Publications by authors named "Jeffrey A Alexander"

178 Publications

Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS).

J Allergy Clin Immunol 2021 Jul 6. Epub 2021 Jul 6.

Inform Diagnostics, Irving, Tex; Department of Pathology, Baylor College of Medicine, Houston, Tex.

Background: End points used to determine treatment efficacy in eosinophilic esophagitis (EoE) have evolved over time. With multiple novel therapies in development for EoE, harmonization of outcomes measures will facilitate evidence synthesis and appraisal when comparing different treatments.

Objective: We sought to develop a core outcome set (COS) for controlled and observational studies of pharmacologic and diet interventions in adult and pediatric patients with EoE.

Methods: Candidate outcomes were generated from systematic literature reviews and patient engagement interviews and surveys. Consensus was established using an iterative Delphi process, with items voted on using a 9-point Likert scale and with feedback from other participants to allow score refinement. Consensus meetings were held to ratify the outcome domains of importance and the core outcome measures. Stakeholders were recruited internationally and included adult and pediatric gastroenterologists, allergists, dieticians, pathologists, psychologists, researchers, and methodologists.

Results: The COS consists of 4 outcome domains for controlled and observational studies: histopathology, endoscopy, patient-reported symptoms, and EoE-specific quality of life. A total of 69 stakeholders (response rate 95.8%) prioritized 42 outcomes in a 2-round Delphi process, and the final ratification meeting generated consensus on 33 outcome measures. These included measurement of the peak eosinophil count, Eosinophilic Esophagitis Histology Scoring System, Eosinophilic Esophagitis Endoscopic Reference Score, and patient-reported measures of dysphagia and quality of life.

Conclusions: This interdisciplinary collaboration involving global stakeholders has produced a COS that can be applied to adult and pediatric studies of pharmacologic and diet therapies for EoE and will facilitate meaningful treatment comparisons and improve the quality of data synthesis.
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http://dx.doi.org/10.1016/j.jaci.2021.07.001DOI Listing
July 2021

Same-day opioid administration in opiate naïve patients is not associated with opioid-induced esophageal dysfunction (OIED).

Neurogastroenterol Motil 2021 05 22;33(5):e14059. Epub 2020 Dec 22.

Department of Gastroenterology, Hepatology Mayo Clinic, Rochester, MN, USA.

Background: Opioid-induced esophageal dysfunction (OIED) is a recognized complication of chronic opioid use. However, the impact of acute opioid administration on esophageal motility remains unclear.

Methods: Opioid naïve patients with high-resolution manometry (HRM) <480 min following esophagogastroduodenoscopy (EGD) (opioid-HRM) and a control group with HRM <36 h prior to EGD between January 1, 2016, and November 10, 2018, from a single institution were identified. EGDs were performed exclusively with versed and fentanyl.

Key Results: One hundred and seventy-four patients were identified, with 83 (47.7%) opioid-HRM and 91 (52.3%) controls. Mean time from EGD to HRM was 229 (78-435) min. Baseline clinical features and HRM indications were similar between opioid-HRM and controls. Chicago classification v3.0 defined HRM findings were similar between groups. Major motility disorders as defined by the Chicago classification v3.0 occurred at a similar frequency among opioid-HRM and controls (27.7% vs. 36.3%, p = 0.23). Mean distal contractile integrity (DCI) was higher in opioid-HRM (1939.3 ± 1318.9 vs. 1792.2 ± 2062.3 mmHg∙cm∙s, p = 0.043), but maximum DCI, distal latency, and integrated relaxation pressure did not differ between groups. Subgroup analysis assessing time and dose dependency did not identify differences in individual manometric parameters and Chicago classification v3.0 diagnosis between patients with HRM <240 min after EGD, >240 min after EGD, ≥125 mcg of IV fentanyl, <125 mcg IV fentanyl and controls.

Conclusions And Inferences: Same-day acute opioid administration did not affect HRM findings in opioid naïve patients. Studies assessing the pathophysiology of and duration-dependent relationship with opioids in OIED are needed.
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http://dx.doi.org/10.1111/nmo.14059DOI Listing
May 2021

Mucosal penetration and clearance of gluten and milk antigens in eosinophilic oesophagitis.

Aliment Pharmacol Ther 2021 02 2;53(3):410-417. Epub 2020 Dec 2.

Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, MN, USA.

Background: The Th2 allergic pathway in eosinophilic oesophagitis (EoE) responds to food antigen exposure.

Aim: To compare the presence and temporal pattern of food antigen penetration in oesophageal mucosa in active and inactive EoE and controls METHODS: Thirty-two patients with EoE (20 active) and 10 controls were asked to eliminate all wheat and/or dairy 12, 24, 48, 72 or 96 hours before endoscopy. Immunostaining on endoscopic biopsies was performed for gliadin, casein and whey.

Results: Gluten, casein and whey were detected by positive staining in 17/32 (53.1%), 21/32 (65.6%), and 30/32 (92.0%) of patients, respectively. In active vs inactive EoE, 70.0% vs 25.0% (P < 0.05), 80.0% vs 41.5%, and 90.0% vs 90.9% patients had detectable gliadin, casein and whey, respectively. Casein and whey (20.0% and 100%, respectively) but not gliadin, were present in controls. The gliadin staining density was greater in active compared to inactive disease at ≤ 24 vs >24 hours after exposure (P = 0.05) but no differences were detected when comparing active and inactive patients for casein and whey. There was greater staining density for whey than casein for all patients at ≤24 hours (mean 2.14 ± 0.91 and 1.07 ± 1.33, P = 0.02). In active EoE, IgG4 was present in 14/20 compared to one inactive patient.

