Baseline Characteristics and Longitudinal Outcomes of Traditional Serrated Adenomas: A Cohort Study.

BACKGROUND AND AIMS: Traditional serrated adenomas (TSAs) may confer increased risk for colorectal cancer (CRC). Our objective with this study was to examine clinical characteristics and long-term outcomes associated with TSA diagnosis. METHODS: We conducted a retrospective cohort study of U.S. Veterans ≥18 years of age with ≥1 TSA between 1999 and 2018. Baseline characteristics, colonoscopy findings, and diagnosis of incident and fatal CRC were abstracted. Advanced neoplasia was defined by CRC or adenoma with high-grade dysplasia, villous histology, or size ≥1 cm. Follow-up was through CRC diagnosis, death, or end of study (December 31, 2018). RESULTS: A total of 853 Veterans with a baseline TSA were identified; 74% were ≥60 years of age, 96% were men, 14% were Black, and 73% were non-Hispanic White. About 64% were current or former smokers. Over 2044 total person-years at follow-up, there were 11 incident CRC cases and 1 CRC death. Cumulative CRC incidence was 1.34% (95% confidence interval [CI], 0.67%-2.68%), and cumulative CRC death was 0.12% (95% CI, 0.00%-0.35%). Among the subset of 378 TSA patients with ≥1 surveillance colonoscopy, 65.1% had high-risk neoplasia on follow-up. CRC incidence among TSA patients was significantly higher than in a comparison cohort of patients with normal baseline colonoscopy at baseline (hazard ratio, 3.70; 95% CI, 1.63-8.41) and similar to a comparison cohort with baseline conventional advanced adenoma (hazard ratio, 0.86; 95% CI, 0.45-1.64). CONCLUSION: Individuals with TSA have substantial risk for CRC based on their cumulative CRC incidence, as well as significant risk of developing other high-risk neoplasia at follow-up surveillance colonoscopy. These data underscore importance of current recommendations for close colonoscopy surveillance after TSA diagnosis.

Adenoma Detection Rate and Clinical Characteristics Influence Advanced Neoplasia Risk After Colorectal Polypectomy.

BACKGROUND AND AIMS: Postpolypectomy risk stratification for subsequent metachronous advanced neoplasia (MAN) is imprecise and does not account for colonoscopist adenoma detection rate (ADR). Our aim was to assess association of ADR with MAN and create a prediction model for postpolypectomy risk stratification incorporating ADR and other factors. METHODS: We conducted a retrospective cohort study of individuals with baseline polypectomy and subsequent surveillance colonoscopy from 2004 to 2016 within the U.S. Department of Veterans Affairs (VA). Clinical factors, polyp findings, and baseline colonoscopist ADR were considered for the model. Model performance (sensitivity, specificity, and area under the curve) for identifying individuals with MAN was compared with 2020 U.S. Multi-Society Task Force on Colorectal Cancer (USMSTF) surveillance recommendations. RESULTS: A total of 30,897 individuals were randomly assigned 2:1 into independent model training and validation sets. Increasing age, male sex, diabetes, current smoking, adenoma number, polyp location, adenoma ≥10 mm or with tubulovillous/villous features, and decreasing colonoscopist ADR were independently associated with MAN. A range of 1.48- to 1.66-fold increased risk for MAN was observed for ADR in the lowest 3 quintiles (ADR <19.7%-39.3%) vs the highest quintile (ADR >47.0%). When the final model selected based on the training set was applied to the validation set, improved sensitivity and specificity over 2020 USMSTF risk stratification were achieved (P = .001), with an area under the curve of 0.62 (95% confidence interval, 0.60-0.64). CONCLUSIONS: Colonoscopist ADR is associated with MAN. Combining clinical factors and ADR for risk stratification has potential to improve postpolypectomy risk stratification. Improving ADR is likely to improve postpolypectomy outcomes.

COVID-19 Pandemic Had Minimal Impact on Colonoscopy Completion After Colorectal Cancer Red Flag Sign or Symptoms in US Veterans.

