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Low-Dose Aspirin and Recurrent Thromboembolism Results from the ASPIRE trial add evidence supporting the use of low-dose daily aspirin for preventing recurrent venous thromboembolism in patients who have had an initial unprovoked clotting episode. Patients who have had a first episode of unprovoked venous thromboembolism are at high risk for recurrence after anticoagulant therapy is discontinued. 1 – 4 Long-term treatment with a vitamin K antagonist is very effective in preventing a recurrence of venous thromboembolism while treatment continues 5 but has not been shown to improve survival, is associated with a substantially increased risk of bleeding, and is inconvenient for patients. 6 – 10 Consequently, many patients who have had a first episode of unprovoked venous thromboembolism discontinue anticoagulant therapy after 3 to 6 months despite recommendations to prolong therapy. 5 Low-dose aspirin is a simple, inexpensive, and widely . . .

BackgroundA single assessment of psychological distress, which includes depression and anxiety, has been associated with increased mortality in patients with coronary heart disease, but the prognostic importance of persistence of distress symptoms is less certain.AimTo determine whether intermittent and/or persistent psychological distress is associated with long-term cardiovascular (CV) and total mortality in patients with stable coronary artery disease.Methods950 participants in the Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) trial completed at least four General Health Questionnaires (GHQ-30) at baseline and after ½, 1, 2 and 4 years. In a landmark analysis from 4 years, Cox proportional hazards models evaluated the risk of CV and total mortality by increasing levels of psychological distress: never distressed, sometimes any severity (GHQ score >5), persistent mild (GHQ score >5 on three or more occasions) and persistent moderate distress (GHQ score >10) on three or more occasions, over a median of 12.1 (IQR 8.6–12.5) years. The models were both unadjusted and adjusted for known baseline risk factors.ResultsPersistent moderate or greater psychological stress was reported on three or more assessments by 35 (3.7%) subjects. These patients had a higher risk of both CV death (adjusted HR 3.94, 95% CI 2.05 to 7.56, p<0.001) and all-cause mortality (adjusted HR 2.85, 95% CI 1.74 to 4.66, p<0.001) compared with patients with no distress. In contrast, patients who reported persistent mild distress (n=73, 7.7%) on three or more visits, and those who met criteria for distress on only one or two assessments (n=255, 26.8%), did not have an increased risk of CV or all-cause mortality during follow-up.ConclusionIn patients with stable coronary artery disease, persistent psychological distress of at least moderate severity is associated with a substantial increase in CV and all-cause mortality.

ObjectiveTo compare birth outcomes of women with gestational diabetes mellitus (GDM) with background obstetric population, stratified by models of care.DesignRetrospective cohort study.SettingA tertiary referral centre in Sydney, Australia.ParticipantsAll births 1 January 2018 to 30 November 2020. Births <24 weeks, multiple gestations and women with pre-existing diabetes were excluded.MethodsData were obtained from electronic medical records. Women were classified according to GDM status and last clinic attended prior to delivery. Model of care included attendance at dedicated GDM obstetric clinics, and routine antenatal care.Main outcome measuresHypertensive disorders of pregnancy (HDP), pre-term birth (PTB), induction of labour (IOL), operative delivery, small for gestational age (SGA), large for gestational age, postpartum haemorrhage, obstetric anal sphincter injury (OASIS), neonatal hypoglycaemia, neonatal hypothermia, neonatal respiratory distress, neonatal intensive care unit (NICU) admission.ResultsThe GDM rate was 16.3%, with 34.0% of women managed in dedicated GDM clinics. Women with GDM had higher rates of several adverse outcomes. Only women with GDM attending non-dedicated clinics had increased odds of HDP (adjusted OR (adj OR) 1.6, 95% CI 1.2 to 2.0), PTB (adj OR 1.7, 95% CI 1.4 to 2.0), OASIS (adj OR 1.4, 95% CI 1.0 to 2.0), similar odds of induction (adj OR 1.0, 95% CI 0.9 to 1.1) compared with non-GDM women. There were increased odds of NICU admission (adj OR 1.5, 95% CI 1.3 to 1.8) similar to women attending high-risk GDM clinics.ConclusionsWomen with GDM receiving care in lower risk clinics had similar or higher rates of adverse outcomes. Pathways of care need to be similar in all women with GDM.

ObjectiveEisenmenger syndrome (ES) is a severe form of pulmonary hypertension in adults with congenital heart disease (CHD) and has a poor prognosis. We aimed to understand factors associated with survival in ES and particularly to assess the potential benefits of advanced pulmonary vasodilator therapy (AT).MethodsFrom January 2004, when AT became generally available for patients with ES, we followed 253 ES adults from 12 adult congenital heart disease centres across Australia and New Zealand. Demographic, medical and outcome data were collected and analysed prospectively and retrospectively.ResultsThe patients with ES were predominantly female (60%), aged 31 (SD 12) years. At diagnosis of ES, 64% were WHO functional class ≥3. The most common underlying lesion was ventricular septal defect (33%) with 21% having ‘complex’ anatomy. Over a median follow-up time of 9.1 years, the majority (72%) had been prescribed at least one AT (49% single agent), mostly bosentan (66%, 168 patients). The mean time on AT was 6 (SD 3.6) years. Those on AT were more functionally impaired at presentation (69% WHO ≥3 vs 51%, p=0.007) and more likely to have been prescribed anticoagulation (47% vs 27%, p=0.003). The risk of death/transplant was 4.8 %/year in AT exposed versus 8.4% in those never exposed. On multivariable analysis, exposure to AT was independently associated with greater survival (survival HR 2.27, 95% CI 1.49 to 3.45; p<0.001). WHO ≥3 at presentation was associated with a worse prognosis (mortality HR 1.82, 95% CI 1.19 to 2.78; p=0.006).ConclusionTreatment with AT was independently associated with greater survival in patients with ES, even though they were comparatively sicker prior to treatment.

