bluuebunny/crossref_metadata_2025_split huggingface dataset:
350 Efficacy of Budesonide Oral Suspension for Eosinophilic Esophagitis in Adolescents and Adults: Results From a Phase 3, Randomized, Placebo-Controlled Trial
Authors: Hirano Ikuo , Collins Margaret H. , Katzka David A. , Mukkada Vincent A. , Falk Gary W. , Williams James , Desai Nirav K. , Lan Lan , Morey Robin , Dellon Evan S. 
Published: October 2019

INTRODUCTION:
Eosinophilic esophagitis (EoE) is a chronic immune-mediated disease for which there is an unmet clinical need for new therapies. The safety and efficacy of budesonide oral suspension (BOS) for the treatment of EoE has been demonstrated in a previous phase 2 study. The current phase 3 study evaluated the efficacy and safety of BOS in a large cohort of patients with EoE.

METHODS:
This randomized, double-blind, placebo-controlled trial (SHP621-301; NCT02605837) investigated the safety and efficacy of BOS in patients (11–55 years) with EoE and dysphagia. Patients were randomized 2:1 to 2.0 mg BOS or placebo twice daily (b.i.d.) for 12 weeks (Figure 1). Co-primary endpoints were histologic (peak eosinophil count ≤6 eosinophils/high-powered field [eos/hpf]) and dysphagia symptom (≥30% decrease in symptoms as measured by the Dysphagia Symptom Questionnaire [DSQ]) responses after 12 weeks of therapy. Secondary endpoints included change in DSQ score and change in EoE Endoscopic Reference Score (EREFS) from baseline to final treatment period. Safety was also assessed.

RESULTS:
A total of 322 patients were randomized (BOS, n = 215; placebo, n = 107), of whom 318 patients received at least one dose of double-blind therapy (BOS, n = 213; placebo, n = 105) (Table 1). The primary outcomes were achieved, with significantly more histologic and symptom responders in the BOS-treated than the placebo-treated group (53.1% vs 1.0%, P < 0.001; 52.6% vs 39.1%, P = 0.024, respectively; Figure 2). Improvements in mean DSQ score from baseline to week 12 were significantly greater in the BOS group (n = 197) than the placebo group (n = 89) (−13.0 vs −9.1; P = 0.015). Similarly, improvements in mean EREFS scores were significantly greater with BOS (n = 202) than placebo (n = 93) (−4.0 vs −2.2; P < 0.001). In total, 61.0% of patients reported a treatment-emergent adverse event (TEAE) (BOS, 61.0%; placebo, 61.0%). Only 2.5% of patients experienced a TEAE leading to dose discontinuation (BOS, 1.4%; placebo, 4.8%). Few patients had severe or serious TEAEs on BOS or placebo. No life-threatening TEAEs were reported.

CONCLUSION:
This phase 3 trial demonstrated the efficacy of BOS as induction therapy for EoE. BOS resulted in significant improvements in histologic, symptomatic and endoscopic endpoints compared with placebo. The majority of TEAEs were mild to moderate and comparable between placebo and BOS. A double-blind, placebo-controlled maintenance study (SHP621-302) is ongoing.
354 Cumulative Increase in the Prevalence of Esophageal Cancer in Patients With Gastroesophageal Reflux Disease (GERD) and Multiple Risk Factors
Authors: Alaber Omar A. , Chandar Apoorva K. , Cooper Gregory S. , Thota Prashanthi N. , Mansoor Emad , Chak Amitabh 
Published: October 2019

INTRODUCTION:
The 2015 ACG clinical guidelines on Barrett’s esophagus (BE) recommend endoscopic screening for men with chronic and/or frequent GERD and two or more risk factors for BE or esophageal adenocarcinoma (EAC). However, the additive effect of these risk factors is not known. Our objective was to determine both the individual and combined effect of multiple risk factors on the prevalence of BE associated neoplasia.

