Validation of Novel Predictive Score for Patients With Spinal Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- EuroQuol 5-Dimension (EQ5D) profile
研究概览
简要总结
The investigators are prospectively validating a prognostic clinical tool that uses a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin to predict survival, post-treatment morbidity, and functional outcomes in patients with metastatic disease involving the spine.
详细描述
Recently, the investigators proposed a clinical prediction score that used a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin as a means to predict long-term survival following spine surgery for metastatic disease. This prognostic utility was developed using one-year mortality as the sole outcome measure. While the scoring system demonstrated many of the necessary attributes of a useful prediction tool, including simplicity, ease of use and clinical utility, it has yet to be validated prospectively and its capacity to predict other peri-operative outcomes, including physical and mental function following intervention, pain relief and the risk of complications, remain incompletely explored. To further evaluate the utility of this prognostic score, the investigators propose a series of three integrated experiments that will prospectively determine its capacity to accurately inform clinical decision making and recommendations for surgery for patients with metastatic spinal disease.
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
- •≥ 18 years of age
- •Confirmed diagnosis of cancer with metastatic spread to the mobile spine or sacrum
- •Able to consent for themselves at the time of the intake evaluation
- •Speaks English
排除标准
- •Primary bone tumors or leukemia
- •Metastases to other visceral or skeletal locations, without involvement of the spine or sacrum
- •History of prior spine surgery for metastatic disease
结局指标
主要结局
EuroQuol 5-Dimension (EQ5D) profile
时间窗: Up to 3 years
Assessment of state of health and physical/mental function
Survival
时间窗: Up to 3 years
Mortality is documented using date of death in medical record
Short-Form (SF)-12
时间窗: Up to 3 years
Assessment of state of health and physical/mental function
Visual Analog Scale (VAS) for pain
时间窗: Up to 3 years
Assessment of current level of pain
Patient-Reported Outcomes Measurement Information System (PROMIS)
时间窗: Up to 3 years
Assessment of global health
次要结局
- Post-treatment morbidity and readmissions(Up to 3 years)
研究者
Andrew Schoenfeld
Associate Professor
Brigham and Women's Hospital
