The Role of Patient Expectations in Traumatic Orthopedic Outcomes: the Development of the Trauma Expectation Factor Trauma Outcome Measure (TEFTOM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 5
- 主要终点
- patient reported outcomes
研究概览
简要总结
This study is designed as a prediction trial. That is, our primary purpose is to develop a model that can be applied clinically as a user-friendly "baseline" questionnaire that is capable of predicting "success" or "failure" based on a patient's pre-surgical expectations of their final outcome. In the process, a secondary goal is to develop an outcomes measure.
详细描述
Aims:
- To develop a novel, psychometrically sound, trauma patient expectation instrument that: a) demonstrates content validity; b) considers patient and surgeon expectations; c) predicts orthopedic outcomes; d) is reliable; e) is patient friendly; and f) is easy to score and interpret. This will be known as the Trauma Expectation Factor (TEF).
- To develop a novel, psychometrically sound, trauma patient outcomes instrument that: a) demonstrates content validity; b) measures current condition in the same domains as the expectation instrument; c) demonstrates construct validity; d) demonstrates criterion validity; e) is reliable; f) is patient friendly; and g) is easy to score and interpret. This will be known as the Trauma Outcomes Measure (TOM).
Hypotheses:
H#1. A simple pre-surgical questionnaire that measures patient expectations (i.e., Trauma Expectation Factor) after an ankle fracture requiring surgery will predict an "expected" score on a standardized disease-specific ankle instrument (i.e., AAOS Foot and Ankle Core Score).
H#2. A similar instrument that is reworded to assess current condition (i.e., Trauma Outcomes Measure) instead of expectations, is a valid, reliable, and responsive measure of a traumatic patient's condition.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Isolated ankle or distal tibia fracture
- •Scheduled for and undergoing surgery for their fracture
- •18 years of age or older
排除标准
- •Subject has previously undergone internal fixation surgery for this ankle fracture
- •Subject has disease entity, or condition that precludes likelihood of bony union (eg, metastatic cancer, metabolic bone disease)
- •Subject has severe dementia or other severe mental health problem that may preclude him/her from completing study questionnaires
- •Subject is participating in other competing clinical research that may interfere with participation in this research
- •Subject is unlikely to attend study related follow-up visits
- •Subject has polytrauma (more than one organ system compromised)
- •Subject has fracture(s) other than ankle fracture
- •Subject is a prisoner
- •Fracture occurred more than 4 weeks ago
结局指标
主要结局
patient reported outcomes
时间窗: 12 months post-op
The patient reported outcome includes the Trauma Outcome Measure (TOM), the AAOS Foot and Ankle Core Score, the Foot and Ankle Outcome Scores (FAOS), a 10mm visual analogue scale (VAS), and the SF-36.
次要结局
- Clinician based outcomes(12 months post-op)