Examining Community Engagement Research Strategies Used in Flint, Michigan: The Church Challenge.

BACKGROUND: The ways in which researchers may need to adapt traditional community-based participatory research engagement strategies during ongoing community trauma are understudied. We describe our efforts to engage the Flint, Michigan community in community-based participatory research in the aftermath of the Flint Water Crisis. OBJECTIVES: This manuscript describes 1) recruitment strategies selected before the Flint Water Crisis, 2) engagement lessons learned in the context of the Flint Water Crisis, and 3) barriers and facilitators encountered while engaging African American churches. METHODS: Researchers collaborated with community partners to engage and recruit a traumatized Flint community into the Church Challenge, a multilevel intervention to reduce chronic disease burden. LESSONS LEARNED: Recruitment and engagement strategies must be flexible, innovative, and may require nontraditional methods. CONCLUSIONS: Flexibility and adaptability are crucial for engaging with a traumatized community. Community-based participatory research work in traumatized communities must acknowledge and respond to community trauma to be successful.

Community- vs. hospital-based management of multidrug-resistant TB in Pakistan.

BACKGROUND Multidrug-resistant TB (MDR-TB) treatment takes 18-24 months and is complex, costly and isolating. We provide trial evidence on the WHO Pakistan recommendation for community-based care rather than hospital-based care.METHODS Two-arm, parallel-group, superiority trial was conducted in three programmatic management of drug-resistant TB hospitals in Punjab and Sindh Provinces, Pakistan. We enrolled 425 patients with MDR-TB aged >15 years through block randomisation in community-based care (1-week hospitalisation) or hospital-based care (2 months hospitalisation). Primary outcome was treatment success.RESULTS Among 425 patients with MDR-TB, 217 were allocated to community-based care and 208 to hospital-based care. Baseline characteristics were similar between the community and hospitalised arms, as well as in selected sites. Treatment success was 74.2% (161/217) under community-based care and 67.8% (141/208) under hospital-based care, giving a covariate-adjusted risk difference (community vs. hospital model) of 0.06 (95% CI -0.02 to 0.15; P = 0.144).CONCLUSIONS We found no clear evidence that community-based care was more or less effective than hospital-based care model. Given the other substantial advantages of community-based care over hospital based (e.g., more patient-friendly and accessible, with lower treatment costs), this supports the adoption of the community-based care model, as recommended by the WHO.

Exploring the Readiness of African-American Churches to Engage in a Community-Engaged Blood Pressure Reduction Research Study: Lessons Learned from the Church Challenge.

Introduction: The Transtheoretical Model (TTM) has been used to assess individual readiness for health behavior change. We describe our use of the TTM to assess organizational readiness of African-American churches to participate in the Church Challenge (CC) in Flint, Michigan; the processes of change that moved churches toward readiness for change; and lessons learned. Methods: The CC was a faith-based, multilevel intervention to reduce chronic disease risk. A community-based participatory approach was used to engage and recruit churches. We used the TTM to capture church readiness for change and track church progress through the five stages. Results: We engaged with 70 churches: 35 remained in Stage 1 (precontemplation), 10 remained in Stage 2 (contemplation), 3 remained in Stage 3 (preparation), 5 made it to Stage 4 (action), and 17 finished within Stage 5 (maintenance). Churches engaged in several processes of change as they moved through the various stages of change. Lessons Learned: Utilizing processes of change, establishing rapport, and having previous participants share success stories helped move churches from stage-to-stage. However, certain barriers prevented progression, such as burnout/trauma from the Flint Water Crisis and scheduling conflicts. Discussion: Faith-based organizational readiness greatly impacted participation in the CC. Researchers should utilize established social capital, build rapport, and remain flexible when working with African-American churches. Conclusion: Although traditionally used at the individual level, the TTM works well at the organizational level to assess and monitor church readiness to participate in community-engaged research and health programming to improve health in an African-American faith community.

