Recommendations for Methodology of Virtual Reality Clinical Trials in Health Care by an International Working Group: Iterative Study
Recommendations for Methodology of Virtual Reality Clinical Trials in Health Care by an International Working Group: Iterative Study
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DOI：
10.2196/11973
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发表时间：
2019-01-31
影响因子：
5.2
通讯作者：
Spiegel, Brennan
中科院分区：
文献类型：
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作者：
Birckhead, Brandon;Khalil, Carine;Spiegel, Brennan
背景：治疗性虚拟现实(VR)已经成为一种有效的治疗方式，适用于各种健康状况。然而，尽管早期研究结果令人鼓舞，但在科学框架内开发和评估VR治疗的最佳方式仍需达成共识。目的：我们的目标是建立一个方法学框架，以指导开发和测试VR治疗的试验的设计、实施、分析、解释和交流。方法：根据他们对VR文献的贡献，招募了21名国际专家。由此产生的虚拟现实临床结果研究专家举行了迭代会议，以寻求就虚拟现实治疗的开发和测试的最佳实践达成共识。结果：互动被转录，并确定了关键主题以制定科学框架，以支持临床虚拟现实试验的方法学上的最佳实践。在食品和药物管理局I-III期药物治疗模式的指导下，出现了一个框架来支持VR临床研究设计的三个阶段-VR1、VR2和VR3。VR1研究通过以人为中心的设计原则与患者和提供者合作，专注于内容开发。VR2试验进行早期测试，重点是可行性、可接受性、耐受性和初步临床疗效。VR3试验是针对对照条件评估疗效的随机对照研究。结论：患者、提供者、付款人和监管机构在评估VR治疗的有效性时，应考虑这一最佳实践框架。
Background: Therapeutic virtual reality (VR) has emerged as an efficacious treatment modality for a wide range of health conditions. However, despite encouraging outcomes from early stage research, a consensus for the best way to develop and evaluate VR treatments within a scientific framework is needed.Objective: We aimed to develop a methodological framework with input from an international working group in order to guide the design, implementation, analysis, interpretation, and communication of trials that develop and test VR treatments.Methods: A group of 21 international experts was recruited based on their contributions to the VR literature. The resulting Virtual Reality Clinical Outcomes Research Experts held iterative meetings to seek consensus on best practices for the development and testing of VR treatments.Results: The interactions were transcribed, and key themes were identified to develop a scientific framework in order to support best practices in methodology of clinical VR trials. Using the Food and Drug Administration Phase I-III pharmacotherapy model as guidance, a framework emerged to support three phases of VR clinical study designs-VR1, VR2, and VR3. VR1 studies focus on content development by working with patients and providers through the principles of human-centered design. VR2 trials conduct early testing with a focus on feasibility, acceptability, tolerability, and initial clinical efficacy. VR3 trials are randomized, controlled studies that evaluate efficacy against a control condition. Best practice recommendations for each trial were provided.Conclusions: Patients, providers, payers, and regulators should consider this best practice framework when assessing the validity of VR treatments.