Strategies to improve postpartum engagement in healthcare after high-risk conditions diagnosed in pregnancy: a narrative review.

Transition from antepartum to postpartum care is important, but often fragmented, and attendance at postpartum visits can be poor. Access to care is especially important for individuals diagnosed antepartum with conditions associated with longer-term implications, including gestational diabetes (GDM) and hypertensive disorders in pregnancy (HDP). Strategies to link and strengthen this transition are essential to support people to attend recommended appointments and testing. This narrative review evaluates what is known about postpartum transition of care after higher-risk antepartum conditions, discusses barriers and facilitators to uptake of recommended testing, and outlines strategies trialled to increase both postpartum attendance and testing. Barriers to attendance frequently overlap with general barriers to accessing healthcare. Specific postpartum challenges include difficulties with transport, coordinating breastfeeding and childcare access. Systemic challenges include inadequate communication to women around implications of health conditions diagnosed in pregnancy, and the importance of postpartum follow up. Uptake of recommended testing after a diagnosis of GDM and HDP is variable but generally suboptimal. Strategies which demonstrate promise include the use of patient navigators, focused education and specialised clinics. Reminder systems have had variable impact. Telehealth and technology are under-utilised in this field but offer promising options particularly with the expansion of virtual healthcare into routine maternity care. Strategies to improve both attendance rates and uptake of testing must be designed to address disparities in healthcare access and tailored to the needs of the community. This review provides a starting point to develop such strategies from the community level to the population level.

Potential Cost-Effectiveness of Maternal Influenza Immunisation in Low-Income Countries: An Explorative Modelling Study and Value of Information Analysis to Guide Future Clinical Research.

Maternal influenza immunisation (MII) is recommended for protecting pregnant women and infants under six months of age from severe disease related to influenza. However, few low-income countries have introduced this vaccine. Existing cost-effectiveness studies do not consider potential vaccine non-specific effects (NSE) observed in some settings, such as reductions in preterm birth. A decision tree model was built to examine the potential cost-effectiveness of MII in a hypothetical low-income country compared to no vaccination, considering possible values for NSE on preterm birth in addition to vaccine-specific effects on influenza. We synthesized epidemiological and cost data from low-income countries. All costs were adjusted to 2021 United States dollars (USD). We considered cost-effectiveness thresholds that reflect opportunity costs (USD 188 per disability-adjusted life year averted; range: USD 28-538). Results suggest that even a small (5%) NSE on preterm birth may make MII a cost-effective strategy in these settings. A value of information analysis indicated that acquiring more information on the presence and possible size of NSE of MII could greatly reduce the uncertainty in decision-making on MII. Further clinical research investigating NSE in low-income countries may be of high value to optimise immunisation policy.

Effectiveness of HealthTracker for post-caesarean section surgical site infection surveillance: An intervention study.

This intervention study aimed to implement and evaluate the effectiveness of HealthTracker, a post-discharge surgical site infection surveillance system. Participants were 730 women birthing by caesarean section at a large hospital over a 6-month period. Data were downloaded from clinical data systems and HealthTracker. Receiver operating characteristics were used to assess HealthTracker. Over a 6-month period, 382 women completed HealthTracker, with 83 scoring ≥6, indicating signs and symptoms of surgical site infection. Of this 83, 58 sought advice from health professionals, 29 returned to hospital, and 45 received antibiotics. A total of 20 infections from a total population of 730 were confirmed, with 14 out of 382 respondents confirmed via HealthTracker. Receiver operating characteristics identified HealthTracker as an excellent indicator of surgical site infection. HealthTracker is a feasible mHealth option for monitoring post-discharge surgical site infection post-caesarean section. In addition, by providing alerts, advising women to monitor their symptoms and seek treatment if necessary, HealthTracker has the potential to enhance self-efficacy for surgical wound monitoring at home.

COVID-19 vaccination: are more jabs needed or are we now immune?

