Incidence rates of thrombosis with thrombocytopenia syndrome (TTS) among adults in United States commercial and Medicare claims databases, 2017-2020.

BACKGROUND: Increased risk of thrombosis with thrombocytopenia syndrome (TTS) following adenovirus vector-based COVID-19 vaccinations has been identified in passive surveillance systems. TTS incidence rates (IRs) in the United States (U.S.) are needed to contextualize reports following COVID-19 vaccination. METHODS: We estimated annual and monthly IRs of overall TTS, common site TTS, and unusual site TTS for adults aged 18-64 years in Carelon Research and MarketScan commercial claims (2017-Oct 2020), CVS Health and Optum commercial claims (2019-Oct 2020), and adults aged ≥ 65 years using CMS Medicare claims (2019-Oct 2020); IRs were stratified by age, sex, and race/ethnicity (CMS Medicare). RESULTS: Across data sources, annual IRs for overall TTS were similar between Jan-Dec 2019 and Jan-Oct 2020. Rates were higher in Medicare (IRs: 370.72 and 365.63 per 100,000 person-years for 2019 and 2020, respectively) than commercial data sources (MarketScan IRs: 24.21 and 24.06 per 100,000 person-years; Optum IRs: 32.60 and 31.29 per 100,000 person-years; Carelon Research IRs: 24.46 and 26.16 per 100,000 person-years; CVS Health IRs: 30.31 and 30.25 per 100,000 person-years). Across years and databases, common site TTS IRs increased with age and were higher among males. Among adults aged ≥ 65 years, the common site TTS IR was highest among non-Hispanic black adults. Annual unusual site TTS IRs ranged between 2.02 and 3.04 (commercial) and 12.49 (Medicare) per 100,000 person-years for Jan-Dec 2019; IRs ranged between 1.53 and 2.67 (commercial) and 11.57 (Medicare) per 100,000 person-years for Jan-Oct 2020. Unusual site TTS IRs were higher in males and increased with age in commercial data sources; among adults aged ≥ 65 years, IRs decreased with age and were highest among non-Hispanic American Indian/Alaska native adults. CONCLUSION: TTS IRs were generally similar across years, higher for males, and increased with age. These rates may contribute to surveillance of post-vaccination TTS.

Effectiveness of monovalent COVID-19 booster/additional vaccine doses in the United States.

Background: Monovalent booster/additional doses of COVID-19 vaccines were first authorized in August 2021 in the United States. We evaluated the real-world effectiveness of receipt of a monovalent booster/additional dose of COVID-19 vaccine compared with receiving a primary vaccine series without a booster/additional dose. Methods: Cohorts of individuals receiving a COVID-19 booster/additional dose after receipt of a complete primary vaccine series were identified in 2 administrative insurance claims databases (Optum, CVS Health) supplemented with state immunization information system data between August 2021 and March 2022. Individuals with a complete primary series but without a booster/additional dose were one-to-one matched to boosted individuals on calendar date, geography, and clinical factors. COVID-19 diagnoses were identified in any medical setting, or specifically in hospitals/emergency departments (EDs). Propensity score-weighted hazards ratios (HRs) and 95% confidence intervals (CI) were estimated with Cox proportional hazards models; vaccine effectiveness (VE) was estimated as 1 minus the HR by vaccine brand overall and within subgroups of variant-specific eras, immunocompromised status, and homologous/heterologous booster status. Results: Across both data sources, we identified 752,165 matched pairs for BNT162b2, 410,501 for mRNA-1273, and 11,398 for JNJ-7836735. For any medically diagnosed COVID-19, meta-analyzed VE estimates for BNT162b2, mRNA-1273, and JNJ-7836735, respectively, were: BNT162b2, 54% (95% CI, 53%-56%); mRNA-1273, 58% (95% CI, 56%-59%); JNJ-7836735, 34% (95% CI, 23%-44%). For hospital/ED-diagnosed COVID-19, VE estimates ranged from 70% to 76%. VE was generally lower during the Omicron era than the Delta era and for immunocompromised individuals. There was little difference observed by homologous or heterologous booster status. Conclusion: The original, monovalent booster/additional doses were reasonably effective in real-world use among the populations for which they were indicated during the study period. Additional studies may be informative in the future as new variants emerge and new vaccines become available.Registration: The study protocol was publicly posted on the BEST Initiative website (https://bestinitiative.org/wp-content/uploads/2022/03/C19-VX-Effectiveness-Protocol_2022_508.pdf).

