Perspectives on the role of the nurse ethicist.

This paper offers four contrasting perspectives on the role of the nurse ethicist from authors based in different areas of world, with different professional backgrounds and at different career stages. Each author raises questions about how to understand the role of the nurse ethicist. The first author reflects upon their career, the scope and purpose of their work, ultimately arguing that the distinction between 'nurse ethicist' and 'clinical ethicist' is largely irrelevant. The second author describes the impact and value that a nurse in an ethics role plays, highlighting the 'tacit knowledge' and 'lived experience' they bring to clinical ethics consultation. However, the second author also warns that the 'nurse ethicist' must be cautious in their approach to avoid being viewed as a resource only for nurses. The third author questions the introduction of additional professional distinctions such as 'nurse ethicist' on the basis that distinctions threaten the creation of egalitarian healthcare systems, while also acknowledging that clinical ethicists ought not strive for objective attachment in their work. In direct contrast, the final author suggests that the nurse ethicist can play a pivotal role in highlighting and addressing ethical challenges that are specific to nurses. These four short pieces raise questions and point to concepts that will be expanded upon and debated throughout this special issue of Nursing Ethics.

Overcoming barriers to informed consent in neurological research: Perspectives from a national survey.

The ethical recruitment of participants with neurological disorders in clinical research requires obtaining initial and ongoing informed consent. The purpose of this study is to characterize barriers faced by research personnel in obtaining informed consent from research participants with neurological disorders and to identify strategies applied by researchers to overcome those barriers. This study was designed as a web-based survey of US researchers with an optional follow-up interview. A subset of participants who completed the survey were selected using a stratified purposeful sampling strategy and invited to participate in an in-depth qualitative interview by phone or video conference. Data were analyzed using a mixed methods approach, including content analysis of survey responses and thematic analysis of interview responses. Over 1 year, 113 survey responses were received from US research personnel directly involved in obtaining informed consent from participants in neurological research. Frequently identified barriers to informed consent included: cognitive and communication impairments (e.g. aphasia), unrealistic expectations of research participants, mistrust of medical research, time constraints, literacy barriers, lack of available social support, and practical or resource-related constraints. Strategies to enhance informed consent included: involving close others to support participant understanding of study-related information, collaborating with more experienced research personnel to facilitate training in obtaining informed consent, encouraging participants to review consent forms in advance of consent discussions, and using printed materials and visual references. Beyond conveying study-related information, researchers included in this study endorsed ethical responsibilities to support deliberation necessary to informed consent in the context of misconceptions about research, unrealistic expectations, limited understanding, mistrust, and/or pressure from close others. Findings highlight the importance of training researchers involved in obtaining informed consent in neurological research to address disease-specific challenges and to support the decision-making processes of potential research participants and their close others.

Cerebellar deep brain stimulation for chronic post-stroke motor rehabilitation: a phase I trial.

Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts. In this open-label, non-randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with renewed physical rehabilitation to promote functional reorganization of ipsilesional cortex in 12 individuals with persistent (1-3 years), moderate-to-severe upper-extremity impairment. No serious perioperative or stimulation-related adverse events were encountered, with participants demonstrating a seven-point median improvement on the Upper-Extremity Fugl-Meyer Assessment. All individuals who enrolled with partial preservation of distal motor function exceeded minimal clinically important difference regardless of time since stroke, with a median improvement of 15 Upper-Extremity Fugl-Meyer Assessment points. These robust functional gains were directly correlated with cortical reorganization evidenced by increased ipsilesional metabolism. Our findings support the safety and feasibility of deep brain stimulation to the cerebellar dentate nucleus as a promising tool for modulation of late-stage neuroplasticity for functional recovery and the need for larger clinical trials. ClinicalTrials.gov registration: NCT02835443 .

Virtual prenatal visits associated with high measures of patient experience and satisfaction among average-risk patients: a prospective cohort study.

