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Tu1762 The Reflux Finding Score for Infants (RFS-I): Inter- and Intraobserver Variability
AGA Abstracts
Tu1761 Extra-Esophageal Symptoms in Patients Undergoing Magnetic Sphincter Augmentation for GERD: Clinical Outcomes At 3 Years Philip O. Katz, Santiago Horgan, Paul Taiganides, Robert A. Ganz, James D. Luketich, Chris C. Smith, Steven Schlack-Haerer, Christy M. Dunst, Jeffrey H. Peters, Steven A. Edmundowicz, C. Daniel Smith, John C. Lipham, W. S. Melvin BACKGROUND A prospective, multicenter clinical study to evaluate outcomes of patients undergoing anti-reflux surgery included patients with pre-operative extra-esophageal symptoms (EES) as well as heartburn and regurgitation. All patients underwent a laparoscopic procedure to mechanically augment the lower esophageal sphincter (LES) with a magnetic device (LINX Reflux Management System, Torax Medical). METHOD In post-hoc analysis, patients reporting at least one EES prior to implant were identified from a questionnaire administered before surgery. Patients with pre-operative EES were compared to those without EES. Comparisons included demographics, esophageal pH measurements, GERD-Health Related Quality of Life (GERD-HRQL) score, and PPI use. All clinical outcomes were based on 3-year data, with the exception of the esophageal pH, which was collected at 1-year post-implant. RESULTS 100 hundred patients were enrolled in this study. Prior to implant, all patients were taking daily PPIs and had confirmed abnormal esophageal acid exposure. Of the 100 patients, 51% (51/100) reported at least one EES at baseline. Recurrent cough was reported by 37% (37/100), change of voice by 25% (25/100), nocturnal cough by 13% (13/100) and asthma by 11% (11/100). Of the patients with EES, the mean age was 51.3 years and 41% (21/51) were male and 59% (30/51) female. Baseline characteristics for patients with and without EES were statistically non-significant, expect for gender. Females were more likely than males to report pre-operative extra-esophageal symptoms (p=0.03). After implant, the percentage of patients reporting no EES improved to 88% (84/95) at 1 year, 88% (79/90) at 2 years and 90% (78/87) at 3 years compared to 49% (49/100) at baseline. The median total % time pH , 4 improved from 10.2% at baseline to 2.3% at l year in the EES group and 11.6% to 4.2% in the non-EES group, and the median DeMeester score improved from 33.9 to 9.9 in the EES and 41.0 to 16.1 in the non-EES group. The median GERD-HRQL at 3 years was 2 for the EES group and 3 for the non-EES group compared to 26 and 27 before implant off PPIs, respectively. Cessation of PPIs at 3 years was achieved in 84% (38/45) of patients in the EES group compared to 88% (38/43) in the non-EES group. CONCLUSION In this study of a magnetic sphincter device for GERD, the majority of patients reported extra-esophageal symptoms along with typical symptoms such as heartburn and regurgitation at baseline. Following treatment, the number of patients reporting extra-esophageal symptoms decreased from 51% to 10% at 3 years. Improvement in quality of life, reduction in esophageal acid and cessation of PPIs were reported in patients with pre-operative extra-esophageal symptoms. Magnetic Sphincter augmentation appears to be effective in treating this difficult group of patients and deserves further study.
