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

项目摘要 精神分裂症的认知缺陷是深刻的和功能上的破坏性。FDA已经 指导药物开发人员专注于认知改善，以证明不仅是基本的 认知终点的改善，以及功能能力测量的改善。 功能性能力是指个体进行关键的工具性活动的能力， 日常生活该领域目前提供非常有限的选择，以可靠和有效地测量 满足FDA共同主要要求的功能能力。为了弥补这一差距，VeraSci 开发了虚拟现实功能能力评估工具（VRFCAT），一个计算机化的 测试患者驾驭日常情况的能力，用作联合主要终点， 精神分裂症认知临床试验这个创新的工具包含了独特的内容， 实用性和可扩展性，使其有别于现有的措施。会谈后两国领导 对开发过程和支持其临床试验的定量证据进行初步审查 FDA同意将VRFCAT纳入临床结局评估（COA） 缺乏符合目的的绩效结果（PerfO）衡量标准的资格认证计划 评估功能能力。本提案的目的是获得以下方面的定性证据： FDA认证包所需的VRFCAT内容有效性。 对于这个为期12个月的项目，我们建议使用定性研究方法来证实， 查看VRFCAT测量的一般技能领域和特定任务的内容 病人和他们的护理人员认为这在功能上很重要。VeraSci将与两家 学术网站利用其独特的定性方法的专业知识（大学 加州，圣地亚哥）和临床数据收集资源（迈阿密大学），以实现 （1）召集专家小组，制定半结构化访谈， 利益攸关方对职能能力和《大西洋金枪鱼养护公约》的看法;（2）对 精神分裂症患者（n = 24），家庭成员（n = 12）和同伴的多样性样本 支持专家（n = 12）;（3）进行定性数据分析，使用专题分析 方法，以评估从利益相关者访谈中提取的主题是否支持 VRFCAT的内容有效性。VRFCAT有可能满足FDA的要求 一个有效的，可靠的共同主要措施，这可以帮助确定哪些新药有一个 对认知和精神分裂症患者的生活产生有意义的影响。

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.