Faculty Bibliography

Introduction: Inflammatory bowel disease (IBD) often requires treatment with immune modulating medications (biologics). Although biologic agents have been shown to have excellent efficacy in treating IBD patients, the substantial cost has become a barrier to treatment for many patients. Recently, biosimilar drugs have been developed. Many clinical trials have demonstrated similar efficacy of biosimilars compared to originator biologics in IBD patients. Patients' perception and knowledge regarding these drugs is not known. We surveyed IBD patients to assess perceptions and knowledge regarding biosimilar medications and willingness to switch from biologics to biosimilars. Methods: 121 consecutive adult patients in a single outpatient gastroenterology clinic with a pre-existing diagnosis of IBD were surveyed between March and May 2017. Data was then compiled and analyzed. Patients were excluded if they were not able to read English. Results: The mean age of the survey participants was 37.8 +/- 15.5 years. Sixty-three percent of the participants were male. Fifty-three patients (43.8%) carried a diagnosis of UC. Sixty-seven patients (55.3%) had Crohn's disease (CD). One patient was not sure of his/her diagnosis. Significantly more CD patients than UC were currently on infliximab or adalimumab (35 vs 16, p=0.014). Only 33 participants (27%) have heard of "biosimilar medications" prior to this study. Seventy-six percent of all participants were uncomfortable using a biosimilar medication that had not been tested in clinical trials specifically for UC or CD. 57% participants were uncomfortable exchanging their current medication for a biosimilar. 92% of all participants wanted to be informed prior to switching to a biosimilar medication. There was a statistically significant correlation between the number of years since diagnosis and the patient's comfort with switching to a biosimilar medication (r=0.203, p=0.027). Conclusion: By investigating patient perceptions and knowledge regarding biosimilars, we hope to better understand patients' level of comfort, preferences, and potential barriers to implementation. Most IBD patients were uncomfortable using a biosimilar that has not been evaluate in a clinical trial in IBD. Of interest, a longer time since diagnosis of CD was associated with increased comfort of switching from biologic to biosimilar. This information will help physicians form their approach to introducing and discussing these biosimilars with patients. (Table Presented)

Introduction: Clostridium difficile infection (CDI) occurs frequently in patients with inflammatory bowel disease (IBD) and is associated with increased disease activity. Due to concern for complications, immunosuppressive medication (ISM) is often withheld after CDI, although few data exist to inform this decision. This study aims to assess the influence of ISM on outcomes following CDI in IBD patients. Methods: This multicenter, retrospective cohort study was performed at 4 academic medical centers in New York City. Patient demographic and clinical data was abstracted from databases at each site for adult patients with an established diagnosis of IBD also diagnosed with CDI. Escalation of therapy was defined as initiation or dose escalation of corticosteroids or new biologic use following antibiotic therapy for CDI. Outcomes were assessed at 30 and 90 days after last positive C. difficile test. Continuous variables were compared using two-sided T-tests and proportions were compared using Chi-squared tests. Exact methods were used for expected cell size. Results: 207 patients met inclusion criteria (49 outpatient, 158 inpatient). Demographic information is listed in Table 1. Escalation of IBD regimen (Table 2) was more frequent in outpatients at 90 days (43% vs. 22%, P<0.01), with 49% (39/61) of ISM escalation occurring within 14 days of CDI.) Patients not escalated had higher rates of sepsis than escalated patients (11% vs. 2%, P=0.04). Severe outcomes (death, sepsis, or colectomy) at 90 days were markedly increased in the non-escalation group (15% vs 2%, P<0.01). There was no difference in CDI recurrence or rehospitalization between groups. Conclusion: In this multicenter study assessing outcomes of ISM use in patients with IBD and CDI, initiation of steroid or biologic therapy following CDI treatment was not associated with adverse clinical outcomes. While no difference was observed between CDI recurrence or rehospitalization among groups, sepsis and severe outcomes were significantly more common in patients not undergoing escalation. These data suggest that escalation of IBD therapy following CDI is not associated with worse clinical outcomes and a subset of patients may benefit from timely treatment of underlying inflammatory disease. Prospective studies are needed to validate these data and to inform clinical guidelines regarding the timing of ISM use following CDI

