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Validating Biomarkers and Diagnostic Tests in Clinical Neurophysiology: Developing Strong Experimental Designs and Recognizing Confounds 

Validating Biomarkers and Diagnostic Tests in Clinical Neurophysiology: Developing Strong Experimental Designs and Recognizing Confounds
Chapter:
Validating Biomarkers and Diagnostic Tests in Clinical Neurophysiology: Developing Strong Experimental Designs and Recognizing Confounds
Author(s):

Joshua B. Ewen

, and Sándor Beniczky

DOI:
10.1093/med/9780190228484.003.0009
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date: 15 October 2019

There has been an explosion in the development of electroencephalogram (EEG)-based biomarkers and clinical tests. This upsurge is likely due to an increase in therapies rooted in biological mechanisms rather than behavioral descriptions, as well as to the democratization of computational power and the lower cost of EEG compared with competing methodologies. This increase in motivation and opportunity demands an increased responsibility for proper validation studies. Fields including laboratory medicine and psychometrics have paved the way for rigorous validation methodology. This chapter reviews a systematic methodology for biomarker/clinical test validation, translating approaches from other fields to the specific characteristics of EEG-based metrics. A checklist is provided to help readers design high-quality diagnostic validation studies of EEG-based biomarkers.

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