RESPONSIVENESS OF THE EQ-5D INDEX AND VISUAL ANALOG SCALE TO CHANGES IN LUNG FUNCTION IN PATIENTS WITH CYSTIC FIBROSIS
Author(s)
Solem CT1, Vera LLonch M2, Liu S1, Botteman MF1, Lasch K3, Rodriguez S2, Castiglione B4
1Pharmerit International, Bethesda, MD, USA, 2Vertex Pharmaceuticals, Cambridge, MD, USA, 3Pharmerit International, Cambridge, MA, USA, 4Vertex Pharmaceuticals, Cambridge, MA, USA
OBJECTIVES: This post-hoc analysis examined the relationship between the EQ-5D index and the visual analog scale (VAS), and pulmonary function measured using percent predicted forced expiratory volume in 1 second (FEV), in patients with cystic fibrosis (CF) participating in the STRIVE clinical trial. METHODS: In a 48-week randomized, placebo-controlled study of ivacaftor in patients aged ≥12 years with CF and a G551D-CFTR mutation, the EQ-5D (index and VAS) and FEV were measured directly from patients at baseline, 15 days, 8 weeks, and every 8 weeks thereafter. The EQ-5D index was calculated using the U.S. preference-based algorithm. Pooling assessments and treatments over time, measures were compared among patients with no (FEV≥90%), mild (70-<90%), moderate (40-<70%), and severe (<40%) lung dysfunction. Ceiling effects (EQ-5D index=1 or VAS=100) were also assessed. RESULTS: : 157 no lung dysfunction, 419 mild, 572 moderate, 66 severe). Mean index/VAS scores decreased with worsening lung function (no lung dysfunction: 0.967/90.0; mild: 0.949/84.5; moderate: 0.918/75.1; severe: 0.881/66.4). The EQ-5D index and VAS were at the ceiling in 67.5% (no lung dysfunction: 80.9%; mild: 73.3%; moderate: 62.1%; severe: 45.5%) and 5.6% (no lung dysfunction: 15.9%; mild: 6.9%; moderate: 2.4%; severe: 0.0%) of observations, respectively. CONCLUSIONS: In a clinical study of patients 12 years of age and older with CF and a G551D-CFTR mutation, the EQ-5D index and VAS demonstrated monotonic decreases with decreasing FEV
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
PRS52
Topic
Patient-Centered Research
Topic Subcategory
Health State Utilities, Patient-reported Outcomes & Quality of Life Outcomes, Stated Preference & Patient Satisfaction
Disease
Respiratory-Related Disorders