EMPHYSEMA: OUTCOMES AND TECHNOLOGY ASSESSMENT

肺气肿：结果和技术评估

• 批准号: 6625218
• 负责人: ROGER D YUSEN
• 金额: $ 11.82万
• 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/6625218
• 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治疗结果。 肺减容手术 (LVRS) 和肺移植 (LTx) 等疗法可以改善生活质量，但也会带来很大的风险。 因此，关于使用 LVRS 和 LTx 的决策需要权衡。 对这些权衡的理性分析需要有效衡量影响生活持续时间和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。我们没有商定的成功治疗标准，特别是在生存时间不是唯一问题的情况下。 我们用于评估程序的工具可能无法完全反映最重要的健康和生活质量方面。 需要新的评估结果的工具和模型来补充现有的工具和模型。该项目的具体目标是 1) 进一步开发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（以效用衡量）的影响。 将测量患者人口统计数据、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，主要数据收集将以三种方式进行：仪器验证、横断面和（术前和术后）纵向研究。 将开发肺气肿患者功能状态、满意度、生理学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。我们还将针对接受 LVRS 或 LTx 的肺气肿患者制定成功和不成功治疗的操作定义，其中考虑到功能状态、满意度、生理学、生活质量以及死亡率。将制定接受 LVRS 或 LTx 的肺气肿患者结局的预测规则。该研究计划促进了评估和理解新技术和治疗干预措施对肺气肿患者的作用的方法的开发。