Toward Equitable Kidney Function Estimation in Critical Care Practice: Guidance From the Society of Critical Care Medicine's Diversity, Equity, and Inclusion in Renal Clinical Practice Task Force.

OBJECTIVES: Accurate glomerular filtration rate (GFR) assessment is essential in critically ill patients. GFR is often estimated using creatinine-based equations, which require surrogates for muscle mass such as age and sex. Race has also been included in GFR equations, based on the assumption that Black individuals have genetically determined higher muscle mass. However, race-based GFR estimation has been questioned with the recognition that race is a poor surrogate for genetic ancestry, and racial health disparities are driven largely by socioeconomic factors. The American Society of Nephrology and the National Kidney Foundation (ASN/NKF) recommend widespread adoption of new "race-free" creatinine equations, and increased use of cystatin C as a race-agnostic GFR biomarker. DATA SOURCES: Literature review and expert consensus. STUDY SELECTION: English language publications evaluating GFR assessment and racial disparities. DATA EXTRACTION: We provide an overview of the ASN/NKF recommendations. We then apply an Implementation science methodology to identify facilitators and barriers to implementation of the ASN/NKF recommendations into critical care settings and identify evidence-based implementation strategies. Last, we highlight research priorities for advancing GFR estimation in critically ill patients. DATA SYNTHESIS: Implementation of the new creatinine-based GFR equation is facilitated by low cost and relative ease of incorporation into electronic health records. The key barrier to implementation is a lack of direct evidence in critically ill patients. Additional barriers to implementing cystatin C-based GFR estimation include higher cost and lack of test availability in most laboratories. Further, cystatin C concentrations are influenced by inflammation, which complicates interpretation. CONCLUSIONS: The lack of direct evidence in critically ill patients is a key barrier to broad implementation of newly developed "race-free" GFR equations. Additional research evaluating GFR equations in critically ill patients and novel approaches to dynamic kidney function estimation is required to advance equitable GFR assessment in this vulnerable population.

Improving recognition of early clinical decline: Determining reliability and validity of the Garvey clinical warning curves.

BACKGROUND: New graduate nurses have difficulty recognizing and managing the early signs of clinical decline, resulting in a Failure to Rescue (FTR) event and preventable patient death. To address this gap, Garvey developed a series of Clinical Warning Curves as an instructional tool for new graduate nurses in an academic medical center. The Garvey Clinical Warning Curve models depict the progression of clinical changes in six body systems that occur before cardiac arrest. AIMS: The purpose of this study was to establish the content validity, reliability, and usability of the Garvey Clinical Warning Curves among healthcare experts and new-graduate nurses. METHODS: The current study was a cross-sectional, observational, validation survey design. Content experts used the content validity index (CVI) to evaluate the Curves. RESULTS: All but the temperature curves were rated as "acceptable" (CVI >0.60) for relevance, clarity, and ambiguity. The new graduate nurses who reviewed the case studies and placed patients onto the Clinical Warning Curves did so similarly, generating high intraclass correlation (ICC) scores. The usability survey components measured the perceptions of acceptability, appropriateness, and feasibility for the use of the six Clinical Warning Curves in practice settings. All components of the Curves had an average score of 4.0 or greater except for the level of complexity which scored 3.88. LINKING EVIDENCE TO ACTION: The Garvey Clinical Warning Curves emerged as valid and reliable tools that aid new graduate nurses in recognizing subtle signs of clinical decline. Because timely recognition and communication of clinical decline are key to preventing FTR events and avoiding patient deaths, it would be beneficial to provide the Clinical Warning Curves as a bedside resource for new graduate nurses during their orientation to the unit or within a nurse residency program.

Implementation of Continuous Glucose Monitoring in Critical Care: A Scoping Review.

PURPOSE OF REVIEW: The aim of this review is to identify the implementation approaches, strategies, and outcomes for continuous glucose monitoring (CGM) in the intensive care unit (ICU). Medline and Web of Science databases were searched to report relevant literature published between September 12, 2016 and September 12, 2021. Implementation outcomes and strategies, defined by the Expert Recommendations for Implementing Change (ERIC) project, were extracted. RECENT FINDINGS: Of the 324 titles reviewed, 16 articles were included in the review. While no studies were identified as implementation research, 14 of 16 identified implementation strategies that aligned with ERIC definitions. Included studies described a multi-disciplinary approach. Clinical outcomes included Mean Absolute Relative Difference (MARD), ranging from 7.5 to 15.3%, and 33-71% reduction in frequency of point-of-care (POC) blood glucose monitoring (BGM) using hybrid protocols. This scoping review provides valuable insight into the process of CGM implementation in the ICU. Continued research should include implementation outcomes to inform widespread utilization.

