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 - 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 - RATE-XR Expert Group
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 - Phelan, Ivan
AU - Rölfing, Jan D.
AU - Gödeke, Jan
AU - Stinson, Jennifer N.
AU - Bailenson, Jeremy
AU - Legerstee, Jeroen
AU - Shen, Jiabin
AU - Huiskens, Joost
AU - Tsigarides, Jordan
AU - Costa, Jose F.
AU - Bretón-López, Juana M.
AU - Narang, Karamveer
AU - Valkenet, Karin
AU - Bullock, Kim D.
AU - Rosielle, Kimmy
AU - Hoek, Krista
AU - Pedersen, Line K.
AU - Bulle-Smid, Loes
AU - Staals, Lonneke M.
AU - Kuscu, Kemal
AU - Koornneef, Mareine G. T.
AU - Sageot, Margaux
AU - Paul, Margot D.
AU - Bajwa, Maria
AU - Matsangidou, Maria
AU - Jeitziner, Marie-Madlen
AU - Baluyot, Mariju F.
AU - Schijven, Marlies P.
AU - van Bennekom, Martine J.
AU - Browning, Matthew
AU - Morris, Melissa L.
AU - Oskam, Merel A.
AU - Smits, Merlijn
AU - Gaebler, Michael
AU - Rijsdijk, Mienke
AU - Chen, Njin-Zu
AU - Aly, Omar
AU - Campo-Prieto, Pablo
AU - Kourtesis, Panagiotis
AU - Kellmeyer, Philipp
AU - Posen, Les
AU - Reeves, Rachel
AU - Ahmed, Rami A.
AU - Bruno, Raphael R.
AU - Smeets, Rob J. E. M.
AU - Brouwer, Robbert
AU - Fine, Robert J.
AU - Lundin, Robert M.
AU - van Beek, Roderick F.
AU - Baños, Rosa M.
AU - Pot-Kolder, Roselinde M. C. A.
AU - MacPherson, Sarah E.
AU - Serino, Silvia
AU - Rekers, Sophia
AU - Pillay, Srinivasan S.
AU - Krohn, Stephan
AU - Bouchard, Stéphane
AU - el Mathari, Sulayman
AU - Persky, Susan
AU - Slatman, Syl
AU - Guimond, Synthia
AU - Caruso, Thomas J.
AU - Sauter, Thomas
AU - Wolbers, Thomas
AU - Groenveld, Tjitske D.
AU - Loetscher, Tobias
AU - Chang, Todd
AU - Staring, Tonnie
AU - Prabhu, Vishnunarayan G.
AU - Veling, Wim
AU - Mak, Winnie W. S.
PY - 2024
Y1 - 2024
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 - https://www.scopus.com/pages/publications/85210931400
UR - https://www.ncbi.nlm.nih.gov/pubmed/39612482
U2 - 10.2196/56790
DO - 10.2196/56790
M3 - Article
C2 - 39612482
SN - 1438-8871
VL - 26
JO - Journal of medical Internet research
JF - Journal of medical Internet research
IS - 1
M1 - e56790
ER -