The Conflict between Regulatory Agencies over the 20,000-Fold Lowering of the Tolerable Daily Intake (TDI) for Bisphenol A (BPA) by the European Food Safety Authority (EFSA).

BACKGROUND: The European Food Safety Authority (EFSA) recommended lowering their estimated tolerable daily intake (TDI) for bisphenol A (BPA) 20,000-fold to 0.2 ng/kg body weight (BW)/day. BPA is an extensively studied high production volume endocrine disrupting chemical (EDC) associated with a vast array of diseases. Prior risk assessments of BPA by EFSA as well as the US Food and Drug Administration (FDA) have relied on industry-funded studies conducted under good laboratory practice protocols (GLP) requiring guideline end points and detailed record keeping, while also claiming to examine (but rejecting) thousands of published findings by academic scientists. Guideline protocols initially formalized in the mid-twentieth century are still used by many regulatory agencies. EFSA used a 21st century approach in its reassessment of BPA and conducted a transparent, but time-limited, systematic review that included both guideline and academic research. The German Federal Institute for Risk Assessment (BfR) opposed EFSA's revision of the TDI for BPA. OBJECTIVES: We identify the flaws in the assumptions that the German BfR, as well as the FDA, have used to justify maintaining the TDI for BPA at levels above what a vast amount of academic research shows to cause harm. We argue that regulatory agencies need to incorporate 21st century science into chemical hazard identifications using the CLARITY-BPA (Consortium Linking Academic and Regulatory Insights on BPA Toxicity) nonguideline academic studies in a collaborative government-academic program model. DISCUSSION: We strongly endorse EFSA's revised TDI for BPA and support the European Commission's (EC) apparent acceptance of this updated BPA risk assessment. We discuss challenges to current chemical risk assessment assumptions about EDCs that need to be addressed by regulatory agencies to, in our opinion, become truly protective of public health. Addressing these challenges will hopefully result in BPA, and eventually other structurally similar bisphenols (called regrettable substitutions) for which there are known adverse effects, being eliminated from all food-related and many other uses in the EU and elsewhere. https://doi.org/10.1289/EHP13812.

Emergency preparedness for mass casualty events: South Texas commentary on the development of a statewide emergency response system.

Mass casualty incidents (MCIs) are on the rise in the USA, and hemorrhage is the leading cause of preventable death in trauma. The need for rapid access to life-saving blood and blood products is essential for preventing death due to hemorrhage. It is well established that most major cities in the USA are underprepared to meet blood transfusion requirements in the event of an MCI. The South Texas Whole Blood Consortium sought to rectify this and vowed to be prepared to provide low-titer type O-positive whole blood (LTOWB) and blood components to the people who need it, where and when they need it. This system was able to transport 25 units of LTOWB and packed red blood cells almost 100 miles away to Uvalde Memorial Hospital within just 67 minutes after notification of an active shooter. The regional consortium has created a pool of dedicated LTOWB donors affectionately called Heroes in Arms who can be called on to instantly augment locoregional blood supply. Previously pregnant women have historically been excluded from donating plasma and LTOWB due to the increased rates of human leukocyte antigen (HLA) antibody (Ab) positivity, which is associated with transfusion-related acute lung injury. However, the South Texas Blood and Tissue Center in San Antonio had a large number of qualified, previously pregnant females desire to join the Heroes in Arms program prompting them to assess the feasibility of providing HLA Ab testing for this demographic and the results were promising. This is the first report of previously pregnant women being included in the pool for donation of LTOWB.

Diagnosis of Pancreatic Cancer after Cholecystectomy in the Elderly.

