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'An Ounce of Prevention Is Worth a Pound of Cure`: Using an Objective Structured Clinical Examination to Assess Delivery of Preventative Care in IBD [Meeting Abstract]
Levine, Irving; Zabar, Sondra; Weinshel, Elizabeth; Gillespie, Colleen; Malter, Lisa
ISI:000464611001183
ISSN: 0002-9270
CID: 5524132
Ustekinumab-Associated Thrombocytopenia in a Patient With Refractory Crohn's Disease [Meeting Abstract]
Levine, Irving; Rolston, Vineet; Papademetriou, Marianna; Malter, Lisa
ISI:000464611004081
ISSN: 0002-9270
CID: 5524152
What do i need to know about feeding tubes? Assessing the effect of a multi-modal educational effort on internal medicine residents' competence in discussing feeding tube placement [Meeting Abstract]
Betesh, A; Zalkin, D; Liang, P S; Perskin, M H; Malter, L B
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
EMBASE:620839085
ISSN: 1572-0241
CID: 2968262
Ustekinumab does not increase risk of serious adverse events: A meta-analysis of randomized controlled trials [Meeting Abstract]
Rolston, V S; Kimmel, J; Malter, L B; Hudesman, D P; Bosworth, B P; Chang, S; Popov, V
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
EMBASE:620839005
ISSN: 1572-0241
CID: 2968272
Therapy escalation in patients with inflammatory bowel disease following clostridium difficile infection is not associated with adverse clinical outcomes: An ibd remedy study [Meeting Abstract]
Lukin, D J; Lawlor, G; Hudesman, D P; Durbin, L; Feathers, A; Passi, M; Cavaliere, K; Axelrad, J E; Coburn, E; Loftus, M; Jen, H; Rosen, M H; Malter, L B; Swaminath, A
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
EMBASE:620839458
ISSN: 1572-0241
CID: 2968192
Patient perceptions regarding the use of biosimilars in inflammatory bowel disease [Meeting Abstract]
Pineles, D; Arsuaga, A; Malter, L B; Bosworth, B P; Hudesman, D P; Chang, S
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)
EMBASE:620839629
ISSN: 1572-0241
CID: 2968172
Effect of a multi-modal educational intervention to improve healthcare maintenance of IBD patients in a GI fellow clinic in a large urban medical center [Meeting Abstract]
Ni, K; Rolston, V S; Dikman, A; Liang, P S; Malter, L B
Introduction: Patients with inflammatory bowel disease (IBD) have many unique health maintenance needs and often require therapy necessitating close monitoring. Gastroenterologists often serve as the primary care provider for these patients and therefore must be familiar with the health maintenance needs of IBD patients. In this study, we investigated whether implementing a multimodal educational intervention could improve providers' rates of addressing healthcare maintenance measures. Methods: A retrospective chart review was performed in 2013-2014 on 208 IBD patients to determine adherence to performance practice measures. From February-April 2016, fellows received a recurring in-service lecture and an IBD clinic note template outlining the 2011 healthcare maintenance recommendations by the American Gastroenterological Association. An iBook was also introduced, which provided a comprehensive overview of IBD practice guidelines. Retrospective chart review was then performed 1 year afterwards. For each patient, performance measures were assessed in both pre- and post-intervention notes in the following categories: vaccinations, bone health, therapy-specific maintenance, tobacco cessation counseling, and cancer screening. Each performance measure was given a score of 0 (not addressed), 1 (addressed), or N/A (irrelevant to subject). The primary outcome was improvement in rates of adherence to performance measures. The adherence rates for pre- and post-intervention groups were compared using a chi-squared test. Results: A total of 208 pre-intervention clinic visits and 40 post-intervention visits were included for analysis. After the interventions, the rate of healthcare maintenance measures addressed overall increased from 37% to 52% (p < .001) (Figure 1). There were statistically significant improvements in addressing bone health (29% to 63%, p < .001), vaccination (33% to 47%, p < .001), and therapy-specific measures (53% to 74%, p=.01). There were no statistically significant changes in addressing cancer screening (66% to 58%, p=.19) or smoking (23% to 30%, p=.59). Conclusion: The use of multiple educational interventions to enhance delivery of IBD healthcare maintenance resulted in improved adherence to healthcare maintenance measures. Targeted educational programs and a multi-modal approach may be an effective method for teaching GI fellows and reinforcing the importance of addressing these measures to optimize the care of their IBD patients