Maternal Serum Antioxidants in Mid Pregnancy and Risk of Preterm Delivery and Small for Gestational Age Birth: Results from a Prospective Pregnancy Cohort.

Background: Preterm delivery (PTD) and poor fetal growth are major contributors to neonatal mortality and morbidity that can extend from birth onward. Although overt maternal nutrient deficiencies are associated with adverse pregnancy outcomes, such deficiencies are rare in developed countries. However, some evidence suggests that even within the normal range, higher levels of antioxidant nutrients are protective against adverse pregnancy outcomes. Materials and Methods: Using data from the prospective Pregnancy Outcomes and Community Health (POUCH) Study (n = 301 preterm; n = 246 term), we examined associations between maternal blood levels of selected antioxidants and pregnancy outcomes. Serum collected at 16-27 weeks' gestation was analyzed for carotenoids, retinol, and α- and γ-tocopherol. Using weighted polytomous regression, these nutrient concentrations were assessed in relation to (1) PTD (<37 weeks gestation) overall and grouped as spontaneous or medically indicated; and (2) small for gestational age (SGA) defined as birthweight-for-gestational age <10th percentile of a national reference population. Results: Women with total serum carotenoids in the upper quartile (Q4) had significantly lower odds of medically indicated PTD compared with women in the lower quartiles (Q1-Q3) even after adjustment for maternal characteristics (aOR = 0.4; 95% CI: 0.2-0.9). Odds ratios for SGA were consistently ≤0.5 among women with any of the serum nutrients in Q4 as compared with Q1-Q3, but final models did not reach statistical significance. Conclusion: Results support the possibility that high maternal serum antioxidants and/or the larger dietary or lifestyle pattern they represent may play a protective role in preventing adverse pregnancy outcomes.

Cultivating diversity as an ethos with an anti-racism approach in the scientific enterprise.

The diversity of the U.S. population is currently not reflected in the genomic workforce and across the greater scientific enterprise. Although diversity and inclusion efforts have focused on increasing the number of individuals from underrepresented groups across scientific fields, structural racism remains. Thus, the cultivation and adoption of diversity as an ethos requires shifting our focus to being intentional about an institution's character, culture, and climate. One way for this ethos to be sustained is by facilitating an intentional anti-racism approach within the field. Adopting a new perspective on diversity utilizing an anti-racism approach will support genomics researchers as we build supportive, collaborative research environments. We seek to expand critical thought in the framing of diversity in the research enterprise and propose an anti-racism approach that informs deliberate actions required to address structural racism.

Education, perceived discrimination and risk for depression in a southern black cohort.

Objectives: Assess whether education moderates associations between discrimination and depression risk within a southern Black/African American cohort in a labor market shifting from manufacturing and farming to education-intensive industries, such as health care and technology.Methods: Data are from the Pitt County (NC) Study (n = 1154) collected in 2001. Depression risk was assessed with the Center for Epidemiologic Study-Depression (CES-D) scale. Discrimination was measured using a subset from the Everyday Discrimination Scale. Education was categorized as completion of less than high school (HS), HS/GED (General Educational Development), or any college.Results: Completing any college mitigated the association between discrimination and CES-D among men (b = -1.33, 95% CI = -2.56, -0.09) but not women (b = -0.19, 95% CI = -1.36, 0.98).Conclusions: Education is protective for depression risk related to discrimination for men but not women. Recent macroeconomic changes placed a premium on higher levels of education in 2018, as in the 1990s. Because racial discrimination remains a stressor in the everyday lives of African Americans regardless of education level, the health benefits of higher education for working-aged African Americans in shifting labor markets warrants further investigation.

Glycemic Control in Hospitalized Patients with Diabetes Receiving Corticosteroids Using a Neutral Protamine Hagedorn Insulin Protocol: A Randomized Clinical Trial.

