Faculty Bibliography

High blood pressure (BP) based on measurements obtained in the office setting has been associated with the presence and level of coronary artery calcification (CAC)-a measure of subclinical atherosclerosis. We studied the association between out-of-office BP and CAC among 557 participants who underwent 24-hour ambulatory BP monitoring at visit 1 in 2000-2004 and a computed tomography scan at visit 2 in 2005-2008 as part of the JHS (Jackson Heart Study)-a community-based cohort of African American adults. Mean awake, asleep, and 24-hour BP were calculated for each participant. Among participants included in this analysis, 279 (50%) had any CAC defined by an Agatston score >0. After multivariable adjustment including office systolic BP (SBP), the prevalence ratios for any CAC comparing the highest versus the lowest quartiles of SBP on ambulatory BP monitoring were 1.08 (95% CI, 0.84-1.39) for awake SBP, 1.32 (95% CI, 1.01-1.74) for asleep SBP, and 1.19 (95% CI, 0.91-1.55) for 24-hour SBP. After multivariable adjustment including office diastolic BP, the prevalence ratios for any CAC comparing the highest versus the lowest quartiles of awake, asleep, and 24-hour diastolic BP were 1.27 (95% CI, 1.02-1.59), 1.29 (95% CI, 1.02-1.64), and 1.25 (95% CI, 0.99-1.59), respectively. The current results suggest that higher asleep SBP and higher awake and asleep diastolic BP may be risk factors for subclinical atherosclerosis and underscore the potential role of ambulatory BP monitoring in identifying individuals at high risk for coronary artery disease.

OBJECTIVE:To evaluate the impact of a web-based, plain language decision aid (CHOICES DA) on minority cancer survivors' knowledge of cancer clinical trials (CCTs), readiness for making decisions about clinical trial participation, and willingness to participate in a clinical trial. METHODS:Participants were 64 Black and Hispanic cancer survivors from Miami, Florida. In a single arm intervention study, participants completed self-report assessments of CCT knowledge, decision readiness regarding clinical trial participation, and willingness to participate at three time points. RESULTS:Black and Hispanic participants did not differ on demographic characteristics. Post-test and follow-up measures of CCT knowledge and decision readiness were significantly greater than pre-test measures for the sample overall, and for Black and Hispanic participants separately. Few significant differences were observed between Black and Hispanic participant outcomes at each survey time point, and willingness to participate did not change overall and for either group independently. CONCLUSIONS:Reviewing the CHOICES DA was associated with significantly improved knowledge and decision readiness to participate in a CCT immediately and at 2-week follow-up. PRACTICAL IMPLICATIONS/CONCLUSIONS:These findings suggest that CHOICES DA may support informed decision making about CCT participation within an acute, yet clinically relevant window of time for minority cancer patients who are substantially under-represented in cancer research.

Hypertension is a risk factor for cardiovascular disease. Black women have high rates of hypertension compared to women of other racial or ethnic groups and are disproportionately affected by psychosocial stressors such as racial discrimination, gender discrimination, and caregiving stress. Evidence suggests that stress is associated with incident hypertension and hypertension risk. Stress management is associated with improvements improved blood pressure outcomes. The purpose of this review is to synthesize evidence on effects of stress management interventions on blood pressure in Black women. A comprehensive search of scientific databases was conducted. Inclusion criteria included studies that were: (1) primary research that tested an intervention; (2) in the English language; (3) included African-American women; (4) incorporated stress in the intervention; (5) included blood pressure as an outcome; and (6) were US based. Eighteen studies met inclusion criteria. Ten (56%) studies tested meditation-based interventions, two (11%) tested coping and affirmation interventions, and six (33%) tested lifestyle modification interventions that included stress management content. Thirteen of the studies were randomized controlled trials. Reductions in blood pressure were observed in all of the meditation-based interventions, although the magnitude and statistical significance varied. Comprehensive lifestyle interventions were also efficacious for reducing blood pressure, although the relative contribution of stress management versus behavior modification could not be evaluated. Coping and affirmation interventions did not affect blood pressure. Most of the reviewed studies included small numbers of Black women and did not stratify results by race and gender, so effects remain unclear. This review highlights the urgent need for studies specifically focusing on Black women. Given the extensive disparities in cardiovascular disease morbidity and mortality, whether stress management can lower blood pressure and improve primary and secondary cardiovascular disease prevention among Black women is an important question for future research.

