Faculty Bibliography

OBJECTIVE:To develop and pilot test a patient decision aid (DA) describing small kidney masses and risks and benefits of treatment for the masses. METHODS:An expert committee iteratively designed a small kidney mass DA, incorporating evidence-based risk communication and informational needs for treatment options and shared decision making. After literature review and drafting content with the feedback of urologists, radiologists, and an internist, a rapid qualitative assessment was conducted using two patient focus groups to inform user-centered design. In a pilot study, 30 patients were randomized at the initial urologic consultation to receive the DA or existing institutional patient educational material (PEM). Preconsultation questionnaires captured patient knowledge and shared decision-making preferences. After review of the DA and subsequent clinician consultation, patients completed questionnaires on discussion content and satisfaction. Proportions between arms were compared using Fisher exact tests, and decision measures were compared using Mann-Whitney tests. RESULTS:Patient informational needs included risk of tumor growth during active surveillance and ablation, significance of comorbidities, and posttreatment recovery. For the DA, 84% of patients viewed all content, and mean viewing time was 20 min. Significant improvements in knowledge about small mass risks and treatments were observed (mean total scores: 52.6% DA versus 22.3% PEM, P < .001). DA use also increased the proportion of patients discussing ablation (66.7% DA versus 18.2% PEM, P = .02). Decision satisfaction measures were similar in both arms. DISCUSSION/CONCLUSIONS:Patients receiving a small kidney mass DA are likely to gain knowledge and preparedness to discuss all treatment options over standard educational materials.

BACKGROUND:The need to engage adults, age 65 and older, in clinical trials of conditions typical in older populations, (e.g. hypertension, diabetes mellitus, Alzheimer's disease and related dementia) is exponentially increasing. Older adults have been markedly underrepresented in clinical trials, often exacerbated by exclusionary study criteria as well as functional dependencies that preclude participation. Such dependencies may further exacerbate communication challenges. Consequently, the evidence of what works in subject recruitment is less generalizable to older populations, even more so for those from racial and ethnic minority and low-income communities. METHODS:To support capacity of research staff, we developed a virtual, three station simulation (Group Objective Structured Clinical Experience-GOSCE) to teach research staff communication skills. This 2-h course included a discussion of challenges in recruiting older adults; skills practice with Standardized Participants (SPs) and faculty observer who provided immediate feedback; and debrief to highlight best practices. Each learner had opportunities for active learning and observational learning. Learners completed a retrospective pre-post survey about the experience. SP completed an 11-item communication checklist evaluating the learner on a series of established behaviorally anchored communication skills (29). RESULTS:In the research staff survey, 92% reported the overall activity taught them something new; 98% reported it provided valuable feedback; 100% said they would like to participate again. In the SP evaluation there was significant variation: the percent well-done of items by case ranged from 25-85%. CONCLUSIONS:Results from this pilot suggest that GOSCEs are a (1) acceptable; (2) low cost; and (3) differentiating mechanism for training and assessing research staff in communication skills and structural competency necessary for participant research recruitment.

