Department Of Human Services Research Articles

Long-Acting Cabotegravir Plus Rilpivirine in People with HIV with Adherence Challenges and Viremia: Current Data and Future Directions.

Long-acting injectable cabotegravir plus rilpivirine (LA CAB/RPV) is currently US Food and Drug Administration (FDA)-approved and HIV treatment guideline-endorsed as a switch strategy for patients with HIV (PWH) who are virologically suppressed on oral ART without a history of treatment failure. Recent changes to the International Antiviral Society-USA (IAS-USA) and U.S. Department of Health and Human Services' (DHHS) Panel on Antiretroviral Guidelines recommend the consideration of LA CAB/RPV in select PWH with viremia who are unable to achieve suppression with oral ART due to suboptimal medication adherence. In this article, we review the existing data on this off-label use of LA CAB/RPV, discuss the motivations and specific caveats implicit in the guidelines change, and propose next steps in exploring this novel treatment in this vulnerable patient population.

Prevalence and predictors of coronary heart disease among individuals with and without obesity in North Dakota.

Coronary heart disease (CHD) is the most common cardiovascular disease in the United States and heart disease is the leading cause of death in North Dakota. Although obesity is a major risk factor for CHD, some studies have reported an inverse relationship between body mass index (BMI) and CHD outcomes. Understanding the epidemiology of CHD among individuals with and without obesity is essential to guide health planning. Therefore, the objectives of this study were to estimate the prevalence and identify predictors of CHD among North Dakota adults with and without obesity. Behavioral Risk Factor Surveillance System data from 2017 to 2021 were provided by the North Dakota Department of Health and Human Services. Weighted prevalence estimates and 95% confidence intervals (CIs) were computed for CHD and potential risk factors among respondents with and without obesity (BMI ≥30 kg/m2). Multivariable logistic regression was used to identify significant predictors of CHD in both groups. A total of 17,092 respondents were included in the study. Respondents with obesity had a higher prevalence of CHD (4.7%, 95% CI: 4.2-5.4) than those without obesity (3.0%, 95% CI: 2.7-3.4). Predictors of CHD among both groups included age, sex, self-reported general health, high blood pressure, high cholesterol, chronic obstructive pulmonary disease, and diabetes. Having a personal doctor (Odds Ratio [OR] = 1.91, 95% CI: 1.13-3.23) and arthritis (OR = 1.72, 95% CI: 1.34-2.22) were significant predictors of CHD among respondents without obesity, but not among those without obesity. While the prevalence of CHD was significantly higher among adults with obesity compared to those without obesity, the findings of the stratified analysis indicated that predictors of the condition tended to be similar for the two groups. This study provides useful information to guide health planning and control programs that aim to reduce the burden of CHD in North Dakota.

Understanding We Can Do This COVID-19 vaccine campaign elements through message frames and emotional appeals

This study looks into the message frames, emotional appeals, and approaches used in the We Can Do This COVID-19 vaccine campaign by the U.S. Department of Health and Human Services (HHS). A quantitative content analysis of 145 audio-visual campaign elements was guided by framing theory. Results indicate that the campaign messages primarily focused on vaccine benefits and used an informational approach to messaging. Consistent use of hope is observed alongside frames, such as vaccine information, facts and findings, and preventive measures. The moral obligation frame uses a more negative appeal (i.e., guilt) across the campaign elements. Additionally, while informational messages incorporate a more fear appeal, sadness, guilt, and hope remain the consistent emotional appeals in the transformational message approach. The findings of this study can serve as a valuable resource for the U.S. Government authorities and other healthcare experts in the implementation of comparable vaccination campaigns.

Serologic Evidence of Recent Infection with Highly Pathogenic Avian Influenza A(H5) Virus Among Dairy Workers - Michigan and Colorado, June-August 2024.