BACKGROUND: Delays in colonoscopy work-up for red flag signs or symptoms of colorectal cancer (CRC) during the COVID-19 pandemic are not well characterized. AIMS: To examine colonoscopy uptake and time to colonoscopy after red flag diagnosis, before and during the COVID-19 pandemic. METHODS: Cohort study of adults ages 50-75 with iron deficiency anemia (IDA), hematochezia, or abnormal stool blood test receiving Veterans Health Administration (VHA) care from April 2019 to December 2020. Index date was first red flag diagnosis date, categorized into "pre" (April-December 2019) and "intra" (April-December 2020) policy implementation prioritizing diagnostic procedures, allowing for a 3-month "washout" (January-March 2020) period. Outcomes were colonoscopy completion and time to colonoscopy pre- vs. intra-COVID-19, examined using multivariable Cox models with hazard ratios (aHRs) and 95% confidence intervals (CIs). RESULTS: There were 52,539 adults with red flag signs or symptoms (pre-COVID: 25,154; washout: 7527; intra-COVID: 19,858). Proportion completing colonoscopy was similar pre- vs. intra-COVID-19 (27.0% vs. 26.5%; p = 0.24). Median time to colonoscopy among colonoscopy completers was similar for pre- vs. intra-COVID-19 (46 vs. 42 days), but longer for individuals with IDA (60 vs. 49 days). There was no association between time period and colonoscopy completion (aHR: 0.99, 95% CI 0.95-1.03). CONCLUSIONS: Colonoscopy work-up of CRC red flag signs and symptoms was not delayed within VHA during the COVID-19 pandemic, possibly due to VHA policies supporting prioritization and completion. Further work is needed to understand how COVID-19 policies on screening and surveillance impact CRC-related outcomes, and how to optimize colonoscopy completion after a red flag diagnosis.

Pre-endoscopy coronavirus disease 2019 screening and severe acute respiratory syndrome coronavirus-2 nucleic acid amplification testing in the Veterans Affairs healthcare system: clinical practice patterns, outcomes, and relationship to procedure volume.

BACKGROUND AND AIMS: The coronavirus disease 2019 (COVID-19) pandemic has had profound impacts worldwide, including on the performance of GI endoscopy. We aimed to describe the performance and outcomes of pre-endoscopy COVID-19 symptom and exposure screening and severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) nucleic acid amplification testing (NAAT) across the national Veterans Affairs healthcare system and describe the relationship of SARS-CoV-2 NAAT use and resumption of endoscopy services. METHODS: COVID-19 screening and NAAT results from March 2020 to April 2021 were analyzed to determine use, performance characteristics of screening, and association between testing and endoscopic volume trends. RESULTS: Of 220,891 completed endoscopies identified, 115,890 (52.5%) had documented preprocedure COVID-19 symptom and exposure screenings and 154,127 (69.8%) had preprocedure NAAT results within 7 days before scheduled endoscopy. Of 131,894 total canceled endoscopies, 26,475 (20.1%) had screening data and 28,505 (21.6%) had SARS-CoV-2 NAAT results. Overall, positive NAAT results were reported in 1.8% of all individuals tested and in 1.3% of those who screened negative. Among completed and canceled endoscopies, COVID-19 screening had a 34.6% sensitivity (95% confidence interval [CI], 32.4%-36.8%) and 96.4% specificity (95% CI, 96.2%-96.5%) when compared with NAAT. COVID-19 screening had a positive predictive value of 15.0% (95% CI, 14.0%-16.1%) and a negative predictive value of 98.7% (95% CI, 98.7%-98.8%). There was a very weak correlation between monthly testing and monthly endoscopy volume by site (Spearman rank correlation coefficient = .09). CONCLUSIONS: These findings have important implications for decisions about preprocedure testing, especially given breakthrough infections among vaccinated individuals during the SARS-CoV-2 delta and omicron variant surge.

Adenoma Detection Rate (ADR) Irrespective of Indication Is Comparable to Screening ADR: Implications for Quality Monitoring.

