Evidence map›Paper›PMID 40158520›Full record

ReviewThe Lancet. Infectious diseases2025

Intention-to-diagnose and distinct research foci in diagnostic accuracy studies.

Scott R Evans, Gene Pennello, Shanshan Zhang, Yixuan Li, Yike Wang, Qian Cao, Lauren Komarow, Toshimitsu Hamasaki, Victoria Petrides, Kristen Meier and 10 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in The Lancet. Infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Recent advances in biomarkers for cardiac fibrosis.Frontiers in cardiovascular medicine · 2026
    Review
  4. Article
  5. 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

20 authors.

Scott R EvansThe Biostatistics Center, George Washington University, Rockville, MD, USA; Department of Biostatistics, Milken Institute School of Public Health, George Washington University, Rockville, MD, USA. Electronic address: sevans@bsc.gwu.edu.
Gene PennelloCenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA.
Shanshan ZhangThe Biostatistics Center, George Washington University, Rockville, MD, USA; Department of Biostatistics, Milken Institute School of Public Health, George Washington University, Rockville, MD, USA.
Yixuan LiThe Biostatistics Center, George Washington University, Rockville, MD, USA.
Yike WangThe Biostatistics Center, George Washington University, Rockville, MD, USA; Department of Biostatistics, Milken Institute School of Public Health, George Washington University, Rockville, MD, USA.
Qian CaoCenter for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA.
Lauren KomarowThe Biostatistics Center, George Washington University, Rockville, MD, USA.
Toshimitsu HamasakiThe Biostatistics Center, George Washington University, Rockville, MD, USA; Department of Biostatistics, Milken Institute School of Public Health, George Washington University, Rockville, MD, USA.
Victoria PetridesAbbott, Abbott Park, IL, USA.
Kristen MeierSilver Spring, MD, USA.
Norberto Pantoja GaliciaFoundation Medicine, Boston, MA, USA.
Vance G FowlerDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA; Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
Helen W BoucherTufts University School of Medicine, Boston, MA, USA; Tufts Medicine, Boston, MA, USA.
Sarah B DoernbergDivision of Infectious Diseases, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.
Ritu BanerjeeDivision of Pediatric Infectious Diseases, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, USA.
Maria Helena RigattoMedical Sciences Post-Graduation Program, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil; Department of Internal Medicine, Medical School, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil; Infectious Diseases Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Barry N KreiswirthCenter for Discovery and Innovation, Hackensack Meridian Health, Nutley, NJ, USA.
Robert A BonomoDepartment of Medicine, Case Western Reserve University School of Medicine, Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, OH, USA; Case Western Reserve University VA Center for Antimicrobial Resistance and Epidemiology (Case VA CARES), Research Service, Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, OH, USA; Department of Pharmacology, Case Western Reserve University School of Medicine, Cleveland, OH, USA; Department of Molecular Biology and Microbiology, Case Western Reserve University School of Medicine, Cleveland, OH, USA; Department of Biochemistry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Henry F ChambersDivision of Infectious Diseases, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.
Robin PatelDivision of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA; Division of Public Health, Infectious Diseases, and Occupational Medicine, Department of Medicine, Mayo Clinic, Rochester, MN, USA.

Funding

Antibacterial Resistance Leadership Group (ARLG)UM1AI104681 · NIAID · DUKE UNIVERSITY · PI Vance G. Fowler, Henry F HENRY CHAMBERS · 2013 to 2026
$180.8M
NIAID NIH HHS UM1 AI104681
6 · The paper itself

Abstract

The intention-to-diagnose principle, an analogue to the intention-to-treat principle in clinical trials, protects the foundation for inference in diagnostic test accuracy studies. This foundation provides for robust control of error rates during hypothesis testing and correct coverage probability during confidence interval estimation of accuracy parameters, in well defined populations for transparent generalisability. The intention-to-diagnose principle requires distinguishing between various non-positive non-negative (NPNN) test results, such as equivocal and invalid results, and appropriate handling of these distinct results during statistical analyses. Pragmatic application accuracy, pragmatic scientific accuracy, and explanatory scientific accuracy are three major research foci in studies of diagnostic test accuracy. Selection of appropriate analysis sets and appropriate handling of NPNN results depend on the specific focus. Selection has important implications regarding preservation of the foundation for statistical inference, generalisability, and comparability with results from other studies. We recommended analyses for diagnostic accuracy studies that include the estimation of accuracy parameters associated with each research foci. A free online tool is available to estimate these accuracy parameters. As with dedicated commitment to the intention-to-treat principle in clinical trials, commitment to application of the intention-to-diagnose principle will lead to studies with high integrity, a comprehensive understanding of the scientific and administration characteristics of the diagnostic test, clarity of interpretation and generalisability, and better clinical decision making.

Indexed as

Diagnostic Tests, RoutineIntention to Treat AnalysisResearch DesignHumans

Identifiers

PMID40158520
PMCPMC13592427

What OpenQuestion holds

Textmetadata
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.