Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage.

BACKGROUND: Trials of surgical evacuation of supratentorial intracerebral hemorrhages have generally shown no functional benefit. Whether early minimally invasive surgical removal would result in better outcomes than medical management is not known. METHODS: In this multicenter, randomized trial involving patients with an acute intracerebral hemorrhage, we assessed surgical removal of the hematoma as compared with medical management. Patients who had a lobar or anterior basal ganglia hemorrhage with a hematoma volume of 30 to 80 ml were assigned, in a 1:1 ratio, within 24 hours after the time that they were last known to be well, to minimally invasive surgical removal of the hematoma plus guideline-based medical management (surgery group) or to guideline-based medical management alone (control group). The primary efficacy end point was the mean score on the utility-weighted modified Rankin scale (range, 0 to 1, with higher scores indicating better outcomes, according to patients' assessment) at 180 days, with a prespecified threshold for posterior probability of superiority of 0.975 or higher. The trial included rules for adaptation of enrollment criteria on the basis of hemorrhage location. A primary safety end point was death within 30 days after enrollment. RESULTS: A total of 300 patients were enrolled, of whom 30.7% had anterior basal ganglia hemorrhages and 69.3% had lobar hemorrhages. After 175 patients had been enrolled, an adaptation rule was triggered, and only persons with lobar hemorrhages were enrolled. The mean score on the utility-weighted modified Rankin scale at 180 days was 0.458 in the surgery group and 0.374 in the control group (difference, 0.084; 95% Bayesian credible interval, 0.005 to 0.163; posterior probability of superiority of surgery, 0.981). The mean between-group difference was 0.127 (95% Bayesian credible interval, 0.035 to 0.219) among patients with lobar hemorrhages and -0.013 (95% Bayesian credible interval, -0.147 to 0.116) among those with anterior basal ganglia hemorrhages. The percentage of patients who had died by 30 days was 9.3% in the surgery group and 18.0% in the control group. Five patients (3.3%) in the surgery group had postoperative rebleeding and neurologic deterioration. CONCLUSIONS: Among patients in whom surgery could be performed within 24 hours after an acute intracerebral hemorrhage, minimally invasive hematoma evacuation resulted in better functional outcomes at 180 days than those with guideline-based medical management. The effect of surgery appeared to be attributable to intervention for lobar hemorrhages. (Funded by Nico; ENRICH ClinicalTrials.gov number, NCT02880878.).

A prospective cross-sectional study examining the documented evaluation of patients at high risk for mild traumatic brain injury.

OBJECTIVES: Annually, the CDC reports that 2.5 million Emergency Department (ED) visits occur due to Traumatic Brain Injuries (TBI) with nearly 75% classified as mild TBI (mTBI). Generally, these injuries are thought to be under recognized. This study was done to determine the proportion of patients, who were considered high risk for an mTBI, that had documentation of an mTBI evaluation. METHODS: A prospective cross-section of patients was identified using a 3-question screen at the time of triage: did an injury occur; was the mechanism consistent with mTBI; and was there a period of altered mental status. Chart review was completed for these patients who were thought to meet a minimum threshold warranting an evaluation for mTBI. RESULTS: 38,621 patients were screened over 16 weeks, of whom 441 (1.14%) were identified as being high risk for having an mTBI and met inclusion criteria. Recommended portions of an mTBI evaluation occurred in fewer than 50% of patients. In total, 98 subjects were diagnosed with an mTBI, and 49 received mTBI discharge instructions. The odds ratio for the subgroup of patients who had documented criteria sufficient for diagnosis revealed that an isolated head injury increased a patient's odds of a documented diagnosis by 2.1 times (95%, 1.3-3.4). CONCLUSIONS: Many patients with a possible mTBI did not have significant portions of an mTBI evaluation documented, and roughly half of the patients with a documented mTBI diagnosis did not receive discharge education. Changes in clinicians' approach to mTBI must occur to ensure patients receive appropriate evaluations, management, and education.

Concussion Care in the Emergency Department: A Prospective Observational Brief Report.

