Potential Cost Savings in Medicare Part D Across Gastroenterology: An Assessment of Alternative Drug Sourcing.

INTRODUCTION: Until recently, the Centers of Medicare and Medicaid were restricted from negotiating drug cost. We assessed the potential impact of alternative drug sourcing models on Medicare Part D spending. METHODS: Twenty-seven drugs were extracted from 2021 Medicare Part D claims. Drug-specific/total spending was compared against cost at Mark Cuban Cost Plus Drugs Company, Costco Member Prescription Program, and Veterans Health Administration price point. RESULTS: Potential Part D savings were $798.99 million, $573.84 million, and $1.02 billion (Mark Cuban Cost Plus Drugs Company, Costco Member Prescription Program, and Veterans Health Administration, respectively). DISCUSSION: Disproportionate Part D spending likely reflects less competitive acquisition cost. Provider awareness of medications with advantaged price may promote targeted prescribing with potentially tremendous health care savings.

Endoscopic resection outcomes and predictors of failed en bloc endoscopic mucosal resection of colorectal polyps ≤ 20 mm among advanced endoscopy trainees.

Background and study aims En bloc endoscopic mucosal resection (EMR) is preferred over piecemeal resection for polyps ≤ 20 mm. Data on colorectal EMR training are limited. We aimed to evaluate the en bloc EMR rate of polyps ≤ 20 mm among advanced endoscopy trainees and to identify predictors of failed en bloc EMR. Methods This was a multicenter prospective study evaluating trainee performance in EMR during advanced endoscopy fellowship. A logistic regression model was used to identify the number of procedures and lesion cut-off size associated with an en bloc EMR rate of ≥ 80 %. Multivariate analysis was performed to identify predictors of failed en bloc EMR. Results Six trainees from six centers performed 189 colorectal EMRs, of which 104 (55 %) were for polyps ≤ 20 mm. Of these, 57.7 % (60/104) were resected en bloc. Trainees with ≥ 30 EMRs (OR 6.80; 95 % CI: 2.80-16.50; P  = 0.00001) and lesions ≤ 17 mm (OR 4.56;95 CI:1.23-16.88; P  = 0.02) were more likely to be associated with an en bloc EMR rate of ≥ 80 %. Independent predictors of failed en bloc EMR on multivariate analysis included: larger polyp size (OR:6.83;95 % CI:2.55-18.4; P  = 0.0001), right colon location (OR:7.15; 95 % CI:1.31-38.9; P  = 0.02), increased procedural difficulty (OR 2.99; 95 % CI:1.13-7.91; P  = 0.03), and having performed < 30 EMRs (OR: 4.87; 95 %CI: 1.05-22.61; P  = 0.04). Conclusions In this pilot study, we demonstrated that a relatively low proportion of trainees achieved en bloc EMR for polyps ≤ 20 mm and identified procedure volume and lesion size thresholds for successful en bloc EMR and independent predictors for failed en bloc resection. These preliminary results support the need for future efforts to define EMR procedure competence thresholds during training.

Evaluating learning curves and competence in colorectal EMR among advanced endoscopy fellows: a pilot multicenter prospective trial using cumulative sum analysis.

BACKGROUND AND AIMS: Data on colorectal EMR (C-EMR) training are lacking. We aimed to evaluate C-EMR training among advanced endoscopy fellows (AEFs) by using a standardized assessment tool (STAT). METHODS: This multicenter prospective study used a STAT to grade AEF training in C-EMR during their 12-month fellowship. Cumulative sum analysis was used to establish learning curves and competence for cognitive and technical components of C-EMR and overall performance. Sensitivity analysis was performed by varying failure rates. AEFs completed a self-assessment questionnaire to assess their comfort level with performing C-EMR at the completion of their fellowship. RESULTS: Six AEFs (189 C-EMRs; mean per AEF, 31.5 ± 18.5) were included. Mean polyp size was 24.3 ± 12.6 mm, and mean procedure time was 22.6 ± 16.1 minutes. Learning curve analyses revealed that less than 50% of AEFs achieved competence for key cognitive and technical C-EMR endpoints. All 6 AEFs reported feeling comfortable performing C-EMR independently at the end of their training, although only 2 of them achieved competence in their overall performance. The minimum threshold to achieve competence in these 2 AEFs was 25 C-EMRs. CONCLUSIONS: A relatively low proportion of AEFs achieved competence on key cognitive and technical aspects of C-EMR during their 12-month fellowship. The relatively low number of C-EMRs performed by AEFs may be insufficient to achieve competence, in spite of their self-reported readiness for independent practice. These pilot data serve as an initial framework for competence threshold, and suggest the need for validated tools for formal C-EMR training assessment.

