Validity of the French Version of Deafness Questionnaires for Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Paired student t-test
研究概览
简要总结
The care of deafness in children is difficult and the relevance of interventions is difficult to evaluate based on audiometric measurements alone.
Generic pediatric quality of life tools have been validated and used, among other things, to assess the quality of life of children with deafness. However, these non-specific tools do not make it possible to precisely target which factors and interventions are the most important for the quality of life in this population.
Achieving a score to monitor the quality of life objectively over time is fundamental to verify the effectiveness of interventions, and assess the impact on the child. There is currently no validated test in French for any of these uses and populations.
The objective of the study is to adapt the questionnaires "PEACH", "SSQ child (SSQ-C)" and "SSQ parents (SSQ-P)" to the French child, and statistically measure their internal and external validity by comparing them to a control group.
The validation of these three tests (PEACH, SSQ-P, SSQ-C) would make it possible to assess the hearing performance and quality of life of almost the entire pediatric population, for use in both clinical and academic practice.
详细描述
Neonatal sensorineural hearing loss is a frequent pathology, affecting around 800 newborns per year in France, or an incidence of 0.8 to 1.3 per 1000 births, comparable to other industrialized countries. It can affect the development of speech and language and lead to impaired quality of life.
Studies have shown that children with hearing loss score lower on general quality-of-life measurement tools, compared to their normal-hearing peers. A poorer quality of life in patients with sensorineural hearing loss may also reflect physical, academic, social or emotional difficulties. They are also exposed to an increased risk of poor development of language and social skills, as well as an increased risk of developing psychiatric pathologies.
The care of deafness in children is difficult and the relevance of interventions is difficult to evaluate based on audiometric measurements alone.
Generic pediatric quality of life tools have been validated and used, among other things, to assess the quality of life of children with deafness. However, these non-specific tools do not make it possible to precisely target which factors and interventions are the most important for the quality of life in this population.
Achieving a score to monitor the quality of life objectively over time is fundamental to verify the effectiveness of interventions, and assess the impact on the child. There is currently no validated test in French for any of these uses and populations.
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
- 12 Months 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minors aged 12 months to 17 years (inclusive)
- •Patients followed in consultation at Necker Hospital in the Pediatric ENT department
- •holders of parental authority not opposed to participation in the study
- •Patients with deafness with mean tonal thresholds of at least 30dB, uni- or bilateral
- •Perceptual or transmission deafness or mixed
- •Patients not presenting a hearing disorder at the time of inclusion or in his or her history
- •Examination of the normal eardrums
- •No history of ear surgery
排除标准
- •Psychomotor retardation
- •Abnormal neurological examination
- •Mother tongue of the child and parents other than French
研究组 & 干预措施
Patients with deafness
Patients aged 12 months to 17 years with deafness
干预措施: Questionnaires (Other)
Controls
Normal-hearing patients aged 12 months to 17 years
干预措施: Questionnaires (Other)
结局指标
主要结局
Paired student t-test
时间窗: 1 year
Reproducibility of the questionnaire completed by a subject at 15 days apart
Cronbach alpha test
时间窗: 1 year
Internal consistency
Item-total Pearson correlation
时间窗: 1 year
Measure of reliability
Principal components analysis
时间窗: 1 year
Measure of efficiency
Receiver Operating Characteristic (ROC) curve
时间窗: 1 year
Limit value of normality
次要结局
未报告次要终点
