Overview of economic analysis
SECONDARY
The within-trial economic analyses will be performed using individual patient level data collected from the trial. The analytical approaches will take the form of cost-effectiveness and cost-utility analysis. Based on trial evidence, incremental cost-effectiveness (and cost-utility) ratios will be calculated by taking a ratio of the difference in the mean costs and mean effects (or utility measure). The trial will be conducted in the UK, which has an NHS providing publicly funded healthcare, primarily free of charge at the point of use. The primary economic analysis will be from the NHS and personal social services (PSS) perspective. The primary economic analysis will compare the costs and consequences of each arm over the first 12 weeks after randomisation. A secondary analysis will extend this to compare costs and benefits over six-month follow-up period from randomisation. Stata version 17 or higher will be used for exploratory analysis and Stata and/or WinBUGS for the main statistical analysis.