Emerging Experiences with Virtual Clinical Ethics Consultation: Case Studies from the United States and Malaysia.

AbstractThe COVID-19 pandemic has inspired numerous opportunities for telehealth implementation to meet diverse healthcare needs, including the use of virtual communication platforms to facilitate the growth of and access to clinical ethics consultation (CEC) services across the globe. Here we discuss the conceptualization and implementation of two different virtual CEC services that arose during the COVID-19 pandemic: the Clinical Ethics Malaysia COVID-19 Consultation Service and the Johns Hopkins Hospital Ethics Committee and Consultation Service. A common strength experienced by both platforms during virtual delivery included improved ability for local practitioners to address consultation needs for patient populations otherwise unable to access CEC services in their respective locations. Additionally, virtual platforms allowed for enhanced collaboration and sharing of expertise among ethics consultants. Both contexts encountered numerous challenges related to patient care delivery during the pandemic. The use of virtual technologies resulted in decreased personalization of patient-provider communication. We discuss these challenges with respect to contextual differences specific to each service and setting, including differences in CEC needs, sociocultural norms, resource availability, populations served, consultation service visibility, healthcare infrastructure, and funding disparities. Through lessons learned from a health system in the United States and a national service in Malaysia, we provide key recommendations for health practitioners and clinical ethics consultants to leverage virtual communication platforms to mitigate existing inequities in patient care delivery and increase capacity for CEC globally.

Coamplification of miR-4728 protects HER2-amplified breast cancers from targeted therapy.

HER2 (ERBB2) amplification is a driving oncogenic event in breast cancer. Clinical trials have consistently shown the benefit of HER2 inhibitors (HER2i) in treating patients with both local and advanced HER2+ breast cancer. Despite this benefit, their efficacy as single agents is limited, unlike the robust responses to other receptor tyrosine kinase inhibitors like EGFR inhibitors in EGFR-mutant lung cancer. Interestingly, the lack of HER2i efficacy occurs despite sufficient intracellular signaling shutdown following HER2i treatment. Exploring possible intrinsic causes for this lack of response, we uncovered remarkably depressed levels of NOXA, an endogenous inhibitor of the antiapoptotic MCL-1, in HER2-amplified breast cancer. Upon investigation of the mechanism leading to low NOXA, we identified a micro-RNA encoded in an intron of HER2, termed miR-4728, that targets the mRNA of the Estrogen Receptor α (ESR1). Reduced ESR1 expression in turn prevents ERα-mediated transcription of NOXA, mitigating apoptosis following treatment with the HER2i lapatinib. Importantly, resistance can be overcome with pharmacological inhibition of MCL-1. More generally, while many cancers like EGFR-mutant lung cancer are driven by activated kinases that when drugged lead to robust monotherapeutic responses, we demonstrate that the efficacy of targeted therapies directed against oncogenes active through focal amplification may be mitigated by coamplified genes.

Patient and caregiver characteristics related to completion of advance directives in terminally ill patients.

OBJECTIVE: There is a growing body of literature describing the characteristics of patients who plan for the end of life, but little research has examined how caregivers influence patients' advance care planning (ACP). The purpose of this study was to examine how patient and caregiver characteristics are associated with advance directive (AD) completion among patients diagnosed with a terminal illness. We defined AD completion as having completed a living will and/or identified a healthcare power of attorney. METHOD: A convenience sample of 206 caregiver-patient dyads was included in the study. All patients were diagnosed with an advanced life-limiting illness. Trained research nurses administered surveys to collect information on patient and caregiver demographics (i.e., age, sex, race, education, marital status, and individual annual income) and patients' diagnoses and completion of AD. Multivariate logistic regression was employed to model predictors for patients' AD completion. RESULTS: Over half of our patient sample (59%) completed an AD. Patients who were older, diagnosed with amyotrophic lateral sclerosis, and with a caregiver who was Caucasian or declined to report an income level were more likely to have an AD in place. SIGNIFICANCE OF RESULTS: Our results suggest that both patient and caregiver characteristics may influence patients' decisions to complete an AD at the end of life. When possible, caregivers should be included in advance care planning for patients who are terminally ill.

Symptom frequency, severity, and quality of life among persons with three disease trajectories: cancer, ALS, and CHF.

