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1.
J Am Geriatr Soc ; 2024 Jun 03.
Article En | MEDLINE | ID: mdl-38826070

BACKGROUND: The use of potentially inappropriate medications (PIMs) is associated with increased risk of hospitalizations and emergency room visits and varies by racial and ethnic subgroups. Medicare's nationwide medication therapy management (MTM) program requires that Part D plans offer an annual comprehensive medication review (CMR) to all beneficiaries who qualify, and provides a platform to reduce PIM use. The objective of this study was to assess the impact of CMR on PIM discontinuation in Medicare beneficiaries and whether this differed by race or ethnicity. METHODS: Retrospective cohort study of community-dwelling Medicare Part D beneficiaries ≥66 years of age who were eligible for MTM from 2013 to 2019 based on 5% Medicare fee-for-service claims data linked to the 100% MTM data file. Among those using a PIM, MTM-eligible CMR recipients were matched to non-recipients via sequential stratification. The probability of PIM discontinuation was estimated using regression models that pooled yearly subcohorts accounting for within-beneficiary correlations. The most common PIMs that were discontinued after CMR were reported. RESULTS: We matched 24,368 CMR recipients to 24,368 CMR non-recipients during the observation period. Median age was 74-75, 35% were males, most were White beneficiaries (86%-87%), and the median number of PIMs was 1. In adjusted analyses, CMR receipt was positively associated with PIM discontinuation (adjusted relative risk [aRR]: 1.26, 95% CI: 1.20-1.32). There was no evidence of differential impact of CMR by race or ethnicity. The PIMs most commonly discontinued after CMR were glimepiride, zolpidem, digoxin, amitriptyline, and nitrofurantoin. CONCLUSIONS: Among Medicare beneficiaries who are using a PIM, CMR receipt was associated with PIM discontinuation, suggesting that greater CMR use could facilitate PIM reduction for all racial and ethnic groups.

2.
Pain ; 2024 Jun 04.
Article En | MEDLINE | ID: mdl-38833573

ABSTRACT: Post-traumatic stress disorder (PTSD) is common in patients with chronic pain, adversely affects chronic pain outcomes, and is associated with opioid use and adverse opioid outcomes. Social support is a robust predictor of PTSD incidence and course as well as chronic pain outcome. We determined whether the association between PTSD and persistent opioid use was modified by emotional support in a cohort of patients receiving opioids for noncancer pain. Eligible participants were ≥18 years and had completed a new period of prescription opioid use lasting 30 to 90 days. Bivariate associations between cohort characteristics and each key variable was assessed using χ2 tests for categorical variables and t-tests for continuous variables. Interaction between PTSD and emotional support was assessed by a priori stratification on low vs high emotional support. Participants (n = 808) were 53.6 (SD ± 11.6) years of age, 69.8% female, 69.6% White, and 26.4% African American. Overall, 17.2% had probable PTSD. High emotional support was significantly (P < 0.0001) more common among those without probable PTSD. Prescription opioid use at 6-month follow-up was significantly (P = 0.0368) more common among patients with vs without probable PTSD. In fully adjusted models, PTSD was no longer associated with opioid use at 6-month follow-up among participants with high emotional support. Among those with lower emotional support, PTSD was significantly associated with opioid use at 6-month follow-up in unadjusted (odds ratio = 2.40; 95% confidence interval: 1.24-4.64) and adjusted models (odds ratio = 2.39; 95% confidence interval: 1.14-4.99). Results point to the hypothesis that improvement of emotional support in vulnerable patients with chronic pain and PTSD may help reduce sustained opioid use.

3.
Heart Lung Circ ; 2024 May 02.
Article En | MEDLINE | ID: mdl-38702234

Catheter ablation for atrial fibrillation (AF) has increased exponentially in many developed countries, including Australia and New Zealand. This Expert Position Statement on Catheter and Surgical Ablation for Atrial Fibrillation from the Cardiac Society of Australia and New Zealand (CSANZ) recognises healthcare factors, expertise and expenditure relevant to the Australian and New Zealand healthcare environments including considerations of potential implications for First Nations Peoples. The statement is cognisant of international advice but tailored to local conditions and populations, and is intended to be used by electrophysiologists, cardiologists and general physicians across all disciplines caring for patients with AF. They are also intended to provide guidance to healthcare facilities seeking to establish or maintain catheter ablation for AF.

