Blinded RCT: AI Cardiac Function Assessment Proves Non-Inferior to Sonographers
In the first blinded, randomised trial of AI versus human echocardiographic assessment, AI-derived left ventricular ejection fraction required substantially fewer revisions by cardiologists than sonographer assessments (16.8% vs 27.2% substantially changed). Cardiologists could not distinguish AI from sonographer initial readings (blinding index 0.088), and the AI workflow saved time for both sonographers and cardiologists. This Nature-published trial provides the strongest evidence to date for integrating AI into routine cardiac function assessment.
The original study
Blinded, randomized trial of sonographer versus AI cardiac function assessment.
- Authors
- He B, Kwan AC, Cho JH, Yuan N, Pollick C, Shiota T, et al.
- Journal
- Nature
- Type
- Comparative Study, Equivalence Trial, Journal Article, Randomized Controlled Trial
- PMID
- 37020027
Original abstract
Artificial intelligence (AI) has been developed for echocardiography1-3, although it has not yet been tested with blinding and randomization. Here we designed a blinded, randomized non-inferiority clinical trial (ClinicalTrials.gov ID: NCT05140642; no outside funding) of AI versus sonographer initial assessment of left ventricular ejection fraction (LVEF) to evaluate the impact of AI in the interpretation workflow. The primary end point was the change in the LVEF between initial AI or sonographer assessment and final cardiologist assessment, evaluated by the proportion of studies with substantial change (more than 5% change). From 3,769 echocardiographic studies screened, 274 studies were excluded owing to poor image quality. The proportion of studies substantially changed was 16.8% in the AI group and 27.2% in the sonographer group (difference of -10.4%, 95% confidence interval: -13.2% to -7.7%, P < 0.001 for non-inferiority, P < 0.001 for superiority). The mean absolute difference between final cardiologist assessment and independent previous cardiologist assessment was 6.29% in the AI group and 7.23% in the sonographer group (difference of -0.96%, 95% confidence interval: -1.34% to -0.54%, P < 0.001 for superiority). The AI-guided workflow saved time for both sonographers and cardiologists, and cardiologists were not able to distinguish between the initial assessments by AI versus the sonographer (blinding index of 0.088). For patients undergoing echocardiographic quantification of cardiac function, initial assessment of LVEF by AI was non-inferior to assessment by sonographers.