STUDY OBJECTIVE: Emergency physicians are often the initial-and only-clinical providers for patients who have sustained a mild traumatic brain injury. This prospective observational study seeks to examine the practice patterns of clinicians in an academic Level I trauma center as they relate to the evaluation of patients who were presumed to be at high risk for mild traumatic brain injury. Specifically, we describe the frequency of a documented mild traumatic brain injury evaluation, diagnosis, and discharge education. METHODS: This pilot study took place in a single academic Level I trauma and emergency care center during a 4-week period. Patients were identified by triage nurses, who determined whether they responded affirmatively to 2 questions that indicated a potential risk for mild traumatic brain injury. Data were abstracted from emergency department clinician documentation on identified patients to describe the frequency of a documented mild traumatic brain injury evaluation (history and physical examination), diagnosis, and discharge education among those who were identified to be at risk for a mild traumatic brain injury. RESULTS: Ninety-eight subjects were included in the present study. Documentation of a mild traumatic brain injury evaluation was present for less than 50% of patients, a final diagnosis of mild traumatic brain injury was included for 36 (37%; 95% confidence interval 27.8% to 46.7%), and discharge education was provided to 15 (15%; 95% confidence interval 9.2% to 21.4%). Of the 36 patients who received a documented mild traumatic brain injury diagnosis, 15 (41.5%; 95% confidence interval 26.7% to 57.9%) received mild traumatic brain injury-specific discharge education. CONCLUSION: This study suggests that the majority of patients at high risk for mild traumatic brain injury have no documentation of an evaluation for one. Also, patients with a mild traumatic brain injury diagnosis were unlikely to receive appropriate discharge education about it. Education and standardization are needed to ensure that patients at risk for mild traumatic brain injury receive appropriate evaluation and care.

A Comparison of Satisfaction With Life and the Glasgow Outcome Scale-Extended After Traumatic Brain Injury: An Analysis of the TRACK-TBI Pilot Study.

OBJECTIVE: To evaluate the relationship between satisfaction with life (SWL) and functional outcome after traumatic brain injury (TBI). SETTING AND PARTICIPANTS: The Transforming Research and Clinical Knowledge in Traumatic Brain Injury Pilot study (TRACK-TBI Pilot) enrolled patients at 3 US Level I trauma centers within 24 hours of TBI. DESIGN: Patients were grouped by outcome measure concordance (good-recovery/good-satisfaction, impaired-recovery/impaired-satisfaction) and discordance (good-recovery/impaired-satisfaction, impaired-recovery/good-satisfaction). Logistic regression was utilized to determine predictors of discordance. MAIN MEASURES: Functional outcome: Glasgow Outcome Scale-Extended (GOSE); SWL: Satisfaction with Life Scale (SWLS). RESULTS: Of the 586 enrolled subjects, 298 had completed both outcome measures at 6-month follow-up; the correlation between GOSE and SWLS was 0.380. Patients with impaired-recovery (GOSE < 7)/impaired-satisfaction (SWLS < 20) were more likely to have mild TBI (83% vs 62%, P = .012), baseline depression (42% vs 15%, P < .0001), and 6-month depression (59% vs 21%, P < .0001) when compared with patients with impaired-recovery/good-satisfaction. Patients with good-recovery/impaired-satisfaction were more likely to have baseline depression (31% vs 13%, P < .0001) and 6-month depression (33% vs 6%, P < .0001) compared with good-recovery/good-satisfaction. CONCLUSION: Correlation between SWL and functional outcome was not strong, and depression may modulate the association. Future research should account for functional, mental health, and patient-centered outcomes when assessing TBI recovery.

The FAST-ED App: A Smartphone Platform for the Field Triage of Patients With Stroke.

