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Objectives To identify the instruments for evaluating the clinical findings (ICFs) of laryngopharyngeal reflux (LPR) designed for use with regard to diagnosis and treatment effectiveness. Methods The PubMed, Scopus, and Cochrane databases were used to search for subject headings following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations. Three investigators retrieved relevant studies published between 1990 and 2018 describing the evolution of laryngopharyngeal findings throughout LPR treatment. Issues of clinical relevance, that is, LPR diagnosis, treatments, and signs assessed for diagnosis or as therapeutic outcomes, were assessed. The investigators also evaluated the psychometric properties (conceptual model, content validity, consistency, reliability, concordance, convergent validity, known-groups validity, responsiveness to change, and interpretability) of the ICF. The risk of bias was assessed with the tool of the Clarity Group and Evidence Partners. Results The search identified 1,227 publications with a total of 4,735 LPR patients; of these studies, 53 met the inclusion criteria. Of these 53 studies, we identified 10 unvalidated and six validated ICFs. None of the validated ICFs included all the psychometric properties. The main identified deficiencies related to ICF psychometric validation included variable construct validity, disparate and uncertain reliabilities, and a lack of interpretability. The lack of consideration of certain LPR laryngeal and extralaryngeal signs is the main weakness of ICFs, biasing content, and construct validities. Conclusion The low specificity of LPR signs, the lack of consideration of many findings, and the absence of a gold standard for diagnosis constitute barriers to the further validation of these ICFs. Additional studies are needed to develop complete and reliable ICFs. Laryngoscope, 129:720-736, 2019.

Objective To assess the usefulness of voice quality measurements as a treatment outcome in patients with laryngopharyngeal reflux (LPR)-related symptoms. Design Prospective uncontrolled multi-centre study. Material and methods A total of 80 clinically diagnosed LPR patients with a reflux finding score (RFS)>7 and a reflux symptom index (RSI)>13 were treated with pantoprazole and diet recommendations during 3 or 6 months, according to their evolution. RSI; RFS; blinded Grade, Roughness, Breathiness, Asthenia, Strain and Instability (GRBASI) and aerodynamic and acoustic measurements were evaluated at baseline, 3 months (n = 80), and 6 months (n = 41) post-treatment. We conducted a correlation analysis between the adherence to the diet, and the evolution of both signs and symptoms and between videolaryngostroboscopic signs and acoustic measurements. Results Reflux symptom index, RFS, perceptual voice quality evaluations (dysphonia, roughness, strain and instability), and aerodynamic and acoustic measurements (ie, percent jitter and percent shimmer) were significantly improved at 3 months post-treatment but not at 6 months. Percent jitter was the most useful outcome for evaluating the clinical evolution of patients throughout the treatment course. A significant relationship between globus sensation and posterior commissure hypertrophy was documented; both seemed to significantly improve from 3 to 6 months. The correlation analysis revealed correlations between adherence to diet recommendations and the improvement of symptoms and between posterior commissure granulation severity and acoustic measurement impairments. Conclusion Voice quality improved in a manner similar to both signs and symptoms throughout a 6-month empirical treatment with better improvement the 3 first months. Voice quality assessments can be used as indicators of treatment effectiveness in patients with LPR-related symptoms.

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.