BACKGROUND & AIMS: Adenoma detection rate (ADR) is a key measure of colonoscopy quality. However, efficient measurement of ADR can be challenging because many colonoscopies are performed for non-screening purposes. Measuring ADR without being restricted to screening indication may likely facilitate more widespread implementation of quality monitoring. We hypothesized that the ADR for all colonoscopies, irrespective of the indication, would be equivalent to the ADR for screening colonoscopies. METHODS: We reviewed consecutive colonoscopies at two Veterans Affairs centers performed by 21 endoscopists over 6 months in 2015. We calculated the ADR for screening exams, non-screening (surveillance and diagnostic) exams, and all exams (irrespective of indication), correcting for within-endoscopist correlation. We then performed simulation modeling to calculate the ADRs under 16 hypothetical scenarios of various indication distributions. We simulated 100,000 trials with 3,000 participants, randomly assigned indication (screening, surveillance, diagnostic, and FIT+) from a multinomial distribution, randomly drew adenoma using the observed ADRs per indication, and calculated 95% confidence intervals of the mean differences in ADR of screening and non-screening indications. RESULTS: Among 2628 colonoscopies performed by 21 gastroenterologists, the indication was screening in 28.9%, surveillance in 48.2% and diagnostic in 22.9%. There was no significant difference in the ADR, 50% (95%CI: 45-56%) for all colonoscopies vs 49% (95%CI: 43-56%) for screening exams (p=.55). ADRs were 56% for surveillance and 38% for diagnostic exams. In our simulation modeling, only one out of 16 scenarios (screening 10%, surveillance 70%, diagnostic 10% and FIT+ 10%) resulted in a significant difference between the calculated ADRs for screening and non-screening indications. CONCLUSIONS: In our study, the overall ADR computed from all colonoscopies was not significantly different than the conventional ADR based on screening colonoscopies. Assessing ADR for colonoscopy irrespective of indication may be adequate for quality monitoring, and could facilitate the implementation of quality measurement and reporting. Future prospective studies should evaluate the validity of using overall ADR for quality reporting in other jurisdictions before adopting this method in clinical practice.

Risk Factors for Early-Onset Colorectal Cancer.

BACKGROUND & AIMS: Colorectal cancer (CRC) incidence and mortality are increasing among persons younger than 50 years old in the United States, but risk factors associated with early-onset CRC (EOCRC) have not been widely studied. METHODS: We conducted a case-control study of US veterans 18 to 49 years old who underwent colonoscopy examinations from 1999 through 2014. EOCRC cases were identified from a national cancer registry; veterans who were free of CRC at their baseline colonoscopy through 3 years of follow-up were identified as controls. We collected data on age, sex, race/ethnicity, body weight, body mass index (BMI), diabetes, smoking status, and aspirin use. Multivariate-adjusted EOCRC odds were estimated for each factor, with corresponding 95% confidence interval (CI) values. RESULTS: Our final analysis included 651 EOCRC cases and 67,416 controls. Median age was 45.3 years, and 82.3% were male. Higher proportions of cases were older, male, current smokers, nonaspirin users, and had lower BMIs, compared with controls (P < .05). In adjusted analyses, increasing age and male sex were significantly associated with increased risk of EOCRC, whereas aspirin use and being overweight or obese (relative to normal BMI) were significantly associated with decreased odds of EOCRC. In post hoc analyses, weight loss of 5 kg or more within the 5-year period preceding colonoscopy was associated with higher odds of EOCRC (odds ratio 2.23; 95% CI 1.76-2.83). CONCLUSIONS: In a case-control study of veterans, we found increasing age and male sex to be significantly associated with increased risk of EOCRC, and aspirin use to be significantly associated with decreased risk; these factors also affect risk for CRC onset after age 50. Weight loss may be an early clinical sign of EOCRC. More intense efforts are required to identify the factors that cause EOCRC and signs that can be used to identify individuals at highest risk.

Safety of endoscopist-directed nurse-administered balanced propofol sedation in patients with severe systemic disease (ASA class III).

BACKGROUND AND AIMS: The safety of endoscopist-directed nurse-administered propofol sedation (EDNAPS) has been demonstrated in low-risk patients (American Society of Anesthesiologists [ASA] class I and II). There are limited data regarding the safety of EDNAPS for endoscopic procedures in ASA class III patients. The purpose of this study was to determine the safety of EDNAPS for routine outpatient endoscopy in this population. METHODS: We retrospectively reviewed all outpatient EGDs and colonoscopies performed with EDNAPS at the University of Utah from January 2015 to November 2018. Exclusion criteria were inpatient procedures, combined procedures, ASA IV or higher, use of continuous or bilevel positive airway pressure at the start of the procedure, or procedures performed by a nongastroenterologist. Major adverse events were defined as intubation or death. Minor adverse events were defined as hypoxia, hypotension, bradycardia, or need for airway interventions. Patients were stratified by procedure type and ASA I/II status and were compared with patients with ASA III status and matched according to age, gender, and the involvement of a fellow in a 3 to 1 fashion. RESULTS: The final sample size was 18,910 colonoscopy procedures (17,205 patients) and 9178 EGD procedures (6827 patients). In both colonoscopy and EGD procedures, there were no major adverse events such as intubation, need for resuscitation, or death. The rates of any airway intervention, jaw thrust, oral nasal airway, or use of positive pressure ventilation were low in both procedure types and not different between ASA I/II and ASA III patients. CONCLUSION: EDNAPS is safe in both ASA I/II and ASA class III patients undergoing routine outpatient endoscopy.

