Table 7 Responsiveness: mean change from baseline in PSQ item scores, effect size, and Guyatt's statistic by subject-rated CGI-I at Week 12
Subject-rated Clinical Global Impression of Change | ||||||
|---|---|---|---|---|---|---|
PSQ domains | Very Much Improved n = 175 | Much Improved n = 130 | Minimally Improved n = 61 | No Change n = 65 | Worse n = 15 | p-value |
Sleep quality | ||||||
Mean delta (SD) | -0.92 (0.77) | -0.68 (0.60) | -0.31 (0.59) | -0.14 (0.56) | 0.00 (0.38) | <0.0001 |
Guyatt's statistic | 1.66 | 1.23 | 0.56 | 0.25 | 0.00 | |
Daytime functioning | ||||||
Mean delta (SD) | -1.01 (0.92) | -0.68 (0.77) | -0.33 (0.60) | -0.05 (0.80) | -0.13 (0.74) | <0.0001 |
Guyatt's statistic | 1.27 | 0.85 | 0.41 | 0.06 | 0.17 | |
Nights with RLS symptoms | ||||||
Mean selta (SD) | -2.74 (0.99) | -1.70 (1.22) | -0.93 (1.06) | -0.25 (0.79) | 0.00 (1.41) | <0.0001 |
Guyatt's statistic | 3.46 | 2.15 | 1.18 | 0.31 | 0.00 | |
RLS-related sleep disturbance | ||||||
Mean delta (SD) | -1.67 (1.15) | -0.89 (1.01) | -0.48 (0.74) | -0.32 (0.94) | -0.47 (1.19) | <0.0001 |
Guyatt's statistic | 1.78 | 0.95 | 0.51 | 0.34 | 0.50 | |
RLS-related sleep latency | ||||||
Mean delta (SD) | -1.82 (1.41) | -0.86 (1.35) | -0.38 (1.20) | -0.32 (1.00) | -0.73 (1.44) | <0.0001 |
Guyatt's statistic | 1.82 | 0.86 | 0.38 | 0.32 | 0.73 | |