What Makes Palliative Mental Health Care Ethical Health Care?

Treatment-resistant schizophrenia can create a high disease burden for some patients, making it challenging for all involved to navigate a good outcome. Such cases require physicians to regard symptom eradication and treatment success as the same. This commentary on a case considers a palliative psychiatry approach grounded in the well-being of patients and inclusion of all stakeholders in decision-making processes.

Assessing Breast Cancer Molecular Subtypes Using Extracellular Vesicles' mRNA.

Extracellular vesicles (EVs) carry RNA cargo that is believed to be associated with the cell-of-origin and thus have the potential to serve as a minimally invasive liquid biopsy marker for supplying molecular information to guide treatment decisions (i.e., precision medicine). We report the affinity isolation of EV subpopulations with monoclonal antibodies attached to the surface of a microfluidic chip that is made from a plastic to allow for high-scale production. The EV microfluidic affinity purification (EV-MAP) chip was used for the isolation of EVs sourced from two-orthogonal cell types and was demonstrated for its utility in a proof-of-concept application to provide molecular subtyping information for breast cancer patients. The orthogonal selection process better recapitulated the epithelial tumor microenvironment by isolating two subpopulations of EVs: EVEpCAM (epithelial cell adhesion molecule, epithelial origin) and EVFAPα (fibroblast activation protein α, mesenchymal origin). The EV-MAP provided recovery >80% with a specificity of 99 ± 1% based on exosomal mRNA (exo-mRNA) and real time-droplet digital polymerase chain reaction results. When selected from the plasma of healthy donors and breast cancer patients, EVs did not differ in size or total RNA mass for both markers. On average, 0.5 mL of plasma from breast cancer patients yielded ∼2.25 ng of total RNA for both EVEpCAM and EVFAPα, while in the case of cancer-free individuals, it yielded 0.8 and 1.25 ng of total RNA from EVEpCAM and EVFAPα, respectively. To assess the potential of these two EV subpopulations to provide molecular information for prognostication, we performed the PAM50 test (Prosigna) on exo-mRNA harvested from each EV subpopulation. Results suggested that EVEpCAM and EVFAPα exo-mRNA profiling using subsets of the PAM50 genes and a novel algorithm (i.e., exo-PAM50) generated 100% concordance with the tumor tissue.

Addressing Anti-Black Racism in Bioethics: Responding to the Call.

As a field concerned with ethical issues in health and health care, particularly how structures, policies, and practices unfairly advantage some and disadvantage others, bioethics has a moral obligation to address the long-standing challenges that racism has posed to the overall health and well-being of Black, Indigenous, and Latinx people and other people of color. Arguably, the premature death and disease disproportionately affecting Black Americans and the well-documented association of such death and illness with racism are issues that have not gained due attention in bioethics. This multiauthored report highlights the intergenerational work of mostly Black scholars and aims to create an agenda for bioethics that addresses anti-Black racism and the ways in which this form of racism threatens the actualization of justice in health and health care, not only for Black people and other minoritized groups but also for all people. This special report contains five major sections representing different approaches to scholarship, including theoretical, empirical, and narrative forms. The first section features two target articles focused on anti-Black racism and health care settings, with each article accompanied by two commentaries. The second section includes four essays thematically centered around anti-Black racism and health equity research and practice. Section three features four essays that explore anti-Black racism and bioethics. The next section consists of four essays framing a braver, bolder, and broader bioethics. We conclude with a powerful tribute to the late Marian Gray Secundy, a bioethics luminary, friend, colleague, role model, and mentor, and a tie that binds together many bioethics scholars who prioritize social justice in their scholarship and praxis.

A certified child life specialist influences the emotional response during polysomnography setup.