A National Survey on Coma Epidemiology, Evaluation, and Therapy in India: Revisiting the Curing Coma Campaign Come Together Survey.

BACKGROUND: The limited representation from developing countries in the original COME TOGETHER survey gave us an impetus to conduct this survey in the Indian subcontinent. METHODS: This cross-sectional online survey was conducted from August through September 2022. Participants were health care physicians caring for patients with coma and disorders of consciousness. Fischer's exact test or the Mann-Whitney U-test was used to compare respondents who agreed or disagreed with the preestablished coma definition. Fleiss κ values were calculated to assess agreement among respondents. A p value less than 0.05 was considered statistically significant. RESULTS: The survey was completed by 130 physicians. We found substantial interrater agreement on absence of wakefulness (71.54%; κ = 0.71), Glasgow Coma Score ≤ 8 (78.46%; κ = 0.78), and failure to respond purposefully to visual, verbal, or tactile stimuli (66.15%; κ = 0.66). Reported common etiologies of coma included traumatic brain injury (50.76%), ischemic stroke (30%), and intracerebral hemorrhage (29.23%). The most common clinical assessment tools used for coma included the Glasgow Coma Score (92.3%) and neurological examination (60.8%). Neurological examination was the most common diagnostic tool used (100%), followed by magnetic resonance imaging (89.2%), basic laboratory studies (88.5%), and head computed tomography/angiography (86.9%). Pharmacological interventions used to stimulate arousal in patients with coma were sedation vacation (91.5%), electrolyte/endocrine correction (65.4%), osmotic therapy with mannitol (60%), hypertonic saline (54.6%), modafinil (46.9%), and antidote for drugs (45.4%). Among the nonpharmacological interventions, sensory stimulation (57.7%) was the most commonly used modality. The most common discharge disposition for comatose patients who survived hospitalization were home with or without services (70.0%). CONCLUSIONS: Differences from the global survey were noted regarding the following: traumatic brain injury being the most common etiology of coma in India, more frequent practice of sedation interruption, less frequent use of electroencephalography in India, rare use of pharmacological neurostimulants, and home being the most common discharge disposition in India.

Common Data Elements for Disorders of Consciousness: Recommendations from the Working Group on Behavioral Phenotyping.

BACKGROUND: The recent publication of practice guidelines for management of patients with disorders of consciousness (DoC) in the United States and Europe was a major step forward in improving the accuracy and consistency of terminology, diagnostic criteria, and prognostication in this population. There remains a pressing need for a more precise brain injury classification system that combines clinical semiology with neuroimaging, electrophysiologic, and other biomarker data. To address this need, the National Institute of Neurological Disorders and Stroke launched the Common Data Elements (CDEs) initiative to facilitate systematic collection of high-quality research data in studies involving patients with neurological disease. The Neurocritical Care Society's Curing Coma Campaign expanded this effort in 2018 to develop CDEs for DoC. Herein, we present CDE recommendations for behavioral phenotyping of patients with DoC. METHODS: The Behavioral Phenotyping Workgroup used a preestablished, five-step process to identify and select candidate CDEs that included review of existing National Institute of Neurological Disorders and Stroke CDEs, nomination and systematic vetting of new CDEs, CDE classification, iterative review, and approval of panel recommendations and development of corresponding case review forms. RESULTS: We identified a slate of existing and newly proposed basic, supplemental, and exploratory CDEs that can be used for behavioral phenotyping of adult and pediatric patients with DoC. CONCLUSIONS: The proposed behavioral phenotyping CDEs will assist with international harmonization of DoC studies and allow for more precise characterization of study cohorts, favorably impacting observational studies and clinical trials aimed at improving outcome in this population.

Development and Evaluation of the Fuld Institute Evidence-based Implementation and Sustainability Toolkit for Health Care Settings.

