title: Risk, diagnostic error, and the clinical science of consciousness.
abstract: In recent years, a number of new neuroimaging techniques have detected covert awareness in some patients previously thought to be in a vegetative state/unresponsive wakefulness syndrome. This raises worries for patients, families, and physicians, as it indicates that the existing diagnostic error rate in this patient group is higher than assumed. Recent research on a subset of these techniques, called active paradigms, suggests that false positive and false negative findings may result from applying different statistical methods to patient data. Due to the nature of this research, these errors may be unavoidable, and may draw into question the use of active paradigms in the clinical setting. We argue that false positive and false negative findings carry particular moral risks, which may bear on investigators' decisions to use certain methods when independent means for estimating their clinical utility are absent. We review and critically analyze this methodological problem as it relates to both fMRI and EEG active paradigms. We conclude by drawing attention to three common clinical scenarios where the risk of diagnostic error may be most pronounced in this patient group.
authors.affiliation: Brain and Mind Institute, Western University, Natural Sciences Centre, London, Ontario N6A 5B7, Canada ; Rotman Institute of Philosophy, Western University, Stevenson Hall, London, Ontario N6A 5B7, Canada.
authors.forename: Andrew
authors.initials: A
authors.lastname: Peterson
authors.affiliation: Brain and Mind Institute, Western University, Natural Sciences Centre, London, Ontario N6A 5B7, Canada.
authors.forename: Damian
authors.initials: D
authors.lastname: Cruse
authors.affiliation: Brain and Mind Institute, Western University, Natural Sciences Centre, London, Ontario N6A 5B7, Canada.
authors.forename: Lorina
authors.initials: L
authors.lastname: Naci
authors.affiliation: Brain and Mind Institute, Western University, Natural Sciences Centre, London, Ontario N6A 5B7, Canada ; Rotman Institute of Philosophy, Western University, Stevenson Hall, London, Ontario N6A 5B7, Canada ; Department of Epidemiology and Biostatistics, Western University, Kresge Building, London, Ontario N6A 5B7, Canada.
authors.forename: Charles
authors.initials: C
authors.lastname: Weijer
authors.affiliation: Brain and Mind Institute, Western University, Natural Sciences Centre, London, Ontario N6A 5B7, Canada ; Rotman Institute of Philosophy, Western University, Stevenson Hall, London, Ontario N6A 5B7, Canada.
authors.forename: Adrian M
authors.initials: AM
authors.lastname: Owen
mesh_terms: D003244:Consciousness Disorders / Q000175:diagnosis*; D003951:Diagnostic Errors; D004569:Electroencephalography / Q000379:methods*; D005188:False Negative Reactions; D005189:False Positive Reactions; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods*; D012306:Risk
keywords: Active paradigm; Brain injury; Disorders of consciousness; Ethics; Mental imagery; Minimally conscious state; Neuroethics; Neurology; Statistical methods; Unresponsive wakefulness syndrome; Vegetative state
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