Cervical High-Grade Squamous Intraepithelial Lesion Burden and Standard of Care Treatment Effectiveness and Safety in the United States, 2008-2018: The EACH-WOMAN Project.

OBJECTIVE: Management of cervical high-grade squamous intraepithelial lesions (HSILs), the immediate precursor of cervical cancer, consists largely of surgical treatment for women at higher risk for progression to cancer. The authors' objective was to describe the occurrence of cervical HSIL in the United States and various outcomes for women who received surgical treatment. METHODS: From a US commercial health insurer, a cohort of adult women with cervical HSIL diagnoses receiving surgical treatment within 3 months of diagnosis between January 2008 and September 2018 was identified. This cohort was followed for several outcomes, including cervical HSIL recurrence, human papillomavirus clearance, preterm birth, infection, and bleeding. RESULTS: The incidence rate of cervical HSIL declined from 2.34 (95% CI = 2.30-2.39) cases per 1,000 person-years in 2008 to 1.39 (95% CI = 1.35-1.43) cases per 1,000 person-years in 2014, remaining near that level through 2018. Among 65,527 women with cervical HSIL, 47,067 (72%) received surgical treatment within 3 months of diagnosis. Among the women receiving surgical treatment, cervical HSIL recurred in 6% of surgically treated women, whereas 45% of surgically treated women underwent subsequent virological testing that indicated human papillomavirus clearance. Preterm birth was observed in 5.9% by 5 years follow-up and bleeding and infection each at 2.2% by 7 days follow-up. CONCLUSIONS: From 2008 through 2018, the incidence of diagnosed cervical HSIL decreased for several years before stabilizing. Surgical treatment of HSIL may be beneficial in removing the precancerous lesion, but cervical HSIL may recur, and the surgery is associated with complications including preterm birth, infection, and bleeding.

Background rates of adverse events of special interest for COVID-19 vaccine safety monitoring in the United States, 2019-2020.

BACKGROUND: The U.S. Food and Drug Administration (FDA) Biologics Effectiveness and Safety (BEST) Initiative conducts active surveillance of adverse events of special interest (AESI) after COVID-19 vaccination. Historical incidence rates (IRs) of AESI are comparators to evaluate safety. METHODS: We estimated IRs of 17 AESI in six administrative claims databases from January 1, 2019, to December 11, 2020: Medicare claims for adults ≥ 65 years and commercial claims (Blue Health Intelligence®, CVS Health, HealthCore Integrated Research Database, IBM® MarketScan® Commercial Database, Optum pre-adjudicated claims) for adults < 65 years. IRs were estimated by sex, age, race/ethnicity (Medicare), and nursing home residency (Medicare) in 2019 and for specific periods in 2020. RESULTS: The study included >100 million enrollees annually. In 2019, rates of most AESI increased with age. However, compared with commercially insured adults, Medicare enrollees had lower IRs of anaphylaxis (11 vs 12-19 per 100,000 person-years), appendicitis (80 vs 117-155), and narcolepsy (38 vs 41-53). Rates were higher in males than females for most AESI across databases and varied by race/ethnicity and nursing home status (Medicare). Acute myocardial infarction (Medicare) and anaphylaxis (all databases) IRs varied by season. IRs of most AESI were lower during March-May 2020 compared with March-May 2019 but returned to pre-pandemic levels after May 2020. However, rates of Bell's palsy, Guillain-Barré syndrome, narcolepsy, and hemorrhagic/non-hemorrhagic stroke remained lower in multiple databases after May 2020, whereas some AESI (e.g., disseminated intravascular coagulation) exhibited higher rates after May 2020 compared with 2019. CONCLUSION: AESI background rates varied by database and demographics and fluctuated in March-December 2020, but most returned to pre-pandemic levels after May 2020. It is critical to standardize demographics and consider seasonal and other trends when comparing historical rates with post-vaccination AESI rates in the same database to evaluate COVID-19 vaccine safety.

