Lung Transplant for COPD: Outcomes/Technology Assessment

肺移植治疗慢性阻塞性肺病：结果/技术评估

• 批准号: 7020453
• 负责人: ROGER D YUSEN
• 金额: $ 26.74万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-01-01 至 2010-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7020453
• 关键词: behavioral /social science research tag; chronic obstructive pulmonary disease; clinical research; health care service planning; health care service utilization; health services research tag; human subject; lung transplantation; outcomes research; patient oriented research; quality of life

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.

描述（由申请人提供）：本提案的总体目标是在新的供肺分配系统中对COPD患者的肺移植（LTx） LTx进行技术评估。我们将比较患者在新系统中LTx后和LTx前的生活质量。此外，我们将比较新系统和旧系统的生活质量结果。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：评估LTx在新的供肺分配系统中对COPD患者的有效性。A.对于接受LTx治疗的患者，评估效用（生活质量）的变化，比较LTx治疗后6个月的效用与LTx治疗前的效用。B.假设LTx是有效的，通过比较LTx后的效用和LTx前的效用来评估效用（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。特异性目的2：比较新供肺分配系统与旧供肺分配系统中LTx对COPD患者生活质量的影响。在控制两种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，比较新旧系统的效用和效用变化。为了对新分配系统的潜在修订提出假设，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后预后的术前预测因素。执行多变量线性回归来开发一个模型，该模型使用详细的基线数据作为解释变量，并将从ltx之前到ltx之后的效用变化作为结果变量。我们还将后ltx效用分数（不是变化分数）作为结果变量建模。考虑到患者、提供者和医疗保健系统的巨大利益，我们必须评估LTx的有效性和新的器官分配方法的影响。本研究将试图确定在新的供肺分配系统中，LTx对COPD患者的生存和生活质量的影响。