BACKGROUND: Previous studies evaluating whether recent cholecystectomy is associated with a pancreas cancer diagnosis are limited. We aimed to examine if cholecystectomy was performed more frequently in the year prior to cancer diagnosis than would be expected in a similar non-cancer population. METHODS: SEER-Medicare linked files were used to identify patients with pancreatic adenocarcinoma. Cancer diagnoses were considered to be "timely" if within 2 months of cholecystectomy or "delayed" if 2-12 months after cholecystectomy. Clinical factors and survival outcomes were compared using chi-square and Kaplan-Meier analyses. RESULTS: Rate of cholecystectomy in the year prior to diagnosis of cancer was 1.9% for the cancer group, compared to .4% in the non-cancer group (OR = 4.7, 95% CI 4.4-5.1). Differences in the cancer vs non-cancer cohorts at the time of cholecystectomy included a higher age (74 vs 70, P < .0001), more males (49.9% vs 41.7%, P < .0001), and more frequent open technique (21.0% vs 9.4%, P < .0001). Acute pancreatitis was nearly twice as common in the cancer cohort (19.1%) vs the non-cancer cohort (10.7%), P < .0001. There were no differences between patients who had a timely diagnosis after cholecystectomy compared to a delayed diagnosis with regard to age, gender, comorbidity index, race, or rural/urban designation. The rates of localized disease and subsequent resection were also similar between the delayed and timely groups. Overall unadjusted survival was no different between timely and delayed diagnoses, P = .96. DISCUSSION: Elderly patients diagnosed with pancreatic adenocarcinoma are more likely to have had a recent cholecystectomy compared to those without.

Stereo-EEG-guided network modulation for psychiatric disorders: Surgical considerations.

BACKGROUND: Deep brain stimulation (DBS) and other neuromodulatory techniques are being increasingly utilized to treat refractory neurologic and psychiatric disorders. OBJECTIVE: /Hypothesis: To better understand the circuit-level pathophysiology of treatment-resistant depression (TRD) and treat the network-level dysfunction inherent to this challenging disorder, we adopted an approach of inpatient intracranial monitoring borrowed from the epilepsy surgery field. METHODS: We implanted 3 patients with 4 DBS leads (bilateral pair in both the ventral capsule/ventral striatum and subcallosal cingulate) and 10 stereo-electroencephalography (sEEG) electrodes targeting depression-relevant network regions. For surgical planning, we used an interactive, holographic visualization platform to appreciate the 3D anatomy and connectivity. In the initial surgery, we placed the DBS leads and sEEG electrodes using robotic stereotaxy. Subjects were then admitted to an inpatient monitoring unit for depression-specific neurophysiological assessments. Following these investigations, subjects returned to the OR to remove the sEEG electrodes and internalize the DBS leads to implanted pulse generators. RESULTS: Intraoperative testing revealed positive valence responses in all 3 subjects that helped verify targeting. Given the importance of the network-based hypotheses we were testing, we required accurate adherence to the surgical plan (to engage DBS and sEEG targets) and stability of DBS lead rotational position (to ensure that stimulation field estimates of the directional leads used during inpatient monitoring were relevant chronically), both of which we confirmed (mean radial error 1.2±0.9 mm; mean rotation 3.6±2.6°). CONCLUSION: This novel hybrid sEEG-DBS approach allows detailed study of the neurophysiological substrates of complex neuropsychiatric disorders.

European Medicines Agency Conflicts With the European Food Safety Authority (EFSA) on Bisphenol A Regulation.

The European Food Safety Authority (EFSA) has revised their estimate of the toxicity of bisphenol A (BPA) and, as a result, have recommended reducing the tolerable daily intake (TDI) by 20 000-fold. This would essentially ban the use of BPA in food packaging such as can liners, plastic food containers, and in consumer products. To come to this conclusion, EFSA used a systematic approach according to a pre-established protocol and included all guideline and nonguideline studies in their analysis. They found that Th-17 immune cells increased with very low exposure to BPA and used this endpoint to revise the TDI to be human health protective. A number of regulatory agencies including the European Medicines Agency (EMA) have written formal disagreements with several elements of EFSA's proposal. The European Commission will now decide whether to accept EFSA's recommendation over the objections of EMA. If the Commission accepts EFSA's recommendation, it will be a landmark action using knowledge acquired through independent scientific studies focused on biomarkers of chronic disease to protect human health. The goal of this Perspective is to clearly articulate the monumental nature of this debate and decision and to explain what is at stake. Our perspective is that the weight of evidence clearly supports EFSA's proposal to reduce the TDI by 20 000-fold.

