Showing papers by "Michael Klompas published in 2017"
Brigham and Women's Hospital1, Harvard University2, Centers for Disease Control and Prevention3, Emory University4, University of Pittsburgh5, University of Michigan6, National Institutes of Health7, Hospital Corporation of America8, Texas A&M Health Science Center College of Medicine9, Washington University in St. Louis10
TL;DR: In clinical data from 409 hospitals, sepsis was present in 6% of adult hospitalizations, and in contrast to claims-based analyses, neither the incidence of sepsi nor the combined outcome of death or discharge to hospice changed significantly between 2009-2014.
Abstract: Importance Estimates from claims-based analyses suggest that the incidence of sepsis is increasing and mortality rates from sepsis are decreasing. However, estimates from claims data may lack clinical fidelity and can be affected by changing diagnosis and coding practices over time. Objective To estimate the US national incidence of sepsis and trends using detailed clinical data from the electronic health record (EHR) systems of diverse hospitals. Design, Setting, and Population Retrospective cohort study of adult patients admitted to 409 academic, community, and federal hospitals from 2009-2014. Exposures Sepsis was identified using clinical indicators of presumed infection and concurrent acute organ dysfunction, adapting Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria for objective and consistent EHR-based surveillance. Main Outcomes and Measures Sepsis incidence, outcomes, and trends from 2009-2014 were calculated using regression models and compared with claims-based estimates using International Classification of Diseases, Ninth Revision, Clinical Modification codes for severe sepsis or septic shock. Case-finding criteria were validated against Sepsis-3 criteria using medical record reviews. Results A total of 173 690 sepsis cases (mean age, 66.5 [SD, 15.5] y; 77 660 [42.4%] women) were identified using clinical criteria among 2 901 019 adults admitted to study hospitals in 2014 (6.0% incidence). Of these, 26 061 (15.0%) died in the hospital and 10 731 (6.2%) were discharged to hospice. From 2009-2014, sepsis incidence using clinical criteria was stable (+0.6% relative change/y [95% CI, −2.3% to 3.5%], P = .67) whereas incidence per claims increased (+10.3%/y [95% CI, 7.2% to 13.3%], P P = .004), but there was no significant change in the combined outcome of death or discharge to hospice (−1.3%/y [95% CI, −3.2% to 0.6%], P = .19). In contrast, mortality using claims declined significantly (−7.0%/y [95% CI, −8.8% to −5.2%], P P P P = .23). Conclusions and Relevance In clinical data from 409 hospitals, sepsis was present in 6% of adult hospitalizations, and in contrast to claims-based analyses, neither the incidence of sepsis nor the combined outcome of death or discharge to hospice changed significantly between 2009-2014. The findings also suggest that EHR-based clinical data provide more objective estimates than claims-based data for sepsis surveillance.
1,105 citations
TL;DR: A clinical surveillance definition based on concurrent vasopressors, blood cultures, and antibiotics accurately identifies septic shock hospitalizations and suggests that the incidence of patients receiving treatment for sepsis has risen and mortality rates have fallen, but less dramatically than estimated on the basis of ICD‐9 codes.
163 citations
TL;DR: Chronic disease surveillance using electronic health record data is feasible and generates estimates comparable with Behavioral Risk Factor Surveillance System state and small-area estimates.
Abstract: Objectives. To assess the feasibility of chronic disease surveillance using distributed analysis of electronic health records and to compare results with Behavioral Risk Factor Surveillance System (BRFSS) state and small-area estimates.Methods. We queried the electronic health records of 3 independent Massachusetts-based practice groups using a distributed analysis tool called MDPHnet to measure the prevalence of diabetes, asthma, smoking, hypertension, and obesity in adults for the state and 13 cities. We adjusted observed rates for age, gender, and race/ethnicity relative to census data and compared them with BRFSS state and small-area estimates.Results. The MDPHnet population under surveillance included 1 073 545 adults (21.8% of the state adult population). MDPHnet and BRFSS state-level estimates were similar: 9.4% versus 9.7% for diabetes, 10.0% versus 12.0% for asthma, 13.5% versus 14.7% for smoking, 26.3% versus 29.6% for hypertension, and 22.8% versus 23.8% for obesity. Correlation coefficients fo...
85 citations
TL;DR: A multifaceted intervention was associated with improved compliance with evidence-based interventions and decreases in ventilator-associated event, infection-related ventilATOR-associated complication, and probable ventilators-associated pneumonia.
Abstract: Objectives:Ventilator-associated events are associated with increased mortality, prolonged mechanical ventilation, and longer ICU stay. Given strong national interest in improving ventilated patient care, the National Institute of Health and Agency for Healthcare Research and Quality funded a two-st
43 citations
TL;DR: New sepsis definitions shift emphasis from the systemic inflammatory response syndrome to organ dysfunction, quantified using the Sequential Organ Failure Assessment (SOFA) score.
