Efficacy, Safety, and Immunogenicity of the MATISSE (Maternal Immunization Study for Safety and Efficacy) Maternal Respiratory Syncytial Virus Prefusion F Protein Vaccine Trial.

Objective: To evaluate descriptive efficacy data, exploratory immunogenicity data, and safety follow-up through study completion from the global, phase 3 MATISSE (Maternal Immunization Study for Safety and Efficacy) maternal vaccination trial of bivalent respiratory syncytial virus (RSV) prefusion F protein vaccine (RSVpreF).

Methods: MATISSE was a phase 3, randomized, double-blinded, placebo-controlled trial. Healthy pregnant participants aged 49 years or younger at 24-36 weeks of gestation were randomized (1:1) to receive a single RSVpreF 120 micrograms or placebo dose.

Mortality associated with moderate and severe mitral regurgitation in 608 570 men and women undergoing echocardiography.

Background: Although the prognostic implications of severe mitral regurgitation (MR) are well recognised, they are less clear in moderate MR. We therefore explored the prognostic impact of both moderate and severe MR within the large National Echocardiography Database Australia cohort.

Methods: Echocardiography reports from 608 570 individuals were examined using natural language processing to identify MR severity and leaflet pathology.

Sustained impacts of the COVID-19 pandemic on medical student learning and well-being in rural Australia: findings from a repeated national multicentre survey.

Objective: The impact of COVID-19 on medical students has predominantly been assessed by one-off survey studies at the pandemic onset. This national study investigated the sustained impacts of the COVID-19 pandemic on medical students' rural clinical placement learning and well-being.

Design: Repeated cross-sectional survey design.

Phase 1 trial of an investigational Tdap booster vaccine with CpG 1018 adjuvant compared with Boostrix in healthy adults and adolescents.

This phase 1 trial assessed the safety and immunogenicity of an investigational tetanus/diphtheria/acellular pertussis vaccine combined with CpG 1018 adjuvant 1500 μg (Tdap-1018 1500 μg) or 3000 μg (Tdap-1018 3000 μg) in adults and adolescents. In this randomized, active-controlled, multicenter, dose-escalation trial, healthy participants aged 10 to 22 years received 1 dose of Tdap-1018 1500 μg, Tdap-1018 3000 μg, or Boostrix. Geometric mean concentrations (GMCs) and booster response rates (BRRs) for antibodies against pertussis (pertussis toxin, filamentous hemagglutinin, pertactin), tetanus, and diphtheria antigens, and neutralizing antibodies against pertussis toxin were assessed 4 weeks after vaccination.

Impact of COVID-19 on asthma management in general practice: A qualitative study.

Background And Objectives: The COVID-19 pandemic catalysed unprecedented changes to healthcare delivery in Australia, leading to a rapid transformation of asthma management, to which healthcare providers and patients have had to adapt. Understanding the impact of these changes is critical as we emerge from pandemic-affected workflows.

Method: A qualitative study using semistructured interviews was conducted with 19 general practitioners across Sydney and regional New South Wales.

Sensory neuropathy as a manifestation of multiple acyl-coenzyme A dehydrogenase deficiency.

Multiple acyl-coenzyme A dehydrogenase deficiency (MADD) is a rare metabolic disorder which typically manifests with muscle weakness. However, despite late-onset MADD being treatable, it is often misdiagnosed, due in part to the heterogeneity of presentations. We report a case of late-onset MADD manifesting first as a sensory neuropathy before progressing to myopathic symptoms and acute metabolic decompensation.

Access to child developmental assessment services in culturally and linguistically diverse metropolitan Sydney: a retrospective cohort analysis.

Background: Despite the increasing prevalence of neurodevelopmental disorders (NDD), data regarding access to child development services have remained limited globally. Long wait times are a major barrier to developmental assessments, impacting on care and outcomes. The aim is to retrospectively analyse the demographic profile and prioritisation of patients seen at a child developmental assessment service (CDAS) in a vulnerable region of Sydney, and explore factors affecting wait times.

Global Prevalence of Varicella-Associated Complications: A Systematic Review and Meta-Analysis.

Introduction: Varicella (chickenpox) is an infectious disease caused by the varicella zoster virus affecting children, adolescents, and adults. Varicella symptoms are usually self-limiting; however, different complications with widespread and systemic manifestations can occur. This systematic literature review aims to explore and quantify varicella-associated complication rates.

Dying at home: enablers and barriers.

Background: According to the Grattan institute in 2014, 70% of Australians indicated a preference to die at home, however, only 14% of all deaths were at home.

Aims: To identify how patients can be supported to die at home if that is their preference.

Methods: A retrospective medical record audit of eligible Community Palliative Care (CPC) patients who indicated a wish to die at home was undertaken.

Rapid Rescoping and Adaptation: An Evaluation of the Impact of COVID-19 on Postgraduate Medical Student Research Projects.

The COVID-19 pandemic has adversely affected tertiary science and medical education, with significant impact on research-related activities. Research projects are a mandatory requirement of the Doctor of Medicine (MD) Program at the University of Sydney, and medical student projects are delivered across multiple sites in metropolitan and rural New South Wales, Australia. Several cohorts of medical students had projects that were affected by COVID-19.

Non-COVID-19 intensive care admissions during the pandemic: a multinational registry-based study.

