Early Convalescent Plasma for High-Risk Outpatients with Covid-19.

BACKGROUND: Early administration of convalescent plasma obtained from blood donors who have recovered from coronavirus disease 2019 (Covid-19) may prevent disease progression in acutely ill, high-risk patients with Covid-19. METHODS: In this randomized, multicenter, single-blind trial, we assigned patients who were being treated in an emergency department for Covid-19 symptoms to receive either one unit of convalescent plasma with a high titer of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or placebo. All the patients were either 50 years of age or older or had one or more risk factors for disease progression. In addition, all the patients presented to the emergency department within 7 days after symptom onset and were in stable condition for outpatient management. The primary outcome was disease progression within 15 days after randomization, which was a composite of hospital admission for any reason, seeking emergency or urgent care, or death without hospitalization. Secondary outcomes included the worst severity of illness on an 8-category ordinal scale, hospital-free days within 30 days after randomization, and death from any cause. RESULTS: A total of 511 patients were enrolled in the trial (257 in the convalescent-plasma group and 254 in the placebo group). The median age of the patients was 54 years; the median symptom duration was 4 days. In the donor plasma samples, the median titer of SARS-CoV-2 neutralizing antibodies was 1:641. Disease progression occurred in 77 patients (30.0%) in the convalescent-plasma group and in 81 patients (31.9%) in the placebo group (risk difference, 1.9 percentage points; 95% credible interval, -6.0 to 9.8; posterior probability of superiority of convalescent plasma, 0.68). Five patients in the plasma group and 1 patient in the placebo group died. Outcomes regarding worst illness severity and hospital-free days were similar in the two groups. CONCLUSIONS: The administration of Covid-19 convalescent plasma to high-risk outpatients within 1 week after the onset of symptoms of Covid-19 did not prevent disease progression. (SIREN-C3PO ClinicalTrials.gov number, NCT04355767.).

The Effect of Language on the Decision to Image in the Evaluation of Atraumatic Headache.

BACKGROUND: Patients with limited English proficiency seen in the emergency department (ED) experience lower quality of care and higher diagnostic resource utilization unless they are evaluated in their own language. Despite a low rate of serious pathology identified and the availability of guidelines to direct its use, computed tomography (CT) is commonly used to evaluate atraumatic headache in the ED. OBJECTIVE: Our aim was to determine whether Spanish-speaking patients with atraumatic headache were more likely than their English-speaking counterparts to undergo head CT, and whether evaluation by a clinician who passed a Spanish proficiency test mitigated this difference. METHODS: This retrospective observational study used electronic health record data of adult patients presenting with atraumatic headache to a level I trauma center during a 2-year period. Spanish-language testing of clinicians consisted of a brief, unvalidated, in-person, nonmedical verbal test administered by human resources staff. RESULTS: A total of 3030 patients with atraumatic headache were identified; 1437 were English speaking and 1593 were Spanish speaking. Spanish-speaking patients were older (48.3 vs. 41.9 years), more likely to be women (68.8% vs. 60.5%), and more likely to undergo head CT (31.8% vs. 26.4%). Evaluation by a clinician who passed the Spanish proficiency test had no significant influence on the likelihood of head CT for Spanish-speaking patients after controlling for confounding variables (adjusted odds ratio 0.95; 95% CI 0.75-1.20). CONCLUSIONS: Spanish-speaking patients are more likely to undergo head CT when evaluated for atraumatic headache than English-speaking patients. Evaluation by a clinician who passed a brief Spanish proficiency test did not mitigate this disparity.

A Mixed Methods Evaluation of Interventions to Meet the Requirements of California Senate Bill 1152 in the Emergency Departments of a Public Hospital System.

