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.

Abstract

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). 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 In Part 1, published and unpublished evidence regarding the suitability of the VRFCAT is synthesized, focusing on content validity, including concept mapping to an updated CIAS conceptual model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. 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. 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.