(0.00 = no agreement, 0.01 to 0.20 = slight agreement, 0.21 to 0.40 = fair agreement, 0.41 to 0.60 = moderate agreement, 0.61 to 0.80 = substantial agreement, 0.81 to 0.99 = excellent agreement and 1.00 = perfect agreement) Tu1763 Proton Pump Inhibitor Prescriptions and Agreement in Diagnoses Between Otolaryngologists and Gastroenterologists Michael I. Ellenbogen, Andrew J. Gawron, Stephanie Shintani-Smith, John E. Pandolfino Background: Otolaryngologists (ENT) often prescribe proton pump inhibitors (PPIs) for symptoms associated with laryngopharyngeal reflux (LPR). Variation in diagnosis and management of reflux symptoms between ENT and gastroenterologists (GI) is unknown. Objective: To determine 1) PPI prescriptions, diagnoses, and testing in patients seen by ENT and 2) Compare agreement in PPI prescriptions, diagnoses, and testing in patients also seen by GI. Methods: Patients aged 18-90 seen in the Northwestern University ENT practice and provided a new PPI prescription from 2005-2011 were included. PPI prescription, diagnoses, and procedure data were obtained from the electronic database. Chart review was performed on patients with both an ENT and GI evaluation to determine differences in diagnoses, PPI prescriptions, and diagnostic testing. Descriptive statistics and tests for agreement in diagnoses were performed. Results: 2,427 patients were provided a new PPI prescription by ENT between 2005 and 2011. Patients were 52.2 yrs of age (sd 15.4) and predominantly female (56.4%), white (58.1%), and non-Hispanic (65.6%). Esomeprazole accounted for the greatest number of prescriptions (722, 29.8%), followed by omeprazole (582, 24.0%). Of patients given a PPI prescription, the primary, secondary, or tertiary ENT diagnosis was reflux (GERD, LPR) in 1,018 patients (41.9%). Other diagnoses are listed in Table 1. Diagnostic laryngoscopy was performed in 672 encounters (27.7%). A total of 140 patients (5.8% of 2,427) also saw GI (90 after ENT, 48 prior to ENT, and 2 on the same day). Of these 140 patients, 94 (67.1%) were given a standard diagnosis of GERD by GI and 33 (23.6%) were documented to have extra-esophageal symptoms (e.g. sore throat, globus). GI and ENT agreed 55.7% of the time in a standard reflux diagnosis (kappa statistic = 0.08). GI diagnoses, including extra-esophageal symptoms, supported reflux in 81.4% of patients who were prescribed a PPI by ENT. GI and ENT prescribed the same PPI in 73 patients (59.8%). PPI dose and frequency were the same in 78 (70.9%) and 77 patients (63.6%), respectively. Instructions on PPI timing were the same in 57 patients (47.1%). Laryngoscopy was performed in 135 patients, and 90 of these exams showed evidence of reflux. Upper endoscopy was performed in 96 patients (34.4% with hiatal hernia, 13.5% with esophagitis) and 19 had pH testing (11 with positive results for reflux). Of 17 patients with pH testing and laryngoscopy, 5 (29.4%) had evidence of reflux on both tests. Conclusions: In patients evaluated by ENT and GI, agreement in diagnosis of standard reflux disease is poor, PPI prescriptions between the two specialties are highly variable, and esophageal reflux testing is rarely used. Future work should focus on increased efforts to coordinate care and align management strategies for this group. Table 1. Diagnoses (ICD-9) associated with ENT visits when a PPI was prescribed
Tu1762 The Reflux Finding Score for Infants (RFS-I): Inter- and Intraobserver Variability Rachel J. van der Pol, Maartje M. Singendonk, Hans J. Hoeve, Quinten Kammeijer, Bas Pullens, Erik van Spronsen, George Thomas, Lenka Vermeeren, Astrid M. Konig, Marc A. Benninga, Michiel P. van Wijk Introduction: Larynxedema is encountered frequently in infants with laryngomalacia. It is hypothesized that larynxedema is caused by gastroesophageal reflux (GER). In adults, the Reflux Finding Score (RFS) is a validated tool to assess larynx edema. Anatomy and the size of the larynx differ significantly in infants compared to adults. Aim: To test the reliability of assessing reflux associated edema in infants when evaluated through flexible laryngoscopy (FL) with the use of an adapted RFS for infants (RFS-I). Methods: A pre-validation study was performed to assess the visibility of anatomic landmarks in the infant larynx. Items were selected by assessing inter- and intraobserver variability by three ENT specialists and through a review process of expert opinions. Table 1 represents all items that were subsequently included to form the RFS-I. Forty infants (3-18 months) were selected from a database of FL procedures. Twenty infants with reported evidence of larynx edema on FL and twenty infants with no reported pathologic findings during FL were selected. Next, 3 pediatric othorhinolaryngologists, 2 ENT doctors and 2 gastroenterology fellows (group 1,2 and 3 respectively), from 2 different centers were presented an educational tutorial that explained the scoring items. Finally, reviewers were presented the video clips in a randomized order, blinded for the clinical profile and findings during initial FL. To ensure intra-rater consistency, all reviewers performed a second rating of the video clips at least 2 days after their first view. Cohen's kappa ( κ) was calculated for categorical data and for analysis of .2 raters Fleiss' kappa ( κ) was used, for ordinal data the intraclass correlation coefficient (ICC) was used. Results: Of the 40 infants, (median age: 4 (0-16) months), age and gender did not differ significantly between the two groups. Overall interobserver agreement was moderate (ICC=0.45). Intraobserver agreement ranged from moderate to excellent agreement (ICC=0.50-0.87). Agreement values per item and per observer group are presented in table 2. A ROC-curve of group 3 showed an AUC of 0.77, 0.65 and 0.59 respectively. With a cutoff value of ,4 for the RFS-I, sensitivity and specificity were 95% and 26.3%, 60% and 36.8%, 65% and 31.6% respectively per observer. Conclusion: Inter- and intraobserver variability of the RFS-I is moderate. GER related larynx edema in infants, when assessed through flexible laryngoscopy, should be used with caution in research settings and cannot guide clinical practice. Other diagnostic tools, such as rigid laryngotracheoscopy should be considered and further investigated as a valid approach to detect larynx edema in infants. Table 1. RFS-I items and scores
1 Excluding acute laryngitis, irritable larynx, irritable larynx syndrome, laryngeal granuloma, larynx ulceration, and spasmodic dysphonia 2N=50 Primary diagnosis not designated 3N= 718, Secondary diagnosis missing 4N=1495 Tertiary diagnosis missing
Table 2. Inter- & intraobserver agreement per item, per group
AGA Abstracts
S-838
Tu1761 Extra-Esophageal Symptoms in Patients Undergoing Magnetic Sphincter Augmentation for GERD: Clinical Outcomes At 3 Years Philip O. Katz, Santiago Horgan, Paul Taiganides, Robert A. Ganz, James D. Luketich, Chris C. Smith, Steven Schlack-Haerer, Christy M. Dunst, Jeffrey H. Peters, Steven A. Edmundowicz, C. Daniel Smith, John C. Lipham, W. S. Melvin BACKGROUND A prospective, multicenter clinical study to evaluate outcomes of patients undergoing anti-reflux surgery included patients with pre-operative extra-esophageal symptoms (EES) as well as heartburn and regurgitation. All patients underwent a laparoscopic procedure to mechanically augment the lower esophageal sphincter (LES) with a magnetic device (LINX Reflux Management System, Torax Medical). METHOD In post-hoc analysis, patients reporting at least one EES prior to implant were identified from a questionnaire administered before surgery. Patients with pre-operative EES were compared to those without EES. Comparisons included demographics, esophageal pH measurements, GERD-Health Related Quality of Life (GERD-HRQL) score, and PPI use. All clinical outcomes were based on 3-year data, with the exception of the esophageal pH, which was collected at 1-year post-implant. RESULTS 100 hundred patients were enrolled in this study. Prior to implant, all patients were taking daily PPIs and had confirmed abnormal esophageal acid exposure. Of the 100 patients, 51% (51/100) reported at least one EES at baseline. Recurrent cough was reported by 37% (37/100), change of voice by 25% (25/100), nocturnal cough by 13% (13/100) and asthma by 11% (11/100). Of