Trends in COVID-19 patient characteristics in a large electronic health record database in the United States: A cohort study.

BACKGROUND: Electronic health record (EHR) databases provide an opportunity to facilitate characterization and trends in patients with COVID-19. METHODS: Patients with COVID-19 were identified based on an ICD-10 diagnosis code for COVID-19 (U07.1) and/or a positive SARS-CoV-2 viral lab result from January 2020 to November 2020. Patients were characterized in terms of demographics, healthcare utilization, clinical comorbidities, therapies, laboratory results, and procedures/care received, including critical care, intubation/ventilation, and occurrence of death were described, overall and by month. RESULTS: There were 393,773 patients with COVID-19 and 56,996 with a COVID-19 associated hospitalization. A greater percentage of patients hospitalized with COVID-19 relative to all COVID-19 cases were older, male, African American, and lived in the Northeast and South. The most common comorbidities before admission/infection date were hypertension (40.8%), diabetes (29.5%), and obesity (23.8%), and the most common diagnoses during hospitalization were pneumonia (59.6%), acute respiratory failure (44.8%), and dyspnea (28.0%). A total of 85.7% of patients hospitalized with COVID-19 had CRP values > 10 mg/L, 75.5% had fibrinogen values > 400 mg/dL, and 76.8% had D-dimer values > 250 ng/mL. Median values for platelets, CRP, lactate dehydrogenase, D-dimer, and fibrinogen tended to decrease from January-March to November. The use of chloroquine/hydroxychloroquine during hospitalization peaked by March (71.2%) and was used rarely by May (5.1%) and less than 1% afterwards, while the use of remdesivir had increased by May (10.0%) followed by dexamethasone by June (27.7%). All-cause mortality was 3.2% overall and 15.0% among those hospitalized; 21.0% received critical care and 16.0% received intubation/ventilation/ECMO. CONCLUSIONS: This study characterizes US patients with COVID-19 and their management during hospitalization over the first eleven months of this disease pandemic.

Risk of myocarditis and pericarditis after the COVID-19 mRNA vaccination in the USA: a cohort study in claims databases.

BACKGROUND: Several passive surveillance systems reported increased risks of myocarditis or pericarditis, or both, after COVID-19 mRNA vaccination, especially in young men. We used active surveillance from large health-care databases to quantify and enable the direct comparison of the risk of myocarditis or pericarditis, or both, after mRNA-1273 (Moderna) and BNT162b2 (Pfizer-BioNTech) vaccinations. METHODS: We conducted a retrospective cohort study, examining the primary outcome of myocarditis or pericarditis, or both, identified using the International Classification of Diseases diagnosis codes, occurring 1-7 days post-vaccination, evaluated in COVID-19 mRNA vaccinees aged 18-64 years using health plan claims databases in the USA. Observed (O) incidence rates were compared with expected (E) incidence rates estimated from historical cohorts by each database. We used multivariate Poisson regression to estimate the adjusted incidence rates, specific to each brand of vaccine, and incidence rate ratios (IRRs) comparing mRNA-1273 and BNT162b2. We used meta-analyses to pool the adjusted incidence rates and IRRs across databases. FINDINGS: A total of 411 myocarditis or pericarditis, or both, events were observed among 15 148 369 people aged 18-64 years who received 16 912 716 doses of BNT162b2 and 10 631 554 doses of mRNA-1273. Among men aged 18-25 years, the pooled incidence rate was highest after the second dose, at 1·71 (95% CI 1·31 to 2·23) per 100 000 person-days for BNT162b2 and 2·17 (1·55 to 3·04) per 100 000 person-days for mRNA-1273. The pooled IRR in the head-to-head comparison of the two mRNA vaccines was 1·43 (95% CI 0·88 to 2·34), with an excess risk of 27·80 per million doses (-21·88 to 77·48) in mRNA-1273 recipients compared with BNT162b2. INTERPRETATION: An increased risk of myocarditis or pericarditis was observed after COVID-19 mRNA vaccination and was highest in men aged 18-25 years after a second dose of the vaccine. However, the incidence was rare. These results do not indicate a statistically significant risk difference between mRNA-1273 and BNT162b2, but it should not be ruled out that a difference might exist. Our study results, along with the benefit-risk profile, continue to support vaccination using either of the two mRNA vaccines. FUNDING: US Food and Drug Administration.

