PURPOSE: To estimate the number of screenings received, life-years (LYs) saved, and number of screenings per LY saved per woman who participated in the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) (Program) compared with those who did not participate (no Program). METHODS: We developed a time-to-event simulation model to compare the outcomes of women participating in the Program vs. no Program, categorized by race/ethnicity. Model input parameters included data from the Program's minimum data elements, United States Cancer Statistics, National Health Interview Survey, and published literature. The Program's impact was calculated as the difference in LYs between the Program and no Program using data from 2010 to 2019. RESULTS: Among 1 million women of all races/ethnicities who participated in the NBCCEDP in the last 10 years, 457,152 (standard deviation [SD]: 848) received more screenings than those who did not participate. These participants saved an average of 0.027 LYs per woman screened. In addition, we estimated that about 17 screenings would be required to save an additional 1 LY per woman screened in the Program compared with no Program. Per woman screened by race/ethnicity, non-Hispanic Black women had the highest estimated 0.075 LYs saved, followed by Hispanic women with 0.025 LYs, non-Hispanic White with 0.014 LYs, and non-Hispanic American Indian/Alaska Native and Asian/Pacific Islander had the least health outcome with 0.011 LYs. CONCLUSION: The reported findings underscore the importance of providing preventive health services to populations that might not otherwise have access to these services.

Racial misclassification on death certificates leads to inaccurate mortality data for American Indian and Alaska Native (AI/AN) populations. We describe methods for correcting for racial misclassification among non-Hispanic AI/AN (NH-AI/AN) populations using data from the year 2020. We linked National Death Index (NDI) records with the Indian Health Service (IHS) patient registration database to identify AI/AN decedents. Matches were then linked to the National Vital Statistics System (NVSS) mortality data to identify AI/AN individuals that had been misclassified as another race on their death certificates. Analyses were limited to NH-AI/AN and purchased/referred care delivery areas (PRCDA) or urban areas. We compared death rates and counts pre- and post- linkage and calculated sensitivity and classification ratios by region, sex, age, cause of death (COD) and urban area. Racial misclassification on death certificates among NH-AI/AN varied by geographic region. Some of the highest racial misclassification occurred in the Southern Plains and Pacific Coast. Death rates for NH-AI/AN people and differences between NH-AI/AN and Non-Hispanic White (NHW) people were larger using the linked data. Improving AI/AN mortality data using linkages between vital statistics data and IHS strengthens data quality and can help address health disparities through public health planning efforts.

IMPORTANCE: The oral microbiome likely plays key roles in human health. Yet, population-representative characterizations are lacking. OBJECTIVE: To characterize the composition, diversity, and correlates of the oral microbiome in US adults. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study analyzed data from the population-representative National Health and Nutrition Examination Survey (NHANES) from 2009 to 2012. Microbiome data were made publicly available in 2024. NHANES participants were aged 18 to 69 years and provided oral rinse samples in 1 of 2 consecutive NHANES cycles (2009-2010 and 2011-2012). EXPOSURES: Demographic, socioeconomic, behavioral, anthropometric, metabolic, and clinical characteristics. MAIN OUTCOMES AND MEASURES: Oral microbiome measures, characterized through 16S ribosomal RNA gene sequencing, included α diversity (observed amplicon sequence variants [ASVs], Faith phylogenetic diversity, Shannon-Weiner Index, and Simpson Index); β diversity (unweighted UniFrac, weighted UniFrac, and Bray-Curtis dissimilarity); and prevalence and relative abundance at phylum level through genus level. Analyses accounted for the NHANES complex sample design. RESULTS: This study included 8237 US adults aged 18 to 69 years, representing 202 314 000 individuals (102 813 000 men [50.8%]; mean [SD] age, 42.3 [14.4] years; 9.3% self-reported as Mexican American, 12.1% as non-Hispanic Black, 64.7% as non-Hispanic White, 5.9% as other Hispanic, and 8.1% as other non-Hispanic individuals). The oral microbiome encompassed 37 bacterial phyla, 99 classes, 212 orders, 446 families, and 1219 genera. Five phyla (Firmicutes, Actinobacteria, Bacteroidetes, Proteobacteria, and Fusobacteria) and 6 genera (Veillonella, Streptococcus, Prevotella 7, Rothia, Actinomyces, and Gemella) were present in nearly all US adults (weighted prevalence, >99%). These genera were the most abundant, accounting for 65.7% of total abundance. Observed ASVs showed a quadratic pattern with age (peak at 30 years), were similar by sex, significantly lower among non-Hispanic White individuals, and increased with greater body mass index (BMI), alcohol use, and periodontal disease severity. All covariates together accounted for a modest proportion of oral microbiome variability as measured by β diversity: R2 = 8.7% (95% CI, 8.4%-9.1%) for unweighted UniFrac, R2 = 7.2% (95% CI, 6.6%-7.7%) for weighted UniFrac, and R2 = 6.3% (95% CI, 3.1%-6.7%) for Bray-Curtis matrices. By contrast, relative abundance of a few genera explained a high percentage of variability in β diversity for weighted UniFrac: Aggregatibacter (R2 = 22.4%; 95% CI, 22.1%-22.8%), Lactococcus (R2 = 21.6%; 95% CI, 20.9%-22.3%), and Haemophilus (R2 = 18.4%; 95% CI, 18.1%-18.8%). Prevalence and relative abundance of numerous genera were associated with age, race and ethnicity, smoking, BMI categories, alcohol use, and periodontal disease severity. CONCLUSIONS AND RELEVANCE: This cross-sectional study of the oral microbiome in US adults showed that a few genera were universally present and a different set of genera explained a high percentage of oral microbiome diversity across the population. This comprehensive characterization provides a contemporary reference standard for future studies.