34 citations
TL;DR: Pediatric AVAC is proposed for surveillance related to antimicrobial use, with pediatric PVAP as a subset of AVAC, to determine whether lower pediatric VAE rates are associated with improvements in other outcomes.
Abstract: OBJECTIVE Adult ventilator-associated event (VAE) definitions include ventilator-associated conditions (VAC) and subcategories for infection-related ventilator-associated complications (IVAC) and possible ventilator-associated pneumonia (PVAP). We explored these definitions for children. DESIGN Retrospective cohort SETTING Pediatric, cardiac, or neonatal intensive care units (ICUs) in 6 US hospitals PATIENTS Patients ≤18 years old ventilated for ≥1 day METHODS We identified patients with pediatric VAC based on previously proposed criteria. We applied adult temperature, white blood cell count, antibiotic, and culture criteria for IVAC and PVAP to these patients. We matched pediatric VAC patients with controls and evaluated associations with adverse outcomes using Cox proportional hazards models. RESULTS In total, 233 pediatric VACs (12,167 ventilation episodes) were identified. In the cardiac ICU (CICU), 62.5% of VACs met adult IVAC criteria; in the pediatric ICU (PICU), 54.2% of VACs met adult IVAC criteria; and in the neonatal ICU (NICU), 20.2% of VACs met adult IVAC criteria. Most patients had abnormal white blood cell counts and temperatures; we therefore recommend simplifying surveillance by focusing on "pediatric VAC with antimicrobial use" (pediatric AVAC). Pediatric AVAC with a positive respiratory diagnostic test ("pediatric PVAP") occurred in 8.9% of VACs in the CICU, 13.3% of VACs in the PICU, and 4.3% of VACs in the NICU. Hospital mortality was increased, and hospital and ICU length of stay and duration of ventilation were prolonged among all pediatric VAE subsets compared with controls. CONCLUSIONS We propose pediatric AVAC for surveillance related to antimicrobial use, with pediatric PVAP as a subset of AVAC. Studies on generalizability and responsiveness of these metrics to quality improvement initiatives are needed, as are studies to determine whether lower pediatric VAE rates are associated with improvements in other outcomes. Infect Control Hosp Epidemiol 2017;38:327-333.
33 citations
TL;DR: The theoretical basis for adding chlor hexidine to oral care regimens is reviewed, potential biases in randomized controlled trials comparing oral care Regimens with and without chlorhexidine are delineated, and the unexpected mortality signal associated with oral chlor Hexidine is explored.
Abstract: Daily oral care with chlorhexidine for mechanically ventilated patients is ubiquitous in contemporary intensive care practice. The practice is predicated upon meta-analyses suggesting that adding chlorhexidine to daily oral care regimens can reduce ventilator-associated pneumonia (VAP) rates by up to 40%. Close analysis, however, raises three concerns: (1) the meta-analyses are dominated by studies in cardiac surgery patients in whom average duration of mechanical ventilation is
33 citations
TL;DR: VAP rates may still be elevated despite multiple reports to the contrary, and new evidence suggests new ways to optimize the selection of ventilator bundle components and their implementation.
Abstract: Purpose of reviewTo summarize and contextualize recent evidence on preventing ventilator-associated pneumonia (VAP).Recent findingsMany centers continue to report dramatic decreases in VAP rates after implementing ventilator bundles. Interpreting these reports is complicated, however, by the subject
27 citations
TL;DR: Prospective surveillance using VAE criteria is more reliable than traditional VAP surveillance and clinical VAP diagnosis; the correlation between VAEs and clinically recognized pulmonary deterioration is poor.