Gastrointestinal Disease in Patients with Common Variable Immunodeficiency: A Retrospective Observational Study.

BACKGROUND: Gastrointestinal (GI) symptoms are common among patients with common variable immunodeficiency disorder (CVID) yet remain poorly understood. AIMS: The aim of this study was to characterize the demographic, clinical, endoscopic and histologic features of patients with CVID and GI symptoms. METHODS: We conducted a retrospective observational study of all patients with CVID at a large Canadian tertiary care centre between January 2000 and May 2018. RESULTS: We included 95 patients with CVID. The mean age of patients at the time of CVID diagnosis was 38.2(±16.0). Fifty-three (56%) patients were female. Sixty-four (67%) patients had GI symptoms, with a mean age of onset for GI symptoms of 43.4(±15.1) years. The most common symptoms were bowel movement changes (n = 55 [58%]) and abdominal pain (n = 44 [46%]). Patients with GI symptoms were more likely to have anemia (n = 23 [36%] versus n = 3 [10%], P = 0.0129), iron deficiency (n = 16 [25%] versus n = 2 [7%], P = 0.0481), and have received GI antibiotics (n = 37 [58%] versus n = 0, P < 0.0001) and proton pump inhibitors for reflux (n = 24 [38%] versus n = 3 [10%], P = 0.0067). The most common GI infections were Giardia lamblia (n = 14 [15%]) and Clostridium difficile (n = 4 [4%]). Forty-three (45%) patients with GI symptoms underwent colonoscopy, esophagogastroduodenoscopy or both. The most common findings were inflammation, nodular lymphoid hyperplasia, reduced plasma cells and increased intraepithelial lymphocytes. CONCLUSIONS: This is the largest study on CVID patients in a North American setting. The majority of patients experienced GI symptoms. Future studies should study response to treatment for GI disease among patients with CVID.

Inflammatory Bowel Disease Training During Adult Gastroenterology Residency: A National Survey of Canadian Program Directors and Trainees.

BACKGROUND: Clinical training in inflammatory bowel disease (IBD) is a mandated component of adult gastroenterology fellowship. This study aims to assess methods of instruction in IBD and identify priorities and gaps in IBD clinical training among residents and program directors (PDs). METHODS: Using both an online and in-person platform, we administered a 15-question PD survey and 19-question trainee survey that assessed the methods of IBD teaching and trainee perceptions of knowledge transfer of 22 IBD topics. The survey was previously developed and administered to US gastroenterology trainees and PDs. RESULTS: Surveys were completed by 9 of 14 (62.3%) PDs and 44 of 62 (71%) trainees. Both trainee years were equally represented (22 residents in each year of training). All respondents were based at university teaching hospitals with full-time IBD faculty on staff. Dedicated IBD rotations were not offered by more than half of training programs, and IBD exposure was most commonly encountered during inpatient rotations. Overall, only 14 (31.2%) trainees were fully satisfied with the level of IBD exposure during their training. Thirty-six (81.8%) trainees reported being comfortable with inpatient IBD management, whereas only 23 (52.3%) trainees reported being comfortable with outpatient IBD management. There was strong concordance between the proportion of PDs ranking an IBD topic as essential and trainee comfort in that area (Pearson's rho 0.59; P=0.004). Fewer than half of trainees reported comfort in 11 of 22 (50%) proposed IBD topics. Identified areas of deficiency included phenotypic and endoscopic classification of IBD, inpatient management of severe active IBD, perianal disease management, monitoring biologic therapy and extra-intestinal manifestations of IBD. CONCLUSIONS: Only one-third of Canadian gastroenterology trainees are fully satisfied with the level of IBD exposure under the current training model. Furthermore, several IBD topics appear to be inadequately covered during training. Our findings, which are similar to previously published US data, highlight the need for additional focus on IBD during gastroenterology residency.

