2006 OPEN FORUM Abstracts
AN EVALUATION OF HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE USING THE SF-12v2
Anna W Parkman, PhD, RRT1, Fernando J Martinez, MD2, Anastasia E Raczek, MEd3, Michael A DeRosa, MA3, Tammy G Curtice, PharmD, MS4, Amy L Phillips, PharmD4
1 Ohio Dominican University, Columbus, OH; 2 University of Michigan, Ann Arbor, MI; 3 QualityMetric Incorporated, Lincoln, RI; 4 Boehringer Ingelheim, Ridgefield, CT, USA.
Background: Chronic Obstructive Pulmonary Disease (COPD) has a profound impact on patients' functioning and well-being and is the fourth leading cause of death in the US. Health care practitioners caring for COPD patients work to recognize and understand the significant impact of this disease.
Objective: To assess health-related quality-of-life (HRQOL) for patients with COPD in comparison to the general US population.
Methods: 700 patients cared for by pulmonologists or general practitioners at 12 sites across the US were enrolled in a clinical development and validation study for a COPD population screener (COPD-PS). Patients completed a 90-item survey, which included the SF-12v2, a widely-used and validated patient-reported outcome tool that measures eight domains of health, as well as physical (PCS) and mental (MCS) summary components. Patients also completed pre- and post-bronchodilator spirometry. Spirometry results for 295 patients met standards for acceptability and reproducibility. COPD was defined as airway obstruction that was not fully reversible (post-bronchodilator FEV1/FVC<70%). Descriptive statistics for SF-12v2 measures were calculated for mild (post-bronchodilator FEV1≥80% predicted) and moderate/very severe (post-bronchodilator FEV1<80% predicted) COPD. Disease burden was estimated by adjusting general population normative data from the 1998 National Survey of Functional Health Status (NSFHS) to age and sex characteristics of the COPD sample. Multivariate and univariate analyses of variance (MANOVA, ANOVA) F-statistics were used to test for differences between COPD patients' HRQOL and adjusted norms.
Results: Of 295 patients, 38% (N=113) had COPD based on spirometry (15% mild, 85% moderate/very severe). Patients with COPD were less likely to describe their health as very good or excellent (15.0% vs. 29.3%, p<0.001), and more likely to describe their health as fair or poor (44.2% vs. 29.3%, p<0.006) compared to those without COPD. MANOVA revealed that the full SF-12v2 profile was significantly lower for COPD patients compared to the US general population (p<0.0001); age- and gender-adjusted means for each of the eight scales and PCS also were significantly lower for COPD patients (p<0.04 to p<0.0001). Considering COPD severity, patients with mild COPD had significantly lower (mean, SD) Role Physical scores (39.6, 12.0; p<0.04) and moderate/very severe COPD patients had statistically significant decrements across all SF-12v2 measures except MCS, compared to adjusted norm values [Physical Functioning (33.9, 12.0; p<0.0001), PCS (34.7, 10.8; p<0.0001), Role Physical (35.7, 11.2; p<0.0001), General Health (38.1, 11.0; p<0.0001), Vitality (43.8, 10.5; p<0.0001), Role Emotional (42.1, 13.6; p<0.001), Bodily Pain (43.4, 12.5; p<0.002), Social Functioning (45.3, 12.5; p<0.004) and Mental Health (48.9, 9.9; p<0.03)].
Conclusion: Compared to the general US population, patients with COPD based on spirometry experienced a decrease in HRQOL that was notable in patients with mild disease and pronounced in patients with moderate/very severe disease.
Funded by Boehringer Ingelheim and Pfizer.