Abstract: OBJECTIVE To compare interrater reliabilities for ventilator-associated event (VAE) surveillance, traditional ventilator-associated pneumonia (VAP) surveillance, and clinical diagnosis of VAP by intensivists. DESIGN A retrospective study nested within a prospective multicenter quality improvement study. SETTING Intensive care units (ICUs) within 5 hospitals of the Centers for Disease Control and Prevention Epicenters. PATIENTS Patients who underwent mechanical ventilation. METHODS We selected 150 charts for review, including all VAEs and traditionally defined VAPs identified during the primary study and randomly selected charts of patients without VAEs or VAPs. Each chart was independently reviewed by 2 research assistants (RAs) for VAEs, 2 hospital infection preventionists (IPs) for traditionally defined VAP, and 2 intensivists for any episodes of pulmonary deterioration. We calculated interrater agreement using κ estimates. RESULTS The 150 selected episodes spanned 2,500 ventilator days. In total, 93-96 VAEs were identified by RAs; 31-49 VAPs were identified by IPs, and 29-35 VAPs were diagnosed by intensivists. Interrater reliability between RAs for VAEs was high (κ, 0.71; 95% CI, 0.59-0.81). Agreement between IPs using traditional VAP criteria was slight (κ, 0.12; 95% CI, -0.05-0.29). Agreement between intensivists was slight regarding episodes of pulmonary deterioration (κ 0.22; 95% CI, 0.05-0.39) and was fair regarding whether episodes of deterioration were attributable to clinically defined VAP (κ, 0.34; 95% CI, 0.17-0.51). The clinical correlation between VAE surveillance and intensivists' clinical assessments was poor. CONCLUSIONS Prospective surveillance using VAE criteria is more reliable than traditional VAP surveillance and clinical VAP diagnosis; the correlation between VAEs and clinically recognized pulmonary deterioration is poor. Infect Control Hosp Epidemiol 2017;38:172-178.
25 citations
TL;DR: Possible new approaches to prevent Clostridium difficile infection are suggested, including screening to identify and isolate carriers, universal gloving, greater use of sporicidal cleaning methods, enhancing antibiotic and possibly proton pump inhibitor stewardship, and prescribing prophylactic vancomycin and/or probiotics to colonized patients to prevent progression from colonization to infection.
Abstract: Typing studies suggest that most cases of hospital-onset Clostridium difficile infection (CDI) are unrelated to other cases of active disease in the hospital New cases may instead be due to transmissions from asymptomatic carriers or progression of latent C difficile present on admission to active infection Direct exposure to antibiotics remains the primary risk factor for CDI but ward-level antibiotic use, antibiotic exposure of the prior room occupant, and C difficile status of the prior room occupant increase risk for C difficile acquisition while antibiotic exposure, gastric acid suppression, and immunosuppression increase risk for progression to infection These insights suggest possible new approaches to prevent CDI, including screening to identify and isolate carriers, universal gloving, greater use of sporicidal cleaning methods, enhancing antibiotic and possibly proton pump inhibitor stewardship, and prescribing prophylactic vancomycin and/or probiotics to colonized patients to prevent progression from colonization to infection We review current evidence and questions related to these interventions
24 citations
TL;DR: Next steps include studying propensity-matched cohorts and prospectively testing whether changes in sedation management, transfusion thresholds, and fluid management can decrease pediatric ventilator-associated conditions rates and improve patient outcomes.
Abstract: Objectives:A newly proposed surveillance definition for ventilator-associated conditions among neonatal and pediatric patients has been associated with increased morbidity and mortality among ventilated patients in cardiac ICU, neonatal ICU, and PICU. This study aimed to identify potential risk fact
TL;DR: Recommendations in favor of combination therapy can be traced to observational studies from the 1970s, 1980s, and 1990s that documented lower mortality rates in patients with Gram-negative bacteremia treated with two antibiotics rather than one, particularly among patients infected with Pseudomonas aeruginosa.
Abstract: 1930 www.ccmjournal.org November 2017 • Volume 45 • Number 11 Septic shock is rapidly becoming critical care’s last remaining bastion for unrestrained antibiotic prescribing. Just about every other area of critical care is moving toward using antibiotics more parsimoniously. Recent studies and guidelines attest to the feasibility of waiting for diagnostic data before prescribing antibiotics for ICU patients without septic shock, the fact that many severe respiratory infections are caused by viruses rather than bacteria, the fact that many sepsis-like syndromes in the ICU are not infections, the relative paucity of drug-resistant organisms even among patients with “healthcare-associated” infections, the safety of shortening treatment courses for patients with established infections, and the futility of antibiotic prophylaxis in noninfectious inflammatory conditions (1–10). By contrast, the latest treatment guidelines for septic shock advise more antibiotics rather than less. They suggest that treating septic shock with two antibiotics, both active against a patient’s known or suspected pathogens, for “several days” is likely to be clinically useful. They recommend continuing combination therapy with two active agents until there is clinical improvement and/or evidence of infection resolution, regardless of when susceptibility results return (11). This aggressive recommendation bears contemplation. What is the origin of the enduring perception that septic shock requires sustained double coverage? Is this recommendation supported by current literature? How in practice should we be treating patients with Gram-negative septic shock? Three reasons for double