Medication use evaluation of tocilizumab implementation in COVID-19 treatment guidelines: A causal inference approach.

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: Introduction of new medications to health-system formularies is often not accompanied by assessments of their clinical impact on the local patient population. The growing availability of electronic health record (EHR) data and advancements in pharmacoepidemiology methods offer institutions the opportunity to monitor the medication implementation process and assess clinical effectiveness in the local clinical context. In this study, we applied novel causal inference methods to evaluate the effects of a formulary policy introducing tocilizumab therapy for critically ill patients with coronavirus disease 2019 (COVID-19). METHODS: We conducted a medication use evaluation utilizing EHR data from patients admitted to a large medical center during the 6 months before and after implementation of a formulary policy endorsing the use of tocilizumab for treatment of COVID-19. The impact of tocilizumab on 28-day all-cause mortality was assessed using a difference-in-differences analysis, with ineligible patients serving as a nonequivalent control group, and a matched analysis guided by a target trial emulation framework. Safety endpoints assessed included the incidence of secondary infections and liver enzyme elevations. Our findings were benchmarked against clinical trials, an observational study, and a meta-analysis. RESULTS: Following guideline modification, tocilizumab was administered to 69% of eligible patients. This implementation was associated with a 3.1% absolute risk reduction in 28-day mortality (odds ratio, 0.86; number needed to treat to prevent one death, 32) attributable to the inclusion of tocilizumab in the guidelines and an additional 8.6% absolute risk reduction (odds ratio, 0.65; number needed to treat to prevent one death, 12) linked to its administration. These findings were consistent with estimates from published literature, although the effect estimates from the difference-in-differences analysis exhibited imprecision. CONCLUSION: Evaluating formulary management decisions through novel causal inference approaches offers valuable estimates of clinical effectiveness and the potential to optimize the impact of new medications on population outcomes.

On-Site More Frequent Dialysis May Hasten Return Home for Nursing Home End-Stage Renal Disease Patients.

BACKGROUND: A direct outcome comparison between Skilled nursing facility (SNF) patients receiving on-site more frequent dialysis (MFD) targeting 14 hours of treatment over five sessions weekly compared to on-site conventional dialysis for death, hospitalization and speed of return home has not been reported. METHODS: From Jan 1, 2022, to July 1, 2023, in a retrospective prospective observational design, using an intent to treat and competing risk strategy, all new admissions to an on-site in SNF dialysis service admitted to nursing homes with on-site MFD dialysis were compared to admissions to nursing homes providing on-site conventional dialysis for the outcome goal of 90 day cumulative incidence of discharge to home, while monitoring safety issues represented by the competing risks of hospitalization and death. RESULTS: 10,246 MFD dialytic episodes and 3,451 conventional dialytic episodes were studied in 195 nursing homes in 12 states. At baseline the MFD population was consistently sicker than CONVENTIONAL dialysis population with a first systolic blood pressure in 23% vs 7.6% (p<.001), lower mean hemoglobin (9.3g/dl vs 10.4g/dl; p<.001), lower iron saturation (25.7% vs 26.6%; p=0.02), higher Charlson score (3.5 vs 3.0; p<.001), higher mean age (67.6 vs 66.7; p<.001). ), more complicated diabetes (31% vs 24%; P<.001), cerebrovascular disease ( 12.6% vs 6.8%:p<.001), and congestive heart failure (24% vs 18%). At 42 days, discharge to home was 25% greater in the MFD than conventional group (17.5% vs 14%) without worsened hospitalization or death. CONCLUSION: Despite a handicap of sicker patients at baseline, real-world application of MFD appears to hasten return home from SNFs compared to conventional dialysis. The findings suggests that MFD allows for SNF acceptance of sicker patients, presumably permitting earlier hospital discharge, without safety compromise as measured by death or rehospitalization benefitting hospitals, patients, and payers.

Imaging Utilization and Cost of Substance Use in an Urban Academic Medical Center During the Contemporary Opioid Epidemic.