PURPOSE: National reports on end-of-life symptom management reveal a gap in the evidence regarding symptoms other than pain and studies of diseases other than cancer. This study examines the frequency and severity of symptoms and quality of life (QOL) in persons with advanced cancer, amyotrophic lateral sclerosis (ALS), and congestive heart failure (CHF). METHODS: The present study is a cross-sectional examination of symptoms and QOL measured using the McGill QOL Questionnaire, among 147 participants. RESULTS: Forty one percent of participants had advanced cancer, 22% had ALS, and 37% had advanced CHF. A total of 266 symptoms were reported, with the common symptom categories being discomfort/pain, weakness/fatigue/sleep, and respiratory. Participants with CHF had the highest mean symptom severity and the lowest QOL. CONCLUSION: Clinicians should be aware and attentive for symptoms other than pain in patients with advanced illness. Studies on diseases other than cancer, such as CHF and ALS, are important to improve symptom management in all disease groups.

The growth of palliative care in the United States.

Palliative care has been one of the most rapidly growing fields of health care in the United States in the past decade. The benefits of palliative care have now been shown in multiple clinical trials, with increased patient and provider satisfaction, equal or better symptom control, more discernment of and honoring choices about place of death, fewer and less intensive hospital admissions in the last month of life, less anxiety and depression, less caregiver distress, and cost savings. The cost savings come from cost avoidance, or movement of a patient from a high cost setting to a lower cost setting. Barriers to expanded use include physician resistance, unrealistic expectations of patients and families, and lack of workforce. The future of palliative care includes more penetration into other fields such as nephrology, neurology, and surgery; further discernment of the most effective and cost-effective models; and establishment of more outpatient services.

"They Would Lift My Spirits": Sources of Support for Family Surrogate Decision-Makers at the End of Life.

Surrogate decision-makers make critical decisions for loved ones at the end of life, and some experience lasting negative psychological outcomes. Understanding whom they rely on for support and the types of support they value may inform nursing care and that of other health team members who work with surrogates. The purpose of the study was to explore decision support and other types of support provided to surrogate decision-makers at the end of life of their loved one and perceived usefulness of the support. This secondary analysis of data from a mixed-methods study involved the examination of the transcripts of qualitative interviews with 13 surrogate decision-makers in the United States, conducted between 2010 and 2014. A constant comparative method was used to identify common themes surrounding surrogate decision support at the end of life. Surrogates valued advance directives and conversations with their loved one about treatment preferences. Surrogates described involving many different types of people in decision-making and other types of support. Finally, surrogates appreciated being reassured that they were doing a good job in making decisions and seemed to seek out this type of affirmation from various sources including the health care team, family, and friends. Nurses are well-positioned to provide this affirmation because of the time that they spend caring for the patient and family. Future research should further explore the concept of affirmation of surrogates in their role as a means of support as they make decisions for a loved one.

Learner feedback and educational outcomes with an internet-based ambulatory curriculum: a qualitative and quantitative analysis.

BACKGROUND: Online medical education curricula offer new tools to teach and evaluate learners. The effect on educational outcomes of using learner feedback to guide curricular revision for online learning is unknown. METHODS: In this study, qualitative analysis of learner feedback gathered from an online curriculum was used to identify themes of learner feedback, and changes to the online curriculum in response to this feedback were tracked. Learner satisfaction and knowledge gains were then compared from before and after implementation of learner feedback. RESULTS: 37,755 learners from 122 internal medicine residency training programs were studied, including 9437 postgraduate year (PGY)1 residents (24.4 % of learners), 9864 PGY2 residents (25.5 %), 9653 PGY3 residents (25.0 %), and 6605 attending physicians (17.0 %). Qualitative analysis of learner feedback on how to improve the curriculum showed that learners commented most on the overall quality of the educational content, followed by specific comments on the content. When learner feedback was incorporated into curricular revision, learner satisfaction with the instructive value of the curriculum (1 = not instructive; 5 = highly instructive) increased from 3.8 to 4.1 (p < 0.001), and knowledge gains (i.e., post test scores minus pretest scores) increased from 17.0 % to 20.2 % (p < 0.001). CONCLUSIONS: Learners give more feedback on the factual content of a curriculum than on other areas such as interactivity or website design. Incorporating learner feedback into curricular revision was associated with improved educational outcomes. Online curricula should be designed to include a mechanism for learner feedback and that feedback should be used for future curricular revision.

