The clinical effectiveness of REGEN-COV in SARS-CoV-2 infection with Omicron versus Delta variants.

BACKGROUND: In vitro studies suggesting that REGEN-COV (casirivimab plus imdevimab monoclonal antibodies) had poor efficacy against Omicron-variant SARS-CoV-2 infection led to amendment of REGEN-COV's Emergency Use Authorization to recommend use only in regions without high Omicron prevalence. REGEN-COV's relative clinical effectiveness for Omicron is unknown. METHODS AND FINDINGS: We conducted a retrospective cohort study of non-hospitalized adults who tested positive for SARS-CoV-2 by polymerase chain reaction at the University of Miami Health System from July 19 -November 21, 2021 (Delta period) and December 6, 2021 -January 7, 2022 (Omicron period). Subjects were stratified be REGEN-COV receipt within 72h of test positivity and by time period of infection. We constructed multivariable logistic regression models to assess the differential association of REGEN-COV receipt with hospitalization within 30 days (primary outcome) and ED presentation; all models included three exposure terms (REGEN-COV receipt, Omicron vs Delta period, interaction of REGEN-COV with time period) and potential confounders (vaccination status, vaccine boosting, cancer diagnosis). Our cohort consisted of 2,083 adults in the Delta period (213 [10.2%] received REGEN-COV) and 4,201 in the Omicron period (156 [3.7%] received REGEN-COV). Hospitalization was less common during the Omicron period than during Delta (0.9% vs 1.7%, p = 0.78) and more common for patients receiving REGEN-COV than not (5.7% vs 0.9%, p<0.001). After adjustment, we found no differential association of REGEN-COV use during Omicron vs Delta with hospitalization within 30d (adjusted odds ratio [95% confidence interval] for the interaction term: 2.31 [0.76-6.92], p = 0.13). Similarly, we found no differential association for hospitalization within 15d (2.45 [0.63-9.59], p = 0.20) or emergency department presentation within 30d (1.43 [0.57-3.51], p = 0.40) or within 15d (1.79 [0.65-4.82], p = 0.30). CONCLUSIONS: Within the limitations of this study's power to detect a difference, we identified no differential effectiveness of REGEN-COV in the context of Omicron vs Delta SARS-CoV-2 infection.

A Brief Overview of Adaptive Designs for Phase I Cancer Trials.

Phase I studies are used to estimate the dose-toxicity profile of the drugs and to select appropriate doses for successive studies. However, literature on statistical methods used for phase I studies are extensive. The objective of this review is to provide a concise summary of existing and emerging techniques for selecting dosages that are appropriate for phase I cancer trials. Many advanced statistical studies have proposed novel and robust methods for adaptive designs that have shown significant advantages over conventional dose finding methods. An increasing number of phase I cancer trials use adaptive designs, particularly during the early phases of the study. In this review, we described nonparametric and algorithm-based designs such as traditional 3 + 3, accelerated titration, Bayesian algorithm-based design, up-and-down design, and isotonic design. In addition, we also described parametric model-based designs such as continual reassessment method, escalation with overdose control, and Bayesian decision theoretic and optimal design. Ongoing studies have been continuously focusing on improving and refining the existing models as well as developing newer methods. This study would help readers to assimilate core concepts and compare different phase I statistical methods under one banner. Nevertheless, other evolving methods require future reviews.

Prevalence and Inpatient Hospital Outcomes of Malignancy-Related Ascites in the United States.

OBJECTIVE: Malignancy-related ascites (MRA) is the terminal stage of many advanced cancers, and the treatment is mainly palliative. This study looked for epidemiology and inpatient hospital outcomes of patients with MRA in the United States using a national database. METHODS: The current study was a cross-sectional analysis of 2015 National Inpatient Sample data and consisted of patients ≥18 years with MRA. Descriptive statistics were used for understanding demographics, clinical characteristics, and MRA hospitalization costs. Multivariate regression models were used to identify predictors of length of hospital stay and in-hospital mortality. RESULTS: There were 123 410 MRA hospitalizations in 2015. The median length of stay was 4.7 days (interquartile range [IQR]: 2.5-8.6 days), median cost of hospitalization was US$43 543 (IQR: US$23 485-US$82 248), and in-hospital mortality rate was 8.8% (n = 10 855). Multivariate analyses showed that male sex, black race, and admission to medium and large hospitals were associated with increased hospital length of stay. Factors associated with higher in-hospital mortality rates included male sex; Asian or Pacific Islander race; beneficiaries of private insurance, Medicaid, and self-pay; patients residing in large central and small metro counties; nonelective admission type; and rural and urban nonteaching hospitals. CONCLUSIONS: Our study showed that many demographic, socioeconomic, health care, and geographic factors were associated with hospital length of stay and in-hospital mortality and may suggest disparities in quality of care. These factors could be targeted for preventing unplanned hospitalization, decreasing hospital length of stay, and lowering in-hospital mortality for this population.

