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Sa1295 Developmental Characteristics of GERD and Dysphagia-Related Patient-Reported Outcome Measures: A Systematic Review
AGA Abstracts
MI variability is greater using the free technique compared to the balloon-inflated technique throughout the esophagus.
Figure 1. Kaplan-Meier analysis of time to bronchiolitis obliterans syndrome (BOS) by pretransplant acid exposure. Abnormally increased acid exposure (>4.2% of time with pH<4) resulted in earlier development of BOS in transplant recipients.
Sa1295 Developmental Characteristics of GERD and Dysphagia-Related PatientReported Outcome Measures: A Systematic Review Rohit Sharda, Dhyanesh Patel, Kristen L. Hovis, David Penson, Irene Feurer, Melissa McPheeters, Michael Vaezi, David O. Francis Objectives: Patient-reported outcome (PRO) measures provide a means of capturing patient perspective and are critical in assessing patient experience related to treatment. Their use is now required in most NIH-funded randomized clinical trials. As such, the number of gastroesophageal reflux disease- (GERD) and dysphagia-related PRO measures has increased dramatically, albeit with variable developmental rigor. Inappropriate application of these measures is common and can lead to distorted results. The aims of this study were to perform a comprehensive systematic review of the literature on GERD and dysphagia-related PRO measures in adults and to rigorously evaluate each instrument for the presence of important developmental characteristics. Methods: MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature (CINAHL), and the Health and Psychosocial Instrument (HaPI) database were searched using relevant vocabulary terms and key terms related to PRO measures, GERD, and dysphagia. Inclusion and exclusion criteria were developed in consultation with an expert panel that included a psychometrician, systematic review methodologists, and researchers/clinicians who study/treat these conditions. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed: 1) conceptual model, 2) content validity, 3) reliability, 4) construct validity, 6) scoring and interpretation, and 7) burden and presentation. Score discrepancies were resolved through consensus or adjudication. Components of PRO measure development were critically examined. Results: Of 4,952 abstracts reviewed, a total of 65 PRO measures (publication year range 1987 - 2014) met criteria for extraction and analysis. Intended target populations and constructs were variable. In all, 34 GERD- and 31 dysphagia-related measures were identified. Among dysphagia questionnaires 16 were disease specific (e.g., achalasia, eosinophilic esophagitis) and 15 were designed for the general dysphagia population. No PRO measure met all criteria on the checklist. Several PRO measures met at least one criterion per domain (GERD=17; dysphagia=15). Figure 1 and 2 provide itemized, schematic overviews of developmental characteristics for PRO measures in GERD and dysphagia. Four thematic deficiencies in current measures are lack of: 1) patient involvement in item development process, 2) construct validity, 3) plan for interpreting missing responses, and 4) literacy level assessment. Conclusion: Current available PRO measures in GERD and dysphagia-related constructs have disparate developmental rigor and care must be taken to understand their measurement characteristics, contextual relevance, and track record before applying them to clinical, research, and quality initiatives.
Figure 2. Kaplan-Meier analysis of time to bronchiolitis obliterans syndrome (BOS) by pretransplant Demeester score. Abnormally elevated Demeester score (>14.7) resulted in earlier development of BOS in transplant recipients.
