EMPHYSEMA: OUTCOMES AND TECHNOLOGY ASSESSMENT

肺气肿：结果和技术评估

• 批准号: 6032123
• 负责人: ROGER D YUSEN
• 金额: $ 11.77万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-01-10 至 2004-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6032123
• 关键词: behavioral /social science research tag; clinical research; emphysema; human subject; human therapy evaluation; lung transplantation; outcomes research; pneumonectomy; quality of life

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.

该项目旨在改善肺气肿患者的结局。 诸如减少肺部体积手术（LVR）和肺移植（LTX）等疗法可实现生活质量的潜在改善，但它们造成了重大风险。 因此，关于使用LVR和LTX的决策需要权衡。 对这些权衡的合理分析需要对所有相关领域中患者的收益和损害有效测量，以影响持续时间和生活质量，包括发病率，功能状况，症状和满意度。我们没有达成成功治疗标准的商定，特别是在生存期限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获最重要的健康和生活质量的各个方面。 为了补充存在的新工具和模型，必须进行评估结果。该项目的具体目的是1）进一步开发评估肺气肿患者结局的方法，以及2）评估肺部容量减少手术和肺移植对肺气肿患者结局的影响。将评估疗法对以实用程序测量的死亡率和生活质量的影响。 将测量患者人口统计学，合并症，功能状况，症状和满意度以及中间的生理结果和资源利用。为了达到特定目的，将以三种方式进行主要数据收集：仪器验证，横截面和（术前和后）纵向研究。 将开发肺气肿患者的功能状况，满意度，生理和生活质量之间的关系模型，并用于解释各种结果之间的关系。我们还将在经历LVRS或LTX的患者中成功进行成功和失败治疗的操作定义，以解释功能状况，满意度，生理学和生活质量以及死亡率。将制定经历LVR或LTX的肺气肿患者的预测规则。该研究计划促进了评估和了解新技术和治疗干预措施在肺气肿患者中的作用的方法。