Publications by authors named "Karen Margolis"

230 Publications

Economic outcomes of depression screening after acute coronary syndromes: The CODIACS-QoL randomized clinical trial.

Gen Hosp Psychiatry 2021 Apr 3;71:47-54. Epub 2021 Apr 3.

Columbia University Irving Medical Center, New York, NY, United States of America.

Objective: To evaluate the cost-effectiveness of screening for depression in patients with acute coronary syndrome (ACS) and no history of depression.

Methods: Cost-effectiveness analysis of a randomized trial enrolling 1500 patients with ACS between 2013 and 2017. Patients were randomized to no screening, screening and notifying the primary care provider (PCP), and screening, notifying the PCP, and providing enhanced depression treatment. Outcomes measured were Healthcare utilization, costs, and incremental cost-effectiveness ratios.

Results: 7.1% of patients screened positive for depressive symptoms. There was no significant difference in usage of mental health services, cardiovascular tests and procedures, and medications. Mean total costs in No Screen group ($7440), in Screen, Notify, and Treat group ($6745), and in Screen and Notify group ($6204). The difference was only significant in the Screen and Notify group versus the No Screen group (-$1236, 95% confidence interval -$2388 to -$96). Because mean QALYs were higher (+0.003 QALY in Screen and Notify; +0.004 QALYs in Screen, Notify, and Treat) and mean total costs were lower in both intervention groups, these interventions were cost-effective. There was substantial uncertainty because confidence intervals around cost differences were wide and QALY effects were small.

Conclusion: Depression screening strategies for patients with ACS may be modestly cost-effective.
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http://dx.doi.org/10.1016/j.genhosppsych.2021.04.001DOI Listing
April 2021

Long-Term Blood Pressure Variability and Risk of Cardiovascular Disease Events Among Community-Dwelling Elderly.

Hypertension 2020 12 2;76(6):1945-1952. Epub 2020 Nov 2.

Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia (E.K.C., R.W., A.M.T., J.R., R.L.W., J.J.M., C.M.R.).

High office blood pressure variability (OBPV) in midlife increases the risk of cardiovascular disease (CVD), but the impact of OBPV in older adults without previous CVD is unknown. We conducted a post hoc analysis of ASPREE trial (Aspirin in Reducing Events in the Elderly) participants aged 70-years and older (65 for US minorities) without history of CVD events at baseline, to examine risk of incident CVD associated with long-term, visit-to-visit OBPV. CVD was a prespecified, adjudicated secondary end point in ASPREE. We estimated OBPV using within-individual SD of mean systolic BP from baseline and first 2 annual visits. Cox proportional hazards regression was used to calculate hazard ratios (HR) and 95% CI for associations with CVD events. In 16 475 participants who survived to year 2 without events, those in the highest tertile of OBPV had increased risk of CVD events after adjustment for multiple covariates, when compared with participants in the lowest tertile (HR, 1.36 [95% CI, 1.08-1.70]; =0.01). Similar increased risk was observed for ischemic stroke (HR, 1.56 [95% CI, 1.04-2.33]; =0.03), heart failure hospitalization, or death (HR, 1.73 [95% CI, 1.07-2.79]; =0.02), and all-cause mortality (HR, 1.27 [95% CI, 1.04-1.54]; =0.02). Findings were consistent when stratifying participants by use of antihypertensive drugs, while sensitivity analyses suggested the increased risk was especially for individuals whose BP was uncontrolled during the OBPV estimation period. Our findings support increased OBPV as a risk factor for CVD events in healthy older adults with, or without hypertension, who have not had such events previously. Registration- URL: https://www.clinicaltrials.gov; Unique identifiers: NCT01038583; URL: https://www.isrctn.com; Unique identifiers: ISRCTN83772183.
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http://dx.doi.org/10.1161/HYPERTENSIONAHA.120.16209DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7666049PMC
December 2020

Evidence and Recommendations on the Use of Telemedicine for the Management of Arterial Hypertension: An International Expert Position Paper.

Hypertension 2020 11 14;76(5):1368-1383. Epub 2020 Sep 14.

Sinclair School of Nursing, University of Missouri, Columbia (B.J.W.).

Telemedicine allows the remote exchange of medical data between patients and healthcare professionals. It is used to increase patients' access to care and provide effective healthcare services at a distance. During the recent coronavirus disease 2019 (COVID-19) pandemic, telemedicine has thrived and emerged worldwide as an indispensable resource to improve the management of isolated patients due to lockdown or shielding, including those with hypertension. The best proposed healthcare model for telemedicine in hypertension management should include remote monitoring and transmission of vital signs (notably blood pressure) and medication adherence plus education on lifestyle and risk factors, with video consultation as an option. The use of mixed automated feedback services with supervision of a multidisciplinary clinical team (physician, nurse, or pharmacist) is the ideal approach. The indications include screening for suspected hypertension, management of older adults, medically underserved people, high-risk hypertensive patients, patients with multiple diseases, and those isolated due to pandemics or national emergencies.
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http://dx.doi.org/10.1161/HYPERTENSIONAHA.120.15873DOI Listing
November 2020

Cardiovascular Events and Costs With Home Blood Pressure Telemonitoring and Pharmacist Management for Uncontrolled Hypertension.

Hypertension 2020 10 31;76(4):1097-1103. Epub 2020 Aug 31.

From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).

Uncontrolled hypertension is a leading contributor to cardiovascular disease. A cluster-randomized trial in 16 primary care clinics showed that 12 months of home blood pressure telemonitoring and pharmacist management lowered blood pressure more than usual care (UC) for 24 months. We report cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, hospitalized heart failure, coronary revascularization, and cardiovascular death) and costs over 5 years of follow-up. In the telemonitoring intervention (TI group, n=228), there were 15 cardiovascular events (5 myocardial infarction, 4 stroke, 5 heart failure, 1 cardiovascular death) among 10 patients. In UC group (n=222), there were 26 events (11 myocardial infarction, 12 stroke, 3 heart failure) among 19 patients. The cardiovascular composite end point incidence was 4.4% in the TI group versus 8.6% in the UC group (odds ratio, 0.49 [95% CI, 0.21-1.13], =0.09). Including 2 coronary revascularizations in the TI group and 10 in the UC group, the secondary cardiovascular composite end point incidence was 5.3% in the TI group versus 10.4% in the UC group (odds ratio, 0.48 [95% CI, 0.22-1.08], =0.08). Microsimulation modeling showed the difference in events far exceeded predictions based on observed blood pressure. Intervention costs (in 2017 US dollars) were $1511 per patient. Over 5 years, estimated event costs were $758 000 in the TI group and $1 538 000 in the UC group for a return on investment of 126% and a net cost savings of about $1900 per patient. Telemonitoring with pharmacist management lowered blood pressure and may have reduced costs by avoiding cardiovascular events over 5 years. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT00781365.
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http://dx.doi.org/10.1161/HYPERTENSIONAHA.120.15492DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7484110PMC
October 2020

Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial.

Gut 2021 Apr 3;70(4):717-724. Epub 2020 Aug 3.

School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.

Objective: There is a lack of robust data on significant gastrointestinal bleeding in older people using aspirin. We calculated the incidence, risk factors and absolute risk using data from a large randomised, controlled trial.

