Pediatric Rome IV diagnosis agreement is greater than agreement on diagnostic testing.

BACKGROUND: Pediatric Rome IV criteria are used to diagnose childhood functional gastrointestinal disorders (FGIDs). This study of pediatric gastroenterology physicians measured their agreement in (1) Making a pediatric Rome IV FGID diagnosis; and (2) Diagnostic testing for patients with FGIDs. METHODS: Pediatric gastroenterologists and pediatric gastroenterology fellows at two medical centers completed a survey containing clinical FGID vignettes. For each vignette, raters identified the most likely Rome IV diagnosis(es) and selected which diagnostic test(s) (if any) they typically would obtain. The survey was re-administered within 3 months. Inter-rater and intra-rater weighted percent agreement was determined. Linear mixed modeling identified sources of variability in diagnostic testing. KEY RESULTS: Thirty-four raters completed the initial survey of whom thirty-one (91%) completed the repeat survey. Overall inter-rater agreement on Rome IV diagnoses was 68% for initial and repeat surveys whereas intra-rater agreement was 76%. In contrast, overall inter-rater agreement on diagnostic testing was <30% for both initial and repeat surveys and intra-rater agreement was only 57%. Between-physician differences accounted for 43% of the variability in the number of tests selected. Rater identified use of Rome criteria in clinical practice was associated with 1.1 fewer diagnostic tests on average (95% CI 0.2-2.0, p = 0.015). Higher intra-rater agreement was noted for diagnostic testing in faculty when compared to fellows (p = 0.009). CONCLUSIONS & INFERENCES: In a multicenter evaluation among pediatric gastroenterology physicians, pediatric Rome IV diagnostic agreement was higher than that reported for previous Rome versions, and higher than agreement on diagnostic testing.

New Devices for Endoscopic Treatments in Gastroenterology: A Narrative Review.

Endoscopy is in a period of continuous innovations in terms of image quality, endoscopes, post-processing software and lastly, application of Artificial Intelligence. Therapeutic boundaries have expanded, widening the grey zone between endoscopy and surgery, and increasing endoscopic approaches in clinical scenarios where, until a few years ago, surgery was the only option. New scopes and accessories have made it easier to access critical areas such as the biliary tree and the small bowel intestine. In the field of hepato-pancreato-biliary endoscopy (HPB), it is now possible to directly access the biliary ducts or cystic lesions though dedicated stents and scopes, rather than having to rely only on fluoroscopy and ultrasound, increasing the diagnostic and therapeutic options by applying a three-dimensional approach. This narrative review will give an overview of some of the most relevant emerging fields in luminal and HPB endoscopy, highlighting advantages and main limitations of the techniques, and providing considerations for future development.

Automatic task recognition in a flexible endoscopy benchtop trainer with semi-supervised learning.

PURPOSE: Inexpensive benchtop training systems offer significant advantages to meet the increasing demand of training surgeons and gastroenterologists in flexible endoscopy. Established scoring systems exist, based on task duration and mistake evaluation. However, they require trained human raters, which limits broad and low-cost adoption. There is an unmet and important need to automate rating with machine learning. METHOD: We present a general and robust approach for recognizing training tasks from endoscopic training video, which consequently automates task duration computation. Our main technical novelty is to show the performance of state-of-the-art CNN-based approaches can be improved significantly with a novel semi-supervised learning approach, using both labelled and unlabelled videos. In the latter case, we assume only the task execution order is known a priori. RESULTS: Two video datasets are presented: the first has 19 videos recorded in examination conditions, where the participants complete their tasks in predetermined order. The second has 17 h of videos recorded in self-assessment conditions, where participants complete one or more tasks in any order. For the first dataset, we obtain a mean task duration estimation error of 3.65 s, with a mean task duration of 159 s ([Formula: see text] relative error). For the second dataset, we obtain a mean task duration estimation error of 3.67 s. We reduce an average of 5.63% in error to 3.67% thanks to our semi-supervised learning approach. CONCLUSION: This work is the first significant step forward to automate rating of flexible endoscopy students using a low-cost benchtop trainer. Thanks to our semi-supervised learning approach, we can scale easily to much larger unlabelled training datasets. The approach can also be used for other phase recognition tasks.

Accuracy of medical billing data against the electronic health record in the measurement of colorectal cancer screening rates.

OBJECTIVE: Medical billing data are an attractive source of secondary analysis because of their ease of use and potential to answer population-health questions with statistical power. Although these datasets have known susceptibilities to biases, the degree to which they can distort the assessment of quality measures such as colorectal cancer screening rates are not widely appreciated, nor are their causes and possible solutions. METHODS: Using a billing code database derived from our institution's electronic health records, we estimated the colorectal cancer screening rate of average-risk patients aged 50-74 years seen in primary care or gastroenterology clinic in 2016-2017. 200 records (150 unscreened, 50 screened) were sampled to quantify the accuracy against manual review. RESULTS: Out of 4611 patients, an analysis of billing data suggested a 61% screening rate, an estimate that matches the estimate by the Centers for Disease Control. Manual review revealed a positive predictive value of 96% (86%-100%), negative predictive value of 21% (15%-29%) and a corrected screening rate of 85% (81%-90%). Most false negatives occurred due to examinations performed outside the scope of the database-both within and outside of our institution-but 21% of false negatives fell within the database's scope. False positives occurred due to incomplete examinations and inadequate bowel preparation. Reasons for screening failure include ordered but incomplete examinations (48%), lack of or incorrect documentation by primary care (29%) including incorrect screening intervals (13%) and patients declining screening (13%). CONCLUSIONS: Billing databases are prone to substantial bias that may go undetected even in the presence of confirmatory external estimates. Caution is recommended when performing population-level inference from these data. We propose several solutions to improve the use of these data for the assessment of healthcare quality.

