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Item Budesonide Oral Suspension Improves Symptomatic, Endoscopic, and Histologic Parameters Compared With Placebo in Patients With Eosinophilic Esophagitis(Elsevier, 2017-03) Dellon, Evan S.; Katzka, David A.; Collins, Margaret H.; Hamdani, Mohamed; Gupta, Sandeep K.; Hirano, Ikuo; Pediatrics, School of MedicineBackground & Aims Pharmacologic treatment of eosinophilic esophagitis (EoE) is limited to off-label use of corticosteroids not optimized for esophageal delivery. We performed a randomized, controlled phase 2 trial to assess the ability of budesonide oral suspension (BOS), a novel muco-adherent topical steroid formulation, to reduce symptoms and esophageal eosinophilia in adolescents and adults with EoE. Methods In this multicenter, randomized, double-blind, placebo-controlled, parallel-group trial, 93 EoE patients between the ages of 11 and 40 years with dysphagia and active esophageal eosinophilia were randomized to receive either BOS 2 mg or placebo twice daily for 12 weeks. Co-primary outcomes were change in Dysphagia Symptom Questionnaire (DSQ) score from baseline, and proportion of patients with a histologic response (≤6 eosinophils/high-power field) after treatment. Endoscopic severity scores and safety parameters were assessed. Results At baseline, mean DSQ scores were 29.3 and 29.0, and mean peak eosinophil counts were 156 and 130 per hpf in the BOS and placebo groups, respectively. After treatment, DSQ scores were 15.0 and 21.5, and mean peak eosinophil counts were 39 and 113 per high-power field, respectively (P < .05 for all). For BOS vs placebo, change in DSQ score was −14.3 vs −7.5 (P = .0096), histologic response rates were 39% vs 3% (P < .0001), and change in endoscopic severity score was −3.8 vs 0.4 (P < .0001). Adverse events were similar between groups. Conclusions Treatment with BOS was well tolerated in adolescent and young adult patients with EoE and resulted in improvement in symptomatic, endoscopic, and histologic parameters using validated outcome instruments.Item Eosinophilic Esophagitis Symptom Scores Are High in Children Without Eosinophilic Disease(Wolters Kluwer, 2021-10) Bose, Paroma; Albright, Eric; Idrees, Muhammad T.; Perkins, Anthony; Sawyers, Cindy; Gupta, Sandeep K.; Hon, Emily C.; Biostatistics, School of Public HealthObjectives: The Pediatric Eosinophilic Esophagitis (EoE) Symptom Score version 2 (PEESSv2.0) is an EoE-specific validated metric for disease monitoring, but its use has not been explored outside of EoE. Our aim was to determine if PEESSv2.0 scores differentiate between children with EoE and non-EoE esophageal dysfunction undergoing initial esophagogastroduodenoscopy (EGD). Methods: A prospective cohort study of pediatric subjects was conducted. Children ages 1–18 undergoing initial EGD for esophageal dysfunction were enrolled. Demographics, clinical history, and child self-report and parent-proxy report PEESSv2.0 symptom scores were collected at the time of EGD. Esophageal biopsies were reviewed, and EoE was defined as >15 eosinophils/high powered field (hpf) seen in any level of the esophagus. Non-EoE was defined as <15 eosinophils/hpf. Results: Seventy-one children were included in the study from 2015 to 2018 [59% (42/71) males; mean age 9.2 years; range 1–17 years]. Fifty-eight percent (41/71) met criteria for EoE, and 42% (30/71) were labeled non-EoE. Non-EoE children and their parents had higher/worse median PEESSv2.0 total scores than those with EoE [47.0 vs 28.0 (P = 0.001) and 40.5 vs 26.5 (P = 0.012), respectively]. Non-EoE children reported higher median GERD [9.0 vs 4.0 (P = 0.003)], nausea/vomiting [9.0 vs 4.0 (P = 0.003)], and pain [11.0 vs 6.0 (P = 0.001)] subdomain scores compared to those with EoE. PEESSv2.0 dysphagia subdomain scores (child and parent-proxy) did not differ between EoE and non-EoE groups [22.0 vs 15.0 (P = 0.184) and 18.5 vs 17.4 (P = 0.330), respectively]. Discussion: Total PEESSv2.0 scores were worse in non-EoE group compared to EoE group. Although PEESSv2.0 is validated for use in monitoring EoE therapy, it does not distinguish children with EoE from non-EoE esophageal dysfunction at the time of diagnostic EGD.Item Long-Lasting Dissociation of Esophageal Eosinophilia and Symptoms Following Dilation in Adults with Eosinophilic Esophagitis(Elsevier, 2021-05-29) Safroneeva, Ekaterina; Pan, Zhaoxing; King, Eileen; Martin, Lisa J.; Collins, Margaret H.; Yang, Guang-Yu; Capocelli, Kelley E.; Arva, Nicoleta C.; Abonia, J. Pablo; Atkins, Dan; Bonis, Peter A.; Dellon, Evan S.; Falk, Gary W.; Gonsalves, Nirmala; Gupta, Sandeep K.; Hirano, Ikuo; Leung, John; Menard-Katcher, Paul A.; Mukkada, Vincent A.; Schoepfer, Alain M.; Spergel, Jonathan M.; Wershil, Barry K.; Rothenberg, Marc E.; Aceves, Seema S.; Furuta, Glenn T.; Pediatrics, School of MedicineBackground and aims Esophageal dilation improves dysphagia but not inflammation in eosinophilic esophagitis (EoE) patients. We investigated if dilation modifies the association between symptoms and esophageal eosinophil count (eos/hpf). Methods Adults enrolled in a multisite, prospective Consortium of Gastrointestinal Eosinophilic Disease