Table 2.
Primary and Secondary Outcomes.*
| Treatment Assigned |
|||||
|---|---|---|---|---|---|
| Hypothermia | Normothermia | Risk Difference | Relative Risk | P Value | |
| Primary Outcome | |||||
| Survival at 12 months with VABS ≥ 70 | 75/271 (28%) | 63/246 (26%) | 2.1 (−5.6, 9.7) | 1.08 (0.81, 1.42) | 0.611† |
| One year status (detailed) | 0.40‡ | ||||
| Death | 152/271 (56%) | 155/246 (63%) | |||
| Profound disability (VABS < 45 or lowest possible)§ | 18/271 (7%) | 11/246 (4%) | |||
| Moderate to severe disability (VABS 45-69)¶ | 26/271 (10%) | 17/246 (7%) | |||
| Good functional status (VABS ≥ 70)‖ | 75/271 (28%) | 63/246 (26%) | |||
| Secondary Outcomes | |||||
| Survival at 12 months | 138/317 (44%) | 113/297 (38%) | 5.5 (−2.3, 13.2) | 1.15 (0.95, 1.38) | 0.15† |
| One year change from baseline | 0.20** | ||||
| Death | 179/315 (57%) | 184/287 (64%) | |||
| Lowest possible VABS score | 7/315 (2%) | 1/287 (0%) | |||
| VABS decreased > 30 points | 31/315 (10%) | 23/287 (8%) | |||
| VABS decreased 16-30 points | 28/315 (9%) | 18/287 (6%) | |||
| VABS decreased no more than 15 points or improved | 70/315 (22%) | 61/287 (21%) | |||
The primary outcome was evaluated in patients with a baseline Vineland Adaptive Behaviour Scales, Second Edition (VABS-II), score of 70 or higher at 12 months (scores on the VABS-II 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 and study.
The P value was calculated by means of the Mann-Whitney test on the basis of the 1-yr continuous VABS-II score, stratified according to age category and study. Deceased patients and those with the lowest possible VABS-II score were assigned ranks of −2000 and −1000, respectively (i.e., the worst possible scores).
Profound disability was defined as a VABS-II score of less than 45 or the lowest possible score.
Moderate-to-severe disability was defined as a VABS-II score of 45 to 69.
Good functional status was defined as a VABS-II score of 70 or higher.
The P value was calculated by means of the Mann-Whitney test on the basis of the continuous change in VABS-II score, stratified according to age category and study. Deceased patients and those with the lowest possible VABS-II score were assigned ranks of −2000 and −1000, respectively (i.e., the worst possible scores).Table 3. Cause of Death by Study Day.