Background
Exception from informed consent (EFIC) regulations for research in emergency settings contain unique requirements for community consultation and public disclosure. These requirements ...address ethical challenges intrinsic to this research context. Multiple approaches have evolved to accomplish these activities that may reflect and advance different aims. This scoping review was designed to identify areas of consensus and lingering uncertainty in the literature.
Methods
Scoping review methodology was used. Conceptual and empirical literature related to community consultation and public disclosure for EFIC research was included and identified through a structured search using Embase, HEIN Online, PubMed, and Web of Science. Data were extracted using a standardized tool with domains for major literature categories.
Results
Among 84 manuscripts, major domains included conceptual or policy issues, reports of community consultation processes and results, and reports of public disclosure processes and results. Areas of consensus related to community consultation included the need for a two‐way exchange of information and use of multiple methods. Public acceptance of personal EFIC enrollment is commonly 64% to 85%. There is less consensus regarding how to assess attitudes, what “communities” to prioritize, and how to determine adequacy for individual projects. Core goals of public disclosure are less well developed; no metrics exist for assessing adequacy.
Conclusions
Multiple methods are used to meet community consultation and public disclosure requirements. There remain no settled norms for assessing adequacy of public disclosure, and there is lingering debate about needed breadth and depth of community consultation.
Patient-clinician relationship quality and patient activation can both improve patient health outcomes, but prior work has primarily examined these factors independently. We examine how these two ...factors shape patient behavior in the setting of ambulatory heart failure care, where serial intensification of multiple medications is central to chronic care delivery.
We used content analysis to analyze 22 in-depth patient interviews and 32 audio-recorded clinic visits collected for the EPIC-HF Trial. This was a secondary analysis providing qualitative depth to the parent RCT.
We identified a typology of patient activation and patient-clinician relationship quality, with four types: Supported, Skeptical, Deferential, and Unempowered. Types were sensitive to time and context; a given patient might occupy multiple types throughout the course of a single clinic visit. The effects of patient-activation and the patient-clinician relationship appeared to be bidirectional, with each influencing the other.
Patient-clinician relationship quality and patient activation are dominant in shaping clinical interactions and disease management. This interaction is dynamic, and patients may change types depending on time, place, or context.
These findings suggest that both patient activation and high relationship quality work together to create a supportive environment for chronic care, where intermittent skepticism, deference or empowerment may be useful at particular times or in certain situations.
•Relationship quality and patient activation work in tandem in HF settings.•Relationship quality and activation interact to generate unique clinical typologies.•Typologies identified were Supported, Skeptical, Deferential and Disengaged.•Each typology has distinct implications for successful short- and long-term care.
The Shock Academic Research Consortium is a multi-stakeholder group, including representatives from the US Food and Drug Administration and other government agencies, industry, and payers, convened ...to develop pragmatic consensus definitions useful for the evaluation of clinical trials enrolling patients with cardiogenic shock, including trials evaluating mechanical circulatory support devices. Several in-person and virtual meetings were convened between 2020 and 2022 to discuss the need for developing the standardized definitions required for evaluation of mechanical circulatory support devices in clinical trials for cardiogenic shock patients. The expert panel identified key concepts and topics by performing literature reviews, including previous clinical trials, while recognizing current challenges and the need to advance evidence-based practice and statistical analysis to support future clinical trials. For each category, a lead (primary) author was assigned to perform a literature search and draft a proposed definition, which was presented to the subgroup. These definitions were further modified after feedback from the expert panel meetings until a consensus was reached. This manuscript summarizes the expert panel recommendations focused on outcome definitions, including efficacy and safety.
The prevalence of cardiovascular disease (CVD) in pregnancy, both diagnosed and previously unknown, is rising, and CVD is a leading cause of maternal morbidity and mortality. Historically, women of ...child-bearing potential have been underrepresented in research, leading to lasting knowledge gaps in the cardiovascular care of pregnant and lactating women. Despite these limitations, clinicians should be familiar with the safety of frequently used diagnostic and therapeutic interventions to adequately care for this at-risk population. This review, the fourth of a 5-part series, provides evidence-based recommendations regarding the use of common cardiovascular diagnostic tests and medications in pregnant and lactating women.
Background
In 2018, the Centers for Medicare and Medicaid Services (CMS) mandated that patients considering implantation of an implantable cardioverter‐defibrillator (ICD) for primary prevention of ...sudden cardiac death undergo shared decision‐making (SDM) using a decision‐aid.
Objective
To observe the impact of the CMS's mandate on core measures of SDM using a natural experiment.
Research design, subjects, and measures
Patients who underwent implantation of a primary prevention ICD within the Emory Healthcare system between 2017–2019 (pre and post SDM mandate) were surveyed. Survey domains included knowledge about the ICD, decisional conflict, values‐choice concordance, and engagement in decision‐making. Patients who had an ICD implant after the mandate were also asked about their views of the decision aid (DA). Responses of patients who had ICD implanted prior to the mandate were compared to those after the mandate using either Student t test or Chi‐Squared tests.
Results
Of 101 patients who completed the survey, 45 had an ICD placed before the mandate and 56 had an ICD placed after. There were no major differences between knowledge, decisional conflict, values choice concordance, or patient engagement. Compared to patients with ICDs placed before the mandate, patients with ICDs after the mandate were more likely to subjectively feel more informed about the benefits of the procedure but were less likely to be able to correctly identify the frequency of complications.
