JMIR Publications

ABSTRACT

Background:

Extended reality (XR), encompassing technologies like virtual reality (VR), augmented reality (AR), and mixed reality (MR), has rapidly gained prominence in healthcare. However, existing XR research often lacks rigor, proper controls, and standardization.

Objective:

To address this, we present the "Reporting for the early-phase clinical evaluation of applications using extended reality" (RATE-XR) guideline. RATE-XR is the result of a consensus-based, multi-stakeholder effort, aiming to enhance the transparency and quality of reporting in early-phase clinical evaluations of XR applications.

Methods:

We conducted a two-round modified Delphi process involving experts from diverse stakeholder categories.

Results:

The guideline comprises 17 XR-specific (made of 18 subitems) and 14 generic reporting items, each with a complementary Explanation & Elaboration (E&E) section in the Supplementary Note.

Conclusions:

The items encompass critical aspects of XR research, from clinical utility and safety to human factors and ethics. By offering a comprehensive checklist for reporting, the RATE-XR guideline facilitates robust assessment and replication of early-stage clinical XR studies. It underscores the need for transparency, patient-centeredness, and balanced evaluation of XR applications in healthcare. By providing an actionable checklist of minimal reporting items, this guideline will facilitate the responsible development and integration of XR technologies into healthcare and related fields.