BACKGROUND AND PURPOSE: The Emergency Medical Services field triage to stroke centers has gained considerable complexity with the recent demonstration of clinical benefit of endovascular treatment for acute ischemic stroke. We sought to describe a new smartphone freeware application designed to assist Emergency Medical Services professionals with the field assessment and destination triage of patients with acute ischemic stroke. METHODS: Review of the application's platform and its development as well as the different variables, assessments, algorithms, and assumptions involved. RESULTS: The FAST-ED (Field Assessment Stroke Triage for Emergency Destination) application is based on a built-in automated decision-making algorithm that relies on (1) a brief series of questions assessing patient's age, anticoagulant usage, time last known normal, motor weakness, gaze deviation, aphasia, and hemineglect; (2) a database of all regional stroke centers according to their capability to provide endovascular treatment; and (3) Global Positioning System technology with real-time traffic information to compute the patient's eligibility for intravenous tissue-type plasminogen activator or endovascular treatment as well as the distances/transportation times to the different neighboring stroke centers in order to assist Emergency Medical Services professionals with the decision about the most suitable destination for any given patient with acute ischemic stroke. CONCLUSIONS: The FAST-ED smartphone application has great potential to improve the triage of patients with acute ischemic stroke, as it seems capable to optimize resources, reduce hospital arrivals times, and maximize the use of both intravenous tissue-type plasminogen activator and endovascular treatment ultimately leading to better clinical outcomes. Future field studies are needed to properly evaluate the impact of this tool in stroke outcomes and resource utilization.

Temporal profile of care following mild traumatic brain injury: predictors of hospital admission, follow-up referral and six-month outcome.

OBJECTIVE: To investigate the clinical management and medical follow-up of patients with mild traumatic brain injury (mTBI) presenting to emergency departments (EDs). METHODS: Overall, 168 adult patients with mTBI from the prospective, multicentre Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) Pilot study with Glasgow Coma Scale (GCS) 13-15, no polytrauma and alive at six months were included. Predictors for hospital admission, three-month follow-up referral and six-month functional disability (Glasgow Outcome Scale-Extended (GOSE) ≤ 6) were analysed using multivariable regression. RESULTS: Overall, 48% were admitted to hospital, 22% received three-month referral and 27% reported six-month functional disability. Intracranial pathology on ED head computed tomography (multivariable odds ratio (OR) = 81.08, 95% confidence interval (CI) [10.28-639.36]) and amnesia (>30-minutes: OR = 5.27 [1.75-15.87]; unknown duration: OR = 4.43 [1.26-15.62]) predicted hospital admission. Older age (per-year OR = 1.03 [1.01-1.05]) predicted three-month referral, while part-time/unemployment predicted lack of referral (OR = 0.17 [0.06-0.50]). GCS < 15 (OR = 2.46 [1.05-5.78]) and prior history of seizures (OR = 3.62 [1.21-10.89]) predicted six-month functional disability, while increased education (per-year OR = 0.86 [0.76-0.97]) was protective. CONCLUSIONS: Clinical factors modulate triage to admission, while demographic/socioeconomic elements modulate follow-up care acquisition; six-month functional disability associates with both clinical and demographic/socioeconomic variables. Improving triage to acute and outpatient care requires further investigation to optimize resource allocation and outcome after mTBI. ClinicalTrials.gov registration: NCT01565551.

Emergency Neurological Life Support: Intracranial Hypertension and Herniation.

Sustained intracranial hypertension and acute brain herniation are "brain codes," signifying catastrophic neurological events that require immediate recognition and treatment to prevent irreversible injury and death. As in cardiac arrest, a brain code mandates the organized implementation of a stepwise management algorithm. The goal of this Emergency Neurological Life Support protocol is to implement an evidence-based, standardized approach to the evaluation and management of patients with intracranial hypertension and/or herniation.

ED disposition of the Glasgow Coma Scale 13 to 15 traumatic brain injury patient: analysis of the Transforming Research and Clinical Knowledge in TBI study.