Predictors of critical care, mechanical ventilation, and mortality among hospitalized patients with COVID-19 in an electronic health record database.

BACKGROUND: There are limited data on risk factors for serious outcomes and death from COVID-19 among patients representative of the U.S. POPULATION: The objective of this study was to determine risk factors for critical care, ventilation, and death among hospitalized patients with COVID-19. METHODS: This was a cohort study using data from Optum's longitudinal COVID-19 electronic health record database derived from a network of healthcare provider organizations across the US. The study included patients with confirmed COVID-19 (presence of ICD-10-CM code U07.1 and/or positive SARS-CoV-2 test) between January 2020 and November 2020. Patient characteristics and clinical variables at start of hospitalization were evaluated for their association with subsequent serious outcomes (critical care, mechanical ventilation, and death) using odds ratios (OR) and 95% confidence intervals (CI) from logistic regression, adjusted for demographic variables. RESULTS: Among 56,996 hospitalized COVID-19 patients (49.5% male and 72.4% ≥ 50 years), 11,967 received critical care, 9136 received mechanical ventilation, and 8526 died. The median duration of hospitalization was 6 days (IQR: 4, 11), and this was longer among patients that experienced an outcome: 11 days (IQR: 6, 19) for critical care, 15 days (IQR: 8, 24) for mechanical ventilation, and 10 days (IQR: 5, 17) for death. Dyspnea and hypoxemia were the most prevalent symptoms and both were associated with serious outcomes in adjusted models. Additionally, temperature, C-reactive protein, ferritin, lactate dehydrogenase, D-dimer, and oxygen saturation measured during hospitalization were predictors of serious outcomes as were several in-hospital diagnoses. The strongest associations were observed for acute respiratory failure (critical care: OR, 6.30; 95% CI, 5.99-6.63; ventilation: OR, 8.55; 95% CI, 8.02-9.11; death: OR, 3.36; 95% CI, 3.17-3.55) and sepsis (critical care: OR, 4.59; 95% CI, 4.39-4.81; ventilation: OR, 5.26; 95% CI, 5.00-5.53; death: OR, 4.14; 95% CI, 3.92-4.38). Treatment with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers during hospitalization were inversely associated with death (OR, 0.57; 95% CI, 0.54-0.61). CONCLUSIONS: We identified several clinical characteristics associated with receipt of critical care, mechanical ventilation, and death among COVID-19 patients. Future studies into the mechanisms that lead to severe COVID-19 disease are warranted.

Incidence of VTE in Patients With OSA: A Cohort Study.

BACKGROUND: Previous studies suggesting that OSA may be an independent risk factor for VTE have been limited by reliance on administrative data and lack of adjustment for clinical variables, including obesity. RESEARCH QUESTION: Does OSA confer an independent risk of incident VTE among a large clinical cohort referred for sleep-disordered breathing evaluation? STUDY DESIGN AND METHODS: We analyzed the clinical outcomes of 31,309 patients undergoing overnight polysomnography within a large hospital system. We evaluated the association of OSA severity with incident VTE, using Cox proportional hazards modeling accounting for age, sex, BMI, and common comorbid conditions. RESULTS: Patients were of mean age 50.4 years, and 50.1% were female. There were 1,791 VTE events identified over a mean follow-up of 5.3 years. In age- and sex-adjusted analyses, each 10-event/h increase in the apnea-hypopnea index was associated with a 4% increase in incident VTE risk (hazard ratio [HR], 1.04; 95% CI, 1.02-1.06). After adjusting for BMI, this association disappeared (HR, 1.01; 95% CI, 0.99-1.03). In contrast, nocturnal hypoxemia had an independent association with incident VTE. Patients with > 50% sleep time spent with oxyhemoglobin saturation < 90% are at 48% increased VTE risk compared with those without nocturnal hypoxemia (HR, 1.48; 95% CI, 1.16-1.69). INTERPRETATION: In this large cohort, we found that patients with more severe OSA as measured by the apnea-hypopnea index are more likely to have incident VTE. Adjusted analyses suggest that this association is explained on the basis of confounding by obesity. However, severe nocturnal hypoxemia may be a mechanism by which OSA heightens VTE risk.

