Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 270
- 主要终点
- The cost-effectiveness ratio in the treatment group as compared to the control group at 180 days
研究概览
简要总结
The purpose of the VENT Cost-Effectiveness Sub-Study is to gather healthcare utilization and quality of life information on patients enrolled in the VENT study in order to analyze the relative cost-effectiveness of the endobronchial valve implant procedure.
详细描述
Therapeutic interventions in health care require the use of resources. Since these resources are limited, it is important for clinical decision-makers to have economic information in addition to safety and efficacy data. In the economic environment of health care today, the incremental costs for a new therapeutic intervention must be offset by the value associated with better outcomes such as improved health and health-related quality of life and/or lower health care utilization costs over time.
Questions about the cost and effectiveness of medical care have generated considerable attention in medical outcomes research. In 1993, the Department of Health and Human Services appointed a multi-disciplinary group to recommend standards for the evaluation of health care. The panel's report suggested that standardized outcomes analyses be conducted to evaluate the cost-effectiveness of medical care. These analyses require preference-weighted measures of health-related quality of life. Such measures are needed in order to adjust survival time for health-related quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed by high-resolution computed tomography (HRCT) with eligible heterogeneous disease distribution
- •Forced expiratory volume in 1 second (FEV1) < 45% predicted
- •Total lung capacity (TLC) > 100% predicted
- •Residual volume (RV) > 150% predicted
- •Post rehabilitation 6 minute walk test > 140m
- •Non-smoking for 4 months
排除标准
- •Prior lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy or lobectomy
- •History of recurrent respiratory infections
- •Evidence of large bullae (> 30% of either lung) in a non-target lobe
- •FEV1 < 15% predicted
- •Diffusing capacity of the lung for carbon monoxide (DLCO) < 20% predicted
结局指标
主要结局
The cost-effectiveness ratio in the treatment group as compared to the control group at 180 days
次要结局
- The cost-effectiveness ratio in the treatment group of the study will be compared to established therapies and standards.