BACKGROUND: Quality assessment of diagnostic accuracy studies (QUADAS), and more recently QUADAS-2, were developed to aid the evaluation of methodological quality within primary diagnostic accuracy studies. However, its current form, QUADAS-2 does not address the unique considerations raised by artificial intelligence (AI)-centered diagnostic systems. The rapid progression of the AI diagnostics field mandates suitable quality assessment tools to determine the risk of bias and applicability, and subsequently evaluate translational potential for clinical practice. OBJECTIVE: We aim to develop an AI-specific QUADAS (QUADAS-AI) tool that addresses the specific challenges associated with the appraisal of AI diagnostic accuracy studies. This paper describes the processes and methods that will be used to develop QUADAS-AI. METHODS: The development of QUADAS-AI can be distilled into 3 broad stages. Stage 1-a project organization phase had been undertaken, during which a project team and a steering committee were established. The steering committee consists of a panel of international experts representing diverse stakeholder groups. Following this, the scope of the project was finalized. Stage 2-an item generation process will be completed following (1) a mapping review, (2) a meta-research study, (3) a scoping survey of international experts, and (4) a patient and public involvement and engagement exercise. Candidate items will then be put forward to the international Delphi panel to achieve consensus for inclusion in the revised tool. A modified Delphi consensus methodology involving multiple online rounds and a final consensus meeting will be carried out to refine the tool, following which the initial QUADAS-AI tool will be drafted. A piloting phase will be carried out to identify components that are considered to be either ambiguous or missing. Stage 3-once the steering committee has finalized the QUADAS-AI tool, specific dissemination strategies will be aimed toward academic, policy, regulatory, industry, and public stakeholders, respectively. RESULTS: As of July 2024, the project organization phase, as well as the mapping review and meta-research study, have been completed. We aim to complete the item generation, including the Delphi consensus, and finalize the tool by the end of 2024. Therefore, QUADAS-AI will be able to provide a consensus-derived platform upon which stakeholders may systematically appraise the methodological quality associated with AI diagnostic accuracy studies by the beginning of 2025. CONCLUSIONS: AI-driven systems comprise an increasingly significant proportion of research in clinical diagnostics. Through this process, QUADAS-AI will aid the evaluation of studies in this domain in order to identify bias and applicability concerns. As such, QUADAS-AI may form a key part of clinical, governmental, and regulatory evaluation frameworks for AI diagnostic systems globally. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/58202.
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