Inpatient Palliative Care Use Among Critically III Brain Metastasis Patients in the United States.

OBJECTIVE: The objective of this study was to understand the trends and characteristics of palliative care delivery among critically ill brain metastasis patients using a nationally representative database. MATERIALS AND METHODS: This study was a retrospective analysis of Nationwide Inpatient Sample data collected during 2005 to 2014. This study included critically ill patients, 18 years and above, diagnosed with brain metastasis, identified using International Classification of Diseases-Ninth Revision-Clinical Modification diagnosis and procedure codes. Multivariable logistic regression models were used for predicting factors associated with inpatient palliative care use. RESULTS: Among 18,309 critically ill patients with brain metastasis, 3298 (18.0%) received inpatient palliative care. The rate of inpatient palliative care use among these patients increased from 3.2% to 28.5%, during 2005 to 2014 (P<0.001). Regression analysis showed that hospital teaching status (odds ratio [ORs], 1.45; 95% confidence interval [CI], 1.14-1.84), primaries located in head and neck (OR, 1.42; 95% CI, 1.21-2.05) or lung (OR, 1.32; 95% CI, 1.22-1.44), and primary diagnosis of pneumonia (OR, 1.42; 95% CI, 1.22-1.97) or septicemia (OR, 1.59; 95% CI, 1.30-1.97), were associated with higher palliative care use. Hispanic ethnicity (OR, 0.86; 95% CI, 0.67-0.96), and hospital location in Northeast (OR, 0.73; 95% CI, 0.54-0.96), Midwest (OR, 0.63; 95% CI, 0.45-0.87), or South (OR, 0.64; 95% CI, 0.48-0.86) were associated with lower palliative care use. CONCLUSIONS: Inpatient palliative care use increased significantly among critically ill patients with brain metastases, though overall rate was low. There were geographical and racial disparities among these patients. Health care providers and policy makers should focus on decreasing these disparities. In addition, hospitals should focus on adopting more palliative care services.

A risk model for prediction of 30-day readmission rates after surgical treatment for colon cancer.

PURPOSE: The purpose of this study was to develop a risk model for the prediction of 30-day unplanned readmission rate after surgery for colon cancer. METHOD: This study was a cross-sectional analysis of data from Nationwide Readmissions Database, collected during 2010-2014. Patients ≥ 18 years of age who underwent surgery for colon cancer were included in the study. The primary outcome of the study was 30-day unplanned readmission rate. RESULTS: There were 141,231 index hospitalizations for surgical treatment of colon cancers and 16,551 had unplanned readmissions. Age, sex, primary payer, Elixhauser comorbidity index, node positive or metastatic disease, length of stay, hospital bedsize, teaching status, hospital ownership, presence of stoma, surgery types, surgery procedures, infectious complications, surgical complications, mechanical wounds, pulmonary complications, and gastrointestinal complications were selected for the risk analysis during backward regression model. Based on the estimated coefficients of selected variables, risk scores were developed and stratified as low risk (≤ 1.08), moderate risk (> 1.08 to ≤ 1.5), and high risk (> 1.5) for unplanned readmission. Validation analysis (n = 42,269) showed that 7.1% of low-risk individuals, 11.1% of moderate-risk individuals, and 17.1% of high-risk individuals experienced unplanned readmissions (P < 0.001). Pairwise comparisons also showed statistically significant differences between low-risk and moderate-risk participants (P < 0.001), between moderate-risk and high-risk participants (P < 0.001), and between low-risk and high-risk participants (P < 0.001). The area under the ROC curve was 0.622. CONCLUSIONS: Our risk model could be helpful for risk-stratifying patients for readmission after surgical treatment for colon cancer. This model needs further validation by incorporating all possible clinical variables.