Policy Points Clarifications to Senate Bill (SB) 1152 are necessary to address the differences between inpatient and emergency department (ED) discharge processes, determine how frequently an ED must deliver the SB 1152 bundle of services to a single patient, and establish expectations for compliance during off-hours when social services are unavailable. Because homelessness cannot be resolved in a single ED visit, the state should provide funding to support housing-focused case workers that will follow patients experiencing homelessness (PEH) through the transition from temporary shelters to permanent supportive housing. Medi-Cal could fund the delivery of the SB 1152 bundle of services to defray the costs to public hospitals that provide care for high numbers of PEH. California legislators should consider complementary legislation to increase funding for shelters so that sufficient capacity is available to accept PEH from EDs and hospitals, and to fund alternative strategies to prevent poverty and the upstream root causes of homelessness itself. CONTEXT: Prompted by stories of "patient dumping," California enacted Senate Bill (SB) 1152, which mandates that hospitals offer patients experiencing homelessness (PEH) a set of resources at discharge to ensure safety and prevent dumping. METHODS: To evaluate interventions to meet the requirements of SB 1152 across three emergency departments (EDs) of a Los Angeles County public hospital system with a combined annual census of 260,000 visits, we used an explanatory sequential mixed methods approach, focusing first on quantitative evaluation and then using information from qualitative interviews to explain the quantitative findings. FINDINGS: In total, 2.9% (1,515/52,607) of encounters involved PEH. Documentation of compliance with the eight required components of SB 1152 was low, ranging from 9.0% to 33.9%. Twenty-five provider interviews confirmed support for providing assistance to PEH in the ED, but the participants described barriers to compliance, including challenges in implementing universal screening for homelessness, incongruity of the requirements with the ED setting, the complexity of the patients, and the limitations of SB 1152 as a health policy. CONCLUSIONS: Despite operationalizing universal screening for homelessness, we found poor compliance with SB 1152 and identified multiple barriers to implementation.

Making Artificial Intelligence Lemonade Out of Data Lemons: Adaptation of a Public Apical Echo Database for Creation of a Subxiphoid Visual Estimation Automatic Ejection Fraction Machine Learning Algorithm.

OBJECTIVES: A paucity of point-of-care ultrasound (POCUS) databases limits machine learning (ML). Assess feasibility of training ML algorithms to visually estimate left ventricular ejection fraction (EF) from a subxiphoid (SX) window using only apical 4-chamber (A4C) images. METHODS: Researchers used a long-short-term-memory algorithm for image analysis. Using the Stanford EchoNet-Dynamic database of 10,036 A4C videos with calculated exact EF, researchers tested 3 ML training permeations. First, training on unaltered Stanford A4C videos, then unaltered and 90° clockwise (CW) rotated videos and finally unaltered, 90° rotated and horizontally flipped videos. As a real-world test, we obtained 615 SX videos from Harbor-UCLA (HUCLA) with EF calculations in 5% ranges. Researchers performed 1000 randomizations of EF point estimation within HUCLA EF ranges to compensate for ML and HUCLA EF mismatch, obtaining a mean value for absolute error (MAE) comparison and performed Bland-Altman analyses. RESULTS: The ML algorithm EF mean MAE was estimated at 23.0, with a range of 22.8-23.3 using unaltered A4C video, mean MAE was 16.7, with a range of 16.5-16.9 using unaltered and 90° CW rotated video, mean MAE was 16.6, with a range of 16.3-16.8 using unaltered, 90° CW rotated and horizontally flipped video training. Bland-Altman showed weakest agreement at 40-45% EF. CONCLUSIONS: Researchers successfully adapted unrelated ultrasound window data to train a POCUS ML algorithm with fair MAE using data manipulation to simulate a different ultrasound examination. This may be important for future POCUS algorithm design to help overcome a paucity of POCUS databases.

Randomized clinical trial of parental psychosocial stress management to improve asthma outcomes.

OBJECTIVE: Because higher parental psychosocial stress is associated with worsened asthma outcomes in children, we sought to determine if a parent-focused stress management intervention would improve outcomes among their at-risk African American children. METHODS: We enrolled self-identified African American parent-child dyads (children aged 4-12 years old with persistent asthma, no co-morbidities, on Medicaid) in a prospective, single-blind, randomized clinical trial with follow-up at 3, 6, and 12 months. All children received care based on the guidelines of the National Institutes of Health. Developed with extensive local stakeholder engagement, the intervention consisted of four individual sessions with a community wellness coach (delivered over 3 months) supplemented with weekly text messaging and twice monthly group sessions (both delivered for 6 months). The main outcome was asthma symptom-free days in the prior 14 days by repeated measures at 3 and 6 months follow-up. RESULTS: We randomized 217 parent-child dyads and followed 196 (90.3%) for 12 months. Coaches completed 338/428 (79%) of all individual sessions. Symptom-free days increased significantly from baseline in both groups at 3, 6, and 12 months, but there were no significant differences between groups over the first 6 months. At 12 months, the intervention group sustained a significantly greater increase in symptom-free days from baseline [adjusted difference = 0.92 days, 95% confidence interval (0.04, 1.8)]. CONCLUSION: The intervention did not achieve its primary outcome. The efficacy of providing psychosocial stress management training to parents of at-risk African American children with persistent asthma in order to improve the children's outcomes may be limited. CLINICALTRIALS.GOV: NCT02374138.

