Introduction: Consensus criteria for pediatric severe sepsis have standardized enrollment for research studies.
However, the extent to which critically ill children identified by consensus criteria reflect physician diagnosis of
severe sepsis, which underlies external validity for pediatric sepsis research, is not known. We sought to determine
the agreement between physician diagnosis and consensus criteria to identify pediatric patients with severe sepsis
across a network of international pediatric intensive care units (PICUs).
Methods: We conducted a point prevalence study involving 128 PICUs in 26 countries across 6 continents. Over
the course of 5 study days, 6925 PICU patients <18 years of age were screened, and 706 with severe sepsis defined
either by physician diagnosis or on the basis of 2005 International Pediatric Sepsis Consensus Conference consensus
criteria were enrolled. The primary endpoint was agreement of pediatric severe sepsis between physician diagnosis
and consensus criteria as measured using Cohen’s κ. Secondary endpoints included characteristics and clinical
outcomes for patients identified using physician diagnosis versus consensus criteria.
Results: Of the 706 patients, 301 (42.6 %) met both definitions. The inter-rater agreement (κ ± SE) between physician
diagnosis and consensus criteria was 0.57 ± 0.02. Of the 438 patients with a physician’s diagnosis of severe sepsis, only
69 % (301 of 438) would have been eligible to participate in a clinical trial of pediatric severe sepsis that enrolled
patients based on consensus criteria. Patients with physician-diagnosed severe sepsis who did not meet consensus
criteria were younger and had lower severity of illness and lower PICU mortality than those meeting consensus criteria
or both definitions. After controlling for age, severity of illness, number of comorbid conditions, and treatment in
developed versus resource-limited regions, patients identified with severe sepsis by physician diagnosis alone or by
consensus criteria alone did not have PICU mortality significantly different from that of patients identified by both
physician diagnosis and consensus criteria.
Conclusions: Physician diagnosis of pediatric severe sepsis achieved only moderate agreement with consensus criteria,
with physicians diagnosing severe sepsis more broadly. Consequently, the results of a research study based on
consensus criteria may have limited generalizability to nearly one-third of PICU patients diagnosed with severe sepsis.
