Central Hemodynamics in African American Women: Examining the Role of Superwoman Schema Endorsement.

BACKGROUND: African American women bear a disproportionate burden of cardiovascular diseases, potentially due to altered central hemodynamics. Racism and sexism often lead to African American women taking on numerous caretaking roles and overall increases their use of the Strong Black Woman (ie, Superwoman) mindset, which may have negative health consequences. We hypothesized that endorsing the Superwoman role and its Obligation to Help Others dimension would be associated with a deleterious central hemodynamics profile in African American women. METHODS AND RESULTS: Using cross-sectional data, we examined central systolic blood pressure (mm Hg; n=408), augmentation index (percentage, adjusted for height and heart rate; n=408), and pulse wave velocity (m/s; n=368) in African American women aged 30 to 46 years. The Giscombe Superwoman Schema (SWS) questionnaire assessed endorsement of Overall SWS (range, 0-105) and SWS-Obligation to Help Others (range, 0-3). Multiple linear regression modeled associations between Overall SWS (10-unit increments) and SWS-Obligation to Help Others (1-unit increments) and central hemodynamics while adjusting for pertinent sociodemographic, clinical, and psychosocial factors. In fully adjusted models, central systolic blood pressure was significantly associated with Overall SWS (ß=0.83 [95% CI, 0.19-1.47]) and SWS-Obligation to Help Others (ß=2.03 [95% CI, 0.39-3.67]). Augmentation index was associated with Overall SWS (ß=0.66 [95% CI, 0.02-1.30]) and SWS-Obligation to Help Others (ß=2.21 [95% CI, 0.58-3.84]). Significant associations were not observed between pulse wave velocity and SWS. CONCLUSIONS: Greater endorsement of the Superwoman role and prioritizing caregiving over self-care were associated with higher central systolic blood pressure and augmentation index, which may contribute to adverse cardiovascular health among African American women.

Does stress from incarceration of family and friends contribute to signs of early vascular ageing in African American women?

BACKGROUND: Early vascular ageing (EVA) contributes to elevated risk of cardiovascular disease (CVD), which disproportionately affects African American women. Incarceration, an event disproportionately impacting African Americans, may be a stressor contributing to EVA in African American women. Further, the subjective perspective, commonly referred to as appraisal, of incarceration may also be important for health. We hypothesised that having family and/or friends incarcerated and appraising the incarceration as upsetting would be associated with indices of EVA. METHODS: In a community-based cohort of African American women aged 30-46 living in Atlanta, Georgia (n=391), participants were asked, at baseline, about family and/or friend incarceration and to appraise how upsetting the incarceration was. Multivariable linear regression examined associations between: (1) family and/or friend incarceration and indices of EVA (pulse wave velocity, augmentation index, central systolic blood pressure (SBP) and pulse pressure amplification) and (2) appraisal of incarceration and EVA indices. RESULTS: 45% of participants (n=174) reported having a loved one incarcerated, and 59% (n=102) reported the incarceration as upsetting. Having a loved one incarcerated was associated with a higher central SBP (b=4.30; 95% CI 1.61, 6.99) and augmentation index (b=2.29; 95% CI 0.26, 4.33). Appraisal of incarceration was only associated with central SBP. CONCLUSIONS: Family or friend incarceration was highly prevalent in this cohort of African American women and associated with indices of EVA. Mass incarceration of others may affect the physical health of African American women which may contribute to CVD disparities.

Financial Hardship and Sleep Quality Among Black American Women With and Without Systemic Lupus Erythematosus.

OBJECTIVE: To compare dimensions of financial hardship and self-reported sleep quality among Black women with versus without systemic lupus erythematosus (SLE). METHODS: Participants were 402 Black women (50% with validated diagnosis of SLE) living in Georgia between 2017 and 2020. Black women with SLE were recruited from a population-based cohort established in Atlanta, and Black women without SLE were recruited to be of comparable age and from the same geographic areas as SLE women. Financial hardship was measured using three different scales: financial adjustments, financial setbacks, and financial strain. Sleep was assessed continuously using the Pittsburgh Sleep Quality Index (PSQI) scale. Each dimension of financial hardship was analyzed separately in SLE-stratified multivariable linear regression models and adjusted by sociodemographic and health status factors. RESULTS: Dimensions of financial hardship were similarly distributed across the two groups. Sleep quality was worse in Black women with, versus without, SLE (p < .001). Among Black women with SLE, financial adjustment was positively associated with a 0.40-unit increase in poor sleep quality (95% CI = 0.12-0.67, p = .005). When accounting for cognitive depressive symptoms, financial setbacks and strain were somewhat attenuated for Black women with SLE. Overall, no associations between financial hardships and sleep quality were observed for the women without SLE. CONCLUSIONS: Black women with SLE who experience financial hardships may be more at risk for poor sleep quality than Black women without SLE. Economic interventions targeting this population may help improve their overall health and quality of life.

