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

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 infec-tion, 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 defini-tion 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 adjudi-cation (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 com-pared to having multiple physicians adjudicate a patient's chart.

Automated summary

This study compared three methods for retrospectively identifying infection in emergency department patients and found that using modified definitions of infection had similar agreement with physician adjudication, while emergency department treating physician behavior was less accurate.