Chest
Original Research COPDHospitalized Exacerbations of COPD: Risk Factors and Outcomes in the ECLIPSE Cohort
Section snippets
Study Design and Ethics
The design of the ECLIPSE study (SCO104960, NCT00292552) has been published elsewhere.9 In brief, patients between 40 and 75 years old were included if they had a history of ≥ 10 pack-years of smoking, as well as an FEV1< 80% of predicted value and a ratio of FEV1to FVC ≤ 0.7; both were measured after bronchodilator use. COPD severity for each subject was graded according to GOLD (Global Initiative for Chronic Obstructive Lung Disease).3 The study was conducted in accordance with the
Baseline Measurements
The methodology used in the ECLIPSE study has been described in detail elsewhere.9 Briefly, standardized questionnaires were used to measure dyspnea (modified Medical Research Council dyspnea scale),13 health status (St. George's Respiratory Questionnaire for patients with COPD),14 fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue Questionnaire)15 and depression (Center for Epidemiologic Studies of Depression Scale).16 Likewise, information on symptoms of cough, sputum
Follow-up and Exacerbation Ascertainment
Subjects were followed-up at 3 months, 6 months, and every 6 months thereafter for a maximum of 3 years. All patients had their vital status confirmed 3 years after recruitment.
Information on COPD exacerbations was collected at scheduled visits by investigators using the case report forms and based on either subjects' recall of exacerbation events or available medical records for exacerbation events, supplemented by monthly phone calls. For the purpose of the current analysis, we focused on
Statistical Analysis
To investigate the prespecified goals of the study, we used the following analyses: (1) baseline differences between patients with and without hospitalized exacerbation during follow-up were tested using analysis of variance or Wilcoxon rank-sum test for continuous variables, and χ2test for categorical variables; (2) the incidence (first hospitalized exacerbation during the prospective follow-up) and recurrence (second hospitalized exacerbation during the prospective follow-up) of hospitalized
Results
Figure 1 presents the flow diagram of the study. In total, 2,138 patients with COPD with complete exacerbation data during follow-up were included in the analysis. Overall, the patient population baseline characteristics were similar to those of the entire ECLIPSE COPD population (N = 2,164).22
Discussion
The main findings of this study are (1) COPD exacerbations requiring hospital admission are relatively frequent events occurring in about 30% of patients during the 3-year follow-up; (2) past history of hospitalized exacerbations is most predictive of future events, and other risk factors include the severity of airflow limitation, poor health status, radiologic evidence of emphysema, older age, and presence of systemic inflammation; and (3) a history of hospitalized exacerbations heralds poor
Acknowledgments
Author contributions:H. M. had full access to the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis, including and especially any adverse effects, and served as principal author. H. M., D. J. M., and N. L. contributed to drafting the manuscript; H. M., D. J. M., N. L., J. V., J. R. H., J. A. W., A. Agusti, and A. Anzueto contributed to study conception and design; H. M. and N. L. contributed to data analysis; and H. M., D. J. M., N.
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Cited by (0)
Dr Wedzicha is currently at the National Heart and Lung Institute, Imperial College London (London, England).Funding/Support:The ECLIPSE study was funded by GlaxoSmithKline. Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.