OBJECTIVE: Mild traumatic brain injury (mTBI) patients are frequently admitted to high levels of care despite limited evidence suggesting benefit. Such decisions may contribute to the significant cost of caring for mTBI patients. Understanding the factors that drive disposition decision making and how disposition is associated with outcomes is necessary for developing an evidence-base supporting disposition decisions. We evaluated factors associated with emergency department triage of mTBI patients to 1 of 3 levels of care: home, inpatient floor, or intensive care unit (ICU). METHODS: This multicenter, prospective, cohort study included patients with isolated head trauma, a cranial computed tomography as part of routine care, and a Glasgow Coma Scale (GCS) score of 13 to 15. Data analysis was performed using multinomial logistic regression. RESULTS: Of the 304 patients included, 167 (55%) were discharged home, 76 (25%) were admitted to the inpatient floor, and 61 (20%) were admitted to the ICU. In the multivariable model, admission to the ICU, compared with floor admission, varied by study site, odds ratio (OR) 0.18 (95% confidence interval [CI], 0.06-0.57); antiplatelet/anticoagulation therapy, OR 7.46 (95% CI, 1.79-31.13); skull fracture, OR 7.60 (95% CI, 2.44-23.73); and lower GCS, OR 2.36 (95% CI, 1.05-5.30). No difference in outcome was observed between the 3 levels of care. CONCLUSION: Clinical characteristics and local practice patterns contribute to mTBI disposition decisions. Level of care was not associated with outcomes. Intracranial hemorrhage, GCS 13 to 14, skull fracture, and current antiplatelet/anticoagulant therapy influenced disposition decisions.

Early Minimally Invasive Removal of Intracerebral Hemorrhage (ENRICH): Study protocol for a multi-centered two-arm randomized adaptive trial.

Background: Intracerebral hemorrhage (ICH) is a potentially devastating condition with elevated early mortality rates, poor functional outcomes, and high costs of care. Standard of care involves intensive supportive therapy to prevent secondary injury. To date, there is no randomized control study demonstrating benefit of early evacuation of supratentorial ICH. Methods: The Early Minimally Invasive Removal of Intracerebral Hemorrhage (ENRICH) Trial was designed to evaluate the minimally invasive trans-sulcal parafascicular surgery (MIPS) approach, a technique for safe access to deep brain structures and ICH removal using the BrainPath® and Myriad® devices (NICO Corporation, Indianapolis, IN). ENRICH is a multi-centered, two-arm, randomized, adaptive comparative-effectiveness study, where patients are block randomized by ICH location and Glasgow Coma Score (GCS) to early ICH evacuation using MIPS plus standard guideline-based management vs. standard management alone to determine if MIPS results in improved outcomes defined by the utility-weighted modified Rankin score (UWmRS) at 180 days as the primary endpoint. Secondary endpoints include clinical and economic outcomes of MIPS using cost per quality-adjusted life years (QALYs). The inclusion and exclusion criteria aim to capture a broad group of patients with high risk of significant morbidity and mortality to determine optimal treatment strategy. Discussion: ENRICH will result in improved understanding of the benefit of MIPS for both lobar and deep ICH affecting the basal ganglia. The ongoing study will lead to Level-I evidence to guide clinicians treatment options in the management of acute treatment of ICH. Trial registration: This study is registered with clinicaltrials.gov (Identifier: NCT02880878).

The Prognostic Value of Quantitative EEG in Patients Undergoing Mechanical Thrombectomy for Acute Ischemic Stroke.

PURPOSE: Previous work has shown that quantitative EEG measures correlate with the severity of ischemic stroke. This has not been systematically validated in patients with acute ischemic stroke who have undergone mechanical thrombectomy. METHODS: Data were collected from 73 patients who underwent mechanical thrombectomy and had a standard head set EEG performed during their hospital admission. For each patient, the global delta-alpha ratio (DAR) and its difference between the two hemispheres were calculated. Associations between the global and interhemispheric DAR difference with the patients' National Institutes of Health Stroke and Modified Rankin Scale scores at discharge and 3 months after thrombectomy were assessed. RESULTS: The interhemispheric DAR difference correlated with the National Institutes of Health Stroke scores at discharge (Spearman R = 0.41, P = 0.0008), National Institutes of Health Stroke scores at 3 months (Spearman R = 0.60, P = 0.02) and Modified Rankin Scale scores at 3 months (Spearman R = 0.27, P = 0.01). In contrast, the global DAR did not correlate significantly with any of these clinical outcomes when evaluated as continuous variables. In a multivariate logistic regression model, both the interhemispheric DAR difference (ß = 0.25, P = 0.03) and the infarct volume (ß = 0.02, P = 0.03) were independently predictive of good versus poor functional outcome (Modified Rankin Scale score ≤2 vs. >2) at 3 months. CONCLUSIONS: The quantitative EEG measure of interhemispheric slow relative to fast frequencies power asymmetry correlated with the discharge and 3-month National Institutes of Health Stroke and Modified Rankin Scale scores and provided added value to infarct volume in predicting functional outcome at 3 months. These data support the prognostic value of quantitative EEG in ischemic stroke patients who have undergone mechanical thrombectomy.