Introduction: Patients and families are often asked to make decisions regarding feeding tube placement during a medical crisis. The risks, benefits, and alternative treatment choices are not communicated by a standard method, and the consultants placing the tubes are often invited to join the discussion at a late stage. Our aim is to improve this process with a focus on patient and family preferences and patient safety, by educating medicine residents about feeding tubes and providing them with a shared decision making tool utilizing an electronic book (iBook). Methods: We created a one hour noon conference program for residents in which we reviewed information about enteral feeding, including types of tubes, placement methods, indications, contraindications, complications, and feeding tube use in selected medical conditions, with a focus on dementia. During this session the iBook was introduced for use in discussions with patients and families. Pre- and postintervention surveys were given to the residents to determine their knowledge and comfort level with the content. Gastroenterology fellows were also surveyed to determine if there was a difference in the nature of the feeding tube consults before and after the intervention. We used the chi-squared or Fisher's exact test to compare dichotomous outcomes in the pre- and post- intervention groups. Results: Among residents, there was a statistically significant increase in the proportion of individuals who answered that they were very comfortable/competent in all six questions regarding feeding tube placement after the intervention (p < 0.01 for all). Among fellows, there was perceived improvement in resident and patient knowledge regarding feeding tube placement as well as appropriateness of consults after the intervention, however these were not statistically significant due to the small sample size. There was a perceived decrease in the frequency of appropriate feeding tube placements after the intervention, which was also statistically non-significant. None of the residents reported that they had used the iBook with patients. Conclusion: Residents are often the first physicians to discuss feeding tube placement with patients and families in the acute inpatient setting, however many report that they are not equipped to lead this discussion. Formal education about feeding tubes improves resident comfort/competence in this area and should be incorporated into medicine housestaff curricula

Introduction: Inflammatory bowel disease (IBD) therapy is continuously evolving with novel drugs targeting various inflammatory pathways. Ustekinumab (USK), a monoclonal antibody inhibiting the IL-12/23 pathway, was approved in September 2016 to treat moderate-to-severe Crohn's disease (CD). While safety data in IBD is limited, USK has been used to treat other autoimmune diseases with favorable safety profiles. We aimed to establish rates of adverse events (AE) and demonstrate non-inferiority of AE of USK compared to placebo and other biologics. Methods: MEDLINE, PubMed and Embase databases were searched in May 2017 using terms "ustekinumab" and "clinical trials." Two authors independently performed quality assessment and dual extraction. Randomized control trials comparing USK to placebo or other biologics regardless of disease were included. The primary outcome was the odds ratio (OR) of AE of USK vs placebo, expressed as pooled OR and 95% confidence interval (CI). Secondary outcomes included OR of mild/moderate and serious AE (SAE) in USK vs placebo, USK vs biologics, and low vs high-dose USK, respectively (Table 2). A sub-analysis of outcomes in CD trials was performed. Random effects meta-analysis was performed for all outcomes. Results: 16 papers with 6756 subjects (44% female) were included (Fig 1). Infections were the most common AE (Table 1). The OR of serious AE in USK vs placebo was 0.76 (95% CI 0.56-1.03, Fig 2). The OR of mild-to-moderate AE in the USK vs placebo was 1.12 (95% CI 1.01-1.24), suggesting increased risk of mild/moderate AE with USK (Fig 3). However, this was no longer significant after sub-analysis of the three CD trials. Analysis of 5 trials comparing low vs high-dose USK revealed an OR of 0.96 (95% CI 0.46-2.04) for SAE and 1.17 (95% CI 0.98-1.39) for mild-to-moderate AE. Use of USK was not associated with increased AE compared to other biologics, with OR of 0.91 (95% CI 0.61-1.35) for SAE and 0.98 (95% CI 0.85-1.13) for mild/moderate AE. Heterogeneity was low for all calculations. Conclusion: USK has a comparable safety profile to placebo and other biologics in the treatment of various diseases, although we did find a mildly elevated risk of mild/moderate AE with USK; however, this (Figure Presented) was not seen in CD trials. The favorable safety profile of USK is of clinical importance with the advent of USK in CD and ongoing clinical trials for ulcerative colitis. More data on long-term safety data in the IBD population is needed