Sa1294 Reducing Mucosal Impedance Variability by Ensuring Direct Contact with Esophageal Mucosa Rohit Sharda, Yash A. Choksi, Tina Higginbotham, James C. Slaughter, Pooja Lal, Elif S. Yuksel, Fehmi Ates, Michael Vaezi Objective: A minimally invasive catheter that measures mucosal impedance (MI) at various points along the esophagus has previously demonstrated that MI is a useful marker of chronic reflux and can detect GERD with a higher specificity and positive predictive value compared to traditional wireless pH monitoring. The MI catheter has been shown to reliably distinguish GERD from non-GERD conditions based on impedance values (GERD leads to lower values). However, there is room to improve impedance variability by reducing the impact of air and liquid surrounding MI sensors. One strategy to accomplish this is by utilizing an esophageal balloon to push sensors directly onto epithelium to reduce contact with air and liquid. As such, the aim of this prospective study was to compare MI values obtained in the same subjects with and without balloon inflation in order to assess the impact of balloon-inflated measurements on MI values along the esophageal epithelium. Methods: 25 patients with suspected GERD undergoing endoscopy with wireless pH monitoring were enrolled in the study. MI was prospectively measured using a custom-designed through-the-scope catheter with an axial array of 20 sensors (3 mm in size, separated by 2 mm each). Esophageal mucosal impedance (in W) was measured upon direct mucosal contact with a 10 cm segment of esophagus. In each patient, the MI catheter was first applied directly to the esophageal mucosa along the esophageal axis, and impedance values were obtained over 5 seconds ("free" technique). Subsequently, an esophageal balloon was passed transorally to the level of the MI catheter and fully inflated to a diameter of 2 cm, and impedance values were again recorded. Measurements were obtained along the esophagus, and the variability of measurements (assessed by range of MI values) was compared between "free" and "ballooninflated" methods. Results: Of the 25 study patients [median (IQR) age = 56 (37-62); 76% female; 72% Caucasian; Median (IQR) BMI = 28.2 (26-34)], 7 had erosive esophagitis, 9 had non-erosive reflux (abnormal pH), 7 had no reflux (normal endoscopy and pH), and two were missing pH data. Mean impedance values were significantly reduced (p <0.001) by inflating the balloon at the same location for all MI values along the esophagus (2842.8 W versus 3593.9 W). The MI range of values at a given location along the esophageal axis were also significantly reduced (p<0.001) by balloon inflation (820.6 W) as compared to those obtained through the free technique (1523.1 W) (see Figure 1). Conclusion: Variability in MI is decreased by ensuring direct contact of MI sensors with the mucosa by eliminating measurement error due to air or intraluminal fluids. Future studies that utilize the MI catheter to record esophageal impedance should be performed with balloon assistance to obtain less varied and more reproducible measurements.
Figure 1
AGA Abstracts
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Background/Aims The gastroesophageal junction (GEJ) is an important barrier against gastroesophageal reflux. Endoscopic grading of gastroesophageal flap valve (GEFV) is simple, reproducible, and suggested to be a good predictor for reflux activity. This study aimed to investigate the potential correlation between GEFV grading and structural properties of the GEJ using abdomen computed tomography (CT). Methods A total of 138 patients with early gastric cancer who underwent both pre-treatment esophagogastroduodenoscopy and water-distended stomach two-phase CT were included in this study. Endoscopic GEFV grade and abdomen CT findings were analyzed to assess anatomical factors including the GEJ and related organs. Results The His angle increased significantly as the GEFV grades increased (65.2 ± 19.6o in grade I, 66.6 ± 19.8o in grade II, 76.7 ± 11.9o in grade III and 120.0 ± 30.3o in grade IV, P < 0.001). The size of the diaphragmatic hiatus increased as the GEFV grades increased (213.0 ± 53.8 mm2 in grade I, 232.6 ± 71.0 mm2 in grade II, 292.3 ± 99.2 mm2 in grade III and 584.4 ± 268.3 mm2 in grade IV, P < 0.001). The length of the abdominal esophagus decreased as the GEFV grades increased (34.6 ± 5.8 mm in grade I, 32.0 ± 6.5 mm in grade II, 24.6 ± 7.8 mm in grade III, and -22.6 ± 38.2 mm in grade IV, P < 0.001). There was no significant relationship between GEFV grade and visceral and subcutaneous fat areas (P = 0.877 and P = 0.508, respectively). Conclusions Endoscopic grading of GEFV is well correlated with anatomical change around the GEJ in abdomen CT. Analysis of Esophagogastric Junction on Computed Tomography According to the Gastroesophageal Flap Valve Grade
Figure 2