Association Between Sleep Disordered Breathing and Left Ventricular Function: A Cross-Sectional Analysis of the ECHO-SOL Ancillary Study.

BACKGROUND: Prior studies have found that sleep-disordered breathing (SDB) is common among those with left ventricular (LV) dysfunction and heart failure. Few epidemiological studies have examined this association, especially in US Hispanic/Latinos, who may be at elevated risk of SDB and heart failure. METHODS: We examined associations between SDB and LV diastolic and systolic function using data from 1506 adults aged 18 to 64 years in the Hispanic Community Health Study/Study of Latinos ECHO-SOL Ancillary Study (2011-2014). Home sleep testing was used to measure the apnea-hypopnea index, a measure of SDB severity. Echocardiography was performed a median of 2.1 years later to quantify LV diastolic function, systolic function, and structure. Multivariable linear regression was used to model the association between apnea-hypopnea index and echocardiographic measures while accounting for the complex survey design, demographics, body mass, and time between sleep and echocardiographic measurements. RESULTS: Each 10-unit increase in apnea-hypopnea index was associated with 0.2 (95% CI, 0.1-0.3) lower E', 0.3 (0.1-0.5) greater E/E' ratio, and 1.07-fold (1.03-1.11) higher prevalence of diastolic dysfunction as well as 1.3 (0.3-2.4) g/m2 greater LV mass index. These associations persisted after adjustment for hypertension and diabetes mellitus. In contrast, no association was identified between SDB severity and subclinical markers of LV systolic function. CONCLUSIONS: Greater SDB severity was associated with LV hypertrophy and subclinical markers of LV diastolic dysfunction. These findings suggest SDB in Hispanic/Latino men and women may contribute to the burden of heart failure in this population.

Diagnosed Sleep Apnea and Cardiovascular Disease in Atrial Fibrillation Patients: The Role of Measurement Error from Administrative Data.

BACKGROUND: Atrial fibrillation and obstructive sleep apnea are common conditions, but little is known about obstructive sleep apnea and cardiovascular risk among atrial fibrillation patients. METHODS: Using the Truven Health MarketScan databases, we constructed a prospective cohort of atrial fibrillation patients from 2007 to 2014. Atrial fibrillation, obstructive sleep apnea, stroke, myocardial infarction, and confounders were defined using the International Classification of Disease-9-CM codes. We matched individuals with an obstructive sleep apnea diagnosis with up to five individuals without a diagnosis by age, sex, and enrollment date. Cox proportional hazards models adjusted for confounders and high-dimensional propensity scores. We included migraines as a control outcome. Bias analysis used published sensitivities and specificities to generate rate ratios adjusted for obstructive sleep apnea misclassification. RESULTS: We matched 56,969 individuals with an obstructive sleep apnea diagnosis to 323,246 without. During a mean follow-up of 16 months, 3234 incident strokes and 4639 incident myocardial infarctions occurred. After adjustment, obstructive sleep apnea diagnosis was strongly associated with reduced risk of incident stroke (hazard ratio = 0.48, 95% confidence interval = 0.43, 0.53) and myocardial infarction (0.40, [0.37, 0.44]) and a smaller reduced risk of migraines (0.82, [0.68, 0.99]). Bias analysis produced wide-ranging or inestimable rate ratios adjusted for misclassification of obstructive sleep apnea. CONCLUSIONS: Obstructive sleep apnea diagnosis in atrial fibrillation patients was strongly associated with reduced risk of incident cardiovascular disease. We discuss misclassification, selection bias, and residual confounding as potential explanations.

Association of Short Sleep Duration and Atrial Fibrillation.