Cecal retroflexion is infrequently performed in routine practice and the retroflexed view is of poor quality.

BACKGROUND: As right colon polyps are challenging to detect, a retroflexed view of right colon (RV) may be useful. However, cecal retroflexion (CR) without a RV to the hepatic flexure (HF) is inadequate. We aimed to determine the frequency of CR and quality of the RV in routine practice. METHODS: This prospective observational study performed at an academic medical center assessed colonoscopy inspection technique of endoscopists who had performed ≥ 100 annual screening colonoscopies. We video recorded ≥ 28 screening/surveillance colonoscopies per endoscopist and randomly evaluated 7 videos per endoscopist. Six gastroenterologists blindly reviewed the videos to determine if CR was performed and HF withdrawal time (cecum to HF time, excluding ileal/polypectomy time). RESULTS: Reviewers assessed 119 colonoscopies performed by 17 endoscopists. The median HF withdrawal time was 3 min and 46 s. CR was performed in 31% of colonoscopies. CR frequency varied between endoscopists with 9 never performing CR and 2 performing CR in all colonoscopies. When performed, nearly half (43%) of RVs did not extend to the HF with median RV duration of 16 s (IQR 9-30 s). Three polyps were identified in the RV (polyp detection rate of 8.1%), all identified prior to a forward view. CONCLUSIONS: CR is performed infrequently in routine practice. When CR is performed, the RV is of low quality with a very short inspection duration and insufficient ascending colon examination. Further education is required to educate endoscopists in optimal technique to improve overall colonoscopy quality.

Impact of Health Insurance, Poverty, and Comorbidities on Colorectal Cancer Screening: Insights from the Medical Expenditure Panel Survey.

BACKGROUND: Despite national campaigns and other efforts to improve colorectal cancer (CRC) screening, participation rates remain below targets set by expert panels. We hypothesized that availability and practice patterns of healthcare providers may contribute to this gap. METHOD: Using data of the Medical Expenditure Panel Survey for the years between 2000 and 2016, we extracted demographic, socioeconomic, and health-related data as well as reported experiences about barriers to care, correlating results with answers about recent participation in colorectal cancer screening. As CRC screening guidelines recommend initiation of testing at age 50, we focused on adults 50 years or older. RESULTS: We included responses of 163,564 participants for the period studied. There was a significant increase in CRC screening rates over time. Comorbidity burden, poverty, race, and ethnicity independently predicted participation in screening. Lack of insurance coverage and cost of care played an important role as reported barrier. Convenient access to care, represented by availability of appointments beyond typical business hours, and frequency of provider interactions, correlated with higher rates of screening. CONCLUSION: Our data show a positive effect of educational efforts and healthcare reform with coverage of screening. Easy and more frequent access to individual providers predicted a higher likelihood of completed screening tests. This finding could translate into more widespread implementation of screening programs, as the increasingly common virtual care delivery offers a new and convenient option to patients.

Simplifying Measurement of Adenoma Detection Rates for Colonoscopy.

BACKGROUND: Adenoma detection rate (ADR) is the colonoscopy quality metric with the strongest association to interval or "missed" cancer. Accurate measurement of ADR can be laborious and costly. AIMS: Our aim was to determine if administrative procedure codes for colonoscopy and text searches of pathology results for adenoma mentions could estimate ADR. METHODS: We identified US Veterans with a colonoscopy using Current Procedure Terminology (CPT) codes between January 2013 and December 2016 at ten Veterans Affairs sites. We applied simple text searches using Microsoft SQL Server full-text searches to query all pathology notes for "adenoma(s)" or "adenomatous" text mentions to calculate ADRs. To validate our identification of colonoscopy procedures, endoscopists of record, and adenoma detection from the electronic health record, we manually reviewed a random sample of 2000 procedure and pathology notes from the 10 sites. RESULTS: Structured data fields were accurate in identification of colonoscopies being performed (PPV = 0.99; 95% CI 0.99-1.00) and identifying the endoscopist of record (PPV of 0.95; 95% CI 0.94-0.96) for ADR measurement. Simple text searches of pathology notes for adenoma mentions had excellent performance statistics as follows: sensitivity 0.99 (95% CI 0.98-1.00), specificity 0.93 (95% CI 0.92-0.95), NPV 0.99 (95% CI 0.98-1.00), and PPV 0.93 (0.91-0.94) for measurement of ADR. There was no clinically significant difference in the estimates of overall ADR vs. screening ADR (p > 0.05). CONCLUSIONS: Measuring ADR using administrative codes and text searches from pathology results is an efficient method to broadly survey colonoscopy quality.

