Data analysis plan
syncope
REGRESSION, EVENT, SECONDARY
The primary outcome, number of self-reported episodes of syncope in the 12 months following randomisation, will be analysed by negative binomial regression. The primary outcome event rate ratio (14-day ambulatory heart monitor vs standard care) will be reported with its 95% CI. An offset term for follow-up duration will be included to account for participants with partial follow-up.The secondary outcomes for the number of syncope episodes at 90 days and 2 years, will be analysed similarly. Binary secondary outcomes will be analysed by logistic regression, reporting the OR (14-day ambulatory heart monitor vs standard care) and its 95% CI. Full details of analysis, including the estimand(s) of interest and methods for handling missing data, will be written into a Statistical Analysis Plan, which will be finalised prior to database lock without knowledge of the unblinded treatment allocations.