Estimation of the Minimal Important Difference and Validation of Finnish Versions of Foot and Ankle Patient-reported Outcome Instruments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 4
- 主要终点
- Minimal important difference
研究概览
简要总结
The present study investigates the minimal important change and validity of foot and ankle measures.
详细描述
Patients who are waiting for foot and ankle surgery are recruited from four large referral centers (Peijas Hospital, Seinäjoki Central Hospital, Central Finland Central Hospital, Oulu University Hospital). Participants fill in foot and ankle-specific, generic and sosiodemographic questionnaires on the day of surgery, 6 months after surgery, and 6 months 2 weeks after surgery. Both pen-and-paper and electronic options for completing the questionnaire set are provided.
The data obtained from the Foot and ankle outcome score (FAOS), European foot and ankle society (EFAS) score, modified Lower extremity functional scale (LEFS), Visual analog scale foot and ankle (VAS-FA), Manchester Oxford foot and ankle (MOxFA) questionnaire, and the Foot and ankle ability measure (FAAM) are analyzed using the Rasch Measurement Theory and several other psychometric approaches to investigate minimal important change, reliability, responsiveness and validity of foot and ankle PRO instruments.
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
- •Full understanding of Finnish language
- •Undergoing foot or ankle surgery
- •At least 18 years old
排除标准
- •Unbalanced mental disorder such as schizophrenia or depression
- •Age under 18
- •Does not understand Finnish
- •Undergoing operation other than foot or ankle
结局指标
主要结局
Minimal important difference
时间窗: Baseline, 6 months
Change from baseline scores at 6 months
次要结局
- Validity(6 months)
- Reliability(6 months, 6.5 months)
- General health question(6 months, 6.5 months)
- Global assessment scale(6 months)
研究者
Jussi Repo
Resident surgeon
Central Finland Hospital District