Design: Data were extracted from an aspirin versus placebo primary prevention trial conducted throughout 2010-2017 ('ASPirin in Reducing Events in the Elderly (ASPREE)', n=19 114) in community-dwelling persons aged ≥70 years. Clinical characteristics were collected at baseline and annually. The endpoint was major GI bleeding that resulted in transfusion, hospitalisation, surgery or death, adjudicated independently by two physicians blinded to trial arm.

Results: Over a median follow-up of 4.7 years (88 389 person years), there were 137 upper GI bleeds (89 in aspirin arm and 48 in placebo arm, HR 1.87, 95% CI 1.32 to 2.66, p<0.01) and 127 lower GI bleeds (73 in aspirin and 54 in placebo arm, HR 1.36, 95% CI 0.96 to 1.94, p=0.08) reflecting a 60% increase in bleeding overall. There were two fatal bleeds in the placebo arm. Multivariable analyses indicated age, smoking, hypertension, chronic kidney disease and obesity increased bleeding risk. The absolute 5-year risk of bleeding was 0.25% (95% CI 0.16% to 0.37%) for a 70 year old not on aspirin and up to 5.03% (2.56% to 8.73%) for an 80 year old taking aspirin with additional risk factors.

Conclusion: Aspirin increases overall GI bleeding risk by 60%; however, the 5-year absolute risk of serious bleeding is modest in younger, well individuals. These data may assist patients and their clinicians to make informed decisions about prophylactic use of aspirin.

Trial Registration Number: ASPREE. NCT01038583.
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http://dx.doi.org/10.1136/gutjnl-2020-321585DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7957959PMC
April 2021

Impact of the 2017 American Heart Association and American College of Cardiology hypertension guideline in aged individuals.

J Hypertens 2020 12;38(12):2527-2536

Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, Victoria.

Objectives: The AHA/ACC-2017 hypertension guideline recommends an age-independent target blood pressure (BP) of less than 130/80 mmHg. In an elderly cohort without established cardiovascular disease (CVD) at baseline, we determined the impact of this guideline on the prevalence of hypertension and associated CVD risk.

Methods: Nineteen thousand, one hundred and fourteen participants aged at least 65 years from the ASPirin in Reducing Events in the Elderly (ASPREE) study were grouped by baseline BP: 'pre-2017 hypertensive' (BP ≥140/90 mmHg and/or on antihypertensive drugs); 'reclassified hypertensive' (normotensive by pre-2017 guidelines; hypertensive by AHA/ACC-2017 guideline), and 'normotensive' (BP <130 and <80 mmHg). For each group, we evaluated CVD risk factors, predicted 10-year CVD risk using the Atherosclerotic Cardiovascular Disease (ASCVD) risk equation, and reported observed CVD event rates during a median 4.7-year follow-up.

Results: Overall, 74.4% (14 213/19 114) were 'pre-2017 hypertensive'; an additional 12.3% (2354/19 114) were 'reclassified hypertensive' by the AHA/ACC-2017 guideline. Of those 'reclassified hypertensive', the majority (94.5%) met criteria for antihypertensive treatment although 29% had no other traditional CVD risk factors other than age. Further, a relatively lower mean 10-year predicted CVD risk (18% versus 26%, P < 0.001) and lower CVD rates (8.9 versus 12.1/1000 person-years, P = 0.01) were observed in 'reclassified hypertensive' compared with 'pre-2017 hypertensive'. Compared with 'normotensive', a hazard ratio (95% confidence interval) for CVD events of 1.60 (1.26-2.02) for 'pre-2017 hypertensive' and 1.26 (0.93-1.71) for 'reclassified hypertensive' was observed.

Conclusion: Applying current CVD risk calculators in the elderly 'reclassified hypertensive', as a result of shifting the BP threshold lower, increases eligibility for antihypertensive treatment but documented CVD rates remain lower than hypertensive patients defined by pre2017 BP thresholds.
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http://dx.doi.org/10.1097/HJH.0000000000002582DOI Listing
December 2020

Association between post-stroke disability and 5-year hip-fracture risk: The Women's Health Initiative.

J Stroke Cerebrovasc Dis 2020 Aug 10;29(8):104976. Epub 2020 Jun 10.

Division of Epidemiology and Community Health, School of Public Health, University of Minnesota, Minneapolis, MN. Electronic address:

Background: Hip fractures are a significant post-stroke complication. We examined predictors of hip fracture risk after stroke using data from the Women's Health Initiative (WHI). In particular, we examined the association between post-stroke disability levels and hip fracture risk.

Methods: The WHI is a prospective study of 161,808 postmenopausal women aged 50-79 years. Trained physicians adjudicated stroke events and hip fractures. Our study included stroke survivors from the observational and clinical trial arms who had a Glasgow Outcome Scale of good recovery, moderately disabled, or severely disabled and survived more than 7 days post-stroke. Hip fracture-free status was compared across disability levels. Secondary analysis examined hip fracture risk while accounting for competing risk of death.

Results: Average age at time of stroke was 74.6±7.2 years; 84.3% were white. There were 124 hip fractures among 4,640 stroke survivors over a mean follow-up time of 3.1±1.8 years. Mortality rate was 23.3%. Severe disability at discharge (Hazard Ratio (HR): 2.1 (95% Confidence Interval (CI): 1.4-3.2), but not moderate disability (HR: 1.1 (95%CI: 0.7-1.7), was significantly associated with an increased risk of hip fracture compared to good recovery status. This association was attenuated after accounting for mortality. White race, increasing age and higher Fracture Risk Assessment Tool (FRAX)-predicted hip fracture risk (without bone density information) were associated with an increased hip fracture risk. After accounting for mortality, higher FRAX risk and white race remained significant.

Conclusion: Severe disability after stroke and a higher FRAX risk score were associated with risk of subsequent hip fracture. After accounting for mortality, only the FRAX risk score remained significant. The FRAX risk score appears to identify stroke survivors at high risk of fractures. Our results suggest that stroke units can consider the incorporation of osteoporosis screening into care pathways.
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http://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2020.104976DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7394038PMC
August 2020

Antihypertensive medication use and blood pressure control among treated older adults.

J Clin Hypertens (Greenwich) 2020 08 15;22(8):1406-1414. Epub 2020 Jul 15.

ASPREE Investigator Group listed at, www.ASPREE.org.

The association of different antihypertensive regimens with blood pressure (BP) control is not well-described among community-dwelling older adults with low comorbidity. We examined antihypertensive use and BP control in 10 062 treated hypertensives from Australia and the United States (US) using baseline data from the ASPirin in Reducing Events in the Elderly (ASPREE) trial. Renin-angiotensin system (RAS) drugs were the most prevalently used antihypertensive in both countries (Australia: 81.7% of all regimens; US: 62.9% of all regimens; P < .001). Diuretics were the next most commonly used antihypertensive in both countries, but were more often included in regimens of US participants (48.9%, vs 33.3% of regimens in Australia; P < .001). Among all antihypertensive classes and possible combinations, monotherapy with a RAS drug was the most common regimen in both countries, but with higher prevalence in Australian than US participants (35.9% vs 20.9%; P < .001). For both monotherapy and combination users, BP control rates across age, ethnicity, and sex were consistently lower in Australian than US participants. After adjustment for age, sex, ethnicity, and BMI, significantly lower BP control rates remained in Australian compared to US participants for the most commonly used classes and regimens (RAS blocker monotherapy: BP control = 45.5% vs 54.2%; P = .002; diuretic monotherapy: BP control = 45.2% vs 64.5%; P = .001; and RAS blocker/diuretic combo: BP control = 50.2% vs 65.6%; P = .001). Our findings highlight variation in antihypertensive use in older adults treated for hypertension, with implications for BP control. Differences in BP control that were observed may be influenced, in part, by reasons other than choice of specific regimens.
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http://dx.doi.org/10.1111/jch.13934DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7901812PMC
August 2020

Self-Measured Blood Pressure Monitoring at Home: A Joint Policy Statement From the American Heart Association and American Medical Association.

