Publications by authors named "Christopher J Lindsell"

255 Publications

Understanding timely STEMI treatment performance: A 3-year retrospective cohort study using diagnosis-to-balloon-time and care subintervals.

J Am Coll Emerg Physicians Open 2021 Feb 17;2(1):e12379. Epub 2021 Feb 17.

Department of Biostatistics Vanderbilt University Medical Center Nashville Tennessee USA.

Objective: From the perspective of percutaneous coronary intervention (PCI) centers, locations of ST-segment elevation myocardial infarction (STEMI) diagnosis can include a referring facility, emergency medical services (EMS) transporting to a PCI center, or the PCI center's emergency department (ED). This challenges the use of door-to-balloon-time as the primary evaluative measure of STEMI treatment pathways. Our objective was to identify opportunities to improve care by quantifying differences in the timeliness of STEMI treatment mobilization based on the location of the diagnostic ECG.

Methods: This 3-year, single-center, retrospective cohort study classified patients by diagnostic ECG location: referring facility, EMS, or PCI center ED. We quantified door-to-balloon-time and diagnosis-to-balloon-time with its care subintervals.

Results: Of 207 ED STEMI patients, 180 (87%) received PCI. Median diagnosis-to-balloon-times were shortest among the ED-diagnosed (78 minutes [interquartile range (IQR), 61-92]), followed by EMS-identified patients (89 minutes [IQR, 78-122]), and longest among those referred (140 minutes [IQR, 119-160]), reflecting time for transport to the PCI center. Conversely, referred patients had the shortest median door-to-balloon-times (38 minutes [IQR, 34-43]), followed by the EMS-identified (64 minutes [IQR, 47-77]), whereas ED-diagnosed patients had the longest (89 minutes [IQR, 70-114]), reflecting diagnosis and catheterization lab activation frequently occurring before PCI center ED arrival for referred and EMS-identified patients.

Conclusions: Diagnosis-to-balloon-time and its care subintervals are complementary to the traditional door-to-balloon-times as measures of the STEMI treatment process. Together, they highlight opportunities to improve timely identification among ED-diagnosed patients, use of out-of-hospital cath lab activation for EMS-identified patients, and encourage pathways for referred patients to bypass PCI center EDs.
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http://dx.doi.org/10.1002/emp2.12379DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7890036PMC
February 2021

Learning From What We Do, and Doing What We Learn: A Learning Health Care System in Action.

Acad Med 2021 Feb 23. Epub 2021 Feb 23.

C.J. Lindsell is professor of biostatistics, associate director, Center for Clinical Quality and Implementation Research, director, Vanderbilt Institute for Clinical and Translational Research Methods Program, and co-director, Center for Health Data Science, Vanderbilt University Medical Center, Nashville, Tennessee. C.L. Gatto is research assistant professor of biostatistics and associate director, Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee. M.L. Dear is project manager, Learning Healthcare System Platform, Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee. R. Buie is health policy service analyst, Learning Healthcare System Platform, Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee. T.W. Rice is associate professor of medicine, Department of Allergy, Pulmonary and Critical Care Medicine, vice president for clinical trial innovation and operations, Vanderbilt Institute for Clinical and Translational Research, and medical director, Vanderbilt Human Research Protection Program, Vanderbilt University Medical Center, Nashville, Tennessee. J.M. Pulley is research associate professor of medicine, Department of Allergy, Pulmonary and Critical Care Medicine, and executive director, Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee. T.V. Hartert is professor of medicine, Department of Allergy, Pulmonary and Critical Care Medicine, director, Center for Asthma Research, assistant vice president for translational science, and Lulu H. Owen Chair in Medicine, Vanderbilt University Medical Center, Nashville, Tennessee. S. Kripalani is professor of medicine, Department of General Internal Medicine and Public Health, director, Center for Clinical Quality and Implementation Research, and co-director, Center for Effective Health Communication, Vanderbilt University Medical Center, Nashville, Tennessee. F.E. Harrell is professor and founding chair, Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee. D.W. Byrne is senior associate in biostatistics and director, Quality Improvement and Program Evaluation, Vanderbilt University Medical Center, Nashville, Tennessee. M.C. Edgeworth was chief executive officer, Vanderbilt University Hospital, Vanderbilt University Medical Center, Nashville, Tennessee, at the time this manuscript was written. R. Steaban is chief nursing officer, Vanderbilt University Medical Center, Nashville, Tennessee. R.S. Dittus is the Albert and Bernard Werthan Professor of Medicine, Division of General Internal Medicine and Public Health, senior vice president and chief innovation officer, Vanderbilt Health Affiliated Network, executive vice president for public health and health care, and senior associate dean for population health sciences, Vanderbilt University Medical Center and VA Tennessee Valley Healthcare System Geriatric Research, Education and Clinical Center, Nashville, Tennessee. G.R. Bernard is the Melinda Owen Bass Professor of Medicine, Department of Allergy, Pulmonary and Critical Care Medicine, executive vice president for research, senior associate dean for clinical sciences, and director, Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee.

Different models of learning health systems are emerging. At Vanderbilt University Medical Center, the Learning Health System (LHS) Platform was established with the goal of creating generalizable knowledge. This differentiates the LHS Platform from other efforts that have adopted a quality improvement paradigm. By supporting pragmatic trials at the intersection of research, operations, and clinical care, the LHS Platform was designed to yield evidence for advancing content and processes of care through carefully designed, rigorous study. The LHS Platform provides the necessary infrastructure and governance to leverage translational, transdisciplinary team science to inform clinical and operational decision-making across the health system. The process transforms a clinical or operational question into a research question amenable to a pragmatic trial. Scientific, technical, procedural, and human infrastructure is maintained for the design and execution of individual LHS projects. This includes experienced pragmatic trialists, project management, data science inclusive of biostatistics and clinical informatics, and regulatory support. Careful attention is paid to stakeholder engagement, including health care providers and the community. Capturing lessons from each new study, the LHS Platform continues to mature with plans to integrate implementation science, and to complement clinical and process outcomes with cost and value considerations. The Vanderbilt University Medical Center LHS Platform is now a pillar of the health care system and leads the evolving culture of learning from what we do and doing what we learn.
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http://dx.doi.org/10.1097/ACM.0000000000004021DOI Listing
February 2021

Sepsis Subclasses: A Framework for Development and Interpretation.

Crit Care Med 2021 Feb 15. Epub 2021 Feb 15.

Department of Critical Care Medicine, The Clinical Research, Investigation, and Systems Modeling of Acute illness (CRISMA) Center, University of Pittsburgh School of Medicine, Pittsburgh, PA. Anaesthesia, Critical Care, and Pain Medicine, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom. Division of Pulmonary and Critical Care Medicine, University of California San Francisco, San Francisco, CA. Division of Pediatric Critical Care Medicine, Department of Critical Care Medicine, Children's Hospital of Pittsburgh, Pittsburgh, PA. Department of Medicine, University of Pittsburgh, Pittsburgh, PA. Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA. Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Michigan, Ann Arbor, MI. Division of Anaesthetics, Pain Medicine, and Intensive Care, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, United Kingdom. Wellcome Centre for Human Genetics, University of Oxford, Oxford, United Kingdom. Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN. Kaiser Permanente Division of Research, Oakland, CA. Keenan Research Centre for Biomedical Science, St Michael's Hospital, Toronto, ON, Canada. Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA. Center for Experimental and Molecular Medicine, Amsterdam University Medical Centers, Location Academic Medical Center, University of Amsterdam, Amsterdam, NL. Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, location Academic Medical Center, University of Amsterdam, Amsterdam, NL. Guy's and St Thomas' NHS Foundation Trust, ICU support Offices, St Thomas' Hospital, London, United Kingdom. School of Immunology and Microbial Sciences, Kings College London, London, United Kingdom. Department of Emergency Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA. Inflammatix, Burlingame, CA. Department of Intensive Care Medicine, Nepean Hospital, Sydney, AU. Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA. Department of Medicine, Center for Applied Genomics and Precision Medicine, Duke University School of Medicine, Durham, NC. Division of Critical Care Medicine, Cincinnati Children's Hospital Medical Center and Cincinnati Children's Research Foundation, Cincinnati, OH. Department of Critical Care Medicine, Peking University People's Hospital, Beijing, China.