The association between Superwoman schema and subjective sleep quality among Black women.

OBJECTIVES: Similar to women overall, Black women are socialized to be communal and "self-sacrificing," but unlike women from other racial/ethnic backgrounds, Black women are also socialized to be "strong" and "invulnerable." This phenomenon is labeled Superwoman schema. This study examined associations between Superwoman schema endorsement and subjective sleep quality. METHODS: Participants included 405 Black women (ages 30-46). Superwoman schema was measured using a 35-item scale capturing five dimensions: obligation to present strength, suppress emotions, resistance to vulnerability, motivation to succeed, and obligation to help others. Superwoman schema overall and the five dimensions/subscales were analyzed. The Pittsburgh Sleep Quality Index (PSQI) was used to investigate overall subjective sleep quality (range: 0-19), poor sleep quality (PSQI >5), and specific sleep domains (eg, sleep duration, sleep disturbances). We fit linear and binary logistic regression models, adjusting for health-related and sociodemographic factors. RESULTS: Superwoman schema dimension obligation to help others was associated with lower overall subjective sleep quality (ß: .81, 95%CI=0.29, 1.32) and poor sleep quality (OR: 1.55, 95%CI=1.10, 2.19), as well as bad subjective sleep quality (OR: 1.76, 95%CI=1.18, 2.66), sleep disturbances (ß: .73, 95%CI =0.07, 1.41), and daytime sleepiness (OR: 2.01, 95%CI=1.25, 3.26). Suppress emotions (OR: 1.41, 95%CI=1.01, 1.99) was associated with poor subjective sleep quality. Superwoman schema overall was associated with daytime sleepiness (OR: 2.01, 95%CI=1.06, 3.82). CONCLUSION: Superwoman schema endorsement, especially obligation to help others and suppress emotions, may be important psychosocial risk factors for Black women's sleep health.

Financial responsibility, financial context, and ambulatory blood pressure in early middle-aged African-American women.

BACKGROUND: African-American women have excess rates of elevated blood pressure (BP) and hypertension compared to women of all other racial/ethnic backgrounds. Several researchers have speculated that race and gender-related socioeconomic status (SES) stressors might play a role. OBJECTIVE: To examine the association between a novel SES-related stressor highly salient among African-American women, financial responsibility for one's household, and 48-h ambulatory BP. We further examined whether aspects related to African-American women's financial context (e.g., single parenthood, household income, marital status) played a role. METHODS: Participants were N = 345 employed, healthy African-American women aged 30-46 from diverse SES backgrounds who underwent 48-h ambulatory BP monitoring. Linear regression analyses were conducted to examine associations between self-reported financial responsibility and daytime and nighttime BP, adjusting for age, SES and other sociodemographics, cardiovascular risk factors, financial strain and depressive symptoms. Interactions between financial responsibility and single parenthood, household income, and marital/partnered status were tested. RESULTS: In age-adjusted analyses, reporting financial responsibility was associated with higher daytime systolic (ß = 4.42, S.E. = 1.36, p = 0.0013), and diastolic (ß = 2.82, S.E. = 0.98, p = 0.004) BP. Associations persisted in fully adjusted models. Significant associations were also observed for nighttime systolic and diastolic BP. There were no significant interactions with single parenthood, household income, nor marital/partnered status. CONCLUSION: Having primary responsibility for one's household may be an important driver of BP in early middle-aged African-American women, independent of SES, financial strain, and across a range of financial contexts. Future studies examining prospective associations are needed, and policy interventions targeting structural factors contributing to financial responsibility in African-American women may be warranted.

Superwoman Schema and self-rated health in black women: Is socioeconomic status a moderator?