OBJECTIVES: To examine if the presence of a certified child life specialist (CCLS) had a positive impact on patient emotion at the time of polysomnography setup and to determine the optimal timing of CCLS intervention prior to polysomnography (PSG) in our sleep center. METHODS: We implemented a study which measured the impact of a CCLS on the emotional manifestation score (EMS) of pediatric patients (4 months-17 years, median 7 years) during PSG setup. CCLS intervention was either at the time of sleep medicine consultation (daytime) or during PSG setup (evening). We used Emotional Manifestations Scores (EMS) as well as patient/caregiver satisfaction data to measure the impact of a CCLS and inform decision-making regarding ongoing employment of a CCLS in our sleep lab. RESULTS: High EMS scores were noted during PSG setup in all groups indicating the emotional distress of children undergoing PSG. The EMS improved more when CCLS was present at the time of PSG setup. Statistically significant improvements occurred in level of cooperation, pain/discomfort, and child coping. Based on the results of the study, we hired a CCLS to work in our sleep center at the time of PSG setup 2 evenings per week. CONCLUSIONS: PSG is emotionally stressful for pediatric patients as seen on EMS. A CCLS present in the evening at our sleep lab led to an improvement in EMS in children being prepared for PSG set-up. After implementation of a CCLS two nights per week in our sleep lab, parents/caregiver satisfaction scores were higher on nights a CCLS was present at setup.

Rapid response to medical device recalls: an organized patient-centered team effort.

As more patients depend upon mechanical or electronic technologies for treatment, medical device recalls-like the recent recall of common positive airway pressure treatment devices-impact millions of patients, often causing significant anxiety, extra costs, and interruption of care for patients. When recalls require health care and/durable medical equipment providers to be part of the solution, the burden on practices and businesses can be significant, creating strains on access for new patients and on limited medical supplies. We have observed that having an established and well-organized medical device recall plan in place allows for a rapid response, decreased practice burden, and reduced provider stress. Coupling the organized response with proactive, empathic, and clear communication with patients reduces their anxiety, provides clear directions for how to address the issue constructively, and reduces reactive communications. We share what we believe are key components of a medical device and produce recall procedure as we describe our institutions response in hopes that others can build on these basics as they design their own response plans. CITATION: Morgenthaler TI, Linginfelter EA, Gay PC, et al. Rapid response to medical device recalls: an organized patient-centered team effort. J Clin Sleep Med. 2022;18(2):663-667.

Centering Social Justice for Covid-19 Resources and Research.

In the September-October 2021 issue of the Hastings Center Report, neither the article by MaryKatherine Gaurke et al. nor the article by Alex Rajczi et al. offers a comprehensive analysis of a just allocation of scarce resources-one "rooted in a collective agreement about what constitutes health in/justice." This omission reflects a larger problem in bioethics: the field's praxis continues to fail to recognize and respond to the obligation to address the fair distribution of burdens and benefits that comes with the principle of justice. This commentary calls on bioethics to incorporate a community-based participatory research (CBPR) framework as part of its praxis. The cocreation of crisis standards of care with community stakeholders, whether the standards were focused on treatments, vaccines, or novel community-engagement strategies, could set a new gold standard for the practice of social justice in research.

Psychiatric Advance Directives as an Ethical Communication Tool: An Analysis of Definitions.

A psychiatric advance directive (PAD) is a communication tool that promotes patients' autonomy and gives capacitated adults who live with serious mental illnesses the ability to record their preferences for care and designate a proxy decision maker before a healthcare crisis. Despite a high degree of interest by patients and previous studies that recommend that clinicians facilitate the completion of PADs, the rate of implementation of PAD remains low. Research indicates that many clinicians lack the necessary experience to facilitate the completion of PADs and to use them, and, as a consequence, do not effectively engage patients about PADs. This study developed practical recommendations for clinicians to improve their ability to communicate and facilitate PADs. We (1) thematically analyzed definitions of PADs published in 118 articles across disciplines, and (2) presented our recommendations for enhanced communication in clinical practice that emphasizes patient-centeredness, usefulness, and clarity, aligned with evidence-based practices that put patients' autonomy and understanding first. While there is no one-size-fits-all script to engage patients in complex conversations, our recommended strategies include an emphasis on patients' autonomy, the adaptation of word choices, the use of metaphor not simile, and checking for patients' understanding as effective methods of clinical communication.

