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

被引：5

作者：

Whitfield, Natalie N. ^{[1
]}

Hogan, Catherine A. ^{[1
]}

Chenoweth, James ^{[2
]}

Hansen, Jonathan ^{[3
]}

Hsu, Edbert B. ^{[3
]}

Humphries, Roger ^{[4
]}

Mann, Edana ^{[3
]}

May, Larissa ^{[2
]}

Michelson, Edward A. ^{[5
]}

Rothman, Richard ^{[3
]}

Self, Wesley H. ^{[6
]}

Smithline, Howard A. ^{[7
]}

Karita, Helen Cristina Stankiewicz ^{[9
]}

Steingrub, Jay S. ^{[8
]}

Swedien, Daniel ^{[3
]}

Weissman, Alexandra ^{[10
]}

Wright, David W. ^{[11
]}

Liesenfeld, Oliver ^{[1
]}

Shapiro, Nathan I. ^{[12
]}

机构：

[1] Inflammatix Inc, Sunnyvale, CA 94085 USA

[2] Univ Calif Davis, Sch Med, Dept Emergency Med, Sacramento, CA USA

[3] Johns Hopkins Univ, Sch Med, Dept Emergency Med, Baltimore, MD USA

[4] Univ Kentucky, Coll Med, Dept Emergency Med, Lexington, KY USA

[5] Texas Tech Univ, Hlth Sci Ctr, Paul L Foster Sch Med, Dept Emergency Med, El Paso, TX 79905 USA

[6] Vanderbilt Univ, Med Ctr, Dept Emergency Med, Nashville, TN USA

[7] Univ Massachusetts, Chan Med Sch Baystate, Dept Emergency Med, Springfield, MA USA

[8] Univ Massachusetts, Chan Med Sch Baystate, Dept Med, Springfield, MA USA

[9] Univ Calif San Francisco, Dept Med, San Francisco, CA USA

[10] Univ Pittsburgh, Sch Med, Dept Emergency Med, Pittsburgh, PA USA

[11] Emory Univ, Sch Med, Dept Emergency Med, Atlanta, GA USA

[12] Beth Israel Deaconess Med Ctr, Emergency Med, Boston, MA 02215 USA

来源：

DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE | 2024年 / 110卷 / 01期

关键词：

Adjudication; Clinical; Bacterial; Viral; BACTERIAL; IDENTIFICATION; AGREEMENT; SKIN;

D O I：

10.1016/j.diagmicrobio.2024.116382

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

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.

引用

页数：8

共 35 条

[1] A Novel 29-Messenger RNA Host-Response Assay From Whole Blood Accurately Identifies Bacterial and Viral Infections in Patients Presenting to the Emergency Department With Suspected Infections: A Prospective Observational Study* [J].