Application of a framework to assess the usefulness of alternative sepsis criteria

Seymour, Christopher W.; Coopersmith, Craig M.; Deutschman, Clifford S.; Gesten, Foster; Klompas, Michael; Levy, Mitchell; Martin, Gregory S.; Osborn, Tiffany M.; Rhee, Chanu; Warren, David K.; Watson, R. Scott; Angus, Derek C.

doi:10.1097/ccm.0000000000001724

Cited by 71Sepsis Diagnosis and TreatmentInflammation biomarkers and pathwaysAcute Kidney Injury Research

Application of a framework to assess the usefulness of alternative sepsis criteria

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Seymour, Christopher W., Coopersmith, Craig M., Deutschman, Clifford S., Gesten, Foster, Klompas, Michael, Levy, Mitchell, Martin, Gregory S., Osborn, Tiffany M. +4 more·2016·Critical Care Medicine

DOI 10.1097/ccm.0000000000001724PMC PMC4765919

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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.

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Traditional scoring systems rely on a limited number of variables and predefined thresholds, which may not capture the complexity of sepsis and may be influenced by confounding factors.
“Traditional scoring systems rely on a limited number of variables and predefined thresholds (e.g., qSOFA only requires three readily available clinical parameters), which may not capture the complexity of sepsis and may be influenced by confounding factors.29,30”
From Development and validation of a screening tool for sepsis without laboratory results in the emergency department: a machine learning study (2025) · cites this paper as [29]
The Clinical care > Example of clinical criteria section describes qSOFA as a low-burden prompt and says important elements of sepsis were not given criteria, supporting the concern that simplified criteria may not capture its complexity. It gives a SOFA threshold, but the passages do not specify qSOFA’s three parameters or say that these systems are influenced by confounding factors (searched: qSOFA parameters, thresholds, confounding). No page number is available in our copy. (LLM, conf=0.84)
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A Framework for the Development and Interpretation of Different Sepsis Definitions and Clinical Criteria
Angus, D. C., Seymour, C. W., Coopersmith, C. M., Deutschman, C. S., Klompas, M., Levy, M. M., Martin, G. S., Osborn, T. M., Rhee, C., & Watson, R. S. (2016) · Critical Care Medicine · doi:10.1097/ccm.0000000000001730 · Cited by 164 · see citing works
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Authors: Seymour, C. W., Coopersmith, C. M., Deutschman, C. S., Gesten, F., Klompas, M., Levy, M., Martin, G. S., Osborn, T. M., Rhee, C., Warren, D. K., Watson, R. S., & Angus, D. C.
Affiliations: Brigham and Women's Hospital (US)
ORCID: Seymour, Christopher W.
Coopersmith, Craig M.
Deutschman, Clifford S.
Klompas, Michael
Levy, Mitchell
Osborn, Tiffany M.
Rhee, Chanu
Warren, David K.
Watson, R. Scott
Angus, Derek C.
Venue: Critical Care Medicine
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2016-03
Volume: 44
Issue: 3
Pages: e122-e130
ISSN: 0090-3493 (ISSN-L)
DOI: 10.1097/ccm.0000000000001724
PMC: PMC4765919
OpenAlex: W2276212977
Cited by: 71
References: 39
Citations by year: 2026: 1 · 2025: 3 · 2024: 3 · 2023: 1 · 2022: 6 · 2021: 2 · 2020: 9 · 2019: 12 · 2018: 16 · 2017: 8 · 2016: 10
FWCI: 14.35
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Critical Care Medicine (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: Centers for Disease Control and Prevention
National Heart, Lung, and Blood Institute (HL123020, U01HL123020)
National Institute of General Medical Sciences (GM107650, K23GM104022, P50GM076659, R34GM107650, GM104022)
Topics: Health Sciences › Medicine › Epidemiology › Sepsis Diagnosis and Treatment
Life Sciences › Immunology and Microbiology › Immunology › Inflammation biomarkers and pathways
Health Sciences › Medicine › Nephrology › Acute Kidney Injury Research
Keywords: sepsis, sepsis diagnostic criteria, reliability statistics, construct validity, criterion validity, measurement burden, timeliness, quality improvement, hospital surveillance, case finding, mortality, vital signs, discharge information
MeSH terms: Hospitalization, Humans, Reproducibility of Results, Sepsis, Organ Dysfunction Scores

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