Overcoming Pandemic-Related Challenges in Recruitment and Screening: Strategies and Representation of Older Women With Cardiovascular Disease for a Multidomain Lifestyle Trial to Prevent Cognitive Decline.

BACKGROUND: Recruiting participants with cardiovascular disease into research during the COVID-19 pandemic was challenging, particularly those at risk of health disparities. OBJECTIVE: During the pandemic, 12 cohorts of older women with cardiovascular disease were recruited from cardiology clinics into a lifestyle intervention trial to prevent cognitive decline. Objectives were to (a) describe the results of modified recruitment/screening strategies to overcome pandemic-related challenges and (b) evaluate differences in age, race, and ethnicity between patients recruited/randomized, recruited/not randomized (entered recruitment but not randomized because of being ineligible or not interested), and not recruited (clinic patients who met preliminary criteria but did not enter recruitment). METHODS: This was a cross-sectional descriptive analysis. In-person study strategies proposed before the COVID-19 pandemic were modified before study onset (September 2020). Women 65 years or older with cardiovascular disease were recruited from cardiology clinics by clinicians, posted flyers, and letters mailed to patients randomly selected from electronic health record data extractions. Patients were classified as recruited/randomized, recruited/not randomized, and not recruited. RESULTS: Of 5719 patients potentially eligible, 1689 patients entered recruitment via referral (49.1%), posted flyers (0.5%), or mailed letters (50.3%), and 253 patients were successfully recruited/randomized. Recruited/randomized participants were, on average, 72.4 years old (range, 65-90 years old), non-Hispanic White (54.2%), non-Hispanic Black (38.3%), Hispanic/Latinx (1.6%), and other/not reported (5.1%). The recruited/randomized group was significantly younger with fewer patients of Hispanic/Latinx ethnicity compared with those not recruited. CONCLUSIONS: During the pandemic, all recruitment/screening goals were met using modified strategies. Differences in sociodemographic representation indicate a need for tailored strategies.

Use of Risk Assessment Tools to Guide Decision-Making in the Primary Prevention of Atherosclerotic Cardiovascular Disease: A Special Report From the American Heart Association and American College of Cardiology.

Risk assessment is a critical step in the current approach to primary prevention of atherosclerotic cardiovascular disease. Knowledge of the 10-year risk for atherosclerotic cardiovascular disease identifies patients in higher-risk groups who are likely to have greater net benefit and lower number needed to treat for both statins and antihypertensive therapy. Current US prevention guidelines for blood pressure and cholesterol management recommend use of the pooled cohort equations to start a process of shared decision-making between clinicians and patients in primary prevention. The pooled cohort equations have been widely validated and are broadly useful for the general US clinical population. But, they may systematically underestimate risk in patients from certain racial/ethnic groups, those with lower socioeconomic status or with chronic inflammatory diseases, and overestimate risk in patients with higher socioeconomic status or who have been closely engaged with preventive healthcare services. If uncertainty remains for patients at borderline or intermediate risk, or if the patient is undecided after a patient-clinician discussion with consideration of risk enhancing factors (eg, family history), additional testing with measurement of coronary artery calcium can be useful to reclassify risk estimates and improve selection of patients for use or avoidance of statin therapy. This special report summarizes the rationale and evidence base for quantitative risk assessment, reviews strengths and limitations of existing risk scores, discusses approaches for refining individual risk estimates for patients, and provides practical advice regarding implementation of risk assessment and decision-making strategies in clinical practice.

Statin Safety and Associated Adverse Events: A Scientific Statement From the American Heart Association.