Sepsis is defined as a dysregulated host response to infection that leads to life-threatening acute organ dysfunction. It afflicts approximately 50 million people worldwide annually and is often deadly, even when evidence-based guidelines are applied promptly. Many randomized trials tested therapies for sepsis over the past 2 decades, but most have not proven beneficial. This may be because sepsis is a heterogeneous syndrome, characterized by a vast set of clinical and biologic features. Combinations of these features, however, may identify previously unrecognized groups, or "subclasses" with different risks of outcome and response to a given treatment. As efforts to identify sepsis subclasses become more common, many unanswered questions and challenges arise. These include: 1) the semantic underpinning of sepsis subclasses, 2) the conceptual goal of subclasses, 3) considerations about study design, data sources, and statistical methods, 4) the role of emerging data types, and 5) how to determine whether subclasses represent "truth." We discuss these challenges and present a framework for the broader study of sepsis subclasses. This framework is intended to aid in the understanding and interpretation of sepsis subclasses, provide a mechanism for explaining subclasses generated by different methodologic approaches, and guide clinicians in how to consider subclasses in bedside care.
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http://dx.doi.org/10.1097/CCM.0000000000004842DOI Listing
February 2021

Delirium as a predictor of mortality and disability among hospitalized patients in Zambia.

PLoS One 2021 11;16(2):e0246330. Epub 2021 Feb 11.

Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.

Objective: To study the epidemiology and outcomes of delirium among hospitalized patients in Zambia.

Methods: We conducted a prospective cohort study at the University Teaching Hospital in Lusaka, Zambia, from October 2017 to April 2018. The primary exposure was delirium duration over the initial 3 days of hospitalization, assessed daily using the Brief Confusion Assessment Method. The primary outcome was 6-month mortality. Secondary outcomes included 6-month disability, evaluated using the World Health Organization Disability Assessment Schedule 2.0.

Findings: 711 adults were included (median age, 39 years; 461 men; 459 medical, 252 surgical; 323 with HIV). Delirium prevalence was 48.5% (95% CI, 44.8%-52.3%). 6-month mortality was higher for delirious participants (44.6% [39.3%-50.1%]) versus non-delirious participants (20.0% [15.4%-25.2%]; P < .001). After adjusting for covariates, delirium duration independently predicted 6-month mortality and disability with a significant dose-response association between number of days with delirium and odds of worse clinical outcome. Compared to no delirium, presence of 1, 2 or 3 days of delirium resulted in odds ratios for 6-month mortality of 1.43 (95% CI, 0.73-2.80), 2.20 (1.07-4.51), and 3.92 (2.24-6.87), respectively (P < .001). Odds of 6-month disability were 1.20 (0.70-2.05), 1.73 (0.95-3.17), and 2.80 (1.78-4.43), respectively (P < .001).

Conclusion: Among hospitalized medical and surgical patients in Zambia, delirium prevalence was high and delirium duration independently predicted mortality and disability at 6 months. This work lays the foundation for prevention, detection, and management of delirium in low-income countries. Long-term follow up of outcomes of critical illness in resource-limited settings appears feasible using the WHO Disability Assessment Schedule.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0246330PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7877643PMC
February 2021

Embedding Learning in a Learning Health Care System to Improve Clinical Practice.

Acad Med 2021 Feb 9. Epub 2021 Feb 9.

M.D. McEvoy is professor of anesthesiology and surgery, vice chair for educational affairs, program director of the perioperative medicine fellowship, and director of the Center for Innovation in Perioperative Health, Education, and Research, Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee. M.L. Dear is project manager, Learning Healthcare System Platform, Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee. R. Buie is health policy service analyst, Learning Healthcare System Platform, Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee. L.C. Fowler is director of the Educational Development and Research Office of Educational Affairs, Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee. B. Miller is professor of medical education and administration and vice president for educational affairs, Vanderbilt University Medical Center, Nashville, Tennessee. G.M. Fleming was professor of pediatrics and associate director of the pediatric critical care fellowship, Monroe Carell Jr. Children's Hospital, and vice president, Continuous Professional Development, Office of Health Sciences Education, Vanderbilt University Medical Center, Nashville, Tennessee. D. Moore is professor of medical education and administration and director of the Office for Continuing Professional Development, Vanderbilt University School of Medicine, Nashville, Tennessee. T.W. Rice is associate professor of medicine, Department of Allergy, Pulmonary and Critical Care Medicine, and medical director, Vanderbilt Human Research Protection Program, Vanderbilt University Medical Center, Nashville, Tennessee. G.R. Bernard is the Melinda Owen Bass Professor of Medicine, executive vice president for research, senior associate dean for clinical sciences, and director of the Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee. C.J. Lindsell is professor of biostatistics, associate director of the Center for Clinical Quality and Implementation Research, director of the Vanderbilt Institute for Clinical and Translational Research Methods Program, and director of the Center for Health Data Science, Vanderbilt University Medical Center, Nashville, Tennessee.

Problem: In an ideal learning health care system (LHS), clinicians learn from what they do and do what they learn, closing the evidence-to-practice gap. In operationalizing an LHS, great strides have been made in knowledge generation. Yet, considerable challenges remain to the broad uptake of identified best practices. To bridge the gap from generating actionable knowledge to applying that knowledge in clinical practice, and ultimately to improving outcomes, new information must be disseminated to and implemented by frontline clinicians. To date, the dissemination of this knowledge through traditional avenues has not achieved meaningful practice change quickly.

Approach: Vanderbilt University Medical Center (VUMC) developed QuizTime, a smartphone application learning platform, to provide a mechanism for embedding workplace-based clinician learning in the LHS. QuizTime leverages spaced education and retrieval-based practice to facilitate practice change. Beginning in January 2020, clinician-researchers and educators at VUMC designed a randomized, controlled trial to test whether the QuizTime learning system influenced clinician behavior in the context of recent evidence supporting the use of balanced crystalloids rather than saline for intravenous fluid management and new regulations around opioid prescribing.

Outcomes: Whether spaced education and retrieval-based practice influence clinician behavior and patient outcomes at the VUMC system level will be tested using the data currently being collected.

Next Steps: These findings will inform future directions for developing and deploying learning approaches at scale in an LHS, with the goal of closing the evidence-to-practice gap.
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http://dx.doi.org/10.1097/ACM.0000000000003969DOI Listing
February 2021

Protocol to evaluate an enterprise-wide initiative to increase access to lung cancer screening in the Veterans Health Administration.

Clin Imaging 2020 Dec 26;73:151-161. Epub 2020 Dec 26.

VA Tennessee Valley Healthcare System, Geriatric Research, Education and Clinical Center (GRECC), Nashville, TN, United States of America; Division of General Internal Medicine and Public Health, Vanderbilt University Medical Center, Nashville, TN, United States of America.

Introduction: The Veterans Affairs Partnership to increase Access to Lung Screening (VA-PALS) is an enterprise-wide initiative to implement lung cancer screening programs at VA medical centers (VAMCs). VA-PALS will be using implementation strategies that include program navigators to coordinate screening activities, trainings for navigators and radiologists, an open-source software management system, tools to standardize low-dose computed tomography image quality, and access to a support network. VAMCs can utilize strategies according to their local needs. In this protocol, we describe the planned program evaluation for the initial 10 VAMCs participating in VA-PALS.

