Department Of Health Services Research Articles

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.

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.

Clinical benefit and safety profile of cross-line therapy with CDK4/6 inhibitors: a retrospective study of HR+/HER2- advanced breast cancer.

CDK4/6 inhibitors (CDK4/6is) in combination with endocrine therapy have secured a central role in the treatment of hormone receptor (HR)-positive advanced breast cancer (ABC) and have transformed the therapeutic landscape. Cross-line CDK4/6i therapy in which another CDK4/6i is continued after progression on a prior CDK4/6i may still offer advantageous therapeutic effects. Cross-line CDK4/6i therapy is an area of active investigation in the ongoing pursuit to improve outcomes for patients with HR+/human epidermal growth factor receptor 2 (HER2)- ABC. This retrospective study enrolled 82 patients with HR+/HER2- ABC who were treated with cross-line CDK4/6is (abemaciclib, palbociclib, ribociclib, and dalpiciclib) after progression with another CDK4/6i. The primary endpoint was progression-free survival (PFS) according to version 1.1 of the Response Evaluation Criteria in Solid Tumors. Secondary endpoints included toxicity, objective response rate, disease control rate, and overall survival. Adverse events (AEs) were graded according to version 5.0 of the Common Terminology Criteria for Adverse Events, as promulgated by the U.S. Department of Health and Human Services. Eighty-two HR+/HER2- ABC patients who received cross-line CDK4/6i therapy from January 2022 to February 2024 were enrolled. The median age of the patients was 60 years. The median PFS of all patients was 7.6 months (95% CI, 5.9-9.2). Cox regression analysis identified lung metastasis and a switch to endocrine therapy following prior CDK4/6i therapy as independent predictive factors for PFS. Notably, patients who previously received abemaciclib and switched to palbociclib upon disease progression had a median PFS of 10.7 months. The strategy of transitioning to chemotherapy after progression on a prior CDK4/6i, then to a subsequent CDK4/6i merits further investigation. Hematologic toxicity was the most common grade ≥ 3 AEs. No instances of fatal safety events were observed. Cross-line CDK4/6i therapy is associated with significant clinical benefits and manageable safety profiles in patients with HR+/HER2- ABC, which underscores cross-line CDK4/6i therapy potential as an effective treatment strategy.

Adaptive Governance: Empowering Data Sharing for Public Health Impact - Insights from North Carolina Department of Health and Human Services

Objective and ApproachAt the 2022 IPDLN Conference, we presented work led by the North Carolina Department of Health and Human Services (NCDHSS), in partnership with university-based researchers, to build legal and ethical processes for routine data sharing. This session provides significant updates on the methods, results, and implications of these efforts–namely, that NCDHHS implemented an enterprise-wide data governance process and a legal framework that has enabled timely, impactful use of cross-sector data. We relied on Participatory Action Research and Deliberative Dialogue methods to engage a diverse range of partners in a data landscape overview and the co-creation of new data sharing processes that better enables the enterprise to adapt to a changing world. ResultsFour key actions were taken as a result of the participatory research process: NCDHHS developed a data strategy, created a data sharing guidebook, staffed their Data Office, and implemented a new legal framework. In addition to describing how these actions support data use across a large US state health and human services agency, we provide three use cases demonstrating the impact of this work. ConclusionsEstablishing routine data sharing presents legal, technical, and cultural challenges, particularly in large agencies. Through a collaborative, participatory approach, the NCDHHS successfully established enterprise-wide data governance and a legal framework to support data-driven policymaking and, ultimately, improve health outcomes for residents. ImplicationsThis research presents a successful, actionable, and replicable framework for developing and implementing processes to support intradepartmental data access, linkage, and use.

Identifying Population Segments by Differing Levels of COVID-19 Vaccine Confidence and Evaluating Subsequent Uptake of COVID-19 Prevention Behaviors: Web-Based, Longitudinal, Probability-Based Panel Survey.