Conclusion: The oesophageal epithelium is selectively permeable and has relatively long dwell times for food antigens known to trigger EoE. The precise mechanism of antigen-specific mucosal entry and the factors that determine the induction or effector trigger of the Th2 pathway activation merit further study.
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http://dx.doi.org/10.1111/apt.16180DOI Listing
February 2021

Proton Pump Inhibitor Therapy in Eosinophilic Esophagitis: Predictors of Nonresponse.

Dig Dis Sci 2021 09 29;66(9):3096-3104. Epub 2020 Sep 29.

Department of Gastroenterology and Hepatology, Mayo Clinic, 200 First Street, SW, Rochester, MN, 55905, USA.

Background: Identification of clinical predictors of response to first-line therapies for EoE is needed to guide initial medical management.

Study Design: A retrospective analysis of patients diagnosed with EoE from 2011 to 2018 was conducted. Clinical and diagnostic variables including demographics, endoscopic, and esophagram findings were compared between PPI responders and PPI nonresponders. All patients underwent a standard 8-week twice-daily PPI trial, with PPI responsiveness defined as < 15 eos/hpf on repeat EGD. Univariate and multivariable analyses were conducted to identify risk factors for nonresponse, and ROC curves were created to identify cutoff values.

Results: A total of 223 EoE patients (135 male, median age 39 (29-51)) were identified, with PPI nonresponse (PPI-NR) in 71% of patients. PPI-NR was seen in all 10 patients with failure of scope passage, with an OR of 9.06 by univariate analysis (P = 0.1485). In a multivariable model, age per 10 years (OR 0.71; P = 0.007), BMI per 1 kg/m (OR 0.94; P = 0.03), and peripheral eosinophil count per 100 per mm (OR 1.37; P = 0.003) were independent risk factors. Dichotomization to maximize sensitivity and specificity identified age ≤ 36 years old, BMI ≤ 25.2 kg/m, and peripheral eos > 460 per mm as predictive thresholds for PPI-NR. The probability of PPI-NR was 72.4-84.5% with 1 risk factor, 87.9-93.8% with 2 risk factors, and 97.2% with all 3 risk factors.

Conclusions: Young age, reduced BMI, elevated peripheral eosinophil count, and likely inability to pass an endoscope predict lack of response to PPIs in patients with EoE.
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http://dx.doi.org/10.1007/s10620-020-06633-4DOI Listing
September 2021

Evaluating a combined bowel preparation for small-bowel capsule endoscopy: a prospective randomized-controlled study.

Gastroenterol Rep (Oxf) 2020 Feb 19;8(1):31-35. Epub 2019 Oct 19.

Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.

Background: Capsule endoscopy (CE) is frequently hindered by intra-luminal debris. Our aim was to determine whether a combination bowel preparation would improve small-bowel visualization, diagnostic yield, and the completion rate of CE.

Methods: Single-blind, prospective randomized-controlled study of outpatients scheduled for CE. Bowel-preparation subjects ingested 2 L of polyethylene glycol solution the night prior to CE, 5 mL simethicone and 5 mg metoclopramide 20 minutes prior to CE and laid in the right lateral position 30 minutes after swallowing CE. Controls had no solid food after 7 p.m. the night prior to CE and no liquids 4 hours prior to CE. Participants completed a satisfaction survey. Capsule readers completed a small-bowel-visualization assessment.

Results: Fifty patients were prospectively enrolled (56% female) with a median age of 54.4 years and 44 completed the study (23 patients in the control group and 21 in the preparation group). There was no significant difference between groups on quartile-based small-bowel visualization (all >0.05). There was no significant difference between groups in diagnostic yield (=0.69), mean gastric (=0.10) or small-bowel transit time (=0.89). The small-bowel completion rate was significantly higher in the preparation group (100% vs 78%; =0.02). Bowel-preparation subjects reported significantly more discomfort than controls (62% vs 17%; =0.01).

Conclusions: Combined bowel preparation did not improve small-bowel visualization but did significantly increase patient discomfort. The CE completion rate improved in the preparation group but the diagnostic yield was unaffected. Based on our findings, a bowel preparation prior to CE does not appear to improve CE performance and results in decreased patient satisfaction (ClinicalTrials.gov, No. NCT01243736).
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http://dx.doi.org/10.1093/gastro/goz054DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7217271PMC
February 2020

Effect of Maintenance Therapy for Eosinophilic Esophagitis on Need for Recurrent Dilation.

Dig Dis Sci 2021 02 12;66(2):503-510. Epub 2020 Mar 12.

Division of Gastroenterology and Hepatology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.

Background: Eosinophilic esophagitis is an inflammatory condition in which eosinophil infiltration leads to esophageal remodeling and stricturing, with dilation therapy often needed. Achieving histologic remission reduces the need for repeat dilation, although little is known about the effects of long-term maintenance therapy.

Aims: To further assess the relationship between short-term histologic remission and maintenance therapy on need for repeat dilation in eosinophilic esophagitis.

Methods: A total of 77 patients with eosinophilic esophagitis (59.7% male; mean age 41.6 years) seen at a single medical center from June 2000 to August 2017 were included. Information on history of dilation and therapy [proton pump inhibitors (PPIs), steroids, elimination diet] was collected. Mean follow-up was 164 weeks. Fifty-one patients achieved histologic remission and 42 of these remained on maintenance therapy (23 PPIs, 14 topical steroids, and 5 dietary therapy). Standard phone interview was completed in cases with lack of follow-up. Only patients who underwent esophageal dilation to ≥ 17 mm were included.

Results: A significantly lower proportion of patients on maintenance therapy required repeat dilation (12/42) compared with patients not on maintenance therapy (8/9) (hazard ratio 0.12; p < 0.001). Of patients who received maintenance therapy, 9.1% required re-dilation. The difference in need for repeat dilation in patients who achieved histologic remission on therapy (14/26) versus those who did not (20/51) was not significant (hazard ratio 1.34; p = 0.45).

