Translation and Validation of the French Version of the Health-related Quality of Life Questionnaire for the Polycystic Ovary Syndrome: the mPCOSQ-F.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CHU de Reims
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Content validity of mPCOSQ as determined by the experts group
研究概览
简要总结
This study is a prospective, observational, bicentric study, evaluating the validity and reliability of a French version of the mPCOSQ questionnaire (mPCOSQ-F), used to assess health-related quality of life (HRQOL) in women with polycystic ovary syndrome.
The first stage of the study consisted in translating the questionnaire from English to French.
Patients agreeing to take part in the study will complete the mPCOSQ-F and the SF-36 (generic HRQOL questionnaire). After 1 to 2 weeks, patients will receive the mPCOSQ-F and complete it again.
详细描述
The aim of this study is to assess the validity and reliability of a French version of the mPCOSQ questionnaire (mPCOSQ-F), used to assess health-related quality of life (HRQOL) in women with polycystic ovary syndrome.
Women aged 18 to 45 years with a diagnosis of polycystic ovary syndrome will be included.
The first stage of the study consisted in translating the questionnaire from English to French.
Patients agreeing to take part in the study will complete the mPCOSQ-F and the SF-36 (generic HRQOL questionnaire). After 1 to 2 weeks, patients will receive the mPCOSQ-F and complete it again.
The pre-test phase purpose is to appraise the face validity and feasibility of the questionnaire through phone interviews with the thirty first respondents.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Content validity of mPCOSQ as determined by the experts group
时间窗: At 2 years
Feasibility of mPCOSQ
时间窗: At 2 years
Acceptability of mPCOSQ
时间窗: At 2 years
Structure validity of mPCOSQ
时间窗: At 2 years
Reproductibility of mPCOSQ
时间窗: At 2 years
Reliabilty of mPCOSQ
时间窗: At 2 years
Total mPCSOQ score
时间窗: At 15 days
SF-36 scores
时间窗: At 1 day
Scores in the " weight " domain based on BMI
时间窗: At 1 day
Scores in the " fertility " domain based on the need for reproductive medicine or parenthood
时间窗: At 1 day
Scores in the " hirsutism " domain based on the Ferriman-Gallwey score
时间窗: At 1 day
次要结局
未报告次要终点