Search

Background: Research suggests that healthcare workers are at greater risk for suicide than other occupations, but most published studies focus on physicians. This study examines the prevalence of suicidal ideation (SI) and associated occupational factors among a broad group of non-physician healthcare staff., Methods: An anonymous online survey was sent to a random sample of 30 % of non-physician healthcare staff at a large urban healthcare system between September and November 2022. Weighted multivariable binary logistic regressions were conducted to determine the workplace and mental health factors associated with SI., Results: The 1084 respondents included nurses, administrative staff, research staff, medical assistants, nurse practitioners, physician assistants, and other roles. Of the sample, 8.8 % endorsed having SI over the prior two weeks. Results of the regression indicated that, after adjusting for demographic factors, greater odds of SI were associated with physical violence experienced from a patient or visitor (odds ratio [OR] = 2.15, 95 % confidence interval [CI] = 1.06-4.37), lower perceived leadership support (OR = 0.95, 95 % CI = 0.92-0.98), and positive screening for depression (OR = 4.66, 95 % CI = 2.45-8.86). Exploratory analysis suggests that depression may be a mediating factor between workplace stressors and SI., Limitations: Limitations include the response rate, the use of a single item to assess SI, and the cross-sectional design., Conclusion: Findings suggest that workplace violence and leadership support are important occupational factors associated with SI among healthcare workers. Reducing and mitigating workplace violence, enhancing leadership support, and improving access to mental health care should be considered targets for interventions to decrease suicide risk in this population., Competing Interests: Declaration of competing interest Jonathan M. DePierro receives book royalties from Cambridge University Press and compensation related to an editor in chief role with Springer Press; and is named on a U.S. patent application for a digital health intervention, an intellectual property that that has yet to be licensed. He has received honoraria from New York University, University of New Mexico, Ro Health Ventures Inc., the Canadian Institutes of Health Research, and the US Department of State. Lauren Peccoralo received honoraria from Atrium Health Wake Forest Baptist, American Society of Health-System Pharmacists, Stanford University, University of Montana and Baylor, Scott & White Health. Jonathan Ripp received honoraria for numerous speaking engagements at professional societies, academic medical centers, health care institutions; serves as a course director for the Institute for Healthcare Improvement, worked as a consultant for the well-being program at the NYU School of Medicine Long Island; served as a non-fiduciary board member of the Lorna Breen Foundation; and served on a temporary advisory board established by PEPSICO to inform employee well-being efforts, and provides consultation to Marvin Behavioral Health, Inc. The remaining authors have no conflict of interest to disclose., (Published by Elsevier B.V.)

Background: The relationship between vitamin D and prostate cancer has primarily been characterized among White men. However, Black men have higher prostate cancer incidence and mortality rates, chronically low circulating vitamin D levels, and ancestry-specific genetic variants in vitamin D-related genes. Here, we examine six critical genes in the vitamin D pathway and prostate cancer risk in Black men., Methods: We assessed a total of 69 candidate variants in six genes ( GC, CYP27A1, CYP27B1, CYP24A1, VDR , and RXRA ) including functional variants previously associated with prostate cancer and circulating 25(OHD) in White men. Associations with prostate cancer risk were examined using genome-wide association study data for approximately 10,000 prostate cancer cases and 10,000 controls among Black men and over 85,000 cases and 91,000 controls among White men. A statistical significance threshold of 0.000724 was used to account for the 69 variants tested., Results: None of the variants examined were significantly associated with prostate cancer risk among Black men after multiple comparison adjustment. Four variants tested P<0.05 in Black men, including two in RXRA (rs41400444 OR=1.09, 95% CI: 1.01-1.17, P = 0.024 and rs10881574 OR = 0.93, 0.87-1.00, P = 0.046) and two in VDR (rs2853563 OR = 1.07, 1.01-1.13, P = 0.017 and rs1156882 OR = 1.06, 1.00-1.12, P = 0.045). Two variants in VDR were also positively associated with risk in White men (rs11568820 OR = 1.04, 1.02-1.06, P = 0.00024 and rs4516035 OR = 1.03, 1.01-1.04, P = 0.00055)., Conclusion: We observed suggestive non-significant associations between genetic variants in RXRA and VDR and prostate cancer risk in Black men. Future research exploring the relationship of vitamin D with cancer risk in Black men will need larger sample sizes to identify ancestry-specific variants relevant to risk in this population.