Conclusion: In a retrospective analysis of patients with eosinophilic esophagitis, we found that a significantly lower proportion who received maintenance therapy (PPIs, steroids, or dietary exclusions) required repeat dilation.
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http://dx.doi.org/10.1007/s10620-020-06192-8DOI Listing
February 2021

A decreased abundance of clostridia characterizes the gut microbiota in eosinophilic esophagitis.

Physiol Rep 2019 10;7(20):e14261

Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.

Abnormalities in the gut microbiome are associated with suppressed Th2 response (Belizario et al., 2018 Mediators Inflamm. 2018:2037838) and predisposition to atopic disease such as asthma and eczema. We investigated if this applies to eosinophilic esophagitis (EoE). Stool bacterial DNA was extracted and followed by 16S rRNA amplification from 12 patients with eosinophilic esophagitis and 12 controls. Alpha- and beta-diversity were analyzed. Only two patients had asthma or atopy and one patient was on budesonide. No patients were on PPIs. Patients with EoE had lower gut microbiota alpha diversity (species richness, P = 0.09; Shannon index, P = 0.01). The microbial composition was distinct as evidenced by significantly different beta diversity (P = 0.03) when compared to healthy controls. There were also significant differences in relative abundance at multiple taxonomic levels when comparing the two communities; at the phylum level, we observed a marked decrease in Firmicutes and increase in Bacteroidetes and at the order and family level there were significant decreases in Clostridia and Clostridiales in patients with EoE (q ≤ 0.1). We conclude that there are significant differences in microbial community structure, microbial richness, and evenness and a significant decrease in taxa within the Clostridia in patients with EoE. Our data suggest that Clostridia based interventions could be tested as adjuncts to current therapeutic strategies in EoE.
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http://dx.doi.org/10.14814/phy2.14261DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6813259PMC
October 2019

Dissemination of quality improvement innovations by multisector health care alliances.

J Health Organ Manag 2019 Jun 12;33(4):511-528. Epub 2019 Jun 12.

Center for Health Care and Policy Research, Pennsylvania State University , University Park, Pennsylvania, USA.

Purpose: Multisector health care alliances (alliances) are increasingly viewed as playing an important role in improving the health and health care of local populations, in part by disseminating innovative practices, yet alliances face a number of challenges to disseminating these practices beyond a limited set of initial participants. The purpose of this paper is to examine how alliances attempt to disseminate innovative practices and the facilitating and inhibiting factors that alliances confront when trying to do so.

Design/methodology/approach: The authors adopted multiple holistic case study design of eight alliances with a maximum variation case selection strategy to reflect a range of structural and geographic characteristics. Semi-structured interviews with staff, leaders and board members were used.

Findings: The findings show that dissemination is a multidirectional process that is closely if not inextricably intertwined with capacity- and context-related factors (of the alliance, partnering organizations and target organizations). Thus, standardized approaches to dissemination are likely the exception and not the rule, and highlight the value of existing frameworks as a starting point for conceptualizing the important aspects of dissemination, but they are incomplete in their description of the "on-the-ground" dissemination processes that occur in the context of collaborative organizational forms such as alliances.

Originality/value: Despite a rapidly expanding evidence base to guide clinical and managerial decision making, this knowledge often fails to make its way into routine practice. Consequently, the search for effective strategies to reduce this gap has accelerated in the past decade. This study sheds light on those strategies and the challenges to implementing them.
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http://dx.doi.org/10.1108/JHOM-08-2017-0195DOI Listing
June 2019

The evolution of treatment and complications of esophageal food impaction.

United European Gastroenterol J 2019 05 5;7(4):548-556. Epub 2019 Mar 5.

Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.

Background: Esophageal food impaction is relatively common and increasing over time. Treatment ranges from medications to invasive endoscopic therapies. The endoscopic push technique has been advised against in favor of endoscopic retrieval for safety concerns. We sought to assess use patterns and safety of treatments for food impaction in a population-based retrospective review.

Methods: A database of recorded esophageal food impactions in Olmsted County, MN, USA, from 1975-2011 was reviewed for patient demographics, treatment, and complications.

Results: A total of 645 impactions occurred, with increasing incidence over time, peaking at 23.2 per year (2000-2004). Medications (almost exclusively glucagon) were successful in relieving impactions 34.5% of the time when trialed. Urgent endoscopy was common (74.0%), as was the need for endoscopic therapy (67.1%). Endoscopic therapy increased over time, with the endoscopic push technique becoming most common. Esophageal complications (deep mucosal injury or perforation) increased over time but remained rare (peak 11%). There was no difference in complications between push and retrieval techniques.

Conclusions: The endoscopic push technique is safe in comparison to endoscopic retrieval in esophageal food impactions. While complications surrounding impaction have increased, they remain rare. Medication trials are reasonable, as long as they do not delay endoscopy, and may prevent the need for emergent endoscopy in one-third of cases.
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http://dx.doi.org/10.1177/2050640619836052DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6488802PMC
May 2019

Penetration of the Esophageal Epithelium by Dust Mite Antigen in Patients With Eosinophilic Esophagitis.

Gastroenterology 2019 07 5;157(1):255-256. Epub 2019 Mar 5.

Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota. Electronic address:

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http://dx.doi.org/10.1053/j.gastro.2019.02.042DOI Listing
July 2019

Diagnostic and Therapeutic Long-term Management of Eosinophilic Esophagitis- Current Concepts and Perspectives for Steroid Use.

Clin Transl Gastroenterol 2018 12;9(12):e212

Division of Gastroenterology and Hepatology, Mayo Clinic Rochester, Rochester, MN, USA.