As the COVID-19 pandemic has progressed, it has become apparent that COVID-19 vaccination has limited impact on SAR-CoV-2 transmission and provides only short-term protection against acquiring infection, but more robust protection against severe disease and death. As a result, vaccinated people remain susceptible to SARS-CoV-2 infection but are less likely to experience severe outcomes. Studies show that immunity derived from the combination of vaccination and natural infection, so-called hybrid immunity, is superior to that provided by vaccination or natural infection alone. Since most Australian adults have received three or more doses of COVID-19 vaccines and >70% have also been infected with SARS-CoV-2, we now have a population with high levels of hybrid immunity. This was mostly achieved by receiving original Wuhan strain vaccines and then experiencing Omicron strain infections. The original Wuhan strain of SARS-CoV-2 has now disappeared and been replaced with Omicron-lineage variants globally. The predominance of the Omicron strain initially led to the development of bivalent vaccines containing both the Wuhan strain and Omicron variants. Currently, vaccines containing the original Wuhan strain of spike protein are being phased out, and new COVID-19 vaccines based exclusively on the Omicron strain XBB have become available in Australia. This article explores the question of whether further doses will be required from 2024 onwards and, if so, who should receive them?

Effectiveness of hybrid digital breast tomosynthesis/digital mammography compared to digital mammography in women presenting for routine screening at Maroondah BreastScreen: Study protocol for a co-designed, non-randomised prospective trial.

BACKGROUND: Digital breast tomosynthesis (DBT) for breast cancer screening has been shown in international trials to increase cancer detection compared with mammography; however, results have varied across screening settings, and currently there is limited and conflicting evidence on interval cancer rates (a surrogate for screening effectiveness). Australian pilot data also indicated substantially longer screen-reading time for DBT posing a barrier for adoption. There is a critical need for evidence on DBT to inform its role in Australia, including evaluation of potentially more feasible models of implementation, and quantification of screening outcomes by breast density which has global relevance. METHODS: This study is a prospective trial embedded in population-based Australian screening services (Maroondah BreastScreen, Eastern Health, Victoria) comparing hybrid screening comprising DBT (mediolateral oblique view) and digital mammography (cranio-caudal view) with standard mammography screening in a concurrent group attending another screening site. All eligible women aged ≥40 years attending the Maroondah service for routine screening will be enrolled (unless they do not provide verbal consent and opt-out of hybrid screening; are unable to provide consent; or where a 'pushback' image on hybrid DBT cannot be obtained). Each arm will enrol 20,000 women. The primary outcomes are cancer detection rate (per 1000 screens) and recall rate (percentage). Secondary outcomes include 'opt-out' rate; cohort characteristics; cancer characteristics; assessment outcomes; screen-reading time; and interval cancer rate at 24-month follow-up. Automated volumetric breast density will be measured to allow stratification of outcomes by mammographic density. Stratification by age and screening round will also be undertaken. An interim analysis will be undertaken after the first 5000 screens in the intervention group. DISCUSSION: This is the first Australian prospective trial comparing hybrid DBT/mammography with standard mammography screening that is powered to show differences in cancer detection. Findings will inform future implementation of DBT in screening programs world-wide and provide evidence on whether DBT should be adopted in the broader BreastScreen program in Australia or in subgroups of screening participants. TRIAL REGISTRATION: The trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR, ACTRN12623001144606, https://www.anzctr.org.au/). Registration will be updated to reflect trial progress and protocol amendments.

Implementation and evaluation of a nurse-led intervention to augment an existing residential aged care facility outreach service with a visual telehealth consultation: stepped-wedge cluster randomised controlled trial.