4.
J Gen Intern Med ; 2024 May 08.
Article En | MEDLINE | ID: mdl-38717665

BACKGROUND: Health care systems are increasingly screening for unmet social needs. The association between patient-reported social needs and health care utilization is not well understood. OBJECTIVE: To investigate the association between patient-reported social needs, measured by the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE), and inpatient and emergency department (ED) utilization. DESIGN: This cohort study analyzed merged 2017-2019 electronic health record (EHR) data across multiple health systems. PARTICIPANTS: Adult patients from a federally qualified health center (FQHC) in central North Carolina who completed PRAPARE as part of a primary care visit with behavioral health services. MAIN MEASURES: The count of up to 12 unmet social needs, aggregated as 0, 1, 2, or 3 + . Outcomes include the probability of an ED visit and hospitalization 12 months after PRAPARE assessment, modeled by logistic regressions controlling for age, sex, race, ethnicity, comorbidity burden, being uninsured, and prior utilization in the past 12 months. KEY RESULTS: The study population consisted of 1924 adults (38.7% male, 50.1% Black, 36.3% Hispanic, 55.9% unemployed, 68.2% of patients reported 1 + needs). Those with more needs were younger, more likely to be unemployed, and experienced greater comorbidity burden. 35.3% of patients had ED visit(s) and 36.3% had hospitalization(s) 1 year after PRAPARE assessment. In adjusted analysis, having 3 + needs was associated with a percentage point increase in the predicted probability of hospitalization (average marginal effect 0.06, SE 0.03, p < 0.05) compared with having 0 needs. Similarly, having 2 needs (0.07, SE 0.03, p < 0.05) or 3 + needs (0.06, SE 0.03, p < 0.05) was associated with increased probability of ED visits compared to 0 needs. CONCLUSIONS: Patient-reported social needs were common and associated with health care utilization patterns. Future research should identify interventions to address unmet social needs to improve health and avoid potentially preventable escalating medical intervention.

5.
JAMA Health Forum ; 5(5): e240807, 2024 May 03.
Article En | MEDLINE | ID: mdl-38700854

Importance: Comprehensive medication reviews (CMRs) are offered to qualifying US Medicare beneficiaries annually to optimize medication regimens and therapeutic outcomes. In 2016, Medicare adopted CMR completion as a Star Rating quality measure to encourage the use of CMRs. Objective: To examine trends in CMR completion rates before and after 2016 and whether racial, ethnic, and socioeconomic disparities in CMR completion changed. Design, Setting, and Participants: This observational study using interrupted time-series analysis examined 2013 to 2020 annual cohorts of community-dwelling Medicare beneficiaries aged 66 years and older eligible for a CMR as determined by Part D plans and by objective minimum eligibility criteria. Data analysis was conducted from September 2022 to February 2024. Exposure: Adoption of CMR completion as a Star Rating quality measure in 2016. Main Outcome and Measures: CMR completion modeled via generalized estimating equations. Results: The study included a total of 561 950 eligible beneficiaries, with 253 561 in the 2013 to 2015 cohort (median [IQR] age, 75.8 [70.7-82.1] years; 90 778 male [35.8%]; 6795 Asian [2.7%]; 24 425 Black [9.6%]; 7674 Hispanic [3.0%]; 208 621 White [82.3%]) and 308 389 in the 2016 to 2020 cohort (median [IQR] age, 75.1 [70.4-80.9] years; 126 730 male [41.1%]; 8922 Asian [2.9%]; 27 915 Black [9.1%]; 7635 Hispanic [2.5%]; 252 781 White [82.0%]). The unadjusted CMR completion rate increased from 10.2% (7379 of 72 225 individuals) in 2013 to 15.6% (14 185 of 90 847 individuals) in 2015 and increased further to 35.8% (18 376 of 51 386 individuals) in 2020, in part because the population deemed by Part D plans to be MTM-eligible decreased by nearly half after 2015 (90 487 individuals in 2015 to 51 386 individuals in 2020). Among a simulated cohort based on Medicare minimum eligibility thresholds, the unadjusted CMR completion rate increased but to a lesser extent, from 4.4% in 2013 to 12.6% in 2020. Compared with White beneficiaries, Asian and Hispanic beneficiaries experienced greater increases in likelihood of CMR completion after 2016 but remained less likely to complete a CMR. Dual-Medicaid enrollees also experienced greater increases in likelihood of CMR completion as compared with those without either designation, but still remained less likely to complete CMR. Conclusion and Relevance: This study found that adoption of CMR completion as a Star Rating quality measure was associated with higher CMR completion rates. The increase in CMR completion rates was achieved partly because Part D plans used stricter eligibility criteria to define eligible patients. Reductions in disparities for eligible Asian, Hispanic, and dual-Medicaid enrollees were seen, but not eliminated. These findings suggest that quality measures can inform plan behavior and could be used to help address disparities.