Eosinophilic esophagitis (EoE) is a chronic inflammatory disease of the esophagus, which requires short- and long-term treatment. In addition, patients under long-term treatment for any chronic condition should have a structured follow-up. The mainstays in EoE treatment are drugs (such as swallowed topical corticosteroids [STC] and proton pump inhibitors), dietary exclusions, and endoscopic dilations. STC are the most widely used treatment and have proven efficacy in inducing clinical, endoscopic and histological remission in active EoE. However, data regarding maintaining disease remission and long-term management are limited. Ongoing disease activity and relapses despite STC treatment are frequently observed. This sheds light on the urgent need for adequate maintenance strategies, which have not been well defined. In terms of follow-up concepts, to date neither guidelines nor consensus recommendations have been published. To summarize the current knowledge on long-term diagnostic and therapeutic STC management of EoE, we conducted a literature search using PubMed and Embase applying the following key search items: Eosinophilic esophagitis, eosinophils, esophagus, swallowed topical corticosteroids, fluticasone, budesonide, long-term, treatment, therapy, and follow-up. In addition, we present empirically developed long-term management concepts applied at two large EoE centers, with a special focus on STC treatments. Finally, we highlight areas of future research and perspectives regarding the long-term management of EoE.
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http://dx.doi.org/10.1038/s41424-018-0074-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6303250PMC
December 2018

The perceived importance of intersectoral collaboration by health care alliances.

J Community Psychol 2019 05 21;47(4):856-868. Epub 2019 Jan 21.

Pennsylvania State University.

There is growing interest in the use of intersectoral collaboration (e.g., alliances, coalitions, partnerships) to address complex, health-related issues in local communities. Relatively little empirical research, however, has examined how to foster and sustain collaboration across sectors during later stages of development, despite a recognition that the needs and goals for collaboration may change over time. The purpose of this study was to address this gap by examining the perceptions of alliance participants regarding the importance of collaborating with different industry sectors as alliances transitioned from stable, prescriptive foundation support to a more uncertain future. Our findings suggest that, in addition to the contextual characteristics highlighted in previous research, the perceived importance of intersectoral collaboration varies for different types of alliances and participants. Moreover, the salience of these characteristics varied for different types of collaboration, in our case, collaboration with nonmedical health care sectors and nonhealth care sectors. Collectively, our findings point to the importance of thinking more comprehensively, across multiple levels of influence, when considering ways to foster or sustain intersectoral collaboration.
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http://dx.doi.org/10.1002/jcop.22158DOI Listing
May 2019

Measurement of Observed Eating Behaviors in Patients With Active and Inactive Eosinophilic Esophagitis.

Clin Gastroenterol Hepatol 2019 10 14;17(11):2371-2373. Epub 2018 Dec 14.

Department of Gastroenterology, Mayo Clinic, Rochester, Minnesota. Electronic address:

Subjective measures of eating difficulties in eosinophilic esophagitis (EoE) such as the presence of dysphagia, food modifications, and prolonged eating times are well documented. Although it is assumed that these measures reflect adaptive measures for eating with EoE, this is not well studied. The aim of this study was to directly observe and measure eating behaviors in patients with EoE and assess the degree of correlation to subjective assessment and validated EoE scoring systems.
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http://dx.doi.org/10.1016/j.cgh.2018.12.011DOI Listing
October 2019

Variation in Endoscopic Activity Assessment and Endoscopy Score Validation in Adults With Eosinophilic Esophagitis.

Clin Gastroenterol Hepatol 2019 07 23;17(8):1477-1488.e10. Epub 2018 Nov 23.

Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.

Background & Aims: Eosinophilic esophagitis (EoE) is assessed endoscopically (endoscopic activity), based on grades of edema, rings, exudates, furrows, and strictures (EREFS). We examined variations in endoscopic assessments of severity, developed and validated 3 EREFS-based scoring systems, and assessed responsiveness of these systems using data from a randomized placebo-controlled trial of patients with EoE.

Methods: For the development set, 5 gastroenterologists reviewed EREFS findings from 266 adults with EoE and provided endoscopist global assessment scores (EndoGA, scale of 0 to 10); variation (ΔEndoGA) was assessed using linear regression. We evaluated simple scores (features given arbitrary values from 0 to 3) and developed 2 scoring systems (adjusted score range, 0-100). We then fitted our linear regression model with mean EndoGA to data from 146 adults recruited in centers in Switzerland and the United States between April 2011 and December 2012. For the validation set, we collected data from 120 separate adults (recruited in centers in Switzerland and the United States between May 2013 and July 2014), assessing regression coefficient-based scores using Bland-Altman method. We assessed the responsiveness of our scoring systems using data from a randomized trial of patients with EoE given fluticasone (n=16) or placebo (n=8).

Results: The distribution of EndoGA values differed among endoscopists (mean ΔEndoGA, 2.6±1.8; range 0-6.6). We developed 2 regression-based scoring systems to assess overall and proximal and distal esophageal findings; variation in endoscopic features accounted for more than 90% of the mean EndoGA variation. In the validation group, differences between mean EndoGA and regression-based scores were small (ranging from -4.70 to 2.03), indicating good agreement. In analyses of data from the randomized trial, the baseline to end of study change in patients given fluticasone was a reduction of 24.3 in simple score (reduction of 4.6 in patients given placebo, P=.052); a reduction of 23.5 in regression-based overall score (reduction of 6.56 in patients given placebo, P=.12), and a reduction of 23.8 (reduction of 8.44 in patients given placebo, P=.11).

Conclusion: Assessments of endoscopic activity in patients with EoE vary among endoscopists. In an analysis of data from a randomized controlled trial, we found that newly developed scoring systems are no better than simple scoring system in detecting changes in endoscopic activity. These results support the use of a simple scoring system in evaluation of endoscopic activity in patients with EoE. clinicaltrials.gov no: NCT00939263 and NCT01386112.
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http://dx.doi.org/10.1016/j.cgh.2018.11.032DOI Listing
July 2019

Small bowel bleeding in patients with left ventricular assist device: outcomes of conservative therapy versus balloon-assisted enteroscopy.

