TY  - JOUR
AU  - Vlake, Johan H
AU  - Drop, Denzel LQ
AU  - Van Bommel, Jasper
AU  - Riva, Giuseppe
AU  - Wiederhold, Brenda K
AU  - Cipresso, Pietro
AU  - Rizzo, Albert S
AU  - Rothbaum, Barbara O
AU  - Botella, Cristina
AU  - Hooft, Lotty
AU  - Bienvenu, Oscar J
AU  - Jung, Christian
AU  - Geerts, Bart
AU  - Wils, Evert-Jan
AU  - Gommers, Diederik
AU  - van Genderen, Michel E
PY  - 2024
DA  - 2024/11/29
TI  - Reporting Guidelines for the Early-Phase Clinical Evaluation of Applications Using Extended Reality: RATE-XR Qualitative Study Guideline
JO  - J Med Internet Res
SP  - e56790
VL  - 26
KW  - extended reality
KW  - XR
KW  - virtual reality
KW  - augmented reality
KW  - mixed reality
KW  - reporting guideline
KW  - Delphi process
KW  - consensus
KW  - computer-generated simulation
KW  - simulation
KW  - virtual world
KW  - simulation experience
KW  - clinical evaluation
AB  - Background: Extended reality (XR), encompassing technologies such as virtual reality, augmented reality, and mixed reality, has rapidly gained prominence in health care. However, existing XR research often lacks rigor, proper controls, and standardization. Objective: To address this and to enhance the transparency and quality of reporting in early-phase clinical evaluations of XR applications, we present the “Reporting for the early-phase clinical evaluation of applications using extended reality” (RATE-XR) guideline. Methods: We conducted a 2-round modified Delphi process involving experts from diverse stakeholder categories, and the RATE-XR is therefore the result of a consensus-based, multistakeholder effort. Results: The guideline comprises 17 XR-specific (composed of 18 subitems) and 14 generic reporting items, each with a complementary Explanation & Elaboration section. 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 the applications of XR in health care. By providing an actionable checklist of minimal reporting items, this guideline will facilitate the responsible development and integration of XR technologies into health care and related fields. 
SN  - 1438-8871
UR  - https://www.jmir.org/2024/1/e56790
UR  - https://doi.org/10.2196/56790
DO  - 10.2196/56790
ID  - info:doi/10.2196/56790
ER  -