RATIONALE AND OBJECTIVES: To determine the recent impact of illicit substance use on imaging utilization and associated costs. METHODS: Retrospective study from an inner city urban multi-site academic medical center. Institutional Review Board (IRB) approval was obtained with a waiver of informed consent. A substance use cohort comprised patients 12 years old presenting to the Emergency Department (ED) January 2017 to June 2019 with a positive urine toxicology and an ICD code associated with substance use. The comparison cohort was randomly selected from a group of ED patients who presented with no or negative urine toxicology and no documented substance use ICD code. Data extracted from the EMR included demographics, number and type of imaging studies, Charlson comorbidity index, and in-hospital mortality during the study period. RESULTS: The substance use and comparison cohorts comprised 3191 and 3200 patients, respectively. The substance use cohort was older on average (mean age 45.67 ± 14.88 vs 43.91 ± 20.57 years), more often male (63% [2026/3191] vs. 39% [1255/3200]) and had a mean Charlson score 88% higher than the comparison cohort (3.33 vs 1.78). The majority of both cohorts were ethnic minorities (<10% white). The substance use cohort had significantly more imaging vs the comparison cohort, total 36,413 (mean 11.41 exams/patient) vs total 12,399 (mean 3.87 exams/patient), p < 0.0001, and was higher for all modalities except mammography. Average imaging costs per patient were nearly 300% higher for the substance use vs comparison cohort, ($1287.18 vs. $434.70). CONCLUSION: Imaging utilization and associated costs were substantially higher for patients with a positive urine toxicology and substance use related ICD codes compared to the broader ED population in an underserved urban population.

Improved nursing home end-stage renal disease patient participation in physical therapy with onsite, more frequent dialysis.

INTRODUCTION: For end-stage renal disease (ESRD) patients residing in skilled nursing facilities (SNFs), the logistics and physical exhaustion of life-saving hemodialysis therapy often conflict with rehabilitation goals. Integration of dialysis care with rehabilitation programs in a scalable and cost-efficient manner has been a significant challenge. SNF-resident ESRD patients receiving onsite, more frequent hemodialysis (MFD) have reported rapid post-dialysis recovery. We examined whether such patients have improved Physical Therapy (PT) participation. METHODS: We conducted a retrospective electronic medical records review of SNF-resident PT participation rates within a multistate provider of SNF rehabilitation care from January 1, 2022 to June 1, 2022. We compared three groups: ESRD patients receiving onsite MFD (Onsite-MFD), ESRD patients receiving offsite, conventional 3×/week dialysis (Offsite-Conventional-HD), and the general non-ESRD SNF rehabilitation population (Non-ESRD). We evaluated physical therapy participation rates based on a predefined metric of missed or shortened (<15 min) therapy days. Baseline demographics and functional status were assessed. FINDINGS: Ninety-two Onsite-MFD had 2084 PT sessions scheduled, 12,916 Non-ESRD had 225,496 PT sessions scheduled, and 562 Offsite-Conventional-HD had 9082 PT sessions scheduled. In mixed model logistic regression, Onsite-MFD achieved higher PT participation rates than Offsite-Conventional-HD (odds ratio: 1.8, CI: 1.1-3.0; p < 0.03), and Onsite-MFD achieved equivalent PT participation rates to Non-ESRD (odds ratio: 1.2, CI: 0.3-1.9; p < 0.46). Baseline mean ± SD Charlson Comorbidity score was significantly higher in Onsite-MFD (4.9 ± 2.0) and Offsite-Conventional-HD (4.9 ± 1.8) versus Non-ESRD (2.6 ± 2.0; p < 0.001). Baseline mean self-care and mobility scores were significantly lower in Onsite-MFD versus Non-ESRD or Offsite-Conventional-HD. DISCUSSION: SNF-resident ESRD patients receiving MFD colocated with rehabilitation had higher PT participation rates than those conventionally dialyzed offsite and equivalent PT participation rates to the non-ESRD SNF-rehabilitation general population, despite being sicker, less independent, and less mobile. We report a scalable program integrating dialysis and rehabilitation care as a potential solution for ESRD patients recovering from acute hospitalization.

Evaluating Pharmacist-Led Heart Failure Transitions of Care Clinic: Impact of Analytic Approach on Readmission Rate Endpoints.

