Objectives/Hypothesis To develop and validate the Reflux Symptom Score (RSS), a self‐administered patient‐reported outcome questionnaire for patients with laryngopharyngeal reflux (LPR). Study Design Prospective controlled study. Methods A total of 113 patients with LPR were enrolled and treated with diet and 3 months of pantoprazole, alginate, and/or magaldrate depending on the LPR characteristics (acid, nonacid, or mixed). Eighty asymptomatic individuals completed the study. Patients and controls completed the RSS twice within a 7‐day period to assess test‐retest reliability. Internal consistency was measured using Cronbach's α for the RSS items in patients and controls. Validity was assessed by comparing the baseline RSS with the Reflux Symptom Index (RSI) and Voice Handicap Index (VHI). Seventy‐seven patients completed the RSS at baseline and after 6 and 12 weeks of treatment to assess responsiveness to change. The RSS cutoff for determining the presence and absence of LPR was examined by receiver operating characteristic analysis. Results Test‐retest reliability (rs = 0.921) and internal consistency reliability (α = 0.969) were high. RSS exhibited high external validity indicated by a significant correlation with the RSI (rs = 0.831). Internal validity was excellent based on the higher RSS in patients compared with controls (P = .001). RSS, RSI, and VHI scores significantly improved from pre‐ to posttreatment, indicating a high responsiveness to change. RSS >13 can be considered suggestive of LPR‐related symptoms. RSS was not influenced by the occurrence of gastroesophageal reflux disease, LPR subtypes, or patient characteristics. Conclusions RSS is a self‐administered patient‐reported outcome questionnaire that demonstrates high reliability and excellent criterion‐based validity. RSS can be used in diagnosing and monitoring LPR disease. Level of Evidence 3b Laryngoscope, 130:E98–E107, 2020

Objective: To develop and validate the Reflux Sign Assessment (RSA), a clinical instrument evaluating the physical findings of laryngopharyngeal reflux (LPR). Methods: A total of 106 patients completed a 3-month treatment based on the association of diet, pantoprazole, alginate, or magaldrate with the LPR characteristics (acid, nonacid, mixed). Forty-two asymptomatic individuals completed the study (control group). The RSA results and reflux finding score (RFS) were documented for the LPR patients at baseline and after treatment. Intrarater reliability was assessed through a test-retest blinded evaluation of signs (7-day intervals). Interrater reliability was assessed by comparing the RSA evaluations of three blinded otolaryngologists through Kendall’s W. Responsiveness to change was evaluated through a comparison of the baseline and 3-month posttreatment findings. The RSA cutoffs for determining the presence and absence of LPR were examined by receiver operating characteristic (ROC) analysis. Results: A total of 102 LPR patients completed the study (68 females). The mean age was 53 years. The mean RSA at baseline was 25.95 ± 9.58; it significantly improved to 18.96 ± 7.58 after 3 months of therapy ( P < .001). RSA exhibited good intra- ( r = 0.813) and interrater (Kendall’s W = 0.663) reliabilities (N = 56). There was no significant association between the RSA, gastrointestinal endoscopy findings, and the types of reflux (acid, nonacid, or mixed) according to impedance-pH monitoring. An RSA >14 may be suggestive of LPR. Conclusion: The RSA is a complete clinical instrument evaluating both laryngeal and extralaryngeal findings associated with LPR. The RSA demonstrated high intra- and interrater reliabilities and responsiveness to change.

Objective To investigate the clinical features and the therapeutic response of laryngopharyngeal reflux (LPR) patients with or without gastroesophageal reflux disease (GERD). Methods Patients with LPR symptoms were enrolled from three European Hospitals. The diagnosis of LPR and GERD was made through impedance‐pH monitoring (MII‐pH). A gastrointestinal endoscopy was realized in patients with digestive complaints or ≥60 years old. The 3‐ to 6‐month treatment was based on the association of diet, pantoprazole, alginate, and magaldrate regarding the MII‐pH characteristics. Reflux Symptom Score (RSS) and Reflux Sign Assessment (RSA) were used to evaluate the clinical evolution throughout treatment. The gastrointestinal endoscopy findings, clinical features, and therapeutic response were compared between patients with LPR and GERD (LPR/GERD) and patients with LPR. Results One hundred and eleven LPR patients were included, 54 being LPR/GERD. LPR/GERD patients had a higher number of proximal reflux episodes compared with LPR patients. The prevalence of esophagitis, hernia hiatal, and lower esophageal sphincter insufficiency did not differ between groups. The presence of GERD was strongly associated with acid LPR. Patients without GERD had a higher proportion of nonacid and mixed LPR compared with LPR/GERD patients. The pre‐ to posttreatment evolutions of RSS and RSA were quite similar in both groups, with the exception of the 3‐ to 6‐month improvement of digestive symptoms, which was better in LPR/GERD group. The therapeutic success rates were 79.6% and 77.2% in GERD/LPR and LPR group, respectively. Conclusion GERD is predictive of acid LPR. The clinical evolution and the therapeutic response rates were quite similar in both groups. Level of Evidence 4 Laryngoscope, 130: E479–E489, 2020

