A qualitative analysis of post-hoc interviews with multilevel participants of a randomized controlled trial of a community-based intervention.

INTRODUCTION: Community-based health interventions often demonstrate efficacy in clinical trial settings but fail to be implemented in the real-world. We sought to identify the key operational and contextual elements of the Los Angeles Barbershop Blood Pressure Study (LABBPS), an objectively successful community-based health intervention primed for real-world implementation. LABBPS was a cluster randomized control trial that paired the barbers of Black-owned barbershops with clinical pharmacists to manage uncontrolled hypertension in Black male patrons, demonstrating a substantial 21.6 mmHg reduction in systolic blood pressure. Despite this success, the LABBPS intervention has not expanded beyond the original clinical trial setting. The aim of this study was to determine the facilitating and limiting factors to expansion of the LABBPS intervention. METHODS: We undertook a qualitative assessment of semi-structured interviews with study participants performed after trial completion. Interviews included a total of 31 participants including 20 (6%) of the 319 LABBPS program participants ("patrons"), 10 (19%) barbers, and one (50%) clinical pharmacist. The semi-structured interviews were focused on perceptions of the medical system, study intervention, and influence of social factors on health. RESULTS: Several common themes emerged from thematic analysis of interview responses including: importance of care provided in a convenient and safe environment, individual responsibility for health and health-related behaviors, and engagement of trusted community members. In particular, patrons reported that receiving the intervention from their barber in a familiar environment positively influenced the formation of relationships with clinical pharmacists around shared efforts to improve medication adherence and healthy habits. All interviewee groups identified the trust diad, comprising the familiar environment and respected community member, as instrumental in increasing health-related behaviors to a degree not usually achieved by traditional healthcare providers. DISCUSSION: In conclusion, participants of an objectively successful community-based intervention trial consistently identified key features that could facilitate wider implementation and efficacy: social trust relationships, soliciting insights of trust bearers, and consistent engagement in a familiar community setting. These findings can help to inform the design and operations of future community-based studies and programs aiming to achieve a broad and sustainable impact.

A Pharmacologic Update: New Treatments for Patients with Cardiovascular Disease.

Pharmacologic agents are a key part of the medical armamentarium aimed at reducing the significant morbidity and mortality caused by cardiovascular disease (CVD). In recent years, the landscape of CVD treatment has evolved with the development of new medication classes and the repurposing of existing medications for new indications. This article provides nurses with a pharmacologic update on new and emerging therapies for the treatment of hypertrophic cardiomyopathy, familial hypercholesterolemia, and heart failure. The authors review clinical indications, pharmacology, practical considerations for the safe and appropriate use of these medications, and implications for nurses.

Oral Contraceptive Pills and Hypertension: A Review of Current Evidence and Recommendations.

Oral contraceptive pills (OCPs) have been used as effective and popular forms of contraception since the middle of the last century. By 2019, over 150 million reproductive-aged individuals were using OCPs to prevent unintended pregnancies worldwide. Safety concerns regarding the effects of OCPs on blood pressure were reported soon after these pills gained approval. Although OCP doses were subsequently reduced, epidemiologic evidence continued to support a smaller, but significant association between OCPs and hypertension. Given the rising prevalence of hypertension, as well as the adverse effects of cumulative exposure to blood pressure elevations on cardiovascular disease risk, understanding the nature of the association between OCPs and hypertension is important for clinicians and patients to assess the risks and benefits of use, and make individualized decisions regarding contraception. Therefore, this review summarizes the current and historical evidence describing the association between OCP use and blood pressure elevations. Specifically, it identifies the pathophysiologic mechanisms linking OCPs to hypertension risk, describes the magnitude of the association between OCPs and blood pressure elevations, and distinguishes the effects of various OCP types on blood pressure. Finally, it describes current recommendations regarding hypertension and OCP use, as well as identifies strategies, such as over-the-counter OCP prescribing, to safely and equitably improve access to oral contraception.

Behavioural Economics to Improve Antihypertensive Therapy Adherence (BETA): protocol for a pilot randomised controlled trial in Los Angeles.

