In This Together: Navigating Ethical Challenges Posed by Family Clustering during the Covid-19 Pandemic.

Harrowing stories reported in the media describe Covid-19 ravaging through families. This essay reports professional experiences of this phenomenon, family clustering, as encountered during the pandemic's spread across Southern California. We identify three ethical challenges following from it: Family clustering impedes shared decision-making by reducing available surrogate decision-makers for incapacitated patients, increases the emotional burdens of surrogate decision-makers, and exacerbates health disparities for and the suffering of people of color at increased likelihood of experiencing family clustering. We propose that, in response to these challenges, efforts in advance care planning be expanded, emotional support offered to surrogates and family members be increased, more robust state guidance be issued on ethical decision-making for unrepresented patients, ethics consultation be increased in the setting of conflict following from family clustering dynamics, and health care professionals pay more attention to systemic and personal racial biases and inequities that affect patient care and the surrogate experience.

Retrieving the Moral in the Ethics of Maternal-Fetal Surgery.

Open-uterine surgery to repair spina bifida, or 'fetal surgery of open neural tube defects,' has generated questions throughout its history-and continues to do so in a variety of contexts. As clinical ethics consultants who worked (Mark J. Bliton) and trained (Virginia L. Bartlett) at Vanderbilt University-where the first successful cases of open-uterine repair of spina bifida were carried out-we lived with these questions for nearly two decades. We worked with clinicians as they were developing and offering the procedure, with researchers in refining and studying the procedure, and with pregnant women and their partners as they considered whether to undergo the procedure. From this experience in the early studies at Vanderbilt, we learned that pregnant women and their partners approach the clinical uncertainty of such a risky procedure with a curious and unique combination of practicality, self-reflection, fear, and overwhelming hope. These early experiences were a major contributing factor to the inclusion of an ethics-focused interview in the informed consent process for the Management of Myelomeningocele Study (MOMS) trial study design.

Just a Collection of Recollections: Clinical Ethics Consultation and the Interplay of Evaluating Voices.

Despite increased attention to the question of how best to evaluate clinical ethics consultations and emphasis on external evaluation (Hastings Center Report, ASBH Quality Attestation Process), there has been little sustained focus on how we, as clinicians, make sense of and learn from our own experiences in the midst of any one consultation. Questions of how we evaluate the request for, unfolding of, and conclusion of any specific ethics consultation are often overlooked, along with the underlying question of whether it is possible to give an accurate account of clinical ethics consultants' experience as experienced by ethics consultants. Before the challenge of submitting one's accounts or case reports for review and evaluation from others (at one's local institution or in the broader field), there is an underlying challenge of understanding and evaluating our own accounts. To highlight this crucial and deeply challenging dimension of actual clinical ethics practice, we present an account of a complex consultation, explicitly constructed to engage the reader in the unfolding experience of the consultant by emphasizing the multiple perspectives unfolding within the consultant's experience. Written in script format, the three perspectives presented-prototypical clinically descriptive account; didactically reflective and self-evidentiary account often seen in journal presentations; highly self-critical reflective account emphasizing uncertainties inherent to clinical ethics practice-reflect different manners for responding to the ways actual clinical involvement in ethics consultation practice accentuates and refocuses the question of how to understand and evaluate our own work, as well as that of our colleagues.

Subthalamic nucleus deep brain stimulation in early stage Parkinson's disease.

BACKGROUND: Deep brain stimulation (DBS) is an effective and approved therapy for advanced Parkinson's disease (PD), and a recent study suggests efficacy in mid-stage disease. This manuscript reports the results of a pilot trial investigating preliminary safety and tolerability of DBS in early PD. METHODS: Thirty subjects with idiopathic PD (Hoehn & Yahr Stage II off medication), age 50-75, on medication ≥6 months but ≤4 years, and without motor fluctuations or dyskinesias were randomized to optimal drug therapy (ODT) (n = 15) or DBS + ODT (n = 15). Co-primary endpoints were the time to reach a 4-point worsening from baseline in the UPDRS-III off therapy and the change in levodopa equivalent daily dose from baseline to 24 months. RESULTS: As hypothesized, the mean UPDRS total and part III scores were not significantly different on or off therapy at 24 months. Medication requirements in the DBS + ODT group were lower at all time points with a maximal difference at 18 months. With a few exceptions, differences in neuropsychological functioning were not significant. Two subjects in the DBS + ODT group suffered serious adverse events; remaining adverse events were mild or transient. CONCLUSIONS: This study demonstrates that subjects with early stage PD will enroll in and complete trials testing invasive therapies and provides preliminary evidence that DBS is well tolerated in early PD. The results of this trial provide the data necessary to design a large, phase III, double-blind, multicenter trial investigating the safety and efficacy of DBS in early PD.