The COVID-19 pandemic prompted the launch of the US Department of Health and Human Services' COVID-19 Public Education Campaign to boost vaccine confidence and uptake among adults, as vaccines are key to preventing severe illness and death. Past segmentation research relevant to COVID-19 behavior has found important differences in attitudes, sociodemographics, and subsequent COVID-19 prevention behaviors across population segments. This study extends prior work by incorporating a more comprehensive set of attitudes, behaviors, and sociodemographic variables to identify population segments by differing levels of COVID-19 vaccine confidence and evaluate differences in their subsequent uptake of COVID-19 prevention behaviors. Data were obtained from 5 waves (January 2021 to June 2022) of a web-based longitudinal, probability-based panel survey of US adults (N=4398) administered in English and in Spanish. Participants were recruited from NORC at the University of Chicago's national AmeriSpeak panel and were invited to participate across multiple waves. Latent class cluster analysis estimated segments of respondents based on over 40 COVID-19 attitudes, beliefs, behaviors, and sociodemographics as reported in wave 1. Survey-weighted cross-tabulations and bivariate regression analyses assessed differences in COVID-19 vaccine uptake, booster uptake, mask use, and social distancing in all segments across all 5 survey waves. A total of 6 segments (hardline nonintenders, prevention-compliant nonintenders, burned-out waiters, anxious waiters, skeptical confidents, and ready confidents) were identified, which differed by their COVID-19 vaccine confidence, prevention-related attitudes and behaviors, and sociodemographics. Cross-tabulations and regression results indicated significant segment membership differences in COVID-19 vaccine and booster timing, mask use, and social distancing. Results from survey-weighted cross-tabulations comparing COVID-19 vaccine and booster uptake across segments indicate statistically significant differences in these outcomes across the 6 segments (P<.001). Results were statistically significant for each segment (P<.01 for booster uptake among burned-out waiters; P<.001 for all other coefficients), indicating that, on average, respondents in segments with lower intentions to vaccinate reported later receipt of COVID-19 vaccines and boosters relative to the timing of vaccine and booster uptake among ready confidents. Results extend previous research by showing that initial beliefs and behaviors relevant to COVID-19 vaccination, mask use, and social distancing are important for understanding differences in subsequent compliance with recommended COVID-19 prevention measures. Specifically, we found that across respondent segments, the probability of vaccine and booster uptake corresponded with both COVID-19 vaccine confidence and mask use and social distancing compliance; more compliant segments were more likely to get vaccinated or boosted than less compliant segments given similar levels of vaccine confidence. These findings help identify appropriate audiences for campaigns. Results highlight the use of a comprehensive list of attitudes, behaviors, and other individual-level characteristics that can serve as a basis for future segmentation efforts relevant to COVID-19 and other infectious diseases.

Naloxone vending machines in county jail

IntroductionThe overdose epidemic in the United States has intensified following the introduction of illicitly manufactured fentanyl to drug markets with recent estimates indicating 110,000 deaths in 2022 and longer-term trends adversely impacting national life expectancy. A period of incarceration has been identified as a critical touchpoint for overdose prevention given its strong association with risk of overdose. In this paper we describe efforts funded by the Centers for Disease Control and Prevention (CDC) Overdose Data to Action (OD2A) grant to design and implement naloxone vending machines that provide free naloxone within county jails to returning citizens and those visiting county jail facilities. MethodsThis study utilized three sources of data. First, we describe the results of a pre-implementation survey administered by technical assistance providers to 18 jails across the state of Michigan. Second, among the 6 jail facilities that accepted a naloxone vending machine we examine administrative data from Michigan Department of Health and Human Services on naloxone orders to look at changes 6-months before and after implementation. Third and lastly, we conducted semi-structured interviews (N = 6) with jail administrators (i.e., County Sheriffs) on the barriers and facilitators to implementing a naloxone vending machine. ResultsSix facilities indicated they would accept a vending machine to distribute free naloxone. Overall, the total number of naloxone box orders that were distributed across all jail sites increased by 63.5 % from 4104 boxes pre-naloxone vending machine to 6708 boxes post-naloxone vending machine implementation. Qualitative interviews revealed that prior naloxone distribution efforts and foundational knowledge about opioids, overdose, and naloxone emerged as facilitators for vending machine implementation. ConclusionThis study illustrates the utility of policy-driven funding strategies aimed at mitigating accidental overdose deaths among a high-risk population while building community naloxone saturation efforts.

Expert-Level Detection of Referable Glaucoma from Fundus Photographs in a Safety Net Population: The AI and Teleophthalmology in Los Angeles Initiative.

