Cost-Effectiveness of Hypertension Treatment by Pharmacists in Black Barbershops.

BACKGROUND: In LABBPS (Los Angeles Barbershop Blood Pressure Study), pharmacist-led hypertension care in Los Angeles County Black-owned barbershops significantly improved blood pressure control in non-Hispanic Black men with uncontrolled hypertension at baseline. In this analysis, 10-year health outcomes and health care costs of 1 year of the LABBPS intervention versus control are projected. METHODS: A discrete event simulation of hypertension care processes projected blood pressure, medication-related adverse events, fatal and nonfatal cardiovascular disease events, and noncardiovascular disease death in LABBPS participants. Program costs, total direct health care costs (2019 US dollars), and quality-adjusted life-years (QALYs) were estimated for the LABBPS intervention and control arms from a health care sector perspective over a 10-year horizon. Future costs and QALYs were discounted 3% annually. High and intermediate cost-effectiveness thresholds were defined as <$50 000 and <$150 000 per QALY gained, respectively. RESULTS: At 10 years, the intervention was projected to cost an average of $2356 (95% uncertainty interval, -$264 to $4611) more per participant than the control arm and gain 0.06 (95% uncertainty interval, 0.01-0.10) QALYs. The LABBPS intervention was highly cost-effective, with a mean cost of $42 717 per QALY gained (58% probability of being highly and 96% of being at least intermediately cost-effective). Exclusive use of generic drugs improved the cost-effectiveness to $17 162 per QALY gained. The LABBPS intervention would be only intermediately cost-effective if pharmacists were less likely to intensify antihypertensive medications when systolic blood pressure was ≥150 mm Hg or if pharmacist weekly time driving to barbershops increased. CONCLUSIONS: Hypertension care delivered by clinical pharmacists in Black barbershops is a highly cost-effective way to improve blood pressure control in Black men.

It's Time for a Haircut: a Perspective on Barbershop Health Interventions Serving Black Men.

Black men in the USA experience disproportionate cardiovascular disease mortality compared to their white counterparts, in part due to an excess of uncontrolled hypertension. A promising intervention to address these disparities involves the direct pharmacologic management of hypertension by clinical pharmacists in Black male patrons of barbershops, as demonstrated in the Los Angeles Barbershop Blood Pressure Study (LABBPS). Despite the observed reduction in systolic blood pressure of > 20 mmHg after 1 year, the feasibility of scaling up such an intervention to a regional or national platform remains uncertain. Here we explore the success of LABBPS in the context of prior barbershop interventions and theorize the most important aspects driving the observed reductions. We further make a case for prioritizing preventive care in nontraditional settings in an effort to reduce health disparities.

Microneedle-Based Delivery of Amphotericin B for Treatment of Cutaneous Leishmaniasis.

Current therapeutic options against cutaneous leishmaniasis are plagued by several weaknesses. The effective topical delivery of an antileishmanial drug would be useful in treating some forms of cutaneous leishmaniasis. Toward this end, a microneedle based delivery approach for the antileishmanial drug amphotericin B was investigated in murine models of both New World (Leishmania mexicana) and Old World (Leishmania major) infection. In the L. mexicana model, ten days of treatment began on day 35 post infection, when the area of nodules averaged 9-15 mm2. By the end of the experiment, a significant difference in nodule area was observed for all groups receiving topical amphotericin B at 25 mg/kg/day after application of microneedle arrays of 500, 750, and 1000 µM in nominal length compared to the group that received this dose of topical amphotericin B alone. In the L. major model, ten days of treatment began on day 21 post infection when nodule area averaged 51-65 mm2 in the groups. By the end of the experiment, there was no difference in nodule area between the group receiving 25 mg/kg of topical amphotericin B after microneedle application and any of the non-AmBisome groups. These results show the promise of topical delivery of amphotericin B via microneedles in treating relatively small nodules caused by L. mexicana. These data also show the limitations of the approach against a disseminated L. major infection. Further optimization of microneedle delivery is needed to fully exploit this strategy for cutaneous leishmaniasis treatment.

Cost-Effectiveness and Challenges of Implementing Intensive Blood Pressure Goals and Team-Based Care.