Circulation 2020 Jul 22;142(4):e42-e63. Epub 2020 Jun 22.

The diagnosis and management of hypertension, a common cardiovascular risk factor among the general population, have been based primarily on the measurement of blood pressure (BP) in the office. BP may differ considerably when measured in the office and when measured outside of the office setting, and higher out-of-office BP is associated with increased cardiovascular risk independent of office BP. Self-measured BP monitoring, the measurement of BP by an individual outside of the office at home, is a validated approach for out-of-office BP measurement. Several national and international hypertension guidelines endorse self-measured BP monitoring. Indications include the diagnosis of white-coat hypertension and masked hypertension and the identification of white-coat effect and masked uncontrolled hypertension. Other indications include confirming the diagnosis of resistant hypertension and detecting morning hypertension. Validated self-measured BP monitoring devices that use the oscillometric method are preferred, and a standardized BP measurement and monitoring protocol should be followed. Evidence from meta-analyses of randomized trials indicates that self-measured BP monitoring is associated with a reduction in BP and improved BP control, and the benefits of self-measured BP monitoring are greatest when done along with cointerventions. The addition of self-measured BP monitoring to office BP monitoring is cost-effective compared with office BP monitoring alone or usual care among individuals with high office BP. The use of self-measured BP monitoring is commonly reported by both individuals and providers. Therefore, self-measured BP monitoring has high potential for improving the diagnosis and management of hypertension in the United States. Randomized controlled trials examining the impact of self-measured BP monitoring on cardiovascular outcomes are needed. To adequately address barriers to the implementation of self-measured BP monitoring, financial investment is needed in the following areas: improving education and training of individuals and providers, building health information technology capacity, incorporating self-measured BP readings into clinical performance measures, supporting cointerventions, and enhancing reimbursement.
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http://dx.doi.org/10.1161/CIR.0000000000000803DOI Listing
July 2020

The Women's Health Initiative Estrogen-alone Trial had differential disease and medical expenditure consequences across age groups.

Menopause 2020 06;27(6):632-639

Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.

Objectives: The Women's Health Initiative (WHI) randomized trial identified age differences in the benefit-risk profile of estrogen-alone (ET) use. The impact of WHI trial on disease-associated medical expenditures attributable to subsequent decreased ET utilization has, however, not been measured. Therefore, the objective of this analysis was to quantify the age-specific disease-associated medical expenditures attributable to reduced ET utilization after the WHI Hormone Therapy (HT) trials.

Methods: Population-level disease counts and associated expenditures between 2003 and 2015 were compared between an observed ET-user population versus a hypothetical ET-user population assuming absence of the WHI HT trials, constructed by extrapolating ET utilization rates from 1996 to 2002 assuming pre-WHI HT rates would have continued without publication of the WHI HT trial data (2002-2004). Analyses were stratified by age (50-59, 60-69, and 70-79 years). Input data were extracted from Medical Expenditure Panel Survey and the literature. The primary outcomes were: ET utilization, chronic diseases (breast cancer, stroke, coronary heart disease, colorectal cancer, pulmonary embolism, and hip fracture) and disease-associated direct medical expenditures.

Results: Over 13 years, the decline in ET utilization was associated with $4.1 billion expenditure for excess chronic diseases (37,549 excess events) among women in their 50s, compared to savings of $1.5 billion and $4.4 billion for diseases averted by lower ET utilization among women in their 60s (13,495 fewer events) and 70s (40,792 fewer events), respectively.

Conclusion: The decline in ET utilization had differential disease and expenditure consequences by age groups in the United States. These results are limited by the lack of inclusion of vasomotor symptom benefit and costs of alternative medications for these symptoms in the analysis.
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http://dx.doi.org/10.1097/GME.0000000000001517DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7255959PMC
June 2020

Design of a pragmatic cluster-randomized trial comparing telehealth care and best practice clinic-based care for uncontrolled high blood pressure.

Contemp Clin Trials 2020 05 22;92:105939. Epub 2020 Jan 22.

Rutgers Robert Wood Johnson Medical School, Department of Family Medicine and Community Health, New Brunswick, NJ 08901, United States of America.

Background: Uncontrolled hypertension is the largest single contributor to all-cause and cardiovascular mortality in the U.S.

Population: Nurse- and pharmacist-led team-based care and telehealth care interventions have been shown to result in large and lasting improvements in blood pressure (BP); however, it is unclear how successfully these can be implemented at scale in real-world settings. It is also uncertain how telehealth interventions impact patient experience compared to traditional clinic-based care.

Aims/objectives: To compare the effects of two evidence-based blood pressure care strategies in the primary care setting: (1) best-practice clinic-based care and (2) telehealth care with home BP telemonitoring and management by a clinical pharmacist. To evaluate implementation using mixed-methods supported by the RE-AIM framework and Consolidated Framework for Implementation Research.

Methods: The design is a cluster-randomized comparative effectiveness pragmatic trial in 21 primary care clinics (9 clinic-based care, 12 telehealth care). Adult patients (age 18-85) with hypertension are enrolled via automated electronic health record (EHR) tools during primary care encounters if BP is elevated to ≥150/95 mmHg at two consecutive visits. The primary outcome is change in systolic BP over 12 months as extracted from the EHR. Secondary outcomes are change in key patient-reported outcomes over 6 months as measured by surveys. Qualitative data are collected at various time points to investigate implementation barriers and help explain intervention effects.

Conclusion: This pragmatic trial aims to inform health systems about the benefits, strengths, and limitations of implementing home BP telemonitoring with pharmacist management for uncontrolled hypertension in real-world primary care settings.
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http://dx.doi.org/10.1016/j.cct.2020.105939DOI Listing
May 2020

Factors Associated With Treatment and Control of Hypertension in a Healthy Elderly Population Free of Cardiovascular Disease: A Cross-sectional Study.

Am J Hypertens 2020 04;33(4):350-361

Department of Epidemiology & Preventive Medicine, Monash University, Melbourne, VIC, Australia.

Background: Despite readily available treatments, control of blood pressure (BP) with population aging remains suboptimal. Further, there are gaps in the understanding of the management of high BP in the aged. We explored antihypertensive treatment and control among elderly hypertensive participants free from overt cardiovascular disease (CVD), and identified factors related to both "untreated" and "treated but uncontrolled" high BP.

Methods: We analyzed baseline data from 19,114 individuals aged ≥65 years enrolled from Australia and United States (US) in the ASPirin in Reducing Events in the Elderly study. Hypertension was defined as an average systolic/diastolic BP ≥140/90 mm Hg and/or the use of any BP lowering medication. "Controlled hypertension" was defined if participants were receiving antihypertensive medication and BP <140 and 90 mm Hg. Descriptive analyses were used to summarize hypertension control rates; logistic regression was used to investigate relationships with treatment and BP control.