To develop and test a deep learning (DL) algorithm for detecting referable glaucoma in the Los Angeles County (LAC) Department of Health Services (DHS) teleretinal screening program. Fundus photographs and patient-level labels of referable glaucoma (defined as cup-to-disc ratio [CDR] ≥ 0.6) provided by 21 trained optometrist graders were obtained from the LAC DHS teleretinal screening program. A DL algorithm based on the VGG-19 architecture was trained using patient-level labels generalized to images from both eyes. Area under the receiver operating curve (AUC), sensitivity, and specificity were calculated to assess algorithm performance using an independent test set that was also graded by 13 clinicians with one to 15 years of experience. Algorithm performance was tested using reference labels provided by either LAC DHS optometrists or an expert panel of 3 glaucoma specialists. 12,098 images from 5,616 patients (2,086 referable glaucoma, 3,530 non-glaucoma) were used to train the DL algorithm. In this dataset, mean age was 56.8 ± 10.5 years with 54.8% females and 68.2% Latinos, 8.9% Blacks, 2.7% Caucasians, and 6.0% Asians. 1,000 images from 500 patients (250 referable glaucoma, 250 non-glaucoma) with similar demographics (p ≥ 0.57) were used to test the DL algorithm. Algorithm performance matched or exceeded that of all independent clinician graders in detecting patient-level referable glaucoma based on LAC DHS optometrist (AUC = 0.92) or expert panel (AUC = 0.93) reference labels. Clinician grader sensitivity (range: 0.33-0.99) and specificity (range: 0.68-0.98) ranged widely and did not correlate with years of experience (p ≥ 0.49). Algorithm performance (AUC = 0.93) also matched or exceeded the sensitivity (range: 0.78-1.00) and specificity (range: 0.32-0.87) of 6 LAC DHS optometrists in the subsets of the test dataset they graded based on expert panel reference labels. A DL algorithm for detecting referable glaucoma developed using patient-level data provided by trained LAC DHS optometrists approximates or exceeds performance by ophthalmologists and optometrists, who exhibit variable sensitivity and specificity unrelated to experience level. Implementation of this algorithm in screening workflows could help reallocate eye care resources and provide more reproducible and timely glaucoma care.

WHEN PHYSICIAN SUPPLY DOES NOT MEET PATIENT DEMAND: A LOOMING EPIDEMIC IN VASCULAR AND RENAL CARE FOR A COMMUNITY WITH THE HIGHEST INCIDENCE OF END-STAGE RENAL DISEASE IN THE UNITED STATES.

South Texas and the Rio Grande Valley (RGV) are medically underserved-communities near the Texas-Mexico border with the highest incidence of end-stage renal disease (ESRD) in the nation, and a shortage of available full-time equivalent (FTE) specialty-physicians. Data on the incidence/prevalence of ESRD and workforce projections on vascular-surgeons and nephrologists were collected from the United States Renal Data System and Texas Department of State Health Services. We then merged data from both datasets to identify population-specific healthcare-trends. Texas had the highest rates of ESRD from 2016 to 2020, with its border regions leading the state. By 2032, vascular-surgery and nephrology are projected to have the 1st and 4th worst physician-shortages in the state respectively, with the percentage of these FTE specialty-physicians available to meet the need of the RGV ranging from 42.3 to 58.4​%. The RGV is experiencing increased rates of ESRD, while having a paradoxical-decline in specialty-physicians available to provide adequate care.

Discontinued Maternal Health Care Utilization in Bhojpur District, Nepal

Why all pregnant women did not receive all care at antenatal period; those who did not even utilize any ANC visit may also prefer to utilize facility-based delivery or postnatal care related queries are rarely available in several rounds of NDHS data set. A study conducted in Tarai region of Nepal, analysis of Nepal demographic and health surveys of several rounds, Annual Health Report 2077/78 published by the Department of health services, Ministry of health and population were taken into study. A qualitative study designed in 2014-15 from the women of reproductive health having children of 2-23 months were asked their discontinuation, if any. Maternal health service utilization through national and the district level data were analysed to study about the discontinuation in utilization.Several factors are identified as the cause for discontinuation in the Tarai region of Nepal. Data revealed by department of health services for the fiscal year 2077-78 show discontinued maternal health service utilization (MHSU) in Bhojpur district. The NDHS 2022 report still found some level of discontinuation in national level. Therefore, urgent need of qualitative study is a most for Bhojpur district which has low level of utilization. In the new administrative set-up according to constitution of Nepal, effective functional policy adopted by municipal region may solve several issues of maternal health. Hilly regions could have different response than Tarai region of Nepal. Therefore, local bodies of hilly regions should bring maternal health policy and program to achieve continuum of maternal health care which will ultimately help Nepal to achieve SDG related goal and target.