Objectives. To characterize the intersection of social determinants of health, measured as the availability of community opportunities for healthy living, and sexually transmitted infections (STIs) in California. Methods. Geocoded 2013-2021 California bacterial STI cases were aggregated into Healthy Places Index (HPI) quartiles. Communities in the lowest scoring HPI quartile have the fewest opportunities for healthy living, while communities in the highest scoring quartile have the most opportunities. Results. As community opportunities became more available, bacterial STI risk decreased. Asian people had the lowest bacterial STI rates, while Black/African American people had the highest. As community opportunities increased, White people had the largest overall STI risk reduction, Native Hawaiian and other Pacific Islander people had the smallest reduction, Hispanic/Latino people had equivalent gonorrhea and early syphilis risk, and American Indian/Alaska Native people had equivalent chlamydia risk. Conclusions. Although STI incidence decreased as community opportunities increased, people of different racial and ethnic identities were differentially affected. Because the availability of community opportunities is not enough to mitigate racial health disparities, more work is needed to ensure community-level STI prevention efforts are accessible and inclusive. (Am J Public Health. 2025;115(5):799-807. https://doi.org/10.2105/AJPH.2024.307963).

BACKGROUND: Split-hand/foot malformation (SHFM) is a rare, genetically heterogeneous, congenital limb defect. Some but not all associated genes are known; therefore, the aim was to identify genes underlying SHFM. METHODS: Buccal cell-derived DNA from 26 children with SHFM and their parents who participated in the National Birth Defects Prevention Study was exome sequenced. Family-based trio analyzes prioritized rare coding variants by inheritance patterns, predicted pathogenicity, and location within putative limb development genes. Copy-number variants in SHFM candidate genomic regions were also examined. Case-control analyzes compared coding variants between case children and 1191 controls (parents of children with non-limb birth defects). Variant validation was by Sanger sequencing or droplet digital polymerase chain reaction. RESULTS: In family-based analyzes, the prioritized and validated variants (each in a single family) included likely damaging variants that were heterozygous and de novo in speckle type BTB/POZ protein (SPOP) and ubiquitin-like modifier activating enzyme 2 (UBA2), X-linked recessive in fibroblast growth factor 13 (FGF13) and RNA binding motif protein 10 (RBM10), and compound heterozygous in interleukin enhancer binding factor 3 (ILF3). Validation assays did not confirm predicted de novo copy-number gains at chromosomes 10q24 and 19p13.11. Case-control analyzes did not identify statistically significant associations. CONCLUSION: Exome analysis nominated new susceptibility genes (FGF13, ILF3, RBM10, SPOP) and detected a variant in a known candidate gene (UBA2). Follow-up investigation is needed to ascertain damaging variants in these genes in additional cases with SHFM and evaluate the impact of the variants on gene expression, protein function, and limb development.

The protocol of a randomized trial is the foundation for study planning, conduct, reporting and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. Here, we aimed to systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomized trial. We completed a scoping review and developed a project-specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting. Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct and reporting. The updated SPIRIT 2025 statement consists of an evidence-based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrollment, interventions and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators and other reviewers.

IMPORTANCE: The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. OBJECTIVE: To systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial. DESIGN: We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting. FINDINGS: Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrolment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. CONCLUSIONS AND RELEVANCE: Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators, and other reviewers.

IMPORTANCE: The protocol of a randomized trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. Herein, we systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomized trial. OBSERVATIONS: We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (harms, outcomes, nonpharmacological treatment) and other reporting guidelines (Template for Intervention Description and Replication [TIDieR]). The potential modifications were rated in a 3-round Delphi survey followed by a consensus meeting. Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of 2 new protocol items, revision to 5 items, deletion/merger of 5 items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open-science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrollment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. CONCLUSIONS AND RELEVANCE: Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policy makers, regulators, and other reviewers.

IMPORTANCE: The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. OBJECTIVE: To systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial. DESIGN: We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting. FINDINGS: Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence-based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrolment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. CONCLUSIONS AND RELEVANCE: Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators, and other reviewers.

BACKGROUND: Well designed and properly executed randomised trials are considered the most reliable evidence on the benefits of healthcare interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Here, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users. METHODS: We conducted a scoping review of the literature and developed a project-specific database of empirical and theoretical evidence related to CONSORT, to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (Harms, Outcomes, Non-pharmacological Treatment), other related reporting guidelines (TIDieR) and recommendations from other sources (e.g., personal communications). The list of potential changes to the checklist was assessed in a large, international, online, three-round Delphi survey involving 317 participants and discussed at a two-day online expert consensus meeting of 30 invited international experts. RESULTS: We have made substantive changes to the CONSORT checklist. We added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomised trial and a diagram for documenting the flow of participants through the trial. To facilitate implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item. CONCLUSIONS: Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomised trials to ensure that trial reports are clear and transparent.

