INTRODUCTION: Concern for gastroesophageal reflux disease (GERD) is the most common reason to consult gastroenterology. We aimed to optimize routine GERD evaluation on cost-effectiveness according to the dominant typical symptom among patients with persistent symptoms failing empiric proton-pump inhibitors (PPI).

METHODS: We developed a decision analytic model evaluating all permutations of GERD diagnostics including empiric trials of PPI optimization or discontinuation, upper endoscopy, wireless pH-monitoring, and pH-impedance monitoring. The model was applied to patients with heartburn, regurgitation, and chest pain in general gastroenterology to identify the appropriate combination and order of testing from insurer and patient perspectives. Health outcomes were informed by systematic reviews of clinical trials. Cost outcomes were informed by Centers for Medicare and Medicaid Services and commercial datasets and national observational studies. The time horizon was 1 year, and willingness-to-pay threshold was $100,000/quality-adjusted life year gained.

RESULTS: For patients with typical persistent GERD symptoms failing empiric PPI, routine up-front ambulatory reflux testing saved $2,500-$4,500 compared with endoscopy alone when no erosive esophagitis is found. The most cost-effective initial ambulatory reflux test was 96-hour wireless pH-monitoring for patients with heartburn and chest pain and 24-hour pH-impedance monitoring for patients with regurgitation, both performed OFF-PPI. Adding ON-PPI pH-impedance monitoring optimized cost-effectiveness for patients with documented evidence of GERD and PPI-refractory symptoms. Patient and insurer perspectives aligned on these optimal diagnostic strategies.

DISCUSSION: Compared with a one-size-fits-all strategy, a tailored approach based on Lyon 2.0 optimizes cost-effective evaluation and management of GERD by phenotyping the appropriate diagnostics to dominant symptom.

INTRODUCTION: The term laryngopharyngeal reflux (LPR) is frequently applied to aerodigestive symptoms despite lack of objective reflux evidence. The aim of this initiative was to develop a modern care paradigm for LPR supported by otolaryngology and gastroenterology disciplines.

METHODS: A 28-member international interdisciplinary working group developed practical statements within the following domains: definition/terminology, initial diagnostic evaluation, reflux monitoring, therapeutic trials, behavioral factors and therapy, and risk stratification. Literature reviews guided statement development and were presented at virtual/in-person meetings. Each statement underwent 2 or more rounds of voting per the RAND Appropriateness Method; statements reaching appropriateness with ≥80% agreement are included as recommendations.

RESULTS: The term laryngopharyngeal symptoms (LPS) applies to aerodigestive symptoms with potential to be induced by reflux and include cough, voice change, throat clearing, excess throat phlegm, and throat pain. Laryngopharyngeal reflux disease (LPRD) refers to patients with LPS and objective evidence of reflux. Importantly, the presence of LPS does not equate to LPRD. Laryngoscopy has value in assessing for nonreflux laryngopharyngeal processes, but laryngoscopic findings alone cannot diagnose LPRD. LPS patients should be categorized as with or without concurrent esophageal reflux symptoms. While lifestyle modification and empiric trials of acid suppression ± alginates are appropriate when esophageal reflux symptoms coexist, upper endoscopy and ambulatory reflux monitoring are required for LPRD diagnosis when symptoms persist, when LPS is isolated, or when management needs to be escalated to include invasive antireflux management. The two recommended ambulatory reflux monitoring modalities, 24-hour pH-impedance and 96-hour wireless pH monitoring, are not mutually exclusive with distinct roles for the evaluation of LPS. Laryngeal hyperresponsiveness and hypervigilance commonly contribute to both LPS and LPRD presentations and are responsive to laryngeal recalibration therapy and neuromodulators.

DISCUSSION: The San Diego Consensus represents the formal modern-day interdisciplinary care paradigm to evaluate and manage LPS and LPRD.

INTRODUCTION: We explored if a score derived from parameters from esophageal testing could increase confidence in diagnosing conclusive gastroesophageal reflux disease and in predicting outcome.

METHODS: A prediction score was developed using metrics based on Lyon Consensus 2.0 thresholds extracted from endoscopy and pH-impedance monitoring. The Lyon score was the sum of weighted scores derived from a logistic regression model. The outcome was response to antireflux therapy, defined as 50% reduction in global symptoms on validated questionnaires. An existing database of endoscopy-negative patients with typical reflux symptoms undergoing esophageal testing from 2 centers (Europe and the United States) constituted the developmental cohort, while 2 separate cohorts (Europe and Asia) served as validation cohorts. Receiver operating characteristics analysis determined performance of the Lyon score in predicting treatment response.

RESULTS: In 281 developmental cohort patients (median age 53 years, 57.7% female), the Lyon score demonstrated an area under the curve (AUC) of 0.819 in predicting 50% symptom improvement ( P < 0.001) on receiver operating characteristics, with an optimal threshold of 6.25 (sensitivity 81.2%, specificity 73.4%). Of the individual components, only acid exposure time (AUC 0.799, P < 0.001), mean nocturnal baseline impedance (AUC 0.785, P < 0.001), and reflux episodes (AUC 0.764, P < 0.001) approached the Lyon score performance. The Lyon score segregated treatment response in both the European (AUC 0.908, P < 0.001) and Asian validation cohorts (AUC 0.637, P < 0.001) and outperformed the DeMeester score in sensitivity for predicting outcome in the developmental and Asian validation cohorts.

