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Common Consent Elements for Research Involving Persons with Disorders of Consciousness (CCE-DOC)
Young, Michael J; Lalgudi Ganesan, Saptharishi; Jox, Ralf J; Mazzeo, Anna Teresa; Rubin, Michael A; Walter, Jennifer K; Lewis, Ariane; ,
Persons with disorders of consciousness (DoC) occupy an ethically charged space in modern medicine and biomedical research. Their decisional capacity is characteristically absent or limited or unpredictably fluctuates, requiring clinicians and investigators to rely on surrogates. Although there is general guidance for informed consent (IC) for research studies, there is no specific guidance for research involving persons with DoC. There are inconsistencies in IC forms for these studies related to explanation of a DoC, evaluation of capacity, description of risks/benefits, and sharing investigational results. This is problematic for persons with DoC, their surrogates, researchers, and institutional review boards (IRBs)/research ethics boards (REBs). To address these issues, the Curing Coma Campaign (CCC) Ethics Workgroup developed the Common Consent Elements for Research Involving Persons with Disorders of Consciousness (CCE-DoC). This practical framework aims to clarify and standardize consent processes in this complex and ethically sensitive research area. Through this structured, adaptable approach, CCE-DoC may have the potential to enhance participant protections, strengthen trust, help families and decision-makers understand studies, reduce duplicative efforts across research groups, and guide investigators and IRBs/REBs in navigating the complex ethical terrain of consent in DoC research. In so doing, CCE-DoC seeks to extend respect for autonomy and trust and promote responsible research urgently needed to advance paradigms of diagnosis, prognosis, and treatment for individuals with disorders of consciousness. The framework offers example language to encourage standardization, while allowing teams flexibility to customize to local needs.
PMID: 42156702
ISSN: 1556-0961
CID: 6038132
Determination of Brain Death/Death by Neurologic Criteria in Adults: A Structured Framework for Medical Educators [Case Report]
Cormier, Justine; Marinelli, Sean; Albin, Catherine S W; Morris, Nicholas A; Lewis, Ariane; Beekman, Rachel B; Greer, David Matthew; Wahlster, Sarah; Town, James A
PMCID:13155692
PMID: 42111365
ISSN: 2771-9979
CID: 6037362
Preadmission, admission, and post-discharge factors associated with impaired communication after hemorrhagic stroke
Avadhani, Nikhil; Melmed, Kara R; Hanley, Kaitlin; Brush, Benjamin; Lord, Aaron; Frontera, Jennifer; Ishida, Koto; Torres, Jose; Dickstein, Leah; Kahn, Ethan; Zhou, Ting; Lewis, Ariane
BACKGROUND:Many survivors of hemorrhagic stroke have impaired communication. We aimed to identify preadmission, admission, and post-discharge factors associated with self-reported impaired communication after hemorrhagic stroke. DESIGN/METHODS:Patients with intracerebral or subarachnoid hemorrhage (ICH or SAH) admitted at an urban academic medical center were assessed 3-months post-bleed using the communication Quality of Life in Neurological Disorders (Neuro-QoL) short form inventory. Multivariate analysis was performed to evaluate the relationship between impaired communication (Neuro-QoL scaled score < 100) and preadmission, admission, and post-discharge factors. RESULTS:Of 108 patients (68 ICH and 40 SAH), 59 (54.6%) had impaired communication 3-months post-bleed. On multivariate analysis of the full cohort, when controlling for NIHSS score on admission, impaired communication was associated with: retirement prior to admission (OR: 8.18, 95% CI 1.95-40.5, p = 0.005), hospital length-of-stay (OR: 1.11, 95% CI 1.03-1.22, p = 0.012), and cognitive impairment post-bleed (OR: 32.1, 95% CI 8.93-146, p < 0.001). There were 43 (63.2%) ICH patients with impaired communication 3-months post-bleed. On multivariate analysis, impaired communication was associated with: retirement prior to admission (OR: 9.46, 95% CI 1.76-71.8, p = 0.014), supratentorial location (OR: 8.93, 95% CI 1.22-93.6, p = 0.043), hospital length-of-stay (OR: 1.21, 95% CI 1.01-1.45, p = 0.018), and cognitive impairment post-bleed (OR: 16.3, 95% CI 3.58-102, p < 0.001). CONCLUSIONS:Impaired communication after hemorrhagic stroke is more common in patients who were retired prior to admission and who have post-bleed comorbid cognitive impairment. Increased surveillance is recommended for retired and cognitively impaired patients. Additional investigation into the relationship between communication and both retirement status and cognitive impairment is needed.
