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In his editorial on the Brain Trauma Foundation guidelines for the management of severe head injury, Kirkpatrick argues that standardisation of care is a prerequisite for the conduct of multicentre randomised trials.1 A similar concern seems to have motivated the European Brain Injury Consortium to develop its “expert opinion” based guidelines.2 This is not the case. Providing that a trial is large enough, randomisation will ensure that the intervention and control groups are identical with regard to known and unknown confounders. It is conceivable that the size of the intervention effect may vary a little depending on the other aspects of care given, but not the direction of the effect. Patients in the future will almost certainly receive different forms of care than they do today, and treatments shown to be effective today may be more or less effective in the future, but the direction of the effect …