Healthcare Disparities , Humans , United States , Aged , Male , Female , Aged, 80 and over , Healthcare Disparities/statistics & numerical data , Healthcare Disparities/ethnology , Medicare/statistics & numerical data , Interrupted Time Series Analysis , Medicare Part D/statistics & numerical data , Ethnicity/statistics & numerical data
6.
AEM Educ Train ; 8(Suppl 1): S36-S42, 2024 May.
Article En | MEDLINE | ID: mdl-38774826

Background: Community engagement is increasingly recognized as a necessity in addressing intractable racial and ethnic health disparities in the United States. However, institutions have not adequately trained resident physicians in developing symbiotic community partnerships that preserve community autonomy and identity without exploitation. Our goals were to highlight the experiences of expert academic emergency physicians in creating innovative, community-driven, and anti-racist solutions to achieving measurable equity in health outcomes and to introduce a novel framework entitled the Social Change Method to take a community-embedded intervention from concept to creation. Methods: The methodology was based on the development of a didactic session at the 2023 SAEM Annual Meeting. The three novel initiatives discussed were Emergency Medicine Remix (EMR); Trust, Research, Access, and Prevention (TRAP) Medicine; and The Health Equity Accelerator (HEA). A team of multi-institutional experts convened to develop the session objectives through priority setting. Results: Our expert panel discussed successes and challenges encountered while using evidence-informed strategies to conduct their community-based programming. Participant questions were centered on fostering sustainability, emphasizing the importance of carefully crafted interventions in the face of uncertain legislative challenges and strategies to empower others. Conclusions: Emergency medicine residency education should incorporate training on methods to leverage community partnerships to improve individual and community health outcomes. The Social Change Method can be used as a conceptual framework to generate easily re-creatable and scalable partnerships that establish trust and forge relationships that honor identity and autonomy without exploiting community members.

7.
Nat Commun ; 15(1): 2864, 2024 Apr 05.
Article En | MEDLINE | ID: mdl-38580657

Global climate patterns fundamentally shape the distribution of species and ecosystems. For example, Bergmann's rule predicts that homeothermic animals, including birds and mammals, inhabiting cooler climates are generally larger than close relatives from warmer climates. The modern world, however, lacks the comparative data needed to evaluate such macroecological rules rigorously. Here, we test for Bergmann's rule in Mesozoic dinosaurs and mammaliaforms that radiated within relatively temperate global climate regimes. We develop a phylogenetic model that accounts for biases in the fossil record and allows for variable evolutionary dispersal rates. Our analysis also includes new fossil data from the extreme high-latitude Late Cretaceous Arctic Prince Creek Formation. We find no evidence for Bergmann's rule in Mesozoic dinosaurs or mammaliaforms, the ancestors of extant homeothermic birds and mammals. When our model is applied to thousands of extant dinosaur (bird) and mammal species, we find that body size evolution remains independent of latitude. A modest temperature effect is found in extant, but not in Mesozoic, birds, suggesting that body size evolution in modern birds was influenced by Bergmann's rule during Cenozoic climatic change. Our study provides a general approach for studying macroecological rules, highlighting the fossil record's power to address longstanding ecological principles.


Dinosaurs , Animals , Phylogeny , Ecosystem , Models, Biological , Body Size , Mammals , Biological Evolution
8.
Cancer Res Commun ; 4(3): 811-821, 2024 Mar 18.
Article En | MEDLINE | ID: mdl-38441644

This study investigated the association between health care access (HCA) dimensions and racial disparities in end-of-life (EOL) care quality among non-Hispanic Black (NHB), non-Hispanic White (NHW), and Hispanic patients with ovarian cancer. This retrospective cohort study used the Surveillance, Epidemiology, and End Results-linked Medicare data for women diagnosed with ovarian cancer from 2008 to 2015, ages 65 years and older. Health care affordability, accessibility, and availability measures were assessed at the census tract or regional levels, and associations between these measures and quality of EOL care were examined using multivariable-adjusted regression models, as appropriate. The final sample included 4,646 women [mean age (SD), 77.5 (7.0) years]; 87.4% NHW, 6.9% NHB, and 5.7% Hispanic. In the multivariable-adjusted models, affordability was associated with a decreased risk of intensive care unit stay [adjusted relative risk (aRR) 0.90, 95% confidence interval (CI): 0.83-0.98] and in-hospital death (aRR 0.91, 95% CI: 0.84-0.98). After adjustment for HCA dimensions, NHB patients had lower-quality EOL care compared with NHW patients, defined as: increased risk of hospitalization in the last 30 days of life (aRR 1.16, 95% CI: 1.03-1.30), no hospice care (aRR 1.23, 95% CI: 1.04-1.44), in-hospital death (aRR 1.27, 95% CI: 1.03-1.57), and higher counts of poor-quality EOL care outcomes (count ratio:1.19, 95% CI: 1.04-1.36). HCA dimensions were strong predictors of EOL care quality; however, racial disparities persisted, suggesting that additional drivers of these disparities remain to be identified. SIGNIFICANCE: Among patients with ovarian cancer, Black patients had lower-quality EOL care, even after adjusting for three structural barriers to HCA, namely affordability, availability, and accessibility. This suggests an important need to investigate the roles of yet unexplored barriers to HCA such as accommodation and acceptability, as drivers of poor-quality EOL care among Black patients with ovarian cancer.