PMID: 41819739
ISSN: 1532-2653
CID: 6015942
Education Research: Feasibility and Impact of Academic Half-Day at a Large Academic Neurology Residency Program
Greenberg, Julia H; Patel, Riddhi; Flagiello, Thomas A; Kumar, Sungita; Malhotra, Nisha Aparna; Prasad, Nithisha; Kvernland, Alexandra; Charlson, Robert W; Motiwala, Rajeev; Lewis, Ariane; Kurzweil, Arielle M
BACKGROUND AND OBJECTIVES/UNASSIGNED:The aim of this study was to assess the limitations of a traditional twice-daily lecture format and evaluate the feasibility and impact of implementing an academic half-day (AHD) for neurology residents at a multisite academic institution. AHD has the potential to improve attendance, satisfaction, and clinical competency compared with traditional didactics in graduate medical education. However, its feasibility and impact within neurology residency programs remain underexplored, with few adopting this model to date. Coverage logistics, faculty availability, and neurologic emergencies continue to pose challenges, particularly in large, multisite institutions. METHODS/UNASSIGNED:A needs assessment survey was administered to 36 neurology residents (postgraduate year [PGY]2-PGY4) in spring 2024 to evaluate attendance, satisfaction, and suggestions for improvement. Attendance was recorded over 1 month (August 2024). Based on survey feedback, a new 3.5-hour AHD curriculum was developed collaboratively by residents and faculty, held Tuesday mornings every week with varied lecture formats. One resident per class covered urgent clinical duties at each of 3 sites, while faculty and advanced practice providers (APPs) independently conducted rounds. Attendance was recorded for one month after implementation (September 2024), and surveys were distributed to assess satisfaction with both the curriculum and the coverage model. Residency In-Training Examination (RITE) scores were compared between the 2022 and 2024 cohorts (before AHD) and the 2025 cohort (after AHD implementation). RESULTS/UNASSIGNED:= 0.0013). Faculty and APPs reported positive or neutral effects on workflow (82.6% and 100%, respectively) and patient safety (95.6% and 100%, respectively). DISCUSSION/UNASSIGNED:Implementation of AHD across a large, multisite neurology residency program was feasible and associated with higher attendance, improved resident satisfaction, and enhanced RITE performance, without adverse effects on workflow or patient safety. Key factors for success included resident involvement, a targeted needs assessment, and strong coverage support from faculty and APPs.
PMCID:12893798
PMID: 41685358
ISSN: 2771-9979
CID: 6002572
Bedside Neurological Check Frequency Does Not Explain Outcomes for Patients With Coma and Disorders of Consciousness: A Curing Coma Campaign Scoping Review
Murtaugh, Brooke; Olson, DaiWai; Sharma, Kartyva; Lewis, Ariane; Zink, Elizabeth; Bombino-Elliott, Jessica; Weaver, Jennifer A; Sampaio-Silva, Gisele; ,
The frequency and nature of neurological exams (neuro-checks) in patients with severe acquired brain injury resulting in coma or disorders of consciousness (DoC) remain variable, with limited evidence guiding practice and poor understanding of their role in predicting and preventing neurological deterioration, functional recovery and adverse effects such as delirium. This scoping review aims to explore the frequency of bedside neurological exams within the first 7 days of injury impact on clinical outcomes in adult patients with severe acquired brain injury including mortality, neurological deterioration, long-term function, and delirium. METHODS: A comprehensive literature search was conducted using the PubMed, CINAHL, Medline and EMBASE databases from 2003 to 2023. Search terms captured a range of acute brain injuries and neuro-assessment tools. Eligible studies included adult patients with severe traumatic or non-traumatic brain injury or stroke that addressed frequency of bedside neurological exams within the first 7 days of admission. RESULTS: Of 1327 studies screened, 20 met inclusion criteria, representing over 16,000 patients across 14 countries. Assessment tools varied, but use of the Glasgow Coma Scale was prevalent. Frequency of neuro-checks ranged from hourly to daily. Multiple outcome measures were utilized. Some studies found that continuing hourly neuro-checks beyond the first 48 hours did not provide additional clinical benefit. Others associated excessive assessment with increased stress or delirium. CONCLUSION: There is very low evidence supporting an association between the frequency of neuro-checks and functional outcomes, mortality, length of stay, or delirium. Although early assessments may aid prognostication, excessive exams may not improve outcomes and may contribute to harm. The heterogeneity, lack of evidence, and limited standardization of neuro-check frequency highlight the need for clinical research to guide future practice.
