Reporting the early stage clinical evaluation of virtual-reality-based intervention trials: RATE-VR

Virtual reality (VR) is rapidly emerging as an impactful healthcare technology1. As with artificial intelligence (AI) algorithms, the number of VR-based studies and applications is growing exponentially, and the US Food and Drug Administration recently approved a medical extended reality program. VR has recently made substantial technological progress, particularly in terms of simulation capacities, and it is expected that this ongoing development will eventually result in preventive or therapeutic interventions for mental health disorders, pain management, surgical simulation and perioperative management. We make the case for an easy and practical reporting standard for early and small-scale clinical evaluation, between the preclinical technological development of VR and the design of large-scale clinical VR intervention trials. Because a comprehensive guideline for the standardization of clinical VR is necessary to avoid preventable harm and research waste, we are initiating a Delphi process with strong stakeholder engagement to reach expert consensus on adequate and transparent reporting under the name: ‘Reporting guideline and quality criteria for the early-stage clinical evaluation of virtual-reality-based intervention trials: RATE-VR’. Despite our focus on VR, this guideline will also be applicable to other emerging extended reality (XR) technologies, including augmented reality and mixed reality, as the methodological, human factors and safety considerations are largely similar to VR.