BACKGROUND: The Superwoman Schema (SWS) construct elucidates Black women's socialization to be strong, suppress their emotions, resist vulnerability, succeed despite limited resources, and help others at their own expense. Drawing from intersectionality and social psychological research on self-schemas, this study examined the extent to which SWS was associated with Black women's self-rated health. We also investigated whether socioeconomic status (SES) moderated the association between SWS, its five dimensions, and self-rated health. METHODS: Data were from the Mechanisms Underlying Stress and Emotions (MUSE) in African-American Women's Health Study, a cohort of African American self-identified women. SWS was assessed using Giscombé's 35-item Superwoman Schema Scale. Socioeconomic status was measured by household income and educational attainment. Ordered logistic regression models were used and statistical interactions were run to test for moderation (N = 408). RESULTS: First, SWS dimension "obligation to help others" was associated with worse self-rated health (p < .05). Second, household income, but not education, moderated the association between SWS and self-rated health (p < .05): SWS overall was associated with worse self-rated health among higher income women but better self-rated health among lower income women. Third, income moderated the association between SWS dimension "obligation to present an image of strength" and self-rated health (p < .05): presenting strength was associated with better self-rated health for lower income women only. Fourth, moderation results revealed that SWS dimension "obligation to help others" was inversely associated with self-rated health particularly among higher income women. CONCLUSIONS: Findings speak to the complex interplay between SES and SWS dimensions as they relate to Black women's perceived health.

"My wellbeing-their wellbeing "- An eHealth intervention for managing obesity in early care and education: Protocol for the Go NAPSACC Cares cluster randomized control trial.

BACKGROUND: To fully leverage the potential of the early care and education (ECE) setting for childhood obesity prevention, initiatives must not intervene solely at the organizational level, but rather they should also address the health needs of the ECE workers. Workers suffer disproportionately high rates of obesity, and have reported low confidence in modeling and promoting healthy eating and activity behaviors. However, information regarding the effectiveness of improving ECE workers' health behaviors or whether such improvements elicit meaningful change in the ECE environment and/or the children in their care is limited. METHOD: The proposed study will integrate a staff wellness intervention into a nationally recognized, ECE obesity prevention initiative (Go NAPSACC). Go NAPSACC+ Staff Wellness program will be assessed using a clustered randomized controlled trial including 84 ECE centers, 168 workers, and 672 2-5-year-old children. Centers will be randomly assigned to 1) standard "Go NAPSACC" or 2) Go NAPSACC+ Staff Wellness. Outcome measures will assess impact on dietary intake and PA behaviors of 2-5-year-old children at 6 months (primary aim) and 12 months. Secondarily, we will compare the impact of the intervention on centers' implementation of healthy weight practices and the effect on ECE workers' diet quality and PA at 6- and 12 months. DISCUSSION: This trial expects to increase our understanding of how ECE worker's personal health behaviors impact the health behaviors of the children in their care and the ECE environment. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05656807, registered on 19 December 2022. Protocol version 1.0, 22 March 2023.

Network stressors, personal stressors, and ambulatory blood pressure in African-American women-Does superwoman schema play a role?

OBJECTIVE: Life stressors have been linked to cardiovascular risk; however, studies typically focus on stressors that directly impact the individual, that is, personal stressors. Research suggests that women, particularly African-American women, may be more vulnerable to network stressors that involve family members and friends-potentially due to norms around needing to be a "Superwoman." Yet few studies have examined these phenomena. METHOD: We examined associations between network, versus personal, stressors, and elevated blood pressure (BP) in N = 392 African-American women aged 30-46. Questionnaire-assessed negative life events were classified into upsetting network or personal stressors. BP was assessed in clinic and via 48-hr ambulatory monitoring. Linear and logistic regression models examined associations between type of stressors and 48-hr daytime and nighttime systolic BP (SBP) and diastolic BP (DBP), and sustained hypertension after adjusting for relevant covariates. Interactions with questionnaire-assessed superwoman schema (SWS) were tested in exploratory analyses. RESULTS: In age and sociodemographic-adjusted models, network stressors were significantly associated with daytime SBP, ß (SE) = 2.01 (0.51), p ≤ .0001, and DBP, ß (SE) = 1.59 (0.37), p ≤ .0001, but personal stressors were not (p values > .10). Associations persisted after adjustment for cardiovascular and psychosocial risk factors. Patterns were similar for nighttime BP and sustained hypertension. There were no interactions with SWS. CONCLUSIONS: Network, but not personal, stressors were associated with elevated rates of daytime SBP and DBP, as well as sustained hypertension in African-American women, irrespective of SWS endorsement. Future research is needed to determine whether stress-management interventions focused on network stressors might impact BP in this high-risk population. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Evaluating Rural Ethiopian Youths' Willingness and Competency to Promote Literacy Regarding G × E Influences on Podoconiosis.

