Qualitative Analysis of the Content Validity of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) in Schizophrenia

项目总结

Project Summary Cognitive deficits in schizophrenia are profound and functionally devastating. The FDA has guided drug developers focused on cognitive improvement to demonstrate not only basic improvement on cognitive endpoints, but also improvement on a measure of functional capacity. Functional capacity refers to an individual’s capacity to perform key instrumental activities of daily living. The field currently offers very limited options to reliably and validly measure functional capacity to fulfill the FDA co-primary requirement. To address this gap, VeraSci developed the Virtual Reality Functional Capacity Assessment Tool (VRFCAT), a computerized test of a patient’s ability to navigate everyday situations, for use as a co-primary endpoint in schizophrenia cognition clinical trials. This innovative tool incorporates unique content, practicality, and scalability features that set it apart from existing measures. Following their initial review of the development process and quantitative evidence supporting its clinical trial utility, the FDA agreed to enter the VRFCAT into the Clinical Outcome Assessment (COA) Qualification Program given the lack of fit-for-purpose Performance Outcome (PerfO) measures assessing functional capacity. The purpose of this proposal is to obtain qualitative evidence on the content validity of the VRFCAT that is required for the FDA qualification package. For this 12-month project, we propose to use qualitative research methods to confirm that the general skill areas and the content of the specific tasks measured by the VRFCAT are viewed as functionally important by patients and their care providers. VeraSci will partner with two academic sites to utilize their unique qualitative methodological expertise (University of California, San Diego) and clinical data collection resources (University of Miami) to achieve the following aims: (1) Convene an expert panel to develop a semi-structured interview to elicit key stakeholder views about functional capacity and the VRFCAT; (2) Administer interviews to a diverse sample of patients with schizophrenia (n = 24), family members (n = 12), and peer support specialists (n = 12); (3) Conduct qualitative data analyses, using a thematic analytic approach, to evaluate whether the themes extracted from the stakeholder interviews support the content validity of the VRFCAT. The VRFCAT has the potential to fulfill the FDA’s requirement of a valid, reliable co-primary measure, which could help determine which new drugs have a meaningful impact on cognition and on the lives of schizophrenia patients.