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临床试验/NCT04117646
NCT04117646已完成不适用

Validity of the French Version of the Child's Chronic Rhinosinusitis Questionnaire

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2020年4月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
89
试验地点
1
主要终点
Item-total Pearson correlation

研究概览

简要总结

A single quality questionnaire evaluating the symptoms of chronic rhinosinusitis in children currently exists. It has been validated in English for children aged 2 to 12. It comprises five areas of quality of life, each rated by a score ranging from 1 to 7 : sinus infection, nasal obstruction, allergic symptoms, emotional distress and activity limitation, coupled with an overall assessment of quality of life with an analogue visual scale (score from 1 to 10). This SN-5 (sinus and nasal quality of life survey) score showed excellent statistics of reproducibility, internal validity and ease of response. It is currently used in several international publications evaluating chronic sinus pathology in children.

The objective of the study is to validate the translation of the SN-5 questionnaire in French.

详细描述

Chronic rhinosinusitis is a common pathology that entrains significant medical consumption. The prevalence of chronic rhinosinusitis in children is estimated to be 7.6%. Cardinal symptoms include nasal congestion, purulent rhinorrhea, facial pain, and persistent daytime cough. All these nasal symptoms often have an impact on the quality of life. The main objective of medical treatment is to improve this quality of life.

The treatment of chronic rhinosinusitis is mainly medical and includes nose washes with physiological serum, topical or general corticosteroid treatment or antibiotics. Surgical treatments such as adenoidectomy or endonasal functional surgery are reserved for medical treatment failures. According to a European consensus paper of 2012, the surgical strategy of the chronic rhinosinusitis of the child must start with a adenoidectomy with physiological serum washes, and then secondarily a endonasal functional surgery.

The ability of quality of life questionnaires to measure subjective symptoms over a certain length of time can help in the medical decision by determining the benefit of taking care. A single quality questionnaire evaluating the symptoms of chronic rhinosinusitis in children currently exists. It has been validated in English for children aged 2 to 12. It comprises five areas of quality of life, each rated by a score ranging from 1 to 7 : sinus infection, nasal obstruction, allergic symptoms, emotional distress and activity limitation, coupled with an overall assessment of quality of life with an analogue visual scale (score from 1 to 10). This SN-5 (sinus and nasal quality of life survey) score showed excellent statistics of reproducibility, internal validity and ease of response. It is currently used in several international publications evaluating chronic sinus pathology in children.

The objective of the study is to validate the translation of the SN-5 questionnaire in French.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Non-opposition of the holders of parental authority and the subject to participation in the study
  • Subjects between 2 and 12 years of age Patients : - Patients followed in consultation at Necker Hospital in pediatric department of otolaryngology and cervico-facial surgery for chronic rhinosinusitis (rhinosinusitis more than 12 weeks)
  • - Subject without chronic rhinosinusitis at the time of inclusion and without chronic rhinitis history

排除标准

  • French language not spoken by parents

研究组 & 干预措施

Controls

Subjects of 2 and 12 years of age without chronic rhinosinusitis.

干预措施: Sinus and nasal quality of life survey questionnaire (SN-5) (Other)

Patients

Patients of 2 and 12 years of age with chronic rhinosinusitis.

干预措施: Sinus and nasal quality of life survey questionnaire (SN-5) (Other)

结局指标

主要结局

Item-total Pearson correlation

时间窗: 1 year

Measure of efficiency. Comparison of questionnaires completed by patients and controls.

Consistency reliability test

时间窗: 1 year

Measure of efficiency. Comparison of questionnaires completed by patients and controls.

Reproducibility

时间窗: 1 year

Reproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test.

Principal components analysis

时间窗: 1 year

Measure of efficiency. Comparison of questionnaires completed by patients and controls.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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