Researchers OMEGA observational study (NCT02523118) completed the symptom-based EoE activity index (EEsAI) patient-reported outcome instrument and underwent endoscopy with biopsies. Patients were stratified based on dilation status as absent, performed ≤1 and >1 year before endoscopy. Assessments included Spearman’s correlations of the relationship between symptoms and eos/hpf and linear regression with EEsAI as the outcome, eos/hpf as predictor, and interaction for dilation and eos/hpf. Results Amongst 100 patients (n=61 male, median age 37 years), 15 and 40 patients underwent dilation ≤1 year and >1 year before index endoscopy, respectively. In non-dilated patients, association between eos/hpf and symptoms was moderate (Rho=0.49, p-value<0.001); for 10 eos/hpf increase, the predicted EEsAI increased by 2.69 (p-value=0.002). In patients dilated ≤1 and >1 year before index endoscopy, this association was abolished (Rho=-0.38, p-value=0.157 for ≤1 year and Rho=0.02, p-value=0.883 >1 year); for 10 eos/hpf increase, the predicted EEsAI changed by -1.64 (p-value=0.183) and 0.78 (p-value=0.494), respectively). Dilation modifies association between symptoms and eos/hpf (p-value=0.005 and p-value=0.187 for interaction terms of eos/hpf and dilation ≤1 year and >1 year before index endoscopy, respectively). Conclusion In non-dilated EoE adults, eos/hpf correlates modestly with symptoms; this correlation was no longer appreciated in dilated patients, and the dilation effects lasted longer than one year. Dilation status should be considered in studies evaluating EoE treatment and for clinical follow-up.Item Post-extubation Dysphagia in Liver Transplant Patients(2020-09-12) Atoa, S.; Kubal, C.A.; Ekser, B.; Spears, M.; Wrightson, T.; Mangus, M.J.; Mangus, R.S.Item Postoperative Dysphagia Following Esophagogastric Fundoplication: Does the Timing to First Dilation Matter?(Springer, 2021-11) Athanasiadis, Dimitrios I.; Selzer, Don; Stefanidis, Dimitrios; Choi, Jennifer N.; Banerjee, Ambar; Surgery, School of MedicineBackground Postoperative dysphagia after anti-reflux surgery typically resolves in a few weeks. However, even after the initial swelling has resolved at 6 weeks, dysphagia can persist in 30% of patients necessitating esophageal dilation. The purpose of this study was to investigate the effect of esophageal dilation on postoperative dysphagia, the recurrence of reflux symptoms, and the efficacy of pneumatic dilations on postoperative dysphagia. Methods A prospectively collected database was reviewed for patients who underwent partial/complete fundoplication with/without paraesophageal hernia repair between 2006 and 2014. Patient age, sex, BMI, DeMeester score, procedure type, procedure duration, length of stay, postoperative dysphagia, time to first pneumatic dilation, number of dilations, and the need for reoperations were collected. Results The study included 902 consecutive patients, 71.3% females, with a mean age of 57.8 ± 14.7 years. Postoperative dysphagia was noted in 26.3% of patients, of whom 89% had complete fundoplication (p < 0.01). Endoscopic dilation was performed in 93 patients (10.3%) with 59 (63.4%) demonstrating persistent dysphagia. Recurrent reflux symptoms occurred in 35 (37.6%) patients who underwent endoscopic dilation. Patients who underwent a dilation for symptoms of dysphagia were less likely to require a revisional surgery later than patients who had dysphagia but did not undergo a dilation before revisional surgery (17.2% vs 41.7%, respectively, p < 0.001) in the 4-year follow-up period. The duration of initial dilation from surgery was inversely related to the need for revisional surgery (p = 0.047), while more than one dilation was not associated with additive benefit. Conclusion One attempt at endoscopic dilation of the esophagogastric fundoplication may provide relief in patients with postoperative dysphagia and can be used as a predictive factor for the need of revision. However, there is an increased risk for recurrent reflux symptoms and revisional surgery may ultimately be indicated for control of symptoms.Item A Rare Cause of Dysphagia(Elsevier, 2020) Fatima, Hala; Wajid, Maryiam; Cummings, Oscar W.; Medicine, School of MedicineItem Simulation instruction for direct support professionals: A pilot study between a school of nursing and community providers supporting persons with intellectual and developmental disability(2016) Auberry, KathyThis pilot study was developed in a school of nursing simulation center geared toward direct support professionals (DSPs) working in community-based agencies in south-east Indiana. The study educated direct support professionals who support individuals with intellectual and developmental disability by using simulation based learning to increase their knowledge related to two common health conditions in this population; epilepsy and dysphagia. On the basis of study results, partnerships between schools of nursing and community providers for persons with intellectual and developmental disability can be developed. Simulation Centers within schools of nursing may be used to augment current training of direct support professionals working with this population.