INTRODUCTION: Hospitalized patients with diabetes receiving corticosteroids are at risk of developing hyperglycemia and related complications. This study evaluated a neutral protamine Hagedorn (NPH) insulin-based protocol in improving glycemic control in hospitalized patients receiving corticosteroids. METHODS: This was a randomized, prospective, non-blinded study in an inpatient setting involving patients with diabetes who were hospitalized and receiving prednisone ≥ 10 mg per day or equivalent. High dose corticosteroids group (prednisone > 40 mg/day or equivalent) received NPH insulin 0.3 U/kg between 0600 and 2000 hours if eating or 0.2 U/kg between 2000 and 0600 hours if not eating. Low dose corticosteroids group (prednisone 10-40 mg/day or equivalent) received 0.15 U/kg between 0600 and 2000 hours if eating or 0.1 U/kg between 2000 and 0600 hours if not eating. Primary outcome measure was mean blood glucose level measured pre-meal and at bedtime for days 1-5. RESULTS: Mean blood glucose level was lower in the intervention (n = 29) than in the usual care (n = 31) group [226.12 vs. 268.57 mg/dL, respectively, (95% CI for difference - 63.195 to - 21.695), p < 0.0001]. Significant differences in mean glucose level were noted at fasting [170.96 vs. 221.13 mg/dL, respectively, (95% CI for difference - 72.70 to - 27.63), p < 0.0001] and pre-lunch [208 vs. 266.48 mg/dL, respectively, (95% CI for difference - 86.61 to - 30.36), p < 0.0001]. CONCLUSION: In hospitalized patients with diabetes receiving corticosteroids, an NPH insulin-based protocol improves glycemic control. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01970241. FUNDING: Eli Lilly and Company.

Secular trends of Streptococcus pyogenes sepsis in Pakistan and analysis of clinical features in a hospitalized cohort.

Streptococcus pyogenes or Group A Streptococcus (GAS) is a re-emerging pathogen of significant public health importance. We present trends in GAS blood cultures over a 10 year period in Pakistan and characteristics of hospitalized patients with GAS sepsis over three years at a tertiary care hospital in Karachi, Pakistan. Blood cultures positive for GAS from 2004 -2014 were recorded at the clinical microbiology laboratory of the Aga Khan University and studied for trends in positivity rates. Medical records of patients hospitalized at the Aga Khan University hospital from 2012-2014 were also examined for clinical features and outcomes. GAS trends show a steady rate of blood culture positivity over 11 years, with higher rates in those >50 years, and seasonality favouring winter months. Case fatality rate in the hospitalized cohort was 34.1% (n= 14; of 41 patients). Malignancy predominated as the underlying predisposing factor among the 15-49 age group. Presence of sepsis was an independent predictor of mortality in GAS bacteremia. Studies of GAS trends in developing regions are important to inform changing epidemiology. GAS septic shock continues to have high case fatality despite antibiotic treatment. Early recognition, aggressive, goal-directed therapy for sepsis and prevention are possible control measures to prevent high mortality.

Effects of Vitamin D Supplementation on C-peptide and 25-hydroxyvitamin D Concentrations at 3 and 6 Months.

The link between African-Americans' disproportionate rates of diabetes, obesity and vitamin D deficiency may be marked by C-peptide as an indicator of insulin secretion. We hypothesize that vitamin D supplementation will increase C-peptide, a marker of insulin secretion. During 3 winters from 2007-2010, 328 healthy African-Americans (median age, 51 years) living in Boston, MA were randomized into a 4-arm, double-blind trial for 3 months of placebo, 1000, 2000, or 4000 IU of vitamin D3. The differences in non-fasting C-peptide between baseline and 3 months were -0.44 ng/mL for those receiving placebo, -0.10 ng/mL for those receiving 1000 IU/d, 0 ng/mL for those receiving 2000 IU/d, 1.24 ng/mL for those receiving 4000 IU/d (C-peptide increased 0.42 ng/mL for each additional 1000 IU/d of vitamin D3, p < 0.001). Vitamin D supplementation increased C-peptide in overweight African-Americans and may be compatible with other recommendations for diabetes prevention and management including weight loss and increased physical activity.