Studies evaluating pharmacist-led transitions of care (TOC) services for heart failure patients reported profound decreases in hospital readmissions. Most studies restricted their analysis to clinic attendees (as-treated analysis), which can introduce selection and immortal time bias. In this study, we evaluated the impact of including only clinic attendees vs all clinic referrals in assessing the effectiveness of a pharmacist-led heart failure transitions of care (PharmD HF TOC) clinic program on 30-day readmissions. This is a retrospective, observational study of patients discharged from a heart failure hospitalization at a large urban academic medical center from August 2016 to December 2018. Primary exposure was the provision of a PharmD HF TOC clinic appointment in the intent-to-treat analysis and the attendance of the clinic in the as-treated analysis. Primary outcome was all-cause readmissions within 30 days of discharge. There were 766 and 1015 patients included in the as-treated and intent-to-treat analyses, respectively. In the as-treated analysis, 30-day all-cause readmissions were significantly lower in the intervention group compared to the control group (12.4% vs 19.6%, P = 0.018). In contrast, the intent-to-treat analysis did not reveal a significant difference in 30-day all-cause readmissions between the intervention group and the control group (18.2% vs 19.6%, P = 0.643). Pharmacist-led heart failure TOC program is associated with a reduction in 30-day all-cause readmissions only when restricting the analysis to clinic attendees. Future studies evaluating the effectiveness of post-discharge TOC services need to carefully consider the biases inherent in the evaluation methods employed.

Does comorbidity burden explain the higher COVID-19 mortality risk among men? A retrospective cross-sectional analysis of a well-defined cohort of patients in Bronx, New York.

OBJECTIVES: Men have a higher mortality rate and more severe COVID-19 infection than women. The mechanism for this is unclear. We hypothesise that innate sex differences, rather than comorbidity burden, drive higher male mortality. DESIGN: Retrospective cohort. SETTING: Montefiore Health System (MHS) in Bronx, New York, USA. PARTICIPANTS: A cohort population of 364 992 patients at MHS between 1 January 2018 and 1 January 2020 was defined, from which individuals hospitalised during the pre-COVID period (1 January 2020-15 February 2020) (n=5856) and individuals hospitalised during the COVID-19 surge (1 March 2020-15 April 2020) (n=4793) were examined for outcomes. A subcohort with confirmed COVID-19+ hospitalisation was also examined (n=1742). PRIMARY AND SECONDARY OUTCOME MEASURES: Hospitalisation and in-hospital mortality. RESULTS: Men were older, had more comorbidities, lower body mass index and were more likely to smoke. Unadjusted logistic regression showed a higher odds of death in hospitalised men than women during both the pre-COVID-19 and COVID-19 periods (pre-COVID-19, OR: 1.66 vs COVID-19 OR: 1.98). After adjustment for relevant clinical and demographic factors, the higher risk of male death attenuated towards the null in the pre-COVID-19 period (OR 1.36, 95% CI 1.05 to 1.76) but remained significantly higher in the COVID-19 period (OR 2.02; 95% CI 1.73 to 2.34).In the subcohort of COVID-19+ hospitalised patients, men had 1.37 higher odds of in-hospital death (95% CI 1.09 to 1.72), which was not altered by adjustment for comorbidity (OR remained at 1.38 (95% CI 1.08 to 1.76)) but was attenuated with addition of initial pulse oximetry on presentation (OR 1.26, 95% CI 0.99 to 1.62). CONCLUSIONS: Higher male mortality risk during the COVID-19 period despite adjustment for comorbidity supports the role of innate physiological susceptibility to COVID-19 death. Attenuation of higher male risk towards the null after adjustment for severity of lung disease in hospitalised COVID-19+ patients further supports the role of higher severity of COVID-19 pneumonia in men.

Preoperative Treatment of Severe Diabetes Mellitus and Hypertension Mitigates Healthcare Disparities and Prevents Adverse Postoperative Discharge to a Nursing Home.

OBJECTIVE: To evaluate whether patients of Black race are at higher risk of adverse postoperative discharge to a nursing home, and if a higher prevalence of severe diabetes mellitus and hypertension are contributing. BACKGROUND: It is unclear whether a patient's race predicts adverse discharge to a nursing home after surgery, and if preexisting diseases are contributing. METHODS: A total of 368,360 adults undergoing surgery between 2007 and 2020 across 2 academic healthcare networks in New England were included. Patients of self-identified Black or White race were compared. The primary outcome was postoperative discharge to a nursing facility. Mediation analysis was used to examine the impact of preexisting severe diabetes mellitus and hypertension on the primary association. RESULTS: In all, 10.3% (38,010/368,360) of patients were Black and 26,434 (7.2%) patients were discharged to a nursing home. Black patients were at increased risk of postoperative discharge to a nursing facility (adjusted absolute risk difference: 1.9%; 95% confidence interval: 1.6%-2.2%; P <0.001). A higher prevalence of preexisting severe diabetes mellitus and hypertension in Black patients mediated 30.2% and 15.6% of this association. Preoperative medication-based treatment adherent to guidelines in patients with severe diabetes mellitus or hypertension mitigated the primary association ( P -for-interaction <0.001). The same pattern of effect mitigation by pharmacotherapy was observed for the endpoint 30-day readmission. CONCLUSIONS: Black race was associated with postoperative discharge to a nursing facility compared to White race. Optimized preoperative assessment and treatment of diabetes mellitus and hypertension improves surgical outcomes and provides an opportunity to the surgeon to help eliminate healthcare disparities.