PROBLEM/CONDITION: Autism spectrum disorder (ASD). PERIOD COVERED: 2022. DESCRIPTION OF SYSTEM: The Autism and Developmental Disabilities Monitoring Network is an active surveillance program that estimates prevalence and characteristics of ASD and monitors timing of ASD identification among children aged 4 and 8 years. In 2022, a total of 16 sites (located in Arizona, Arkansas, California, Georgia, Indiana, Maryland, Minnesota, Missouri, New Jersey, Pennsylvania, Puerto Rico, Tennessee, Texas [two sites: Austin and Laredo], Utah, and Wisconsin) conducted surveillance for ASD among children aged 4 and 8 years and suspected ASD among children aged 4 years. Surveillance included children who lived in the surveillance area at any time during 2022. Children were classified as having ASD if they ever received 1) an ASD diagnostic statement in a comprehensive developmental evaluation, 2) autism special education eligibility, or 3) an ASD International Classification of Diseases, Ninth Revision (ICD-9) code in the 299 range or International Classification of Diseases, Tenth Revision (ICD-10) code of F84.0, F84.3, F84.5, F84.8, or F84.9. Children aged 4 years were classified as having suspected ASD if they did not meet the case definition for ASD but had an evaluator's suspicion of ASD documented in a comprehensive developmental evaluation. RESULTS: Among children aged 8 years in 2022, ASD prevalence was 32.2 per 1,000 children (one in 31) across the 16 sites, ranging from 9.7 in Texas (Laredo) to 53.1 in California. The overall observed prevalence estimate was similar to estimates calculated using Bayesian hierarchical and random effects models. ASD was 3.4 times as prevalent among boys (49.2) than girls (14.3). Overall, ASD prevalence was lower among non-Hispanic White (White) children (27.7) than among Asian or Pacific Islander (A/PI) (38.2), American Indian or Alaska Native (AI/AN) (37.5), non-Hispanic Black or African American (Black) (36.6), Hispanic or Latino (Hispanic) (33.0), and multiracial children (31.9). No association was observed between ASD prevalence and neighborhood median household income (MHI) at 11 sites; higher ASD prevalence was associated with lower neighborhood MHI at five sites.Record abstraction was completed for 15 of the 16 sites for 8,613 children aged 8 years who met the ASD case definition. Of these 8,613 children, 68.4% had a documented diagnostic statement of ASD, 67.3% had a documented autism special education eligibility, and 68.9% had a documented ASD ICD-9 or ICD-10 code. All three elements of the ASD case definition were present for 34.6% of children aged 8 years with ASD.Among 5,292 (61.4% of 8,613) children aged 8 years with ASD with information on cognitive ability, 39.6% were classified as having an intellectual disability. Intellectual disability was present among 52.8% of Black, 50.0% of AI/AN, 43.9% of A/PI, 38.8% of Hispanic, 32.7% of White, and 31.2% of multiracial children with ASD. The median age of earliest known ASD diagnosis was 47 months and ranged from 36 months in California to 69.5 months in Texas (Laredo).Cumulative incidence of ASD diagnosis or eligibility by age 48 months was higher among children born in 2018 (aged 4 years in 2022) than children born in 2014 (aged 8 years in 2022) at 13 of the 15 sites that were able to abstract records. Overall cumulative incidence of ASD diagnosis or eligibility by age 48 months was 1.7 times as high among those born in 2018 compared with those born in 2014 and ranged from 1.4 times as high in Arizona and Georgia to 3.1 times as high in Puerto Rico. Among children aged 4 years, for every 10 children meeting the case definition of ASD, one child met the definition of suspected ASD.Children with ASD who were born in 2018 had more evaluations and identification during ages 0-4 years than children with ASD who were born in 2014 during the 0-4 years age window, with an interruption in the pattern in early 2020 coinciding with onset of the COVID-19 pandemic.Overall, 66.5% of children aged 8 years with ASD had a documented autism test. Use of autism tests varied widely across sites: 24.7% (New Jersey) to 93.5% (Puerto Rico) of children aged 8 years with ASD had a documented autism test in their records. The most common tests documented for children aged 8 years were the Autism Diagnostic Observation Schedule, Autism Spectrum Rating Scales, Childhood Autism Rating Scale, Gilliam Autism Rating Scale, and Social Responsiveness Scale. INTERPRETATION: Prevalence of ASD among children aged 8 years was higher in 2022 than previous years. ASD prevalence was higher among A/PI, Black, and Hispanic children aged 8 years than White children aged 8 years, continuing a pattern first observed in 2020. A/PI, Black, and Hispanic children aged 8 years with ASD were also more likely than White or multiracial children with ASD to have a co-occurring intellectual disability. Identification by age 48 months was higher among children born in 2018 compared with children born in 2014, suggesting increased early identification consistent with historical patterns. PUBLIC HEALTH ACTION: Increased identification of autism, particularly among very young children and previously underidentified groups, underscores the increased demand and ongoing need for enhanced planning to provide equitable diagnostic, treatment, and support services for all children with ASD. The substantial variability in ASD identification across sites suggests opportunities to identify and implement successful strategies and practices in communities to ensure all children with ASD reach their potential.

Leptospirosis (caused by pathogenic bacteria in the genus Leptospira) is prevalent worldwide but more common in tropical and subtropical regions. Transmission can occur following direct exposure to infected urine from reservoir hosts, or a urine-contaminated environment, which then can serve as an infection source for additional rats and other mammals, including humans. The brown rat, Rattus norvegicus, is an important reservoir of Leptospira spp. in urban settings. We investigated the presence of Leptospira spp. among brown rats in Boston, Massachusetts and hypothesized that rat population dynamics in this urban setting influence the transportation, persistence, and diversity of Leptospira spp. We analyzed DNA from 328 rat kidney samples collected from 17 sites in Boston over a seven-year period (2016-2022); 59 rats representing 12 of 17 sites were positive for Leptospira spp. We used 21 neutral microsatellite loci to genotype 311 rats and utilized the resulting data to investigate genetic connectivity among sampling sites. We generated whole genome sequences for 28 Leptospira spp. isolates obtained from frozen and fresh tissue from some of the 59 positive rat kidneys. When isolates were not obtained, we attempted genomic DNA capture and enrichment, which yielded 14 additional Leptospira spp. genomes from rats. We also generated an enriched Leptospira spp. genome from a 2018 human case in Boston. We found evidence of high genetic structure among rat populations that is likely influenced by major roads and/or other dispersal barriers, resulting in distinct rat population groups within the city; at certain sites these groups persisted for multiple years. We identified multiple distinct phylogenetic clades of L. interrogans among rats that were tightly linked to distinct rat populations. This pattern suggests L. interrogans persists in local rat populations and its transportation is influenced by rat population dynamics. Finally, our genomic analyses of the Leptospira spp. detected in the 2018 human leptospirosis case in Boston suggests a link to rats as the source. These findings will be useful for guiding rat control and human leptospirosis mitigation efforts in this and other similar urban settings.

Critical appraisal of the quality of randomised trials is possible only if their design, conduct, analysis, and results are completely and accurately reported. Without transparent reporting of the methods and results, readers will not be able to fully evaluate the reliability and validity of trial findings. The CONSORT (Consolidated Standards of Reporting Trials) statement aims to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomised trial. CONSORT was first published in 1996 and was updated in 2001 and 2010. CONSORT comprises a checklist of essential items that should be included in reports of randomised trials and a diagram for documenting the flow of participants through a trial. The CONSORT statement has been updated (CONSORT 2025) to reflect recent methodological advancements and feedback from end users, ensuring that it remains fit for purpose. Here, we present the updated CONSORT explanation and elaboration document, which has been extensively revised and describes the rationale and scientific background for each CONSORT 2025 checklist item and provides published examples of good reporting. The objective is to enhance the use, understanding, and dissemination of CONSORT 2025 and provide guidance to authors about how to improve the reporting of their trials and ensure trial reports are complete, and transparent.

