoscopy Database (NED) analysis on behalf of the JAG and BSG.

Objectives: This analysis assessed current endoscopic retrograde cholangiopancreatography (ERCP) practice within the UK, including use of sedation and patient comfort. Methods: ERCPs conducted over 1 year (1 July 2021-30 June 2022) and uploaded to the National Endoscopy Database (NED) were analysed. The endoscopist workforce was classified by gender and specialty, use of sedation was analysed. Logistic regression was used to assess associations between patient age, gender and procedure indications on moderate to severe discomfort risk. Results: 27 812 ERCPs were performed by 491 endoscopists in 175 sites and uploaded to NED, an estimated 50% of total UK activity. 13% were training procedures, 94% of the endoscopists were male, with 72% being gastroenterologists. Most ERCPs were performed under conscious sedation (89%). The discomfort rate among patients aged 60-90 undergoing ERCP under conscious sedation was 4.2% (95% CI 3.9% to 4.5%), with only 5.5% (95% CI 5.2% to 5.9%) receiving greater than 5 mg midazolam or 100 µg fentanyl.Younger patients (<30 years) had a higher discomfort risk during conscious sedation ERCPs than those aged 70-79 (OR 3.0, 95% CI 2.2 to 4.3, p<0.05), while male patients had a lower discomfort risk compared with females (OR 0.9, 95% CI 0.8 to 1.0, p=0.05).Enhanced sedation (propofol or general anaesthetic) was associated with lower frequency of discomfort (0.3%, 95% CI 0.1 to 0.6) compared with conscious sedation (5.1%, 95% CI 4.9% to 5.4%, p<0.05). Conclusions: Conscious sedation is well tolerated for most patients and prescribing practices have improved. However, triage of more patients, particularly young females, to enhanced sedation lists should be considered to reduce discomfort rates in future.

Development, validation, and results of a national endoscopy safety attitudes questionnaire (Endo-SAQ).

Background and study aims Safety attitudes are linked to patient outcomes. The Joint Advisory Group on Gastrointestinal Endoscopy (JAG) identifies the need to improve our understanding of safety culture in endoscopy. We describe the development and validation of the Endo-SAQ (endoscopy safety attitudes questionnaire) and the results of a national survey of staff attitudes. Methods Questions from the original SAQ were adapted to reflect endoscopy-specific content. This was refined by an expert group, followed by a pilot study to assess acceptability. The refined Endo-SAQ (comprising 35 questions across six domains) was disseminated to endoscopy staff across the UK and Ireland. Outcomes were domain scores and the percentage of positive responses (score ≥75/100) per domain. Descriptive and comparative analyses were performed. Binary logistic regression identified staff and service factors associated with positive scores. Validity and reliability of Endo-SAQ were assessed through psychometric analysis. Results After expert review, four questions in the preliminary Endo-SAQ were adjusted. Sixty-one participants undertook the pilot study with good acceptability. A total of 453 participants completed the refined Endo-SAQ. There were positive responses in teamwork, safety climate, job satisfaction, and working conditions domains. Endoscopists had significantly more positive responses to stress recognition and working conditions than nursing staff. JAG accreditation was associated with positive scores in safety climate and job satisfaction domains. Endo-SAQ met thresholds of construct validity and reliability. Conclusions Endoscopy staff had largely positive safety attitudes scores but there were significant differences across domains and staff. There is evidence for the validity and reliability of Endo-SAQ. Endo-SAQ could complement current measures of patient safety in endoscopy and be used in evaluation and research.

Standardizing Scoring Conventions for Crohn's Disease Endoscopy: An International RAND/UCLA Appropriateness Study.

BACKGROUND AND AIMS: Endoscopic assessment of disease activity is integral for evaluating treatment response in patients with Crohn's disease (CD). We aimed to define appropriate items for evaluating endoscopic activity and conventions for consistent endoscopic scoring rules in CD. METHODS: A 2-round modified RAND/University of California at Los Angeles Appropriateness Method study was conducted. A panel of 15 gastroenterologists used a 9-point Likert scale to rate the appropriateness of statements pertaining to the Simple Endoscopic Score for CD, Crohn's Disease Endoscopic Index of Severity, and additional items relevant to endoscopy scoring in CD. Each statement was voted as appropriate, uncertain, or inappropriate based on the median panel rating and presence of disagreement. RESULTS: Panelists voted that it is appropriate for all ulcers to contribute to endoscopic scoring in CD, including aphthous ulcers, ulcerations at a surgical anastomosis, and anal canal ulcers (scored in the rectum). Endoscopic healing should reflect an absence of ulcers. Narrowing should be defined as a clear decrease in luminal diameter; stenosis should be defined by an impassable narrowing, and if occurring at the junction of 2 segments, scored in the distal segment. Scarring and inflammatory polyps were considered inappropriate for including in the affected area score. The optimal method for defining ulcer depth remains uncertain. CONCLUSIONS: We outlined scoring conventions for the Simple Endoscopic Score for CD and Crohn's Disease Endoscopic Index of Severity, noting that both scores have limitations. Therefore, we identified priorities for future research and steps for developing and validating a more representative endoscopic index in CD.

