Diagnostic Errors in Sepsis: A Systematic Review of the Literature

Background/Objectives: Sepsis is a major cause of hospitalization and mortality which may be prevented with early diagnosis. This systematic review aims to evaluate the literature on diagnostic errors in sepsis. Methods: We conducted a systematic review to evaluate the rate and outcomes of diagnostic errors in sepsis. We searched MEDLINE and EMBASE in September 2026 for studies that evaluated diagnostic errors in sepsis. Data were extracted into tables and narratively synthesized. Results: Twenty-six studies involving 868,057 patients diagnosed with sepsis were included. Definitions of diagnostic error varied and included misdiagnosis, missed diagnosis, delayed diagnosis, failure of recognition systems, and overdiagnosis. Among adults, reported rates of diagnostic error ranged from 0.6% to 86.2%, depending on the definition used. Misdiagnosis of infection source occurred in 11.6% of patients, sepsis misdiagnosis rates ranged from 8.3% to 25.3% in most cohorts, and delayed recognition ranged from 20.0% to 72.9%. In pediatric studies, missed or delayed sepsis occurred in 2.9% to 16.9% of patients. Diagnostic error was associated with delayed antibiotic administration, increased illness severity, longer hospitalization, and higher intensive care utilization. However, findings regarding mortality were inconsistent, with several studies reporting no significant association after adjustment. In children, missed sepsis was associated with increased risk of intensive care admission, but no difference in mortality. Conclusions: Diagnostic error in sepsis is common and variably defined across studies. Evidence linking diagnostic error to mortality and intensive care admission is inconsistent; however, diagnostic error is frequently associated with delayed treatment.