Since April 2024, sporadic infections with highly pathogenic avian influenza (HPAI) A(H5) viruses have been detected among dairy farm workers in the United States. To date, infections have mostly been detected through worker monitoring, and have been mild despite the possibility of more severe illness. During June-August 2024, CDC collaborated with the Michigan Department of Health and Human Services and the Colorado Department of Public Health and Environment to implement cross-sectional serologic surveys to ascertain the prevalence of recent infection with HPAI A(H5) virus among dairy workers. In both states, a convenience sample of persons who work in dairies was interviewed, and blood specimens were collected. Among 115 persons, eight (7%; 95% CI=3.6%-13.1%) had serologic evidence of recent infection with A(H5) virus; all reported milking cows or cleaning the milking parlor. Among persons with serologic evidence of infection, four recalled being ill around the time cows were ill; symptoms began before or within a few days of A(H5) virus detections among cows. This finding supports the need to identify and implement strategies to prevent transmission among dairy cattle to reduce worker exposures and for education and outreach to dairy workers concerning prevention, symptoms, and where to seek medical care if the workers develop symptoms. Timely identification of infected herds can support rapid initiation of monitoring, testing, and treatment for human illness, including mild illness, among exposed dairy workers.

Patient Health Record Protection Beyond the Health Insurance Portability and Accountability Act: Mixed Methods Study

Background The security and privacy of health care information are crucial for maintaining the societal value of health care as a public good. However, governance over electronic health care data has proven inefficient, despite robust enforcement efforts. Both federal (HIPAA [Health Insurance Portability and Accountability Act]) and state regulations, along with the ombudsman rule, have not effectively reduced the frequency or impact of data breaches in the US health care system. While legal frameworks have bolstered data security, recent years have seen a concerning increase in breach incidents. This paper investigates common breach types and proposes best practices derived from the data as potential solutions. Objective The primary aim of this study is to analyze health care and hospital breach data, comparing it against HIPAA compliance levels across states (spatial analysis) and the impact of the Omnibus Rule over time (temporal analysis). The goal is to establish guidelines for best practices in handling sensitive information within hospitals and clinical environments. Methods The study used data from the Department of Health and Human Services on reported breaches, assessing the severity and impact of each breach type. We then analyzed secondary data to examine whether HIPAA’s storage and retention rule amendments have influenced security and privacy incidents across all 50 states. Finally, we conducted a qualitative analysis of textual data from vulnerability and breach reports to identify actionable best practices for health care settings. Results Our findings indicate that hacking or IT incidents have the most significant impact on the number of individuals affected, highlighting this as a primary breach category. The overall difference-in-differences trend reveals no significant reduction in breach rates (P=.50), despite state-level regulations exceeding HIPAA requirements and the introduction of the ombudsman rule. This persistence in breach trends implies that even strengthened protections and additional guidelines have not effectively curbed the rising number of affected individuals. Through qualitative analysis, we identified 15 unique values and associated best practices from industry standards. Conclusions Combining quantitative and qualitative insights, we propose the “SecureSphere framework” to enhance data security in health care institutions. This framework presents key security values structured in concentric circles: core values at the center and peripheral values around them. The core values include employee management, policy, procedures, and IT management. Peripheral values encompass the remaining security attributes that support these core elements. This structured approach provides a comprehensive security strategy for protecting patient health information and is designed to help health care organizations develop sustainable practices for data security.

Temporal and spatial trends of fentanyl co-occurrence in the illicit drug supply in the United States: a serial cross-sectional analysis

BackgroundFentanyl and its analogs contribute substantially to drug overdose deaths in the United States. There is concern that people using drugs are being unknowingly exposed to fentanyl, increasing their risk of overdose death. This study examines temporal trends and spatial variations in the co-occurrence of fentanyl with other seized drugs. MethodsWe identified fentanyl co-occurrence (the proportion of samples of non-fentanyl substances that also contain fentanyl) among 9 substances or substance classes of interest: methamphetamine, cannabis, cocaine, heroin, club drugs, hallucinogens, and prescription opioids, stimulants, and benzodiazepines. We used serial cross-sectional data on drug reports across 50 states and the District of Columbia from the National Forensic Laboratory Information System, the largest available database on the U.S. illicit drug supply, from January 2013 to December 2023. FindingsWe analyzed data from 11,940,207 samples. Fentanyl co-occurrence with all examined substances increased monotonically over time (Mann-Kendall p<0.0001). Nationally, fentanyl co-occurrence was highest among heroin samples (approx. 50%), but relatively low among methamphetamine (≤1%), cocaine (≤4%), and other drug samples. However, co-occurrence rates have grown to over 10% for cocaine and methamphetamine in several Northeast states in 2017-2023. InterpretationFentanyl co-occurs most commonly with heroin, but its presence in stimulant supplies is increasing in some areas, where it may pose a disproportionately high risk of overdose. FundingThis work was partly supported by FDA grant U01FD00745501. This article reflects the views of the authors and does not represent the views or policies of the FDA or US Department of Health and Human Services.