BACKGROUND: Virtual visits have the potential to decrease barriers to prenatal care stemming from transportation, work, and childcare concerns. However, data regarding patient experience and satisfaction with virtual visits remain limited in obstetrics. To address this gap, we explore average-risk pregnant women's experiences with virtual visits and compare satisfaction with virtual vs. in-person visits as a secondary aim. METHODS: In this IRB-approved, prospective cohort study, we surveyed pregnant women after their first virtual visit between October 7, 2019 and March 20, 2020. Using heterogeneous purposive sampling, we identified a subset of respondents with diverse experiences and opinions for interviews. For comparison, Consumer Assessment of Healthcare Providers and Systems (CAHPS) satisfaction data were collected after in-person visits during the study timeframe from a control cohort with the same prenatal providers. Logistic regression controlling for age, previous pregnancies, and prior live births compared satisfaction data between virtual and in-person visits. Other quantitative survey data were analyzed through descriptive statistics. Free text survey responses and interview data were analyzed using content analysis. RESULTS: Ninety five percent (n = 165/174) of surveys and 90% (n = 18/20) of interviews were completed. Most participants were Caucasian, married, and of middle to high income. 69% (114/165) agreed that their virtual appointment was as good as in-person; only 13% (21/165) disagreed. Almost all (148/165, 90%) would make another virtual appointment. Qualitative data highlighted ease of access, comparable provider-patient communication, confidence in care quality, and positive remote monitoring experiences. Recognizing these advantages but also inherent limitations, interviews emphasized interspersing telemedicine with in-person prenatal encounters. CAHPS responses after in-person visits were available for 60 patients. Logistic regression revealed no significant difference in three measures of satisfaction (p = 0.16, 0.09, 0.13) between virtual and in-person visits. CONCLUSIONS: In an average-risk population, virtual prenatal visits provide a patient-centered alternative to traditional in-person encounters with high measures of patient experience and no significant difference in satisfaction. Obstetric providers should explore telemedicine to improve access - and, during the ongoing pandemic, to minimize exposures - using patients' experiences for guidance. More research is needed regarding virtual visits' medical quality, integration into prenatal schedules, and provision of equitable care for diverse populations.

Exit from Brain Device Research: A Modified Grounded Theory Study of Researcher Obligations and Participant Experiences.

As clinical trials end, little is understood about how participants exiting from clinical trials approach decisions related to the removal or post-trial use of investigational brain implants, such as deep brain stimulation (DBS) devices. This empirical bioethics study examines how research participants experience the process of exit from research at the end of clinical trials of implanted neural devices. Using a modified grounded theory study design, we conducted semi-structured, in-depth interviews with 16 former research participants from clinical trials of DBS and responsive neurostimulation (RNS). Open-ended questions elicited motivations for joining the trial, understanding of study procedures at the time of initial informed consent, the process of exiting from research, and decisions about device removal or post-trial device use. Thematic analysis identified categories related to: limited preparedness for the end of research participation, straightforwardness of decisions to explant or keep the device, reconciling with the end of research participation, reconciling post-trial expectations, and achieving a sense of closure after exit from research. A preliminary theoretical model describes contextual factors influencing the process and experience of exit from research. Experiences of clinical trial participants should guide research practices to enhance the ethical design and conduct of clinical trials in DBS and other brain devices.

Improving Real-World Innovation and Problem Solving in Clinical Ethics: Insights from the First Clinical Ethics Un-Conference.

Despite an abundance of academic conferences, clinical ethicists lacked a forum to share innovative practices with peers and to generate solutions to common challenges. Organizers of the first Clinical Ethics Un-Conference developed a working event centered on active participation and problem solving through peer learning, with the goal of improving real-world practice. Registrants included 95 individuals from 64 institutions. Attendees were surveyed immediately after the Un-Conference, and again eight months later. After eight months, 85 percent (n = 33/39) of the survey respondents reported that they found the event "highly impactful" or "somewhat impactful" to their clinical practice, and 23 attendees reported that they had implemented ideas or projects inspired by the event. Three sets of best practice guidelines and four white papers were published from the event. As the field of clinical ethics continues to advance and evolve, this working event format offers an innovative, disruptive alternative to a traditional conference format and may serve as a model for future efforts aimed at improving real-world clinical ethics practice.

