Subject and Family Perspectives from the Central Thalamic Deep Brain Stimulation Trial for Traumatic Brain Injury: Part II.

This is the second paper in a two-part series describing subject and family perspectives from the CENTURY-S (CENtral Thalamic Deep Brain Stimulation for the Treatment of Traumatic Brain InjURY-Safety) first-in-human invasive neurological device trial to achieve cognitive restoration in moderate to severe traumatic brain injury (msTBI). To participate, subjects were independently assessed to formally establish decision-making capacity to provide voluntary informed consent. Here, we report on post-operative interviews conducted after a successful trial of thalamic stimulation. All five msTBI subjects met a pre-selected primary endpoint of at least a 10% improvement in completion time on Trail-Making-Test Part B, a marker of executive function. We describe narrative responses of subjects and family members, refracted against that success. Interviews following surgery and the stimulation trial revealed the challenge of adaptation to improvements in cognitive function and emotional regulation as well as altered (and restored) relationships and family dynamics. These improvements exposed barriers to social reintegration made relevant by recoveries once thought inconceivable. The study's success sparked concerns about post-trial access to implanted devices, financing of device maintenance, battery replacement, and on-going care. Most subjects and families identified the need for supportive counseling to adapt to the new trajectory of their lives.

Dignity of Risk, Reemergent Agency, and the Central Thalamic Stimulation Trial for Moderate to Severe Brain Injury.

This article discusses the utility of Perske's "dignity of risk" as a useful heuristic to explain the consent process for a study to evaluate central thalamic deep brain stimulation as a means to restore cognitive function in moderate to severe brain injury. Narratives of interviews with subjects and their families from a related BRAIN Initiative study reveal discordant views on risk, with subjects being more risk-tolerant than their loved ones. This is a challenge for families who remain protective of subjects who have recovered to the point that they are capable of independent decision-making. While the legal threshold for consent has been met, normative and psychological challenges remain as families accommodate themselves to the reemergent agency of the subject. Dignity of risk is a constructive framework to apprehend how families come to appreciate the primacy of the subject's voice and affirm their reemergent agency following a devastating brain injury.

Subject and Family Perspectives from the Central Thalamic Deep Brain Stimulation for Traumatic Brain Injury Study: Part I.

This is the first article in a two-part series describing subject and family perspectives from the central thalamic deep brain stimulation for the treatment of traumatic brain injury using the Medtronic PC + S first-in-human invasive neurological device trial to achieve cognitive restoration in moderate to severe traumatic brain injury, with subjects who were deemed capable of providing voluntary informed consent. In this article, we report on interviews conducted prior to surgery wherein we asked participants about their experiences recovering from brain injury and their perspectives on study enrollment and participation. We asked how risks and benefits were weighed, what their expectations and fears were, and how decisions were reached about trial participation. We found that informed consent and enrollment decisions are fraught. Subjects and families were often split, with subjects more focused on putative benefits and families concerned about incremental risk. Both subjects and families viewed brain injury as disruptive to personal identity and relationships. As decisions were made about study enrollment, families struggled with recognizing the re-emergent agency of subjects and ceding decision-making authority to subjects who had previously been dependent upon them for protection and guidance. Subjects and family members reported a hope for the relief of cognitive disabilities, improved quality of life, normalization of interpersonal interactions, and a return to work or school as reasons for study participation, along with altruism and a desire to advance science. Despite these aspirations, both subjects and families appreciated the risks of the intervention and did not suffer from a therapeutic misconception. A second essay to be published in the next issue of Cambridge Quarterly of Healthcare Ethics-Clinical Neuroethics will describe interviews conducted after surgery, the effects of cognitive restoration for subjects, families, and challenges presented to the social structures they will call upon to support them through recovery. This subsequent article will be available online prior to its formal publication in October 2023.

Rights language and disorders of consciousness: a call for advocacy.

Drawing upon sources in neuroethics, civil rights, and disability rights law, we argue for the reintegration of people with severe brain injury back into the nexus of their families and communities consistent with the Americans with Disabilities Act (ADA) and the UN Convention on the Rights of Persons with Disabilities, both of which call for the maximal integration of people with disability into society. To this end, we offer a rights-based argument to address the care of people with severe brain injury. Instead of viewing the provision of rehabilitation as a reimbursement issue, which it surely is, we argue that it can be productively understood as a question of civil rights for a population generally segregated from the medical mainstream and from society itself. Their segregation in the chronic care sector constitutes disrespect for persons, made all the more consequential because recent advances in brain injury rehabilitation make reintegration into civil society an aspirational, if not achievable goal.

Guardianship and Clinical Research Participation: The Case of Wards with Disorders of Consciousness.