Potential subjects' responses to an ethics questionnaire in a phase I study of deep brain stimulation in early Parkinson's disease.

BACKGROUND: Central to ethically justified clinical trial design is the need for an informed consent process responsive to how potential subjects actually comprehend study participation, especially study goals, risks, and potential benefits. This will be particularly challenging when studying deep brain stimulation and whether it impedes symptom progression in Parkinson's disease, since potential subjects will be Parkinson's patients for whom deep brain stimulation will likely have therapeutic value in the future as their disease progresses. METHOD: As part of an expanded informed consent process for a pilot Phase I study of deep brain stimulation in early stage Parkinson's disease, an ethics questionnaire composed of 13 open-ended questions was distributed to potential subjects. The questionnaire was designed to guide potential subjects in thinking about their potential participation. RESULTS: While the purpose of the study (safety and tolerability) was extensively presented during the informed consent process, in returned responses 70 percent focused on effectiveness and 91 percent included personal benefit as poten- tial benefit from enrolling. However, 91 percent also indicated helping other Parkinson's patients as motivation when considering whether or not to enroll. CONCLUSIONS: This combination of responses highlights two issues to which investigators need to pay close attention in future trial designs: (1) how, and in what ways, informed consent processes reinforce potential subjects' preconceived understandings of benefit, and (2) that potential subjects see themselves as part of a community of Parkinson's sufferers with responsibilities extending beyond self-interest. More importantly, it invites speculation that a different paradigm for informed consent may be needed.

Pilot study assessing the feasibility of applying bilateral subthalamic nucleus deep brain stimulation in very early stage Parkinson's disease: study design and rationale.

BACKGROUND: Deep brain stimulation provides significant symptomatic benefit for people with advanced Parkinson's disease whose symptoms are no longer adequately controlled with medication. Preliminary evidence suggests that subthalamic nucleus stimulation may also be efficacious in early Parkinson's disease, and results of animal studies suggest that it may spare dopaminergic neurons in the substantia nigra. OBJECTIVE: We report the methodology and design of a novel Phase I clinical trial testing the safety and tolerability of deep brain stimulation in early Parkinson's disease and discuss previous failed attempts at neuroprotection. METHODS: We recently conducted a prospective, randomized, parallel-group, single-blind pilot clinical trial of deep brain stimulation in early Parkinson's disease. Subjects were randomized to receive either optimal drug therapy or deep brain stimulation plus optimal drug therapy. Follow-up visits occurred every six months for a period of two years and included week-long therapy washouts. RESULTS: Thirty subjects with Hoehn & Yahr Stage II idiopathic Parkinson's disease were enrolled over a period of 32 months. Twenty-nine subjects completed all follow-up visits; one patient in the optimal drug therapy group withdrew from the study after baseline. Baseline characteristics for all thirty patients were not significantly different. CONCLUSIONS: This study demonstrates that it is possible to recruit and retain subjects in a clinical trial testing deep brain stimulation in early Parkinson's disease. The results of this trial will be used to support the design of a Phase III, multicenter trial investigating the efficacy of deep brain stimulation in early Parkinson's disease.

Deep brain stimulation for early-stage Parkinson's disease: an illustrative case.

OBJECTIVES: Subthalamic nucleus (STN) deep brain stimulation (DBS) is an effective intervention in advanced Parkinson's disease (PD), but its efficacy and safety in early PD are unknown. We are conducting a randomized pilot trial investigating DBS in early PD. This report describes one participant who received bilateral STN-DBS. MATERIALS AND METHODS: Thirty subjects have been randomized to either optimal drug therapy (ODT) or DBS + ODT. Microelectrode recordings from the STN and substantia nigra are collected at implantation. The Unified Parkinson's Disease Rating Scale Motor Subscale (UPDRS-III) is administered in the ON and OFF states semi-annually and neuropsychological function and quality of life are assessed annually. We describe a 54-year-old man with a two-year history of PD who was randomized to DBS + ODT and followed for two years. RESULTS: The subject showed a lower STN to substantia nigra ratio of neuronal activity than advanced PD patients, and higher firing rate than non-PD patients. The subject's total UPDRS and UPDRS-III scores improved during the two-year follow-up, while his OFF UPDRS-III score and levodopa equivalent daily dose increased. Quality of life, verbal fluency, and verbal learning improved. He did not experience any serious adverse events. CONCLUSIONS: This report details the first successful application of bilateral STN-DBS for early-stage PD during a clinical trial.

Responsibility after the apparent end: 'following-up' in clinical ethics consultation.

