Table 2.
Primary and Secondary Outcomes.*
| Outcome | Hypothermia Group | Normothermia Group | Risk Difference | Relative Risk (95% CI) | P Value |
|---|---|---|---|---|---|
| no./total no. (%) | percentage points (95% CI) | ||||
| Primary outcome | |||||
| Alive with VABS-II score ≥70 at 1 yr | 48/133 (36) | 48/124 (39) | −2.6 (−14.5 to 9.2) | 0.92 (0.67 to 1.27) | 0.63† |
| Detailed supportive analysis‡ | 0.85§ | ||||
| Death | 65/133 (49) | 67/124 (54) | |||
| VABS-II score | |||||
| <45 or lowest possible | 2/133 (2) | 0/124 | |||
| 45–69 | 18/133 (14) | 9/124 (7) | |||
| ≥70 | 48/133 (36) | 48/124 (39) | |||
| Secondary outcomes | |||||
| Alive at 1 yr | 81/166 (49) | 74/161 (46) | 2.8 (−8.0 to 13.7) | 1.07 (0.85 to 1.34) | 0.56† |
| Change in VABS-II score from baseline to 1 yr¶ | 0.70‖ | ||||
| Death | 85/164 (52) | 87/153 (57) | |||
| Lowest possible VABS-II score | 1/164 (1) | 0/153 | |||
| Decrease in VABS-II score from baseline | |||||
| >30 points | 12/164 (7) | 8/153 (5) | |||
| 16–30 points | 17/164 (10) | 14/153 (9) | |||
| ≤15 points or improved | 49/164 (30) | 44/153 (29) | |||
The primary outcome was evaluated in patients with a baseline score of 70 or higher on the Vineland Adaptive Behavior Scales, second edition (VABS-II, on which scores range from 20 to 160, with higher scores indicating better function). The secondary outcomes were evaluated in all patients with available data. Denominators reported are for patients whose outcomes were known. CI denotes confidence interval.
The P value was calculated by means of the Cochran–Mantel–Haenszel test, with adjustment for age category.
Patients who had died and patients with the lowest possible VABS-II score were assigned ranks of −2000 and −1000, respectively (i.e., the worst possible scores). A VABS-II score of less than 45 or the lowest possible score indicated profound disability, a score of 45 to 69 moderate-to-severe disability, and a score of 70 or higher good functional status.
The P value was calculated by means of the Mann–Whitney test on the basis of the 1-yr continuous VABS-II score, with stratification according to age category.
Patients who had died and patients with the lowest possible VABS-II score were assigned ranks of −2000 and −1000, respectively (i.e., the worst possible scores).
The P value was calculated by means of the Mann–Whitney test on the basis of the continuous change in VABS-II score, with stratification according to age category.