Financial Conflicts of Interest in Inflammatory Bowel Disease Guidelines.

BACKGROUND: Industry payments can lead to financial conflicts of interest (FCOI) among authors of clinical practice guidelines (CPGs). Guidelines for inflammatory bowel disease (IBD) may be at particularly high risk. We determined the prevalence of FCOI in IBD CPGs produced by various gastroenterology societies. METHODS: We conducted a cross-sectional analysis of FCOI disclosure among CPGs related to the management of IBD. We ascertained the prevalence and types of FCOI for each guideline and determined adherence to National Academy of Medicine (NAM) standards. FCOI disclosures were compared between societies producing CPGs. RESULTS: We identified 11 relevant CPGs with 173 total authors. There were 117 (68%) authors who declared a payment. A total of 107 (62%) authors declared FCOI related to a medication recommended in the guideline. There was a significant difference (P < 0.001) between the proportion of authors with FCOI between countries or regions. Authors of US CPGs had a significantly lower FCOI prevalence (19%) compared with other societies. Authors of UK CPGs had a significantly lower FCOI prevalence (56%) compared with Canadian (84%) and European (94%) CPGs. Three (27%) guidelines adhered to both NAM standards. CONCLUSIONS: A substantial portion of authors of IBD CPGs had FCOI. Our study found a significant difference in FCOI prevalence based on CPG sponsor nationality. Most CPGs for IBD did not adhere to NAM standards for FCOI disclosure.

Clinical, endoscopic, and histologic characteristics of lymphocytic esophagitis: a systematic review.

OBJECTIVE: Lymphocytic esophagitis (LyE) is a novel, yet poorly described, clinicopathologic entity. The aim of this systematic review was to characterize the demographic, clinical, endoscopic, and histologic features of LyE in observational studies of adult and pediatric patients. DESIGN: We searched the Embase, MEDLINE, and SCOPUS databases for relevant studies in 2018. Two authors reviewed and extracted data from studies that met the inclusion and exclusion criteria. RESULTS: We identified 20 studies for analysis of demographic, clinical, and endoscopic features of LyE. The mean age ranged from 9 to 67 years. When pooled, there were 231 (52.7%) patients with LyE that were female. The most common presenting symptom was dysphagia reported in 191 (48.8%) patients. On endoscopy, most patients with LyE tended to have abnormal findings (69.0%), which included erosive esophagitis, multiple esophageal rings, linear furrows, and narrow-caliber esophagus. In the 31 studies used to assess the histologic definition, the cut-off number of intraepithelial lymphocytes (IELs) was reported in 16 (51.6%) studies, peripapillary IEL specification in 18 (58.1%) studies, and presence of spongiosis in 6 (19.4%) studies. CONCLUSION: We identified a spectrum of demographic, clinical, and endoscopic findings characteristic of patients with LyE. A consensus on the diagnostic criteria of LyE is required.

Perspectives on endoscopic surveillance of dysplasia in inflammatory bowel disease: a survey of academic gastroenterologists.

BACKGROUND AND STUDY AIMS: Dye-based chromoendoscopy (DBC) is the preferred method for endoscopic dysplasia surveillance in patients with inflammatory bowel disease (IBD). We sought to examine the uptake of, and perception toward DBC among academic gastroenterologists. METHODS: We conducted an online survey of academic members of the Canadian Association of Gastroenterology to assess their current dysplasia surveillance practice, uptake of DBC, and perceived barriers to adoption of DBC. RESULTS: Of the 150 physicians contacted, 49 (32.7 %) responded to the survey. The majority of respondents reported subspecialty training in IBD (71.4 %), and the median number of years in practice was 12. White-light endoscopy with random colonic biopsies was the preferred dysplasia screening method (73.5 %). Only 26.5 % of respondents routinely used DBC, despite institutional availability of over 60 %. The major barriers to adoption of DBC were concerns about procedure duration (46.9 %), concerns about cost (44.9 %), and inadequate training (40.8 %). CONCLUSION: There is low uptake of DBC for dysplasia surveillance in IBD patients among academic gastroenterologists practicing in Canada. Additional studies should be completed to determine how to improve the uptake of DBC.

