Kazakh Version of Reflux Symptom Index

Completed

• Conditions: Laryngopharyngitis Chronic; Gastro Esophageal Reflux Disease; Laryngopharyngeal Reflux Symptoms
• Interventions: Other: Reflux Symptom Index Inventory (diagnostic survey); Other: Reflux finding score

• Registration Number: NCT05296655
• Lead Sponsor: Kazakh Medical University of Continuing Education

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2022-02-15
• Study Completion: 2022-02-16
• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-25
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Asymptomatic laryngopharegeal reflux patients	Reflux Symptom Index Inventory (diagnostic survey)	patients without symptoms of laryngopharyngeal reflux who applied for an appointment with an otorhinolaryngologist
Laryngopharegeal reflux symptoms patients	Reflux Symptom Index Inventory (diagnostic survey)	patients with symptoms of laryngopharyngeal reflux detected at an outpatient appointment with an ENT doctor
Laryngopharegeal reflux symptoms patients	Reflux finding score	patients with symptoms of laryngopharyngeal reflux detected at an outpatient appointment with an ENT doctor

Primary Outcome Measures

Name	Time	Method
Reliability and validity of RSI at Days 10-14.	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.
RSI Score at Baseline:	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.
Reliability and validity of RSI at Baseline:	RSI Score 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 Days 10-14	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.
RFS Score at Baseline:	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 Days 10-14	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.
Laryngopharyngeal reflux diagnosis at baseline	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.
Laryngopharyngeal reflux diagnosis at Days 10-14.	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.
Test - retest reliability of the RSI questtionaire	Days 10-14	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).
Test - retest reliability of the RFS	Days 10-14	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).

Trial Locations

Locations (2)

SOS Medical Assistance; 🇰🇿 Almaty, Kazakhstan

V-ent; 🇰🇿 Almaty, Kazakhstan