METHODS:
Data were obtained from a commercial de-identified patient database (Explorys, IBM, Inc.) that integrates electronic health records from 26 major U.S. hospital systems from 1999 to May 2019. We identified adult patients (≥18 years) with chronic GERD for ≥5 years (having a GERD diagnosis from May 2014 to May 2019) using Systematized Nomenclature of Medicine - Clinical Terms (SNOMED-CT). Controls were defined as any patient in the Explorys database with chronic GERD, whereas cases were defined as those with chronic GERD and one or more additional BE/EAC associated risk factors per ACG guidelines such as male sex, smoking, age > 50 years, and Caucasian race. Odds ratios (OR) and confidence intervals (CI) for the ORs were calculated for the risk of association of each individual risk factor and with multiple risk factors combined.

RESULTS:
A total of 4,424,810 patients had GERD for ≥5 years. When compared to GERD controls, cases with GERD and obesity (BMI >30) had a 1.4 (95% CI 1.24 – 1.55) times higher odds of a primary neoplasm of the lower esophagus. Addition of each individual risk factor as described in Table 1 shows the incremental effect of these risk factors on development of primary neoplasm of the lower esophagus. With any three out of four risk factors (chronic GERD and age >50 + any three out of four associated risk factors), the odds of having a primary neoplasm of the lower esophagus increased to 6.26 (5.77 – 6.79) when compared to GERD controls.

CONCLUSION:
The incremental and strong association of multiple risk factors with primary neoplasm of the lower esophagus suggests a role for screening endoscopies when clinicians encounter GERD patients with multiple associated risk factors. Although this was a retrospective analysis that relied on diagnosis coding, and despite other limitations of Explorys such as lack of histology reports, and unavailability of family history of BE/EAC, our study further validates the utility of the 2015 ACG Barrett’s guidelines in everyday clinical practice.
359 The Critical and Often Disregarded Role of Surgery in Curing Anemia in Patients With Hiatal Hernia
Authors: Laliberte Anne-Sophie , Brandabur Jack , Baik Peter , Jackson Anee Sophia , Bograd Adam J. , Aye Ralph W. , Farivar Alexander , Louie Brian E. 
Published: October 2019

INTRODUCTION:
During iron deficiency anemia evaluation, patients may be found to have a paraesophageal hernia (PEH). Current GI guidelines recommend iron supplements and proton pump inhibitors (PPIs). Surgical repair is not recommended despite evidence of cure in the surgical literature, even in the absence of Cameron’s lesions. We examine the patterns of care of patients with pre-existing anemia who had PEH repair. We hypothesize that a more robust correction of anemia will be achieved in patients undergoing surgery.

METHODS:
We performed a retrospective chart review of consecutives patients with anemia and hiatal hernia that underwent a surgical repair between 2005-2016 in our system. Normal hemoglobin (Hgb) was defined for females as 12 g/dL and males 13 based on W.H.O. criteria and assessed at diagnosis, preoperatively and postoperatively.

RESULTS:
We analyzed 116 patients who were predominantly females with type 3 PEH of which 52.6% had Cameron ulcers. (Table 1) After diagnosis, 24.1% were transfused, 52% started on iron supplements, 72% on PPIs and 10% on H2-blocker. Patients underwent 1.6 (IQR = 1-5) EGDs, 1.1 (IQR = 1-3) colonoscopies along with CT scans in 39% and capsule endoscopy in 16%. Median time from diagnosis to surgical referral was 381 days (IQR = 129-1332). All patients underwent laparoscopic hernia repair with a total fundoplication (90%), partial fundoplication (6%) or hernia repair only (4%). There were no mortalities. Only 16% experienced a morbidity with 5.6% being major. The mean Hgb at diagnosis was 9.79 in females and 10.9 in males. It increased to 11.1 and 11.4 with medical management. With the addition of surgical repair, it increased to 12.3 and 13.4 at short term follow up. This was sustained at 12.8 and 14.2 long term. (Figure 1) The Hgb was normalized in only 36% of patients after medical management. Comparatively, the Hgb normalized after surgical repair in 62% at short term and in 74% at long term. Patients without Cameron’s ulcers normalized in 62%. (Table 2) After surgery, 95% ceased iron therapy and 73% were free from PPIs.