Ovarian Neoplasms , Terminal Care , Humans , Female , Aged , United States/epidemiology , Retrospective Studies , Hospital Mortality , Black or African American , Medicare , Ovarian Neoplasms/therapy , Health Services Accessibility , White
9.
J Infect Dis ; 2024 Feb 22.
Article En | MEDLINE | ID: mdl-38385566

BACKGROUND: An mRNA-based RSV vaccine, mRNA-1345, is under clinical investigation to address RSV disease burden in older adults. METHODS: This phase 1, randomized, observer-blind, placebo-controlled, dose-ranging study evaluated safety, reactogenicity, and immunogenicity of mRNA-1345 in adults 65-79 years (NCT04528719). Participants were randomized to receive 1-dose of mRNA-1345 (12.5, 25, 50, 100, or 200-µg) or placebo and matched mRNA-1345 booster or placebo at 12-months. RESULTS: Overall, 298 participants received the first injection; 247 received the 12-month booster injection. mRNA-1345 was generally well-tolerated after both injections, with the most frequently reported solicited adverse reactions being injection-site pain, fatigue, headache, arthralgia, and myalgia. Reactogenicity was higher after the booster injection than the first injection but similar severity, time-to-onset, and duration. A single mRNA-1345 injection boosted RSV-A and RSV-B neutralizing antibody titers (nAb) and prefusion-F-binding antibody (preF-bAb) concentrations at 1-month (geometric mean-fold rises: RSV-A, 10.2-16.5; RSV-B, 5.3-12.5; preF-bAb, 7.2-12.1). RSV antibody levels remained above baseline through 12-months, indicating immune persistence. A 12-month booster injection also increased RSV-A and RSV-B nAb titers and preF-bAb concentrations; titers post-booster injection were numerically lower compared to titers after the first-dose, with overlapping 95% CIs. CONCLUSIONS: mRNA-1345 was well-tolerated and immunogenic following a single injection and a 12-month booster. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04528719.

10.
J Infect Dis ; 2024 Jan 31.
Article En | MEDLINE | ID: mdl-38298125

BACKGROUND: Respiratory syncytial virus (RSV) presents a global health concern. A lipid nanoparticle-encapsulated mRNA-based RSV vaccine (mRNA-1345) encoding the membrane-anchored RSV prefusion stabilised F glycoprotein (preF) is under clinical investigation. METHODS: This phase 1, randomized, observer-blind, placebo-controlled dose escalation study assessed safety and immunogenicity of mRNA-1345 in healthy adults aged 18-49 years (NCT04528719). Participants were randomized to receive one dose of mRNA-1345 (50, 100, or 200 µg) or placebo, or 3 doses of mRNA-1345 (100 µg) or placebo 56 days apart. RESULTS: mRNA-1345 was well-tolerated at all dose levels. The most common solicited adverse reactions were pain, headache, fatigue, myalgia, or chills, which were all generally mild to moderate. A single injection of mRNA-1345 boosted RSV neutralizing antibody titers (geometric mean fold rise [GMFR]: RSV-A, 20.0 to 23.5; RSV-B, 11.7 to 16.0) and RSV preF binding antibody concentrations (GMFR: 16.1 to 21.8) at 1 month post injection, with no apparent dose response. Antibody levels remained above baseline through 6 months. Sequential doses of 100 µg were well tolerated but did not further boost antibody levels. CONCLUSIONS: A single mRNA-1345 injection demonstrated an acceptable safety profile in younger adults and induced a durable neutralizing antibody response, supporting its continued development.

