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Objective: To explore the influence of age and sex on the clinical presentation and therapeutic response of patients with laryngopharyngeal reflux (LPR). Study Design: Prospective study. Setting: Prospective multicenter study of 271 patients with a diagnosis of LPR confirmed by impedance-pH monitoring. Methods: Patients were prescribed 6 months of diet changes and a combination of pantoprazole and/or alginate depending on the results of their impedance-pH results. The Reflux Symptom Score (RSS) and Reflux Sign Assessment (RSA) were collected at baseline and at 3 and 6 months posttreatment. Data were explored according to sex and age. Results: A total of 237 patients completed the evaluations (138 females). On the RSS, patients of the oldest group (>60 years) had lower symptom scores (throat pain, ear pain, odynophagia, chest pain, tongue burning, nausea, halitosis, and indigestion) and lower quality-of-life scores than younger individuals. RSS and RSA outcomes significantly improved from pretreatment to 3 months posttreatment in all groups. Scores on the RSS and RSA continued to improve from 3 to 6 months posttreatment in the elderly group. Females with LPR had a higher score on the RSS at baseline as compared with males. On the RSS, scores significantly improved after 3 months in males and females; however, they continued to improve from 3 to 6 months in the female group. Conclusion: Age and sex may influence the clinical presentation and pre- to posttreatment evolution of symptoms and findings. Age and sex differences could be considered in future therapeutic approaches to guide more effective personalized treatment plans for patients with LPR. [ABSTRACT FROM AUTHOR]

Objective: To study the profile and the therapeutic response of patients with laryngopharyngeal reflux (LPR) at the hypopharyngeal-esophageal multichannel intraluminal impedance-pH monitoring (HEMII-pH) according to the initial pepsin saliva concentration. Methods: From January 2018 to January 2020, patients with positive LPR diagnosis at the HEMII-pH were consecutively recruited from 3 European Hospitals. Saliva pepsin concentration (Peptest™) was measured during the HEMII-pH testing period and patients were classified into 2 groups: negative versus positive Peptest. The clinical outcomes, that is, gastrointestinal and HEMII-pH findings, reflux symptom score-12 (RSS-12), and 3-month therapeutic response, were compared between groups. Results: A total of 124 patients completed the study. Among them, 30 patients had negative Peptest. Pharyngeal reflux events occurred outside 1-hour post-meal time in 74.0%, after the meals in 20.5% and nighttime in 5.5%. The pepsin saliva level was not significantly associated with the reflux events preceding the sample collection. Patients with positive Peptest had better improvement of RSS-12 digestive and respiratory subscores and oral, pharyngeal, and laryngeal findings compared with patients with negative Peptest. Conclusion: Patients with high saliva pepsin concentration had no stronger gastrointestinal, HEMII-pH, or clinical outcomes compared with those with low or undetectable saliva pepsin concentration. [ABSTRACT FROM AUTHOR]

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.Level Of Evidence: 3 Laryngoscope, 131:1332-1342, 2021. [ABSTRACT FROM AUTHOR]