Results: Overall, 74% (14,213/19,114) of participants were hypertensive; and of these 29% (4,151/14,213) were untreated. Among those treated participants, 53% (5,330/10,062) had BP ≥140/90 mm Hg. Participants who were untreated were more likely to be men, have higher educational status, and be in good physical health, and less likely to have significant comorbidities. The factors related to "treated but uncontrolled" BP included older age, male, Black race (vs. White), using antihypertensive monotherapy (vs. multiple) and residing in Australia (vs. US).

Conclusions: High levels of "untreated" and "treated but uncontrolled" BP occur in healthy elderly people without CVD, suggesting there are opportunities for better BP control in the primary prevention of CVD in this population.

Clinical Trials Registration: NCT01038583.
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http://dx.doi.org/10.1093/ajh/hpz192DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7109352PMC
April 2020

Antihypertensive Medication Use in Older Adults at Risk for Hip Fracture.

Authors:
Karen L Margolis

JAMA 2019 10;322(16):1608-1609

HealthPartners Institute, Minneapolis, Minnesota.

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http://dx.doi.org/10.1001/jama.2019.13951DOI Listing
October 2019

Effect of Depression Screening After Acute Coronary Syndromes on Quality of Life: The CODIACS-QoL Randomized Clinical Trial.

JAMA Intern Med 2020 Jan;180(1):45-53

Department of Medicine, Northwell Health, New York, New York.

Importance: Patients with acute coronary syndrome (ACS) and elevated depressive symptoms are at increased risk for recurrent cardiovascular events and mortality, worse quality of life, and higher health care costs. These observational findings prompted multiple scientific panels to advise universal depression screening in survivors of ACS prior to evidence from randomized screening trials.

Objective: To determine whether systematically screening for depression in survivors of ACS improves quality of life and depression compared with usual care.

Design, Setting, And Participants: A 3-group multisite randomized trial enrolled 1500 patients with ACS from 4 health care systems between November 1, 2013, and March 31, 2017, with follow-up ending July 31, 2018. Patients were eligible if they had been hospitalized for ACS in the previous 2 to 12 months and had no prior history of depression. All analyses were performed on an intention-to-treat basis.

Interventions: Patients with ACS were randomly assigned 1:1:1 to receive (1) systematic depression screening using the 8-item Patient Health Questionnaire, with notification of primary care clinicians and provision of centralized, patient-preference, stepped depression care for those with positive screening results (8-item Patient Health Questionnaire score ≥10; screen, notify, and treat, n = 499); (2) systematic depression screening, with notification of primary care clinicians for those with positive screening results (screen and notify, n = 501); and (3) usual care (no screening, n = 500).

Main Outcomes And Measures: The primary outcome was change in quality-adjusted life-years. The secondary outcome was depression-free days. Adverse effects and mortality were assessed by patient interview and hospital records.

Results: A total of 1500 patients (424 women and 1076 men; mean [SD] age, 65.9 [11.5] years) were randomized in the 18-month trial. Only 71 of 1000 eligible survivors of ACS (7.1%) had elevated 8-item Patient Health Questionnaire scores indicating depressive symptoms at screening. There were no differences in mean (SD) change in quality-adjusted life-years (screen, notify and treat, -0.06 [0.20]; screen and notify, -0.06 [0.20]; no screen, -0.06 [0.18]; P = .98) or cumulative mean (SD) depression-free days (screen, notify and treat, 343.1 [179.0] days; screen and notify, 351.3 [175.0] days; no screen, 339.0 [176.6] days; P = .63). Harms including death, bleeding, or sleep difficulties did not differ among groups.

Conclusions And Relevance: In patients with ACS without a history of depression, systematic depression screening with or without providing depression treatment did not alter quality-adjusted life-years, depression-free days, or harms.

Trial Registration: ClinicalTrials.gov identifier: NCT01993017.
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http://dx.doi.org/10.1001/jamainternmed.2019.4518DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6806435PMC
January 2020

Rationale, design, and baseline data for a multicenter randomized clinical trial comparing depression screening strategies after acute coronary syndrome: The comparison of depression identification after acute Coronary Syndromes-Quality of Life and Cost Outcomes (CODIACS-QOL) trial.

Contemp Clin Trials 2019 09 13;84:105826. Epub 2019 Aug 13.

Columbia University Medical Center, New York, NY, United States of America.

Background: Elevated depressive symptoms among survivors of acute coronary syndromes (ACS) confer recurrent cardiovascular events and mortality, worse quality of life, and higher healthcare costs. While multiple scientific groups advise routine depression screening for ACS survivors, no randomized trials exist to inform this screening recommendation. We aimed to assess the effect of screening for depression on change in quality of life over 18 months among ACS patients.

Methods: The Comparison of Depression Identification after Acute Coronary Syndrome on Quality of Life and Cost Outcomes (CODIACS-QoL) trial is a pragmatic, 3-arm trial that randomized ACS patients to 1) systematic depression screening using the 8-item Patient Health Questionnaire (PHQ-8) and if positive screen (PHQ-8 ≥ 10), notification of primary care providers (PCPs) and invitation to participate in centralized, patient-preference, stepped depression care (Screen, Notify, and Treat, N = 499); 2) systematic depression screening and PCP notification only (Screen and Notify, N = 501); and 3) usual care (No Screen, N = 500). Adults hospitalized for ACS in the previous 2-12 months without prior history of depression were eligible for participation. Key outcomes will be quality-adjusted life years (primary), cost of health care utilization, and depression-free days across 18 months.

Results: A total of 1500 patients were randomized in the CODIACS-QOL trial (28.3% women; 16.3% Hispanic; mean age 65.9 (11.5) years). Only 7% of ACS survivors had elevated depressive symptoms.

Conclusions: Using a novel randomization schema and pragmatic design principles, the CODIACS-QoL trial achieved its enrollment target. Eventual results of this trial will inform future depression screening recommendations in cardiac patients.

Trial Registration: ClinicalTrials.gov (NCT01993017).
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http://dx.doi.org/10.1016/j.cct.2019.105826DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6754099PMC
September 2019

Improving Health and Well-Being: Connecting Research and Practice. The 24th Annual Conference of the Health Care Systems Research Network.

J Patient Cent Res Rev 2018 30;5(3):244-247. Epub 2018 Jul 30.

HealthPartners Institute, Minneapolis, MN.

The 24th annual conference of the Health Care Systems Research Network (HCSRN, formerly the HMO Research Network), held April 11-13, 2018, in Minneapolis, Minnesota, attracted 357 attendees. The HCSRN is a consortium of 18 community-based research organizations embedded in or affiliated with large health care delivery systems. Its annual research conference, held since 1994, is a unique venue that brings diverse stakeholders (eg, research teams, clinicians, patients, funders) together to explore a range of health research topics and scientific findings, with a unifying goal of connecting applied research to real-world care delivery for the betterment of individual and community health. The 2018 conference was hosted by Minneapolis-based HealthPartners Institute and organized around 3 tracks: Research & Results, Practical Application, and Data Science & Informatics. Themes of the 4 plenary, 7 panel, 36 oral abstract, and 111 poster presentations included the learning health system, the opioid epidemic, health disparities, high costs of care, informing population health policy with evidence, and how to use storytelling to present data to inspire change, among others.
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http://dx.doi.org/10.17294/2330-0698.1641DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6664328PMC
July 2018

PCSK9 Inhibitor Use in the Real World: Data From the National Patient-Centered Research Network.