IMPORTANCE: Well-designed and properly executed randomized trials are considered the most reliable evidence on the benefits of health care interventions. However, there is overwhelming evidence that the quality of reporting is not optimal. The CONSORT (Consolidated Standards of Reporting Trials) statement was designed to improve the quality of reporting and provides a minimum set of items to be included in a report of a randomized trial. CONSORT was first published in 1996, then updated in 2001 and 2010. Herein, we present the updated CONSORT 2025 statement, which aims to account for recent methodological advancements and feedback from end users. OBSERVATIONS: We conducted a scoping review of the literature and developed a project-specific database of empirical and theoretical evidence related to CONSORT to generate a list of potential changes to the checklist. The list was enriched with recommendations provided by the lead authors of existing CONSORT extensions (harms, outcomes, nonpharmacological treatment), other related reporting guidelines (Template for Intervention Description and Replication [TIDieR]), and recommendations from other sources (eg, personal communications). The list of potential changes to the checklist was assessed in a large, international, online, 3-round Delphi survey involving 317 participants and discussed at a 2-day online expert consensus meeting of 30 invited international experts. We have made substantive changes to the CONSORT checklist. We added 7 new checklist items, revised 3 items, deleted 1 item, and integrated several items from key CONSORT extensions. We also restructured the CONSORT checklist, with a new section on open science. The CONSORT 2025 statement consists of a 30-item checklist of essential items that should be included when reporting the results of a randomized trial and a diagram for documenting the flow of participants through the trial. To facilitate implementation of CONSORT 2025, we have also developed an expanded version of the CONSORT 2025 checklist, with bullet points eliciting critical elements of each item. CONCLUSIONS AND RELEVANCE: Authors, editors, reviewers, and other potential users should use CONSORT 2025 when writing and evaluating manuscripts of randomized trials to ensure that trial reports are clear and transparent.

BACKGROUND: Since 2013, national trends in behavioral factors that increase STI risk among adolescent and young adult (A/YA) females have been mixed (e.g., fewer sex partners, lower condom use). We used data from a national sample of A/YA females to examine racial disparities in CT prevalence considering these trends. METHODS: Using 2011-March 2020 National Health and Nutrition Examination Survey data, we estimated the prevalence, unadjusted and adjusted prevalence ratios (APRs) of a positive CT urine test among sexually experienced non-Hispanic Black (Black), Hispanic, non-Hispanic Other race (NHO), and non-Hispanic White (White) A/YA females. Percentages were categorized by race/ethnicity, and each compared to the average of the other race/ethnic groups (e.g., Black vs. Hispanic, NHO and White). Covariates included age group, health insurance coverage, number of sex partners and condom use (both past year). RESULTS: Overall, the prevalence of CT infection among A/YA females was 5.8% (95% CI: 4.5%-7.3%). CT prevalence was higher among Black females (vs. Hispanic, NHO, and White) (11.7%; 95%CI: 8.7%-15.2%) and lower among White females (vs. Black, Hispanic, and NHO) (3.2%; 95%CI: 1.7%-5.5%). Compared with the average CT prevalence for Hispanic, NHO, and White females, Black females had a higher adjusted CT prevalence (APR: 2.48, 95%CI: 1.63-3.75). CONCLUSIONS: Nationally, CT prevalence was 2.5 times as high among Black A/YA females than the average prevalence for Hispanic, NHO, and White females. Inclusion of behavioral STI risk factors did not attenuate this association. Research incorporating sexual network-level factors associated with CT transmission may provide additional insights.

IMPORTANCE: Invasive group A Streptococcus (GAS) infections are associated with substantial morbidity, mortality, and economic burden. OBJECTIVE: To update trends in invasive GAS disease incidence rates in 10 US states between 2013 and 2022. DESIGN, SETTING, AND PARTICIPANTS: Clinical, demographic, and laboratory data for invasive GAS cases were collected as part of population-based surveillance in the Active Bacterial Core surveillance network covering 34.9 million persons across 10 US states. A case was defined as isolation of GAS from a normally sterile site or from a wound in a patient with necrotizing fasciitis or streptococcal toxic shock syndrome between January 1, 2013, and December 31, 2022. Demographic and clinical data were collected from medical record review. From 2013 to 2014, available isolates were emm typed and antimicrobial susceptibilities determined using conventional methods; from 2015 onward, whole-genome sequencing was used. MAIN OUTCOMES AND MEASURES: Incidence rates by sex, age, race, and selected risk factors; clinical syndromes, outcomes, and underlying patient conditions; and isolate characteristics, including antimicrobial susceptibility. RESULTS: Surveillance in 10 US states identified 21 312 cases of invasive GAS from 2013 through 2022, including 1981 deaths. The majority of cases (57.5%) were in males. Among case-patients, 1272 (6.0%) were aged 0 to 17 years, 13 565 (63.7%) were aged 18 to 64 years, and 6474 (30.4%) were 65 years or older; 5.5% were American Indian or Alaska Native, 14.3% were Black, and 67.1% were White. Incidence rose from 3.6 per 100 000 persons in 2013 to 8.2 per 100 000 persons in 2022 (P < .001 for trend). Incidence was highest among persons 65 years or older; however, the relative increase over time was greatest among adults aged 18 to 64 years (3.2 to 8.7 per 100 000 persons). Incidence was higher among American Indian or Alaska Native persons than in other racial and ethnic groups. People experiencing homelessness, people who inject drugs, and residents of long-term care facilities had substantially elevated GAS incidence rates. Among tested isolates, those nonsusceptible to macrolides and clindamycin increased from 12.7% in 2013 to 33.1% in 2022. CONCLUSIONS: Invasive GAS infections increased substantially in 10 US states during a surveillance period from 2013 to 2022. Accelerated efforts to prevent and control GAS are needed, especially among groups at highest risk of infection.