BACKGROUND: Short sleep may be a risk factor for atrial fibrillation. However, previous investigations have been limited by lack of objective sleep measurement and small sample size. We sought to determine the association between objectively measured sleep duration and atrial fibrillation. METHODS: All 31,079 adult patients undergoing diagnostic polysomnography from 1999 to 2015 at multiple sites within a large hospital network were identified from electronic medical records. Prevalent atrial fibrillation was identified by continuous ECG during polysomnography. Incident atrial fibrillation was identified by diagnostic codes and 12-lead ECGs. Logistic regression and Cox proportional hazards modeling were used to examine the association of sleep duration and atrial fibrillation prevalence and incidence, respectively, adjusting for age, sex, BMI, hypertension, coronary artery disease, cerebrovascular disease, peripheral vascular disease, heart failure, and sleep apnea severity. RESULTS: We identified 404 cases of prevalent atrial fibrillation among 30,061 individuals (mean age ± SD, 51.0 ± 14.5 years; 51.6% women) undergoing polysomnography. After adjustment, each 1-h reduction in sleep duration was associated with a 1.17-fold (95% CI, 1.11-1.30) increased risk of prevalent atrial fibrillation. Among 27,589 patients without atrial fibrillation at baseline, we identified 1,820 cases of incident atrial fibrillation over 4.6 years median follow-up. After adjustment, each 1-h reduction in sleep duration was associated with a 1.09-fold (95% CI, 1.05-1.13) increased risk for incident atrial fibrillation. CONCLUSIONS: Short sleep duration is independently associated with prevalent and incident atrial fibrillation. Further research is needed to determine whether interventions to extend sleep can lower atrial fibrillation risk.

Sex and race differences in the association between sleep duration and adiposity: the Bogalusa Heart Study.

BACKGROUND: Short sleep duration has been consistently associated with obesity. However, few studies in adults have assessed whether this association varies by sex and race. METHODS: In the 2013-2016 examination of 1116 participants from the biracial Bogalusa Heart Study, habitual sleep duration was measured in categories (<6 hours, 6-7 hours, 7-8 hours, > 8 hours) using self-report. Anthropometry was performed and adiposity was assessed using body mass index (BMI) and waist circumference. Linear regression models estimated the relationship between sleep duration and adiposity adjusting for age, education, employment, bed partner status, depressive symptoms, smoking status, physical activity, and the use of alcohol and sleeping pills. Effect modification by sex and race was examined using cross-product terms in the models and marginal means were reported. RESULTS: Of 1116 participants (mean age 48.2 years), 58.3% were female, and 31.7% were Black. In adjusted analyses, women sleeping <6 hours had a 3.2 (95% CI 1.4, 5.0) kg/m2 greater BMI and 6.1 (1.8, 10.4) cm greater waist circumference compared to women sleeping 7-8 hours. In contrast, men had similar BMIs and waist circumferences regardless of sleep duration (p's for interaction = 0.04 & 0.11). There was no effect modification by race. CONCLUSIONS: In this sample, lower habitual sleep duration was associated with greater adiposity among women compared to men. Further research is needed to understand the potential mechanisms of the adverse metabolic effects of short sleep in women.

Associations between polysomnography and actigraphy-based sleep indices and glycemic control among those with and without type 2 diabetes: the Multi-Ethnic Study of Atherosclerosis.

Study Objectives: To examine the associations of sleep measures with hemoglobin A1c (HbA1c) among individuals with and without type 2 diabetes. Methods: Data were from 2049 Multi-Ethnic Study of Atherosclerosis participants taking part in a sleep ancillary study. Cross-sectional linear regression models examined associations of actigraphy estimates of sleep (sleep duration, variability, and maintenance efficiency) and polysomnography measures (obstructive sleep apnea [OSA] and hypoxemia) with HbA1c, stratified by diabetes status. Primary models were adjusted for demographics, lifestyle behaviors, and obesity. Results: Among individuals with diabetes (20 per cent population), those who slept <5 hr/night had greater HbA1c than those who slept 7-8 hr/night (7.44 vs. 6.98 per cent, ptrend = 0.04), with no attenuation of associations after adjusting for OSA/hypoxemia. In women with diabetes, but not men, those in the lowest quartile of sleep maintenance efficiency had greater HbA1c than those in the highest quartile of sleep maintenance efficiency (7.60 vs. 6.97 per cent, ptrend < 0.01). Among those without diabetes, individuals with severe OSA or in the highest quartile of hypoxemia had significantly greater HbA1c than those without OSA or who were in the lowest quartile of hypoxemia (5.76 vs. 5.66 per cent, ptrend = 0.01; 5.75 vs. 5.66 per cent, ptrend < 0.01, respectively). Associations did not meaningfully differ by race/ethnicity. Conclusions: Among individuals with diabetes, HbA1c was significantly higher in men and women with short sleep duration and in women with poor sleep maintenance efficiency, suggesting a role for behavioral sleep interventions in the management of diabetes. Among individuals without diabetes, untreated severe OSA/hypoxemia may adversely influence HbA1c.

