Table 5 Intention to treat analysis for primary and secondary outcomes at 4 weeks
Treatment as usual (n = 7) Mean (SD) | Trial treatment (n = 7) Mean (SD) | Adjusted mean difference at 4 weeks unless stated (95% CI) | Linear regression p-value | |
|---|---|---|---|---|
Volumeter (ml) | 490.71 (59.47) | 476.43 (103.27) | 11.99 (−44.74 to 68.72) | 0.651 |
PEM (0–100) | 46.20 (19.39) | 44.90 (14.57) | 8.86 (−2.92 to 20.64) | 0.126 |
ORS (0−6) | ||||
0−2 | 3 (43%) | 2 (29%) | 1.60a (0.16 to 16.23) | 0.692b |
3−6 | 4 (57%) | 5 (71%) | ||
EQ-5D-5L utility (−0.594–1) | 0.65 (0.14) | 0.76 (0.13) | −0.87 (−0.25 to 0.07) | 0.251 |
EQ-5D-5L VAS (0–100) | 70.71 (14.84) | 85.00 (12.91) | −14.29 (−31.36 to 2.79) | 0.093 |