One in 4 Americans >40 years of age takes a statin to reduce the risk of myocardial infarction, ischemic stroke, and other complications of atherosclerotic disease. The most effective statins produce a mean reduction in low-density lipoprotein cholesterol of 55% to 60% at the maximum dosage, and 6 of the 7 marketed statins are available in generic form, which makes them affordable for most patients. Primarily using data from randomized controlled trials, supplemented with observational data where necessary, this scientific statement provides a comprehensive review of statin safety and tolerability. The review covers the general patient population, as well as demographic subgroups, including the elderly, children, pregnant women, East Asians, and patients with specific conditions such as chronic disease of the kidney and liver, human immunodeficiency viral infection, and organ transplants. The risk of statin-induced serious muscle injury, including rhabdomyolysis, is <0.1%, and the risk of serious hepatotoxicity is ≈0.001%. The risk of statin-induced newly diagnosed diabetes mellitus is ≈0.2% per year of treatment, depending on the underlying risk of diabetes mellitus in the population studied. In patients with cerebrovascular disease, statins possibly increase the risk of hemorrhagic stroke; however, they clearly produce a greater reduction in the risk of atherothrombotic stroke and thus total stroke, as well as other cardiovascular events. There is no convincing evidence for a causal relationship between statins and cancer, cataracts, cognitive dysfunction, peripheral neuropathy, erectile dysfunction, or tendonitis. In US clinical practices, roughly 10% of patients stop taking a statin because of subjective complaints, most commonly muscle symptoms without raised creatine kinase. In contrast, in randomized clinical trials, the difference in the incidence of muscle symptoms without significantly raised creatinine kinase in statin-treated compared with placebo-treated participants is <1%, and it is even smaller (0.1%) for patients who discontinued treatment because of such muscle symptoms. This suggests that muscle symptoms are usually not caused by pharmacological effects of the statin. Restarting statin therapy in these patients can be challenging, but it is important, especially in patients at high risk of cardiovascular events, for whom prevention of these events is a priority. Overall, in patients for whom statin treatment is recommended by current guidelines, the benefits greatly outweigh the risks.

Heart Centers for Women: Historical Perspective on Formation and Future Strategies to Reduce Cardiovascular Disease.

Heart Centers for Women (HCW) developed as a response to the need for improved outcomes for women with cardiovascular disease (CVD). From 1984 until 2012, more women died of CVD every single year in comparison with men. Initially, there was limited awareness and sex-specific research regarding mortality or outcomes in women. HCW played an active role in addressing these disparities, provided focused care for women, and contributed to improvements in these gaps. In 2014 and 2015, death from CVD in women had declined below the level of death from CVD in comparison with men. Even though awareness of CVD in women has increased among the public and healthcare providers and both sex- and gender-specific research is currently required in all research trials, not all women have benefitted equally in mortality reduction. New strategies for HCW need to be developed to address these disparities and expand the current HCW model. The HCW care team needs to direct academic curricula on sex- and gender-specific research and care; expand to include other healthcare professionals and other subspecialties; provide new care models; address diversity; and include more male providers.

Palliative Care and Cardiovascular Disease and Stroke: A Policy Statement From the American Heart Association/American Stroke Association.

The mission of the American Heart Association/American Stroke Association includes increasing access to high-quality, evidence-based care that improves patient outcomes such as health-related quality of life and is consistent with the patients' values, preferences, and goals. Awareness of and access to palliative care interventions align with the American Heart Association/American Stroke Association mission. The purposes of this policy statement are to provide background on the importance of palliative care as it pertains to patients with advanced cardiovascular disease and stroke and their families and to make recommendations for policy decisions. Palliative care, defined as patient- and family-centered care that optimizes health-related quality of life by anticipating, preventing, and treating suffering, should be integrated into the care of all patients with advanced cardiovascular disease and stroke early in the disease trajectory. Palliative care focuses on communication, shared decision making about treatment options, advance care planning, and attention to physical, emotional, spiritual, and psychological distress with inclusion of the patient's family and care system. Our policy recommendations address the following: reimbursement for comprehensive delivery of palliative care services for patients with advanced cardiovascular disease and stroke; strong payer-provider relationships that involve data sharing to identify patients in need of palliative care, identification of better care and payment models, and establishment of quality standards and outcome measurements; healthcare system policies for the provision of comprehensive palliative care services during hospitalization, including goals of care, treatment decisions, needs of family caregivers, and transition to other care settings; and health professional education in palliative care as part of licensure requirements.

Impact of Individual and Neighborhood Factors on Cardiovascular Risk in White Hispanic and Non-Hispanic Women and Men.

