Re-examining the relationship between moral distress and moral agency in nursing.

In recent years, the phenomenon of moral distress has been critically examined-and for a good reason. There have been a number of different definitions suggested, some that claimed to be consistent with the original definition but in fact referred to different epistemological states. In this paper, we re-examine moral distress by exploring its relationship with moral agency. We critically examine three conceptions of moral agency and argue that two of these conceptions risk placing nurses' values at the center of moral action when it ought to be the patient's values that shape nurses' obligations. We propose that the conception of moral agency advanced by Aimee Milliken which re-centers patient values, should be more broadly accepted within nursing. We utilize a case example to demonstrate a situation in which the values of a patient's parents (surrogates) justifiably constrained nurses' moral agency, creating moral distress. Through an examination of constraints on nurse agency in this case, we illustrate the problematic nature of 'narrow' moral distress and the value of re-considering moral distress.  Finally, we provide an action-oriented proposal identifying mediating steps that we argue have utility for nurses (and other healthcare professionals) to mediate between experiences of narrow moral distress and the exercise of moral agency.

Nurturing moral community: A novel moral distress peer support navigator tool.

Moral distress is a pervasive phenomenon in healthcare for which there is no straightforward "solution." Rhetoric surrounding moral distress has shifted over time, with some scholars arguing that moral distress needs to be remedied, resolved, and eradicated, while others recognize that moral distress can have some positive value. The authors of this paper recognize that moral distress has value in its function as a warning sign, signaling the presence of an ethical issue related to patient care that requires deeper exploration, rather than evidencing identification of the "right" course of action. Once the experience of moral distress is identified, steps ought to be taken to clarify the moral issue, and, if possible and reasonable, the patient's values ought to be prioritized. This paper offers concrete actions steps, drawn from theory, which can be used in clinical practice to provide peer support or to facilitate self-reflection for morally distressed individuals. This approach empowers morally distressed individuals to explore ethical issues, identify concrete steps that can be taken, and mitigate feelings of powerlessness that are often associated with moral-constraint distress. The questions guide individuals and peers to reflect first on the micro-space and then more broadly on the institutional culture, facilitating meso- and macro-reflection and action.

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 .

Best Practices from the American Society of Pain and Neuroscience (ASPN) for Clinical Research During a Pandemic or Emergency.

The COVID-19 pandemic caught many areas of medicine in a state of unpreparedness for conducting research and completing ongoing projects during a global crisis, including the field of pain medicine. Waves of infection led to a disjointed ability to provide care and conduct clinical research. The American Society of Pain and Neuroscience (ASPN) Research Group has created guidance for pragmatic and ethical considerations for research during future emergency or disaster situations. This analysis uses governmental guidance, scientific best practices, and expert opinion to address procedure-based or device-based clinical trials during such times. Current literature offers limited recommendations on this important issue, and the findings of this group fill a void for protocols to improve patient safety and efficacy, especially as we anticipate the impact of future disasters and spreading global infectious diseases. We recommend local adaptations to best practices and innovations to enable continued research while respecting the stressors to the research subjects, investigator teams, health-care systems, and to local infrastructure.

Telepsychology May Improve Treatment Adherence in Patients with Psychogenic Nonepileptic Seizures.

Introduction: Access to mental health care is a significant challenge in patients with psychogenic nonepileptic seizures (PNES). Telepsychology can curb the access barriers and improve adherence but the role of telepsychology in improving adherence has not been well investigated. The current study examines the utility of telepsychology during the COVID-19 pandemic and treatment adherence in PNES patients. Materials and Methods: Patients with PNES admitted to a 12-week counseling program were offered two visit types: telepsychology and in-office. Visit type, visit status, and demographic information were obtained from department database. Follow-up visits in 6 months were used to examine the effect of visit type on visit status. Adherence to treatment was measured by higher attendance of scheduled visits and less cancellation and no-show rates. Results: Two hundred fifty-seven (n) patients who scheduled virtual or telepsychology visits were included in the study. After adjusting for demographic variables, and accounting for repeated measures, telepsychology visits were significantly more likely to be attended (odds ratio [OR] = 2.40, 95% confidence interval [CI] = 1.69-3.41, p < 0.001) and were significantly less likely to be canceled (OR = 0.43, 95% CI = 0.29-0.64, p < 0.001). The regression model showed patients in the telepsychology visit group attended more than three times as many visits as in-office patients (incidence rate ratios = 3.16, 95% CI = 2.13-4.73, p < 0.001). Conclusions: Patients with PNES have logistical and psychological barriers that can impede their ability to attend counseling treatment. Receiving care remotely may have been associated with higher engagement with mental health treatment compared to having to travel to counseling clinics. Considering the symptom-related restrictions patients with PNES have and the barriers presented by the COVID-19 pandemic, telepsychology played a key role for continuation of mental health treatment.

