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Introduction Despite the growing recognition of the importance of neighborhood conditions for cardiometabolic health, causal relationships have been difficult to establish owing to a reliance on cross-sectional designs and selection bias. This is the first natural experiment to examine the impact of neighborhood revitalization on cardiometabolic outcomes in residents from 2 predominantly African American neighborhoods, one of which has experienced significant revitalization (intervention), whereas the other has not (comparison). Methods The sample included 532 adults (95% African American, 80% female, mean age=58.9 years) from 2 sociodemographically similar, low-income neighborhoods in Pittsburgh, PA, with preintervention and postintervention measures (2016 and 2018) of BMI, diastolic and systolic blood pressure, HbA1c, and high-density lipoprotein cholesterol and covariates. Data were collected in 2016 and 2018 and analyzed in 2020. Results Difference-in-difference analyses showed significant improvement in high-density lipoprotein cholesterol in intervention residents relative to that in the comparison neighborhood (β=3.88, 95% CI=0.47, 7.29). There was also a significant difference-in-difference estimate in diastolic blood pressure (β=3.00, 95% CI=0.57, 5.43), with residents of the intervention neighborhood showing a greater increase in diastolic blood pressure than those in the comparison neighborhood. No statistically significant differences were found for other outcomes. Conclusions Investing in disadvantaged neighborhoods has been suggested as a strategy to reduce health disparities. Using a natural experiment, findings suggest that improving neighborhood conditions may have a mixed impact on certain aspects of cardiometabolic health. Findings underscore the importance of examining the upstream causes of health disparities using rigorous designs and longer follow-up periods that provide more powerful tests of causality.

Objectives: This study sought to: 1) under­stand how the perceived food environment (availability, accessibility, and affordability) is associated with cardiometabolic health outcomes in predominately low-income Black residents in urban neighborhoods with limited healthy food access; and 2) examine the association of shopping at specific store types with cardiometabolic health outcomes. Methods: We report on cross-sectional data from 459 individuals participating in the Pittsburgh, PA Hill/Homewood Research on Neighborhoods and Health (PHRESH) study. Mean participant age was 60.7 (SD=13.9); 81.7% were female. We used logistic regression to examine associations between three factors (perceived fruit and vegetable availability, quality, and price; primary food shopping store characteristics; and frequency of shopping at stores with low or high access to healthy foods) and cardiometabolic and self-rated health. Results: Adjusting for sociodemographic characteristics, participants with higher perceived fruit and vegetable accessibility (AOR:.47, 95%CI: .28-.79, P=.004) and affordability (AOR:.59, 95%CI: .36-.96, P=.034) had lower odds of high blood pres­sure. Shopping often (vs rarely) at stores with low access to healthy foods was associated with higher odds of high total cholesterol (AOR:3.52, 95%CI: 1.09-11.40, P=.035). Finally, primary food shopping at a discount grocery (vs full-service supermarket) was as­sociated with lower odds of overweight/obe­sity (AOR:.51, 95%CI: .26-.99, P=.049). Conclusions: These results suggest that both perceived accessibility and affordability of healthy foods are associated with reduced cardiometabolic risk factors in this urban, low-income predominantly Black population. Additionally, discount grocery stores may be particularly valuable by providing access and affordability of healthy foods in this population. Ethn Dis. 2021;31(4):537-546; doi:10.18865/ed.31.4.537

STUDY OBJECTIVES: Black individuals and individuals of low socioeconomic status are at increased risk for obstructive sleep apnea (OSA). The Berlin Questionnaire is one of the most widely used screening tools for OSA; however, there is limited research on its diagnostic accuracy in low-income Black populations. METHODS: This study analyzed data from an ongoing study taking place among a cohort from 2 predominantly Black neighborhoods in Pittsburgh, Pennsylvania (96.3% Black, 79.6% female). The sample included 269 individuals without a prior diagnosis of OSA who completed the Berlin Questionnaire and also participated in a home sleep apnea test. An apnea-hypopnea index ≥ 15 events/h was used to identify individuals with moderate or severe OSA. RESULTS: 19.3% of individuals met criteria for moderate to severe OSA based on home sleep apnea test, while 31.2% of participants screened as high risk for OSA based on the overall Berlin index. Using apnea-hypopnea index ≥ 15 events/h as the reference standard, the Berlin Questionnaire had a sensitivity of 46.2%, specificity of 72.4%, positive predictive value of 28.6%, and negative predictive value of 84.9% among this sample. Analyses stratified by sex suggested that the Berlin Questionnaire had better diagnostic validity in women than men. CONCLUSIONS: The Berlin Questionnaire has lower sensitivity and positive predictive value in our sample than those observed in general population samples. The measure performed better among women, though a higher proportion of men fell into the moderate or severe OSA range based on the home sleep apnea test. Given the significant downstream consequences of OSA, utilizing screening tools that better detect OSA in Black communities is key. CITATION: Holliday SB, Haas A, Dong L, et al. Examining the diagnostic validity of the Berlin Questionnaire in a low-income Black American sample. J Clin Sleep Med. 2021;17(10):1987–1994.

Summary Background Patients with systemic lupus erythematosus (SLE) are at risk of developing COVID-19 due to underlying immune abnormalities and regular use of immunosuppressant medications. We aimed to evaluate the presence of SARS-CoV-2 IgG antibodies in patients with SLE with or without previous COVID-19-related symptoms or RT-PCR-confirmed SARS-CoV-2 infection. Methods For this analysis, we included patients with SLE from two cohorts based in New York City: the Web-based Assessment of Autoimmune, Immune-Mediated and Rheumatic Patients during the COVID-19 pandemic (WARCOV) study; and the NYU Lupus Cohort (a prospective registry of patients at NYU Langone Health and NYC Health + Hospitals/Bellevue). Patients in both cohorts were tested for SARS-CoV-2 IgG antibodies via commercially available immunoassays, processed through hospital or outpatient laboratories. Patients recruited from the NYU Lupus Cohort, referred from affiliated providers, or admitted to hospital with COVID-19 were tested for SARS-CoV-2 IgG antibodies as part of routine surveillance during follow-up clinical visits. Findings 329 patients with SLE were included in this analysis, 146 from the WARCOV study and 183 from the NYU Lupus Cohort, and were tested for SARS-CoV-2 antibodies between April 29, 2020, and Feb 9, 2021. 309 (94%) were women and 91 (28%) were of Hispanic ethnicity. 51 (16%) of 329 patients had a positive SARS-CoV-2 IgG antibody test. Seropositive patients were more likely than seronegative patients to be Hispanic (24 [47%] of 51 vsz 67 [24%] of 278). Other demographic variables, SLE-specific factors, and immunosuppressant use were not associated with SARS-CoV-2 positivity. Of the 29 patients with COVID-19 previously confirmed by RT-PCR, 18 (62%) were on immunosuppressants; 24 (83%) of 29 patients tested positive for SARS-CoV-2 IgG antibodies. Of 17 patients who had symptoms of COVID-19 but negative concurrent RT-PCR testing, one (6%) developed an antibody response. Of 26 patients who had COVID-19-related symptoms but did not undergo RT-PCR testing, six (23%) developed an antibody response. Of 83 patients who had no symptoms of COVID-19 and no RT-PCR testing, four (5%) developed an antibody response. Among 36 patients who were initially SARS-CoV-2 IgG positive, the majority maintained reactivity serially (88% up to 10 weeks, 83% up to 20 weeks, and 80% up to 30 weeks). Seven (70%) of ten patients with confirmed COVID-19 had antibody positivity beyond 30 weeks from disease onset. Interpretation Most patients with SLE and confirmed COVID-19 were able to produce and maintain a serological response despite the use of a variety of immunosuppressants, providing reassurance about the efficacy and durability of humoral immunity and possible protection against re-infection with SARS-CoV-2. Funding National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, and Bloomberg Philanthropies COVID-19 Response Initiative Grant.

As the world faced the devastation of the COVID‐19 pandemic in late 2019 and early 2020, numerous clinical trials were initiated in many locations in an effort to establish the efficacy (or lack thereof) of potential treatments. As the pandemic has been shifting locations rapidly, individual studies have been at risk of failing to meet recruitment targets because of declining numbers of eligible patients with COVID‐19 encountered at participating sites. It has become clear that it might take several more COVID‐19 surges at the same location to achieve full enrollment and to find answers about what treatments are effective for this disease. This paper proposes an innovative approach for pooling patient‐level data from multiple ongoing randomized clinical trials (RCTs) that have not been configured as a network of sites. We present the statistical analysis plan of a prospective individual patient data (IPD) meta‐analysis (MA) from ongoing RCTs of convalescent plasma (CP). We employ an adaptive Bayesian approach for continuously monitoring the accumulating pooled data via posterior probabilities for safety, efficacy, and harm. Although we focus on RCTs for CP and address specific challenges related to CP treatment for COVID‐19, the proposed framework is generally applicable to pooling data from RCTs for other therapies and disease settings in order to find answers in weeks or months, rather than years.