We review relevant federal law about research on human subjects and state laws on guardian authority to determine whether guardians can consent on behalf of their wards to participation in research. The Common Rule is silent on the issue as are most state guardianship laws. Our analysis shows significant variation in guardians' decision-making authority in the states that do regulate wards' participation in research.We consider how the appointment of guardians for patients with disorders of consciousness (DOC) impacts such patients' access to research. We assert that it is important that such persons be permitted to participate in research, so that their conditions and potential medical interventions can be studied, and that those with similar conditions can benefit from the knowledge gained from these studies. We argue that state guardianship laws should be adapted to specifically give guardians the authority to consent to research on behalf of wards who may be able to regain decisional capacity.

Rehabilitation, Education, and the Integration of Individuals with Severe Brain Injury into Civil Society: Towards an Expanded Rights Agenda in Response to New Insights from Translational Neuroethics and Neuroscience.

Many minimally conscious patients are segregated in nursing homes, and are without access to rehabilitative technologies that could help them reintegrate into their communities. In this Article, we argue that persons in a minimally conscious state or who have the potential to progress to such a state must be provided rehabilitative services instead of being isolated in custodial care. The right to rehabilitative technologies for the injured brain stems by analogy to the expectation of free public education for children and adolescents, and also by statute under the Americans with Disabilities Act and under Supreme Court jurisprudence, namely the leading deinstitutionalization case, Olmstead v. L.C. ex rel. Zimring.

Brain injury, medical progress, and the disability paradox: Towards an Americans with Abilities Act.

It is helpful to think about the needs of patients with moderate to severe brain injury through the lens of disability law. However, there are limitations to current disability law that contribute to ongoing segregation and marginalization of individuals with severe brain injury. Indeed, one of the paradoxes of American jurisprudence is that more clear constitutional protections accrue to those who have definitively immutable conditions. Thus, as neuroscience brings new therapies to those with brain injury, they may become less protected by the constitutional elements of disability law because their conditions have changed and become mutable. This is the clinical progress that brain injury professionals all seek to achieve, but ironically these advances could potentially degrade the legal protections of patients who benefit from emerging treatments. In this paper, we will critically examine this paradox at the interface of medicine and the law and suggest that the Americans with Disabilities Act (ADA) could be nicely complemented by legislation we have named the Americans with Abilities Act (AWAA). Instead of focusing on disabilities that need protection, the AWAA seeks to sustain and foster newfound abilities made possible by the fruits of medicine and neuroscience.

Identity Theft, Deep Brain Stimulation, and the Primacy of Post-trial Obligations.

Patient narratives from two investigational deep brain stimulation trials for traumatic brain injury and obsessive-compulsive disorder reveal that injury and illness rob individuals of personal identity and that neuromodulation can restore it. The early success of these interventions makes a compelling case for continued post-trial access to these technologies. Given the centrality of personal identity to respect for persons, a failure to provide continued access can be understood to represent a metaphorical identity theft. Such a loss recapitulates the pain of an individual's initial injury or illness and becomes especially tragic because it could be prevented by robust policy. A failure to fulfill this normative obligation constitutes a breach of disability law, which would view post-trial access as a means to achieve social reintegration through this neurotechnological accommodation.

Timing of treatment for opioid use disorder among birthing people.

BACKGROUND: The number of pregnant women with opioid use disorder (OUD) has increased over time. Although effective treatment options exist, little is known about the extent to which women receive treatment during pregnancy and at what stage of pregnancy care is initiated. METHODS: Using a national private health insurance claims database, we identified women aged 13-49 who gave birth in 2006-2019 and had an OUD or nonfatal opioid overdose (NFOO) diagnosis during the year prior to or at delivery. We then identified women who received their first OUD treatment prior to or during pregnancy. In this cross-sectional study, we investigated how rates and timing of the initial OUD treatment changed over time. Furthermore, we examined factors associated with early initiation of OUD treatment among birthing people. RESULTS: Of the 7057 deliveries from 6747 women with OUD or NFOO, 63.3 % received any OUD treatment. Rates of OUD treatment increased from 42.9 % in 2006 to 69 % in 2019. Of those treated, in 2006, 54.5 % received their first treatment prior to conception and 24.2 % initiated care during the 1st trimester. In 2019, 68.9 % received their first treatment prior to conception, and 15.1 % initiated care during the 1st trimester. The percentage of women who were first treated in the 2nd trimester or later decreased from 21.2 % in 2006 to 16.1 % in 2019. Factors associated with early treatment initiation include being 25 years or older (age 25-34: aOR, 1.51, 95 % CI, 1.28-1.78; age 35-49: aOR, 1.82, 95 % CI, 1.39-2.37), living in urban areas (aOR, 1.28; 95 % CI, 1.05-1.56), having pre-existing behavioral health comorbidities such as anxiety disorders (aOR, 1.8; 95 % CI, 1.40-2.32), mood disorders (aOR, 1.63; 95 % CI, 1.02-2.61), and substance use disorder other than OUD (aOR, 2.56; 95 % CI, 2.03-3.32). CONCLUSION: Overall, rates of OUD treatment increased over time, and more women initiated OUD treatment prior to conception. Despite these improvements, over one-third of pregnant women with OUD/NFOO either received no treatment or did not initiate care until the 3rd trimester in 2019. Future research should examine barriers to OUD treatment initiation among pregnant women.