11.
Bone ; 181: 117039, 2024 Apr.
Article En | MEDLINE | ID: mdl-38325649

CONTEXT: People living with spinal cord injury (SCI) are at high risk for bone fractures. Neural, hormonal and metabolic contributors to bone microarchitectural alterations are incompletely understood. OBJECTIVE: To determine the relationship of physical, metabolic and endocrine characteristics with bone microarchitecture, characterized using high-resolution peripheral quantitative computed tomography (HRpQCT) in SCI. DESIGN: Cross-sectional analyses of bone properties in people with SCI. PARTICIPANTS: Twenty adults with SCI and paraplegia (12) or motor incomplete quadriplegia (8). OUTCOME MEASURES: Distal tibia and radius HRpQCT parameters, including density, microstructure and strength by microfinite element anaysis (µFEA); sex hormones; metabolic and inflammatory markers. RESULTS: The mean age of the participants with SCI was 41.5 ± 10.3 years, BMI 25.7 ± 6.2 kg/m2, time since injury 10.4 ± 9.0 years. Participants with SCI had significantly lower median total (Z score - 3.3), trabecular (-2.93), and cortical vBMD (-1.87), and Failure Load by µFEA (-2.48) at the tibia than controls. However, radius vBMD, aBMD and microarchitecture were similar in participants with SCI and un-injured controls. Unexpectedly, C-Reactive Protein (CRP) was positively associated with tibial trabecular vBMD (ß = 0.77, p = 0.02), thickness (ß = 0.52, p = 0.04) and number (ß = 0.92, p = 0.02). At the radius, estradiol level was positively associated with total vBMD (ß = 0.59, p = 0.01), trabecular thickness (ß = 0.43, p = 0.04), cortical thickness (ß = 0.63, p = 0.01) and cortical porosity (ß = 0.74 p = 0.04). CONCLUSIONS: Radius vBMD and microarchitecture is preserved but tibial total, cortical and trabecular vBMD, and estimated bone strength are markedly lower and bone microarchitectural parameters substantially degraded in people with SCI. The alterations in bone microarchitecture in people with SCI are likely multifactorial, however marked degradation of bone microarchitecture in tibia but not radius suggests that unloading is an important contributor of site-specific alterations of bone microarchitecture after SCI. Fracture prevention in SCI should focus on strategies to safely increase bone loading. CLINICALTRIALS: gov registration #: (NCT03576001).


Fractures, Bone , Spinal Cord Injuries , Adult , Humans , Middle Aged , Bone Density , Absorptiometry, Photon/methods , Cross-Sectional Studies , Radius , Tibia/diagnostic imaging , Gonadal Steroid Hormones
12.
Breast Cancer Res Treat ; 203(2): 329-338, 2024 Jan.
Article En | MEDLINE | ID: mdl-37875669

PURPOSE: Treatment for HER2-low [defined as ImmunoHistoChemistry (IHC) 1 + or 2 + and negative/normal in Situ Hybridization (ISH)] breast cancer patients is rapidly evolving, yet we lack critical information about the HER2-low population. METHODS: We conducted a retrospective cohort study of women aged 18 years or older diagnosed with breast cancer between 2010 and 2016 in North Carolina. Analyses were conducted for the overall cohort and a stage IV sub-cohort. We examined demographic and clinical characteristics, and characterized prevalence of HER2-low disease and healthcare utilization. We estimated adjusted rate ratios for the association between HER2 classifications and utilization outcomes, and hazard ratios for 3-year all cause mortality (stage IV only). RESULTS: The overall and stage IV cohorts included 12,965 and 635 patients, respectively. HER2-low patients represented more than half of both cohorts (59% overall, 53% stage IV). HER2-low patients were more likely than IHC 0 patients to have hormone receptor (HR)-positive disease. In the stage IV cohort, HER2-low patients were more likely to be Black (26% vs. 16% IHC 0, p = 0.0159). In both cohorts, rates of hospitalizations were slightly higher among HER2-low patients. There were no survival differences between HER2-low and IHC 0 among stage IV patients. CONCLUSION: New treatment options for HER2-low breast cancer may have potential for significant impact at the population level particularly for patients with stage IV disease. In light of racial differences between HER2-low and IHC 0 patients observed in our cohort, research- and practice-based efforts to ensure equitable adoption of new treatment guidelines for patients with HER2-low metastatic breast cancer will be essential.