BACKGROUND: Up to 75% of residents from residential aged care facilities (RACF) are transferred to emergency departments (ED) annually to access assessment and care for unplanned or acute health events. Emergency department presentations of RACF residents can be both expensive and risky, and many are unnecessary and preventable. Processes or triage systems to assess residents with a health event, prior to transfer, may reduce unnecessary ED transfer. The Aged Care Emergency (ACE) service is a nurse-led ED outreach service that provides telephone support to RACF nurses regarding residents' health events. This service is available Monday to Friday, 8am to 4 pm (ED ACE hours). The primary objective of this study was to assess whether the augmentation of the phone-based ED ACE service with the addition of a visual telehealth consultation (VTC) would reduce RACF rate of ED presentations compared to usual care. The secondary objectives were to 1) monitor presentations to ED within 48 h post VTC to detect any adverse events and 2) measure RACF staff perceptions of VTC useability and acceptability. METHODS: This implementation study used a stepped wedge cluster randomised controlled trial design. Study settings were four public hospital EDs and 16 RACFs in two Local Health Districts. Each ED was linked to 4 RACFs with approximately 350 RACF beds, totalling 1435 beds across 16 participating RACFs. Facilities were randomised into eight clusters with each cluster comprising one ED and two RACFs. RESULTS: A negative binomial regression demonstrated a 29% post-implementation reduction in the rate of ED presentations (per 100 RACF beds), within ED ACE hours (IRR [95% CI]: 0.71 [0.46, 1. 09]; p = 0.122). A 29% reduction, whilst not statistically significant, is still clinically important and impactful for residents and EDs. A post-hoc logistic regression demonstrated a statistically significant 69% reduction in the probability that an episode of care resulted in an ED presentation within ED ACE hours post-implementation compared to pre-implementation (OR [95% CI]: 0.31 [0.11, 0.87]; p = 0.025). CONCLUSION: Findings have shown the positive impact of augmenting ACE with a VTC. Any reduction of resident presentations to a busy ED is beneficial to healthcare overall, but more so to the individual older person who can recover safely and comfortably in their own RACF. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ID ACTR N12619001692123) (02/12/2019) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378629andisReview=true.

Factors Associated with Early Versus Late Uptake of the COVID-19 Vaccine during Pregnancy over Time in Australia: A Population-Based Cohort Study.

BACKGROUND: Pregnant women are at an increased risk of hospitalisation, admission to the intensive care unit, mechanical ventilation, and death from SARS-CoV-2 infection. The aim of this study is to determine the predictive factors associated with COVID-19 vaccine uptake during pregnancy over time in a population with a high background uptake of maternal influenza and pertussis vaccination. METHODS: This is a population-based, cohort study of all pregnant women who gave birth in Victoria, Australia between 1 July 2021 and 30 June 2022. Data from the Victorian Perinatal Data Collection were analysed using univariable and multivariable logistic regression. RESULTS: This study reports on 77,719 women who gave birth over a 12 month period, of whom 49,281 (63.4%) received a COVID-19 vaccine, 54,887 (70.6%) received an influenza vaccination and 63,594 (81.8%) received a pertussis vaccine by the time of delivery. Pregnant women aged >30 years (aOR 1.31 CI 1.27, 1.36), who had >=8 antenatal visits (aOR 1.08 CI 1.04, 1.12), and those who received influenza vaccine (aOR 1.23 CI 1.19, 1.28) were more likely to have received a COVID-19 vaccine. Those who smoked (aOR 0.7 CI 0.66, 0.74), were First Nations (aOR 0.83 CI 0.74, 0.93) and those who gave birth in public hospitals (aOR 0.65 CI 0.63, 0.68) were less likely to receive COVID-19 vaccine in the first 12 months of the rollout. CONCLUSION: Maternal age, smoking, parity and Indigenous status were factors associated with delayed and sustained lower coverage, even in a population with background maternal influenza and pertussis coverage of 70.6% and 81.8%, respectively.

Interim results from a phase I randomized, placebo-controlled trial of novel SARS-CoV-2 beta variant receptor-binding domain recombinant protein and mRNA vaccines as a 4th dose booster.

