Validating an SVM-based neonatal seizure detection algorithm for generalizability, non-inferiority and clinical efficacy. (June 2022)

• Record Type: Journal Article
• Authors: Tapani, Karoliina T.; Nevalainen, Päivi; Vanhatalo, Sampsa; Stevenson, Nathan J.
• Is Part Of: Computers in biology and medicine. Volume 145(2022)
• Publication Date: 2022-06
• Subjects: neonatal EEG -- EEG monitoring -- Neonatal intensive care unit -- Seizure -- Support vector machine; Medicine -- Data processing -- Periodicals; Biology -- Data processing -- Periodicals; 610.285
• DOI: 10.1016/j.compbiomed.2022.105399
• Languages: English
• ISSNs: 0010-4825

Abstract

Abstract: Neonatal seizure detection algorithms (SDA) are approaching the benchmark of human expert annotation. Measures of algorithm generalizability and non-inferiority as well as measures of clinical efficacy are needed to assess the full scope of neonatal SDA performance. We validated our neonatal SDA on an independent data set of 28 neonates. Generalizability was tested by comparing the performance of the original training set (cross-validation) to its performance on the validation set. Non-inferiority was tested by assessing inter-observer agreement between combinations of SDA and two human expert annotations. Clinical efficacy was tested by comparing how the SDA and human experts quantified seizure burden and identified clinically significant periods of seizure activity in the EEG. Algorithm performance was consistent between training and validation sets with no significant worsening in AUC ( p > 0.05, n = 28). SDA output was inferior to the annotation of the human expert, however, re-training with an increased diversity of data resulted in non-inferior performance (Δ κ = 0.077, 95% CI: −0.002-0.232, n = 18). The SDA assessment of seizure burden had an accuracy ranging from 89 to 93%, and 87% for identifying periods of clinical interest. The proposed SDA is approaching human equivalence and provides a clinically relevant interpretation of the EEG. Highlights: Neonatal SDA outputs are compared to a subjective gold standard. Neonatal SDAs must be tested on independent validation sets. We benchmark against generalizability, non-inferiority and clinical relevance. Our neonatal SDA generalizes, is clinically relevant and approaches human equivalence.