The current definition of sepsis is life-threatening, acute organ dysfunction secondary to a dysregulated host response to infection. Criteria to operationalize this definition can be judged by six domains of usefulness (reliability, content, construct and criterion validity, measurement burden, and timeliness). The relative importance of these six domains depends on the intended purpose for the criteria (clinical care, basic and clinical research, surveillance, or quality improvement [QI] and audit). For example, criteria for clinical care should have high content and construct validity, timeliness, and low measurement burden to facilitate prompt care. Criteria for surveillance or QI/audit place greater emphasis on reliability across individuals and sites and lower emphasis on timeliness. Criteria for clinical trials require timeliness to ensure prompt enrollment and reasonable reliability but can tolerate high measurement burden. Basic research also tolerates high measurement burden and may not need stability over time. In an illustrative case study, we compared examples of criteria designed for clinical care, surveillance and QI/audit among 396,241 patients admitted to 12 academic and community hospitals in an integrated health system. Case rates differed four-fold and mortality three-fold. Predictably, clinical care criteria, which emphasized timeliness and low burden and therefore used vital signs and routine laboratory tests, had the greater case identification with lowest mortality. QI/audit criteria, which emphasized reliability and criterion validity, used discharge information and had the lowest case identification with highest mortality. Using this framework to identify the purpose and apply domains of usefulness can help with the evaluation of existing sepsis diagnostic criteria and provide a roadmap for future work.
1The Clinical Research, Investigation, and Systems Modeling of Acute illness (CRISMA) Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.
2Department of Surgery, Emory University School of Medicine, Atlanta, GA.
3Hofstra-North Shore-LIJ School of Medicine, Cohen Children’s Medical Center, New Hyde Park, NY.
4Office of Quality and Patient Safety, New York State Health Department, Albany, NY.
5Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA; Department of Medicine, Brigham and Women’s Hospital, Boston, MA.
6Division of Pulmonary and Critical Care Medicine, Brown University School of Medicine, Providence, RI.
7Department of Critical Care, Division of Pulmonary, Allergy, and Critical Care Medicine, Emory University School of Medicine, Atlanta, GA.
8Departments of Surgery and Emergency Medicine, Washington University School of Medicine, St. Louis, MO.
9Department of Medicine, Infectious Diseases, Washington University School of Medicine, St. Louis, MO.
10Department of Pediatrics, Pediatric Critical Care Medicine, University of Washington and Center for Child Health Behavior and Development, Seattle Children’s Research Institute, Seattle, WA.
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Drs. Seymour and Angus were supported in part by grants from the National Institutes of Health (NIH) (GM104022, GM107650, and HL123020). Dr. Seymour received support for article research from the NIH and received funding from Beckman Coulter (personal fees). His institution received funding from NIH. Dr. Coopersmith disclosed receiving other support (He was the president of the Society of Critical Care Medicine [SCCM] when the manuscript was submitted. Salary support for effort was paid to Emory University for this position. He receives grant support from the NIH paid to Emory University unrelated to this paper. He also receives salary support from the Centers for Disease Control and Prevention [CDC] related to sepsis surveillance). Dr. Deutschman disclosed receiving other support (Northern Ireland Society of Critical Care Medicine, International Sepsis Forum, Stanford University Department of Anesthesia, ADQI, European Society of Intensive Care Medicine, and the NYU Department of Medicine) and he received funding from the CDC (hotel and travel expenses, per diem), World Federation of Critical Care Societies, Pennsylvania Assembly of Critical Care Medicine, and SCCM. Dr. Klompas’ institution received funding from the CDC. Dr. Levy’s institution received grant support from ImmuneExpress (Gene Analysis for Early Identification of Sepsis). Dr. Martin received support for article research from the NIH and received funding from CR Bard and Medscape. His institution received funding from the CDC, NIH, FDA, and Baxter Healthcare. Dr. Osborn’s institution received funding from Cheetah Inc. and ImaCor. Dr. Warren received funding from Novaerus, Inc (consultant) and from Worrell Inc. (consultant). Dr. Watson disclosed receiving other support (University of Washington and University of Pittsburgh UPMC), received funding from the CDC (paid for travel to a meeting to discuss sepsis monitoring), and received funding from SCCM and the Seattle Children's Hospital. His institution received funding from the NIH/NICHD. The remaining authors have disclosed that they do not have any potential conflicts of interest.
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