Ann Gastroenterol 2018 Nov-Dec;31(6):692-697. Epub 2018 Sep 26.

Division of Gastroenterology and Hepatology (Badr Al-Bawardy, Emmanuel Gorospe, Louis M. Wong Kee Song, Jeffrey A. Alexander, David H. Bruining, Nayantara Coelho-Prabhu, Elizabeth Rajan).

Background: Small bowel bleeding (SBB) accounts for 30% of gastrointestinal bleeding (GIB) episodes in patients with a left ventricular assist device (LVAD). The aim of this study was to determine the outcomes of conservative therapy (CT) compared to balloon-assisted enteroscopy (BAE) in the management of SBB in LVAD patients.

Methods: A retrospective review was performed of a prospectively maintained LVAD database from January 2003 to July 2015. LVAD patients with SBB were classified into a BAE group or a CT group according to whether they did or did not undergo BAE.

Results: Forty-two patients (22 BAE, 20 CT) with mean age 66±9.3 years (79% male) were included. The yield of BAE was 64% without reported complications. Overt re-bleeding occurred in 40% of the BAE group compared to 22% of the CT group. The BAE group had a higher mean number of GIB hospitalizations per month compared to the CT group (0.07 vs. 0.03; incidence rate ratio [IRR] 2.72, 95% CI 1.06-6.98; P=0.04). There was no significant difference between the BAE and the CT groups in the number of packed red blood cell (pRBC) transfusions per month (0.42 vs. 0.18; IRR 2.31, 95% CI 0.88-6.04; P=0.09) or all-cause mortality (61% in the CT group and 42% in the BAE group; P=0.90).

Conclusion: BAE is safe in LVAD patients and has a moderate therapeutic yield. In our cohort of patients, BAE did not appear to improve re-bleeding rate, GIB-related hospitalizations, pRBC transfusions or mortality compared to CT. However, future prospective trials with larger sample sizes are needed to confirm these findings.
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http://dx.doi.org/10.20524/aog.2018.0316DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6191869PMC
September 2018

Comparison of mucosal impedance measurements throughout the esophagus and mucosal eosinophil counts in endoscopic biopsy specimens in eosinophilic esophagitis.

Gastrointest Endosc 2019 04 24;89(4):693-700.e1. Epub 2018 Aug 24.

Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.

Background And Aims: Assessing eosinophilic esophagitis (EoE) activity from limited esophageal mucosal biopsy samples has been questioned. Here our aim was to compare mucosal impedance (MI) throughout the esophagus and eosinophil counts in endoscopic biopsy samples in EoE.

Methods: We compared 20-site MI using a balloon catheter in the esophagus and eosinophils per high-power field (eos/HPF) in esophageal mucosal biopsy samples. Data are summarized as median (interquartile range) comparing control subjects and EoE using Mann-Whitney rank sum test and between endoscopic reference score and MI (minimal and average) using rank Spearman correlation.

Results: Ten adult control patients (ages 38-70) and 23 EoE patients (ages 21-80, 18 active) were studied. The mean (range) pan-esophageal MI in control subjects was significantly higher (6435 ohms [4546-7301]) compared with EoE patients (2004 ohms [1437-2546], P < .001). In control patients 172 of 180 (95.6%) individual impedance measurements (18 per patient) were normal when compared with 126 of 432 (29.2%) measurements in EoE. No EoE patient had uniformly normal MI. MI varied widely, with 19 of 23 patients having values above and below 2300 ohms (normal) regardless of EoE activity. Correlation of maximim eos/HPF with minimum and average MI per patient was r = -.243, P = .072 and r = -.358, P = .086, respectively. Of 5 patients with inactive EoE, 3 had >50% abnormal MI segments. Correlation coefficients of the endoscopic reference score with minimum and average MI were r = -.154, P = .47 and r = -.27, P = .20, respectively. The procedure was <5 minutes without adverse events.

Conclusions: MI is lower in the esophagus of EoE patients compared with control subjects with poor correlation between peak esophageal eosinophil counts, EoE activity, and MI. Segmental esophageal MI provides a unique marker of esophageal dysfunction in EoE. (Clinical trial registration number: NCT02995395.).
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http://dx.doi.org/10.1016/j.gie.2018.08.031DOI Listing
April 2019

Sustaining participation in multisector health care alliances: The role of personal and stakeholder group influence.

Health Care Manage Rev 2020 Jul/Sep;45(3):196-206

Larry R. Hearld, PhD, is Associate Professor, Department of Health Services Administration, School of Health Professions, University of Alabama at Birmingham. E-mail: Jeffrey A. Alexander, PhD, is Professor Emeritus, Department of Health Management and Policy, School of Public Health, The University of Michigan, Ann Arbor.

Background: Cross-sectoral collaborative organizations (e.g., alliances, coalitions) bring together members from different industry sectors to ameliorate multifaceted problems in local communities. The ability to leverage the diverse knowledge and skills of these members is predicated on their sustained participation, which research has shown to be a significant challenge.

Purpose: The purpose of this study was to investigate how alliance member perceptions of decision-making influence relate to sustained participation in the alliance and its activities.

Methodology: An Internet-based survey of 638 members of 15 multistakeholder health care alliances participating in the Robert Wood Johnson Foundation's Aligning Forces for Quality program was conducted. Ordinal logistic regression path analysis was used to estimate the relationship between two types of influence (personal influence and general stakeholder influence), perceived value of alliance participation, and intentions regarding future participation.

