Published ahead of print on May 29, 2009, doi:10.1164/rccm.200809-1383OC Am. J. Respir. Crit. Care Med., Volume 180, Number 3, August 2009, 239-246 A more recent version of this article appeared on August 1, 2009
Submitted on September 2, 2008 Integrating Health Status and Survival Data: The Palliative Effect of Lung Volume Reduction SurgeryRoberto Benzo1*,1 Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, Minnesota, United States, 2 Division of General Internal Medicine, Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 3 Division of General Internal Medicine, Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, United States; Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 4 Internal Medicine, Division of Pulmonary & Critical Care Medicine, University of Michigan, Ann Arbor, Michigan, United States, 5 Department of Health Services, University of California, Los Angeles, Los Angeles, California, United States, 6 Division of Pulmonary and Critical Care Medicine, Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 7 Division of Pulmonary & Critical Care Medicine, Temple University, Philadelphia, Pennsylvania, United States, 8 Division of Pulmonary & Critical Care Medicine, John Hopkins University, Baltimore, Maryland, United States, 9 Division of Pulmonary Sciences, National Jewish Medical Center and Research Center, Denver, Colorado, United States, 10 Division of Thoracic and Foregut Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 11 Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, United States * To whom correspondence should be addressed. E-mail: benzo.roberto{at}mayo.edu.
Rationale: In studies that address health related quality of life (QoL) and survival, subjects that die are usually censored from QoL assessments. This practice tends to inflate the apparent benefits of interventions with high risk of mortality. Assessing a composite QoL-death outcome is a potential solution to this problem. Objectives: To determine the effect of Lung Volume Reduction Surgery (LVRS) on a composite endpoint consisting of the occurrence of death or a clinically meaningful decline in QoL defined as an increase of at least 8-points in the St. George's Respiratory Questionnaire total score from the National Emphysema Treatment Trial. Methods: In patients with Chronic Obstructive Pulmonary Disease and Emphysema randomized to receive medical treatment (n=610) or LVRS (n=608), we analyzed the survival to the composite endpoint, the hazard functions and constructed prediction models of the slope of QOL decline. Measurements and Main Results: The time to the composite endpoint was longer in the LVRS group (2 years) than the medical treatment group (1 year) (P<0.0001). It was even longer in the subsets of LVRS patients without a "high risk" for perioperative death and with upper-lobepredominant emphysema. The hazard for the composite event significantly favored the LVRS group although it was most significant in patients with predominantly upper-lobe emphysema. The beneficial impact of LVRS on QoL decline was most significant during the two years following LVRS. Conclusions: LVRS has a significant effect on the composite QoL-survival endpoint tested, indicating its meaningful palliative role, particularly in patients with upper lobe predominant emphysema. Key words: COPD • Outcome Assessment • Palliative Care • Quality of Life • Survival
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
