Abstract
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).
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.
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 (P = .06).
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.