UK endoscopy workload and workforce patterns: is there potential to increase capacity? A BSG analysis of the National Endoscopy Database.

Background: The lack of comprehensive national data on endoscopy activity and workforce hampers strategic planning. The National Endoscopy Database (NED) provides a unique opportunity to address this in the UK. We evaluated NED to inform service planning, exploring opportunities to expand capacity to meet service demands. Design: Data on all procedures between 1 March 2019 and 29 February 2020 were extracted from NED. Endoscopy activity and endoscopist workforce were analysed. Results: 1 639 640 procedures were analysed (oesophagogastroduodenoscopy (OGD) 693 663, colonoscopy 586 464, flexible sigmoidoscopy 335 439 and endoscopic retrograde cholangiopancreatography 23 074) from 407 sites by 4990 endoscopists. 89% of procedures were performed in NHS sites. 17% took place each weekday, 10% on Saturdays and 6% on Sundays. Training procedures accounted for 6% of total activity, over 99% of which took place in NHS sites. Median patient age was younger in the independent sector (IS) (51 vs 60 years, p<0.001). 74% of endoscopists were male. Gastroenterologists and surgeons each comprised one-third of the endoscopist workforce; non-medical endoscopists (NMEs) comprised 12% yet undertook 23% of procedures. Approximately half of endoscopists performing OGD (52%) or colonoscopies (48%) did not meet minimum annual procedure numbers. Conclusion: This comprehensive analysis reveals endoscopy workload and workforce patterns for the first time across both the NHS and the IS in all four UK nations. Half of all endoscopists perform fewer than the recommended minimum annual procedure numbers: a national strategy to address this, along with expansion of the NME workforce, would increase endoscopy capacity, which could be used to exploit latent weekend capacity.

Power of big data to improve patient care in gastroenterology.

Big data is defined as being large, varied or frequently updated, and usually generated from real-world interaction. With the unprecedented availability of big data, comes an obligation to maximise its potential for healthcare improvements in treatment effectiveness, disease prevention and healthcare delivery. We review the opportunities and challenges that big data brings to gastroenterology. We review its sources for healthcare improvement in gastroenterology, including electronic medical records, patient registries and patient-generated data. Big data can complement traditional research methods in hypothesis generation, supporting studies and disseminating findings; and in some cases holds distinct advantages where traditional trials are unfeasible. There is great potential power in patient-level linkage of datasets to help quantify inequalities, identify best practice and improve patient outcomes. We exemplify this with the UK colorectal cancer repository and the potential of linkage using the National Endoscopy Database, the inflammatory bowel disease registry and the National Health Service bowel cancer screening programme. Artificial intelligence and machine learning are increasingly being used to improve diagnostics in gastroenterology, with image analysis entering clinical practice, and the potential of machine learning to improve outcome prediction and diagnostics in other clinical areas. Big data brings issues with large sample sizes, real-world biases, data curation, keeping clinical context at analysis and General Data Protection Regulation compliance. There is a tension between our obligation to use data for the common good and protecting individual patient's data. We emphasise the importance of engaging with our patients to enable them to understand their data usage as fully as they wish.

JAG/BSG national survey of UK endoscopy services: impact of the COVID-19 pandemic and early restoration of endoscopy services.