PURPOSE: Obesity increases the risk of cancer recurrence and death in survivors of breast cancer. This study tested the hypothesis that exercise alone, diet alone, and the combination of exercise plus diet reduce body weight and improve body composition in survivors of breast cancer. METHODS: In this 2×2 factorial trial, 351 survivors of breast cancer with overweight or obesity were randomized to one of four treatment groups for 52 weeks: control, exercise alone, diet alone, or exercise plus diet. Endpoints included body weight and body composition measured by dual-energy x-ray absorptiometry. RESULTS: After 52 weeks, compared with control, diet alone [−5.39 kg (95% CI: −7.24, −3.55); −6.0% (95% CI: −8.0, −3.9)] and exercise plus diet [−6.68 kg (95% CI: −8.46, −4.90); −7.4% (95% CI: −9.4, −5.4)] reduced body weight; exercise alone did not change body weight. Compared with control, diet alone [−3.59 kg (95% CI: −5.00, −2.17)] and exercise plus diet [−4.28 kg (95% CI: −5.71, −2.84)] reduced fat mass; exercise alone did not change fat mass. Compared with control, diet alone [−0.82 kg (95% CI: −1.50, −0.15)] and exercise plus diet [−1.24 kg (95% CI: −1.92, −0.56)] reduced lean mass; exercise alone did not change lean mass. Compared with control, exercise alone, diet alone, and exercise plus diet did not change bone mineral density. CONCLUSION: In survivors of breast cancer with overweight or obesity, diet alone or diet plus exercise produced clinically meaningful weight loss at week 52. The majority of weight loss was fat mass.

Background Black adults in the U.S. experience significant health disparities related to tobacco use and obesity. Conducting observational studies of the associations between smoking and other health behaviors and indicators among Black adults may contribute to the development of tailored interventions. Purpose We examined associations between change in cigarette smoking and alcohol use, body mass index, eating behavior, perceived stress, and self-rated health in a cohort of Black adults who resided in low-income urban neighborhoods and participated in an ongoing longitudinal study. Methods Interviews were conducted in 2011, 2014, and 2018; participants (N = 904) provided at least two waves of data. We fit linear and logistic mixed-effects models to evaluate how changes in smoking status from the previous wave to the subsequent wave were related to each outcome at that subsequent wave. Results Compared to repeated smoking (smoking at previous and subsequent wave), repeated nonsmoking (nonsmoking at previous and subsequent wave) was associated with greater likelihood of recent dieting (OR = 1.59, 95% CI [1.13, 2.23], p = .007) and future intention (OR = 2.19, 95% CI [1.61, 2.98], p < .001) and self-efficacy (OR = 1.64, 95% CI [1.21, 2.23], p = .002) to eat low calorie foods, and greater odds of excellent or very good self-rated health (OR = 2.47, 95% CI [1.53, 3.99], p < .001). Transitioning from smoking to nonsmoking was associated with greater self-efficacy to eat low calorie foods (OR = 1.89, 95% CI [1.1, 3.26], p = .021), and lower perceived stress (β = −0.69, 95% CI [−1.34, −0.05], p = .036). Conclusions We found significant longitudinal associations between smoking behavior and eating behavior, perceived stress, and self-rated health. These findings have implications for the development of multiple behavior change programs and community-level interventions and policies.

Background Toxic metabolic encephalopathy (TME) has been reported in 7–31% of hospitalized patients with coronavirus disease 2019 (COVID-19); however, some reports include sedation-related delirium and few data exist on the etiology of TME. We aimed to identify the prevalence, etiologies, and mortality rates associated with TME in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-positive patients. Methods We conducted a retrospective, multicenter, observational cohort study among patients with reverse transcriptase–polymerase chain reaction-confirmed SARS-CoV-2 infection hospitalized at four New York City hospitals in the same health network between March 1, 2020, and May 20, 2020. TME was diagnosed in patients with altered mental status off sedation or after an adequate sedation washout. Patients with structural brain disease, seizures, or primary neurological diagnoses were excluded. The coprimary outcomes were the prevalence of TME stratified by etiology and in-hospital mortality (excluding comfort care only patients) assessed by using a multivariable time-dependent Cox proportional hazards models with adjustment for age, race, sex, intubation, intensive care unit requirement, Sequential Organ Failure Assessment scores, hospital location, and date of admission. Results Among 4491 patients with COVID-19, 559 (12%) were diagnosed with TME, of whom 435 of 559 (78%) developed encephalopathy immediately prior to hospital admission. The most common etiologies were septic encephalopathy (n = 247 of 559 [62%]), hypoxic-ischemic encephalopathy (HIE) (n = 331 of 559 [59%]), and uremia (n = 156 of 559 [28%]). Multiple etiologies were present in 435 (78%) patients. Compared with those without TME (n = 3932), patients with TME were older (76 vs. 62 years), had dementia (27% vs. 3%) or psychiatric history (20% vs. 10%), were more often intubated (37% vs. 20%), had a longer hospital length of stay (7.9 vs. 6.0 days), and were less often discharged home (25% vs. 66% [all P

BackgroundEvidence on heterogeneity in outcomes of surgical quality interventions in low-income and middle-income countries is limited. We explored factors driving performance in the Safe Surgery 2020 intervention in Tanzania’s Lake Zone to distil implementation lessons for low-resource settings.MethodsWe identified higher (n=3) and lower (n=3) performers from quantitative data on improvement from 14 safety and teamwork and communication indicators at 0 and 12 months from 10 intervention facilities, using a positive deviance framework. From 72 key informant interviews with surgical providers across facilities at 1, 6 and 12 months, we used a grounded theory approach to identify practices of higher and lower performers.ResultsPerformance experiences of higher and lower performers differed on the following themes: (1) preintervention context, (2) engagement with Safe Surgery 2020 interventions, (3) teamwork and communication orientation, (4) collective learning orientation, (5) role of leadership, and (6) perceived impact of Safe Surgery 2020 and beyond. Higher performers had a culture of teamwork which helped them capitalise on Safe Surgery 2020 to improve surgical ecosystems holistically on safety practices, teamwork and communication. Lower performers prioritised overhauling safety practices and began considering organisational cultural changes much later. Thus, while also improving, lower performers prioritised different goals and trailed higher performers on the change continuum.ConclusionFuture interventions should be tailored to facility context and invest in strengthening teamwork, communication and collective learning and facilitate leadership engagement to build a receptive climate for successful implementation of safe surgery interventions.

INTRODUCTION: This guideline establishes clinical practice recommendations for the use of behavioral and psychological treatments for chronic insomnia disorder in adults. METHODS: The American Academy of Sleep Medicine (AASM) commissioned a task force of experts in sleep medicine and sleep psychology to develop recommendations and assign strengths based on a systematic review of the literature and an assessment of the evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. The task force evaluated a summary of the relevant literature and the quality of evidence, the balance of clinically relevant benefits and harms, patient values and preferences, and resource use considerations that underpin the recommendations. The AASM Board of Directors approved the final recommendations. RECOMMENDATIONS: The following recommendations are intended as a guide for clinicians in choosing a specific behavioral and psychological therapy for the treatment of chronic insomnia disorder in adult patients. Each recommendation statement is assigned a strength (“strong” or “conditional”). A “strong” recommendation (ie, “We recommend…”) is one that clinicians should follow under most circumstances. A “conditional” recommendation is one that requires that the clinician use clinical knowledge and experience, and to strongly consider the patient’s values and preferences to determine the best course of action. 1. We recommend that clinicians use multicomponent cognitive behavioral therapy for insomnia for the treatment of chronic insomnia disorder in adults. (STRONG). 2. We suggest that clinicians use multicomponent brief therapies for insomnia for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). 3. We suggest that clinicians use stimulus control as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). 4. We suggest that clinicians use sleep restriction therapy as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). 5. We suggest that clinicians use relaxation therapy as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). 6. We suggest that clinicians not use sleep hygiene as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). CITATION: Edinger JD, Arnedt JT, Bertisch SM, et al. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021;17(2):255–262.

INTRODUCTION: The purpose of this systematic review is to provide supporting evidence for a clinical practice guideline on the use of behavioral and psychological treatments for chronic insomnia disorder in adult populations. METHODS: The American Academy of Sleep Medicine commissioned a task force of 9 experts in sleep medicine and sleep psychology. A systematic review was conducted to identify randomized controlled trials that addressed behavioral and psychological interventions for the treatment of chronic insomnia disorder in adults. Statistical analyses were performed to determine if the treatments produced clinically significant improvements in a range of critical and important outcomes. Finally, the Grading of Recommendations Assessment, Development, and Evaluation process was used to evaluate the evidence for making specific treatment recommendations. RESULTS: The literature search identified 1,244 studies; 124 studies met the inclusion criteria, and 89 studies provided data suitable for statistical analyses. Evidence for the following interventions is presented in this review: cognitive-behavioral therapy for insomnia, brief therapies for insomnia, stimulus control, sleep restriction therapy, relaxation training, sleep hygiene, biofeedback, paradoxical intention, intensive sleep retraining, and mindfulness. This review provides a detailed summary of the evidence along with the quality of evidence, the balance of benefits vs harms, patient values and preferences, and resource use considerations. CITATION: Edinger JD, Arnedt JT, Bertisch SM, et al. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment. J Clin Sleep Med. 2021;17(2):263–298.

