EMPHYSEMA: OUTCOMES AND TECHNOLOGY ASSESSMENT

该项目旨在改善肺气肿患者的预后。肺减容手术（LVRS）和肺移植（LTx）等治疗方法可能改善生活质量，但它们带来了巨大的风险。因此，关于使用LVRS和LTx的决策需要权衡。对这些权衡的合理分析需要有效地测量在影响持续时间和生活质量的所有相关领域对患者的益处和危害，包括发病率、功能状态、症状和满意度。我们对成功治疗的标准没有一致的看法，特别是在生存时间不是唯一问题的情况下。我们用来评估程序的工具可能无法完全捕捉到最重要的健康和生活质量方面。需要新的评估成果的工具和模式来补充现有的工具和模式。本课题的具体目的是：1)进一步发展评估肺气肿患者预后的方法；2)评估肺减容手术和肺移植对肺气肿患者预后的影响。将评估治疗对死亡率和生活质量的影响，以效用来衡量。将测量患者人口统计学、合并症、功能状态、症状和满意度，以及中间生理结果和资源利用率。为了实现具体目标，主要数据收集将通过三种方式进行：器械验证、横断面和（术前和术后）纵向研究。将开发肺气肿患者的功能状态、满意度、生理和生活质量之间关系的模型，并用于解释各种结果之间的关系。我们还将对肺气肿患者进行LVRS或LTx治疗的成功和不成功的操作定义，包括功能状态、满意度、生理、生活质量以及死亡率。肺气肿患者接受LVRS或LTx的预后预测规则将被制定。这项研究计划促进了评估和理解新技术和治疗干预在肺气肿患者中的作用的方法的发展。

This project seeks to improve outcomes in patients with emphysema. Therapies such as lung volume reduction surgery (LVRS) and lung transplantation (LTx) offer potential improvements in quality of life, but they impose substantial risks. Thus, decision making about the use of LVRS and LTx requires trade-offs. Rational analyses of these trade-offs require valid measurements of the benefits and harms to the patients in all relevant domains that effect duration and quality of life, including morbidity, functional status, symptoms, and satisfaction. We do not have an agreed upon standard of successful therapy, specifically in situations where duration of survival is not the only issue. The instruments we use to assess procedures may not fully capture the aspects of health and quality of life that are most important. New instruments and models for assessing outcomes are necessary to complement those that exist. The specific aims of this project are 1) to further develop methods to assess outcomes of patients with emphysema, and 2) to assess the effects of lung volume reduction surgery and lung transplant on outcomes of patients with emphysema. The effects of therapies on mortality and quality of life, measured as utilities, will be assessed. Patient demographics, co-morbidity, functional status, symptoms, and satisfaction, as well as intermediate physiologic outcomes, and utilization of resources will be measured. To achieve the specific aims, primary data collection will be performed in three ways: instrument validation, cross-sectional and (pre and post-operative) longitudinal studies. Models of the relationships among functional status, satisfaction, physiology, and quality of life in patients with emphysema will be developed and used to explain the relationships among the various outcomes. We will also develop operational definitions of successful and unsuccessful treatments among patients with emphysema undergoing LVRS or LTx that account for functional status, satisfaction, physiology, and quality of life, as well as mortality. Prediction rules for outcomes among patients with emphysema undergoing LVRS or LTx will be developed. This research plan promotes the development of methods for assessing and understanding the role of new technologies and therapeutic interventions in patients with emphysema.