Sa1296 A Sub-classification of Esophago-Gastric Junction Morphology Type I May Be Useful To Better Recognize GERD Patients With a Positive Impedance-pH Monitoring Salvatore Tolone, Nicola de Bortoli, Manuele Furnari, Marzio Frazzoni, Paola Iovino, Vincenzo Savarino, Ludovico Docimo, Edoardo Savarino Background High-resolution manometry (HRM) provides information on esophagogastric junction (EGJ) morphology, being able to distinguish whether the lower esophageal sphincter (LES) and crural diaphragm (CD) are superimposed or separated. Actually, three different subtypes can be described by means of HRM, and it was recently demonstrated that increasing separation between LES and CD could cause a gradual and significant increase of reflux. Type I morphology is the group with the lowest incidence of a positive impedance-pH test. However, this latter type also includes in its definition the presence of LES-CD axial separation up to 1 cm. Aim To verify if a sub-classification of the EGJ Type I could better correlate with a positive impedance-pH test in patients with reflux symptoms. MethodsConsecutive patients with heartburn and/or regurgitation and a recent endoscopic exam were enrolled. All patients underwent HRM to assess the EGJ and the esophageal peristalsis. Each trace and EGJ were classified based on the Chicago Classification (CC) 3.0. EGJ Type I was further divided into Type IA, a complete overlap of LES and CD, and Type IB, a minimal separation, with LES located from the upper border of CD (in correspondence of pressure inversion point, 0.0 cm) to 1 cm above. The patients then underwent impedance-pH test off-therapy. We measured the esophageal acid exposure time (AET), number of total impedance-detected reflux episodes and symptom association analysis using symptom association probability (SAP+ if ‡95%) and symptom index (SI+ if ‡50%). Results We enrolled 168 [75M/93F; mean age 47 (18-81)] consecutive patients and identified 101 (60.1%) patients with Type I EGJ, 37 (22%) with Type II EGJ and 30 (17.9%) with Type III EGJ. Patients with Type III EGJ had an higher median number of reflux episodes, a greater mean AET and had more frequently a positive symptoms association compared to patients with Type II and Type I EGJ (Table 1). Overall, Type I subjects showed a positive MII-pH in 45.5% of cases, with the lowest value of number of reflux episodes, AET and positive symptom association. Using the sub-classification, we identified 54 (53.6%) Type IA and 47 (46.5%) Type IB subjects. Type IB had a higher number of reflux episodes (42 vs. 28, p<0.03), a greater mean AET (4.7 vs. 2.9, p<0.05) and a greater positive symptom association (54% vs. 26%, p<0.02) compared to Type IA. Type IB morphology had a more frequent probability to show a positive MII-pH than Type IA (70.2% vs. 30%, p<0.001). Conclusions With increasing separation between the LES and the CD patients had a gradually and significantly increase of reflux episodes and esophageal acid exposure. The sub-classification of EGJ Type I can be useful to better estimate an abnormal impedance-pH testing in GERD patients and it supports the role of the intra-abdominal LES segment in preventing reflux. Table 1
Sa1298 Proton Pump Inhibitor Prescribing Patterns After Negative pH Studies Vishnu Vardhan Reddy Naravadi, Christopher Haydek, Neelam Balasubramanian, Beverly Gonzalez, Mukund Venu Background Patients with refractory GERD symptoms are difficulty to treat. Specifically, management of patients with a negative endoscopy and negative pH studies is variable amongst different providers. Aim To determine if PPI therapy is appropriately stopped in patients with no objective evidence of acid reflux during pH studies, and whether alternative therapies are recommended following a negative pH study. Methods In this single center retrospective cohort study, medical records of all adult patients (> 18 years old) who had pH studies (wireless pH capsule or multichannel intraluminal impedance-pH (MII-pH)) performed between January 2013 and August 2015 were reviewed. Patients who had pH studies performed while taking PPI and those who had a positive test result were excluded from the study. Patients who could not complete the test or had incomplete data from the study, and who were lost to follow up were excluded from the study. Patient demographics, psychiatric history, symptoms that led to pH testing and recommendations after the pH testing were collected. Test results were reported as positive or negative based on the presence or absence of pathological GERD (total acid (pH<4) exposure time < 5%) and symptom correlation (SAP >95% and SI > 50%). Results A total of 71 patients met the study criteria with 55 wireless pH capsules and 16 MII pH studies. 51 were women and 20 were men. Refractory GERD symptoms were either typical (heartburn, chest pain, regurgitation) or atypical (chronic cough). 29 patients had a history of anxiety and/or depression. Recommendations for PPI use after the negative pH testing did not vary by age (> 65 years), presence of typical or atypical symptoms, or obesity. Men were more likely (p=.04) to be recommended PPI therapy after a negative test than women.