Routine implementation and sustainability of evidence-based practices (EBPs) into health care is often the most difficult stage in the change process. Despite major advances in implementation science and quality improvement, a persistent 13- to 15-year research-to-practice gap remains. Nurse leaders may benefit from tools to support implementation that are based on scientific evidence and can be readily integrated into complex health care settings. This article describes development and evaluation of an evidence-based implementation and sustainability toolkit used by health care clinicians seeking to implement EBPs. For this project, implementation science and EBP experts created initial iterations of the toolkit based on Rogers' change theory, the Advancing Research through Close Collaboration (ARCC) model, and phases and strategies from implementation science. Face validity and end-user feedback were obtained after piloting the tool with health care clinicians participating in immersive EBP sessions. The toolkit was then modified, with subsequent content validity and usability evaluations conducted among implementation science experts and health care clinicians. This article presents the newly updated Fuld Institute Evidence-based Implementation and Sustainability Toolkit for health care settings. Nurse leaders seeking to implement EBPs may benefit from an evidence-based toolkit to provide a science-informed approach to implementation and sustainability of practice changes.

The Postpandemic Nursing Workforce: Increasing Fill Rates and Reducing Workload Through a Generational Design of Workforce Layers.

Inequities between nursing workforce supply and demand continue to challenge nurse executives in creating the vision for a postpandemic nursing workforce. Health system's workforce redesign strategies must prioritize the changing needs of the multigenerational workforce to maximize the available supply of nurses willing to remain in the workforce. A test of a newly designed flexible workforce framework, aimed to meet the needs of the multigenerational workforce, resulted in increased fill rates and decreased costs of labor.

Evidence-based practice improves patient outcomes and healthcare system return on investment: Findings from a scoping review.

BACKGROUND: Evidence-based practice and decision-making have been consistently linked to improved quality of care, patient safety, and many positive clinical outcomes in isolated reports throughout the literature. However, a comprehensive summary and review of the extent and type of evidence-based practices (EBPs) and their associated outcomes across clinical settings are lacking. AIMS: The purpose of this scoping review was to provide a thorough summary of published literature on the implementation of EBPs on patient outcomes in healthcare settings. METHODS: A comprehensive librarian-assisted search was done with three databases, and two reviewers independently performed title/abstract and full-text reviews within a systematic review software system. Extraction was performed by the eight review team members. RESULTS: Of 8537 articles included in the review, 636 (7.5%) met the inclusion criteria. Most articles (63.3%) were published in the United States, and 90% took place in the acute care setting. There was substantial heterogeneity in project definitions, designs, and outcomes. Various EBPs were implemented, with just over a third including some aspect of infection prevention, and most (91.2%) linked to reimbursement. Only 19% measured return on investment (ROI); 94% showed a positive ROI, and none showed a negative ROI. The two most reported outcomes were length of stay (15%), followed by mortality (12%). LINKING EVIDENCE TO ACTION: Findings indicate that EBPs improve patient outcomes and ROI for healthcare systems. Coordinated and consistent use of established nomenclature and methods to evaluate EBP and patient outcomes are needed to effectively increase the growth and impact of EBP across care settings. Leaders, clinicians, publishers, and educators all have a professional responsibility related to improving the current state of EBP. Several key actions are needed to mitigate confusion around EBP and to help clinicians understand the differences between quality improvement, implementation science, EBP, and research.

The Curing Coma Campaign and the Future of Coma Research.

Recovery from coma or disordered consciousness is a central issue in patients with acute brain injuries such as stroke, trauma, cardiac arrest, and brain infections. Yet, major gaps remain in the scientific underpinnings of coma and this has led to inaccuracy in prognostication and limited interventions for coma recovery. Even so, recent studies have begun to elucidate mechanisms of consciousness early and prolonged after acute brain injury and some pilot interventions have begun to be tested. The importance and scope of this led in 2019 to the development of the Curing Coma Campaign, an initiative of the Neurocritical Care Society designed to provide a platform for scientific collaboration across the patient care continuum and to empower a community for purposes of research, education, implementation science, and advocacy. Seen as a "grand challenge," the Curing Coma Campaign has developed an infrastructure of scientific working groups and operational modules, along with a 10-year roadmap.

The Curing Coma Campaign International Survey on Coma Epidemiology, Evaluation, and Therapy (COME TOGETHER).

