Validity and Reliability of the Reflux Sign Assessment

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.

[1]  L. Crevier-Buchman,et al.  Development of scores assessing the refluxogenic potential of diet of patients with laryngopharyngeal reflux , 2019, European Archives of Oto-Rhino-Laryngology.

[2]  G. Dapri,et al.  Validity and reliability of the reflux symptom score , 2020, The Laryngoscope.

[3]  J. Richter,et al.  Laryngopharyngeal Reflux: Prospective Cohort Study Evaluating Optimal Dose of Proton‐Pump Inhibitor Therapy and Pretherapy Predictors of Response , 2005, The Laryngoscope.

[4]  C. Finck,et al.  Alkaline, protein, low‐fat and low‐acid diet in laryngopharyngeal reflux disease: Our experience on 65 patients , 2019, Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery.

[5]  Jo Shapiro,et al.  The Reliability of the Assessment of Endoscopic Laryngeal Findings Associated With Laryngopharyngeal Reflux Disease , 2002, The Laryngoscope.

[6]  J. Ponsky,et al.  Surgical fundoplication in laryngopharyngeal reflux unresponsive to aggressive acid suppression: a controlled study. , 2006, Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association.

[7]  J. Koufman,et al.  The Validity and Reliability of the Reflux Finding Score (RFS) , 2001, The Laryngoscope.

[8]  W. Issing,et al.  Should patients with pH-documented laryngopharyngeal reflux routinely undergo oesophagogastroduodenoscopy? A retrospective analysis. , 2007, The Journal of laryngology and otology.

[9]  D. Steward,et al.  Proton Pump Inhibitor Therapy for Chronic Laryngo-Pharyngitis: A Randomized Placebo-Control Trial , 2004, Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery.

[10]  J. Lechien,et al.  Laryngopharyngeal reflux disease: clinical presentation, diagnosis and therapeutic challenges in 2018 , 2018, Current opinion in otolaryngology & head and neck surgery.

[11]  J. Dent,et al.  Gastro-oesophageal reflux monitoring: review and consensus report on detection and definitions of acid, non-acid, and gas reflux , 2004, Gut.

[12]  J. Richter,et al.  The prevalence of hypopharynx findings associated with gastroesophageal reflux in normal volunteers. , 2002, Journal of voice : official journal of the Voice Foundation.

[13]  B. Chang,et al.  The Reliability of the Reflux Finding Score Among General Otolaryngologists. , 2015, Journal of voice : official journal of the Voice Foundation.

[14]  D. Penson,et al.  Patient-Reported Outcome Measures Related to Laryngopharyngeal Reflux , 2016, Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery.

[15]  C. Ford.  Treatment of Chronic Posterior Laryngitis With Esomeprazole , 2006, The Laryngoscope.

[16]  E. Weitzel,et al.  Diagnosis of Laryngopharyngeal Reflux Disease with Digital Imaging , 2003, Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery.

[17]  I. Cook,et al.  Predictors of Outcome in an Open Label, Therapeutic Trial of High-Dose Omeprazole in Laryngitis , 2004, American Journal of Gastroenterology.

[18]  F. Journé,et al.  Saliva pepsin level of laryngopharyngeal reflux patients is not correlated with reflux episodes , 2020, The Laryngoscope.

[19]  Bernard Harmegnies,et al.  Clinical outcomes of laryngopharyngeal reflux treatment: A systematic review and meta‐analysis , 2018, The Laryngoscope.

[20]  J. Wilson,et al.  Empiric Treatment of Laryngopharyngeal Reflux with Proton Pump Inhibitors: A Systematic Review , 2006, The Laryngoscope.

[21]  Bernard Harmegnies,et al.  Instruments evaluating the clinical findings of laryngopharyngeal reflux: A systematic review , 2018, The Laryngoscope.

[22]  John M. DelGaudio,et al.  Proximal pharyngeal reflux correlates with increasing severity of lingual tonsil hypertrophy , 2008, Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery.

[23]  R. Shaker,et al.  Treatment of Chronic Posterior Laryngitis With Esomeprazole , 2006, The Laryngoscope.

[24]  Thomas L. Carroll,et al.  How Much Pharyngeal Exposure Is “Normal”? Normative Data for Laryngopharyngeal Reflux Events Using Hypopharyngeal Multichannel Intraluminal Impedance (HMII) , 2011, Journal of Gastrointestinal Surgery.

[25]  J. Koufman,et al.  Validity and reliability of the reflux symptom index (RSI). , 2002, Journal of voice : official journal of the Voice Foundation.

[26]  J. Koufman,et al.  Laryngopharyngeal Reflux: Position Statement of the Committee on Speech, Voice, and Swallowing Disorders of the American Academy of Otolaryngology-Head and Neck Surgery , 2002, Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery.

[27]  C. Finck,et al.  Impact of age on laryngopharyngeal reflux disease presentation: a multi-center prospective study , 2017, European Archives of Oto-Rhino-Laryngology.

[28]  J. Richter,et al.  Prevalence of Laryngeal Irritation Signs Associated with Reflux in Asymptomatic Volunteers: Impact of Endoscopic Technique (Rigid vs. Flexible Laryngoscope) , 2005, The Laryngoscope.

[29]  Y. Yıldırım,et al.  Photographic Objective Alterations for Laryngopharyngeal Reflux Diagnosis. , 2017, Journal of voice : official journal of the Voice Foundation.

[30]  L. Crevier-Buchman,et al.  Evaluation and Management of Laryngopharyngeal Reflux Disease: State of the Art Review , 2019, Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery.

[31]  J. Lechien,et al.  Young Otolaryngologists of International Federation of Oto-rhino-laryngological Societies (YO-IFOS) committees. , 2018, European annals of otorhinolaryngology, head and neck diseases.

[32]  J. Koufman.  The Otolaryngologic Manifestations of Gastroesophageal Reflux Disease (GERD): A Clinical Investigation of 225 Patients Using Ambulatory 24‐Hour pH Monitoring and an Experimental Investigation of the Role of Acid and Pepsin in the Development of Laryngeal Injury , 1991, The Laryngoscope.