title: Discordant identification of pediatric severe sepsis by research and clinical definitions in the SPROUT international point prevalence study.
abstract: BACKGROUND
  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.
authors.affiliation: Division of Critical Care Medicine, Department of Anesthesia and Critical Care, The Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA. weisss@email.chop.edu.
authors.forename: Scott L
authors.initials: SL
authors.lastname: Weiss
authors.affiliation: Division of Critical Care Medicine, Department of Anesthesia and Critical Care, The Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA. fitzgeraldj@email.chop.edu.
authors.forename: Julie C
authors.initials: JC
authors.lastname: Fitzgerald
authors.affiliation: Division of Pediatric Critical Care, Janet Weis Children's Hospital at Geisinger Health System, Danville, PA, USA. famaffei@geisinger.edu.
authors.forename: Frank A
authors.initials: FA
authors.lastname: Maffei
authors.affiliation: Department of Pediatrics, Section of Critical Care, University of Chicago Medicine, Comer Children's Hospital, Chicago, IL, USA. jmkanemd@gmail.com.
authors.forename: Jason M
authors.initials: JM
authors.lastname: Kane
authors.affiliation: Division of Pediatric Emergency and Critical Care, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain. antonio.rodriguez.nunez@sergas.es.
authors.forename: Antonio
authors.initials: A
authors.lastname: Rodriguez-Nunez
authors.affiliation: Division of Pediatric Critical Care Medicine, New York Presbyterian Hospital, Weill Cornell Medical School, New York, NY, USA. ddh9002@med.cornell.edu.
authors.forename: Deyin D
authors.initials: DD
authors.lastname: Hsing
authors.affiliation: Division of Critical Care Medicine, Department of Pediatrics, Lucile Packard Children's Hospital, Stanford University, Palo Alto, CA, USA. dfranzon@stanford.edu.
authors.forename: Deborah
authors.initials: D
authors.lastname: Franzon
authors.affiliation: Department of Pediatric Pulmonology, University Malaya Medical Centre, University of Malaya, Kuala Lumpur, Malaysia. sy_kee2004@icloud.com.
authors.forename: Sze Ying
authors.initials: SY
authors.lastname: Kee
authors.affiliation: Division of Critical Care Medicine, Department of Anesthesia and Critical Care, The Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA. bushj1@email.chop.edu.
authors.forename: Jenny L
authors.initials: JL
authors.lastname: Bush
authors.affiliation: Center for Clinical Epidemiology and Biostatistics, Department of Biostatistics and Epidemiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA. jaroy@mail.med.upenn.edu.
authors.forename: Jason A
authors.initials: JA
authors.lastname: Roy
authors.affiliation: Division of Pediatric Critical Care Medicine, Penn State Hershey Children's Hospital, Penn State University College of Medicine, Hershey, PA, USA. nthomas@hmc.psu.edu.
authors.forename: Neal J
authors.initials: NJ
authors.lastname: Thomas
authors.affiliation: Division of Critical Care Medicine, Department of Anesthesia and Critical Care, The Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA. nadkarni@email.chop.edu.
authors.forename: Vinay M
authors.initials: VM
authors.lastname: Nadkarni
mesh_terms: D000293:Adolescent; D035843:Biomedical Research / Q000592:standards; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D015588:Observer Variation; D010818:Practice Patterns, Physicians'; D015995:Prevalence; D018805:Sepsis / Q000175:diagnosis* / Q000453:epidemiology / Q000401:mortality; D016896:Treatment Outcome