Cardiovascular disease (CVD) is the leading cause of mortality for adults in the US, regardless of ethnicity. A cross-sectional correlational design was used to describe and compare CVD risk and cardiac mortality in White Hispanic and non-Hispanic women and men. Data from 3,317 individuals (1,523 women and 1,794 men) hospitalized for non-cardiac causes during 2012-2013, and data from the 2010 United States Census were included. The sex-specific 10-year Framingham General Cardiovascular Risk Score (FRS-10) was used to estimate long-term risk for major cardiac events. Approximately three-quarters of the sample was White Hispanic. FRS-10 scores were generally low, but a high prevalence of risk factors not included in the standard FRS-10 scoring formula was seen. White Hispanic women had significantly lower estimated CVD risk scores compared to White Hispanic and non-Hispanic men despite higher non-FRS-10 risks. Neighborhood median household income had a significant negative relationship and Hispanic neighborhood concentration had a significant positive relationship with cardiac mortality. Hispanic concentration was the only predictor of estimated CVD risk in a multilevel model. CVD risk assessment tools that are calibrated for ethnic groups and socioeconomic status may be more appropriate for Hispanic individuals than the FRS-10. Neighborhood-level factors should be included in clinical cardiac assessment in addition to individual characteristics and behavioral risks. Researchers should continue to seek additional risk factors that may contribute to or protect against CVD in order to close the gap between estimated CVD risk and actual cardiac mortality for Hispanics in the US. © 2016 Wiley Periodicals, Inc.

Cardiovascular Risk in Midlife African American Women Participating in a Lifestyle Physical Activity Program.

BACKGROUND: Cardiovascular disease (CVD) is the largest contributor to disparate morbidity and mortality in African American women. OBJECTIVE: The aims of this article are to describe in a cohort of sedentary, urban community-based midlife African American women eligible for a physical activity program their (1) CVD risk factors and (2) awareness, treatment, and control of hypertension and hypercholesterolemia. METHODS: Cross-sectional baseline findings on 297 women were examined at baseline of a controlled physical activity clinical trial. Cardiovascular disease risks included hypertension, hypercholesterolemia, smoking, diabetes, and obesity. Among women with hypertension and hypercholesterolemia, rates of awareness, treatment, and control were calculated. RESULTS: Our sample had significantly more hypertension and obesity than reported in other national samples of African American women. The women mirrored national samples of African American women: fewer than 60% had adequate control of hypertension. Versus national samples of African Americans (men/women combined), our study groups both showed significantly lower low-density-lipoprotein cholesterol level: treatment, 33% versus 63.8%, and control, 24.8% versus 45.3%. CONCLUSIONS: Because national samples are more heterogeneous, our sample provides important information about CVD risks in inactive, urban community-dwelling, midlife African American women. Given the opportunity, many such women at elevated risk for CVD are willing to participate in a physical activity intervention. They must be identified and offered pharmacological and lifestyle interventions.

Reducing Medication Costs to Prevent Cardiovascular Disease: A Community Guide Systematic Review.

INTRODUCTION: Hypertension and hyperlipidemia are major cardiovascular disease risk factors. To modify them, patients often need to adopt healthier lifestyles and adhere to prescribed medications. However, patients' adherence to recommended treatments has been suboptimal. Reducing out-of-pocket costs (ROPC) to patients may improve medication adherence and consequently improve health outcomes. This Community Guide systematic review examined the effectiveness of ROPC for medications prescribed for patients with hypertension and hyperlipidemia. METHODS: We assessed effectiveness and economics of ROPC for medications to treat hypertension, hyperlipidemia, or both. Per Community Guide review methods, reviewers identified, evaluated, and summarized available evidence published from January 1980 through July 2015. RESULTS: Eighteen studies were included in the analysis. ROPC interventions resulted in increased medication adherence for patients taking blood pressure and cholesterol medications by a median of 3.0 percentage points; proportion achieving 80% adherence to medication increased by 5.1 percentage points. Blood pressure and cholesterol outcomes also improved. Nine studies were included in the economic review, with a median intervention cost of $172 per person per year and a median change in health care cost of -$127 per person per year. CONCLUSION: ROPC for medications to treat hypertension and hyperlipidemia is effective in increasing medication adherence, and, thus, improving blood pressure and cholesterol outcomes. Most ROPC interventions are implemented in combination with evidence-based health care interventions such as team-based care with medication counseling. An overall conclusion about the economics of the intervention could not be reached with the small body of inconsistent cost-benefit evidence.

