Validation of Two Self-questinnaires on Olfactory Disorders for French Speaking Patients: the Self-evaluation of Olfactory Capacities and Quality of Life Questionnaires
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Reliability of the self-assessment questionnaire
研究概览
简要总结
Sense of smell disorders are common and are said to affect up to 20% of the general population. They are often disabling and have a real impact on the quality of life. Smell disorders are most often assessed using a visual analogue scale and more rarely with objective tests (Sniffing Stick Test). Many ENT units do not have these objective tests because they are time-consuming and are not covered by health insurance.
Some teams, such as that of Dr Thomas Hummel of the Carl Gustav Carus University Clinic in Dresden Germany, have developed self-assessment questionnaires for the sense of smell in order to improve the overall care of patients with olfactory disorders. Two of these self-questionnaires seem to us to be particularly relevant for use in everyday practice.
Since then, these questionnaires have already been validated in different languages (English, Chinese, Korean...), but have never been translated and validated in French. Translating and validating these questionnaires into French would make it possible to improve the management and follow-up of French patients with olfactory disorders and to assess the impact of loss of smell on their quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient > 18 years old
- •Patient affiliated to a sickness insurance social protection scheme, beneficiary or rightful claimant
- •Patient who has not expressed his or her opposition to the collection and processing of his or her data for research purposes after the investigator has provided informed information.
- •Patient presenting an olfactory dysfunction of any acquired aetiology that has been evolving for at least 3 months without total recovery (case group).
- •Patient with no sense of smell problems followed up in ENT for another pathology that does not affect the sense of smell (control group).
排除标准
- •Patient in an emergency or life-threatening situation
- •Patient under judicial protection
- •Patient under guardianship or trusteeship
- •Inability to provide informed information to the patient (patient does not speak or understand French)
- •Patient with congenital syndromic or non-syndromic congenital anosmia
结局指标
主要结局
Reliability of the self-assessment questionnaire
时间窗: 3 months
To assess the reliability of the self-assessment questionnaire of his olfactory capacities (Self-MOQ) in French in patients presenting an olfactory dysfunction of any acquired etiology for more than 3 months using a test-retest trial.
次要结局
未报告次要终点