Principles of Interoperability of Diabetes Devices.

Better interoperability is essential to derive maximum benefit from connected wireless diabetes devices. The need for this feature of diabetes devices is supported by trends in designing better performance for three types of devices: nonmedical devices, medical devices, and diabetes devices. First, interoperability is a standard attribute for the performance of nonmedical devices contained in smart systems that can sense and actuate. Second, interoperability is now mandated by the US Department of Health and Human Services as carried out by the Office of the National Coordinator for Health Information technology (ONC) and the US Food and Drug Administration (FDA) to improve the performance of all medical devices. Third, new guidance from the FDA and nongovernmental professional organizations are intended to promote interoperability because this feature will improve the performance of all diabetes devices. Wireless devices perform best when they are interoperable, and this is particularly true for diabetes devices.

Short-term associations between precipitation and gastrointestinal illness-related hospital admissions: A multi-city study in Texas

The ongoing climate change crisis presents challenges to the global public health system. The risk of gastrointestinal illness (GI) related hospitalization increases following extreme weather events but is largely under-reported and under-investigated. This study assessed the association between precipitation and GI-related hospital admissions in four major cities in Texas. Daily data on GI-related hospital admissions and precipitation from 2004 to 2014 were captured from the Texas Department of State Health Services and the National Climate Data Center. Distributed lagged nonlinear modeling approaches were employed to examine the association between precipitation and GI-related hospital admissions. Results showed that the cumulative risk ratios (RRs) of GI-related hospital admissions were elevated in the 2 weeks following precipitation events; however, there were differences observed across study locations. The cumulative RR of GI-related hospitalizations was significantly higher when the amount of daily precipitation ranged from 3.3 mm to 13.5 mm in Dallas and from 6.0 mm to 24.5 mm in Houston. Yet, substantial increases in the cumulative RRs of GI-related hospitalizations were not observed in Austin or San Antonio. Age-specific and cause-specific GI-related hospitalizations were also found to be associated with precipitation events following the same pattern. Among them, Houston depicted the largest RR for overall GI and subgroup GI by age and cause, particularly for the overall GI among children aged 6 and under (RR = 1.35; 95 % CI = 1.11, 1.63), diarrhea-caused GI among children aged 6 and under (RR = 1.38, 95 % CI = 1.13, 1.69), and other-caused GI among children age 6 and under (RR = 1.46; 95 % CI = 1.12, 1.80). The findings underscore the need for public health interventions and adaptation strategies to address climate change-related health outcomes such as GI illness associated with extreme precipitation events.

Impact of internal standard selection on measurement results for long chain fatty acids in blood

IntroductionInternal standards correct for measurement variation due to sample loss. Isotope labeled analytes are ideal internal standards for the measurement of fatty acids in human plasma but are not always readily available. For this reason, quantification of multiple analytes at once is most often done using only a single or few internal standards. The magnitude of the impact this has on method accuracy and precision is not well studied for gas chromatography-mass spectrometry systems. ObjectiveThis study aims to estimate bias and changes in uncertainty associated with using alternative fatty acid isotopologue internal standards for the estimation of similar or dissimilar long chain fatty acids. MethodUsing a previously reported method for the quantification of 27 fatty acids in human plasma using 18 internal standards we obtained estimates of bias and uncertainty at up to three levels of fatty acid concentration. ResultsWith some notable exceptions, method accuracy remained relatively stable when using an alternative internal standard (Median Relative Absolute Percent Bias: 1.76%, Median Spike-Recovery Absolute Percent Bias: 8.82%), with larger changes in method precision (Median Increase in Variance: 141%). Additionally, the degree of difference between analyte and internal standard structure was related to the magnitude of bias and uncertainty of the measurement. ConclusionThe data presented here show that the choice of internal standard used to estimate fatty acid concentration can affect the accuracy and reliability of measurement results and, therefore, needs to be assessed carefully when developing analytical methods for the measurement of fatty acid profiles.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.

