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临床试验/NCT03444441
NCT03444441已完成不适用

Estimation of the Minimal Important Difference and Validation of Finnish Versions of Foot and Ankle Patient-reported Outcome Instruments

Helsinki University Central Hospital4 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2018年1月15日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jussi Repo

Resident surgeon

Central Finland Hospital District

研究点 (4)

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