Kazakh Version of Reflux Symptom Index

Gastro Esophageal Reflux Disease Clinical Trial

Official title:

Validity and Reliability of a Kazakh Version of Reflux Symptom Index

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05296655
• Other study ID #: 14-2020/1
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: February 16, 2022

Study information

• Verified date: May 2022
• Source: Kazakh Medical University of Continuing Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: February 16, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastro Esophageal Reflux Disease
• Gastroesophageal Reflux
• Laryngopharyngeal Reflux
• Laryngopharyngitis Chronic

Intervention

Other:
• Reflux Symptom Index Inventory (diagnostic survey)
Kazakh versions of the Reflux Symptom Index Inventory will be filled patients
• Reflux finding score
laryngoscopy with a score RFS

Locations

Country	Name	City	State
Kazakhstan	SOS Medical Assistance	Almaty
Kazakhstan	V-ent	Almaty

Sponsors (2)

Lead Sponsor	Collaborator
Kazakh Medical University of Continuing Education	Asfendiyarov Kazakh National Medical University

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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