Buccally absorbed vs intravenous prochlorperazine for treatment of migraines headaches.

OBJECTIVE: To compare the efficacy of buccally absorbed prochlorperazine (BAP) to intravenous prochlorperazine (IVP) for the abortive treatment of migraine headaches. METHODS: Randomized double-blind trial. Eighty subjects aged 18-65 presenting with migraines to the ED of a safety-net, urban hospital. Subjects were randomized to receive either 6 mg BAP plus 2.25 mL saline IV placebo or 10 mg IVP and buccally absorbed saccharine pill placebo. A 100 mm visual analog scale (VAS) was used to assess pain, nausea, and sedation. Comparisons between groups were analyzed by the Mann-Whitney U test or Fisher's exact test. RESULTS: Eighty subjects were recruited from November 2016 to December 2017; 79 completed the study. Demographics: 60 women and 19 men with a mean age of 38 ± 12.2 years. Initial mean VAS pain scores were similar between groups (BAP: 78.5 ± 19.9 mm vs IVP: 76.9 ± 19.5 mm). The improvement in mean VAS pain scores over 60 minutes for the BAP group was not significantly different from the IVP group (-54.9 ± 29.7 mm vs -66.7 ± 23.2 mm, respectively; P = 0.08). No significant differences were found in rates of nausea or sedation. Nine subjects in the BAP group required rescue treatment compared to 1 in the IVP group. Five subjects reported symptoms consistent with akathisia in the IVP group while no adverse effects were reported in the BAP group. CONCLUSION: Buccally absorbed prochlorperazine (BAP) is an effective, non-invasive treatment for migraine headaches when compared to intravenous prochlorperazine (IVP).

A Multicenter Evaluation of Emergency Department Pain Care Across Different Types of Fractures.

Objectives: To identify differences in emergency department (ED) pain-care based on the type of fracture sustained and to examine whether fracture type may influence the more aggressive analgesic use previously demonstrated in older patients. Design: Secondary analysis of retrospective cohort study. Setting: Five EDs (four academic, one community) in the United States. Participants: Patients (1,664) who presented in January, March, July, and October 2009 with a final diagnosis of fracture (774 long bone [LBF], 890 shorter bone [SBF]). Measurements: Primary-predictor was type of fracture (LBF vs. SBF). Pain-care process outcomes included likelihood of analgesic administration, opioid-dose, and time to first analgesic. General estimating equations were used to control for age, gender, race, baseline pain score, triage acuity, comorbidities and ED crowding. Subgroup analyses were conducted to analyze age-based differences in pain care by fracture type. Results: A larger proportion of patients with LBF (30%) were older (>65 years old) compared to SBF (13%). Compared with SBF, patients with LBF were associated with greater likelihood of analgesic-administration (OR = 2.03; 95 CI = 1.58 to 2.62; P < 0.001) and higher opioid-doses (parameter estimate = 0.268; 95 CI = 0.239 to 0.297; P < 0.001). When LBF were examined separately, older-patients had a trend to longer analgesic wait-times (99 [55-163] vs. 76 [35-149] minutes, P = 0.057), but no other differences in process outcomes were found. Conclusion: Long bone fractures were associated with more aggressive pain care than SBF. When fracture types were examined separately, older patients did not appear to receive more aggressive pain care. This difference should be accounted for in further research.

Using stakeholder engagement to develop a patient-centered pediatric asthma intervention.