CONCLUSION:
Anemia associated with a PEH improves with medical therapy, but the addition of surgery normalizes Hgb and seems durable at 4 years without additional medical therapy. We recommend that surgical repair should be an integral part in the treatment, regardless of the presence of Cameron’s ulcers.
362 Factors Associated With Esophagogastric Junction Outflow Obstruction and Spastic Esophageal Motility Disorders
Authors: Foromera Joshua , Jonas Daniel , Ross Kristina , Van De Voorde Zoe , Kaizer Alexander , Menard-Katcher Paul , Yadlapati Rena 
Published: October 2019

INTRODUCTION:
Advances in high resolution manometry (HRM) have resulted in increasing identification of major esophageal motility disorders in addition to achalasia type I and II. These include esophagogatric junction outflow obstruction (EGJOO) and spastic esophageal disorders (SEDs) which include distal esophageal spasm, jackhammer esophagus, and type III achalasia. The aim of this study was to identify the prevalence of and factors associated with EGJOO and SEDs among patients referred for high resolution esophageal manometry.

METHODS:
This is a retrospective study of adult patients who underwent high resolution manometry at a single tertiary-care center between 1/1/14-11/1/18. The following data were collected through electronic health records: demographics, medical and surgical history, medications, endoscopic findings and manometry results. Patients diagnosed with normal esophageal motility, EGJOO or a SED according to Chicago Classification v3.0, without prior history of foregut surgery were included.

RESULTS:
Overall, 911 studies were performed during the study period: 293 (32%) normal motor function, 88 (10%) EGJOO and 44 (5%) SEDs (17 type III achalasia, 19 jackhammer esophagus, 8 distal esophageal spasm). Thus, 425 patients were included in the final analysis [95 (32%) male, mean age 55.8 years, mean body mass index 27.5 kg/m2]. Patients with SEDs or EGJOO were more likely to have comorbid hypertension (55% or 46% vs 32%; P = 0.02 or P = 0.05, respectively) when compared to patients with normal motility. Further, patients with EGJOO and SEDs were older (62.8 or 58.8 vs 53.7 years; P < 0.01 for both) and those with SEDs were more likely to use opiates (43% vs 20%; P = 0.01). Patients with SEDs and EGJOO were also more likely to have comorbid connective tissue disease (17.2% or 14.0% vs 9.7%; P = 0.09 for both) (Table 1).

CONCLUSION:
Among 911 patients who underwent high resolution manometry studies, 10% had EGJOO and 5% had SEDs. Those with EGJOO and SEDs were likely to be older and had comorbid hypertension. Further, connective tissue disorder was more common with EGJOO and SED. These results suggest that the underlying physiologic of spastic and obstructive esophageal motility disorders may be related to microvascular or connective tissue pathology.
363 Reducing Over-Prescription of Proton Pump Inhibitors at an Internal Medicine Residency Clinic
Authors: Scholl Amy , Onwe Ifeanyichukwu , Lee Andrew , Chou Edgar 
Published: October 2019

INTRODUCTION:
Proton pump inhibitors (PPIs) are widely prescribed medications for the treatment of acid suppression for a variety of conditions. The American College of Gastroenterology recommends that the continued use of PPIs be re-assessed 8-12 weeks after the initial start of treatment, but unfortunately, PPIs tend to be prescribed for much longer than this. Our Quality Improvement project investigates the over-prescription of PPIs in an Internal Medicine Residency outpatient clinic. We created an intervention to decrease the inappropriate prescription of PPIs.

METHODS:
This is a prospective study of 150 patients in an outpatient setting and their use of PPIs over the course of a year. Patients had an active diagnosis of either gastroesophageal reflux disease or functional dyspepsia. We performed an educational session as well as an electronic-medical record reminder to tell residents to re-assess the continued use of PPI. Patients were re-assessed 5 months after the intervention. Primary endpoints were the overall number of patients prescribed PPIs, if they were being prescribed PPIs appropriately, and if residents were re-assessing patients’ symptoms and continued need for PPI.

RESULTS:
The final sample size was 133 patients. The average duration that patients were prescribed PPIs was 73.4 weeks, and there were 7.5% associated adverse complications noted. After the intervention, there was a 12.1% decrease in the number of patients prescribed a PPI. Before the intervention 30% (n = 40) of patients were appropriately prescribed a PPI, and this number increased to 39.1% (n = 52) after the intervention (P = 0.023). Before the intervention, 34.58% (n = 46) of patients had their symptoms re-assessed by residents, and this number increased to 47.3% (n = 63) after the intervention (P = 0.001).