INTRODUCTION: Engaging youth as peer educators has yet to be considered to promote literacy concerning conjoint genetic and environmental (G × E) influences on health conditions. Whether youth living in low- and middle-income countries (LMICs) could and would be willing to serve as lay educators of G × E education is unclear. METHODS: A cross-sectional survey of youth living in Southern Ethiopia was conducted from August to September 2017. Trained data collectors administered the survey on 377 randomly selected youth who ranged in age from 15 to 24; 52% were female and 95% reported having some formal education. Self-reported willingness and a constructed competency score were assessed. Bivariate analyses tested for factors associated with willingness and competency to serve as lay G × E literacy builders. RESULTS: Competency and willingness were significantly greater (p < 0.05) for youth who were male, had some formal education, and had civic or leadership experience. Differences in median willingness were significant for youth who scored as more competent versus those who scored as less competent (p < 0.001). There were no characteristics that moderated the association of competency with willingness. CONCLUSION: Youth peer educator programs hold promise for disseminating improved G Χ E literacy and reducing stigma associated with deterministic misunderstandings. Thoughtful recruitment and training strategies will be needed to ensure that the broadest representation of youth in LMIC contexts has the opportunity to serve in this role, particularly girls and those without formal education.

Effects of pair housing on behavior, cortisol, and clinical outcomes during quarantine-like procedures for rhesus macaques (Macaca mulatta).

BACKGROUND: Compatible pair housing of macaques in research settings increases species-typical behaviors and facilitates beneficial social buffering. It is not yet established whether these benefits are maintained after intrafacility transfer and domestic quarantine, which are two stressors that can lead to behavioral and clinical abnormalities. METHODS: We evaluated 40 adolescent male rhesus macaques who were single- or pair-housed immediately following an intrafacility transfer. We measured behavior, fecal cortisol, body weight, and diarrhea occurrence. Body weight and diarrhea occurrence were also retrospectively analyzed in an additional 120 adolescent rhesus who underwent a similar transfer. RESULTS AND CONCLUSIONS: Pair-housed macaques exhibited less of some undesirable behaviors (e.g., self-clasping) and experienced less diarrhea than single-housed subjects; however, no significant differences in cortisol levels or alopecia measures were found. The demonstrated beneficial effects of pair housing for rhesus macaques following intrafacility transfer and adjustment suggest pairing upon arrival at a new facility will bolster animal welfare.

Extreme racism-related events and poor sleep in African-American women.

RATIONALE: Much of the research linking racism-related stressors to poor health has focused on fairly non-violent forms of racism that directly impact individuals under study. Exposure to particularly extreme and/or violent racist events are increasingly visible via smartphone recordings and social media, with consistent anecdotal reports of the effects of seeing and hearing about these events on sleep among minorities who racially identify with the victims. OBJECTIVE: This study examines whether exposure to direct and vicarious racism-related events (RREs), including more extreme events, are associated with sleep quality. Additionally, we examine effects of less and more violent direct RREs and vicarious RREs witnessed in person and via social media. METHODS: Among 422 African-American women, we assessed exposure to RREs using a modified version of the Race-Related Events Scale and assessed sleep quality using the Pittsburgh Sleep Quality Index (PSQI). Linear regression analyses were used to model continuous global sleep. RESULTS: Direct (ß = 0.24 [95% CI: 0.13, 0.35]) RREs were associated with worse continuous global sleep quality scores in analyses adjusted for sociodemographics and risk factors for poor sleep. More violent direct RREs (ß = 0.59 [95% CI: 0.30, 0.89]) had stronger associations with poor sleep quality than less violent direct RREs (ß = 0.25 [95% CI: 0.11, 0.40]). Vicarious RREs overall (ß = 0.04 [95% CI: 0.14, 0.21]) and those witnessed via social media (ß = -0.07 [95% CI: 0.29, 0.14]) were not associated with global sleep quality; conversely, vicarious RREs witnessed in person were (ß = 0.52 [95% CI: 0.21, 0.83]). CONCLUSION: Extreme, direct experiences of racism, particularly those that are violent in nature, are associated with poor sleep quality. However, extreme vicarious experiences are not-- unless witnessed in person.

