Detection of Patient-Level Immunotherapy-Related Adverse Events (irAEs) from Clinical Narratives of Electronic Health Records: A High-Sensitivity Artificial Intelligence Model

Md Muntasir Zitu,1 Margaret E Gatti-Mays,2 Kai C Johnson,2 Shijun Zhang,1 Aditi Shendre,1 Mohamed I Elsaid,1 Lang Li1 1Department of Biomedical Informatics, College of Medicine, The Ohio State University, Columbus, OH, 43210, USA; 2Division of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH, 43210, USACorrespondence: Lang Li, Department of Biomedical Informatics, College of Medicine, The Ohio State University, Columbus, OH, 43210, USA, Email [email protected]: We developed an artificial intelligence (AI) model to detect immunotherapy -related adverse events (irAEs) from clinical narratives of electronic health records (EHRs) at the patient level.Patients and Methods: Training data, used for internal validation of the AI model, comprised 1230 clinical notes from 30 patients at The Ohio State University James Cancer Hospital− 20 patients who experienced irAEs and ten who did not. 3256 clinical notes of 50 patients were utilized for external validation of the AI model.Results: Use of a leave-one-out cross-validation technique for internal validation among those 30 patients yielded accurate identification of 19 of 20 with irAEs (positive patients; 95% sensitivity) and correct dissociation of eight of ten without (negative patients; 80% specificity). External validation on 3256 clinical notes of 50 patients yielded high sensitivity (95%) but moderate specificity (64%). If we improve the model’s specificity to 100%, it could eliminate the need to manually review 2500 of those 3256 clinical notes (77%).Conclusion: Combined use of this AI model with the manual review of clinical notes will improve both sensitivity and specificity in the detection of irAEs, decreasing workload and costs and facilitating the development of improved immunotherapies.Keywords: immunotherapy, cancer, adverse events, machine learning, natural language processing, artificial intelligence, electronic health records