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11 result(s) for "Sheffield, Tamara"
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Respiratory syncytial virus (RSV) vaccine effectiveness against RSV-associated hospitalisations and emergency department encounters among adults aged 60 years and older in the USA, October, 2023, to March, 2024: a test-negative design analysis
Respiratory syncytial virus vaccines first recommended for use during 2023 were efficacious against lower respiratory tract disease in clinical trials. Limited real-world data regarding respiratory syncytial virus vaccine effectiveness are available. To inform vaccine policy and address gaps in evidence from the clinical trials, we aimed to assess the effectiveness against respiratory syncytial virus-associated hospitalisations and emergency department encounters among adults aged at least 60 years. We conducted a test-negative design analysis in an electronic health records-based network in eight states in the USA, including hospitalisations and emergency department encounters with respiratory syncytial virus-like illness among adults aged at least 60 years who underwent respiratory syncytial virus testing from Oct 1, 2023, to March 31, 2024. Respiratory syncytial virus vaccination status at the time of the encounter was derived from electronic health record documentation, state and city immunisation registries, and, for some sites, medical claims. Vaccine effectiveness was estimated by immunocompromise status, comparing the odds of vaccination among respiratory syncytial virus-positive case patients and respiratory syncytial virus-negative control patients, and adjusting for age, race and ethnicity, sex, calendar day, social vulnerability index, number of underlying non-respiratory medical conditions, presence of respiratory underlying medical conditions, and geographical region. Among 28 271 hospitalisations for respiratory syncytial virus-like illness among adults aged at least 60 years without immunocompromising conditions, vaccine effectiveness was 80% (95% CI 71–85) against respiratory syncytial virus-associated hospitalisations, and vaccine effectiveness was 81% (52–92) against respiratory syncytial virus-associated critical illness (ICU admission or death, or both). Among 8435 hospitalisations for respiratory syncytial virus-like illness among adults with immunocompromising conditions, vaccine effectiveness was 73% (48–85) against associated hospitalisation. Among 36 521 emergency department encounters for respiratory syncytial virus-like illness among adults aged at least 60 years without an immunocompromising condition, vaccine effectiveness was 77% (70–83) against respiratory syncytial virus-associated emergency department encounters. Vaccine effectiveness estimates were similar by age group and product type. Respiratory syncytial virus vaccination was effective in preventing respiratory syncytial virus-associated hospitalisations and emergency department encounters among adults aged at least 60 years in the USA during the 2023–24 respiratory syncytial virus season, which was the first season after respiratory syncytial virus vaccine was approved. The Centers for Disease Control and Prevention.
Effectiveness of 2023–2024 seasonal influenza vaccine against influenza-associated emergency department and urgent care encounters among pregnant and non-pregnant women of reproductive age
Influenza vaccination is particularly important for pregnant women. Using a test-negative, case-control design, we estimated the effectiveness of 2023–2024 seasonal influenza vaccination against influenza-associated emergency department and urgent care (ED/UC) encounters among pregnant and non-pregnant women of reproductive age using data from seven healthcare systems. Eligible encounters were among individuals aged 18–49 years with documented female sex. Vaccine effectiveness (VE) was estimated by comparing the odds of vaccination among influenza-positive cases versus influenza-negative controls, adjusting for site, age, race/ethnicity, calendar time, and gestational age at encounter (in pregnant women). Among pregnant women (N = 3539), VE against influenza-associated ED/UC encounters was 46 % (95 % CI: 36–55) and did not differ by gestational age at vaccination. Among non-pregnant women (N = 57,709), VE against influenza-associated ED/UC encounters was 54 % (95 % CI: 51–56). Influenza vaccination during the 2023–2024 season was similarly effective in both pregnant and non-pregnant women and by timing of vaccine receipt during pregnancy.
