EchoNet-RCT

Blinded, Randomized Trial of Sonographer versus AI Cardiac Function Assessment

Patient / Population Intervention / Exposition Comparaison Critère de jugement

In 3,495 echocardiographic studies (3,769 screened, 274 excluded for poor image quality) undergoing quantification of cardiac function, initial AI assessment of left ventricular ejection fraction was non-inferior to initial sonographer assessment for the proportion of studies substantially changed (>5% LVEF) by the final cardiologist, and superior.

N
3 495
Schéma
Blinded, randomised non-inferiority trial
Critère
Proportion of studies with substantial (>5%) change in LVEF between initial AI or sonographer assessment and final cardiologist assessment
Pertinence
1
RésultatSubstantial change 16.8% (AI) vs 27.2% (sonographer); difference −10.4% (95% CI −13.2% to −7.7%; P<0.001 for non-inferiority and for superiority). Mean absolute difference from a prior independent cardiologist 6.29% vs 7.23% (difference −0.96%, 95% CI −1.34% to −0.54%); blinding index 0.088.
He B, et al. Nature. 2023;616(7957):520-524. 10.1038/s41586-023-05947-3
Discussion et critique

The first blinded randomised trial of AI in cardiac imaging: cardiologists edited AI-initiated LVEF less often than sonographer-initiated values, with time saved for both, establishing the design template for AI-versus-human reader trials. The endpoint is cardiologist editing rather than patient outcome, 274 poor-quality studies were excluded before randomisation, and a cardiologist still finalised every report, so the trial tested AI-assisted workflow rather than autonomous AI.