n | QOLS Q1 | QOLS Q2 | Change in QOLS Q2-Q1a | Change in QOLS from Q1 to Q2a | Change in QOLS from Q1 to Q2a | |
---|---|---|---|---|---|---|
Mean (range) | Mean (range) | Mean of change (range) | Crude change (β) (95% CI) | Adjustedb change (β) (95% CI) | ||
Primary analyses | ||||||
Intention-to-treat | ||||||
Intervention | 119 | 89 (42, 108) | 86 (16, 111) | -3 (-44, 40) | 1.5 (-1.4, 4.5) | 0.7 (-2.1, 3.4) |
Control group | 126 | 91 (62, 112) | 86 (38, 111) | -4 (-58, 24) | Reference | Reference |
Secondary stratified analyses | ||||||
No/mild NVPc | ||||||
Intervention | 62 | 88 (43, 112) | 86 (16, 111) | -3 (-44, 34) | -0.4 (-4.2, 3.3) | -1.4 (-5.1, 2.2) |
Control group | 69 | 93 (70, 111) | 90 (66, 111) | -3 (-23, 22) | Reference | Reference |
Moderate/severe NVPc | ||||||
Intervention | 57 | 89 (42, 112) | 87 (52, 110) | -2 (-33, 40) | 3.8 (-1.0, 8.5) | 3.6 (-0.6, 7.7) |
Control group | 57 | 89 (62, 112) | 84 (38, 105) | -6 (-58, 24) | Reference | Reference |
Sensitivity analyses | ||||||
Per-protocol | ||||||
Intervention | 103 | 90 (43, 112) | 88 (42, 111) | -3 (-38, 40) | 1.6 (-1.4, 4.6) | 1.2 (-1.6, 3.9) |
Control group | 126 | 91 (62, 112) | 87 (38, 111) | -4 (-58, 24) | Reference | Reference |