Breast Neoplasms , Humans , Female , Breast Neoplasms/epidemiology , Breast Neoplasms/therapy , Breast Neoplasms/diagnosis , Receptor, ErbB-2/analysis , Retrospective Studies , Delivery of Health Care , Patient Acceptance of Health Care
13.
Clin J Pain ; 40(2): 67-71, 2024 Feb 01.
Article En | MEDLINE | ID: mdl-37819213

OBJECTIVE: Engagement in evidence-based psychological interventions for pain management is low. Identifying characteristics associated with interest in interventions can inform approaches to increase uptake and engagement. The purpose of this study was to examine factors associated with interest in psychological interventions among persons with chronic noncancer pain receiving prescription opioids. METHODS: Participants with chronic noncancer pain and a new 30 to 90 day opioid prescription were recruited from 2 health systems. Participants (N=845) completed measures regarding pain, opioid use, psychiatric symptoms, emotional support, and interest in psychological interventions for pain management. RESULTS: There were 245 (29.0%) participants who reported a high interest in psychological interventions for pain management. In bivariate analyses, variables associated with interest included younger age, female sex, greater pain severity, greater pain interference, greater number of pain sites, lower emotional support, depression, anxiety, and post-traumatic stress disorder ( P <0.05). In a multivariate model, greater pain severity (odds ratio [OR]=1.17; CI: 1.04-1.32), depression (OR=2.10; CI: 1.39-3.16), post-traumatic stress disorder (OR=1.85; CI: 1.19-2.95), and lower emotional support (OR=0.69; CI: 0.5-0.97) remained statistically significant. DISCUSSION: The rate of interest in psychological interventions for pain management was low, which may indicate that patients initiating opioid treatment of chronic noncancer pain have low interest in psychological interventions. Greater pain severity and psychiatric distress were related to interest, and patients with these characteristics may especially benefit from psychological interventions. Providers may want to refer to psychological interventions before or when opioids are initiated. Additional work is needed to determine whether this would reduce long-term opioid use.


Chronic Pain , Pain Management , Humans , Female , Analgesics, Opioid/therapeutic use , Chronic Pain/therapy , Chronic Pain/psychology , Psychosocial Intervention , Anxiety/therapy
14.
N Engl J Med ; 389(24): 2233-2244, 2023 Dec 14.
Article En | MEDLINE | ID: mdl-38091530

BACKGROUND: Respiratory syncytial virus (RSV) can cause substantial morbidity and mortality among older adults. An mRNA-based RSV vaccine, mRNA-1345, encoding the stabilized RSV prefusion F glycoprotein, is under clinical investigation. METHODS: In this ongoing, randomized, double-blind, placebo-controlled, phase 2-3 trial, we randomly assigned, in a 1:1 ratio, adults 60 years of age or older to receive one dose of mRNA-1345 (50 µg) or placebo. The two primary efficacy end points were the prevention of RSV-associated lower respiratory tract disease with at least two signs or symptoms and with at least three signs or symptoms. A key secondary efficacy end point was the prevention of RSV-associated acute respiratory disease. Safety was also assessed. RESULTS: Overall, 35,541 participants were assigned to receive the mRNA-1345 vaccine (17,793 participants) or placebo (17,748). The median follow-up was 112 days (range, 1 to 379). The primary analyses were conducted when at least 50% of the anticipated cases of RSV-associated lower respiratory tract disease had occurred. Vaccine efficacy was 83.7% (95.88% confidence interval [CI], 66.0 to 92.2) against RSV-associated lower respiratory tract disease with at least two signs or symptoms and 82.4% (96.36% CI, 34.8 to 95.3) against the disease with at least three signs or symptoms. Vaccine efficacy was 68.4% (95% CI, 50.9 to 79.7) against RSV-associated acute respiratory disease. Protection was observed against both RSV subtypes (A and B) and was generally consistent across subgroups defined according to age and coexisting conditions. Participants in the mRNA-1345 group had a higher incidence than those in the placebo group of solicited local adverse reactions (58.7% vs. 16.2%) and of systemic adverse reactions (47.7% vs. 32.9%); most reactions were mild to moderate in severity and were transient. Serious adverse events occurred in 2.8% of the participants in each trial group. CONCLUSIONS: A single dose of the mRNA-1345 vaccine resulted in no evident safety concerns and led to a lower incidence of RSV-associated lower respiratory tract disease and of RSV-associated acute respiratory disease than placebo among adults 60 years of age or older. (Funded by Moderna; ConquerRSV ClinicalTrials.gov number, NCT05127434.).