Tracheostomies of Patients With COVID-19: A Survey of Infection Reported by Health Care Professionals.

BACKGROUND: Health care professionals (HCPs) performing tracheostomies in patients with COVID-19 may be at increased risk of infection. OBJECTIVE: To evaluate factors underlying HCPs' COVID-19 infection and determine whether tracheostomy providers report increased rates of infection. METHODS: An anonymous international survey examining factors associated with COVID-19 infection was made available November 2020 through July 2021 to HCPs at a convenience sample of hospitals, universities, and professional organizations. Infections reported were compared between HCPs involved in tracheostomy on patients with COVID-19 and HCPs who were not involved. RESULTS: Of the 361 respondents (from 33 countries), 50% (n = 179) had performed tracheostomies on patients with COVID-19. Performing tracheostomies on patients with COVID-19 was not associated with increased infection in either univariable (P = .06) or multivariable analysis (odds ratio, 1.48; 95% CI, 0.90-2.46; P = .13). Working in a low- or middle-income country (LMIC) was associated with increased infection in both univariable (P < .001) and multivariable analysis (odds ratio, 2.88; CI, 1.50-5.53; P = .001). CONCLUSIONS: Performing tracheostomy was not associated with COVID-19 infection, suggesting that tracheostomies can be safely performed in infected patients with appropriate precautions. However, HCPs in LMICs may face increased infection risk.

Gendered Racial Microaggressions and Black Women's Sleep Health.

Gendered racial microaggressions reflect historical and contemporary gendered racism that Black women encounter. Although gendered racial microaggressions are related to psychological outcomes, it is unclear if such experiences are related to sleep health. Moreover, the health effects of gendered racial microaggressions dimensions are rarely investigated. Using a cohort of Black women (N = 400), this study employs an intracategorical intersectional approach to (1) investigate the association between gendered racial microaggressions and sleep health, (2) assess whether gendered racial microaggressions dimensions are related to sleep health, and (3) examine whether the gendered racial microaggressions-sleep health association persists after accounting for depressive symptoms and worry. Gendered racial microaggressions were associated with poor sleep quality overall and four specific domains: subjective sleep quality, latency, disturbance, and daytime sleepiness. Two gendered racial microaggressions dimensions were especially detrimental for sleep: assumptions of beauty/sexual objectification and feeling silenced and marginalized. After accounting for mental health, the effect of gendered racial microaggressions on sleep was reduced by 47 percent. Future research implications are discussed.

Monitoring Multiple U.S. Government-Supported Covid-19 Vaccine Trials.

Monitoring U.S. Government-Supported Covid-19 Vaccine TrialsOperation Warp Speed was a partnership created to accelerate the development of Covid-19 vaccines. The National Institutes of Health oversaw one data and safety monitoring board to review/monitor all Operation Warp Speed trials. This article describes the challenges faced in monitoring these trials and provides ideas for future similar endeavors.

Safety and biomarker effects of candesartan in non-hypertensive adults with prodromal Alzheimer's disease.