Introduction In a five-arm randomized clinical trial (RCT) with stratified randomization across 54 sites, we encountered low primary outcome event proportions, resulting in multiple sites with zero events either overall or in one or more study arms. In this paper, we systematically evaluated different statistical methods of accounting for center in settings with low outcome event proportions. Methods We conducted a simulation study and a reanalysis of a completed RCT to compare five popular methods of estimating an odds ratio for multicenter trials with stratified randomization by center: (i) no center adjustment, (ii) random intercept model, (iii) Mantel–Haenszel model, (iv) generalized estimating equation (GEE) with an exchangeable correlation structure, and (v) GEE with small sample correction (GEE-small sample correction). We varied the number of total participants (200, 500, 1000, 5000), number of centers (5, 50, 100), control group outcome percentage (2%, 5%, 10%), true odds ratio (1, > 1), intra-class correlation coefficient (ICC) (0.025, 0.075), and distribution of participants across the centers (balanced, skewed). Results Mantel–Haenszel methods generally performed poorly in terms of power and bias and led to the exclusion of participants from the analysis because some centers had no events. Failure to account for center in the analysis generally led to lower power and type I error rates than other methods, particularly with ICC = 0.075. GEE had an inflated type I error rate except in some settings with a large number of centers. GEE-small sample correction maintained the type I error rate at the nominal level but suffered from reduced power and convergence issues in some settings when the number of centers was small. Random intercept models generally performed well in most scenarios, except with a low event rate (i.e., 2% scenario) and small total sample size (n ≤ 500), when all methods had issues. Discussion Random intercept models generally performed best across most scenarios. GEE-small sample correction performed well when the number of centers was large. We do not recommend the use of Mantel–Haenszel, GEE, or models that do not account for center. When the expected event rate is low, we suggest that the statistical analysis plan specify an alternative method in the case of non-convergence of the primary method.

OBJECTIVE: To characterize the hospitalization and death rates among patients with inflammatory arthritis (IA) affected by coronavirus disease 2019 (COVID-19) and to analyze the associations of comorbidities and immunomodulatory medications with infection outcomes. METHODS: Data on clinical and demographic features, maintenance treatment, disease course, and outcomes in individuals with IA (rheumatoid arthritis and spondyloarthritis) with symptomatic COVID-19 infection were prospectively assessed via web-based questionnaire followed by individual phone calls and electronic medical record review. Baseline characteristics and medication use were summarized for hospitalized and ambulatory patients, and outcomes with the different medication classes were compared using multivariable logistic regression. RESULTS: A total of 103 patients with IA were included in the study (80 with confirmed COVID-19 and 23 with high suspicion of COVID-19). Hospitalization was required in 26% of the participants, and 4% died. Patients who were hospitalized were significantly more likely to be older (P < 0.001) and have comorbid hypertension (P = 0.001) and chronic obstructive pulmonary disease (P = 0.02). IA patients taking oral glucocorticoids had an increased likelihood of being admitted for COVID-19 (P < 0.001), while those receiving maintenance anticytokine biologic therapies did not. CONCLUSION: Among patients with underlying IA, COVID-19 outcomes were worse in those receiving glucocorticoids but not in patients receiving maintenance anticytokine therapy. Further work is needed to understand whether immunomodulatory therapies affect COVID-19 incidence.

ObjectiveTo determine the prevalence and associated mortality of well-defined neurologic diagnoses among patients with coronavirus disease 2019 (COVID-19), we prospectively followed hospitalized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)–positive patients and recorded new neurologic disorders and hospital outcomes.MethodsWe conducted a prospective, multicenter, observational study of consecutive hospitalized adults in the New York City metropolitan area with laboratory-confirmed SARS-CoV-2 infection. The prevalence of new neurologic disorders (as diagnosed by a neurologist) was recorded and in-hospital mortality and discharge disposition were compared between patients with COVID-19 with and without neurologic disorders.ResultsOf 4,491 patients with COVID-19 hospitalized during the study timeframe, 606 (13.5%) developed a new neurologic disorder in a median of 2 days from COVID-19 symptom onset. The most common diagnoses were toxic/metabolic encephalopathy (6.8%), seizure (1.6%), stroke (1.9%), and hypoxic/ischemic injury (1.4%). No patient had meningitis/encephalitis or myelopathy/myelitis referable to SARS-CoV-2 infection and 18/18 CSF specimens were reverse transcriptase PCR negative for SARS-CoV-2. Patients with neurologic disorders were more often older, male, white, hypertensive, diabetic, intubated, and had higher sequential organ failure assessment (SOFA) scores (all p < 0.05). After adjusting for age, sex, SOFA scores, intubation, history, medical complications, medications, and comfort care status, patients with COVID-19 with neurologic disorders had increased risk of in-hospital mortality (hazard ratio [HR] 1.38, 95% confidence interval [CI] 1.17–1.62, p < 0.001) and decreased likelihood of discharge home (HR 0.72, 95% CI 0.63–0.85, p < 0.001).ConclusionsNeurologic disorders were detected in 13.5% of patients with COVID-19 and were associated with increased risk of in-hospital mortality and decreased likelihood of discharge home. Many observed neurologic disorders may be sequelae of severe systemic illness.

Study objectives The current study examined the prevalence and correlates of obstructive sleep apnea in a sample of low-income, predominantly African-American women using two waves of data. Methods Participants were adults from two urban neighborhoods who enrolled in the PHRESH Zzz Study (N = 828; Pittsburgh Hill/Homewood Research on Neighborhoods, Sleep, and Health). A subsample who reported never receiving OSA diagnosis completed home sleep apnea testing in 2016 (n = 269, mean age 55.0 years, 79.6% female) and again in 2018 (n = 135). Correlates of OSA tested included demographic and anthropometric variables, health behavior/conditions, psychological distress and general health, smoking status, actigraphy-measured sleep, and neighborhood factors measured at baseline. Results 18.0% of all 2016 participants reported receiving physician diagnoses of OSA. Among those who completed in–home assessment, 19.3% had AHI ≥15 and 33.8% had AHI ≥5 plus one or more sleep symptoms. Estimates of the prevalence of OSA in all 2016 participants were 33.8%–45.7% based on physician diagnoses and AHI results, depending on the criteria used. Age, gender, BMI, blood pressure, habitual snoring, neighborhood walkability, actigraphy-measured sleep characteristics, and smoking were concurrently associated with OSA in 2016. Changes in AHI categories from 2016 to 2018 were documented. Conclusions Low-income African Americans, including women, are a high-risk group for OSA, but remain under-diagnosed and under-treated. The current findings show a high prevalence of OSA in African-American women and are among the first to demonstrate that both individual and neighborhood factors are implicated in OSA prevalence.

