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

精神分裂症虚拟现实功能能力评估工具（VRFCAT）内容效度的定性分析

基本信息

批准号：
9988046
负责人：
WILLIAM P. HORAN
金额：
$ 24.98万
依托单位：
VERASCI, LLC
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-01 至 2021-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9988046
关键词：
Qualitative Analysis Content Validity Virtual

项目摘要

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.

项目概要精神分裂症的认知缺陷是严重且具有功能性破坏性的。 FDA 有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，以及功能能力衡量标准的改善。功能能力是指个人执行关键工具性活动的能力日常生活。该领域目前提供的可靠且有效测量的选项非常有限满足 FDA 共同主要要求的功能能力。为了解决这一差距，VeraSci 开发了虚拟现实功能能力评估工具（VRFCAT），一种计算机化的测试患者处理日常情况的能力，用作联合主要终点精神分裂症认知临床试验。这个创新工具融合了独特的内容，实用性和可扩展性特征使其与现有措施区分开来。跟随他们的开发过程的初步审查和支持其临床试验的定量证据 FDA 同意将 VRFCAT 纳入临床结果评估 (COA) 鉴于缺乏适合目的的绩效成果 (PerfO) 衡量标准，资格计划评估功能能力。该提案的目的是获得有关以下方面的定性证据： FDA 资格包所需的 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确认查看 VRFCAT 测量的一般技能领域和特定任务的内容对患者及其护理人员来说具有重要的功能。 VeraSci 将与两家公司合作学术网站利用其独特的定性方法专业知识（大学加利福尼亚州、圣地亚哥）和临床数据收集资源（迈阿密大学）以实现目标如下： (1) 召集专家小组开展半结构化访谈，以获取关键信息利益相关者对职能能力和 VRFCAT 的看法； (2) 进行面谈精神分裂症患者 (n = 24)、家庭成员 (n = 12) 和同伴的不同样本支持专家（n = 12）； (3) 使用主题分析进行定性数据分析方法，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 有潜力满足 FDA 的要求有效、可靠的共同主要措施，可以帮助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。