TY - JOUR
T1 - Validation of a Computerized test of Functional Capacity
AU - Keefe, Richard S.E.
AU - Davis, Vicki G.
AU - Atkins, Alexandra S.
AU - Vaughan, Adam
AU - Patterson, Tom
AU - Narasimhan, Meera
AU - Harvey, Philip D.
N1 - Funding Information:
Dr. Keefe currently or in the past 3 years has received investigator-initiated research funding support from the Department of Veteran's Affair, Feinstein Institute for Medical Research, National Institute of Mental Health, Psychogenics, Research Foundation for Mental Hygiene, Inc., and the Singapore National Medical Research Council. He currently or in the past 3 years has received honoraria, served as a consultant, or advisory board member for Abbvie, Akebia, Asubio, Avanir, AviNeuro/ChemRar, BiolineRx, Biogen Idec, BiolineRx, Biomarin, Boehringer-Ingelheim, EnVivo/FORUM, GW Pharmaceuticals, Janssen, Johnson & Johnson, Lundbeck, Merck, Minerva Neurosciences, Inc., Mitsubishi, Neuralstem, Neuronix, Novartis, NY State Office of Mental Health, Otsuka, Pfizer, Reviva, Roche, Sanofi/Aventis, Shire, Sunovion, Takeda, Targacept, and the University of Texas South West Medical Center. Dr. Keefe receives royalties from the BACS testing battery, the MATRICS Battery (BACS Symbol Coding) and the Virtual Reality Functional Capacity Assessment Tool (VRFCAT). He is also a shareholder in NeuroCog Trials, Inc. and Sengenix.
Funding Information:
Funding provided by the National Institute of Mental Health Grant Numbers 1R43MH084240-01A2 and 2R44MH084240-02 .
Funding Information:
Dr. Narasimhan currently or in the past 3 years has received investigator-initiated research funding support from NIMH, NIDA, NIAAA, NIH, Eli Lilly, Janssen Pharmaceuticals, Forest Labs, and Pfizer. She currently or in the past 3 years has received honoraria, served as a consultant, or advisory board member for Eli Lilly.
Publisher Copyright:
© 2016 The Authors
PY - 2016/8/1
Y1 - 2016/8/1
N2 - 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.
AB - 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.
KW - Cognition
KW - Computerized testing
KW - Everyday functioning
KW - Functional capacity
KW - Virtual reality
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U2 - 10.1016/j.schres.2016.03.038
DO - 10.1016/j.schres.2016.03.038
M3 - Article
C2 - 27091656
AN - SCOPUS:84963681253
VL - 175
SP - 90
EP - 96
JO - Schizophrenia Research
JF - Schizophrenia Research
SN - 0920-9964
IS - 1-3
ER -