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

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.

SUBMITTER: Seymour CW

PROVIDER: S-EPMC4765919 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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

Seymour Christopher W CW Coopersmith Craig M CM Deutschman Clifford S CS Gesten Foster F Klompas Michael M Levy Mitchell M Martin Gregory S GS Osborn Tiffany M TM Rhee Chanu C Warren David K DK Watson R Scott RS Angus Derek C DC

Critical care medicine 20160301 3

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 a ...[more]

PMID: 26901560

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Project description:The main objective of this methodological manuscript was to illustrate the role of using qualitative research in emergency settings. We outline rigorous criteria applied to a qualitative study assessing perceptions and experiences of staff working in Australian emergency departments.We used an integrated mixed-methodology framework to identify different perspectives and experiences of emergency department staff during the implementation of a time target government policy. The qualitative study comprised interviews from 119 participants across 16 hospitals. The interviews were conducted in 2015-2016 and the data were managed using NVivo version 11. We conducted the analysis in three stages, namely: conceptual framework, comparison and contrast and hypothesis development. We concluded with the implementation of the four-dimension criteria (credibility, dependability, confirmability and transferability) to assess the robustness of the study, RESULTS: We adapted four-dimension criteria to assess the rigour of a large-scale qualitative research in the emergency department context. The criteria comprised strategies such as building the research team; preparing data collection guidelines; defining and obtaining adequate participation; reaching data saturation and ensuring high levels of consistency and inter-coder agreement.Based on the findings, the proposed framework satisfied the four-dimension criteria and generated potential qualitative research applications to emergency medicine research. We have added a methodological contribution to the ongoing debate about rigour in qualitative research which we hope will guide future studies in this topic in emergency care research. It also provided recommendations for conducting future mixed-methods studies. Future papers on this series will use the results from qualitative data and the empirical findings from longitudinal data linkage to further identify factors associated with ED performance; they will be reported separately.

Project description:OBJECTIVES:Sepsis-3 defines organ dysfunction as an increase in the Sequential Organ Failure Assessment score by greater than or equal to 2 points. However, some Sequential Organ Failure Assessment score components are not routinely recorded in all hospitals' electronic health record systems, limiting its utility for wide-scale sepsis surveillance. The Centers for Disease Control and Prevention recently released the Adult Sepsis Event surveillance definition that includes simplified organ dysfunction criteria optimized for electronic health records (eSOFA). We compared eSOFA versus Sequential Organ Failure Assessment with regard to sepsis prevalence, overlap, and outcomes. DESIGN:Retrospective cohort study. SETTING:One hundred eleven U.S. hospitals in the Cerner HealthFacts dataset. PATIENTS:Adults hospitalized in 2013-2015. INTERVENTIONS:None. MEASUREMENTS AND MAIN RESULTS:We identified clinical indicators of presumed infection (blood cultures and antibiotics) concurrent with either: 1) an increase in Sequential Organ Failure Assessment score by 2 or more points (Sepsis-3) or 2) 1 or more eSOFA criteria: vasopressor initiation, mechanical ventilation initiation, lactate greater than or equal to 2.0 mmol/L, doubling in creatinine, doubling in bilirubin to greater than or equal to 2.0?mg/dL, or greater than or equal to 50% decrease in platelet count to less than 100 cells/?L (Centers for Disease Control and Prevention Adult Sepsis Event). We compared area under the receiver operating characteristic curves for discriminating in-hospital mortality, adjusting for baseline characteristics. Of 942,360 patients in the cohort, 57,242 (6.1%) had sepsis by Sequential Organ Failure Assessment versus 41,618 (4.4%) by eSOFA. Agreement between sepsis by Sequential Organ Failure Assessment and eSOFA was good (Cronbach's alpha 0.81). Baseline characteristics and infectious diagnoses were similar, but mortality was higher with eSOFA (17.1%) versus Sequential Organ Failure Assessment (14.4%; p < 0.001) as was discrimination for mortality (area under the receiver operating characteristic curve, 0.774 vs 0.759; p < 0.001). Comparisons were consistent across subgroups of age, infectious diagnoses, and comorbidities. CONCLUSIONS:The Adult Sepsis Event's eSOFA organ dysfunction criteria identify a smaller, more severely ill sepsis cohort compared with the Sequential Organ Failure Assessment score, but with good overlap and similar clinical characteristics. Adult Sepsis Events may facilitate wide-scale automated sepsis surveillance that tracks closely with the more complex Sepsis-3 criteria.

