Patients stratified to group I or II were randomised according to a per centre 1 : 1 randomisation.
The process quality of one group per centre was observed.
The dropout rates per centre ranged from 2 to 14%%.
During the 1 year 2015, 360 SCD patients were managed (median 7 SCD per centre, range 0 127) of which 137 (38%) for an ACS (median 4ACS per centre, range 0 34).
We took data from a total of 360 patients and from two to six physicians and up to six other HCPs per centre.
Over a 66-week period, the study recruitment rate was 0.5±0.3 subjects per week per centre, which was approximately half of the target recruitment rate of 1 subject per week per centre.
Thus, our target sample size was 200 subjects (one subject per week per centre for 50 weeks for 4 centres).
The study recruitment rate was 0.5±0.3 subjects per week per centre; the recruitment rate varied between centres (Table 5).
The target sample size for this subset was at least 100 per centre (i.e. a total of 600 women across the trial).
Minimum of three interventional cardiologists per centre.
Recruitment rate per centre of less than 5 per annum.
