title: A Framework for the Development and Interpretation of Different Sepsis Definitions and Clinical Criteria.
abstract: Although sepsis was described more than 2,000 years ago, and clinicians still struggle to define it, there is no "gold standard," and multiple competing approaches and terms exist. Challenges include the ever-changing knowledge base that informs our understanding of sepsis, competing views on which aspects of any potential definition are most important, and the tendency of most potential criteria to be distributed in at-risk populations in such a way as to hinder separation into discrete sets of patients. We propose that the development and evaluation of any definition or diagnostic criteria should follow four steps: 1) define the epistemologic underpinning, 2) agree on all relevant terms used to frame the exercise, 3) state the intended purpose for any proposed set of criteria, and 4) adopt a scientific approach to inform on their usefulness with regard to the intended purpose. Usefulness can be measured across six domains: 1) reliability (stability of criteria during retesting, between raters, over time, and across settings), 2) content validity (similar to face validity), 3) construct validity (whether criteria measure what they purport to measure), 4) criterion validity (how new criteria fare compared to standards), 5) measurement burden (cost, safety, and complexity), and 6) timeliness (whether criteria are available concurrent with care decisions). The relative importance of these domains of usefulness depends on the intended purpose, of which there are four broad categories: 1) clinical care, 2) research, 3) surveillance, and 4) quality improvement and audit. This proposed methodologic framework is intended to aid understanding of the strengths and weaknesses of different approaches, provide a mechanism for explaining differences in epidemiologic estimates generated by different approaches, and guide the development of future definitions and diagnostic criteria.
authors.affiliation: 1Department of Critical Care Medicine, The Clinical Research, Investigation, and Systems Modeling of Acute illness (CRISMA) Center, University of Pittsburgh School of Medicine, Pittsburgh, PA.2Department of Surgery, Emory University School of Medicine, Atlanta, GA.3Department of Pediatrics, Hofstra-North Shore-LIJ School of Medicine, Cohen Children's Medical Center, New Hyde Park, NY.4Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA.5Department of Medicine, Brigham and Women's Hospital, Boston, MA.6Division of Pulmonary/Critical Care Medicine, Alpert Medical School at Brown University, Providence, RI.7Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Critical Care, Emory University School of Medicine, Atlanta, GA.8Departments of Surgery and Emergency Medicine, Washington University School of Medicine, St. Louis, MO.9Department of Pediatrics, Pediatric Critical Care Medicine, University of Washington; Center for Child Health Behavior and Development, Seattle Children's Research Institute, Seattle, WA.
authors.forename: Derek C
authors.initials: DC
authors.lastname: Angus
authors.forename: Christopher W
authors.initials: CW
authors.lastname: Seymour
authors.forename: Craig M
authors.initials: CM
authors.lastname: Coopersmith
authors.forename: Clifford S
authors.initials: CS
authors.lastname: Deutschman
authors.forename: Michael
authors.initials: M
authors.lastname: Klompas
authors.forename: Mitchell M
authors.initials: MM
authors.lastname: Levy
authors.forename: Gregory S
authors.initials: GS
authors.lastname: Martin
authors.forename: Tiffany M
authors.initials: TM
authors.lastname: Osborn
authors.forename: Chanu
authors.initials: C
authors.lastname: Rhee
authors.forename: R Scott
authors.initials: RS
authors.lastname: Watson
mesh_terms: D006801:Humans; D015203:Reproducibility of Results; D018805:Sepsis / Q000145:classification* / Q000175:diagnosis*