Colonoscopy-Naïve Raters Can Be Trained to Assess Colonoscopy Quality.

The ability of a colonoscopist to detect colon polyps is commonly measured by the adenoma detection rate (ADR). The outcome of colonoscopy varies based on ADR, and the relationship between decreasing provider ADR and the increased risk of subsequent fatal colorectal cancer has been clearly established.1 Despite the importance of provider ADR, it is of limited value at lower provider volumes due to imprecise measurements. We have previously shown that ratings of colonoscopy inspection quality (CIQ) from video-taped colonoscopies by experts highly correlate with provider ADR, and can provide colonoscopists with specific techniques in need of remediation.2 It is unclear, however, whether these video-based evaluations are a feasible method of assessing colonoscopy quality due to a reliance upon expert evaluations. The primary aim of this study was to determine whether video-based assessments of colonoscopy inspection quality by colonoscopy-naïve raters (novice raters) correlate with assessments by expert raters and with established colonoscopy quality metrics.

Esophageal Manometry Competency Program Improves Gastroenterology Fellow Performance in Motility Interpretation.

INTRODUCTION: Competency-based medical education (CBME) for interpretation of esophageal manometry is lacking; therefore, motility experts and instructional designers developed the esophageal manometry competency (EMC) program: a personalized, adaptive learning program for interpretation of esophageal manometry. The aim of this study was to implement EMC among Gastroenterology (GI) trainees and assess the impact of EMC on competency in manometry interpretation. METHODS: GI fellows across 14 fellowship programs were invited to complete EMC from February 2018 to October 2018. EMC includes an introductory video, baseline assessment of manometry interpretation, individualized learning pathways, and final assessment of manometry interpretation. The primary outcome was competency for interpretation in 7 individual skill sets. RESULTS: Forty-four GI trainees completed EMC. Participants completed 30 cases, each including 7 skill sets. At baseline, 4 (9%) participants achieved competency for all 7 skills compared with 24 (55%) at final assessment (P < 0.001). Competency in individual skills increased from a median of 4 skills at baseline to 7 at final assessment (P < 0.001). The greatest increase in skill competency was for diagnosis (Baseline: 11% vs Final: 68%; P < 0.001). Accuracy improved for distinguishing between 5 diagnostic groups and was highest for the Outflow obstructive motility disorder (Baseline: 49% vs Final: 76%; P < 0.001) and Normal motor function (50% vs 80%; P < 0.001). DISCUSSION: This prospective multicenter implementation study highlights that an adaptive web-based training platform is an effective tool to promote CBME. EMC completion was associated with significant improvement in identifying clinically relevant diagnoses, providing a model for integrating CBME into subspecialized areas of training.

Surgical and endoscopic management options for patients with GERD based on proton pump inhibitor symptom response: recommendations from an expert U.S. panel.

BACKGROUND AND AIMS: The objective of this study was to examine expert opinion and agreement on the treatment of distinct GERD profiles from surgical and therapeutic endoscopy perspectives. METHODS: We used the RAND/University of California, Los Angeles Appropriateness Method over 6 months (July 2018 to January 2019) to assess the appropriateness of antireflux interventions among foregut surgeons and therapeutic gastroenterologists. Patients with primary atypical or extraesophageal symptoms were not considered. Patient scenarios were grouped according to their symptom response to proton pump inhibitor (PPI) therapy. The primary outcome was appropriateness of an intervention. RESULTS: Antireflux surgery with laparoscopic fundoplication (LF) and magnetic sphincter augmentation (MSA) were ranked as appropriate for all complete and partial PPI responder scenarios. Transoral incisionless fundoplication was ranked as appropriate in complete and partial PPI responders without a hiatal hernia. Radiofrequency energy was not ranked as appropriate for complete or partial responders. There was lack of agreement between surgery and interventional gastroenterology groups on the appropriateness of LF and MSA for PPI nonresponders. Rankings for PPI nonresponders were similar when results from impedance-pH testing on PPI therapy were available, except that LF and MSA were not ranked as appropriate for PPI nonresponders if the impedance-pH study was negative. CONCLUSIONS: This work highlights areas of agreement for invasive therapeutic approaches for GERD and provides impetus for further interdisciplinary collaboration and trials to compare and generate novel and effective treatment approaches and care pathways, including the role of impedance-pH testing in PPI nonresponders.

