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Purpose: To describe potential gender differences in the psychosocial evaluation for left ventricular assist devices (VADs) using retrospective data from the DECIDE-LVAD trial. Method: Psychosocial evaluations performed as part of pre-VAD evaluations, including all female participants as well as men matched by site and age. 55 notes from 5 institutions were analyzed using a mixed method approach. Analytic codes were developed a priori, using domains assessed in the Stanford Integrated Psychosocial Assessment for Transplant (SIPAT) and others addressing caregiver attributes. Overall risk was calculated using a composite percent-of-perfect formula based on various adaptations of the SIPAT used in some evaluations. After notes were coded across each domain, a content analysis was performed. Results: Records from 28 male and 27 female patients were analyzed. Lack of standardized assessment limited our ability to draw comparisons. However, men were more likely to be clinically depressed (55.9% vs 44.1%), have substance use problems (53.4% vs. 46.6%), understand their HF (57.7% vs. 42.3%), and to have a caregiver (54.5% vs. 45.6%). While the number of assessments including quantitative assessment was low, men scored better than women (53.1% men [n=11] vs. 46.9% women [n=12]).The way in which caregivers were identified was different for men and women. Qualitatively, female caregivers seemed to be preferred, implicitly favoring male patients in many circumstances. This was apparent in how caregiving plans were described and in a seeming desire to supplement male caregivers' effort with support from women ( Table 1). Conclusion: Across our sample, men trended toward being rated as better VAD candidates than women, despite higher rates of depression and substance use. Caregiver identification was different in ways which may be due to differences in how male vs. female caregivers are perceived. Differences in caregiver identification need to be explored further, but could stem from women being unable to find a caregiver for themselves, serving as caregivers for others, or from men not being viewed as able caregivers. Standardized evaluation, including quantification of risk and caregiver appropriateness, would enhance efforts to reduce implicit bias in evaluation.

Background: Home-based cardiac rehabilitation (CR) has similar efficacy as center-based CR, but the choice of which meets the needs of individual patients is preference-sensitive. Our objective was to develop a knowledge measure to be used to evaluate a shared decision-making tool for patients choosing between home and center-based CR. Methods: We generated 11 true/false questions about home and hospital-based CR. The statements were reviewed for accuracy by 8 exercise physiologists. Cognitive testing was performed with 10 patients using the “think-aloud” method to understand their interpretation of what each item was asking. The statements were then revised to improve acceptability and clarity. We tested the knowledge statements in a sample of 124 participates from the lay public recruited via mTurk. Psychometric properties of item difficulty, item uncertainty, and index of discrimination were evaluated. Differences between groups based on education level, age, sex, and race/ethnicity were also evaluated. Results: Of 124 respondents 66% were female, 69% were white, 69% were between 18-44 years of age, and 89% had at least some college education. On average respondents answered 70% of questions correctly. Item difficulty ranged from 51% to 98% correct. Item uncertainty ranged from 9% to 36%. Index of discrimination was highest for questions 2 (75%), 7 (74%) and 9 (68%). (see Table) Within each subgroup, the following groups had the highest average score: African Americans, (77%), females (74%), advanced degree (80%) and ages 55-64 (78%). Conclusion: The knowledge measure developed in this study can be used to assesses knowledge about key concepts central to making an informed decision about home vs. hospital-based CR. This knowledge measure will be further validated and used to evaluate a decision aid for patients in our safety net hospital system choosing between home and hospital-based CR.

