A scoping review of silent trials for medical artificial intelligence

Abstract

Abstract A ‘silent trial’ refers to the prospective, noninterventional testing of artificial intelligence (AI) models in the intended clinical setting without affecting patient care or institutional operations. The silent evaluation phase has received less attention than in silico algorithm development or formal clinical evaluations, despite its increasing recognition as a critical phase. There are no formal guidelines for performing silent AI evaluations in healthcare settings. We conducted a scoping review to identify silent AI evaluations described in the literature and to summarize current practices for performing silent testing. We screened the PubMed, Web of Science and Scopus databases for articles fitting our criteria for silent AI evaluations, or silent trials, published from 2015 to 2025. A total of 891 articles were identified, of which 75 met the criteria for inclusion in the final review. We found wide variance in terminology, description and rationale for silent evaluations, leading to substantial heterogeneity in the reported information. Overwhelmingly, the papers reported measurements of area under the curve and similar metrics of technical performance. Far fewer studies reported verification of outputs against an in situ clinical ground truth; when reported, the approaches varied in comprehensiveness. We noted less discussion of sociotechnical components, such as stakeholder engagement and human–computer interaction elements. We conclude that there is an opportunity to bring together diverse evaluative practices (for example, from data science, human factors and other fields) if the silent evaluation phase is to be maximally effective. These gaps mirror challenges in the effective translation of AI tools from computer to bedside and identify opportunities to improve silent evaluation protocols that address key needs.

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