Affinity enrichment of extracellular vesicles from plasma reveals mRNA changes associated with acute ischemic stroke.

Currently there is no in vitro diagnostic test for acute ischemic stroke (AIS), yet rapid diagnosis is crucial for effective thrombolytic treatment. We previously demonstrated the utility of CD8(+) T-cells' mRNA expression for AIS detection; however extracellular vesicles (EVs) were not evaluated as a source of mRNA for AIS testing. We now report a microfluidic device for the rapid and efficient affinity-enrichment of CD8(+) EVs and subsequent EV's mRNA analysis using droplet digital PCR (ddPCR). The microfluidic device contains a dense array of micropillars modified with anti-CD8α monoclonal antibodies that enriched 158 ± 10 nm sized EVs at 4.3 ± 2.1 × 109 particles/100 µL of plasma. Analysis of mRNA from CD8(+) EVs and their parental T-cells revealed correlation in the expression for AIS-specific genes in both cell lines and healthy donors. In a blinded study, 80% test positivity for AIS patients and controls was revealed with a total analysis time of 3.7 h.

Visible photorelease of liquid biopsy markers following microfluidic affinity-enrichment.

We detail a heterobifunctional, 7-aminocoumarin photocleavable (PC) linker with unique properties to covalently attach Abs to surfaces and subsequently release them with visible light (400-450 nm). The PC linker allowed rapid (2 min) and efficient (>90%) release of CTCs and EVs without damaging their molecular cargo.

Enhancing the patient and family experience during pediatric sleep studies.

STUDY OBJECTIVES: Pediatric polysomnography can result in suboptimal patient and provider (physician and advanced practice provider) experiences. We embarked on a project aimed at increasing the proportion of maximal satisfaction survey scores by a minimum of 10% in 1 year without adding personnel or major expenses. METHODS: We used a Six Sigma framework, define, measure, analyze, improve, and control (DMAIC), to conduct our analysis. For measurement, we designed a project-specific survey that was given to caregivers of children who underwent PSG in February 2018 and repeated the survey after interventions in February 2019. Lean and Six Sigma quality improvement tools were used to define important processes that influence patient satisfaction, including: supplier, input, process, output, customer, and requirements (SIPOC-R); journey mapping; 1-2-4-All brainstorming; and views solicited from our center's Patient and Family Advisory Council. We analyzed the relationships between identified processes and outcomes using usual descriptive statistics. We prioritized interventions using a Kano model and a quality function deployment (QFD) technique to rank priorities for interventions. Multiple opportunities to improve patient and family satisfaction before, during, and after a pediatric polysomnography were identified. Many were simple, one-step interventions and were implemented simultaneously. For those that required substantial training and/or scheduling changes, pilots were performed and plan, do, study, act (PDSA) cycles were used to check effectiveness. RESULTS: After implementation, top box scores rose 20%, from 51% (n = 47) in 2018 to 71% (n = 50) in 2019. CONCLUSIONS: Various quality improvement techniques employed in business, engineering, and manufacturing were used to identify and address areas of improvement in the pediatric polysomnography experience.

Infusing Adult Education Principles Into a Health Insurance Literacy Program.

Health insurance literacy is an emerging concept in the health education and health promotion field. The passage of the Affordable Care Act highlighted the link between health insurance and health outcomes. However, the law does not specifically address how the public should be educated on choosing an appropriate health insurance plan. Research shows adults, regardless of previous health insurance status, are likely confused and uncertain about their selection. The University of Maryland Extension developed and created health insurance Smart Choice Health Insurance™ to reduce confusion and increase confidence and capability to make this decision. Andragogy, an adult learning theory, was used to guide the development of the program and help ensure best practices are used to achieve desired outcomes. Using the six principles of andragogy, the team incorporated reality-based case studies, allowed adults time to practice, and emphasized choice making and many other elements to create an atmosphere conducive to adult learning. Results from Smart Choice indicate the program is successful in reducing confusion and increasing confidence. Furthermore, feedback from participants and trained educators indicates that adults were engaged in the program and found the materials useful. Based on program success, creation of new health insurance literacy programs grounded in adult education principles is under way.