BACKGROUND: SARS-CoV-2 booster vaccination should ideally enhance protection against variants and minimise immune imprinting. This Phase I trial evaluated two vaccines targeting SARS-CoV-2 beta-variant receptor-binding domain (RBD): a recombinant dimeric RBD-human IgG1 Fc-fusion protein, and an mRNA encoding a membrane-anchored RBD. METHODS: 76 healthy adults aged 18-64 y, previously triple vaccinated with licensed SARS-CoV-2 vaccines, were randomised to receive a 4th dose of either an adjuvanted (MF59®, CSL Seqirus) protein vaccine (5, 15 or 45 µg, N = 32), mRNA vaccine (10, 20, or 50 µg, N = 32), or placebo (saline, N = 12) at least 90 days after a 3rd boost vaccination or SARS-CoV-2 infection. Bleeds occurred on days 1 (prior to vaccination), 8, and 29. CLINICALTRIALS: govNCT05272605. FINDINGS: No vaccine-related serious or medically-attended adverse events occurred. The protein vaccine reactogenicity was mild, whereas the mRNA vaccine was moderately reactogenic at higher dose levels. Best anti-RBD antibody responses resulted from the higher doses of each vaccine. A similar pattern was seen with live virus neutralisation and surrogate, and pseudovirus neutralisation assays. Breadth of immune response was demonstrated against BA.5 and more recent omicron subvariants (XBB, XBB.1.5 and BQ.1.1). Binding antibody titres for both vaccines were comparable to those of a licensed bivalent mRNA vaccine. Both vaccines enhanced CD4+ and CD8+ T cell activation. INTERPRETATION: There were no safety concerns and the reactogenicity profile was mild and similar to licensed SARS-CoV-2 vaccines. Both vaccines showed strong immune boosting against beta, ancestral and omicron strains. FUNDING: Australian Government Medical Research Future Fund, and philanthropies Jack Ma Foundation and IFM investors.

The pregnant traveller: An overview of common preventable infections.

Pregnant travellers are often unaware of the various infections that can be acquired during travel and that pregnant people may be at increased risk of severe disease compared to their non-pregnant counterparts. Pregnant people often seek pre-travel counselling from their obstetrician or primary care physicians, who may not be well versed in travel medicine. This paper aims to provide information for maternity care providers regarding important travel-related food, water and mosquito-borne illnesses, including their prevention and treatment methods, equipping maternity care providers to confidently counsel prospective travellers during pregnancy.

Vaccination recommendations for pregnant people travelling overseas.

With international travel on the rise following pandemic restrictions, the number of pregnant travellers is likely to proportionally increase. Recent published data suggest most pregnant travellers seek pre-travel advice from their maternity and primary care providers. With these data, it is important to provide maternity and primary care providers with guidelines and resources to help aid safe, informed, and timely delivery of vaccinations prior to travel. Vaccination for travel during pregnancy is fundamental in mitigating maternal and fetal communicable disease morbidity and mortality. This clinical perspective provides an overview of the indications, safety, and recommendations for pre-travel vaccines in pregnancy.

The pregnant traveller: An overview of general travel advice.

Travel during pregnancy is common, but is associated with a number of risks and potential problems. There are many pregnancy-specific and destination-specific issues to be considered along with issues related to method of transport. Travel experiences should be made as safe as possible through evidence-based counselling via pregnancy healthcare providers prior to travel. This travelling in pregnancy article has been created to facilitate pregnancy healthcare providers in having these pre-travel discussions to optimise maternal and fetal wellbeing.

ATAGI 2023 Annual Statement on Immunisation.

The Australian Technical Advisory Group on Immunisation (ATAGI) 2023 Annual Statement on Immunisation is the third publication in this series. It highlights the key successes, trends and challenges in the use of vaccines and control of vaccine preventable diseases (VPDs) in Australia in 2022. It also signals ATAGI's priority actions for addressing key issues for 2023 and beyond.

CO-Sprout-A Pilot Double-Blinded Placebo-Controlled Randomised Trial of Broccoli Sprout Powder Supplementation for Pregnant Women with COVID-19 on the Duration of COVID-19-Associated Symptoms: Study Protocol.

