Table 2.
Clinical Outcomes.*
| Variable | Pressure-Monitoring Group (N = 157) | Imaging–Clinical Examination Group (N = 167) | P Value | Proportional Odds Ratio (95% CI)† |
|---|---|---|---|---|
| Patients assessed at 6 mo — no. (%) | 144 (92) | 153 (92) | ||
| Primary outcome‡ | 0.49§ | 1.09 (0.74–1.58) | ||
| Median | 56 | 53 | ||
| Interquartile range | 22–77 | 21–76 | ||
| Cumulative mortality at 6 mo — % | 39 | 41 | 0.60¶ | 1.10 (0.77–1.57) |
| GOS-E scale at 6 mo — no. (%)|| | ||||
| Death | 56 (39) | 67 (44)** | 0.40§ | 1.23 (0.77–1.96) |
| Unfavorable outcome | 24 (17) | 26 (17) | ||
| Favorable outcome | 63 (44) | 60 (39) |
Additional outcomes are listed in Table S7A in the Supplementary Appendix. Outcomes for survivors only are in listed Table S7B in the Supplementary Appendix.
Proportional odds ratios were adjusted for site, age, and severity of injury. A value of more than 1 indicates a better outcome for the pressure-monitoring group. The study was designed to detect a difference corresponding to an odds ratio of 1.5. CI denotes confidence interval.
The primary outcome was based on a composite measure and calculated as an average percentile over 21 elements. The range is 0 to 100, and a higher percentile indicates a better outcome. A detailed description of the composite outcome appears in the outcomes section in the Supplementary Appendix; individual elements are listed in Table S2 in the Supplementary Appendix.
Statistical significance was determined by means of a blocked Wilcoxon test stratified according to site, age, and severity of injury at randomization.
Statistical significance was determined by means of Cox model regression with adjustment for site, age, and severity of injury at randomization.
The Extended Glasgow Outcome Scale (GOS-E) ranges from 1 to 8, with 1 indicating death and 8 indicating the most favorable recovery. Patients with scores ranging from 2 to 4 were classified as having an unfavorable outcome, and those with scores ranging from 5 to 8 were classified as having a favorable outcome.
Mortality for the 6-month GOS-E assessment was higher than cumulative mortality because data for participants who were lost to follow-up were excluded from the 6-month GOS-E assessment but were included as censored data for the calculation of cumulative mortality.