Adam Haycock

Development and validation of a training module on the use of narrow-band imaging in differentiation of small adenomas from hyperplastic colorectal polyps.

BACKGROUND Experts are accurate in differentiating small adenomas from hyperplastic polyps at colonoscopy by using narrow-band imaging (NBI). OBJECTIVE To prospectively evaluate the effectiveness of an NBI training module on individuals with varying colonoscopy experience. DESIGN Prospective educational evaluation study. SETTING Academic endoscopy unit. PARTICIPANTS Twenty-one participants of varying colonoscopy experience (novices, trainees, and experienced gastroenterologists) and 5 experts in NBI. INTERVENTION Participants completed a computer-based test module consisting of 30 NBI polyp images. No feedback was given. They then completed a computer-based training module on the use of NBI in the differentiation of adenomas and hyperplastic polyps. The test module was then completed a second time. MAIN OUTCOME MEASUREMENTS Construct validity (the difference in baseline accuracy on the test module between different groups of participants) and content validity (difference in accuracy achieved on the test module before and after training) of the training module. RESULTS There was a significant difference in the baseline accuracy (P < .001) between experts (0.95; 95% confidence interval [CI], 0.92-0.97), experienced colonoscopists (0.68; 95% CI, 0.68-0.74), trainees (0.75; 95% CI, 0.67-0.82), and novices (0.62; 95% CI, 0.46-0.77). Accuracy increased significantly (P < .001) for all 3 groups after training (novices 0.84; 95% CI, 0.78-0.88, trainees 0.90; 95% CI, 0.84-0.93, and experienced colonoscopists 0.84; 95% CI, 0.76-0.89). After training, the agreement was moderate at least (κ = 0.56 for novices, κ = 0.70 for trainees, and κ = 0.54 for experienced colonoscopists). LIMITATIONS This study did not assess the accuracy of optical diagnosis in routine clinical practice. CONCLUSION A short, computer-based training module can improve the diagnostic accuracy and interobserver agreement for the use of NBI to differentiate adenomas from hyperplastic polyps and could be used for the initial training in optical diagnosis.

Training and transfer of colonoscopy skills: a multinational, randomized, blinded, controlled trial of simulator versus bedside training

BACKGROUND The Olympus colonoscopy simulator provides a high-fidelity training platform designed to develop knowledge and skills in colonoscopy. It has the potential to shorten the learning process to competency. OBJECTIVE To investigate the efficacy of the simulator in training novices in colonoscopy by comparing training outcomes from simulator training with those of standard patient-based training. DESIGN Multinational, multicenter, single-blind, randomized, controlled trial. SETTING Four academic endoscopy centers in the United Kingdom, Italy, and The Netherlands. PARTICIPANTS AND INTERVENTION This study included 36 novice colonoscopists who were randomized to 16 hours of simulator training (subjects) or patient-based training (controls). Participants completed 3 simulator cases before and after training. Three live cases were assessed after training by blinded experts. MAIN OUTCOME MEASUREMENTS Automatically recorded performance metrics for the simulator cases and blinded expert assessment of live cases using Direct Observation of Procedural Skills and Global Score sheets. RESULTS Simulator training significantly improved performance on simulated cases compared with patient-based training. Subjects had higher completion rates (P=.001) and shorter completion times (P < .001) and demonstrated superior technical skill (reduced simulated pain scores, correct use of abdominal pressure, and loop management). On live colonoscopy, there were no significant differences between the 2 groups. LIMITATIONS Assessment tools for live colonoscopies may lack sensitivity to discriminate between the skills of relative novices. CONCLUSION Performance of novices trained on the colonoscopy simulator matched the performance of those with standard patient-based colonoscopy training, and novices in the simulator group demonstrated superior technical skills on simulated cases. The simulator should be considered as a tool for developing knowledge and skills prior to clinical practice.

Evaluation of a Minimally Invasive Cell Sampling Device Coupled with Assessment of Trefoil Factor 3 Expression for Diagnosing Barrett's Esophagus: A Multi-Center Case-Control Study