Materials And Methods: The implementation of programs will be evaluated using the Consolidated Framework for Implementation Research to ensure broad contextual guidance. Program evaluation measures have been developed using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Adaptations of screening processes will be assessed using the Framework for Reporting Adaptations and Modifications to Evidence Based Interventions. Measures collected will reflect the inner settings, estimate and describe the population reached, adoption by providers, implementation of the programs, report clinical outcomes and maintenance of programs. Analyses will include descriptive statistics and regression to evaluate predictors and assess implementation over time.

Discussion: This theory-based protocol will evaluate the implementation of lung cancer screening programs across the Veterans Health Administration using scientific frameworks. The findings will inform plans to expand the VA-PALS initiative beyond the original sites and can guide implementation of lung cancer screening programs more broadly.
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http://dx.doi.org/10.1016/j.clinimag.2020.11.059DOI Listing
December 2020

Symptoms and recovery among adult outpatients with and without COVID-19 at 11 healthcare facilities-July 2020, United States.

Influenza Other Respir Viruses 2021 Jan 6. Epub 2021 Jan 6.

CDC COVID-19 Response Team, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA.

Background: Symptoms of mild COVID-19 illness are non-specific and may persist for prolonged periods. Effects on quality of life of persistent poor physical or mental health associated with COVID-19 are not well understood.

Methods: Adults aged ≥18 years with laboratory-confirmed COVID-19 and matched control patients who tested negative for SARS-CoV-2 infection at outpatient facilities associated with 11 medical centers in the United States were interviewed to assess symptoms, illness duration, and health-related quality of life. Duration of symptoms, health-related quality of life measures, and days of poor physical health by symptoms experienced during illness were compared between case patients and controls using Wilcoxon rank-sum tests. Symptoms associated with COVID-19 case status were evaluated by multivariable logistic regression.

Results: Among 320 participants included, 157 were COVID-19 cases and 163 were SARS-CoV-2 negative controls. Loss of taste or smell was reported by 63% of cases and 6% of controls and was strongly associated with COVID-19 in logistic regression models (adjusted odds ratio [aOR] = 32.4; 95% confidence interval [CI], 12.6-83.1). COVID-19 cases were more likely than controls to have experienced fever, body aches, weakness, or fatigue during illness, and to report ≥1 persistent symptom more than 14 days after symptom onset (50% vs 32%, P < .001). Cases reported significantly more days of poor physical health during the past 14 days than controls (P < .01).

Conclusions: Differentiating COVID-19 from other acute illnesses will require widespread diagnostic testing, especially during influenza seasons. Persistent COVID-19-related symptoms may negatively affect quality of life, even among those initially presenting with mild illness.
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http://dx.doi.org/10.1111/irv.12832DOI Listing
January 2021

Decline in SARS-CoV-2 Antibodies After Mild Infection Among Frontline Health Care Personnel in a Multistate Hospital Network - 12 States, April-August 2020.

MMWR Morb Mortal Wkly Rep 2020 Nov 27;69(47):1762-1766. Epub 2020 Nov 27.

Most persons infected with SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), develop virus-specific antibodies within several weeks, but antibody titers might decline over time. Understanding the timeline of antibody decline is important for interpreting SARS-CoV-2 serology results. Serum specimens were collected from a convenience sample of frontline health care personnel at 13 hospitals and tested for antibodies to SARS-CoV-2 during April 3-June 19, 2020, and again approximately 60 days later to assess this timeline. The percentage of participants who experienced seroreversion, defined as an antibody signal-to-threshold ratio >1.0 at baseline and <1.0 at the follow-up visit, was assessed. Overall, 194 (6.0%) of 3,248 participants had detectable antibodies to SARS-CoV-2 at baseline (1). Upon repeat testing approximately 60 days later (range = 50-91 days), 146 (93.6%) of 156 participants experienced a decline in antibody response indicated by a lower signal-to-threshold ratio at the follow-up visit, compared with the baseline visit, and 44 (28.2%) experienced seroreversion. Participants with higher initial antibody responses were more likely to have antibodies detected at the follow-up test than were those who had a lower initial antibody response. Whether decay in these antibodies increases risk for reinfection and disease remains unanswered. However, these results suggest that serology testing at a single time point is likely to underestimate the number of persons with previous SARS-CoV-2 infection, and a negative serologic test result might not reliably exclude prior infection.
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http://dx.doi.org/10.15585/mmwr.mm6947a2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7727600PMC
November 2020

Multicenter International Cohort Validation of a Modified Sequential Organ Failure Assessment Score Using the Richmond Agitation-sedation Scale.

Ann Surg 2020 Dec 14. Epub 2020 Dec 14.

Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Nashville, TN.

Objective: In a multicenter, international cohort, we aimed to validate a modified Sequential Organ Failure Assessment (mSOFA) using the Richmond Agitation-Sedation Scale, hypothesized as comparable to the Glasgow Coma Scale (GCS)-based Sequential Organ Failure Assessment (SOFA).

Summary Background Data: The SOFA score, whose neurologic component is based on the GCS, can predict intensive care unit (ICU) mortality. But, GCS is often missing in lieu of other assessments, such as the also reliable and validated Richmond Agitation Sedation Scale (RASS). Single-center data suggested an RASS-based SOFA (mSOFA) predicted ICU mortality.

Methods: Our nested cohort within the prospective 2016 Fourth International Study of Mechanical Ventilation contains 4120 ventilated patients with daily RASS and GCS assessments (20,023 patient-days, 32 countries). We estimated GCS from RASS via a proportional odds model without adjustment. ICU mortality logistic regression models and c-statistics were constructed using SOFA (measured GCS) and mSOFA (measured RASS-estimated GCS), adjusted for age, sex, body-mass index, region (Europe, USA-Canada, Latin America, Africa, Asia, Australia-New Zealand), and postoperative status (medical/surgical).

Results: Cohort-wide, the mean SOFA=9.4+/-2.8 and mean mSOFA = 10.0+/-2.3, with ICU mortality = 31%. Mean SOFA and mSOFA similarly predicted ICU mortality (SOFA: AUC = 0.784, 95% CI = 0.769-0.799; mSOFA: AUC = 0.778, 95% CI = 0.763-0.793, P = 0.139). Across models, other predictors of mortality included higher age, female sex, medical patient, and African region (all P < 0.001).

Conclusions: We present the first SOFA modification with RASS in a "real-world" international cohort. Estimating GCS from RASS preserves predictive validity of SOFA to predict ICU mortality. Alternative neurologic measurements like RASS can be viably integrated into severity of illness scoring systems like SOFA.
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http://dx.doi.org/10.1097/SLA.0000000000004484DOI Listing
December 2020

Clinical Effects of Balanced Crystalloids vs Saline in Adults With Diabetic Ketoacidosis: A Subgroup Analysis of Cluster Randomized Clinical Trials.

JAMA Netw Open 2020 11 2;3(11):e2024596. Epub 2020 Nov 2.

Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.

Importance: Saline (0.9% sodium chloride), the fluid most commonly used to treat diabetic ketoacidosis (DKA), can cause hyperchloremic metabolic acidosis. Balanced crystalloids, an alternative class of fluids for volume expansion, do not cause acidosis and, therefore, may lead to faster resolution of DKA than saline.

Objective: To compare the clinical effects of balanced crystalloids with the clinical effects of saline for the acute treatment of adults with DKA.