Application of the RE-AIM Framework for the Pediatric Mild Traumatic Brain Injury Evaluation and Management Intervention: A Study Protocol for Program Evaluation.

BACKGROUND: Children who experience a mild Traumatic Brain Injury (mTBI) may encounter cognitive and behavioral changes that often negatively impact school performance. Communication linkages between the various healthcare systems and school systems are rarely well-coordinated, placing children with an mTBI at risk for prolonged recovery, adverse impact on learning, and mTBI re-exposure. The objective of this study is to rigorously appraise the pediatric Mild Traumatic Brain Injury Evaluation and Management (TEaM) Intervention that was designed to enhance diagnosis and management of pediatric mTBI through enhanced patient discharge instructions and communication linkages between school and primary care providers. METHODS: This is a combined randomized and 2 × 2 quasi-experimental study design with educational and technology interventions occurring at the clinician level with patient and school outcomes as key endpoints. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework will be utilized as a mix methods approach to appraise a multi-disciplinary, multi-setting intervention with the intent of improving outcomes for children who have experienced mTBI. DISCUSSION: Utilization of the RE-AIM framework complemented with qualitative inquiry is suitable for evaluating effectiveness of the TEaM Intervention with the aim of emphasizing priorities regarding pediatric mTBI. This program evaluation has the potential to support the knowledge needed to critically appraise the impact of mTBI recovery interventions across multiple settings, enabling uptake of the best-available evidence within clinical practice.

The Intracerebral Hemorrhage Score: A Self-Fulfilling Prophecy?

BACKGROUND: The ICH Score has become the standard for risk-stratification of 30-d mortality in patients with intracerebral hemorrhage (ICH), but treatment has evolved over the last 17 yr since its inception. We sought to determine if the ICH Score remains an accurate predictor of 30-d mortality in these high acuity patients. OBJECTIVE: To determine the role the ICH Score has on mortality in current treatment of patients. METHODS: A retrospective review of 554 patients treated for acute, spontaneous ICH at 2 large academic institutions between 2010 and 2014 was carried out. Surgical intervention in the form of external ventricular drain or craniotomy was performed when indicated. All patients were managed medically until discharge or death. RESULTS: Over half (53.6%) of the patients presented with ICH of the basal ganglia/thalamus and the majority (71%) presented with ICH Scores of 0 to 2. Overall mortality was 25.1%. Observed mortality in moderate grade ICH Score patients (3 and 4) was lower than expected (49% vs 72%, P < .001) and (71% vs 97%, P < .001) when compared to the original ICH Score results. Despite differences in ICH and intraventricular hemorrhage volume, and Glasgow Coma Scale there was no difference in surgical intervention (12.2% vs 11.8%, P = .94) between the two groups. Withdrawal of care was instituted in 56.6% of all patients who died and increased with ICH Score. CONCLUSION: In our cohort, the original ICH score did not accurately predict the mortality rate. Patient survival exceeded ICH Score-predicted mortality regardless of surgical intervention. Reevaluation of predictive scores could be useful to aid in more accurate prognoses.

West Nile virus among hospitalized, febrile patients: a case for expanding diagnostic testing.