BACKGROUND: Inflammatory bowel diseases (IBD) are believed to be driven by dysregulated interactions between the host and the gut microbiota. Our goal is to characterize and infer relationships between mucosal T cells, the host tissue environment, and microbial communities in patients with IBD who will serve as basis for mechanistic studies on human IBD. METHODS: We characterized mucosal CD4 T cells using flow cytometry, along with matching mucosal global gene expression and microbial communities data from 35 pinch biopsy samples from patients with IBD. We analyzed these data sets using an integrated framework to identify predictors of inflammatory states and then reproduced some of the putative relationships formed among these predictors by analyzing data from the pediatric RISK cohort. RESULTS: We identified 26 predictors from our combined data set that were effective in distinguishing between regions of the intestine undergoing active inflammation and regions that were normal. Network analysis on these 26 predictors revealed SAA1 as the most connected node linking the abundance of the genus Bacteroides with the production of IL17 and IL22 by CD4 T cells. These SAA1-linked microbial and transcriptome interactions were further reproduced with data from the pediatric IBD RISK cohort. CONCLUSIONS: This study identifies expression of SAA1 as an important link between mucosal T cells, microbial communities, and their tissue environment in patients with IBD. A combination of T cell effector function data, gene expression and microbial profiling can distinguish between intestinal inflammatory states in IBD regardless of disease types.

Receptive anal intercourse and its association with sexually transmitted infections and human papillomavirus-related anal dysplasia has been well studied in various at-risk groups including men who have sex with men. However, the relationship between receptive anal intercourse and its potential complications in patients with inflammatory bowel disease is not fully understood. This narrative review discusses sexually transmitted infections and anal dysplasia in patients with inflammatory bowel disease who engage in receptive anal intercourse and the lack of evidence-based data to guide clinical practice. It addresses the psychosocial effects of stigmatization in these patients and its consequences in the clinical encounter. We review the need for sufficient data on infection, cancer prevention, and precoital and postcoital hygienic practices with hopes that future studies establish standardized guidelines and recommendations.

AIM: To assess first-year gastroenterology fellows' ability to address difficult interpersonal situations in the workplace using objective structured clinical examinations (OSCE). METHODS: Two OSCEs ("distracted care team" and "frazzled intern") were created to assess response to disruptive behavior. In case 1, a fellow used a colonoscopy simulator while interacting with a standardized patient (SP), nurse, and attending physician all played by actors. The nurse and attending were instructed to display specific disruptive behavior and disregard the fellow unless requested to stop the disruptive behavior and focus on the patient and procedure. In case 2, the fellow was to calm an intern managing a patient with massive gastrointestinal bleeding. The objective in both scenarios was to assess the fellows' ability to perform their duties while managing the disruptive behavior displayed by the actor. The SPs used checklists to rate fellows' performances. The fellows completed a self-assessment survey. RESULTS: Twelve fellows from four gastrointestinal fellowship training programs participated in the OSCE. In the "distracted care team" case, one-third of the fellows interrupted the conflict and refocused attention to the patient. Half of the fellows were able to display professionalism despite the heated discussion nearby. Fellows scored lowest in the interprofessionalism portion of post-OSCE surveys, measuring their ability to handle the conflict. In the "frazzled intern" case, 68% of fellows were able to establish a calm and professional relationship with the SP. Despite this success, only half of the fellows were successfully communicate a plan to the SP and only a third scored "well done" in a domain that focused on allowing the intern to think through the case with the fellow's guidance. CONCLUSION: Fellows must receive training on how to approach disruptive behavior. OSCEs are a tool that can assess fellow skills and set a culture for open discussion.