Background: The COVID-19 pandemic resulted in a large number of critical care admissions. While national reports have described the outcomes of patients with COVID-19, there is limited international data of the pandemic impact on non-COVID-19 patients requiring intensive care treatment.

Methods: We conducted an international, retrospective cohort study using 2019 and 2020 data from 11 national clinical quality registries covering 15 countries.

Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants.

Background: Whether vaccination during pregnancy could reduce the burden of respiratory syncytial virus (RSV)-associated lower respiratory tract illness in newborns and infants is uncertain.

Methods: In this phase 3, double-blind trial conducted in 18 countries, we randomly assigned, in a 1:1 ratio, pregnant women at 24 through 36 weeks' gestation to receive a single intramuscular injection of 120 μg of a bivalent RSV prefusion F protein-based (RSVpreF) vaccine or placebo. The two primary efficacy end points were medically attended severe RSV-associated lower respiratory tract illness and medically attended RSV-associated lower respiratory tract illness in infants within 90, 120, 150, and 180 days after birth.

Prevalence of pulmonary hypertension in aortic regurgitation and its influence on outcomes.

Objective: Aortic regurgitation (AR) can lead to pulmonary hypertension (PHT). There is a paucity of data on the prognostic importance of PHT in these patients. We therefore aimed to describe the prevalence and prognostic importance of PHT in such patients.

Health-related quality of life following lung transplantation for cystic fibrosis: A systematic review.

Background: Lung transplantation represents the definite treatment for CF patients with advanced-stage pulmonary disease. Recent major developments in the treatment of CF indicate the need for an evaluation of lung transplantation as the current best practice in end-stage disease. This systematic review was performed to evaluate the impact of lung transplantation on health-related quality of life in patients with CF.

Effects of adjunctive brexpiprazole on sleep-wake and circadian parameters in youth with depressive disorders: study protocol for a clinical trial.

Introduction: Sleep-wake and circadian disturbance is a key feature of mood disorders with a potential causal role and particular relevance to young people. Brexpiprazole is a second-generation antipsychotic medication with demonstrated efficacy as an adjunct to antidepressant treatment for major depressive disorder (MDD) in adults, with preliminary evidence suggesting greater effectiveness in subgroups of depressed patients with sleep disturbances. This clinical trial aims to evaluate the relationships between changes in sleep-wake and circadian parameters and changes in depressive symptoms following adjunctive brexpiprazole treatment in young adults with MDD and sleep-wake disturbance.

Health-related Quality of Life Outcomes Following Single or Bilateral Lung Transplantation: A Systematic Review.

Background: Lung transplantation is the definitive treatment for end-stage lung disease. There has been uncertainty regarding whether single or bilateral lung transplantation confers patients' greater health-related quality of life. This systematic review was performed to evaluate the impact of single lung transplantation (SLTx) against bilateral lung transplantation on short- and long-term health-related quality of life.

A phase 3, multicenter, randomized, double-blind study to evaluate the interchangeability of V114, a 15-valent pneumococcal conjugate vaccine, and PCV13 with respect to safety, tolerability, and immunogenicity in healthy infants (PNEU-DIRECTION).

Background: Pneumococcal disease (PD) remains a major health concern globally. In children, pneumococcal conjugate vaccines (PCVs) provide protection against PD from most vaccine serotypes, but non-vaccine serotypes contribute to residual disease. V114 is a 15-valent PCV containing all 13 serotypes in Prevnar 13™ (PCV13) and public health important serotypes 22F and 33F.

Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD: a V114-023 (PNEU-SICKLE) study.

Sickle cell disease (SCD) is an inherited red blood cell disease that results in a multitude of medical complications, including an increased risk of invasive disease caused by encapsulated bacteria, such as Streptococcus pneumoniae. Pneumococcal vaccines have contributed to a significant reduction in pneumococcal disease (PD) in children and adults, including those with SCD. This phase 3 study evaluated the safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine (PCV), in children with SCD.

Mortality and neurodevelopmental outcomes of infants with spontaneous intestinal perforation: a systematic review and meta-analysis.

Background: There is limited information about the mortality and neurodevelopmental outcomes of very preterm infants (<32 weeks) with spontaneous intestinal perforation (SIP).

Objective: To explore the association between SIP and neurodevelopmental outcomes and mortality in very preterm infants.

Data Sources: Medline, EMBASE, Cochrane Library, EMCARE and MedNar.

The importance of bone sample selection when using radiocarbon analysis in cases of unidentified human remains.

The radiocarbon (C) analysis of skeletonised human remains can provide vital information regarding the time since death. This study analysed the C content in both cortical and trabecular bone from the femur and rib of 18 human remains donated to the Australian Facility for Taphonomic Experimental Research. To determine the most appropriate bone to sample for C analysis when estimating the time since death, differences in turnover time between the bone types, and the difference between environmental C during the year of death (YOD) and the level of C found within the bone (i.

Safety and immunogenicity of a primary series and booster dose of the meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) in healthy children aged 1-9 years: two phase 2 randomised, controlled, observer-blinded studies.

Background: The meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) is licensed for use in children aged 10 years or older for protection against invasive serogroup B meningococcal disease. Because young children are at increased risk of invasive meningococcal disease, MenB-FHbp clinical data in this population are needed.

Methods: We conducted two phase 2 randomised, controlled, observer-blinded studies including healthy toddlers (age 12-23 months) across 26 Australian, Czech, Finnish, and Polish centres, and older children (age 2-9 years) across 14 Finnish and Polish centres.