Eliciting patient preferences and goals of care are foundational to the shared decision-making process and are also important to consider in clinical trial design. This qualitative study was part of formative work of a planning study to determine optimal design for a future randomized clinical trial comparing revascularization with coronary artery bypass grafting vs. percutaneous coronary intervention in patients with ischemic cardiomyopathy.
Objective(s): To elicit patient preferences for CABG vs. PCI among ischemic heart disease patients for use in refining study design and methods.
Method(s): We conducted individual interviews and focus groups with 20 subjects (>age 18) with ischemic cardiomyopathy to elicit patient attitudes and descriptions of patient preferences for treatment option. A semi-structured interview guide that included open-ended questions "What is the most important thing you consider when" provided structure but allowed participants to communicate attitudes and patient preferences. All interviews and focus groups were audiotaped and transcribed verbatim; and analyzed using Atlas ti v 8.0 to identify attributes and levels of attributes that influence decision making.
Result(s): Among this sample of patients with ischemic cardiomyopathy (85% male; 80% non-hispanic White); patients described that they are most likely to take the advice of their trusted provider "he's the expert and he knows my caseI do what he says". Five attributes of patient preferences emerged: invasiveness, quality of life, sustainability, complications and recovery period. In each category, subjects described 3 levels of attributes they deemed as influential (e.g., critical, major or minor complication). They also described preferences as a trade off or balancing of attributes. For example trading a longer recovery period for sustainability "If I'm in the hospital longer, I'll manageI prefer one and done!" Or balancing procedure invasiveness with impact to quality of life "I don't want to crack my chest but if it means I will play tennis again".
Conclusion(s): Preferences for CABG vs. PCI among ischemic heart disease patients provide important data for determination of study feasibility, entry criteria and recruitment strategies to support planning of a future clinical trial.
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Randomized controlled trials (RCTs) remain the gold standard to evaluate clinical interventions, producing the highest level of evidence while minimizing potential bias. Inadequate recruitment is a commonly encountered problem that undermines the completion and generalizability of RCTs-and is even more challenging when enrolling amidst a pandemic. Here, we reflect on our experiences with virtual recruitment of non-hospitalized patients in the United States for ColCorona, an international, multicenter, randomized, placebo-controlled coronavirus disease 2019 (COVID-19) drug trial. Recruitment challenges during a pandemic include constraints created by shelter-in-place policies and targeting enrollment according to national and local fluctuations in infection rate. Presenting a study to potential participants who are sick with COVID-19 and may be frightened, overwhelmed, or mistrusting of clinical research remains a challenge. Strategies previously reported to improve recruitment include transparency, patient and site education, financial incentives, and person-to-person outreach. Active measures taken during ColCorona to optimize United States recruitment involved rapid expansion of sites, adjustment of recruitment scripts, assessing telephone calls versus text messages for initial contact with participants, institutional review board-approved financial compensation, creating an infrastructure to systematically identify potentially eligible patients, partnering with testing sites, appealing to both self-interest and altruism, and large-scale media efforts with varying degrees of success.

PURPOSE/OBJECTIVE:Black men have the highest incidence and mortality from prostate cancer (PCa) and lower quality of life compared to other U.S. racial groups. Additionally, more Latinx men are diagnosed with advanced disease and fewer receive guideline-concordant care. As many men seek medical information online, high-quality information targeting diverse populations may mitigate disparities. We examined racial/ethnic representation and information quality in online PCa content. MATERIALS AND METHODS/METHODS:We retrieved 150 websites and 150 videos about "prostate cancer" using the most widely used search engine (Google) and social network (YouTube). We assessed quality of health information, reading level, perceived race/ethnicity of people featured in the content and discussion of racial/ethnic disparities. RESULTS:Among 81 websites and 127 videos featuring people, 37% and 24% had perceived Black representation, and racial/ethnic disparities were discussed in 27% and 17%, respectively. Among 1,526 people featured, 9% and 1% were perceived as Black and Latinx, respectively. No content with Black or Latinx representation was high quality, understandable, actionable and at the recommended reading level. CONCLUSIONS:Black and Latinx adults are underrepresented in online PCa content. Online media have significant potential for public education and combating health disparities. However, most PCa content lacks diversity and is not readily understandable.

