Validation of a Computerized test of Functional Capacity.
Regulatory guidance for schizophrenia cognition clinical trials requires that the assessment of cognitive change is accompanied by a functionally meaningful endpoint. However, currently available measures are challenged by resistance to change, psychometric weaknesses, and for interview-based assessments, dependence upon the presence of an informant. The aims of the current study were to: 1) assess the validity, sensitivity, and reliability of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) as a measure of functional capacity; 2) determine the association between performance on the VRFCAT and performance on the MATRICS Consensus Cognitive Battery (MCCB); and 3) compare the metrics of the VRFCAT with the UCSD Performance-based Skills Assessment (UPSA). 167 patients with schizophrenia and 166 healthy controls completed the VRFCAT, UPSA, and the MCCB at baseline. The VRFCAT and UPSA were completed again at follow-up. The VRFCAT, MCCB, and UPSA were very sensitive to impairment in schizophrenia (d=1.16 to 1.22). High test-retest reliability was demonstrated for VRFCAT total completion time and the UPSA total score in patients (ICC=0.81 and 0.78, respectively). The UPSA demonstrated significant practice effects in patients (d=0.35), while the VRFCAT did not (d=-0.04). VRFCAT total completion time was correlated with both UPSA (r=-0.56, p<0.0001 for patients and -0.58, p<0.0001 for controls) and MCCB Composite (r=-0.57, p<0.0001 for patients and -0.68, p<0.0001 for controls). The VRFCAT is a highly reliable and sensitive measure of functional capacity with associations to the UPSA and MCCB. These results provide encouraging support for a computerized functional capacity assessment for use in schizophrenia.
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA; NeuroCog Trials, Inc., Durham, NC, USA. Electronic address: richard.keefe@duke.edu.
Richard S E
RSE
Keefe
NeuroCog Trials, Inc., Durham, NC, USA.
Vicki G
VG
Davis
NeuroCog Trials, Inc., Durham, NC, USA.
Alexandra S
AS
Atkins
NeuroCog Trials, Inc., Durham, NC, USA.
Adam
A
Vaughan
Department of Psychiatry, University of California San Diego, San Diego, CA, USA.
Tom
T
Patterson
Department of Neuropsychiatry, University of South Carolina, Columbia, SC, USA.
Meera
M
Narasimhan
Department of Psychiatry and Behavioral Sciences, University of Miami School of Medicine, Miami, FL, USA; Research Service, Bruce W. Carter VA Medical Center, Miami, FL, USA.
Philip D
PD
Harvey
D000328:Adult; D003936:Diagnosis, Computer-Assisted; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007406:Interview, Psychological; D008297:Male; D011569:Psychiatric Status Rating Scales; D011581:Psychological Tests; D015203:Reproducibility of Results; D012559:Schizophrenia / Q000175:diagnosis; D012680:Sensitivity and Specificity; D014584:User-Computer Interface
Cognition; Computerized testing; Everyday functioning; Functional capacity; Virtual reality