The Epidemiology of Sleep and Diabetes.

PURPOSE OF REVIEW: To provide an overview of the mechanistic and epidemiologic evidence linking sleep-related exposures, such as short sleep duration, obstructive sleep apnea, shift work, and insomnia, with type 2 diabetes risk in adults. RECENT FINDINGS: Both poor sleep habits and sleep disorders are highly prevalent among adults with type 2 diabetes. In observational studies, short sleep duration, obstructive sleep apnea, shift work, and insomnia are all associated with higher risk of incident type 2 diabetes and may predict worse outcomes in those with existing diabetes. However, interventional studies addressing sleep abnormalities in populations with or at high risk for type 2 diabetes are scarce. Although common sleep abnormalities are associated with risk of incident type 2 diabetes and worse prognosis in those with established diabetes, there are few randomized trials evaluating the impact of sleep-focused interventions on diabetes, making it difficult to determine whether the relationship is causal.

Exploring the mechanisms of the racial disparity in drowsy driving.

OBJECTIVE: Drowsy driving is a significant cause of traffic accidents and fatalities. Although previous reports have shown an association between race and drowsy driving, the reasons for this disparity remain unclear. STUDY DESIGN: A cross-sectional analysis of responses from 193,776 White, Black, and Hispanic adults participating in the US Behavioral Risk Factor Surveillance System from 2009 to 2012 who answered a question about drowsy driving. MEASUREMENTS: Drowsy driving was defined as self-reporting an episode of falling asleep while driving in the past 30 days. All analyses were adjusted for age, sex, and medical comorbidities. Subsequent modeling evaluated the impact of accounting for differences in health care access, alcohol consumption, risk-taking behaviors, and sleep quality on the race-drowsy driving relationship. RESULTS: After adjusting for age, sex, and medical comorbidities, the odds ratio (OR) for drowsy driving was 2.07 (95% confidence interval [CI] 1.69-2.53) in Blacks and 1.80 (95% CI 1.51-2.15) in Hispanics relative to Whites. Accounting for health care access, alcohol use, and risk-taking behaviors had little effect on these associations. Accounting for differences in sleep quality resulted in a modest reduction in the OR for drowsy driving in Blacks (OR = 1.55, 95% CI 1.27-1.89) but not Hispanics (OR = 1.74, 95% CI 1.45-2.08). CONCLUSION: US Blacks and Hispanics have approximately twice the risk of drowsy driving compared to whites. Differences in sleep quality explained some of this disparity in Blacks but not in Hispanics. Further research to understand the root causes of these disparities is needed.

Restless legs syndrome and periodic limb movements during sleep in the Multi-Ethnic Study of Atherosclerosis.