Exhaled breath analysis in hepatology: State-of-the-art and perspectives.

Liver disease is characterized by breath exhalation of peculiar volatile organic compounds (VOCs). Thanks to the availability of sensitive technologies for breath analysis, this empiric approach has recently gained increasing attention in the context of hepatology, following the good results obtained in other fields of medicine. After the first studies that led to the identification of selected VOCs for pathophysiological purposes, subsequent research has progressively turned towards the comprehensive assessment of exhaled breath for potential clinical application. Specific VOC patterns were found to discriminate subjects with liver cirrhosis, to rate disease severity, and, eventually, to forecast adverse clinical outcomes even beyond existing scores. Preliminary results suggest that breath analysis could be useful also for detecting and staging hepatic encephalopathy and for predicting steatohepatitis in patients with nonalcoholic fatty liver disease. However, clinical translation is still hampered by a number of methodological limitations, including the lack of standardization and the consequent poor comparability between studies and the absence of external validation of obtained results. Given the low-cost and easy execution at bedside of the new technologies (e-nose), larger and well-structured studies are expected in order to provide the adequate level of evidence to support VOC analysis in clinical practice.

More movement with evaluating colonic transit in humans.

BACKGROUND: Colonic functions (ie, absorption of fluids and electrolytes, digestion of selected nutrients, harbor for microbes, and elimination of excreta) necessitate complex patterns of storage and transit. Indeed, colonic transit accounts for a major part of the mouth-to-anus transit time. Colonic transit assessments are useful for understanding the pathophysiology of disease, the pharmacodynamic effects of new medications and to diagnose slow transit constipation. Currently, radiopaque markers, scintigraphy, and a colonic pH-pressure capsule are used to measure overall colonic transit. Radioopaque markers, scintigraphy, and the electromagnetic capsule, which is a newer technique, also evaluate regional colonic transit. The pH-pressure capsule also measures colonic pressures. Magnetic resonance imaging and a radio-frequency identification-based device are evolving methods for assessing colonic transit. PURPOSE: This mini-review, which accompanies a study evaluating the assessment of colon transit with the electromagnetic capsule, evaluates and compares existing and evolving methods for evaluating colonic transit in humans (Neurogastroenterol Motil. 2018; in press). In addition to overall and regional colonic transit, the electromagnetic capsule evaluates colonic motor patterns without radiation exposure. These patterns are summarized by analyzing the characteristics (ie, distance and velocity) of discrete antegrade and retrograde capsule movements as they travel in the colon. However, the electromagnetic capsule does not measure pressure or colonic wall movement (ie, contractions). The motor patterns identified by this capsule should be compared with motor patterns identified with manometry. The next challenge is to harness different techniques to evaluate the relationships between colonic pressures and transit or, even better, the trifecta of colonic contractions, pressure events, and transit.

Motion control skill assessment based on kinematic analysis of robotic end-effector movements.

BACKGROUND: The performance of robotic end-effector movements can reflect the user's operation skill difference in robot-assisted minimally invasive surgery. This study quantified the trade-off of speed-accuracy-stability by kinematic analysis of robotic end-effector movements to assess the motion control skill of users with different levels of experience. METHODS: Using 'MicroHand S' system, 10 experts, 10 residents and 10 novices performed single-hand test and bimanual coordination test. Eight metrics based on the movements of robotic end-effectors were applied to evaluate the users' performance. RESULTS: In the single-hand test, experts outperformed other groups except for movement speed; in the bimanual coordination test, experts also performed better except for movement time and movement speed. No statistically significant difference in performance was found between residents and novices. CONCLUSIONS: The kinematic differences obtained from the movements of robotic end-effectors can be applied to assess the motion control skill of users with different skill levels.

Optical coherence tomography in gastroenterology: a review and future outlook.

Optical coherence tomography (OCT) is an imaging technique optically analogous to ultrasound that can generate depth-resolved images with micrometer-scale resolution. Advances in fiber optics and miniaturized actuation technologies allow OCT imaging of the human body and further expand OCT utilization in applications including but not limited to cardiology and gastroenterology. This review article provides an overview of current OCT development and its clinical utility in the gastrointestinal tract, including disease detection/differentiation and endoscopic therapy guidance, as well as a discussion of its future applications.

Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss. Final order.

The Food and Drug Administration (FDA or Agency) is classifying the oral removable palatal space occupying device for weight management and/or weight loss into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the oral removable palatal space occupying device for weight management and/or weight loss classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories. Final rule; technical amendment.