Reduction of Parathyroid Hormone with Vitamin D Supplementation in Blacks: A Randomized Controlled Trial.

BACKGROUND: Response of parathyroid hormone (PTH) to vitamin D supplementation is determined by the baseline PTH level and change in vitamin D status. Conflicting reports in Blacks exist on the PTH response to vitamin D to supplementation. METHODS: During 3 winters from 2007-2010, 328 healthy Blacks (median age, 51 years) living in Boston, MA were randomized into a 4-arm, double-blind trial for 3 months of placebo, 1000, 2000, or 4000 IU of vitamin D3. PTH was measured in 254 participants at baseline and at the end of vitamin D supplementation period. RESULTS: The differences in PTH between baseline and 3 months were 3.93 pg/mL for those receiving placebo, -3.37 pg/mL for those receiving 1000 IU/d, -6.76 pg/mL for those receiving 2000 IU/d, and -8.99 pg/mL for those receiving 4000 IU/d ( -2.98 pg/mL for each additional 1000 IU/d of vitamin D3; p<0.001). CONCLUSION: We found a significant decrease in PTH with increasing doses of vitamin D supplementation up to intakes of 4000 IU/d in Blacks. Clinical Trials.gov: NCT00585637.

Null association between vitamin D and PSA levels among black men in a vitamin D supplementation trial.

BACKGROUND: Black men exhibit a high prevalence of vitamin D deficiency as well as a higher incidence of prostate cancer and higher mortality rates from prostate cancer than Whites. There are few data about the effect of vitamin D3 (cholecalciferol) supplementation on prostate-specific antigen (PSA) in healthy Black men. METHODS: During three winters from 2007 to 2010, 105 Black men (median age, 48.9 years) of Boston, MA were randomized into a four-arm, double-blind trial for 3 months of placebo, 1,000, 2,000, or 4,000 U of vitamin D3. At baseline and 3 months, free and total PSA was measured. RESULTS: With vitamin D supplementation, no significant differences in free and total PSA were observed; free PSA, -0.0004 ng/mL (P = 0.94) and total PSA, -0.004 ng/mL (P = 0.92) for each additional 1,000 U/d of vitamin D3. CONCLUSION: Within an unselected population of healthy Black men without a cancer diagnosis, we found no effect of vitamin D supplementation on free or total PSA. IMPACT: These findings support prior findings of no change in PSA with vitamin D supplementation and emphasize the need for new methods to assess the influence of vitamin D supplementation on prostate cancer prevention.

Risk of hypercalcemia in blacks taking hydrochlorothiazide and vitamin D.

INTRODUCTION: Hydrochlorothiazide, an effective antihypertensive medication commonly prescribed to blacks, decreases urinary calcium excretion. Blacks have significantly higher rates of hypertension and lower levels of 25-hydroxyvitamin D. Thus, they are more likely to be exposed to vitamin D supplementation and thiazide diuretics. The risk for hypercalcemia among blacks using vitamin D and hydrochlorothiazide is undefined. METHODS: We assessed the frequency of hypercalcemia in hydrochlorothiazide users in a post hoc analysis of a randomized, double-blind, dose-finding trial of 328 blacks (median age 51 years) assigned to either placebo, or 1000, 2000, or 4000 international units of cholecalciferol (vitamin D3) daily for 3 months during the winter (2007-2010). RESULTS: Of the 328 participants, 84 reported hydrochlorothiazide use and had serum calcium levels assessed. Additionally, a comparison convenience group of 44 enrolled participants who were not taking hydrochlorothiazide had serum calcium measurements at 3 months, but not at baseline. At 3 months, hydrochlorothiazide participants had higher calcium levels (0.2 mg/dL, P <.001) than nonhydrochlorothiazide participants, but only one participant in the hydrochlorothiazide group had hypercalcemia. In contrast, none of the nonhydrochlorothiazide participants had hypercalcemia. In a linear regression model adjusted for age, sex, 25-hydroxyvitamin D at 3 months, and other covariates, only hydrochlorothiazide use (Estimate [SE]: 0.05 [0.01], P = .01) predicted serum calcium at 3 months. CONCLUSION: In summary, vitamin D3 supplementation up to 4000 IU in hydrochlorothiazide users is associated with an increase in serum calcium but a low frequency of hypercalcemia. These findings suggest that participants of this population can use hydrochlorothiazide with up to 4000 IU of vitamin D3 daily and experience a low frequency of hypercalcemia.

