Standards for testing and clinical validation of seizure detection devices.

Détails

ID Serval
serval:BIB_ED81E0B0601D
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Synthèse (review): revue aussi complète que possible des connaissances sur un sujet, rédigée à partir de l'analyse exhaustive des travaux publiés.
Collection
Publications
Institution
Titre
Standards for testing and clinical validation of seizure detection devices.
Périodique
Epilepsia
Auteur⸱e⸱s
Beniczky S., Ryvlin P.
ISSN
1528-1167 (Electronic)
ISSN-L
0013-9580
Statut éditorial
Publié
Date de publication
06/2018
Peer-reviewed
Oui
Volume
59 Suppl 1
Pages
9-13
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: ppublish
Résumé
To increase the quality of studies on seizure detection devices, we propose standards for testing and clinical validation of such devices. We identified 4 key features that are important for studies on seizure detection devices: subjects, recordings, data analysis and alarms, and reference standard. For each of these features, we list the specific aspects that need to be addressed in the studies, and depending on these, studies are classified into 5 phases (0-4). We propose a set of outcome measures that need to be reported, and we propose standards for reporting the results. These standards will help in designing and reporting studies on seizure detection devices, they will give readers clear information on the level of evidence provided by the studies, and they will help regulatory bodies in assessing the quality of the validation studies. These standards are flexible, allowing classification of the studies into one of the 5 phases. We propose actions that can facilitate development of novel methods and devices.
Mots-clé
Diagnostic Techniques, Neurological/instrumentation, Diagnostic Techniques, Neurological/standards, Epilepsy/diagnosis, Epilepsy/physiopathology, Humans, Outcome Assessment (Health Care), Reference Values, Reproducibility of Results, clinical trials, mobile health, seizure detection, standards, validation studies, wearable devices
Pubmed
Web of science
Création de la notice
15/06/2018 17:18
Dernière modification de la notice
20/08/2019 17:15
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