PURPOSE OF REVIEW: Review the effectiveness, cost-effectiveness, and implementation challenges of intensive blood pressure (BP) control and team-based care initiatives. RECENT FINDINGS: Intensive BP control is an effective and cost-effective intervention; yet, implementation in routine clinical practice is challenging. Several models of team-based care for hypertension management have been shown to be more effective than usual care to control BP. Additional research is needed to determine the cost-effectiveness of team-based care models relative to one another and as they relate to implementing intensive BP goals. As a focus of healthcare shifts to value (i.e., cost, effectiveness, and patient preferences), formal cost-effectiveness analyses will inform which team-based initiatives hold the highest value in different healthcare settings with different populations and needs. Several challenges, including clinical inertia, financial investment, and billing restrictions for pharmacist-delivered services, will need to be addressed in order to improve public health through intensive BP control and team-based care.

Interventions to Increase Depression Treatment Initiation in Primary Care Patients: a Systematic Review.

INTRODUCTION: Nearly 50% of depressed primary care patients referred to mental health services do not initiate mental health treatment. The most promising interventions for increasing depression treatment initiation in primary care settings remain unclear. METHODS: We performed a systematic search of publicly available databases from inception through August 2017 to identify interventions designed to increase depression treatment initiation. Two authors independently selected, extracted data, and rated risk of bias from included studies. Eligible studies used a randomized or pre-post design and assessed depression treatment initiation (i.e., ≥ 1 mental health visit or antidepressant fill) among adults, the majority of whom met criteria for depression. Interventions were classified as simple or complex and sub-classified into intervention strategies that were graded for strength of evidence. RESULTS: Of 9516 articles identified, we included 14 unique studies representing 16 (4 simple and 12 complex) interventions and 8 treatment initiation strategies. We found low to moderate strength of evidence for collaborative/integrated care (3 studies), treatment preference matching (2 studies), and case management (2 studies) strategies. However, there was insufficient evidence to determine the benefit of cultural tailoring (2 studies), motivation (alone, with reminders or with cultural tailoring (5 studies)), education (1 study), and shared decision-making strategies (1 study). Overall, we found moderate strength of evidence for complex interventions (8 of 12 complex interventions demonstrated statistically significant effects on treatment initiation). DISCUSSION: Collaborative/integrated care, preference treatment matching, and case management strategies had the best evidence for improving depression treatment initiation, but none of the strategies had high strength of evidence. While primary care settings can consider using some of these strategies when referring depressed patients to treatment, our review highlights the need for further rigorous research in this area.

Effectiveness of Hypertension Management Strategies in SPRINT-Eligible US Adults: A Simulation Study.

BACKGROUND: Despite reducing cardiovascular disease (CVD) events and death in SPRINT (Systolic Blood Pressure Intervention Trial), intensive systolic blood pressure goals have not been adopted in the United States. This study aimed to simulate the potential long-term impact of 4 hypertension management strategies in SPRINT-eligible US adults. METHODS AND RESULTS: The validated Blood Pressure Control-Cardiovascular Disease Policy Model, a discrete event simulation of hypertension care processes (ie, visit frequency, blood pressure [BP] measurement accuracy, medication intensification, and medication adherence) and CVD outcomes, was populated with 25 000 SPRINT-eligible US adults. Four hypertension management strategies were simulated: (1) usual care targeting BP <140/90 mm Hg (Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure usual care), (2) intensive care per the SPRINT protocol targeting BP <120/90 mm Hg (SPRINT intensive), (3) usual care targeting guideline-recommended BP <130/80 mm Hg (American College of Cardiology/American Heart Association usual care), and (4) team-based care added to usual care and targeting BP <130/80 mm Hg. Relative to the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure usual care, among the 18.1 million SPRINT-eligible US adults, an estimated 138 100 total CVD events could be prevented per year with SPRINT intensive, 33 900 with American College of Cardiology/American Heart Association usual care, and 89 100 with team-based care. Compared with the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure usual care, SPRINT intensive care was projected to increase treatment-related serious adverse events by 77 600 per year, American College of Cardiology/American Heart Association usual care by 33 300, and team-based care by 27 200. CONCLUSIONS: As BP control has declined in recent years, health systems must prioritize hypertension management and invest in effective strategies. Adding team-based care to usual care may be a pragmatic way to manage risk in this high-CVD-risk population.

Effectiveness and Cost-Effectiveness of Team-Based Care for Hypertension: A Meta-Analysis and Simulation Study.

