Lisa Malter

Disease monitoring in inflammatory bowel disease

The optimal method for monitoring quiescent disease in patients with Crohns disease (CD) and ulcerative colitis is yet to be determined. Endoscopic evaluation with ileocolonoscopy is the gold standard but is invasive, costly, and time-consuming. There are many commercially available biomarkers that may be used in clinical practice to evaluate disease status in patients with inflammatory bowel disease (IBD), but the most widely adopted biomarkers are C-reactive protein (CRP) and fecal calprotectin (FC). This review summarizes the evidence for utilizing CRP and FC for monitoring IBD during clinical remission and after surgical resection. Endoscopic correlation with CRP and FC is evaluated in each disease state. Advantages and drawbacks of each biomarker are discussed with special consideration of isolated ileal CD. Fecal immunochemical testing, traditionally used for colorectal cancer screening, is mentioned as a potential new alternative assay in the evaluation of IBD. Based on a mixture of information gleaned from biomarkers, clinical status, and endoscopic evaluation, the best treatment decisions can be made for the patient with IBD.

Improving handoff communication: a gastroenterology fellowship performance improvement project.

The gastroenterology training program at New York University (NYU) has evolved over the years to include three hospital training sites for its fellows. The program based at Bellevue Hospital merged with the VA New York Harbor Healthcare System New York campus (formerly the Manhattan VA) in 1994. In 2004, the training program expanded to include rotations at the New York University Langone Medical Center. Each hospital had its own culture and schedule for its house staff. The training program had a schedule of conferences and clinics that the fellows were expected to attend regardless of the hospital at which they were rotating. It became increasingly difficult for the fellows and the faculty to provide quality care for their patients when their day was constantly interrupted by activities at another hospital site. In 2003, while we were successfully merging three hospitals’ cultures, the Accreditation Council for Graduate Medical Education (ACGME) added a policy calling for a reduction in permitted duty hours (1). The reduced work hours were intended to minimize sleep deprivation experienced by house staff and associated errors in patient care (2). House staff programs all over the country were forced to adjust their rotations and their call schedules in order to adhere to the new duty hour requirements (3). Reduced work hours meant shorter shifts for physicians in training and required more physicians to be responsible for the care of a given patient. As work hours were limited, effective patient handoffs became crucial. The key component to ensuring safe and efficient patient care is the handoff of patient data at the completion of a shift (4). We set out to identify factors that could improve the process of handoff between our physicians as a performance improvement project for our fellowship training program. Our aim was twofold: to assess the current handoff system within the gastroenterology division at NYU and to devise a method for change that would enhance patient care, and ultimately patient safety, via improved communication between our physicians.

Objective structured clinical examination as a novel tool in inflammatory bowel disease fellowship education.

Background:Experiential learning in medical education, as exemplified by objective structured clinical examinations (OSCEs), is a well-validated approach for improving trainee performance. Furthermore, the Accreditation Council for Graduate Medical Education has identified OSCEs as an ideal method for assessing the core competency of interpersonal and communication skills. Here, we describe a novel educational tool, the inflammatory bowel disease OSCE (IBD OSCE), to assess and improve this clinical skill set in Gastroenterology fellows. Methods:We developed a 4-station IBD OSCE that assessed shared decision making, physician–physician communication, and physician–patient consultative skills specifically related to the care of patients with IBD. Each station was videotaped and observed live by faculty gastroenterologists. Behaviorally anchored checklists were scored independently by a faculty observer and the standardized patient/physician, who both provided feedback to the fellow immediately after each case. Post-OSCE, fellows attended a debriefing session on patient communication and were surveyed to assess their perspective on the examinations educational value. Results:Twelve second-year gastroenterology fellows from 5 fellowship programs participated in the IBD OSCE. Fellows performed well in all measured domains and rated the experience highly for its educational value. Fellows cited IBD as an area of relative deficiency in their education compared with other knowledge areas within gastroenterology. Conclusions:To our knowledge, this is the first OSCE designed specifically for the evaluation of skills as they relate to IBD management. Using OSCEs for IBD education provides an opportunity to robustly assess core competencies and the role of the physician as an educator.

Isolation and cytokine analysis of lamina propria lymphocytes from mucosal biopsies of the human colon

Much of our understanding of gut-microbial interactions has come from mouse models. Intestinal immunity is complex and a combination of host genetics and environmental factors play a significant role in regulating intestinal immunity. Due to this complexity, no mouse model to date gives a complete and accurate representation of human intestinal diseases, such as inflammatory bowel diseases. However, intestinal tissue from patients undergoing bowel resection reflects a condition of severe disease that has failed treatment; hence a more dynamic perspective of varying inflammatory states in IBD could be obtained through the analyses of pinch biopsy material. Here we describe our protocol for analyzing mucosal pinch biopsies collected predominantly during colonoscopies. We have optimized flow cytometry panels to analyze up to 8 cytokines produced by CD4+ and CD8+ cells, as well as for characterizing nuclear proteins and transcription factors such as Ki67 and Foxp3. Furthermore, we have optimized approaches to analyze the production of cytokines, including TGF-beta from direct ex vivo cultures of pinch biopsies and LPMCs isolated from biopsies. These approaches are part of our workflow to try and understand the role of the gut microbiota in complex and dynamic human intestinal diseases.

Cutaneous Crohn's disease of the vulva.

