Death, Bereavement and randomised controlled trials (BRACELET): a methodological study of policy and practice in neonatal and paediatric intensive care trials

If randomised controlled trials (RCTs) are to generate a sound evidence base to support the care of sick children and to improve survival and disability rates in settings where children are most at risk then the critically ill - who are most at risk of death and disability - are the clear target population for inclusion in research. This is especially the case in some of the trials conducted in neonatal and paediatric intensive care (NIC/PIC) settings. In such trials, comparison of mortality rates between intervention arms is a central analytical strategy. This reflects an explicit understanding that, given the severity of the condition of many of the children in the target population, some of those enrolled do not survive their illness or their clinical circumstances. It is the work of the trial to determine the effect that an intervention might have on a range of outcomes, including mortality. Whether mortality rates are lowered, raised or unaffected by a given intervention is considered at a group level, but behind the collective mortality rates are individual families who make the decision to enrol their child in a trial and whose child does not survive.