Video-Based Assessments of Colonoscopy Inspection Quality Correlate With Quality Metrics and Highlight Areas for Improvement.

BACKGROUND & AIMS: Adenoma detection rate (ADR) and serrated polyp detection rate (SDR) vary significantly among colonoscopists. Colonoscopy inspection quality (CIQ) is the quality with which a colonoscopist inspects for polyps and may explain some of this variation. We aimed to determine the relationship between CIQ and historical ADRs and SDRs in a cohort of colonoscopists and assess whether there is variation in CIQ components (fold examination, cleaning, and luminal distension) among colonoscopists with similar ADRs and SDRs. METHODS: We conducted a prospective observational study to assess CIQ among 17 high-volume colonoscopists at an academic medical center. Over 6 weeks, we video-recorded >28 colonoscopies per colonoscopist and randomly selected 7 colonoscopies per colonoscopist for evaluation. Six raters graded CIQ using an established scale, with a maximum whole colon score of 75. RESULTS: We evaluated 119 colonoscopies. The median whole-colon CIQ score was 50.1/75. Whole-colon CIQ score (r=0.71; P<.01) and component scores (fold examination r=0.74; cleaning r=0.67; distension r=0.77; all P<.01) correlated with ADR. Proximal colon CIQ score (r=0.67; P<.01) and component scores (fold examination r=0.71; cleaning r=0.62; distension r=0.65; all P<.05) correlated with SDR. CIQ component scores differed significantly between colonoscopists with similar ADRs and SDRs for most of the CIQ skills. CONCLUSION: In a prospective observational study, we found CIQ and CIQ components to correlate with ADR and SDR. Colonoscopists with similar ADRs and SDRs differ in their performance of the 3 CIQ components-specific, actionable feedback might improve colonoscopy technique.

Ascertainment of Aspirin Exposure Using Structured and Unstructured Large-scale Electronic Health Record Data.

BACKGROUND: Aspirin impacts risk for important outcomes such as cancer, cardiovascular disease, and gastrointestinal bleeding. However, ascertaining exposure to medications available both by prescription and over-the-counter such as aspirin for research and quality improvement purposes is a challenge. OBJECTIVES: Develop and validate a strategy for ascertaining aspirin exposure, utilizing a combination of structured and unstructured data. RESEARCH DESIGN: This is a retrospective cohort study. SUBJECTS: In total, 1,869,439 Veterans who underwent usual care colonoscopy 1999-2014 within the Department of Veterans Affairs. MEASURES: Aspirin exposure and dose were obtained from an ascertainment strategy combining query of structured medication records available in electronic health record databases and unstructured data extracted from free-text progress notes. Prevalence of any aspirin exposure and dose-specific exposure were estimated. Positive predictive value and negative predictive value were used to assess strategy performance, using manual chart review as the reference standard. RESULTS: Our combined strategy for ascertaining aspirin exposure using structured and unstructured data reached a positive predictive value and negative predictive value of 99.2% and 97.5% for any exposure, and 92.6% and 98.3% for dose-specific exposure. Estimated prevalence of any aspirin exposure was 36.3% (95% confidence interval: 36.2%-36.4%) and dose-specific exposure was 35.4% (95% confidence interval: 35.3%-35.5%). CONCLUSIONS: A readily accessible approach utilizing a combination of structured medication records and query of unstructured data can be used to ascertain aspirin exposure when manual chart review is impractical.

Risk of Pancreatitis Following Treatment of Irritable Bowel Syndrome With Eluxadoline.

