Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
EVENT
All randomised patient data will be analysed by intention-to-treat, regardless of treatment received. However, a per-protocol analysis for trial participants who consented, were randomised, completed the baseline assessment, and had at least one outcome assessment will also be conducted. Where enrolled participants do not have at least one outcome assessment (due to for example unexpected early discharge), they will be defined as “lost to follow-up”, regardless of their time in the trial. While all efforts are made to reduce loss to follow-up, as in most trials, it is inevitable that some missing outcome data may occur. In such circumstances, we envisage using best (no PI) and worst case (PI) scenarios to analyse the impact of missing outcome. These scenarios will form sensitivity analyses to assess the impact of missing outcome data, assuming those missing outcomes had no event or had an event.