BACKGROUND: Team-based care (TBC), a team of ≥2 healthcare professionals working collaboratively toward a shared clinical goal, is a recommended strategy to manage blood pressure (BP). However, the most effective and cost-effective TBC strategy is unknown. METHODS: A meta-analysis of clinical trials in US adults (aged ≥20 years) with uncontrolled hypertension (≥140/90 mm Hg) was performed to estimate the systolic BP reduction for TBC strategies versus usual care at 12 months. TBC strategies were stratified by the inclusion of a nonphysician team member who could titrate antihypertensive medications. The validated BP Control Model-Cardiovascular Disease Policy Model was used to project the expected BP reductions out to 10 years and simulate cardiovascular disease events, direct healthcare costs, quality-adjusted life years, and cost-effectiveness of TBC with physician and nonphysician titration. RESULTS: Among 19 studies comprising 5993 participants, the 12-month systolic BP change versus usual care was -5.0 (95% CI, -7.9 to -2.2) mm Hg for TBC with physician titration and -10.5 (-16.2 to -4.8) mm Hg for TBC with nonphysician titration. Relative to usual care at 10 years, TBC with nonphysician titration was estimated to cost $95 (95% uncertainty interval, -$563 to $664) more per patient and gain 0.022 (0.003-0.042) quality-adjusted life years, costing $4400/quality-adjusted life year gained. TBC with physician titration was estimated to cost more and gain fewer quality-adjusted life years than TBC with nonphysician titration. CONCLUSIONS: TBC with nonphysician titration yields superior hypertension outcomes compared with other strategies and is a cost-effective way to reduce hypertension-related morbidity and mortality in the United States.

Predicting Out-of-Office Blood Pressure in a Diverse US Population.

BACKGROUND: The PRedicting Out-of-OFfice Blood Pressure (PROOF-BP) algorithm accurately predicted out-of-office blood pressure (BP) among adults with suspected high BP in the United Kingdom and Canada. We tested the accuracy of PROOF-BP in a diverse US population and evaluated a newly developed US-specific algorithm (PROOF-BP-US). METHODS: Adults with ≥2 office BP readings and ≥10 awake BP readings on 24-hour ambulatory BP monitoring from 4 pooled US studies were included. We compared mean awake BP with predicted out-of-office BP using PROOF-BP and PROOF-BP-US. Our primary outcomes were hypertensive out-of-office systolic BP (SBP) ≥130 mm Hg and diastolic BP (DBP) ≥80 mm Hg. RESULTS: We included 3,058 adults, mean (SD) age was 52.0 (11.9) years, 38% were male, and 54% were Black. The area under the receiver-operator characteristic (AUROC) curve (95% confidence interval) for hypertensive out-of-office SBP was 0.81 (0.79-0.82) and DBP was 0.76 (0.74-0.78) for PROOF-BP. For PROOF-BP-US, the AUROC curve for hypertensive out-of-office SBP was 0.82 (0.81-0.83) and for DBP was 0.81 (0.79-0.83). The optimal predicted out-of-office BP ranges for out-of-office BP measurement referral were 120-134/75-84 mm Hg for PROOF-BP and 125-134/75-84 mm Hg for PROOF-BP-US. The 2017 American College of Cardiology/American Heart Association BP guideline (referral range 130-159/80-99 mm Hg) would refer 93.1% of adults not taking antihypertensive medications with office BP ≥130/80 mm Hg in the National Health and Nutrition Examination Survey for out-of-office BP measurement, compared with 53.1% using PROOF-BP and 46.8% using PROOF-BP-US. CONCLUSIONS: PROOF-BP and PROOF-BP-US accurately predicted out-of-office hypertension in a diverse sample of US adults.

Depressive symptoms do not discriminate: racial and economic influences between time-varying depressive symptoms and mortality among REGARDS participants.

PURPOSE: Depressive symptoms relapse and remit over time, perhaps differentially by race and income. Few studies have examined whether time-varying depressive symptoms (TVDS) differentially predict mortality. We sought to determine whether race (white/black) and income (

Time-Varying Depressive Symptoms and Cardiovascular and All-Cause Mortality: Does the Risk Vary by Age or Sex?

