Sensitivity, Specificity, and Reproducibility of the Brazilian Portuguese Version of the Reflux Symptom Index
Introduction
The diagnosis of laryngopharyngeal reflux (LPR) is controversial.1, 2, 3, 4 Traditional diagnostic instruments such as esophagogastroduodenoscopy (EGD) and prolonged esophageal monitoring (24-hour double-probe pH-metry or pH-impedance tests—MII-pH) show low sensitivity to this atypical form of gastroesophageal disease (GERD).1, 2, 5, 6, 7, 8 Other diagnostic tools such as dosing salivary pepsin as a biomarker for LPR has found growing interest in recent years, although questions remain about its optimal timing, location, and threshold values.9, 10 Thus, there is currently no gold standard for the diagnosis of LPR,1, 2, 3, 4, 5, 6, 7, 8 which relies mainly on clinical symptoms, videolaryngoscopic findings, and a positive therapeutic trial with proton pump inhibiors.1, 3, 8 However, such symptoms and signs are also common to a number of other conditions that may affect the pharynx and larynx, such as infection, vocal abuse or misuse, allergies, alcohol and tobacco abuse, and neuropsychiatric disorders.1, 2, 3, 4, 5, 6, 7, 8, 11
In order to minimize subjectivity, a number of instruments have been designed with the purpose of diagnosing LPR.1, 2, 812, 13, 14, 15, 16, 17 The most widely used in clinical practice were proposed by Belafsky et al: the Reflux Finding Score (RFS)16 designed to assess videolaryngoscopic signs suggestive of the disease, and the Reflux Symptom Index (RSI)17 a questionnaire validated for clinical symptoms related to LPR.
The RSI, proposed by Belafsky et al in 2002,16 is a nine subdomain questionnaire based on the most common symptoms associated with LPR. Scores range from 0 to 45, whereas scores above 13 are considered positive for LPR.16 This instrument has been widely used in the international literature for both diagnosis and assessment of treatment outcome.1, 218, 19, 20 The objective of using such an instrument is to minimize subjectivity, and its quality is determined based on its reliability, internal consistency, and validity.15, 16 Previous research has proven the RSI to have high psychometric properties, which allows its reliable use in clinical practice.18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 Several translations and adaptations of the RSI into other languages have been published, such as Hebrew,20 Italian,21 Greek,22 Arabic,23 Chinese,25 French,26 Filipino,27 Polish,28 Spanish,29 and Turkish30 showing high psychometric properties and proving a reliable, reproducible clinical method of diagnosing and following clinical outcome in patients with LPR.2, 1315, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30
It was also translated and culturally adapted into Brazilian Portuguese in 2015,24 but still lacks proper validation (Figure 1). The objective of the current study was to assess the reliability and reproducibility of the Brazilian Portuguese version of the RSI as a diagnostic tool.
Section snippets
Materials and methods
The study was conducted in accordance with the principles of the Declaration of Helsinki and approval was granted by the Institutional Ethics Committee for Research in Humans (IFSP#3.244.947). The studied population consisted of adults over 18 and under 70 years of age that consented in participating in the current protocol after proper information on its objectives and methods.
A study group was formed by patients with symptoms and videolaryngoscopic signs suggestive of LPR19 corroborated by a
Results
Over an 8-month period, the Brazilian Portuguese version of the RSI (“Índice de Sintomas de Refluxo –ISR”) (Figure 1) was applied to a group of 154 subjects: 88 patients with LPR with a mean age of 52.3 years (SD ± 10.89), 34 females and 54 males; and 66 controls with a mean age of 47.33 years (SD ± 12.84), 40 females and 26 males. Controls had no symptoms or videolaryngoscopic signs of LPR and had no abnormalities on objective GERD tests. Although patients and controls showed a statistically
Discussion
The diagnosis of LPR remains a great challenge for clinicians, as symptoms of chronic laryngitis are common and can be caused by a number of allergic, infectious, irritant, or even psychogenic or neurogenic triggers. In most patients, there is an association of different causes, which adds to the diagnostic challenge. Ideally, there should be a cost-effective, minimally invasive, and highly sensitive objective test for LPR. Unfortunately, that is not the case. Esophageal pH-impedance and
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From Diagnostic Laboratories Fleury Medicina e Saúde São Paulo, Brazil.