Recent Health Care Expenditure Trends Among Adult Cancer Survivors in United States, 2009-2016.

OBJECTIVE: The objective of this study was to understand recent trends in direct health care expenditures among cancer survivors using novel cost-estimation methods and a nationally representative database. MATERIALS AND METHODS: This study was a retrospective analysis of 193,003 adults, ≥18 years of age, using the Medical Expenditure Panel Survey during the years 2009-2016. Manning and Mullahy two-part model was used to calculate adjusted mean and incremental medical expenditures after adjusting for covariates. RESULTS: The mean direct annual health care expenditure among cancer survivors ($13,025.0 [$12,572.0 to $13,478.0]) was nearly 3 times greater than noncancer participants ($4689.3 [$4589.2 to $4789.3]) and were mainly spent on inpatient services, office-based visits, and prescription medications. Cancer survivors had an additional health care expenditure of $4407.6 ($3877.6, $4937.6) per person per year, compared with noncancer participants after adjusting for covariates (P<0.001). The total mean annual direct health care expenditure for cancer survivors increased from $12,960.0 (95% confidence interval: $12,291.0-$13,628.0) in 2009-2010 to $13,807.0 ($12,828.0 to $14,787.0) in 2015-2016. CONCLUSIONS: Given the higher health care expenditures among cancer survivors and the increasing prevalence of cancers, cost-saving measures should be planned through multidisciplinary initiatives, collaborative research, and importantly, health care planning and policy changes. Our findings could be helpful in streamlining health care resources and interventions, developing national health care coverage policies, and possibly considering radically new insurance strategies for cancer survivors.

Increasing Sepsis Rates in the United States: Results From National Inpatient Sample, 2005 to 2014.

OBJECTIVES: To examine the trends in hospitalization rates, mortality, and costs for sepsis during the years 2005 to 2014. METHODS: This was a retrospective serial cross-sectional analysis of patients ≥18 years admitted for sepsis in National Inpatient Sample. Trends in sepsis hospitalizations were estimated, and age- and sex-adjusted rates were calculated for the years 2005 to 2014. RESULTS: There were 541 694 sepsis admissions in 2005 and increased to 1 338 905 in 2014. Sepsis rates increased significantly from 1.2% to 2.7% during the years 2005 to 2014 (relative increase: 123.8%; P trend < .001). However, the relative increase changed by 105.8% (P trend < .001) after adjusting for age and sex and maintained significance. Although total cost of hospitalization due to sepsis increased significantly from US$22.2 to US$38.1 billion (P trend < .001), the mean hospitalization cost decreased significantly from US$46,470 to US$29,290 (P trend < .001). CONCLUSIONS: Hospitalizations for sepsis increased during the years 2005 to 2014. Our study paradoxically found declining rates of in-hospital mortality, length of stay, and mean hospitalization cost for sepsis. These findings could be due to biases introduced by International Classification of Diseases, Ninth Revision, Clinical Modification coding rules and increased readmission rates or alternatively due to increased awareness and surveillance and changing disposition status. Standardized epidemiologic registries should be developed to overcome these biases.

Prevalence of Cardiovascular Risk Factors Among Cancer Patients in the United States.

Background: Cancer and cardiovascular diseases (CVDs) are leading causes of morbidity and mortality. We analyzed national data to examine the prevalence of CVD risk factors among adult cancer survivors in the United States. Methods: Participants included adults ≥18 years of age from the National Health and Nutrition Examination Survey 2001-2002 to 2013-2014. CVD risk factors included hypertension, diabetes, dyslipidemia, obesity, smoking, and physical activity. Prevalence of 1, 2, or ≥3 CVD risk factors was compared between cancer and noncancer participants. All CVD risk factors were adjusted for age and smoking and additionally for sex. Differences in CVD risk factors among cancer and noncancer participants were identified using logistic regression analysis. Results: Among 35,379 eligible participants, 2906 (8.4%) had a history of cancer. The proportion of participants having a single CVD risk factor was lower among cancer survivors compared with noncancer participants (25.8% vs. 33.9%, P < 0.001). The proportions of participants having two CVD risk factors (33.5% vs. 24.6%, P < 0.001) and ≥3 CVD risk factors (27.4% vs. 16.4%, P < 0.001) were higher among cancer survivors. However, these associations lost significance upon adjusting for age. The odds of total hypertension (odds ratio [OR] 1.25, 95% confidence interval [CI]: 1.11-1.40) and total diabetes (OR 1.33, 95% CI: 1.08-1.65) were significantly higher among cancer survivors. Conclusions: Our study showed that adult cancer survivors in the United States had higher levels of CVD risk factors primarily due to age-related factors, in addition to cancer complications. There is a significant need for improved CVD risk assessment and prevention services for cancer survivors.

