Once-daily omeprazole/sodium bicarbonate heals severe refractory reflux esophagitis with morning or nighttime dosing.

BACKGROUND: Morning dose or twice-daily proton pump inhibitor (PPI) use is often prescribed to heal severe reflux esophagitis. AIM: Compare the effect of single dose morning (control arm) versus nighttime (experimental arm) omeprazole/sodium bicarbonate (Zegerid(®)) (IR-OME) on esophagitis and gastroesophageal reflux symptoms. METHODS: Adult outpatients with Los Angeles grade C or D esophagitis were allocated to open-label 40 mg IR-OME once a day for 8 weeks in a prospective, randomized, parallel design, single center study. Esophagogastroduodenoscopy (EGD) and validated self-report symptom questionnaires were completed at baseline and follow-up. Intention-to-treat and per-protocol analyses were performed. RESULTS: Ninety-two of 128 (72 %) eligible subjects participated [64 (70 %) male, mean age 58 (range 19-86), median BMI 29 (range 21-51), 58 C:34 D]. Overall, 81 (88 %) subjects healed [n = 70 (76 %)] or improved [n = 11 (12 %)] erosions. There was no significant difference (morning vs. night) in mucosal healing [81 vs. 71 %, (p = 0.44)] or symptom resolution [heartburn (77 vs. 65 %, p = 0.12), acid regurgitation (82 vs. 73 %, p = 0.28)]. Prevalence of newly identified Barrett's esophagus was 14 % with half diagnosed only after treatment. CONCLUSIONS: Once-daily IR-OME (taken morning or night) effectively heals severe reflux esophagitis and improves GERD symptoms. Results support the clinical practice recommendation to repeat EGD after 8 weeks PPI therapy in severe esophagitis patients to assure healing and exclude Barrett's esophagus.

Marital status and quality of life in patients with esophageal cancer or Barrett's esophagus: the mayo clinic esophageal adenocarcinoma and Barrett's esophagus registry study.

BACKGROUND: Patients with esophageal carcinoma (EC) report deficits in quality of life (QOL), depending on the extent of malignant disease and the goals of treatment at the time of QOL measurement. AIMS: To quantify the association of marital status and changes in QOL over time in patients with EC and patients with Barrett's esophagus (BE). METHODS: Eligible patients in the Mayo Clinic Esophageal Adenocarcinoma and Barrett's Esophagus Registry completed QOL assessments at baseline and approximately 1 year later. QOL was determined with a ten-point linear analog self-assessment scale evaluating overall QOL and 12 subscales. RESULTS: Overall, 489 BE patients and 212 EC patients were evaluated. Married EC patients reported higher baseline QOL in legal concerns (8.1 vs. 7.1; p = .04) and friend and family support (9.3 vs. 8.4; p = .02) than single EC patients. Over time, married EC patients had a decrease in pain frequency QOL compared to single EC patients (-0.9 vs. +0.6; p = .02), with other QOL measures being stable. Married BE patients showed higher social activity QOL at baseline than single BE patients (7.5 vs. 6.9; p = .02); QOL was stable over time between the marital status groups. CONCLUSIONS: Minor, but statistically significant, changes were reported regarding QOL in two categories at baseline and over time among married and single patients with EC. Minor differences may be present between married and single EC patients regarding spiritual QOL at baseline and in overall physical well-being QOL at baseline and over time, although these differences did not reach statistical significance.

The Mayo Dysphagia Questionnaire-30: documentation of reliability and validity of a tool for interventional trials in adults with esophageal disease.

The aim of this study was to develop the Mayo Dysphagia Questionnaire-30 Day (MDQ-30), a tool to measure esophageal dysphagia, by adapting items from validated instruments for use in clinical trials, and assess its feasibility, reproducibility, and concurrent validity. Outpatients referred to endoscopy for dysphagia or seen in a specialty clinic were recruited. Feasibility testing was done to identify problematic items. Reproducibility was measured by test-retest format. Concurrent validity reflects agreement between information gathered in a structured interview versus the patients' written responses. The MDQ-30, a 28-item instrument, took 10 min (range = 5-30 min) to complete. Four hundred thirty-one outpatients [210 (49%) men; mean age = 61 years] participated. Overall, most concurrent validity kappa values for dysphagia were very good to excellent with a median of 0.78 (min 0.28, max 0.95). The majority of reproducibility kappa values for dysphagia were moderate to excellent with a median kappa value of 0.66 (min 0.07, max 1.0). Overall, concurrent validity and reproducibility kappa values for gastroesophageal reflux disease (GERD) symptoms were 0.81 (95% CI = 0.72, 0.91) and 0.66 (95% CI = 0.55, 0.77), respectively. Individual item percent agreement was generally very good to excellent. Internal consistency was excellent. We conclude that the MDQ-30 is an easy-to-complete tool to evaluate reliably dysphagia symptoms over the last 30 days.