PMID: 41671576
ISSN: 1945-2810
CID: 6002262
Neurocritical Care Experience and Attitudes Related to Organ Donation in the USA
Lewis, Ariane; Hargis, Mitch; Durrant, Julia; Cappucci, Stefanie; Choi, Richard; Condie, Chad; Gandee, Richard; Lim-Hing, Krista; McHugh, Daryl; Patel, Vishal; Reynolds, Alexandra; Tompeck, Allison; Jaffa, Matthew N
INTRODUCTION/BACKGROUND:There has been a surge in attention to ethical controversies associated with organ donation in the USA. The Neurocritical Care Society (NCS) Ethics Committee sought to understand member experiences and attitudes related to organ donation in the USA. METHODS:We designed a survey of members who practice in the USA and have interacted with an organ procurement organization (OPO)/potential donor. The survey was disseminated by NCS from 1 June 2025 to 1 September 2025. Free-text responses were reviewed to identify themes. RESULTS:Of 2204 NCS members in the USA, there were 71 respondents who completed the survey and 37 respondents who provided free-text comments. Experiences and attitudes varied, but 59% of respondents indicated that they generally think that communication between the OPO and patient surrogates about donation after brain death/death by neurologic criteria seems appropriate, and 34% indicated that they generally think that communication between the OPO and patient surrogates regarding donation after cardiac death/death by circulatory-respiratory criteria (DCD) seems appropriate. Themes included (1) the need to improve education for the treatment team about organ donation; (2) blurred boundaries between patient care and care directed toward organ donation; (3) misalignment between OPOs and treatment team priorities; (4) loss of trust between patient surrogates and the treatment team based on interactions with OPOs; (5) suboptimal timing of communication between OPOs and patient surrogates; (6) concerns regarding a potential lack of transparency, empathy, and cultural sensitivity in communication between OPOs and patient surrogates; (7) opportunities for improvement in preoperative care before donation and palliation after extubation for DCD; and (8) changes in willingness to donate organs based on interactions with OPOs. CONCLUSIONS:Although the results from this survey reflect the experience and attitudes of a small percentage of NCS members in the USA, they indicate that there are opportunities for improvement in organ donation processes. Survey results will guide the NCS Ethics Committee in supporting members navigating ethical controversies related to organ donation.
PMID: 41634498
ISSN: 1556-0961
CID: 5999832
Ethical Controversies in the Adriana Smith Case in Georgia: Brain Death/Death by Neurologic Criteria in Pregnancy [Case Report]
Lewis, Ariane; Quinn, Gwendolyn; Mutcherson, Kimberly
This manuscript explores the myriad ethical controversies associated with declaration of brain death/death by neurologic criteria (BD/DNC) during pregnancy raised by the case of Ms. Adriana Smith, a 30-year-old Georgia nurse, who came to international attention in May 2025. We will discuss: (1) the factors that may have impacted the decision not to perform neuroimaging when she first presented to medical attention; (2) the significance of identifying and deferring performance of futile interventions to decrease intracranial pressure relative to BD/DNC declaration; (3) the medical, ethical and legal complexities associated with BD/DNC declaration and continuation of maternal organ support in pregnancy; (4) the impact of continuing maternal organ support after BD/DNC declaration on the fetus, the family, Ms. Smith and the treatment team; and (5) the effects of media coverage of this case. This case's influence on future BD/DNC declarations during pregnancy, both in Georgia and elsewhere, remains to be seen.
PMID: 40928476
ISSN: 1536-0075
CID: 5985732
Informed Consent Practices in Research Involving Persons with Disorders of Consciousness
Lewis, Ariane; Ganesan, Saptharishi Lalgudi; Jox, Ralf J; Mazzeo, Anna Teresa; Rubin, Michael A; Walter, Jennifer K; Young, Michael J; ,
INTRODUCTION/BACKGROUND:The Curing Coma Campaign Ethics Working Group sought to understand informed consent practices for research involving persons with disorders of consciousness (DoC) to establish an empirical foundation to formulate common consent elements for research regarding this vulnerable population. METHODS:Consent forms for research involving persons with DoC were collected from the Curing Coma Campaign members and Clinicaltrials.gov in the fall of 2024. We abstracted data about study specifics, the consent process, and unique considerations related to persons with DoC and then reviewed and collated them using descriptive statistics. RESULTS:The collection process yielded 58 consent forms: 40 (69%) from member submissions and 18 (31%) from Clinicaltrials.gov. After excluding duplicates and studies that did not pertain to persons with DoC, there were 43 forms, which included 62 unique terms to describe acute brain injury/consciousness/DoC. Of 41 studies that enrolled persons with DoC, there were 4 (10%) that mentioned an evaluation for covert consciousness. Although only 3 (7%) forms mentioned an evaluation for capacity of the person with DoC/recovered from DoC, 16 (39%) referenced first-person consent if the person with DoC regained capacity. Most studies that involved study-specific medications/interventions/tests included some mention of experiential risks (26/32, 81%), but only 2 (6%) specifically addressed the challenges associated with these risks in a person with DoC. CONCLUSIONS:Consent forms for research involving persons with DoC include inconsistent terminology to describe acute brain injury/consciousness/DoC, the capacity to consent, and the potential experiential risks of study participation in the context of a DoC. There are opportunities to improve transparency and consistency of communication about research involving persons with DoC via creation of common consent elements to ensure the informed consent process protects individual autonomy.
PMID: 41199102
ISSN: 1556-0961
CID: 5960202
Pontine hemorrhage due to a Charcot-Bouchard aneurysm
Hayek, Reya; Imossi, Catherine; Touray, Mustapha; Rethana, Melissa; Sharashidze, Vera; Raz, Eytan; Lewis, Ariane
PMID: 41240418
ISSN: 1532-2653
CID: 5967242
Informed Consent Practices in Research Involving Persons with Disorders of Consciousness
Lewis, Ariane; Ganesan, Saptharishi Lalgudi; Jox, Ralf J.; Mazzeo, Anna Teresa; Rubin, Michael A.; Walter, Jennifer K.; Young, Michael J.
ISI:001609043500001
ISSN: 1541-6933
CID: 5965372