Qualitative Analysis of the Content Validity of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) in Schizophrenia: A Multi-Stakeholder Perspective.
Qualitative Analysis of the Content Validity of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) in Schizophrenia: A Multi-Stakeholder Perspective.
复制标题
DOI：
10.1093/schizbullopen/sgad012
复制
发表时间：
2023-01
期刊：
影响因子：
--
通讯作者：
中科院分区：
文献类型：
--
作者：
美国食品药品监督管理局（FDA）要求针对精神分裂症相关认知障碍（CIAS）的临床试验通过采用功能共同主要指标来证明认知改善的功能相关性。尽管定量证据支持虚拟现实功能评估工具（VRFCAT）适用于此目的，但FDA临床结局评估资格认证指南要求提供内容有效性证据，定义为关键利益相关者认为该措施相关且重要的定性证据。为了收集这一重要的定性数据，对门诊精神分裂症患者（n = 24）、照顾者（n = 12）和专业同伴支持专家（n = 12）进行了半结构化访谈，以了解他们对功能独立的定义和重要性以及VRFCAT评估的功能领域的重要性的看法（用餐计划、使用交通工具、处理资金、购物）以及《大西洋金枪鱼养护公约》任务与这些领域的相关性。定性专题分析显示，在定义功能独立性，包括执行工具自我照顾，财务和社会任务，自主决策，不依赖于他人进行日常活动的群体一致的主题。然而，他们对职能独立的重要性和障碍的看法存在明显分歧。所有小组都认为《大西洋金枪鱼养护公约》评估的是对独立运作至关重要的技能领域，除了一些微小的差别之外，《大西洋金枪鱼养护公约》的任务被视为这些领域的相关和有意义的例子。这些定性结果提供了一致的证据，表明主要利益攸关方认为《大西洋金枪鱼养护公约》是一项内容有效的措施。
The US Food and Drug Agency (FDA) requires clinical trials targeting cognitive impairment associated with schizophrenia (CIAS) to demonstrate the functional relevance of cognitive improvements by employing a functional co-primary measure. Although quantitative evidence supports the suitability of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) for this purpose, FDA guidelines for qualification of clinical outcome assessments require evidence of content validity, defined as qualitative evidence that key stakeholders view the measure as relevant and important. To collect this important qualitative data, semi-structured interviews were conducted with outpatients with schizophrenia (n = 24), caregivers (n = 12), and professional peer support specialists (n = 12) to elicit their views about the definition and importance of functional independence, the importance of the functional domains assessed by the VRFCAT (meal planning, using transportation, handling money, shopping), and the relevance of the VRFCAT tasks to these domains. Qualitative thematic analyses revealed consistent themes across groups in defining functional independence, including performing instrumental self-care, financial, and social tasks; making decisions autonomously; and not depending on others to carry out daily activities. There were, however, notable differences in their views regarding the importance of and barriers to functional independence. All groups viewed the VRFCAT as assessing skill domains that are central to independent functioning and, with some minor differences, the VRFCAT tasks were viewed as relevant and meaningful examples of the domains. These qualitative results provide converging evidence that key stakeholders view the VRFCAT as a content-valid measure.