Impact of vitamin D supplementation on inflammatory markers in African Americans: results of a four-arm, randomized, placebo-controlled trial.

African Americans have a disproportionate burden of inflammation-associated chronic diseases such as cancer and lower circulating levels of 25-hydroxyvitamin D [25(OH)D]. The effect of vitamin D3 (cholecalciferol) supplementation on inflammatory markers is uncertain. We conducted a randomized, double-blind, placebo-controlled trial of supplemental oral vitamin D (placebo, 1,000, 2,000, or 4,000 IU/day of vitamin D3 orally for 3 months) in 328 African Americans (median age, 51 years) of public housing communities in Boston, MA, who were enrolled over three consecutive winter periods (2007-2010). Change from 0 to 3 months of plasma levels of 25(OH)D, high-sensitivity C-reactive protein (CRP), interleukin (IL)-6, IL-10, and soluble TNF-α receptor type 2 (sTNF-R2) in 292 (89%) participants were measured. Overall, no statistically significant changes in CRP, IL-6, IL-10, and sTNF-R2 were observed after the vitamin D supplementation period. Baseline CRP was significantly inversely associated with the baseline 25(OH)D level (P < 0.001) in unadjusted and adjusted models. An interaction between baseline 25(OH)D and vitamin D supplementation was observed for outcome change in log CRP (month 3-month 0; P for interaction = 0.04). Within an unselected population of African Americans, short-term exposure to vitamin D supplementation produced no change in circulating inflammatory markers. This study confirms the strong independent association of CRP with 25(OH)D status even after adjusting for body mass index. Future studies of longer supplemental vitamin D3 duration are necessary to examine the complex influence of vitamin D3 on CRP and other chronic inflammatory cytokines for possible reduction of cancer health disparities in African Americans.

Dose response to vitamin D supplementation in African Americans: results of a 4-arm, randomized, placebo-controlled trial.

BACKGROUND: Association studies have suggested that lower circulating 25-hydroxyvitamin D [25(OH)D] in African Americans may partially underlie higher rates of cardiovascular disease and cancer in this population. Nonetheless, the relation between vitamin D supplementation and 25(OH)D concentrations in African Americans remains undefined. OBJECTIVE: Our primary objective was to determine the dose-response relation between vitamin D and plasma 25(OH)D. DESIGN: A total of 328 African Americans in Boston, MA, were enrolled over 3 winters from 2007 to 2010 and randomly assigned to receive a placebo or 1000, 2000, or 4000 IU vitamin D3/d for 3 mo. Subjects completed sociodemographic and dietary questionnaires, and plasma samples were drawn at baseline and 3 and 6 mo. RESULTS: Median plasma 25(OH)D concentrations at baseline were 15.1, 16.2, 13.9, and 15.7 ng/mL for subjects randomly assigned to receive the placebo or 1000, 2000, or 4000 IU/d, respectively (P = 0.63). The median plasma 25(OH)D concentration at 3 mo differed significantly between supplementation arms at 13.7, 29.7, 34.8, and 45.9 ng/mL, respectively (P < 0.001). An estimated 1640 IU vitamin D3/d was needed to raise the plasma 25(OH)D concentration to ≥ 20 ng/mL in ≥ 97.5% of participants, whereas a dose of 4000 IU/d was needed to achieve concentrations ≥ 33 ng/mL in ≥ 80% of subjects. No significant hypercalcemia was seen in a subset of participants. CONCLUSIONS: Within African Americans, an estimated 1640 IU vitamin D3/d was required to achieve concentrations of plasma 25(OH)D recommended by the Institute of Medicine, whereas 4000 IU/d was needed to reach concentrations predicted to reduce cancer and cardiovascular disease risk in prospective observational studies. These results may be helpful for informing future trials of disease prevention.