A vision for safer food contact materials: Public health concerns as drivers for improved testing.

Food contact materials (FCMs) and food contact articles are ubiquitous in today's globalized food system. Chemicals migrate from FCMs into foodstuffs, so called food contact chemicals (FCCs), but current regulatory requirements do not sufficiently protect public health from hazardous FCCs because only individual substances used to make FCMs are tested and mostly only for genotoxicity while endocrine disruption and other hazard properties are disregarded. Indeed, FCMs are a known source of a wide range of hazardous chemicals, and they likely contribute to highly prevalent non-communicable diseases. FCMs can also include non-intentionally added substances (NIAS), which often are unknown and therefore not subject to risk assessment. To address these important shortcomings, we outline how the safety of FCMs may be improved by (1) testing the overall migrate, including (unknown) NIAS, of finished food contact articles, and (2) expanding toxicological testing beyond genotoxicity to multiple endpoints associated with non-communicable diseases relevant to human health. To identify mechanistic endpoints for testing, we group chronic health outcomes associated with chemical exposure into Six Clusters of Disease (SCOD) and we propose that finished food contact articles should be tested for their impacts on these SCOD. Research should focus on developing robust, relevant, and sensitive in-vitro assays based on mechanistic information linked to the SCOD, e.g., through Adverse Outcome Pathways (AOPs) or Key Characteristics of Toxicants. Implementing this vision will improve prevention of chronic diseases that are associated with hazardous chemical exposures, including from FCMs.

Effect of a Commercial NCLEX-RN Preparation Product on First Time Pass Rates.

Introduction: Passing the National Council Licensure Exam-Registered Nurse (NCLEX-RN) is the entry into the profession for nurses, and rates of passing the exam on the first attempt are used as an important outcome measure for schools, students, and accrediting agencies. Objective: This study was conducted in order to investigate if a commercial NCLEX-RN test preparation product impacted first time pass rates. Methods: Data were collected from 688 students from six institutions who were taking the NCLEX-RN for the first time. The intervention group (n = 396) received a 6-month subscription to a commercial product with which to prepare for the NCLEX-RN, and was compared to the control group (n = 292) to test for differences in demographics and test pass rates. Results: The intervention group was more likely to be younger than 25 years of age (n = 160, 55.8% vs. n = 76, 34.6%; p < .001) when compared with the control group. No other significant differences in demographics or NCLEX-RN pass rates were observed between the groups. Conclusion and Recommendations: This study failed to demonstrate a change in the likelihood of passing NCLEX-RN on the first attempt in a group of students who used a commercial test preparation product. We recommend that instructor-guided use of a test-preparation product, along with other interventions to support test success, be considered in creating an individualized plan for nursing students preparing for NCLEX-RN.

The BETTER Traumatic Brain Injury Transitional Care Intervention: A Feasibility Study.

This study aimed to investigate the feasibility, acceptability, and clinical outcome measures of BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery), a culturally tailored traumatic brain injury (TBI) transitional care intervention, among diverse younger adult patients with TBI (age 18-64) and their caregivers. Trained clinical interventionists addressed patient/family needs; established goals; coordinated post-hospital care and resources; and provided patient/family training on self- and family-management coping skills. Fifteen dyads enrolled (N = 31, 15 patients, 16 caregivers). All completed baseline data; 74.2% (n = 23; 10 patients, 13 caregivers) completed 8-week data; 83.8% (n = 26; 13 each) completed 16-week data. Approximately 38% (n = 12, 3 patients, 9 caregivers) completed acceptability data, showing positive experiences (mean = 9.25, range 0-10; SD = 2.01). Overall and mental quality of life (QOL) scores did not differ over time but physical QOL scores did improve over time (baseline: 30.3, 8 weeks: 46.5, 16 weeks: 61.6; p = 0.0056), which was considered to be a suitable outcome measure for a future trial. BETTER is a promising intervention with implications to improve TBI care standards. Research is needed to determine efficacy in a randomized trial.