(Table 2) Of patients with prior PPI use, 48% were recommended to continue PPI after a negative pH test. Amongst patients with no prior PPI use, 37% were recommended to start PPI after a negative pH test result.(Table 1) Gender, age, symptoms (typical vs atypical), presence or absence of psychiatric illness and obesity were not found to be predictors of recommendations for pain modulator therapy (TCA/ SSRI/SNRI).(Table 2). Overall only 14 patients (20%) were recommended to start pain modulator therapy. Conclusions Overuse of PPI therapy is a well-established issue. Despite negative pH testing, providers continue or even start PPI therapy. Increased awareness of treatment alternatives for functional heartburn may be helpful in improving outcomes and reducing PPI use. Table 1: PPI Recommendations post testing based on prior PPI use
* p<0.001 between EGJ Type III vs II, III vs I, III vs IA, III vs IB, II vs I, II vs IA, IB vs IA § p<0.001 between EGJ Type III vs II, III vs I, III vs IA, III vs IB, II vs I, II vs IA, IB vs IA ° p<0.001 between EGJ Type III vs II, III vs I, III vs IA, III vs IB, II vs I, II vs IA, II vs IB, IB vs IA ç p<0.001 between EGJ Type III vs II, III vs I, III vs IA, III vs IB, II vs I, II vs IA, IB vs IA Note:N=71. First percentage shown is within row and second is within column. Significance determined using McNemar's chi-square test for concordance.
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AGA Abstracts
Analysis of Computed Tomographic Findings According to the Grade of Gastroesophageal Flap Valve Gwang Ha Kim, Hye Kyung Jeon, Byeong Gu Song, Sung Yong Han, Bong Eun Lee, Geun Am Song
MI variability is greater using the free technique compared to the balloon-inflated technique throughout the esophagus.
Figure 1. Kaplan-Meier analysis of time to bronchiolitis obliterans syndrome (BOS) by pretransplant acid exposure. Abnormally increased acid exposure (>4.2% of time with pH<4) resulted in earlier development of BOS in transplant recipients.
Sa1295 Developmental Characteristics of GERD and Dysphagia-Related PatientReported Outcome Measures: A Systematic Review Rohit Sharda, Dhyanesh Patel, Kristen L. Hovis, David Penson, Irene Feurer, Melissa McPheeters, Michael Vaezi, David O. Francis Objectives: Patient-reported outcome (PRO) measures provide a means of capturing patient perspective and are critical in assessing patient experience related to treatment. Their use is now required in most NIH-funded randomized clinical trials. As such, the number of gastroesophageal reflux disease- (GERD) and dysphagia-related PRO measures has increased dramatically, albeit with variable developmental rigor. Inappropriate application of these measures is common and can lead to distorted results. The aims of this study were to perform a comprehensive systematic review of the literature on GERD and dysphagia-related PRO measures in adults and to rigorously evaluate each instrument for the presence of important developmental characteristics. Methods: MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature (CINAHL), and the Health and Psychosocial Instrument (HaPI) database were searched using relevant vocabulary terms and key terms related to PRO measures, GERD, and dysphagia. Inclusion and exclusion criteria were developed in consultation with an expert panel that included a psychometrician, systematic review methodologists, and researchers/clinicians who study/treat these conditions. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed: 1) conceptual model, 2) content validity, 3) reliability, 4) construct validity, 6) scoring and interpretation, and 7) burden and presentation. Score discrepancies were resolved through consensus or adjudication. Components of PRO measure development were critically examined. Results: Of 4,952 abstracts reviewed, a total of 65 PRO measures (publication year range 1987 - 2014) met criteria for extraction and analysis. Intended target populations and constructs were variable. In all, 34 GERD- and 31 dysphagia-related measures were identified. Among dysphagia questionnaires 16 were disease specific (e.g., achalasia, eosinophilic esophagitis) and 15 were designed for the general dysphagia population. No PRO measure met all criteria on the checklist. Several PRO measures met at least one criterion per domain (GERD=17; dysphagia=15). Figure 1 and 2 provide itemized, schematic overviews of developmental characteristics for PRO measures in GERD and dysphagia. Four thematic deficiencies in current measures are lack of: 1) patient involvement in item development process, 2) construct validity, 3) plan for interpreting missing responses, and 4) literacy level assessment. Conclusion: Current available PRO measures in GERD and dysphagia-related constructs have disparate developmental rigor and care must be taken to understand their measurement characteristics, contextual relevance, and track record before applying them to clinical, research, and quality initiatives.