J Am Heart Assoc 2019 05;8(9):e011246

4 Colleges of Pharmacy and Medicine University of Florida Gainesville FL.

Background PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors effectively lower LDL (low-density lipoprotein) cholesterol and have been shown to reduce cardiovascular outcomes in high-risk patients. We used real-world electronic health record data to characterize use of PCSK9 inhibitors, in addition to standard therapies, according to cardiovascular risk status. Methods and Results Data were obtained from 18 health systems with data marts within the National Patient-Centered Clinical Research Network (PCORnet) using a common data model. Participating sites identified >17.5 million adults, of whom 3.6 million met study criteria. Patients were categorized into 3 groups: (1) dyslipidemia, (2) untreated LDL ≥130 mg/dL, and (3) coronary artery disease or coronary heart disease. Demographics, comorbidities, estimated 10-year atherosclerotic cardiovascular disease risk, and lipid-lowering pharmacotherapies were summarized for each group. Participants' average age was 62 years, 50% were female, and 11% were black. LDL cholesterol ranged from 85 to 151 mg/dL. Among patients in groups 1 and 3, 54% received standard lipid-lowering therapies and a PCSK9 inhibitor was prescribed in <1%. PCSK9 inhibitor prescribing was greatest for patients with coronary artery disease or coronary heart disease and, although prescribing increased during the study period, overall PCSK9 inhibitor prescribing was low. Conclusions We successfully used electronic health record data from 18 PCORnet data marts to identify >3.6 million patients meeting criteria for 3 patient groups. Approximately half of patients had been prescribed lipid-lowering medication, but <1% were prescribed PCSK9 inhibitors. PCSK9 inhibitor prescribing increased over time for patients with coronary artery disease or coronary heart disease but not for those with dyslipidemia.
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http://dx.doi.org/10.1161/JAHA.118.011246DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6512121PMC
May 2019

Priorities Wizard: Multisite Web-Based Primary Care Clinical Decision Support Improved Chronic Care Outcomes with High Use Rates and High Clinician Satisfaction Rates.

EGEMS (Wash DC) 2019 Apr 3;7(1). Epub 2019 Apr 3.

HealthPartners Institute, US.

Introduction: Priorities Wizard is an electronic health record-linked, web-based clinical decision support (CDS) system designed and implemented at multiple Health Care Systems Research Network (HCSRN) sites to support high quality outpatient chronic disease and preventive care. The CDS system (a) identifies patients who could substantially benefit from evidence-based actions; (b) presents prioritized evidence-based treatment options to both patient and clinician at the point of care; and (c) facilitates efficient ordering of recommended medications, referrals or procedures.

Methods: The CDS system extracts relevant data from electronic health records (EHRs), processes the data using Web-based clinical decision support algorithms, and displays the CDS output seamlessly on the EHR screen for use by the clinician and patient. Through a series of National Institutes of Health-funded projects led by HealthPartners Institute and the HealthPartners Center for Chronic Care Innovation and HCSRN partners, Priorities Wizard has been evaluated in cluster-randomized trials and expanded to include over 20 clinical domains.

Results: Cluster-randomized trials show that this CDS system significantly improved glucose and blood pressure control in diabetes patients, reduced 10-year cardiovascular (CV) risk in high-CV risk adults without diabetes, improved management of smoking in dental patients, and improved high blood pressure identification and management in adolescents. CDS output was used at 71-77 percent of targeted visits, 85-98 percent of clinicians were satisfied with the CDS system, and 94 percent reported they would recommend it to colleagues.

Conclusions: Recently developed EHR-linked, Web-based CDS systems have significantly improved chronic disease care outcomes and have high use rates and primary care clinician satisfaction.
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http://dx.doi.org/10.5334/egems.284DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6450247PMC
April 2019

Blood Pressure Assessment in Adults in Clinical Practice and Clinic-Based Research: JACC Scientific Expert Panel.

J Am Coll Cardiol 2019 01;73(3):317-335

Department of Medicine, Johns Hopkins University, Baltimore, Maryland.

The accurate measurement of blood pressure (BP) is essential for the diagnosis and management of hypertension. Restricted use of mercury devices, increased use of oscillometric devices, discrepancies between clinic and out-of-clinic BP, and concerns about measurement error with manual BP measurement techniques have resulted in uncertainty for clinicians and researchers. The National Heart, Lung, and Blood Institute of the U.S. National Institutes of Health convened a working group of clinicians and researchers in October 2017 to review data on BP assessment among adults in clinical practice and clinic-based research. In this report, the authors review the topics discussed during a 2-day meeting including the current state of knowledge on BP assessment in clinical practice and clinic-based research, knowledge gaps pertaining to current BP assessment methods, research and clinical needs to improve BP assessment, and the strengths and limitations of using BP obtained in clinical practice for research and quality improvement activities.
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http://dx.doi.org/10.1016/j.jacc.2018.10.069DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6573014PMC
January 2019

Long-term Outcomes of the Effects of Home Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure Among Adults With Uncontrolled Hypertension: Follow-up of a Cluster Randomized Clinical Trial.

JAMA Netw Open 2018 09 7;1(5):e181617. Epub 2018 Sep 7.

HealthPartners Institute for Education and Research, Minneapolis, Minnesota.

Importance: Hypertension is a leading cause of cardiovascular disease. The results were previously reported of a trial of home blood pressure (BP) telemonitoring and pharmacist management intervention in which the interventions stopped after 12 months. There were significantly greater reductions in systolic BP (SBP) in the intervention group than in the usual care group at 6, 12, and 18 months (-10.7, -9.7, and -6.6 mm Hg, respectively).

Objectives: To examine the durability of the intervention effect on BP through 54 months of follow-up and to compare BP measurements performed in the research clinic and in routine clinical care.

Design, Setting, And Participants: Follow-up of a cluster randomized clinical trial among 16 primary care clinics and 450 patients with uncontrolled hypertension in a large health system from March 2009 to November 2015.

Interventions: A home BP telemonitoring intervention with pharmacist management or usual care.

Main Outcomes And Measures: Change from baseline to 54 months in SBP and diastolic BP (DBP) measured as the mean of 3 measurements obtained at each research clinic visit.

Results: Among 450 patients, 228 (mean [SD] age, 62.0 [11.7] years; 54.8% male) were randomized to the telemonitoring intervention and 222 (mean [SD] age, 60.2 [12.2] years; 55.9% male) to usual care. Research clinic BP measurements were obtained from 326 of 450 (72.4%) study patients at the 54-month follow-up visit, including 162 (mean [SD] age, 62.0 [11.1] years; 54.9% male) randomized to the telemonitoring intervention and 164 (mean [SD] age, 60.0 [11.2] years; 57.3% male) to usual care. Routine clinical care BP measurements were obtained from 439 of 450 (97.6%) study patients at 6248 visits during the follow-up period. Based on research clinic measurements, baseline mean SBP was 148 mm Hg in both groups. In the intervention group, mean SBP at 6-, 12-, 18-, and 54-month follow-up was 126.7, 125.7, 126.9, and 130.6 mm Hg, respectively. In the usual care group, mean SBP at 6-, 12-, 18-, and 54-month follow-up was 136.9, 134.8, 133.0, and 132.6 mm Hg, respectively. The differential reduction by study group in SBP from baseline to 54 months was -2.5 mm Hg (95% CI, -6.3 to 1.2 mm Hg; P = .18). The DBP followed a similar pattern, with a differential reduction by study group from baseline to 54 months of -1.0 mm Hg (95% CI, -3.2 to 1.2 mm Hg; P = .37). The SBP and DBP results from routine clinical measurements suggested significantly lower BP in the intervention group for up to 24 months.