Ethics and Well-Being: The Health Professions and the COVID-19 Pandemic.

The COVID-19 pandemic has had a profound impact on health professionals, adding to the moral suffering and burnout that existed prepandemic. The physical, psychological, and moral toll of the pandemic has threatened the well-being and integrity of clinicians. The narrative of self-sacrifice and heroism bolstered people early on but was not sustainable over time. For health professions students, the learning environment changed dramatically, limiting opportunities in direct patient care and raising concerns for meeting training requirements. Learners lost social connections and felt isolated while learning remotely, and they witnessed ethical tensions between patient-centered care and parallel obligations to public health. Worries about transmission of the virus and uncertainty about its management contributed to their moral suffering. Educators adjusted curricula to address the changing ethical landscape. Preparing learners for the realities of their future professional identities requires creation of interprofessional moral communities that provide support and help develop the moral agency and integrity of its members using experiential and relational learning methods. Investing in the well-being and resilience of clinicians, implementing the recommendations of the National Academy of Medicine, and engaging learners and faculty as cocreators of ethical practice have the potential to transform the learning environment. Faculty need to be trained as effective mentors to create safe spaces for exploring challenges and address moral adversity. Ethics education will need to expand to issues related to health systems science, social determinants of health, and public health, and the cultivation of moral sensitivity, character development, professional identity formation, and moral resilience.

A video-intervention to improve clinician attitudes toward patients with sickle cell disease: the results of a randomized experiment.

BACKGROUND: Clinician attitudes toward patients are associated with variability in the quality of health care. Attitudes are typically considered difficult to change, and few interventions have attempted to do so. Negative attitudes toward adults with sickle cell disease have been identified as an important barrier to the receipt of appropriate pain management for this patient population. OBJECTIVE: To test the effect of a video-intervention designed to improve clinician attitudes toward adults with sickle cell disease. INTERVENTIONS: An 8-minute video depicting a clinician expert and patients discussing challenges in seeking treatment for sickle cell pain. DESIGN AND PARTICIPANTS: A randomized post-test only control group design was used to assess the impact of the intervention on the attitudes of 276 nurses and housestaff working at a large, urban, academic medical center. MAIN MEASURES: Attitudes toward adult sickle cell patients assessed using 5- and 6-point Likert-scale items. Exploratory factor analysis was used to identify underlying attitudinal domains and develop scales. Examples of the negative and positive attitudes assessed include clinician estimates of the percentage of SCD patients that exaggerate pain (negative) or make clinicians glad they went into medicine (positive). KEY RESULTS: Compared to the control group, the intervention group exhibited decreased negative attitudes (Difference in means = -8.9, 95%CI [-14.2, -3.6]; Cohen's d = 0.41), decreased endorsement of certain patient behaviors as "concern-raising" (Difference in means = -7.8, 95%CI [-13.1, -2.5]; Cohen's d = 0.36), and increased positive attitudes toward sickle cell patients (Difference in means = 6.6, 95% CI [0.6, 12.6]; Cohen's d = 0.27). CONCLUSIONS: Our results suggest that the attitudes of clinicians toward sickle cell patients may be improved through a short and relatively easy to implement intervention. Whether the attitudinal differences associated with our intervention are sustainable or are linked to clinical outcomes remains to be seen.

Family understanding of seriously-ill patient preferences for family involvement in healthcare decision making.

