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

Catherine S. O'Neal, 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.
Diana Hamer, 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.
Mandi W. Musso, 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.
Terrell S. Caffery, 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.
Morgan K. Walker, National Institutes of Health, Bethesda, MD, USA.
Katherine W. Lavie, 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.
Matthew S. Berlinger, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Christopher B. Thomas, 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.
Shannon M. Alwood, 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.
Tonya Jagneaux, 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.
Michael A. Sanchez, Louisiana State University Health Sciences Center, Internal Medicine Residency Program, Baton Rouge, LA, USA; Baton Rouge General Medical Center, Baton Rouge, LA, USA.
Hollis R. O'Neal, 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.

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.