Guidelines for the primary prevention of stroke: a statement for healthcare professionals from the American Heart Association/American Stroke Association.

The aim of this updated statement is to provide comprehensive and timely evidence-based recommendations on the prevention of stroke among individuals who have not previously experienced a stroke or transient ischemic attack. Evidence-based recommendations are included for the control of risk factors, interventional approaches to atherosclerotic disease of the cervicocephalic circulation, and antithrombotic treatments for preventing thrombotic and thromboembolic stroke. Further recommendations are provided for genetic and pharmacogenetic testing and for the prevention of stroke in a variety of other specific circumstances, including sickle cell disease and patent foramen ovale.

Dyslipidemia management in women of reproductive potential: An expert clinical consensus from the national lipid association.

Cardiovascular disease (CVD) is the leading cause of death among women and its incidence has been increasing recently, particularly among younger women. Across major professional society guidelines, dyslipidemia management remains a central tenet for atherosclerotic CVD prevention for both women and men. Despite this, women, particularly young women, who are candidates for statin therapy are less likely to be treated and less likely to achieve their recommended therapeutic objectives for low-density lipoprotein cholesterol (LDL-C) levels. Elevated LDL-C and triglycerides are the two most common dyslipidemias that should be addressed during pregnancy due to the increased risk for adverse pregnancy outcomes, such as preeclampsia, gestational diabetes mellitus, and pre-term delivery, as well as pancreatitis in the presence of severe hypertriglyceridemia. In this National Lipid Association Expert Clinical Consensus, we review the roles of nutrition, physical activity, and pharmacotherapy as strategies to address elevated levels of LDL-C and/or triglycerides among women of reproductive age. We include a special focus on points to consider during the shared decision-making discussion regarding pharmacotherapy for dyslipidemia during preconception planning, pregnancy, and lactation.

Effectiveness, efficiency, duration, and costs of recruiting for an African American women's lifestyle physical activity program.

In a 48-week lifestyle physical activity controlled trial in African American women, we analyzed recruitment effectiveness, efficiency, duration, and costs. Social networking was the most effective approach for inviting women to the trial. Of the 609 who responded to invitations, 514 completed telephone screening; of these, 409 (80%) were found eligible. The health assessment screening was completed by 337 women; of these, 297 (88%) were found eligible. The mean number of days from completion of the telephone and health assessment screenings to beginning the intervention was 23.01, and the mean cost was $74.57 per person. Results suggest that provision of health assessment screening by study staff as part of recruitment is effective for minimizing attrition and also might be cost-effective.

DNP-PhD Collaboration in NINR-Funded Physical Activity Trials: A Series of Case Studies.

Collaboration between Doctor of Nursing Practice (DNP) scholars and Doctor of Philosophy (PhD) scholars is crucial to efficiently advance and disseminate nursing science. Also, DNP-PhD collaboration can help achieve priorities outlined in the recent National Institute of Nursing Research (NINR) Strategic Plan. The purpose of this series of case studies is to describe exemplars of ongoing DNP-PhD collaborations across three NINR-funded trials (1 completed, 2 ongoing) testing physical activity interventions for women at risk for cardiovascular disease. In our three physical activity intervention trials for women, we categorized examples of DNP-PhD collaboration by the four phases of the team-based research model (development, conceptualization, implementation, and translation). Across all three trials, DNP and PhD scholars contributed successfully to all phases of research in an iterative manner. Future work should focus on expanding DNP-PhD collaboration in behavioral trials, which can inform adapted, contemporary models of iterative DNP-PhD collaboration.

Study of warfarin patients investigating attitudes toward therapy change (SWITCH Survey).