Enhancing insights in sexually transmitted infection mapping: Syphilis in Forsyth County, North Carolina, a case study.

In 2008-2011 Forsyth County, North Carolina experienced a four-fold increase in syphilis rising to over 35 cases per 100,000 mirroring the 2021 state syphilis rate. Our methodology extends current models with: 1) donut geomasking to enhance resolution while protecting patient privacy; 2) a moving window uniform grid to control the modifiable area unit problem, edge effect and remove kriging islands; and 3) mitigating the "small number problem" with Uniform Model Bayesian Maximum Entropy. Data is 2008-2011 early syphilis cases reported to the NC Department of Health and Human Services for Forsyth County. Results were assessed using latent rate theory cross validation. We show combining a moving window and a UMBME analysis with geomasked data effectively predicted the true or latent syphilis rate 5% to 26% more accurate than the traditional, geopolitical boundary method. It removed kriging islands, reduced background incidence rate to 0, relocated nine outbreak hotspots to more realistic locations, and elucidated hotspot connectivity producing more realistic geographical patterns for targeted insights. Using the Forsyth outbreak as a case study showed how the outbreak emerged from endemic areas spreading through sexual core transmitters and contextualizing the outbreak to current and past outbreaks. As the dynamics of sexually transmitted infections spread have changed to online partnership selection and demographically to include more women, partnership selection continues to remain highly localized. Furthermore, it is important to present methods to increase interpretability and accuracy of visual representations of data.

The Effectiveness of Face Mask Mandates on COVID-19 Transmission in Utah.

Throughout the COVID-19 pandemic, the effectiveness of face mask mandates was intensely debated. The objective of this study was to describe how face mask mandates at the state, county, and local levels differed in their effectiveness in reducing the number of COVID-19 cases in the jurisdiction where the mandate was implemented and throughout Utah. We used publicly available data from the Utah Department of Health and Human Services. We calculated the effectiveness of face mask mandates (EFm) in each local health district after 3 key mandates: the enactment of face mask mandates in Salt Lake and Summit counties (SLSC) on June 28, 2020, and June 27, 2020, respectively; the enactment of a statewide face mask mandate on November 9, 2020; and the lifting of the statewide face mask mandate on April 10, 2021. Most counties in Utah had a reduction in the growth rate of COVID-19 cases after enactment of face mask mandates. We found an average 11.9% reduction in EFm after the introduction of the SLSC face mask mandates, with 8 of 13 local health districts experiencing a reduction, and an average 12.7% reduction after introduction of the statewide mandate, with 12 of 13 local health districts experiencing a reduction. After mandates were lifted, many counties had an increase in EFm. Face mask mandates were an effective way to reduce transmission of COVID-19 in local jurisdictions and in neighboring jurisdictions in Utah. Our evidence supports the use of face mask mandates as a way to prevent disease transmission and be better equipped to respond to future pandemics.

Participation With Compensation: Ethical Considerations for Research Payment Practices With People Who Are Incarcerated.

