Outcomes of extremely low gestational age neonates (ELGANs) may be adversely impacted by packed red blood cell (pRBC) transfusions. We investigated the impact of transfusions on neurodevelopmental ...outcome in the Preterm Erythropoietin (Epo) Neuroprotection (PENUT) Trial population.
This is a post hoc analysis of 936 infants 24-0/6 to 27-6/7 weeks' gestation enrolled in the PENUT Trial. Epo 1000 U/kg or placebo was given every 48 h × 6 doses, followed by 400 U/kg or sham injections 3 times a week through 32 weeks postmenstrual age. Six hundred and twenty-eight (315 placebo, 313 Epo) survived and were assessed at 2 years of age. We evaluated associations between BSID-III scores and the number and volume of pRBC transfusions.
Each transfusion was associated with a decrease in mean cognitive score of 0.96 (95% CI of -1.34, -0.57), a decrease in mean motor score of 1.51 (-1.91, -1.12), and a decrease in mean language score of 1.10 (-1.54, -0.66). Significant negative associations between BSID-III score and transfusion volume and donor exposure were observed in the placebo group but not in the Epo group.
Transfusions in ELGANs were associated with worse outcomes. We speculate that strategies to minimize the need for transfusions may improve outcomes.
Transfusion number, volume, and donor exposure in the neonatal period are associated with worse neurodevelopmental (ND) outcome at 2 years of age, as assessed by the Bayley Infant Scales of Development, Third Edition (BSID-III). The impact of neonatal packed red blood cell transfusions on the neurodevelopmental outcome of preterm infants is unknown. We speculate that strategies to minimize the need for transfusions may improve neurodevelopmental outcomes.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
At Westminster College, an undergraduate institution, a cadaveric gross anatomical dissection was completed using the thirteenth edition of Grant's Dissector. The objectives of this dissection were ...to determine possible indicated health conditions, pathologies, and anatomical variations present in a single cadaver. Anatomical variations in the cadaver included renal, pelvic, coronary, porta hepatic, and transverse cervical vasculature, as well as variations of rib structure. In addition to anatomical variations, pathologies were studied by comparing findings to anatomical standards. Pathologies included pleural adhesion of the left lung, bronchopulmonary lymph nodes with anthracotic pigmentation, and calcification of the abdominal aorta. The analyses of pathologies were conducted to include histopathology of pulmonary, vascular, and cardiovascular tissue, as well as a calcium analysis of the abdominal aorta. These pathological test results assisted in confirming the indicated health condition of the cadaver. Overall, students gained an understanding and appreciation of standard human anatomy, pathologies, and anatomical variations through this exploration.
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•Light attenuation through riverine Cladophora glomerata filaments was measured.•Experiments were completed with a fiber-optic sensor in a flume and in situ.•Volumetric biomass provided suitable ...explanation of downward light attenuation.•Areal biomass density was a poor predictor of the light extinction coefficient.•Drag from water velocity compresses the algal mat reducing downwelling irradiance.
The attenuation of photosynthetically active radiation (PAR) through the filamentous alga Cladophora glomerata was investigated both in situ and in an experimental flow tank under natural and artificial lighting using a fiber-optic sensor. Over 35 separate experiments were completed to characterize downward light attenuation and water velocity effects. Measured extinction coefficients ranged from 4.3 to 150.7 m−1 for biomass samples ranging from 40 to 253 mg chlorophyll-a m−2 (41 to 381 g ash free dry weight m−2) at shear velocities from 0 to 51.8 cm s−1. An exponential relationship between light attenuation coefficient (Kalg) and algal biomass thickness (δ) was found (lnKalg = −1.1831 lnδ + 8.3789; r2 = 0.41, p < 0.001). Unexpectedly, chlorophyll-a (Chla) and ash free dry weight (AFDW) areal density were poor predictors of Kalg. No significant correlations (p > 0.01) were found amongst any of the other experimental variables (e.g., shear velocity, Reynolds number, etc.). Cladophora mat thickness (δ) and volumetric biomass (Chla m−3) provided the greatest explanation of downward light attenuation in flowing water, reducing irradiance in proportion to how closely the filaments are pressed together. Observed δ generally decreased with increasing shear velocity, albeit not predictably. Results have important implications on aquatic systems where macroalgae generate variable light regimes on understory aquatic species.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