During the 2023-2024 respiratory syncytial virus (RSV) season, vaccination was recommended for adults ≥60 years based on shared clinical decision-making with their healthcare providers. We examined RSV vaccine uptake and characteristics associated with uptake among age-eligible Kaiser Permanente Southern California (KPSC) patients. Our study cohort included all patients ≥60 years from September 23, 2023 (i.e., date RSV vaccination first became available at KPSC; N = 1,003,132) to April 9, 2024 (i.e., end of local RSV season). To identify sociodemographic and clinical characteristics associated with RSV vaccination, we used multivariable robust Poisson regression to estimate the adjusted relative risk (aRR) and 95 % CI. Overall, 7.6 % of patients were vaccinated for RSV. In multivariable regression analyses, those aged 70-79.9 years (aRR: 1.36; 95 % CI: 1.34-1.39) and aged ≥80 years (aRR: 1.35; 95 % CI: 1.32-1.38) were more likely to be vaccinated, compared with those aged 60-69.9 years. Compared with Non-Hispanic White patients, Asian (aRR: 0.95; 95 % CI: 0.93-0.97), Hispanic (aRR: 0.52; 95 % CI: 0.51-0.54), Non-Hispanic Black (aRR: 0.69; 95 % CI: 0.67-0.71), Pacific Islander (aRR: 0.91; 95 % CI: 0.84-0.98), and Native American or Alaska Native (aRR: 0.80; 95 % CI: 0.70-0.92) patients were less likely to be vaccinated. Those in higher neighborhood deprivation quartiles were less likely to be vaccinated (Q2: aRR: 0.86; 95 % CI: 0.85-0.88; Q3: aRR: 0.77; 95 % CI: 0.76-0.79; and Q4: aRR: 0.67; 95 % CI: 0.65-0.68), compared with those in the lowest deprivation quartile. We found low vaccination uptake and identified disparities in vaccination that might exacerbate existing disparities in RSV infection and severe RSV disease among certain populations. CDC's ACIP recently updated their recommendations for all adults 75+ years, and this might begin to address these disparities.

Introduction: Motor-vehicle crash (MVC) deaths increased by a record 10% from 2020 to 2021 in the United States and disproportionately impacted persons of certain racial/ethnic groups. Methods: Mortality data from the National Vital Statistics System was used to describe MVC death rate trends during 2019–2022 by six racial/ethnic groups: non-Hispanic (NH) American Indian or Alaska Native (AIAN), NH Asian, NH Black, NH Native Hawaiian or Other Pacific Islander (NHOPI), NH White, and Hispanic. Age-adjusted death rates per 100,000 population, 95% confidence intervals (CIs), and annual percent change in rates were calculated. Results: Overall MVC death rates increased during 2019–2022, and rates were highest among NH AIAN and NH Black persons across all years. During 2019–2020, death rates increased the most among NH Black persons (+26.0%). During 2020–2021, rates increased among all racial/ethnic groups, with the greatest increase among NH NHOPI persons (+66.7%) and NH AIAN persons (+27.8%). Conclusions: These findings highlight stark differences by racial/ethnic group in MVC death rates and changes in these rates. Between 2019 and 2022, NH AIAN, NH Black, and NH NHOPI populations experienced the largest increases in MVC death rates, although there was large variation in rates and trends. Widespread adoption of a comprehensive suite of prevention strategies, such as the Safe System approach, while targeting subpopulations with the greatest burden of MVC deaths could reduce these differences and the overall burden of MVCs. Practical Applications: These findings show which subpopulations could experience the greatest impacts from transportation safety investments in reducing overall MVC death rates in the United States. © 2025

BACKGROUND: While the estimated number of US influenza-associated deaths is reported annually, detailed data on the epidemiology of influenza-associated deaths, including the burden of in-hospital vs post-hospital discharge deaths, are limited. METHODS: Using data from the 2010-2011 through 2018-2019 seasons from the Influenza Hospitalization Surveillance Network, we linked cases to death certificates to identify patients who died from any cause during their influenza hospital stay or within 30 days post discharge. We described demographic and clinical characteristics of patients who died in the hospital vs post discharge and characterized locations and causes of death (CODs). RESULTS: Among 121 390 cases hospitalized with laboratory-confirmed influenza over 9 seasons, 5.5% died; 76% of deaths were in patients aged ≥65 years, 71% were non-Hispanic White, and 34% had 4 or more underlying medical conditions. Among all patients with an influenza-associated hospitalization who died, 48% of deaths occurred after hospital discharge; the median number of days from discharge to death was 9 (interquartile range, 3-19). Post-discharge deaths more often occurred in older patients and among those with underlying medical conditions. Only 37% of patients who died had "influenza" as a COD on their death certificate. Influenza was more frequently listed as a COD among persons who died in the hospital compared with cardiovascular disease among those who died after discharge. CONCLUSIONS: All-cause mortality burden is substantial among patients hospitalized with influenza, with almost 50% of deaths occurring within 30 days after hospital discharge. Surveillance systems should consider capture of post-discharge outcomes to better characterize the impact of influenza on all-cause mortality.