The participation of incarcerated individuals in research is necessary to appropriately address the health disparities that affect them and to adapt and implement health services for the carceral setting. Incarceration significantly impacts health, leading to negative outcomes including accelerated aging and increased mortality, with these effects disproportionately impacting communities of color. The U.S. Department of Health and Human Services' Office for Human Research Protections outlines ethical approaches to compensating individuals who participate in research activities, yet lacks specific guidance for payment within carceral settings. Historical abuses in carceral research underscore the persistent need for robust protections for incarcerated research participants. Existing regulations offer some protection but inadequately address ethical payment practices. Substantial variability in payment policies across carceral systems and vague national guidelines pose ethical challenges in ensuring equitable treatment for incarcerated research participants. We outline the ethical concerns related to compensating incarcerated individuals for participating in research and present a framework of approaches to payment. We argue for payment parity between incarcerated and community research participants. More community-engaged research is needed to understand the perspectives of incarcerated individuals on ethical payment.

Joint regression analysis of clustered current status data with latent variables.

Clustered current status data frequently occur in many fields of survival studies. Some potential factors related to the hazards of interest cannot be directly observed but are characterized through multiple correlated observable surrogates. In this article, we propose a joint modeling method for regression analysis of clustered current status data with latent variables and potentially informative cluster sizes. The proposed models consist of a factor analysis model to characterize latent variables through their multiple surrogates and an additive hazards frailty model to investigate covariate effects on the failure time and incorporate intra-cluster correlations. We develop an estimation procedure that combines the expectation-maximization algorithm and the weighted estimating equations. The consistency and asymptotic normality of the proposed estimators are established. The finite-sample performance of the proposed method is assessed via a series of simulation studies. This procedure is applied to analyze clustered current status data from the National Toxicology Program on a tumorigenicity study given by the United States Department of Health and Human Services.

Safety of Kidney Transplantation from Donors with HIV

BackgroundKidney transplantation from donors with human immunodeficiency virus (HIV) to recipients with HIV is an emerging practice. It has been performed since 2016 under the U.S. congressional HIV Organ Policy Equity Act and is currently approved for research only. The Department of Health and Human Services is considering expanding the procedure to clinical practice, but data are limited to small case series that did not include donors without HIV as controls.MethodsIn an observational study conducted at 26 U.S. centers, we compared transplantation of kidneys from deceased donors with HIV and donors without HIV to recipients with HIV. The primary outcome was a safety event (a composite of death from any cause, graft loss, serious adverse event, HIV breakthrough infection, persistent failure of HIV treatment, or opportunistic infection), assessed for noninferiority (margin for the upper bound of the 95% confidence interval, 3.00). Secondary outcomes included overall survival, survival without graft loss, rejection, infection, cancer, and HIV superinfection.ResultsWe enrolled 408 transplantation candidates, of whom 198 received a kidney from a deceased donor; 99 received a kidney from a donor with HIV and 99 from a donor without HIV. The adjusted hazard ratio for the composite primary outcome was 1.00 (95% confidence interval [CI], 0.73 to 1.38), which showed noninferiority. The following secondary outcomes were similar whether the donor had HIV or not: overall survival at 1 year (94% vs. 95%) and 3 years (85% vs. 87%), survival without graft loss at 1 year (93% vs. 90%) and 3 years (84% vs. 81%), and rejection at 1 year (13% vs. 21%) and 3 years (21% vs. 24%). The incidence of serious adverse events, infections, surgical or vascular complications, and cancer was similar in the groups. The incidence of HIV breakthrough infection was higher among recipients of kidneys from donors with HIV (incidence rate ratio, 3.14; 95%, CI, 1.02 to 9.63), with one potential HIV superinfection among the 58 recipients in this group with sequence data and no persistent failures of HIV treatment.ConclusionsIn this observational study of kidney transplantation in persons with HIV, transplantation from donors with HIV appeared to be noninferior to that from donors without HIV. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT03500315.)