BACKGROUND: Surrogate accuracy in predicting patient treatment preferences (i.e., what patients want) has been studied extensively, but it is not known whether surrogates can predict how patients want loved ones to make end-of-life decisions on their behalf. OBJECTIVE: To evaluate the ability of family members to correctly identify the preferences of seriously-ill patients regarding family involvement in decision making. DESIGN: Cross-sectional survey. PARTICIPANTS: Twenty-five pancreatic cancer and 27 amyotrophic lateral sclerosis (ALS) patients and their family members (52 dyads total). MAIN MEASURES: Patients and family members completed the Decision Control Preferences (DCP) scale regarding patient preferences for family involvement in health care decisions using conscious and unconscious scenarios. KEY RESULTS: Patient and family member agreement was 56% (29/52 dyads) for the conscious scenario (kappa 0.29) and 46% (24/52 dyads) for the unconscious scenario (kappa 0.15). Twenty-four family members identified the patient's preference as independent in the unconscious scenario, but six of these patients actually preferred shared decision making and six preferred reliant decision making. In the conscious scenario, preference for independent decision making was associated with higher odds of patient-family agreement (AOR 5.28, 1.07-26.06). In the unconscious scenario, cancer patients had a higher odds of agreement than ALS patients (AOR 3.86; 95% CI 1.02-14.54). CONCLUSION: Family members were often unable to correctly identify patient preferences for family involvement in end-of-life decision making, especially when patients desired that decisions be made using the best-interest standard. Clinicians and family members should consider explicitly eliciting patient preferences for family involvement in decision making. Additional research is still needed to identify interventions to improve family member understanding of patient preferences regarding the decision-making process itself.

Everyday ethics in internal medicine resident clinic: an opportunity to teach.

OBJECTIVES: Being a good doctor requires competency in ethics. Accordingly, ethics education during residency training is important. We studied the everyday ethics-related issues (i.e. ordinary ethics issues commonly faced) that internal medical residents encounter in their out-patient clinic and determined whether teaching about these issues occurred during faculty preceptor-resident interactions. METHODS: This study involved a multi-method qualitative research design combining observation of preceptor-resident discussions with preceptor interviews. The study was conducted in two different internal medicine training programme clinics over a 2-week period in June 2007. Fifty-three residents and 19 preceptors were observed, and 10 preceptors were interviewed. Transcripts of observer field notes and faculty interviews were carefully analysed. The analysis identified several themes of everyday ethics issues and determined whether preceptors identified and taught about these issues. RESULTS: Everyday ethics content was considered present in 109 (81%) of the 135 observed case presentations. Three major thematic domains and associated sub-themes related to everyday ethics issues were identified, concerning: (i) the Doctor-Patient Interaction (relationships; communication; shared decision making); (ii) the Resident as Learner (developmental issues; challenges and conflicts associated with training; relationships with colleagues and mentors; interactions with the preceptor), and; (iii) the Doctor-System Interaction (financial issues; doctor-system issues; external influences; doctor frustration related to system issues). Everyday ethics issues were explicitly identified by preceptors (without teaching) in 18 of 109 cases (17%); explicit identification and teaching occurred in only 13 cases (12%). CONCLUSIONS: In this study a variety of everyday ethics issues were frequently encountered as residents cared for patients. Yet, faculty preceptors infrequently explicitly identified or taught these issues during their interactions with residents. Ethics education is important and residents may regard teaching about the ethics-related issues they actually encounter to be highly relevant. A better understanding of the barriers to teaching is needed in order to promote education about everyday ethics in the out-patient setting.

A Palliative Care Intervention for Patients on Phase 1 Studies.

Background: Phase 1 clinical trials remain vital for oncology care. Patients on these trials require supportive care for quality-of-life (QOL) concerns. Objective: To test a Palliative Care Intervention (PCI) for patients with solid tumors enrolled in Phase I therapeutic trials with a priori hypothesis that psychological distress, QOL, satisfaction, symptoms, and resource utilization would be improved in the PCI group. Design: This unblinded randomized trial compared the PCI with usual care in patients accrued to Phase I Clinical Trials. Subjects (n = 479) were followed for 24 weeks, with 12 weeks as the primary outcome. Setting: Two Comprehensive Cancer Centers in the United States. Subjects: A consecutive sample, 21 years or older, English fluency, with solid tumors initiating a Phase 1 trial. Measurements: Psychological Distress (Distress Thermometer), QOL total and subscales (FACT-G), satisfaction (FAM-CARE), survival, and resource utilization (chart audit). Results: PCI subjects showed improved Psychological Distress (-0.47, p = 0.015) and Emotional Well-Being (0.81, p = 0.045), with differences on variables of QOL and distress between sites. High rates of symptom-management admissions (41.3%) and low rates of Advance Directive completion (39.0%), and hospice enrollment (30.7%), despite a median survival in both groups of 10.1 months from initiating a Phase 1 study. Conclusions: A nurse-delivered PCI can improve some QOL outcomes and distress for patients participating in Phase 1 trials. Greater integration of PC is needed to provide quality care to these patients and to support transitions from treatment to supportive care, especially at the end of life. ClinicalTrials.gov Identifier: NCT01612598.