Background Depressive symptoms are associated with mortality. Data regarding moderation of this effect by age and sex are inconsistent, however. We aimed to identify whether age and sex modify the association between depressive symptoms and all-cause and cardiovascular disease (CVD) mortality. Methods and Results The REGARDS (Reasons for Geographic and Racial Differences in Stroke) study is a prospective cohort of Black and White individuals recruited between 2003 and 2007. Associations between time-varying depressive symptoms (Center for Epidemiologic Studies Depression scale score ≥4 versus <4) and all-cause and CVD mortality were measured using Cox proportional hazard models adjusting for demographic and clinical risk factors. All results were stratified by age or sex and by self-reported health status. Of 29 491 participants, 3253 (11%) had baseline elevated depressive symptoms. Mean age was 65 (9.4) years, with 55.1% of participants female, 41.1% Black, and 46.4% had excellent/very good health. Depressive symptoms were measured at baseline, on average 4.9 (SD, 1.5), then 2.1 (SD, 0.4) years later. Neither age nor sex moderated the association between elevated time-varying depressive symptoms and all-cause or CVD mortality (all-cause: age 45-64 years adjusted hazard ratio [aHR], 1.38; 95% CI, 1.18-1.61 versus age ≥65 years aHR,1.36; 95% CI, 1.23-1.50; P=0.05; CVD: age 45-64 years aHR, 1.17; 95% CI, 0.90-1.53 versus age ≥65 years aHR, 1.26; 95% CI, 1.06-1.50; P=0.54; all-cause: males aHR, 1.46; 95% CI, 1.29-1.64 versus female aHR, 1.34; 95% CI, 1.19-1.50; P=0.35; CVD: male aHR, 1.32; 95% CI, 1.08-1.62 versus female aHR, 1.22; 95% CI, 1.00-1.47; P=0.64). Similar results were observed when stratified by self-reported health status. Conclusions Depressive symptoms confer mortality risk regardless of age and sex, including individuals who report excellent/very good health.

Impact of Self-Monitoring of Blood Pressure on Processes of Hypertension Care and Long-Term Blood Pressure Control.

Background Self-monitoring of blood pressure (SMBP) improves blood pressure (BP) outcomes at 12-months, but information is lacking on how SMBP affects hypertension care processes and longer-term BP outcomes. Methods and Results We pooled individual participant data from 4 randomized clinical trials of SMBP in the United Kingdom (combined n=2590) with varying intensities of support. Multivariable random effects regression was used to estimate the probability of antihypertensive intensification at 12 months for usual care versus SMBP. Using these data, we simulated 5-year BP control rates using a validated mathematical model. Trial participants were mostly older adults (mean age 66.6 years, SD 9.5), male (53.9%), and predominantly white (95.6%); mean baseline BP was 151.8/85.0 mm Hg. Compared with usual care, the likelihood of antihypertensive intensification increased with both SMBP with feedback to patient or provider alone (odds ratio 1.8, 95% CI 1.2-2.6) and with telemonitoring or self-management (3.3, 2.5-4.2). Over 5 years, we estimated 33.4% BP control (<140/90 mm Hg) with usual care (95% uncertainty interval 27.7%-39.4%). One year of SMBP with feedback to patient or provider alone achieved 33.9% (28.3%-40.3%) BP control and SMBP with telemonitoring or self-management 39.0% (33.1%-45.2%) over 5 years. If SMBP interventions and associated BP control processes were extended to 5 years, BP control increased to 52.4% (45.4%-59.8 %) and 72.1% (66.5%-77.6%), respectively. Conclusions One year of SMBP plus telemonitoring or self-management increases the likelihood of antihypertensive intensification and could improve BP control rates at 5 years; continuing SMBP for 5 years could further improve BP control.

Nitrones reverse hyperglycemia-induced endothelial dysfunction in bovine aortic endothelial cells.

Hyperglycemia has been implicated in the development of endothelial dysfunction through heightened ROS production. Since nitrones reverse endothelial nitric oxide synthase (eNOS) dysfunction, increase antioxidant enzyme activity, and suppress pro-apoptotic signaling pathway and mitochondrial dysfunction from ROS-induced toxicity, the objective of this study was to determine whether nitrone spin traps DMPO, PBN and PBN-LA were effective at duplicating these effects and improving glucose uptake in an in vitro model of hyperglycemia-induced dysfunction using bovine aortic endothelial cells (BAEC). BAEC were cultured in DMEM medium with low (5.5mM glucose, LG) or high glucose (50mM, HG) for 14 days to model in vivo hyperglycemia as experienced in humans with metabolic disease. Improvements in cell viability, intracellular oxidative stress, NO and tetrahydrobiopterin (BH4)​ levels, mitochondrial membrane potential, glucose transport, and activity of antioxidant enzymes were measured from single treatment of BAEC with nitrones for 24h after hyperglycemia. Chronic hyperglycemia significantly increased intracellular ROS by 50%, decreased cell viability by 25%, reduced NO bioavailability by 50%, and decreased (BH4) levels by 15% thereby decreasing NO production. Intracellular glucose transport and superoxide dismutase (SOD) activity were also decreased by 50% and 25% respectively. Nitrone (PBN and DMPO, 50 µM) treatment of BAEC grown in hyperglycemic conditions resulted in the normalization of outcome measures except for SOD and catalase activities. Our findings demonstrate that the nitrones reverse the deleterious effects of hyperglycemia in BAEC. We believe that in vivo testing of these nitrone compounds in models of cardiometabolic disease is warranted.