Design, Setting, And Participants: This study was a subgroup analysis of adults with DKA in 2 previously reported companion trials-Saline Against Lactated Ringer's or Plasma-Lyte in the Emergency Department (SALT-ED) and the Isotonic Solutions and Major Adverse Renal Events Trial (SMART). These trials, conducted between January 2016 and March 2017 in an academic medical center in the US, were pragmatic, multiple-crossover, cluster, randomized clinical trials comparing balanced crystalloids vs saline in emergency department (ED) and intensive care unit (ICU) patients. This study included adults who presented to the ED with DKA, defined as a clinical diagnosis of DKA, plasma glucose greater than 250 mg/dL, plasma bicarbonate less than or equal to 18 mmol/L, and anion gap greater than 10 mmol/L. Data analysis was performed from January to April 2020.

Interventions: Balanced crystalloids (clinician's choice of Ringer lactate solution or Plasma-Lyte A solution) vs saline for fluid administration in the ED and ICU according to the same cluster-randomized multiple-crossover schedule.

Main Outcomes And Measures: The primary outcome was time between ED presentation and DKA resolution, as defined by American Diabetes Association criteria. The secondary outcome was time between initiation and discontinuation of continuous insulin infusion.

Results: Among 172 adults included in this secondary analysis of cluster trials, 94 were assigned to balanced crystalloids and 78 to saline. The median (interquartile range [IQR]) age was 29 (24-45) years, and 90 (52.3%) were women. The median (IQR) volume of isotonic fluid administered in the ED and ICU was 4478 (3000-6372) mL. Cumulative incidence analysis revealed shorter time to DKA resolution in the balanced crystalloids group (median time to resolution: 13.0 hours; IQR: 9.5-18.8 hours) than the saline group (median: 16.9 hours; IQR: 11.9-34.5 hours) (adjusted hazard ratio [aHR] = 1.68; 95% CI, 1.18-2.38; P = .004). Cumulative incidence analysis also revealed shorter time to insulin infusion discontinuation in the balanced crystalloids group (median: 9.8 hours; IQR: 5.1-17.0 hours) than the saline group (median: 13.4 hours; IQR: 11.0-17.9 hours) (aHR = 1.45; 95% CI, 1.03-2.03; P = .03).

Conclusions And Relevance: In this secondary analysis of 2 cluster randomized clinical trials, compared with saline, treatment with balanced crystalloids resulted in more rapid resolution of DKA, suggesting that balanced crystalloids may be preferred over saline for acute management of adults with DKA.

Trial Registration: ClinicalTrials.gov Identifiers: NCT02614040; NCT02444988.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.24596DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7670314PMC
November 2020

Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients With COVID-19: A Randomized Clinical Trial.

Authors:
Wesley H Self Matthew W Semler Lindsay M Leither Jonathan D Casey Derek C Angus Roy G Brower Steven Y Chang Sean P Collins John C Eppensteiner Michael R Filbin D Clark Files Kevin W Gibbs Adit A Ginde Michelle N Gong Frank E Harrell Douglas L Hayden Catherine L Hough Nicholas J Johnson Akram Khan Christopher J Lindsell Michael A Matthay Marc Moss Pauline K Park Todd W Rice Bryce R H Robinson David A Schoenfeld Nathan I Shapiro Jay S Steingrub Christine A Ulysse Alexandra Weissman Donald M Yealy B Taylor Thompson Samuel M Brown Jay Steingrub Howard Smithline Bogdan Tiru Mark Tidswell Lori Kozikowski Sherell Thornton-Thompson Leslie De Souza Peter Hou Rebecca Baron Anthony Massaro Imoigele Aisiku Lauren Fredenburgh Raghu Seethala Lily Johnsky Richard Riker David Seder Teresa May Michael Baumann Ashley Eldridge Christine Lord Nathan Shapiro Daniel Talmor Thomas O’Mara Charlotte Kirk Kelly Harrison Lisa Kurt Margaret Schermerhorn Valerie Banner-Goodspeed Katherine Boyle Nicole Dubosh Michael Filbin Kathryn Hibbert Blair Parry Kendall Lavin-Parsons Natalie Pulido Brendan Lilley Carl Lodenstein Justin Margolin Kelsey Brait Alan Jones James Galbraith Rebekah Peacock Utsav Nandi Taylor Wachs Michael Matthay Kathleen Liu Kirsten Kangelaris Ralph Wang Carolyn Calfee Kimberly Yee Gregory Hendey Steven Chang George Lim Nida Qadir Andrea Tam Rebecca Beutler Joseph Levitt Jenny Wilson Angela Rogers Rosemary Vojnik Jonasel Roque Timothy Albertson James Chenoweth Jason Adams Skyler Pearson Maya Juarez Eyad Almasri Mohamed Fayed Alyssa Hughes Shelly Hillard Ryan Huebinger Henry Wang Elizabeth Vidales Bela Patel Adit Ginde Marc Moss Amiran Baduashvili Jeffrey McKeehan Lani Finck Carrie Higgins Michelle Howell Ivor Douglas Jason Haukoos Terra Hiller Carolynn Lyle Alicia Cupelo Emily Caruso Claudia Camacho Stephanie Gravitz James Finigan Christine Griesmer Pauline Park Robert Hyzy Kristine Nelson Kelli McDonough Norman Olbrich Mark Williams Raj Kapoor Jean Nash Meghan Willig Henry Ford Jayna Gardner-Gray Mayur Ramesh Montefiore Moses Michelle Ng Gong Michael Aboodi Ayesha Asghar Omowunmi Amosu Madeline Torres Savneet Kaur Jen-Ting Chen Aluko Hope Brenda Lopez Kathleen Rosales Jee Young You Jarrod Mosier Cameron Hypes Bhupinder Natt Bryan Borg Elizabeth Salvagio Campbell R Duncan Hite Kristin Hudock Autumn Cresie Faysal Alhasan Jose Gomez-Arroyo Abhijit Duggal Omar Mehkri Andrei Hastings Debasis Sahoo Francois Abi Fadel Susan Gole Valerie Shaner Allison Wimer Yvonne Meli Alexander King Thomas Terndrup Matthew Exline Sonal Pannu Emily Robart Sarah Karow Catherine Hough Bryce Robinson Nicholas Johnson Daniel Henning Monica Campo Stephanie Gundel Sakshi Seghal Sarah Katsandres Sarah Dean Akram Khan Olivia Krol Milad Jouzestani Peter Huynh Alexandra Weissman Donald Yealy Denise Scholl Peter Adams Bryan McVerry David Huang Derek Angus Jordan Schooler Steven Moore Clark Files Chadwick Miller Kevin Gibbs Mary LaRose Lori Flores Lauren Koehler Caryn Morse John Sanders Caitlyn Langford Kristen Nanney Masiku MdalaGausi Phyllis Yeboah Peter Morris Jamie Sturgill Sherif Seif Evan Cassity Sanjay Dhar Marjolein de Wit Jessica Mason Andrew Goodwin Greg Hall Abbey Grady Amy Chamberlain Samuel Brown Joseph Bledsoe Lindsay Leither Ithan Peltan Nathan Starr Melissa Fergus Valerie Aston Quinn Montgomery Rilee Smith Mardee Merrill Katie Brown Brent Armbruster Estelle Harris Elizabeth Middleton Robert Paine Stacy Johnson Macy Barrios John Eppensteiner Alexander Limkakeng Lauren McGowan Tedra Porter Andrew Bouffler J. Clancy Leahy Bennet deBoisblanc Matthew Lammi Kyle Happel Paula Lauto Wesley Self Jonathan Casey Matthew Semler Sean Collins Frank Harrell Christopher Lindsell Todd Rice William Stubblefield Christopher Gray Jakea Johnson Megan Roth Margaret Hays Donna Torr Arwa Zakaria David Schoenfeld Taylor Thompson Douglas Hayden Nancy Ringwood Cathryn Oldmixon Christine Ulysse Richard Morse Ariela Muzikansky Laura Fitzgerald Samuel Whitaker Adrian Lagakos Roy Brower Lora Reineck Neil Aggarwal Karen Bienstock Michelle Freemer Myron Maclawiw Gail Weinmann Laurie Morrison Mark Gillespie Richard Kryscio Daniel Brodie Wojciech Zareba Anne Rompalo Michael Boeckh Polly Parsons Jason Christie Jesse Hall Nicholas Horton Laurie Zoloth Neal Dickert Deborah Diercks

JAMA 2020 12;324(21):2165-2176

Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray, Utah.

