Participant flow
RECRUITMENT
The STAR trial included 363 participants randomly allocated to intervention or usual care and 313 participants provided data at the 12-month follow-up timepoint [Overall, 226/337 (67%) of those still enrolled in the trial at 12 months provided follow-up data at four years after randomisation and gave consent for extraction of information from their medical records; of these, 159 (70%) had received the intervention and 67 (30%) had usual care. This distribution was broadly reflective of the 2:1 randomisation ratio, albeit with a higher attrition rate (41%) in the usual care arm than in the intervention arm (30%) over time.
Extended CONSORT for participant flow from randomisation follow-up at four yearsMedian participant age at recruitment was 67 years (inter-quartile range 61–73), 217/363 (60%) were female and 335/363 (92%) were White. There were no substantial imbalances in participant characteristics between treatment arms at baseline; these data have been published [