A multi-year study of tillage and amendment effects on compacted soils.

Constructing roads and buildings often involves removal of topsoil, grading, and traffic from heavy machinery. The result is exposed, compacted subsoil with low infiltration rate (IR), which hinders post-construction vegetation establishment and generates significant runoff, similar to impervious surfaces. Our goal was to assess tillage and adding amendments for improving density and maintaining perviousness of subsoils compacted during construction. The effects of tillage with and without amendments on (1) soil compaction, (2) IR, and (3) vegetative growth at five sites in North Carolina, USA were evaluated over a period of up to 32 months. The sites, representing a range of soil conditions, were located at three geographic regions; one in the Sandhills (located in Coastal Plain), one in the mountains, and three in the Piedmont. Amendments varied by site and included: (1) compost, (2) cross-linked polyacrylamide (xPAM), and (3) gypsum. Bulk density (BD) and soil penetration resistance (PR) tests were used to characterize soil physical condition. The IR was measured using a Cornell Sprinkle Infiltrometer. Vegetative growth was evaluated by measuring shoot mass and vegetative cover at all sites and root density at the Piedmont sites. Tillage decreased BD and PR compared to the compacted soil at four out of five sites for observations ranging from 24 to 32 months. Compost was applied to four sites prior to tillage and reduced BD in two of them compared to tillage alone. The IR in the tilled plots was maintained at about 3-10 times that of the compacted soil among the five sites over the monitoring periods. Adding amendments did not increase IR relative to tillage alone except at one Piedmont site, where compost and xPAM increased IR at 12 months and compost at 24 months after site establishment. Vegetative responses to tillage and amendments were inconsistent across sites. Results suggest that tillage is a viable option to reduce bulk density and increase infiltration for areas with compacted soils where vegetation is to be established, and that the effect is maintained for at least several years.

Smart Choice Health Insurance©: A New, Interdisciplinary Program to Enhance Health Insurance Literacy.

Smart Choice Health Insurance© is a consumer education program based on the definition and emerging measurement of health insurance literacy and a review of literature and appropriate theoretical frameworks. An interdisciplinary team of financial and health educators was formed to develop and pilot the program, with the goal of reducing confusion and increasing confidence in the consumer's ability to make a smart health insurance decision. Educators in seven states, certified to teach the program, conducted workshops for 994 consumers. Results show statistically significant evidence of increased health insurance literacy, confidence, and capacity to make a smart choice health insurance choice. Discussion centers on the impact the program had on specific groups, next steps to reach a larger audience, and implications for educators, consumers, and policymakers nationwide.

Intranasal delivery of a peptide with antidepressant-like effect.

A critical issue in drug development is developing effective, noninvasive delivery routes to the central nervous system (CNS). Major depressive disorder (MDD) is an illness associated with significant morbidity. Even with multiple antidepressant trials, 10-15% of patients continue to experience persistent depressive symptoms. We previously developed an interfering peptide that has antidepressant-like effects in rats when injected directly into the brain. To be clinically viable, it must demonstrate efficacy via a noninvasive administration route. We report here that the interfering peptide designed to disrupt the interaction between the D1 and D2 dopamine receptors can be delivered to relevant brain areas using the Pressurized Olfactory Device (POD), a novel intranasal delivery system developed by Impel NeuroPharma. We validate this delivery method by demonstrating that, at doses ⩾1.67 nmol/g, the D1-D2 interfering peptide has a significant antidepressant-like effect comparable to that of imipramine in the forced swimming test (FST), a common test for antidepressant efficacy. The antidepressant-like effect of the interfering peptide can be detected for 2 h after intranasal administration. Furthermore, we show that the interfering peptide disrupts the D1-D2 interaction and it can be detected in the prefrontal cortex after intranasal administration. This study provides strong preclinical support for intranasal administration of the D1-D2 interfering peptide as a new treatment option for patients suffering from MDD.

