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Reporting the early stage clinical evaluation of virtual-reality-based intervention trials: RATE-VR

Nature Medicine volume 29, pages 12–13 (2023)Cite this article

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Virtual reality (VR) is rapidly emerging as an impactful healthcare technology1. As with artificial intelligence (AI) algorithms, the number of VR-based studies and applications is growing exponentially, and the US Food and Drug Administration recently approved a medical extended reality program2. Although VR research is heterogeneous, the most cited work is in clinically related research areas such as surgery, psychology, neurosciences and rehabilitation3.

VR has recently made substantial technological progress, particularly in terms of simulation capacities, and it is expected that this ongoing development will eventually result in preventive or therapeutic interventions for mental health disorders, pain management, surgical simulation and perioperative management. Meanwhile, the number of publications concerning VR in healthcare has grown rapidly since 1992 — for example, 100 publications were recorded in 2005, with a gradual yearly increase leading to more than 1,000 publications per year since 2018 (ref. 3). Although the number of studies is growing, most studies thus far only evaluate a treatment effect, tend to be small and heterogeneous, and often lack a proper control4. VR studies pose several unique implementation and technological challenges for the field of medicine, including the frequency and dosing of newly designed VR treatments and a lack of scientific rigor. A structured approach that addresses technological, methodological and safety challenges is therefore necessary to facilitate optimal reporting of the clinical utility of VR-based interventions and to increase generalizability and validity of the findings5.

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Authors and Affiliations

  1. Department of Intensive Care, Erasmus MC, Rotterdam, The Netherlands

    Johan H. Vlake, Jasper van Bommel, Diederik Gommers & Michel E. van Genderen

  2. Department of Intensive Care, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands

    Johan H. Vlake & Evert-Jan Wils

  3. Applied Technology for Neuro-Psychology Lab, IRCCS Istituto Auxologico Italiano, Milan, Italy

    Giuseppe Riva

  4. Department of Psychology, Università Cattolica del Sacro Cuore, Milan, Italy

    Giuseppe Riva

  5. Virtual Reality Medical Centers, San Diego, CA, USA

    Brenda K. Wiederhold

  6. Department of Psychology, University of Turin, Turin, Italy

    Pietro Cipresso

  7. Medical Virtual Reality Lab, University of Southern California Institute for Creative Technologies, Playa Vista, CA, USA

    Albert Skip Rizzo

  8. Department of Basic Psychology, Clinic and Psychobiology, Jaume I University, Castellón, Spain

    Cristina Botella

  9. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands

    Lotty Hooft

  10. Department of Psychiatry and Behavioural Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA

    O. Joseph Bienvenu

  11. Healthplus.ai-R&D BV, Amsterdam, The Netherlands

    Bart Geerts

Authors
  1. Johan H. Vlake
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  2. Jasper van Bommel
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  3. Giuseppe Riva
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  6. Albert Skip Rizzo
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  7. Cristina Botella
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  8. Lotty Hooft
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  9. O. Joseph Bienvenu
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  10. Bart Geerts
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  11. Evert-Jan Wils
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  12. Diederik Gommers
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  13. Michel E. van Genderen
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Corresponding author

Correspondence to Michel E. van Genderen.

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Competing interests

B.G. has received consultancy and research grants from Philips and Edwards Lifesciences, and is owner and board member of Healthplus.ai and its subsidiaries. D.G. has received speaker fees and travel expenses from Dräger, GE Healthcare (medical advisory board 2009–2012), Maquet and Novalung (medical advisory board 2015–2018). All other authors declare no competing interests.

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Vlake, J.H., van Bommel, J., Riva, G. et al. Reporting the early stage clinical evaluation of virtual-reality-based intervention trials: RATE-VR. Nat Med 29, 12–13 (2023). https://doi.org/10.1038/s41591-022-02085-7

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