Observational studies suggest that angiotensin receptor blockers in hypertensive adults are associated with lower post-mortem indicators of Alzheimer's disease pathology. Candesartan, an angiotensin receptor blocker, has a positive cognitive effect in mild cognitive impairment with hypertension. However, its safety and effects in non-hypertensive individuals with Alzheimer's disease are unclear. This is the first double-blind randomized placebo-controlled trial aimed to assess safety and effects of 1-year therapy of candesartan on biomarkers and clinical indicators of Alzheimer's disease in non-hypertensive individuals with biomarker-confirmed prodromal Alzheimer's disease. Seventy-seven non-hypertensive participants 50 years or older (mean age: 68.1 years; 62% women; 20% African American) with mild cognitive impairment and biomarker confirmed Alzheimer's disease were randomized to escalating doses of once daily oral candesartan (up to 32 mg) or matched placebo. Main outcomes included safety and tolerability of candesartan, cerebrospinal fluid biomarkers (amyloid-ß42, amyloid-ß40, total tau and phospho-tau). Additional exploratory outcomes included PET imaging (Pittsburgh Compound-B (11C-PiB) and 18F-flortaucipir), brain MRI (structural and connectivity measures) and cognitive functioning. Analyses used intention-to-treat approach with group comparisons of safety measures using Chi-square test, and repeated measures mixed effects models were used to assess candesartan effects on main and exploratory outcomes (ClinicalTrials.gov, NCT02646982). Candesartan was found to be safe with no significant difference in safety measures: symptoms of hypotension, renal failure or hyperkalemia. Candesartan was also found to be associated with increases in cerebrospinal fluid Aß40 (between-group mean difference: 1211.95 pg/ml, 95% confidence interval: 313.27, 2110.63) and Aß42 (49.51 pg/ml, 95% confidence interval: -98.05, -0.98) reflecting lower brain amyloid accumulation. Candesartan was associated with decreased 11C-PiB in the parahippocampal region (-0.1104, 95% confidence interval: -0.19, -0.029) which remained significant after false discovery rate correction, and with an increase in functional network connectivity in the subcortical networks. Candesartan was further associated with improved executive function (Trail Making Test Part B) performance (-11.41 s, 95% confidence interval: -11.94, -10.89) and trended for an improved global cognitive functioning reflected by a composite cognitive score (0.002, 95% confidence interval: -0.0002, 0.005). We did not observe significant effects on tau levels, hippocampal volume or other cognitive measures (memory or clinical dementia rating scale-sum of boxes). In conclusion, among non-hypertensive prodromal Alzheimer's disease, candesartan is safe and likely decreases brain amyloid biomarkers, enhances subcortical brain connectivity and has favourable cognitive effects. These findings suggest that candesartan may have an important therapeutic role in Alzheimer's disease, and warrant further investigation given the lack of clear treatment options for this devastating illness.

Extreme racism-related events and poor sleep in African-American women.

RATIONALE: Much of the research linking racism-related stressors to poor health has focused on fairly non-violent forms of racism that directly impact individuals under study. Exposure to particularly extreme and/or violent racist events are increasingly visible via smartphone recordings and social media, with consistent anecdotal reports of the effects of seeing and hearing about these events on sleep among minorities who racially identify with the victims. OBJECTIVE: This study examines whether exposure to direct and vicarious racism-related events (RREs), including more extreme events, are associated with sleep quality. Additionally, we examine effects of less and more violent direct RREs and vicarious RREs witnessed in person and via social media. METHODS: Among 422 African-American women, we assessed exposure to RREs using a modified version of the Race-Related Events Scale and assessed sleep quality using the Pittsburgh Sleep Quality Index (PSQI). Linear regression analyses were used to model continuous global sleep. RESULTS: Direct (ß = 0.24 [95% CI: 0.13, 0.35]) RREs were associated with worse continuous global sleep quality scores in analyses adjusted for sociodemographics and risk factors for poor sleep. More violent direct RREs (ß = 0.59 [95% CI: 0.30, 0.89]) had stronger associations with poor sleep quality than less violent direct RREs (ß = 0.25 [95% CI: 0.11, 0.40]). Vicarious RREs overall (ß = 0.04 [95% CI: 0.14, 0.21]) and those witnessed via social media (ß = -0.07 [95% CI: 0.29, 0.14]) were not associated with global sleep quality; conversely, vicarious RREs witnessed in person were (ß = 0.52 [95% CI: 0.21, 0.83]). CONCLUSION: Extreme, direct experiences of racism, particularly those that are violent in nature, are associated with poor sleep quality. However, extreme vicarious experiences are not-- unless witnessed in person.

Nested and multipart prospective observational studies, flaming fiasco or efficiently economical?: The Brain, Bone, Heart case study.