In Georgia, most individuals reported with West Nile virus (WNV) disease have been diagnosed with West Nile neuroinvasive disease (WNND). Relatively few cases of West Nile Fever (WNF) are reported, and the burden of illness due to WNV is likely underestimated. From July through October 2003, WNV serologic testing was performed on enrolled patients>or=18 years of age with fever admitted to a large, urban hospital in Atlanta, Georgia through the emergency department (ED). Patients' history, clinical, and laboratory data were recorded. Residual blood drawn in the ED was tested to determine the presence of WNV IgG and IgM antibodies. Of 254 patients tested for WNV, four (1.6%) patients were positive for WNV IgM and IgG antibodies, and had a clinical illness compatible with WNV. None of the four positive patients were clinically suspected of having WNV infection; discharge diagnoses included pneumonia, migraine, stroke, and gout. These four patients accounted for 80% of all WNV diagnosed in this hospital, 44% of all cases in Fulton County, and 7% of all cases reported in Georgia in 2003. The occurrence of WNV disease may be substantially greater than currently reflected in disease statistics in Georgia and many other states. When indicators of WNV activity are present and patients are likely to have had intensive mosquito exposure, WNV should be considered in the differential diagnosis of seriously ill, febrile patients.

The validity and reliability of the affective competency score to evaluate death disclosure using standardized patients.

OBJECTIVE: To explore the validity and reliability of the affective competency score (ACS), compared to a global rating measure to predict overall competency to perform a death disclosure in a standardized patient exercise and to investigate useful thresholds of the ACS. METHODS: Thirty-seven fourth-year students underwent standardized patient training in death disclosure during a fourth-year emergency medicine clerkship. Students were evaluated using a checklist, an ACS, and a global rating assessment. ACS interrater reliability, interitem reliability, item-total reliability, and split-half reliability were calculated. Area under the curve (AUC) measurements were used to establish criterion validity. RESULTS: For the ACS, item-total correlations ranged from 0.76 to 0.85, 0.76 to 0.93, and 0.42 to 0.87; the split-half reliability was 0.82 (p = 0.0001), 0.86 (p = 0.0001) and 0.55 (p = 0.0007) for the standardized patient (SP), the faculty and the medical students, respectively. Interitem correlations were adequate. A moderate interrater correlation of the ACS was observed between the faculty observer and the SP (r = 0.47; p = 0.04); however, the medical students' self evaluation did not correlate significantly with either the SP (r = -0.04; p = 0.79), or the faculty observer (r = 0.00; p = 0.99). The AUC for was 0.98 (95% confidence interval [CI] 0.94 to 1.00), 0.87 (95% CI 0.73 to 0.99), and 0.74 (95% CI 0.53 to 0.95) for the faculty, SP, and medical student, respectively. CONCLUSIONS: The ACS may be a valid, reliable, and useful measure to assess communication skills by faculty or SPs in this setting. At an ACS score of 16, 19, and 21 points for faculty, SPs, and medical students, respectively, there is 100% specificity for the detection of competency assessed on a global rating. However, the ACS appears to have limited reliability and validity when used by medical students.

A Novel Tool for Evaluation of Mild Traumatic Brain Injury Patients in the Emergency Department: Does Robotic Assessment of Neuromotor Performance Following Injury Predict the Presence of Postconcussion Symptoms at Follow-up?

OBJECTIVES: Postconcussion symptoms (PCS) are a common complication of mild traumatic brain injury (TBI). Currently, there is no validated clinically available method to reliably predict at the time of injury who will subsequently develop PCS. The purpose of this study was to determine if PCS following mild TBI can be predicted during the initial presentation to an emergency department (ED) using a novel robotic-assisted assessment of neurologic function. METHODS: All patients presenting to an urban ED with a chief complaint of head injury within the preceding 24 hours were screened for inclusion from March 2013 to April 2014. The enrollment criteria were as follows: 1) age of 18 years or greater, 2) ability and willingness to provide written informed consent, 3) blunt head trauma and clinical diagnosis of isolated mild TBI by the treating physician, and 4) blood alcohol level of <100 mg/dL. Eligible mild TBI patients were enrolled and their neuromotor function was assessed in the ED using a battery of five tests that cover a range of proprioceptive, visuomotor, visuospatial, and executive function performance metrics. At 3 weeks postinjury, participants were contacted via telephone to complete the Rivermead Post-Concussion Symptoms Questionnaire to assess the presence of significant PCS. RESULTS: A total of 66 mild TBI patients were enrolled in the study with 42 of them completing both the ED assessment and the follow-up; 40 patients were included in the analyses. The area under the receiver operating characteristic curve (AUC) for the entire test battery was 0.72 (95% confidence interval [CI] = 0.54 to 0.90). The AUC for tests that primarily measure visuomotor and proprioceptive performance were 0.80 (95% CI = 0.65 to 0.95) and 0.71 (95% CI = 0.53 to 0.89), respectively. CONCLUSIONS: The robotic-assisted test battery has the ability to discriminate between subjects who developed PCS and those who did not. Additionally, poor visuomotor and proprioceptive performance were most strongly associated with subsequent PCS.