The Food and Drug Administration (FDA) is amending the identification of manual gastroenterology-urology surgical instruments and accessories to reflect that the device does not include specialized surgical instrumentation for use with urogyencologic surgical mesh specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures ("specialized surgical instrumentation for use with urogynecologic surgical mesh"). These amendments are being made to reflect changes made in the recently issued final reclassification order for specialized surgical instrumentation for use with urogynecologic surgical mesh.

Retrospective study of Candida sp. contaminations of endoscopes at the University Hospital of Tlemcen (Algeria).

BACKGROUND: Improper cleaning and disinfection of endoscopes has been responsible for multiple nosocomial outbreaks and sometimes serious life-threatening infections. OBJECTIVE: The aim of our study is, at first, to identify Candida species responsible for the contamination of endoscopes, and to determine the minimal inhibitory concentrations of planktonic (MIC) and sessile cells (SMIC) of amphotericin B (AmB) against our isolated strains. MATERIALS AND METHODS: The present study was performed on four endoscopes in the department of gastroenterology at the University Hospital of Tlemcen (Algeria). A total of 300 samples from endoscopes were examined over a period of 3years. RESULTS: Thirty-four strains of Candida sp. were isolated, representing 11.33% of the considered samples. The number of isolated strains dropped significantly in the second and the third year compared to the first year of our study. After testing the antifungal property of amphotericin B, we showed clearly that the sessile cells of Candida sp. were much more resistant than their planktonic counterparts (suspended cells). CONCLUSION: The methods of sterilization of the endoscopes are very important; drying by compressed air is a critical step that reduces significantly the number of yeasts contamination.

The Efficacy of a Newly Designed, Easy-to-Manufacture Training Simulator for Endoscopic Biopsy of the Stomach.

BACKGROUND/AIMS: We developed a new endoscopic biopsy training simulator and determined its efficacy for improving the endoscopic biopsy skills of beginners. METHODS: This biopsy simulator, which presents seven biopsy sites, was constructed using readily available materials. We enrolled 40 participants: 14 residents, 11 first-year clinical fellows, 10 second-year clinical fellows, and five staff members. We recorded the simulation completion time for all participants, and then simulator performance was assessed via a questionnaire using the 7-point Likert scale. RESULTS: The mean times for completing the five trials were 417.7±138.8, 145.2±31.5, 112.7±21.9, and 90.5±20.0 seconds for the residents, first-year clinical fellows, second-year clinical fellows, and staff members, respectively. Endoscopists with less experience reported that they found this simulator more useful for improving their biopsy technique (6.8±0.4 in the resident group and 5.7±1.0 in the first-year clinical fellow group). The realism score of the simulator for endoscopic handling was 6.4±0.5 in the staff group. CONCLUSIONS: This new, easy-to-manufacture endoscopic biopsy simulator is useful for biopsy training for beginner endoscopists and shows good efficacy and realism.

Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures. Final order.

The Food and Drug Administration (FDA) is classifying the metallic biliary stent system for benign strictures into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the metallic biliary stent system for benign strictures' classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Developing the Pediatric Gastrointestinal Endoscopy Unit: A Clinical Report by the Endoscopy and Procedures Committee.

There is significant variability in the design and management of pediatric endoscopy units. Although there is information on adult endoscopy units, little guidance is available to the pediatric endoscopy practitioner. The purpose of this clinical report, prepared by the NASPGHAN Endoscopy and Procedures Committee, is to review the important considerations for setting up an endoscopy unit for children. A systematic review of the literature was undertaken in the preparation of this report regarding the design, management, needed equipment, motility setup, billing and coding, and pediatric specific topics.

Regional gastrointestinal transit times in severe ulcerative colitis.

BACKGROUND: Gastrointestinal (GI) dysmotility may present secondary to inflammatory bowel disease. The main aim of this study was to investigate GI motility in ulcerative colitis (UC) patients during severe disease activity. METHODS: Twenty patients with severe UC were studied with a novel telemetric capsule system (3D-Transit) designed for minimally invasive, ambulatory assessment of total and regional GI transit times. Ten patients were available for follow-up during remission. Data were compared to those of 20 healthy subjects (HS). KEY RESULTS: Total GI transit time was significantly longer in patients with severe UC (median 44.5 h [range 9.9-102.7 h]) than in HS (median 27.6 h [range 9.6-56.4 h]) (p = 0.032). Additionally, during severe UC, transit time was prolonged through the proximal colon (p = 0.003) and there were strong trends toward longer than normal small intestinal transit time (HS: median 4.9 h [range 3.4-8.3 h] vs severe UC patients: median 5.9 h [range 3.9-11.9 h]; p = 0.053) and colorectal transit times (HS: median 18.2 h [range 1.5-43.7] vs severe UC patients: median 34.9 h [range 0.4-90.9 h]; p = 0.056). Our data further indicate that total GI and colorectal transit times may be prolonged in UC during early remission. CONCLUSIONS & INFERENCES: Total GI transit times are significantly prolonged during severe UC.