INTRODUCTION: The COVID-19 pandemic has profoundly affected UK endoscopy workload. The Joint Advisory Group on GI endoscopy and British Society of Gastroenterology issued guidelines on endoscopy service delivery changes and restoration. We surveyed UK endoscopy clinical leads to gain insights into service restoration. METHODS: A Google Forms-designed survey, assessing endoscopy provision, Covid minimisation and referral pathways was circulated to all UK endoscopy leads. The survey was open between 19 and 24 May 2020. RESULTS: 97 endoscopy leads completed the survey, with all UK nations and regions represented. Analysis showed 20% of endoscopy services were not providing endoscopy. Workload limitations were due to enforced interprocedural downtime (92%; with some services enforcing >1-hour downtime between procedures), social distancing (88%) and working in personal protective equipment (PPE) (87%). 91% of services reported a referral backlog (urgent median 2 months, routine median 6 months). 96% of services reported no current problems accessing PPE. Level 1/2 PPE use in colonoscopy was not uniform. 63% of services routinely swab patients for COVID-19 before endoscopy, 88% of services do not routinely swab asymptomatic staff. Comments addressed reducing endoscopy demand through vetting and changing referral criteria, the mostly commonly cited strategy being increased faecal immunochemical testing in symptomatic patients (70% of services). CONCLUSION: This survey demonstrates the pandemic's profound impact on UK endoscopy. Challenges include standardising Covid-minimisation strategies and recovering staffing levels. To improve endoscopy services, there is a need to refine referral pathways, improve vetting and clarify guidance on downtime and PPE within endoscopy.

Engaging Undergraduates in Research Experiences at a Distance: Insights and Recommendations for Remote URE.

Undergraduates phenotyping Arabidopsis knockouts (unPAK) is a biology research network that has provided undergraduate research experiences (URE) since 2010. In 2019, unPAK expanded to include a summer URE that engaged undergraduate researchers from across the network in an intensive collaborative program. In response to the COVID-19 pandemic in 2020, unPAK rapidly shifted to provide the summer URE program remotely. This article describes (i) the instructional and communication processes of unPAK in the remote URE; and (ii) a summative assessment of the outcomes associated with the remote summer program as compared with the 2019 in-person program. We conclude by offering timely recommendations for educators in biology that emerged from the 2020 remote summer research experience, which may be applicable to other remote UREs and course-based research experiences (CUREs).

Water-assisted colonoscopy: an international modified Delphi review on definitions and practice recommendations.

BACKGROUND AND AIMS: Since 2008, a plethora of research studies has compared the efficacy of water-assisted (aided) colonoscopy (WAC) and underwater resection (UWR) of colorectal lesions with standard colonoscopy. We reviewed and graded the research evidence with potential clinical application. We conducted a modified Delphi consensus among experienced colonoscopists on definitions and practice of water immersion (WI), water exchange (WE), and UWR. METHODS: Major databases were searched to obtain research reports that could potentially shape clinical practice related to WAC and UWR. Pertinent references were graded (Grading of Recommendations, Assessment, Development and Evaluation). Extracted data supporting evidence-based statements were tabulated and provided to respondents. We received responses from 55 (85% surveyed) experienced colonoscopists (37 experts and 18 nonexperts in WAC) from 16 countries in 3 rounds. Voting was conducted anonymously in the second and third round, with ≥80% agreement defined as consensus. We aimed to obtain consensus in all statements. RESULTS: In the first and the second modified Delphi rounds, 20 proposed statements were decreased to 14 and then 11 statements. After the third round, the combined responses from all respondents depicted the consensus in 11 statements (S): definitions of WI (S1) and WE (S2), procedural features (S3-S5), impact on bowel cleanliness (S6), adenoma detection (S7), pain score (S8), and UWR (S9-S11). CONCLUSIONS: The most important consensus statements are that WI and WE are not the same in implementation and outcomes. Because studies that could potentially shape clinical practice of WAC and UWR were chosen for review, this modified Delphi consensus supports recommendations for the use of WAC in clinical practice.

The National Endoscopy Database (NED) Automated Performance Reports to Improve Quality Outcomes Trial (APRIQOT) randomized controlled trial design.