Findings: Alliance members saw less participation value when their personal influence was believed to be lower than the influence of other alliance members (b = -0.09, p < .05). This type of influence was not significantly associated with the anticipated level of future participation. In contrast, imbalances in general stakeholder group influence was not significantly associated with perceived value, but greater imbalances were associated with a decreased likelihood of future participation (OR = 0.52, 95% CI [0.32, 0.83]).

Practice Implications: Our findings highlight the important yet complicated task of balancing perceptions of influence; leaders must keep the desired outcomes in mind when considering what type of influence to attend to.
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http://dx.doi.org/10.1097/HMR.0000000000000216DOI Listing
September 2021

How different governance models may impact physician-hospital alignment.

Health Care Manage Rev 2020 Apr/Jun;45(2):173-184

Lawton R. Burns, PhD, MBA, The James Joo-Jin Kim Professor, Department of Health Care Management, The Wharton School, University of Pennsylvania, Philadelphia. E-mail: Jeffrey A. Alexander, PhD, is Professor Emeritus, Department of Health Management & Policy, School of Public Health, University of Michigan, Ann Arbor. Ronald M. Andersen, PhD, is Wasserman Professor Emeritus, Department of Health Policy & Management, University of California-Los Angeles, California.

Background: Hospitals utilize three ideal type models for governing relationships with their physicians: the traditional medical staff, strategic alliances, and employment. Little is known about how these models impact physician alignment.

Purpose: The study compares the level of physician-hospital alignment across the three models.

Approach: We used survey data from 1,895 physicians in all three models across 34 hospitals in eight systems to measure several dimensions of alignment. We used logistic equations to predict survey nonresponse and differential physician selection into the alliance and employment models. Controlling for these selection effects, we then used multiple regression to estimate the effects of alliance and employment models on alignment.

Results: Physicians in employment models express greater alignment with their hospital on several dimensions, compared to physicians in alliances and the traditional medical staff. There were no differences in physician alignment between the latter two models.

Conclusions: Employment models promote greater alignment on some (but not all) dimensions, controlling for physician selection. The impact of employment on alignment is not large, however.

Practice Implications: Hospitals and accountable care organizations that rely on employment may achieve higher physician alignment compared to the other two models. It is not clear that the gain in alignment is worth the cost of employment. Given the small impact of employment on alignment, it is also clear that they are not identical. Hospitals may need to go beyond structural models of integration to achieve alignment with their physicians.
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http://dx.doi.org/10.1097/HMR.0000000000000214DOI Listing
June 2021

Updated International Consensus Diagnostic Criteria for Eosinophilic Esophagitis: Proceedings of the AGREE Conference.

Gastroenterology 2018 10 6;155(4):1022-1033.e10. Epub 2018 Sep 6.

Division of Pediatric Gastroenterology, Hepatology and Nutrition, Children's Hospital of Illinois, University of Illinois, Peoria, Illinois.

Background & Aims: Over the last decade, clinical experiences and research studies raised concerns regarding use of proton pump inhibitors (PPIs) as part of the diagnostic strategy for eosinophilic esophagitis (EoE). We aimed to clarify the use of PPIs in the evaluation and treatment of children and adults with suspected EoE to develop updated international consensus criteria for EoE diagnosis.

Methods: A consensus conference was convened to address the issue of PPI use for esophageal eosinophilia using a process consistent with standards described in the Appraisal of Guidelines for Research and Evaluation II. Pediatric and adult physicians and researchers from gastroenterology, allergy, and pathology subspecialties representing 14 countries used online communications, teleconferences, and a face-to-face meeting to review the literature and clinical experiences.

Results: Substantial evidence documented that PPIs reduce esophageal eosinophilia in children, adolescents, and adults, with several mechanisms potentially explaining the treatment effect. Based on these findings, an updated diagnostic algorithm for EoE was developed, with removal of the PPI trial requirement.

Conclusions: EoE should be diagnosed when there are symptoms of esophageal dysfunction and at least 15 eosinophils per high-power field (or approximately 60 eosinophils per mm) on esophageal biopsy and after a comprehensive assessment of non-EoE disorders that could cause or potentially contribute to esophageal eosinophilia. The evidence suggests that PPIs are better classified as a treatment for esophageal eosinophilia that may be due to EoE than as a diagnostic criterion, and we have developed updated consensus criteria for EoE that reflect this change.
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http://dx.doi.org/10.1053/j.gastro.2018.07.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6174113PMC
October 2018

Funding profiles of multisector health care alliances and their positioning for sustainability.

J Health Organ Manag 2018 Jun 18;32(4):587-602. Epub 2018 May 18.

Center for Health Care and Policy Research, Pennsylvania State University , University Park, Pennsylvania, USA.

Purpose The purpose of this paper is to examine the relationship between different aspects of alliance funding profiles (e.g. range of sources, dependence on specific sources) and participant' perceptions of how well the organization is positioned for the future. Design/methodology/approach A mixed method study in the context of eight alliances participating in the Robert Wood Johnson Foundation's Aligning Forces for Quality program. Data collection approaches included surveys of alliance participants and semi-structured interviews with alliance leaders. Findings The findings indicate that dependence on grant revenues, in particular, may be problematic for how well alliances are positioned for sustainability. While a number of approaches were identified to reduce dependence on grants, implementing these strategies presented more of a challenge for alliances due to the contextual demands of their external environment and a need to strike a balance between pursuing alternative revenue sources and fidelity to the mission and identity of the organization. Practical implications Alliance leaders need to have not only a broad and accurate understanding of their external environment, but also an appreciation of the alliance's identity in that environment. Collectively, the findings can help organizational leaders be more informed about their funding choices and the implications those choices have for the future of their organization. Originality/value Collaborative forms of organizations (e.g. alliances, coalitions, networks) are increasingly viewed as an effective means of addressing complex, multifaceted health, and social challenges. For collaborative organizations that depend on the coordinated efforts of volunteers, addressing such complex issues is predicated on sustaining programmatic activities as well as the interest and participation of stakeholders over extended periods of time. This study sheds light on how leaders of these organizations may improve their prospects for sustainability.
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http://dx.doi.org/10.1108/JHOM-01-2018-0003DOI Listing
June 2018

Lichen planus: a rare cause of a narrowed esophagus.