New US DHHS Guidelines for Feeding of HIV Exposed Infants: Uptake, Practice Variability and Concerns

Abstract Background Approximately 5000 infants are born to mothers living with HIV annually in the US. In the past, the Center for Disease Control (CDC), American Academy of Pediatrics (AAP), and US Department of Health and Human Services (DHHS) have recommended that people living with HIV (PWH) not breast/chest feed their infants. Recent changes published in January 2023 in the “Section on Infant Feeding for Individuals Living with HIV” in the US DHHS HIV Guidelines, now include that individuals with HIV who are on antiretroviral therapy (ART) with a sustained undetectable viral load (VL) and who choose to breastfeed should be supported in this decision. We evaluated the uptake of these guidelines, and practice variability across providers who care for such mothers and infants. Methods We surveyed Pediatric Infectious Diseases Society members who practice clinically in the US, via an internal email list serve. The ten-question survey assessed uptake of the updated DHHS guidelines and respondents’ clinical practice in three key areas that are subject to interpretation in the guidelines: VL control, mixed feeding, and ART prophylaxis. We used descriptive statistics to examine guideline uptake and variability in practice. We used inductive qualitative thematic analysis to identify themes in open-ended survey responses. Results Of 915 individuals who opened the survey, 165 responded and 129 were included in the final analysis. Respondents represented 86 US clinical centers. Uptake varied: 14 respondents (10.8%) were unaware of the new guidelines, 103 (79.8%) had implemented or were planning to implement the new guidelines, and 12 (9.3%) were not planning to implement the guidelines. The table summarizes variability in pre-delivery VL suppression and mixed feeding criteria used by 117 respondents who are either planning/already implementing guidelines or who are unaware of guidelines. Areas of concern revealed by thematic analysis included insufficient data to support guidelines and lack of specific criteria for implementation. Conclusion We identified substantial heterogeneity in provider uptake and comfort with new breastfeeding guidelines among US pediatric infectious diseases practitioners, and variability in assessment of safety to breastfeed. Further research is essential to explore patient preferences, define necessary follow-up, and address provider concerns regarding insufficient data to support guidelines and lack of specific criteria for implementation.

B-021 Impact of Assay Conditions on FT4 Measurement Accuracy of Equilibrium Dialysis LC/MS/MS Clinical Assay

Abstract Background Reliable FT4 measurements are vital for accurate diagnosis and effective management of thyroid disorders. However, currently used FT4 immunoassays (IAs) lack standardization, leading to significant variations between platforms. Equilibrium dialysis (ED) coupled with LC-MS/MS analysis, considered the gold standard for FT4 measurement, has been adopted as a reference measurement procedure (RMP) for IA standardization. This study aimed to establish a high-throughput version of the routine clinical FT4 assay based on ED-LC/MS/MS technology and assess the impact of altered assay conditions on measurement accuracy. Methods A commercially available micro-ED plate was employed for ED-LC/MS/MS analysis. FT4 extraction from the dialysate was performed by utilizing a 96-well C18 SPE plate, followed by FT4 quantitation via LC-MS/MS in positive ion mode. Certified primary reference material was used to calibrate the assay. To evaluate assay robustness, the effects of minor method modifications were studied, including incubation time of ED, serum/buffer ratios in ED inserts, ED incubation temperature, shaker speed during ED, serum sample dilution ratio, and dialysate sample dilution ratio. Additionally, short-term and long-term stability of serum FT4 were assessed. Results The developed ED-LC/MS/MS assay successfully resolved T4, T3, reverse triiodothyronine (rT3), and other interferences within 4 minutes using C18 chromatography. The assay's linear range (0.5-100 pg/mL) encompassed clinically relevant FT4 concentrations across hypo- and hyperthyroid patient samples. Excellent agreement was observed between the routine assay based on ED-LC/MS/MS and CDC RMP with a Deming regression slope near 1 (95%CI: 0.87-1.06). Furthermore, serum/buffer ratios from 1:1 to 1:2.5 in ED inserts, shaker speeds from 75 to 150 rpm, and ED incubation times from 16 to 20 hours did not significantly affect FT4 measurement. However, elevated ED temperature (38°C) led to a more than 10% increase in FT4 values. Serum FT4 remained stable when exposed to room temperature for 12 hours, five freeze-thaw cycles, and -70°C storage for 1.5 years. Additionally, dilution of sera by up to 3-fold before ED did not alter FT4 measurement results. Diluting dialysate samples at least 3 times prior to SPE extraction proved accurate for samples exceeding the calibration curve range. Conclusions In conclusion, we successfully developed a routine clinical FT4 assay based on ED-LC/MS/MS that generates data comparable to the RMP. The assay exhibits robustness, with several altered conditions not significantly impacting measurement accuracy. This high-throughput and accurate assay demonstrates suitability for both clinical laboratories and large-scale epidemiological studies. Disclaimer: The findings and conclusions in this report are those of the author(s) and do not necessarily represent the official position of the Centers for Disease Control and Prevention/the Agency for Toxic Substances and Disease Registry. Use of trade names is for identification only and does not imply endorsement by the Centers for Disease Control and Prevention, the Public Health Service, and the US Department of Health and Human Services.

