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New, Useful Criteria for Assessing the Evidence of Infection in Sepsis Research
Lisa Mellhammar1, Sixten Elén1, Simone Ehrhard2
1Department of Clinical Sciences, Division of Infection Medicine, Lund University, Lund, Sweden.
Objectives:
The Sepsis-3 definition states the clinical criteria for sepsis but lacks clear definitions of the underlying infection. To address the lack of applicable definitions of infection for sepsis research, we propose new criteria, termed the Linder-Mellhammar criteria of infection (LMCI). The aim of this study was to validate these new infection criteria.
Design:
A multicenter cohort study of patients with suspected infection who were admitted to emergency departments or ICUs. Data were collected from medical records and from study investigators.
Setting:
Four academic hospitals in Sweden, Switzerland, the Netherlands, and Germany.
Patients:
A total of 934 adult patients with suspected infection or suspected sepsis.
Interventions:
None.
Measurements And Main Results:
Agreement of infection site classification was measured using the LMCI with Cohen κ coefficient, compared with the Calandra and Cohen definitions of infection and diagnosis on hospital discharge as references. In one of the cohorts, comparisons were also made to adjudications by an expert panel. A subset of patients was assessed for interobserver agreement.
Measurements And Main Results:
The precision of the LMCI varied according to the applied reference. LMCI performed better than the Calandra and Cohen definitions (κ = 0.62 [95% CI, 0.59-0.65] vs κ = 0.43 [95% CI, 0.39-0.47], respectively) and the diagnosis on hospital discharge (κ = 0.57 [95% CI, 0.53-0.61] vs κ = 0.43 [95% CI, 0.39-0.47], respectively). The interobserver agreement for the LMCI was evaluated in 91 patients, with agreement in 77%, κ = 0.72 (95% CI, 0.60-0.85). When tested with adjudication as the gold standard, the LMCI still outperformed the Calandra and Cohen definitions (κ = 0.65 [95% CI, 0.60-0.70] vs κ = 0.29 [95% CI, 0.24-0.33], respectively).
Conclusions:
The LMCI is useful criterion of infection that is intended for sepsis research, in and outside of the ICU. Useful criteria for infection have the potential to facilitate more comparable sepsis research and exclude sepsis mimics from clinical studies, thus improving and simplifying sepsis research.
Insights
The Linder-Mellhammar criteria of infection (LMCI) offer a validated method for defining infection in sepsis research. LMCI improves upon existing definitions, enhancing the comparability and accuracy of sepsis studies.
Area of Science:
- Critical Care Medicine
- Infectious Diseases
- Clinical Research Methodology
Background:
- The Sepsis-3 definition lacks precise criteria for underlying infections, hindering sepsis research.
- A need exists for standardized infection definitions to improve the quality and comparability of sepsis studies.
Purpose of the Study:
- To validate the newly proposed Linder-Mellhammar criteria of infection (LMCI).
- To establish a reliable method for defining infection in the context of sepsis research.
Main Methods:
- A multicenter cohort study involving 934 adult patients with suspected infection or sepsis across four European academic hospitals.
- Data collected from medical records and investigator assessments.
- Validation of LMCI against Calandra and Cohen definitions, hospital discharge diagnoses, and expert panel adjudication.
Main Results:
- LMCI demonstrated superior performance compared to Calandra and Cohen definitions (κ=0.62) and hospital discharge diagnoses (κ=0.57).
- High interobserver agreement for LMCI was observed (77% agreement, κ=0.72).
- LMCI outperformed Calandra and Cohen definitions when expert adjudication was used as the gold standard (κ=0.65).
Conclusions:
- The Linder-Mellhammar criteria of infection (LMCI) provide a useful and validated tool for defining infection in sepsis research.
- LMCI has the potential to standardize infection definitions, facilitate comparable research, and exclude sepsis mimics.
- These criteria can improve and simplify sepsis research both within and outside the ICU setting.
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