Background: Historically, women of color showed poorer oral health and lower dental service utilization in the USA. These barriers to dental care during pregnancy included dental coverage, primary language, dental provider availability, safety concerns, affordability of dental care, and perceived oral health benefits during pregnancy., Methods: The purpose of this study is to examine whether race/ethnicity modified the associations between barriers to accessing dental care and dental service utilization during pregnancy. This cross-sectional study sample included 62,189 women aged 20 and older with a recent birth history in 21 states from the Pregnancy Risk Assessment Monitoring System (PRAMS) data from 2016 to 2019. We introduced a race/ethnicity by barrier interaction term to our multiple logistic regression models., Results: After adjusting for other confounders, dental insurance during pregnancy and perceived oral health benefits were associated with 4.0- and 5.6-fold higher odds, respectively, of dental service utilization during pregnancy. Statistically significant effect modification by race/ethnicity was observed in crude and adjusted analyses of the relationship between dental service utilization for all barriers included in the interaction analyses with all adjusted p-values < 0.001., Conclusion: The interaction analysis found that racial/ethnic disparity in visiting dentists during pregnancy was significant among women who reported these dental barriers. In contrast, such racial/ethnic disparity was substantially attenuated among women who did not report such barriers., Practical Implications: The observed racial/ethnic disparities could be mitigated by such supporting mechanisms: dental coverage, provider availability and willingness to treat pregnant women, oral health education on the safety of dental care during pregnancy, and affordable dental care costs., (© 2024. The Author(s).)

The autonomic nervous system (ANS) plays a complex role in the regulation of the immune system, with generally inhibitory effects via activation of β-adrenergic receptors on immune cells. We hypothesized that HIV-associated autonomic neuropathy (HIV-AN) would result in immune hyperresponsiveness which could be depicted using network analyses. Forty-two adults with well-controlled HIV underwent autonomic testing to yield the Composite Autonomic Severity Score (CASS). The observed range of CASS was 2-5, consistent with normal to moderate HIV-AN. To construct the networks, participants were divided into 4 groups based on the CASS (i.e., 2, 3, 4 or 5). Forty-four blood-based immune markers were included as nodes in all networks and the connections (i.e., edges) between pairs of nodes were determined by their bivariate Spearman's Rank Correlation Coefficient. Four centrality measures (strength, closeness, betweenness and expected influence) were calculated for each node in each network. The median value of each centrality measure across all nodes in each network was calculated as a quantitative representation of network complexity. Graphical representation of the four networks revealed greater complexity with increasing HIV-AN severity. This was confirmed by significant differences in the median value of all four centrality measures across the networks (p ≤ 0.025 for each). Among people with HIV, HIV-AN is associated with stronger and more numerous positive correlations between blood-based immune markers. Findings from this secondary analysis can be used to generate hypotheses for future studies investigating HIV-AN as a mechanism contributing to the chronic immune activation observed in HIV., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

A crucial reckoning was initiated when the COVID-19 pandemic began to expose and intensify long-standing racial/ethnic health inequities, all while various sectors of society pursued racial justice reform. As a result, there has been a contextual shift towards broader recognition of systemic racism, and not race, as the shared foundational driver of both societal maladies. This confluence of issues is of particular relevance to Black populations disproportionately affected by the pandemic and racial injustice. In response, institutions have initiated diversity, equity, and inclusion (DEI) efforts as a way forward. This article considers how the dual pandemic climate of COVID-19-related health inequities and the racial justice movement could exacerbate the "time and effort tax" on Black faculty to engage in DEI efforts in academia and biomedicine. We discuss the impact of this "tax" on career advancement and well-being, and introduce an operational framework for considering the interconnected influence of systemic racism, the dual pandemics, and DEI work on the experience of Black faculty. If not meaningfully addressed, the "time and effort tax" could contribute to Black and other underrepresented minority faculty leaving academia and biomedicine - consequently, the very diversity, equity, and inclusion work meant to increase representation could decrease it., (© The Author(s) 2022.)