Clinical ethics literature typically presents ethics consultations as having clear beginnings and clear ends. Experience in actual clinical ethics practice, however, reflects a different characterization, particularly when the moral experiences of ethics consultants are included in the discussion. In response, this article emphasizes listening and learning about moral experience as core activities associated with clinical ethics consultation. This focus reveals that responsibility in actual clinical ethics practice is generated within the moral scope of an ethics consultant's activities as she or he encounters the unique and specific features that emerge from interactions with a specific patient, or family, or practitioner within a given situation and over time. A long-form narrative about an ethics consultant's interactions is interwoven with a more didactic discussion to highlight the theme of responsibility and to probe questions that arise regarding follow-up within the practice of clinical ethics consultation.

Echo calling narcissus: what exceeds the gaze of clinical ethics consultation?

Guiding our response in this essay is our view that current efforts to demarcate the role of the clinical ethicist risk reducing its complex network of authorizations to sites of power and payment. In turn, the role becomes susceptible to various ideologies-individualisms, proceduralisms, secularisms-that further divide the body from the web of significances that matter to that body, where only she, the patient, is located. The security of policy, standards, and employment will pull against and eventually sever the authorization secured by authentic moral inquiry. Instead of asking "What do I need to know?", the question animating the drive to standardize will be "What is the policy or standard?" The claims of the authors in this issue of HEC Forum confirm these suspicions.

Richard Zaner's "troubled" voice in Troubled Voices: poseur, posing, possibilizing?

This essay considers Richard Zaner's storytelling in Troubled Voices as a form of possibilizing which uses the stories to exemplify important moral themes such as contingency and freedom. Distinguishing between activities of moral discovery through the telling of a story and "posing" in the sense of writing to tell the "moral" of the story, I suggest that something crucial goes on for Zaner in his own tellings. Several of the more insistent implications Zaner reveals about the moral relationships encountered in the activity of clinical ethics consultation are examined in that light, especially regarding this question: is it more beneficial, or harmful, to articulate elements of core meanings and values that are entailed in individual viewpoints, which, prior to an ethics consultant's participation, may have remained unspoken and possibly unacknowledged?

Ethics: "life before birth" and moral complexity in maternal-fetal surgery for spina bifida.

This article considers the ethical significance of a moral belief common among pregnant women (and their partners) who seek open uterine repair for fetal spina, namely that their fetuses are already "babies." The need to recognize and interact sensitively with a pregnant woman's vulnerability to her own beliefs and concerns regarding potential disabilities, the fetal intervention, and its potential outcome is emphasized. Such recognition and explicit discussions are ethically important for informed consent and to safeguard against the judgments, enthusiasms, and biases of surgeons and other team members.

Traversing boundaries: clinical ethics, moral experience, and the withdrawal of life supports.

While many have suggested that to withdraw medical interventions is ethically equivalent to withholding them, the moral complexity of actually withdrawing life supportive interventions from a patient cannot be ignored. Utilizing interplay between expository and narrative styles, and drawing upon our experiences with patients, families, nurses, and physicians when life supports have been withdrawn, we explore the changeable character of "boundaries" in end-of-life situations. We consider ways in which boundaries imply differences--for example, between cognition and performance--and how the encounter with boundaries can generate altered meanings important for understanding decisions and actions in these contexts. We conclude that the reliance on mere roles to support the moral weight of withdrawing medical interventions is inadequate. Roles that lead us to such moments are exceeded by the responsibility encountered in such moments. And here, we suggest, is the momentous character of withdrawal: it presents the grave astonishment, the trembling awe, in the "not-being-there" of the other in death.

The injustice of it all: caring for the chronically ill.

... While Spiegelberg emphasizes these "cosmic" -- perhaps more accurately, ontological -- features of birth and undeserved inequalities, it seems to us not inappropriate to suggest that what Douard terms "outrage" and Annas "instinct" go in the same direction. When impairment occurs without desert, something should be done to help. This is all the more true when, as in cases of chronic affliction that concern Douard or the case of the Siamese twins that fascinates Annas, something helpful can be done. Then, in Spiegelberg's words, what is "undeserved" demands redress. In these terms, each of these authors points to a deeply rooted sense of our common human lot. Or, in Albert Schweitzer's apt phrase, to witness such undeserved misfortune is to awaken "a moral sense that is usually dormant but that on special occasions can be brought to the surface." Chronic illnesses, we suggest -- no less than the "accidents of birth" that concern Spiegelberg -- are just such "special occasions" for awakening that "moral sense" suggested by Douard in his appeal to the "outrage" of doing nothing for, or refusing to help, the chronically ill.