Reporting Guidelines for the Early-Phase Clinical Evaluation of Applications Using Extended Reality : RATE-XR Qualitative Study Guideline
(2024) In Journal of Medical Internet Research 26. p.1-13- Abstract
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... (More)
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.
(Less)
- author
- contributor
- Geraets, Chris N.W. LU
- author collaboration
- organization
- publishing date
- 2024
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- augmented reality, clinical evaluation, computer-generated simulation, consensus, Delphi process, extended reality, mixed reality, reporting guideline, simulation, simulation experience, virtual reality, virtual world, XR
- in
- Journal of Medical Internet Research
- volume
- 26
- article number
- e56790
- pages
- 1 - 13
- publisher
- JMIR Publications Inc.
- external identifiers
-
- pmid:39612482
- scopus:85210931400
- ISSN
- 1438-8871
- DOI
- 10.2196/56790
- language
- English
- LU publication?
- yes
- additional info
- Publisher Copyright: ©Johan H Vlake, Denzel LQ Drop, Jasper Van Bommel, Giuseppe Riva, Brenda K Wiederhold, Pietro Cipresso, Albert S Rizzo, Barbara O Rothbaum, Cristina Botella, Lotty Hooft, Oscar J Bienvenu, Christian Jung, Bart Geerts, Evert-Jan Wils, Diederik Gommers, Michel E van Genderen, RATE-XR Expert Group.
- id
- 46b05b52-bf89-459a-9ef2-0d26bd465d6f
- date added to LUP
- 2025-04-10 10:52:30
- date last changed
- 2025-06-19 15:32:34
@article{46b05b52-bf89-459a-9ef2-0d26bd465d6f,
abstract = {{<p>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.</p>}},
author = {{Vlake, Johan H. and Drop, Denzel L.Q. and Van Bommel, Jasper and Riva, Giuseppe and Wiederhold, Brenda K. and Cipresso, Pietro and Rizzo, Albert S. and Rothbaum, Barbara O. and Botella, Cristina and Hooft, Lotty and Bienvenu, Oscar J. and Jung, Christian and Geerts, Bart and Wils, Evert Jan and Gommers, Diederik and van Genderen, Michel E.}},
issn = {{1438-8871}},
keywords = {{augmented reality; clinical evaluation; computer-generated simulation; consensus; Delphi process; extended reality; mixed reality; reporting guideline; simulation; simulation experience; virtual reality; virtual world; XR}},
language = {{eng}},
pages = {{1--13}},
publisher = {{JMIR Publications Inc.}},
series = {{Journal of Medical Internet Research}},
title = {{Reporting Guidelines for the Early-Phase Clinical Evaluation of Applications Using Extended Reality : RATE-XR Qualitative Study Guideline}},
url = {{http://dx.doi.org/10.2196/56790}},
doi = {{10.2196/56790}},
volume = {{26}},
year = {{2024}},
}