Medical Extended Reality Trials: Building Robust Comparators, Controls, and Sham

The explosive pace of development and research in medical extended reality (MXR) is a testament to its promise for health care and medicine. In comparison with this growth, there is a relative sparsity of rigorous clinical trials that establish the efficacy and effectiveness of these interventions....

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Bibliographic Details
Published in:Journal of medical Internet research 2023-11, Vol.25 (11), p.e45821-e45821
Main Authors: Persky, Susan, Colloca, Luana
Format: Article
Language:English
Subjects:
Analysis
Clinical outcomes
Clinical research
Clinical trials
Delivery of Health Care
Efficacy
Evidence-based medicine
Health care
Humans
Intervention
Knowledge
Medicine
Personal health
Virtual Reality
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Summary:The explosive pace of development and research in medical extended reality (MXR) is a testament to its promise for health care and medicine. In comparison with this growth, there is a relative sparsity of rigorous clinical trials that establish the efficacy and effectiveness of these interventions. Explicating mechanisms of action across clinical areas and MXR applications is another major area of need. A primary impediment to these goals is a lack of frameworks for trial design, more specifically, the selection of appropriate controls that effectively address unique elements of MXR. This paper delineates a framework for designing controls, sham conditions, and comparators, as well as proposed considerations for MXR trial designs. Special consideration is given to the design of sham conditions. Improved designs would enable more robust findings and the development of generalizable knowledge that could be adopted across MXR interventions.
ISSN:1438-8871
1439-4456
1438-8871
DOI:10.2196/45821