Importance: Data on the efficacy of hydroxychloroquine for the treatment of coronavirus disease 2019 (COVID-19) are needed.

Objective: To determine whether hydroxychloroquine is an efficacious treatment for adults hospitalized with COVID-19.

Design, Setting, And Participants: This was a multicenter, blinded, placebo-controlled randomized trial conducted at 34 hospitals in the US. Adults hospitalized with respiratory symptoms from severe acute respiratory syndrome coronavirus 2 infection were enrolled between April 2 and June 19, 2020, with the last outcome assessment on July 17, 2020. The planned sample size was 510 patients, with interim analyses planned after every 102 patients were enrolled. The trial was stopped at the fourth interim analysis for futility with a sample size of 479 patients.

Interventions: Patients were randomly assigned to hydroxychloroquine (400 mg twice daily for 2 doses, then 200 mg twice daily for 8 doses) (n = 242) or placebo (n = 237).

Main Outcomes And Measures: The primary outcome was clinical status 14 days after randomization as assessed with a 7-category ordinal scale ranging from 1 (death) to 7 (discharged from the hospital and able to perform normal activities). The primary outcome was analyzed with a multivariable proportional odds model, with an adjusted odds ratio (aOR) greater than 1.0 indicating more favorable outcomes with hydroxychloroquine than placebo. The trial included 12 secondary outcomes, including 28-day mortality.

Results: Among 479 patients who were randomized (median age, 57 years; 44.3% female; 37.2% Hispanic/Latinx; 23.4% Black; 20.1% in the intensive care unit; 46.8% receiving supplemental oxygen without positive pressure; 11.5% receiving noninvasive ventilation or nasal high-flow oxygen; and 6.7% receiving invasive mechanical ventilation or extracorporeal membrane oxygenation), 433 (90.4%) completed the primary outcome assessment at 14 days and the remainder had clinical status imputed. The median duration of symptoms prior to randomization was 5 days (interquartile range [IQR], 3 to 7 days). Clinical status on the ordinal outcome scale at 14 days did not significantly differ between the hydroxychloroquine and placebo groups (median [IQR] score, 6 [4-7] vs 6 [4-7]; aOR, 1.02 [95% CI, 0.73 to 1.42]). None of the 12 secondary outcomes were significantly different between groups. At 28 days after randomization, 25 of 241 patients (10.4%) in the hydroxychloroquine group and 25 of 236 (10.6%) in the placebo group had died (absolute difference, -0.2% [95% CI, -5.7% to 5.3%]; aOR, 1.07 [95% CI, 0.54 to 2.09]).

Conclusions And Relevance: Among adults hospitalized with respiratory illness from COVID-19, treatment with hydroxychloroquine, compared with placebo, did not significantly improve clinical status at day 14. These findings do not support the use of hydroxychloroquine for treatment of COVID-19 among hospitalized adults.

Trial Registration: ClinicalTrials.gov: NCT04332991.
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http://dx.doi.org/10.1001/jama.2020.22240DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7653542PMC
December 2020

External Corroboration That Corticosteroids May Be Harmful to Septic Shock Endotype A Patients.

Crit Care Med 2021 Jan;49(1):e98-e101

Inflammatix, Burlingame, CA.

Objectives: We previously reported gene expression-based endotypes of pediatric septic shock, endotypes A and B, and that corticosteroid exposure was independently associated with increased mortality among pediatric endotype A patients. The Vasopressin vs Norepinephrine as Initial Therapy in Septic Shock trial tested the efficacy of vasopressin as initial vasopressor therapy for septic shock among adult patients, when compared with norepinephrine. Patients who reached a prespecified dose of either vasopressor were further randomized to receive hydrocortisone or placebo. A proportion of patients in the Vasopressin vs Norepinephrine as Initial Therapy in Septic Shock trial had transcriptomic data generated at baseline using whole blood-derived messenger RNA. We used the publicly available transcriptomic data from the Vasopressin vs Norepinephrine as Initial Therapy in Septic Shock trial to assign the study subjects to pediatric septic shock endotype A or B, and tested the hypothesis that hydrocortisone treatment is associated with increased mortality among patients in endotype A.

Design: Secondary analysis of publicly available transcriptomic data.

Setting: Multiple adult ICUs.

Patients: Adults with septic shock randomized to hydrocortisone (n = 47) or placebo (n = 50).

Interventions: Randomization to the Vasopressin vs Norepinephrine as Initial Therapy in Septic Shock trial experimental arms.

Measurements And Main Results: Endotype A patients receiving hydrocortisone had a mortality rate of 46%, whereas endotype A patients receiving placebo had a mortality rate of 22% (p = 0.105). In contrast, the mortality rates for endotype B patients receiving hydrocortisone or placebo were 19% and 22%, respectively. The odds of death were more than three times greater in endotype A patients receiving hydrocortisone than endotype A patients receiving placebo (p = 0.05).

Conclusions: This exploratory analysis provides further evidence that corticosteroid exposure may be associated with increased mortality among septic shock endotype A patients.
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http://dx.doi.org/10.1097/CCM.0000000000004709DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7746624PMC
January 2021

Telework Before Illness Onset Among Symptomatic Adults Aged ≥18 Years With and Without COVID-19 in 11 Outpatient Health Care Facilities - United States, July 2020.

MMWR Morb Mortal Wkly Rep 2020 Nov 6;69(44):1648-1653. Epub 2020 Nov 6.

Since March 2020, large-scale efforts to reduce transmission of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), have continued. Mitigation measures to reduce workplace exposures have included work site policies to support flexible work site options, including telework, whereby employees work remotely without commuting to a central place of work.* Opportunities to telework have varied across industries among U.S. jobs where telework options are feasible (1). However, little is known about the impact of telework on risk for SARS-CoV-2 infection. A case-control investigation was conducted to compare telework between eligible symptomatic persons who received positive SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) test results (case-patients, 153) and symptomatic persons with negative test results (control-participants, 161). Eligible participants were identified in outpatient health care facilities during July 2020. Among employed participants who reported on their telework status during the 2 weeks preceding illness onset (248), the percentage who were able to telework on a full- or part-time basis was lower among case-patients (35%; 42 of 120) than among control-participants (53%; 68 of 128) (p<0.01). Case-patients were more likely than were control-participants to have reported going exclusively to an office or school setting (adjusted odds ratio [aOR] = 1.8; 95% confidence interval [CI] = 1.2-2.7) in the 2 weeks before illness onset. The association was also observed when further restricting to the 175 participants who reported working in a profession outside the critical infrastructure (aOR = 2.1; 95% CI = 1.3-3.6). Providing the option to work from home or telework when possible, is an important consideration for reducing the risk for SARS-CoV-2 infection. In industries where telework options are not available, worker safety measures should continue to be scaled up to reduce possible worksite exposures.
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http://dx.doi.org/10.15585/mmwr.mm6944a4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7643895PMC
November 2020

Efficacy and safety of dapagliflozin in acute heart failure: Rationale and design of the DICTATE-AHF trial.