Evaluating Quality of Cancer Care in Delaware using Commission on Cancer (CoC) Quality Measures, 2018-2019.

American College of Surgeons Commission on Cancer (CoC) quality measures are used to monitor and evaluate metrics among their CoC-accredited programs, which include seven of Delaware's hospitals. The Delaware Department of Health and Social Services, Division of Public Health (DPH) also utilizes these metrics to monitor and evaluate Delaware's overall performance on these standards of care as it relates to the health care provided to cancer patients. Delaware Cancer Registry (DCR) cases diagnosed in 2018 and 2019 were selected and were analyzed separately to calculate results for each selected measure by year: HT, nBX, LNoSurg, and RECRTCT. Results of the analysis showed that three out of the four CoC quality measures evaluated met the CoC standard of care for both 2018 and 2019 data. The three measures that met the CoC standards for 2018 were HT (90.4%), nBX (87.6%), and LNoSurg (93.3%). The RECRTCT measure did not meet the CoC standard for 2018 data with 71.4%. All four measures evaluated met the CoC standards for 2019 (HT - 91.6%; nBX - 85.2%; LNoSurg - 92.7%; RECRTCT - 92.3%). A majority of cases assessed met the CoC quality measure standards, meeting standards of cancer care and treatment. More discovery work needs to be done to assess the RECRTCT metric to explore reasons why cases did not meet the CoC quality measure standards. There was notable improvement seen for the HT measure over time, where cases had not met the CoC standard in previous years. When CoC quality measures are met, medical providers can ensure patients receive effective and targeted cancer care. This practice ultimately saves resources, reduces cancer burden, impacts survival, and improves public health outcomes.

Pediatric surgical border health: Supply may not be meeting demand in South Texas communities

IntroductionThe Rio Grande Valley (RGV) has historically high incidence of congenital defects (CDs) necessitating intervention by pediatric surgical specialties. We examined mortality in this region and related workforce patterns. MethodsMortality data related to CDs (2007–2021) and surgical workforce trends/projections (2024–2032) were collected using multiple databases: National Vital Statistics System, Texas Department of State Health Services, Texas Medical Board, Center for Disease Control. ResultsNationally, RGV counties rank as high as 5th in CD mortality rates. Between 2020 and 2024, 3 of 4 studied pediatric surgical specialties experienced stagnant/decreasing workforces ranging from 0 to 66 ​%. Furthermore, the RGV is projected to have some of the most marked state-wide disparities in surgical providers over the next 8 years. ConclusionHigh infant mortality rates along with ongoing and future shortages of surgical specialists is concerning. These results may inform allocation of public health resources and workforce distribution to improve outcomes.

Knowledge mapping of macrophage and its role in aneurysm from 1999 to 2022: A bibliometric analysis

BackgroundVarious factors play crucial roles in aneurysm development and prognosis. Macrophages have recently emerged as a major research focus. Despite the numerous studies on the role and function of macrophages in aneurysm pathogenesis, no bibliometric analyses have focused on this topic. ObjectiveThis study aimed to analyze articles related to macrophages and aneurysms to reveal trends, hotspots, and new frontiers in macrophage-related aneurysm research. MethodsWe retrieved and incorporated 1211 articles from the Science Citation Index Expanded database of the Web of Science Core Collection between 1999 and 2022. The data were analyzed and visualized using CiteSpace and VOSviewer, and Microsoft Excel 2019 was used to plot the data. ResultsThe most influential articles were published between 1999 and 2022, with a total citation count of 43870. This study encompassed a comprehensive analysis of 74 research directions. The year with the highest number of publications was 2021 when 109 articles were published. 'ARTERIOSCLEROSIS THROMBOSIS AND VASCULAR BIOLOGY' journal has made significant contributions by publishing the highest number of articles (99 articles), while funding support primarily came from the National Institutes of Health and United States Department of Health and Human Services. The United States exerted a substantial influence within this field, with a total publication count of 453 publications and the highest centrality value (0.63). Recent studies have focused on understanding the developmental processes underlying aneurysms and devising preventive measures to effectively impede disease progression. ConclusionsOur analysis demonstrates the rapid growth in research exploring the relationship between macrophages and aneurysms over the past two decades. Continued exploration and collaboration among different specialties and manufacturers will facilitate innovative approaches for effective management strategies that target patients with diverse forms of aneurysms.

