Consort chart.
Intention-to-treat analysis was undertaken based on the initial randomised population for costs, including hospital costs. QOL data have been analysed based on the starting population for whom AQoL-8D baseline data were recorded.The ICER is calculated as the difference in cost between study groups divided by the difference in QALY outcomes [Modelled analyses were undertaken to account for the originally planned population of 200 participants in the intervention. We modelled the spread of fixed intervention and staffing costs over the assumption of 200 participants instead of the actual 86 participants (