Stakeholder engagement has the potential to develop research interventions that are responsive to patient and provider preferences. This approach contrasts with traditional models of clinical research in which researchers determine the study's design. This article describes the effect of stakeholder engagement on the design of a randomized trial of an intervention designed to improve child asthma outcomes by reducing parental stress. The study team developed and implemented a stakeholder engagement process that provided iterative feedback regarding the study design, patient-centered outcomes, and intervention. Stakeholder engagement incorporated the perspectives of parents of children with asthma; local providers of community-based medical, legal, and social services; and national experts in asthma research methodology and implementation. Through a year-long process of multidimensional stakeholder engagement, the research team successfully refined and implemented a patient-centered study protocol. Key stakeholder contributions included selection of patient-centered outcome measures, refinement of intervention content and format, and language framing the study in a culturally appropriate manner. Stakeholder engagement was a useful framework for developing an intervention that was acceptable and relevant to our target population. This approach might have unique benefits in underserved populations, leading to sustainable improvement in health outcomes and reduced disparities.

Bedside Ultrasound Reduces Diagnostic Uncertainty and Guides Resuscitation in Patients With Undifferentiated Hypotension.

OBJECTIVES: Utilization of ultrasound in the evaluation of patients with undifferentiated hypotension has been proposed in several protocols. We sought to assess the impact of an ultrasound hypotension protocol on physicians' diagnostic certainty, diagnostic ability, and treatment and resource utilization. DESIGN: Prospective observational study. SETTING: Emergency department in a single, academic tertiary care hospital. SUBJECTS: A convenience sample of patients with a systolic blood pressure less than 90 mm Hg after an initial fluid resuscitation, who lacked an obvious source of hypotension. INTERVENTIONS: An ultrasound-trained physician performed an ultrasound on each patient using a standardized hypotension protocol. Differential diagnosis and management plan was solicited from the treating physician immediately before and after the ultrasound. Blinded chart review was conducted for management and diagnosis during the emergency department and inpatient hospital stay. MEASUREMENTS AND MAIN RESULTS: The primary endpoints were the identification of an accurate cause for hypotension and change in physicians' diagnostic uncertainty. The secondary endpoints were changes in treatment plan, use of resources, and changes in disposition after performing the ultrasound. One hundred eighteen patients with a mean age of 62 years were enrolled. There was a significant 27.7% decrease in the mean aggregate complexity of diagnostic uncertainty before and after the ultrasound hypotension protocol (1.85-1.34; -0.51 [95% CI, -0.41 to -0.62]) as well as a significant increase in the absolute proportion of patients with a definitive diagnosis from 0.8% to 12.7%. Overall, the leading diagnosis after the ultrasound hypotension protocol demonstrated excellent concordance with the blinded consensus final diagnosis (Cohen k = 0.80). Twenty-nine patients (24.6%) had a significant change in the use of IV fluids, vasoactive agents, or blood products. There were also significant changes in major diagnostic imaging (30.5%), consultation (13.6%), and emergency department disposition (11.9%). CONCLUSIONS: Clinical management involving the early use of ultrasound in patients with hypotension accurately guides diagnosis, significantly reduces physicians' diagnostic uncertainty, and substantially changes management and resource utilization in the emergency department.

A Multicenter Evaluation of the Impact of Sex on Abdominal and Fracture Pain Care.

BACKGROUND: Previous studies examining sex-based disparities in emergency department (ED) pain care have been limited to a single pain condition, a single study site, and lack rigorous control for confounders. OBJECTIVE: A multicenter evaluation of the effect of sex on abdominal pain (AP) and fracture pain (FP) care outcomes. RESEARCH DESIGN: A retrospective cohort review of ED visits at 5 US hospitals in January, April, July, and October 2009. SUBJECTS: A total of 6931 patients with a final ED diagnosis of FP (n=1682) or AP (n=5249) were included. MEASURES: The primary predictor was sex. The primary outcome was time to analgesic administration. Secondary outcomes included time to medication order, and the likelihood of receiving an analgesic and change in pain scores 360 minutes after triage: Multivariable models, clustered by study site, were conducted to adjust for race, age, comorbidities, initial pain score, ED crowding, and triage acuity. RESULTS: On adjusted analyses, compared with men, women with AP waited longer for analgesic administration [AP women: 112 (65-187) minutes, men: 96 (52-167) minutes, P<0.001] and ordering [women: 84 (41-160) minutes, men: 71 (32-137) minutes, P<0.001], whereas women with FP did not (Administration: P=0.360; Order: P=0.133). Compared with men, women with AP were less likely to receive analgesics in the first 90 minutes (OR=0.766; 95% CI, 0.670-0.875; P<0.001), whereas women with FP were not (P=0.357). DISCUSSION: In this multicenter study, we found that women experienced delays in analgesic administration for AP, but not for FP. Future research and interventions to decrease sex disparities in pain care should take type of pain into account.