BACKGROUND: Although coma is commonly encountered in critical care, worldwide variability exists in diagnosis and management practices. We aimed to assess variability in coma definitions, etiologies, treatment strategies, and attitudes toward prognosis. METHODS: As part of the Neurocritical Care Society Curing Coma Campaign, between September 2020 and January 2021, we conducted an anonymous, international, cross-sectional global survey of health care professionals caring for patients with coma and disorders of consciousness in the acute, subacute, or chronic setting. Survey responses were solicited by sequential emails distributed by international neuroscience societies and social media. Fleiss κ values were calculated to assess agreement among respondents. RESULTS: The survey was completed by 258 health care professionals from 41 countries. Respondents predominantly were physicians (n = 213, 83%), were from the United States (n = 141, 55%), and represented academic centers (n = 231, 90%). Among eight predefined items, respondents identified the following cardinal features, in various combinations, that must be present to define coma: absence of wakefulness (81%, κ = 0.764); Glasgow Coma Score (GCS) ≤ 8 (64%, κ = 0.588); failure to respond purposefully to visual, verbal, or tactile stimuli (60%, κ = 0.552); and inability to follow commands (58%, κ = 0.529). Reported etiologies of coma encountered included medically induced coma (24%), traumatic brain injury (24%), intracerebral hemorrhage (21%), and cardiac arrest/hypoxic-ischemic encephalopathy (11%). The most common clinical assessment tools used for coma included the GCS (94%) and neurological examination (78%). Sixty-six percent of respondents routinely performed sedation interruption, in the absence of contraindications, for clinical coma assessments in the intensive care unit. Advanced neurological assessment techniques in comatose patients included quantitative electroencephalography (EEG)/connectivity analysis (16%), functional magnetic resonance imaging (7%), single-photon emission computerized tomography (6%), positron emission tomography (4%), invasive EEG (4%), and cerebral microdialysis (4%). The most commonly used neurostimulants included amantadine (51%), modafinil (37%), and methylphenidate (28%). The leading determinants for prognostication included etiology of coma, neurological examination findings, and neuroimaging. Fewer than 20% of respondents reported routine follow-up of coma survivors after hospital discharge; however, 86% indicated interest in future research initiatives that include postdischarge outcomes at six (85%) and 12 months (65%). CONCLUSIONS: There is wide heterogeneity among health care professionals regarding the clinical definition of coma and limited routine use of advanced coma assessment techniques in acute care settings. Coma management practices vary across sites, and mechanisms for coordinated and sustained follow-up after acute treatment are inconsistent. There is an urgent need for the development of evidence-based guidelines and a collaborative, coordinated approach to advance both the science and the practice of coma management globally.

Proceedings of the Second Curing Coma Campaign NIH Symposium: Challenging the Future of Research for Coma and Disorders of Consciousness.

This proceedings article presents actionable research targets on the basis of the presentations and discussions at the 2nd Curing Coma National Institutes of Health (NIH) symposium held from May 3 to May 5, 2021. Here, we summarize the background, research priorities, panel discussions, and deliverables discussed during the symposium across six major domains related to disorders of consciousness. The six domains include (1) Biology of Coma, (2) Coma Database, (3) Neuroprognostication, (4) Care of Comatose Patients, (5) Early Clinical Trials, and (6) Long-term Recovery. Following the 1st Curing Coma NIH virtual symposium held on September 9 to September 10, 2020, six workgroups, each consisting of field experts in respective domains, were formed and tasked with identifying gaps and developing key priorities and deliverables to advance the mission of the Curing Coma Campaign. The highly interactive and inspiring presentations and panel discussions during the 3-day virtual NIH symposium identified several action items for the Curing Coma Campaign mission, which we summarize in this article.

EBP education and skills building for leaders: An RCT to promote EBP infrastructure, process and implementation in a comprehensive cancer center.

BACKGROUND: Implementation of evidence-based practice (EBP) in healthcare remains challenging. The influence of leadership has been recognized. However, few randomized trials have tested effects of an educational and skills building intervention for leaders in clinical settings. AIMS: Test effects of an EBP leadership immersion intervention on EBP attributes over time among two cohorts of leaders at a national comprehensive cancer center. METHODS: A stratified, randomized, wait-list group, controlled design was conducted. Participants received the evidence-based intervention one year apart (2020, n = 36; 2021, n = 30) with EBP knowledge, beliefs, competencies, implementation self-efficacy, implementation behaviors, and organizational readiness measured at pre- and post-intervention, and one- and two-year follow-ups. Participants applied learnings to a specific clinical or organization priority topic. RESULTS: Baseline outcomes variables and demographics did not differ between cohorts except for age and years of experience. Both cohorts demonstrated significant changes in EBP attributes (except organizational readiness) post-intervention. Mixed linear modeling revealed group by time effects at 3-months for all EBP attributes except implementation behaviors and organizational readiness after the first intervention, favoring cohort 2020, with retained effects for EBP beliefs and competencies at one year. Following Cohort 2021 intervention, at 12-weeks post-intervention, implementation behaviors were significantly higher for cohort 2021. LINKING EVIDENCE TO ACTION: An intensive EBP intervention can increase healthcare leaders' EBP knowledge and competencies. Aligning EBP projects with organizational priorities is strategic. Follow-up with participants to retain motivation, knowledge and competencies is essential. Future research must demonstrate effects on clinical outcomes.

