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严重的，在功能上是毁灭性的。美国食品和药物管理局已经 受指导的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，但也改善了功能能力的衡量标准。 功能能力指的是个人进行关键的工具性活动的能力 日常生活。目前，该领域提供的可靠和有效测量的选择非常有限 满足FDA共同首要要求的功能能力。为了弥补这一差距，VeraSci 开发了虚拟现实功能评估工具(VRFCAT)，它是一个计算机化的 测试患者驾驭日常情况的能力，以作为共同的主要终点 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，使其有别于现有的衡量标准。遵循他们的 其开发过程和支持其临床试验的定量证据的初步综述 公用事业，FDA同意将VRFCAT纳入临床结果评估(COA) 考虑到缺乏适合用途的绩效结果(PERO)衡量标准的资格认证计划 评估功能能力。这项建议的目的是为了获得关于 FDA资质包所需的VRFCAT的内容有效性。 对于这个为期12个月的项目，我们建议使用定性研究的方法来证实 查看VRFCAT衡量的一般技能领域和特定任务的内容 被患者和他们的护理提供者视为重要的功能。VeraSci将与两家公司合作 学术网站利用其独特的定性方法论专业知识(大学 加州圣迭戈)和临床数据收集资源(迈阿密大学)，以实现 以下目标：(1)召集专家小组进行半结构化访谈，以获取关键信息 利益相关者对功能能力和VRFCAT的看法；(2)管理对 精神分裂症患者(n=24)、家庭成员(n=12)和同伴的不同样本 支助专家(n=12)；(3)利用专题分析进行定性数据分析 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 一项有效、可靠的共同初选措施，这可能有助于确定哪些新药具有 对精神分裂症患者的认知和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.