LEARNINGOBJECTIVES 1: Interpersonal /Communication Skill: 1) Identify communication skills needed to recruit older adults LEARNING OBJECTIVES 2: 2) Assess feasibility of GOSCEs to enhance recruitment skills in RAs. SETTING AND PARTICIPANTS: Convenience sample of 18 (5 male, 13 female) Research Assistants (RAs) at an urban hospital who recruit older adults for clinical trials. DESCRIPTION: Increasing older adults' participation in clinical trials is urgently needed. We developed a remote, three station simulation (Group Objective Structured Clinical Exam - GOSCE) to teach RAs communication skills. This 2-hour course included a discussion of challenges in recruiting older adults; skills practice with Standardized Participants (SPs); and a debrief to review experiences, highlight best practices. After discussion, RAs rotated (3 per group) through the stations, each with SP and faculty observer who provided immediate feedback. Thus, learners had opportunities for active and observational learning.Scenarios were: 1) an older white woman with hearing impairment; 2) an older white woman and family member together; and 3) an older Black man mistrustful due to history of racism in medical research. SPs completed behaviorally anchored checklists (11 communication skills across all cases, and 5-7 case-specific questions). Learners completed a 36- item survey of self-assessed change in skill after the workshop; insights on recruitment practice; and educational value. EVALUATION: The communication checklist across all cases included: relationship development (5 items, mean of 58% well done (range: 50-75%), patient education (3 items, 44% (42-58%)), patient satisfaction (2 items, 54% (50-58%)), and information gathering (1 item, 92%). Seventeen RAs completed the survey, 100% felt the workshop provided valuable feedback and taught relevant material, 88% would participate again and 52%reported that the workshop improved their recruitment skills. All RAs reported encountering situations similar to hearing impairment and family member cases, and the majority rated the cases as high in educational value. Just 45% reported experiencing a case similar to the Black male case, and 100% rate it as high in educational value. Key points identified by RAs included the value of building a trusting relationship with potential subjects, recognizing possible barriers to communication early on and addressing these directly in a supportive and respectful style. DISCUSSION / REFLECTION / LESSONS LEARNED: Remote GOSCEs are a feasible mechanism for training RAs in subject recruitment focused on the unique needs of older adults. Responses to the RA survey suggest that GOSCEs are feasible for training RAs in simulated clinical scenarios with which participants are familiar and unfamiliar. SP assessment of RAs identified areas for further reinforcement to improve recruitment skills. This innovation is a feasible, high yield strategy for training research staff. It is highly adaptable to the specific recruitment needs and skills of a clinical trials and will add to the literature on educating RAs

BACKGROUND:Decades of effectiveness research has established the benefits of using patient decision aids (PtDAs), yet broad clinical implementation has not yet occurred. Evidence to date is mainly derived from highly controlled settings; if clinicians and health care organizations are expected to embed PtDAs as a means to support person-centered care, we need to better understand what this might look like outside of a research setting. AIM/OBJECTIVE:This review was conducted in response to the IPDAS Collaboration's evidence update process, which informs their published standards for PtDA quality and effectiveness. The aim was to develop context-specific program theories that explain why and how PtDAs are successfully implemented in routine healthcare settings. METHODS:Rapid realist review methodology was used to identify articles that could contribute to theory development. We engaged key experts and stakeholders to identify key sources; this was supplemented by electronic database (Medline and CINAHL), gray literature, and forward/backward search strategies. Initial theories were refined to develop realist context-mechanism-outcome configurations, and these were mapped to the Consolidated Framework for Implementation Research. RESULTS:We developed 8 refined theories, using data from 23 implementation studies (29 articles), to describe the mechanisms by which PtDAs become successfully implemented into routine clinical settings. Recommended implementation strategies derived from the program theory include 1) co-production of PtDA content and processes (or local adaptation), 2) training the entire team, 3) preparing and prompting patients to engage, 4) senior-level buy-in, and 5) measuring to improve. CONCLUSIONS:We recommend key strategies that organizations and individuals intending to embed PtDAs routinely can use as a practical guide. Further work is needed to understand the importance of context in the success of different implementation studies.

