HRQoL assessment | Scoring and interpretation | Baseline | End of study (week 53 or extension week 88) | Intra-subject change from baselinea | |||
---|---|---|---|---|---|---|---|
n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | ||
EQ-5D | |||||||
Health state value | Health state value: scored from 0 (dead) to 1 (full health); population norm in the US = 0.825 [34] VAS: scored from 0 (worst) to 100 (best imaginable health state); population norm in the US = 80.0 [34] | 114 | 0.90 (0.168) | 100 | 0.95 (0.098) | 92 | 0.05 (0.153) |
VAS | 114 | 81.32 (17.600) | 100 | 87.72 (13.036) | 92 | 5.83 (14.601) | |
HADS | |||||||
Depression | Both domains: 0–7 (normal) 8–10 (suggestive of the mood disorder) > 11 (probable presence of the mood disorder) Maximum (worst) score possible per domain = 21 | 114 | 2.88 (2.930) | 100 | 1.91 (2.629) | 92 | − 0.80 (2.641) |
Anxiety | 114 | 5.48 (3.863) | 100 | 4.11 (3.533) | 92 | − 1.23 (3.089) | |
WPAI | |||||||
Absenteeism (% work time missed)b | All domains Higher % = greater impairment (maximum score = 100%) | 69 | 6.15 (17.056) | 68 | 2.67 (11.670) | 52 | − 4.89 (23.296) |
Presenteeism (% impairment while working)b | 68 | 19.71 (26.653) | 68 | 8.24 (18.604) | 51 | − 14.31 (31.765) | |
Work productivity loss (% overall work impairment)b | 68 | 22.11 (29.018) | 68 | 9.45 (20.766) | 51 | − 15.97 (34.946) | |
Activity impairment (% activity (non-work) impairment | 114 | 27.54 (29.436) | 100 | 14.40 (24.917) | 92 | − 14.35 (32.013) | |
TSQM | |||||||
Effectiveness | Each domain Scoring range is 0–100; higher scores indicate better outcomes | 104 | 73.88 (25.000) | 100 | 83.67 (27.237) | 82 | 15.04 (29.854) |
Convenience | 104 | 70.94 (16.965) | 100 | 80.56 (17.470) | 82 | 8.81 (17.632) | |
Overall satisfaction | 104 | 78.79 (22.414) | 100 | 92.42 (13.253) | 82 | 14.57 (23.016) |