NCT05598541招募中不适用
Finnish Patient-Reported Outcomes Initiative for Shoulder and Elbow
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Validation
研究概览
简要总结
The purpose of φ-PROMISE project is to carry out a cultural adaptation (translate into Finnish and validate) some of the most frequently used shoulder- and elbow-specific patient-reported outcome measures, PROMs. In addition, we aim to investigate which outcome measures are the most relevant for assessing the severity of complaints and treatment outcomes. Also, we will define the Patients Acceptable Symptomatic State (PASS) and the Minimal Important Difference (MID) of the individual outcome measures.
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
- •Orthopedic outpatient visit at the Helsinki University Hospital
- •Signed informed consent
- •Age over 18 years
- •Finnish as language of communication
排除标准
- •Recent surgery (within 2 months)
- •Insufficient compliance
结局指标
主要结局
Validation
时间窗: 2 weeks
Assessment of inter- and intra- observer reliability of different outcome measures
次要结局
- MID(1 year)
- PASS(1 year)
研究者
Thomas Ibounig
MD
Helsinki University Central Hospital
研究点 (1)
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