Post-dialysis recovery time in ESRD patients receiving more frequent hemodialysis in skilled nursing facilities.

INTRODUCTION: Post-dialysis recovery time (DRT) has an important relationship to quality of life and survival, as identified in studies of ESRD patients on conventional dialysis. ESRD patients are often discharged from hospitals to skilled nursing facilities (SNFs) where on-site treatment using home hemodialysis technology is increasingly offered, but nothing is known about DRT in this patient population. METHODS: From November 4, 2019 to June 11, 2021, within a dialysis organization providing service across 12 states and 154 SNFs, patients receiving in-SNF, more frequent dialysis (MFD) (modeled to deliver 14 treatment hours minimum per week and stdKt/V ≥2.0) were asked to describe their post-dialysis recovery time following their previous treatment, within predefined categoric choices: 0-½, ½-1, 1-2, 2-4, 4-8, 8-12 h, by next morning, or not even by next morning. Patients reporting DRT following at least one full-week treatment opportunity were included in a mixed model logistic regression of rapid recovery (DRT ≤2 h). FINDINGS: Two thousand three hundred and nine patients met the statistical modeling inclusion criteria, providing DRT on 108,876 dialysis sessions, while receiving mean (SD) 4.3 (0.96) weekly dialysis treatments. 2118 (92%) reported DRT ≤2 h. Results appeared biologically plausible, as lower odds of rapid DRT were observed for patients who were older, missed their previous treatment, or experienced intradialytic hypotension. Greater odds of rapid DRT were observed in patients receiving five dialyses in the previous week or having 160-179 mmHg pre-hemodialysis systolic blood pressure. Rapid recovery was associated with reduced mortality or hospitalization. DISCUSSION: SNF dialysis patients receiving 5x per week MFD report rapid recovery time ≤2 h in 92% of dialyses despite advanced age, frailty, and comorbidities. Future studies will assess the practical ramifications of rapid DRT perception/experience on nursing home rehabilitation programs, which could impact patient health beyond the nursing home stay.

Private High School Reopened-COVID Mitigation and Clinical Surveillance Using an Internet Application.

CONTEXT: Recommendations for COVID-safe, in-person, high school education have included masks and distancing between students but do not describe a scalable surveillance solution to rapidly identify and mitigate disease prevalence or exposure. METHODS: Through an Internet application, all school participants reported symptoms, illness, or exposure daily. Physician-supervised follow-up interviews were reviewed and recorded in daily rounds. Students and faculty were allowed or prohibited to enter school based on the results. RESULTS: From August 30, 2020, until April 13, 2021, a high school in Bergen County, New Jersey (an epicenter of high COVID prevalence), with 889 students and 214 faculty members, staff, and volunteers, generated 1497 assessments. Reasons for initial evaluation included 48 (3%) participants with positive COVID tests, 520 (34%) COVID-exposed, 178 (12%) exposed to someone with symptoms and unknown COVID status, 208 (14%) subjects with symptoms themselves, 525 (35%) exposed to a high-risk geography or air travel, and 12 (1%) contacts of a contact. Of the 61 subjects ultimately diagnosed with COVID, the sources of infection were 36 (57%) home exposure, 16 (27%) confirmed nonschool sources, 8 (13%) unknown, 1 (2%) travel to a high-risk area, and only one potential case of in-school transmission. CONCLUSIONS: Masks, distance, and aggressive contact tracing supported by an Internet application with consistent application of quarantine protocols successfully permitted in-school education without COVID spread in a high prevalence environment. This finding remains important to guide safety measures should vaccine-resistant strains-or new pandemics-challenge us in the future.

Post-severe Acute Respiratory Syndrome Coronavirus 2 Monoclonal Antibody Treatment Hospitalizations as a Sentinel for Emergence of Viral Variants in New York City.

