Table 4.
Prespecified outcomes at 6 months
| Early surgery group | Initial conservative treatment group | p value | Absolute difference (95% CI) | |||
|---|---|---|---|---|---|---|
| Primary outcome | 297 | 286 | ||||
| Prognosis based | 0·367* | 3·7% (−4·3 to 11·6) | ||||
| Unfavourable | 174 (59%) | 178 (62%) | .. | .. | ||
| Favourable | 123 (41%) | 108 (38%) | .. | .. | ||
| Secondary outcomes | 298 | 291 | ||||
| Mortality at 6 months | 0·095* | 5·6% (−1·0 to 12·2) | ||||
| Dead | 54 (18%) | 69 (24%) | .. | .. | ||
| Alive | 244 (82%) | 222 (76%) | .. | .. | ||
| Prognosis-based modified Rankin | 0·456* | 3·1% (−5·0 to 11·2) | ||||
| Unfavourable | 155 (53%) | 158 (56%) | .. | .. | ||
| Favourable | 140 (47%) | 126 (43%) | .. | .. | ||
| GOSE | 0·091*; 0·075† | .. | ||||
| Dead | 54 (18%) | 69 (24%) | .. | .. | ||
| Vegetative | 0 | 0 | .. | .. | ||
| Lower severe disability | 64 (22%) | 66 (23%) | .. | .. | ||
| Upper severe disability | 72 (24%) | 59 (21%) | .. | .. | ||
| Lower moderate disability | 20 (7%) | 15 (5%) | .. | .. | ||
| Upper moderate disability | 32 (11%) | 35 (12%) | .. | .. | ||
| Lower good recovery | 37 (12%) | 26 (9%) | .. | .. | ||
| Upper good recovery | 18 (6%) | 16 (6%) | .. | .. | ||
| Rankin | 0·128*; 0·147† | .. | ||||
| 0 | 20 (7%) | 16 (6%) | .. | .. | ||
| 1 | 54 (18%) | 57 (20%) | .. | .. | ||
| 2 | 58 (20%) | 41 (14%) | .. | |||
| 3 | 35 (12%) | 32 (11%) | .. | .. | ||
| 4 | 40 (14%) | 28 (10%) | .. | .. | ||
| 5 | 34 (12%) | 41 (14%) | .. | .. | ||
| Dead | 54 (18%) | 69 (24%) | .. | .. | ||
| EuroQoL Index | 235 | 210 | 0·751‡ | .. | ||
| Median (IQR; range) | 0·64 (0·20 to 0·85; −0·59 to 1·00) | 0·69 (0·08 to 0·82; −0·59 to 1·00) | .. | .. | ||
Data are number or number (%), unless otherwise indicated. EuroQol utility index was calculated with UK weightings provided by the EuroQol Group Foundation. Absolute differences (95% CIs) are provided for binary outcomes. Rankin was not available for three patients in the early surgery group and for seven in the initial conservative group. GOSE was not available for one patient in the early surgery group and five patients in the initial conservative group. GOSE=Extended Glasgow Outcome Scale.
*
χ2 test.
†
Proportional odds model.
‡
Mann-Whitney test.