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.

Clinician and Ethicist Perspectives: Understanding Moral Distress in Gender-Affirming Care for Pediatric Patients.

Using case examples and other common scenarios, the authors outline several types of moral distress that clinicians may experience when providing pediatric gender-affirming care. The authors also offer strategies for managing moral distress and issue a call to action for professional organizations to enhance support for gender-affirming clinicians.

Outcomes in the treatment of psychogenic nonepileptic seizures (PNES) with CBTip: Response in seizure frequency, depression, anxiety, and quality of life.

RATIONALE: Psychogenic Nonepileptic Seizures (PNES) are seizure-like episodes without EEG abnormality, and are of psychological origin. Cognitive Behavioral Therapy (CBT), a type of psychological counseling, is known to be the best intervention to treat PNES and the underlying psychiatric symptoms. Yet, many remain untreated because of limited access to specialized counseling programs. In this study, first we intended to see if the positive outcomes of the CBTip can be replicated in our patient population using within-group comparison. We also aimed to examine the outcomes of patients who received a variable dose of treatment than the established treatment protocol. METHOD: We obtained retrospective patient reported outcomes (PRO) data from patients treated with Cognitive Behavioral Therapy-informed psychotherapy (CBT-ip) from January 2015 to January 2020 in an outpatient tertiary care epilepsy center. The CBTip program is a 12-session intervention delivered weekly by a seizure counselor. Although the program comprises 12 sessions of treatment, we included patients who attended at least 7 sessions consistent with previous research that used a similar cutoff. We had a total of 160 patient PROs included in the analysis. Outcome variables including seizure frequency, depression, anxiety, and quality of life were examined using self-report outcome scores. Demographic and other clinical and psychosocial confounding variables were controlled. RESULTS: In the first analysis in which we compared pre-treatment scores with 3-month posttreatment scores, there was no significant change in seizure frequency, depression, anxiety, and quality-of-life outcomes. In the second analysis when we compared pre- and posttreatment scores in patients who completed the treatment in longer than 3-month time, there were significant improvement in primary and secondary outcomes. For seizure frequency, 10 patients had data for "seizures per day in the last 6 months" and 5 participants (50%) improved by 50% or more in the number of seizures per day. There were also significant reductions in depression and anxiety scores but not in quality of life. IMPLICATION AND CONCLUSIONS: Our analysis showed that patients treated with CBTip with a minimum of 7 sessions in 3 months did not have significant improvement. However, attending at least 7 sessions of CBTip in longer than 3 months was effective for seizure control, depression, and anxiety. The observational and exploratory nature of our study, however, limits the generalizability of our findings outside of the single tertiary clinical care setting.

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.

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.

Proceedings of the Seventh Annual Deep Brain Stimulation Think Tank: Advances in Neurophysiology, Adaptive DBS, Virtual Reality, Neuroethics and Technology.

The Seventh Annual Deep Brain Stimulation (DBS) Think Tank held on September 8th of 2019 addressed the most current: (1) use and utility of complex neurophysiological signals for development of adaptive neurostimulation to improve clinical outcomes; (2) Advancements in recent neuromodulation techniques to treat neuropsychiatric disorders; (3) New developments in optogenetics and DBS; (4) The use of augmented Virtual reality (VR) and neuromodulation; (5) commercially available technologies; and (6) ethical issues arising in and from research and use of DBS. These advances serve as both "markers of progress" and challenges and opportunities for ongoing address, engagement, and deliberation as we move to improve the functional capabilities and translational value of DBS. It is in this light that these proceedings are presented to inform the field and initiate ongoing discourse. As consistent with the intent, and spirit of this, and prior DBS Think Tanks, the overarching goal is to continue to develop multidisciplinary collaborations to rapidly advance the field and ultimately improve patient outcomes.

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.