Am Heart J 2021 02 2;232:116-124. Epub 2020 Nov 2.

Division of Cardiology, Vanderbilt University Medical Center, Nashville, TN.

Background: Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, reduces cardiovascular death and worsening heart failure in patients with chronic heart failure and reduced ejection fraction. Early initiation during an acute heart failure (AHF) hospitalization may facilitate decongestion, improve natriuresis, and facilitate safe transition to a beneficial outpatient therapy for both diabetes and heart failure.

Objective: The objective is to assess the efficacy and safety of initiating dapagliflozin within the first 24 hours of hospitalization in patients with AHF compared to usual care.

Methods: DICTATE-AHF is a prospective, multicenter, open-label, randomized trial enrolling a planned 240 patients in the United States. Patients with type 2 diabetes hospitalized with hypervolemic AHF and an estimated glomerular filtration rate of at least 30 mL/min/1.73m are eligible for participation. Patients are randomly assigned 1:1 to dapagliflozin 10 mg once daily or structured usual care until day 5 or hospital discharge. Both treatment arms receive protocolized diuretic and insulin therapies. The primary endpoint is diuretic response expressed as the cumulative change in weight per cumulative loop diuretic dose in 40 mg intravenous furosemide equivalents. Secondary and exploratory endpoints include inpatient worsening AHF, 30-day hospital readmission for AHF or diabetic reasons, change in NT-proBNP, and measures of natriuresis. Safety endpoints include the incidence of hyper/hypoglycemia, ketoacidosis, worsening kidney function, hypovolemic hypotension, and inpatient mortality.

Conclusions: The DICTATE-AHF trial will establish the efficacy and safety of early initiation of dapagliflozin during AHF across both AHF and diabetic outcomes in patients with diabetes.
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http://dx.doi.org/10.1016/j.ahj.2020.10.071DOI Listing
February 2021

Mechanical Ventilation of Severe Traumatic Brain Injury Patients in the Prehospital Setting.

Air Med J 2020 Sep - Oct;39(5):410-413. Epub 2020 Jun 10.

Department of Emergency Medicine, University of Cincinnati College of Medicine, Cincinnati, OH.

Objective: Suboptimal ventilation may impact outcomes in patients with traumatic brain injury (TBI). This study compares the incidence of eucapnia between manually and mechanically ventilated patients with severe TBI during helicopter transport.

Methods: This retrospective chart review included consecutive intubated adults with severe TBI (Glasgow Coma Scale score < 9) transported by helicopter from the scene of injury to a level 1 trauma center between 2009 and 2015. The primary outcome was the first venous partial pressure of carbon dioxide obtained in the emergency department. Hypocapnia, eucapnia, and hypercapnia were defined based on the normal range for the testing instrument. The Fisher exact test was used to compare groups.

Results: Of 1,070 trauma patients intubated and transported, 93 met the inclusion criteria with full data. The mean age was 43 years, 81 of 93 were white, and 70 of 93 were men. The mean Injury Severity Score was 29, and 26 of 93 were mechanically ventilated. Hypocapnia occurred in 4 of 93 and hypercapnia in 56 of 93. There was no difference in the rate of eucapnia in manually ventilated compared with mechanically ventilated patients (36% vs. 35%, P = 1.00).

Conclusion: Eucapnia at emergency department arrival occurred in 36% of patients and was unaffected by whether ventilation was manually or mechanically controlled. Few patients were hypocapnic, indicating a low incidence of hyperventilation during helicopter transport.
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http://dx.doi.org/10.1016/j.amj.2020.04.020DOI Listing
June 2020

Incorporating real-time influenza detection into the test-negative design for estimating influenza vaccine effectiveness: The real-time test-negative design (rtTND).

Clin Infect Dis 2020 Sep 25. Epub 2020 Sep 25.

Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.

With rapid and accurate molecular influenza testing now widely available in clinical settings, influenza vaccine effectiveness (VE) studies can prospectively select participants for enrollment based on real-time results rather than enrolling all eligible patients regardless of influenza status, as in the traditional test-negative design (TND). Thus, we explore advantages and disadvantages of modifying the TND for estimating VE by using real-time, clinically available viral testing results paired with acute respiratory infection eligibility criteria for identifying influenza cases and test-negative controls prior to enrollment. This modification, which we have called the real-time test-negative design (rtTND), has the potential to improve influenza VE studies by optimizing the case-to-test-negative control ratio, more accurately classifying influenza status, improving study efficiency, reducing study cost, and increasing study power to adequately estimate VE. Important considerations for limiting biases in the rtTND include the need for comprehensive clinical influenza testing at study sites and accurate influenza tests.
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http://dx.doi.org/10.1093/cid/ciaa1453DOI Listing
September 2020

Socioeconomic Factors and Intensive Care Unit-Related Cognitive Impairment.

Ann Surg 2020 10;272(4):596-602

Section of Surgical Sciences, Vanderbilt University Medical Center, Nashville, TN.

Objective: We aimed to identify socioeconomic and clinical risk factors for post-intensive care unit (ICU)-related long-term cognitive impairment (LTCI).

Summary Background Data: After delirium during ICU stay, LTCI has been increasingly recognized, but without attention to socioeconomic factors.

Methods: We enrolled a prospective, multicenter cohort of ICU survivors with shock or respiratory failure from surgical and medical ICUs across 5 civilian and Veteran Affairs (VA) hospitals from 2010 to 2016. Our primary outcome was LTCI at 3- and 12 months post-hospital discharge defined by the Repeatable Battery for Assessment of Neuropsychological Symptoms (RBANS) global score. Covariates adjusted using multivariable linear regression included age, sex, race, AHRQ socioeconomic index, Charlson comorbidity, Framingham stroke risk, Sequential Organ Failure Assessment, duration of coma, delirium, hypoxemia, sepsis, education level, hospital type, insurance status, discharge disposition, and ICU drug exposures.

Results: Of 1040 patients, 71% experienced delirium, and 47% and 41% of survivors had RBANS scores >1 standard deviation below normal at 3- and 12 months, respectively. Adjusted analysis indicated that delirium, non-White race, lower education, and civilian hospitals (as opposed to VA), were associated with at least a half standard deviation lower RBANS scores at 3- and 12 months (P ≤ 0.03). Sex, AHRQ socioeconomic index, insurance status, and discharge disposition were not associated with RBANS scores.

Conclusions: Socioeconomic and clinical risk factors, such as race, education, hospital type, and delirium duration, were linked to worse PICS ICU-related, LTCI. Further efforts may focus on improved identification of higher-risk groups to promote survivorship through emerging improvements in cognitive rehabilitation.
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http://dx.doi.org/10.1097/SLA.0000000000004377DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7739516PMC
October 2020

Community and Close Contact Exposures Associated with COVID-19 Among Symptomatic Adults ≥18 Years in 11 Outpatient Health Care Facilities - United States, July 2020.

MMWR Morb Mortal Wkly Rep 2020 Sep 11;69(36):1258-1264. Epub 2020 Sep 11.

