BACKGROUND
The number of artificial intelligence (AI) studies in medicine has exponentially increased recently. However, there is no clear quantification of clinical benefit when AI-assisted tools are implemented in patient care.
OBJECTIVE
We aim to systematically review all published randomized controlled trials (RCTs) of AI-assisted tools to characterize their performance in clinical practice.
METHODS
CINAHL, Cochrane Central, Embase, Medline and PubMed were searched to identify relevant RCTs comparing the performance of AI-assisted tool against conventional clinical management without AI-assistance published up to July 2021. We evaluated the primary endpoints of each study to determine which were clinically relevant.
RESULTS
Among 11,839 articles searched, only 38 RCTs identified were included. These RCTs were conducted in a roughly equal distribution from North America, Europe, and Asia. AI-assisted tools were implemented in 13 different clinical specialties. Most RCTs were published in the field of Gastroenterology, with 15 studies on AI-assisted endoscopy. The majority of RCTs studied image-based AI-assisted tools, and a minority of RCTs studied AI-assisted tools that drew from tabular patient. In 29 out of 38 RCTs, AI-assisted interventions outperformed usual clinical care, and clinically relevant outcomes improved with AI assisted intervention in 21 out of 29 studies. Small sample size and single-centre design limit the generalizability of these studies.
CONCLUSIONS
There is growing evidence supporting the implementation of AI-assisted tool in daily clinical practice, yet the number of available RCTs is limited and heterogeneous. Future studies are needed to quantify the benefit of AI-assisted tools in clinical practice.
CLINICALTRIAL
This study was registered on PROSPERO (ID: CRD42021286539).