BACKGROUND: Collecting new data from cross-sectional/survey and cohort observational study designs can be expensive and time-consuming. Nested (hierarchically cocooned within an existing parent study) and/or Multipart (≥ 2 integrally interlinked projects) study designs can expand the scope of a prospective observational research program beyond what might otherwise be possible with available funding and personnel. The Brain, Bone, Heart (BBH) study provides an exemplary case to describe the real-world advantages, challenges, considerations, and insights from these complex designs. MAIN: BBH is a Nested, Multipart study conducted by the Specialized Center for Research Excellence (SCORE) on Sex Differences at Emory University. BBH is designed to examine whether estrogen insufficiency-induced inflammation compounds HIV-induced inflammation, leading to end-organ damage and aging-related co-morbidities affecting the neuro-hypothalamic-pituitary-adrenal axis (brain), musculoskeletal (bone), and cardiovascular (heart) organ systems. Using BBH as a real-world case study, we describe the advantages and challenges of Nested and Multipart prospective cohort study design in practice. While excessive dependence on its parent study can pose challenges in a Nested study, there are significant advantages to the study design as well. These include the ability to leverage a parent study's resources and personnel; more comprehensive data collection and data sharing options; a broadened community of researchers for collaboration; dedicated longitudinal research participants; and, access to historical data. Multipart, interlinked studies that share a common cohort of participants and pool of resources have the advantage of dedicated key personnel and the challenge of increased organizational complexity. Important considerations for each study design include the stability and administration of the parent study (Nested) and the cohesiveness of linkage elements and staff organizational capacity (Multipart). CONCLUSION: Using the experience of BBH as an example, Nested and/or Multipart study designs have both distinct advantages and potential vulnerabilities that warrant consideration and require strong biostatistics and data management leadership to optimize programmatic success and impact.

Profiling of hMPV F-specific antibodies isolated from human memory B cells.

Human metapneumovirus (hMPV) belongs to the Pneumoviridae family and is closely related to respiratory syncytial virus (RSV). The surface fusion (F) glycoprotein mediates viral fusion and is the primary target of neutralizing antibodies against hMPV. Here we report 113 hMPV-F specific monoclonal antibodies (mAbs) isolated from memory B cells of human donors. We characterize the antibodies' germline usage, epitopes, neutralization potencies, and binding specificities. We find that unlike RSV-F specific mAbs, antibody responses to hMPV F are less dominant against the apex of the antigen, and the majority of the potent neutralizing mAbs recognize epitopes on the side of hMPV F. Furthermore, neutralizing epitopes that differ from previously defined antigenic sites on RSV F are identified, and multiple binding modes of site V and II mAbs are discovered. Interestingly, mAbs that bind preferentially to the unprocessed prefusion F show poor neutralization potency. These results elucidate the immune recognition of hMPV infection and provide novel insights for future hMPV antibody and vaccine development.

Implementation of an EMS protocol to improve prehospital sepsis recognition.

PURPOSE: Optimal sepsis outcomes are achieved when sepsis is recognized early. Recognizing sepsis in the prehospital, EMS setting can be challenging and unreliable. The purpose of this study is to evaluate whether implementation of an EMS sepsis screening and prehospital alert protocol called PRESS (PREhospital SepsiS) is associated with improved sepsis recognition by EMS providers. DESIGN: We conducted a 12-month, before-after implementation study of the PRESS protocol in a large, public EMS system. The study intervention was a PRESS training program delivered to EMS providers. EMS patient inclusion criteria included: age ≥ 18 years, EMS systolic blood pressure < 110 mmHg, EMS heart rate > 90 bpm, and EMS respiratory rate > 20 bpm. Study exclusion criteria included the presence of any of following EMS conditions: trauma, cardiac arrest, pregnancy, toxic ingestion, or psychiatric emergency. Retrospective chart review was performed on all eligible EMS encounters during the study period. The primary outcome variable was the proportion of patients with sepsis who were identified by EMS providers. RESULTS: Approximately 300 EMS providers were trained to use PRESS. A total of 498 patient encounters met criteria for study inclusion; 222 were excluded, primarily due to trauma. A total of 276 patient encounters were analyzed. Sepsis recognition by EMS providers increased from 12% pre-PRESS protocol to 59% post-PRESS protocol (p < 0.001). In a post-hoc analysis of the post-PRESS cohort, septic patients who were identified by EMS received antibiotics 24 min faster than septic patients who were not identified by EMS [28 min (IQR 18-48) vs 52 (IQR 27-98), respectively, p = 0.021]. CONCLUSION: Implementation of an EMS sepsis screening and prehospital alert protocol was associated with an increase in sepsis recognition rates by EMS providers and a decrease in time to first antibiotic administration in the emergency department. Further studies are needed to evaluate the impact of this protocol in other populations.