BACKGROUND:The Accreditation Council for Graduate Medical Education has described 6 core competencies with which trainees should demonstrate proficiency. Using the Objective Structured Clinical Examination (OSCE), we aimed to assess 4 of these competencies among Pediatric Gastrointestinal (GI) fellows (PGs). METHODS:Eight first-year PGs from 6 medical centers in the New York area participated in a 4-station OSCE with trained standardized patient (SP) actors. The cases included an emergency department (ED) consult, or "ED Consult" for lower gastrointestinal bleeding; "Breaking Bad News" focusing on CF nutritional complications; "Second Opinion" for abdominal pain; "Transition of Care" for inflammatory bowel disease. At each station, attending faculty observed the encounters behind a 1-way mirror. SPs and faculties provided immediate feedback to the examined fellows. Previously validated OSCE checklists were used to assess performance. On completion, fellows attended debriefing sessions and completed surveys about the educational value. RESULTS:Median overall milestone competency scores were 6.9 (PC1), 4.8 (PC2), 5.9 (MK1), 5.7 (MK2), 6.4 (ICS1), 6.9 (Prof1), and 6.7 (Prof3). Overall, fellows score highest (7/9) on the inflammatory bowel disease "Transition of Care" case, found the "Breaking Bad News" Cystic Fibrosis OSCE to be the most challenging, and were most comfortable with the "ED Consult" OSCE, as a commonly encountered scenario. Overall, the fellows rated the educational value of the program highly. CONCLUSIONS:To our knowledge, although the OSCE has been validated in other medical fields, this is the first OSCE program developed for PGs fellows. These OSCEs have included Accreditation Council for Graduate Medical Education competencies, serving to assess fellows' skills in these areas while exposing them to challenging medical and psychosocial cases that they may not frequently encounter.

Background: The rising incidence of antibiotic-resistant disease is partially attributable to the extensive use and misuse of antibiotics. Ecuador has the second highest rate of per-capita antibiotic consumption in Latin America. The purpose of this study is to identify factors that contribute to self-prescribed antibiotic use in a low-income neighborhood of Guayaquil, Ecuador's largest city, where antibiotics are frequently available over-the-counter. Methods: Qualitative, oral interviews were conducted with local residents who had seen a physician in the last two years (group A, 101 subjects) and those who had not for two years or more (group B, 100 subjects). Subjects were recruited at a local medical clinic and a nearby food market. Findings: Although 71% of subjects overall report that they believe antibiotics could be dangerous for them, 74% have self-medicated with antibiotics in their lifetime, and 43% have taken antibiotics in the last month. 73% of subjects report taking just one or two antibiotic pills when they self-medicate. There were no differences between groups for these findings, but subjects in group A were more than twice as likely to have spoken with a physician before starting antibiotics the last time they took them (56% vs. 25% p<0.001), and more than three times as likely to complete a full course of antibiotics that had been prescribed by a physician (41% vs. 13% p<0.001). Overall, 78% of subjects who had children under the age of 18 reported self-medicating with antibiotics, but 85% said they would not give antibiotics to their children without taking them to a physician first. Subjects in group B were more than twice as likely to give antibiotics to their children without seeking the advice of a physician (21% vs. 9% p=0.04). Interpretation: Lifetime patterns and perceptions of self-prescribed antibiotic use were generally the same between groups, but when looking at recent behavior, subjects who had seen a physi-cian in the last two years were more likely to get a prescription and take the full course as prescribed. Further studies should be conducted to determine whether improving healthcare access and/or enforc-ing regulations on antibiotic sales could reduce antibiotic misuse in the region