INTRODUCTION: Non-adherence to antihypertensive therapy is one of the major barriers to reducing the risk of cardiovascular disease. Several interventions have targeted higher medication adherence, yet most do not result in sustained adherence. Routinisation has emerged as a potential method for mitigating this problem, but requires high motivation during the relatively long habit formation phase. This pilot randomised controlled trial aims to test the feasibility, acceptability, and preliminary efficacy of behavioural economics-based incentives and text messages to support the routinisation of the medication-taking behaviour for promoting long-term medication adherence. METHODS AND ANALYSIS: This study will recruit and randomly assign 60 adult patients seeking care for hypertension at the Cedars-Sinai Medical Center in Los Angeles to one of the three groups, Control (n=20), Messages (n=20) and Incentives (n=20) in a 1:1:1 ratio. All participants will receive information about the importance of routinisation and will select an existing behavioural routine ('anchor') to which they will tie their pill-taking to, and the corresponding time. Additionally, participants in the Messages group will receive daily text messages reminding them of the importance of routines, while those in the Incentives group will receive daily text messages and conditional prize drawings. The interventions will be delivered over three months. Participants will be followed for six months post-intervention to measure behavioural persistence. Surveys will be administered at baseline, month-3 and month-9 visits. Primary outcomes include: (1) electronically measured mean medication adherence during the intervention period and (2) post-intervention period; and (3) mean timely medication adherence based around the time of the participants' anchor during the intervention period, and (4) post-intervention period. ETHICS AND DISSEMINATION: The study was approved by the Cedars-Sinai Institutional Review Board (Study ID: Pro00057764). Findings will be published in scientific peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04029883.

Variability independent of mean blood pressure as a real-world measure of cardiovascular risk.

Background: Individual-level blood pressure (BP) variability, independent of mean BP levels, has been associated with increased risk for cardiovascular events in cohort studies and clinical trials using standardized BP measurements. The extent to which BP variability relates to cardiovascular risk in the real-world clinical practice setting is unclear. We sought to determine if BP variability in clinical practice is associated with adverse cardiovascular outcomes using clinically generated data from the electronic health record (EHR). Methods: We identified 42,482 patients followed continuously at a single academic medical center in Southern California between 2013 and 2019 and calculated their systolic and diastolic BP variability independent of the mean (VIM) over the first 3 years of the study period. We then performed multivariable Cox proportional hazards regression to examine the association between VIM and both composite and individual outcomes of interest (incident myocardial infarction, heart failure, stroke, and death). Findings: Both systolic (HR, 95% CI 1.22, 1.17-1.28) and diastolic VIM (1.24, 1.19-1.30) were positively associated with the composite outcome, as well as all individual outcome measures. These findings were robust to stratification by age, sex and clinical comorbidities. In sensitivity analyses using a time-shifted follow-up period, VIM remained significantly associated with the composite outcome for both systolic (1.15, 1.11-1.20) and diastolic (1.18, 1.13-1.22) values. Interpretation: VIM derived from clinically generated data remains associated with adverse cardiovascular outcomes and represents a risk marker beyond mean BP, including in important demographic and clinical subgroups. The demonstrated prognostic ability of VIM derived from non-standardized BP readings indicates the utility of this measure for risk stratification in a real-world practice setting, although residual confounding from unmeasured variables cannot be excluded. Funding: This study was funded in part by National Institutes of Health grants R01-HL134168, R01-HL131532, R01-HL143227, R01-HL142983, U54-AG065141; R01-HL153382, K23-HL136853, K23-HL153888, and K99-HL157421; China Scholarship Council grant 201806260086; Academy of Finland (Grant no: 321351); Emil Aaltonen Foundation; Finnish Foundation for Cardiovascular Research.

Improving Efficiency of the Barbershop Model of Hypertension Care for Black Men With Virtual Visits.

Background The LABBPS (Los Angeles Barbershop Blood Pressure Study) developed a new model of hypertension care for non-Hispanic Black men that links health promotion by barbers to medication management by pharmacists. Barriers to scaling the model include inefficiencies that contribute to the cost of the intervention, most notably, pharmacist travel time. To address this, we tested whether virtual visits could be substituted for in-person visits after blood pressure (BP) control was achieved. Methods and Results We enrolled 10 Black male patrons with systolic BP ≥140 mm Hg into a proof-of-concept study in which barbers promoted follow-up with pharmacists who initially met each patron in the barbershop, where they prescribed BP medication under a collaborative practice agreement with the patrons' physician. Medications were titrated during bimonthly in-person visits to achieve a BP goal of ≤130/80 mm Hg. Once BP goal was reached, visits were done by videoconference. Final BP and safety outcomes were assessed at 12 months. Nine patients completed the intervention. Baseline BP of 155±14/83.9±11 mm Hg decreased by -28.7±13/-8.9±15 mm Hg (P<0.0001). These data are statistically indistinguishable from prior LABBPS data (P=0.8 for change in systolic BP and diastolic BP). Hypertension control (≤130/80 mm Hg) was 67% (6 of 9), numerically greater than the 63% observed in LABBPS (P=not significant). As intended, the mean number of in-person visits decreased from 11 in LABBPS to 6.6 visits over 12 months. No treatment-related serious adverse events occurred. Conclusions Virtual visits represent a viable substitute for in-person visits, both improving pharmacist efficiency and reducing cost while preserving intervention potency. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03726710.