We present a simulated cosmology analysis using the second and third moments of the weak lensing mass (convergence) maps. The second moment, or variances, of the convergence as a function of smoothing scale contains information similar to standard shear two-point statistics. The third moment, or the skewness, contains additional non-Gaussian information. The analysis is geared towards the third year (Y3) data from the Dark Energy Survey (DES), but the methodology can be applied to other weak lensing data sets. We present the formalism for obtaining the convergence maps from the measured shear and for obtaining the second and third moments of these maps given partial sky coverage. We estimate the covariance matrix from a large suite of numerical simulations. We test our pipeline through a simulated likelihood analyses varying 5 cosmological parameters and 10 nuisance parameters and identify the scales where systematic or modelling uncertainties are not expected to affect the cosmological analysis. Our simulated likelihood analysis shows that the combination of second and third moments provides a 1.5 per cent constraint on S8 σ8(ωm/0.3)0.5 for DES Year 3 data. This is 20 per cent better than an analysis using a simulated DES Y3 shear two-point statistics, owing to the non-Gaussian information captured by the inclusion of higher order statistics. This paper validates our methodology for constraining cosmology with DES Year 3 data, which will be presented in a subsequent paper., Funding for the DES Projects has been provided by the U.S. Department of Energy, the U.S. National Science Foundation, the Ministry of Science and Education of Spain, the Science and Technology Facilities Council of the United Kingdom, the Higher Education Funding Council for England, the National Center for Supercomputing Applications at the University of Illinois at Urbana-Champaign, the Kavli Institute of Cosmological Physics at the University of Chicago, the Center for Cosmology and Astro-Particle Physics at the Ohio State University, the Mitchell Institute for Fundamental Physics and Astronomy at Texas A&M University, Financiadora de Estudos e Projetos, Fundac¸ao Carlos Chagas Filho de Amparo ˜ a Pesquisa do ` Estado do Rio de Janeiro, Conselho Nacional de Desenvolvimento Cient´ıfico e Tecnologico and the Minist ´ erio da Ci ´ encia, Tecnologia ˆ e Inovac¸ao, the Deutsche Forschungsgemeinschaft and the Collabo- ˜ rating Institutions in the Dark Energy Survey. The Collaborating Institutions are Argonne National Laboratory, the University of California, Santa Cruz, the University of Cambridge, Centro de Investigaciones Energeticas, Medioambientales y ´ Tecnologicas-Madrid, the University of Chicago, University College ´ London, the DES-Brazil Consortium, the University of Edinburgh, the Eidgenossische Technische Hochschule (ETH) Z ¨ urich, Fermi ¨ National Accelerator Laboratory, the University of Illinois at UrbanaChampaign, the Institut de Ciencies de l’Espai (IEEC/CSIC), the ` Institut de F´ısica d’Altes Energies, Lawrence Berkeley National Laboratory, the Ludwig-Maximilians Universitat M¨ unchen, and the ¨ associated Excellence Cluster Universe, the University of Michigan, the National Optical Astronomy Observatory, the University of Nottingham, the Ohio State University, the University of Pennsylvania, the University of Portsmouth, SLAC National Accelerator Laboratory, Stanford University, the University of Sussex, Texas A&M University, and the OzDES Membership Consortium. Based in part on observations at Cerro Tololo Inter-American Observatory, National Optical Astronomy Observatory, which is operated by the Association of Universities for Research in Astronomy (AURA) under a cooperative agreement with the National Science Foundation. The DES data management system is supported by the National Science Foundation under Grant Numbers AST-1138766 and AST-1536171. The DES participants from Spanish institutions are partially supported by MINECO under grants AYA2015- 71825, ESP2015-66861, FPA2015-68048, SEV-2016-0588, SEV2016-0597, and MDM-2015-0509, some of which include ERDF funds from the European Union. IFAE is partially funded by the CERCA program of the Generalitat de Catalunya. Research leading to these results has received funding from the European Research Council under the European Union 7th Framework Program (FP7/2007-2013) including ERC grant agreements 240672, 291329, and 306478. We acknowledge support from the Brazilian Instituto Nacional de Ciencia e Tecnologia (INCT) e-Universe (CNPq grant ˆ 465376/2014-2). This manuscript has been authored by Fermi Research Alliance, LLC under Contract No. DE-AC02-07CH11359 with the U.S. Department of Energy, Office of Science, Office of High Energy Physics.

Introduction Perceived stress is linked to poor sexual and reproductive health, but its relationship with sexually transmitted infections (STIs) is less clear. The elevated burden of stress and STI among Black women suggests a need to examine racial differences in the associations on additive and multiplicative scales. Methods Using data from Black and White female participants from wave IV of the National Longitudinal Study of Adolescent to Adult Health (n = 4744), we examined the association of high stress (scores ≥6 on the Perceived Stress Scale-4) with self-reported past-year chlamydia diagnosis, combined curable STI, and lifetime pelvic inflammatory disease using modified Poisson regression with robust variance to estimate prevalence ratios and prevalence differences. Models included a race-stress product-interaction term and adjusted for sociodemographic variables, prior trauma and stressors, and mental health factors. Results In unadjusted analyses, stress was associated with STI among Black and White women. Adjusted associations were attenuated among White women; among Black women, stress remained associated with chlamydia (adjusted prevalence ratio, 2.22; 95% confidence interval, 1.30-3.79) and curable STI (adjusted prevalence ratio, 1.59; 95% confidence interval, 1.05-2.40), corresponding to approximately 5 excess cases of each. Among White women, poverty and personality traits were the strongest confounders; among Black women, poverty, trauma, and neurotic personality traits were the strongest confounders for chlamydia, although no factors seemed to confound the association with curable STI. Conclusions Stress is independently linked to STI, particularly among Black women. Additional research with longitudinal data is needed to understand the role of stress on STI and address a significant health disparity.

Background Palbociclib is highly active in oestrogen-receptor positive (ER+) metastatic breast cancer, but neutropenia is dose limiting. The goal of this study was to determine whether early neutropenia is associated with disease response to single-agent palbociclib. Methods Blood count and disease-response data were analysed from two Phase 2 clinical trials at different institutions using single-agent palbociclib: advanced solid tumours positive for retinoblastoma protein and advanced liposarcoma. The primary endpoint was PFS. The primary exposure variable was the nadir absolute neutrophil count (ANC) during the first two cycles of treatment. Results One hundred and ninety-six patients (61 breast, 135 non-breast) were evaluated between the two trials. Development of any grade neutropenia was significantly associated with longer median PFS in both the breast cancer (HR 0.29, 95% CI 0.11–0.74, p = 0.010) and non-breast cancer (HR 0.57, 95% CI 0.38–0.85, p = 0.006) cohorts. Grade 3–4 neutropenia was significantly associated with prolonged PFS in the non-breast cohort (HR 0.57, 95% CI 0.38–0.85, p = 0.006) but not in the breast cohort (HR 0.87, 95% CI 0.51–1.47, p = 0.596). Multivariate analysis yielded similar results. Conclusions Treatment-related neutropenia in the first two cycles was significantly and independently associated with prolonged PFS, suggesting that neutropenia may be a useful pharmacodynamic marker to guide individualised palbociclib dosing. Clinical trials registration information Basket Trial: NCT01037790; Sarcoma Trial: NCT01209598.

This qualitative study investigated the experiences of first- and second-year migrant undergraduate students and staff in the College Assistance Migrant Program (CAMP) at Arizona State University (...

Background There is concern about the potential of an increased risk related to medications that act on the renin–angiotensin–aldosterone system in patients exposed to coronavirus disease ...

Purpose To present the results of a survey of the Zoster Eye Disease Study (ZEDS) investigators regarding barriers to the enrollment of study participants and approaches to overcome them. Methods ZEDS is a multicenter randomized clinical trial supported by the National Eye Institute to determine whether prolonged suppressive valacyclovir reduces the complications of herpes zoster ophthalmicus (HZO), relative to placebo. Enrollment of study participants is currently far below expectations. An institutional review board-approved anonymous internet survey was conducted of ZEDS investigators to study their experiences and opinions regarding barriers to enrollment and various approaches to overcome them. Results The overall survey response rate was 54% (79/145). Only 29% (23/79) agreed that it is easy to enroll study participants. Regarding patient barriers, 69% (55/79) agreed that HZO patients want to be treated with antiviral medication and 69% (54/78) agreed that HZO patients on antivirals do not want to be randomized. Regarding personal barriers facing investigators, 91% (72/79) agreed that antivirals are effective and 100% that the research questions ZEDS is designed to answer are very important. Fewer than 30% of respondents believed that steps taken to increase enrollment have been very helpful. Over half (54%, 42/78) believed that advertising on social media would be moderately or very effective. Conclusions Belief among ZEDS investigators that antivirals are effective, and the preference of patients to be treated with antivirals rather than be randomized in ZEDS, are major barriers to enrollment. New approaches to overcoming barriers are necessary to develop an evidence-based standard of care for treatment of HZO.

The last decade has seen a dramatic increase in small satellite missions for commercial, public, and government intelligence applications. Given the rapid commercialization of constellation-driven services in Earth Observation, situational domain awareness, communications including machine-to-machine interface, exploration etc., small satellites represent an enabling technology for a large growth market generating truly Big Data. Examples of modern sensors that can generate very large amounts of data are optical sensing, hyperspectral, Synthetic Aperture Radar (SAR), and Infrared imaging. Traditional handling and downloading of Big Data from space requires a large onboard mass storage and high bandwidth downlink with a trend towards optical links. Many missions and applications can benefit significantly from onboard cloud computing similarly to Earth-based cloud services. Hence, enabling space systems to provide near real-time data and enable low latency distribution of critical and time sensitive information to users. In addition, the downlink capability can be more effectively utilized by applying more onboard processing to reduce the data and create high value information products. This paper discusses current implementations and roadmap for leveraging high performance computing tools and methods on small satellites with radiation tolerant hardware. This includes runtime analysis with benchmarks of convolutional neural networks and matrix multiplications using industry standard tools (e.g., TensorFlow and PlaidML). In addition, a ½ CubeSat volume unit (0.5U) (10 × 10 × 5 cm3) cloud computing solution, called SpaceCloud™ iX5100 based on AMD 28 nm APU technology is presented as an example of heterogeneous computer solution. An evaluation of the AMD 14 nm Ryzen APU is presented as a candidate for future advanced onboard processing for space vehicles.

Atypical response patterns following immune checkpoint blockade (ICB) in Hodgkin lymphoma (HL) led to the concept of continuation of treatment beyond progression (TBP); however, the longitudinal benefit of this approach is unclear. We therefore performed a retrospective analysis of 64 patients treated with ICB; 20 who received TBP (TBP cohort) and 44 who stopped ICB at initial progression (non-TBP cohort). The TBP cohort received ICB for a median of 4.7 months after initial progression and delayed subsequent treatment by a median of 6.6 months. Despite receiving more prior lines of therapy, the TBP cohort achieved longer progression-free survival with post-ICB treatment (median, 17.5 months vs. 6.1 months, p = .035) and longer time-to-subsequent treatment failure, defined as time from initial ICB progression to failure of subsequent treatment (median, 34.6 months vs. 9.9 months, p = .003). With the limitations of a retrospective study, these results support the clinical benefit of TBP with ICB for selected patients.