A 26-year-old woman was referred to dermatology department from an outside clinic for a 1-year history of recurrent draining lesions of the vulva and buttock treated unsuccessfully with doxycycline for presumed lymphogranuloma venereum. Physical examination was notable for an oedematous vulva (figure 1) with knife-like fissuring of the genitocrural folds (figure 2), superficial erosions and scattered draining papulonodules (figure 1). Biopsy showed granulomatous dermatitis consistent with cutaneous Crohns disease. Colonoscopy revealed normal-appearing mucosa in the colon and terminal ileum, however, random …

Integrated Analysis of Biopsies from Inflammatory Bowel Disease Patients Identifies SAA1 as a Link Between Mucosal Microbes with TH17 and TH22 Cells

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.

The nocebo effect and patient perceptions of biosimilars in inflammatory bowel disease

We read with great interest a recent paper by Boone et al. [1]. In this 1-year observational study, the authors sought to quantify the nocebo rate in individuals with an immune-mediated inflammatory disease who were switched from the originator infliximab to a biosimilar for a non-medical reason. Patients were provided informed consent and voluntarily agreed to transition to the infliximab biosimilar. The patients in this study were stable on infliximab, with the average duration of infliximab treatment being more than 3 years prior to switching. The results demonstrated an overall nocebo response of 12.8%, (12.5% for rheumatologic disorders and 12.9% for inflammatory bowel disease (IBD)). Patients with a nocebo response endorsed Bless exerted effect,^ chills during infusions, numbness, and tingling, and headache. All nocebo-response patients were able to be re-initiated on the infliximab originator. The authors concluded that non-medical switching may have a negative impact on patient’s perceived disease burden and sense of well-being. The investigators hypothesized that shared decision-making and patient education may decrease the nocebo-response rate. However, there is currently limited data regarding patient perception and knowledge of biosimilars to help physicians address potential concerns with their patients [2, 3]. The infliximab biosimilar was approved in the USA in 2016, but penetration into our marketplace has only recently accelerated. As such, we recently performed a small, prospective study aimed at gauging IBD patients’ initial perceptions of biosimilars. In 2017, we surveyed 132 adult patients with IBD at two university-affiliated gastroenterology clinics regarding their current impression of biosimilars. A standardized cover sheet was included with the 14-question survey which described the purpose of the study and a brief explanation of biosimilars. We found that a large proportion of surveyed participants (75%), despite themajority beingwell-educated with a university education or more, had never heard of biosimilar medications. In regard to participant concerns with biosimilars, 81% were concerned with the efficacy, 74% were concerned with the side effects, and 70% were concerned with the safety of these medications. Significantly more biologic-experienced participants were concerned about the effectiveness and the safety of biosimilars when compared to biologic-naive participants (86 vs 62%, p = 0.003 and 75 vs 55%, p = 0.041, respectively). Regarding switching, 58% of all participants were uncomfortable exchanging their current medication for a biosimilar. Not surprisingly, significantly more patients currently or previously on a biologic were uncomfortable switching to a biosimilar compared to patients not currently on a biologic (61 vs 45%, p = 0.032). Our study highlights a lack of awareness of biosimilars as well as main concerns regarding these medications. These findings can be used to help physicians to construct a patient-centered approach to introducing biosimilars. For the most part, the decision to switch to a biosimilar will be driven by economics rather than patient preference. Patients who switch to the biosimilar are at risk of nocebo effects given concerns regarding efficacy, side effects, and safety. In the study by Boone et al., patients voluntarily switched to the biosimilar. In real-world practice, the nocebo response may be higher in patients who do not voluntarily switch. We agree with Boone et al. that patient education is paramount to limiting patient noncompliance and the nocebo effect. * Shannon Chang shannon.chang@nyumc.org

Escalation of Immunosuppressive Therapy for Inflammatory Bowel Disease Is Not Associated With Adverse Outcomes After Infection With Clostridium difficile

BACKGROUND Clostridium difficile infection (CDI) is common in patients with inflammatory bowel disease (IBD), often leading to diagnostic confusion and delays in IBD therapy escalation. This study sought to assess outcomes after CDI in IBD patients exposed to new or escalated immunosuppressive therapy. METHODS This multicenter retrospective cohort study included IBD patients with documented CDI at 4 academic medical centers. Data were abstracted from clinical databases at each institution. Outcomes at 30 and 90 days were compared between patients undergoing new or intensified immunosuppressive therapy and those without therapy escalation. Continuous variables were compared using t tests, and proportions using chi-square tests. Multivariable logistic regression was used to determine the association of individual variables with severe outcomes (including death, sepsis, and/or colectomy) within 90 days. Secondary outcomes included CDI recurrence, rehospitalization, worsening of IBD, and severe outcomes within 30 days. RESULTS A total of 207 adult patients with IBD and CDI were included, of whom 62 underwent escalation to biologic or corticosteroid therapy (median time to escalation, 13 days). Severe outcomes within 90 days occurred in 21 (15.6%) nonescalated and 1 (1.8%) therapy-escalated patients. Serum albumin <2.5 mg/dL, lactate >2.2 mg/dL, intensive care unit admission, hypotension, and comorbid disease were associated with severe outcomes. Likelihood of severe outcomes was decreased in patients undergoing escalation of IBD therapy after CDI (adjusted odds ratio [aOR], 0.12) and increased among patients aged >65 years (aOR, 4.55). CONCLUSIONS Therapy escalation for IBD within 90 days of CDI was not associated with worse clinical outcomes. Initiation of immunosuppression for active IBD may therefore be appropriate in carefully selected patients after treatment of CDI.

Disruptive behavior in the workplace: Challenges for gastroenterology fellows

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.

Using the Objective Structured Clinical Examination to Assess ACGME Competencies in Pediatric Gastroenterology Fellows

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.