Background: Although racial and ethnic minorities disproportionately use some hospitals, hospital-based racial and ethnic composition relative to geographic region and its association with quality indicators has not been systematically analyzed., Methods: We used four race and ethnicity categories: non-Hispanic white (NHW), non-Hispanic black (NHB), Hispanic, and Asian/Pacific Islander/Alaskan Native/American Indian (API/AIAN), as well as a combined non-NHW category, from the 2010 (latest year publicly available) Medicare Institutional Provider & Beneficiary Summary public use file for 84 hospitals in the New York City region. We assessed the relative distribution of race and ethnicity across hospitals grouped at different geographic levels (region, county, hospital referral region [HRR], or hospital service areas [HSA]) using the dissimilarity index. Hospital characteristics included quality star ratings, essential professional services and diagnostic/treatment equipment, bed size, total expenses, and patients with dual Medicare and Medicaid enrollment. We assessed Spearman's rank correlation between hospital-based racial and ethnic composition and quality/structural measures., Results: Dissimilarity Index decreases from region (range 30.3-40.1%) to county (range 13.7-23.5%), HRR (range 10.5-27.5%), and HSA (range 12.0-16.9%) levels. Hospitals with larger non-NHW patients tended to have lower hospital ratings and higher proportions of dually-enrolled patients. They were also more likely to be safety net hospitals and non-federal governmental hospitals., Conclusions: In the NYC metropolitan region, there is considerable hospital-based racial and ethnic segregation of Medicare patients among non-NHW populations, extending previous research limited to NHB. Availability of data on racial and ethnic composition of hospitals should be made publicly available for researchers and consumers., (© 2022. The Author(s).)

Purpose: Resting heart rate variability (HRV) is an important biomarker linking mental health to cardiovascular outcomes. However, resting HRV is also impaired in autonomic neuropathy, a common and underdiagnosed complication of common medical conditions which is detected by testing autonomic reflexes. We sought to describe the relationship between autonomic reflex abnormalities and resting HRV, taking into consideration medical comorbidities and demographic variables., Methods: Participants (n = 209) underwent a standardized autonomic reflex screen which was summarized as the Composite Autonomic Severity Score (CASS) and included measures of reflexive HRV, e.g., heart rate with deep breathing (HRDB). Resting HRV measures were: pNN50 (percentage of NN intervals that differ by > 50 ms) and cvRMSSD (adjusted root mean square of successive differences)., Results: In univariate analyses, lower resting HRV was associated with: older age, higher CASS, neuropathy on examination, hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, and psychiatric disease. Adaptive regression spline analysis revealed that HRDB explained 27% of the variability in resting HRV for participants with values of HRDB in the normal range. Outside this range, there was no linear relationship because: (1) when HRDB was low (indicating autonomic neuropathy), resting HRV was also low with low variance; and (2) when HRDB was high, the variance in resting HRV was high. In multivariate models, only HRDB was significantly independently associated with cvRMSSD and pNN50., Conclusion: Subclinical autonomic neuropathy, as evidenced by low HRDB and other autonomic reflexes, should be considered as a potential confounder of resting HRV in research involving medically and demographically diverse populations., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Background: The 2016 U.S. Centers for Disease Control Opioid Prescribing Guideline (CDC Guideline) is currently being revised amid concern that it may be harmful to people with chronic pain on long-term opioid therapy (CP-LTOT). However, a methodology to faithfully implement the CDC guideline, measure prescriber adherence, and systematically test its effect on patient and public health outcomes is lacking. We developed and tested a CDC Guideline implementation strategy (termed TOWER), focusing on an outpatient HIV-focused primary care setting., Methods: TOWER was developed in a stakeholder-engaged, multi-step iterative process within an Information, Motivation and Behavioral Skills (IMB) framework of behavior change. TOWER consists of: 1) a patient-facing opioid management app (OM-App); 2) a progress note template (OM-Note) to guide the office visit; and 3) a primary care provider (PCP) training. TOWER was evaluated in a 9-month, randomized-controlled trial of HIV-PCPs (N = 11) and their patients with HIV and CP-LTOT (N = 40). The primary outcome was CDC Guideline adherence based on electronic health record (EHR) documentation and measured by the validated Safer Opioid Prescribing Evaluation Tool (SOPET). Qualitative data including one-on-one PCP interviews were collected. We also piloted patient-reported outcome measures (PROMs) reflective of domains identified as important by stakeholders (pain intensity and function; mood; substance use; medication use and adherence; relationship with provider; stigma and discrimination)., Results: PCPs randomized to TOWER were 48% more CDC Guideline adherent (p < 0.0001) with significant improvements in use of: non-pharmacologic treatments, functional treatment goals, opioid agreements, prescription drug monitoring programs (PDMPs), opioid benefit/harm assessment, and naloxone prescribing. Qualitative data demonstrated high levels of confidence in conducting these care processes among intervention providers, and that OM-Note supported these efforts while experience with OM-App was mixed. There were no intervention-associated safety concerns (defined as worsening of any of the PROMs)., Conclusions: CDC-guideline adherence can be promoted and measured, and is not associated with worsening of outcomes for people with HIV receiving LTOT for CP. Future work would be needed to document scalability of these results and to determine whether CDC-guideline adherence results in a positive effect on public health. Trial registration https://clinicaltrials.gov/ct2/show/NCT03669939 . Registration date: 9/13/2018., (© 2022. The Author(s).)