Age and racial and ethnic disparities in filled buprenorphine prescriptions post-emergency department visit in Nevada.

We described age, gender, race, and ethnicity associations with filling buprenorphine prescriptions post-emergency department (post-ED) visits. We analyzed 1.5 years (July 1, 2020-December 31, 2021) of encounter-level Medicaid ED and retail pharmacy claims data obtained from the Nevada Department of Health and Human Services. We studied ED patients with an opioid use disorder (OUD) diagnosis who did not fill a prescription for OUD medications within 6 months before the ED encounter. Using logistic regression, we modeled the associations between the patient's demographic characteristics and the outcome, filling a buprenorphine prescription at a community pharmacy within 14 or 30 days of the ED encounter. Among 2781 ED visits, representing 2094 patients, the median age was 39 years, 54% were male, 18.5% were Black, 11.7% were Hispanic, and 62.3% were White. Only 4% of the ED visits were followed by a filled buprenorphine prescription. Increasing age (14-day window: adjusted odds ratio (aOR)=0.965, 95% confidence interval [CI]: 0.948-0.983) and being a Black patient (14-day window: aOR: 0.114, 95% CI 0.036-0.361) were both associated with lower odds of filled buprenorphine prescriptions. These results were similar within 30 days of an ED visit. Initiation of buprenorphine following an ED visit remains low among Nevadan Medicaid patients and is less likely with increasing age and among Black patients, despite strong evidence supporting its use. Overburdened EDs, lack of attention from managers, and substance use stigma are among possible explanations. When ED clinicians do write buprenorphine prescriptions, peer recovery support could increase the fill rates.

National Institutes of Health COVID-19 Treatment Guidelines Panel: Perspectives and Lessons Learned.

In March 2020, the White House Coronavirus Task Force determined that clinicians in the United States needed expert treatment guidelines to optimally manage patients with COVID-19, a potentially life-threatening disease caused by a new pathogen for which no specific treatments were known to be effective. The U.S. Department of Health and Human Services requested that the National Institutes of Health (NIH) take the lead in expeditiously convening a panel of experts to create "living" guidelines that would be widely accessible and capable of frequent updating as important new information became available. The purpose of this article is to expand on the experiences of the NIH COVID-19 Treatment Guidelines Panel (the Panel) over the past 4 years, summarize the Panel's final recommendations for COVID-19, highlight some challenges and unanswered questions about COVID-19 management, and inform future responses to public health emergencies. The Panel was formed in March 2020, and the first iteration of the guidelines was released in April 2020. Now that the public health emergency has ended, the NIH COVID-19 Treatment Guidelines have sunsetted. This role will now fall to professional societies and organizations, such as the American College of Physicians, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the World Health Organization, all of which have been active in this area.

A bibliometric analysis and visualization of literature on the relationship between vitamin D and obesity over the last two decades