What Can the Health Humanities Contribute to Our Societal Understanding of and Response to the Deaths of Despair Crisis?

Deaths of Despair (DoD), or mortality resulting from suicide, drug overdose, and alcohol-related liver disease, have been rising steadily in the United States over the last several decades. In 2020, a record 186,763 annual despair-related deaths were documented, contributing to the longest sustained decline in US life expectancy since 1915-1918. This forum feature considers how health humanities disciplines might fruitfully engage with this era-defining public health catastrophe and help society better understand and respond to the crisis.

The Scholarly and Pedagogical Benefits of the Legal Laboratory: Lessons from the Consortium for the Advanced Study of Brain Injury at Yale Law School.

In our article, we share the lessons we have learned after creating and running a successful legal laboratory over the past seven years at Yale Law School. Our legal laboratory, which focuses on the intersection of law and severe brain injury, represents a unique pedagogical model for legal academia, and is closely influenced by the biomedical laboratory.

The Neglect of Persons with Severe Brain Injury in the United States: An International Human Rights Analysis.

Brain injury contributes more to death and disability globally than any other traumatic incident.1 While the past decade has seen significant medical advances, laws and policies remain stumbling blocks to treatment and care. The quality of life of persons with severe brain injury often declines with unnecessary institutionalization and inadequate access to rehabilitation and assistive technologies.62 This raises a host of rights violations that are hidden, given that persons with severe brain injury are generally invisible and marginalized. This article highlights the current neglect and experiences of persons with severe brain injury in the United States, analyzing the rights to life, health, benefit from scientific progress, education, freedom of expression, community, family, and equality.

Disorders of Consciousness and Disability Law.

In 2018, the American Academy of Neurology, the American Congress of Rehabilitation Medicine, and the National Institute on Disability, Independent Living, and Rehabilitation Research published a systematic evidence-based review and an associated practice guideline for improved assessment, treatment, and rehabilitation of patients with disorders of consciousness. Patients with disorders of consciousness include individuals in the vegetative and minimally conscious states, as well as others with covert consciousness and cognitive motor dissociation. These landmark publications (concurrently published in Neurology and Archives of Physical Medicine and Rehabilitation) supplant the 1994 New England Journal of Medicine Multi-Society Task Force report on the vegetative state and the 2002 criteria establishing minimally conscious states. The guideline re-designates the permanent vegetative state as chronic. In our article, we consider the legal and ethical implications of the practice guideline for clinical practice and explain the vulnerability of these patients who suffer from high rates of misdiagnosis, inadequate medical surveillance, undertreatment of pain, inadequate rehabilitation, and segregation in chronic care. We argue that these deficiencies in medical care are inconsistent with our growing appreciation of the dynamic nature of these brain states and an emerging standard of care as articulated by the national guideline. These deficiencies also violate domestic and international disability law. To substantiate this latter claim, we apply disability law to this population, focusing on key Americans with Disabilities Act mandates, the relevance of the 1999 Supreme Court, Olmstead v. L.C., and the utility of Olmstead enforcement actions to integrate the care of these individuals into the medical mainstream.

Dementia, Healthcare Decision Making, and Disability Law.

Persons with dementia often prefer to participate in decisions about their health care, but may be prevented from doing so because healthcare decision-making law facilitates use of advance directives or surrogate decision makers for persons with decisional impairments such as dementia. Federal and state disability law provide alternative decision-making models that do not prevent persons with mild to moderate dementia from making their own healthcare decisions at the time the decision needs to be made. In order to better promote autonomy and wellbeing, persons with dementia should be accommodated and supported so they can make their own healthcare decisions.

Change without Change? Assessing Medicare Reimbursement for Advance Care Planning.

In January 2016, Medicare began reimbursing clinicians for time spent engaging in advance care planning with their patients or patients' surrogates. Such planning involves discussions of the care an individual would want to receive should he or she one day lose the capacity to make health care decisions or have conversations with a surrogate about, for example, end-of-life wishes. Clinicians can be reimbursed for face-to-face explanation and discussion of care and advance directives and for the completion of advance care planning forms. Although it seems that political barriers to reimbursement for such planning have largely faded, the Medicare policy's impact on provider billing practices appears to be limited, suggesting other barriers to clinician engagement in advance care planning. Additionally, the effects of this policy on patient behavior and the clinician-patient relationship are not yet known.