Respiratory Syncytial Virus Infections , Respiratory Syncytial Virus Vaccines , Respiratory Syncytial Virus, Human , mRNA Vaccines , Aged , Humans , Antibodies, Viral , Double-Blind Method , Respiratory Syncytial Virus Infections/epidemiology , Respiratory Syncytial Virus Infections/prevention & control , Respiratory Syncytial Virus, Human/genetics , Respiratory Tract Diseases/diagnosis , Respiratory Tract Diseases/epidemiology , Respiratory Tract Diseases/prevention & control , Treatment Outcome , mRNA Vaccines/adverse effects , mRNA Vaccines/therapeutic use , Respiratory Syncytial Virus Vaccines/adverse effects , Respiratory Syncytial Virus Vaccines/therapeutic use , Middle Aged
15.
PLoS One ; 18(12): e0296251, 2023.
Article En | MEDLINE | ID: mdl-38157342

Central retinal artery occlusion (CRAO; retinal stroke or eye stroke) is an under-recognized, disabling form of acute ischemic stroke which causes severe visual loss in one eye. The classical risk factor for CRAO is ipsilateral carotid stenosis; however, nearly half of patients with CRAO do not have high-grade carotid stenosis, suggesting that other cardiovascular risk factors may exist for CRAO. Specifically, prior studies have suggested that cardioembolism, driven by underlying atrial fibrillation, may predispose patients to CRAO. We describe the design of an observational, population-based study in this protocol. We evaluate two specific objectives: 1) To determine if atrial fibrillation is an independent risk factor for CRAO after adjusting for medical and cardiovascular risk; 2) To determine if use of oral anticoagulation can modify the risk of CRAO for patients with atrial fibrillation. This protocol lays out our strategy for cohort definition, case and control definition, comorbidity ascertainment, and statistical methods.


Atrial Fibrillation , Carotid Stenosis , Ischemic Stroke , Retinal Artery Occlusion , Stroke , Humans , Retrospective Studies , Atrial Fibrillation/complications , Atrial Fibrillation/epidemiology , Stroke/epidemiology , Stroke/etiology , Risk Factors , Retinal Artery Occlusion/complications , Retinal Artery Occlusion/epidemiology , Observational Studies as Topic
16.
Biomolecules ; 13(11)2023 10 24.
Article En | MEDLINE | ID: mdl-38002248

Autoantibodies to tumor-associated antigens (anti-TAA) are potential biomarkers for breast cancer, but their relationship systemic autoimmunity as ascertained though antinuclear antibodies (ANA) is unknown and warrants consideration given the common occurrence of autoimmunity and autoimmune diseases among women. The relationship between anti-TAAs and ANA among women who were later diagnosed with breast cancer and others who remained cancer free in the Women's Health Initiative cohort. The study sample included 145 post-menopausal women with baseline ANA data. A total of 37 ANA-positive women who developed breast cancer (i.e., cases; mean time to diagnosis 6.8 years [SE 3.9]) were matched to a random sample of 36 ANA-negative cases by age and time to diagnosis. An age-matched control sample was selected including 35 ANA-positive and 37 ANA-negative women who did not develop breast cancer (i.e., controls; follow-up time ~13 years [SE 3]). Baseline sera were assessed for Immunoglobulin G (IgG) antibodies, measured by custom microarray for 171 breast and other cancer-associated TAA. We used linear regression to estimate cross-sectional associations of ANA with log-transformed anti-TAA among cases and controls. Most anti-TAA did not vary by ANA status. Two anti-TAA were elevated in ANA-positive compared to ANA-negative cases: anti-PGM3 (p = 0.004) and anti-TTN (p = 0.005, especially in cases up to 7 years before diagnosis, p = 0.002). Anti-TAA antibodies were not generally related to ANA, a common marker of systemic autoimmunity. Associations of ANA with particular antigens inducing autoimmunity prior to breast cancer warrant further investigation.


Autoimmune Diseases , Breast Neoplasms , Humans , Female , Autoimmunity , Cross-Sectional Studies , Postmenopause , Antibodies, Antinuclear
17.
SSM Popul Health ; 24: 101546, 2023 Dec.
Article En | MEDLINE | ID: mdl-37954012