J Gastrointestin Liver Dis 2018 06;27(2):117

Division of Gastroenterology and Hepatology,Mayo Clinic, Rochester, MN, USA.

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http://dx.doi.org/10.15403/jgld.2014.1121.272.lchDOI Listing
June 2018

Outcomes of repeat balloon assisted enteroscopy in small-bowel bleeding.

Endosc Int Open 2018 Jun 25;6(6):E694-E699. Epub 2018 May 25.

Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.

Background/aims:  The rate of recurrent small-bowel bleeding (SBB) remains high despite the advent of balloon assisted enteroscopy (BAE). The study aims were to determine: (1) the diagnostic and therapeutic yields, and adverse event rate of repeat BAE in SBB, and (2) the predictors of a positive repeat BAE.

Methods:  A retrospective review of a BAE database was conducted. Patients who had > 1 BAE for SBB were included. Primary outcomes were diagnostic yield, therapeutic yield, and adverse events of repeat BAE. Secondary outcomes were predictors of a positive repeat BAE.

Results:  A total of 175 patients (55 % men; mean age 64.1 ± 16.3 years) were included. The diagnostic and therapeutic yields of repeat BAE were 55 % and 42 %, respectively. Repeat BAE adverse events occurred in 5 % with self-limited abdominal pain being most common. Patients with a positive repeat BAE were significantly older than the negative group (68.6 ± 13.9 vs. 60.9 ± 17.1;  = 0.001) and were more likely to have cardiac comorbidities (OR 2.4, 95 %CI: 1.3 - 4.6;  = 0.01), chronic kidney disease (OR 2.3, 95 %CI: 1.1 - 4.9;  = 0.04), chronic obstructive pulmonary disease (OR 3.3, 95 %CI: 1.3 - 8.1;  = 0.01), positive initial BAE (OR 3.6, 95 %CI: 1.9 - 6.8;  < 0.001), and antegrade procedure (OR 3.3, 95 %CI: 1.7 - 6.1;  < 0.001). On multivariate analysis, a positive initial BAE and antegrade route were the only significant predictive factors.

Conclusions:  Performing a repeat BAE for SBB appears safe and provided modest yields. A positive initial BAE and antegrade route were predictive of a positive repeat BAE.
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http://dx.doi.org/10.1055/a-0599-6085DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5979197PMC
June 2018

Proton Pump Inhibitors: Review of Emerging Concerns.

Mayo Clin Proc 2018 02;93(2):240-246

Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN. Electronic address:

First introduced in 1989, proton pump inhibitors (PPIs) are among the most widely utilized medications worldwide, both in the ambulatory and inpatient clinical settings. The PPIs are currently approved by the US Food and Drug Administration for the management of a variety of gastrointestinal disorders including symptomatic peptic ulcer disease, gastroesophageal reflux disease, and nonulcer dyspepsia as well as for prevention of gastrointestinal bleeding in patients receiving antiplatelet therapy. PPIs inhibit gastric acid secretion, and the most commonly associated adverse effects include abdominal pain, diarrhea, and headache. Although PPIs have had an encouraging safety profile, recent studies regarding the long-term use of PPI medications have noted potential adverse effects, including risk of fractures, pneumonia, Clostridium difficile diarrhea, hypomagnesemia, vitamin B deficiency, chronic kidney disease, and dementia. These emerging data have led to subsequent investigations to assess these potential risks in patients receiving long-term PPI therapy. However, most of the published evidence is inadequate to establish a definite association between PPI use and the risk for development of serious adverse effects. Hence, when clinically indicated, PPIs can be prescribed at the lowest effective dose for symptom control.
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http://dx.doi.org/10.1016/j.mayocp.2017.10.022DOI Listing
February 2018

Efficacy of Atopy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study.

Dig Dis Sci 2018 03 18;63(3):694-702. Epub 2018 Jan 18.

Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, 55905, USA.

Background: Atopy patch testing (APT) has shown potential for predicting dietary food triggers in studies of children and adolescents with eosinophilic esophagitis (EoE).

Aims: To assess the efficacy of APT in adults with EoE.

Methods: We conducted a prospective open-label pilot study of patients ≥ 18 years old with diagnosis of EoE at Mayo Clinic in Rochester, Minnesota, from November 2014 to January 2016. All patients underwent patch testing using intact food products, followed by a six food elimination diet and stepwise food reintroduction. Response to elimination diet was assessed with serial endoscopy with biopsies as well as clinical symptoms. APT results were directly compared to elimination diet results for assessment of efficacy. Correlation between clinical symptoms, endoscopic score, and histology was also qualitatively evaluated.

Results: Fifty percent of the patients had a positive APT, while only 16% had an APT result confirmed histologically during food reintroduction. Sensitivity of APT was calculated to be 5.9%, with specificity of 92.0%. Furthermore, we found significant qualitative inter-patient heterogeneity in the correlation between clinical symptoms, EREFS score, and histology.

Conclusions: APT does not reliably predict food triggers identified by food elimination diet in adult patients with EoE. As a result, APT does not have a clear role in the evaluation of patients with EoE.
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http://dx.doi.org/10.1007/s10620-018-4928-4DOI Listing
March 2018

Management of eosinophilic esophagitis and celiac disease.

Curr Opin Pharmacol 2017 12 11;37:118-125. Epub 2017 Nov 11.