We partnered with the US Department of Health and Human Services to treat high-risk, nonadmitted coronavirus disease 2019 (COVID-19) patients with bamlanivimab in the Bronx, New York per Emergency Use Authorization criteria. Increasing posttreatment hospitalizations were observed monthly between December 2020 and March 2021 in parallel to the emergence of severe acute respiratory syndrome coronavirus 2 variants in New York City.

Epidemiology of nursing home dialysis patients-A hidden population.

INTRODUCTION: Dialysis patients are often discharged from hospitals to skilled nursing facilities (SNFs), but little has been published about their natural history. METHODS: Using electronic medical record data, we conducted a retrospective cohort study of nursing home patients treated with in-SNF hemodialysis from January 1, 2018 through June 20, 2020 within a dialysis organization across eight states. A dialytic episode began with the first in-SNF dialysis and was ended by hospitalization, death, transfer, or cessation of treatment. The clinical characteristics and natural history of these patients and their dialytic episodes are described. FINDINGS: Four thousand five hundred and ten patients experienced 9274 dialytic episodes. Dialytic episodes had a median duration of 18 days (IQR: 8-38) and were terminated by a hospitalization n = 5747 (62%), transfer n = 2638 (28%), death n = 568 (6%), dialysis withdrawal n = 129 (1.4%), recovered function n = 2 (0.02%), or other cause n = 6 (0.06%). Increased patient mortality was associated with advancing age, low serum creatinine, albumin, or sodium, and low pre-dialytic systolic blood pressure (sBP). U-shaped relationships to mortality were observed for intradialytic hypotension frequency and for post- > pre-hemodialysis sBP frequency. Prescription of dialysis five times weekly in the first 2 weeks was associated with better survival in the first 90 days (HR 0.77, CI 0.62-0.96; p < 0.02). DISCUSSION: Provision of in-SNF dialysis by an external dialysis organization enables discharge from the acute care setting for appropriate treatment with increased nursing contact time in an otherwise under-resourced environment. SNF ESRD patient clinical characteristics and outcomes are extensively characterized for the first time.

Using Automated Machine Learning to Predict the Mortality of Patients With COVID-19: Prediction Model Development Study.

BACKGROUND: During a pandemic, it is important for clinicians to stratify patients and decide who receives limited medical resources. Machine learning models have been proposed to accurately predict COVID-19 disease severity. Previous studies have typically tested only one machine learning algorithm and limited performance evaluation to area under the curve analysis. To obtain the best results possible, it may be important to test different machine learning algorithms to find the best prediction model. OBJECTIVE: In this study, we aimed to use automated machine learning (autoML) to train various machine learning algorithms. We selected the model that best predicted patients' chances of surviving a SARS-CoV-2 infection. In addition, we identified which variables (ie, vital signs, biomarkers, comorbidities, etc) were the most influential in generating an accurate model. METHODS: Data were retrospectively collected from all patients who tested positive for COVID-19 at our institution between March 1 and July 3, 2020. We collected 48 variables from each patient within 36 hours before or after the index time (ie, real-time polymerase chain reaction positivity). Patients were followed for 30 days or until death. Patients' data were used to build 20 machine learning models with various algorithms via autoML. The performance of machine learning models was measured by analyzing the area under the precision-recall curve (AUPCR). Subsequently, we established model interpretability via Shapley additive explanation and partial dependence plots to identify and rank variables that drove model predictions. Afterward, we conducted dimensionality reduction to extract the 10 most influential variables. AutoML models were retrained by only using these 10 variables, and the output models were evaluated against the model that used 48 variables. RESULTS: Data from 4313 patients were used to develop the models. The best model that was generated by using autoML and 48 variables was the stacked ensemble model (AUPRC=0.807). The two best independent models were the gradient boost machine and extreme gradient boost models, which had an AUPRC of 0.803 and 0.793, respectively. The deep learning model (AUPRC=0.73) was substantially inferior to the other models. The 10 most influential variables for generating high-performing models were systolic and diastolic blood pressure, age, pulse oximetry level, blood urea nitrogen level, lactate dehydrogenase level, D-dimer level, troponin level, respiratory rate, and Charlson comorbidity score. After the autoML models were retrained with these 10 variables, the stacked ensemble model still had the best performance (AUPRC=0.791). CONCLUSIONS: We used autoML to develop high-performing models that predicted the survival of patients with COVID-19. In addition, we identified important variables that correlated with mortality. This is proof of concept that autoML is an efficient, effective, and informative method for generating machine learning-based clinical decision support tools.

Anticoagulation in COVID-19: Effect of Enoxaparin, Heparin, and Apixaban on Mortality.