Background and study aims Colonoscopists with low polyp detection have higher post colonoscopy colorectal cancer incidence and mortality rates. The United Kingdom's National Endoscopy Database (NED) automatically captures patient level data in real time and provides endoscopy key performance indicators (KPI) at a national, endoscopy center, and individual level. Using an electronic behavior change intervention, the primary objective of this study is to assess if automated feedback of endoscopist and endoscopy center-level optimal procedure-adjusted detection KPI (opadKPI) improves polyp detection performance. Methods This multicenter, prospective, cluster-randomized controlled trial is randomizing NHS endoscopy centres to either intervention or control. The intervention is targeted at independent colonoscopists and each center's endoscopy lead. The intervention reports are evidence-based from endoscopist qualitative interviews and informed by psychological theories of behavior. NED automatically creates monthly reports providing an opadKPI, using mean number of polyps, and an action plan. The primary outcome is opadKPI comparing endoscopists in intervention and control centers at 9 months. Secondary outcomes include other KPI and proximal detection measures at 9 and 12 months. A nested histological validation study will correlate opadKPI to adenoma detection rate at the center level. A cost-effectiveness and budget impact analysis will be undertaken. Conclusion If the intervention is efficacious and cost-effective, we will showcase the potential of this learning health system, which can be implemented at local and national levels to improve colonoscopy quality, and demonstrate that an automated system that collects, analyses, and disseminates real-time clinical data can deliver evidence- and theory-informed feedback.

Efficacy of Per-oral Methylene Blue Formulation for Screening Colonoscopy.

BACKGROUND & AIMS: Topically applied methylene blue dye chromoendoscopy is effective in improving detection of colorectal neoplasia. When combined with a pH- and time-dependent multimatrix structure, a per-oral methylene blue formulation (MB-MMX) can be delivered directly to the colorectal mucosa. METHODS: We performed a phase 3 study of 1205 patients scheduled for colorectal cancer screening or surveillance colonoscopies (50-75 years old) at 20 sites in Europe and the United States, from December 2013 through October 2016. Patients were randomly assigned to groups given 200 mg MB-MMX, placebo, or 100 mg MB-MMX (ratio of 2:2:1). The 100-mg MB-MMX group was included for masking purposes. MB-MMX and placebo tablets were administered with a 4-L polyethylene glycol-based bowel preparation. The patients then underwent colonoscopy by an experienced endoscopist with centralized double-reading. The primary endpoint was the proportion of patients with 1 adenoma or carcinoma (adenoma detection rate [ADR]). We calculated odds ratios (ORs) and 95% confidence intervals (CIs) for differences in detection between the 200-mg MB-MMX and placebo groups. False-positive (resection rate for non-neoplastic polyps) and adverse events were assessed as secondary endpoints. RESULTS: The ADR was higher for the MB-MMX group (273 of 485 patients, 56.29%) than the placebo group (229 of 479 patients, 47.81%) (OR 1.46; 95% CI 1.09-1.96). The proportion of patients with nonpolypoid lesions was higher in the MB-MMX group (213 of 485 patients, 43.92%) than the placebo group (168 of 479 patients, 35.07%) (OR 1.66; 95% CI 1.21-2.26). The proportion of patients with adenomas ≤5 mm was higher in the MB-MMX group (180 of 485 patients, 37.11%) than the placebo group (148 of 479 patients, 30.90%) (OR 1.36; 95% CI 1.01-1.83), but there was no difference between groups in detection of polypoid or larger lesions. The false-positive rate did not differ significantly between groups (83 [23.31%] of 356 patients with non-neoplastic lesions in the MB-MMX vs 97 [29.75%] of 326 patients with non-neoplastic lesions in the placebo group). Overall, 0.7% of patients had severe adverse events but there was no significant difference between groups. CONCLUSIONS: In a phase 3 trial of patients undergoing screening or surveillance colonoscopies, we found MB-MMX led to an absolute 8.5% increase in ADR, compared with placebo, without increasing the removal of non-neoplastic lesions. Clinicaltrials.gov no: NCT01694966.

Chromoendoscopy versus autofluorescence imaging for neoplasia detection in patients with longstanding ulcerative colitis (FIND-UC): an international, multicentre, randomised controlled trial.

