TY - JOUR
T1 - Reporting Guidelines for the Early-Phase Clinical Evaluation of Applications Using Extended Reality
T2 - RATE-XR Qualitative Study Guideline
AU - Vlake, Johan H.
AU - Drop, Denzel L.Q.
AU - RATE-XR Expert Group
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.
AU - Flynn, Aisling
AU - Chirico, Alice
AU - Sadeghi, Amir H.
AU - Gaggioli, Andrea
AU - Won, Andrea S.
AU - van Haaps, Annelotte P.
AU - Garcia-Palacios, Azucena
AU - Dejaco, Beate
AU - Dierckx, Bram
AU - Finke, Carsten
AU - van Driel, Catheleine
AU - Geraets, Chris N.W.
AU - Eccleston, Christopher
AU - Madan, Christopher R.
AU - van Oel, Clarine
AU - Panayi, Constantinos
AU - Ummels, Darcy
AU - Thomas, Dave
AU - Safer, Debra L.
AU - Zandee, Elsbeth
AU - Høeg, Emil R.
AU - Hüttner, Felix J.
AU - van der Breggen, Floris
AU - van Geffen, Geert Jan
AU - Hakvoort, Gido A.
AU - Corno, Giulia
AU - Hosseini, Hadi
AU - Demirci, Hafize
AU - Konradsen, Hanne
AU - Xiang, Henry
AU - Legerstee, Jeroen
AU - Staals, Lonneke M.
AU - Rijsdijk, Mienke
AU - Staring, Tonnie
N1 - 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.
PY - 2024/11/29
Y1 - 2024/11/29
N2 - 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.
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.
UR - http://www.scopus.com/inward/record.url?scp=85210931400&partnerID=8YFLogxK
U2 - 10.2196/56790
DO - 10.2196/56790
M3 - Article
C2 - 39612482
SN - 1439-4456
VL - 26
JO - Journal of Medical Internet Research
JF - Journal of Medical Internet Research
IS - 1
M1 - e56790
ER -