Liberal policies does not mean equitable policies: Latinx families' experiences navigating social policies in Oregon and California.

The United States government has implemented various social policies (e.g., Medicare) to support children and families (U.S. Department of Health and Human Services, 2023). An emerging body of research seems to indicate that many of these programs are being underutilized by Latinx families even though they are sorely needed. Latinx families are often framed as undeserving, taking advantage of social policies, and as a criminal threat to the United States (Baranauskas & Stowell, 2022). Drawing on cultural stress theory (Salas-Wright & Schwartz, 2019), the present study explores how the deficit framing of Latinx families influences how they navigate social policies. This study draws on data from four qualitative projects across Oregon and California that explored the experiences of Latinx families accessing services to support their families. Findings indicate that Latinx families experience multiple stressors when navigating social policies or programs (e.g., shame/fear and racism) for their families. These stressors discourage Latinx families from accessing social programs, which exacerbates disparities in the health, development, and learning of Latinx children and families. Findings from this study can further inform advocacy efforts to create meaningful systemic changes that reduce inequities and call out discrimination/racism within our policy system. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

A Comprehensive Framework for Evaluating the Value Created by Real-World Evidence for Diverse Stakeholders: The Case for Coordinated Registry Networks.

This manuscript presents a comprehensive framework for the assessment of the value of real-world evidence (RWE) in healthcare decision-making. While RWE has been proposed to overcome some limitations of traditional, one-off studies, no systematic framework exists to measure if RWE actually lowers the burden. This framework aims to fill that gap by providing conceptual approaches for evaluating the time and cost efficiencies of RWE, thus guiding strategic investments in RWE infrastructure. The framework consists of four components: (114th Congress. 21st Century Cures Act.; 2015. https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf .) identification of stakeholders using and producing RWE, (National Health Council. Glossary of Patient Engagement Terms. Published 2019. Accessed May 18. 2021. https://nationalhealthcouncil.org/glossary-of-patient-engagement-terms/ .) understanding value propositions on how RWE can benefit stakeholders, (Center for Drug Evaluation and Research. CDER Patient-Focused Drug Development. U.S. Food & Drug Administration.) defining key performance indicators (KPIs), and (U.S. Department of Health and Human Services - Food and Drug Administration: Center for Devices and Radiological Health and Center for Biologics Evaluation and Research. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff. 2017. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida .) establishing metrics and case studies to assess value. KPIs are categorized as 'better, faster, or cheaper" as an indicator of value: better focusing on high-quality actionable evidence; 'faster,' denoting time-saving in evidence generation, and 'cheaper,' emphasizing cost-efficiency decision compared to methodologies that do not involve data routinely collected in clinical practice. Metrics and relevant case studies are tailored based on stakeholder value propositions and selected KPIs that can be used to assess what value has been created by using RWE compared to traditional evidence-generation approaches and comparing different RWE sources. Operationalized through metrics and case studies drawn from the literature, the value of RWE is documented as improving treatment effect heterogeneity evaluation, expanding medical product labels, and expediting post-market compliance. RWE is also shown to reduce the cost and time required to produce evidence compared to traditional one-off approaches. An original example of a metric that measures the time saved by RWE methods to detect a signal of a product failure was presented based on analysis of the National Cardiovascular Disease Registry. The framework presented in this manuscript offers a comprehensive approach for evaluating the value of RWE, applicable to all stakeholders engaged in leveraging RWE for healthcare decision-making. Through the proposed metrics and illustrated case studies, valuable insights are provided into the heightened efficiency, cost-effectiveness, and improved decision-making within clinical and regulatory domains facilitated by RWE. While this framework is primarily focused on medical devices, it could potentially inform the determination of RWE value in other medical products. By discerning the variations in cost, time, and data utility among various evidence-generation methods, stakeholders are empowered to invest strategically in RWE infrastructure and shape future research endeavors.

Rapid initiation of bictegravir/emtricitabine/tenofovir alafenamide as first-line therapy in HIV infection. A prospective study.

