French Linguistic Validation of Questionnaires for Patients With Axial Spondyloarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- BAS-G validity in French
研究概览
简要总结
The aim is to do a French linguistic validation of three questionnaires used in axial Spondyloarthritis (BASFI, BAS-G, Dougados Functional Index).
In order to validate the questionnaires, a prospective, qualitative, observational and monocentric study will be conducted.
详细描述
Axial spondyloarthritis (SpA) is a chronic rheumatic diseases affecting axial skeleton and sacro-iliac joints. SpA can have functional consequences, often assessed with the Bath Ankylosing Spondylitis Functional Index (BASFI), the Dougados functional index, or more globally with the Bath Ankylosing Spondylitis Global (BAS-G). If these questionnaires are validated in English, there are not validated in French. The aim is to do a french linguistic validation of these questionnaires.
A translation, reconciliation and retro-translation will be conducted for each of the questionnaires by two bilingual translators. The last version of each questionnaire will be then validated by clinicians experts in SpA. The version will be further validated by 5 patients. If necessary and if changes occured on the version of the questionnaire, another version will be validated by 5 other patients until full understanding is obtained.
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
- •Patients diagnosed with axial spondyloarthritis or ankylosing spondylitis
排除标准
- •Patients who do not understand French
- •Patients with cognitive impairments
- •People protected by law
- •People who do not want to participate
结局指标
主要结局
BAS-G validity in French
时间窗: Day 0
The self-administered Bath Ankylosing Spondylitis Global (BAS-G) measures global consequences of axial spondyloarthritis on well-being. The score will be validated in French if the clarity and understanding is approved by 5 french native-language patients.
BASFI validity in French
时间窗: Day 0
The self-administered Bath Ankylosing Spondylitis Functional Index (BASFI) measures functional consequences of axial spondyloarthritis. The score will be validated in French if the clarity and understanding is approved by 5 french native-language patients.
Dougados validity in French
时间窗: Day 0
The self-administered Dougados functional Index measures functional capacities of patients with axial spondyloarthritis. The score will be validated in French if the clarity and understanding is approved by 5 french native-language patients.
次要结局
未报告次要终点