The Impact of Lifestyle Modification on Cardiometabolic Risk Factors in Health-Care Employees With Type 2 Diabetes.

PURPOSE: Diabetes imposes a significant economic burden on employers, particularly when including productivity costs. Given the great interest on multicomponent lifestyle interventions in these individuals, we assessed the short-term and long-term efficacy of a structured lifestyle modification program, My Unlimited Potential, among employees with diabetes of Baptist Health South Florida (BHSF), a large non-for profit health-care system. DESIGN: This is a pre- and post-effectiveness of a workplace health promotion program. SETTING: Worksite intervention at BHSF. PARTICIPANTS: The study analyzed the data of 93 employees with diabetes involved in a worksite wellness program after completion of a year long program. INTERVENTION: The intervention was an intense lifestyle modification program that was targeted to the individual needs of the participants. MEASURES: Cardimetabolic risk factors such as body mass index (BMI), weight, systolic blood pressure, diastolic blood pressure, glycated hemoglobin, total cholesterol, triglycerides, high-sensitivity C-reactive protein, low-density lipoprotein, high-density lipoprotein, and maximal oxygen consumption. ANALYSIS: Paired 2-sample t tests for means and descriptive statistics were used. RESULTS: A mean decrease of 0.6 percentage points was observed in HbA1c values from baseline to 12 months. Weight, BMI, blood pressure, and lipid profile improved significantly after 12 months. CONCLUSION: This study suggests worksites with existing health promotion programs, and health-care staff can effectively deliver a diabetes prevention program that appears to have a long-term impact on employee health.

Palliative Care Consultation Trends Among Hospitalized Patients With Advanced Cancer in the United States, 2005 to 2014.

BACKGROUND:: Although palliative care services are increasing in the United States, disparities exist in access and utilization. Hence, we explored these factors in hospitalized patients with advanced cancers using the National Inpatient Sample (NIS). METHODS:: This was a retrospective analysis of NIS data, 2005 to 2014, and included patients ≥18 years with advanced cancers with and without palliative care consultations. Both χ2 and independent t tests were used for categorical and continuous variables. Multivariate logistic regressions were used for identifying factors associated with palliative care consultations. RESULTS:: Palliative care consultations were recorded in 9.9% of 4 732 172 weighted advanced cancer hospitalizations and increased from 3.0% to 15.5% during 2005 to 2014 (relative increase, 172.2%, Ptrend < .01). Factors associated with higher palliative care consultations were increasing age, ≥80 years (odds ratio [OR]: 1.47; 95% confidence interval [CI]: 1.38-1.56); black race (OR: 1.21; 95% CI: 1.14-1.28); private insurance coverage (OR: 1.10; 95% CI: 1.02-1.18); West region (OR: 1.15; 95% CI: 1.01-1.33); large hospitals (OR: 1.19; 95% CI: 1.02-1.34); high income (OR: 1.08; 95% CI: 1.08-1.17); do-not-resuscitate (dying patients) status (OR: 10.55; 95% CI: 10.14-10.99); and in-hospital radiotherapy (OR: 1.13; 95% CI: 1.06-1.21). Palliative care consultations were lower in patients with chemotherapy (OR: 0.71; 95% CI: 0.60-0.84). CONCLUSION:: Many demographic, socioeconomic, health-care, and geographic disparities were identified in palliative care consultations. Additionally, palliative care resources were underutilized by hospitalized patients with advanced cancers and commonly utilized by patients who are dying. Health-care providers and policy makers should focus on these disparities in order to improve palliative care use.

Psychological Factors and Their Association with Ideal Cardiovascular Health Among Women and Men.

