Content Validity and Psychometric Properties Assessment of the Virtual Reality Functional Capacity Assessment Tool and Application in Multiregional Clinical Trials of Cognitive Impairment Associated with Schizophrenia.
11 affiliations
- 1WCG Clinical Endpoints Solutions, Cary, NC 27513, United States.
- 2Department of Psychiatry and Biobehavioral Sciences, Jane and Terry Semel Institute for Neuroscience and Human Behavior, UCLA, Los Angeles, CA 90095, United States.
- 3Clinical Development, Engrail Therapeutics, San Diego, CA 92130, United States.
- 4Patient-Centered Outcomes, Adelphi Values, Bollington, Cheshire SK10 5JB, United Kingdom.
- 5Patient-Centred Solutions, IQVIA, London W2 1AF, United Kingdom.
- 6Patient-Centred Solutions, IQVIA, Athens 15232, Greece.
- 7Patient-Centred Solutions, IQVIA, Reading RG1 3JH, United Kingdom.
- 8Global Regulatory Strategy, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877, United States.
- 9Clinical Development, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Mainz-Bingen 55216, Germany.
- 10Department of Psychiatry, University of Miami Miller School of Medicine, Miami, FL 33136, United States.
- 11Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, United States.
Abstract
Background and hypothesis
Cognitive impairment associated with schizophrenia (CIAS) substantially impacts daily living and is a valuable prognostic indicator of functional outcomes in people living with schizophrenia. The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) is used to assess functional capacity, facilitating the development of new treatments for cognitive impairment. This paper aims to provide evidence supporting the use of the VRFCAT as a valid and reliable performance outcome measure to assess functional change (ie, a fit-for-purpose clinical outcome assessment instrument).Study design
This paper is divided into two parts. In Part 1, published and unpublished evidence regarding the suitability of the VRFCAT is synthesized, focusing on content validity, including concept mapping to an updated CIAS conceptual model informed by patient input and evaluation, and known psychometric properties. In Part 2, data collected from three multinational CIAS clinical trials are used to evaluate additional psychometric properties (practice effects, test-retest, and convergent validity) and assess the utility of the VRFCAT within its intended context of use.Study results
Published literature supports content validity and key psychometric properties of the VRFCAT. The VRFCAT demonstrates alignment with the signs, symptoms, and impacts in the CIAS conceptual model. Analysis of clinical trial data substantiates published psychometric properties within the intended context of use, with no practice effects identified.Conclusions
These findings provide evidence that the VRFCAT is a valid and reliable performance outcome measure for use in assessing functional capacity in people with CIAS, supporting its suitability for use in clinical trials.
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BibTeX
@article{klein2026content,
title = {{Content Validity and Psychometric Properties Assessment of the Virtual Reality Functional Capacity Assessment Tool and Application in Multiregional Clinical Trials of Cognitive Impairment Associated with Schizophrenia.}},
author = {Hans Klein and William P Horan and Nathan Clarke and Fleur M Howells and Kim Cocks and Christina Daskalopoulou and Ben Pascoe and Matthew Reaney and Nicholas Langevin and Justin Corey Fowler and Wenbo Tang and Philip D Harvey and Richard S E Keefe},
journal = {Schizophrenia bulletin},
year = {2026},
month = oct,
doi = {10.1093/schbul/sbag167},
url = {https://europepmc.org/article/MED/42951687},
note = {CC BY},
}
RIS
TY - JOUR
TI - Content Validity and Psychometric Properties Assessment of the Virtual Reality Functional Capacity Assessment Tool and Application in Multiregional Clinical Trials of Cognitive Impairment Associated with Schizophrenia.
AU - Hans Klein
AU - William P Horan
AU - Nathan Clarke
AU - Fleur M Howells
AU - Kim Cocks
AU - Christina Daskalopoulou
AU - Ben Pascoe
AU - Matthew Reaney
AU - Nicholas Langevin
AU - Justin Corey Fowler
AU - Wenbo Tang
AU - Philip D Harvey
AU - Richard S E Keefe
PY - 2026
DA - 2026/10/01
JO - Schizophrenia bulletin
DO - 10.1093/schbul/sbag167
UR - https://europepmc.org/article/MED/42951687
AB - Background and hypothesis Cognitive impairment associated with schizophrenia (CIAS) substantially impacts daily living and is a valuable prognostic indicator of functional outcomes in people living with schizophrenia. The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) is used to assess functional capacity, facilitating the development of new treatments for cognitive impairment. This paper aims to provide evidence supporting the use of the VRFCAT as a valid and reliable performance outcome measure to assess functional change (ie, a fit-for-purpose clinical outcome assessment instrument).Study design This paper is divided into two parts. In Part 1, published and unpublished evidence regarding the suitability of the VRFCAT is synthesized, focusing on content validity, including concept mapping to an updated CIAS conceptual model informed by patient input and evaluation, and known psychometric properties. In Part 2, data collected from three multinational CIAS clinical trials are used to evaluate additional psychometric properties (practice effects, test-retest, and convergent validity) and assess the utility of the VRFCAT within its intended context of use.Study results Published literature supports content validity and key psychometric properties of the VRFCAT. The VRFCAT demonstrates alignment with the signs, symptoms, and impacts in the CIAS conceptual model. Analysis of clinical trial data substantiates published psychometric properties within the intended context of use, with no practice effects identified.Conclusions These findings provide evidence that the VRFCAT is a valid and reliable performance outcome measure for use in assessing functional capacity in people with CIAS, supporting its suitability for use in clinical trials.
SN - 1787-9965
SN - 1745-1701
SN - 0586-7614
ER -