Cotton fiber cell walls of Gossypium hirsutum and Gossypium barbadense have differences related to loosely-bound xyloglucan.

Cotton fiber is an important natural textile fiber due to its exceptional length and thickness. These properties arise largely through primary and secondary cell wall synthesis. The cotton fiber of commerce is a cellulosic secondary wall surrounded by a thin cuticulated primary wall, but there were only sparse details available about the polysaccharides in the fiber cell wall of any cotton species. In addition, Gossypium hirsutum (Gh) fiber was known to have an adhesive cotton fiber middle lamella (CFML) that joins adjacent fibers into tissue-like bundles, but it was unknown whether a CFML existed in other commercially important cotton fibers. We compared the cell wall chemistry over the time course of fiber development in Gh and Gossypium barbadense (Gb), the two most important commercial cotton species, when plants were grown in parallel in a highly controlled greenhouse. Under these growing conditions, the rate of early fiber elongation and the time of onset of secondary wall deposition were similar in fibers of the two species, but as expected the Gb fiber had a prolonged elongation period and developed higher quality compared to Gh fiber. The Gb fibers had a CFML, but it was not directly required for fiber elongation because Gb fiber continued to elongate rapidly after CFML hydrolysis. For both species, fiber at seven ages was extracted with four increasingly strong solvents, followed by analysis of cell wall matrix polysaccharide epitopes using antibody-based Glycome Profiling. Together with immunohistochemistry of fiber cross-sections, the data show that the CFML of Gb fiber contained lower levels of xyloglucan compared to Gh fiber. Xyloglucan endo-hydrolase activity was also higher in Gb fiber. In general, the data provide a rich picture of the similarities and differences in the cell wall structure of the two most important commercial cotton species.

Minimal access excision of aortic valve fibroelastoma: a case report and review of the literature.

Papillary fibroelastomas are rare primary tumours of cardiac origin accounting for approximately 10% of all primary cardiac neoplasms. Due to a high thromboembolic risk, surgical excision is the mainstay of treatment in these patients and median sternotomy the most widely used approach. We describe the case of a 43 year-old lady presenting with acute myocardial infarction secondary to aortic valve papillary fibroelastoma subsequently excised using a minimal access technique. From our experience mini-sternotomy offers excellent exposure and allows for safe resection in such cases, improving cosmesis without compromising either intra or post-operative outcome.

Training in clinical ethics: launching the clinical ethics immersion course at the Center for Ethics at the Washington Hospital Center.

In May 2011, the clinical ethics group of the Center for Ethics at Washington Hospital Center launched a 40-hour, three and one-half day Clinical Ethics Immersion Course. Created to address gaps in training in the practice of clinical ethics, the course is for those who now practice clinical ethics and for those who teach bioethics but who do not, or who rarely, have the opportunity to be in a clinical setting. "Immersion" refers to a high-intensity clinical ethics experience in a busy, urban, acute care hospital. During the Immersion Course, participants join clinical ethicists on working rounds in intensive care units and trauma service. Participants engage in a videotaped role-play conversation with an actor. Each simulated session reflects a practical, realistic clinical ethics case consultation scenario. Participants also review patients' charts, and have small group discussions on selected clinical ethics topics. As ethics consultation requests come into the center, Immersion Course participants accompany clinical ethicists on consultations. Specific to this pilot, because participants' evaluations and course faculty impressions were positive, the Center for Ethics will conduct the course twice each year. We look forward to improving the pilot and establishing the Immersion Course as one step towards addressing the gap in training opportunities in clinical ethics.