Table 3 Summary statistics, mean, standard deviation (SD) and range, and between-group mean differences of the potential primary outcome measures
Time point | Usual care | BRiMS | Difference between allocated groups (BRiMS–usual care) Mean (95% CI) | Minimal clinically important difference (MCID), where available | ||||
|---|---|---|---|---|---|---|---|---|
N | Mean (SD) [Min–max] | N | Mean (SD) [Min–max] | Unadjusted | Adjusted | |||
MSWS-12v2a (range 0–100) | Baseline | 26 | 79.6 (14.4) | 30 | 84.2 (16.2) | Between 4.0 and 6.0 [33] | ||
[52.0–100.0] | [45.0–100.0] | |||||||
Week 15 | 24 | 79.8 (13.9) | 25 | 75.6 (19.4) | − 4.2 (− 14 to 5.5) | − 10.6 (− 18.9 to 2.2) | ||
[48.0–100.0] | [33.0–100.0] | |||||||
Week 27 | 22 | 79.5 (21.9) | 22 | 75.4 (16.8) | − 4.0 (− 15.9 to 7.8) | − 7.7 (− 17.2 to 1.8) | ||
[21.0–100.0] | [40.0–100.0] | |||||||
EQ5D-3Lb (crosswalk) | Baseline | 26 | 0.58 (0.16) | 29 | 0.54 (0.17) | 0.05–0.08 [34] | ||
[0.04–0.77] | [− 0.04–0.88] | |||||||
Week 15 | 24 | 0.60 (0.18) | 25 | 0.59 (0.17) | − 0.01 (− 0.11 to 0.09) | 0.03 (− 0.07 to 0.14) | ||
[0.20–0.91] | [− 0.01–0.88] | |||||||
Week 27 | 22 | 0.59 (0.25) | 22 | 0.57 (0.11) | − 0.02 (− 0.13 to 0.10) | 0.02 (− 0.09 to 0.14) | ||
[− 0.13–0.91] | [0.30–0.77] | |||||||
MSIS-29v2a (physical) (range 0–100) | Baseline | 26 | 64.2 (21.7) | 30 | 64.8 (16.4) | 8.0 [35] | ||
[25.0–97.0] | [32.0–93.0] | |||||||
Week 15 | 24 | 59.4 (23) | 25 | 54.8 (19.5) | − 4.6 (− 16.8 to 7.7) | − 4.9 (− 13.2 to 3.5) | ||
[13.0–98] | [13–92] | |||||||
Week 27 | 22 | 59.0 (24.9) | 22 | 57.9 (15.2) | − 1.2 (− 13.7 to 11.4) | 0.6 (− 7.8 to 9) | ||
[0.0.–92] | [27–88] | |||||||
MSIS-29v2a (psychological) (range 0–100) | Baseline | 26 | 45.1 (29.7) | 30 | 50.4 (22.8) | N/A | ||
[0.0–85] | [4.0–96] | |||||||
Week 15 | 24 | 43.3 (26.8) | 25 | 43.7 (19) | 0.5 (− 12.8 to 13.8) | − 5.0 (− 15.5 to 5.5) | ||
[0–89] | [0.0–70.0] | |||||||
Week 27 | 22 | 40.0 (26.8) | 22 | 43.3 (22.6) | 3.3 (− 11.8 to 18.4) | − 0.4 (− 9.9 to 9) | ||
[0.0–93] | [7.0–81] | |||||||