EMBASE:620839769
ISSN: 1572-0241
CID: 2968142
Catastrophic systemic embolism resulting from spontaneous pulmonary vein thrombosis with extension into the left atrium in a patient with Crohn's disease [Meeting Abstract]
Lowe, S C; Pitman, M; Grieco, M; Malter, L B
Patients with inflammatory bowel disease (IBD) are well known to be at increased risk of venous thromboembolism. Systemic thrombotic events are rare, but likely more common among IBD patients as well. We describe a case of Crohn's colitis complicated by spontaneous pulmonary vein thrombosis eventually resulting in systemic embolism and acute mesenteric ischemia. A 25-year-old female with stricturing Crohn's colitis presented to the emergency department with one week of back pain and pleuritic chest pain. She was initially diagnosed with Crohn's disease three years prior, when she presented with large bowel obstruction requiring emergent transverse colostomy. Infliximab was begun after surgery, and she achieved complete clinical remission. She continued to feel well until the present illness. Upon hospital admission, a computed tomography (CT) scan revealed multiple right sided pulmonary emboli as well as a large pulmonary vein thrombus extending into the left atrium. Echocardiogram revealed no evidence of right heart strain. Anticoagulation was initiated with unfractionated heparin, and the patient was eventually transitioned to apixaban. On the evening prior to anticipated discharge, she developed sudden onset fever and epigastric pain. A CT scan of the abdomen revealed acute thrombosis of the superior mesenteric artery. The patient underwent emergent laparotomy with thrombectomy, initially without small bowel resection. Subsequent second-look laparotomy revealed 75cm of ischemic small bowel, which was resected. The patient continued to have fever and abdominal pain, however, and further exploration revealed necrosis of the entire remaining small bowel, which was resected leaving only a duodenal stump. The patient was eventually transferred to another center for consideration of intestinal transplant. Pulmonary vein thrombosis is an extremely rare condition usually precipitated by intrathoracic neoplasm or thoracic surgery, particularly lung transplantation. There is an associated risk of pulmonary hypertension as well as systemic arterial embolization. To our knowledge, this is the first reported case of spontaneous pulmonary vein thrombosis with IBD as the inciting factor. Due to the risk of catastrophic complications from systemic embolism, rapid diagnosis and treatment are essential. Anticoagulation alone may not be sufficient in all cases, and thrombectomy may be considered if the thrombus does not resolve with medical management
EMBASE:620839789
ISSN: 1572-0241
CID: 2968132
Integrated Analysis of Biopsies from Inflammatory Bowel Disease Patients Identifies SAA1 as a Link Between Mucosal Microbes with TH17 and TH22 Cells
Tang, Mei San; Bowcutt, Rowann; Leung, Jacqueline M; Wolff, Martin J; Gundra, Uma M; Hudesman, David; Malter, Lisa B; Poles, Michael A; Chen, Lea Ann; Pei, Zhiheng; Neto, Antonio G; Abidi, Wasif M; Ullman, Thomas; Mayer, Lloyd; Bonneau, Richard A; Cho, Ilseung; Loke, P'ng
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.
PMCID:5613756
PMID: 28806280
ISSN: 1536-4844
CID: 2669222
Receptive Anal Intercourse in Patients with Inflammatory Bowel Disease: A Clinical Review
Martin, Tracey; Smukalla, Scott M; Kane, Sunanda; Hudesman, David P; Greene, Richard; Malter, Lisa B
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.
PMID: 28708804
ISSN: 1536-4844
CID: 2630822