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An Exploratory Analysis of Preclinical and Clinical Factors Associated With Sleep Disturbance Assessed via the Neuro-QoL After Hemorrhagic Stroke

Ecker, Sarah; Lord, Aaron; Gurin, Lindsey; Olivera, Anlys; Ishida, Koto; Melmed, Kara R; Torres, Jose; Zhang, Cen; Frontera, Jennifer; Lewis, Ariane
BACKGROUND AND PURPOSE/UNASSIGNED:Sleep disturbance after hemorrhagic stroke (intracerebral or subarachnoid hemorrhage) can impact rehabilitation, recovery, and quality of life. We sought to explore preclinical and clinical factors associated with sleep disturbance after hemorrhagic stroke assessed via the Quality of Life in Neurological Disorders (Neuro-QoL) short form sleep disturbance inventory. METHODS/UNASSIGNED:We telephonically completed the Neuro-QoL short form sleep disturbance inventory 3-months and 12-months after hemorrhagic stroke for patients >18-years-old hospitalized between January 2015 and February 2021. We examined the relationship between sleep disturbance (T-score >50) and social and neuropsychiatric history, systemic and neurological illness severity, medical complications, and temporality. RESULTS/UNASSIGNED:= .046). CONCLUSION/UNASSIGNED:This exploratory analysis did not demonstrate a sustained relationship between any preclinical or clinical factors and sleep disturbance after hemorrhagic stroke. Larger studies that include comparison to patients with ischemic stroke and healthy individuals and utilize additional techniques to evaluate sleep disturbance are needed.
PMCID:11181970
PMID: 38895018
ISSN: 1941-8744
CID: 5672082

Perspectives of Medical Organizations, Organ Procurement Organizations, and Advocacy Organizations About Revising the Uniform Determination of Death Act (UDDA)

Lewis, Ariane
BACKGROUND:The Uniform Law Commission paused work of the Drafting Committee to Revise the Uniform Determination of Death Act (UDDA) in September 2023. METHODS:Thematic review was performed of comments submitted to the Uniform Law Commission by medical organizations (MO), organ procurement organizations (OPO), and advocacy organizations (AO) from 1/1/2023 to 7/31/2023. RESULTS:Of comments from 41 organizations (22 AO, 15 MO, 4 OPO), 34 (83%) supported UDDA revision (50% OPO, 33% MO recommended against revision). The most comments addressed modifications to "all functions of the entire brain, including the brainstem" (31; 95% AO, 75% OPO, 47% MO), followed by irreversible versus permanent (25; 77% AO, 50% OPO, 40% MO), accommodation of brain death/death by neurologic criteria (BD/DNC) objections (23; 100% OPO, 80% MO, 32% AO), consent for BD/DNC evaluation (18; 75% OPO, 47% MO, 36% AO), "accepted medical standards" (13; 36% AO, 33% MO, 0% OPO), notification before BD/DNC evaluation (14; 100% OPO, 53% MO, 9% AO), time to gather before discontinuation of organ support after BD/DNC determination (12; 60% MO, 25% OPO, 9% AO), and BD/DNC examiner credential requirements (2; 13% MO, 0% AO, 0% OPO). The predominant themes were that the revised UDDA should include the term "irreversible" and shouldn't (1) stipulate specific medical guidelines, (2) require notification before BD/DNC evaluation, or (3) require time to gather before discontinuation of organ support after BD/DNC determination. Views on other topics were mixed, but MO and OPO generally advocated for the revised UDDA to take a functional approach to BD/DNC, not require consent for BD/DNC evaluation, and not require opt-out accommodation of BD/DNC objections. Contrastingly, many AO and some MO with religious affiliations or a focus on advocacy favored the revised UDDA take an anatomic approach to BD/DNC or eliminate BD/DNC altogether, require consent for BD/DNC evaluation, and require opt-out accommodation of BD/DNC objections. CONCLUSIONS:Most commenting organizations support UDDA revision, but perspectives on the approach vary, so the Drafting Committee could not formulate revisions that would be agreeable to all stakeholders.
PMID: 37880474
ISSN: 1556-0961
CID: 5664542

Beyond the Final Heartbeat: Neurological Perspectives on Normothermic Regional Perfusion for Organ Donation after Circulatory Death

