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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Rhinosinusitis
• Intervention / Treatment: Other: Sinus and nasal quality of life survey questionnaire (SN-5)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 116

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Rhinosinusitis patients were recruited from pediatric clinics practicing Western or Chinese medicine

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rhinosinusitis without treatment group; children aged 2 and 12 years with rhinosinusitis not receiving treatment	Other: Sinus and nasal quality of life survey questionnaire (SN-5); 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)
Rhinosinusitis with treatment group; children aged 2 and 12 years with rhinosinusitis receiving treatment	Other: Sinus and nasal quality of life survey questionnaire (SN-5); 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)
healthy volunteers; children aged 2 and 12 years without rhinosinusitis	Other: Sinus and nasal quality of life survey questionnaire (SN-5); 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Publications and helpful links

General Publications

• Lai WY, Kay DJ, Wei CC, Huang FW, Liang KL, Yen HR. Validation of the traditional Chinese version of the Sinus and Nasal Quality of Life Survey (SN-5) for children. Pediatr Neonatol. 2022 Jul;63(4):410-417. doi: 10.1016/j.pedneo.2022.01.008. Epub 2022 May 2.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Quality of life; children; SN-5
• Other Study ID Numbers: CMUH105-REC1-138(AR-1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No