BACKGROUND: Patients with longstanding ulcerative colitis undergo regular dysplasia surveillance because they have an increased colorectal cancer risk. Autofluorescence imaging and chromoendoscopy improve dysplasia detection. The aim of this study was to determine whether autofluorescence imaging should be further studied as an alternative method for dysplasia surveillance in patients with longstanding ulcerative colitis. METHODS: This prospective, international, randomised controlled trial included patients from an ulcerative colitis-dysplasia surveillance cohort from five centres in the Netherlands and the UK. Eligible patients were aged 18 years or older who were undergoing dysplasia surveillance after being diagnosed with extensive colitis (Montreal E3) at least 8 years before study start or with left-sided colitis (Montreal E2) at least 15 years before study start. Randomisation (1:1) was minimised for a previous personal history of histologically proven dysplasia and concomitant primary sclerosing cholangitis. The coprimary outcomes were the proportion of patients in whom at least one dysplastic lesion was detected and the mean number of dysplastic lesions per patient. The relative dysplasia detection rate, calculated as the ratio of the detection rates by autofluorescence imaging and chromoendoscopy, needed to be more than 0·67 (using an 80% CI) for both primary outcomes to support a subsequent large non-inferiority trial. Outcomes were analysed on a per-protocol basis. The trial is registered at the Netherlands Trial Register, number NTR4062. FINDINGS: Between Aug 1, 2013, and March 10, 2017, 210 patients undergoing colonoscopy surveillance for longstanding ulcerative colitis were randomised for inspection with either autofluorescence imaging (n=105) or chromoendoscopy (n=105). Dysplasia was detected in 13 (12%) patients by autofluorescence imaging and in 20 patients (19%) by chromoendoscopy. The relative dysplasia detection rate of autofluorescence imaging versus chromoendoscopy for the proportion of patients with ulcerative colitis with at least one dysplastic lesion was 0·65 (80% CI 0·43-0·99). The mean number of detected dysplastic lesions per patient was 0·13 (SD 0·37) for autofluorescence imaging and 0·37 (1·02) for chromoendoscopy (relative dysplasia detection rate 0·36, 80% CI 0·21-0·61). Adverse events were reported for two patients in the autofluorescence imaging group (one patient had intraprocedural mild bleeding, and one patient had abdominal pain) and for three patients in the chromoendoscopy group (two patients had intraprocedural mild bleeding, and one patient had perforation). INTERPRETATION: Autofluorescence imaging did not meet criteria for proceeding to a large non-inferiority trial. Therefore, existing autofluorescence imaging technology should not be further investigated as an alternative dysplasia surveillance method. FUNDING: Olympus Europe and Olympus Keymed.

Pit pattern analysis with high-definition chromoendoscopy and narrow-band imaging for optical diagnosis of dysplasia in patients with ulcerative colitis.

BACKGROUND AND AIMS: Patients with longstanding ulcerative colitis (UC) are at increased risk of developing colorectal neoplasia. Chromoendoscopy (CE) increases detection of lesions, and Kudo pit pattern classification I and II have been suggested to be predictive of benign polyps in UC. Little is known on the use of this classification in nonmagnified high-definition (HD) (virtual) CE and narrow-band Imaging (NBI) or on the interobserver agreement. The aim of this pilot study was to assess the diagnostic accuracy and the interobserver agreement of the Kudo pit pattern classification in UC patients undergoing surveillance with methylene blue CE or NBI in a multicenter study. METHODS: Fifty images of lesions identified in 27 UC patients (13 neoplastic) either with classical CE (methylene blue .1%; n = 24) or NBI (n = 26) were selected by an independent investigator. Images were selected from a randomized controlled trial to compare CE and NBI. All nonmagnified images were obtained with a processor and mounted in a PowerPoint file in a standardized way (same size; black background). Ten endoscopists with extensive experience in NBI/CE were asked to assess the lesions for the predominant Kudo pit pattern (I, II, IIIL, IIIS, IV, and V) to indicate if they believed the lesion was neoplastic and how confident they were about the diagnosis. Histology was used as the criterion standard. RESULTS: Median sensitivity, specificity, negative predictive value, and positive predictive value for diagnosing neoplasia based on the presence of pit pattern other than I or II was 77%, 68%, 88%, and 46%, respectively. Diagnostic accuracy was significantly higher when a diagnosis was made with a high level of confidence (77% vs 21%, P < .001). The overall interobserver agreement for any pit pattern was only fair (κ = .282), with CE being significantly better than NBI (.322 vs .224, P < .001). From a clinical viewpoint the difference between neoplastic and non-neoplastic lesions is important. The agreement for differentiation between non-neoplastic patterns (I, II) and neoplastic patterns (IIIL, IIIS, IV, or V) was moderate (κ = .587) and even significantly better for NBI in comparison with CE (κ = .653 vs .495, P < .001). CONCLUSIONS: Differentiation between non-neoplastic and neoplastic pit patterns in UC lesions shows a moderate to substantial agreement among expert endoscopists. The agreement for differentiating neoplastic from non-neoplastic lesions is significantly better for NBI in comparison with HD CE. The assessment of pit pattern I or II with nonmagnified HD CE or NBI has a high negative predictive value to rule out neoplasia. (Clinical trial registration number: NCT01882205.).