BACKGROUND:Knowledge about clinical trials affects efficient and equitable clinical trial recruitment and retention. This study explored correlates of clinical trial knowledge in a nationally representative sample of US adults. METHODS:Cross-sectional data from the 2020 Health Information National Trends Survey (HINTS 5, Cycle 4) were evaluated. There were 3,865 responses in the full dataset; 2,648 remained after eliminating respondents without complete data for all covariates of interest. Participants were asked, "How would you describe your level of knowledge about clinical trials?" The response options "know a little bit" and "know a lot" were combined and compared to the response option "don't know anything." Covariates of interest included patient-provider communication, history of medical conditions, eHealth use, knowledge of clinicaltrials.gov, prior invitation to join a clinical trial, and socio-demographic factors. RESULTS:Participants with a history of cancer were 1.6 times more likely [CI 1.2, 2.2] to have knowledge of clinical trials. Participants who used electronic means to look for health information were 1.7 times more likely [CI 1.2, 2.4] to have knowledge of clinical trials. Participants who had heard of the website clinicaltrials.gov had 5.1 times greater odds of knowing about clinical trials [CI 2.6, 10.3] and 4.5 greater odds if they had been invited to participate in a clinical trial [CI 2.0, 9.8]. College graduates had higher odds than others. CONCLUSION/CONCLUSIONS:Several factors affect clinical trial knowledge in US adults. Findings from this study may inform interventions to raise awareness about clinical trials and thereby, potentially improve enrollment.

Objective/UNASSIGNED:Social media use has grown over time. However, it is unclear how people with a self-reported history of cardiovascular disease or cardiovascular disease-related risk factors such as diabetes and hypertension use social media. Methods/UNASSIGNED:-values were calculated. Results/UNASSIGNED:In respondents with a heart condition, hypertension, or diabetes, 5.4%, 8.4%, and 10.3% had participated in an online support group and 29.6%, 40.4%, and 36.6% had watched health-related videos on YouTube, respectively. Univariately, the odds of using online support groups was associated with younger age (vs. > = 65) in people with a heart condition and hypertension, but not diabetes. Regarding YouTube, younger age was associated with watching health-related videos across all three medical conditions, with additional gender and education associations observed in those with hypertension. There were no associations between social media use and patient-provider communication. Conclusions/UNASSIGNED:These findings may inform the selection of social media platforms for behavioral interventions depending on the intended patient population and goals (e.g. social support vs. video-based health education).

Introduction/UNASSIGNED:There are significant and pervasive disparities in police violence and discrimination toward African Americans/Blacks. It is possible that these disparities may lead to heightened vulnerability for poor mental health outcomes. The purpose of this study was to ascertain the associations between experiences of police discrimination and depressive symptoms in a community-based sample of African American/Black women. Methods/UNASSIGNED:We performed a cross-sectional multivariable regression analysis using data from the Intergenerational Impact of Genetic and Psychological Factors on Blood Pressure Study that were collected over a 4-year period from September 2015 to June 2019. Depressive symptoms were assessed using 21 items from the Beck Depression Inventory. Police discrimination was assessed by questionnaires ascertaining experiences of discrimination by police; harassment by police or security guards; and experiences of being unfairly stopped, searched, threatened, or abused by police. Results/UNASSIGNED:<0.01). Conclusion/UNASSIGNED:African American/Black women who experienced police discrimination experienced higher prevalence of depressive symptoms. There is an urgent need for reliable population-level data on police mistreatment and interventions at the individual, community, and societal levels.

Shared decision-making (SDM) has been advocated to improve patient care, patient decision acceptance, patient-provider communication, patient motivation, adherence, and patient reported outcomes. Documentation of SDM is endorsed in several society guidelines and is a condition of reimbursement for selected cardiovascular and cardiac arrhythmia procedures. However, many clinicians argue that SDM already occurs with clinical encounter discussions or the process of obtaining informed consent and note the additional imposed workload of using and documenting decision aids without validated tools or evidence that they improve clinical outcomes. In reality, SDM is a process and can be done without decision tools, although the process may be variable. Also, SDM advocates counter that the low-risk process of SDM need not be held to the high bar of demonstrating clinical benefit and that increasing the quality of decision-making should be sufficient. Our review leverages a multidisciplinary group of experts in cardiology, cardiac electrophysiology, epidemiology, and SDM, as well as a patient advocate. Our goal is to examine and assess SDM methodology, tools, and available evidence on outcomes in patients with heart rhythm disorders to help determine the value of SDM, assess its possible impact on electrophysiological procedures and cardiac arrhythmia management, better inform regulatory requirements, and identify gaps in knowledge and future needs.