Purpose: To evaluate mortality risk of CKD patients infected with COVID-19, and assess shared characteristics associated with health disparities in CKD outcome., Methods: We extracted the data from a case series of 7624 patients presented at Mount Sinai Health System, in New York for testing between 3/28/2020 and 4/16/2020. De-identified patient data set is being produced by the Scientific Computing department and made available to the Mount Sinai research community at the following website: https://msdw.mountsinai.org/ ., Results: Of 7624 COVID-19 patients, 7.8% (n = 597) had CKD on hospital admission, and 11.2% (n = 856) died of COVID-19 infection. CKD patients were older, more likely to have diabetes, hypertension, and chronic obstructive pulmonary disease (COPD), were current or former smokers, had a longer time to discharge, and had worse survival compared to non-CKD patients (p < 0.05). COVID-19 mortality rate was significantly higher in CKD patients (23.1% vs 10.2%) with a 1.51 greater odds of dying (95% CI: 1.19-1.90). Controlling for demographic, behavioral, and clinical covariates, the logistic regression analysis showed significant and consistent effects of CKD, older age, male gender, and hypertension with mortality (p < 0.05)., Conclusion: CKD was a significant independent predictor of COVID-19 mortality, along with older age, male gender, and hypertension. Future research will investigate the effects of COVID-19 on long-term renal function., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part of Springer Nature.)

Purpose: HIV-associated autonomic neuropathy (HIV-AN) is common and may be associated with both sympathetic and parasympathetic dysfunction. Sympathetic nervous system (SNS) dysfunction occurs on a continuum of hyper-to hypo-adrenergic function, and may be a mediator between psychological stress and chronic inflammation. We sought to describe patterns of SNS dysfunction in people living with HIV, and to determine whether SNS dysfunction is associated with markers of systemic inflammation (focusing on IL-6 and TNF-α) and pain and anxiety., Methods: Forty-seven people with well-controlled HIV and without confounding medical conditions or medications completed the Medical Outcomes Survey (MOS-HIV), quantification of a panel of 41 plasma cytokines/chemokines, and a standardized, non-invasive autonomic reflex screen (ARS). Adrenergic baroreflex sensitivity (BRSA) was calculated from the ARS as a measure of SNS function., Results: Pain (46%) and anxiety (52%) were commonly reported on the MOS-HIV. BRSA was reduced in 30% of participants and elevated in 9% with the latter occurring only in participants with normal to mild HIV-AN. BRSA was significantly associated with IL-6, but not with TNF-α, pain or anxiety. Exploratory analyses also revealed positive associations of BRSA with numerous other cytokines with no significant inverse associations., Conclusion: Higher BRSA, indicative of a more hyperadrenergic state, can be part of the spectrum of early HIV-AN, and may be associated with elevations in multiple cytokines including IL-6. These associations do not appear to be driven by stressors such as pain or anxiety., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.., (© 2020 The Author(s).)

This study aims to describe the acceptability and feasibility of an educational and training experiential intervention (ETEI) we developed to enhance muscle invasive bladder cancer (MIBC) patients with treatment decision-making and post-operative self-care. Twenty-five patients were randomized to a control group (N = 8) or ETEI group (N = 17). ETEI group participated in a nurse-led session on MIBC education. The control group received diet and nutrition education. Study questionnaires were completed at baseline and at 1-month post-intervention. Our results showed acceptable recruitment (58%) and retention rates (68%). The ETEI group reported increased knowledge (82% vs. 50%), improved decisional support (64% vs. 50%), improved communication (73% vs. 50%), and increased confidence in treatment decisions (73% vs. 50%) compared to the control group. Patients in the control group reported improved diet (50% v. 27%) as well as maintaining a healthy lifestyle (67% vs. 45%) compared to the ETEI group. Patients in the ETEI group reported a significant decrease in cancer worries and increases in self-efficacy beliefs over time compared to the control group. The ETEI was feasible, acceptable, and showed a potential for inducing desired changes in cancer worries and efficacy beliefs.

