PURPOSE Ibrutinib reduces mortality in chronic lymphocytic leukemia (CLL). It increases the risk of atrial fibrillation (AF) and bleeding and there are concerns about heart failure (HF) and central nervous system ischemic events. The magnitude of these risks remains poorly quantified. METHODS Using linked administrative databases, we conducted a population-based cohort study of Ontario patients who were treated for CLL diagnosed between 2007 and 2019. We matched ibrutinib-treated patients with controls treated with chemotherapy but unexposed to ibrutinib on prior AF, age ≥ 66 years, anticoagulant exposure, and propensity for receiving ibrutinib. Study outcomes were AF-related health care contact, hospital-diagnosed bleeding, new diagnoses of HF, and hospitalizations for stroke and acute myocardial infarction (AMI). The cumulative incidence function was used to estimate absolute risks. We used cause-specific regression to study the association of ibrutinib with bleeding rates, while adjusting for anticoagulation as a time-varying covariate. RESULTS We matched 778 pairs of ibrutinib-treated and unexposed patients with CLL (N = 1,556). The 3-year incidence of AF-related health care contact was 22.7% (95% CI, 19.0 to 26.6) in ibrutinib-treated patients and 11.7% (95% CI, 9.0 to 14.8) in controls. The 3-year risk of hospital-diagnosed bleeding was 8.8% (95% CI, 6.5 to 11.7) in ibrutinib-treated patients and 3.1% (95% CI, 1.9 to 4.6) in controls. Ibrutinib-treated patients were more likely to start anticoagulation after the index date. After adjusting for anticoagulation as a time-varying covariate, ibrutinib remained positively associated with bleeding (HR, 2.58; 95% CI, 1.76 to 3.78). The 3-year risk of HF was 7.7% (95% CI, 5.4 to 10.6%) in ibrutinib-treated patients and 3.6% (95% CI, 2.2 to 5.4) in controls. There was no significant difference in the risk of ischemic stroke or AMI. CONCLUSION Ibrutinib is associated with higher risk of AF, bleeding, and HF, but not AMI or stroke.

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Background: Assessment of competence in endoscopic retrograde cholangiopancreatography (ERCP) is critical to support learning and document competence. Validity evidence supporting ERCP observational assessment tools has not been systematically evaluated. Methods: We conducted a systematic search using electronic databases and hand-searching from inception until August 2021 for studies evaluating observational assessment tools of ERCP performance. We used a unified validity framework to characterize validity evidence from five sources: content, response process, internal structure, relations to other variables, and consequences. Each domain was assigned a score of 0-3 (maximum score 15). We assessed educational utility and methodological quality using the Accreditation Council for Graduate Medical Education framework and the Medical Education Research Quality Instrument, respectively. Results: From 2769 records, we included 17 studies evaluating 7 assessment tools. Five tools were studied for clinical ERCP, one on simulated ERCP, and one on simulated and clinical ERCP. Validity evidence scores ranged from 2-12. The Bethesda ERCP Skills Assessment Tool (BESAT), ERCP Direct Observation of Procedural Skills Tool (ERCP DOPS), and The Endoscopic Ultrasound (EUS) and ERCP Skills Assessment Tool (TEESAT) had the strongest validity evidence with scores of 10, 12, and 11, respectively. Regarding educational utility, most tools were easy to use and interpret, and required minimal additional resources. Overall methodological quality was strong, with scores ranging from 10-12.5 (maximum 13.5). Conclusions: The BESAT, ERCP DOPS, and TEESAT have strong validity evidence compared to other assessments. Integrating tools into training may help drive learners’ development and support competency decision-making.

Background: Credentialing, the process through which an institution assesses and validates an endoscopist’s qualifications to independently perform a procedure, can vary by region and country. Little is known about these inter-societal and geographic differences. We aimed to systematically characterize credentialing recommendations and requirements worldwide. Methods: We conducted a systematic review of credentialing practices among gastrointestinal and endoscopy societies worldwide. An electronic search as well as hand-search of World Endoscopy Organization members’ websites was performed for credentialing documents. Abstracts were screened in duplicate and independently. Data were collected on procedures included in each document (e.g. colonoscopy, ERCP) and types of credentialing statements (procedural volume, key performance indicators (KPIs), and competency assessments). The primary objective was to qualitatively describe and compare the available credentialing recommendations and requirements from the included studies. Descriptive statistics were used to summarize data when appropriate. Results: We screened 653 records and included 20 credentialing documents from 12 societies. Guidelines most commonly included credentialing statements for colonoscopy, esophagogastroduodenoscopy (EGD), and ERCP. For colonoscopy, minimum procedural volumes ranged from 150-275 and adenoma detection rate (ADR) from 20-30%. For EGD, minimum procedural volumes ranged from 130-1000, and duodenal intubation rate of 95-100%. For ERCP, minimum procedural volumes ranged from 100-300 with selective duct cannulation success rate of 80-90%. Guidelines also reported on flexible sigmoidoscopy, capsule endoscopy, and endoscopic ultrasound. Conclusions: While some metrics such as ADR were relatively consistent among societies, there was substantial variation among societies with respect to procedural volume and KPI statements.