Patient Perceptions of FDA Approval: Gaps in Education or Variation in Values?

OBJECTIVE: To assess perceptions and opinions about the Food and Drug Administration (FDA) approval process for disease-modifying therapies (DMT) in people living with multiple sclerosis (MS). METHODS: People living with MS were invited to complete a web-based survey of their perceptions of the FDA role and process for approval of MS medications. The survey asked about the role of the FDA, factors involved in the approval process, which voices should represent those with MS in deliberations about drug approval, and the level of comfort with uncertain safety of newly approved therapies. RESULTS: Three thousand thirty-three respondents met inclusion criteria for data analysis. Most respondents seemed to understand the role of the FDA, although only half understood a fundamental FDA role: balancing the risks and benefits when considering drug approval. Significant differences were observed in many areas between those who have and have not tried DMTs. Comfort with uncertainty was associated with several factors relating to side effects and benefits believed important for the FDA to consider. Most respondents reported that people who participated in the medication's clinical trial were particularly able to represent people living with MS. CONCLUSION: Perceptions regarding the FDA and views of who should represent people living with MS varied between those who have and have not tried DMT. There is variability in personal values that should be recognized and taken into account when considering regulatory responsibilities. Interventions are needed to address educational gaps regarding the mission and trustworthiness of the FDA as an oversight body.

Incorporating Stakeholder Perspectives on Scarce Resource Allocation: Lessons Learned from Policymaking in a Time of Crisis.

The coronavirus disease (COVID-19) crisis provoked an organizational ethics dilemma: how to develop ethical pandemic policy while upholding our organizational mission to deliver relationship- and patient-centered care. Tasked with producing a recommendation about whether healthcare workers and essential personnel should receive priority access to limited medical resources during the pandemic, the bioethics department and survey and interview methodologists at our institution implemented a deliberative approach that included the perspectives of healthcare professionals and patient stakeholders in the policy development process. Involving the community more, not less, during a crisis required balancing the need to act quickly to garner stakeholder perspectives, uncertainty about the extent and duration of the pandemic, and disagreement among ethicists about the most ethically supportable way to allocate scarce resources. This article explains the process undertaken to garner stakeholder input as it relates to organizational ethics, recounts the stakeholder perspectives shared and how they informed the triage policy developed, and offers suggestions for how other organizations may integrate stakeholder involvement in ethical decision-making as well as directions for future research and public health work.

Changes in Patients' Desired Control of Their Deep Brain Stimulation and Subjective Global Control Over the Course of Deep Brain Stimulation.

Objective: To examine changes in patients' desired control of the deep brain stimulator (DBS) and perception of global life control throughout DBS. Methods: A consecutive cohort of 52 patients with Parkinson's disease (PD) was recruited to participate in a prospective longitudinal study over three assessment points (pre-surgery, post-surgery months 3 and 6). Semi-structured interviews assessing participants' desire for stimulation control and perception of global control were conducted at all three points. Qualitative data were coded using content analysis. Visual analog scales were embedded in the interviews to quantify participants' perceptions of control over time. Results: Participants reported significant increases in their perception of global control over time and significant declines in their desired control of the stimulation. These changes were unrelated to improvements in motor symptoms. Improvements in global control were negatively correlated with a decline in desired stimulation control. Qualitative data indicate that participants have changed, nuanced levels of desired control over their stimulators. Increased global life control following DBS may be attributed to increased control over PD symptoms, increased ability to engage in valued activities, and increased overall self-regulation, while other domains related to global control remained unaffected by DBS. Conclusions: There are few empirical data documenting patients' desire for stimulation control throughout neuromodulation and how stimulation control is related to other aspects of control despite the growing application of neuromodulation devices to treat a variety of disorders. Our data highlight distinctions in different types of control and have implications for the development of patient-controlled neurostimulation devices.

Publication of Study Exit Procedures in Clinical Trials of Deep Brain Stimulation: A Focused Literature Review.