The European Academy of Neurology COVID-19 registry (ENERGY): an international instrument for surveillance of neurological complications in patients with COVID-19.

The COVID-19 pandemic is a global public health issue. Neurological complications have been reported in up to one-third of affected cases, but their distribution varies significantly in terms of prevalence, incidence and phenotypical characteristics. Variability can be mostly explained by the differing sources of cases (hospital vs. community-based), the accuracy of the diagnostic approach and the interpretation of the patients' complaints. Moreover, after recovering, patients can still experience neurological symptoms. To obtain a more precise picture of the neurological manifestations and outcome of the COVID-19 infection, an international registry (ENERGY) has been created by the European Academy of Neurology in collaboration with European national neurological societies and the Neurocritical Care Society and Research Network. ENERGY can be implemented as a stand-alone instrument for patients with suspected or confirmed COVID-19 and neurological findings or as an addendum to an existing registry not targeting neurological symptoms. Data are also collected to study the impact of neurological symptoms and neurological complications on outcomes. The variables included in the registry have been selected in the interests of most countries, to favour pooling with data from other sources and to facilitate data collection even in resource-poor countries. Included are adults with suspected or confirmed COVID-19 infection, ascertained through neurological consultation, and providing informed consent. Key demographic and clinical findings are collected at registration. Patients are followed up to 12 months in search of incident neurological manifestations. As of 19 August, 254 centres from 69 countries and four continents have made requests to join the study.

Facilitators and Barriers to Nursing Implementation of Continuous Glucose Monitoring (CGM) in Critically Ill Patients With COVID-19.

OBJECTIVE: We describe our implementation of a continuous glucose monitoring (CGM) guideline to support intravenous insulin administration and reduce point of care (POC) glucose monitoring frequency in the coronavirus disease 2019 medical intensive care unit (MICU) and evaluate nurses' experience with implementation of CGM and hybrid POC + CGM protocol using the Promoting Action on Research in Health Services framework. METHODS: A multidisciplinary team created a guideline providing criteria for establishing initial sensor-meter agreement within each individual patient followed by hybrid use of CGM and POC. POC measures were obtained hourly during initial validation, then every 6 hours. We conducted a focus group among MICU nurses to evaluate initial implementation efforts with content areas focused on initial assessment of evidence, context, and facilitation to identify barriers and facilitators. The focus group was analyzed using a qualitative descriptive approach. RESULTS: The protocol was integrated through a rapid cycle review process and ultimately disseminated nationally. The Diabetes Consult Service performed device set-up and nurses received just-in-time training. The majority of barriers centered on contextual factors, including limitations of the physical environment, complex device set-up, hospital firewalls, need for training, and CGM documentation. Nurses' perceived device accuracy and utility were exceptionally high. Solutions were devised to maximize facilitation and sustainability for nurses while maintaining patient safety. CONCLUSION: Outpatient CGM systems can be implemented in the MICU using a hybrid protocol implementation science approach. These efforts hold tremendous potential to reduce healthcare worker exposure while maintaining glucose control during the COVID-19 pandemic.

Proceedings of the First Curing Coma Campaign NIH Symposium: Challenging the Future of Research for Coma and Disorders of Consciousness.

Coma and disorders of consciousness (DoC) are highly prevalent and constitute a burden for patients, families, and society worldwide. As part of the Curing Coma Campaign, the Neurocritical Care Society partnered with the National Institutes of Health to organize a symposium bringing together experts from all over the world to develop research targets for DoC. The conference was structured along six domains: (1) defining endotype/phenotypes, (2) biomarkers, (3) proof-of-concept clinical trials, (4) neuroprognostication, (5) long-term recovery, and (6) large datasets. This proceedings paper presents actionable research targets based on the presentations and discussions that occurred at the conference. We summarize the background, main research gaps, overall goals, the panel discussion of the approach, limitations and challenges, and deliverables that were identified.