BACKGROUND: Mortality in coronavirus disease of 2019 (COVID-19) is associated with increases in prothrombotic parameters, particularly D-dimer levels. Anticoagulation has been proposed as therapy to decrease mortality, often adjusted for illness severity. OBJECTIVE: We wanted to investigate whether anticoagulation improves survival in COVID-19 and if this improvement in survival is associated with disease severity. METHODS: This is a cohort study simulating an intention-to-treat clinical trial, by analyzing the effect on mortality of anticoagulation therapy chosen in the first 48 hours of hospitalization. We analyzed 3,625 COVID-19+ inpatients, controlling for age, gender, glomerular filtration rate, oxygen saturation, ventilation requirement, intensive care unit admission, and time period, all determined during the first 48 hours. RESULTS: Adjusted logistic regression analyses demonstrated a significant decrease in mortality with prophylactic use of apixaban (odds ratio [OR] 0.46, p = 0.001) and enoxaparin (OR = 0.49, p = 0.001). Therapeutic apixaban was also associated with decreased mortality (OR 0.57, p = 0.006) but was not more beneficial than prophylactic use when analyzed over the entire cohort or within D-dimer stratified categories. Higher D-dimer levels were associated with increased mortality (p < 0.0001). When adjusted for these same comorbidities within D-dimer strata, patients with D-dimer levels < 1 µg/mL did not appear to benefit from anticoagulation while patients with D-dimer levels > 10 µg/mL derived the most benefit. There was no increase in transfusion requirement with any of the anticoagulants used. CONCLUSION: We conclude that COVID-19+ patients with moderate or severe illness benefit from anticoagulation and that apixaban has similar efficacy to enoxaparin in decreasing mortality in this disease.

The association of race and COVID-19 mortality.

BACKGROUND: COVID-19 mortality disproportionately affects the Black population in the United States (US). To explore this association a cohort study was undertaken. METHODS: We assembled a cohort of 505,992 patients receiving ambulatory care at Bronx Montefiore Health System (BMHS) between 1/1/18 and 1/1/20 to evaluate the relative risk of hospitalization and death in two time-periods, the pre-COVID time-period (1/1/20-2/15/20) and COVID time-period (3/1/20-4/15/20). COVID testing, hospitalization and mortality were determined with the Black and Hispanic patient population compared separately to the White population using logistic modeling. Evaluation of the interaction of pre-COVID and COVID time periods and race, with respect to mortality was completed. FINDINGS: A total of 9,286/505,992 (1.8%) patients were hospitalized during either or both pre-COVID or COVID periods. Compared to Whites the relative risk of hospitalization of Black patients did not increase in the COVID period (p for interaction=0.12). In the pre- COVID period, compared to Whites, the odds of death for Blacks and Hispanics adjusted for comorbidity was statistically equivalent. In the COVID period compared to Whites the adjusted odds of death for Blacks was 1.6 (95% CI 1.2-2.0, p = 0.001). There was a significant increase in Black mortality risk from pre-COVID to COVID periods (p for interaction=0.02). Adjustment for relevant clinical and social indices attenuated but did not fully explain the observed difference in Black mortality. INTERPRETATION: The BMHS COVID experience demonstrates that Blacks do have a higher mortality with COVID incompletely explained by age, multiple reported comorbidities and available metrics of sociodemographic disparity. FUNDING: N/A.

Derivation of a Model to Guide Empiric Therapy for Carbapenem-Resistant Klebsiella pneumoniae Bloodstream Infection in an Endemic Area.

BACKGROUND: Appropriate therapy for carbapenem-resistant Klebsiella pneumoniae (CRKP) bloodstream infection (BSI) is often given late in the course of infection, and strategies for identifying CRKP BSI earlier are needed. METHODS: A retrospective case-control study was performed at a tertiary care hospital, university hospital, and community hospital in Bronx, New York. All participants had a blood culture sent and received an antibiotic within 48 hours of the culture. The case group (n = 163) had a blood culture with CRKP. The control group (n = 178) had a blood culture with carbapenem-susceptible Klebsiella. Data were obtained by electronic or conventional medical record abstraction. A multiple logistic regression model was built to identify associated factors and develop a clinical model for CRKP BSI. Model performance characteristics were estimated using a 10-fold cross-validation analysis. RESULTS: A prior nonblood culture with carbapenem-resistant Enterobacteriaceae, skilled nursing facility (SNF) residence, mechanical ventilation, and admission >3 days were strongly associated risk factors. A significant interaction led to development of separate clinical models for subjects admitted <3 days at the time of positive blood culture from those admitted at least 3 days. The derived models had a good ability to discriminate between subjects with and without CRKP BSI. A clinical classification rule to guide therapy can prioritize sensitivity or specificity. CONCLUSIONS: Prior nonblood cultures showing resistance and exposure to SNF and health care settings are factors associated with carbapenem resistance. The clinical classification rules derived in this work should be validated for ability to guide therapy.

