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Integrating Survival and Quality of Life Data in Clinical Trials of Lung Disease : The Case of Lung Volume Reduction Surgery

Roger D. Yusen, MD, MPH, FCCP; Benjamin Littenberg, MD
Author and Funding Information

Affiliations: St. Louis, MO
 ,  Dr. Yusen is an Assistant Professor of Medicine, Divisions of Pulmonary and Critical Care Medicine and General Medical Sciences, Washington University School of Medicine. Dr. Littenberg is the Henry and Carleen Tufo Professor of Medicine, Division of General Internal Medicine, University of Vermont.,  Burlington, VT
 ,  Dr. Yusen is a consultant for Spiration, Inc. Spiration is developing and testing an intrabronchial valve for endoscopic lung volume reduction surgery, and a lung volume reduction surgery lung capturing device. Dr. Yusen also serves on a clinical events committee for two related studies.

Correspondence to: Dr. Roger D. Yusen, Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, Campus Box 8052, 660 S. Euclid Ave, St. Louis, MO 63110; e-mail: ryusen@im.wustl.edu



Chest. 2005;127(4):1094-1096. doi:10.1378/chest.127.4.1094
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Most patients with severe COPD remain significantly symptomatic despite medical therapy, and they have a disturbingly high short-term mortality. Many patients desperately seek symptomatic relief, and they would consider undergoing a major procedure such as lung volume reduction surgery (LVRS) to improve quality of life, whether or not the treatment produces a survival benefit.

In this issue of CHEST (see page 1108), Miller et al describe the combined results of two modestly sized randomized controlled trials of LVRS. The four-center Canadian Lung Volume Reduction (CLVR) study and the six-center US Overholt Blue Cross Emphysema Surgery Trial (OBEST) compared the effects of bilateral LVRS to medical therapy in patients with COPD due to emphysema. Almost all of the patients had heterogeneously distributed emphysema demonstrated by chest CT scan, with a predominance of disease in the upper lobes. The CLVR trial excluded patients with α1-antitrypsin deficiency, and OBEST excluded patients with a lower lobe predominance of emphysema. Each patient completed a required pulmonary rehabilitation program of 6 to 8 weeks duration prior to randomization. Of the combined 93 enrolled patients, 54 were randomized to LVRS and 39 were randomized to medical therapy alone (OBEST used a 2:1 allocation ratio).

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