Validation of the Chinese Version of the Sinus and Nasal Quality of Life Survey (SN-5)

Study Overview
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Brief Summary
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The purpose of our study was to validate the Chinese version of the Sinus and Nasal Quality of Life Survey (SN-5)and correlation with the incidence of pediatric obstructive sleep apnea and asthma. The study will enroll pediatric patients of rhino-sinusitis and their parents to finish Questionnaire 1, including Chinese version of SN-5, visual analogue scale (VAS), Pediatric allergy disease Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ), OSA-18 quality of Life Survey, and asthma-diagnostic questionnaire . Some patients re-tested SN-5 in 1 week later. After four weeks, participants finish these questionnaire 2, including SN-5, VAS, and PADQLQ. In addition, the author will invite health children without rhino-sinusitis disease and their parents to fill in Questionnaire 1. The Chinese version of SN-5 will be validated to establish its reliability and validity.

Detailed Description
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The purpose of the study was to validate the Chinese version of the Sinus and Nasal Quality of Life Survey (SN-5)and correlation with the incidence of pediatric obstructive sleep apnea and asthma. The study will enroll pediatric patients of rhino-sinusitis and parents to finish Questionnaire 1, including Chinese version of SN-5, visual analogue scale (VAS), Pediatric allergy disease Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ), OSA-18 quality of Life Survey, and asthma-diagnostic questionnaire . Some patients re-tested SN-5 in 1 week later. After four weeks, they finish these questionnaire 2, including SN-5, VAS, and PADQLQ. In addition, the author will invite health children without rhino-sinusitis disease and their parents to fill in Questionnaire 1. The Chinese version of SN-5 will be validated to establish its reliability and validity. From December 2016 to December 2017, healthy volunteers and children with persistent sinonasal symptoms were enrolled. Guardians of the participants completed the SN-5, a visual analog scale (VAS) of nasal symptoms, and the Obstructive Sleep Apnea-18 (OSA-18) ; the responses were used to assess internal consistency, discriminant validity, and treatment responsiveness. A nontreatment group was administered the SN-5 1 week later to assess test-retest reliability.

Official Title
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Validation of the Chinese Version of the Sinus and Nasal Quality of Life Survey (SN-5) and Correlation With Pediatric Obstructive Sleep Apnea and Asthma

Conditions
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Chronic Rhinosinusitis

Intervention / Treatment
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* Other: Sinus and nasal quality of life survey questionnaire (SN-5)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with one or more of the following symptoms, purulent nasal discharge, nasal congestion, cough, or postnasal drip for at least 1 month. Exclusion Criteria: craniofacial anomalies cognitive deficits illiteracy in traditional Chinese.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rhinosinusitis without treatment group<br>children aged 2 and 12 years with rhinosinusitis not receiving treatment | Other: Sinus and nasal quality of life survey questionnaire (SN-5)<br>* The SN-5 consists of five questions on a 7-point scale that assesses the frequency of the following symptoms: (1) nasal obstruction, (2) sinus infection, (3) allergies, (4) emotional distress, and (5) activity limitations. The scoring system is as follows: 1 indicates none of the time, 2 indicating hardly any time at all, 3 indicates a small part of the time, 4 indicates some of the time, 5 indicates a good part of the time, 6 indicates most of the time, and 7 indicates all of the time. Higher scores indicate more severe sinonasal symptoms. One item from a global faces scale scored from 0 to 10 is used to evaluate overall QoL related to nasal or sinus disease. Higher scores on this scale indicate a less severe impact of nasal or sinus disease. The scores from the first five items (1-7 each)<br>|
| Rhinosinusitis with treatment group<br>children aged 2 and 12 years with rhinosinusitis receiving treatment | Other: Sinus and nasal quality of life survey questionnaire (SN-5)<br>* The SN-5 consists of five questions on a 7-point scale that assesses the frequency of the following symptoms: (1) nasal obstruction, (2) sinus infection, (3) allergies, (4) emotional distress, and (5) activity limitations. The scoring system is as follows: 1 indicates none of the time, 2 indicating hardly any time at all, 3 indicates a small part of the time, 4 indicates some of the time, 5 indicates a good part of the time, 6 indicates most of the time, and 7 indicates all of the time. Higher scores indicate more severe sinonasal symptoms. One item from a global faces scale scored from 0 to 10 is used to evaluate overall QoL related to nasal or sinus disease. Higher scores on this scale indicate a less severe impact of nasal or sinus disease. The scores from the first five items (1-7 each)<br>|
| healthy volunteers<br>children aged 2 and 12 years without rhinosinusitis | Other: Sinus and nasal quality of life survey questionnaire (SN-5)<br>* The SN-5 consists of five questions on a 7-point scale that assesses the frequency of the following symptoms: (1) nasal obstruction, (2) sinus infection, (3) allergies, (4) emotional distress, and (5) activity limitations. The scoring system is as follows: 1 indicates none of the time, 2 indicating hardly any time at all, 3 indicates a small part of the time, 4 indicates some of the time, 5 indicates a good part of the time, 6 indicates most of the time, and 7 indicates all of the time. Higher scores indicate more severe sinonasal symptoms. One item from a global faces scale scored from 0 to 10 is used to evaluate overall QoL related to nasal or sinus disease. Higher scores on this scale indicate a less severe impact of nasal or sinus disease. The scores from the first five items (1-7 each)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test-retest reliability | A nontreatment group was administered the SN-5 1 week later to assess test-retest reliability. | 1 week | 
| Concurrent validity | The correlation between SN-5 and VAS scores was used to analyze the concurrent validity of the SN-5. | baseline | 
| Discriminant validity | Discriminant validity was assessed by calculating the difference between the SN-5 scores for participants with rhinosinusitis and for the healthy participants. These differences were analyzed with the Mann-Whitney U test. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mean scores of SN-5 | To evaluate the responsiveness of the treatment , the author compare the mean score of treatment group after 4-week-treatment compared to baseline mean score of SN-5 before treatment.Data analyzed with the Wilcoxon signed-rank test. Effects were evaluated through intention-to-treat analysis. | 4 week | 
| correlation with score of SN-5 and score of OSA-18 quality of life questionnaire (OSA-18) | To evaluate the correlation of SN-5 and OSA-18, Spearman correlation coefficients between the SN-5 and OSA-18 scores were analyzed. | baseline and 4 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SN-5, Quality of life, children