Factors defining expertise in screening colonoscopy.

BACKGROUND AND STUDY AIMS: There is very little literature defining characteristics of expert endoscopists. It is hypothesised that previously undetermined human factors may correlate with high performance in screening colonoscopists. The aim of this study was to determine factors contributing towards expertise in screening colonoscopy. MATERIALS AND METHODS: A focus group was used to hypothesise skills considered to be relevant to high performance in colonoscopy. The skills were then ranked in order of importance by an independent group of screening colonoscopists for both diagnostic and therapeutic colonoscopy. Twenty screening colonoscopists subsequently participated in individual semi-structured interviews to explore participants' views of expertise and the factors contributing to it. Data extracted from the interview transcripts were used to identify the thematic framework associated with expertise. RESULTS: The 5 initial highest-ranked themes were low complication rates, high adenoma detection rates, interpersonal skills with staff, communication skills, and manner with patients. Interviewees considered technical skills (20/20), previous experience of colonoscopy (19/20), judgment/decision-making (18/20), communication (18/20), teamwork (15/20), resources (11/20) and leadership (8/20) to be the most important themes related to expertise. CONCLUSIONS: Both technical and non-technical abilities are considered essential components of expertise by experienced colonoscopists. Further research into targeted interventions to improve the rate of acquisition of these skills in training endoscopists may be useful in improving performance.

Risk stratification of Barrett's oesophagus using a non-endoscopic sampling method coupled with a biomarker panel: a cohort study.

BACKGROUND: Barrett's oesophagus predisposes to adenocarcinoma. However, most patients with Barrett's oesophagus will not progress and endoscopic surveillance is invasive, expensive, and fraught by issues of sampling bias and the subjective assessment of dysplasia. We investigated whether a non-endoscopic device, the Cytosponge, could be coupled with clinical and molecular biomarkers to identify a group of patients with low risk of progression suitable for non-endoscopic follow-up. METHODS: In this multicentre cohort study (BEST2), patients with Barrett's oesophagus underwent the Cytosponge test before their surveillance endoscopy. We collected clinical and demographic data and tested Cytosponge samples for a molecular biomarker panel including three protein biomarkers (P53, c-Myc, and Aurora kinase A), two methylation markers (MYOD1 and RUNX3), glandular atypia, and TP53 mutation status. We used a multivariable logistic regression model to compute the conditional probability of dysplasia status. We selected a simple model with high classification accuracy and applied it to an independent validation cohort. The BEST2 study is registered with ISRCTN, number 12730505. FINDINGS: The discovery cohort consisted of 468 patients with Barrett's oesophagus and intestinal metaplasia. Of these, 376 had no dysplasia and 22 had high-grade dysplasia or intramucosal adenocarcinoma. In the discovery cohort, a model with high classification accuracy consisted of glandular atypia, P53 abnormality, and Aurora kinase A positivity, and the interaction of age, waist-to-hip ratio, and length of the Barrett's oesophagus segment. 162 (35%) of 468 of patients fell into the low-risk category and the probability of being a true non-dysplastic patient was 100% (99% CI 96-100) and the probability of having high-grade dysplasia or intramucosal adenocarcinoma was 0% (0-4). 238 (51%) of participants were classified as of moderate risk; the probability of having high-grade dysplasia was 14% (9-21). 58 (12%) of participants were classified as high-risk; the probability of having non-dysplastic endoscopic biopsies was 13% (5-27), whereas the probability of having high-grade dysplasia or intramucosal adenocarcinoma was 87% (73-95). In the validation cohort (65 patients), 51 were non-dysplastic and 14 had high-grade dysplasia. In this cohort, 25 (38%) of 65 patients were classified as being low-risk, and the probability of being non-dysplastic was 96·0% (99% CI 73·80-99·99). The moderate-risk group comprised 27 non-dysplastic and eight high-grade dysplasia cases, whereas the high-risk group (8% of the cohort) had no non-dysplastic cases and five patients with high-grade dysplasia. INTERPRETATION: A combination of biomarker assays from a single Cytosponge sample can be used to determine a group of patients at low risk of progression, for whom endoscopy could be avoided. This strategy could help to avoid overdiagnosis and overtreatment in patients with Barrett's oesophagus. FUNDING: Cancer Research UK.