Reporting Guidelines for the Early-Phase Clinical Evaluation of Applications Using Extended Reality: RATE-XR Qualitative Study Guideline.

Autor:	Vlake JH; Department of Intensive Care, Erasmus Medical Center, Rotterdam, Netherlands.; Department of Intensive Care, Franciscus Gasthuis & Vlietland, Rotterdam, Netherlands., Drop DLQ; Department of Intensive Care, Erasmus Medical Center, Rotterdam, Netherlands., Van Bommel J; Department of Intensive Care, Erasmus Medical Center, Rotterdam, Netherlands., Riva G; Applied Technology for Neuro-Psychology Lab, IRCCS Istituto Auxologico Italiano, Milan, Italy.; Department of Psychology, Catholic University of the Sacred Heart, Milan, Italy., Wiederhold BK; Virtual Reality Medical Center, San Diego, CA, United States., Cipresso P; Applied Technology for Neuro-Psychology Lab, IRCCS Istituto Auxologico Italiano, Milan, Italy.; Department of Psychology, University of Turin, Turin, Italy., Rizzo AS; Medical Virtual Reality Lab, University of Southern California Institute for Creative Technologies, Los Angeles, CA, United States., Rothbaum BO; Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, United States., Botella C; Department of Basic Psychology, Clinic, and Psychobiology, University Jaume I, Castellón, Spain.; CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto Salud Carlos III, Madrid, Spain., Hooft L; Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands., Bienvenu OJ; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States., Jung C; Department of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.; Cardiovascular Research Institute Düsseldorf (CARID), Medical Faculty, University Hospital of Düsseldorf, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany., Geerts B; R&D BV, Healthplus.ai, Amsterdam, Netherlands., Wils EJ; Department of Intensive Care, Franciscus Gasthuis & Vlietland, Rotterdam, Netherlands., Gommers D; Department of Intensive Care, Erasmus Medical Center, Rotterdam, Netherlands., van Genderen ME; Department of Intensive Care, Erasmus Medical Center, Rotterdam, Netherlands.
Jazyk:	angličtina
Zdroj:	Journal of medical Internet research [J Med Internet Res] 2024 Nov 29; Vol. 26, pp. e56790. Date of Electronic Publication: 2024 Nov 29.
DOI:	10.2196/56790
Abstrakt:	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. (©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. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 29.11.2024.)
Databáze:	MEDLINE
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