Study Objectives: To investigate the prevalence of concurrent periodic limb movements during sleep (PLMS) and restless leg syndrome (RLS), as well as the prevalence of PLMS and RLS separately. Additionally, we document these prevalences by age, race/ethnicity, sex, and obesity status. Methods: Cross-sectional data from 2041 Multi-Ethnic Study of Atherosclerosis (MESA) Sleep ancillary study participants were used. PLMS (>15 periodic limb movements per hour of sleep) was measured by polysomnography. RLS symptoms were assessed using the 2009 International Restless Legs Syndrome Study Group clinical criteria. Results: The prevalence of RLS with PLMS was 6.7%, RLS alone 16.1%, and PLMS alone 21.2%. RLS with PLMS was prevalent in 7.0% of whites, 4.9% of blacks, 10.1% of Hispanics, and 3.3% of Chinese-Americans. In adjusted models, odds of RLS with PLMS was higher for those older than 67 years versus those younger (odds ratio [OR] [95% confidence interval [CI]] = 1.62 [1.09-2.40]). Relative to white participants, the prevalence of RLS with PLMS tended to be lower among blacks (0.56 [0.32-0.96]). The prevalence of concurrent RLS and PLMS did not statistically differ by sex or obesity status. RLS alone was more common in women. Conclusions: Approximately 7% of our sample had RLS with PLMS ("electro-clinical RLS"). This condition was more common among older individuals, did not vary by sex, and was less common among blacks. The findings provide some of the first information about the prevalence of concurrent RLS and PLMS in a community-based sample and show distinct sex and race associations for RLS versus electro-clinical RLS.

Are the U.S. territories lagging behind in diabetes care practices?

AIMS: Although U.S. territories fall within the mandate outlined by Healthy People 2020, they remain neglected in diabetes care research. We compared the prevalence and secular trends of four recommended diabetes care practices in the U.S. territories of Guam, Puerto Rico, and the U.S. Virgin Islands to the 50 United States and D.C. ("U.S. States") in 2001-2015. METHODS: Data were from 390,268 adult participants with self-reported physician diagnosed diabetes in the Behavioral Risk Factor Surveillance System. Diabetes care practices included biannual HbA1c tests, attendance of diabetes education classes, daily self-monitoring of blood glucose, and receipt of annual foot examination. Practices were compared by U.S. territory and between territories and U.S. states. Multivariable models accounted for age, sex, education, and year. RESULTS: Of adults with diagnosed diabetes, 7% to 11% in the U.S. territories engaged in all four recommended diabetes care practices compared with 25% for those, on average, in U.S. states. Relative to the U.S. states, on average, the proportion achieving biannual HbA1c testing was lower in Guam and the U.S. Virgin Islands (45.6% and 44.9% vs. 62.2%), while annual foot examinations were lower in Puerto Rico (45.9% vs 66.1% in the U.S. states). Diabetes education and daily glucose self-monitoring were lower in all three territories. CONCLUSIONS: U.S. territories lag behind U.S. states in diabetes care practices. Policies aimed at improving diabetes care practices are needed in the U.S. territories to achieve Healthy People 2020 goals and attain parity with U.S. states.

Joint effects of OSA and self-reported sleepiness on incident CHD and stroke.

BACKGROUND: Although excessive daytime sleepiness (EDS) is a common symptom of obstructive sleep apnea (OSA), and both EDS and OSA have separately been associated with increased risk of cardiovascular disease (CVD), their joint association with CVD risk is unknown. METHODS: Among 3874 Sleep Heart Health Study (SHHS) participants without prevalent CVD, moderate to severe OSA was defined by an apnea hypopnea index (AHI) ≥ 15 on an in-home polysomnography. EDS was defined as an Epworth Sleepiness Scale score ≥11. Incident CVD events included total CVD events (coronary heart disease (CHD) and stroke), as well as CHD and stroke separately. Cox proportional hazards models adjusted for age, sex, alcohol, smoking, and body mass index. RESULTS: Compared to those with AHI <15, the hazard ratios (95% CI) for the association of moderate-severe OSA (AHI ≥15) were as follows: CVD 1.06 (0.85-1.33); CHD 1.08 (0.85-1.33); and stroke 1.18 (0.75-1.84). Weak associations between EDS and CVD risk = [1.22 (1.01-1.47)] and CHD risk [1.25 (1.02-1.53)] were present, however there were none for stroke risk [1.10 (0.75-1.63)]. When jointly modeled, both AHI ≥15 and EDS (compared with having AHI <15 and no EDS) was associated with HRs of 1.26 (0.91-1.73) for CVD, 1.24 (0.87-1.75) for CHD and 1.49 (0.78-2.86) for stroke. There were no statistically significant interactions between daytime sleepiness and OSA on the multiplicative or additive scales. CONCLUSIONS: Having both EDS and moderate-severe OSA was not associated with an increased risk of CVD in the SHHS data.