Development and initial validation of a video-based peroral endoscopic myotomy assessment tool.

BACKGROUND AND AIMS: Video analysis has emerged as a potential strategy for performance assessment and improvement. We aimed to develop a video-based skill assessment tool for peroral endoscopic myotomy (POEM). METHODS: POEM was deconstructed into basic procedural components through video analysis by an expert panel. A modified Delphi approach and 2 validation exercises were conducted to refine the POEM assessment tool (POEMAT). Twelve assessors used the final POEMAT version to grade 10 videos. Fully crossed generalizability (G) studies investigated the contributions of assessors, endoscopists' performance, and technical elements to reliability. G coefficients below .5 were considered unreliable, between .5 and .7 as modestly reliable, and above .7 as indicative of satisfactory reliability. RESULTS: After task deconstruction, discussions, and the modified Delphi process, the final POEMAT comprised 9 technical elements. G analysis showed low variance for endoscopist performance (.8%-24.9%) and high interrater variability (range, 63.2%-90.1%). The G score was moderately reliable (≥.60) for "submucosal tunneling" and "myotomy" and satisfactorily reliable (≥.70) for "active hemostasis" and "mucosal closure." CONCLUSIONS: We developed and established initial content and response process validity evidence for the POEMAT. Future steps include appraisal of the tool using a wider range of POEM videos to establish and improve the discriminative validity of this tool.

Prospective evaluation of an assessment tool for technical performance of duodenoscopes.

OBJECTIVE: While single-use and detachable-tip duodenoscopes have been recently developed to overcome risks of infection transmission, there are no reliable tools to objectively assess their technical performance. We evaluated the reliability and validity of a newly developed tool to assess the technical performance of reusable duodenoscopes. METHODS: An assessment tool was developed to measure duodenoscope performance based on three distinct criteria: maneuverability, mechanical/imaging characteristics and ability to perform requisite interventions. The assessment tool was tested prospectively on duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures at nine academic medical centers over a 6-month period. The main outcome was reliability of the duodenoscope assessment tool, which was estimated using Cronbach's coefficient alpha (α). The secondary outcome was validity of the assessment tool. RESULTS: The assessment tool evaluated technical performance of reusable duodenoscopes in 1080 ERCP procedures. Indications were biliary in 92.8% and pancreatic in 7.2% procedures. The overall Cronbach's coefficient α for maneuverability was 0.81, assessment of mechanical/imaging characteristics was 0.92, and ability to perform requisite interventions was 0.87. On multiple linear regression analysis, prolonged procedure duration, older patient age and pancreatic interventions were significantly positively associated with higher (worse) scores. CONCLUSIONS: The newly developed assessment tool appears reliable and valid for evaluating the technical performance of duodenoscopes. Registration: ClinicalTrials.gov Identifier: NCT04004533.

Development and initial validation of an instrument for video-based assessment of technical skill in ERCP.

BACKGROUND AND AIMS: The accurate measurement of technical skill in ERCP is essential for endoscopic training, quality assurance, and coaching of this procedure. Hypothesizing that technical skill can be measured by analysis of ERCP videos, we aimed to develop and validate a video-based ERCP skill assessment tool. METHODS: Based on review of procedural videos, the task of ERCP was deconstructed into its basic components by an expert panel that developed an initial version of the Bethesda ERCP Skill Assessment Tool (BESAT). Subsequently, 2 modified Delphi panels and 3 validation exercises were conducted with the goal of iteratively refining the tool. Fully crossed generalizability studies investigated the contributions of assessors, ERCP performance, and technical elements to reliability. RESULTS: Twenty-nine technical elements were initially generated from task deconstruction. Ultimately, after iterative refinement, the tool comprised 6 technical elements and 11 subelements. The developmental process achieved consistent improvements in the performance characteristics of the tool with every iteration. For the most recent version of the tool, BESAT-v4, the generalizability coefficient (a reliability index) was .67. Most variance in BESAT scores (43.55%) was attributed to differences in endoscopists' skill, indicating that the tool can reliably differentiate between endoscopists based on video analysis. CONCLUSIONS: Video-based assessment of ERCP skill appears to be feasible with a novel instrument that demonstrates favorable validity evidence. Future steps include determining whether the tool can discriminate between endoscopists of varying experience levels and predict important outcomes in clinical practice.

The status of training in new technologies in advanced endoscopy: from defining competence to credentialing and privileging.

The landscape of advanced endoscopy continues to evolve as new technologies and techniques become available. Although postgraduate advanced endoscopy fellowships have traditionally centered on ERCP and diagnostic EUS, the breadth of training has increased over the years in response to the ever-growing demand for therapeutic endoscopy. The increasing diversity and complexity of emerging endoscopic techniques accompanied by the shift in focus toward competency-based medical education requires innovative changes to the curriculum that will ensure adequate training yet without compromising best patient practices. The purpose of this review is to highlight the expansive array of advanced endoscopic procedures and the challenges of both defining and measuring competence during training. All authors are interventional endoscopists at their respective institutions performing these complex procedures, as well as training fellows in these techniques. We share our perspectives based on our experience navigating through these issues at our institutions and discuss strategies to standardize training and how to potentially incorporate these measures in the process of credentialing and privileging in endoscopy.

