Medical Extended Reality Trials: Building Robust Comparators, Controls, and Sham

Abstract

The explosive pace of development and research in medical extended reality (MXR) is a testament to its promise for health care and medicine. In comparison with this growth, there is a relative sparsity of rigorous clinical trials that establish the efficacy and effectiveness of these interventions. Explicating mechanisms of action across clinical areas and MXR applications is another major area of need. A primary impediment to these goals is a lack of frameworks for trial design, more specifically, the selection of appropriate controls that effectively address unique elements of MXR. This paper delineates a framework for designing controls, sham conditions, and comparators, as well as proposed considerations for MXR trial designs. Special consideration is given to the design of sham conditions. Improved designs would enable more robust findings and the development of generalizable knowledge that could be adopted across MXR interventions.

Unveiling the Evolution of Virtual Reality in Medicine: A Bibliometric Analysis of Research Hotspots and Trends over the Past 12 Years

“…For example, in fields such as anatomy teaching [2], surgical training [3], the treatment of children with autism [4], post-stroke rehabilitation [5], the treatment of post-traumatic stress disorder (PTSD) [6], and telemedicine systems [7], VR application produces outstanding results. With the development of VR, subcategories, such as mixed reality (MR) [8], an overlay of synthetic content that is anchored to and interacts with objects in the real world-in real time, augmented reality (AR) [9], an overlay of computer-generated content on the real world that can superficially interact with the environment in real time, and extended reality (XR) [10], referring to all real and virtual environments generated by computer technology and wearables, have been applied to promote the development of medicine. Furthermore, the emergence of a 3D digital space that blends the real and virtual worlds, the metaverse, could also significantly affect future clinical practice and human health [11,12].…”