Evidence map›Paper›PMID 35469355›Full record

ArticleJournal of digital imaging2022

Evaluation Challenges for the Application of Extended Reality Devices in Medicine.

Ryan Beams, Ellenor Brown, Wei-Chung Cheng, Janell S Joyner, Andrea S Kim, Kimberly Kontson, Dimitri Amiras, Tassilo Baeuerle, Walter Greenleaf, Rafael J Grossmann and 11 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of digital imaging, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 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

23 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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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

21 authors.

Ryan BeamsCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA. Ryan.Beams@fda.hhs.gov.ORCID 0000-0003-2592-6064
Ellenor BrownCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
Wei-Chung ChengCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
Janell S JoynerCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
Andrea S KimCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
Kimberly KontsonCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.
Dimitri AmirasDepartment of Imaging, Imperial College Healthcare NHS Trust, London, UK.
Tassilo BaeuerleCognifiSense, Inc., Sunnyvale, CA, USA.
Walter GreenleafStanford University Virtual Human Interaction Lab, Stanford University, Stanford, CA, USA.
Rafael J GrossmannNorthern Light Health, Brewer, ME, USA.
Atul GuptaPhilips, Cambridge, MA, USA.
Christoffer HamiltonBrainlab AG, Munich, Germany.
Hong HuaJames C. Wyant College of Optical Sciences, University of Arizona, Tucson, AZ, USA.
Tran Tu HuynhOpticSurg Inc., Wilmington, DE, USA.
Christoph LeuzeDepartment of Radiology, Stanford University, Stanford, CA, USA.
Sarah B MurthiR Adams Cowley Shock Trauma Center, University of Maryland Baltimore, Baltimore, MD, USA.
John PenczekNIST, Boulder, CO, USA.
Jennifer SilvaSentiAR, Inc., St Louis, MT, USA.
Brennan SpiegelDepartment of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Amitabh VarshneyDepartment of Computer Science, University of Maryland, College Park, MD, USA.
Aldo BadanoCenter for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Augmented and virtual reality devices are being actively investigated and implemented for a wide range of medical uses. However, significant gaps in the evaluation of these medical devices and applications hinder their regulatory evaluation. Addressing these gaps is critical to demonstrating the devices' safety and effectiveness. We outline the key technical and clinical evaluation challenges discussed during the US Food and Drug Administration's public workshop, "Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine" and future directions for evaluation method development. Evaluation challenges were categorized into several key technical and clinical areas. Finally, we highlight current efforts in the standards communities and illustrate connections between the evaluation challenges and the intended uses of the medical extended reality (MXR) devices. Participants concluded that additional research is needed to assess the safety and effectiveness of MXR devices across the use cases.

Indexed as

Augmented RealityMedicineVirtual RealityHumansUnited StatesAugmented realityImage qualityMedical imagingVirtual reality

Identifiers

PMID35469355
PMCPMC9582055

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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.