Biostatisticians with advanced degrees are highly sought after. Employment opportunities in the fields of mathematics and statistics are expected to increase dramatically by 2028. Underrepresentation of minorities in biostatistics has been a persistent problem, yielding a demographic landscape that differs substantially from the general US population. In some instances, students may have the appropriate quantitative skills, but are unaware of biostatistics and in other instances, students may not yet have the appropriate quantitative background, but are intellectually capable and willing to shore up those skills once they learn about biostatistics as a viable, exciting career option. Therefore, in order to ensure robust scientific advancement, there must be a concerted effort to increase the pipeline of intellectually talented persons available with exposure to the appropriate quantitative skills who are interested in careers in biostatistics. The overarching goal of this paper is to discuss the development, implementation, and impact of a federally funded pipeline initiative aimed at increasing the number of underrepresented minorities successful in graduate training and professional careers in biostatistics as well as establishing effective mentoring and networking relationships. Our findings provide a roadmap for the development of sustainable initiatives to promote diversity in biostatistics and STEM fields more broadly.

Background: There is a high level of interest in the potential role of diet among the MS community. There is a limited level of evidence for a Mediterranean-style dietary pattern in MS; the feasibility of conducting studies using educational tools to deliver this type of intervention and study its effects is unknown., Objectives: To establish clinical trial feasibility for future studies utilizing educational delivery of a dietary intervention in MS; to explore the effects of a modified Mediterranean dietary intervention in MS., Methods: We randomly assigned women with MS to follow/not follow the prescribed modified Mediterranean dietary intervention for 6 months, delivered through educational sessions. The diet encouraged the intake of fish and other foods high in poly- and monounsaturated fats, fresh fruits, vegetables, and whole grains and eliminated meat, dairy, and most processed foods and limited salt intake to <2 g/day. Primary endpoints related to meeting target enrollment within the specified time frame, adherence, and study completion. Clinical endpoints were evaluated in an exploratory fashion., Results: We screened 128 potential participants and enrolled 36 within 9 months, surpassing target enrollment of 30 participants at a single center in 1 year. Self-reported adherence was excellent (90.3%), with an overall study completion rate of 94.4%. The intervention group exhibited a statistically significant decline in the trajectory of Neurological Fatigue Index-MS scores (p = 0.01), a trend toward reduced Multiple Sclerosis Impact Scale-29 scores that became significant after outlier removal (p = 0.12; p = 0.023), and a reduction in Expanded Disability Status Scale (p = 0.01) over time as compared to the non-intervention group., Conclusions: It is reasonable to expect a high level of interest and commitment to this type of dietary intervention study in MS, and feasible to deliver it purely through education in a clinical setting with high adherence levels despite restrictive requirements. In this pilot study, a modified Mediterranean dietary intervention reduced fatigue, impact of MS symptoms, and disability. Further work is needed., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Many people with HIV (PWH) experience chronic pain that limits daily function and quality of life. PWH with chronic pain have commonly been prescribed opioids, sometimes for many years, and it is unclear if and how the management of these legacy patients should change in light of the current US opioid epidemic. Guidelines, such as the Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain (CDCG), provide recommendations for the management of such patients but have yet to be translated into easily implementable interventions; there is also a lack of strong evidence that adhering to these recommendations improves patient outcomes such as amount of opioid use and pain levels. Herein we describe the development and preliminary testing of a theory-based intervention, called TOWER ( TOW ard Saf ER Opioid Prescribing), designed to support HIV primary care providers in CDCG-adherent opioid prescribing practices with PWH who are already prescribed opioids for chronic pain. TOWER incorporates the content of the CDCG into the theoretical and operational framework of the Information Motivation and Behavioral Skills (IMB) model of health-related behavior. The development process included elicitation research and incorporation of feedback from providers and PWH; testing is being conducted via an adaptive feasibility clinical trial. The results of this process will form the basis of a large, well-powered clinical trial to test the effectiveness of TOWER in promoting CDCG-adherent opioid prescribing practices and improving outcomes for PWH with chronic pain., (© 2019 The Authors.)

Small intestinal bacterial overgrowth (SIBO) is common among patients with HIV-associated autonomic neuropathies (HIV-AN) and may be associated with increased bacterial translocation and elevated plasma inflammatory biomarkers. Pyridostigmine is an acetylcholinesterase inhibitor which has been used to augment autonomic signaling. We sought preliminary evidence as to whether pyridostigmine could improve proximal gastrointestinal motility, reduce SIBO, reduce plasma sCD14 (a marker of macrophage activation and indirect measure of translocation), and reduce the inflammatory cytokines IL-6 and TNFα in patients with HIV-AN. Fifteen participants with well-controlled HIV, HIV-AN, and SIBO were treated with 8 weeks of pyridostigmine (30 mg PO TID). Glucose breath testing for SIBO, gastric emptying studies (GES) to assess motility, plasma sCD14, IL-6, and TNFα, and gastrointestinal autonomic symptoms were compared before and after treatment. Thirteen participants (87%) experienced an improvement in SIBO following pyridostigmine treatment; with an average improvement of 50% (p = 0.016). There was no change in gastrointestinal motility; however, only two participants met GES criteria for gastroparesis at baseline. TNFα and sCD14 levels declined by 12% (p = 0.004) and 19% (p = 0.015), respectively; there was no significant change in IL-6 or gastrointestinal symptoms. Pyridostigmine may ameliorate SIBO and reduce levels of sCD14 and TNFα in patients with HIV-AN. Larger placebo-controlled studies are needed to definitively delineate how HIV-AN affects gastrointestinal motility, SIBO, and systemic inflammation in HIV, and whether treatment improves clinical outcomes.