BACKGROUND: The cardiovascular effects of stress and other psychological factors may be different between women and men. We assessed whether self-perceived adverse psychological factors were associated with achievement of ideal cardiovascular health (CVH) as measured by the American Heart Association's Life's Simple Seven (LS7) and whether this differed by sex. METHODS: This was a cross-sectional study of employees from a large healthcare organization. The LS7 metrics (smoking, physical activity, diet, body mass index, blood pressure, cholesterol, and glucose) were each scored as ideal (2), intermediate (1), or poor (0). Total scores were categorized as optimal (11-14), average (9-10), and inadequate (0-8). Using logistic regression, we tested whether psychological factors obtained by questionnaire (self-perceived stress, low life satisfaction, hopelessness, sadness, depression, and anxiety) were associated with CVH, after adjustment for age, ethnicity, and education. RESULTS: Among 9,056 participants, the mean (SD) age was 43 (12) years, 74% were women, 57% Hispanic/Latino, 17% white, and 16% black. Stress was associated with reduced odds of having optimal/average CVH [OR 0.58 (95% CI 0.50-0.66) and 0.63 (0.50-0.81), for women and men, respectively]. Similarly, depression was associated with reduced odds of optimal/average CVH [0.58 (0.43-0.78) and 0.44 (0.26-0.76), for women and men, respectively]. Low life satisfaction, hopelessness, sadness, and anxiety were also associated with statistically significantly lower odds of optimal/average CVH in women, but not in men; however, there were no interactions by sex. CONCLUSIONS: In an ethnically diverse population, both women and men with several adverse self-perceived psychological factors were less likely to have optimal or adequate CVH. Future studies are needed to determine whether addressing psychological stressors can improve CVH.

Association between self-rated health and ideal cardiovascular health: The Baptist Health South Florida Employee Study.

Background: There is increasing evidence of the role psychosocial factors play as determinants of cardiovascular health (CVH). We examined the association between self-rated health (SRH) and ideal CVH among employees of a large healthcare organization. Methods: Data were collected in 2014 from employees of Baptist Health South Florida during an annual voluntary health risk assessment and wellness fair. SRH was measured using a self-administered questionnaire where responses ranged from poor, fair, good, very good to excellent. A CVH score (the proxy for CVH) that ranged from 0 to 14 was calculated, where 0-8 indicate an inadequate score, 9-10, average and 11-14, optimal. A multinomial logistic regression was used to examine the association between SRH and CVH. Results: Of the 9056 participants, 75% were female and mean age (SD) was 43 ± 12 years. The odds of having a higher CVH score increased as SRH improved. With participants who reported their health status as poor-fair serving as reference, adjusted odds ratios for having an optimal CVH score by the categories of SRH were: excellent, 21.04 (15.08-29.36); very good 10.04 (7.25-13.9); and good 3.63 (2.61-5.05). Conclusion: Favorable SRH was consistently associated with better CVH.

Does education modify the effect of ethnicity in the expression of ideal cardiovascular health? The Baptist Health South Florida Employee Study.

BACKGROUND: Despite the progress made to decrease risk factors for cardiovascular diseases, disparities still exist. We examined how education and ethnicity interact to determine disparities in cardiovascular health (CVH) as defined by the American Heart Association. HYPOTHESIS: Education modifies the effect of ethnicity on CVH. METHODS: Individual CVH metrics (smoking, physical activity, body mass index, diet, total cholesterol, blood pressure, and blood glucose) were defined as ideal, intermediate, or poor. Combined scores were categorized as inadequate, average, or optimal CVH. Education was categorized as postgraduate, college, some college, and high school or less; ethnicity was categorized as white, Hispanic, black, and other. Main and interactive associations between education, ethnicity, and the measures of CVH were calculated with multinomial logistic regression. RESULTS: Of 9056 study participants, 74% were women, and mean age was 43 (±12) years. Over half were Hispanic, and two-thirds had at least a college education. With postgraduate education category as the reference, participants with less than a college education were less likely to achieve ideal status for most of the individual CVH metrics, and also less likely to achieve 6 to 7 ideal metrics, and optimal CVH scores. In most of the educational categories, Hispanic participants had the highest proportion with optimal CVH scores and 6 to 7 ideal metrics, whereas black participants had the lowest proportion. However, there were no statistically significant interactions of education and ethnicity for ideal CVH measures. CONCLUSIONS: Higher educational attainment had variable associations with achieved levels of ideal CVH across race/ethnic groups. Interventions to improve CVH should be tailored to meet the needs of target communities.