Objective: To assess the evolution of symptoms and findings of laryngopharyngeal reflux (LPR) patients according to the type of reflux (acid, non‐acid, mixed and gastro‐oesophageal (GERD)). Design: Prospective uncontrolled multicentre study. Methods: One hundred and six patients with LPR have been recruited from 3 European Hospitals. According to the reflux characteristics at the impedance‐pH monitoring (acid, non‐acid, mixed, GERD), patients received a personalised treatment based on the association of diet, pantoprazole, alginate or magaldrate for 3 months. Reflux Symptom Score (RSS) was assessed at baseline, 6 and 12 weeks post‐treatment. Reflux Sign Assessment (RSA) has been used to rate laryngeal and extra‐laryngeal findings at baseline and 12 weeks post‐treatment. Overall success rate and the evolution of symptoms and findings were evaluated according to the LPR types. Results: One hundred and two LPR patients (42 acid, 33 non‐acid, 27 mixed, including 49 with LPR and GERD) completed the study. RSS and RSA total scores significantly improved from baseline to post‐treatment time in acid, mixed and non‐acid groups. The presence of GERD in addition to LPR did not impact the clinical improvement. The 3‐month success rates of treatment ranged from 62% to 64%, and there were no significant differences between groups. The success rate of patients with non‐acid LPR was similar to those of patients with mixed and acid LPR. Conclusion: MII‐pH is useful to specify the type of LPR and the related most adequate therapeutic regimen. Non‐acid or mixed LPR similarly respond to treatment than acid LPR but require a treatment based on alginate or magaldrate covering the non‐acid proximal reflux events. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objectives/hypothesis: To assess the impact of diet on the saliva pepsin concentration of patients with laryngopharyngeal reflux (LPR).Study Design: Non-controlled Prospective Study.Methods: Patients with positive LPR regarding hypopharyngeal-esophageal impedance-pH monitoring (HEMII-pH) were enrolled from three European Hospitals. Patients collected three saliva samples, respectively, in the morning (fasting), and 1 to 2 hour after lunch and dinner. Patients carefully detailed foods and beverages consumed during meals and before the pepsin samples. The 3-month treatment was based on the association of diet, proton pump inhibitors, alginate, or magaldrate regarding the HEMII-pH characteristics. Reflux Symptom Score (RSS) and Reflux Sign Assessment (RSA) were used for assessing the pre- to posttreatment clinical evolution. The Refluxogenic Diet Score and the Refluxogenic Score of a Dish (RESDI) were used to assess the refluxogenic potential of foods and beverages. The relationship between saliva pepsin concentration, HEMII-pH, RESDI, RSS, and RSA was investigated through multiple linear regression.Results: Forty-two patients were included. The saliva pepsin concentration of the 24-hour period of testing was significantly associated with foods and beverages consumed during the testing period and the evening dinner (rs = 0.973, P < .001). RSS and RSA significantly improved throughout treatment. The level of saliva pepsin in the morning was a negative predictive factor of the therapeutic response regarding RSA and RSS (P < .036).Conclusions: Foods and beverages may significantly impact the saliva pepsin concentration of patients with LPR. Patients with high-level saliva pepsin in the morning had lower therapeutic response compared with those with low-level saliva pepsin.Level Of Evidence: 4 Laryngoscope, 131:350-359, 2021. [ABSTRACT FROM AUTHOR]

Objective: To develop and validate a short version of the Reflux Symptom Score—the 12-question Reflux Symptom Score–12 (RSS-12)—for patients with laryngopharyngeal reflux disease (LPR). Study Design: Prospective study. Setting: Multicenter academic hospitals. Methods: Patients with LPR diagnosed via multichannel intraluminal impedance pH monitoring were enrolled from 3 European hospitals. Healthy individuals completed the study. Individuals completed the Reflux Symptom Score, Reflux Symptom Index (RSI), and Voice Handicap Index (VHI) at baseline and 3 months posttreatment. The Reflux Symptom Score was completed twice within a 7-day period to assess test-retest reliability. Cronbach's α was used for assessing internal consistency. The RSS-12 was developed and validity assessed through a comparison of the RSS-12, RSI, and VHI. Responsiveness to change was evaluated through the pre- to posttreatment evolution of the RSS-12 total score. Receiver operating characteristic analysis was used to determine the RSS-12 threshold that is suggestive of LPR. Results: The RSS-12 was characterized by high test-retest reliability (r s = 0.956) and adequate internal consistency reliability (α = 0.739). The RSS-12 was significantly correlated with the RSI (r s = 0.845), suggesting high external validity. The RSS-12 total and item scores were significantly higher in patients with LPR as compared with healthy individuals (P =.001), supporting high internal validity. RSS-12, VHI, and RSI significantly improved throughout treatment. Regarding the receiver operating characteristic curve, an RSS-12 score >11 is suggestive of LPR, exhibiting a sensitivity of 94.5% and a specificity of 86.2%. Conclusion: The RSS-12 is a shorter, reliable, and valid self-administered patient-reported outcome measure questionnaire that can be used in the outpatient setting to suggest and monitor LPR. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]