Sex-specific disparities in COVID-19 outcomes.

Objectives: Sex-specific disparities in morbidity and mortality of COVID-19 illness are not well understood. Neutralizing antibodies (Ab) may protect against severe COVID-19 illness. We investigated the association of sex with disease progression and SARS-CoV-2 Ab response. Methods: In this exploratory analysis of the phase 3, multicenter, randomized, placebo-controlled Convalescent Plasma in Outpatients (C3PO) trial, we examined whether sex was associated with progression to severe illness, defined as a composite of all-cause hospitalization, emergency/urgent care visit, or death within 15 days from study enrollment. Patients had a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test, symptom onset within 7 days, stable condition for emergency department discharge, and were either ≥50 years old or had at least one high-risk feature for disease progression. Patients received blinded convalescent plasma or placebo in a 1:1 fashion and were evaluated on days 15 and 30 after infusion. Blood samples were collected on day 0 (pre-/post-infusion), 15, and 30 to measure Ab levels with the Broad Institute using the Plaque Reduction Neutralization Test assay. Results: Of 511 patients enrolled (median age 54 [Iinterquartile range 41-62] years, 46% male, 66% white, 20% black, 3.5% Asian), disease progression occurred in 36.7% of males and 25.9% of females (unadjusted risk difference 10.8%, 95% confidence interval [CI], 2.8-18.8%). Sex-disparities did not persist when adjusted for treatment group, age, viremic status, symptom onset, and tobacco use (adjusted risk difference 5.6%, 95% confidence interval [CI], -2.2% to 13.4%), but were present in the subgroup presenting 3 or more days after symptom onset (adjusted risk difference 12.6%, 95% CI, 3.4% to 21.9%). Mean baseline Ab levels (log scale) available for 367 patients were similar between sexes (difference 0.19 log units, 95% CI, -0.08 to 0.46). The log-scale mean increase from baseline to day 15 after adjusting for treatment assignment and baseline levels was larger in males than females (3.26 vs. 2.67). A similar difference was noted when the groups were subdivided by outcome. Conclusions: Progression of COVID-19 was similar in males and females when adjusted for age, tobacco use, and viremia status in this study. However, in the cohort presenting 3 or more days after symptom onset, COVID-19 outcomes were worse in males than females. Neutralizing Ab levels increased more in males but did not correlate with sex differences in outcomes.

Ultrasound-guided peripheral intravenous access program is associated with a marked reduction in central venous catheter use in noncritically ill emergency department patients.

STUDY OBJECTIVE: We examine the central venous catheter placement rate during the implementation of an ultrasound-guided peripheral intravenous access program. METHODS: We conducted a time-series analysis of the monthly central venous catheter rate among adult emergency department (ED) patients in an academic urban ED between 2006 and 2011. During this period, emergency medicine residents and ED technicians were trained in ultrasound-guided peripheral intravenous access. We calculated the monthly central venous catheter placement rate overall and compared the central venous catheter reduction rate associated with the ultrasound-guided peripheral intravenous access program between noncritically ill patients and patients admitted to critical care. Patients receiving central venous catheters were classified as noncritically ill if admitted to telemetry or medical/surgical floor or discharged home from the ED. RESULTS: During the study period, the ED treated a total of 401,532 patients, of whom 1,583 (0.39%) received a central venous catheter. The central venous catheter rate decreased by 80% between 2006 (0.81%) and 2011 (0.16%). The decrease in the rate was significantly greater among noncritically ill patients (mean for telemetry patients 4.4% per month [95% confidence interval {CI} 3.6% to 5.1%], floor patients 4.8% [95% CI 4.2% to 5.3%], and discharged patients 7.6% [95% CI 6.2% to 9.1%]) than critically ill patients (0.9%; 95% CI 0.6% to 1.2%). The proportion of central venous catheters that were placed in critically ill patients increased from 34% in 2006 to 81% in 2011 because fewer central venous catheterizations were performed in noncritically ill patients. CONCLUSION: The ultrasound-guided peripheral intravenous access program was associated with reductions in central venous catheter placement, particularly in noncritically ill patients. Further research is needed to determine the extent to which such access can replace central venous catheter placement in ED patients with difficult vascular access.