Correction to: Pathological assessment of endoscopic resections of the gastrointestinal tract: a comprehensive clinicopathologic review.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Pathological assessment of endoscopic resections of the gastrointestinal tract: a comprehensive clinicopathologic review.

Endoscopic resection (ER) allows optimal staging with potential cure of early-stage luminal malignancies while maintaining organ preservation. ER and surgery are non-competing but complementary therapeutic options. In addition, histological examination of ER specimens can either confirm or refine the pre-procedure diagnosis. ER is used for the treatment of Barrett's related early carcinomas and dysplasias, early-esophageal squamous cell carcinomas and dysplasias, early gastric carcinomas and dysplasia, as well as low-risk submucosal invasive carcinomas (LR-SMIC) and, large laterally spreading adenomas of the colon. For invasive lesions, histological risk factors predict risk of lymph node metastasis and residual disease at the ER site. Important pathological risk factors predictive of lymph node metastasis are depth of tumor invasion, poor differentiation, and lymphovascular invasion. Complete resection with negative margins is critical to avoid local recurrences. For non-invasive lesions, complete resection is curative. Therefore, a systematic approach for handling and assessing ER specimens is recommended to evaluate all above key prognostic features appropriately. Correct handling starts with pinning the specimen before fixation, meticulous macroscopic assessment with orientation of appropriate margins, systematic sectioning, and microscopic assessment of the entire specimen. Microscopic examination should be thorough for accurate assessment of all pathological risk factors and margin assessment. Site-specific issues such as duplication of muscularis mucosa of the esophagus, challenges of assessing ampullectomy specimens and site-specific differences of staging of early carcinomas throughout the gastrointestinal tract (GI) tract should be given special consideration. Finally, a standard, comprehensive pathology report that allows optimal staging with potential cure of early-stage malignancies or better stratification and guidance for additional treatment should be provided.

Life after per-oral endoscopic myotomy: long-term outcomes of quality of life and their association with Eckardt scores.

BACKGROUND AND AIMS: The clinical efficacy of per-oral endoscopic myotomy (POEM) has been commonly established by reduction in the Eckardt score (<3) after the procedure. However, achalasia can lead to significant impairment in the patient's quality of life that may go beyond the 4 classic achalasia symptoms as measured by the Eckardt score. The aims of our study were to evaluate the effect of POEM on short-term and long-term health-related quality of life (HRQOL) and to assess the association between HRQOL and Eckardt scores. METHODS: Single-center, prospective, cohort study of consecutive POEMs during a 3-year period. Eckardt and HRQOL scores as measured by the short-form survey questionnaire (SF-36) were obtained at baseline and at various intervals after POEM. Comparison of the mean scores was described by using univariate linear regression. The association between Eckardt scores and HRQOL were calculated by using a linear, mixed-model analysis. RESULTS: POEM was performed in 143 consecutive patients (54% male; mean ± standard deviation [SD] age, 56.9 ± 17.9 years). At long-term follow-up (mean 16.4 months, range 12-40), both the HRQOL baseline mental and physical component scores improved significantly from 61.5 ± 2.2 to 71.2 ± 3.6; (P < .021) and from 55.8 ± 2.2 to 63.6 ± 3.3; (P = < .034), respectively. Mixed-model analysis showed a significant association between Eckardt and all HRQOL scores (P < .001). CONCLUSION: POEM improved all dimensions of HRQOL as measured by the SF-36 survey at both short-term and long-term follow-up. A strong association was seen between Eckardt scores and all HRQOL domains. Further studies with the use of disease-specific HRQOL instruments are warranted. (Clinical trial registration number: NCT01832779.).

Esophageal perforation management using a multidisciplinary minimally invasive treatment algorithm.

BACKGROUND: The surgical management of esophageal perforation (EP) often results in mortality and significant morbidity. Recent less invasive approaches to EP management include endoscopic luminal stenting and minimally invasive surgical therapies. We wished to establish therapeutic efficacy of minimally invasive therapies in a consecutive series of patients. STUDY DESIGN: An IRB-approved retrospective review of all acute EPs between 2007 and 2013 at a single institution was performed. Patient demographic, clinical outcomes data, and hospital charges were collected. RESULTS: We reviewed 76 consecutive patients with acute EP presenting to our tertiary care center. Median age was 64 ± 16 years (range 25 to 87 years), with 50 men and 26 women. Ninety percent of EPs were in the distal esophagus, with 67% of iatrogenic perforations occurring within 4 cm of the gastroesophageal junction. All patients were treated within 24 hours of initial presentation with a removable covered esophageal stent. Leak occlusion was confirmed within 48 hours of esophageal stent placement in 68 patients. Median lengths of ICU and hospital stay were 3 and 10 days, respectively (range 1 to 86 days). One-third of the patients were noted to have prolonged intubation (>7 days) and pneumonia that required a tracheostomy. One in-hospital (1.3%) mortality occurred within 30 days. Median total hospital charges for EP were $85,945. CONCLUSIONS: Endoscopically placed removable esophageal stents with minimally invasive repair of the perforation and feeding access is an effective treatment method for patients with EP. This multidisciplinary method enabled us to care for severely ill patients while minimizing morbidity and mortality and avoiding open esophageal surgery.