Community and close contact exposures continue to drive the coronavirus disease 2019 (COVID-19) pandemic. CDC and other public health authorities recommend community mitigation strategies to reduce transmission of SARS-CoV-2, the virus that causes COVID-19 (1,2). Characterization of community exposures can be difficult to assess when widespread transmission is occurring, especially from asymptomatic persons within inherently interconnected communities. Potential exposures, such as close contact with a person with confirmed COVID-19, have primarily been assessed among COVID-19 cases, without a non-COVID-19 comparison group (3,4). To assess community and close contact exposures associated with COVID-19, exposures reported by case-patients (154) were compared with exposures reported by control-participants (160). Case-patients were symptomatic adults (persons aged ≥18 years) with SARS-CoV-2 infection confirmed by reverse transcription-polymerase chain reaction (RT-PCR) testing. Control-participants were symptomatic outpatient adults from the same health care facilities who had negative SARS-CoV-2 test results. Close contact with a person with known COVID-19 was more commonly reported among case-patients (42%) than among control-participants (14%). Case-patients were more likely to have reported dining at a restaurant (any area designated by the restaurant, including indoor, patio, and outdoor seating) in the 2 weeks preceding illness onset than were control-participants (adjusted odds ratio [aOR] = 2.4; 95% confidence interval [CI] = 1.5-3.8). Restricting the analysis to participants without known close contact with a person with confirmed COVID-19, case-patients were more likely to report dining at a restaurant (aOR = 2.8, 95% CI = 1.9-4.3) or going to a bar/coffee shop (aOR = 3.9, 95% CI = 1.5-10.1) than were control-participants. Exposures and activities where mask use and social distancing are difficult to maintain, including going to places that offer on-site eating or drinking, might be important risk factors for acquiring COVID-19. As communities reopen, efforts to reduce possible exposures at locations that offer on-site eating and drinking options should be considered to protect customers, employees, and communities.
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http://dx.doi.org/10.15585/mmwr.mm6936a5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7499837PMC
September 2020

Seroprevalence of SARS-CoV-2 Among Frontline Health Care Personnel in a Multistate Hospital Network - 13 Academic Medical Centers, April-June 2020.

MMWR Morb Mortal Wkly Rep 2020 Sep 4;69(35):1221-1226. Epub 2020 Sep 4.

Health care personnel (HCP) caring for patients with coronavirus disease 2019 (COVID-19) might be at high risk for contracting SARS-CoV-2, the virus that causes COVID-19. Understanding the prevalence of and factors associated with SARS-CoV-2 infection among frontline HCP who care for COVID-19 patients are important for protecting both HCP and their patients. During April 3-June 19, 2020, serum specimens were collected from a convenience sample of frontline HCP who worked with COVID-19 patients at 13 geographically diverse academic medical centers in the United States, and specimens were tested for antibodies to SARS-CoV-2. Participants were asked about potential symptoms of COVID-19 experienced since February 1, 2020, previous testing for acute SARS-CoV-2 infection, and their use of personal protective equipment (PPE) in the past week. Among 3,248 participants, 194 (6.0%) had positive test results for SARS-CoV-2 antibodies. Seroprevalence by hospital ranged from 0.8% to 31.2% (median = 3.6%). Among the 194 seropositive participants, 56 (29%) reported no symptoms since February 1, 2020, 86 (44%) did not believe that they previously had COVID-19, and 133 (69%) did not report a previous COVID-19 diagnosis. Seroprevalence was lower among personnel who reported always wearing a face covering (defined in this study as a surgical mask, N95 respirator, or powered air purifying respirator [PAPR]) while caring for patients (5.6%), compared with that among those who did not (9.0%) (p = 0.012). Consistent with persons in the general population with SARS-CoV-2 infection, many frontline HCP with SARS-CoV-2 infection might be asymptomatic or minimally symptomatic during infection, and infection might be unrecognized. Enhanced screening, including frequent testing of frontline HCP, and universal use of face coverings in hospitals are two strategies that could reduce SARS-CoV-2 transmission.
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http://dx.doi.org/10.15585/mmwr.mm6935e2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7470460PMC
September 2020

Exposures in adult outpatients with COVID-19 infection during early community transmission, Tennessee.

Influenza Other Respir Viruses 2021 01 4;15(1):175-177. Epub 2020 Aug 4.

Vanderbilt University School of Medicine, Nashville, TN, USA.

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http://dx.doi.org/10.1111/irv.12792DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7436307PMC
January 2021

Impact of a Follow-up Telephone Call Program on 30-Day Readmissions (FUTR-30): A Pragmatic Randomized Controlled Real-world Effectiveness Trial.

Med Care 2020 09;58(9):785-792

Medicine, Vanderbilt University.

Background: Telephone call programs are a common intervention used to improve patients' transition to outpatient care after hospital discharge.

Objective: To examine the impact of a follow-up telephone call program as a readmission reduction initiative.

Research Design: Pragmatic randomized controlled real-world effectiveness trial.

Subjects: We enrolled and randomized all patients discharged home from a hospital general medicine service to a follow-up telephone call program or usual care discharge. Patients discharged against medical advice were excluded. The intervention was a hospital program, delivering a semistructured follow-up telephone call from a nurse within 3-7 days of discharge, designed to assess understanding and provide education, and assistance to support discharge plan implementation.

Measures: Our primary endpoint was hospital inpatient readmission within 30 days identified by the electronic health record. Secondary endpoints included observation readmission, emergency department revisit, and mortality within 30 days, and patient experience ratings.

Results: All 3054 patients discharged home were enrolled and randomized to the telephone call program (n=1534) or usual care discharge (n=1520). Using a prespecified intention-to-treat analysis, we found no evidence supporting differences in 30-day inpatient readmissions [14.9% vs. 15.3%; difference -0.4 (95% confidence interval, 95% CI), -2.9 to 2.1; P=0.76], observation readmissions [3.8% vs. 3.6%; difference 0.2 (95% CI, -1.1 to 1.6); P=0.74], emergency department revisits [6.1% vs. 5.4%; difference 0.7 (95% CI, -1.0 to 2.3); P=0.43], or mortality [4.4% vs. 4.9%; difference -0.5 (95% CI, -2.0 to 1.0); P=0.51] between telephone call and usual care groups.

Conclusions: We found no evidence of an impact on 30-day readmissions or mortality due to the postdischarge telephone call program.
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http://dx.doi.org/10.1097/MLR.0000000000001353DOI Listing
September 2020

Symptom Duration and Risk Factors for Delayed Return to Usual Health Among Outpatients with COVID-19 in a Multistate Health Care Systems Network - United States, March-June 2020.

MMWR Morb Mortal Wkly Rep 2020 Jul 31;69(30):993-998. Epub 2020 Jul 31.

Prolonged symptom duration and disability are common in adults hospitalized with severe coronavirus disease 2019 (COVID-19). Characterizing return to baseline health among outpatients with milder COVID-19 illness is important for understanding the full spectrum of COVID-19-associated illness and tailoring public health messaging, interventions, and policy. During April 15-June 25, 2020, telephone interviews were conducted with a random sample of adults aged ≥18 years who had a first positive reverse transcription-polymerase chain reaction (RT-PCR) test for SARS-CoV-2, the virus that causes COVID-19, at an outpatient visit at one of 14 U.S. academic health care systems in 13 states. Interviews were conducted 14-21 days after the test date. Respondents were asked about demographic characteristics, baseline chronic medical conditions, symptoms present at the time of testing, whether those symptoms had resolved by the interview date, and whether they had returned to their usual state of health at the time of interview. Among 292 respondents, 94% (274) reported experiencing one or more symptoms at the time of testing; 35% of these symptomatic respondents reported not having returned to their usual state of health by the date of the interview (median = 16 days from testing date), including 26% among those aged 18-34 years, 32% among those aged 35-49 years, and 47% among those aged ≥50 years. Among respondents reporting cough, fatigue, or shortness of breath at the time of testing, 43%, 35%, and 29%, respectively, continued to experience these symptoms at the time of the interview. These findings indicate that COVID-19 can result in prolonged illness even among persons with milder outpatient illness, including young adults. Effective public health messaging targeting these groups is warranted. Preventative measures, including social distancing, frequent handwashing, and the consistent and correct use of face coverings in public, should be strongly encouraged to slow the spread of SARS-CoV-2.
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http://dx.doi.org/10.15585/mmwr.mm6930e1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7392393PMC
July 2020

Seroprevalence of SARS-CoV-2 Among Frontline Healthcare Personnel During the First Month of Caring for COVID-19 Patients - Nashville, Tennessee.