Background Acute, severe, ulcerative colitis (ASUC) is associated with a high morbidity and mortality. Current guidelines recommend the initiation of high dose intravenous steroids, followed by anti-TNF therapy if a satisfactory therapeutic response is not rapidly achieved. However, guidelines are agnostic on how to manage patients who are admitted for ASUC despite being on established biologic therapy. Furthermore, short-term clinical outcomes in this population are not well characterized. Purpose The aim of this study is to assess the differences in short-term clinical outcomes in patients admitted with ASUC who are on established biologic therapy compared to those not on established biologic therapy. Method We conducted a retrospective chart review of patients admitted with ASUC to Mount Sinai Hospital (MSH) in Toronto, Ontario from January 2018 until December 2021. Patients were included if they were deemed to have a severe flare, defined as having 6 or more loose bowel movements per day with at least one of the following features: temperature of 38.0 Celsius, tachycardia, anemia, or elevated inflammatory markers. Included subjects were considered to be on established biologic therapy if they had a biologic within 56 days prior to admission, all other admitted subjects were included as controls. Our primary outcome was the difference in hospital length of stay (HLOS). We also contrasted duration of intravenous steroids, rates of surgical consultation, rates of in-hospital colectomy, and readmission rates within 90 days of discharge. Result(s) 130 charts were included in our study, 53 of which were patients on established biologic therapy, and 77 of which were patients not on established biologic therapy. The HLOS between the two groups was not significantly different, (7.23 days [established biologic therapy] vs.7.47 days [not on biologic therapy], p value = 0.77). Patients on established biologic therapy were more likely to receive an inpatient surgical consultation (33.96% vs 7.79%, p-value <0.001). However, rates of colectomy prior to discharge were not statistically different (1.89% vs 0%, p-value = 0.23). Patients on established biologic therapy were significantly more likely to be readmitted within 90 days of discharge (30.19% vs 12.99%, p-value = 0.016). Image Conclusion(s) Although there were no differences in HLOS and colectomy rates between the 2 groups, patients with ASUC on established biologic therapy were more likely to be readmitted within 3 months of discharge. Further work is required to define optimal medical management of persons admitted with ASUC who are failing biologic therapies. Please acknowledge all funding agencies by checking the applicable boxes below None Disclosure of Interest None Declared

Background Credentialing in GI endoscopy is not a universally standardized process. National guidelines may provide a framework for local training, however in certain settings, training committees set minimal competency requirements that must be met before a clinician can be accredited to practice independently. There is a paucity of literature assessing the inter-societal and geographic variability in guidelines and training requirements in endoscopy. Purpose To systematically review the available credentialing guidelines proposed by different GI endoscopy societies and affiliated training committees internationally. Method We conducted a systematic review according to the PRISMA guidelines. A comprehensive literature search was performed for credentialing guidelines for GI endoscopy from inception until January 2022. Two reviewers screened and one reviewer abstracted data using a pre-defined data collection form. Result(s) From the 653 records obtained from our search, 20 credentialing guidelines from 12 different GI societies were ultimately included in the review. These guidelines encompassed the following procedures and outlined the following key-performance indicators; a) Colonoscopy: the recommended minimum number of procedures performed ranged from 150-275 with a minimum cecal intubation and adenoma detection rate of 85-90% and 20-30% respectively; b) EGD: the minimum number of procedures prior to credentialing ranged from 130-1000, the minimum duodenal intubation rate ranged from 95-100%, and the range for minimum number of upper GI bleeds managed was 20-45 (in addition to other procedural KPIs); c) ERCP: the recommended minimum number of procedures prior to credentialing ranged from 100-300 cases with a minimum selective duct cannulation rate of 80-90%. Guidelines for flexible sigmoidoscopy, EUS and capsule endoscopy were also obtained. Image Conclusion(s) There is a general concordance amongst the various international GI societies with regards to minimum procedural volume and performance in key procedural tasks prior to credentialing, however the use of validated education assessment tools was lacking in the majority of guidelines. Additional KPI’s need to be explored for less routinely performed procedures such as EUS and capsule endoscopy. Please acknowledge all funding agencies by checking the applicable boxes below None Disclosure of Interest None Declared

Background Assessment of competence in endoscopic retrograde cholangiopancreatography (ERCP) is essential to ensure trainees possess the skills needed for independent practice. Traditionally, ERCP training has used the apprenticeship model, whereby novices learn skills under the supervision of an expert. A growing focus on procedural quality, however, has supported the implementation of competency-based medical education models which require documentation of a trainee’s competence for independent practice. Observational assessment tools with strong evidence of validity are critical to this process. Validity evidence supporting ERCP observational assessment tools has not been systematically evaluated. Purpose To conduct a systematic review of ERCP assessment tools and identify tools with strong evidence of validity using a unified validity evidence framework Method We conducted a systematic search using electronic databases and hand-searching from inception until August 2021 for studies evaluating observational assessment tools of ERCP performance. We used a unified validity framework to characterize validity evidence from five sources: content, response process, internal structure, relations to other variables, and consequences. Each domain was assigned a score of 0-3 (maximum score 15). We assessed educational utility and methodological quality using the Accreditation Council for Graduate Medical Education framework and the Medical Education Research Quality Instrument, respectively. Result(s) From 2769 records, we included 17 studies evaluating 7 assessment tools. Five tools were studied for clinical ERCP, one on simulated ERCP, and one on simulated and clinical ERCP. Validity evidence scores ranged from 2-12. The Bethesda ERCP Skills Assessment Tool (BESAT), ERCP Direct Observation of Procedural Skills Tool (ERCP DOPS), and The Endoscopic Ultrasound (EUS) and ERCP Skills Assessment Tool (TEESAT) had the strongest validity evidence with scores of 10, 12, and 11, respectively. Regarding educational utility, most tools were easy to use and interpret, and required minimal additional resources. Overall methodological quality was strong, with scores ranging from 10-12.5 (maximum 13.5). Conclusion(s) The BESAT, ERCP DOPS, and TEESAT have strong validity evidence compared to other assessments. Integrating tools into training may help drive learners’ development and support competency decision-making. Please acknowledge all funding agencies by checking the applicable boxes below CAG Disclosure of Interest None Declared

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