Since its discovery in late 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been estimated to be responsible for at least 769.3 million infections and over 6.95 million deaths. Despite significant global vaccination efforts, there are limited therapies that are considered safe and effective for use in the management of COVID-19 during pregnancy despite the common knowledge that pregnant patients have a much higher risk of adverse outcomes. A bioactive compound found in broccoli sprout-sulforaphane-is a potent inducer of phase-II detoxification enzymes promoting a series of potentially beneficial effects notably as an antioxidant, anti-inflammatory, and anti-viral. A pilot, double-blinded, placebo-controlled randomised trial is to be conducted in Melbourne, Australia, across both public and private hospital sectors. We will assess a commercially available broccoli sprout extract in pregnant women between 20+0 and 36+0 weeks gestation with SARS-CoV-2 infection to investigate (i) the duration of COVID-19 associated symptoms, (ii) maternal and neonatal outcomes, and (iii) biomarkers of infection and inflammation. We plan to enrol 60 outpatient women with COVID-19 irrespective of vaccination status diagnosed by PCR swab or RAT (rapid antigen test) within five days and randomised to 14 days of oral broccoli sprout extract (42 mg of sulforaphane daily) or identical microcrystalline cellulose placebo. The primary outcome of this pilot trial will be to assess the feasibility of conducting a larger trial investigating the duration (days) of COVID-19-associated symptoms using a broccoli sprout supplement for COVID-19-affected pregnancies. Pregnant patients remain an at-risk group for severe disease following infection with SARS-CoV-2 and currently unclear consequences for the offspring. Therefore, this study will assess feasibility of using a broccoli sprout supplement, whilst providing important safety data for the use of sulforaphane in pregnancy.

Psychosocial outcomes and health service use after notifying women participating in population breast screening when they have dense breasts: a BreastScreen Queensland randomised controlled trial.

BACKGROUND: Robust evidence regarding the benefits and harms of notifying Australian women when routine breast screening identifies that they have dense breasts is needed for informing future mammography population screening practice and policy. OBJECTIVES: To assess the psychosocial and health services use effects of notifying women participating in population-based breast cancer screening that they have dense breasts; to examine whether the mode of communicating this information about its implications (print, online formats) influences these effects. METHODS AND ANALYSIS: The study population comprises women aged 40 years or older who attend BreastScreen Queensland Sunshine Coast services for mammographic screening and are found to have dense breasts (BI-RADS density C or D). The randomised controlled trial includes three arms (952 women each): standard BreastScreen care (no notification of breast density; control arm); notification of dense breasts in screening results letter and print health literacy-sensitive information (intervention arm 1) or a link or QR code to online video-based health literacy-sensitive information (intervention arm 2). Baseline demographic data will be obtained from BreastScreen Queensland. Outcomes data will be collected in questionnaires at baseline and eight weeks, twelve months, and 27 months after breast screening. Primary outcomes will be psychological outcomes and health service use; secondary outcomes will be supplemental screening outcomes, cancer worry, perceived breast cancer risk, knowledge about breast density, future mammographic screening intentions, and acceptability of notification about dense breasts. ETHICS APPROVAL: Gold Coast Hospital and Health Service Ethics Committee (HREC/2023/QGC/89770); Sunshine Coast Hospital and Health Service Research Governance and Development (SSA/2023/QSC/89770). DISSEMINATION OF FINDINGS: Findings will be reported in peer-reviewed journals and at national and international conferences. They will also be reported to BreastScreen Queensland, BreastScreen Australia, Cancer Australia, and other bodies involved in cancer care and screening, including patient and support organisations. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12623000001695p (prospective: 9 January 2023).

Unravelling the mechanisms by which chronic hepatitis B infection is associated with an increased risk of gestational diabetes.

An independent association between chronic hepatitis B virus (HBV) and the development of gestational diabetes (GDM) has been reported in the literature. Ethnic background and regional influences have been demonstrated to play a role in the reporting of incidence rates of GDM among women with chronic HBV. The mechanisms behind this association are poorly understood, but evidence suggests an inflammatory basis. Viral factors such as chronic HBV replication, quantifiable by HBV viral load, have been proposed to contribute to the increasing risk of insulin resistance in pregnancy. More research is needed to better characterise the association and determine if any interventions early in pregnancy for women infected with chronic HBV would mitigate the development of GDM.

Influenza and pertussis vaccine coverage in pregnancy in Australia, 2016-2021.

