Stable subsample | Worsening subsample | Improvement subsample | |
---|---|---|---|
Subsamples defined according to the EQ-VASa | |||
EQ-5D-Y utility Index | |||
n | 24 | 17 | 18 |
1st administration, mean (SD) | 0.94 (0.11) | 0.98 (0.04) | 0.90 (0.12) |
2nd administration, mean (SD) | 0.95 (0.09) | 0.95 (0.10) | 0.94 (0.10) |
Change, mean (SD) | 0.01 (0.08) | − 0.04 (0.09) | 0.04 (0.11) |
P value | .50 | .12 | .18 |
Effect size | 0.14 | 0.68d | |
ICCb | 0.81 | N/Ac | N/Ac |
PROMIS-PAIS raw scoree | |||
n | 19 | 12 | 15 |
1st administration, mean (SD) | 39.0 (7.4) | 41.4 (7.8) | 38.0 (6.6) |
2nd administration, mean (SD) | 39.5 (9.8) | 36.5 (5.8) | 37.6 (6.0) |
Change, mean (SD) | − 0.5 (5.5) | 5.0 (8.7) | 0.4 (10.1) |
P value | .71 | .07 | .88 |
Effect size | 0.09 | 1.08d | |
ICCb | 0.89 | N/Ac | N/Ac |
Subsamples defined according to the ACQf | |||
EQ-5D-Y utility Index | |||
n | 29 | 6 | 16 |
1st administration, mean (SD) | 0.94 (0.10) | 0.92 (0.15) | 0.95 (0.08) |
2nd administration, mean (SD) | 0.96 (0.09) | 0.88 (0.14) | 0.95 (0.08) |
Change, mean (SD) | 0.02 (0.08) | − 0.04 (0.13) | 0.00 (0.11) |
P value | .31 | .50 | .94 |
Effect size | 0.19 | 0.78d | |
ICCb | 0.79 | N/Ac | N/Ac |
EQ-VASa | |||
n | 30 | 6 | 16 |
1st administration, mean (SD) | 88.9 (14.1) | 78.5 (22.3) | 80.4 (16.3) |
2nd administration, mean (SD) | 90.8 (11.7) | 83.0 (19.3) | 83.1 (18.1) |
Change, mean (SD) | 2.0 (12.5) | 4.5 (24.0) | 2.7 (20.2) |
P value | .40 | .67 | .59 |
Effect size | 0.16 | 1.15d | |
ICCb | 0.70 | N/Ac | N/Ac |
PROMIS-PAIS raw scoree | |||
n | 25 | 6 | 11 |
1st administration, mean (SD) | 36.5 (4.0) | 48.0 (10.1) | 42.1 (9.0) |
2nd administration, mean (SD) | 36.7 (5.2) | 46.6 (11.8) | 38.5 (7.1) |
Change, mean (SD) | − 0.2 (4.6) | 1.4 (13.8) | 3.7 (10.3) |
P value | .83 | .82 | .27 |
Effect size | 0.04 | 1.28d | |
ICCb | 0.68 | N/Ac | N/Ac |