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.

Barbershop Management of Hypertension in the African American Population: Pitfalls and Opportunities for Extension to Other Underserved Communities.

PURPOSE OF REVIEW: This review summarizes the results of recent barbershop-based studies focusing on the diagnosis and management of hypertension (HTN) in black adults. The pitfalls of prior attempts and opportunities for the development of future programs to address health disparities on a larger scale are also reviewed. RECENT FINDINGS: While barbershop health outreach has become a commonplace in recent years, the quality of the evidence on the effectiveness of such programs has been weak, until the Los Angeles Barbershop Blood Pressure Study (LABBPS), a rigorously carried out cluster-randomized trial, demonstrated a - 21 mmHg greater reduction in BP among black hypertensive men who were assigned to a pharmacist-led HTN intervention when compared with usual care. Given the available evidence, barber health promotion paired with focused hypertension-specialty care has the potential to reduce, if not eliminate, the present wide gap in hypertension care and ultimately lead to a reduction of hypertension-related complications among blacks. Future research should seek to improve the scalability and transferability of the LABBPS model both to other geographic regions and to other at-risk groups.

Sustainability of blood pressure reduction in black barbershops.

PURPOSE OF REVIEW: The prevalence of hypertension (HTN) among non-Hispanic blacks increased from 41 to 55% with the release of the new 2017 ACC/AHA guidelines - the highest among any racial group. Non-Hispanic black men have less physician interaction and lower blood pressure (BP) treatment and control rates when compared with their female counterparts, necessitating community outreach. Here, we review the Los Angeles Barbershop Blood Pressure Study (LABBPS) which demonstrated a community-based approach involving pharmacists, physicians, and barbers could improve BP control rates among black men. RECENT FINDINGS: LABBPS was a cluster-randomized trial that evaluated both the efficacy and sustainability of a pharmacist-led HTN management program in which barbers promoted follow-up with pharmacists who prescribed antihypertensive therapy under collaborative practice agreements with intervention participant's primary care providers. After 6 months researchers observed a 21 mmHg greater fall in SBP among intervention group participants when compared with the control group participants who received 'usual care.' The 6-month extension phase of the study showed that the impressive BP reduction achieved was sustained with less pharmacist contact. SUMMARY: Multidisciplinary, community-based approaches to HTN management can be effective and are necessary to tackle the current disparity seen in BP control rates. The model developed in LABBPS represents one such approach.

Nocturia as an Unrecognized Symptom of Uncontrolled Hypertension in Black Men Aged 35 to 49 Years.

Background Hypertension is assumed to be asymptomatic. Yet, clinically significant nocturia (≥2 nightly voids) constitutes a putative symptom of uncontrolled hypertension. Black men with hypertension may be prone to nocturia because of blunted nocturnal blood pressure ( BP ) dipping, diuretic drug use for hypertension, and comorbidity that predisposes to nocturia. Here, we test the hypothesis that nocturia is a common and potentially reversible symptom of uncontrolled hypertension in black men. Methods and Results We determined the strength of association between nocturia (≥2 nightly voids) and high BP (≥135/85 mm Hg) by conducting in-person health interviews and measuring BP with an automated monitor in a large community-based sample of black men in their barbershops. Because nocturia is prevalent and steeply age-dependent after age 50 years, we studied men aged 35 to 49 years. Among 1673 black men (mean age, 43±4 years [ SD ]), those with hypertension were 56% more likely than men with normotension to have nocturia after adjustment for diabetes mellitus and sleep apnea (adjusted odds ratio, 1.56; 95% CI , 1.25-1.94 [ P<0.0001]). Nocturia prevalence varied by hypertension status, ranging from 24% in men with normotension to 49% in men whose hypertension was medically treated but uncontrolled. Men with untreated hypertension were 39% more likely than men with normotension to report nocturia ( P=0.02), whereas men whose hypertension was treated and controlled were no more likely than men with normotension to report nocturia ( P=0.69). Conclusions Uncontrolled hypertension was an independent determinant of clinically important nocturia in a large cross-sectional community-based study of non-Hispanic black men aged 35 to 49 years. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unqiue identifier: NCT 02321618.

Sustainability of Blood Pressure Reduction in Black Barbershops.