1505 Background: Expert consensus supports a multidisciplinary strategy in cancer survivorship care to enhance patient outcomes and quality of life. We hypothesized that introducing a women’s ...survivorship clinic into routine follow up care would be feasible, and associated with improved symptom management and quality of life (QOL). Methods: LYSA was a multisite randomized controlled trial with parallel arms (experimental and active comparator), co-designed with public and patient involvement. Eligibility: early-stage hormone receptor-positive breast or gynaecologic cancer (GYN) within 12 months of completing primary therapy, and internet access (NCT05035173). Experimental arm attended a nurse-led clinic targeting symptom management, and dietetic consultation. Electronic patient-reported outcome (ePRO) assessments were undertaken at baseline, and bimonthly to 12 months. An online trigger alert system facilitated symptom management. Active comparator arm attended the nurse-led clinic at baseline and end of study. Primary endpoint (feasibility): Proportions of participants completing baseline and follow up ePRO surveys, and engaging in healthcare consultations after ePRO triggers. Pilot efficacy endpoints: changes in cancer-related symptom (PROMIS, PRO-CTCAE, Fear of Cancer Recurrence), health-related QOL Questionnaires (EORTC-QLQ, EQ5D5L) . Sample size target (n=200) facilitated feasibility outcomes. Between arm differences were estimated using generalized linear model, adjusted for baseline outcome. Results: 200 women were randomized, March 2021-August 2022 across two sites; 84% breast and 16% GYN. Consent was obtained in clinic (51%), video call (33%) or phone (16%). Median age was 54 (range 23-78). Of the 173 participants completing the study (n = 90 experimental, 83 comparator), all completed both baseline and end of study surveys. Following symptom triggers (experimental arm), there were 322 study nurse visits across 86 participants, and 243 dietician visits across 73 participants. Engagement with healthcare and other supportive resources was approximately twice more than comparator arm, due to referral. There were no notable between-arm differences with respect to EQ5D5L items at study end. However, experimental arm participants had better EORTC Total scores at study end relative to comparator (difference in means -3.87 95%CI -6.58 to -1.16, p=0.005). There were also significant (p < 0.05) differences observed between the arms for 8/12 symptom items reflecting less fatigue, anxiety and depression in experimental arm at study end. Conclusions: The LYSA trial met its primary feasibility endpoint, with high rates of ePRO completion. Secondary endpoint analysis is ongoing including an economic analysis and future studies. Clinical trial information: NCT05035173 .
IntroductionJapanese encephalitis virus (JEV) is a mosquito-borne flavivirus that causes encephalitis and other morbidity in Southeast Asia. Since February 2022, geographically dispersed JEV human, ...animal and vector detections occurred on the Australian mainland for the first time. This study will determine the prevalence of JEV-specific antibodies in human blood with a focus on populations at high risk of JEV exposure and determine risk factors associated with JEV seropositivity by location, age, occupation and other factors.MethodSamples are collected using two approaches: from routine blood donors (4153 samples), and active collections targeting high-risk populations (convenience sampling). Consent-based sampling for the latter includes a participant questionnaire on demographic, vaccination and exposure data. Samples are tested for JEV-specific total antibody using a defined epitope-blocking ELISA, and total antibody to Australian endemic flaviviruses Murray Valley encephalitis and Kunjin viruses.AnalysisTwo analytic approaches will occur: descriptive estimates of seroprevalence and multivariable logistic regression using Bayesian hierarchical models. Descriptive analyses will include unadjusted analysis of raw data with exclusions for JEV-endemic country of birth, travel to JEV-endemic countries, prior JEV-vaccination, and sex-standardised and age-standardised analyses. Multivariable logistic regression will determine which risk factors are associated with JEV seropositivity likely due to recent transmission within Australia and the relative contribution of each factor when accounting for effects within the model.EthicsNational Mutual Acceptance ethical approval was obtained from the Sydney Children’s Hospitals Network Human Research Ethics Committee (HREC). Local approvals were planned to be sought in each jurisdiction, as per local ethics processes. Ethical approval was also obtained from the Australian Red Cross Lifeblood HREC.DisseminationFindings will be communicated to participants and their communities, and human and animal health stakeholders and policy-makers iteratively and after final analyses. Understanding human infection rates will inform procurement and targeted allocation of limited JEV vaccine, and public health strategies and communication campaigns, to at-risk populations.
An effective therapeutic vaccine that could augment immune control of HIV-1 replication may abrogate or delay the need for antiretroviral therapy. AIDS Clinical Trials Group (ACTG) A5187 was a phase ...I/II, randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of an HIV-1 DNA vaccine (VRC-HVDNA 009-00-VP) in subjects treated with antiretroviral therapy during acute/early HIV-1 infection. (clinicaltrials.gov NCT00125099)
Twenty healthy HIV-1 infected subjects who were treated with antiretroviral therapy during acute/early HIV-1 infection and had HIV-1 RNA<50 copies/mL were randomized to receive either vaccine or placebo. The objectives of this study were to evaluate the safety and immunogenicity of the vaccine. Following vaccination, subjects interrupted antiretroviral treatment, and set-point HIV-1 viral loads and CD4 T cell counts were determined 17-23 weeks after treatment discontinuation.