Parabens are widely used preservatives with endocrine-disrupting properties, but their role in glucose metabolism during pregnancy is unclear. This study examines prospective associations between urinary concentrations of four parabens in early and mid-pregnancy and gestational diabetes (GDM). A matched case-control study nested within a diverse longitudinal pregnancy cohort (PETALS) with universal GDM screening matched GDM cases to two controls (111 cases; 222 controls). Urine samples collected 2015-2017 in early (14 ± 2.3 weeks) and mid-pregnancy (20 ± 2.4 weeks) were analyzed for paraben concentrations with mass spectrometry. Area-under-the-time-concentration-curve (AUC) assessed cumulative exposure. Conditional logistic regression models evaluated associations between paraben concentrations and GDM, adjusting for covariates. We a priori examined effect modification by Asian/Pacific Islander (A/PI) race/ethnicity due to the case-control matching and GDM prevalence highest among A/PI. Participants were 31 ± 5 years old and 40 % A/PI, 33 % Hispanic, 14 % White and 9 % Black. Methylparaben and propylparaben had >94 % detection, while ethylparaben and butylparaben ranged from 22 %-51 %. Paraben exposure was not associated with GDM overall. Among A/PI, higher methylparaben concentrations exhibited higher odds of GDM: early-pregnancy OR 1.14 per IQR (95 % CI: 0.89,1.45) and AUC 1.07 (0.89,1.30) compared to non-A/PI (early-pregnancy 0.81 [0.62,1.06] and AUC 0.70 [0.44,1.12]; P(interaction) = 0.01 and 0.03, respectively). A/PI mid-pregnancy ethylparaben exposure (detectable vs non-detectable) was linked to higher GDM odds (2.00 [0.84,4.76] vs. non-A/PI 0.47 [0.17,1.27]; P(interaction) = 0.04) as was mid-pregnancy propylparaben exposure (Tertile 2 vs. 1: 3.67 [1.21,11.1] vs. non-A/PI 0.70 [0.22, 2.25]; P(interaction) = 0.04). Although overall paraben exposure was not associated with GDM, interactions by A/PI race/ethnicity suggested potential increased odds of GDM related to propylparaben, methylparaben, and ethylparaben exposure. Future studies should explore paraben exposure in diverse populations.

IMPORTANCE: In 2023, the first respiratory syncytial virus (RSV) vaccines were recommended for US adults 60 years or older, but few data are available about which patients were most likely to receive vaccine to inform future RSV vaccine outreach efforts. OBJECTIVE: To assess patient- and community-level characteristics associated with RSV vaccine receipt and patient knowledge and attitudes related to RSV disease and RSV vaccines. DESIGN, SETTING, AND PARTICIPANTS: During the first season of RSV vaccine use from October 1, 2023, to April 30, 2024, adults 60 years or older hospitalized with RSV-negative acute respiratory illness were enrolled in this cross-sectional study from 26 hospitals in 20 US states. Sociodemographic and clinical data were abstracted from health records, and structured interviews were conducted for knowledge and attitudes about RSV disease and RSV vaccines. EXPOSURES: Age, sex, race and ethnicity, pulmonary disease, immunocompromised status, long-term care facility residence, medical insurance, social vulnerability index (SVI), and educational level. MAIN OUTCOMES AND MEASURES: The exposures were identified a priori as possible factors associated with RSV vaccine receipt and were entered into a modified Poisson regression model accounting for state clustering, to assess for association with RSV vaccine receipt. Knowledge and attitudes were summarized with frequencies and proportions. RESULTS: Among 6746 hospitalized adults 60 years or older, median age was 73 (IQR, 66-80) years and 3451 (51.2%) were female. Among the 6599 patients with self-reported race and ethnicity, 699 (10.6%) were Hispanic, 1288 (19.5%) were non-Hispanic Black, 4299 (65.1%) were non-Hispanic White, and 313 (4.7%) were other race or ethnicity. There were 700 RSV-vaccinated (10.4%) and 6046 unvaccinated (89.6%) adults. Among 3219 unvaccinated adults who responded to RSV knowledge questions, 1519 (47.2%) had not heard of RSV or were unsure; 2525 of 3218 (78.5%) were unsure if they were eligible for RSV vaccine or thought they were not. In adjusted analyses, characteristics associated with RSV vaccination were being 75 years or older (adjusted risk ratio [ARR], 1.23; 95% CI, 1.10-1.38, P < .001), being male (ARR, 1.15; 95% CI, 1.01-1.30; P = .04), and having pulmonary disease (ARR, 1.39; 95% CI, 1.16-1.67; P < .001), immunocompromised status (ARR, 1.30; 95% CI, 1.14-1.48; P < .001), low (ARR, 1.47; 95% CI, 1.18-1.83, P < .001) or moderate (ARR, 1.47; 95% CI, 1.21-1.79; P < .001) SVI, and educational level consisting of 4 or more years of college (ARR, 2.91; 95% CI, 2.14-3.96; P < .001), at least some college or technical training (ARR, 1.85; 95% CI, 1.35-2.53; P < .001), or grade 12 education or General Educational Development (ARR, 1.44; 95% CI, 1.03-2.00; P = .03). RSV vaccination was less likely among residents of long-term care facilities, patients with Medicaid coverage, and uninsured patients. CONCLUSIONS AND RELEVANCE: In this cross-sectional study of hospitalized adults, knowledge of RSV disease and RSV vaccine eligibility was low. Older adults and those with certain medical conditions were more likely to have received vaccine, suggesting appropriate prioritization, but sociodemographic differences in vaccine uptake occurred.

PURPOSE: Chlamydia and gonorrhea are the 2 most common bacterial sexually transmitted infections in the United States. Nonadherence to the Centers for Disease Control and Prevention treatment guidelines remains a concern. We examined how well chlamydia and gonorrhea treatment in primary care settings adhered to guidelines. METHODS: We used electronic health records from the PRIME registry to identify patients with diagnosis codes or positive test results for chlamydia and/or gonorrhea from 2018 to 2022. Outcomes were the first dates of antibiotic administered within 30 days after a positive test result for the infection. Descriptive statistics were calculated for patient sociodemographic characteristics. We used a multivariate parametric accelerated failure time analysis with shared frailty modeling to assess associations between these characteristics and time to treatment. RESULTS: We identified 6,678 cases of chlamydia confirmed by a positive test and 2,206 cases of gonorrhea confirmed by a positive test; 75.3% and 69.6% of these cases, respectively, were treated. Females, individuals aged 10-29 years, suburban dwellers, and patients with chlamydia-gonorrhea coinfection had higher treatment rates than comparator groups. Chlamydia was infrequently treated with the recommended antibiotic, doxycycline (14.0% of cases), and gonorrhea was infrequently treated with the recommended antibiotic, ceftriaxone (38.7% of cases). Time to treatment of chlamydia was longer for patients aged 50-59 years (time ratio relative to those aged 20-29 years = 1.61; 95% CI, 1.12-2.30) and for non-Hispanic Black patients (time ratio relative to White patients = 1.17; 95% CI, 1.04-1.33). CONCLUSIONS: Guideline adherence remains suboptimal for chlamydia and gonorrhea treatment across primary care practices. Efforts are needed to develop interventions to improve quality of care for these sexually transmitted infections.

