Minimum clinical utility standards for wearable seizure detectors: A simulation study.

Autor: Goldenholz DM; Department of Neurology, Harvard Medical School, Boston, Massachusetts, USA.; Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA., Karoly PJ; Department of Neurology, University of Melbourne, Melbourne, Victoria, Australia., Viana PF; School of Neuroscience, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.; Faculty of Medicine, University of Lisbon, Lisbon, Portugal., Nurse E; Seer Medical, Melbourne, Victoria, Australia., Loddenkemper T; Department of Neurology, Harvard Medical School, Boston, Massachusetts, USA.; Department of Neurology, Boston Children's Hospital, Boston, Massachusetts, USA., Schulze-Bonhage A; Epilepsy Center, University Medical Center Freiburg-University of Freiburg, Freiburg, Germany., Vieluf S; Department of Neurology, Harvard Medical School, Boston, Massachusetts, USA.; Department of Neurology, Boston Children's Hospital, Boston, Massachusetts, USA., Bruno E; School of Neuroscience, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK., Nasseri M; Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA., Richardson MP; School of Neuroscience, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK., Brinkmann BH; Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA., Westover MB; Department of Neurology, Harvard Medical School, Boston, Massachusetts, USA.; Department of Neurology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.; Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.; McCace Center, Boston, Massachusetts, USA.
Jazyk: angličtina
Zdroj: Epilepsia [Epilepsia] 2024 Apr; Vol. 65 (4), pp. 1017-1028. Date of Electronic Publication: 2024 Feb 17.
DOI: 10.1111/epi.17917
Abstrakt: Objective: Epilepsy management employs self-reported seizure diaries, despite evidence of seizure underreporting. Wearable and implantable seizure detection devices are now becoming more widely available. There are no clear guidelines about what levels of accuracy are sufficient. This study aimed to simulate clinical use cases and identify the necessary level of accuracy for each.
Methods: Using a realistic seizure simulator (CHOCOLATES), a ground truth was produced, which was then sampled to generate signals from simulated seizure detectors of various capabilities. Five use cases were evaluated: (1) randomized clinical trials (RCTs), (2) medication adjustment in clinic, (3) injury prevention, (4) sudden unexpected death in epilepsy (SUDEP) prevention, and (5) treatment of seizure clusters. We considered sensitivity (0%-100%), false alarm rate (FAR; 0-2/day), and device type (external wearable vs. implant) in each scenario.
Results: The RCT case was efficient for a wide range of wearable parameters, though implantable devices were preferred. Lower accuracy wearables resulted in subtle changes in the distribution of patients enrolled in RCTs, and therefore higher sensitivity and lower FAR values were preferred. In the clinic case, a wide range of sensitivity, FAR, and device type yielded similar results. For injury prevention, SUDEP prevention, and seizure cluster treatment, each scenario required high sensitivity and yet was minimally influenced by FAR.
Significance: The choice of use case is paramount in determining acceptable accuracy levels for a wearable seizure detection device. We offer simulation results for determining and verifying utility for specific use case and specific wearable parameters.
(© 2024 International League Against Epilepsy.)
Databáze: MEDLINE
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