Background: Incarceration is linked to risk of sexually transmitted infection (STI) postrelease among women. There has been little examination of incarceration's association with related sexual and reproductive outcomes such as pelvic inflammatory disease (PID) and pregnancy loss, or the role of STI in this relationship and whether these relationships differ between Black and White women. Methods: Using data from the National Longitudinal Study of Adolescent to Adult Health, we examined cross-sectional associations between incarceration (Wave IV; 2007–2008; ages 24–34) and history of STI and PID (n = 5,968), and longitudinal associations between incarceration and later pregnancy loss in mid-adulthood (Wave V; 2016–2018; ages 34–43) among women who had ever been pregnant (n = 2,353); we estimated racial differences. Using causal mediation, we explored whether STI mediated associations with pregnancy loss. Results: Incarceration was associated with a history of STI (White adjusted prevalence ratio [APR]: 1.54, 95% confidence interval [CI] 1.14–2.06; Black APR: 1.26, 95% CI 1.02–1.56); the association between incarceration and PID was null among White women (APR: 0.99, 95% CI 0.47–2.09) and elevated among Black women (APR: 2.82, 95% CI 1.36–5.83). Prior incarceration did not appear associated with pregnancy loss among White women (APR: 1.01, 95% CI 0.70–1.45), but was associated among Black women (APR: 1.38, 95% CI: 0.97–1.97), with STI appearing to partially mediate. Conclusions: Pregnancy loss may be elevated among Black women who have been incarcerated, and incarceration-related increases in STI may account for some of this association.

BackgroundConvalescent plasma (CP) for hospitalized patients with COVID-19 has not demonstrated clear benefits. However, data on outpatients with early symptoms are scarce. We aimed to assess whether treatment with CP administered during the first 7 days of symptoms reduced the disease progression or risk of hospitalization of outpatients.MethodsTwo double-blind randomized trials (NCT04621123, NCT04589949) were merged with data pooling starting when ResultsOf 797 patients included, 390 received CP and 392 placebo. At baseline, they had a median age of 58 years, 1 comorbidity, symptoms for 5 days and 93% tested negative for SARS-CoV-2 S-protein IgG antibodies. Seventy-four patients were hospitalized, 6 required mechanical ventilation and 3 died. The OR of CP for an improved disease severity scale was 0.936 (credible interval (CI) 0.667-1.311). The OR for hospitalization or death was 0.919 (CI 0.592-1.416). The effect of CP on hospital admission or death was largest in patients with ≤5 days of symptoms (OR 0.658, 95% CI 0.394-1.085). CP did not decrease the time to full symptom resolution (p=0.62).ConclusionTreatment with CP of outpatients in the first 7 days of symptoms did not improve the outcome of COVID-19. The possible beneficial effect in patients with ≤5 days of symptoms requires further study.RegistrationNCT04621123 and NCT04589949 on https://www.clinicaltrials.govFunding sourceZONMW, the Netherlands, grant number 10430062010001.SUPPORT-E, grant number 101015756YoMeCorono, www.tomecorono.comThe Fight AIDS and Infectious Diseases Foundation with funding from the pharmaceutical company Grifols S.A

Since the onset of the COVID‐19 pandemic, a substantial proportion of COVID‐19 patients had documented thrombotic complications and ischemic stroke. Several mechanisms related to immune‐mediated thrombosis, the renin angiotensin system and the effect of SARS‐CoV‐2 in cardiac and brain tissue may contribute to the pathogenesis of ischemic stroke in patients with COVID‐19. Simultaneously, significant strains on global healthcare delivery, including ischemic stroke management, have made treatment of stroke in the setting of COVID‐19 particularly challenging. In this review, we summarize the current knowledge on epidemiology, clinical manifestation, and pathophysiology of ischemic stroke in patients with COVID‐19 to bridge the gap from bench to bedside and clinical practice during the most challenging global health crisis of the last decades., Ischemic stroke among COVID‐19 patients correlates with increased disability and mortality. Hypercoagulopathy, angiotensin‐converting enzyme 2 inhibition, and cardioembolism are potential stroke mechanisms in COVID‐19. SARS‐CoV‐2–specific vaccinations and immunomodulatory agents may affect stroke prevention and treatment in COVID‐19 patients.

Purpose: To describe steps taken that enabled a high rate of retention and early resumption of enrollment in the Zoster Eye Disease Study (ZEDS), a randomized controlled trial funded by the National Eye Institute, during the first 13 months (3/1/2020-3/31/2021) of the COVID-19 pandemic. Methods: A number of responses were implemented in ZEDS when the focus shifted to retention of study participants at the beginning of the pandemic including frequent communication with the participating clinical centers (PCCs) about remote visits, local lab work, shipping study medication, and completion of revised case report forms. Additional payments were provided to the PCCs. Remote activation of PCCs continued. Screening and enrollment visits gradually resumed when allowed. Results: Communication with PCCs increased, and average attendance at monthly coordinator teleconferences went up from 17 to 47. Remote visits peaked in April 2020, accounting for 75% (33/44) of study visits, then declined to less than 10% of study visits beginning August 2020. Overall, 97% (590/609) of study visits were completed. Only 5.5% (9/165) of study participants withdrew consent, and 2.4% (4/165) were lost to follow-up. Enrollment returned to pre-pandemic levels by September 2020. Discussion: Strong communication and unwavering commitment, combined with the technological capability for remote work, visits, and shipment of study medication, were key to the successful retention of study participants and resumption of enrollment. Conclusions: Rapid responses to challenges to trials caused by the COVID-19 pandemic can enable them to continue successfully and provide insights into the planning of future trials.

Background A number of studies have identified patient-, provider-, and community-level barriers to effective diabetes management among South Asian Americans, who have a high prevalence of type 2 diabetes. However, no multi-level, integrated community health worker (CHW) models leveraging health information technology (HIT) have been developed to mitigate disease among this population. This paper describes the protocol for a multi-level, community-clinical linkage intervention to improve glycemic control among South Asians with uncontrolled diabetes. Methods The study includes three components: 1) building the capacity of primary care practices (PCPs) to utilize electronic health record (EHR) registries to identify patients with uncontrolled diabetes; 2) delivery of a culturally- and linguistically-adapted CHW intervention to improve diabetes self-management; and 3) HIT-enabled linkage to culturally-relevant community resources. The CHW intervention component includes a randomized controlled trial consisting of group education sessions on diabetes management, physical activity, and diet/nutrition. South Asian individuals with type 2 diabetes are recruited from 20 PCPs throughout NYC and randomized at the individual level within each PCP site. A total of 886 individuals will be randomized into treatment or control groups; EHR data collection occurs at screening, 6-, 12-, and 18-month. We hypothesize that individuals receiving the multi-level diabetes management intervention will be 15% more likely than the control group to achieve ≥0.5% point reduction in hemoglobin A1c (HbA1c) at 6-months. Secondary outcomes include change in weight, body mass index, and LDL cholesterol; the increased use of community and social services; and increased health self-efficacy. Additionally, a cost-effectiveness analysis will focus on implementation and healthcare utilization costs to determine the incremental cost per person achieving an HbA1c change of ≥0.5%. Discussion Final outcomes will provide evidence regarding the effectiveness of a multi-level, integrated EHR-CHW intervention, implemented in small PCP settings to promote diabetes control among an underserved South Asian population. The study leverages multisectoral partnerships, including the local health department, a healthcare payer, and EHR vendors. Study findings will have important implications for the translation of integrated evidence-based strategies to other minority communities and in under-resourced primary care settings. Trial registration This study was registered with clinicaltrials.gov: NCT03333044 on November 6, 2017.

