A standardized protocol using clinical adjudication to define true infection status in patients presenting to the emergency department with suspected infections and/or sepsis
Author Department
Emergency Medicine; Pulmonary/Critical Care Medicine
Document Type
Article, Peer-reviewed
Publication Date
5-2024
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.
Recommended Citation
Whitfield NN, Hogan CA, Chenoweth J, Hansen J, Hsu EB, Humphries R, Mann E, May L, Michelson EA, Rothman R, Self WH, Smithline HA, Karita HCS, Steingrub JS, Swedien D, Weissman A, Wright DW, Liesenfeld O, Shapiro NI. A standardized protocol using clinical adjudication to define true infection status in patients presenting to the emergency department with suspected infections and/or sepsis. Diagn Microbiol Infect Dis. 2024 May 31;110(1):116382. doi: 10.1016/j.diagmicrobio.2024.116382. Epub ahead of print.
PMID
38850687