Therapeutic Advances in Infectious Disease · Published 2026-07-01 · DOI 10.1177/20499361261467605
Daniele Roberto Giacobbe, Riccardo Lucis, Suryabrata Banerjee, Giorgia Carra, Eric Dexter, Benjamin R. McFadden, Alberto Rizzo
Background: General-purpose large language model (LLM)–based systems are increasingly accessible to clinicians and are being explored for applications in clinical microbiology and infectious diseases (ID). However, rapid adoption has outpaced the development of specialty-specific guidance, raising concerns related to safety, reliability, accountability, and antimicrobial stewardship. Objectives: The project aims to develop consensus-based statements, endorsed by Study Group for Artificial Intelligence and Digitalisation of the European Society of Clinical Microbiology and Infectious Diseases (ESGAID), that describe principles, opportunities, and limitations in the interactions of clinical microbiologists and ID specialists with general-purpose LLM-based systems. Secondary objectives are to quantify expert agreement and identify areas of uncertainty and disagreement. Design: The project follows a structured expert consensus design using the RAND/UCLA Appropriateness Method. Methods and analysis: A multidisciplinary panel of 15 experts will be selected through ESGAID using predefined criteria to ensure balanced expertise across clinical microbiology, infectious diseases, ethics, legal aspects, and patient safety. Ten draft statements, each supported by a structured literature review, will be developed by project coordinators. Statements will be evaluated through iterative rounds of anonymous rating on a 1–9 scale, combined with moderated remote discussions. Median scores will classify statements as supported, uncertain, or unsupported. Consensus will be defined as ⩾70% agreement with <15% disagreement during final anonymous voting. Discussion: This protocol provides a transparent and reproducible framework to generate interim, specialty-specific statements on principles, opportunities, and limitations in the interactions of clinical microbiologists and ID specialists with general-purpose LLM-based systems. By combining structured evidence review with expert judgment, the resulting statements aim to delineate guidance on principles for interacting with these systems, highlight the nature of both existing risks and excessive skepticism, and identify research priorities in a rapidly evolving technological and regulatory landscape.
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Giacobbe, D., Lucis, R., Banerjee, S., et al. (2026). European Society of Clinical Microbiology and Infectious Diseases Study Group for Artificial Intelligence and Digitalisation consensus statements on key aspects in the interaction of clinical microbiologists and infectious disease specialists with general-purpose large language model-based systems: project protocol. Therapeutic Advances in Infectious Disease. https://doi.org/10.1177/20499361261467605