ObjectiveThe purpose of this study was to employ bibliometric analysis to visualize hot spots and evolving trends in the studies on the relationship between vitamin D and obesity. MethodsFrom the Web of Science Core Collection database, articles on vitamin D and obesity from 2001 to 2021 were retrieved. For the bibliometric visualization analysis, CiteSpace was employed. Some of the figures were created using GraphPad software. Results4454 pieces of articles and reviews were found, with an average citation of 30.68 times. There are many more published papers in the area of "nutrition dietetics" (1166, 26.179 %). The United States possesses the largest number of publications (1297, 29.12 %) and demonstrates definitive leadership in this field. The League of European Research Universities generates a higher percentage of publications (256, 5.748 %) than other institutions. Major studies are funded by the United States Department of Health and Human Services (531, 11.922 %) and the National Institutes of Health, USA (528, 11.855 %). The top five keywords with the highest co-occurrence frequency are “obesity” (1260), “vitamin d” (943), “insulin resistance” (651), “risk” (642), and “d deficiency” (636). The biggest keyword cluster was #0 "adolescent" among the 18 keyword clusters. The three latest keywords in the keyword burst were "mineral density"、"d insufficiency" and "25 hydroxyvitamin d concentration". ConclusionThis bibliometric analysis shows an overview of the current status of the research on the association between vitamin D and obesity. The prevalence of vitamin D deficiency and the relationship between vitamin D and metabolic syndrome in obese individuals remains hot topics. We speculate that the effect of obesity on vitamin D levels and bone mineral density, and the influence of vitamin D insufficiency on various body systems in obese populations will be future trends.

The influence of the American Association for Thoracic Surgery on clinical trial development by cardiothoracic surgeons

ObjectiveClinical trials play a critical role in the rapidly evolving field of cardiothoracic surgery and the American Association for Thoracic Surgery Clinical Trials Methods Course has provided a biannual symposium led by preeminent surgeons with vast experience in planning, conducting, and analyzing surgical clinical trials. This study hypothesizes that participation in the course is associated with future success in clinical trial leadership. MethodsA list of course attendees (2014-2022) was queried in ClinicalTrials.gov, a database of clinical trials funded by the US Department of Health and Human Services and the National Institutes of Health. The type of clinical trial and publications from the trial were collected. Demographic information about the participants was collected from faculty pages. ResultsA total of 107 participants from various professional backgrounds attended the American Association for Thoracic Surgery Clinical Trials Methods course and led 91 clinical trials. The average time to starting a clinical trial after attending the workshop was 3.04 years for participants who had not already been involved with a trial. Of the 107 participants, 36 (33.6%) were either the principal investigator or a subinvestigator for 91 clinical trials. ConclusionsThe American Association for Thoracic Surgery Clinical Trials Methods course provides participants the tools for successfully leading surgical clinical trials. Although participation has been limited, those who attend the course and lead a clinical trial do so within approximately 3 years. The Clinical Trials Methods Course provides an excellent return on investment and the American Association for Thoracic Surgery should continue sponsorship of this program because it supports the develop of future leaders in cardiothoracic surgery.

Going in Blind: A Common Scenario in an Uncommon Situation.

Medical students, interns, junior resident physicians, senior resident physicians. Power outages have been increasing in frequency in the past few years, therefore becoming an increased threat to healthcare delivery.1 While most studies related to the effects of power outages are focused on outpatient care, such as acute exacerbations of chronic lung conditions and the lack of chargeable equipment, with the increasing number of power outages, hospitals must be prepared for this situation as well.2,3 Although agencies such as the Federal Emergency Management Agency (FEMA) and the US Department of Health and Human Services (HHS) have provided guidelines for the response of hospitals to temporary loss of power,12,13 hospitals generally rely on institutional policies in response to the event of a power outage. Given the relative rarity but increasing frequency of power outages in hospital settings, this medical simulation was created to present a common occurrence in the emergency department (eg, cardiac arrest) in an uncommon setting of a power outage. Simulation has been shown to improve learner self-efficacy, confidence, and leadership skills among resuscitation teams.4,5 The role of simulation also helps learners identify latent safety threats, in this case a power outage.6 The goal of this simulation is to improve the skills of healthcare professionals with regards to managing cardiac arrest and to encourage these practitioners to consider their own hospital guidelines in response to a power outage. By the end of this simulation, learners will be able to (1) evaluate and treat a patient experiencing myocardial infarction and subsequent cardiac arrest during a power outage, (2) describe the local protocols for managing patient care during a power outage, (3) demonstrate the ability to coordinate a medical team during a simulated power outage in an emergency department with limited resources, (4) manage a cardiac arrest patient by following Advanced Cardiac Life Support (ACLS) protocols for bradycardia and ventricular fibrillation, and (5) justify the urgency of transfer to a certified ST segment elevation myocardial infarction center/cardiac intensive care unit, referencing the recommended 120-minute door-to-balloon time. This simulation was conducted with a high-fidelity mannequin. A total of six residents of various post-graduate year (PGY) levels participated in the simulated patient encounter as part of the simulation competition at the Western Regional meeting of the Society for Academic Emergency Medicine. This case was assessed for educational content and piloted by emergency medicine attendings from several institutions prior to running the case for the Western Regional meeting. The efficacy of the content was assessed by oral feedback. The case was well-received by both the attending physicians who evaluated the case prior to running the scenario at the Western Regional meeting and the emergency medicine residents who participated in the case at the Western Regional meeting. Overall, this simulation was well received by both the learners and the debriefers. General feedback was positive, with the perception of increased confidence among learners and reflection upon individual hospital policy in the event of a power outage. Simulation, acute myocardial infarction, cardiac arrest, power outage.

