Application of a Framework to Assess the Usefulness of Alternative Sepsis Criteria

• Type of Material: Article
• Authors: Christopher W. Seymour, University of Pittsburgh; Craig Coopersmith, Emory University; Clifford S Deutschman, Hofstra-North Shore-LIJ School of Medicine; Foster Gesten, New York State Health Department; Michael Klompas, Harvard Medical School; Mitchell Levy, Brown University; Gregory Martin, Emory University; Tiffany M. Osborn, Washington University; Chanu Rhee, Harvard Medical School; David Warren, University of Washington; R. Scott Watson, Seattle Children’s Research Institute and University of Washington; Derek C. Angus, University of Pittsburgh
• Language: English
• Date: 2016-03-01
• Publisher: Lippincott, Williams & Wilkins
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2016 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc.
• Final Published Version (URL): http://dx.doi.org/10.1097/CCM.0000000000001724
• Title of Journal or Parent Work: Critical Care Medicine
• ISSN: 0090-3493
• Volume: 44
• Issue: 3
• Start Page: E122
• End Page: E130
• Grant/Funding Information: Drs. Seymour and Angus were supported in part by grants from the National Institutes of Health (GM104022, GM107650, and HL123020).
• Keywords: General & Internal Medicine; MORTALITY; diagnosis; validity; reliability; UNITED-STATES; SEVERITY; PROGRAM; measurement; CARE; Science & Technology; SEPTIC SHOCK; sepsis; ACCESS; SYSTEM; DEFINITION; diagnostic criteria; Life Sciences & Biomedicine; Critical Care Medicine; RESPIRATORY-DISTRESS-SYNDROME; definitions
• Research Categories: Health Sciences, Health Care Management; Health Sciences, Medicine and Surgery

Abstract

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.