CONCLUSION:
By educating residents on the proper use of PPIs and by placing alert reminders in patients’ charts, we observed a decrease in the overall number of prescriptions of PPIs in the outpatient clinic. After the intervention, the frequency of residents re-assessing patients’ symptoms and need for continued use of PPI as well as the overall number of patients appropriately prescribed PPIs increased. We were unable to determine which intervention had the greatest impact (educational session versus alerts) as both interventions were looked at at the same time. Future studies could expand on this by just studying one intervention to see what has the greatest effect on the prescription of PPIs.
372 An Automated, Quantitative Multiplex Immunofluorescence Assay Accurately Risk Stratifies Barrett’s Esophagus Patients With a Community-Based Diagnosis of Low-Grade Dysplasia at a Rate Comparable to Expert Pathologists
Authors: Frei Nicola , Konté Kadere , Bossart Emily , Zhang Yi , Critchley-Thorne Rebecca , Pouw Roos , Bergman Jacques 
Published: October 2019

INTRODUCTION:
The majority of community-based LGD diagnoses are down-staged to non-dysplastic (ND) BE when reviewed by an expert pathologist, whereas patients with confirmed LGD have a 10% annual risk of progression to high-grade dysplasia (HGD) or cancer (Ca). Although recommended by guidelines, expert review is poorly defined, prone to observer variation, and not widely available. Recent studies suggest that an automated, quantitative multiplex immunofluorescence assay may identify NDBE patients with an increased risk of malignant progression. We investigated if this assay also allows objective risk stratification for cases with a community-based diagnosis of LGD at a rate comparable to expert pathologists.

METHODS:
A blinded nested case-control cohort was derived from the screening cohort of a randomized controlled trial of SUrveillance vs. RadioFrequency ablation (SURF) for BE patients with LGD. 60 patients with a community-based diagnosis of LGD of whom 30 progressed to HGD/Ca and 30 patients who did not progress were matched for age, sex and maximal BE length. All random biopsy levels of the baseline endoscopy were independently reviewed by 3 expert pathologists with an international reputation. All levels were additionally tested by a multiplex biomarker assay. The assay classifies patients into low-risk (LR), intermediate-risk (IR) and high-risk (HR) for progression to HGD/Ca within 5 years. A histological revision diagnosis of NDBE was considered as low- (LR), while indefinite for dysplasia (IND) and LGD were considered as high-risk (HR) for progression.

RESULTS:
60 BE patients (52 male), mean age 63 ± 9 years, were studied. Median time between baseline endoscopy and progression was 2.5 years (1.3-5.4). Accuracy, sensitivity and specificity of the biomarker assay vs. the 3 expert pathologists were 73% vs 72-77%, 66% vs 77-80% and 80% vs 63-77%, respectively. 20/26 (78%) patients classified as IR/HR by the biomarker panel and 69-77% classified as HR (IND/LGD) by the 3 expert pathologists progressed to HGD/Ca.

CONCLUSION:
A quantitative multiplex immunofluorescence assay risk stratified BE patients with a community-based diagnosis of LGD with an accuracy comparable to three renowned expert pathologists. The assay allows for automated, objective risk stratification which may be a practical and effective solution to the lack of standardization of expert pathology review of LGD as advocated by all guidelines.
374 Practice Patterns in Patients Admitted for Denovo Acute Food Impaction: A Multi-Center Retrospective Study
Authors: Cavaliere Kimberly , Berkowitz Joshua , Melnyk Janet L. , Raphael Kara L. , Chowdhury Pratik , Benias Petros , Cheung Mary , Trindade Arvind , Whitson Matthew , Josephs Joshua 
Published: October 2019

INTRODUCTION:
Food impactions are a medical emergency for gastroenterologists. Despite their common occurrence, recent data shows high variability in self-reported practice patterns of how gastroenterologists approach food impactions. This may lead to delayed diagnosis and care for patients, particularly in eosinophilic esophagitis (EoE). There is limited data available assessing real life practice habits and recommendations based on endoscopic findings.

METHODS:
This is a multi-centered, single-system retrospective chart review of all patients admitted with de novo food impaction between Jan 2013 and Sept 2018. Data collected includes demographics, clinical, endoscopic, and discharge recommendations. Patients with diagnosis of achalasia, EoE, malignancy, or stricture were excluded. Our primary aim was to characterize GI practice habits and discharge planning. A planned secondary analysis comparing practice habits in patients with and without presumed EoE was done.

