This study develops a multi-agent collaborative prediction model to forecast adverse drug reactions using real-world clinical medical records. It validates model performance via evidence-based data and compares decision outputs between the AI model and clinical physicians, aiming to improve early identification of drug adverse events. Only de-identified historical medical data will be analyzed; no new clinical interventions will be conducted, with no additional risks to participants.
This observational study first retrospectively collects desensitization cases related to adverse drug reactions to construct a predictive model, and then prospectively enrolls patients to evaluate model efficacy and conduct comparative research with expert blind assessment.
Study Type
OBSERVATIONAL
Enrollment
20,000
This study only analyzes de-identified historical electronic medical record data to build a multi-agent AI prediction model for adverse drug reactions. No drugs, medical devices, or clinical treatment interventions will be applied to any human subjects.
Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University Third Hospital
Beijing, China
NOT_YET_RECRUITINGCoverage rate of known ADRs
Time frame: Up to 8 weeks
Objective question accuracy
Time frame: Up to 24 weeks
Concordance rate of predicted unknown ADRs
Time frame: Up to 8 weeks
Expert-rated subjective answer quality
Time frame: Up to 24 weeks
Subgroup differences in ADR recognition coverage rate
Time frame: Up to 24 weeks
Inter-rater consistency
Time frame: Up to 24 weeks
Subgroup differences in answer quality score
Time frame: Up to 24 weeks
Rater acceptance scale score
Time frame: Up to 24 weeks
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