Kirschen, Matthew P; Lewis, Ariane; Rubin, Michael A; Varelas, Panayiotis N; Greer, David M
Normothermic regional perfusion (NRP) has recently been used to augment organ donation after circulatory death (DCD) to improve the quantity and quality of transplantable organs. In DCD-NRP, after withdrawal of life-sustaining therapies and cardiopulmonary arrest, patients are cannulated onto extracorporeal membrane oxygenation to reestablish blood flow to targeted organs including the heart. During this process, aortic arch vessels are ligated to restrict cerebral blood flow. We review ethical challenges including whether the brain is sufficiently reperfused through collateral circulation to allow reemergence of consciousness or pain perception, whether resumption of cardiac activity nullifies the patient's prior death determination, and whether specific authorization for DCD-NRP is required. ANN NEUROL 2024.
PMID: 38501716
ISSN: 1531-8249
CID: 5640372

An Update on Brain Death/Death by Neurologic Criteria since the World Brain Death Project

Lewis, Ariane
The World Brain Death Project (WBDP) is a 2020 international consensus statement that provides historical background and recommendations on brain death/death by neurologic criteria (BD/DNC) determination. It addresses 13 topics including: (1) worldwide variance in BD/DNC, (2) the science of BD/DNC, (3) the concept of BD/DNC, (4) minimum clinical criteria for BD/DNC determination, (5) beyond minimum clinical BD/DNC determination, (6) pediatric and neonatal BD/DNC determination, (7) BD/DNC determination in patients on ECMO, (8) BD/DNC determination after treatment with targeted temperature management, (9) BD/DNC documentation, (10) qualification for and education on BD/DNC determination, (11) somatic support after BD/DNC for organ donation and other special circumstances, (12) religion and BD/DNC: managing requests to forego a BD/DNC evaluation or continue somatic support after BD/DNC, and (13) BD/DNC and the law. This review summarizes the WBDP content on each of these topics and highlights relevant work published from 2020 to 2023, including both the 192 citing publications and other publications on BD/DNC. Finally, it reviews questions for future research related to BD/DNC and emphasizes the need for national efforts to ensure the minimum standards for BD/DNC determination described in the WBDP are included in national BD/DNC guidelines and due consideration is given to the recommendations about social and legal aspects of BD/DNC determination.
PMID: 38621707
ISSN: 1098-9021
CID: 5671482

New Reasons to Revise the UDDA: Controversies Related to Death by Circulatory-Respiratory Criteria

Lewis, Ariane
PMID: 38829584
ISSN: 1536-0075
CID: 5664992

Standards and Ethics Issues in the Determination of Death

Omelianchuk, Adam; Lewis, Ariane
PMID: 38768490
ISSN: 1539-3704
CID: 5654222

The 2023 American Academy of Neurology, American Academy of Pediatrics, Child Neurology Society, and Society of Critical Care Medicine Pediatric and Adult Brain Death/Death by Neurologic Criteria Determination Consensus Guidelines: What the Critical Care Team Needs to Know

Kirschen, Matthew P; Lewis, Ariane; Greer, David M
Guidelines for brain death/death by neurologic criteria (BD/DNC) determination were revised to provide a consistent and updated approach to BD/DNC evaluation across all ages by the American Academy of Neurology, American Academy of Pediatrics, Child Neurology Society, and Society of Critical Care Medicine. This article is intended to complement the guidelines and highlight aspects relevant to the critical care community; the actual guidelines should be used to update hospital protocols and dictate clinical practice. Because BD/DNC evaluations are conducted in the ICU, it is essential for members of the critical care community to familiarize themselves with these guidelines. The fundamental concept of BD/DNC has not changed; BD/DNC is permanent loss of function of the brain as a whole, including the brain stem, resulting in coma, brainstem areflexia, and apnea in the setting of an adequate stimulus. The BD/DNC evaluation requires a sufficient observation period to ensure there is no chance of recovery, followed by exclusion of potentially confounding conditions like hypothermia, hypotension, severe metabolic disturbances, or medication effects. Specific guidance is provided for patients who were treated with therapeutic hypothermia or medical or surgical interventions to manage intracranial hypertension. The guidelines outline a structured and meticulous neurologic examination and detail the responses consistent with BD/DNC. A protocol is provided for how to safely perform apnea testing, including modifications needed for patients on extracorporeal membrane oxygenation. Controversial issues such as consent, BD/DNC evaluation in pregnancy, preservation of neuroendocrine function, and primary posterior fossa injuries are addressed. The ultimate goal is to ensure a consistent and accurate approach to BD/DNC evaluation in patients of all ages, fostering public trust in the medical community's ability to determine death. By adhering to these guidelines, critical care clinicians can confidently navigate the challenging aspects of BD/DNC determination.
PMID: 37921516
ISSN: 1530-0293
CID: 5633732

