David Hagaman

Caution About Overinterpretation of Symptom Indexes in Reflux Monitoring for Refractory Gastroesophageal Reflux Disease

BACKGROUND & AIMS Symptom index (SI) and symptom association probability (SAP) are indexes used to analyze data collected from ambulatory pH and/or impedance monitoring and quantify the association between symptoms and reflux events. However, their characteristics are not well defined. We measured factors that affect SI and SAP values to determine their utility in assessing patients with refractory gastroesophageal reflux disease (GERD). METHODS We conducted a cross-sectional study of 254 patients with poor responses to proton pump inhibitor (PPI) therapy. Participants underwent esophagogastroduodenoscopy and wireless pH (n = 127) or impedance/pH monitoring when they were not receiving PPI therapy (n = 41) or impedance/pH monitoring while they received twice-daily PPI therapy (n = 86). SI and SAP values were calculated individually; ranges of values for each cell in the 2 × 2 contingency table were determined. Monte Carlo simulation was conducted to determine how varying reflux and symptom rates within the contingency table impacted the expected value and variability in SI and SAP. RESULTS At best, only 33% of patients who were refractory to PPI therapy had positive SI or SAP scores for acid or nonacid reflux events. Abnormal SAP (>95%) and SI (>50%) scores required high rates of reflux. At reflux rates less than 10%, observed in 70% of the studied population, SI and SAP values were largely determined by chance occurrences, rather than the relationship between symptoms and reflux. The values for each index varied significantly day-to-day. CONCLUSIONS SI or SAP indexes can be overinterpreted, unless patients with gastroesophageal reflux disease who are refractory to PPI therapy have high rates of reflux.

High economic burden of caring for patients with suspected extraesophageal reflux.

OBJECTIVES:Extraesophageal symptoms are common manifestations of gastroesophageal reflux disease (GERD). Lack of a definitive diagnostic or treatment standards complicate management, which often leads to multiple specialty consultations, procedures, pharmaceuticals and diagnostic tests. The aim of this study was to determine the economic burden associated with extraesophageal reflux (EER).METHODS:Direct costs of evaluation were estimated for patients referred with symptoms attributed to EER between 2007 and 2011. Medicare payment for evaluation and management and pharmaceutical prices was used to calculate first year and overall costs of evaluating and treating extraesophageal symptoms attributed to reflux.RESULTS:Overall, 281 patients were studied (cough (50%), hoarseness (23%), globus/post-nasal drainage (15%), asthma (9%), and sore throat (3%)). Over a median (interquartile range) of 32 (16–46) months follow-up, patients had a mean (95% confidence interval) of 10.1 (9.4–10.9) consultations with specialists and underwent 6.4 (3–9) diagnostic procedures. Overall, the mean initial year direct cost was

Symptom reports are not reliable during ambulatory reflux monitoring.

5,438 per patient being evaluated for EER. Medical and non-medical components contributed

Proton Pump Inhibitor Therapy Improves Symptoms in Postnasal Drainage

5,154 and

Impact of chronic rhinosinusitis on work productivity through one-year follow-up after balloon dilation of the ethmoid infundibulum.

283. Of the overall cost, 52% were attributable to the use of proton pump inhibitors. During the initial year, direct costs were 5.6 times higher than those reported for typical GERD (

Topical pimecrolimus in the treatment of human allergic contact dermatitis.

971). A total of 54% of patients reported improvement of symptoms. Overall cost per improved patient was

Dilated intercellular space in chronic laryngitis and gastro-oesophageal reflux disease: at baseline and post-lansoprazole therapy

13,700.CONCLUSIONS:EER contributes substantially to health-care expenditures. In this cohort, the cost for initial years evaluation and treatment of EER symptoms was quintuple that of typical GERD. Prescription costs and, in particular, proton pump inhibitors were the single greatest contributor to the cost of EER management.

Nonlinear Relationship Between Body Mass Index and Esophageal Acid Exposure in the Extraesophageal Manifestations of Reflux

OBJECTIVES:Patient reporting of symptom events during ambulatory reflux monitoring is commonly performed with little data regarding its accuracy. We employed a novel time-synchronized ambulatory audio recording of symptom events simultaneously with prolonged pH/impedance monitoring to assess temporal accuracy of patient-reported symptoms.METHODS:An acoustic monitoring system was employed to detect cough events via tracheal and chest wall sounds and it was temporally synchronized with an ambulatory impedance/pH monitoring system. Patients were instructed to record their symptoms in the usual manner. Six separate observers independently listened to the 24-h audio recordings and logged the exact timing of each cough event. Patients were blinded to study design and the audio reviewers were blinded to their own reports and those of patients and other reviewers. Concurrence of audio recordings and patient-reported symptoms were tested for three separate time thresholds: 1, 2, and 5 min.RESULTS:The median (interquartile range (IQR)) number of cough events by audio detection was significantly (P<0.001) higher than those reported by patients: 216 (90–275) and 34 (22–60), respectively. There was significantly (P<0.001) higher agreement among the audio recording listeners (substantial to almost perfect agreement; kappa=0.77–0.82) than between the audio recording and patient-reported symptoms (slight to fair agreement; kappa=0.13–0.27). Patients did not report 91, 82, and 71% of audible cough events based on 1-, 2-, and 5-min concordance time windows, respectively.CONCLUSIONS:We found that patients do not report the majority of their symptoms during ambulatory reflux monitoring even within a 5-min time window of the true event and advise caution in clinical decision-making based solely on symptom indices.

The role of impedance monitoring in patients with extraesophageal symptoms

BACKGROUND & AIMS Gastroesophageal reflux is common among patients with postnasal drainage. We investigated whether proton pump inhibitor therapy improved symptoms in patients with postnasal drainage without sinusitis or allergies. METHODS In a parallel-group, double-blind, multi-specialty trial, we randomly assigned 75 participants with continued symptoms of chronic postnasal drainage to groups that were given 30 mg of lansoprazole twice daily or placebo. Participants were followed up for 16 weeks. Symptoms were assessed at baseline and after 8 and 16 weeks. Ambulatory pH and impedance monitoring assessed presence of baseline reflux. The primary objective of the study was to determine if acid suppressive therapy improved postnasal drainage symptoms. The secondary objective was to assess if pH and impedance monitoring at baseline predicted response to treatment. RESULTS Postnasal drainage symptoms improved significantly among patients given lansoprazole compared with placebo. After 8 and 16 weeks, participants given lansoprazole were 3.12-fold (1.28-7.59) and 3.50-fold (1.41-8.67) more likely to respond, respectively, than participants given placebo. After 16 weeks, median (interquartile) percent symptom improvements were 50.0% (10.0%-72.0%) for participants given lansoprazole and 5.0% (0.0%-40.0%) for participants given placebo (P = .006). Neither baseline presence of typical reflux symptoms nor esophageal physiologic parameters predicted response to therapy. CONCLUSIONS Among participants with chronic postnasal drainage without evidence of sinusitis and allergies, twice-daily therapy with proton pump inhibitors significantly improved symptoms after 8 and 16 weeks. The presence of heartburn, regurgitation, abnormal levels of esophageal acid, or nonacid reflux did not predict response to therapy.

Doxycycline desensitization for a suspected case of ehrlichiosis.

Although multiple clinical trials have demonstrated that balloon dilation of sinus ostia in patients diagnosed with chronic rhinosinusitis (CRS) results in sustained symptomatic improvement, less data are available to measure the effects of sinusitis on worker productivity. The objective of our research was to analyze work and activity impairment before and after transantral, endoscopically‐guided balloon dilation of the maxillary sinus ostia and ethmoid infundibulum.