Wise Robert A, Drummond M Bradley
Department of Medicine, Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland 21224, USA.
Proc Am Thorac Soc. 2008 May 1;5(4):385-92. doi: 10.1513/pats.200709-153ET.
Lung volume reduction surgery (LVRS) is one of a long lineage of surgical approaches to emphysema. The reintroduction of this operation in the mid-1990s led to great controversy over the value of the procedure and its long-term outcomes. The National Emphysema Treatment Trial (NETT) represented an historical scientific collaboration of the National Institutes of Health (NIH), the Centers for Medicare and Medicaid Services (CMS), and the Agency for Health Research and Quality (AHRQ). NETT was designed primarily as a pivotal surgical clinical trial, but also incorporated data collection to inform health policy and cost-benefit analyses. NETT faced challenges that included practical and ethical matters, statistical design and analysis issues, and intense public and political scrutiny. The study design required the development of methods for pulmonary rehabilitation, lung imaging, and exercise testing that have become templates for current clinical and research practice. During the course of the trial, the confidential deliberations of the Data and Safety Monitoring Board (DSMB) played an important role in the ultimate success of the trial and protection of research participants. Because of the importance of the NETT outcomes, the results were disseminated to the medical community and transformed into health policy in a rapid and efficient manner. In many ways, the story of NETT serves as a model for evaluation of new surgical approaches to chronic diseases.
肺减容手术（LVRS）是肺气肿外科治疗方法中的一种，历史悠久。20世纪90年代中期该手术重新引入后，引发了关于该手术价值及其长期疗效的巨大争议。国家肺气肿治疗试验（NETT）是美国国立卫生研究院（NIH）、医疗保险和医疗补助服务中心（CMS）以及卫生研究与质量机构（AHRQ）开展的一项具有历史意义的科学合作项目。NETT主要设计为一项关键的外科临床试验，但也纳入了数据收集，以为卫生政策和成本效益分析提供信息。NETT面临诸多挑战，包括实际和伦理问题、统计设计与分析问题，以及公众和政治的严格审查。该研究设计要求开发肺康复、肺部成像和运动测试方法，这些方法已成为当前临床和研究实践的模板。在试验过程中，数据与安全监测委员会（DSMB）的保密审议对试验的最终成功以及研究参与者的保护起到了重要作用。由于NETT结果的重要性，其结果迅速有效地传播给了医学界，并转化为卫生政策。在很多方面，NETT的故事可作为评估慢性疾病新外科治疗方法的典范。
