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Procedures for the Comparative Testing of Noninvasive Neuroassessment Devices.

Paul E Rapp1, David O Keyser1, Adele M K Gilpin2

  • 11 Department of Military and Emergency Medicine, Uniformed Services University of the Health Sciences , Bethesda, Maryland.

Journal of Neurotrauma
|January 15, 2015
PubMed
Summary

A structured five-step process is recommended before clinical comparison testing of neuroassessment devices. This approach prioritizes computational research and reliability testing in healthy populations over immediate clinical trials.

Keywords:
assessmentpsychophysiologytest–retest reliabilityvalidity qEEG

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Area of Science:

  • Neuroscience
  • Biomedical Engineering
  • Clinical Research Methodology

Background:

  • Noninvasive neuroassessment devices require rigorous comparison testing.
  • Current methods may not adequately precede clinical evaluation with essential preliminary research.

Purpose of the Study:

  • To present a sequential, five-step process for the comparison testing of noninvasive neuroassessment devices.
  • To emphasize the importance of computational and reliability testing before clinical validation.

Main Methods:

  • Literature review to identify candidate neuroassessment measures.
  • Systematic simulation studies to determine computational properties and data requirements.
  • Test-retest reliability assessment in healthy and clinical populations.
  • Clinical validity investigation in defined clinical populations.
  • Device usability assessment for promising candidates.

Main Results:

  • A structured five-step evaluation process is outlined.
  • Prioritizes computational and reliability testing in healthy subjects before clinical populations.
  • Usability assessment is a subordinate consideration after initial validation.

Conclusions:

  • A sequential, evidence-based approach enhances the validity of noninvasive neuroassessment device comparison.
  • Preliminary computational and reliability testing is crucial for efficient and accurate clinical evaluation.