To examine clinical trials and observational studies that compared use of management protocols (MPs) versus usual care for adult intensive care unit (ICU) patients with acute severe traumatic brain injury (TBI) on 6-month neurologic outcome (Glasgow Outcome Scale, GOS) and mortality, major electronic databases were searched from 1950 to April 18, 2011. Abstracts from major international meetings were searched to identify gray literature. A total of 6,151 articles were identified; 488 were reviewed in full and 13 studies were included. Data on patient and MP characteristics, outcomes and methodological quality were extracted. All 13 included studies were observational. A random effects model showed that use of MPs was associated with a favorable neurologic outcome (GOS 4 or 5) at 6 months (odds ratio [OR] and 95 % confidence interval [CI] 3.84 (2.47-5.96)) but not 12 months (OR, 95 % CI 0.87 (0.56-1.36)). Use of MPs was associated with reduced mortality at hospital discharge and 6 months (OR and 95 % CI 0.72 (0.45-1.14) and 0.33 (0.13-0.82) respectively), but not 12 months (OR, 95 % CI 0.79 (0.5-1.24)). Sources of heterogeneity included variation in study design, methodological quality, MP design, MP neurophysiologic endpoints, and type of ICU. MPs for severe TBI were associated with reductions in death and improved neurologic outcome. Although no definitive conclusions about the efficacy of MPs for severe TBI can be drawn from our study, these results should encourage the conduct of randomized controlled trials to more rigorously examine the efficacy of MPs for severe TBI.
