Evidence map›Paper›PMID 40408138›Full record

ArticleJournal of medical Internet research2025

Developing a Core Outcome Set for Pediatric and Adult Acute and Chronic Pain Extended Reality Trials: Delphi Consensus-Building Process.

Courtney W Hess, Deirdre E Logan, Brittany N Rosenbloom, Giulia Mesaroli, Laura E Simons, Carley Ouellette, Cynthia Nguyen, Fahad Alam, Jennifer N Stinson

Abstract readConsensus Statement
In one paragraph

Article in Journal of medical Internet research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Courtney W Hess *Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Palo Alto, CA, United States.ORCID 0000-0001-5207-7411
Deirdre E Logan *Department of Anesthesia, Perioperative and Pain Medicine, Boston Children's Hospital, Boston, MA, United States.ORCID 0000-0002-9253-0097
Brittany N RosenbloomToronto Academic Pain Medicine Institute, Women's College Hospital, Toronto, ON, Canada.ORCID 0000-0002-5881-4045
Giulia MesaroliResearch Institute, Hospital for Sick Children, Toronto, ON, Canada.ORCID 0000-0001-6583-5082
Laura E SimonsDepartment of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine, Palo Alto, CA, United States.ORCID 0000-0002-3395-9483
Carley OuelletteSchool of Nursing, McMaster University, Hamilton, ON, Canada.ORCID 0000-0003-3242-6164
Cynthia NguyenResearch Institute, Hospital for Sick Children, Toronto, ON, Canada.ORCID 0000-0001-9741-2463
Fahad AlamDepartment of Anesthesiology & Pain Medicine, University of Toronto, Toronto, ON, Canada.ORCID 0000-0001-9300-5713
Jennifer N StinsonResearch Institute, Hospital for Sick Children, Toronto, ON, Canada.ORCID 0000-0002-9969-8052

Funding

Mentoring and Research in Biobehavioral Aspects of Pediatric PainK24AR078945 · NIAMS · STANFORD UNIVERSITY · PI LAURA E SIMONS · 2022 to 2026
$970k
Pain Rehabilitation Virtual Reality (PRVR): Innovations to enhance mobility in the presence of painR21AR079140 · NIAMS · STANFORD UNIVERSITY · PI SIMONS, LAURA E · 2021 to 2023
$552k
NIAMS NIH HHS K24 AR078945NIAMS NIH HHS R21 AR079140
6 · The paper itself

Abstract

backgroundAppropriate outcome assessment strategies and high-quality trials are critical to advancing care of patients with acute and chronic pain. Using extended reality (XR), namely, virtual and augmented reality, as a nonpharmacological treatment for pain has accelerated in the last decade. XR allows users to engage completely in immersive, gamified, sensorial digital experiences. Currently, no standardized approach to assessing outcomes of XR-based interventions for pain exists.

objectiveOur aim was to recommend a core set of outcomes for pediatric and adult acute and chronic pain XR intervention trials.

methodsTo identify core outcomes, we conducted a multiphase process. In phase 1, we conducted systematic reviews on XR in pediatric and adult acute and chronic pain trials to identify the most common core outcome domains assessed in existing published studies. Primary outcome domains were identified and informed the development of the survey for phase 2, a Delphi survey of clinicians and researchers who were actively researching or using XR for pain treatment. Together, results from the systematic reviews and Delphi survey responses were collated, and in phase 3, a 2-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 2 additional rounds of the Delphi survey to broaden consensus and refine the domains and definitions. Following the Outcome Measures in Rheumatology guidelines for consensus building, outcomes were organized into 3 categories: mandatory, important to consider but optional, and research agenda.

resultsA systematic review including XR trials for adult and pediatric acute and chronic pain was conducted in March 2023, and 90 pediatric and 104 adult studies were included. The round 1 Delphi survey, completed by 66 respondents, revealed the following commonly measured outcomes: pain intensity or quality, distraction, anxiety or fear, satisfaction, and adverse events. Respondents indicated the following domains to be of highest importance to measure in studies: safety, feasibility, and acceptability; pain intensity or quality; pain interference or functioning; emotional functioning; and user experience or immersion. By unanimous vote at the consensus conference, pain severity, adverse events, user experience, and psychological constructs were identified as mandatory domains to be assessed in all XR 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.

conclusionsAn established core outcome set will help strengthen the emerging evidence base supporting XR interventions for children and adults with pain. Future work is underway to provide recommendations for appropriate validated measures to assess each established outcome domain.

Indexed as

Acute PainChronic PainDelphi TechniqueOutcome Assessment, Health CarePain ManagementAdultChildHumansacute pain chronic painadultsaugmented realityclinical trialscore outcome setextended realityinterventionspediatricvirtual reality

Identifiers

PMID40408138
PMCPMC12144474

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.