The IMPACT database includes patients with moderate and severe TBI (GCS ≤ 12) from eight randomized controlled trials and three observational studies conducted between 1984 and 1997 [11 (link)]. Detailed characteristics of these 11 studies and data management have been described previously [15 (link)]. The endpoint for the prognostic analyses was the 6 mo GOS, which is an ordered outcome with five categories: 1, dead; 2, vegetative state; 3, severe disability; 4, moderate disability; and 5, good recovery. In patients whose 6 mo assessment was not available we used the 3 mo GOS (n = 1,611, 19% of the patients). We selected 8,509 patients aged ≥ 14 y [12 (link)].
We externally validated prognostic models using patients enrolled in the Medical Research Council Corticosteroid Randomisation after Significant Head Injury (MRC CRASH) trial (trial registration ISRCTN74459797, ISRCTN Register,http://www.controlled-trials.com/ ), who were recruited between 1999 and 2004 [13 (link)]. This was a large international double-blind, randomized placebo-controlled trial of the effect of early administration of a 48-h infusion of methylprednisolone on outcome after head injury. It was found that the risks of death and disability were higher in the corticosteroid group than in the placebo group. The trial included 10,008 adults with GCS ≤ 14, who were enrolled within 8 h after injury. We selected 6,681 patients with a GCS ≤ 12 and with complete 6 mo GOS. Secondary analyses considered only placebo patients (n = 3,287) and patients from high-income countries (n = 1,588). For the validation we focused on prediction of mortality (GOS 1) versus survival (GOS 2–5) and of unfavorable (GOS 1–3) versus favorable outcome (GOS 4–5).
We externally validated prognostic models using patients enrolled in the Medical Research Council Corticosteroid Randomisation after Significant Head Injury (MRC CRASH) trial (trial registration ISRCTN74459797, ISRCTN Register,