Frequency and Variables Associated with Fasting Orders in Inpatients with Ulcerative Colitis: The Audit of Diet Orders-Ulcerative Colitis (ADORE-UC) Study.

INTRODUCTION: Current clinical practice guidelines suggest that patients with ulcerative colitis (UC) hospitalized because of a disease flare should be offered a normal diet, unless such a diet is not tolerated. Studies of hospitalized patients have demonstrated iatrogenic malnutrition from unjustified or inappropriate nil per os (NPO) or clear liquid diet (CLD) orders. In this study, we aim to characterize the burden of this problem in hospitalized patients with UC. METHODS: We conducted a retrospective cohort study of all patients with UC admitted to the gastroenterology service or the general internal medicine service at a tertiary, academic hospital between January 2009 and December 2014, with a length of stay between 2 and 30 days. The frequency and duration of bowel rest and CLD orders was recorded, and the number of meals missed because of these orders was assessed. NPO or CLD diet orders were considered justified if the patient had intractable nausea or vomiting, pancreatitis, bowel obstruction, toxic megacolon or were awaiting endoscopy, or if alternative enteral nutrition was provided. Clinical and demographic factors associated with unjustified underfeeding were identified. RESULTS: A total of 187 admissions among 158 patients with UC were identified during the study period and included in the final analysis. Most admissions were to the gastroenterology service (148/187, 79.1%). The mean age at admission was 35.0 years (SD = 15), and 83/158 (52.5%) were female. The median length of stay was 8 days (interquartile range = 4-12). Registered dietician consultation was obtained in only 32 admissions (17.1%), and admission weight was recorded in only 68 (36.4%) admissions. A total of 252 NPO or CLD dietary orders were encountered in 142 admissions (75.9%). Of those, 112 orders were unjustified (44%). On average, patients with unjustified NPO or CLD orders spent 3 days on an NPO or CLD diet, which corresponded to a mean of 10 missed meals. Characteristics associated with unnecessary fasting included female gender, less frequent endoscopic disease staging, less frequent escalation of therapy to prednisone and/or biologics, and admission to a non-gastroenterology service. CONCLUSIONS: There is a high burden of unjustified underfeeding among hospitalized patients with UC, particularly in patients admitted without evidence of objective disease flare. This may lead to nutritional compromise in an at-risk population, and further studies are needed to assess the nutritional impact of unjustified bowel rest on patients with UC. Our findings also suggest that targeted quality improvement interventions are needed to decrease the frequency of inappropriate bowel rest among hospitalized patients with UC.

Public versus Private Drug Insurance and Outcomes of Patients Requiring Biologic Therapies for Inflammatory Bowel Disease.

Background. Antitumor necrosis factor (anti-TNF) therapy is a highly effective but costly treatment for inflammatory bowel disease (IBD). Methods. We conducted a retrospective cohort study of IBD patients who were prescribed anti-TNF therapy (2007-2014) in Ontario. We assessed if the insurance type was a predictor of timely access to anti-TNF therapy and nonroutine health utilization (emergency department visits and hospitalizations). Results. There were 268 patients with IBD who were prescribed anti-TNF therapy. Public drug coverage was associated with longer median wait times to first dose than private one (56 versus 35 days, P = 0.002). After adjusting for confounders, publicly insured patients were less likely to receive timely access to anti-TNF therapy compared with those privately insured (adjusted hazard ratio, 0.66; 95% CI: 0.45-0.95). After adjustment for demographic and clinical characteristics, publicly funded subjects were more than 2-fold more likely to require hospitalization (incidence rate ratio [IRR], 2.30; 95% CI: 1.19-4.43) and ED visits (IRR 2.42; 95% CI: 1.44-4.08) related to IBD. Conclusions. IBD patients in Ontario with public drug coverage experienced greater delays in access to anti-TNF therapy than privately insured patients and have a higher rate of hospitalizations and ED visits related to IBD.

Recurrence of Clostridium difficile Infection in Patients with Inflammatory Bowel Disease: The RECIDIVISM Study.