AKI in Hospitalized Patients with and without COVID-19: A Comparison Study.

BACKGROUND: Reports from centers treating patients with coronavirus disease 2019 (COVID-19) have noted that such patients frequently develop AKI. However, there have been no direct comparisons of AKI in hospitalized patients with and without COVID-19 that would reveal whether there are aspects of AKI risk, course, and outcomes unique to this infection. METHODS: In a retrospective observational study, we evaluated AKI incidence, risk factors, and outcomes for 3345 adults with COVID-19 and 1265 without COVID-19 who were hospitalized in a large New York City health system and compared them with a historical cohort of 9859 individuals hospitalized a year earlier in the same health system. We also developed a model to identify predictors of stage 2 or 3 AKI in our COVID-19. RESULTS: We found higher AKI incidence among patients with COVID-19 compared with the historical cohort (56.9% versus 25.1%, respectively). Patients with AKI and COVID-19 were more likely than those without COVID-19 to require RRT and were less likely to recover kidney function. Development of AKI was significantly associated with male sex, Black race, and older age (>50 years). Male sex and age >50 years associated with the composite outcome of RRT or mortality, regardless of COVID-19 status. Factors that were predictive of stage 2 or 3 AKI included initial respiratory rate, white blood cell count, neutrophil/lymphocyte ratio, and lactate dehydrogenase level. CONCLUSIONS: Patients hospitalized with COVID-19 had a higher incidence of severe AKI compared with controls. Vital signs at admission and laboratory data may be useful for risk stratification to predict severe AKI. Although male sex, Black race, and older age associated with development of AKI, these associations were not unique to COVID-19.

Older Adults and Covid-19: The Most Vulnerable, the Hardest Hit.

Older adults in the United States have been the age group hardest hit by the Covid pandemic. They have suffered a disproportionate number of deaths; Covid patients eighty years or older on ventilators had fatality rates higher than 90 percent. How could we have better protected older adults? Both the popular press and government entities blamed nursing homes, labeling them "snake pits" and imposing harsh fines and arduous new regulations. We argue that this approach is unlikely to improve protections for older adults. Rather than focusing exclusively on acute and critical resources, including ventilators, a plan that respected the best interests of older adults would have also supported nursing homes, a critical part of the health care system. Better access to protective equipment for staff members, early testing of staff members and patients, and enhanced means of communication with families were what was needed. These preventive measures would have offered greater benefit to the oldest members of our population than the exclusive focus on acute care.

The relationship between adrenal incidentalomas and mortality risk.

OBJECTIVE: To determine all-cause mortality risk in patients with and without adrenal incidentaloma. METHODS: Retrospective cohort study of patients with CT abdomen performed within 24 h of emergency room presentation at an academic medical center from January 1, 2005, to December 31, 2009, without history of adrenal disease, adrenal lab testing, or cancer. Incidentaloma cohort identified by database query of imaging reports followed by manual review and matched to no-nodule controls at 3:1 on age ± 1 year and exam date ± 3 months. Mortality ascertained by in-hospital deaths and National Death Index query. Survival analysis performed with Kaplan-Meier curves and Cox proportional hazards models. RESULTS: Among 42,575 adults with abdominal CT exams, 969 adrenal incidentaloma patients and 2907 no-nodule controls were identified. All 3876 individuals entered survival analysis with 31,182 person-years at risk (median follow-up 8.9 years [IQR, 6.9-10.7]). All-cause mortality was significantly higher among those with adrenal incidentalomas (353/969, 36.4%) compared with those without (919/2907, 31.6%; mortality difference 7.6 per 1000 person-years; multivariable-adjusted hazard ratio [aHR] 1.14; 95% CI, 1.003-1.29). Exploratory analyses, limited by missing covariates, found that adrenal incidentalomas were associated with significantly increased incidence of malignancy (aHR 1.61; 95% CI, 1.22-2.12), diabetes (aHR 1.43; 95% CI, 1.18-1.71), heart failure (aHR 1.32; 95% CI, 1.07-1.63), peripheral vascular disease (aHR 1.28; 95% CI, 1.95-1.56), renal disease (aHR 1.21; 95% CI, 1.01-1.44), and chronic pulmonary disease (aHR 1.22; 95% CI, 1.01-1.46) compared with controls. CONCLUSIONS: Adrenal incidentalomas are associated with increased mortality and may represent a clinically valuable biomarker. KEY POINTS: • Adrenal incidentalomas are associated with increased mortality. • Adrenal incidentaloma size is not predictive of mortality. • On exploratory analyses, adrenal incidentalomas are associated with chronic illnesses.