Background The integration of behavioral economics (BE) principles and electronic health records (EHRs) using clinical decision support (CDS) tools is a novel approach to improving health outcomes. Meanwhile, the American Geriatrics Society has created the Choosing Wisely (CW) initiative to promote less aggressive glycemic targets and reduction in pharmacologic therapy in older adults with type 2 diabetes mellitus. To date, few studies have shown the effectiveness of combined BE and EHR approaches for managing chronic conditions, and none have addressed guideline-driven deprescribing specifically in type 2 diabetes. We previously conducted a pilot study aimed at promoting appropriate CW guideline adherence using BE nudges and EHRs embedded within CDS tools at 5 clinics within the New York University Langone Health (NYULH) system. The BE-EHR module intervention was tested for usability, adoption, and early effectiveness. Preliminary results suggested a modest improvement of 5.1% in CW compliance. Objective This paper presents the protocol for a study that will investigate the effectiveness of a BE-EHR module intervention that leverages BE nudges with EHR technology and CDS tools to reduce overtreatment of type 2 diabetes in adults aged 76 years and older, per the CW guideline. Methods A pragmatic, investigator-blind, cluster randomized controlled trial was designed to evaluate the BE-EHR module. A total of 66 NYULH clinics will be randomized 1:1 to receive for 18 months either (1) a 6-component BE-EHR module intervention + standard care within the NYULH EHR, or (2) standard care only. The intervention will be administered to clinicians during any patient encounter (eg, in person, telemedicine, medication refill, etc). The primary outcome will be patient-level CW compliance. Secondary outcomes will measure the frequency of intervention component firings within the NYULH EHR, and provider utilization and interaction with the BE-EHR module components. Results Study recruitment commenced on December 7, 2020, with the activation of all 6 BE-EHR components in the NYULH EHR. Conclusions This study will test the effectiveness of a previously developed, iteratively refined, user-tested, and pilot-tested BE-EHR module aimed at providing appropriate diabetes care to elderly adults, compared to usual care via a cluster randomized controlled trial. This innovative research will be the first pragmatic randomized controlled trial to use BE principles embedded within the EHR and delivered using CDS tools to specifically promote CW guideline adherence in type 2 diabetes. The study will also collect valuable information on clinician workflow and interaction with the BE-EHR module, guiding future research in optimizing the timely delivery of BE nudges within CDS tools. This work will address the effectiveness of BE-inspired interventions in diabetes and chronic disease management. Trial Registration ClinicalTrials.gov NCT04181307; https://clinicaltrials.gov/ct2/show/NCT04181307 International Registered Report Identifier (IRRID) DERR1-10.2196/28723

BackgroundObstructive sleep apnea (OSA) is a serious health condition that affects approximately 30–50% of older adults and contributes to risk for cardiometabolic disorders and dementia. Despite the well-documented role of partners in treatment seeking and adherence to positive airway pressure (PAP), treatments for OSA have nearly exclusively focused on the patient and current treatments for OSA do not address co-existing sleep problems such as insomnia that are prevalent in both patients with OSA and their partners. Therefore, the goal of this study is to develop and test a novel couples-based sleep health intervention to promote adherence to PAP and improve sleep health of the couple.MethodsWe are conducting a two-arm, parallel group, single blind, randomized controlled pilot/feasibility trial to compare our novel couples-based sleep health intervention (We-PAP) to an information control group (IC). We-PAP is based on a transdiagnostic model and uses a dyadic approach including increasing effective partner support, communication skills, and couple-level goal-setting. We-PAP involves 3 sessions and is delivered via telehealth in weekly sessions. The IC includes standardized patient educational materials. Both groups receive the usual follow-up with their medical team. The study involves assessments at pre-treatment, post-intervention (approximately 1 month after starting PAP and completing We-PAP sessions or IC) and 3 months after starting PAP. Our main outcomes are feasibility and acceptability ratings. Secondary outcomes include comparing We-PAP to IC for PAP adherence, sleep quality (self-report and objective) and cognitive measures.DiscussionWe-PAP is the first couples-based transdiagnostic sleep health intervention for patients with OSA and their partners. Results of this study will be used to inform the design of a subsequent fully adequately-powered clinical trial. If successful, this intervention could significantly advance current clinical practice in the treatment of OSA and sleep health more comprehensively in older adults. Moreover, this intervention may be useful for improving sleep in other aging populations with multiple sleep and other health problems, including patients with chronic illnesses or those at risk for Alzheimer’s disease and their caregivers.Trial registrationNCT04759157

African Americans and socioeconomically disadvantaged individuals have higher rates of a variety of sleep disturbances, including short sleep duration, poor sleep quality, and fragmented sleep. Such sleep disturbances may contribute to pervasive and widening racial and socioeconomic (SES) disparities in health. A growing body of literature demonstrates that over and above individual-level SES, indicators of neighborhood disadvantage are associated with poor sleep. However, there has been scant investigation of the association between sleep and the most proximal environments, the home and residential block. This is the first study to examine the association between objective and self-reported measures of housing and block conditions and sleep. The sample included 634 adults (mean age = 58.7 years; 95% African American) from two low-income urban neighborhoods. Study participants reported whether they experienced problems with any of seven different housing problems (e.g., broken windows) and rated the overall condition of their home. Trained data collectors rated residential block quality. Seven days of wrist actigraphy were used to measure average sleep duration, efficiency, and wakefulness after sleep onset (WASO), and a sleep diary assessed sleep quality. Multivariate regression analyses were conducted for each sleep outcome with housing or block conditions as predictors in separate models. Participants reporting “fair” or “poor” housing conditions had an adjusted average sleep duration that was 15.4 min shorter than that of participants reporting “good” or “excellent” conditions. Those reporting any home distress had 15.9 min shorter sleep and .19 units lower mean sleep quality as compared with participants who did not report home distress. Poor objectively measured block quality was associated with 14.0 min shorter sleep duration, 1.95% lower sleep efficiency, and 10.7 additional minutes of WASO. Adverse housing and proximal neighborhood conditions are independently associated with poor sleep health. Findings highlight the importance of considering strategies that target upstream determinants of sleep health disparities.

To evaluate whether the implementation of a new population-based primary care payment system, Population-Based Payments for Primary Care (3PC), initiated by Hawaii Medical Service Association (HMSA; the Blue Cross Blue Shield of Hawaii), was associated with changes in spending and utilization for outpatient imaging in its first year.In this observational study, we used claims data from January 1, 2012, to December 31, 2016. We used a propensity-weighted difference-in-differences design to compare 70,284 HMSA patients in Hawaii attributed to 107 primary care physicians (PCPs) and 4 physician organizations participating in 3PC in its first year of implementation (2016) and 195,902 patients attributed to 312 PCPs and 14 physician organizations that used a fee-for-service model during the study period. The primary outcome was total spending on outpatient imaging tests, and secondary outcomes included spending and utilization by modality.The study included 266,186 HMSA patients (mean age of 43.3 years; 51.7% women) and 419 PCPs (mean age of 54.9 years; 34.8% women). The 3PC system was not significantly associated with changes in total spending for outpatient imaging. Of 12 secondary outcomes, only 3 were statistically significant, including changes in nuclear medicine spending (adjusted differential change = -20.1% [95% confidence interval = -27.5% to -12.1%]; P.001) and utilization (adjusted differential change = -18.1% [95% confidence interval = -23.8 to -11.9%]; P.001).The HMSA 3PC system was not associated with significant changes in total spending for outpatient imaging, though spending and utilization on nuclear medicine tests decreased.

Millions of patients worldwide suffer disability and death due to complications related to surgery. Many of these complications can be reduced by the use of the World Health Organization (WHO) Surgical Safety Checklist (SSC), a simple tool that can enhance teamwork and communication and improve patient safety. Despite the evidence on benefits of its use, introducing and sustaining the use of the checklist are challenging. We present a team-based approach employed in a low-resource setting in Tanzania, which resulted in high checklist utilization and compliance rates. We reviewed reported data from facility registers supplemented by direct observation data by mentors to evaluate the use of the WHO SSC across 40 health facilities in two regions of Tanzania between January and December 2018. We analyzed the self-reported monthly data on total number of major surgeries performed and proportion of surgeries where the checklist was used. We also analyzed the use of the SSC during direct observation by external mentors and completion rates of the SSC in a random selection of patient files during two mentorship visits between June and December 2018. During the review period, the average self-reported checklist utilization rate was 79.3% (11,564 out of 14,580 major surgeries). SSC utilization increased from 0% at baseline in January 2018 to 98% in December 2018. The proportion of checklists that were completely and correctly filled out increased between the two mentor visits from 82.1 to 92.8%, but the gain was significantly greater at health centers than at hospitals (p

During the 1990s, the U.S. Department of Housing and Urban Development awarded more than $6 billion in competitive grants called HOPE VI to spur neighborhood redevelopment. We add to HOPE VI research by examining the impacts of a large set of public-private real estate investments, including HOPE VI, made over a 16-year period in a distressed Pittsburgh neighborhood called the Hill District. Specifically, we estimate the effects of the $468 million additional public-private investments that Hill District received compared to a demographically similar neighborhood on sale prices, rental prices, and crime. We find large and statistically significant impacts of the public-private investments on residential sales prices, commercial sales prices, and on rental prices, but only a marginally significant yet meaningful decline in non-violent arrests. For each additional $10 million of public-private investment, we find a 0.95 percent increase in residential sales prices, 2.7 percent increase in commercial sales prices, and 0.55 percent increase in rental prices. Because there was an accumulated difference over 16 years of $468 million in the amount of public-private investment across the two neighborhoods we examine, these percentage increases amount to large changes in real estate prices over that time. Commercial real estate investors and homeowners benefited the most, followed by residential landlords. Our analyses imply cities should anticipate the potential impacts of major neighborhood investment on low-income households, especially unsubsidized renters that most directly experience the brunt of rising rents.