OBJECTIVES: Recurrent Clostridium difficile infection (rCDI) contributes to a significant burden of disease in patients with inflammatory bowel disease (IBD). In this study, we seek to identify risk factors for rCDI in a population of IBD patients at the Mount Sinai Hospital IBD Centre. METHODS: In this retrospective cohort study, IBD patients with rCDI diagnosed between 2010 and 2013 were identified and compared with IBD patients with single-episode CDI. Multivariate regression was used to identify predictors of rCDI in IBD. Outcome analysis was performed for hospitalizations due to CDI, colectomy, and CDI-attributable mortality. RESULTS: A total of 503 patients were included, 110 (22%) of whom had IBD (49% CD, 51% ulcerative colitis). Recurrent CDI occurred in 32% of IBD patients compared with 24% of non-IBD patients (P<0.01). IBD patients with rCDI were more likely than those without rCDI to report recent antibiotic therapy (42.9 vs. 30.7%, P<0.01), 5-aminosalicylic acid (5-ASA) use (51.5 vs. 30.7%, P<0.001), steroid use (51.4 vs. 33.3%, P<0.001), and biologic therapy (48.6 vs. 40.0%, P<0.01). Infliximab (34.3 vs. 17.3%, P<0.01) but not adalimumab was associated with more rCDI events. Using a Cox model of predictors of rCDI in IBD, significant predictors included non-ileal Crohn's disease (hazard ratio (HR) 2.85, 95% confidence interval (CI) 1.30-6.30) and the use of 5-ASA (HR 2.15, 95% CI 1.11-4.18). CONCLUSIONS: Compared with the general population, IBD patients are 33% more likely to experience rCDI. Within the IBD cohort, exposure to certain drug classes (antibiotics, 5-ASA, steroids, certain biologics) and non-ileal Crohn's disease were found to be the predictors of rCDI.

Perceptions and Attitudes Towards Medication Adherence during Pregnancy in Inflammatory Bowel Disease.

BACKGROUND AND AIMS: Women with inflammatory bowel disease [IBD] report concerns about medication safety during pregnancy. Adherence to IBD medications may be lower in pregnant patients as a result. The aim of this study was to assess medication adherence during pregnancy in women with inflammatory bowel disease. METHODS: Female patients of childbearing age completed a self-administered, structured survey. We collected demographic data, medication history, and self-reported adherence to IBD medications during pregnancy. We also assessed knowledge and perceptions of IBD medication safety in pregnancy. A time trade-off [TTO] analysis was done to assess health utilities for continuing or discontinuing IBD medications during pregnancy. RESULTS: A total of 204 women completed the survey [mean age was 32.8 years]. Current or previous pregnancy was reported by 101 patients [median parity 2, median gravity 1]. While pregnant or attempting to conceive, 47 [46.5%] participants reported stopping a prescribed IBD medication. Of those, 20 participants reported stopping medications without the advice of a physician. TTO analysis was completed by 31 patients. When presented with the option of continuing a potentially teratogenic medication, switching to less effective medication that is non-teratogenic, or stopping medication all together, participants consistently preferred to not remain on the most effective IBD therapy. CONCLUSIONS: Women with IBD report preference to not remain on IBD medications during pregnancy. This is driven by concerns about safety and uncertainty about teratogenic effects. Women with IBD may benefit from increased education about medication safety in pregnancy.

Vaccination in inflammatory bowel disease patients: attitudes, knowledge, and uptake.