BACKGROUND & AIMS: The Food and Drug Administration approved eluxadoline for the treatment of diarrhea-predominant irritable bowel syndrome despite cases of pancreatitis in early stage trials. We investigated the frequency of pancreatitis attributed to eluxadoline in postmarketing surveillance. METHODS: We extracted reports on eluxadoline submitted to the Federal Adverse Event Reporting System from January through September 2016. We collected data on patient age and sex, event date, reporting entity (consumer, physician, pharmacist, legal worker, or other), medications, dosages, presumed role in the event (coinciding, primary, or secondary suspect), treatment indication, and outcome (death, life threatening, hospitalization, disability, or other).We compared data for eluxadoline with data from antidiarrheals, oxycodone, and rifaximin using the κ2 test, Kruskal-Wallis rank test, and analysis of variance; findings with P < .05 were considered statistically significant. RESULTS: Pancreatitis accounted for 16.4% of the 597 reports of adverse events linked to eluxadoline; 53 cases required hospitalization. Pancreatitis was listed as treatment complication of other agents in significantly lower proportions of cases (loperamide, 0.3%; diphenoxylate, 0.4%; oxycodone, 0.2%; rifaximin, 0.5%), with 75% of these submissions not considering the agent as causal. CONCLUSIONS: In an analysis of reports on eluxadoline submitted to the Federal Adverse Event Reporting System, we confirmed a previously reported risk of pancreatitis associated with eluxadoline. The need for hospitalization in at least half of these instances and a recent report of 2 fatalities should prompt reassessments of the agent's risk-benefit ratio.

A System to Assess the Competency for Interpretation of Esophageal Manometry Identifies Variation in Learning Curves.

BACKGROUND & AIMS: Quality esophageal high-resolution manometry (HRM) studies require competent interpretation of data. However, there is little understanding of learning curves, training requirements, or measures of competency for HRM. We aimed to develop and use a competency assessment system to examine learning curves for interpretation of HRM data. METHODS: We conducted a prospective multicenter study of 20 gastroenterology trainees with no experience in HRM, from 8 centers, over an 8-month period (May through December 2015). We designed a web-based HRM training and competency assessment system. After reviewing the training module, participants interpreted 50 HRM studies and received answer keys at the fifth and then at every second interpretation. A cumulative sum procedure produced individual learning curves with preset acceptable failure rates of 10%; we classified competency status as competency not achieved, competency achieved, or competency likely achieved. RESULTS: Five (25%) participants achieved competence, 4 (20%) likely achieved competence, and 11 (55%) failed to achieve competence. A minimum case volume to achieve competency was not identified. There was no significant agreement between diagnostic accuracy and accuracy for individual HRM skills. CONCLUSIONS: We developed a competency assessment system for HRM interpretation; using this system, we found significant variation in learning curves for HRM diagnosis and individual skills. Our system effectively distinguished trainee competency levels for HRM interpretation and contrary to current recommendations, found that competency for HRM is not case-volume specific.

Oesophageal disease in systemic sclerosis: does heritability play a role?

OBJECTIVES: In systemic sclerosis (SSc) the most common gastrointestinal tract (GIT) complaint is gastroesophageal reflux disease (GERD), which may contribute to oesophagitis, stricture, Barrett's oesophagus, and oesophageal adenocarcinoma. We used a genealogical resource the Utah Population Database (UPDB) to analyse SSc pedigrees for hereditability of oesophageal disease. METHODS: SSc, GERD, oesophagitis, stricture, Barrett's, and oesophageal adenocarcinoma were defined by ICD Ninth and Tenth Revision codes. Familial aggregation, relative risk (RR) of the GIT disease in SSc proband and their relatives was estimated by Cox regression model. The model (adjusted for sex and birth year) was used to evaluate the effects of having or being related to, a case or control for SSc, on GIT diseases. RESULTS: We identified 2,227 unique SSc patients and 11,136 randomly selected controls matched by birth year, gender, and whether born in Utah, in an approximately 1:5 ratio. A SSc proband had a significant high risk of GERD (RR: 3.28), dysphagia (RR 5.58), oesophageal stricture (RR: 5.16), oesophagitis (RR: 4.86), and Barrett's (RR: 4.52) all with significant p-values <2e-16. First-degree relatives of a SSc proband were at elevated risk of GERD (RR: 1.14, p=6.85e-05), dysphagia (RR: 1.22 p=0.002), and oesophagitis (RR: 1.37, p=2.10e-06). First cousins (RR: 1.09, p=0.03) and spouses (RR; 1.37, p=0.02) were at increased risk of esophagitis and dysphagia. CONCLUSIONS: These data suggest that independent of GERD, oesophagitis in SSc patients and their relatives may have both a hereditable and environmental etiology. There does not seem to be a heritable component to Barrett's oesophagus.