Background: Therapy for aortic stenosis (AS) is quickly evolving, with treatment options expanded by transcatheter aortic valve replacement (TAVR). The complexity of information patients need to make value-concordant decisions highlights the need for accessible, acceptable, and unbiased decision aids (DAs) for patients considering AS treatment. Methods: Using a rapid-development process adapted from our team’s earlier work creating DAs for ICD and LVAD candidates, and guided by International Patient Decision Aid Standards (IPDAS), we created decision support materials for AS patients. This process included simultaneous 1) qualitative assessments of decision support needs & experience among TAVR recipients, 2) alpha testing iterative versions of paper DAs with patients to assess for accessibility & bias, and 3) assessment of clinical accuracy and usability of DAs with clinicians through individual feedback and expert panel consensus (Figure 1). Results: Over a 14 month period, we created two paper and two video DAs (corresponding to high or non-operative surgical risk), including input from interviews with 17 patients and 3 caregivers, 6 clinician reviews, and 4 expert panel assessments. Patient/caregiver feedback included DA usability and when it should be introduced into the clinical process. Clinician feedback focused on expected valve durability, procedural risks, and clinical accuracy. While most patients and clinicians expressed enthusiasm about TAVR, they described subpopulations of AS patients for whom the decision of whether to accept TAVR should be weighed within the context of clinical uncertainty about expected benefits (i.e. patients with prohibitive surgical risk and multi-comorbid conditions) or valve durability (i.e. surgery candidates). The DAs are currently available on the American College of Cardiology’s patient-facing CardioSmart website. Conclusion: AS treatment options are technically complex and have patient-centered trade-offs. Developing and adapting patient decision aids for AS can improve the decision making process. This development process offers lessons for improving shared decision making for evolving therapies for other life-threatening disease.

Since their initial clinical demonstration in 1980, implantable cardioverter–defibrillators (ICDs) have prolonged countless lives with successful treatment of sudden cardiac arrest.1 No other therapy has proved as effective in preventing death from ventricular arrhythmias, and important advances in ICD technology continue to improve outcomes for well-selected patients.2 Although indicated for a wide range of inherited and acquired conditions,3 ICDs are predominantly placed in older patients with left ventricular systolic dysfunction and either previous myocardial infarction or congestive heart failure.4 In the United States alone, >50 000 ICDs are placed annually in patients aged > 65 years, and nearly 500 000 more may meet current guidelines for device implantation.5 However, decision making for older patients considering ICD implantation is particularly challenging. Subjects in the landmark trials had average ages in the 60s, and thus the survival benefits of ICDs in older age groups is less well-established.6 In addition, compared with the younger participants in most clinical trials, older adults have a lower ratio of arrhythmic death to nonarrhythmic death because of competing risks for mortality, resulting in a potentially lower absolute risk reduction. At the same time, living and eventually dying with an ICD introduces potential risks, including a lower quality of life (QoL), hospitalizations, and potential suffering at the end of life.7 A rigorous consideration of the benefits, risks, and ongoing care surrounding ICD use in older patients is long overdue. On April 22, 2014, we convened a conference of multidisciplinary experts in cardiac electrophysiology, heart failure, geriatrics, ethics, and palliative care in Boston, supported by the Hartford Change AGEnts and Paul B. Beeson Career Development Award programs, and the Hebrew SeniorLife Institute for Aging Research. The objectives of the conference were (1) to review what is currently known about ICD use in …

Background: Shared decision making (SDM) is a mainstream component of cardiovascular disease care in the US. This is particularly true in light of support for SDM from the IOM, the ACA, the FDA 1-3, several professional societies, and Cochrane Review findings of improved patient-centered outcomes4. Given the complex nature of advanced CV therapies - characterized by the IOM as having “more to do, more to manage, and more people involved than ever before”5 - SDM programs are critical to patient-centered assessment of quality of care in CV. Human rights-based approaches (HRBAs)6-7 are common in evaluations of programs targeting communicable disease in developing countries, but are underutilized in CVD care in the US. HRBAs ground assessment in international human rights law, and provide a normative framework for the design, implementation, monitoring and evaluation of interventions, policy, and programs. An HRBA to health aims to realize the right to the “highest attainable standard of health”—including the availability, accessibility, acceptability, and quality of health facilities, information, goods, and services—and other health-related human rights (including autonomy and full and informed decisionmaking, the right to participation, and accountability).8-12 Approach: Using decision support regarding ICDs as a model, we created a conceptual framework highlighting synergies between HRBAs and SDM. This model of HRBA assessment of SDM programs covers four stages of design/deployment of decision aids (design of tools; implementation; use of PtDAs with patients; monitoring, evaluation and accountability), with accompanying rights-based considerations for each. The model is replicable across decision support related to other complex therapies with preference-sensitive trade-offs. Results & Implications: There is considerable synergy between HRBAs and SDM. Both empower patients, emphasize autonomy, and have potential to improve processes and outcomes. This model offers legal grounding and a normative framework through which one can evaluate SDM programming, improving decisionmaking processes and better aligning outcomes with patients’ values and goals. Research into the use of HRBA assessment of SDM is warranted; the goal being to respect, protect, and fulfill human rights obligations.