Figure 2. Kaplan-Meier analysis of time to bronchiolitis obliterans syndrome (BOS) by pretransplant Demeester score. Abnormally elevated Demeester score (>14.7) resulted in earlier development of BOS in transplant recipients.
Sa1294 Reducing Mucosal Impedance Variability by Ensuring Direct Contact with Esophageal Mucosa Rohit Sharda, Yash A. Choksi, Tina Higginbotham, James C. Slaughter, Pooja Lal, Elif S. Yuksel, Fehmi Ates, Michael Vaezi Objective: A minimally invasive catheter that measures mucosal impedance (MI) at various points along the esophagus has previously demonstrated that MI is a useful marker of chronic reflux and can detect GERD with a higher specificity and positive predictive value compared to traditional wireless pH monitoring. The MI catheter has been shown to reliably distinguish GERD from non-GERD conditions based on impedance values (GERD leads to lower values). However, there is room to improve impedance variability by reducing the impact of air and liquid surrounding MI sensors. One strategy to accomplish this is by utilizing an esophageal balloon to push sensors directly onto epithelium to reduce contact with air and liquid. As such, the aim of this prospective study was to compare MI values obtained in the same subjects with and without balloon inflation in order to assess the impact of balloon-inflated measurements on MI values along the esophageal epithelium. Methods: 25 patients with suspected GERD undergoing endoscopy with wireless pH monitoring were enrolled in the study. MI was prospectively measured using a custom-designed through-the-scope catheter with an axial array of 20 sensors (3 mm in size, separated by 2 mm each). Esophageal mucosal impedance (in W) was measured upon direct mucosal contact with a 10 cm segment of esophagus. In each patient, the MI catheter was first applied directly to the esophageal mucosa along the esophageal axis, and impedance values were obtained over 5 seconds ("free" technique). Subsequently, an esophageal balloon was passed transorally to the level of the MI catheter and fully inflated to a diameter of 2 cm, and impedance values were again recorded. Measurements were obtained along the esophagus, and the variability of measurements (assessed by range of MI values) was compared between "free" and "ballooninflated" methods. Results: Of the 25 study patients [median (IQR) age = 56 (37-62); 76% female; 72% Caucasian; Median (IQR) BMI = 28.2 (26-34)], 7 had erosive esophagitis, 9 had non-erosive reflux (abnormal pH), 7 had no reflux (normal endoscopy and pH), and two were missing pH data. Mean impedance values were significantly reduced (p <0.001) by inflating the balloon at the same location for all MI values along the esophagus (2842.8 W versus 3593.9 W). The MI range of values at a given location along the esophageal axis were also significantly reduced (p<0.001) by balloon inflation (820.6 W) as compared to those obtained through the free technique (1523.1 W) (see Figure 1). Conclusion: Variability in MI is decreased by ensuring direct contact of MI sensors with the mucosa by eliminating measurement error due to air or intraluminal fluids. Future studies that utilize the MI catheter to record esophageal impedance should be performed with balloon assistance to obtain less varied and more reproducible measurements.