Background Barretts esophagus (BE) is a commonly undiagnosed condition that predisposes to esophageal adenocarcinoma. Routine endoscopic screening for BE is not recommended because of the burden this would impose on the health care system. The objective of this study was to determine whether a novel approach using a minimally invasive cell sampling device, the Cytosponge, coupled with immunohistochemical staining for the biomarker Trefoil Factor 3 (TFF3), could be used to identify patients who warrant endoscopy to diagnose BE. Methods and Findings A case–control study was performed across 11 UK hospitals between July 2011 and December 2013. In total, 1,110 individuals comprising 463 controls with dyspepsia and reflux symptoms and 647 BE cases swallowed a Cytosponge prior to endoscopy. The primary outcome measures were to evaluate the safety, acceptability, and accuracy of the Cytosponge-TFF3 test compared with endoscopy and biopsy. In all, 1,042 (93.9%) patients successfully swallowed the Cytosponge, and no serious adverse events were attributed to the device. The Cytosponge was rated favorably, using a visual analogue scale, compared with endoscopy (p < 0.001), and patients who were not sedated for endoscopy were more likely to rate the Cytosponge higher than endoscopy (Mann-Whitney test, p < 0.001). The overall sensitivity of the test was 79.9% (95% CI 76.4%–83.0%), increasing to 87.2% (95% CI 83.0%–90.6%) for patients with ≥3 cm of circumferential BE, known to confer a higher cancer risk. The sensitivity increased to 89.7% (95% CI 82.3%–94.8%) in 107 patients who swallowed the device twice during the study course. There was no loss of sensitivity in patients with dysplasia. The specificity for diagnosing BE was 92.4% (95% CI 89.5%–94.7%). The case–control design of the study means that the results are not generalizable to a primary care population. Another limitation is that the acceptability data were limited to a single measure. Conclusions The Cytosponge-TFF3 test is safe and acceptable, and has accuracy comparable to other screening tests. This test may be a simple and inexpensive approach to identify patients with reflux symptoms who warrant endoscopy to diagnose BE.

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

BACKGROUND Barretts oesophagus predisposes to adenocarcinoma. However, most patients with Barretts 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 Barretts 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 Barretts 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 Barretts 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 Barretts oesophagus. FUNDING Cancer Research UK.

The development of a virtual reality training curriculum for colonoscopy.

Objectives: The development of a structured virtual reality (VR) training curriculum for colonoscopy using high-fidelity simulation. Background: Colonoscopy requires detailed knowledge and technical skill. Changes to working practices in recent times have reduced the availability of traditional training opportunities. Much might, therefore, be achieved by applying novel technologies such as VR simulation to colonoscopy. Scientifically developed device-specific curricula aim to maximize the yield of laboratory-based training by focusing on validated modules and linking progression to the attainment of benchmarked proficiency criteria. Methods: Fifty participants comprised of 30 novices (<10 colonoscopies), 10 intermediates (100 to 500 colonoscopies), and 10 experienced (>500 colonoscopies) colonoscopists were recruited to participate. Surrogates of proficiency, such as number of procedures undertaken, determined prospective allocation to 1 of 3 groups (novice, intermediate, and experienced). Construct validity and learning value (comparison between groups and within groups respectively) for each task and metric on the chosen simulator model determined suitability for inclusion in the curriculum. Results: Eight tasks in possession of construct validity and significant learning curves were included in the curriculum: 3 abstract tasks, 4 part-procedural tasks, and 1 procedural task. The whole-procedure task was valid for 11 metrics including the following: “time taken to complete the task” (1238, 343, and 293 s; P < 0.001) and “insertion length with embedded tip” (23.8, 3.6, and 4.9 cm; P = 0.005). Learning curves consistently plateaued at or beyond the ninth attempt. Valid metrics were used to define benchmarks, derived from the performance of the experienced cohort, for each included task. Conclusions: A comprehensive, stratified, benchmarked, whole-procedure curriculum has been developed for a modern high-fidelity VR colonoscopy simulator.

Implementation of an endoscopy safety checklist

Patient safety and quality improvement are increasingly prioritised across all areas of healthcare. Errors in endoscopy are common but often inconsequential and therefore go uncorrected. A series of minor errors, however, may culminate in a significant adverse event. This is unsurprising given the rising volume and complexity of cases coupled with shift working patterns. There is a growing body of evidence to suggest that surgical safety checklists can prevent errors and thus positively impact on patient morbidity and mortality. Consequently, surgical checklists are mandatory for all procedures. Many UK hospitals are mandating the use of similar checklists for endoscopy. There is no guidance on how best to implement endoscopy checklists nor any measure of their usefulness in endoscopy. This article outlines lessons learnt from innovating service delivery in our unit.

Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) on the use of endoscopy simulators for training and assessing skill