Effect of vitamin D supplementation on blood pressure in blacks.

Blacks have significantly higher rates of hypertension than whites, and lower circulating levels of 25-hydroxyvitamin D. There are few data about the effect of vitamin D3 (cholecalciferol) supplementation on blood pressure in blacks. During 2 winters from 2008 to 2010, 283 blacks (median age, 51 years) were randomized into a 4-arm, double-blind trial for 3 months of placebo, 1000, 2000, or 4000 international units of cholecalciferol per day. At baseline, 3 months, and 6 months, systolic and diastolic pressure and 25-hydroxyvitamin D were measured. The 3-month follow-up was completed in 250 (88%) participants. The difference in systolic pressure between baseline and 3 months was +1.7 mm Hg for those receiving placebo, -0.66 mm Hg for 1000 U/d, -3.4 mm Hg for 2000 U/d, and -4.0 mm Hg for 4000 U/d of cholecalciferol (-1.4 mm Hg for each additional 1000 U/d of cholecalciferol; P=0.04). For each 1-ng/mL increase in plasma 25-hydroxyvitamin D, there was a significant 0.2-mm Hg reduction in systolic pressure (P=0.02). There was no effect of cholecalciferol supplementation on diastolic pressure (P=0.37). Within an unselected population of blacks, 3 months of oral vitamin D3 supplementation significantly, yet modestly, lowered systolic pressure. Future trials of vitamin D supplementation on blood pressure are needed to confirm these promising results, particularly among blacks, a population for whom vitamin D deficiency may play a more specific mechanistic role in the pathogenesis of hypertension.

Vascular closure devices in acute coronary syndromes: from arbitrary to a necessity?

Vascular closure devices (VCDs) were initially developed to improve access site hemostasis and allow for earlier ambulation in patients undergoing diagnostic catheterization and percutaneous coronary intervention (PCI). Though initially thought to be beneficial, large meta-analysis has shown conflicting data regarding whether VCDs alter access site bleeding in a variety of clinical settings. One area of particular interest for the adoption of VCDs has been in the setting of acute coronary syndromes (ACS) in which multiple antiplatelet strategies are often employed leading to a high risk of bleeding. Bleeding in ACS has been shown to be a powerful independent predictor of 30-day mortality. Recently, investigators have reported that VCDs reduce access site bleeding in the setting of ACS. In our review, we use several selected representative clinical trials to provide a historical account for the use of VCDs. We also provide for a review of data as it relates to access site bleeding in ACS along with analysis showing that VCDs may potentially provide for reductions in bleeding and vascular complications in patients with ACS undergoing PCI.

Micronutrient deficiencies an unmet need in heart failure.

Heart failure (HF) is a common, disabling, and costly disease. Despite major advances in medical therapy, morbidity and mortality remain high, in part because current pharmacological regimens may not fully address some unique requirements of the heart for energy. The heart requires a continuous supply of energy-providing substrates and amino acids in order to maintain its function. In HF, defects in substrate metabolism and cardiac energy and substrate utilization may contribute to contractile dysfunction. HF is often accompanied by a deficiency in key micronutrients required for unimpeded energy transfer. Correcting these deficits has been proposed as a method to limit or even reverse the progressive myocyte dysfunction and/or necrosis in HF. This review summarizes the existing HF literature with respect to supplementation trials of key micronutrients involved in cardiac metabolism: coenzyme Q10, l-carnitine, thiamine, and amino acids, including taurine. Studies using a broader approach to supplementation are also considered. Although some of the results are promising, none are conclusive. There is a need for a prospective trial to examine the effects of micronutrient supplementation on morbidity and mortality in patients with HF.