the patients with EES, the mean age was 51.3 years and 41% (21/51) were male and 59% (30/51) female. Baseline characteristics for patients with and without EES were statistically non-significant, expect for gender. Females were more likely than males to report pre-operative extra-esophageal symptoms (p=0.03). After implant, the percentage of patients reporting no EES improved to 88% (84/95) at 1 year, 88% (79/90) at 2 years and 90% (78/87) at 3 years compared to 49% (49/100) at baseline. The median total % time pH , 4 improved from 10.2% at baseline to 2.3% at l year in the EES group and 11.6% to 4.2% in the non-EES group, and the median DeMeester score improved from 33.9 to 9.9 in the EES and 41.0 to 16.1 in the non-EES group. The median GERD-HRQL at 3 years was 2 for the EES group and 3 for the non-EES group compared to 26 and 27 before implant off PPIs, respectively. Cessation of PPIs at 3 years was achieved in 84% (38/45) of patients in the EES group compared to 88% (38/43) in the non-EES group. CONCLUSION In this study of a magnetic sphincter device for GERD, the majority of patients reported extra-esophageal symptoms along with typical symptoms such as heartburn and regurgitation at baseline. Following treatment, the number of patients reporting extra-esophageal symptoms decreased from 51% to 10% at 3 years. Improvement in quality of life, reduction in esophageal acid and cessation of PPIs were reported in patients with pre-operative extra-esophageal symptoms. Magnetic Sphincter augmentation appears to be effective in treating this difficult group of patients and deserves further study.
(0.00 = no agreement, 0.01 to 0.20 = slight agreement, 0.21 to 0.40 = fair agreement, 0.41 to 0.60 = moderate agreement, 0.61 to 0.80 = substantial agreement, 0.81 to 0.99 = excellent agreement and 1.00 = perfect agreement) Tu1763 Proton Pump Inhibitor Prescriptions and Agreement in Diagnoses Between Otolaryngologists and Gastroenterologists Michael I. Ellenbogen, Andrew J. Gawron, Stephanie Shintani-Smith, John E. Pandolfino Background: Otolaryngologists (ENT) often prescribe proton pump inhibitors (PPIs) for symptoms associated with laryngopharyngeal reflux (LPR). Variation in diagnosis and management of reflux symptoms between ENT and gastroenterologists (GI) is unknown. Objective: To determine 1) PPI prescriptions, diagnoses, and testing in patients seen by ENT and 2) Compare agreement in PPI prescriptions, diagnoses, and testing in patients also seen by GI. Methods: Patients aged 18-90 seen in the Northwestern University ENT practice and provided a new PPI prescription from 2005-2011 were included. PPI prescription, diagnoses, and procedure data were obtained from the electronic database. Chart review was performed on patients with both an ENT and GI evaluation to determine differences in diagnoses, PPI prescriptions, and diagnostic testing. Descriptive statistics and tests for agreement in diagnoses were performed. Results: 2,427 patients were provided a new PPI prescription by ENT between 2005 and 2011. Patients were 52.2 yrs of age (sd 15.4) and predominantly female (56.4%), white (58.1%), and non-Hispanic (65.6%). Esomeprazole accounted for the greatest number of prescriptions (722, 29.8%), followed by omeprazole (582, 24.0%). Of patients given a PPI prescription, the primary, secondary, or tertiary ENT diagnosis was reflux (GERD, LPR) in 1,018 patients (41.9%). Other diagnoses are listed in Table 1. Diagnostic laryngoscopy was performed in 672 encounters (27.7%). A total of 140 patients (5.8% of 2,427) also saw GI (90 after ENT, 48 prior to ENT, and 2 on the same day). Of these 140 patients, 94 (67.1%) were given a standard diagnosis of GERD by GI and 33 (23.6%) were documented to have extra-esophageal symptoms (e.g. sore throat, globus). GI and ENT agreed 55.7% of the time in a standard reflux diagnosis (kappa statistic = 0.08). GI diagnoses, including extra-esophageal symptoms, supported reflux in 81.4% of patients who were prescribed a PPI by ENT. GI and ENT prescribed the same PPI in 73 patients (59.8%). PPI dose and frequency were the same in 78 (70.9%) and 77 patients (63.6%), respectively. Instructions