covering Gram negatives have been proposed: 1) to increase the probability that at least one agent will be active against the patient’s infecting pathogen(s), 2) to prevent the emergence of antibiotic-resistant pathogens, and 3) to increase the efficiency of pathogen clearance by taking advantage of additive or synergistic effects between multiple agents drawn from different classes. The quality of evidence supporting these claims varies. There are moderate data that combination therapy is more likely to include an active agent, conflicting data on whether combination therapy decreases or increases selection for resistant organisms, and in vitro data showing that combinations of antibiotics can be synergistic, antagonistic, or neutral (12–17). Recommendations in favor of combination therapy can be traced to observational studies from the 1970s, 1980s, and 1990s that documented lower mortality rates in patients with Gram-negative bacteremia treated with two antibiotics rather than one, particularly among patients infected with Pseudomonas aeruginosa (18–22). A landmark meta-analysis published in 2004 summarized the papers published to that point: no differences in mortality rates with two agents versus one for Gram-negative bacteremia in general, but a 50% decrease in the odds of death when treating Pseudomonas bacteremia with two agents rather than one (23). This finding, however, has not stood the test of time. The five studies included in the 2004 meta-analysis were observational case series at high risk of bias. The studies themselves reported significant differences between patients treated with combination therapy versus those treated with monotherapy. In the largest case series, for example, patients treated with monotherapy were more likely to have nosocomial infections and to require critical care compared with those who received combination therapy (19). More recent case series that rigorously adjusted for potential confounders report no differences in mortality rates or time to shock resolution with combination versus monotherapy and indeed more frequent kidney injury when the second agent is an aminoglycoside (24–27). Likewise, updated meta-analyses published in 2013 and 2014 reported that combination therapy does not confer a survival benefit for patients with sepsis in general nor for patients with Pseudomonas bacteremia in particular (15, 28). It should also be noted that we lack good data on the potential harms associated with antibiotic prescribing, including Clostridium difficile infection, drug adverse effects, and cultivation of antibiotic resistance. These gaps in our knowledge make it that much more difficult to recommend sustained combination therapy. More recently, Kumar et al (29, 30) reawakened interest in the potential advantages of combination therapy by hypothesizing that the benefits of dual coverage may be limited to patients with septic shock. They reasoned that patients in septic shock are at increasing risk of death with every passing moment in shock and that it is critical to clear their infections as quickly as possible. They proposed that two antibiotics with Copyright © 2017 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved. DOI: 10.1097/CCM.0000000000002678 1Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA. 2Department of Medicine, Brigham and Women’s Hospital, Boston, MA. Dr. Klompas’ institution received funding from the Centers for Disease Control and Prevention. For information regarding this article, E-mail: mklompas@bwh.harvard.edu Monotherapy Is Adequate for Septic Shock Due to Gram-Negative Organisms
TL;DR: Almost 5 years have elapsed since the United States Centers for Disease Control and Prevention (CDC) replaced their ventilator-associated pneumonia surveillance definitions with ventilATOR-associated event (VAE) definitions.
Abstract: Almost 5 years have elapsed since the United States Centers for Disease Control and Prevention (CDC) replaced their ventilator-associated pneumonia (VAP) surveillance definitions with ventilator-associated event (VAE) definitions. The CDC shifted to VAE definitions in response to a litany of
TL;DR: This data indicates that smoking cessation among men over the age of 40 may be a risk factor for depression and the use of these techniques should be investigated further to find out the causes.
Abstract: Author Contributions: Dr Hockenberry had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: Favini, Hockenberry, Gilman, Adams, Becker. Acquisition, analysis, or interpretation of data: Favini, Hockenberry, Gilman, Jain, Ong, Becker. Drafting of the manuscript: Favini, Hockenberry, Jain. Critical revision of the manuscript for important intellectual content: Favini, Hockenberry, Gilman, Ong, Adams, Becker. Statistical analysis: Hockenberry, Adams, Becker. Administrative, technical, or material support: Favini, Gilman, Jain. Supervision: Hockenberry.
TL;DR: The study by Sterling et al (5) is instructive, but perhaps not in the way intended, and demonstrates the differences between “definitions” and “clinical criteria.”
Abstract: Critical Care Medicine www.ccmjournal.org 1569 need for two separate diagnoses. Current understanding of the two disorders has not, to date, identified a fundamental difference in the underlying pathobiology. Treatment is, or should be, identical. Indeed, the label “septic shock” may be of epidemiologic value only—based on current understanding, septic shock is basically just “really, really, really bad” sepsis. In summary, the study by Sterling et al (5) is instructive, but perhaps not in the way intended. It again demonstrates the differences between “definitions” and “clinical criteria.” And, more importantly, it points out the dangers inherent in incomplete examination of data and in treating labels or diagnoses instead of patients. Continued validation and improvement of the Sepsis-3 criteria are essential, but it is equally essential these efforts encompass the entire spectrum of disorder and not just pieces of it.
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