Cellulitis in the emergency department: Developing and testing objective outcome measures.

Abstract

Introduction. The treatment of cellulitis with intravenous antibiotics administered in Emergency Departments is a new phenomenon with significant inter-physician variation. A clinical trial will address many of the questions surrounding this practice. Previous trials have been flawed because of the absence of a validated objective outcome measure. Methods. Eligible patients with cellulitis were prospectively recruited for an observational cohort study and underwent daily measurements of their infection. These measurements were evaluated for their feasibility, inter-rater reliability and criterion validity (compared with the primary outcome of treatment failure versus clinical response; a classification based on physician treatment decisions) Results. Only the infection size and change in size over time performed well, obtaining statistical significance in all domains. Conclusions. The change in size of infection over time is a valid and reliable reflection of clinical decisions for patients with cellulitis, and should be used as the primary outcome for clinical trials of cellulitis therapy.