Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Mar 28, 2024
Date Accepted: Apr 8, 2025
Core outcome set for pediatric and adult acute and chronic pain extended reality trials: Results from multi-step consensus building process
ABSTRACT
Background:
Appropriate outcome assessment strategies and high-quality trials are critical to advancing care of pediatric and adult patients in acute and chronic pain using extended reality (XR). XR, namely virtual and augmented reality (VR and AR), as a nonpharmacological treatment for pain has accelerated in the last decade. VR transposes the user to an alternative real or computer-generated environment, while AR enhances an existing physical environment with additional virtual objects embedded in that real setting. XR allows users to engage completely in immersive, gamified, and interactive digital experiences. To date, no standardized approach to assessing outcomes of XR-based interventions for pain exists.
Objective:
Our aim was to recommend a core set of outcome measures for pediatric and adult acute and chronic pain XR intervention trials.
Methods:
In the first phase we conducted two systematic reviews on XR in acute and chronic pain trials in (1) pediatrics and (2) adults, respectively, to identify the most common core outcome domains assessed. These data then informed the second phase, a Delphi survey of clinicians and researchers using XR for pain treatment. In the third phase, a two day in person meeting was held to reach consensus on recommended outcome domains for adult and pediatric acute and chronic pain XR clinical trials. This was followed by a second round of the Delphi survey to broaden consensus.
Results:
By unanimous vote, pain severity, adverse events, user experience, and psychological constructs were identified as mandatory domains to be assessed in all trials for acute and chronic pain, with the addition of pain interference for chronic pain trials. Physiological markers and physical function were deemed important to consider but optional domains. Additional emerging areas for future research did not obtain sufficient support in the consensus process but were noted.
Conclusions:
Future work is underway to provide recommendations for appropriate validated measures to assess each established outcome domain.
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