on PPI timing were the same in 57 patients (47.1%). Laryngoscopy was performed in 135 patients, and 90 of these exams showed evidence of reflux. Upper endoscopy was performed in 96 patients (34.4% with hiatal hernia, 13.5% with esophagitis) and 19 had pH testing (11 with positive results for reflux). Of 17 patients with pH testing and laryngoscopy, 5 (29.4%) had evidence of reflux on both tests. Conclusions: In patients evaluated by ENT and GI, agreement in diagnosis of standard reflux disease is poor, PPI prescriptions between the two specialties are highly variable, and esophageal reflux testing is rarely used. Future work should focus on increased efforts to coordinate care and align management strategies for this group. Table 1. Diagnoses (ICD-9) associated with ENT visits when a PPI was prescribed
Tu1762 The Reflux Finding Score for Infants (RFS-I): Inter- and Intraobserver Variability Rachel J. van der Pol, Maartje M. Singendonk, Hans J. Hoeve, Quinten Kammeijer, Bas Pullens, Erik van Spronsen, George Thomas, Lenka Vermeeren, Astrid M. Konig, Marc A. Benninga, Michiel P. van Wijk Introduction: Larynxedema is encountered frequently in infants with laryngomalacia. It is hypothesized that larynxedema is caused by gastroesophageal reflux (GER). In adults, the Reflux Finding Score (RFS) is a validated tool to assess larynx edema. Anatomy and the size of the larynx differ significantly in infants compared to adults. Aim: To test the reliability of assessing reflux associated edema in infants when evaluated through flexible laryngoscopy (FL) with the use of an adapted RFS for infants (RFS-I). Methods: A pre-validation study was performed to assess the visibility of anatomic landmarks in the infant larynx. Items were selected by assessing inter- and intraobserver variability by three ENT specialists and through a review process of expert opinions. Table 1 represents all items that were subsequently included to form the RFS-I. Forty infants (3-18 months) were selected from a database of FL procedures. Twenty infants with reported evidence of larynx edema on FL and twenty infants with no reported pathologic findings during FL were selected. Next, 3 pediatric othorhinolaryngologists, 2 ENT doctors and 2 gastroenterology fellows (group 1,2 and 3 respectively), from 2 different centers were presented an educational tutorial that explained the scoring items. Finally, reviewers were presented the video clips in a randomized order, blinded for the clinical profile and findings during initial FL. To ensure intra-rater consistency, all reviewers performed a second rating of the video clips at least 2 days after their first view. Cohen's kappa ( κ) was calculated for categorical data and for analysis of .2 raters Fleiss' kappa ( κ) was used, for ordinal data the intraclass correlation coefficient (ICC) was used. Results: Of the 40 infants, (median age: 4 (0-16) months), age and gender did not differ significantly between the two groups. Overall interobserver agreement was moderate (ICC=0.45). Intraobserver agreement ranged from moderate to excellent agreement (ICC=0.50-0.87). Agreement values per item and per observer group are presented in table 2. A ROC-curve of group 3 showed an AUC of 0.77, 0.65 and 0.59 respectively. With a cutoff value of ,4 for the RFS-I, sensitivity and specificity were 95% and 26.3%, 60% and 36.8%, 65% and 31.6% respectively per observer. Conclusion: Inter- and intraobserver variability of the RFS-I is moderate. GER related larynx edema in infants, when assessed through flexible laryngoscopy, should be used with caution in research settings and cannot guide clinical practice. Other diagnostic tools, such as rigid laryngotracheoscopy should be considered and further investigated as a valid approach to detect larynx edema in infants. Table 1. RFS-I items and scores
1 Excluding acute laryngitis, irritable larynx, irritable larynx syndrome, laryngeal granuloma, larynx ulceration, and spasmodic dysphonia 2N=50 Primary diagnosis not designated 3N= 718, Secondary diagnosis missing 4N=1495 Tertiary diagnosis missing
Table 2. Inter- & intraobserver agreement per item, per group
AGA Abstracts
S-838