Translation, Cross-cultural Adaptation and Validation of the MGQOL-15-F
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Perceived quality of life measured via the MGQOL-15-F (French version of the MGQOL-15), a myasthenia-specific quality of life auto-questionnaire
研究概览
简要总结
The purpose of this study is to translate and culturally adapt the MGQOL-15 (health-related quality of life scale for myasthenia gravis) for use with French-speaking patients in France and to evaluate its psychometric properties to ensure reliability and validity.
详细描述
It is a translation and validation of a quality of life scale.
Step 1: Translation and cultural adaptation (Forward and back translation, committee review, pre-testing with 10 patients for content and face validity).
Step 2 : Psychometric testing : Test-retest with a 2 day interval, correlation with clinical scores - the Myasthenic Muscle Score and the (MG-ADL) score and with a global quality of life score (WHOQOL-BREF).
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
- •Auto-immune myasthenia gravis
- •Age ≥ 18 years old
- •Clinical Classification (MGFA) I-IV
- •French speaking
排除标准
- •cognitive or visual impairment which would limit the capacity to fill out the MGQOL-15-F
结局指标
主要结局
Perceived quality of life measured via the MGQOL-15-F (French version of the MGQOL-15), a myasthenia-specific quality of life auto-questionnaire
时间窗: 3 days
次要结局
- Global quality of life evaluated via the WHOQOL-BREF scale(1 day)
- Clinical evaluation : Myasthenic Muscle Score(1 day)
- Disease severity assessed via the Myasthenic Muscle Score(1 day)
- Impact of symptoms on daily activities and daily life using the MG-ADL score(1day)