8Whenever you see a claim that a device is efficacious in improving a clinical outcome, hopefully, that claim was a result of studies comparing one group of patients using the device to another group. Given that a claim requires a study with a comparator, let's chat about the comparisons that could be made for a virtual reality therapy program.Much of my thought has been on VR comparators for clinical trials over the last 3 years. Ill start with nothing and move up from there.Standard of care (nothing)When you read a paper that says standard of care was used in the control group, know that it means nothing in addition to what the patient was going to get for their care was given. Most researchers know that this is not an ideal comparison and should not be part of the design of a trial unless there is a significant medical/ethical reason to provide nothing to the patient. One of the reasons that this is an issue is that the patient will know from the consent form that they were placed into a group that was given nothing for volunteering there time and effort toward the study. This will bias the results decreasing the validity of the claim that your VR program can improve clinical outcomes. Also its just not ethical to provide nothing especially when there are options available to them.WaitlistOne alternative to is a waitlist controlled trial. This can improve the complete disappointment that a patient can have when they provided with nothing. Brandon B, Co-Director of the Virtual Medicine Conference at Cedars-SinaiControls in VR ther-apy clinical trialsCXOINSIGHTSIt can still bias the results as the patient will know from the consent form that they will be given something at some point. Subconsciously a participant may assume that they should feel better during the period they are given something vs the period when not given something leading to a bias in the results. Non-head mounted device (TV/smartphone/Desktop/Game Console/etc.)Providing a control group with a technology is helpful on many levels. There is a benefit above standard of care for the patient's time and effort. Non-immersive technology has been shown to be beneficial in reducing pain but has been shown Brandon B, Co-Director of the Virtual Medicine Conference at Cedars-Sinai
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