Estimated 2023-2024 COVID-19 Vaccine Effectiveness in Adults
SARS-CoV-2 continues to evolve, population immunity changes, and COVID-19 vaccine formulas have been updated, necessitating ongoing COVID-19 vaccine effectiveness (VE) monitoring. To evaluate the VE of 2023-2024 COVID-19 vaccines against COVID-19-associated emergency department (ED) and urgent care (UC) encounters, hospitalizations, and critical illness, including during XBB- and JN.1-predominant periods. This test-negative design VE case-control study was conducted using data from September 21, 2023, to August 22, 2024, from EDs, UC centers, and hospitals in 6 US health care systems. Eligible adults 18 years or older with COVID-19-like illness and molecular or antigen testing for SARS-CoV-2 were studied. Case patients were those with a positive molecular or antigen test result; control patients were those with a negative molecular test result. Receipt of 2023-2024 (monovalent XBB.1.5) COVID-19 vaccination with products approved or authorized for use in the US. Main outcomes were COVID-19-associated ED and UC encounters, hospitalizations, and critical illness (admission to the intensive care unit or in-hospital death). VE was estimated comparing the odds of receipt of the 2023-2024 COVID-19 vaccine with no receipt among case and control patients. Among 345 639 eligible ED and UC encounters in immunocompetent adults 18 years or older with COVID-19-like illness and available test results (median [IQR] age, 53 [34-71] years; 209 087 [60%] female), 37 096 (11%) had a positive SARS-CoV-2 test result. VE against COVID-19-associated ED and UC encounters was 24% (95% CI, 21%-26%) during 7 to 299 days after vaccination. Among 111 931 eligible hospitalizations in immunocompetent adults 18 years or older with COVID-19-like illness and available test results (median [IQR] age, 71 [58-81] years), 10 380 (9%) had a positive SARS-CoV-2 test result. During 7 to 299 days after vaccination, VE was 29% (95% CI, 25%-33%) against COVID-19-associated hospitalization and 48% (95% CI, 40%-55%) against COVID-19-associated critical illness. VE was highest 7 to 59 days after vaccination (VE against ED and UC encounters 49%; 95% CI, 46%-52%; hospitalization, 51%; 95% CI, 46%-56%; critical illness, 68%; 95% CI, 56%-76%) and then waned (VE 180-299 days after vaccination against ED and UC encounters, -7% [95% CI, -13% to -2%]; hospitalization, -4% [95% CI, -14% to 5%]; and critical illness, 16% [95% CI, -6 to 34%]). In this case-control study of VE, 2023-2024 COVID-19 vaccines were estimated to provide additional effectiveness against medically attended COVID-19, with the highest and most sustained estimates against critical illness. These results highlight the importance of receiving recommended COVID-19 vaccination for adults 18 years or older.
Interim Effectiveness of Updated 2023–2024 (Monovalent XBB.1.5) COVID-19 Vaccines Against COVID-19–Associated Hospitalization Among Adults Aged ≥18 Years with Immunocompromising Conditions — VISION Network, September 2023–February 2024
In September 2023, CDC's Advisory Committee on Immunization Practices recommended updated 2023-2024 (monovalent XBB.1.5) COVID-19 vaccination for all persons aged ≥6 months to prevent COVID-19, including severe disease. As with past COVID-19 vaccines, additional doses may be considered for persons with immunocompromising conditions, who are at higher risk for severe COVID-19 and might have decreased response to vaccination. In this analysis, vaccine effectiveness (VE) of an updated COVID-19 vaccine dose against COVID-19-associated hospitalization was evaluated during September 2023-February 2024 using data from the VISION VE network. Among adults aged ≥18 years with immunocompromising conditions, VE against COVID-19-associated hospitalization was 38% in the 7-59 days after receipt of an updated vaccine dose and 34% in the 60-119 days after receipt of an updated dose. Few persons (18%) in this high-risk study population had received updated COVID-19 vaccine. All persons aged ≥6 months should receive updated 2023-2024 COVID-19 vaccination; persons with immunocompromising conditions may get additional updated COVID-19 vaccine doses ≥2 months after the last recommended COVID-19 vaccine.
Effectiveness of 2024-2025 COVID-19 Vaccines in Children in the United States - VISION, August 29, 2024-September 2, 2025
During September 2023-August 2024, approximately 38,000 COVID-19-associated hospitalizations occurred among children and adolescents aged <18 years in the United States, a rate of approximately 53 per 100,000 children, ranging from 600 per 100,000 children aged <6 months to 21 per 100,000 children and adolescents aged 5-17 years. On June 27, 2024, the Advisory Committee on Immunization Practices recommended that all persons aged ≥6 months receive a 2024-2025 COVID-19 vaccine, which targeted Omicron JN.1 and JN.1-derived sublineages. Investigators used a test-negative case-control design to estimate vaccine effectiveness (VE) of 2024-2025 COVID-19 vaccines against COVID-19-associated emergency department or urgent care (ED/UC) visits during August 29, 2024-September 2, 2025, among immunocompetent children aged 9 months-4 years and children and adolescents aged 5-17 years in the CDC-funded Virtual SARS-CoV-2, Influenza, and Other respiratory viruses Network (VISION), a multisite electronic health record-based network in nine states. Among children aged 9 months-4 years, VE against COVID-19-associated ED/UC visits was estimated at 76% (95% CI = 58%-87%) during the first 7-179 days after vaccination. Among children and adolescents aged 5-17 years, VE against COVID-19-associated ED/UC visits was an estimated 56% (95% CI = 35%-70%) during the first 7-179 days after vaccination. These findings suggest that vaccination with a 2024-2025 COVID-19 vaccine dose provided children with additional protection against COVID-19-associated ED/UC encounters compared with no 2024-2025 dose.