Three-tiered risk stratification model to predict progression in Barrett's esophagus using epigenetic and clinical features.

BACKGROUND: Barrett's esophagus predisposes to esophageal adenocarcinoma. However, the value of endoscopic surveillance in Barrett's esophagus has been debated because of the low incidence of esophageal adenocarcinoma in Barrett's esophagus. Moreover, high inter-observer and sampling-dependent variation in the histologic staging of dysplasia make clinical risk assessment problematic. In this study, we developed a 3-tiered risk stratification strategy, based on systematically selected epigenetic and clinical parameters, to improve Barrett's esophagus surveillance efficiency. METHODS AND FINDINGS: We defined high-grade dysplasia as endpoint of progression, and Barrett's esophagus progressor patients as Barrett's esophagus patients with either no dysplasia or low-grade dysplasia who later developed high-grade dysplasia or esophageal adenocarcinoma. We analyzed 4 epigenetic and 3 clinical parameters in 118 Barrett's esophagus tissues obtained from 35 progressor and 27 non-progressor Barrett's esophagus patients from Baltimore Veterans Affairs Maryland Health Care Systems and Mayo Clinic. Based on 2-year and 4-year prediction models using linear discriminant analysis (area under the receiver-operator characteristic (ROC) curve: 0.8386 and 0.7910, respectively), Barrett's esophagus specimens were stratified into high-risk (HR), intermediate-risk (IR), or low-risk (LR) groups. This 3-tiered stratification method retained both the high specificity of the 2-year model and the high sensitivity of the 4-year model. Progression-free survivals differed significantly among the 3 risk groups, with p = 0.0022 (HR vs. IR) and p<0.0001 (HR or IR vs. LR). Incremental value analyses demonstrated that the number of methylated genes contributed most influentially to prediction accuracy. CONCLUSIONS: This 3-tiered risk stratification strategy has the potential to exert a profound impact on Barrett's esophagus surveillance accuracy and efficiency.

Impact of feedback and didactic sessions on the reporting behavior of upper endoscopic findings by physicians and nurses.

BACKGROUND & AIMS: Guidelines for reporting Barrett's esophagus and hiatal hernia measurements and reflux esophagitis grades have been developed to improve consistency, communication, and, ultimately, patient care. Our aims were to assess the percentage of cases in which findings were reported in accordance with guidelines and to assess the impact of education and feedback on reporting behavior. METHODS: Prospective cross-sectional study design was used. Chart reviews were performed for all adult patients who underwent esophagogastroduodenoscopy at a tertiary care center during three 2-month time periods during a 12-month interval: Time 1 (March 1, 2004-April 30, 2004), Time 2 (July 1, 2004-August 31, 2004), and Time 3 (March 1, 2005-April 30, 2005). Standardized educational sessions began 2 years before Time 1. No intervention took place between Time 1 and Time 2; data were collected to examine secular change. Between Time 2 and Time 3, individual and group feedback and refresher sessions were given. RESULTS: Five thousand six hundred nine eligible esophagogastroduodenoscopies were performed, of which 2675 demonstrated Barrett's esophagus, hiatal hernia, and/or reflux esophagitis. At baseline, Barrett's esophagus and hiatal hernia measurements were dictated correctly in a median of 67% and 86% of cases, respectively, improving to 100% (P < .05) and 98% (P < .01) of cases, respectively. The Los Angeles Classification system was used in a median of 100% of cases at baseline and at follow-up. CONCLUSIONS: Anonymous individual and group feedback, in combination with brief, structured didactic educational sessions, significantly improves compliance with established guidelines for the reporting of Barrett's esophagus and hiatal hernia. Once successfully incorporated into clinical practice, adherence to the esophagitis Los Angeles Classification System is easy to maintain.