Cardiac implantable electronic device (CIED) procedures require informed consent and, ideally, shared decision making to guide patients through their experiences as CIED recipients. The information that different patients need or want about cybersecurity risk varies. This article considers device cybersecurity risks in light of federal guidelines and suggests strategies for communicating these risks clearly during informed consent conversations and follow-up.
Publications by Year: 2021
2021
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.
OBJECTIVE: The authors sought to describe state-to-state variations in the scope of statutory authority granted to default surrogates who decide on mental health treatment for incapacitated patients.
METHODS: The authors investigated state statutes delineating the powers of default surrogates to make decisions about mental health treatment. Statutes in all 50 U.S. states and the District of Columbia were identified and analyzed independently by three reviewers. Research was conducted from August 2017 to November 2018 and updated in January 2020.
RESULTS: State statutes varied in approaches to default surrogate decision making for mental health treatment. Eight states' statutes delegate broad authority to surrogates, whereas 25 states prohibit surrogates from giving consent for specific therapies. Thirteen states are silent on whether surrogates may make decisions.
CONCLUSIONS: Heterogeneity among state statutory laws contributes to complexity of treating patients without decisional capacity. This variability encumbers efforts to support surrogates and clinicians and may contribute to health disparities.
While cardiorespiratory fitness is strongly associated with mortality and diverse outcomes, routine measurement is limited. We used smartphone-derived physical activity data to estimate fitness among 50 older adults. We recruited iPhone owners undergoing cardiac stress testing and collected recent iPhone physical activity data. Cardiorespiratory fitness was measured as peak metabolic equivalents of task (METs) achieved on cardiac stress test. We then estimated peak METs using multivariable regression models incorporating iPhone physical activity data, and validated with bootstrapping. Individual smartphone variables most significantly correlated with peak METs (p-values both < 0.001) included daily peak gait speed averaged over the preceding 30 days (r = 0.63) and root mean square of the successive differences of daily distance averaged over 365 days (r = 0.57). The best-performing multivariable regression model included the latter variable, as well as age and body mass index. This model explained 68% of variability in observed METs (95% CI 46%, 81%), and estimated peak METs with a bootstrapped mean absolute error of 1.28 METs (95% CI 0.98, 1.60). Our model using smartphone physical activity estimated cardiorespiratory fitness with high performance. Our results suggest larger, independent samples might yield estimates accurate and precise for risk stratification and disease prognostication.
California has focused on health equity in the state's COVID-19 reopening plan. The Blueprint for a Safer Economy assigns each of California's 58 counties into 1 of 4 tiers based on 2 metrics: test positivity rate and adjusted case rate. To advance to the next less-restrictive tier, counties must meet that tier's test positivity and adjusted case rate thresholds. In addition, counties must have a plan for targeted investments within disadvantaged communities, and counties with more than 106 000 residents must meet an equity metric. California's explicit incorporation of health equity into its reopening plan underscores the interrelated fate of its residents during the COVID-19 pandemic and creates incentives for action. This article evaluates the benefits and challenges of this novel health equity focus, and outlines recommendations for other US states to address disparities in their reopening plans.
The use of remote monitoring technology for cardiovascular electronic implantable devices has grown significantly in recent decades, yet several key questions remain about its integration into clinical care. We performed semi-structured interviews of patients, clinicians, and device clinic technicians involved in clinical remote monitoring of cardiovascular implantable devices at our institution. Twenty-eight interviews comprised of 15 patients and 13 clinicians were conducted from October 2019 through February 2020. Interview transcripts were analyzed using a mixed inductive and deductive approach. Perspectives among clinicians and patients varied regarding familiarity, educational experiences, and preferences regarding how remote monitoring data are handled. Three key domains emerged including knowledge and understanding, managing alerts, and cost transparency. Within these domains, key findings includedvery limited understanding of how remote monitoring functions and how alerts in particular are handled. These knowledge deficits (both patients and providers) appeared to arise in part from different equipment and platforms among manufacturers, the complexity of the technology, and lack of formalized education in remote monitoring. However, interviewees expressed generally high levels of trust in the technology and care systems supporting remote monitoring. Few respondents described concerns around cybersecurity, but patients in particular did raise concerns about cost transparency and frequent billing. In conclusion, conflicting perceptions around remote monitoring persist and indicate important knowledge gaps despite high trust in the care pathway. This qualitative analysis offers insight into patient and clinician understanding of and attitudes toward remote monitoring, and may guide future efforts to improve education and patient-centeredness of remote monitoring.