BACKGROUND: We developed a new model of hypertension care for non-Hispanic black men that links health promotion by barbers to medication management by American Society of Hypertension-certified pharmacists and demonstrated efficacy in a 6-month cluster-randomized trial. The marked reduction in systolic blood pressure (BP) seen at 6 months warranted continuing the trial through 12 months to test sustainability, a necessary precondition for implementation research. METHODS: We enrolled a cohort of 319 black male patrons with systolic BP ≥140 mm Hg at baseline. Fifty-two Los Angeles County barbershops were assigned to either a pharmacist-led intervention or an active control group. In the intervention group, barbers promoted follow-up with pharmacists who prescribed BP medication under a collaborative practice agreement with patrons' primary care providers. In the control group, barbers promoted follow-up with primary care providers and lifestyle modification. After BP assessment at 6 months, the intervention continued with fewer in-person pharmacist visits to test whether the intervention effect could be sustained safely for 1 year while reducing pharmacist travel time. Final BP and safety outcomes were assessed in both groups at 12 months. RESULTS: At baseline, mean systolic BP was 152.4 mm Hg in the intervention group and 154.6 mm Hg in the control group. At 12 months, mean systolic BP fell by 28.6 mm Hg (to 123.8 mm Hg) in the intervention group and by 7.2 mm Hg (to 147.4 mm Hg) in the control group. The mean reduction was 20.8 mm Hg greater in the intervention (95% CI, 13.9-27.7; P<0.0001). A BP <130/80 mm Hg was achieved by 68.0% of the intervention group versus 11.0% of the control group ( P<0.02). These new 12-month efficacy data are statistically indistinguishable from our previously reported 6-month data. No treatment-related serious adverse events occurred in either group over 12 months. Cohort retention at 12 months was 90% in both groups. CONCLUSIONS: Among black male barbershop patrons with uncontrolled hypertension, health promotion by barbers resulted in large and sustained BP reduction over 12 months when coupled with medication management by American Society of Hypertension-certified pharmacists. Broad-scale implementation research is both justified and warranted. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT 02321618.

A Cluster-Randomized Trial of Blood-Pressure Reduction in Black Barbershops.

BACKGROUND: Uncontrolled hypertension is a major problem among non-Hispanic black men, who are underrepresented in pharmacist intervention trials in traditional health care settings. METHODS: We enrolled a cohort of 319 black male patrons with systolic blood pressure of 140 mm Hg or more from 52 black-owned barbershops (nontraditional health care setting) in a cluster-randomized trial in which barbershops were assigned to a pharmacist-led intervention (in which barbers encouraged meetings in barbershops with specialty-trained pharmacists who prescribed drug therapy under a collaborative practice agreement with the participants' doctors) or to an active control approach (in which barbers encouraged lifestyle modification and doctor appointments). The primary outcome was reduction in systolic blood pressure at 6 months. RESULTS: At baseline, the mean systolic blood pressure was 152.8 mm Hg in the intervention group and 154.6 mm Hg in the control group. At 6 months, the mean systolic blood pressure fell by 27.0 mm Hg (to 125.8 mm Hg) in the intervention group and by 9.3 mm Hg (to 145.4 mm Hg) in the control group; the mean reduction was 21.6 mm Hg greater with the intervention (95% confidence interval, 14.7 to 28.4; P<0.001). A blood-pressure level of less than 130/80 mm Hg was achieved among 63.6% of the participants in the intervention group versus 11.7% of the participants in the control group (P<0.001). In the intervention group, the rate of cohort retention was 95%, and there were few adverse events (three cases of acute kidney injury). CONCLUSIONS: Among black male barbershop patrons with uncontrolled hypertension, health promotion by barbers resulted in larger blood-pressure reduction when coupled with medication management in barbershops by specialty-trained pharmacists. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT02321618 .).

The natural history of new orthopaedic devices.

Each year, hundreds of new devices and implants are introduced for orthopaedic surgeons. However, the proportion of new devices which ultimately will be successful is unknown. We investigated the natural history of new devices introduced to the orthopaedic market. From a list of all devices approved for use by the Food & Drug Administration 5 and 10 years before, a cohort of 100 devices was randomly selected using a random number list. Companies were contacted regarding the safety record and current availability of these devices. The company response rate was 93%. Forty-seven percent of devices approved 10 years ago and 25% of devices approved 5 years ago no longer were on the market. Of the 55 companies studied, 18 (33%) were out of business and their devices no longer were available. Devices approved 10 years ago were more likely to be unavailable than devices approved 5 years ago. Devices introduced by smaller companies were more likely to be unavailable. The majority of unavailable devices were discontinued not for clinical problems, but for poor market performance. Only 2% of devices studied had safety problems. Approximately 50% of devices approved for introduction to the orthopaedic marketplace no longer are available 10 years later. However, major device-related problems seem uncommon.