The COVID-19 pandemic has magnified the importance of clinical trials for finding a safe and effective vaccine to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. Although communication about vaccines and vaccine hesitancy were challenges long before COVID-19, the twin facts of a pandemic and an "infodemic" of health information, misinformation, and disinformation have raised new challenges for vaccine-related communication and decision-making. The goal of this commentary is to highlight strategies to improve communication and decision-making for adults considering participation in COVID-19 vaccine clinical trials. First, I present a general conceptual model for clinical trial participation that can be applied to various vaccine and other clinical trial contexts. Next, I introduce the ASK (Assume, Seek, Know) approach for enhancing clinical trial participation: (1) assume that all patients will want to know their options, (2) seek the counsel of stakeholders, and (3) know your numbers. The ideas presented in this commentary are intended to enhance vaccine-specific clinical trial communication, decision-making, and literacy, while dually offering strategies and resources that may help reduce vaccine hesitancy and increase vaccine uptake over time.

Resistant hypertension, defined as blood pressure levels above goal while taking ≥3 classes of antihypertensive medication or ≥4 classes regardless of blood pressure level, is associated with increased cardiovascular disease risk. The 2018 American Heart Association Scientific Statement on Resistant Hypertension recommends healthy lifestyle habits and thiazide-like diuretics and mineralocorticoid receptor antagonists for adults with resistant hypertension. The term apparent treatment-resistant hypertension (aTRH) is used when pseudoresistance cannot be excluded. We estimated the use of healthy lifestyle factors and recommended antihypertensive medication classes among US Black adults with aTRH. Data were pooled for Black participants in the JHS (Jackson Heart Study) in 2009 to 2013 (n=2496) and the REGARDS study (Reasons for Geographic and Racial Differences in Stroke) in 2013 to 2016 (n=3786). Outcomes included lifestyle factors (not smoking, not consuming alcohol, ≥75 minutes of vigorous-intensity or ≥150 minutes of moderate or vigorous physical activity per week, and body mass index <25 kg/m²) and recommended antihypertensive medications (thiazide-like diuretics and mineralocorticoid receptor antagonists). Overall, 28.3% of participants who reported taking antihypertensive medication had aTRH. Among participants with aTRH, 14.5% and 1.2% had ideal levels of 3 and 4 of the lifestyle factors, respectively. Also, 5.9% of participants with aTRH reported taking a thiazide-like diuretic, and 9.8% reported taking a mineralocorticoid receptor antagonist. In conclusion, evidence-based lifestyle factors and recommended pharmacological treatment are underutilized in Black adults with aTRH. Increased use of lifestyle recommendations and antihypertensive medication classes specifically recommended for aTRH may improve blood pressure control and reduce cardiovascular disease-related morbidity and mortality among US Black adults.

BACKGROUND:It is important to monitor the scope of clinical research of all types, to involve participants of all ages and subgroups in studies that are appropriate to their condition, and to ensure equal access and broad validity of the findings. OBJECTIVE:We conducted a review of clinical research performed at New York University with the following objectives: (1) to determine the utility of institutional administrative data to characterize clinical research activity; (2) to assess the inclusion of special populations; and (3) to determine if the type, initiation, and completion of the study differed by age. METHODS:Data for all studies that were institutional review board-approved between January 1, 2014, and November 2, 2016, were obtained from the research navigator system, which was launched in November 2013. One module provided details about the study protocol, and another module provided the characteristics of individual participants. Research studies were classified as observational or interventional. Descriptive statistics were used to assess the characteristics of clinical studies across the lifespan, by type, and over time. RESULTS:A total of 22%-24% of studies included children (minimum age <18 years) and 4%-5% focused exclusively on pediatrics. Similarly, 64%-72% of studies included older patients (maximum age >65 years) but only 5%-12% focused exclusively on geriatrics. Approximately 85% of the studies included both male and female participants. Of the remaining studies, those open only to girls or women were approximately 3 times as common as those confined to boys or men. A total of 56%-58% of projects focused on nonvulnerable patients. Among the special populations studied, children (12%-15%) were the most common. Noninterventional trial types included research on human data sets (24%), observational research (22%), survey research (16%), and biospecimen research (8%). The percentage of projects designed to test an intervention in a vulnerable population increased from 17% in 2014 to 21% in 2015. CONCLUSIONS:Pediatric participants were the special population that was most often studied based on the number of registered projects that included children and adolescents. However, they were much less likely to be successfully enrolled in research studies compared with adults older than 65 years. Only 20% of the studies were interventional, and 20%-35% of participants in this category were from vulnerable populations. More studies are exclusively devoted to women's health issues compared with men's health issues.