Operational Recommendations for Scarce Resource Allocation in a Public Health Crisis.

The coronavirus disease 2019 pandemic may require rationing of various medical resources if demand exceeds supply. Theoretical frameworks for resource allocation have provided much needed ethical guidance, but hospitals still need to address objective practicalities and legal vetting to operationalize scarce resource allocation schemata. To develop operational scarce resource allocation processes for public health catastrophes, including the coronavirus disease 2019 pandemic, five health systems in Maryland formed a consortium-with diverse expertise and representation-representing more than half of all hospitals in the state. Our efforts built on a prior statewide community engagement process that determined the values and moral reference points of citizens and health-care professionals regarding the allocation of ventilators during a public health catastrophe. Through a partnership of health systems, we developed a scarce resource allocation framework informed by citizens' values and by general expert consensus. Allocation schema for mechanical ventilators, ICU resources, blood components, novel therapeutics, extracorporeal membrane oxygenation, and renal replacement therapies were developed. Creating operational algorithms for each resource posed unique challenges; each resource's varying nature and underlying data on benefit prevented any single algorithm from being universally applicable. The development of scarce resource allocation processes must be iterative, legally vetted, and tested. We offer our processes to assist other regions that may be faced with the challenge of rationing health-care resources during public health catastrophes.

Temporal and geographic evidence for evolution of Sin Nombre virus using molecular analyses of viral RNA from Colorado, New Mexico and Montana.

BACKGROUND: All viruses in the family Bunyaviridae possess a tripartite genome, consisting of a small, a medium, and a large RNA segment. Bunyaviruses therefore possess considerable evolutionary potential, attributable to both intramolecular changes and to genome segment reassortment. Hantaviruses (family Bunyaviridae, genus Hantavirus) are known to cause human hemorrhagic fever with renal syndrome or hantavirus pulmonary syndrome. The primary reservoir host of Sin Nombre virus is the deer mouse (Peromyscus maniculatus), which is widely distributed in North America. We investigated the prevalence of intramolecular changes and of genomic reassortment among Sin Nombre viruses detected in deer mice in three western states. METHODS: Portions of the Sin Nombre virus small (S) and medium (M) RNA segments were amplified by RT-PCR from kidney, lung, liver and spleen of seropositive peromyscine rodents, principally deer mice, collected in Colorado, New Mexico and Montana from 1995 to 2007. Both a 142 nucleotide (nt) amplicon of the M segment, encoding a portion of the G2 transmembrane glycoprotein, and a 751 nt amplicon of the S segment, encoding part of the nucleocapsid protein, were cloned and sequenced from 19 deer mice and from one brush mouse (P. boylii), S RNA but not M RNA from one deer mouse, and M RNA but not S RNA from another deer mouse. RESULTS: Two of 20 viruses were found to be reassortants. Within virus sequences from different rodents, the average rate of synonymous substitutions among all pair-wise comparisons (pis) was 0.378 in the M segment and 0.312 in the S segment sequences. The replacement substitution rate (pia) was 7.0 x 10-4 in the M segment and 17.3 x 10-4 in the S segment sequences. The low pia relative to pis suggests strong purifying selection and this was confirmed by a Fu and Li analysis. The absolute rate of molecular evolution of the M segment was 6.76 x 10-3 substitutions/site/year. The absolute age of the M segment tree was estimated to be 37 years. In the S segment the rate of molecular evolution was 1.93 x 10-3 substitutions/site/year and the absolute age of the tree was 106 years. Assuming that mice were infected with a single Sin Nombre virus genotype, phylogenetic analyses revealed that 10% (2/20) of viruses were reassortants, similar to the 14% (6/43) found in a previous report. CONCLUSION: Age estimates from both segments suggest that Sin Nombre virus has evolved within the past 37-106 years. The rates of evolutionary changes reported here suggest that Sin Nombre virus M and S segment reassortment occurs frequently in nature.

Teaching ethics to paediatrics residents: the centrality of the therapeutic alliance.

