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.)

Background We developed a new model of hypertension (HTN) care for non-Hispanic black men that links health promotion by barbers to medication management by specialty-trained pharmacists and demonstrated efficacy in a 6-month randomized trial (Victor et al., NEJM, 2018). 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 subsequent implementation research. Methods We enrolled a cohort of 319 black male patrons with systolic BP ≥ 140 mm Hg at baseline, in a cluster-randomized trial. 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 (PCPs). In the control group, barbers promoted follow-up with PCPs and lifestyle modification. After BP assessment at 6 months, the intervention continued with fewer in-person pharmacist visits to test if the intervention effect could be sustained safely for one year while reducing pharmacist travel time to and from barbershops. 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 with the intervention (95% confidence interval, 13.9 to 27.7; p < 0.0001). A goal BP < 130/80 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. Conclusion Among black male barbershop patrons with uncontrolled HTN, health promotion by barbers resulted in large and sustained BP reduction when coupled with medication management by specialty-trained pharmacists. Broad-scale implementation research is both justified and warranted. Clinical Trial Registration ClinicalTrials.gov,

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.

Background: In the Los Angeles Barbershop Blood Pressure Study (LABBPS), 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 healthcare costs of one 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 non-fatal cardiovascular disease events, and non-cardiovascular disease death in LABBPS participants. Program costs, total direct healthcare costs (2019 USD), and quality-adjusted life years (QALYs) were estimated for the LABBPS intervention and control arms from a healthcare 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 $2,356 (95% uncertainty interval [UI] -$264-$4,611) more per participant than the control arm and gain 0.06 (95% UI 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 mmHg 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.

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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.