Evidence map›Paper›PMID 41787064›Full record

ArticleNPJ digital medicine2026

Clarifying validation terminologies in healthcare.

Amanda Dy, Sandra M Buetow, Andrew J Bredemeyer, Monika Lamba Saini, Fabienne Lucas, Shannon Bennett, Kim R M Blenman, Keith Wharton, Sunil Singhal, M E de Baca and 10 more

Abstract read
In one paragraph

Article in NPJ digital medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

20 authors.

Amanda DyElectrical, Computer, and Biomedical Engineering, Toronto Metropolitan University, Toronto, ON, Canada.
Sandra M BuetowRobert Koch Institute, Berlin, Germany.
Andrew J Bredemeyer
Monika Lamba SainiADC Therapeutics, Imperial College White City, London, UK.
Fabienne LucasUniversity of Washington, Seattle, WA, USA.
Shannon BennettMayo Clinic, Rochester, MN, USA.
Kim R M BlenmanYale School of Medicine, New Haven, CT, USA.
Keith WhartonRoche Diagnostics, Oro Valley, AZ, USA.
Sunil SinghalSynergess LLC, Tampa, FL, USA.
M E de BacaSysmex America Inc., Lincolnshire, IL, USA.
Kevin SchapCollege of American Pathologists, Northfield, IL, USA.
Matthew G HannaUniversity of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Staci J KearneyElevation Strategic Development, Morrison, CO, USA.
Norman ZerbeCharité, Universitätsmedizin Berlin, Berlin, Germany.
Roberto SalgadoDepartment of Pathology, ZAS Hospitals, Antwerp, Belgium.
Jithesh VeetilMedical Device Innovation Consortium, Arlington, VA, USA.
Jansen N SeheultMayo Clinic, Rochester, MN, USA.
David S McClintockMayo Clinic, Rochester, MN, USA.
April KhademiElectrical, Computer, and Biomedical Engineering, Toronto Metropolitan University, Toronto, ON, Canada.
Jochen K LennerzBostonGene Corporation, Waltham, MA, USA. JoeLennerz@gmail.com.

Funding

Bundesministerium für Gesundheit 2523DAT400Natural Sciences and Engineering Research Council of Canada (NSERC) Vanier Canada Graduate Scholarship 198875
6 · The paper itself

Abstract

Validation is a cornerstone of reliability and trust in diagnostics, yet discipline-specific assumptions and unspoken contextual differences often lead to miscommunication, misalignment, and avoidable delays. As AI/ML becomes more integrated into healthcare, there is a growing necessity to re-examine how the term validation is used and understood. We highlight inconsistencies in the use of the term validation through an analysis of 94 themes across five domains, including Communication Science (n = 12), AI/ML (n = 26), Clinical and Laboratory Practice (n = 19), Regulatory Science (n = 22), and Business (n = 15). We emphasize how persistent reliance on domain-specific implied definitions impedes interdisciplinary alignment. Rather than advocating for a single definition, we derived five consensus proposals that collectively advocate for more specific and context-aware additions to the term validation to support clarity, reliability, and compliance across disciplines. Our goal is to support clearer communication and provide useful strategies that inform the development, regulation, and use of digital health technologies.

Identifiers

PMID41787064
PMCPMC13079824

What Socratic holds

Textmetadata
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 Socratic graph.