RESULTS:
199 patients were admitted with food impaction during the study period, 157 meeting inclusion criteria. 36 had endoscopic features of EoE, with 33 having EoE as the presumptive diagnosis. 109 had a food bolus present on endoscopy. To remove this bolus, the ‘push through’ method was used in 29.9% of cases, roth nets in 26.1%, and graspers in 22.9%. On sub-group analysis, there was no statistical difference regarding endoscopic technique between those with and without presumed EoE. Esophageal biopsy was obtained in 40.1% of cases, but in 75.8% of patients with presumed EoE vs. 32.0% without (P ≤ 0.001) . At discharge, 79% of patients were started on a proton pump inhibitor (PPI), 43.9% were instructed to have a follow up endoscopy, with providers more likely to both start a PPI (P = 0.01) and refer for follow up (P = 0.02) if EoE was suspected.

CONCLUSION:
We conducted a multi-center, single-system study on the real life practice of gastroenterologists evaluating patients with de novo food impaction. EoE was suspected in 33 patients with a confirmed diagnosis in 63.6%. Push technique continued to be used as frequently in patients suspected of having EoE. Only 78.8% of patients underwent esophageal biopsy and 93% were started on PPI, though both statistically more frequent in patients with suspected EoE. There remains room for quality improvement in the treatment of de novo food impactions in patients suspected of having EoE and those who are not. A standardized protocol for food impactions would facilitate prompt diagnosis and treatment.
376 Persistent GERD Symptoms Despite PPI Treatment - Prevalence and Patient Characteristics: Results From a Cross-Sectional Patient Survey
Authors: Taylor Douglas C A , Chen Yan , Hanlon Jennifer , Morlock Robert , Morlock Amy , Howden Colin W. 
Published: October 2019

INTRODUCTION:
GERD is a common disorder often treated with proton pump inhibitors (PPIs). However, many patients experience persistent GERD symptoms despite PPI treatment. The objective of this study was to estimate the prevalence of persistent GERD symptoms despite PPI treatment and to describe the characteristics of these patients in the US adult population.

METHODS:
The Acumen Health Research Institute survey is a cross-sectional health survey of US adults in which a subgroup of participants self-identified as having GERD (GERD patients). Participants aged ≥ 18 years were recruited in 2018 using sampling framework that ensured a composition representative of the US population. Patients were asked about their GERD history, treatments, and symptoms using the GERD Symptom Assessment Scale. Health-related quality of life (HRQoL) was assessed using the Veterans RAND 12-item (VR-12) physical component summary (PCS), mental component summary (MCS), and health utility (VR-6D). Work productivity and sleep disturbance due to GERD were also assessed. Persistent GERD was defined a priori as the presence of bothersome symptoms on at least 2 days in the preceding week despite taking PPIs for at least 25 days per month. Effectiveness of PPI treatment was rated as “a little” or “a lot.” GERD patients with and without persistent GERD symptoms were compared using descriptive statistics.

RESULTS:
Of 12,348 survey respondents, 1566 (12.7%) self-identified as GERD patients; 855 (54.6%) reported taking PPIs. Of those, 301 (35.2%) met the definition for persistent GERD. Patients with persistent GERD had decreased HRQoL (36.2 vs. 40.5 PCS, 41.6 vs. 45.7 MCS, and 0.60 vs. 0.66 VR-6D) and greater impairment in work productivity (3.2 vs. 2.1 work hours/week missed due to health) than those without. GERD patients with persistent GERD were more likely to take antacids (50.2%) and H2-receptor antagonists (17.9%) in addition to their PPI than those without (30.9% and 13.4%, respectively). GERD patients with persistent symptoms had more difficulty with sleep than those without. In the preceding week, 38.2% and 14.4%, respectively, reported difficulty falling asleep because of GERD symptoms on > 2 nights, and 29.3% and 10.6%, respectively, woke because of GERD symptoms on > 2 nights.

CONCLUSION:
Among GERD patients taking PPIs, more than one-third had persistent symptoms. Patients with persistent GERD symptoms had decreased HRQoL, greater impairment of work productivity, and greater sleep disturbance than those without.