Editorial Perspective: How should child psychologists and psychiatrists interpret FDA device approval? Caveat emptor

Martijn Arns*, Sandra K. Loo, M. Barry Sterman, Hartmut Heinrich, Jonna Kuntsi, Philip Asherson, Tobias Banaschewski, Daniel Brandeis

*Corresponding author for this work

Research output: Contribution to journalEditorialAcademicpeer-review

17 Citations (Web of Science)

Abstract

Recently several new tests have received US Federal Drug Administration (FDA) marketing approval as aids in the diagnostic process for attention deficit hyperactivity disorder (ADHD), including the Neuropsychiatric electroencephalogram (EEG)-Based ADHD Assessment Aid (NEBA) Health test. The NEBA test relies upon an EEG-based measure, called the theta to beta ratio (TBR). Although this measure has yielded large differences between ADHD and non-ADHD groups in studies prior to 2009, recent studies and a meta-analysis could not replicate these findings. In this article, we have used the NEBA device as an exemplar for a discussion that distinguishes between FDA de novo marketing approval for a device and any claims that that device is empirically supported, scientifically validated with replicated findings. It is understood that the aims of each differ; however, for many, including the lay public as well as some mental health professionals, these terms may be confused and treated as though they are synonymous. With regard to the TBR measure, there is no reliable association or replication for its clinical usage in the ADHD diagnostic process. The recommendation for potential consumers of the NEBA Health test (as well as perhaps for other existing FDA-approved diagnostic tests) is caveat emptor (let the buyer beware!).

Original languageEnglish
Pages (from-to)656-658
Number of pages3
JournalJournal of Child Psychology and Psychiatry
Volume57
Issue number5
DOIs
Publication statusPublished - May 2016
Externally publishedYes

Keywords

  • Attention deficit hyperactivity disorder
  • electroencephalogram
  • Electroencephalogram-Based Attention Deficit Hyperactivity Disorder Assessment Aid
  • theta-to-beta ratio
  • Federal Drug Administration
  • diagnostic test
  • ADHD
  • EEG

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