Authors: Brandon Birckhead, Carine Khalil, Xiaoyu Liu, Samuel Conovitz, Albert Rizzo, Itai Danovitch, Kim Bullock, and Brennan Spiegel

Topic:

Therapeutic virtual reality (VR) is an innovative and efficacious treatment modality gaining considerable attention to manage a broad range of health conditions. However, in spite of encouraging outcomes from early stage research, a consensus is needed for how best to develop and evaluate VR treatments within a scientific framework.

Purpose:

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

Methods:

A group of 21 international experts was recruited based upon contributions to the VR literature. The resulting Virtual Reality Committee of Outcomes Research Experts (VR-CORE) held iterative meetings to seek consensus regarding best practices for development and testing of VR treatments.

Results:

The interactions were transcribed, and key themes were identified to support a scientific framework to support methodology best practices for clinical VR trials. A framework emerged to support three phases of VR clinical study designs, herein named VR1, VR2, and VR3.

VR1studies focus on content development by working with patients and providers through principles of human centered design. VR2trials conduct early testing with a focus on feasibility, acceptability, tolerability and initial clinical efficacy. VR3 trials are randomized, controlled studies to evaluate efficacy versus a control condition. Best practice recommendations for each trial are provided.

Conclusions:

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

https://preprints.jmir.org/preprint/11973/accepted