A call to action to improve the completeness of older adult sexual and gender minority data in electronic health records.

Sexual and gender minority (SGM) older adults experience greater health disparities compared to non-SGM older adults. The SGM older adult population is growing rapidly. To address this disparity and gain a better understanding of their unique challenges in healthcare relies on accurate data collection. We conducted a secondary data analysis of 2018-2022 electronic health record data for older adults aged ≥50 years, in 1 large academic health system to determine the source, magnitude, and correlates of missing sexual orientation and gender identity (SOGI) data among hospitalized older adults. Among 153 827 older adults discharged from the hospital, SOGI data missingness was 67.6% for sexual orientation and 63.0% for gender identity. SOGI data are underreported, leading to bias findings when studying health disparities. Without complete SOGI data, healthcare systems will not fully understand the unique needs of SGM individuals and develop tailored interventions and programs to reduce health disparities among these populations.

A novel non-word speech preparation task to increase stuttering frequency in experimental settings for longitudinal research.

PURPOSE: The variable and intermittent nature of stuttering makes it difficult to consistently elicit a sufficient number of stuttered trials for longitudinal experimental research. This study tests the efficacy of using non-word pairs that phonetically mimic English words with no associated meaning, to reliably elicit balanced numbers of stuttering and fluent trials over multiple sessions. The study also evaluated the effect of non-word length on stuttering frequency, the consistency of stuttering frequency across sessions, and potential carry-over effects of increased stuttering frequency in the experimental task to conversational and reading speech after the task. METHODS: Twelve adults who stutter completed multiple sessions (mean of 4.8 sessions) where they were video-recorded during pre-task reading and conversation, followed by an experimental task where they read 400 non-word pairs randomized for each session, and then a post-task reading and conversation sample. RESULTS: On average, across sessions and participants, non-word pairs consistently yielded a balanced distribution of fluent (60.7%) and stuttered (39.3%) trials over five sessions. Non-word length had a positive effect on stuttering frequency. No carryover effects from experimental to post-task conversation and reading were found. CONCLUSIONS: Non-word pairs effectively and consistently elicited balanced proportions of stuttered and fluent trials. This approach can be used to gather longitudinal data to better understand the neurophysiological and behavioral correlates of stuttering.

Use of aortic wall patches as leaflet replacement material during aortic valve repair.

Objectives: Aortic valve repair can be limited by inadequate leaflet tissue for proper coaptation. Various kinds of pericardium have been used for cusp augmentation, but most have failed because of tissue degeneration. A more durable leaflet substitute is needed. Methods: In this report, 8 consecutive cases are presented in which autologous ascending aortic tissue was used to augment inadequate native cusps during aortic valve repair. Biologically, aortic wall is a living autologous tissue that could have exceptional durability as a leaflet substitute. Techniques for insertion are described in detail, along with procedural videos. Results: Early surgical outcomes were excellent, with no operative mortalities or complications, and all valves were competent with low valve gradients. Patient follow-up and echocardiograms to a maximum of 8 months' postrepair remain excellent. Conclusions: Because of superior biologic characteristics, aortic wall has the potential to provide a better leaflet substitute during aortic valve repair and to expand patient categories amenable to autologous reconstruction. More experience and follow-up should be generated.

Risk factors for massive transfusion in obstetrical hemorrhage and consideration of a whole blood program.

