NCT05296655|CompletedDMC
Kazakh Version of Reflux Symptom Index
Validity and Reliability of a Kazakh Version of Reflux Symptom Index
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Validity and Reliability of a Kazakh Version of Reflux Symptom Index
Sponsor study identifier
observational
248
1 country
2
Study Start
March 1, 2020
Actual (reported)Primary Completion
February 15, 2022
Actual (reported)Study Completion
February 16, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 16, 2022
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2020
Actual (reported)February 15, 2022
Actual (reported)February 16, 2022
Actual (reported)March 17, 2022
Actual (reported)March 25, 2022
Actual (reported)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.
patients with symptoms of laryngopharyngeal reflux detected at an outpatient appointment with an ENT doctor
patients without symptoms of laryngopharyngeal reflux who applied for an appointment with an otorhinolaryngologist
Kazakh versions of the Reflux Symptom Index Inventory will be filled patients
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/
SOS Medical Assistance
Almaty, Kazakhstan
V-ent
Almaty, Kazakhstan
Nukusbekova
Doctor
248 participants (actual enrollment reported by the registry).
First Submitted
March 17, 2022
First Posted
March 25, 2022
Study Start
March 1, 2020
Actual (reported)ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)
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
laryngoscopy with a score RFS
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Primary Completion
February 15, 2022
Actual (reported)Study Completion
February 16, 2022
Actual (reported)Last Updated
May 23, 2022
Record last verified: 2022-05
Non-identifiable IPD will be shared upon request with all required information
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