Table 6 Intention to treat analysis for primary and secondary outcomes at 12 weeks
Treatment as usual n = 7 Mean (SD) | Trial treatment n = 7 Mean (SD) | Adjusted mean difference at 12 weeks unless stated (95% CI) | Linear regression p-value | |
|---|---|---|---|---|
Volumeter (ml) | 473.57 (60.60) | 460.00 (97.47) | 11.21 (−33.42 to 55.83) | 0.591 |
PEM (0–100) | 38.60 (18.15) | 36.31 (16.98) | 6.70 (−12.99 to 26.38) | 0.470 |
ORS (0–6) | ||||
0–2 | 6 (86%) | 4 (57%) | 4.29a (0.79 to 63.2) | 0.288b |
3–6 | 1 (14%) | 3 (43%) | ||
EQ-5D-5L utility (−0.594–1) | 0.69 (0.21) | 0.79 (0.13) | −0.081 (−0.30 to 0.13) | 0.422 |
EQ-5D-5L VAS (0–100) | 76.43 (15.74) | 85.86 (16.30) | −9.43 (−29.02 to 10.16) | 0.312 |