Background: Skin lightening products containing dangerous levels of chemicals pose a serious health concern for consumers. However, to date, the extent of these products in Europe has not been extensively studied. The aim of this study was to determine whether harmful skin lightening products are available for sale in Europe and what violations exist regarding their composition., Materials and Methods: We queried the Rapex database, which is the Rapid Alert System for dangerous non-food products among 31 European countries, to identify skin lightening cosmetics reported between 2005 and 2018, and presented a detailed summary of these notifications., Results: In the years 2005-2018, of all violations regarding cosmetics, 26.3% concerned skin lightening products. In the database, 266 reports on skin lightening products were identified. Most of the notifications came from Germany (17.29%), France (17.29%), Portugal (15.41%), and the United Kingdom (11.65%). The majority of the registered products originated from non-European countries, mainly the Côte d'Ivoire (29.70%). The major reason for the violation was the content of hydroquinone, mercury, or clobetasol propionate., Conclusions: Hazardous skin lightening products that are not in line with European cosmetics legislation are available on the European market. Most of the products are imported. The main risk associated with these products is the content of hydroquinone, mercury, and clobetasol propionate. It is important to bear in mind that this study focuses on the Rapex system and other sources of information may exist. Based on our findings, a more comprehensive evaluation by international authorities is justified., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Introduction: The application of skin bleaching products to inhibit melanogenesis is a common practice within the African diaspora. Despite the adverse health effects of skin bleaching, rigorous studies investigating skin bleaching behavior among these populations in the United States are limited. In our P30 pilot study, we explored predictors of skin bleaching practice intensity among African and Afro-Caribbean women., Methods: In collaboration with our Community Engagement Core, we conducted a cross-sectional study to investigate the relationship between demographic and psychosocial predictors and skin-bleaching-related practice patterns among African and Afro-Caribbean women in New York City., Results: Among the 76 participants recruited, the median age at the initiation of skin bleaching was 19.5 (16-25) years, yielding a median duration of 13.5 (6-23) years. Although pregnant women were not actively recruited for the study, 13.2% (n = 10) of the participants used skin bleaching products while pregnant or possibly breastfeeding. Nativeness and education were associated with various components of skin bleaching practice intensity, including duration of skin bleaching, daily use of products, and bleaching of the entire body. Participants' perceived skin-color-related quality of life was not associated with skin bleaching practice intensity., Conclusion: Skin bleaching is a habitual practice that likely requires culturally sensitive interventions to promote behavioral change. The existence of prenatal and postnatal exposure to mercury, hydroquinone, and other potentially harmful chemicals in skin bleaching products highlights an urgent need to explore the adverse effects of skin bleaching practices on birth outcomes and the growth and neurodevelopment of young babies.

Thyroid cancer incidence is higher in World Trade Center (WTC) responders compared with the general population. It is unclear whether this excess in thyroid cancer is associated with WTC-related exposures or if instead there is an over-diagnosis of malignant thyroid cancer among WTC first responders due to enhanced surveillance and physician bias. To maximize diagnostic yield and determine the false positive rate for malignancy, the histological diagnoses of thyroid cancer tumors from WTC responders and age, gender, and histology matched non-WTC thyroid cancer cases were evaluated using biomarkers of malignancy. Using a highly accurate panel of four biomarkers that are able to distinguish benign from malignant thyroid cancer, our results suggest that over-diagnosis by virtue of misdiagnosis of a benign tumor as malignant does not explain the increased incidence of thyroid cancer observed in WTC responders. Therefore, rather than over-diagnosis due to physician bias, the yearly screening visits by the World Trade Center Health Program are identifying true cases of thyroid cancer. Continuing regular screening of this cohort is thus warranted.