Vaccination in pregnancy is the best strategy to reduce complications from influenza or pertussis infection in infants who are too young to be protected directly from vaccination. Pregnant women are also at risk of influenza complications preventable through antenatal vaccination. Both vaccines are funded under the National Immunisation Program for pregnant women in Australia, but coverage is not routinely reported nationally. We reviewed all reported Australian maternal influenza and pertussis vaccine coverage data for the period 2016-2021, to identify gaps and information needs. Maternal influenza vaccine coverage was suboptimal at < 58% for 2016-2018, with higher coverage of 62-75% reported in two states (Victoria and Western Australia) for 2019-2021. Maternal pertussis vaccine coverage from 2016 was generally higher than for influenza at > 70%, with the highest jurisdictional coverage of 89% reported in Western Australia in 2020. Vaccination rates were often suboptimal among First Nations pregnant women and up to 20% lower than among non-First Nations Australian women; while data were limited, coverage was low among culturally and linguistically diverse women and among women of lower socio-economic status. Jurisdictional perinatal data collections were the best source of information on antenatal vaccine coverage but were only available for a minority of the population; a nationally consistent systematic approach is lacking. Timely and comprehensive data are needed to provide feedback to improve maternal vaccination coverage, particularly among groups with higher risk and/or low uptake, and as new vaccines are recommended, including COVID-19 vaccination.

A brief intervention for improving alcohol literacy and reducing harmful alcohol use by women attending a breast screening service: a randomised controlled trial.

OBJECTIVES: To assess the effectiveness of a brief alcohol intervention for improving awareness of alcohol as a breast cancer risk factor, improving alcohol literacy, and reducing alcohol consumption by women attending routine breast screening. DESIGN: Single-site, double-blinded randomised controlled trial. SETTING: Maroondah BreastScreen (Eastern Health, Melbourne), part of the national breast cancer screening program. PARTICIPANTS: Women aged 40 years or more, with or without a history of breast cancer and reporting any alcohol consumption, who attended the clinic for routine mammography during 5 February - 27 August 2021. INTERVENTION: Active arm: animation including brief alcohol intervention (four minutes) and lifestyle health promotion (three minutes). CONTROL ARM: lifestyle health promotion only. MAJOR OUTCOME MEASURE: Change in proportion of women who identified alcohol use as a clear risk factor for breast cancer (scaled response measure). RESULTS: The mean age of the 557 participants was 60.3 years (standard deviation, 7.7 years; range, 40-87 years); 455 had recently consumed alcohol (82%). The proportions of participants aware that alcohol use increased the risk of breast cancer were larger at four weeks than at baseline for both the active intervention (65% v 20%; odds ratio [OR], 41; 95% confidence interval [CI], 18-97) and control arms of the study (38% v 20%; OR, 4.9; 95% CI, 2.8-8.8), but the change over time was greater for the active intervention arm (arm × time: P < 0.001). Alcohol literacy also increased to a greater extent in the active than the control arm, but alcohol consumption did not significantly change in either arm. CONCLUSION: A tailored brief alcohol intervention for women attending breast screening was effective for improving awareness of the increased breast cancer risk associated with alcohol use and alcohol literacy more broadly. Such interventions are particularly important given the rising prevalence of risky drinking among middle-aged and older women and evidence that even very light alcohol consumption increases breast cancer risk. REGISTRATION: ClinicalTrials.gov, NCT04715516 (prospective; 20 January 2021).

The Reemergence of Syphilis Among Females of Reproductive Age and Congenital Syphilis in Victoria, Australia, 2010 to 2020: A Public Health Priority.