BACKGROUND: Postpartum hemorrhage (PPH) is one of the leading causes of obstetric complications. The goal of this study was to identify risk factors for obstetric (OB) massive transfusion (MT) and determine the feasibility of developing a low-titer group O RhD-positive whole blood (LTO + WB) protocol for OB hemorrhage. STUDY DESIGN AND METHODS: A retrospective study of OB patients who received transfusion within 24 h. MT patients were those who received >3 U of pRBC within 1 h or > 10 U in 24 h. Patient demographics, OB history, comorbidities, blood type, antibody status, and known risk factors for PPH and maternal-fetal outcomes were compared. Logistic regression was used for univariate and multivariate analyses. RESULTS: Of the 610 transfused OB patients, 12.0% (n = 73) required MT. Groups were well matched for body mass index (BMI), maternal comorbidities, and history of spontaneous vaginal deliveries. The incidence of the previous cesarean section was higher in the MT group. Exactly 93.9% of patients were RhD-positive and 3.77% of all patients possessed an antibody on pretransfusion testing. Patients with MT had a longer length of stay (LOS), higher rate of intensive care unit (ICU) admission, fetal death, and hysterectomy. Multivariate analysis found age >35, PPH, placenta percreta, accreta, and increta to be significant (p < .05) risk factors for MT. DISCUSSION: Patients over 35 years and those with abnormal placentation are at increased risk of requiring MT. With a time to delivery of 2 days, potential MT patients can be identified early, and with a 94% rate of RhD-positive+, they are eligible to receive low-titer O whole blood (LTOWB) providing hemostatic resuscitation with reduced donor exposure.

Tumor infiltrating lymphocytes as an endpoint in cancer vaccine trials.

Checkpoint inhibitors have invigorated cancer immunotherapy research, including cancer vaccination. Classic early phase trial design and endpoints used in developing chemotherapy are not suited for evaluating all forms of cancer treatment. Peripheral T cell response dynamics have demonstrated inconsistency in assessing the efficacy of cancer vaccination. Tumor infiltrating lymphocytes (TILs), reflect the local tumor microenvironment and may prove a superior endpoint in cancer vaccination trials. Cancer vaccines may also promote success in combination immunotherapy treatment of weakly immunogenic tumors. This review explores the impact of TILs as an endpoint for cancer vaccination in multiple malignancies, summarizes the current literature regarding TILs analysis, and discusses the challenges of providing validity and a standardized implementation of this approach.

Transfusion-related cost comparison of trauma patients receiving whole blood versus component therapy.

INTRODUCTION: With the emergence of whole blood (WB) in trauma resuscitation, cost-related comparisons are of significant importance to providers, blood banks, and hospital systems throughout the country. The objective of this study was to determine if there is a transfusion-related cost difference between trauma patients who received low titer O+ whole blood (LTO+WB) and component therapy (CT). METHODS: A retrospective review of adult and pediatric trauma patients who received either LTO+WB or CT from time of injury to within 4 hours of arrival was performed. Annual mean cost per unit of blood product was obtained from the regional blood bank supplier. Pediatric and adult patients were analyzed separately and were compared on a cost per patient (cost/patient) and cost per patient per milliliter (cost/patient/mL) basis. Subgroup analysis was performed on severely injured adult patients (Injury Severity Score, >15) and patients who underwent massive transfusion. RESULTS: Prehospital LTO+WB transfusion began at this institution in January 2018. After the initiation of the WB transfusion, the mean annual cost decreased 17.3% for all blood products, and the average net difference in cost related to component blood products and LTO+WB was more than $927,000. In adults, LTO+WB was associated with a significantly lower cost/patient and cost/patient/mL compared with CT at 4 hours ( p < 0.001), at 24 hours ( p < 0.001), and overall ( p < 0.001). In the severely injured subgroup (Injury Severity Score, >15), WB was associated with a lower cost/patient and cost/patient/mL at 4 hours ( p < 0.001), 24 hours ( p < 0.001), and overall ( p < 0.001), with no difference in the prehospital setting. Similar findings were true in patients meeting massive transfusion criteria, although differences in injury severity may account for this finding. CONCLUSION: With increased use of LTO+WB for resuscitation, cost comparison is of significant importance to all stakeholders. Low titer O+ WB was associated with reduced cost in severely injured patients. Ongoing analyses may improve resource utilization and benefit overall healthcare cost. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level IV.

Decoding Depression Severity From Intracranial Neural Activity.