Conclusions And Relevance: This intensive intervention had sustained effects for up to 24 months (12 months after the intervention ended). Long-term maintenance of BP control is likely to require continued monitoring and resumption of the intervention if BP increases.

Trial Registration: ClinicalTrials.gov Identifier: NCT00781365.
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http://dx.doi.org/10.1001/jamanetworkopen.2018.1617DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6324502PMC
September 2018

Blood pressure checks and diagnosing hypertension (BP-CHECK): Design and methods of a randomized controlled diagnostic study comparing clinic, home, kiosk, and 24-hour ambulatory BP monitoring.

Contemp Clin Trials 2019 04 8;79:1-13. Epub 2019 Jan 8.

University of Washington, Department of Family Medicine, United States.

Background: The US Preventive Services Task Force recommends out-of-office blood pressure (BPs) before making a new diagnosis of hypertension, using 24-h ambulatory (ABPM) or home BP monitoring (HBPM), however this is not common in routine clinical practice. Blood Pressure Checks and Diagnosing Hypertension (BP-CHECK) is a randomized controlled diagnostic study assessing the comparability and acceptability of clinic, home, and kiosk-based BP monitoring to ABPM for diagnosing hypertension. Stakeholders including patients, providers, policy makers, and researchers informed the study design and protocols.

Methods: Adults aged 18-85 without diagnosed hypertension and on no hypertension medication with elevated BPs in clinic and at the baseline research visit are randomized to one of 3 regimens for diagnosing hypertension: (1) clinic BPs, (2) home BPs, or (3) kiosk BPs; all participants subsequently complete ABPM. The primary outcomes are the comparability (with daytime ABPM mean systolic and diastolic BP as the reference standard) and acceptability (e.g., adherence to, patient-reported outcomes) of each method compared to ABPM. Longer-term outcomes are assessed at 6-months including: patient-reported outcomes, primary care providers' diagnosis of hypertension; and BP control. We report challenges experienced and our response to these.

Results: Enrollment began in May of 2017 with a target of randomizing 510 participants. BP thresholds for diagnosing hypertension in the US changed after the trial started. We discuss the stakeholder process used to assess and respond to these changes.

Conclusion And Public Health Impact: BP-CHECK will inform which hypertension diagnostic methods are most accurate, acceptable, and feasible to implement in primary care.
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http://dx.doi.org/10.1016/j.cct.2019.01.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7067555PMC
April 2019

Hypertension Treatment and Control and Risk of Falls in Older Women.

J Am Geriatr Soc 2019 04 7;67(4):726-733. Epub 2019 Jan 7.

Division of Epidemiology, Department of Family and Preventive Medicine, University of California San Diego, La Jolla, California.

Background/objectives: A lower risk of falls is commonly cited as a reason to treat hypertension conservatively in older individuals. We examined the effect of hypertension treatment and control status and measured blood pressure (BP) level on the risk of falls in older women.

Design/setting: Prospective cohort study.

Participants: A total of 5971 women (mean age 79 years; 50.4% white, 33.1% black, 16.5% Hispanic/Latina) enrolled in the Women's Health Initiative and Objective Physical Activity and Cardiovascular Health study.

Measurements: BP was measured by trained nurses, and hypertension treatment was assessed by medication inventory. Participants mailed in monthly calendars to self-report falls for 1 year.

Results: Overall, 70% of women had hypertension at baseline (53% treated and controlled, 12% treated and uncontrolled, 5% untreated). There were 2582 women (43%) who reported falls in the 1 year of surveillance. Compared with nonhypertensive women, when adjusted for fall risk factors and lower limb physical function, the incidence rate ratio (IRR) for falls was 0.82 (confidence interval [CI] = 0.74-0.92) in women with treated controlled hypertension (p = .0008) and 0.73 (CI = 0.62-0.87) in women with treated uncontrolled hypertension (p = .0004). Neither measured systolic nor diastolic BP was associated with falls in the overall cohort. In women treated with antihypertensive medication, higher diastolic BP was associated with a lower risk of falls in a model adjusted for fall risk factors (IRR = 0.993 per mm Hg; 95% CI = 0.987-1.000; p = .04). The only class of antihypertensive medication associated with an increased risk of falls compared with all other types of antihypertensive drugs was β-blockers.

Conclusion: Women in this long-term research study with treated hypertension had a lower risk of falls compared with nonhypertensive women. Diastolic BP (but not systolic BP) is weakly associated with fall risk in women on antihypertensive treatment (<1% decrease in risk per mm Hg increase). J Am Geriatr Soc, 2019. J Am Geriatr Soc 67:726-733, 2019.
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http://dx.doi.org/10.1111/jgs.15732DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6458056PMC
April 2019

Accuracy of self-reported weight in the Women's Health Initiative.

Public Health Nutr 2019 04 19;22(6):1019-1028. Epub 2018 Nov 19.

12HealthPartners Institute,Minneapolis, MN,USA.

Objective: To assess the extent of error present in self-reported weight data in the Women's Health Initiative, variables that may be associated with error, and to develop methods to reduce any identified error.

Design: Prospective cohort study.

Setting: Forty clinical centres in the USA.ParticipantsWomen (n 75 336) participating in the Women's Health Initiative Observational Study (WHI-OS) and women (n 6236) participating in the WHI Long Life Study (LLS) with self-reported and measured weight collected about 20 years later (2013-2014).

Results: The correlation between self-reported and measured weights was 0·97. On average, women under-reported their weight by about 2 lb (0·91 kg). The discrepancies varied by age, race/ethnicity, education and BMI. Compared with normal-weight women, underweight women over-reported their weight by 3·86 lb (1·75 kg) and obese women under-reported their weight by 4·18 lb (1·90 kg) on average. The higher the degree of excess weight, the greater the under-reporting of weight. Adjusting self-reported weight for an individual's age, race/ethnicity and education yielded an identical average weight to that measured.

Conclusions: Correlations between self-reported and measured weights in the WHI are high. Discrepancies varied by different sociodemographic characteristics, especially an individual's BMI. Correction of self-reported weight for individual characteristics could improve the accuracy of assessment of obesity status in postmenopausal women.
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http://dx.doi.org/10.1017/S1368980018003002DOI Listing
April 2019

Breastfeeding History and Risk of Stroke Among Parous Postmenopausal Women in the Women's Health Initiative.