OBJECTIVE/ BACKGROUND: Food Insecurity (FI) can be a profound source of stress, which may increase the risk for sleep disturbance. This is the first study to examine the association between FI and objectively and subjectively measured sleep. PARTICIPANTS: The sample included 785 adults living in two low-income neighborhoods (mean age=56; 95% African American). OBJECTIVE: Our study is the first to examine the association between FI and multiple dimensions of sleep, assessed objectively and subjectively. METHODS: FI was measured using a 10-item survey that assesses conditions and behaviors that characterize households when they lack financial resources to meet basic food needs. Sleep duration, efficiency, wakefulness after sleep onset (WASO), and variability in sleep duration were measured via actigraphy. Sleep quality was assessed via sleep diary. Sleep outcomes were analyzed as a function of FI, adjusting for covariates. Psychological distress was tested as a potential mediator. RESULTS: Greater FI was associated with shorter actigraphy-assessed sleep duration (B=−2.44; SE=1.24; i.e., 24 minutes shorter for the most as compared to least insecure group), poorer sleep efficiency (B=−.27; SE=.13); p’s 9 hours; OR =1.19; CI: 1.01–1.39), compared to the recommended sleep duration of 7–9 hours. Psychological distress partially mediated the association between FI and subjective sleep quality. CONCLUSIONS: FI is an independent correlate of sleep disturbance. Findings demonstrate the importance of considering novel social determinants underlying sleep health disparities.

Objective To ascertain caregiver satisfaction with silver diamine fluoride (SDF) application(s) as an intermediate care path for their children with caries. Methods Caregivers were recruited at two community health centers when they arrived for a previously scheduled operating room/sedation appointment for their children with caries who had previously been treated with SDF. They were asked to complete a survey regarding their satisfaction with SDF treatment while they waited during their children's dental treatment. Results Caregivers overwhelmingly reported that they were satisfied with SDF treatment (81.3%), and that the black mark was not an issue for their children (91.7%) or themselves (87.5%). Moreover, their perception of their children's oral health quality of life was high. Conclusions By arresting caries, SDF offers an intermediate care path for pediatric patients for whom OR/sedation treatment was not immediately available. Moreover, most caregivers were satisfied with SDF treatment for their children.

Poor medication adherence contributes to inadequate control of hypertension. However, the value of adherence monitoring is unknown. To evaluate the impact of monitoring adherence with electronic pill bottles or bidirectional text messaging on improving hypertension control. Three-arm pragmatic randomized controlled trial. One hundred forty-nine primary care patients aged 18–75 with hypertension and text messaging capabilities who were seen at least twice in the prior 12 months with at least two out-of-range blood pressure (BP) measurements, including the most recent visit. Patients were randomized in a 1:2:2 ratio to receive (1) usual care, (2) electronic pill bottles for medication adherence monitoring (pill bottle), and (3) bidirectional text messaging for medication adherence monitoring (bidirectional text). Change in systolic BP during the final 4-month visit compared with baseline. At the 4-month follow-up visit, mean (SD) change values in systolic blood pressure were − 4.7 (23.4) mmHg in usual care, − 4.3 (21.5) mmHg in the pill bottle arm, and − 4.6 (19.8) mmHg in the text arm. There was no significant change in systolic blood pressure between control and the pill bottle arm (p = 0.94) or the text messaging arm (p = 1.00), and the two intervention arms did not differ from each other (p = 0.93). Despite good measured adherence, neither feedback with electronic pill bottles nor bidirectional text messaging about medication adherence improved blood pressure control. Adherence to prescribed medications was not improved enough to affect BP control or it was not the primary driver of poor control. clinicaltrials.gov (NCT02778542)

Peer delivered, family-to-family (F2F) support-defined as the provision of outreach, engagement, knowledge, care coordination, and support to family members of children and youth with mental health challenges-is a rapidly growing and needed component of the service array. Progress is occurring toward greater specification of program models and core competencies for the parent support providers (PSPs) with lived experience providing these services; however, strategies to inform quality improvement and ensure accountability are lacking. The Family Journey Assessment (FJA), completed by PSPs and family members, fills this gap by tracking caregiver progress toward self-advocacy and self-efficacy. Analyses of 436 FJAs showed a reliable 3-component structure, reflecting progress in the recognition of needs, collaboration to access help from formal and natural supports, and activation of skills to cope with stress, enhance resilience, and develop and carry out plans of care. PSP feedback provided strong evidence for relevance and usability. Examination of FJAs at baseline and follow-up provides one of the first reports showing significant improvement in key indicators of benefit of F2F for participating families. The FJA holds promise as a measure of the impact of F2F services on key goals and as a way to identify benchmarks for focused and individualized peer-to-peer support depending on the family's level of need. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Aims We investigated associations between the density of medical marijuana dispensaries (MMDs) around young adults' homes and marijuana use outcomes. Design Secondary data analysis. Setting Los Angeles County, CA, USA. Participants A total of 1887 participants aged 18-22 years, surveyed online in 2016-17. Measurements Outcomes were past-month marijuana use (number of days used, number of times each day), positive expectancies and perceived peer use. Density was measured as the total number of MMDs and number of MMDs with storefront signage indicative of marijuana sales, within 4 miles of respondents' homes. Findings Eighty-four per cent of respondents had 10 or more MMDs within 4 miles of their homes. Multiple linear regression analyses that adjusted for individual-level socio-demographic characteristics and neighborhood socio-economic status indicated that living near a higher number of MMDs was associated with greater number of days used in the past month [β = 0.025; 95% confidence interval (CI) = 0.001, 0.049; P = 0.04] and higher positive marijuana expectancies (β = 0.003; 95% CI = 0.001, 0.007; P = 0.04). Living near more MMDs with storefront signage had a four- to six-fold larger effect on number of times used per day and positive expectancies, respectively, compared with associations with the total MMD count. Adjusting for medical marijuana card ownership attenuated the association with number of days used in the past month and positive expectancies, and an unexpected association emerged between higher MMD density and fewer number of times used each day (β = -0.005; 95% CI = -0.009, -0.001; P = 0.03). Conclusions For young adults in Los Angeles County, living near more medical marijuana dispensaries (MMDs) is positively associated with more frequent use of marijuana within the past month and greater expectations of marijuana's positive benefits. MMDs with signage show stronger associations with number of times used each day and positive expectancies.

Pay-for-performance (P4P) has been used expansively to improve quality of care delivered by physicians. However, to what extent P4P works through the provision of information versus financial incentives is poorly understood. To determine whether an increase in information feedback without changes to financial incentives resulted in improved physician performance within an existing P4P program. Implementation of a new registry enabling real-time feedback to physicians on quality measure performance. Observational, predictive piecewise model at the physician-measure level to examine whether registry introduction associated with performance changes. We used detailed physician quality measure data 3 years prior to registry implementation (2010–2012) and 2 years after implementation (2014–2015). We also linked physician-level data including age, gender, and board certification; group-level data including registry click rates; and patient panel data including chronic conditions. Four hundred thirty-four physicians continuously affiliated with Advocate from 2010 to 2015. Physician performance on ten quality metrics. We found no consistent pattern of improvement associated with the availability of real-time information across ten measures. Relative to predicted performance without the registry, average performance increased for two measures (childhood immunization status—rotavirus (p

Metaplastic breast cancer (MPBC) is a rare subtype that accounts for

The efficacy of COVID-19 mRNA vaccines is high, but breakthrough infections still occur. We compared the SARS-CoV-2 genomes of 76 breakthrough cases after full vaccination with BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna), or JNJ-78436735 (Janssen) to unvaccinated controls (February-April 2021) in metropolitan New York, including their phylogenetic relationship, distribution of variants, and full spike mutation profiles. Their median age was 48 years; seven required hospitalization and one died. Most breakthrough infections (57/76) occurred with B.1.1.7 (Alpha) or B.1.526 (Iota). Among the 7 hospitalized cases, 4 were infected with B.1.1.7, including 1 death. Both unmatched and matched statistical analyses considering age, sex, vaccine type, and study month as covariates supported the null hypothesis of equal variant distributions between vaccinated and unvaccinated in chi-squared and McNemar tests (p>0.1) highlighting a high vaccine efficacy against B.1.1.7 and B.1.526. There was no clear association among breakthroughs between type of vaccine received and variant. In the vaccinated group, spike mutations in the N-terminal domain and receptor-binding domain that have been associated with immune evasion were overrepresented. The evolving dynamic of SARS-CoV-2 variants requires broad genomic analyses of breakthrough infections to provide real-life information on immune escape mediated by circulating variants and their spike mutations.

