Evidence map›Paper›PMID 39856145›Full record

ReviewNPJ digital medicine2025

V3+ extends the V3 framework to ensure user-centricity and scalability of sensor-based digital health technologies.

Jessie P Bakker, Roland Barge, Jacob Centra, Bryan Cobb, Chas Cota, Christine C Guo, Bert Hartog, Nathalie Horowicz-Mehler, Elena S Izmailova, Nikolay V Manyakov and 13 more

Abstract readReview
In one paragraph

Review in NPJ digital medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
–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

29 citing papers in PubMed.

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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

23 authors.

Jessie P BakkerDigital Medicine Society, Boston, MA, USA. jessie.bakker@dimesociety.org.ORCID http://orcid.org/0000-0002-2976-4747
Roland BargeRegeneron Pharmaceuticals Inc, New York, NY, USA.ORCID http://orcid.org/0009-0006-9762-4769
Jacob CentraDigital Medicine Society, Boston, MA, USA.ORCID http://orcid.org/0009-0009-6691-7923
Bryan CobbGenentech, South San Francisco, CA, USA.ORCID http://orcid.org/0000-0001-7147-8720
Chas CotaStel Life Inc, Philadelphia, PA, USA.
Christine C GuoActiGraph LLC, Pensacola, FL, USA.ORCID http://orcid.org/0000-0003-1530-0172
Bert HartogJohnson & Johnson Innovative Medicine, Breda, The Netherlands.ORCID http://orcid.org/0000-0002-6631-2379
Nathalie Horowicz-MehlerExponent Inc, New York, NY, USA.ORCID http://orcid.org/0009-0005-7593-9869
Elena S IzmailovaKoneksa Health, New York, NY, USA.ORCID http://orcid.org/0000-0002-7150-1748
Nikolay V ManyakovJohnson & Johnson Innovative Medicine, Beerse, Belgium.ORCID http://orcid.org/0000-0001-9037-1400
Samantha McClenahanDigital Medicine Society, Boston, MA, USA.ORCID http://orcid.org/0000-0002-1792-9700
Stéphane MotolaSysnav Healthcare, Vernon, France.ORCID http://orcid.org/0009-0007-0416-6461
Smit PatelDigital Medicine Society, Boston, MA, USA.ORCID http://orcid.org/0000-0002-9186-0430
Oana PaunAARDEX Group, Liège, Belgium.ORCID http://orcid.org/0009-0007-1418-5850
Marian SchooneNetherlands Organisation for Applied Scientific Research (TNO), Leiden, The Netherlands.ORCID http://orcid.org/0000-0002-6604-5506
Emre SezginNationwide Children's Hospital, Columbus, OH, USA.ORCID http://orcid.org/0000-0001-8798-9605
Thomas SwitzerGenentech, South San Francisco, CA, USA.ORCID http://orcid.org/0009-0004-4998-6453
Animesh TandonDepartment of Heart, Vascular, and Thoracic, Division of Cardiology and Cardiovascular Medicine, Children's Institute, Cleveland Clinic Children's, Cleveland, OH, USA.ORCID http://orcid.org/0000-0001-9769-8801
Willem van den BrinkNetherlands Organisation for Applied Scientific Research (TNO), Leiden, The Netherlands.ORCID http://orcid.org/0000-0002-4493-2382
Srinivasan VairavanJohnson & Johnson Innovative Medicine, New Brunswick, NJ, USA.ORCID http://orcid.org/0000-0001-7975-8436
Benjamin VandendriesscheDigital Medicine Society, Boston, MA, USA.ORCID http://orcid.org/0000-0003-0672-0327
Bernard VrijensAARDEX Group, Liège, Belgium.ORCID http://orcid.org/0000-0002-9090-1253
Jennifer C GoldsackDigital Medicine Society, Boston, MA, USA.ORCID http://orcid.org/0000-0003-0461-0183

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We propose the addition of usability validation to the extended V3 framework, now "V3+", and describe a pragmatic approach to ensuring that sensor-based digital health technologies can be used optimally at scale by diverse users. Alongside the original V3 components (verification; analytical validation; clinical validation), usability validation will ensure user-centricity of digital measurement tools, paving the way for more inclusive, reliable, and trustworthy digital measures within clinical research and clinical care.

Identifiers

PMID39856145
PMCPMC11760348

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

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.