Prevalence, Risk Factors, and Treatment for Overactive Bladder in a Racially Diverse Population.

OBJECTIVE: To evaluate differences in prevalence, overactive bladder (OAB) risk factors, and OAB treatment in a diverse population of underrepresented racial/ethnic groups. METHODS: This is a retrospective cohort study of women ≥ 18 years who had an OAB diagnosis code from June 1, 2013 to June 30, 2016. Women who had neurogenic bladder or pelvic cancer were excluded. OAB risk factors included age, body mass index, socioeconomic status, diabetes, and smoking. OAB treatment included consultation with a specialist, diagnostic testing, medication, and third-line therapy (neuromodulation or chemodennervation). ANOVA and Chi-square were used to compare continuous and categorical variables. Multivariable logistic regression models were developed to examine the association between racial/ethnic groups and OAB management while controlling for risk factors. RESULTS: OAB prevalence was 4.41% (5407/122,606) and was highest in Hispanic women. Black and Hispanic women were significantly younger, had a higher median body mass index, higher rate of diabetes, and lower socioeconomic status compared to White women. There was no racial difference in OAB prescriptions. Black women were less likely to consult with a specialist in multivariable analysis. CONCLUSION: OAB prevalence and presence of OAB risk factors was highest in Hispanic and Black women. Black women were less likely to consult with a specialist suggesting that Black women receive initial therapy from primary care physicians. Future studies will evaluate if racial differences in OAB treatment are due to patient preference or provider practices.

Effectiveness of Lung-RADS in Reducing False-Positive Results in a Diverse, Underserved, Urban Lung Cancer Screening Cohort.

PURPOSE: The Lung CT Screening Reporting and Data SystemTM (Lung-RADSTM) was created to standardize lung cancer screening CT reporting and recommendations but has not been well validated prospectively in clinical practice. The aim of this study was to determine the effectiveness of lung cancer screening using Lung-RADS in a diverse, underserved, academic clinical screening program, focusing on whether Lung-RADS would successfully reduce the 23.3% false-positive rate found in the National Lung Screening Trial. METHODS: Institutional review board approval was obtained to study the clinical lung cancer screening cohort. Low-dose CT results were prospectively assigned a Lung-RADS or equivalent score. The proportion of examinations in each Lung-RADS category and the corresponding lung cancer rate, subsequent imaging, interventions, mortality, and compliance were tracked. The National Death Index was queried for follow-up losses. RESULTS: The cohort comprised 1,181 patients with 2,270 person-years of follow-up from December 2012 to December 2016. The mean age was 64 ± 16.2 years, with 51% women, 63% nonwhite, 71% current smokers, 69% overweight and obese, and multiple comorbidities. The Lung-RADS false-positive rate was 10.4% (95% confidence interval, 8.8%-12.3%). Baseline CT results were negative in 87% (n = 1,031): for Lung-RADS 1, the lung cancer rate was 0.2%, and for Lung-RADS 2, the cancer rate was 0.5%. Positive baseline examinations were Lung-RADS 3 in 10% (n = 119), 4a in 1.2% (n = 14), and 4b in 1.5% (n = 18). Corresponding cancer rates were 3.4%, 43%, and 83%, respectively. Lung cancer prevalence was 2.1%. Mortality was 40% in patients with lung cancer versus 2.5% in the remaining cohort (P < .001). Fifty-four percent of patients were overdue for first annual examinations. Eighty-four percent of patients (n = 989) had follow-up verified via electronic records or personal contact, and the remainder had vital status ascertained via the National Death Index. CONCLUSIONS: Lung cancer screening using Lung-RADS was effective in reducing the false-positive rate compared with the National Lung Screening Trial in a diverse and underserved urban population.