Effect of Thyroxin Treatment on Carotid Intima-Media Thickness (CIMT) Reduction in Patients with Subclinical Hypothyroidism (SCH): a Meta-Analysis of Clinical Trials.

AIM: Research shows that subclinical hypothyroidism (SCH) is related to an increased carotid intima-media thickness (CIMT), a surrogate marker of subclinical cardiovascular disease (CVD). It is controversial whether or not SCH should be treated to reduce CVD morbidity and mortality. This meta-analysis aimed to determine whether SCH is associated with an increase in CIMT as compared to Euthyroidism (EU) and whether thyroxin (T4) treatment in SCH can reverse the change in CIMT. METHODS: Two independent reviewers conducted an extensive database research up to December 2016. A total of 12 clinical trials discussed the effect of Thyroxin on CIMT values at pre- and post-treatment in subjects with SCH. RESULTS: CIMT was significantly higher among SCH (n=280) as compared to EU controls (n=263) at baseline; the pooled weighted mean difference (WMD) of CIMT was 0.44 mm [95% confidence interval (CI) 0.14, 0.74], p=0.004; I2=65%. After treatment with thyroxin in subjects with SCH (n=314), there was a statistically significant decrease in CIMT from pre- to post-treatment; the pooled WMD of CIMT decrease was [WMD －0.32; 95% CI (－0.47, －0.16), p=＜0.0001; I2=2%], and it was no longer different from EU controls [WMD 0.13 mm; 95% CI (－0.04, 0.30); p=0.14; I2=27%]. The total cholesterol (TC), triglycerides (TG), and low-density lipoprotein (LDL) were higher in SCH as compared to EU controls and decreased significantly after treatment with thyroxin. CONCLUSION: This meta-analysis shows that thyroxin therapy in subjects with SCH significantly decreases CIMT and improves lipid profile, modifiable CVD risk factors. Thyroid hormone replacement in subjects with SCH may play a role in slowing down or preventing the progression of atherosclerosis.

Favorable Cardiovascular Health Is Associated With Lower Health Care Expenditures and Resource Utilization in a Large US Employee Population: The Baptist Health South Florida Employee Study.

OBJECTIVE: To examine the association of favorable cardiovascular health (CVH) status with 1-year health care expenditures and resource utilization in a large health care employee population. PARTICIPANTS AND METHODS: Employees of Baptist Health South Florida participated in a health risk assessment from January 1 through September 30, 2014. Information on dietary patterns, physical activity, blood pressure, blood glucose level, total cholesterol level, and smoking were collected. Participants were categorized into CVH profiles using the American Heart Association's ideal CVH construct as optimal (6-7 metrics), moderate (3-5 metrics), and low (0-2 metrics). Two-part econometric models were used to analyze health care expenditures. RESULTS: Of 9097 participants (mean ± SD age, 42.7±12.1 years), 1054 (11.6%) had optimal, 6945 (76.3%) had moderate, and 1098 (12.1%) had low CVH profiles. The mean annual health care expenditures among those with a low CVH profile was $10,104 (95% CI, $8633-$11,576) compared with $5824 (95% CI, $5485-$6164) and $4282 (95% CI, $3639-$4926) in employees with moderate and optimal CVH profiles, respectively. In adjusted analyses, persons with optimal and moderate CVH had a $2021 (95% CI, -$3241 to -$801) and $940 (95% CI, -$1560 to $80) lower mean expenditure, respectively, than those with low CVH. This trend remained even after adjusting for demographic characteristics and comorbid conditions as well as across all demographic subgroups. Similarly, health care resource utilization was significantly lower in those with optimal CVH profiles compared with those with moderate or low CVH profiles. CONCLUSION: Favorable CVH profile is associated with significantly lower total medical expenditures and health care utilization in a large, young, ethnically diverse, and fully insured employee population.

The Association of Sleep Duration and Morbid Obesity in a Working Population: The Baptist Health South Florida Employee Study.