We assessed the impact of pneumococcal conjugate vaccines on pneumococcal otitis media (OM) among children living in Navajo and White Mountain Apache Tribal lands. During the PCV7 era (2000-2009), the proportion of vaccine-type OM declined. However, vaccine-type OM (predominantly 3, 19A, and 19F) persisted in the PCV13 era (2010-2019).

BACKGROUND: Nursing home residents experience a large burden of invasive methicillin-resistant Staphylococcus aureus (MRSA) infections. Data are limited regarding nursing home characteristics associated with differences in facility-level invasive MRSA rates. METHODS: We analyzed 2011-2015 data from CDC's Emerging Infections Program (EIP) active population- and laboratory-based surveillance for invasive MRSA cases within seven states. A nursing home-onset case was defined as MRSA cultured from a normally sterile site in a person living in a nursing home 3 days before culture collection. Facility rates were calculated as nursing home-onset cases per 100,000 resident-days. Nursing home resident-day denominators and facility characteristics were obtained from four Centers for Medicare & Medicaid Services (CMS) datasets. A general estimating equations model with a logit link assessed characteristics of the facilities with highest rates comprising 50% of nursing home MRSA cases ("high rates"). RESULTS: The 626 nursing homes in the surveillance area had 2824 invasive MRSA cases; 82% of facilities had at ≥1 case. The 20% of facilities with highest rates (≥3.84 cases/100,000 resident-days) had 50% of nursing home-onset cases. In multivariable regression, facilities with high rates were more likely to have CMS-derived characteristics of presence of a resident with a multidrug-resistant organism; or greater proportions of residents who were male, were short stay (in the facility <100 days), had a nasogastric or percutaneous gastrostomy tube, or require extensive assistance with bed repositioning; and more likely to be in an EIP area with higher hospital-onset MRSA rates. Higher registered nurses staffing levels (hours/resident/day) and higher proportions of White residents were associated with lower rates. CONCLUSIONS: Facilities with higher invasive MRSA rates served residents with more clinical and functional care needs. Increasing registered nurse staffing in high-risk facilities might assist with reduction of invasive MRSA rates. These findings could help prioritize nursing homes for future MRSA prevention work.

BACKGROUND: Current US hepatitis B mortality rates remain three times higher than the national target. Mortality reduction will depend on addressing hepatitis B disparities influenced by social determinants of health. OBJECTIVES: This study aims to describe characteristics of hepatitis B-listed decedents, which included US birthplace status and county social vulnerability attributes and quantify premature mortality. METHODS: We conducted a cross-sectional analysis of 17,483 hepatitis B-listed decedents using the 2010-2019 US Multiple-Cause-of-Death data merged with the county-level Social Vulnerability Index (SVI). Outcomes included the distribution of decedents according to US birthplace status and residence in higher versus lower death burden counties by sociodemographic characteristics, years of potential life lost (YPLL), and SVI quartiles. RESULTS: Most hepatitis B-listed decedents were US-born, male, and born during 1945-1965. Median YPLL was 17.2; 90.0% died prematurely. US-born decedents were more frequently White, non-college graduates, unmarried, and had resided in a county with < 500,000 people; non-US-born decedents were more frequently Asian/Pacific Islander, college graduates, married, and had resided in a county with ≥ 1 million people. Higher death burden (≥ 20) counties were principally located in coastal states. US-born decedents more frequently resided in counties in the highest SVI quartile for "Household Characteristics" and "Uninsured," whereas non-US-born decedents more frequently resided in counties in the highest SVI quartile for "Racial/Ethnic Minority Status" and "Housing Type/Transportation." CONCLUSION: This analysis found substantial premature hepatitis B mortality and residence in counties ranked high in social vulnerability. Successful interventions should be tailored to disproportionately affected populations and the social vulnerability features of their geographic areas.

Pre-exposure prophylaxis (PrEP) is an effective tool in protecting persons from acquiring HIV infection through sex or injection drug use. However, awareness and willingness to use PrEP among Black gay, bisexual, and other men who have sex with men (BMSM) remain suboptimal compared to White MSM (WMSM) in the United States. Our aims were to (1) assess the factors associated with PrEP awareness and willingness to use PrEP among MSM and (2) compare the PrEP perceptions among BMSM versus non-Black MSM. Data were drawn from two cross-sectional behavioral surveys in Baltimore, MD: Behavioral Surveillance Research (BESURE) conducted in 2017, and Safe Spaces 4 Sexual Health (SS4SH), conducted in 2018 and 2019. Descriptive statistics were used to summarize the study population. We used Poisson regression models to identify variables associated with awareness of PrEP and willingness to use PrEP. PrEP perceptions were assessed via 13 items scored on a 5-point Likert scale. Finally, we conducted a post-hoc exploratory bivariate analysis of the relationship between PrEP perception and willingness to use PrEP, stratified by race/ethnicity. A total of 261 MSM participated in this study. Many of the participants were aware of PrEP (75.1%). Factors associated with greater PrEP awareness included having greater than a high school education (aRR 1.22, 95% CI 1.04, 1.43); and earning more than $25,000 annually (aRR 1.24, 95% CI 1.08, 1.42). Participants who had received money in exchange for sex one or more times were less likely to be aware of PrEP (aRR 0.59, 95% CI 0.36, 0.95). More than half of the participants were willing to use PrEP (55.3%). In bivariate and multivariable analyses, demographic or behavioral characteristics were not significantly associated with willingness to use PrEP. Higher agreement with the following statements was associated with lower willingness to use PrEP: "Having to take a pill every day is difficult" (RR 0.89, 95% CI 0.82-0.97) and, "I am concerned about the side effects of PrEP" (RR 0.89, 95% CI 0.82-0.96), and "PrEP is for people who have riskier sex lives than I do" (RR 0.86, 95% CI 0.78-0.95). Conversely, higher willingness to use PrEP was associated with comfortable having sex without a condom (RR 1.11, 95% CI 1.02-1.21), less anxious about sex (RR 1.12, 95% CI 1.02-1.24), and my friends think that I should take PrEP (RR 1.19, 95% CI 1.07-1.32). We found BMSM compared to non-Black MSM had higher mean scores related to taking a daily pill (p = 0.041), concerns about side effects (p = 0.012), concerns about people thinking they had HIV (p = 0.001), concerns about the financial costs of PrEP (p = 0.038) and caution when dealing with healthcare organizations/medical mistrust (p = 0.019). Perceptions with a statistically significant lower score among BMSM versus non-Black MSM included statements such as, comfortable having sex without a condom (p = 0.003) and less anxious about sex (p < 0.001). We conclude HIV prevention strategies, programs, and interventions should be cognizant of PrEP perceptions that facilitate or hinder PrEP uptake in Baltimore City, MD.