Pre-endoscopic Rockall and Blatchford scores to identify which emergency department patients with suspected gastrointestinal bleed do not need endoscopic hemostasis.

BACKGROUND: The pre-endoscopic Rockall Score (RS) and the Glasgow-Blatchford Scores (GBS) can help risk stratify patients with upper gastrointestinal bleed who are seen in the Emergency Department (ED). The RS and GBS have yet to be validated in a United States patient population for their ability to discriminate which ED patients with upper gastrointestinal bleed do not need endoscopic hemostasis. OBJECTIVE: We sought to determine whether patients who received a score of zero on either score (the lowest risk) in the ED still required upper endoscopic hemostasis during hospitalization. METHODS: Retrospective electronic medical record chart review was performed during a 3-year period (2007-2009) to identify patients with suspected upper gastrointestinal bleed by ED final diagnosis of gastrointestinal hemorrhage and related terms at a single urban academic ED. The RS and GBS were calculated from ED chart abstraction and the hospital records of admitted patients were queried for subsequent endoscopic hemostasis. RESULTS: Six hundred and ninety patients with gastrointestinal bleed were identified and 86% were admitted to the hospital. One hundred and twenty-two patients had an RS equal to zero; 67 (55%; 95% confidence interval [CI] 46-63%) of these patients were admitted to the hospital and 11 (16%; 95% CI 9-27%) received endoscopic hemostasis. Sixty-three patients had a GBS equal to zero; 15 (24%; 95% CI 15-36%) were admitted to the hospital and 2 (13%; 95% CI 4-38%) received endoscopic hemostasis. CONCLUSIONS: Some patients who were identified as lowest risk by the GBS or RS still received endoscopic hemostasis during hospital admission. These clinical decision rules may be insufficiently sensitive to predict which patients do not require endoscopic hemostasis.

Patient-driven resource planning of a health care facility evacuation.

INTRODUCTION: The evacuation of a health care facility is a complex undertaking, especially if done in an immediate fashion, ie, within minutes. Patient factors, such as continuous medical care needs, mobility, and comprehension, will affect the efficiency of the evacuation and translate into evacuation resource needs. Prior evacuation resource estimates are 30 years old. METHODS: Utilizing a cross-sectional survey of charge nurses of the clinical units in an urban, academic, adult trauma health care facility (HCF), the evacuation needs of hospitalized patients were assessed periodically over a two-year period. RESULTS: Survey data were collected on 2,050 patients. Units with patients having low continuous medical care needs during an emergency evacuation were the postpartum, psychiatry, rehabilitation medicine, surgical, and preoperative anesthesia care units, the Emergency Department, and Labor and Delivery Department (with the exception of patients in Stage II labor). Units with patients having high continuous medical care needs during an evacuation included the neonatal and adult intensive care units, special procedures unit, and operating and post-anesthesia care units. With the exception of the neonate group, 908 (47%) of the patients would be able to walk out of the facility, 492 (25.5%) would require a wheelchair, and 530 (27.5%) would require a stretcher to exit the HCF. A total of 1,639 patients (84.9%) were deemed able to comprehend the need to evacuate and to follow directions; the remainder were sedated, blind, or deaf. The charge nurses also determined that 17 (6.9%) of the 248 adult intensive care unit patients were too ill to survive an evacuation, and that in 10 (16.4%) of the 61 ongoing surgery cases, stopping the case was not considered to be safe. CONCLUSION: Heath care facilities can utilize the results of this study to model their anticipated resource requirements for an emergency evacuation. This will permit the Incident Management Team to mobilize the necessary resources both within the facility and the community to provide for the safest evacuation of patients.