J Am Heart Assoc 2018 09;7(17):e008739

11 Stanford Prevention Research Center Stanford University Stanford CA.

Background Stroke is the third leading cause of death among US Hispanic and non-Hispanic black women aged 65 and older. One factor that may protect against stroke is breastfeeding. Few studies have assessed the association between breastfeeding and stroke and whether this association differs by race and ethnicity. Methods and Results Data were taken from the Women's Health Initiative Observational Study with follow-up through 2010; adjusted hazard ratios for stroke subsequent to childbirth were estimated with Cox regression models accounting for left and right censoring, overall and stratified by race/ethnicity. Of the 80 191 parous women in the Women's Health Initiative Observational Study, 2699 (3.4%) had experienced a stroke within a follow-up period of 12.6 years. The average age was 63.7 years at baseline. Fifty-eight percent (n=46 699) reported ever breastfeeding; 83% were non-Hispanic white, 8% were non-Hispanic black, 4% were Hispanic, and 5% were of other race/ethnicity. After adjustment for nonmodifiable potential confounders, compared with women who had never breastfed, women who reported ever breastfeeding had a 23% lower risk of stroke (adjusted hazard ratio=0.77; 95% confidence interval 0.70-0.83). This association was strongest for non-Hispanic black women (adjusted hazard ratio=0.52; 95% confidence interval 0.37-0.71). Further, breastfeeding for a relatively short duration (1-6 months) was associated with a 19% lower risk of stroke (adjusted hazard ratios=0.81; 95% confidence interval 0.74-0.89). This association appeared stronger with longer breastfeeding duration and among non-Hispanic white and non-Hispanic black women (test for trend P<0.01). Conclusions Study results show an association and dose-response relationship between breastfeeding and lower risk of stroke among postmenopausal women after adjustment for multiple stroke risk factors and lifestyle variables. Further investigation is warranted.
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http://dx.doi.org/10.1161/JAHA.118.008739DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6201437PMC
September 2018

Smoking cessation, weight gain, and risk of stroke among postmenopausal women.

Prev Med 2019 01 22;118:184-190. Epub 2018 Oct 22.

Indiana University School of Public Health, 1025 E. 7th Street, Bloomington, IN 47405, United States of America. Electronic address:

The relationship between smoking cessation, concurrent weight gain, and stroke events is not yet understood. Thus, we examined the association between smoking cessation and subsequent stroke risk and whether the association was modified by concurrent weight gain. In 2017, we analyzed data from 109,498 postmenopausal US women enrolled in the Women's Health Initiative from 1993 to 1998. Women with a history of cancer or cardiovascular disease events were excluded. The median length of follow-up time was 14.01 years. Variables of primary focus were smoking cessation, weight change, and clinically confirmed incident cases of hemorrhagic and ischemic stroke. Hazard ratios were estimated for stroke incidences (all, ischemic, and hemorrhagic) associated with smoking cessation using Cox regression. The exposure-outcome relationship of smoking cessation and risk of stroke was evaluated for effect modification by weight change. Recent quitters between baseline and year 3 had a significantly lower risk for all stroke and ischemic stroke, but not hemorrhagic stroke, when compared to the reference group of continuing smokers. In the multivariable-adjusted model for ischemic stroke, the hazard ratio for recent quitters was 0.66 (95% CI: 0.46, 0.95). In the model for hemorrhagic stroke, the hazard ratio for recent quitters was 0.76 (95% CI: 0.36, 1.61). The association between recent quitting and stroke risk was not significantly modified by weight change. Smoking cessation was associated with a significant reduction in stroke risk. The benefit of smoking cessation on the risk of stroke was not attenuated by concurrent weight gain.
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http://dx.doi.org/10.1016/j.ypmed.2018.10.018DOI Listing
January 2019

Economic Evaluation of the Home Blood Pressure Telemonitoring and Pharmacist Case Management to Control Hypertension (Hyperlink) Trial.

J Am Coll Clin Pharm 2018 Oct 14;1(1):21-30. Epub 2018 Apr 14.

HealthPartners Institute, Minneapolis, MN.

Background: Pharmacist-managed (team-based) care for hypertension with home blood pressure monitoring support interventions have been widely studied and shown to be effective in improving rates of hypertension control and lowering blood pressure; however, few studies have evaluated the economic considerations related to bringing these programs into usual practice.

Objective: To analyze the economic outcomes of the Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure (Hyperlink) study, a cluster randomized controlled trial which used home blood pressure telemonitoring and pharmacist case management to achieve better blood pressure control in patients with uncontrolled hypertension.

Methods: A prospective analysis compared differences in medical costs and encounters in the Hyperlink telemonitoring intervention and usual care groups in the 12 months pre- and post-enrollment using medical and pharmacy insurance claims from a health care sector perspective. Generalized estimating equation models were used to estimate differences between groups over time. These results, combined with previously published prospective study results on intervention costs and blood pressure outcomes, were used to estimate cost-effectiveness measures for blood pressure control and reduction.

Findings: Total medical costs in the intervention group were lower compared with the usual care group by an average of $281 per person, but this difference was not statistically significant. Clinic-based office visit, radiology, pharmacy, and hospital costs were also non-significantly lower in the intervention group. Statistically significant differences were found in lipid-related laboratory costs (higher) and in hypertension- (higher) and lipid-related (lower) pharmacy costs. Patterns in medical costs were similar for medical encounters. On average, the intervention cost $7337 per person achieving hypertension control and $139 or $265 per mm Hg reduction in systolic or diastolic blood pressure, respectively.

Conclusions: Home blood pressure monitoring and pharmacist case management to improve hypertension care can be implemented without increasing, and potentially reducing, overall medical care costs.
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http://dx.doi.org/10.1002/jac5.1001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6181443PMC
October 2018

Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly.

N Engl J Med 2018 10 16;379(16):1509-1518. Epub 2018 Sep 16.

From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.W., R.L.W., A.M.T., M.R.N., C.M.R., J.E.L., E.S., S.M.F., S.G.O., R.E.T., C.I.J., J.R., E.M.W., S.E.M.), Baker Heart and Diabetes Institute (C.I.J.), the Department of Cardiology, St. Vincent's Hospital (M.J.), and the Department of Clinical Neurosciences, Central Clinical School, Monash University and Alfred Hospital (G.C.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology and Environment, Australian National University, Canberra, ACT (W.P.A.), and the Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; the Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, Hennepin Healthcare and the University of Minnesota (A.M.M.), Minneapolis, and the School of Nursing, Minnesota State University, Mankato (D.B.) - all in Minnesota; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.); the Department of Cardiovascular Medicine, Vascular Medicine Section, Cleveland Clinic, Cleveland (M.M.); the Center for Primary Care and Prevention, Brown University, Providence, RI (C.B.E.); and the University of Tennessee Health Science Center, Memphis (S.S.).

Background: Aspirin is a well-established therapy for the secondary prevention of cardiovascular events. However, its role in the primary prevention of cardiovascular disease is unclear, especially in older persons, who have an increased risk.

Methods: From 2010 through 2014, we enrolled community-dwelling men and women in Australia and the United States who were 70 years of age or older (or ≥65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or disability. Participants were randomly assigned to receive 100 mg of enteric-coated aspirin or placebo. The primary end point was a composite of death, dementia, or persistent physical disability; results for this end point are reported in another article in the Journal. Secondary end points included major hemorrhage and cardiovascular disease (defined as fatal coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal stroke, or hospitalization for heart failure).

Results: Of the 19,114 persons who were enrolled in the trial, 9525 were assigned to receive aspirin and 9589 to receive placebo. After a median of 4.7 years of follow-up, the rate of cardiovascular disease was 10.7 events per 1000 person-years in the aspirin group and 11.3 events per 1000 person-years in the placebo group (hazard ratio, 0.95; 95% confidence interval [CI], 0.83 to 1.08). The rate of major hemorrhage was 8.6 events per 1000 person-years and 6.2 events per 1000 person-years, respectively (hazard ratio, 1.38; 95% CI, 1.18 to 1.62; P<0.001).