Twenty subjects received all scheduled vaccinations and discontinued antiretroviral therapy at week 30. No subject met a primary safety endpoint. No evidence of differences in immunogenicity were detected in subjects receiving vaccine versus placebo. There were also no significant differences in set-point HIV-1 viral loads or CD4 T cell counts following treatment discontinuation. Median set-point HIV-1 viral loads after treatment discontinuation in vaccine and placebo recipients were 3.5 and 3.7 log(10) HIV-1 RNA copies/mL, respectively.
The HIV-1 DNA vaccine (VRC-HIVDNA 009-00-VP) was safe but poorly immunogenic in subjects treated with antiretroviral therapy during acute/early HIV-1 infection. Viral set-points were similar between vaccine and placebo recipients following treatment interruption. However, median viral load set-points in both groups were lower than in historical controls, suggesting a possible role for antiretroviral therapy in persons with acute or early HIV-1 infection and supporting the safety of discontinuing treatment in this group.
Clinicaltrials.gov NCT00125099.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
IntroductionBCG vaccination modulates immune responses to unrelated pathogens. This off-target effect could reduce the impact of emerging pathogens. As a readily available, inexpensive intervention ...that has a well-established safety profile, BCG is a good candidate for protecting healthcare workers (HCWs) and other vulnerable groups against COVID-19.Methods and analysisThis international multicentre phase III randomised controlled trial aims to determine if BCG vaccination reduces the incidence of symptomatic and severe COVID-19 at 6 months (co-primary outcomes) compared with no BCG vaccination. We plan to randomise 10 078 HCWs from Australia, The Netherlands, Spain, the UK and Brazil in a 1:1 ratio to BCG vaccination or no BCG (control group). The participants will be followed for 1 year with questionnaires and collection of blood samples. For any episode of illness, clinical details will be collected daily, and the participant will be tested for SARS-CoV-2 infection. The secondary objectives are to determine if BCG vaccination reduces the rate, incidence, and severity of any febrile or respiratory illness (including SARS-CoV-2), as well as work absenteeism. The safety of BCG vaccination in HCWs will also be evaluated. Immunological analyses will assess changes in the immune system following vaccination, and identify factors associated with susceptibility to or protection against SARS-CoV-2 and other infections.Ethics and disseminationEthical and governance approval will be obtained from participating sites. Results will be published in peer-reviewed open-access journals. The final cleaned and locked database will be deposited in a data sharing repository archiving system.Trial registrationClinicalTrials.gov NCT04327206
BACKGROUND:Focused attention on Data to Care underlines the importance of high-quality HIV surveillance data. This study identified the number of total duplicate and exact duplicate HIV case records ...in 9 separate Enhanced HIV/AIDS Reporting System (eHARS) databases reported by 8 jurisdictions and compared this approach to traditional Routine Interstate Duplicate Review resolution.
METHODS:This study used the ATra Black Box System and 6 eHARS variables for matching case records across jurisdictionslast name, first name, date of birth, sex assigned at birth (birth sex), social security number, and race/ethnicity, plus 4 system-calculated values (first name Soundex, last name Soundex, partial date of birth, and partial social security number).
RESULTS:In approximately 11 hours, this study matched 290,482 cases from 799,326 uploaded records, including 55,460 exact case pairs. Top case pair overlaps were between NYC and NYS (51%), DC and MD (10%), and FL and NYC (6%), followed closely by FL and NYS (4%), FL and NC (3%), DC and VA (3%), and MD and VA (3%). Jurisdictions estimated that they realized a combined 135 labor hours in time efficiency by using this approach compared with manual methods previously used for interstate duplication resolution.
DISCUSSION:This approach discovered exact matches that were not previously identified. It also decreased time spent resolving duplicated case records across jurisdictions while improving accuracy and completeness of HIV surveillance data in support of public health program policies. Future uses of this approach should consider standardized protocols for postprocessing eHARS data.
The prevalence and consequences of mental health challenges amongst university students is now widely acknowledged and university staff provide an important but often hidden service to these ...students. While completing a university degree is important to the student's long-term outcomes there remains a paucity of literature on the support role provided to these students by staff . To contribute to knowledge in this area, a qualitative exploratory study was completed with academic and professional staff at two Australian universities in 2013. Data were collected using semi-structured interviews with 26 participants to document their experiences and to identify the barriers and enablers to their support role to students.
Data were analysed using thematic analysis and four themes emerged: (1) Factors that facilitate initiation of staff support; (2) barriers to providing support; (3) challenges facing staff; and (4) how universities support students with mental health challenges. Staff acknowledged the personal and organisational challenges they experienced but also highlighted the rewards they received associated with the role. The provision of training and the acknowledgement of the hidden role and workload by universities were important to ensuring positive outcomes for this group of students.
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