Considerable variability exists in the publication of clinical research study procedures related to study enrollment and participant exit from clinical trials. Despite recent efforts to encourage research data sharing and greater transparency regarding research outcomes, reporting of research procedures remains inconsistent. Transparency about study procedures has important implications for the interpretation of study outcomes and the consistent implementation of best practices in clinical trial design and conduct. This review of publications from clinical trials of deep brain stimulation (DBS) using the MEDLINE database examines the frequency and consistency of publication of research procedures and data related to exit from DBS research. Related considerations, such as device explant or continued use, battery and other device hardware replacements, and post-trial follow-up care are also reviewed. This review finds significant variability in the publication and reporting of study exit procedures. Of the 47 clinical trials included in this review, 19% (9) disclosed procedures related to exit from research. Reporting of other exit-related data and study procedures examined in this review was identified in fewer than half of the included clinical trials. The rate of participant retention and duration of follow-up was reported more than any other category of data included in this review. Results inform efforts to improve consistency in research design, conduct, and publication of results from clinical trials in DBS and related areas of clinical research.

Answering the Call for Standardized Reporting of Clinical Ethics Consultation Data.

Benchmarks against which healthcare ethics consultation (HCEC) services can assess their performance are needed. As first-generation benchmarks continue to be developed, it is the obligation of the field to continually evaluate how these measures reflect the performance of any single HCEC service. This will be possible only with widespread reporting of standardized data points. In their article in this issue of The Journal of Clinical Ethics, Glover and colleagues provide a valuable preliminary approach for assessing appropriate consult volumes for a HCEC service. The limitations of their study read as a call to action for the field of clinical ethics to expand and standardize data reporting so that more robust metrics can be developed. In response to this call by Glover and colleagues, the Cleveland Clinic HCEC service provides consult data from 2015 through 2019 for one of its medical centers, and offers an additional volume-based metric, consult-to-ICU-to-bed ratio (CiBR), that may add nuance to any normative assessment of HCEC service consult volume. Given that volume-based metrics are the native language of the clinical environment, efforts to improve such metrics in the field through transparency and standardization are warranted. However, the expositive power of volume- based metrics is limited; additional domains related to quality and outcomes are needed.

Deep Brain Stimulation at End of Life: Clinical and Ethical Considerations.

Deep brain stimulation (DBS) is an implanted neurological device effective in treating motor symptoms of Parkinson disease (PD), such as tremor, rigidity, and bradykinesia. More than 150,000 patients worldwide have been implanted with DBS devices. Questions arise at the end of life concerning how to provide best care for patients with DBS, including its continued benefit or potential complications, yet, no published articles provide guidance for hospice providers regarding the management of DBS devices in end-of-life care. With contributions from hospice physicians, a neurosurgeon, and ethicists, this article provides recommendations to address clinical and ethical challenges in optimizing DBS for patients with PD nearing the end of life.

The personal utility of cfDNA screening: Pregnant patients' experiences with cfDNA screening and views on expanded cfDNA panels.

Prenatal cell-free DNA screening (cfDNA) provides more genetic risk information about the fetus than has ever been possible. At the same time, the rapid expansion of new cfDNA panels raises important questions about how to structure patient-centered discussions that best support patients' decision-making about its use. To address this question, we conducted interviews with pregnant patients to identify decision-making needs and preferences with respect to cfDNA in patient-centered healthcare discussions, given its evolving capability to identify a range of fetal variants. Personal utility was a core concept guiding decision-making. Participants spoke of how their deeply personal values and beliefs about maternal responsibility, actionability, and tolerance of uncertainty framed their view of the personal utility of cfDNA screening. While discussing their notions of personal utility with their healthcare provider, participants also had concerns about potential ramifications for the provider-patient relationship and shared decision-making when disclosing values and preferences regarding disability, quality of life, and termination-particularly as it becomes possible to identify variants with different disease-associated severity and outcomes. The complexities associated with the introduction of genomics in prenatal care present unique challenges to structuring effective shared decision-making discussions between patients and their healthcare providers. While efforts are underway to determine how to best educate patients about the medical aspects of cfDNA, it is equally important to develop approaches in healthcare communication that enable patients to make informed, values-based decisions about the use of cfDNA and its impact on their pregnancy.