Validity and Reliability of a Kazakh Version of Reflux Symptom Index
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 试验地点
- 2
- 主要终点
- Reliability and validity of RSI at Days 10-14.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Reliability and validity of RSI at Days 10-14.
时间窗: 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:
时间窗: 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:
时间窗: 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
时间窗: 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:
时间窗: 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
时间窗: 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
时间窗: 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.
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
未报告次要终点