Rapid initiation of ART after HIV diagnosis is recommended for individual and public health benefits. However, certain clinical and ART-related considerations hinder immediate initiation of therapy. An open-label, single-arm, single-centre 48-week prospective clinical trial involving ART-naïve HIV-diagnosed adults who started bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) within a week from the first hospital visit, before the availability of baseline laboratory and genotype results. The primary aim was to determine the proportion of people with at least one condition that would hinder immediate initiation of any recommended ART regimen other than BIC/FTC/TAF. Clinicaltrials.gov: NCT04416906. We included 100 participants: 79% men, 64% from Latin America, median age 32 years. According to European AIDS Clinical Society (EACS) and US Department of Health and Human Services 2023 guidelines, 11% (95%CI 6; 19) of participants had at least one condition that made any ART different from BIC/FTC/TAF less appropriate for a rapid ART strategy. Seventy-nine percent of the people started BIC/FTC/TAF within the first 48 hours of their first hospital visit. There were 16 early discontinuations (11 lost to follow-up). By week 48, 92% (95%CI 86; 98) of the participants of the ITT population with observed data achieved viral suppression. Eight grade 3-4 adverse events (AEs), five serious AEs and six ART-related AEs were identified. Adherence remained high. BIC/FTC/TAF is an optimal treatment for rapid initiation of ART. However, additional strategies to improve retention in care must be implemented.

Safety and durability of mRNA-1273–induced SARS-CoV-2 immune responses in adolescents: results from the phase 2/3 TeenCOVE trial

Longitudinal changes in vaccination-induced immune response remain inadequately characterized in adolescents. We present long-term safety, immunogenicity, and COVID-19 incidence following a 2-dose mRNA-1273100-μg primary series, and immunogenicity following a single dose of mRNA-1273 50 μg in vaccine-naïve adolescents. TeenCOVE (NCT04649151) Part 1 randomized adolescents (12-17 years) to 2-dose mRNA-1273100 μg (n=2490) or placebo (n=1243) 28 days apart. Subsequently, placebo recipients (n=91) could receive open-label mRNA-1273. Primary objectives included prespecified adverse events through 12 months; secondary objectives were COVID-19 incidence and neutralizing and spike-binding antibodies (nAbs/bAbs) against SARS-CoV-2 (ancestral/variants) through 12 months (study period: December 2020-January 2022). In Part 2, vaccine-naïve adolescents (n=52) received up to 2 doses of mRNA-1273 50 μg; interim analysis included Day 28 (D28) nAbs post-injection 1 in SARS-CoV-2-baseline-positive participants (serologic/virologic evidence of prior infection). In SARS-CoV-2-baseline-negative adolescents (N=369), mRNA-1273 induced robust nAb responses versus baseline (geometric mean concentration [GMC]=11; 95% CI, 11-12) at D28 (1868 [1759-1985]), 6 months (625 [583-670]) and 12 months (550 [490-618]) post-injection 2. Similar bAb responses were observed to alpha/beta/delta/gamma variants; nAb/bAb responses were similar in SARS-CoV-2-baseline-positive adolescents. The 2-dose mRNA-1273100-μg primary series was generally well-tolerated; one case of nonserious, moderate, probable acute myocarditis resolved by 8 days from symptom onset. A single dose of mRNA-1273 50 μg in SARS-CoV-2-baseline-positive adolescents induced higher D28 nAb GMCs against ancestral SARS-CoV-2 than 2-dose mRNA-1273100μg in young adults (geometric mean ratio=4.322 [3.274-5.707]). The overall risk-benefit profile of mRNA-1273 remains favorable in adolescents, with durable 12-month immune responses against SARS-CoV-2 (ancestral/variants). A single mRNA-1273 50-μg injection in vaccine-naïve adolescents elicited robust immune responses against SARS-CoV-2. This project has been funded in whole or in part with federal funds by the Department of Health and Human Services, United States; Administration for Strategic Preparedness and Response, United States; Biomedical Advanced Research and Development Authority, United States, under Contract No. 75A50120C00034. The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the Department of Health and Human Services or its components.

Understanding the Regulatory Pathways Used to Develop, Evaluate, Authorize, and Approve New Drugs and Vaccines in the United States.

The United States (U.S.) Food and Drug Administration (FDA) oversees the safety and quality of drugs and vaccines that are used in the U.S. Administration of the FDA falls under the jurisdiction of the U.S. Department of Health and Human Services (HHS). The regulatory oversight of the FDA is complex and comprehensive, requiring the various roles and responsibilities to be divided across six main centers. The activities of two of these centers, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are the primary focus of this review.