Division of Gastroenterology and Hepatology, Mayo Clinic, 200 1st St SW, Rochester, MN 55905, USA. Electronic address:

Eosinophilic esophagitis (EoE) and celiac disease (CeD) are chronic immune mediated gastrointestinal disorders characterized by mucosal inflammation, both of which are related to food antigens, but with differences in clinical and histopathological features. When untreated, both diseases lead to destruction of the epithelium. While a strict gluten-free diet is the only effective therapy for CeD, several therapeutic options, such as proton pump inhibitors, topical steroids and diet elimination therapy are available for EoE. For EoE patients, all can be efficacious in achieving remission, but the looming question is whether all patients should be on maintenance therapy. New biologic therapies are being studied under study in both diseases, but none are ready for clinical use.
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http://dx.doi.org/10.1016/j.coph.2017.10.007DOI Listing
December 2017

Endoscopic and Radiologic Findings in Eosinophilic Esophagitis.

Gastrointest Endosc Clin N Am 2018 Jan 21;28(1):47-57. Epub 2017 Oct 21.

Division of Gastroenterology and Hepatology, Mayo Clinic School of Medicine, 200 First Street Southwest, Rochester, MN 55905, USA. Electronic address:

Eosinophilic esophagitis (EoE) was first described by Landis in 1978. The disease is characterized by esophageal symptoms, primarily dysphagia in adult patients, and esophageal eosinophilic infiltration. The disease is associated with characteristic endoscopic findings, including edema, rings, furrows, exudates, and strictures. The typical radiographic findings of this disorder are rings, strictures, and small-caliber esophagus. The endoscopic and radiographic findings of EoE are the topic of this review.
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http://dx.doi.org/10.1016/j.giec.2017.07.003DOI Listing
January 2018

Accuracy and Safety of the Cytosponge for Assessing Histologic Activity in Eosinophilic Esophagitis: A Two-Center Study.

Am J Gastroenterol 2017 Oct 15;112(10):1538-1544. Epub 2017 Aug 15.

Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.

Objectives: Management of eosinophilic esophagitis (EoE) requires repeated endoscopic mucosal sampling to assess disease activity. A less invasive and expensive means of monitoring of EoE is required. The objective of this study was to assess the accuracy, safety, and tolerability of the cytosponge compared to endoscopy and biopsy for histologic assessment of EoE.

Methods: In this prospective two-center cross-sectional study, patients with known EoE underwent cytosponge sampling followed by endoscopy and biopsy. Sample adequacy and eosinophil counts (eos/HPF) were determined for both cytosponge and endoscopic samples. The cytosponge was assessed for diagnostic accuracy, safety, and patient preference as compared to endoscopy.

Results: Six patients (7%) failed to swallow the sponge. One hundred and five procedures were successfully performed in 80 patients (66% male, 100% white, 19% stricture). The cytosponge sample was adequate in 102 and the biopsy in 104; 101 procedures had adequate samples by both techniques. Fifty-seven biopsies were graded as active EoE with ≥15 eos/HPF as the gold standard. Eosinophil counts highly correlated between the biopsy and cytosponge (r=0.78, P<0.0001). Using a cutoff of ≤15 eos/HPF for inactive disease, the sensitivity and specificity of the cytosponge was 75% and 86%, respectively. Six patients had active EoE on cytosponge not found on biopsy. For biopsies with inactive EoE, the cytosponge identified 38/44. No complications occurred, and cytosponge endoscopic abrasion scores were low (0.34/4). Patients preferred cytosponge to endoscopy with higher rating scores (7.27 vs. 6.11, P=0.002).

Conclusions: Compared to endoscopy with biopsy, cytosponge provided a minimally invasive, safe, well tolerated, and accurate method to assess EoE histologic activity. (ClinicalTrial.gov number NCT01585103).
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http://dx.doi.org/10.1038/ajg.2017.244DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5848207PMC
October 2017

Subepithelial esophageal tumors: a single-center review of resected and surveilled lesions.

Gastrointest Endosc 2018 02 4;87(2):370-377. Epub 2017 Aug 4.

Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.

Background And Aims: Subepithelial esophageal tumors (SETs) are frequent incidental findings. Although symptomatic tumors are surgically or endoscopically resected, there is no consensus on the management of asymptomatic esophageal leiomyomas.

Methods: Appropriate International Classification of Diseases, Ninth Revision codes followed by medical record review were used to identify patients with SETs from January 1992 to March 2017, with abstraction of basic demographics, surveillance intervals, and mortality. Patients were contacted to complete a phone questionnaire to assess follow-up as well as the validated Brief Esophageal Dysphagia Questionnaire (BEDQ).

Results: Eighty-four leiomyomas, 5 leiomyosarcomas, 13 GI stromal tumors (GISTs), and 4 granular cell tumors were found. Among patients with leiomyomas, 58 (69%) were resected and 26 (31%) were followed under surveillance. Resected esophageal leiomyomas were larger than those under surveillance (49.7 mm vs 17.9 mm, P < .003). Esophageal leiomyoma growth during surveillance was only .5 mm over a mean 70-month follow-up (range, 4-288). No malignant transformation was seen, and only 2 patients required subsequent resection. The phone survey was completed by 35 patients and revealed minimal symptom burden, with only 2 patients (15%) under esophageal leiomyoma surveillance reporting symptoms (BEDQ score ≥10) over a mean 96.7-month follow-up. EUS had high diagnostic accuracy with a positive predictive value of 68% and a negative predictive value of 100% for leiomyomas or GISTs compared with surgical pathology.

Conclusions: EUS demonstrated high diagnostic accuracy in resected SETs. Esophageal leiomyomas demonstrate minimal growth or symptomatic progression. Therefore, long-term EUS surveillance of small asymptomatic esophageal leiomyomas may be unnecessary.
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http://dx.doi.org/10.1016/j.gie.2017.07.043DOI Listing
February 2018
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