Research Letters The MRC CRASH trial (corticosteroid randomisation after significant head injury) is a large international double-blind randomised placebo-controlled trial of the effect of early administration of a 48-h infusion of a corticosteroid (methylprednisolone) on the risk of death and disability after head injury. The background to the trial, methods, and baseline characteristics of the patients randomised have been previously reported in detail. 1 Briefly, we randomly allocated 10 008 adults with head injury and a Glasgow Coma Scale score of 14 or less, within 8 h of injury, to commence either a 48-h infusion of methylprednisolone or matching placebo. The loading dose was 2 g methylprednisolone (or matching placebo) over 1 h in a 100 mL infusion. The maintenance dose was 0·4 g methylprednisolone (or matching placebo) per h for 48 h in a 20 mL per h infusion. Randomisation was achieved either by use of the central telephone randomisation service provided by the Clinical Trial Service Unit in Oxford, UK, or by using a local pack system. In local pack randomisation, the next consecutively numbered treatment pack was taken from a box of eight packs, with an allocation sequence based on a block size of eight, also generated by the Clinical Trial Service Unit. The joint primary outcome measures were death from all causes within 14 days, and death or disability at 6 months. Data on death within 14 days of injury were obtained from a single-sided early outcome form completed at death, discharge, or 14 days after injury, whichever occurred first. Data on deaths after 14 days and within 6 months were obtained by contact with patients’ general practitioners, and by access to death certification records. Before the start of the trial, a simple questionnaire version of the Glasgow Outcome Scale was developed and was shown to provide a reliable and valid assessment of disability. 2 Disability at 6 months was assessed by means of this questionnaire, which was either mailed to patients or their carers, administered by telephone interview, or administered during a home visit or hospital appointment. Treatment allocation remained concealed from patients, carers, and interviewers. For analysis of outcomes at 6 months, we pre-specified that death, persistent vegetative state, and severe disability on the Glasgow Outcome Scale constituted an unfavourable outcome, whereas moderate disability and good recovery constituted a favourable outcome. We planned to report the effects of treatment overall and also subdivided by two characteristics at baseline: time from injury to randomisation (1 h, 1 to 3 h, or 3 to 8 h) and severity of head injury based on the Glasgow Coma Score at randomisation (severe 3–8, moderate 9–12, mild 13–14). Analyses were done on an intention- to-treat basis. The effect measure used was relative risk with 95% CI for the overall risk and 99% CI for the results of subgroups. Homogeneity in treatment effects within subgroups was assessed with a  2 test on two degrees of freedom at a 5% significance level. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN74459797. The protocol for this study was peer-reviewed and accepted by The Lancet; a summary of the protocol was published on the journal’s website. Follow-up data at 6 months are now available for 9673 (96·7%) patients (table). Of 4854 patients allocated corticosteroids, 1248 (25·7%) died within 6 months of randomisation compared with 1075 (22·3%) of 4819 patients allocated matching placebo, yielding a relative Published online May 26, 2005 DOI:10.1016/S0140-6736(05) 66552-X *See end of paper. Correspondence to: CRASH Trials Co-ordinating Centre, London School of Hygiene and Tropical Medicine, Keppel St, London WC1E 7HT, UK crash@lshtm.ac.uk www.thelancet.com Published online May 26, 2005 DOI:10.1016/S0140-6736(05)66552-X 1 Final results of MRC CRASH, a randomised placebo-controlled trial of intravenous corticosteroid in adults with head injury— outcomes at 6 months CRASH trial collaborators* MRC CRASH is a randomised controlled trial (ISRCTN74459797) of the effect of corticosteroids on death and disability after head injury. We randomly allocated 10 008 adults with head injury and a Glasgow Coma Scale score of 14 or less, within 8 h of injury, to a 48-h infusion of corticosteroid (methylprednisolone) or placebo. Data at 6 months were obtained for 9673 (96·7%) patients. The risk of death was higher in the corticosteroid group than in the placebo group (1248 [25·7%] vs 1075 [22·3%] deaths; relative risk 1·15, 95% CI 1·07–1·24; p=0·0001), as was the risk of death or severe disability (1828 [38·1%] vs 1728 [36·3%] dead or severely disabled; 1·05, 0·99–1·10; p=0·079). There was no evidence that the effect of corticosteroids differed by injury severity or time since injury. These results lend support to our earlier conclusion that corticosteroids should not be used routinely in the treatment of head injury. Corticosteroid Placebo allocated allocated (n=5007) (n=5001) Number with known vital status 4854 (96·9%) 4819 (96·4%) Dead* 1248 (25·7%) 1075 (22·3%) Severe disability* 580 (11·9%) 653 (13·6%) Moderate disability* 852 (17·6%) 813 (16·9%) Good recovery* 2120 (43·7%) 2213 (45·9%) Alive (disability status not known)* 54 (1·1%) 65 (1·3%) *Percentages show proportion of number with known vital status. Table: Outcomes 6 months after injury by treatment allocation