Implementation frameworks for end-to-end clinical AI: derivation of the SALIENT framework.

Abstract

To derive a comprehensive implementation framework for clinical AI models within hospitals informed by existing AI frameworks and integrated with reporting standards for clinical AI research. (1) Derive a provisional implementation framework based on the taxonomy of Stead et al and integrated with current reporting standards for AI research: TRIPOD, DECIDE-AI, CONSORT-AI. (2) Undertake a scoping review of published clinical AI implementation frameworks and identify key themes and stages. (3) Perform a gap analysis and refine the framework by incorporating missing items. The provisional AI implementation framework, called SALIENT, was mapped to 5 stages common to both the taxonomy and the reporting standards. A scoping review retrieved 20 studies and 247 themes, stages, and subelements were identified. A gap analysis identified 5 new cross-stage themes and 16 new tasks. The final framework comprised 5 stages, 7 elements, and 4 components, including the AI system, data pipeline, human-computer interface, and clinical workflow. This pragmatic framework resolves gaps in existing stage- and theme-based clinical AI implementation guidance by comprehensively addressing the what (components), when (stages), and how (tasks) of AI implementation, as well as the who (organization) and why (policy domains). By integrating research reporting standards into SALIENT, the framework is grounded in rigorous evaluation methodologies. The framework requires validation as being applicable to real-world studies of deployed AI models. A novel end-to-end framework has been developed for implementing AI within hospital clinical practice that builds on previous AI implementation frameworks and research reporting standards.