Project description:BackgroundCurrently, there is a lack of clear definition for neonatal sepsis. The Pediatric Committee of the European Medicines Agency (EMA) developed consensus criteria to ensure a standardization for neonatal sepsis definition. However, there is no evidence supporting the accuracy of the EMA sepsis criteria in neonatal sepsis diagnosis. The main objective of this study was to evaluate the diagnostic accuracy of EMA sepsis criteria for proven neonatal sepsis.MethodsA multicenter prospective cohort study was conducted from October 2015 to November 2018. Infants with a gestational age over 34th weeks, diagnosed with clinical sepsis and received antibiotics according to the EMA criteria or experienced neonatologists' opinion were included. Blood culture or multiplex real time-PCR or 16S-rRNA positive infants were accepted as "proven sepsis". The predictive performance of EMA criteria for proven sepsis was evaluated by sensitivity, specificity, accuracy, and area under the curve measures of receiver operator characteristic curves. Data-mining methods were used for further analysis.ResultsAmong the 245 included infants, the EMA criteria were positive in 97 infants (39.6%), while proven sepsis was diagnosed in 113 infants (46.1%). The sensitivity, specificity, and accuracy of the EMA criteria for proven sepsis were 44.2% (95%CI: 34.9-53.9), 64.4% (95%CI: 55.6-72.5), 55.1% (95%CI: 46.6-59.4) respectively. None of the clinical and laboratory parameters had sufficient performance individually in terms of sensitivity, specificity and accuracy measures. The diagnostic performance was similar when different clinical findings were added to the EMA sepsis criteria or assessment of the score was interpreted in different ways.ConclusionsResults highlighted that clinician opinion and standard laboratory tests are limited in the neonatal sepsis diagnosis. The EMA criteria also did not efficiently meet the diagnostic accuracy measures for neonatal sepsis. A predictive sepsis definition and rapid bedside point-of care tests are urgently needed.

Project description:BACKGROUND:Inappropriate prescribing in the elderly is a critical issue in primary care, causing a higher risk of Adverse Drug Reactions (ADRs) and resulting in major patient safety concerns. At international level, many tools have been developed to identify Potentially Inappropriate Medications (PIMs). OBJECTIVE:The aim of this study was the application of Beers, Screening Tool of Older People's Prescriptions (STOPP)/Screening Tool to Alert to Right Treatment (START) and Improving Prescribing in the Elderly Tool (IPET) criteria as key tool to improve the quality of prescribing. METHODS:A retrospective study was conducted using the aforementioned criteria. Two different cohorts of elderly patients were enrolled between January 2015 and December 2016, 1800 at admission and 1466 at hospital stay. The index of each criterion divided by politherapy were correlated with comorbidities (Pearson correlation). A comparison was made between admission and hospital stay through a Student's t test of the average of the index. RESULTS:The Proton Pump Inhibitors (PPIs) were the most prescribed PIMs according Beers criteria in both patient cohorts (56%). The most detected drug-drug and drug-disease interactions at admission and at hospital stay were 3 or more drugs active on the Central Nervous System (CNS) as they can predispose to fall-risk. The most detected PIMs with STOPP criteria at admission were PPIs administered for more than 8 weeks. Inhaled ?2-agonists or antimuscarinics were the most prescribed Potential Prescription Omissions (PPOs) according to START criteria. Nonsteroidal Anti-inflammatory Drugs (NSAIDs) in patients with high blood pressure were the most detected PIMs according to IPET criteria during hospital stay. A significant correlation between the comorbidities and the all index at hospital stay, while at admission there was no significant correlation for Beers and IPET index. CONCLUSION:The prescriptive criteria were a useful tool for assessing the quality of prescriptions in the geriatric population and identifying their critical issues.

Project description:BackgroundIdentifying the cause of intracerebral hemorrhage (ICH) is relevant to optimize its management. We aimed to assess the applicability and utility of the Edinburgh CT criteria for cerebral amyloid angiopathy (CAA) in an unselected cohort of hospitalized patients.Patients and methodsWe retrospectively applied the Edinburgh criteria to the first available brain CTs of patients hospitalized for a first-ever lobar ICH in the district of L'Aquila from 2011 to 2017. ICH characteristics and outcomes were compared according to the presence of the Edinburgh CT criteria, including associated subarachnoid hemorrhage (aSAH) and finger-like projections (FLPs). The outcome of ICH in-hospital mortality was assessed with multivariate logistic regression analysis. We adopted the Edinburgh criteria, age, NIHSS and Glasgow Coma Scale scores, systolic blood pressure, antiplatelet treatment, ICH volume, and intraventricular extension on admission as covariates.ResultsOf 178 patients with lobar ICH, 52 (29.2%) had aSAH+FLPs, 60 (33.7%) aSAH only, 1 (0.6%) FLPs, and 65 (36.5%) none. Patients with aSAH+FLPs were older (79.0 ± 9.2 years) than those with only one criterion or none (74.0 ± 15.3 and 72.2 ± 13.8 years, respectively; P = 0.020). Patients with aSAH+FLPs also had more severe ICH at onset, higher in-hospital case-fatality (log rank test P = 0.003) and higher mRS scores at discharge (P < 0.001) as compared to those fulfilling one or none of the Edinburgh criteria. Low Glasgow Coma Scale score was the only factor independently associated to in-hospital case-fatality (odds ratio per point increase 0.51; 95% confidence interval, 0.32-0.91; P = 0.021).DiscussionOur data suggest the applicability of the Edinburgh CT criteria in a hospital setting. The presence of those criteria reflects ICH clinical severity.ConclusionsApplying the Edinburgh CT criteria might help refining the diagnosis and improving the management of patients with lobar ICH.

Dataset Information

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

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

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