BACKGROUND: Syphilis notifications in Victoria, Australia, have been increasing over the past decade, with an increase in infectious syphilis (syphilis of less than 2 years in duration) cases in females of reproductive age and an associated reemergence of congenital syphilis (CS). Before 2017, there had been 2 CS cases in the preceding 26 years. This study describes the epidemiology of infectious syphilis among females of reproductive age and CS in Victoria. METHODS: Routine surveillance data provided by mandatory Victorian syphilis case notifications were extracted and grouped into a descriptive analysis of infectious syphilis and CS incidence data from 2010 to 2020. RESULTS: In 2020, infectious syphilis notifications in Victoria were approximately 5 times more than 2010 (n = 289 in 2010 to n = 1440 in 2020), with a more than 7-fold rise among females (n = 25 in 2010 to n = 186 in 2020). Females made up 29% (n = 60 of 209) of Aboriginal and Torres Strait Islander notifications occurring between 2010 and 2020. Between 2017 and 2020, 67% of notifications in females (n = 456 of 678) were diagnosed in low-caseload clinics, at least 13% (n = 87 of 678) of all female notifications were known to be pregnant at diagnosis, and there were 9 CS notifications. CONCLUSIONS: Cases of infectious syphilis in females of reproductive age and CS are on the rise in Victoria, necessitating sustained public health action. Increasing awareness among individuals and clinicians, and health system strengthening, particularly targeting primary care where most females are diagnosed before pregnancy, are required. Treating infections before or promptly during pregnancy and undertaking partner notification and treatment to reduce risk of reinfection are critical to reducing CS cases.

Two-year follow-up of participants in the BreastScreen Victoria pilot trial of tomosynthesis versus mammography: breast density-stratified screening outcomes.

OBJECTIVE: This follow-up study of BreastScreen Victoria's pilot trial of digital breast tomosynthesis aimed to report interval cancer rates, screening sensitivity, and density-stratified outcomes for tomosynthesis vs mammography screening. METHODS: Prospective pilot trial [ACTRN-12617000947303] in Maroondah BreastScreen recruited females ≥ 40 years presenting for screening (August 2017-November 2018) to DBT; concurrent screening participants who received mammography formed a comparison group. Follow-up of 24 months from screen date was used to ascertain interval cancers; automated breast density was measured. RESULTS: There were 48 screen-detected and 9 interval cancers amongst 4908 tomosynthesis screens, and 34 screen-detected and 16 interval cancers amongst 5153 mammography screens. Interval cancer rate was 1.8/1000 (95%CI 0.8-3.5) for tomosynthesis vs 3.1/1000 (95%CI 1.8-5.0) for mammography (p = 0.20). Sensitivity of tomosynthesis (86.0%; 95% CI 74.2-93.7) was significantly higher than mammography (68.0%; 95% CI 53.3-80.5), p = 0.03. Cancer detection rate (CDR) of 9.8/1000 (95%CI 7.2-12.9) for tomosynthesis was higher than that of 6.6/1000 (95%CI 4.6-9.2) for mammography (p = 0.08); density-stratified analyses showed CDR was significantly higher for tomosynthesis than mammography (10.6/1000 vs 3.5/1000, p = 0.03) in high-density screens. Recall rate for tomosynthesis was significantly higher than for mammography (4.2% vs 3.0%, p < 0.001), and this increase in recall for tomosynthesis was evident only in high-density screens (5.6% vs 2.9%, p < 0.001). CONCLUSION: Although interval cancer rates did not significantly differ between screened groups, sensitivity was significantly higher for tomosynthesis than mammography screening. ADVANCES IN KNOWLEDGE: In a program-embedded pilot trial, both increased cancer detection and recall rates from tomosynthesis were predominantly observed in high-density screens.

The non-specific effects of maternal immunization on birth outcomes: The evidence, mechanisms, and the implications.

Preterm birth (PTB) and stillbirth remain two of the most important causes of death, morbidity, and disability in childhood. Despite efforts to reduce PTB and stillbirth worldwide, rates of these adverse outcomes remain persistently elevated, independent of income setting. There is an urgent need for more effective interventions to reduce associated neonatal and early childhood morbidity and mortality. Maternal vaccines are a well-established strategy used for prevention of pathogen-specific disease in mothers and infants through transplacental antibody transfer. Beyond these pathogen-specific benefits, some studies have also identified non-specific effects (NSEs) of maternal vaccination protecting against several adverse birth outcomes, including PTB and stillbirth. This paper will review the evidence supporting the NSEs of maternal vaccination on birth outcomes, describe the possible underlying mechanisms, outline the research gaps, and summarize the significance from a global health perspective.