Outcomes assessment
SECONDARY
The primary outcome was the change in LVEF between the initial assessment by AI or sonographer and the final cardiologist assessment. The primary outcome was evaluated both as the proportion of studies with substantial change and the mean absolute difference between initial and final assessments. Substantial change was defined as greater than 5% change in LVEF between initial and final assessments. The analysis was performed as randomized and there was no crossover between the two groups.The duration of time for contouring and adjustment by the sonographer and cardiologist was tracked and compared between the sonographer and AI arms. To assess blinding, cardiologists were asked to predict whether the initial interpretation was by AI, sonographer or unable to tell for each study. A key secondary safety end point was change in final cardiologist-adjudicated LVEF compared with the previous cardiologist-reported LVEF. An additional secondary end point includes the proportion of studies with no change in LVEF between initial and final interpretations.