Table 2 Efficacy and safety outcomes

From: Blinded, randomized trial of sonographer versus AI cardiac function assessment

Outcome

AI

(n = 1,740)

Sonographer

(n = 1,755)

Mean difference

(95% confidence interval)

P value

Primary efficacy outcome: initial versus final assessment

  Substantial change

292 (16.8%)

478 (27.2%)

−10.5% (−13.2% to −7.7%)

<0.001a

  Mean absolute difference

2.79 ± 5.53

3.77 ± 5.22

−0.97 (−1.31 to −0.61)

<0.001

Key secondary safety outcome: final versus previous cardiologist assessment

  Substantial change

871 (50.1%)

957 (54.5%)

−4.5% (−7.8% to −1.2%)

0.008

  Mean absolute difference

6.29 ± 5.94

7.23 ± 6.18

−0.94 (−1.34 to −0.54)

<0.001

Other secondary outcomes

  Sonographer time (s), median (IQR)

0 (0–0)

119 (77–173)

−131 (−134 to −127)

<0.001

  Cardiologist time (s), median (IQR)

54 (31–95)

64 (36–108)

−8 (−12 to −4)

<0.001

  Any change

1,100 (63.2%)

1,218 (69.4%)

−6.2% (−9.3% to −3.1%)

<0.001

  1. aFor both non-inferiority and superiority tests, all other tests were for superiority. Fisher’s exact test was used for categorial outcomes and double-sided Student’s t-test was used for quantitative outcomes.