Detecting Algorithmic Errors and Patient Harms for AI-Enabled Medical Devices in Randomized Controlled Trials: Protocol for a Systematic Review.

Journal: JMIR research protocols
PMID: 38941147

Abstract

BACKGROUND: Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have shown potential for a range of clinical tasks such as diagnostics, prognostics, and therapeutic decision-making such as drug dosing. There is, however, an urgent need to ensure that these technologies remain safe for all populations. Recent literature demonstrates the need for rigorous performance error analysis to identify issues such as algorithmic encoding of spurious correlations (eg, protected characteristics) or specific failure modes that may lead to patient harm. Guidelines for reporting on studies that evaluate AI medical devices require the mention of performance error analysis; however, there is still a lack of understanding around how performance errors should be analyzed in clinical studies, and what harms authors should aim to detect and report.

Authors

  • Aditya U Kale
    Department of Ophthalmology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
  • Henry David Jeffry Hogg
    Population Health Science Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.
  • Russell Pearson
    Medicines and Healthcare Products Regulatory Agency, London, UK.
  • Ben Glocker
    Kheiron Medical Technologies, London, UK.
  • Su Golder
    Department of Health Sciences, University of York, York, United Kingdom.
  • April Coombe
    Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.
  • Justin Waring
    Health Services Management Centre, University of Birmingham, Birmingham, United Kingdom.
  • Xiaoxuan Liu
    Birmingham Health Partners Centre for Regulatory Science and Innovation University of Birmingham Birmingham Reino Unido Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, Reino Unido.
  • David J Moore
    Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.
  • Alastair K Denniston
    Centre for Patient Reported Outcomes Research Institute of Applied Health Research University of Birmingham Birmingham Reino Unido Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, Reino Unido.

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