Development of a core outcome set for clinical trials of extended reality for pain

The number of clinical trials of extended reality (XR), including virtual and augmented reality, for pain has exponentially increased in the past 2 decades. To synthesize findings across studies and assess the effectiveness of XR interventions, a core outcome set (COS) is needed. Prior work identified 7 core outcome domains for XR trials in pain through a systematic review and consensus process.

The aim of this study was to establish a finalized COS of outcome measures (adult and pediatric) for XR trials for pain (acute, recurrent, and chronic).

First, potential outcome measures were identified for each core domain through literature reviews. Second, a Delphi study was conducted with experts who rated suitability of each measure. Third, an expert consensus conference (including clinicians, researchers, and people with lived experience) was held to review the measurement properties of each candidate measure and to vote on a final COS of measures for XR.

A total of 52 experts participated in the Delphi survey and 15 attended the consensus conference. Among participants, 8 (52%) specialised in pediatric populations, 5 (33%) in adult populations, and 2 (15%) across the lifespan. Within each outcome domain, 2 to 4 measures with the highest rated suitability were selected as candidates. Consensus was achieved on a final COS consisting of 10 measures for pediatric trials and 8 for adult trials.

This is a promising and necessary step to advance the field of XR pain research and better understand the effectiveness of XR for pain.