Objectives/Hypothesis To investigate the profile of patients with laryngopharyngeal reflux (LPR) at hypopharyngeal–esophageal multichannel intraluminal impedance‐pH (HEMII‐pH) monitoring and the relationship between hypopharyngeal‐proximal reflux episodes (HREs) and saliva pepsin concentration. Study Design Prospective non‐controlled. Methods Patients were recruited from three European hospitals from January 2018 to October 2019. Patients benefited from HEMII‐pH monitoring and saliva collections to measure saliva pepsin concentration in the same time. Saliva pepsin concentration was measured in the morning (fasting), after lunch, and after dinner. The LPR profile of patients was studied through a breakdown of the HEMII‐pH findings over the 24 hours of testing. The relationship between the concentrations of saliva pepsin and 24‐hour HREs was studied through linear multiple regression. Results One hundred twenty‐six patients completed the study. The HEMII‐pH analyses revealed that 73.99% of HREs occurred outside 1‐hour postmeal times, whereas 20.49% and 5.52% of HREs occurred during the 1‐hour postmeal and nighttime, respectively. Seventy‐four patients (58.73%) did not have nighttime HREs. Patients with both daytime and nighttime HREs had more severe HEMII‐pH parameters and reflux symptom score compared with patients with only daytime HREs. There were no significant associations between HREs and saliva pepsin concentration. Conclusions Unlike gastroesophageal reflux disease, HREs occur less frequently after meals and nighttime. The analysis of the HEMII‐pH profile of the LPR patients has to be considered to develop future personalized therapeutic strategies. Level of Evidence 4 Laryngoscope, 131:268–276, 2021

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Objectives To review the normative data for acid, weakly acid, and nonacid proximal esophageal (PRE) and hypopharyngeal reflux (HRE) events in diagnosing laryngopharyngeal reflux (LPR) using ambulatory reflux monitoring. Data Sources PubMed, Cochrane Library, and Scopus. Review Methods A literature search was conducted about the normative data for PRE and HRE on multichannel intraluminal impedance–pH monitoring (MII-pH), hypopharyngeal-esophageal MII-pH (HEMII-pH), or oropharyngeal pH monitoring using PICOTS (population, intervention, comparison, outcome, timing, and setting) and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statements. Outcomes reviewed included device characteristics, impedance/pH sensor placements, study duration, number/average and percentiles of PRE or HRE occurrence, and the event characteristics (pH, composition, and position). Results Of 154 identified studies, 18 met criteria for analysis, including 720 healthy individuals. HEMII-pH, MII-pH, and oropharyngeal pH monitoring were used in 7, 6, and 5 studies, respectively. The definition and inclusion/exclusion criteria of healthy individuals varied substantially across studies, with 6 studies considering only digestive symptoms to exclude potential LPR patients. Substantial heterogeneity across studies was noted, including impedance/pH sensor placements/configurations and definitions of composition (liquid, gas, mixed) and type (acid, weakly acid, nonacid) of PRE/HRE. The 95th percentile thresholds were 10 to 73 events for PRE, 0 to 10 events for HRE on HEMII-pH, and 40 to 128 for events with pH <6.0 on oropharyngeal pH monitoring. Most HREs were nonacid and occurred upright. The mean HRE among healthy individuals was 1. Conclusion The low number of studies and the heterogeneity in inclusion criteria, definitions, and characterization of PRE and HRE limit the establishment of consensual normative criteria for LPR on ambulatory reflux monitoring. Future large multicenter studies are needed.

Objectives/Hypothesis: To assess the evolution of laryngeal and extralaryngeal symptoms and findings of laryngopharyngeal reflux (LPR) throughout a 3-month to 9-month treatment.Study Design: Prospective Controlled Study. Methods: One hundred twenty-seven LPR patients and 123 healthy individuals were enrolled from four European hospitals. Patients were managed with a 3-month personalized treatment considering the LPR characteristics at the impedance-pH monitoring. Regarding the clinical therapeutic response, treatment was adapted for 3 to 6 additional months. Symptoms and findings were assessed throughout the therapeutic course with the Reflux Symptom Score (RSS) and the short version of the Reflux Sign Assessment (sRSA). The relationship between patient and reflux characteristics, symptoms, and findings was assessed.Results: One hundred twenty-one LPR patients completed the study. LPR patients exhibited more laryngeal and extralaryngeal symptoms and findings than healthy individuals. RSS significantly improved from baseline to 6 weeks posttreatment and continued to improve from 3 months to 6 months posttreatment. sRSA significantly improved from baseline to 3 months posttreatment. No further improvement was noted at 6 months posttreatment for pharyngeal and oral findings. Laryngeal findings continued to improve from 3 months to 6 months posttreatment. There was a significant association between patient stress level and RSS (P = .045). At 3 months posttreatment, 28.1% of patients had high or complete response, whereas 47.1% required 6 months or 9 months of treatment. Overall, 24.8% of patients had an LPR chronic course.Conclusions: Laryngeal and extralaryngeal symptoms and findings significantly improved throughout treatment in LPR patients. The improvement of laryngeal findings was slower. Regarding the low prevalence of some digestive or otolaryngological symptoms, a short version of the RSS could be developed.