Integration of New Technology for Research in the Emergency Department: Feasibility of Deploying a Robotic Assessment Tool for Mild Traumatic Brain Injury Evaluation.

UNLABELLED: The objective of this paper is to demonstrate the effective deployment of a robotic assessment tool for the evaluation of mild traumatic brain injury (mTBI) patients in a busy, resource-constrained, urban emergency department (ED). METHODS: Functional integration of new robotic technology for research in the ED presented several obstacles that required a multidisciplinary approach, including participation from electrical and computer engineers, emergency medicine clinicians, and clinical operations staff of the hospital. Our team addressed many challenges in deployment of this advanced technology including: 1) adapting the investigational device for the unique clinical environment; 2) acquisition and maintenance of appropriate testing space for point-of-care assessment; and 3) dedicated technical support and upkeep of the device. Upon successful placement of the robotic device in the ED, the clinical study required screening of all patients presenting to the ED with complaints of head injury. Eligible patients were enrolled and tested using a robot-assisted test battery. Three weeks after the injury, patients were contacted to complete follow-up assessments. RESULTS: Adapting the existing technology to meet anticipated physical constraints of the ED was performed by engineering a mobile platform. Due to the large footprint of the device, it was frequently moved before ultimately being fully integrated into the ED. Over 14 months, 1423 patients were screened. Twenty-eight patients could not be enrolled because the device was unavailable due to operations limitations. Technical problems with the device resulted in failure to include 20 patients. A total of 66 mTBI patients were enrolled and 42 of them completed both robot-assisted testing and follow-up assessment. Successful completion of screening and enrollment demonstrated that the challenges associated with integration of investigational devices into the ED can be effectively addressed through a collaborative patient-oriented research model. CONCLUSION: Effective deployment and use of new robotic technology for research in an urban academic ED required significant planning, coordination, and collaboration with key personnel from multiple disciplines. Clinical Impact: A pilot clinical study on mTBI patients using the robotic device provided useful data without disrupting the ED workflow. Integration of this technology into the ED serves as an important step toward pursing active clinical research in an acute care setting.

Measuring the dyspnea of decompensated heart failure with a visual analog scale: how much improvement is meaningful?

Patients presenting to the emergency department with heart failure are evaluated based on the subjective sensation of dyspnea. In this study, the authors sought to determine the change in dyspnea, measured by a visual analog scale (VAS), which is associated with a meaningful change in the patient's perception and the effect of dyspnea severity on the VAS. In this prospective, observational study the authors defined a meaningful change in VAS dyspnea as the difference between VAS scores when patients reported "a little less difficulty breathing" or "a little more difficulty breathing." Seventy-four patients were evaluated, and the mean for a meaningful change in VAS was 21.1 mm (95% confidence interval, 12.3-29.9 mm). Patients that recorded higher index VAS scores had a significantly greater change in VAS. VAS scores and the changes with treatment provide the treating physician with another means to assess the effects of their interventions.

Proxy identification: a time-dependent analysis.

