Standards for testing and clinical validation of seizure detection devices.

Details

Serval ID
serval:BIB_ED81E0B0601D
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Title
Standards for testing and clinical validation of seizure detection devices.
Journal
Epilepsia
Author(s)
Beniczky S., Ryvlin P.
ISSN
1528-1167 (Electronic)
ISSN-L
0013-9580
Publication state
Published
Issued date
06/2018
Peer-reviewed
Oui
Volume
59 Suppl 1
Pages
9-13
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
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.
Keywords
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
Create date
15/06/2018 16:18
Last modification date
20/08/2019 16:15
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