Advancing Evidence-Based Practice Through Implementation Science: Critical Contributions of Doctor of Nursing Practice- and Doctor of Philosophy-Prepared Nurses.

PURPOSE: Describe the evolution of implementation science and the roles and potential collaborations of doctorally prepared nurses to advance implementation science in practice settings. METHODS: Review of academic preparation and areas of expertise for doctorally prepared nurses as it relates to implementation science and evidence-based practice (EBP). FINDINGS: There have been substantial gains in the number of academic programs in healthcare that include content on EBP, resulting in healthcare teams that are motivated to align practices with best evidence. Unfortunately, many EBP initiatives stall during early stages of implementation, resulting in fragmented practices and persistent gaps between evidence and practice. Implementation science aims to bridge this gap and provides a structured, science-based approach to implementation. Few healthcare teams are familiar with implementation science, and many do not incorporate knowledge from the field when implementing EBPs. Doctorally prepared nurses are in a unique position to serve as leaders in EBP implementation due to the breadth and depth of academic preparation and their pivotal roles across practice settings. CONCLUSIONS: Collaboratively aligning existing strengths of PhD and DNP prepared nurses with knowledge of implementation science can advance implementation of EBP across practice settings to effectively incorporate and sustain meaningful change to improve outcomes. LINKING EVIDENCE TO ACTION SECTION: Doctorally prepared nurses are in a unique position to advance and apply the science of implementation in practice settings. Nurse scientists can generate evidence on effective strategies and outcomes among healthcare teams to successfully integrate evidence based practices into routine care. Nurse leaders and educators can apply these findings and use an implementation science approach when leading clinical teams in evidence-based practice changes.

Implementation Science: Application of Evidence-Based Practice Models to Improve Healthcare Quality.

BACKGROUND: Translating research into practice is complex for clinicians, yet essential for high quality patient care. The field of implementation science evolved to address this gap by developing theoretical approaches to guide adoption and sustained implementation of practice changes. Clinicians commonly lack knowledge, time, and resources of how evidence-based practice (EBP) models can guide implementation, contributing to the knowledge-to-practice gap. AIM: This paper aimed to equip clinicians and other healthcare professionals with implementation science knowledge, confidence, and models to facilitate EBP change in their local setting and ultimately improve healthcare quality, safety, and population health outcomes. METHODS: The field of implementation science is introduced, followed by application of three select models. Models are applied to a clinical scenario to emphasize contextual factors, process, implementation strategies, and outcome evaluation. Key attributes, strengths, opportunities, and utilities of each model are presented, along with general resources for selecting and using published criteria to best fit clinical needs. Partnerships between implementation scientists and clinicians are highlighted to facilitate the uptake of evidence into practice. LINKING EVIDENCE TO ACTION: Knowledge of implementation science can help clinicians adopt high-quality evidence into their practices. Application-oriented approaches can guide clinicians through the EBP processes. Clinicians can partner with researchers in advancing implementation science to continue to accelerate the adoption of evidence and reduce the knowledge-to-action gap.

Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID): Study Design and Rationale.

BACKGROUND: As the COVID-19 pandemic developed, reports of neurological dysfunctions spanning the central and peripheral nervous systems have emerged. The spectrum of acute neurological dysfunctions may implicate direct viral invasion, para-infectious complications, neurological manifestations of systemic diseases, or co-incident neurological dysfunction in the context of high SARS-CoV-2 prevalence. A rapid and pragmatic approach to understanding the prevalence, phenotypes, pathophysiology and prognostic implications of COVID-19 neurological syndromes is urgently needed. METHODS: The Global Consortium to Study Neurological dysfunction in COVID-19 (GCS-NeuroCOVID), endorsed by the Neurocritical Care Society (NCS), was rapidly established to address this need in a tiered approach. Tier-1 consists of focused, pragmatic, low-cost, observational common data element (CDE) collection, which can be launched immediately at many sites in the first phase of this pandemic and is designed for expedited ethical board review with waiver-of-consent. Tier 2 consists of prospective functional and cognitive outcomes assessments with more detailed clinical, laboratory and radiographic data collection that would require informed consent. Tier 3 overlays Tiers 1 and 2 with experimental molecular, electrophysiology, pathology and imaging studies with longitudinal outcomes assessment and would require centers with specific resources. A multicenter pediatrics core has developed and launched a parallel study focusing on patients ages <18 years. Study sites are eligible for participation if they provide clinical care to COVID-19 patients and are able to conduct patient-oriented research under approval of an internal or global ethics committee. Hospitalized pediatric and adult patients with SARS-CoV-2 and with acute neurological signs or symptoms are eligible to participate. The primary study outcome is the overall prevalence of neurological complications among hospitalized COVID-19 patients, which will be calculated by pooled estimates of each neurological finding divided by the average census of COVID-19 positive patients over the study period. Secondary outcomes include: in-hospital, 30 and 90-day morality, discharge modified Rankin score, ventilator-free survival, ventilator days, discharge disposition, and hospital length of stay. RESULTS: In a one-month period (3/27/20-4/27/20) the GCS-NeuroCOVID consortium was able to recruit 71 adult study sites, representing 17 countries and 5 continents and 34 pediatrics study sites. CONCLUSIONS: This is one of the first large-scale global research collaboratives urgently assembled to evaluate acute neurological events in the context of a pandemic. The innovative and pragmatic tiered study approach has allowed for rapid recruitment and activation of numerous sites across the world-an approach essential to capture real-time critical neurological data to inform treatment strategies in this pandemic crisis.

The Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID): Development of Case Report Forms for Global Use.

Since its original report in January 2020, the coronavirus disease 2019 (COVID-19) due to Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) infection has rapidly become one of the deadliest global pandemics. Early reports indicate possible neurological manifestations associated with COVID-19, with symptoms ranging from mild to severe, highly variable prevalence rates, and uncertainty regarding causal or coincidental occurrence of symptoms. As neurological involvement of any systemic disease is frequently associated with adverse effects on morbidity and mortality, obtaining accurate and consistent global data on the extent to which COVID-19 may impact the nervous system is urgently needed. To address this need, investigators from the Neurocritical Care Society launched the Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID). The GCS-NeuroCOVID consortium rapidly implemented a Tier 1, pragmatic study to establish phenotypes and prevalence of neurological manifestations of COVID-19. A key component of this global collaboration is development and application of common data elements (CDEs) and definitions to facilitate rigorous and systematic data collection across resource settings. Integration of these elements is critical to reduce heterogeneity of data and allow for future high-quality meta-analyses. The GCS-NeuroCOVID consortium specifically designed these elements to be feasible for clinician investigators during a global pandemic when healthcare systems are likely overwhelmed and resources for research may be limited. Elements include pediatric components and translated versions to facilitate collaboration and data capture in Latin America, one of the epicenters of this global outbreak. In this manuscript, we share the specific data elements, definitions, and rationale for the adult and pediatric CDEs for Tier 1 of the GCS-NeuroCOVID consortium, as well as the translated versions adapted for use in Latin America. Global efforts are underway to further harmonize CDEs with other large consortia studying neurological and general aspects of COVID-19 infections. Ultimately, the GCS-NeuroCOVID consortium network provides a critical infrastructure to systematically capture data in current and future unanticipated disasters and disease outbreaks.

The Curing Coma Campaign: Framing Initial Scientific Challenges-Proceedings of the First Curing Coma Campaign Scientific Advisory Council Meeting.

Coma and disordered consciousness are common manifestations of acute neurological conditions and are among the most pervasive and challenging aspects of treatment in neurocritical care. Gaps exist in patient assessment, outcome prognostication, and treatment directed specifically at improving consciousness and cognitive recovery. In 2019, the Neurocritical Care Society (NCS) launched the Curing Coma Campaign in order to address the "grand challenge" of improving the management of patients with coma and decreased consciousness. One of the first steps was to bring together a Scientific Advisory Council including coma scientists, neurointensivists, neurorehabilitationists, and implementation experts in order to address the current scientific landscape and begin to develop a framework on how to move forward. This manuscript describes the proceedings of the first Curing Coma Campaign Scientific Advisory Council meeting which occurred in conjunction with the NCS Annual Meeting in October 2019 in Vancouver. Specifically, three major pillars were identified which should be considered: endotyping of coma and disorders of consciousness, biomarkers, and proof-of-concept clinical trials. Each is summarized with regard to current approach, benefits to the patient, family, and clinicians, and next steps. Integration of these three pillars will be essential to the success of the Curing Coma Campaign as will expanding the "curing coma community" to ensure broad participation of clinicians, scientists, and patient advocates with the goal of identifying and implementing treatments to fundamentally improve the outcome of patients.