Long-term effects of COVID-19 on multiple organ systems have been reported. Indigenous persons experienced disproportionate morbidity and mortality from COVID-19; however, Post-COVID-19 Conditions (PCC) have not been well described in this population. We conducted a longitudinal cohort study among Indigenous persons living in the Navajo Nation or White Mountain Apache Tribal lands in the Southwest United States who tested positive for SARS-CoV-2 between February 1, 2021 and August 31, 2022. Participants were enrolled during their acute illness and followed for three months. PCC was defined as the presence of any self-reported symptom and/or any sequelae or new condition recorded in the electronic health record at the 3-month visit. Risk factors for PCC were evaluated using Poisson regression with robust standard errors. The analysis included 258 adults and 84 children. Most participants (98.4% of adults, 90.5% of children) experienced a mild, symptomatic acute illness. Over half of adults (57.8%) and a third (39.3%) of children experienced six or more symptoms during the acute illness. Three months post-acute COVID-19, 39.8% of adults and 15.9% of children had symptoms consistent with PCC. Commonly reported symptoms were fatigue/tiredness, cough, headache, runny nose, and myalgia. Among adults enrolled during Omicron predominance, older age and hospitalization for COVID-19 were significantly associated with an increased risk of PCC, and COVID-19 vaccination was significantly associated with a decreased risk of PCC in univariable analysis. In a multivariable analysis, COVID-19 vaccination (risk ratio: 0.56; 95% confidence interval: 0.34, 0.90) remained significantly associated with a decreased risk of PCC. In this cohort of Indigenous persons in the Southwest US, PCC at three months post-acute COVID-19 illness were common, including among individuals with mild acute illness. While the absence of a control group is a limitation, these findings highlight the potential ongoing healthcare needs related to PCC in Indigenous populations.

Background: The tick-borne pathogens, Bourbon virus (BRBV) and Heartland virus (HRTV) are the cause of febrile illnesses that may progress to severe and fatal diseases. Materials and Methods: As a preliminary effort to determine if these viruses were enzootic in Texas, ticks and blood samples were collected from feral swine (Sus scrofa) and white-tailed deer (Odocoileus virginianus) (WTD) killed by gunning as part of an abatement program during 2019-2021 in Travis County, Texas. Ticks were collected from these animals by hand and blood samples were obtained by cardiac puncture using 22-gauge needles and 5 mL syringes. Information was recorded for each animal, including date, sex, and location. The species of ticks were identified morphologically using a taxonomic key, and serum samples were tested for neutralizing antibodies to BRBV and HRTV. Results: A total of 83 Ixodes scapularis and 58 Amblyomma americanum ticks were collected from feral swine, and 196 I. scapularis and 11 Dermacentor albipictus from WTD. Although A. americanum, the implicated vector of both viruses was collected from feral swine, neutralizing antibody was not detected to BRBV, but 12% (9/75) had antibody to HRTV as evidence of a previous infection. Of the serum samples obtained from WTD, all were negative for BRBV neutralizing antibody, but 6.6%% (5/75) were positive for HRTV antibody. Conclusion: These preliminary results indicated that HRTV was enzootic in Travis, County, Texas and further studies are warranted to determine the specific tick vectors and the possible role of WTD and feral swine in the maintenance and transmission cycle of this virus.

INTRODUCTION: The association between various disparity factors and cardiovascular disease (CVD) prevalence among older US adults with diabetes has not been comprehensively explored. We examined disparities in CVD prevalence among Medicare beneficiaries with diabetes. METHODS: Data were from the 2015-2019 Medicare Current Beneficiary Survey. Diabetes and CVD conditions - myocardial infarction (MI), stroke, and heart failure - were self-reported. We estimated the adjusted prevalence ratios (APRs) of CVD by race and ethnicity, education, income-to-poverty ratio (IPR), urbanicity, food insecurity, and social vulnerability using logistic regressions that controlled for these factors as well as age and sex. RESULTS: Annually, an estimated 9.2 million Medicare beneficiaries aged 65 years or older had diabetes. Among them, 16.7% had MI, 13.7% had stroke, and 12.5% had heart failure. Beneficiaries who were food insecure, socially vulnerable, with an IPR less than or equal to 135%, and residing in rural areas had a higher crude CVD prevalence. After controlling for other factors, low IPR and food insecurity were linked to a higher prevalence of CVD. Hispanic beneficiaries had lower stroke and heart failure prevalence than non-Hispanic (NH) White and NH Black beneficiaries. NH Black beneficiaries had lower MI prevalence but higher heart failure prevalence compared with NH White beneficiaries. Female respondents with an IPR less than or equal to 135% had higher MI and stroke prevalence; this was not seen in male respondents. CONCLUSION: Low IPR and food insecurity were associated with higher MI, stroke, and heart failure prevalence among Medicare beneficiaries with diabetes. Our findings can inform targeted interventions to reduce CVD disparities in these populations.