Background: Low educational attainment is associated with excess cancer mortality. However, the mechanisms driving this association remain unknown. Methods: Using data from the REasons for Geographic and Racial Differences in Stroke (REGARDS) study, we evaluated the associations of participant and parental/caregiver education with cancer mortality using Cox proportional hazards models, adjusting for socio-demographic characteristics and health conditions. We used principal components analysis to generate indices of measures representing the social determinants of health (SDOH) and health behaviors. We used structural equation modeling to determine if the association between educational attainment and cancer mortality was mediated by these domains. Results: Among 30,177 REGARDS participants included in this analysis, 3798 (12.6%) had less than a high school degree. In fully adjusted models, those without a high school education experienced about 50% greater risk of death than high school graduates and higher (White participants HR: 1.47; 95% CI: 1.23, 1.76 and Black HR: 1.54; 95% CI: 1.33, 1.79). There was evidence of a modest mediation effect for the association between education and cancer mortality by the SDOH domain score (White total effect HR: 1.25; 95% CI: 1.18, 1.33, indirect effect HR: 1.04; 95% CI: 1.03, 1.05, direct effect HR: 1.21; 95% CI: 1.14, 1.28 and Black total effect HR: 1.24; 95% CI: 1.18, 1.29, indirect effect HR: 1.04; 95% CI: 1.03, 1.05, direct effect HR: 1.19; 95% CI: 1.14, 1.24). There was no evidence of mediation by the health behaviors score. No significant associations were found for female caregiver/mother's or male caregiver/father's education (N = 13,209). Conclusions: In conclusion, participant education was strongly associated with cancer mortality, and this association was partially mediated by the SDOH domain score.

18.
Dent Clin North Am ; 67(4): 695-698, 2023 10.
Article En | MEDLINE | ID: mdl-37714627

Crohn's disease has been associated with poor oral health and oral health-related quality of life. Myriad-specific and nonspecific oral lesions have been associated with Crohn's disease. Oral lesions in patients with Crohn's disease may be a source of referred pain, especially if mucosal ulcerations or orofacial granulomatosis are involved. The dental provider can play an important role in evaluating for and/or managing oral lesions in patients with Crohn's disease and thereby improving patients' oral health and quality of life.


Crohn Disease , Humans , Crohn Disease/complications , Quality of Life , Pain , Oral Health
19.
J Clin Rheumatol ; 29(8): 370-374, 2023 Dec 01.
Article En | MEDLINE | ID: mdl-37644647

BACKGROUND: Currently, there are 9 states across the United States that do not have a pediatric rheumatologist, including the state of Montana. Patients in these states are often cared for by outreach clinics staffed by pediatric rheumatology (PR) providers from other states or looked after by in-state adult rheumatologists or in-state primary care providers. METHODS: Using a web-based survey, we determined barriers and potential solutions to PR referrals from referring providers (including primary care providers and subspecialists) in Montana state. RESULTS: Eighty-five Montana referring providers responded, with 44% being pediatric physicians and 33% being family medicine physicians. Other respondents were adult rheumatologists, pediatric and family medicine advanced practice providers, orthopedic surgeons, and pediatric subspecialists. Eighty-five percent of providers had previously referred a patient to PR. Referring providers rated difficulty referring MT patients to PR as 27 (on a linear numeric scale of 0-100, with 0 being very difficult) and noted lack of access to local pediatric rheumatologist as the most significant barrier to referral. The top patient barrier as perceived by 95% of providers was travel time. Potential solutions to improve care included presence of local pediatric rheumatologist with 50 miles, development of algorithms for common PR complaints, and outreach clinics. CONCLUSION: Referring providers in Montana report difficulty in referring to PR, with lack of access and travel time being key barriers. Improving access through expanding local PR workforce and increasing access through outreach clinics may help reduce these barriers.


Physicians , Rheumatology , Adult , Humans , Child , Montana , Rheumatologists , Referral and Consultation
20.
Int Wound J ; 20(8): 2953-2963, 2023 Oct.
Article En | MEDLINE | ID: mdl-37529854

Pressure injuries affect 1 to 46% of residents in aged care (long term) facilities and cause a substantial economic burden on health care systems. Remote expert wound nurse consultation has the potential to improve pressure injury outcomes; however, the clinical and cost effectiveness of this intervention for healing of pressure injuries in residential aged care require further investigation. We describe the remote expert wound nurse consultation intervention and the method of a prospective, pilot, cluster randomised controlled trial. The primary outcome is number of wounds healed. Secondary outcomes are wound healing rate, time to healing, wound infection, satisfaction, quality of life, cost of treatment and care, hospitalisations, and deaths. Intervention group participants receive the intervention over a 12-week period and all participants are monitored for 24 weeks. A wound imaging and measurement system is used to analyse pressure injury images. A feasibility and fidelity evaluation will be concurrently conducted. The results of the trial will inform the merit of and justification for a future definitive trial to evaluate the clinical and cost effectiveness of remote expert wound nurse consultation for the healing of pressure injuries in residential aged care.


Cost-Effectiveness Analysis , Pressure Ulcer , Humans , Aged , Pressure Ulcer/therapy , Prospective Studies , Quality of Life , Wound Healing , Referral and Consultation , Cost-Benefit Analysis , Randomized Controlled Trials as Topic
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