National Emphysema Treatment Trial (NETT) Manual of Operations, Part I: Patient211 Procedures

摘要

The National Emphysema Treatment Trial (NETT) is a multicenter, randomized211u001eclinical trial of usual medical therapy alone versus usual medical therapy plus 211u001elung volume reduction surgery (LVRS) for moderate to severe emphysema. Every 211u001epatient will complete 6 to 10 weeks of pulmonary rehabilitation from randomized 211u001eonward. The trial is designed to determine if the addition of LVRS to medical 211u001etherapy results in improved survival. In addition to survival, other outcomes 211u001ewill be used to evaluate the relative benefits and risks of surgical versus 211u001emedical therapy: maximum exercise capacity, pulmonary function, oxygen 211u001erequirement, six minute walk distance, quality of life, respiratory symptoms, and 211u001ehealth care utilization and costs. Two thousand five hundred patients with 211u001emoderate to severe emphysema who have no significant co-morbid conditions will be 211u001erandomized to one of the two treatment groups. The study duration is fixed at 4.5 211u001eyear with a 0.5 year closeout period. The NETT Manual of Operations provides 211u001einstructions for study procedures, including consent administration, patient 211u001eassessment procedures, medical management, pulmonary rehabilitation program, 211u001esurgery, completion of data collection forms, certification of personnel, and 211u001ebilling procedures.