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JMIR Ment Health. 2019 Jan 31;6(1):e11973. doi: 10.2196/11973.

Recommendations for Methodology of Virtual Reality Clinical Trials in Health Care by an International Working Group: Iterative Study.

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Division of Health Services Research, Department of Medicine, Cedars-Sinai Health System, Los Angeles, CA, United States.
Laboratoire Interdisciplinaire de Recherche Appliquée en Économie de la Santé, Paris Descartes University, Paris, France.
Department of Health Policy and Management, Fielding School of Public Health, University of California, Los Angeles, Los Angeles, CA, United States.
Institute for Creative Technologies, University of Southern California, Los Angeles, CA, United States.
Department of Psychiatry, Cedars-Sinai Health System, Los Angeles, CA, United States.
Department of Psychiatry, Stanford University School of Medicine, Palo Alto, CA, United States.



Therapeutic virtual reality (VR) has emerged as an efficacious treatment modality for a wide range of health conditions. However, despite encouraging outcomes from early stage research, a consensus for the best way to develop and evaluate VR treatments within a scientific framework is needed.


We aimed to develop a methodological framework with input from an international working group in order to guide the design, implementation, analysis, interpretation, and communication of trials that develop and test VR treatments.


A group of 21 international experts was recruited based on their contributions to the VR literature. The resulting Virtual Reality Clinical Outcomes Research Experts held iterative meetings to seek consensus on best practices for the development and testing of VR treatments.


The interactions were transcribed, and key themes were identified to develop a scientific framework in order to support best practices in methodology of clinical VR trials. Using the Food and Drug Administration Phase I-III pharmacotherapy model as guidance, a framework emerged to support three phases of VR clinical study designs-VR1, VR2, and VR3. VR1 studies focus on content development by working with patients and providers through the principles of human-centered design. VR2 trials conduct early testing with a focus on feasibility, acceptability, tolerability, and initial clinical efficacy. VR3 trials are randomized, controlled studies that evaluate efficacy against a control condition. Best practice recommendations for each trial were provided.


Patients, providers, payers, and regulators should consider this best practice framework when assessing the validity of VR treatments.


clinical trials; consensus; virtual reality

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