'All About That Bass'? Is non-ideal-weight discrimination unlawful in the UK?
People of non-ideal-weight (overweight or severely underweight) are subjected to discrimination, in the workplace and elsewhere, based on attitudinal assumptions and negative inferences from their membership of a group, such as that they are insufficiently self-motivated to make good employees. But is that discrimination unlawful in the UK? The Equality Act 2010 offers only a very tenuous route for protection, because the Act is based largely on a 'medical model' of disability. EU law, which embraces a 'social model' of disability, drawing from the UN Convention on the Rights of Persons with Disabilities, offers more, at least in theory. But the mechanisms for enforcing individual EU law rights mean that entitlements in EU law are likely to be enforceable in practice only against state employers. This situation leaves a gap in the law which is remediable only by legislative reform.
Efficient assessment of brain fog and fatigue: Development of the Fatigue and Altered Cognition Scale (FACs)
Debilitating symptoms of fatigue and accompanying “brain fog” are observed among patients with various chronic health conditions. Unfortunately, an efficient and psychometrically sound instrument to assess these co-occurring symptoms is unavailable. Here, we report the development and initial psychometric properties of the Fatigue and Altered Cognition Scale (the FACs), a measure of self-reported central fatigue and brain fog. Traumatic brain injury (TBI) was chosen to model and develop the FACs due to research team expertise and established links between TBI and the symptom complex. Potential items were generated by researchers and clinicians with experience treating these symptoms, drawing from relevant literature and review of patient responses to measures from past and current TBI studies. The 20 candidate items for the FACs—ten each to assess altered cognition (i.e., brain fog) and central fatigue–were formatted on an electronic visual analogue response scale (eVAS) via an online survey. Demographic information and history of TBI were obtained. A total of 519 participants consented and provided usable data (average age = 40.23 years; 73% female), 204 of whom self-reported a history of TBI (75% reported mild TBI). Internal consistency and reliability values were calculated. Confirmatory factor analysis (CFA) examined the presumed two-factor structure of the FACs and a one-factor solution for comparison. A measurement invariance test of the two latent constructs (altered cognition, fatigue) among participants with and without TBI was conducted. All items demonstrated normal distribution. Cronbach’s alpha coefficients indicated good internal consistency for both factors (α’s = .95). Omega reliability values were favorable (α’s = .95). CFA supported the presumed two-factor model and item loadings which outperformed the one-factor model. Measurement invariance found the two-factor structure was consistent between the two groups. Implications of these findings, study limitations, and potential use of the FACs in clinical research and practice are discussed.
Breathe Easier Online: Evaluation of a Randomized Controlled Pilot Trial of an Internet-Based Intervention to Improve Well-being in Children and Adolescents With a Chronic Respiratory Condition
Chronic respiratory illnesses are the most common group of childhood chronic health conditions and are overrepresented in socially isolated groups. To conduct a randomized controlled pilot trial to evaluate the efficacy of Breathe Easier Online (BEO), an Internet-based problem-solving program with minimal facilitator involvement to improve psychosocial well-being in children and adolescents with a chronic respiratory condition. We randomly assigned 42 socially isolated children and adolescents (18 males), aged between 10 and 17 years to either a BEO (final n = 19) or a wait-list control (final n = 20) condition. In total, 3 participants (2 from BEO and 1 from control) did not complete the intervention. Psychosocial well-being was operationalized through self-reported scores on depression symptoms and social problem solving. Secondary outcome measures included self-reported attitudes toward their illness and spirometry results. Paper-and-pencil questionnaires were completed at the hospital when participants attended a briefing session at baseline (time 1) and in their homes after the intervention for the BEO group or a matched 9-week time period for the wait-list group (time 2). The two groups were comparable at baseline across all demographic measures (all F < 1). For the primary outcome measures, there were no significant group differences on depression (P = .17) or social problem solving (P = .61). However, following the online intervention, those in the BEO group reported significantly lower depression (P = .04), less impulsive/careless problem solving (P = .01), and an improvement in positive attitude toward their illness (P = .04) compared with baseline. The wait-list group did not show these differences. Children in the BEO group and their parents rated the online modules very favorably. Although there were no significant group differences on primary outcome measures, our pilot data provide tentative support for the feasibility (acceptability and user satisfaction) and initial efficacy of an Internet-based intervention for improving well-being in children and adolescents with a chronic respiratory condition. Australian New Zealand Clinical Trials Registry number: ACTRN12610000214033; http://www.anzctr.org.au/trial_view.aspx?ID=308074 (Archived by WebCite at http://www.webcitation.org/63BL55mXH).
