Retrospective identification of infection in the emergency department: A significant challenge in sepsis clinical trials

Catherine S O'Neal; Diana Hamer; Mandi W Musso; Terrell S Caffery; Morgan K Walker; Katherine W Lavie; Matthew S Berlinger; Christopher B Thomas; Shannon M Alwood; Tonya Jagneaux; Michael A Sanchez; Hollis R O'Neal

doi:10.1016/j.amjms.2022.02.008

Retrospective identification of infection in the emergency department: A significant challenge in sepsis clinical trials

Am J Med Sci. 2022 Aug;364(2):163-167. doi: 10.1016/j.amjms.2022.02.008. Epub 2022 Mar 14.

Affiliations

¹ Louisiana State University Health Sciences Center, Internal Medicine Residency Program, Baton Rouge, LA, USA; Our Lady of the Lake Regional Medical Center, Baton Rouge, LA, USA. Electronic address: coneal@lsuhsc.edu.
² Louisiana State University Health Sciences Center, Internal Medicine Residency Program, Baton Rouge, LA, USA; Our Lady of the Lake Regional Medical Center, Baton Rouge, LA, USA.
³ Our Lady of the Lake Regional Medical Center, Baton Rouge, LA, USA; Louisiana State University Health Sciences Center, Emergency Medicine Residency Program, Baton Rouge, LA, USA.
⁴ National Institutes of Health, Bethesda, MD, USA.
⁵ Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.
⁶ Louisiana State University Health Sciences Center, Internal Medicine Residency Program, Baton Rouge, LA, USA; Our Lady of the Lake Regional Medical Center, Baton Rouge, LA, USA; Baton Rouge General Medical Center, Baton Rouge, LA, USA.
⁷ Louisiana State University Health Sciences Center, Internal Medicine Residency Program, Baton Rouge, LA, USA; Baton Rouge General Medical Center, Baton Rouge, LA, USA.

PMID: 35300978
DOI: 10.1016/j.amjms.2022.02.008

Abstract

Background: This study examined three methods for retrospectively identifying infection in emergency department (ED) patients: modified objective definitions of infection (MODI) from the CDC/NHSN, physician adjudication determination of infection, and ED treating physician behavior.

Methods: This study used a subset of data from a prospective sepsis trial. We used Fleiss's Kappa to compare agreement between two physicians retrospectively adjudicating infection based on the patient's medical record, modified infection definition from the CDC/NHSN, and ED treating physician behavior.

Results: Overall, there was similar agreement between physician adjudication of infection and MODI criteria (Kappa=0.59) compared to having two physicians independently identify infection through retrospective chart review (Kappa=0.58). ED treating physician behavior was a poorer proxy for infection when compared to the MODI criteria (0.41) and physician adjudication (Kappa = 0.50).

Conclusions: Retrospective identification of infection poses a significant challenge in sepsis clinical trials. Using modified definitions of infection provides a standardized, less time consuming, and equally effective means of identifying infection compared to having multiple physicians adjudicate a patient's chart.

Keywords: Agreement; Concordance; Infection; Pneumonia; Sepsis.

MeSH terms

Clinical Trials as Topic
Emergency Service, Hospital*
Humans
Prospective Studies
Retrospective Studies
Sepsis* / diagnosis