OBJECTIVES: To describe the availability of next-of-kin (NOK) for proxy consent over the 24-hour time period following presentation of major trauma patients to a Level I trauma center. METHODS: The study was conducted by using a prospective, observational study design. Consecutive patients meeting predefined major trauma criteria during a three-month study period were enrolled and followed until NOK were contacted, or up to 24 hours. Survival analysis was used to determine the probability of NOK contact during the 24-hour follow-up period. RESULTS: Three hundred fifty (92%) of 382 subjects had NOK contacted during the follow-up period. The probabilities (95% confidence intervals [CIs]) of NOK contact at the time of arrival (t = 0) and 2, 4, 6, and 24 hours postpresentation were 0.25 (95% CI = 0.21 to 0.30), 0.68 (95% CI = 0.63 to 0.72), 0.77 (95% CI = 0.73 to 0.82), 0.80 (95% CI = 0.76 to 0.84), and 0.87 (95% CI = 0.84 to 0.90), respectively. The median time to contact was 40 minutes (95% CI = 27 to 54 min). CONCLUSIONS: One third of the trauma patients in this study did not have NOK available two hours following arrival in the emergency department. For time-critical research protocols, the time to NOK contact can significantly impact the ability to ensure prompt enrollment and treatment in clinical trials. Further studies are needed to assess the generalizability and consistency of these data.

Shedding new light on the "safe" club drug: methylenedioxymethamphetamine (ecstasy)-related fatalities.

OBJECTIVES: To report the pathology, toxicology, cause, and manner of death in 3,4-methylenedioxymethamphetamine (MDMA)-associated fatalities in the United States. Although use trends are increasing, data regarding the hazards of MDMA are limited. METHODS: The authors obtained fatality reports from participating medical examiners in the United States. Cases were identified as "drug-unrelated" when MDMA did not directly cause death (e.g., motor vehicle collision); deaths from drug toxicity were judged "drug-related." RESULTS: Thirty-eight (8%) of the surveyed medical examiners reported 102 deaths associated with MDMA use from 1999 to 2001. Ten percent of fatalities occurred in 1999 and 90% thereafter, representing a 400% relative increase. Victims tended to be young (mean age = 25), white (n = 87 [85%]), male (n = 70 [69%]), and otherwise healthy. Seventy-one (70%) deaths were drug-related (DR) and 31 (30%) were drug-unrelated (DU). Twenty-four (35%) DR deaths had a mean delay of 6.7 hours (95% CI = 5.1 to 8.2) in activating emergency medical services. Fifty-five DR cases (81%) were found in asystole and pronounced dead at the scene. CONCLUSIONS: The MDMA-associated fatal events typically occur in young, otherwise healthy individuals. MDMA's impact on the public health and safety of young adults and teenagers needs further assessment.

The use of standardized patients within a procedural competency model to teach death disclosure.

OBJECTIVE: To design, implement, and evaluate a multi-dimensional, interdisciplinary, educational training module that enables residents to deliver an effective and empathic death disclosure in the emergency setting. The Accreditation Council for Graduate Medical Education (ACGME) "Toolbox of Assessment Methods" to assess competency was adopted as the foundation of this project. METHODS: Sixteen emergency medicine residents, eight postgraduate year 1 (PGY-1) and eight PGY-2, underwent a one-day training and evaluation exercise. The exercise consisted of: 1) a large-group didactic session, 2) a small-group didactic session, and 3) two standardized patient (SP) examinations. Changes in comfort levels, training helpfulness, and competency were measured. Inter-rater agreement between evaluators was examined. RESULTS: Trainees reported improvement in comfort levels and high levels of satisfaction regarding the helpfulness of the training. Good interrater agreement was obtained regarding resident competency to perform a death disclosure between the faculty and SP evaluators [kappa 0.61; 95% confidence interval (95% CI) = 0.33 to 0.88]. However, overall agreement among raters was poor (kappa 0.16; standard error = 0.26). This poor agreement reflected a lack of agreement between resident and SP evaluators (kappa 0.08; 95% CI = 0.16 to 0.33) and resident and faculty evaluators (kappa -0.02; 95% CI = 0.30 to 0.26). CONCLUSIONS: This project used the ACGME "Toolbox of Assessment Methods" to evaluate the competency of emergency medicine trainees to perform an effective and empathic death disclosure. The finding of inconsistent competency assessments by resident self-evaluators compared with those assessments made by faculty and standardized patients have important implications in future curricular design.