Lung Transplant for COPD: Outcomes/Technology Assessment

描述（由申请方提供）：本提案的广泛目标是在新的供体肺分配系统中对COPD患者进行肺移植（LTx）LTx的技术评估。我们将在新系统中比较LTx后与LTx前患者的生活质量。此外，我们将比较新系统与旧系统中的生活质量结果。为了进行这项技术评估，我们提出了两个具体目标：具体目标1：在新的供体肺分配系统中评估LTx对COPD患者的有效性。A.对于接受LTx的患者，评价效用（生活质量）的变化，比较LTx后6个月与LTx前的效用。B。假设LTx有效，通过比较LTx后效用与LTx前效用，评价效用（生活质量）改善的持续时间。C.在调整基线差异（疾病严重程度、年龄、性别、种族等）后，比较移植患者与未移植患者的效用。具体目标二：比较新旧供肺分配系统中LTx对COPD患者生活质量的影响。在控制两个系统中患者的基线差异（疾病严重程度、年龄、LTx类型、性别、种族等）后，比较新旧系统效用和效用变化。为了生成新分配系统潜在修订的假设，我们提出了第三个目标：具体目标3：确定COPD患者新供体肺分配系统中LTx后结果的术前预测因素。进行多变量线性回归，以开发一个模型，该模型使用详细的基线数据作为解释变量，并将LTx前至LTx后的效用变化作为结局变量。我们还将模拟LTx后效用评分（而不是变化评分）作为结局变量。考虑到患者、提供者和医疗系统的巨大风险，我们必须评估LTx的有效性和新器官分配方法的影响。本研究将尝试确定在新的供体肺分配系统中LTx对COPD患者的生存率和生活质量的影响。

DESCRIPTION (provided by applicant): The broad goal of this proposal is to perform a technology assessment of lung transplantation (LTx) LTx for patients with COPD in the new donor lung allocation system. We will compare post-LTx quality of life to pre- LTx quality of life of patients within the new system. In addition, we will compare the quality of life outcomes in the new system to the outcomes in the old system. To perform this technology assessment, we propose two specific aims: Specific Aim 1: Assess the effectiveness of LTx, for patients with COPD, in the new donor lung allocation system. A. For patients that undergo LTx, evaluate the change in utilities (quality of life), comparing 6 months post- LTx utilities to pre-LTx utilities. B. Assuming LTx will be effective, evaluate the duration of improvement in utilities (quality of life), by comparing post-LTx utilities to pre-LTx utilities. C. Compare the utilities of transplanted patients with the utilities of patients not transplanted, after adjusting for baseline differences (severity of illness, age, gender, race, etc). Specific Aim 2: Compare the effects of LTx on the quality of life of patients with COPD in the new donor lung allocation system and the old donor lung allocation system. Compare the new and the old system utilities and utility changes, after controlling for baseline differences (severity of illness, age, type of LTx, gender, race, etc), in patients in the two systems. To generate hypotheses for potential revision of the new allocation system, we propose a third aim: Specific Aim 3: Determine preoperative predictors of post-LTx outcomes in the new donor lung allocation system, for patients with COPD. Perform multivariable linear regression to develop a model that uses detailed baseline data as explanatory variables and the change in utilities from pre-LTx to post-LTx change as the outcome variable. We will also model post-LTx utility scores (not change scores) as the outcome variable. Given the huge stakes for the patients, the providers, and the healthcare system, it is imperative that we assess the effectiveness of LTx and the impact of new organ allocation methods. This study will attempt to determine the survival and quality of life effects of LTx on patients with COPD in the new donor lung allocation system.