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

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

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

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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.
Objective: This systematic review will assess the frequency and severity of AI errors and adverse events (AEs) in randomized controlled trials (RCTs) investigating AI medical devices as interventions in clinical settings. The review will also explore how performance errors are analyzed including whether the analysis includes the investigation of subgroup-level outcomes.
Methods: This systematic review will identify and select RCTs assessing AI medical devices. Search strategies will be deployed in MEDLINE (Ovid), Embase (Ovid), Cochrane CENTRAL, and clinical trial registries to identify relevant papers. RCTs identified in bibliographic databases will be cross-referenced with clinical trial registries. The primary outcomes of interest are the frequency and severity of AI errors, patient harms, and reported AEs. Quality assessment of RCTs will be based on version 2 of the Cochrane risk-of-bias tool (RoB2). Data analysis will include a comparison of error rates and patient harms between study arms, and a meta-analysis of the rates of patient harm in control versus intervention arms will be conducted if appropriate.
Results: The project was registered on PROSPERO in February 2023. Preliminary searches have been completed and the search strategy has been designed in consultation with an information specialist and methodologist. Title and abstract screening started in September 2023. Full-text screening is ongoing and data collection and analysis began in April 2024.
Conclusions: Evaluations of AI medical devices have shown promising results; however, reporting of studies has been variable. Detection, analysis, and reporting of performance errors and patient harms is vital to robustly assess the safety of AI medical devices in RCTs. Scoping searches have illustrated that the reporting of harms is variable, often with no mention of AEs. The findings of this systematic review will identify the frequency and severity of AI performance errors and patient harms and generate insights into how errors should be analyzed to account for both overall and subgroup performance.
Trial Registration: PROSPERO CRD42023387747; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=387747

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(A review) Prevent Medical Errors through Artificial Intelligence

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(A review) Prevent Medical Errors through Artificial Intelligence

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Making illness diagnosis too available may result in people constantly checking symptoms, inducing anxiety/fear.

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People may want to see a real person as a doctor for more in depth conversations and emotional support

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People may want to see a real person as a doctor for more in depth conversations and emotional support

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People may be harmed because the data on which the system has been trained doesn't align with the individual

If an error occurs, there may be no way to fix the error without harming the individual

Missdiagnoses or incorrect diagnoses

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Could cause harm when undergoing surgery using AI if it is not calibrated accurately.

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AI could make errors which could be life threatening errors in vital areas like surgery

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AI could make errors which could be life threatening errors in vital areas like surgery

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Diagnosis is often very context dependent, AI typically doesn't consider context as well as humans

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incorrect diagnosis

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wrong measurements when creating equipment

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Can be used for producing medical

equipment

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Could reduce strain on Healthcare services, redirecting basic queries

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Can be used for statistics in healthcare, clustering working out similar symptoms.

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Will reduce death rates and improve general health.

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Improve accessibility to health advice, no longer need to physically visit a doctor

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Save lives, adapt on surgery and work out/detect diseases