Background Evidence-based strategies for improving surgical quality and patient outcomes in low-resource settings are a priority. Objective To evaluate the impact of a multicomponent safe surgery intervention (Safe Surgery 2020) on (1) adherence to safety practices, teamwork and communication, and documentation in patient files, and (2) incidence of maternal sepsis, postoperative sepsis, and surgical site infection. Methods We conducted a prospective, longitudinal study in 10 intervention and 10 control facilities in Tanzania’s Lake Zone, across a 3-month pre-intervention period in 2018 and 3-month post-intervention period in 2019. SS2020 is a multicomponent intervention to support four surgical quality areas: (i) leadership and teamwork, (ii) evidence-based surgery, anesthesia and equipment sterilization practices, (iii) data completeness and (iv) infrastructure. Surgical team members received training and mentorship, and each facility received up to a $10 000 infrastructure grant. Inpatients undergoing major surgery and postpartum women were followed during their stay up to 30 days. We assessed adherence to 14 safety and teamwork and communication measures through direct observation in the operating room. We identified maternal sepsis (vaginal or cesarean delivery), postoperative sepsis and SSIs prospectively through daily surveillance and assessed medical record completeness retrospectively through chart review. We compared changes in surgical quality outcomes between intervention and control facilities using difference-in-differences analyses to determine areas of impact. Results Safety practices improved significantly by an additional 20.5% (95% confidence interval (CI), 7.2–33.7%; P = 0.003) and teamwork and communication conversations by 33.3% (95% CI, 5.7–60.8%; P = 0.02) in intervention facilities compared to control facilities. Maternal sepsis rates reduced significantly by 1% (95% CI, 0.1–1.9%; P = 0.02). Documentation completeness improved by 41.8% (95% CI, 27.4–56.1%; P Conclusion Our findings demonstrate the benefit of the SS2020 approach. Improvement was observed in adherence to safety practices, teamwork and communication, and data quality, and there was a reduction in maternal sepsis rates. Our results support the emerging evidence that improving surgical quality in a low-resource setting requires a focus on the surgical system and culture. Investigation in diverse contexts is necessary to confirm and generalize our results and to understand how to adapt the intervention for different settings. Further work is also necessary to assess the long-term effect and sustainability of such interventions.

Substantial COVID-19 research investment has been allocated to randomized clinical trials (RCTs) on hydroxychloroquine/chloroquine, which currently face recruitment challenges or early discontinuation. We aim to estimate the effects of hydroxychloroquine and chloroquine on survival in COVID-19 from all currently available RCT evidence, published and unpublished. We present a rapid meta-analysis of ongoing, completed, or discontinued RCTs on hydroxychloroquine or chloroquine treatment for any COVID-19 patients (protocol: https://osf.io/QESV4/ ). We systematically identified unpublished RCTs (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, Cochrane COVID-registry up to June 11, 2020), and published RCTs (PubMed, medRxiv and bioRxiv up to October 16, 2020). All-cause mortality has been extracted (publications/preprints) or requested from investigators and combined in random-effects meta-analyses, calculating odds ratios (ORs) with 95% confidence intervals (CIs), separately for hydroxychloroquine and chloroquine. Prespecified subgroup analyses include patient setting, diagnostic confirmation, control type, and publication status. Sixty-three trials were potentially eligible. We included 14 unpublished trials (1308 patients) and 14 publications/preprints (9011 patients). Results for hydroxychloroquine are dominated by RECOVERY and WHO SOLIDARITY, two highly pragmatic trials, which employed relatively high doses and included 4716 and 1853 patients, respectively (67% of the total sample size). The combined OR on all-cause mortality for hydroxychloroquine is 1.11 (95% CI: 1.02, 1.20; I² = 0%; 26 trials; 10,012 patients) and for chloroquine 1.77 (95%CI: 0.15, 21.13, I² = 0%; 4 trials; 307 patients). We identified no subgroup effects. We found that treatment with hydroxychloroquine is associated with increased mortality in COVID-19 patients, and there is no benefit of chloroquine. Findings have unclear generalizability to outpatients, children, pregnant women, and people with comorbidities.

Background Obesity is a chronic, relapsing, and progressive disease; it is associated with poor health-related quality of life (HRQOL) in survivors of breast cancer. Methods In this 2 × 2 factorial trial, 351 survivors of breast cancer with overweight or obesity were randomized to 1 of 4 treatment groups for 52 weeks: control, exercise alone, diet alone, or exercise plus diet. HRQOL end points were measured at baseline and at week 52 using the 36-Item Medical Outcomes Survey-Short Form (SF-36). Repeated measures analysis of covariance quantified the estimated treatment difference (ETD). Results At baseline, participants had a mean (SD) age of 59.4 years (8.7), body mass index of 34.0 kg/m2 (5.9), and 71 participants (20.2%) self-reported fair or poor general health. After 52 weeks, compared with control, the exercise plus diet improved the physical health summary score (ETD: 5.39; 95% CI, 0.55-10.22); exercise alone (ETD: -1.91; 95% CI, -6.60 to 2.79) and diet alone (ETD: 3.16; 95% CI, -1.52 to 7.83) did not change the physical health summary score. Compared with control, exercise alone (ETD: -0.27; 95% CI, -6.60 to 2.79), diet alone (ETD: 3.25; 95% CI, -1.41 to 7.91), and the exercise plus diet (ETD: 1.75; 95% CI, -2.90 to 6.39) did not change the mental health summary score. Exercise alone did not impact any HRQOL subscale; diet alone improved the vitality subscale; exercise plus diet improved the physical functioning, role-physical and vitality subscales. Conclusion In survivors of breast cancer with overweight or obesity, exercise plus diet improved select HRQOL end points at week 52.

Dyspnoea self-management is often suboptimal for patients with COPD. Many patients with COPD experience chronic dyspnoea as distressing and disabling, especially during physical activities. Breathing therapy is a behavioural intervention that targets reducing the distress and impact of dyspnoea on exertion in daily living. Using a qualitative design, we conducted interviews with 14 patients after they participated in a novel mind–body breathing therapy intervention adjunct, capnography-assisted respiratory therapy (CART), combined with outpatient pulmonary rehabilitation. Comprehensive CART consisted of patient-centred biofeedback, tailored breathing exercises, a home exercise programme and motivational interviewing counselling. We assessed participants’ perceptions and reported experiences to gauge the acceptability of CART and refine CART based on feedback. Constant comparative analysis was used to identify commonalities and themes. We identified three main themes relating to the acceptability and reported benefits of CART: (1) self-regulating breathing; (2) impact on health; and (3) patient satisfaction. Our findings were used to refine and optimise CART (i.e. its intensity, timing and format) for COPD. By addressing dysfunctional breathing behaviours and dysregulated interoception, CART offers a promising new paradigm for relieving dyspnoea and related anxiety in patients with COPD., Capnography-assisted respiratory therapy (CART) is a new adjunctive mind–body therapy. Patients with COPD find CART to be acceptable and to complement pulmonary rehabilitation. https://bit.ly/3iP4glN

OBJECTIVES: To assess the impact of percutaneous dilational tracheostomy in coronavirus disease 2019 patients requiring mechanical ventilation and the risk for healthcare providers. DESIGN: Prospective cohort study; patients were enrolled between March 11, and April 29, 2020. The date of final follow-up was July 30, 2020. We used a propensity score matching approach to compare outcomes. Study outcomes were formulated before data collection and analysis. SETTING: Critical care units at two large metropolitan hospitals in New York City. PATIENTS: Five-hundred forty-one patients with confirmed severe coronavirus disease 2019 respiratory failure requiring mechanical ventilation. INTERVENTIONS: Bedside percutaneous dilational tracheostomy with modified visualization and ventilation. MEASUREMENTS AND MAIN RESULTS: Required time for discontinuation off mechanical ventilation, total length of hospitalization, and overall patient survival. Of the 541 patients, 394 patients were eligible for a tracheostomy. One-hundred sixteen were early percutaneous dilational tracheostomies with median time of 9 days after initiation of mechanical ventilation (interquartile range, 7-12 d), whereas 89 were late percutaneous dilational tracheostomies with a median time of 19 days after initiation of mechanical ventilation (interquartile range, 16-24 d). Compared with patients with no tracheostomy, patients with an early percutaneous dilational tracheostomy had a higher probability of discontinuation from mechanical ventilation (absolute difference, 30%; p < 0.001; hazard ratio for successful discontinuation, 2.8; 95% CI, 1.34-5.84; p = 0.006) and a lower mortality (absolute difference, 34%, p < 0.001; hazard ratio for death, 0.11; 95% CI, 0.06-0.22; p < 0.001). Compared with patients with late percutaneous dilational tracheostomy, patients with early percutaneous dilational tracheostomy had higher discontinuation rates from mechanical ventilation (absolute difference 7%; p < 0.35; hazard ratio for successful discontinuation, 1.53; 95% CI, 1.01-2.3; p = 0.04) and had a shorter median duration of mechanical ventilation in survivors (absolute difference, -15 d; p < 0.001). None of the healthcare providers who performed all the percutaneous dilational tracheostomies procedures had clinical symptoms or any positive laboratory test for severe acute respiratory syndrome coronavirus 2 infection. CONCLUSIONS: In coronavirus disease 2019 patients on mechanical ventilation, an early modified percutaneous dilational tracheostomy was safe for patients and healthcare providers and associated with improved clinical outcomes.