BACKGROUND: Immunomodulators and biological agents, used to treat inflammatory bowel disease [IBD], are associated with an increased risk of infection, including vaccine-preventable infections. We assessed patient attitudes towards vaccination, knowledge of vaccine recommendations, and uptake of recommended vaccines. METHODS: Patients attending IBD clinics completed a self-administered, structured, paper-based questionnaire. We collected demographic data, medical and immunisation history, self-reported patient uptake, knowledge, and perceptions of childhood and adult vaccinations. RESULTS: The prevalence of treatment with biologicals, steroids, thiopurines, and methotrexate among the 300 respondents were 37.3%, 16.0%, 16.0%, and 5.7%, respectively. Self-reported vaccine completion was reported by 45.3% of patients. Vaccination uptake rates were 61.3% for influenza, 10.3% for pneumococcus, 61.0% for hepatitis B, 52.0% for hepatitis A, 26.0% for varicella, 20.7% for meningococcus, 5.3% for herpes zoster, and 11.0% for herpes papilloma virus [females only]. Significant predictors of vaccine completion were annual vaccination review by family physician (odds ratio [OR] = 1.82) or gastroenterologist [OR = 1.72], current steroid use [OR = 1.28], and current or prior treatment with biologicals [OR = 1.42]. The majority of patients reported that the primary responsibility to ensure vaccine completion lies with the patient [41.7%] and the family physician [32.3%]. Uncertainty about indications, fears of side effects, and concerns regarding vaccine safety were the most commonly reported reasons for non-uptake [22.0%, 20.7%, and 5.3%, respectively]. CONCLUSIONS: Uptake of recommended vaccines among IBD patients is suboptimal. Annual vaccination reviews by both family physician and gastroenterologist may improve vaccine uptake. Interventions targeted at improving vaccination uptake in IBD patients are needed.

The utility of transthoracic echocardiography to confirm central line placement: an observational study.

BACKGROUND: Ultrasound visualization of neck vessels is the standard method used to assist with internal jugular vein (IJV) central line placement. Nevertheless, this practice has not eliminated the risk of carotid puncture and/or inadvertent arterial cannulation. Transesophageal echocardiography (TEE) effectively verifies wire placement within the heart but is invasive and not always available. We examined the feasibility and potential utility of using transthoracic echocardiography (TTE) to verify the distal wire in the right atrium (RA) before dilation and cannulation of the IJV. METHODS: Following institutional Research Ethics Board approval and signed consent, 100 patients scheduled for elective cardiac surgery were recruited. As per standard practice at our institution, all patients were to have a central line inserted under general anesthesia with TEE visualization of the guidewire. Transesophageal echocardiography (apical or subcostal four-chamber images) was performed by one of four operators while another anesthesiologist performed central line placement. Following IJV puncture, blood was rapidly aspirated and reinjected to produce microbubbles. Subsequently, a 0.035-inch j-tipped flexible guidewire was inserted and visualized with TEE. The wire was then reinserted into the RA under TTE visualization. RESULTS: Overall, the RA was viewed 94% (95% confidence interval [CI] 87 to 98) of the time with TTE, and both the microbubbles and guidewire were detected 91% (95% CI 84 to 96) of the time. The subjects in whom the guidewire could not be well visualized had a higher mean body mass index (33.6 vs 28.8; P = 0.01). CONCLUSIONS: Transthoracic echocardiography [corrected] is a feasible, noninvasive, and potentially useful method to confirm appropriate placement of the guidewire before dilation and cannulation of the IJV.

Macrocytosis is a predictor of resting lactate concentrations in persons on dideoxynucleoside therapy for HIV infection.

OBJECTIVES: Mitochondrial toxicity is an important toxicity of antiretroviral therapy and may manifest as elevated blood lactate. Macrocytosis has been hypothesized to act as a marker of mitochondrial toxicity in persons with HIV infection. As part of a larger study on markers of mitochondrial toxicity we evaluated the relationship between resting lactate and erythrocyte mean corpuscular volume (MCV). METHODS: We studied the effect of micronutrient supplementation on lactate metabolism in three groups: those with HIV on and not on dideoxynucleoside-containing antiretroviral therapy and those without HIV. As part of the study we measured resting lactate and erythrocyte MCV after a 14-h fast. RESULTS: Erythrocyte MCV was significantly higher among the 11 participants on antiviral therapy (109.3 femtoliters (fl)) compared to five controls without HIV (89.3 fl) and four controls with HIV not on antiviral therapy (88.3 fl). In addition a strong predictive relationship was seen between MCV and resting lactate (R(2)=0.548, p<0.01). CONCLUSIONS: Macrocytosis may be a marker of treatment-related mitochondrial dysfunction in persons on treatment for HIV. Evaluating patients for early evidence of mitochondrial dysfunction in resource-constrained settings could be facilitated by this marker.