BACKGROUND: Disorders of mood and cognition are prevalent, disabling, and notoriously difficult to treat. Fueling this challenge in treatment is a significant gap in our understanding of their neurophysiological basis. METHODS: We recorded high-density neural activity from intracranial electrodes implanted in depression-relevant prefrontal cortical regions in 3 human subjects with severe depression. Neural recordings were labeled with depression severity scores across a wide dynamic range using an adaptive assessment that allowed sampling with a temporal frequency greater than that possible with typical rating scales. We modeled these data using regularized regression techniques with region selection to decode depression severity from the prefrontal recordings. RESULTS: Across prefrontal regions, we found that reduced depression severity is associated with decreased low-frequency neural activity and increased high-frequency activity. When constraining our model to decode using a single region, spectral changes in the anterior cingulate cortex best predicted depression severity in all 3 subjects. Relaxing this constraint revealed unique, individual-specific sets of spatiospectral features predictive of symptom severity, reflecting the heterogeneous nature of depression. CONCLUSIONS: The ability to decode depression severity from neural activity increases our fundamental understanding of how depression manifests in the human brain and provides a target neural signature for personalized neuromodulation therapies.

Depression in association with neutrophil-to-lymphocyte, platelet-to-lymphocyte, and advanced lung cancer inflammation index biomarkers predicting lung cancer survival.

Lung cancer is a product of inflammation and a dysfunctional immune system, and depression has similar dysregulation. Depression disproportionately affects lung cancer patients, having the highest rates of all cancers. Systemic inflammation and depression are both predictive of non-small cell lung cancer (NSCLC) survival, but the existence and extent of any co-occurrence is unknown. Studied is the association between systemic inflammation ratio (SIR) biomarker levels and patients' depressive symptoms, with the hypothesis that depression severity would be significantly associated with prognostically poor inflammation. Newly diagnosed stage-IV non-small cell lung cancer (NSCLC; N = 186) patients were enrolled (ClinicalTrials.gov Identifier: NCT03199651) and blood draws and depression self-reports (Patient Health Questionnaire-9) were obtained. For SIRs, cell counts of neutrophils (N), lymphocytes (L), and platelets (P) were abstracted for ratio (R) calculations for NLR, PLR, and the Advanced Lung cancer Inflammation Index (ALI). Patients were followed and biomarkers were tested as predictors of 2-year overall survival (OS) to confirm their relevance. Next, multivariate linear regressions tested associations of depression with NLR, PLR, and ALI. Overall 2-year mortality was 61% (113/186). Cox model analyses confirmed higher NLR [hazard ratio (HR) = 1.91; p = 0.001] and PLR (HR = 2.08; p<0.001), along with lower ALI (HR = 0.53; p = 0.005), to be predictive of worse OS. Adjusting for covariates, depression was reliably associated with biomarker levels (p ≤ 0.02). Patients with moderate/severe depressive symptoms were 2 to 3 times more likely to have prognostically poor biomarker levels. Novel data show patients' depressive symptoms were reliably associated with lung-relevant systemic inflammation biomarkers, all assessed at diagnosis/pretreatment. The same SIRs were found prognostic for patients' 2-year OS. Intensive study of depression, combined with measures of cell biology and inflammation is needed to extend these findings to discover mechanisms of depression toxicity for NSCLC patients' treatment responses and survival.

Characterising the prevalence of overweight and obese status among adults with sickle cell disease.

Individuals with sickle cell disease (SCD) have historically been considered underweight. Despite increasing body mass index (BMI) in the general population, the prevalence of overweight and obese status remains unclear in the adult SCD population. Our primary aim was to determine the prevalence of overweight and obese status and to identify associations between BMI, demographic, and clinical characteristics. We conducted an analysis of abstracted electronic health record data and patient-reported outcomes from the Sickle Cell Disease Implementation Consortium registry; individuals aged 20-45 years were included. The median (interquartile range) BMI for the 1664 adults in this analysis was 23.9 (21.1-28) kg/m2 . In this cohort, 42.9% had a BMI of >25 kg/m2 (Centers for Disease Control and Prevention definition of overweight/obese). In multivariable analysis, higher odds of being overweight or obese were associated with female gender, older age, college education, private insurance, and hypertension diagnosis. Higher odds of a BMI of >25 kg/m2 were observed in individuals with HbSC or HbSß+ thalassaemia regardless of hydroxycarbamide (hydroxyurea) exposure (odds ratio [OR] 3.4, p < 0.0001) and HbSS or HbSß0 thalassaemia exposed to hydroxycarbamide (OR 1.6, p = 0.0003) compared to those with HbSS or HbSß0 thalassaemia with no hydroxycarbamide exposure. These data highlight the importance of early identification, prevention, and intervention for increasing BMI to reduce obesity-related complications that may impact SCD-related complications.