Conclusions: The use of low-dose aspirin as a primary prevention strategy in older adults resulted in a significantly higher risk of major hemorrhage and did not result in a significantly lower risk of cardiovascular disease than placebo. (Funded by the National Institute on Aging and others; ASPREE ClinicalTrials.gov number, NCT01038583 .).
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http://dx.doi.org/10.1056/NEJMoa1805819DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6289056PMC
October 2018

Effect of Aspirin on Disability-free Survival in the Healthy Elderly.

N Engl J Med 2018 10 16;379(16):1499-1508. Epub 2018 Sep 16.

From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., R.L.W., M.R.N., C.M.R., R.W., E.S., J.E.L., A.M.T., S.M.F., S.G.O., R.E.T., C.I.J., J.R.), the Walter and Eliza Hall Institute of Medical Research (P.G.), and the Baker Heart and Diabetes Institute (C.I.J.), Melbourne, and the Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, the College of Medicine, Biology, and Environment, Australian National University, Canberra, ACT (W.P.A.), and Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Hennepin Healthcare (B.K., R.G., A.M.M.), HealthPartners Institute (K.L.M.), and the Division of Geriatrics, Department of Medicine, University of Minnesota (A.M.M.) - all in Minneapolis; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); the Center for Aging and Population Health, University of Pittsburgh, Pittsburgh (A.B.N.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); and the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.).

Background: Information on the use of aspirin to increase healthy independent life span in older persons is limited. Whether 5 years of daily low-dose aspirin therapy would extend disability-free life in healthy seniors is unclear.

Methods: From 2010 through 2014, we enrolled community-dwelling persons in Australia and the United States who were 70 years of age or older (or ≥65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or physical disability. Participants were randomly assigned to receive 100 mg per day of enteric-coated aspirin or placebo orally. The primary end point was a composite of death, dementia, or persistent physical disability. Secondary end points reported in this article included the individual components of the primary end point and major hemorrhage.

Results: A total of 19,114 persons with a median age of 74 years were enrolled, of whom 9525 were randomly assigned to receive aspirin and 9589 to receive placebo. A total of 56.4% of the participants were women, 8.7% were nonwhite, and 11.0% reported previous regular aspirin use. The trial was terminated at a median of 4.7 years of follow-up after a determination was made that there would be no benefit with continued aspirin use with regard to the primary end point. The rate of the composite of death, dementia, or persistent physical disability was 21.5 events per 1000 person-years in the aspirin group and 21.2 per 1000 person-years in the placebo group (hazard ratio, 1.01; 95% confidence interval [CI], 0.92 to 1.11; P=0.79). The rate of adherence to the assigned intervention was 62.1% in the aspirin group and 64.1% in the placebo group in the final year of trial participation. Differences between the aspirin group and the placebo group were not substantial with regard to the secondary individual end points of death from any cause (12.7 events per 1000 person-years in the aspirin group and 11.1 events per 1000 person-years in the placebo group), dementia, or persistent physical disability. The rate of major hemorrhage was higher in the aspirin group than in the placebo group (3.8% vs. 2.8%; hazard ratio, 1.38; 95% CI, 1.18 to 1.62; P<0.001).

Conclusions: Aspirin use in healthy elderly persons did not prolong disability-free survival over a period of 5 years but led to a higher rate of major hemorrhage than placebo. (Funded by the National Institute on Aging and others; ASPREE ClinicalTrials.gov number, NCT01038583 .).
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http://dx.doi.org/10.1056/NEJMoa1800722DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6426126PMC
October 2018

Effect of Aspirin on All-Cause Mortality in the Healthy Elderly.

N Engl J Med 2018 10 16;379(16):1519-1528. Epub 2018 Sep 16.

From the Department of Epidemiology and Preventive Medicine, Monash University (J.J.M., M.R.N., R.L.W., J.E.L., R.W., C.M.R., E.S., J.R., A.M.T., S.M.F., S.G.O., R.E.T., C.I.J.), Walter and Eliza Hall Institute of Medical Research (P.G.), and Baker Heart and Diabetes Institute (C.I.J.), Melbourne, and Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville (G.A.D.), VIC, Menzies Institute for Medical Research, University of Tasmania, Hobart (M.R.N.), the School of Public Health, Curtin University (C.M.R.), and the School of Medicine, Royal Perth Hospital, University of Western Australia (L.J.B.), Perth, College of Medicine, Biology, and Environment, Australian National University, Canberra, ACT (W.P.A.), and Discipline of General Practice, University of Adelaide, Adelaide, SA (N.S.) - all in Australia; Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute (B.K., R.G., A.M.M.), and the Division of Geriatrics, Department of Medicine (A.M.M.), Hennepin Healthcare, HealthPartners Institute (K.L.M.), and the University of Minnesota (A.M.M.) - all in Minneapolis; the Department of Family Medicine and Rush Alzheimer's Disease Center, Rush University Medical Center, Chicago (R.C.S.); the Center for Aging and Population Health, Department of Epidemiology, University of Pittsburgh, Pittsburgh (D.G.I., A.B.N.); Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC (J.D.W.); the Department of Pharmacy Practice and Science, College of Pharmacy and Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City (M.E.E.); and the Division of Geriatrics and Clinical Gerontology, National Institute on Aging, Bethesda, MD (B.R.).

Background: In the primary analysis of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, now published in the Journal, we report that the daily use of aspirin did not provide a benefit with regard to the primary end point of disability-free survival among older adults. A numerically higher rate of the secondary end point of death from any cause was observed with aspirin than with placebo.

Methods: From 2010 through 2014, we enrolled community-dwelling persons in Australia and the United States who were 70 years of age or older (or ≥65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or disability. Participants were randomly assigned to receive 100 mg of enteric-coated aspirin or placebo. Deaths were classified according to the underlying cause by adjudicators who were unaware of trial-group assignments. Hazard ratios were calculated to compare mortality between the aspirin group and the placebo group, and post hoc exploratory analyses of specific causes of death were performed.

Results: Of the 19,114 persons who were enrolled, 9525 were assigned to receive aspirin and 9589 to receive placebo. A total of 1052 deaths occurred during a median of 4.7 years of follow-up. The risk of death from any cause was 12.7 events per 1000 person-years in the aspirin group and 11.1 events per 1000 person-years in the placebo group (hazard ratio, 1.14; 95% confidence interval [CI], 1.01 to 1.29). Cancer was the major contributor to the higher mortality in the aspirin group, accounting for 1.6 excess deaths per 1000 person-years. Cancer-related death occurred in 3.1% of the participants in the aspirin group and in 2.3% of those in the placebo group (hazard ratio, 1.31; 95% CI, 1.10 to 1.56).

Conclusions: Higher all-cause mortality was observed among apparently healthy older adults who received daily aspirin than among those who received placebo and was attributed primarily to cancer-related death. In the context of previous studies, this result was unexpected and should be interpreted with caution. (Funded by the National Institute on Aging and others; ASPREE ClinicalTrials.gov number, NCT01038583 .).
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http://dx.doi.org/10.1056/NEJMoa1803955DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6433466PMC
October 2018