Background: There is an urgent need to address the safety problems caused by the use of skin lightening cosmetics. Evidence suggests that some of them may contain heavy metals., Objectives: We conducted a systematic review of global legal regulations regarding the permissible level of mercury, lead, arsenic, and cadmium in cosmetic products, with particular emphasis on skin lightening preparations., Methods: The systematic search of documents was a two-stage process. First, official websites of 17 regional organizations and subsequently regulations for countries with a population over 100 million were searched., Results: Fifteen legislative acts, encompassing more than 67·2% of the global population were reviewed. Regulations were identified for 44/59 high income countries, 16/55 upper middle income countries, 9/45 lower income countries, 0/34 low income countries. The median adult literacy rate was 91·4% and 64·2% in countries with and without regulations, respectively. The use of mercury, lead, arsenic, and cadmium has been banned in 67, 67, 65, and 65 out of 69 countries, respectively., Conclusions: While regulations exist in most of the high income countries, in low income countries there is a lack of similar standards. In most countries for which these legal regulations have been identified, restrictions on the permissible level of heavy metals are strict. There is a need for enforcement of existing rules, and rigorous assessment of the effectiveness of these regulations., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: Chronic inflammation in HIV-infected individuals drives disease progression and the development of comorbidities, despite viral suppression with combined antiretroviral therapy. Here, we sought evidence that vagal dysfunction, which occurs commonly as part of HIV-associated autonomic neuropathy, could exacerbate inflammation through gastrointestinal dysmotility, small intestinal bacterial overgrowth (SIBO), and alterations in patterns of soluble immune mediators., Design: This is a cross-sectional observational study., Methods: Forty participants on stable combined antiretroviral therapy with gastrointestinal symptoms, and no causes for vagal or gastrointestinal dysfunction other than HIV, underwent autonomic testing, hydrogen/methane breath testing for SIBO, and gastric emptying scintigraphy. A panel of 41 cytokines, high-mobility group box 1, and markers of bacterial translocation (lipopolysaccharide) and monocyte/macrophage activation (sCD14 and sCD163) were tested in plasma., Results: We found that participants with vagal dysfunction had delayed gastric emptying and higher prevalence of SIBO. SIBO was associated with IL-6, but not sCD14; lipopolysaccharide could not be detected in any participant. We also found alteration of cytokine networks in participants with vagal dysfunction, with stronger and more numerous positive correlations between cytokines. In the vagal dysfunction group, high mobility group box 1 was the only soluble mediator displaying strong negative correlations with other cytokines, especially those cytokines that had numerous other strong positive correlations., Conclusion: The current study provides evidence that the vagal component of HIV-associated autonomic neuropathy is associated with changes in immune and gastrointestinal function in individuals with well treated HIV. Further study will be needed to understand whether therapies targeted at enhancing vagal function could be of benefit in HIV.

While junior clinical researchers at academic medical institutions across the US often desire to be actively engaged in randomized-clinical trials, they often lack adequate resources and research capacity to design and implement them. This insufficiency hinders their ability to generate a rigorous randomization scheme to minimize selection bias and yield comparable groups. Moreover, there are limited online user-friendly randomization tools. Thus, we developed a free robust randomization app (RRApp). RRApp incorporates 6 major randomization techniques: simple randomization, stratified randomization, block randomization, permuted block randomization, stratified block randomization, and stratified permuted block randomization. The design phase has been completed, including robust server scripts and a straightforward user-interface using the "shiny" package in R. Randomization schemes generated in RRApp can be input directly into the Research Electronic Data Capture (REDCap) system. RRApp has been evaluated by biostatisticians and junior clinical faculty at the Icahn School of Medicine at Mount Sinai. Constructive feedback regarding the quality and functionality of RRApp was also provided by attendees of the 2016 Association for Clinical and Translational Statisticians Annual Meeting. RRApp aims to educate early stage clinical trialists about the importance of randomization, while simultaneously assisting them, in a user-friendly fashion, to generate reproducible randomization schemes.

As clinical researchers at academic medical institutions across the United States increasingly manage complex clinical databases and registries, they often lack the statistical expertise to utilize the data for research purposes. This statistical inadequacy prevents junior investigators from disseminating clinical findings in peer-reviewed journals and from obtaining research funding, thereby hindering their potential for promotion. Underrepresented minorities, in particular, confront unique challenges as clinical investigators stemming from a lack of methodologically rigorous research training in their graduate medical education. This creates a ripple effect for them with respect to acquiring full-time appointments, obtaining federal research grants, and promotion to leadership positions in academic medicine. To fill this major gap in the statistical training of junior faculty and fellows, the authors developed the Applied Statistical Independence in Biological Systems (ASIBS) Short Course. The overall goal of ASIBS is to provide formal applied statistical training, via a hybrid distance and in-person learning format, to junior faculty and fellows actively involved in research at US academic medical institutions, with a special emphasis on underrepresented minorities. The authors present an overview of the design and implementation of ASIBS, along with a short-term evaluation of its impact for the first cohort of ASIBS participants.