Indoor coal ash and school and social competency among children aged 6-14 years.

BACKGROUND: A child's ability to succeed in social interactions and in a school setting are important for their development and growth. Exposure to environmental pollutants has been associated with poorer school performance and fewer social interaction in children. Fly ash, a waste product generated when burning coal for energy, is comprised of small glass spheres with neurotoxic heavy metal(loid)s found to be risk factors for learning and social problems in school. OBJECTIVE: The purpose of this novel study was to assess the association of fly ash in children's homes with school and social competency. METHODS: We recruited children aged 6-14 years old from communities located within 10 miles of two coal-burning power plants. In homes of the participants, fly ash was collected on polycarbonate filters using personal modular impactors. We measured school competency and social competency using the validated Child Behavioral Checklist. Using Tobit and linear regression we investigated the relationship of indoor fly ash with school and social competency. RESULTS: Forty-three percent of children in the study had fly ash in their homes. In covariate-adjusted Tobit models, children with fly ash in their homes scored on average 2.63 (95% CI: -4.98, -0.28) points lower on the school competency scale than peers without ash in their homes. We did not observe that fly ash in homes was related with lower social competency. SIGNIFICANCE: Results from this study suggest that children with fly ash in their homes had poorer performance in the school setting, compared to peers without fly ash in their homes. In the US, coal-fired power plants are being closed, however health concerns about pollution from coal ash storage facilities remains. Findings from this study can provide impetus for creating of public health policy and to highlight the need future research on children's exposure to fly ash. IMPACT: Children's growth and development are impacted by their social interactions and ability to perform in school settings. Environmental pollutants may impact these essential elements of development. Millions of children are exposed to fly ash which is a waste product generated from burning coal. Fly ash, an environmental health threat throughout the world, is comprised of small glass spheres with trace concentrations of neurotoxic metal(loid)s. Findings from this research show that children with fly ash in their homes are significantly more likely to have poorer school performance than children without fly ash in their homes.

Safety and utility of modified ultrafiltration in pediatric cardiac surgery.

INTRODUCTION: Modified ultrafiltration (MUF) is employed at the termination of cardiopulmonary bypass (CPB) in pediatric and neonatal patients undergoing congenital heart surgery to reduce the accumulation of total body water thus increasing the concentration of red blood cells and the other formed elements in the circulation. Modified ultrafiltration has been reported to remove circulating pro-inflammatory mediators that result in systemic inflammatory response syndrome (SIRS) postoperatively. METHODS: Four hundred patients undergoing cardiac surgery requiring cardiopulmonary bypass and weighing less than or equal to 12 kg were retrospectively evaluated for the effectiveness of MUF. After the termination of CPB, blood was withdrawn through the aortic cannula and passed through a hemoconcentrator attached to the blood cardioplegia set and returned to the patient through the venous cannula. The entire CPB circuit volume in addition to the patient's circulating blood volume were concentrated until the hematocrit value displayed on the CDI cuvette within the MUF circuit reached 45% or there was no more volume to safely remove. At the same time a full unit of FFP can be infused as water is being removed, thus maintaining euvolemia. RESULTS: MUF was performed in all 400 patients with no MUF-related complications. Following the conclusion of MUF, anecdotal observations included improved surgical hemostasis, improved hemodynamic parameters, decreased transfusion requirements, and decreased ventilator times. CONCLUSIONS: Complete MUF enables the clinician to safely raise the post-CPB hematocrit to at least 40% while potentially removing mediators that could result in SIRS. In addition a full unit of FFP can be administered while maintaining euvolemia.