BACKGROUND: The current study aimed to determine the relationship between self-reported sleep duration and morbid obesity in an employee population. METHODS: Baptist Health South Florida conducts an annual Health Risk Assessment (HRA) for its employees. Data for this cross-sectional study was collected via this HRA in 2014, and included information on self-reported sleep duration, height and weight for body mass index (BMI), and other biometric measures. Average sleep duration was categorized as short sleep (<6 hr), optimal sleep (6-7.9 hr), and long sleep duration (≥8 hr), while obesity status was categorized as nonobese (BMI <30 kg/m2), obese (30-34.9 kg/m2), and morbid obese (≥35 kg/m2). RESULTS: A total of 9505 participants (mean age 42.8 ± 12.1 years, 75% females, and 55% Hispanic) were included in this study. Prevalence of morbid obesity was about 24% among employees who were sleeping for less than 6 hr compared to 13% and 14% among those sleeping for 6-7.9 hours, and 8 or more hours respectively. In regression analyses, persons who slept less than 6 hr had almost twice the odds of morbid obesity compared to those who slept 6-7.9 hr (odds ratio = 1.8; 1.5-2.2). CONCLUSION: Our finding that short sleep duration (<6 hr) is significantly associated with a higher risk of morbid obesity should facilitate the development of workplace-based programs that focus on improving sleep among at-risk employees, especially those who work in shift duties to reduce the risk of morbid obesity and other comorbid conditions. Future studies are needed to further explore the relationship of sleep duration and morbid obesity in employee populations.

Association of Subjective and Objective Sleep Duration as well as Sleep Quality with Non-Invasive Markers of Sub-Clinical Cardiovascular Disease (CVD): A Systematic Review.

AIM: Abnormal daily sleep duration and quality have been linked to hypertension, diabetes, stroke, and overall cardiovascular disease (CVD) morbidity& mortality. However, the relationship between daily sleep duration and quality with subclinical measures of CVD remains less well studied. This systematic review evaluated how daily sleep duration and quality affect burden of subclinical CVD in subjects free of symptomatic CVD. METHODS: Literature search was done via MEDLINE, EMBASE, Web of Science until June 2016 and 32 studies met the inclusion criteria. Sleep duration and quality were measured either via subjective methods, as self-reported questionnaires or Pittsburg Sleep Quality Index (PSQI) or via objective methods, as actigraphy or polysomnography or by both. Among subclinical CVD measures, coronary artery calcium (CAC) was measured by electron beam computed tomography, Carotid intima-media thickness (CIMT) measured by high-resolution B-mode ultrasound on carotid arteries, endothelial/microvascular function measured by flow mediated dilation (FMD) or peripheral arterial tone (PAT) or iontophoresis or nailfold capillaroscopy, and arterial stiffness measured by pulse wave velocity (PWV) or ankle brachial index (ABI). RESULTS: Subjective short sleep duration was associated with CAC and CIMT, but variably associated with endothelial dysfunction (ED) and arterial stiffness; however, subjective long sleep duration was associated with CAC, CIMT and arterial stiffness, but variably associated with ED. Objective short sleep duration was positively associated with CIMT and variably with CAC but not associated with ED. Objective long sleep duration was variably associated with CAC and CIMT but not associated with ED. Poor subjective sleep quality was significantly associated with ED and arterial stiffness but variably associated with CAC and CIMT. Poor objective sleep quality was significantly associated with CIMT, and ED but variably associated with CAC. CONCLUSIONS: Overall, our review provided mixed results, which is generally in line with published literature, with most of the studies showing a significant relationship with subclinical CVD, but only some studies failed to demonstrate such an association. Although such mechanistic relationship needs further evaluation in order to determine appropriate screening strategies in vulnerable populations, this review strongly suggested the existence of a relationship between abnormal sleep duration and quality with increased subclinical CVD burden.

Trends in Ideal Cardiovascular Health Metrics Among Employees of a Large Healthcare Organization (from the Baptist Health South Florida Employee Study).