Conclusions
Policy effects to promote SDM that solely focus on a decision‐aid may not substantively impact patient centered care.
The coronavirus disease (COVID-19) pandemic has forced healthcare systems to develop strategies to allocate critical care resources when demand outstrips supply. The pandemic has also ...disproportionately impacted Black patients, for whom baseline health disparities are well documented and largely driven by inequity in social determinants of health. Concerns about the potential for inequity in resource allocation were raised early in the pandemic, especially if morbidity limiting near-term survival was factored into allocation decisions. Two mitigation strategies to avoid inequity in allocation have been proposed: eliminating consideration of expected survival beyond 1 year and incorporating measures of social disadvantage such as the Area Deprivation Index (ADI). Concerns exist that allocation frameworks aimed at saving the most life-years by prioritizing individuals without preexisting conditions limiting near-term survival could exacerbate systemic disparities in health and healthcare in the United States. In this analysis of ICU patients across a healthcare system, absolute differences in allocation scores by race were small and not statistically significant.
Shared decision-making using a decision aid is required for patients undergoing implantation of primary prevention implantable cardioverter-defibrillators (ICD). It is unknown how much this process ...has impacted patients’ experiences or choices. Effective shared decision-making requires an understanding of how patients make ICD decisions. A qualitative key informant study was chosen to capture the breadth of patients’ experiences making ICD decisions in the context of required shared decision-making.
We conducted in-depth interviews with 20 patients referred to electrophysiology clinics for the consideration of primary prevention ICD implantation. Purposeful sampling from a prior survey study evaluating mandated shared decision-making was based on patient characteristics and responses to the initial survey questions. Qualitative descriptive analysis of the interviews was performed using a multilevel coding strategy. Patients’ paths to an ICD decision often involved multiple visits with multiple clinicians. However, the decision aid was almost exclusively provided to the patient during electrophysiology clinic visits. Some patients used the numeric data in the decision aid to make an ICD decision based on the risk–benefit profile; others made decisions based on other data or based on trust in clinicians’ recommendations. Patients highlighted information related to living with the device as particularly important in helping them to make their ICD decisions. Some patients struggled with the emotional aspects of making an ICD decision.
Patients’ ICD decision-making paths poses a challenge to episodic shared decision-making and may make tools such as decision aids perfunctory if used solely during the electrophysiology visit. Understanding patients’ ICD decision-making paths, especially in the context of encounters with primary cardiologists, can inform the implementation strategies of shared decision-making help to enhance its impact. Components of decision aids focusing on the experience of living with an ICD rather than probabilistic data may also be more impactful, although the nature of their impact will differ.
Evidence-based medical therapy for heart failure with reduced ejection fraction (HFrEF) often entails substantial out-of-pocket costs that can vary appreciably between patients. This has raised ...concerns regarding financial toxicity, equity, and adherence to medical therapy. In spite of these concerns, cost discussions in the HFrEF population appear to be rare, partly because out-of-pocket costs are generally unavailable during clinical encounters. In this trial, out-of-pocket cost information is given to patients and clinicians during outpatient encounters with the aim to assess the impact of providing this information on medication discussions and decisions.
Cost-informed decision-making will be facilitated by providing access to patient-specific out-of-pocket cost estimates at the time of clinical encounter.
Integrating Cost into Shared Decision-Making for Heart Failure with Reduced Ejection Fraction (POCKET-COST-HF) is a multicenter trial based at Emory Healthcare and University of Colorado Health. Adapting an existing patient activation tool from the EPIC-HF trial, patients and clinicians are presented a checklist with medications approved for treatment of HFrEF with or without patient-specific out-of-pocket costs (obtained from a financial navigation firm). Clinical encounters are audio-recorded, and patients are surveyed about their experience. The trial utilizes a stepped-wedge cluster randomized design, allowing for each site to enroll control and intervention group patients while minimizing contamination of the control arm.
This trial will elucidate the potential impact of robust cost disclosure efforts and key information regarding patient and clinician perspectives related to cost and cost communication. It also will reveal important challenges associated with providing out-of-pocket costs for medications during clinical encounters. Acquiring medication costs for this trial requires an involved process and outsourcing of work. In addition, costs may change throughout the year, raising questions regarding what specific information is most valuable. These data will represent an important step towards understanding the role of integrating cost discussions into heart failure care.
NCT04793880.
Barriers to informed consent are ubiquitous in the conduct of emergency care research across a wide range of conditions and clinical contexts. They are largely unavoidable; can be related to time ...constraints, physical symptoms, emotional stress, and cognitive impairment; and affect patients and surrogates. US regulations permit an exception from informed consent for certain clinical trials in emergency settings, but these regulations have generally been used to facilitate trials in which patients are unconscious and no surrogate is available. Most emergency care research, however, involves conscious patients, and surrogates are often available. Unfortunately, there is neither clear regulatory guidance nor established ethical standards in regard to consent in these settings. In this report—the result of a workshop convened by the National Institutes of Health Office of Emergency Care Research and Department of Bioethics to address ethical challenges in emergency care research—we clarify potential gaps in ethical understanding and federal regulations about research in emergency care in which limited involvement of patients or surrogates in enrollment decisions is possible. We propose a spectrum of approaches directed toward realistic ethical goals and a research and policy agenda for addressing these issues to facilitate clinical research necessary to improve emergency care.
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