New developments in guidelines for brain death/death by neurological criteria

Greer, David M; Lewis, Ariane; Kirschen, Matthew P
The declaration of brain death (BD), or death by neurological criteria (DNC), is medically and legally accepted throughout much of the world. However, inconsistencies in national and international policies have prompted efforts to harmonize practice and central concepts, both between and within countries. The World Brain Death Project was published in 2020, followed by notable revisions to the Canadian and US guidelines in 2023. The mission of these initiatives was to ensure accurate and conservative determination of BD/DNC, as false-positive determinations could have major negative implications for the medical field and the public's trust in our ability to accurately declare death. In this Review, we review the changes that were introduced in the 2023 US BD/DNC guidelines and consider how these guidelines compare with those formulated in Canada and elsewhere in the world. We address controversies in BD/DNC determination, including neuroendocrine function, consent and accommodation of objections, summarize the legal status of BD/DNC internationally and discuss areas for further BD/DNC research.
PMID: 38307923
ISSN: 1759-4766
CID: 5627012

Association of Neighborhood Socioeconomic Status With Withdrawal of Life-Sustaining Therapies After Intracerebral Hemorrhage

Melmed, Kara R; Lewis, Ariane; Kuohn, Lindsey; Marmo, Joanna; Rossan-Raghunath, Nirmala; Torres, Jose; Muralidharan, Rajanandini; Lord, Aaron S; Ishida, Koto; Frontera, Jennifer A
BACKGROUND AND OBJECTIVES/OBJECTIVE:Mortality after intracerebral hemorrhage (ICH) is common. Neighborhood socioeconomic status (nSES) is an important social determinant of health (SDoH) that can affect clinical outcome. We hypothesize that SDoH, including nSES, contribute to differences in withdrawal of life-sustaining therapies (WLSTs) and mortality in patients with ICH. METHODS:tests. We performed multivariable analysis using backward stepwise logistic regression. RESULTS:≤ 0.01 for both). In multivariable analysis adjusting for age and clinical severity scores, patients who lived in zip codes with high-income levels were more likely to have WLST (adjusted odds ratio [aOR] 1.88; 95% CI 1.29-2.74) and mortality before discharge (aOR 1.5; 95% CI 1.06-2.13). DISCUSSION/CONCLUSIONS:SDoH, including nSES, are associated with WLST after ICH. This has important implications for the care and management of patients with ICH.
PMID: 38237088
ISSN: 1526-632x
CID: 5624412

Optimal Design of Clinical Trials Involving Persons with Disorders of Consciousness

Cho, Sung-Min; Robba, Chiara; Diringer, Michael N; Hanley, Daniel F; Hemphill, J Claude; Horn, Janneke; Lewis, Ariane; Livesay, Sarah L; Menon, David; Sharshar, Tarek; Stevens, Robert D; Torner, James; Vespa, Paul M; Ziai, Wendy C; Spann, Marcus; Helbok, Raimund; Suarez, Jose I; ,
BACKGROUND:Limited data exist regarding the optimal clinical trial design for studies involving persons with disorders of consciousness (DoC), and only a few therapies have been tested in high-quality clinical trials. To address this, the Curing Coma Campaign Clinical Trial Working Group performed a gap analysis on the current state of clinical trials in DoC to identify the optimal clinical design for studies involving persons with DoC. METHODS:The Curing Coma Campaign Clinical Trial Working Group was divided into three subgroups to (1) review clinical trials involving persons with DoC, (2) identify unique challenges in the design of clinical trials involving persons with DoC, and (3) recommend optimal clinical trial designs for DoC. RESULTS:There were 3055 studies screened, and 66 were included in this review. Several knowledge gaps and unique challenges were identified. There is a lack of high-quality clinical trials, and most data regarding patients with DoC are based on observational studies focusing on patients with traumatic brain injury and cardiac arrest. There is a lack of a structured long-term outcome assessment with significant heterogeneity in the methodology, definitions of outcomes, and conduct of studies, especially for long-term follow-up. Another major barrier to conducting clinical trials is the lack of resources, especially in low-income countries. Based on the available data, we recommend incorporating trial designs that use master protocols, sequential multiple assessment randomized trials, and comparative effectiveness research. Adaptive platform trials using a multiarm, multistage approach offer substantial advantages and should make use of biomarkers to assess treatment responses to increase trial efficiency. Finally, sound infrastructure and international collaboration are essential to facilitate the conduct of trials in patients with DoC. CONCLUSIONS:Conduct of trials in patients with DoC should make use of master protocols and adaptive design and establish international registries incorporating standardized assessment tools. This will allow the establishment of evidence-based practice recommendations and decrease variations in care.
PMID: 37535178
ISSN: 1556-0961
CID: 5635052