Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Sep;110(1):116382.
doi: 10.1016/j.diagmicrobio.2024.116382. Epub 2024 May 31.

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

Natalie N Whitfield  1 , Catherine A Hogan  2 , James Chenoweth  3 , Jonathan Hansen  4 , Edbert B Hsu  4 , Roger Humphries  5 , Edana Mann  4 , Larissa May  3 , Edward A Michelson  6 , Richard Rothman  4 , Wesley H Self  7 , Howard A Smithline  8 , Helen Cristina Stankiewicz Karita  9 , Jay S Steingrub  10 , Daniel Swedien  4 , Alexandra Weissman  11 , David W Wright  12 , Oliver Liesenfeld  2 , Nathan I Shapiro  13
Affiliations

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

Natalie N Whitfield et al. Diagn Microbiol Infect Dis. 2024 Sep.

Abstract

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.

Keywords: Adjudication; Bacterial; Clinical; Viral.

PubMed Disclaimer

Conflict of interest statement

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.

Associated data