Statistical analysis
toxicity, VT, arrhythmogenic life-threatening
EVENTS, SECONDARY, SHOCKS, SENSITIVITY
We will perform intention-to-treat (ITT) and per-protocol (PP) analysis of the primary dataset using multivariate and subgroup analysis to evaluate safety, efficacy, OAR and target doses, and treatment strategies, and pair this with CTCAE events, QoL, and PROMs, as appropriate. The primary (safety outcome), toxicity, will be considered in a time-to-event fashion and a complication-free interval and complication-free overall survival will be estimated using the Kaplan-Meier method. Mortality will be presented as a Kaplan-Meier analysis curve. In addition, toxicity will be summarized in a graph as cumulative frequencies of the standardized toxicity levels for each time point. Statistical analysis of effectiveness (secondary analysis) will be performed by comparing the number of VT events, ICD shocks, and ATP events between the six months prior to the six month after the intervention. Effectiveness is described by measures of location and scatter (95% confidence intervals) of the distributions of the features and differences to baseline. In general, confidence intervals will be derived from the score function for proportions and Hodges-Lehmann intervals for medians. The statistical significance level will be two-sided, α = 0.05.Adverse events will be tabulated by organ or sub-organ system, intensity, and relatedness. During data analysis, relevant stratification criteria are applied to the datasets. Notably, several arrhythmogenic life-threatening entities will be included to determine whether STAR is a ubiquitous treatment or whether certain conditions are more suitable for this innovative approach. VT affects both women and men, irrespective of any stratification criteria.Missing data and dropouts will be dealt with as independent right censoring. Missing data will be listed, showing reasons for unavailability. Sensitivity analyses of efficacy endpoints will be performed on the per-protocol analysis set defined as the subset of the ITT analysis set who have received protocol treatment and who have no other major protocol deviations thought to impact on the efficacy conclusions of the trial. Only patients who discontinued the study due to consent withdrawal will be replaced with new patients and should get only standard follow-up and no further study-specific follow up.Statistical analyses will be performed using R version 4.0.2 (The R Foundation of Statistical Computing, Vienna, Austria).