Clin Infect Dis 2020 Jul 6. Epub 2020 Jul 6.

Department of Emergency Medicine, Vanderbilt University Medical Center.

Among 249 healthcare personnel who worked in hospital units with COVID-19 patients for one month, 19 (7.6%) tested positive for SARS-CoV-2 antibodies. Only 11 (57.9%) of the 19 personnel with positive serology reported symptoms of a prior illness, suggesting asymptomatic healthcare personnel could be an important source of SARS-CoV-2 transmission.
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http://dx.doi.org/10.1093/cid/ciaa936DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7454447PMC
July 2020

Characteristics of Adult Outpatients and Inpatients with COVID-19 - 11 Academic Medical Centers, United States, March-May 2020.

MMWR Morb Mortal Wkly Rep 2020 Jul 3;69(26):841-846. Epub 2020 Jul 3.

Descriptions of coronavirus disease 2019 (COVID-19) in the United States have focused primarily on hospitalized patients. Reports documenting exposures to SARS-CoV-2, the virus that causes COVID-19, have generally been described within congregate settings, such as meat and poultry processing plants (1) and long-term care facilities (2). Understanding individual behaviors and demographic characteristics of patients with COVID-19 and risks for severe illness requiring hospitalization can inform efforts to reduce transmission. During April 15-May 24, 2020, telephone interviews were conducted with a random sample of adults aged ≥18 years who had positive reverse transcription-polymerase chain reaction (RT-PCR) test results for SARS-CoV-2 in outpatient and inpatient settings at 11 U.S. academic medical centers in nine states. Respondents were contacted 14-21 days after SARS-CoV-2 testing and asked about their demographic characteristics, underlying chronic conditions, symptoms experienced on the date of testing, and potential exposures to SARS-CoV-2 during the 2 weeks before illness onset (or the date of testing among those who did not report symptoms at the time of testing). Among 350 interviewed patients (271 [77%] outpatients and 79 [23%] inpatients), inpatients were older, more likely to be Hispanic and to report dyspnea than outpatients. Fewer inpatients (39%, 20 of 51) reported a return to baseline level of health at 14-21 days than did outpatients (64%, 150 of 233) (p = 0.001). Overall, approximately one half (46%) of patients reported known close contact with someone with COVID-19 during the preceding 2 weeks. This was most commonly a family member (45%) or a work colleague (34%). Approximately two thirds (64%, 212 of 333) of participants were employed; only 35 of 209 (17%) were able to telework. These findings highlight the need for screening, case investigation, contact tracing, and isolation of infected persons to control transmission of SARS-CoV-2 infection during periods of community transmission. The need for enhanced measures to ensure workplace safety, including ensuring social distancing and more widespread use of cloth face coverings, are warranted (3).
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http://dx.doi.org/10.15585/mmwr.mm6926e3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7332092PMC
July 2020

Rationale and Design of ORCHID: A Randomized Placebo-controlled Clinical Trial of Hydroxychloroquine for Adults Hospitalized with COVID-19.

Ann Am Thorac Soc 2020 09;17(9):1144-1153

Department of Emergency Medicine, and.

The ORCHID (Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease) trial is a multicenter, blinded, randomized trial of hydroxychloroquine versus placebo for the treatment of adults hospitalized with coronavirus disease (COVID-19). This document provides the rationale and background for the trial and highlights key design features. We discuss five novel challenges to the design and conduct of a large, multicenter, randomized trial during a pandemic, including ) widespread, off-label use of the study drug before the availability of safety and efficacy data; ) the need to adapt traditional procedures for documentation of informed consent during an infectious pandemic; ) developing a flexible and robust Bayesian analysis incorporating significant uncertainty about the disease, outcomes, and treatment; ) obtaining indistinguishable drug and placebo without delaying enrollment; and ) rapidly obtaining administrative and regulatory approvals. Our goals in describing how the ORCHID trial progressed from study conception to enrollment of the first patient in 15 days are to inform the development of other high-quality, multicenter trials targeting COVID-19. We describe lessons learned to improve the efficiency of future clinical trials, particularly in the setting of pandemics. The ORCHID trial will provide high-quality, clinically relevant data on the safety and efficacy of hydroxychloroquine for the treatment of COVID-19 among hospitalized adults.Clinical trial registered with www.clinicaltrials.gov (NCT04332991).
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http://dx.doi.org/10.1513/AnnalsATS.202005-478SDDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7462324PMC
September 2020

The Disruptive bEhavior manageMEnt ANd prevention in hospitalized patients using a behaviORal intervention team (DEMEANOR) study protocol: a pragmatic, cluster, crossover trial.

Trials 2020 May 24;21(1):417. Epub 2020 May 24.

Department of Biostatistics and Vanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.

Background: Disruptive behavior in hospitalized patients has become a priority area of safety concern for clinical staff, and also has consequences for patient management and hospital course. Proactive screening and intervention of patients with behavioral comorbidities has been reported to reduce disruptive behavior in some settings, but it has not been studied in a rigorous way.

Methods: The Disruptive bEhavior manageMEnt ANd prevention in hospitalized patients using a behaviORal intervention team (DEMEANOR) study is a pragmatic, cluster, crossover trial that is being conducted. Each month, the behavioral intervention team, comprising a psychiatric-mental health advanced practice nurse and a clinical social worker, with psychiatrist consultation as needed, rotates between an adult medicine unit and a mixed cardiac unit at Vanderbilt University Medical Center in Nashville, TN, USA. The team proactively screens patients upon admission, utilizing a protocol which includes a comprehensive chart review and, if indicated, a brief interview, seeking to identify those patients who possess risk factors indicative of either a potential psychological barrier to their own clinical progress or a potential risk for exhibiting disruptive, aggressive, or self-injurious behavior during their hospitalization. Once identified, the team provides interventions aimed at mitigating these risks, educates and supports the patient care teams (nurses, physicians, and others), and assists non-psychiatric staff in the management of patients who require behavioral healthcare. Patients who are both admitted to and discharged from either unit are included in the study. Anticipated enrollment is approximately 1790 patients. The two primary outcomes are (1) a composite of objective measures related to the patients' disruptive, threatening, or acting out behaviors, and (2) staff self-reported comfort with and confidence in their ability to manage patients exhibiting disruptive, threatening, or acting out behavior. Secondary outcomes include patient length of stay, patient attendant (sitter) use, and the unit nursing staff retention.

Discussion: This ongoing trial will provide evidence on the real-world effectiveness of a proactive behavioral intervention to prevent disruptive, threatening, or acting out events in adult hospitalized patients.

Trial Registration: ClinicalTrials.gov: NCT03777241. Registered on 14 December 2018.
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http://dx.doi.org/10.1186/s13063-020-04278-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7245750PMC
May 2020

Action-Informed Artificial Intelligence-Matching the Algorithm to the Problem.

JAMA 2020 Jun;323(21):2141-2142

Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee.

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http://dx.doi.org/10.1001/jama.2020.5035DOI Listing
June 2020

In response: Letter on update to the Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) protocol.

Trials 2020 Apr 22;21(1):351. Epub 2020 Apr 22.

Division of Pulmonary & Critical Care Medicine, Department of Medicine, Johns Hopkins University, 1800 Orleans Street, Suite 9121, Baltimore, MD, 21287, USA.

Trial Registration: ClinicalTrials.gov: NCT03509350. Registered on 26 April 2018.
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http://dx.doi.org/10.1186/s13063-020-04290-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7175511PMC
April 2020