BACKGROUND:Tablet and smartphone ownership have increased among US adults over the past decade. However, the degree to which people use mobile devices to help them make medical decisions remains unclear. OBJECTIVE:The objective of this study is to explore factors associated with self-reported use of tablets or smartphones to support medical decision making in a nationally representative sample of US adults. METHODS:Cross-sectional data from participants in the 2018 Health Information National Trends Survey (HINTS 5, Cycle 2) were evaluated. There were 3504 responses in the full HINTS 5 Cycle 2 data set; 2321 remained after eliminating respondents who did not have complete data for all the variables of interest. The primary outcome was use of a tablet or smartphone to help make a decision about how to treat an illness or condition. Sociodemographic factors including gender, race/ethnicity, and education were evaluated. Additionally, mobile health (mHealth)- and electronic health (eHealth)-related factors were evaluated including (1) the presence of health and wellness apps on a tablet or smartphone, (2) use of electronic devices other than tablets and smartphones to monitor health (eg, Fitbit, blood glucose monitor, and blood pressure monitor), and (3) whether people shared health information from an electronic monitoring device or smartphone with a health professional within the last 12 months. Descriptive and inferential statistics were conducted using SAS version 9.4. Weighted population estimates and standard errors, univariate odds ratios, and 95% CIs were calculated, comparing respondents who used tablets or smartphones to help make medical decisions (n=944) with those who did not (n=1377), separately for each factor. Factors of interest with a P value of <.10 were included in a subsequent multivariable logistic regression model. RESULTS:Compared with women, men had lower odds of reporting that a tablet or smartphone helped them make a medical decision. Respondents aged 75 and older also had lower odds of using a tablet or smartphone compared with younger respondents aged 18-34. By contrast, those who had health and wellness apps on tablets or smartphones, used other electronic devices to monitor health, and shared information from devices or smartphones with health care professionals had higher odds of reporting that tablets or smartphones helped them make a medical decision, compared with those who did not. CONCLUSIONS:A limitation of this research is that information was not available regarding the specific health condition for which a tablet or smartphone helped people make a decision or the type of decision made (eg, surgery, medication changes). In US adults, mHealth and eHealth use, and also certain sociodemographic factors are associated with using tablets or smartphones to support medical decision making. Findings from this study may inform future mHealth and other digital health interventions designed to support medical decision making.

OBJECTIVE:To determine whether racial differences exist in patient preferences for prostate cancer treatment after being informed about options using a patient-centered vs. a standard decision aid (DA). METHODS:This article reports secondary analyses of a large study of men diagnosed with early stage prostate cancer. Men were recruited from 4 VA Health Systems and randomized to receive a patient-centered or standard DA about prostate cancer treatment options. Data were collected at 1) baseline, 2) after reading the DA but prior to diagnosis, and 3) after receiving a cancer diagnosis and meeting with a urologist. RESULTS:grade reading level were more likely to prefer active surveillance and less likely to prefer radiation compared to those who received the standard DA written at >9th grade reading level. African American patients' treatment preferences did not differ as a function of DA. CONCLUSIONS:When informed about prostate cancer treatment options through a patient-centered DA, White patients changed their treatment preferences but African American patients did not. PRACTICE IMPLICATIONS/CONCLUSIONS:As DAs are increasingly being used in clinical practice, more research is needed regarding the efficacy, relevance, and receptivity of DAs for African Americans.