Objective To measure stigma associated with four types of postpartum depression therapies and to estimate the association between stigma and the acceptance of these therapies for black and white postpartum mothers. Methods Using data from two postpartum depression randomized trials, this study included 481 black and white women who gave birth in a large urban hospital and answered a series of questions at 6-months postpartum. Survey items included socio demographic and clinical factors, attitudes about postpartum depression therapies and stigma. The associations between race, stigma, and treatment acceptability were examined using bivariate and multivariate analyses. Results Black postpartum mothers were less likely than whites to accept prescription medication (64 vs. 81%, p = 0.0001) and mental health counseling (87 vs. 93%, p = 0.001) and more likely to accept spiritual counseling (70 vs. 52%, p = 0.0002). Women who endorsed stigma about receipt of postpartum depression therapies versus those who did not were less likely to accept prescription medication, mental health and spiritual counseling for postpartum depression. Overall black mothers were less likely to report stigma associated with postpartum depression therapies. In adjusted models, black women versus white women remained less likely to accept prescription medication for postpartum depression (OR = 0.42, 95% CI 0.24-0.72) and stigma did not explain this difference. Conclusions Although treatment stigma is associated with lower postpartum depression treatment acceptance, stigma does not explain the lower levels of postpartum depression treatment acceptance among black women. More research is needed to understand treatment barriers for postpartum depression, especially among black women.

Introduction: It is increasingly essential for medical researchers to be literate in statistics, but the requisite degree of literacy is not the same for every statistical competency in translational research. Statistical competency can range from 'fundamental' (necessary for all) to 'specialized' (necessary for only some). In this study, we determine the degree to which each competency is fundamental or specialized., Methods: We surveyed members of 4 professional organizations, targeting doctorally trained biostatisticians and epidemiologists who taught statistics to medical research learners in the past 5 years. Respondents rated 24 educational competencies on a 5-point Likert scale anchored by 'fundamental' and 'specialized.', Results: There were 112 responses. Nineteen of 24 competencies were fundamental. The competencies considered most fundamental were assessing sources of bias and variation (95%), recognizing one's own limits with regard to statistics (93%), identifying the strengths, and limitations of study designs (93%). The least endorsed items were meta-analysis (34%) and stopping rules (18%)., Conclusion: We have identified the statistical competencies needed by all medical researchers. These competencies should be considered when designing statistical curricula for medical researchers and should inform which topics are taught in graduate programs and evidence-based medicine courses where learners need to read and understand the medical research literature.

Objective: To assess ovarian suppression during oral contraceptive pill (OCP) use among normal-weight and obese women using two OCP doses., Methods: This was a prospective, double-blind, randomized trial of two 21-day monophasic OCP formulations (20-microgram ethinyl estradiol [E2],/100-microgram levonorgestrel compared with 30-microgram ethinyl E2/150-microgram levonorgestrel) among normal-weight (body mass index 19.0-24.9) and obese (body mass index 30.0-39.9) women with regular menses and normal ovarian ultrasonography. Participants underwent transvaginal ultrasonography and phlebotomy twice weekly for 4 weeks during the third or fourth OCP cycle. We assessed OCP compliance using serum levonorgestrel levels. Outcomes included follicular development, endogenous E2 levels, ovulation, and self-reported bleeding patterns., Results: Two hundred twenty-six women enrolled. One hundred eighty-one participants completed the study; we retained 150 consistent OCP users in the main analysis (96 normal weight, 54 obese). Consistent users of either OCP dose had substantial suppression of follicular development; obesity and follicular development were not related. Among the consistent OCP users, 2.7% ovulated during the study cycle (3 of 96 normal-weight and 1 of 54 obese participants). Two ovulations occurred with each OCP formulation. Inconsistent OCP use or nonuse during the study cycle was associated with more ovulation (P<.001). Normal-weight and obese participants had similar follicular development, endogenous estradiol levels, Hoogland scores, and bleeding patterns., Conclusion: Normal-weight and obese participants who were consistent OCP users experienced substantial and comparable ovarian suppression during OCP use. Higher OCP failure rates among obese women reported elsewhere are thus unlikely to be attributable to physiological differences in OCP effect., Clinical Trial Registration: ClinicalTrials.gov, www.clinicaltrials.gov; NCT00827632., Level of Evidence: : I.