An insight on the last two decades of global research on animal tuberculosis: Bibliometric analysis

Abstract Animal tuberculosis is of global concern because of its economic and zoonotic importance. Bibliometric analysis is an important methodology used to analyze articles and other publications in literature. In this study, we performed quantitative studies on animal tuberculosis for the last two decades by March 2024. The data were retrieved from the Web of Science (WOS) database. Statistical data were set for each studied item using the VOSviewer software, with a focus on the top ten results for each item. A total of 11,155 documents were finally included in the evaluation. Results revealed that author Vordermeier H.M. had the highest number of published papers (151, 1.35%), and the publications in 2021 (693, 6.21%) were at the forefront. The United States Department of Health and Human Services was the top funding agency (1093, 9.79%), and the USA was the top nation in publications (3137, 28.12%). The most publications were in English (10898, 97.69%) and the highest publications in WOS categories were collected from Veterinary Sciences (2588, 23.2%). Research articles were the most abundant form (9271, 83.11%). Citation meso indicated that tuberculosis and leprosy (6628, 59.4%) were the top and Elsevier was the main publisher (2577, 23.1%). The results of this bibliometric analysis indicate a growing number of studies on tuberculosis in animals, which reflects the re-emergence of the disease to an alarming degree. The results can help to establish the possible forthcoming plans for its prevention and control.

Potential immunomodulatory effects of CAS+IMD monoclonal antibody cocktail in hospitalized patients with COVID-19

Passive administration of SARS-CoV-2 neutralizing monoclonal antibodies (mAbs), such as CAS+IMD (Casirivimab+Imdevimab) antibody cocktail demonstrated beneficial effects on clinical outcomes in hospitalized patients with COVID-19 who were seronegative at baseline and outpatients. However, little is known about their impact on the host immunophenotypes. We conducted an immunoprofiling study in 46 patients from a single site of a multi-site trial of CAS+IMD in hospitalized patients. We collected longitudinal samples during October 2020∼April 2021, prior to the emergence of the Delta and Omicron variants and the use of COVID-19 vaccines. All collected samples were analyzed without exclusion and post-hoc statistical analysis was performed. We examined the dynamic interplay of CAS+IMD with host immunity applying dimensional reduction approach on plasma proteomics and high dimensional flow cytometry data. Using an unbiased clustering method, we identified unique immunophenotypes associated with acute inflammation and disease resolution. Compared to placebo group, administration of CAS+IMD accelerated the transition from an acute inflammatory immunophenotype, to a less inflammatory or "resolving" immunophenotype, as characterized by reduced tissue injury, proinflammatory markers and restored lymphocyte/monocyte imbalance independent of baseline serostatus. Moreover, CAS+IMD did not impair the magnitude or the quality of host T cell immunity against SARS-CoV-2 spike protein. Our results identified immunophenotypic changes indicative of a possible SARS-CoV-2 neutralizing antibodies-induced anti-inflammatory effect, without an evident impairment of cellular antiviral immunity, suggesting that further studies of Mabs effects on SAS-CoV-2 or other viral mediated inflammation are warranted. Regeneron Pharmaceuticals Inc and federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under OT number: HHSO100201700020C.