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.

Special Considerations for Healthy Lifestyle Promotion Across the Life Span in Clinical Settings: A Science Advisory From the American Heart Association.

At a population level, engagement in healthy lifestyle behaviors is suboptimal in the United States. Moreover, marked disparities exist in healthy lifestyle behaviors and cardiovascular risk factors as a result of social determinants of health. In addition, there are specific challenges to engaging in healthy lifestyle behaviors related to age, developmental stage, or major life circumstances. Key components of a healthy lifestyle are consuming a healthy dietary pattern, engaging in regular physical activity, avoiding use of tobacco products, habitually attaining adequate sleep, and managing stress. For these health behaviors, there are guidelines and recommendations; however, promotion in clinical settings can be challenging, particularly in certain population groups. These challenges must be overcome to facilitate greater promotion of healthy lifestyle practices in clinical settings. The 5A Model (assess, advise, agree, assist, and arrange) was developed to provide a framework for clinical counseling with consideration for the demands of clinical settings. In this science advisory, we summarize specific considerations for lifestyle-related behavior change counseling using the 5A Model for patients across the life span. In all life stages, social determinants of health and unmet social-related health needs, as well as overweight and obesity, are associated with increased risk of cardiovascular disease, and there is the potential to modify this risk with lifestyle-related behavior changes. In addition, specific considerations for lifestyle-related behavior change counseling in life stages in which lifestyle behaviors significantly affect cardiovascular disease risk are outlined. Greater attention to healthy lifestyle behaviors during every clinician visit will contribute to improved cardiovascular health.

Self-Efficacy, Outcome Expectations, Group Social Support, and Adherence to Physical Activity in African American Women.

BACKGROUND: African American women have lower levels of leisure time physical activity compared to White American women. Interventions to improve physical activity have mixed benefits for African American women, even when guided by theory. Understanding how theoretical constructs used in physical activity interventions relate to changing behavior may provide direction for more successful interventions. OBJECTIVE: The study aimed to examine the relationships among social cognitive constructs (self-efficacy, social support from group behavioral meetings, outcome expectations/realizations), and change in physical activity from baseline to 48 weeks in African American women participating in a lifestyle physical activity program. METHODS: A secondary data analysis of longitudinal data using a correlational design was conducted using data from a 48-week physical activity randomized controlled trial (RCT). The RCT included a group behavioral meeting component with one of three telephone intervention conditions (no calls, personal motivation calls, or automated motivational calls) randomly assigned across six community healthcare sites. The participants were 260 sedentary, midlife African American women with no major signs or symptoms of cardiovascular disease who completed baseline and 48-week assessments of the RCT. Measures included self-efficacy for change in overcoming barriers to physical activity at 24 weeks, physical and psychological outcome realizations at 24 weeks, social support from group behavioral meetings at 24 weeks, and physical activity (self-report and device-measured) change from baseline to 48 weeks. RESULTS: In a hierarchical regression model predicting change in self-reported time spent in weekly moderate-vigorous physical activity at 48 weeks, psychological outcome realizations at 24 weeks were significant positive predictors. In a hierarchical regression model for change in device-measured daily steps at 48 weeks, a self-efficacy change at 24 weeks was a significant positive predictor. DISCUSSION: Attention should be given to increasing self-efficacy to overcome physical activity barriers and achieve self-identified physical and psychological outcomes in physical activity programs.

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.

The partners for life program: a couples approach to cardiac risk reduction.

Morbidity and mortality are reliably lower for the married compared with the unmarried across a variety of illnesses. What is less well understood is how a couple uses their relationship for recommended lifestyle changes associated with decreased risk for illness. Partners for Life compared a patient and partner approach to behavior change with a patient only approach on such factors as exercise, nutrition, and medication adherence. Ninety-three patients and their spouses/partners consented to participate (26% of those eligible) and were randomized into either the individual or couples condition. However, only 80 couples, distributed across conditions, contributed data to the analyses, due to missing data and missing data points. For exercise, there was a significant effect of couples treatment on the increase in activity and a significant effect of couples treatment on the acceleration of treatment over time. In addition, there was an interaction between marital satisfaction and treatment condition such that patients who reported higher levels of marital distress in the individuals condition did not maintain their physical activity gains by the end of treatment, while both distressed and nondistressed patients in the couples treatment exhibited accelerating gains throughout treatment. In terms of medication adherence, patients in the couples treatment exhibited virtually no change in medication adherence over time, while patients in the individuals treatment showed a 9% relative decrease across time. There were no condition or time effects for nutritional outcomes. Finally, there was an interaction between baseline marital satisfaction and treatment condition such that patients in the individuals condition who reported lower levels of initial marital satisfaction showed deterioration in marital satisfaction, while non satisfied patients in the couples treatment showed improvement over time.

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.