Figure 1
AGA Abstracts
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Background/Aims The gastroesophageal junction (GEJ) is an important barrier against gastroesophageal reflux. Endoscopic grading of gastroesophageal flap valve (GEFV) is simple, reproducible, and suggested to be a good predictor for reflux activity. This study aimed to investigate the potential correlation between GEFV grading and structural properties of the GEJ using abdomen computed tomography (CT). Methods A total of 138 patients with early gastric cancer who underwent both pre-treatment esophagogastroduodenoscopy and water-distended stomach two-phase CT were included in this study. Endoscopic GEFV grade and abdomen CT findings were analyzed to assess anatomical factors including the GEJ and related organs. Results The His angle increased significantly as the GEFV grades increased (65.2 ± 19.6o in grade I, 66.6 ± 19.8o in grade II, 76.7 ± 11.9o in grade III and 120.0 ± 30.3o in grade IV, P < 0.001). The size of the diaphragmatic hiatus increased as the GEFV grades increased (213.0 ± 53.8 mm2 in grade I, 232.6 ± 71.0 mm2 in grade II, 292.3 ± 99.2 mm2 in grade III and 584.4 ± 268.3 mm2 in grade IV, P < 0.001). The length of the abdominal esophagus decreased as the GEFV grades increased (34.6 ± 5.8 mm in grade I, 32.0 ± 6.5 mm in grade II, 24.6 ± 7.8 mm in grade III, and -22.6 ± 38.2 mm in grade IV, P < 0.001). There was no significant relationship between GEFV grade and visceral and subcutaneous fat areas (P = 0.877 and P = 0.508, respectively). Conclusions Endoscopic grading of GEFV is well correlated with anatomical change around the GEJ in abdomen CT. Analysis of Esophagogastric Junction on Computed Tomography According to the Gastroesophageal Flap Valve Grade
Figure 2
Sa1296 A Sub-classification of Esophago-Gastric Junction Morphology Type I May Be Useful To Better Recognize GERD Patients With a Positive Impedance-pH Monitoring Salvatore Tolone, Nicola de Bortoli, Manuele Furnari, Marzio Frazzoni, Paola Iovino, Vincenzo Savarino, Ludovico Docimo, Edoardo Savarino Background High-resolution manometry (HRM) provides information on esophagogastric junction (EGJ) morphology, being able to distinguish whether the lower esophageal sphincter (LES) and crural diaphragm (CD) are superimposed or separated. Actually, three different subtypes can be described by means of HRM, and it was recently demonstrated that increasing separation between LES and CD could cause a gradual and significant increase of reflux. Type I morphology is the group with the lowest incidence of a positive impedance-pH test. However, this latter type also includes in its definition the presence of LES-CD axial separation up to 1 cm. Aim To verify if a sub-classification of the EGJ Type I could better correlate with a positive impedance-pH test in patients with reflux symptoms. MethodsConsecutive patients with heartburn and/or regurgitation and a recent endoscopic exam were enrolled. All patients underwent HRM to assess the EGJ and the esophageal peristalsis. Each trace and EGJ were classified based on the Chicago Classification (CC) 3.0. EGJ Type I was further divided into Type IA, a complete overlap of LES and CD, and Type IB, a minimal separation, with LES located from the upper border of CD (in correspondence of pressure inversion point, 0.0 cm) to 1 cm above. The patients then underwent impedance-pH test off-therapy. We measured the esophageal acid exposure time (AET), number of total impedance-detected reflux episodes and symptom association analysis using symptom association probability (SAP+ if ‡95%) and symptom index (SI+ if ‡50%). Results We enrolled 168 [75M/93F; mean age 47 (18-81)] consecutive patients and identified 101 (60.1%) patients with Type I EGJ, 37 (22%) with Type II EGJ and 30 (17.9%) with Type III EGJ. Patients with Type III EGJ had an higher median number of reflux episodes, a greater mean AET and had more frequently a positive symptoms association compared to patients with Type II and Type I EGJ (Table 1). Overall, Type I subjects showed a positive MII-pH in 45.5% of cases, with the lowest value of number of reflux episodes, AET and positive symptom association. Using the sub-classification, we identified 54 (53.6%) Type IA and 47 (46.5%) Type IB subjects. Type IB