Although the oral anticoagulant warfarin has undoubtedly saved lives and reduced the number of strokes in patients with atrial fibrillation, it is a cumbersome medication to manage and take. Novel oral anticoagulants, such as dabigatran, offer therapeutic anticoagulation without requisite blood testing or dietary restrictions. We conducted a survey of the attitudes of patients enrolled in a warfarin clinic toward switching to a novel anticoagulant. From September to December 2010, a written survey was offered to 180 patients in the Warfarin Clinic of the Rush University Medical Center and 155 patients filled out the survey (86% response rate). Inclusion criteria included being 18 years of age or older, on warfarin for 2 months. Fifty-eight percent of patients were willing to switch anticoagulants. Women were significantly less willing to switch from warfarin than men (31 of 71, 44% vs. 54 of 78, 69%; P = 0.003). Patients older than 70 years were significantly more willing to switch anticoagulants than those younger than 70 years (48 of 68, 71% vs. 38 of 75, 51%; P = 0.017). There are significant differences across age and gender in the initial willingness of patients to accept novel anticoagulants. These differences may have important implications in the prevention and treatment of thromboembolic events.

JCL Roundtable. The lipidology team.

Clinical lipidology practice works best when implemented by a health care team. The 3 discussants for this JCL Roundtable are National Lipid Association leaders representing essential areas on the team - Registered Dietitian Nutritionist, Advanced Practice Provider, and Clinical Pharmacist. The team approach has been shown more effective than traditional sole provider management for controlling chronic asymptomatic conditions like hypercholesterolemia. Teams also fit better as health care transitions away from fee-for-service into value-based reimbursement. It's worth noting that medicine and even surgery were never entirely solo endeavors. Here we discuss a more expansive team model, which began in the U.S. more than 2 decades ago in the Veterans Administration and certain managed care organizations such as Kaiser Permanente. These health care organizations place themselves at risk, comprising both normative and financial risk, for maintaining their patients' health. Academic medical centers and private health care groups increasingly are adopting the at-risk model and medical teams. Electronic health records facilitate the transition. Team members include not only licensed professionals like our discussants, but also medical assistants, front desk staff, and schedulers. All share decision making and responsibility. Ideally the patient becomes the central member, not merely the focal point, of the team. We explore specific roles within the lipidology team, and we identify continuing barriers to implementation.

Guidelines for the primary prevention of stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association.

BACKGROUND AND PURPOSE: This guideline provides an overview of the evidence on established and emerging risk factors for stroke to provide evidence-based recommendations for the reduction of risk of a first stroke. METHODS: Writing group members were nominated by the committee chair on the basis of their previous work in relevant topic areas and were approved by the American Heart Association (AHA) Stroke Council Scientific Statement Oversight Committee and the AHA Manuscript Oversight Committee. The writing group used systematic literature reviews (covering the time since the last review was published in 2006 up to April 2009), reference to previously published guidelines, personal files, and expert opinion to summarize existing evidence, indicate gaps in current knowledge, and when appropriate, formulate recommendations using standard AHA criteria (Tables 1 and 2). All members of the writing group had the opportunity to comment on the recommendations and approved the final version of this document. The guideline underwent extensive peer review by the Stroke Council leadership and the AHA scientific statements oversight committees before consideration and approval by the AHA Science Advisory and Coordinating Committee. RESULTS: Schemes for assessing a person's risk of a first stroke were evaluated. Risk factors or risk markers for a first stroke were classified according to potential for modification (nonmodifiable, modifiable, or potentially modifiable) and strength of evidence (well documented or less well documented). Nonmodifiable risk factors include age, sex, low birth weight, race/ethnicity, and genetic predisposition. Well-documented and modifiable risk factors include hypertension, exposure to cigarette smoke, diabetes, atrial fibrillation and certain other cardiac conditions, dyslipidemia, carotid artery stenosis, sickle cell disease, postmenopausal hormone therapy, poor diet, physical inactivity, and obesity and body fat distribution. Less well-documented or potentially modifiable risk factors include the metabolic syndrome, excessive alcohol consumption, drug abuse, use of oral contraceptives, sleep-disordered breathing, migraine, hyperhomocysteinemia, elevated lipoprotein(a), hypercoagulability, inflammation, and infection. Data on the use of aspirin for primary stroke prevention are reviewed. CONCLUSIONS: Extensive evidence identifies a variety of specific factors that increase the risk of a first stroke and that provide strategies for reducing that risk.