t n m t s d d t The PIVI (Preservation and Incorporation of Valuable endoscopic Innovations) initiative is an American Society for Gastrointestinal Endoscopy (ASGE) program whose objectives are to identify important clinical questions related to endoscopy and to establish a priori diagnostic and/or therapeutic thresholds for endoscopic technologies designed to resolve these clinical questions. Additionally, PIVIs may also outline the data and/or the research study design required for proving that an established threshold is met. Once endoscopic technologies meet an established PIVI threshold, those technologies are appropriate to incorporate into clinical practice, presuming the appropriate training in that endoscopic technology has been achieved. The ASGE encourages and supports the appropriate use of technologies that meet its established PIVI thresholds. The PIVI initiative was developed primarily to direct endoscopic technology development toward resolving important clinical issues in endoscopy. The PIVI initiative is also designed to minimize the possibility that potentially valuable innovations are prematurely abandoned due to lack of use and to avoid widespread use of an endoscopic technology before clinical studies documenting their effectiveness have been performed. The following document, or PIVI, is one of a series of statements defining the diagnostic or therapeutic threshold that must be met for a technique or device to become considered appropriate for incorporation into clinical practice. It is also meant to serve as a guide for researchers or those seeking to develop technologies that are designed to improve digestive health outcomes. An ad hoc committee under the auspices of the existing ASGE Technology and Standards of Practice Committees Chairs develops PIVIs. An expert in the subject area hairs the PIVI, with additional committee members hosen for their individual expertise. In preparing this ocument, evidence-based methodology was used, with MEDLINE and PubMed literature search to identify ertinent clinical studies on the topic. PIVIs are ulti-

Evaluating changes in gastrointestinal endoscopy training over 5 years: closing the audit loop.

Background An audit in 2002 showed that colonoscopy training in a large London training region was poorly structured, with the quality of supervision below recommendations and high reported complication rates. In 2004, the UK National Endoscopy Training Programme introduced centrally funded, accredited courses and new assessment tools to standardize training and raise the quality of colonoscopy by improving the skills of practicing endoscopists. Aim To evaluate the changes in the standard of colonoscopy training over the last 5 years. Methods Questionnaires used in the earlier study were updated and e-mailed to all gastroenterology trainees in the region and those who participated in the earlier study. Trainees completed and returned the forms electronically. Results Twenty-six out of 37 gastroenterology trainees responded (70.3%). Significantly more trainees said that they had been formally taught the principles of colonoscopy (91 vs. 65%; P = 0.02), polypectomy (81 vs. 52%; P = 0.02) and extubation (88 vs. 56%; P = 0.01) than in 2002, and reported that complication rates were lower. Trainers displayed more appropriate teaching strategies and course attendance had significantly increased (84 vs. 48%, P = 0.003). Eighty-seven percent of the trainees thought that their training had been adequate or better than adequate, compared with 25% in 2002. Conclusion In the 2007 survey, trainees reported a significant improvement both in colonoscopy training at base hospitals and in access to specialist courses compared with those in the 2002 survey. The centrally funded training programme has made a significantly positive impact in this large training region that is likely to be reflected elsewhere in England. The loss of such investment may have a detrimental effect on future colonoscopy training and the quality of service provision.

How we can measure quality in colonoscopy

Measuring quality is a current need of medical services either to assess their cost-effectiveness or to identify discrepancies requiring refinement. With the advent of bowel cancer screening and increasing patient awareness of bowel symptoms, there has been an unprecedented increase in demand for colonoscopy. Consequently, there is an expanding open-discussion on missed rates of cancer or precancerous polyps during diagnostic/screening colonoscopy and on the rate of adverse events related to therapeutic colonoscopy. Delivering a quality colonoscopy service is therefore a healthcare priority. Colonoscopy is a multi-step process and therefore assessment of all aspects of the procedure must be addressed. Quality in colonoscopy refers to a combination of many patient-centered technical and non-technical skills and knowledge aiming to patients safety and satisfaction through a continuous effort for improvement. The benefits of this endless process are hiding behind small details which can eventually make the difference in colonoscopy. Identifying specific quality metrics help to define and shape an optimal service and forms a secure basis of improvement. Τhis paper does not aim to give technical details on how to perform colonoscopy but to summarize what to measure and when, in accordance with the current identified quality indicators and standards for colonoscopy.

The endoscopy safety checklist: A longitudinal study of factors affecting compliance in a tertiary referral centre within the United Kingdom

Abstract Gastrointestinal endoscopy is a widely used diagnostic and therapeutic procedure both within the United Kingdom and worldwide. With an increasingly older population the potential for complications is increased. The Wolfson Unit for Endoscopy at St. Mark’s Hospital in London is a tertiary referral centre, which conducts over 14,000 endoscopic procedures annually. However, despite this high throughput, our baseline observations were that the procedure for safety checks was highly variable. Over a seven-day period we conducted a questionnaire-based survey to all staff members involved with endoscopy within our unit. We found that there was little consensus between team members, both in terms of essential safety checks and designating responsibility for the checks. A panel of experts was convened in order to devise a safety checklist and a strategy for increasing compliance with the checklist among all staff members. Using a combination of electronic and physical reminders and incentives, we found that there was a significant increase in completed checklist (53% to 66%, p = 0.021) and decrease in the number of checklists left blank post intervention (10% to 2%, p=0.03). We believe that post implementation validation of safety checklists is an important method to ensure their proper use.