Evidence map›Paper›PMID 41952794›Full record

ArticleJournal of the American College of Emergency Physicians open2026

Impact of a Cellular Host-Response Sepsis Diagnostic on Clinical Decision Making in the Emergency Department: A Vignette-Based Study.

Roya Sheybani, Hollis R O'Neal, Christopher B Thomas, Robert Scoggins, Christopher Pfaff, Howard Smithline, Donna M Wolk, Eric Melnychuk, Tom P Aufderheide, Thomas Carver and 3 more

Abstract read
In one paragraph

Article in Journal of the American College of Emergency Physicians open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

13 authors.

Roya SheybaniCytovale, Inc, San Francisco, California, USA.
Hollis R O'NealOur Lady of the Lake Regional Medical Center, Baton Rouge, Louisiana, USA.
Christopher B ThomasFranciscan Missionaries of Our Lady Health System, Baton Rouge, Louisiana, USA.
Robert ScogginsKootenai Health, Coeur d'Alene, Idaho, USA.
Christopher PfaffCytovale, Inc, San Francisco, California, USA.
Howard SmithlineDepartment of Emergency Medicine, Baystate Medical Center, University of Massachusetts, Springfield, Massachusetts, USA.
Donna M WolkGeisinger Medical Center Danville, Danville, Pennsylvania, USA.
Eric MelnychukGeisinger Medical Center Danville, Danville, Pennsylvania, USA.
Tom P AufderheideDepartment of Emergency Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Thomas CarverDivision of Trauma and Critical Care Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Matthew ChinnDepartment of Emergency Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Nathan A LedeboerDepartment of Pathology and Laboratory Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Chadd K KrausDepartment of Emergency and Hospital Medicine, at Lehigh Valley Health Network, Allentown, Pennsylvania, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives: Sepsis is a complex pathogen-host interaction that traditional laboratories do not easily detect. A test that rapidly assesses immune dysregulation could improve early diagnosis and clinical decision making. This study evaluates ease of application of a new host-response sepsis diagnostic test (IntelliSep; Cytovale, Inc) and its ability to affect decision making, risk stratification, and diagnostic efficacy in the emergency department (ED). Methods: This was a case vignette-based, randomized, multisite decision-impact study. We conducted the study with ED clinicians from 3 health care institutions, selected among the 5 participating institutions from a previous observational study. Participants were ED-attending physician/fellows, residents, and advanced practice clinicians. The study excluded interns. Finally, 13 clinicians at site 1, 28 at site 2, and 11 at site 3 (total, n = 52) were included. The study used retrospectively de-identified data from patient cases to generate 100 case vignettes. Each participant reviewed 10 cases with IntelliSep results and 10 cases without. Results: The study assessed outcomes including impact of the test results on clinical decision making, confidence in decision, and diagnostic accuracy. The test supported or changed/augmented clinician decisions in 86% of cases. The presence of the test significantly increased the proportion of raters with high confidence in their ratings (from 53.1% without, to 63.1% with). Additionally, diagnostic accuracy increased, with a notable increase in sensitivity for critical bands, from 73.1% without the test to 82.8% with it (95% CI, 63.5-81.3 vs 74.6-89.1); this increase was not statistically significant ( Conclusion: This paper-based study demonstrates that the IntelliSep host-response sepsis test results could impact clinician decisions and may improve the quality of clinical decision making.

Indexed as

clinician confidencedecision impactemergency departmentimmune dysregulationsepsis diagnosis

Identifiers

PMID41952794
PMCPMC13054420

What OpenQuestion holds

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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.