A standardized protocol using clinical adjudication to define true infection status in patients presenting to the emergency department with suspected infections and/or sepsis.

Autor: Whitfield NN; Inflammatix, Inc., Sunnyvale, California, USA. Electronic address: nwhitfield@inflammatix.com., Hogan CA; Inflammatix, Inc., Sunnyvale, California, USA., Chenoweth J; Department of Emergency Medicine, University of California-Davis School of Medicine, Sacramento, California, USA., Hansen J; Department of Emergency Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Hsu EB; Department of Emergency Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Humphries R; Department of Emergency Medicine, University of Kentucky College of Medicine, Lexington, Kentucky, USA., Mann E; Department of Emergency Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., May L; Department of Emergency Medicine, University of California-Davis School of Medicine, Sacramento, California, USA., Michelson EA; Paul L. Foster School of Medicine, Texas Tech University Health Sciences Center, Department of Emergency Medicine, El Paso, Texas, USA., Rothman R; Department of Emergency Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Self WH; Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee., Smithline HA; Department of Emergency Medicine, University of Massachusetts Chan Medical School - Baystate, Springfield, Massachusetts, USA., Karita HCS; Department of Medicine, University of California, San Francisco., Steingrub JS; Department of Critical Care Medicine, University of Massachusetts Chan Medical School - Baystate, Springfield, Massachusetts, USA., Swedien D; Department of Emergency Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Weissman A; Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA., Wright DW; Department of Emergency Medicine, Emory University School of Medicine, Atlanta, Georgia., Liesenfeld O; Inflammatix, Inc., Sunnyvale, California, USA., Shapiro NI; Beth Israel Deaconess Medical Center, Emergency Medicine, Boston, Massachusetts, USA.
Jazyk: angličtina
Zdroj: Diagnostic microbiology and infectious disease [Diagn Microbiol Infect Dis] 2024 Sep; Vol. 110 (1), pp. 116382. Date of Electronic Publication: 2024 May 31.
DOI: 10.1016/j.diagmicrobio.2024.116382
Abstrakt: In absence of a "gold standard", a standardized clinical adjudication process was developed for a registrational trial of a transcriptomic host response (HR) test. Two physicians independently reviewed clinical data to adjudicate presence and source of bacterial and viral infections in emergency department patients. Discordant cases were resolved by a third physician. Agreement among 955 cases was 74.1% (708/955) for bacterial, 75.6% (722/955) for viral infections, and 71.2% (680/955) overall. Most discordances were minor (85.2%; 409/480) versus moderate (11.7%; 56/480) or complete (3.3%; 16/480). Concordance levels were lowest for bacterial skin and soft tissue infections (8.2%) and for viral respiratory tract infections (4.5%). This robust adjudication process can be used to evaluate HR tests and other diagnostics by regulatory agencies and for educating clinicians, laboratorians, and clinical researchers. Clinicaltrials.gov NCT04094818. SUMMARY: Without a gold standard for evaluating host response tests, clinical adjudication is a robust reference standard that is essential to determine the true infection status in diagnostic registrational clinical studies.
Competing Interests: Declaration of competing interest NNW and OL: The authors are employees and stock option holders of Inflammatix, Inc. CH: The author is a consultant of Inflammatix, Inc. JC: The author has no conflicts of interest to disclose. LM: The author has received honoraria from Inflammatix, Inc. and Thermofisher and was a consultant to Cytovale. She is an advisor for Roche, Biomerieux, and Talis Biomedical. JH: The author has served as a consultant to Beckman Coulter on the use of Artificial Intelligence tools in the practice of emergency medicine. EBH: The author has no conflicts of interest to disclose. EM: The author has no conflicts of interest to disclose. RR: The author has received research funding through his University from Inflammatix, Inc. and has served as a paid scientific expert advisor to Inflammatix, Inc. DS: The author has no conflicts of interest to disclose. RH: The author has no conflicts of interest to disclose. EAM: The author has received research funding from Inflammatix, Inc. WHS: The author has received research funding from Inflammatix, Inc. HAS: The author has no conflicts of interest to disclose. JSS: The author has no conflicts of interest to disclose. HCSK: The author has no conflicts of interest to disclose. AW: The author has served as a consultant to Inflammatix, Inc. DWW: The author has no conflicts of interest to disclose. NIS: The author has received research funding from Inflammatix, Inc, and Luminos; and served as a consultant for Diagnostic Robotics and Prenosis.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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