Kazakh Version of Reflux Symptom Index

NCT05296655 | Completed DMC

• 1 other identifier: 14-2020/1
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 2

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.

Conditions

Laryngopharyngeal Reflux Symptoms; Laryngopharyngitis Chronic; Gastro Esophageal Reflux Disease

Keywords

Laryngopharyngeal Reflux; Laryngopharyngeal Reflux Symptoms; Laryngitis; Laryngopharyngitis Chronic; Gastro Esophageal Reflux

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

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); Other: Reflux finding score

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)

Interventions

Reflux Symptom Index Inventory (diagnostic survey) OTHER

Kazakh versions of the Reflux Symptom Index Inventory will be filled patients

Also known as: RSI

Asymptomatic laryngopharegeal reflux patients; Laryngopharegeal reflux symptoms patients

Reflux finding score OTHER

laryngoscopy with a score RFS

Also known as: RFS

Laryngopharegeal reflux symptoms patients

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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/

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kazakh Medical University of Continuing Education: lead
• Asfendiyarov Kazakh National Medical University: collaborator

Study Sites (2)

SOS Medical Assistance

Almaty, Kazakhstan

Location

V-ent

Almaty, Kazakhstan

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Laryngopharyngeal Reflux; Laryngitis

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Otorhinolaryngologic Diseases

Study Officials

• Nukusbekova

  Doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 25, 2022
• Study Start: March 1, 2020
• Primary Completion: February 15, 2022
• Study Completion: February 16, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available upon completion of the study primary analysis
• Access Criteria: Only people with access will be able to see the data

Locations

KA (2)