Kazakh Version of Reflux Symptom Index

Validity and Reliability of a Kazakh Version of Reflux Symptom Index

Reflux symptoms index (RSI) were developed to identify a clinical index of suspicion for laryngopharyngeal reflux (LPR) in patients with ear, nose, and throat symptoms. RSI is an efficient diagnostic tool for LPR/ It is easy to use, even for those who know little about LPR. It does not require special equipment or examinations and is inexpensive. Thus, it can be considered highly efficient and cost-effective. The study will focus on translating and testing the RSI into Kazakh language and comparing its results in healthy people and people with laryngopharyngeal reflux.

Study Overview

• Status: Completed
• Conditions: Gastro Esophageal Reflux Disease; Laryngopharyngitis Chronic; Laryngopharyngeal Reflux Symptoms
• Intervention / Treatment: Other: Reflux Symptom Index Inventory (diagnostic survey); Other: Reflux finding score

• Study Type: Observational
• Enrollment (Actual): 248

Contacts and Locations

Study Locations

• Kazakhstan
  • Almaty, Kazakhstan
    • SOS Medical Assistance
  • Almaty, Kazakhstan
    • V-ent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult female patients between 18 to 74 years of age with a laryngopharengeal symptoms and patients without symptoms of laryngopharyngeal reflux who applied for an appointment with an otorhinolaryngologist/

Description

Inclusion Criteria:

• Patient's informed consent;
• Age: 18-74 years old;
• No serious somatic diseases;
• Patients with complaints of sore throat, coughing, burning sensation in the throat, coughing, frequent sore throat, difficulty swallowing, lump in the throat, foreign body feeling in the throat, voice changes, heartburn and belching;
• Diagnosis: Chronic pharyngitis;
• Chronic laryngitis.

Exclusion Criteria:

• Disagreement to participate in scientific research;
• Age: under 18 and over 74;
• Severe somatic diseases, organic lesions of the gastrointestinal tract and ENT organs;
• Patients with pulmonary pathologies;
• Patients with allergic manifestations (chronic or allergic rhinosinusitis and nasal polyposis);
• With diagnoses: Acute respiratory diseases;
• Patients with general neuralgic disorders;
• Pregnancy;
• Benign lesions of the vocal cords;
• Acid-suppressive therapy within 4 weeks prior to recruitment

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laryngopharegeal reflux symptoms patients; patients with symptoms of laryngopharyngeal reflux detected at an outpatient appointment with an ENT doctor	Other: Reflux Symptom Index Inventory (diagnostic survey); Kazakh versions of the Reflux Symptom Index Inventory will be filled patients; Other Names: RSI; Other: Reflux finding score; laryngoscopy with a score RFS; Other Names: RFS
Asymptomatic laryngopharegeal reflux patients; patients without symptoms of laryngopharyngeal reflux who applied for an appointment with an otorhinolaryngologist	Other: Reflux Symptom Index Inventory (diagnostic survey); Kazakh versions of the Reflux Symptom Index Inventory will be filled patients; Other Names: RSI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RSI Score at Baseline:	Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5. Total score ranges from 0-45; of which 0-12 is considered no laryngopharengeal reflux, above 13 points for the presence of laryngopharyngeal reflux.	RSI Score at Baseline
RSI Score at Days 10-14	Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5. Total score ranges from 0-45; of which 0-12 is considered no laryngopharengeal reflux, above 13 points for the presence of laryngopharyngeal reflux.	Days 10-14
RFS Score at Baseline:	Device: Endoscopic laryngoscopy Video laryngoscopy and assessment of the presence / severity of the symptoms- Reflux finding score. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. Total score ranges from 0-48; of which 0-6 is considered no laryngopharengeal reflux, above 7 points for the presence of laryngopharyngeal reflux.	RFS Score at Baseline
RFS Score at Days 10-14	Device: Endoscopic laryngoscopy Video laryngoscopy and assessment of the presence / severity of the symptoms - Reflux finding score and will be used as a gold standard of diagnosis of laryngopharengeal reflux. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. Total score ranges from 0-48; of which 0-6 is considered no laryngopharengeal reflux, above 7 points for the presence of laryngopharyngeal reflux.	Days 10-14
Reliability and validity of RSI at Baseline:	Reliability and validity of RSI at Baseline using Cronbach's alpha test to check the internal consistency for all the 9 items. Total score ranges from 0-45; of which 0-12 is considered no laryngopharengeal reflux, above 13 points for the presence of laryngopharyngeal reflux.	RSI Score at Baseline
Reliability and validity of RSI at Days 10-14.	Reliability and validity of RSI at Days 10-14 using Cronbach's alpha test to check the internal consistency for all the 9 items. Total score ranges from 0-45; of which 0-12 is considered no laryngopharengeal reflux, above 13 points for the presence of laryngopharyngeal reflux.	Days 10-14
Laryngopharyngeal reflux diagnosis at baseline	Video laryngoscopy and assessment of the presence / severity of the symptoms- Reflux finding score. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. Total score ranges from 0-48; of which 0-6 is considered no laryngopharengeal reflux, above 7 points for the presence of laryngopharyngeal reflux.	Baseline
Laryngopharyngeal reflux diagnosis at Days 10-14.	Video laryngoscopy and assessment of the presence / severity of the symptoms- Reflux finding score. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem. Total score ranges from 0-48; of which 0-6 is considered no laryngopharengeal reflux, above 7 points for the presence of laryngopharyngeal reflux.	Days 10-14
Test - retest reliability of the RSI questtionaire	Test - retest reliability of the RSI questtionaire at Days 10-14. Test-retest reliability coefficients vary between 0 and 1, where: 1 : perfect reliability, 0.9: excellent reliability, 0.8 < 0.9: good reliability, 0.7 < 0.8: acceptable reliability, 0.6 < 0.7: questionable reliability, 0.5 < 0.6: poor reliability, < 0.5: unacceptable reliability, 0: no reliability. On this scale, a correlation of .9(90%) would indicate a very high correlation (good reliability) and a value of 10% a very low one (poor reliability).	Days 10-14
Test - retest reliability of the RFS	Test - retest reliability of the RFS questtionaire at Days 10-14. Test-retest reliability coefficients vary between 0 and 1, where: 1 : perfect reliability, 0.9: excellent reliability, 0.8 < 0.9: good reliability, 0.7 < 0.8: acceptable reliability, 0.6 < 0.7: questionable reliability, 0.5 < 0.6: poor reliability, < 0.5: unacceptable reliability, 0: no reliability. On this scale, a correlation of .9(90%) would indicate a very high correlation (good reliability) and a value of 10% a very low one (poor reliability).	Days 10-14

Collaborators and Investigators

• Sponsor: Kazakh Medical University of Continuing Education
• Collaborators: Asfendiyarov Kazakh National Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): February 15, 2022
• Study Completion (ACTUAL): February 16, 2022

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (ACTUAL): March 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Laryngopharyngeal Reflux; Laryngitis; Laryngopharyngitis Chronic; Gastro Esophageal Reflux; Laryngopharyngeal Reflux Symptoms
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Laryngeal Diseases; Gastroesophageal Reflux; Laryngopharyngeal Reflux
• Other Study ID Numbers: 14-2020/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Non-identifiable IPD will be shared upon request with all required information
• IPD Sharing Time Frame: The data will be available upon completion of the study primary analysis
• IPD Sharing Access Criteria: Only people with access will be able to see the data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No