had a higher number of reflux episodes (42 vs. 28, p<0.03), a greater mean AET (4.7 vs. 2.9, p<0.05) and a greater positive symptom association (54% vs. 26%, p<0.02) compared to Type IA. Type IB morphology had a more frequent probability to show a positive MII-pH than Type IA (70.2% vs. 30%, p<0.001). Conclusions With increasing separation between the LES and the CD patients had a gradually and significantly increase of reflux episodes and esophageal acid exposure. The sub-classification of EGJ Type I can be useful to better estimate an abnormal impedance-pH testing in GERD patients and it supports the role of the intra-abdominal LES segment in preventing reflux. Table 1
Sa1298 Proton Pump Inhibitor Prescribing Patterns After Negative pH Studies Vishnu Vardhan Reddy Naravadi, Christopher Haydek, Neelam Balasubramanian, Beverly Gonzalez, Mukund Venu Background Patients with refractory GERD symptoms are difficulty to treat. Specifically, management of patients with a negative endoscopy and negative pH studies is variable amongst different providers. Aim To determine if PPI therapy is appropriately stopped in patients with no objective evidence of acid reflux during pH studies, and whether alternative therapies are recommended following a negative pH study. Methods In this single center retrospective cohort study, medical records of all adult patients (> 18 years old) who had pH studies (wireless pH capsule or multichannel intraluminal impedance-pH (MII-pH)) performed between January 2013 and August 2015 were reviewed. Patients who had pH studies performed while taking PPI and those who had a positive test result were excluded from the study. Patients who could not complete the test or had incomplete data from the study, and who were lost to follow up were excluded from the study. Patient demographics, psychiatric history, symptoms that led to pH testing and recommendations after the pH testing were collected. Test results were reported as positive or negative based on the presence or absence of pathological GERD (total acid (pH<4) exposure time < 5%) and symptom correlation (SAP >95% and SI > 50%). Results A total of 71 patients met the study criteria with 55 wireless pH capsules and 16 MII pH studies. 51 were women and 20 were men. Refractory GERD symptoms were either typical (heartburn, chest pain, regurgitation) or atypical (chronic cough). 29 patients had a history of anxiety and/or depression. Recommendations for PPI use after the negative pH testing did not vary by age (> 65 years), presence of typical or atypical symptoms, or obesity. Men were more likely (p=.04) to be recommended PPI therapy after a negative test than women.(Table 2) Of patients with prior PPI use, 48% were recommended to continue PPI after a negative pH test. Amongst patients with no prior PPI use, 37% were recommended to start PPI after a negative pH test result.(Table 1) Gender, age, symptoms (typical vs atypical), presence or absence of psychiatric illness and obesity were not found to be predictors of recommendations for pain modulator therapy (TCA/ SSRI/SNRI).(Table 2). Overall only 14 patients (20%) were recommended to start pain modulator therapy. Conclusions Overuse of PPI therapy is a well-established issue. Despite negative pH testing, providers continue or even start PPI therapy. Increased awareness of treatment alternatives for functional heartburn may be helpful in improving outcomes and reducing PPI use. Table 1: PPI Recommendations post testing based on prior PPI use
* p<0.001 between EGJ Type III vs II, III vs I, III vs IA, III vs IB, II vs I, II vs IA, IB vs IA § p<0.001 between EGJ Type III vs II, III vs I, III vs IA, III vs IB, II vs I, II vs IA, IB vs IA ° p<0.001 between EGJ Type III vs II, III vs I, III vs IA, III vs IB, II vs I, II vs IA, II vs IB, IB vs IA ç p<0.001 between EGJ Type III vs II, III vs I, III vs IA, III vs IB, II vs I, II vs IA, IB vs IA Note:N=71. First percentage shown is within row and second is within column. Significance determined using McNemar's chi-square test for concordance.
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Analysis of Computed Tomographic Findings According to the Grade of Gastroesophageal Flap Valve Gwang Ha Kim, Hye Kyung Jeon, Byeong Gu Song, Sung Yong Han, Bong Eun Lee, Geun Am Song