The American Heart Association (AHA)'s 2020 goal is to improve the cardiovascular health (CVH) of people living in the United States (US) by 20% and reduce mortality from cardiovascular diseases and stroke by 20%. Given that 155 million adults are in the US workforce, and >60% have employee-based insurance, workplace studies provide an important opportunity to assess and potentially advance CVH through the use of comprehensive workplace wellness programs. Among a cohort of employees of the Baptist Health System, CVH was assessed annually during voluntary health fairs and health risk assessments (HRA) from 2011 to 2014 using the AHA's 7 CVH metrics: smoking, body mass index (BMI), physical activity, diet, blood pressure, total cholesterol, and blood glucose. Each metric was categorized as ideal, intermediate, or poor according to the AHA criteria. Cochrane-Armitage test was used to detect trends in CVH by year. Ideal CVH, defined as meeting ideal criteria for all 7 metrics, was assessed and compared across years. The overall cohort was 34,746 with 4,895 employees in 2011, 10,724 in 2012, 9,763 in 2013, and 9,364 in 2014. Mean age (SD) was between 43 (±12) and 46 years (±12). Female to male ratio was 3:1. The prevalence of study participants who met the ideal criteria for diet, physical activity, and blood pressure increased significantly from 2011 to 2014 but for BMI, total cholesterol, and blood glucose, a significant decrease was noticed. In addition, the prevalence of study participants in ideal CVH although low, increased significantly over time (0.3% to 0.6%, p <0.0001). In conclusion, this study shows the trends of the AHA's CVH metrics in a large health care organization. The positive findings noted for the metrics of smoking, physical activity, total cholesterol, and blood glucose should be reinforced. However, the metrics of diet, BMI, and blood pressure need more attention.

The Effectiveness of a Worksite Lifestyle Intervention Program on High-Risk Individuals as Potential Candidates for Bariatric Surgery: My Unlimited Potential (MyUP).

This is a single-arm, pre and post effectiveness study that evaluated the impact of a comprehensive workplace lifestyle program on severe obesity among high cardiovascular disease risk individuals in a large, diverse employee population. Employees of Baptist Health South Florida were considered eligible to participate if they had 2 or more of the following cardiometabolic risk factors: total cholesterol ≥200 mg/dL, systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, hemoglobin A1c ≥6.5%, body mass index ≥30kg/m(2). Participants received a personalized diet plan and physical activity intervention, and were followed for 1 year. Data on anthropometric measurements, blood pressure, blood glucose, and other biochemical measures were collected. Participants' body mass index was calculated and their eligibility for bariatric surgery (BS) also assessed. A total of 297 persons participated in the program; 160 participants completed all procedures through 12 months of follow-up. At baseline, 34% (n = 100) of all participants were eligible for BS. In an intention-to-treat analysis, 27% (n = 27) of BS eligible participants at baseline became ineligible after 12 months. Considering program completers only, 46% of BS eligible participants at baseline became ineligible. Irrespective of BS eligibility at 12 months, mean values of cardiometabolic risk factors among program completers improved after the follow-up period. Workplace wellness programs provide an important option for weight loss that can obviate the need for BS, reduce cardiovascular disease risk, and potentially reduce costs. However, in designing future worksite lifestyle interventions, measures should be taken to improve participation and retention rates in such programs.

One-year outcomes of an intense workplace cardio-metabolic risk reduction program among high-risk employees: The My Unlimited Potential.

OBJECTIVE: This study details 6- and 12-month cardio-metabolic outcomes of an intense 12-week workplace lifestyle intervention program, the My Unlimited Potential (MyUP), conducted in a large healthcare organization. METHODS: This study was conducted among 230 employees of Baptist Health South Florida with high cardiovascular disease (CVD) risk. Employees were considered at high risk and eligible for the study if they had two or more of the following cardio-metabolic risk factors: total cholesterol ≥ 200 mg/dl, systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg, hemoglobin A1C (HbA1c) ≥ 6.5%, body mass index (BMI) ≥ 30 kg/m(2) . RESULTS: At the end of 12 weeks, there was significant reduction in the mean BMI, SBP and DBP, serum lipids, and HbA1c among persons with diabetes. At 1 year, there was significant decline in the mean BMI, SBP and DBP, HbA1c, and high-sensitivity C-reactive protein, and in the prevalence of poor BP control, BMI ≥ 35 kg/m(2) , and abnormal HbA1c among all persons and those with diabetes. CONCLUSIONS: This intensive 12-week lifestyle change program was successful at improving cardio-metabolic risk factors at 1 year. This study provides a template for other workplace programs aimed at improving CVD risk in high-risk employees.