MON-028 Symptom Improvement in an Ulcerative Colitis Patient Following 6-Month Recombinant Human Growth Hormone Therapy: A Case Report
Abstract Disclosure: M. Pan: None. R.J. Urban: None. T.J. Wright: None. R.B. Pyles: None. M. Sheffield-Moore: None. K. Randolph: None. K.A. McGovern: None. C.P. Danesi: None. T. Wexler: None. B. Masel: None. A.L. Miller: None. C. Maxwell: None. K.C. Yuen: None. R.D. Batson: None. Introduction Ulcerative colitis is a lifelong condition marked by continuous colonic lesions and inflammation in the mucosal and submucosal layers of the colon and rectum. Patients with this type of inflammatory bowel disease experience symptoms such as bloody diarrhea, rectal urgency, fecal incontinence, and abdominal pain. Common treatments include sulfasalazine and 5-aminosalicylates, with proctocolectomy considered in cases where medical management fails. This report aims to describe symptom improvement in an ulcerative colitis patient receiving growth hormone replacement therapy (GHRT) for 6 months. Clinical Case (Diagnostic evaluation, treatment, follow-up) A 45-year-old female with severe ulcerative colitis (total colectomy at age 16) and a remote history of mild traumatic brain injury (mTBI) presented with symptoms of chronic, debilitating fatigue and brain fog. Based on her history of mTBI, she was tested for growth hormone deficiency (GHD). Adult-onset growth hormone deficiency (AGHD) was confirmed via the glucagon stimulation test (GST) with a peak GH level of 2.7 ng/mL (BMI 24.5 kg/m2). She underwent GHRT with daily injections of 0.6 mg recombinant human growth hormone for 6 months. Following the initial treatment period, she elected to continue GHRT based on notable improvements in fatigue, mood, gastrointestinal symptoms, and IGF-1 levels (pretreatment 52 ng/mL, posttreatment 182 ng/mL, range 118-298, mean 205). Prior to and following treatment, the patient underwent a modified 6-minute walk test and completed self-report measures including the Brief Fatigue Inventory (BFI), Multidimensional Fatigue Symptom Inventory (MFSI), Profile of Mood States (POMS), Beck Depression Inventory (BDI), Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA), Pittsburgh Sleep Quality Index (PSQI), and the Gastrointestinal Symptom Rating Scale (GSRS). Substantial improvements (percent change) were seen in the modified 6-minute walk test, BFI Global Fatigue (12%), MFSI General Fatigue (41.67%), POMS Depression (53%), BDI-II/Depression (91%), POMS Tension-Anxiety (73%), POMS Vigor (160%), POMS Confusion (37.5%), POMS Total Mood Disturbance (72%), QoL-AGHDA (59%), and GSRS (50%). Most notably, she experienced marked decreases in abdominal pain (57%) and diarrhea (78%) scores on the GSRS. Clinical Lessons/Conclusions We present a case of a patient with ulcerative colitis who underwent GHRT for 6 months. The documented improvements in this patient’s symptoms, including abdominal pain and diarrhea as well as physical performance measures, highlight the potential benefits of GHRT for patients with confirmed AGHD who suffer from the long-term symptom burden of ulcerative colitis. Keywords: Ulcerative colitis, growth hormone, brain fog Presentation: Monday, July 14, 2025
Serum ferritin values in neonates <29 weeks’ gestation are highly variable and do not correlate with reticulocyte hemoglobin content
ObjectivesTo compare serum ferritin and RET-He values among extremely low gestational age neonates ELGANs with other markers of iron-deficient erythropoiesis.Study DesignThis is a secondary analysis of the NICHD Darbepoetin Trial. Study data from placebo recipients who had a serum ferritin, a RET-He, and a mean corpuscular volume (MCV) measurement within a 24-hour period were analyzed for correlation.ResultsMixed linear regression models showed no association between ferritin and RET-He at both early (β = 0.0016, p = 0.40) and late (β = −0.0001, p = 0.96) time points. Positive associations were observed between RET-He and MCV at baseline, early, and late time points (p < 0.01, =0.01, <0.001, respectively), while ferritin was not associated with MCV at any time point.ConclusionsOur study shows that RET-He is better correlated with MCV as a marker of iron-limited erythropoiesis than ferritin. The results suggest that ferritin is limited as a marker of iron sufficiency in premature infants.Study IdentificationFDA IND Number 100138; ClinicalTrials.gov number NCT03169881; NRN ID number NICHD-NRN-0058 (Darbe).