DISCUSSION: The novel Lyon score segregates reflux phenotypes and identifies likelihood of symptom response from antireflux therapy.

Patient-reported outcome (PRO) measures are essential tools for assessing a patient's subjective experience related to disease and health. PROs measure symptom severity and evaluate treatment efficacy across a range of conditions at a particular point in time. Although PROs focusing on esophageal symptoms and esophageal hypervigilance exist, disease-specific PROs for commonly encountered benign esophageal disorders such as gastroesophageal reflux disease (GERD), eosinophilic esophagitis (EoE), and achalasia are limited. Most GERD-specific PROs fail to address the complete spectrum of GERD presentations and those that provide daily assessment are more suited for research. Similarly, many EoE-specific PROs were designed for clinical trials. Comprehensive instruments incorporating EoE symptoms, as well as endoscopic and histologic features of active inflammation and fibrostenotic changes are needed. The psychometric properties of the Eckardt Score used for achalasia have significant limitations, stemming primarily from the dominance of dysphagia in scoring. Newer achalasia-specific PROs attempt to overcome this by capturing nuanced patient experiences. Broader symptom PROs are often used to assess esophageal symptoms across the spectrum of benign esophageal disorders, including a PRO that assesses esophageal hypervigilance and symptom-specific anxiety. Future efforts should focus on creating user-friendly PROs that comprehensively evaluate not just clinical presentation but also the disease state, which will enhance clinical symptom follow-up, quality of life assessment, and research applications. Assessments of hypervigilance and visceral anxiety will complement these applications as these measures are both a PRO and an important moderator of symptom severity and quality of life.

BACKGROUND AND AIMS: Functional lumen imaging probe (FLIP) Panometry provides assessment of the esophagogastric junction (EGJ) opening and esophageal body contractile activity during an endoscopic procedure and is increasing being incorporated in comprehensive esophageal motility assessments. We aimed to provide a standardized approach and vocabulary to the procedure and interpretation and update the motility classification scheme.

METHODS: A working group of 19 FLIP Panometry experts convened in a modified Delphi consensus process to produce and assess statements on the FLIP Panometry procedure and interpretation. Three rounds of voting were conducted on an agreement scale of 1-9 for appropriateness followed by face-to-face discussions and opportunity for revisions of statements. The "percent agreement" was proportion of votes with score ≥7 indicating level of agreement on appropriateness.

RESULTS: A total of 40 statements were selected for final inclusion for the Dallas Consensus, including FLIP Panometry protocol, interpretation of EGJ opening and contractile response, and motility classification scheme. Key statements included: "FLIP Panometry should be interpreted in the context of the clinical presentation, the accompanying EGD findings and other relevant complementary testing". (Median response 9.0; 100% agreement). "A major motor disorder is unlikely in the setting of a "Normal" FLIP Panometry classification (Median response 9.0; 94% agreement). "Diminished or absent contractile response with reduced esophageal opening [i.e. "non-spastic obstruction] supports the diagnosis of a disorder of EGJ outflow. (Median response 8.5; 94% agreement).

CONCLUSION: The standardized approach for performance and interpretation of the Dallas Consensus can facilitate use of FLIP Panometry in broad clinical settings.

BACKGROUND AND AIMS: Heartburn symptoms contribute to healthcare-seeking among patients with gastroesophageal reflux disease (GERD). Despite clinical guidance, management is often dictated by insurance restrictions. Several potassium-competitive acid blockers (PCABs) are under development as a new class of therapy. We performed economic analyses to align GERD drug development with the needs of gastroenterologists, insurers and patients in a value-based environment.

METHODS: A decision-analytic model was constructed to compare vonoprazan 20 mg daily (an example of a PCAB), common over-the-counter or prescription proton pump inhibitor regimens, and no treatment over a 1-year time horizon. Clinical responses were evaluated based on the proportions of heartburn-free days in a recent phase 3 multicenter trial. Healthcare utilization for persistent reflux symptoms was derived from national observational studies compared with healthy control subjects. Costs and quality-adjusted life years were reported.

RESULTS: Without insurance coverage for appropriate therapy, patients spend $4443 and insurers spend $3784 on average per year for inadequately treated GERD symptoms. Our model estimates that PCABs could save at least $3000 in annual costs to patients and insurers, could generate quality-adjusted life year gains (+0.06 per year), and could be cost-saving to insurers as a covered option at a price up to $8.57 per pill, if these drugs are able to demonstrate similar effectiveness to proton pump inhibitors in future trials evaluating heartburn relief and erosive esophagitis healing to regulators. Threshold prices reflect pricing after all pharmacy benefits manager rebates and discounts.

DISCUSSION: We demonstrate that aiming GERD-related drug development toward heartburn relief appears critical to align cost-effective incentives for industry and insurers with those of patients and gastroenterologists.