CONTEXT: Previous research on ethical issues encountered by medical professionals in training and practice have presented the thematic content of the cases they encounter rather than the activities in which clinicians engage and in which they most often encounter ethical issues. We conducted a direct observation study of paediatrics residents and their preceptors seeing patients in an out-patient general paediatrics clinic. Our objectives were to describe the everyday ethics-related issues paediatrics residents encounter as they interact with patients. Our ultimate goal is to use this knowledge to enhance current efforts to teach ethics to paediatrics residents. METHODS: The study team directly observed paediatrics residents discussing patients with their faculty preceptors (19 half-day sessions, 76 hours) in an out-patient general paediatrics clinic located in an urban academic medical centre. Each interaction between resident and preceptor about a single patient was considered a case for further analysis. RESULTS: A total of 247 cases were recorded. Forty-one of the cases were coded as having ethics-related content. A constant comparative method of qualitative data analysis revealed that residents were most likely to encounter ethical issues when engaged in the following activities: (i) maintaining a therapeutic alliance with the caregiver (e.g. the parent); (ii) prioritising patient or family needs; (iii) adjusting to the power embodied by the role of doctors, and (iv) distinguishing suboptimal care from abuse or neglect. In addition, our findings indicate that it is through their efforts to maintain the therapeutic alliance with the caregivers of their patients that residents engage in and integrate three processes: developing their medical knowledge; adhering to professional norms, and balancing the power inherent in the doctor's role with their responsibility to serve the patient's interests. CONCLUSIONS: Medical faculty tasked with teaching ethics to paediatrics residents can utilise the results of this project to better target and enhance their ethics education efforts directed at residents in the out-patient setting. Future research could further examine and test these findings in other clinical settings (e.g. adult general medicine).

Development and validation of the Family Decision-Making Self-Efficacy Scale.

OBJECTIVE: Several studies have reported high levels of distress in family members who have made health care decisions for loved ones at the end of life. A method is needed to assess the readiness of family members to take on this important role. Therefore, the purpose of this study was to develop and validate a scale to measure family member confidence in making decisions with (conscious patient scenario) and for (unconscious patient scenario) a terminally ill loved one. METHODS: On the basis of a survey of family members of patients with amyotrophic lateral sclerosis (ALS) enriched by in-depth interviews guided by Self-Efficacy Theory, we developed six themes within family decision making self-efficacy. We then created items reflecting these themes that were refined by a panel of end-of-life research experts. With 30 family members of patients in an outpatient ALS and a pancreatic cancer clinic, we tested the tool for internal consistency using Cronbach's alpha and for consistency from one administration to another using the test-retest reliability assessment in a subset of 10 family members. Items with item to total scale score correlations of less than .40 were eliminated. RESULTS: A 26-item scale with two 13-item scenarios resulted, measuring family self-efficacy in decision making for a conscious or unconscious patient with a Cronbach's alphas of .91 and .95, respectively. Test-retest reliability was r = .96, p = .002 in the conscious senario and r = .92, p = .009 in the unconscious scenario. SIGNIFICANCE OF RESULTS: The Family Decision-Making Self-Efficacy Scale is valid, reliable, and easily completed in the clinic setting. It may be used in research and clinical care to assess the confidence of family members in their ability to make decisions with or for a terminally ill loved one.

From Modules to MOOCs: Application of the Six-Step Approach to Online Curriculum Development for Medical Education.

Online curricula can make high-quality health professions education accessible in virtually any setting. They can enhance teaching and learning by both standardizing curricular resources and individualizing curricular experiences. Despite growing demand for and institutional interest in online curricula for medical education, many medical educators lack a framework for online curriculum development. Without rigorous and thoughtful development, online curricula can waste opportunity and resources by leading to education that is inferior to traditional methods. In this article, the authors describe a systematic approach to online curriculum development based on the Six-Step Approach for Curriculum Development for Medical Education, a widely used method that has led to successful implementation of a variety of traditional and online curricula. In each step, special considerations for curricula with larger and more diverse learner audiences-characteristic of many online curricula-are highlighted. Four common online curricular formats are also discussed: blended curricula, instructor-led fully online curricula, self-paced modules, and massive open online courses (MOOCs). The authors emphasize factors that differentiate one online format from another, including the budgetary, technical, and human resource requirements for each. The article concludes by urging medical educators to pursue opportunities to study and disseminate online curricular work.