Chemical agents commonly used to sedate agitated patients in the emergency department include benzodiazepines, antipsychotics, or a combination of the 2 classes. Our objective was to determine if a class or combination therapy is (1) more effective, as measured by the proportion sedated at 15-20 minutes and the need for repeat sedation, and (2) safer, as measured by the proportion of reported adverse events. Systematic literature review and meta-analysis of studies comparing 2 or more chemical agents for sedation of agitated patients in the emergency department were carried out in PubMed, PsycINFO, Embase, and the Cochrane database. Meta-analyses for pairwise comparisons of drug class (benzodiazepine, antipsychotic, or combination) were carried out for each outcome: proportion sedated, need for repeat sedation, and adverse events. Seven studies with 1135 patients were included. At 15-20 minutes, the proportion of patients sedated was greater with combination therapy than benzodiazepines alone (risk ratio [RR] = 1.31, P < .0001). Antipsychotics and combination agents required significantly less repeat sedations than benzodiazepines alone (RR = 0.49, P < .0001 and RR = 0.64, P = .002). There was significant heterogeneity in adverse event data, with respiratory system adverse events (desaturation, and need for airway and ventilatory support) being the most commonly reported. Benzodiazepines were associated with a higher incidence of adverse events than antipsychotics or combination therapy. Combination therapy sedated a greater proportion of patients at 15-20 minutes than benzodiazepines alone. Antipsychotics and combination therapy were more effective, requiring less repeat doses for sedation than benzodiazepines. The risk of any adverse event was higher with benzodiazepines.

Background The collection of data on ‘infant feeding at hospital discharge’ is used to monitor breastfeeding outcomes, health service benchmarking, and research. While some Australian states have clear definitions of this data collection point, there is no operational definition of ‘infant feeding at hospital discharge’ in the Australian state of New South Wales. Little is known about how midwives interpret the term ‘infant feeding at hospital discharge’, in particular, the timeframe used to calculate these important indicators. The purpose of this study was to explore midwives’ and nurses’ practices of reporting ‘infant feeding at hospital discharge’ in the Australian state of New South Wales. Methods An online survey was distributed across public and private maternity hospitals in New South Wales, Australia. The survey asked midwives and nurses their practice of reporting ‘infant feeding at discharge’ from categories offered by the state Mothers and Babies report of either “ full breastfeeding”, “any breastfeeding”, and “infant formula only ”. The Qualtrics survey was available from December 2021 to May 2022. Results There were 319 completed surveys for analysis and all 15 NSW Health Districts were represented. Some participants reported using the timeframe ‘ since birth’ as a reference (39%), however, the majority (54%, n  = 173) referenced one of the feeding timeframes within the previous 24 h. Most midwives and nurses (83%, n  = 265) recommended 24 h before discharge as the most relevant reference timeframe, and 65% ( n =  207) were in favour of recording data on ‘exclusive breastfeeding’ since birth. Conclusion This study identified multiple practice inconsistencies within New South Wales reporting of ‘infant feeding at hospital discharge’. This has ramifications for key health statistics, state reporting, and national benchmarking. While the Baby Friendly Hospital Initiative accreditation requires hospitals to demonstrate and continuously monitor at least a 75% exclusive breastfeeding rate on discharge, only 11 New South Wales facilities have achieved this accreditation. We recommend introducing an option to collect ‘exclusive breastfeeding’ on discharge’ which is in line with participant recommendations and the Baby Friendly Hospital accreditation. Other important considerations are the updated World Health Organization indicators such as, “ Ever breastfed”; “Early initiation of breastfeeding” (first hour); “Exclusively breastfed for the first two days after birth ”.

IntroductionThe Improving maternal and PeRinatal Outcomes aMongst wOmen with and without obEsity (PROMOTE) cohort study is a prospective pregnancy cohort study that seeks to test current assumptions and understanding of cardiometabolic disease and risk during pregnancy. The demographic shift among pregnant women, including older age and increasing obesity, has resulted in an increased risk of cardiometabolic complications during pregnancy and over the lifetime for mother and offspring. Unfortunately, lifestyle interventions during pregnancy have not yet produced clinically meaningful outcomes. Furthermore, cohort studies in pregnancy are costly and have selection bias due to study burden and attrition. There is an urgent need for high-quality observational data collected pragmatically about cardiometabolic health and determinants during pregnancy, to identify subgroups at highest risk and to provide rich contextual information around the interplay of clinical and social determinants.Methods and analysisThe PROMOTE cohort study is a prospective pregnancy cohort study recruiting pregnant participants <16 weeks’ gestation at a large urban public teaching hospital with high social and cultural diversity in Sydney, Australia. Participants are surveyed about their physical activity levels, dietary quality, emotional well-being and sociodemographic status using validated tools. Participants are consented for biobanking and for use of routinely collected clinical and social data, including medical conditions, body mass index, blood pressure and glycaemia. Follow-up is from routinely collected data. Pregnancy and birth outcomes include maternal and neonatal pregnancy and birth outcomes include gestational diabetes mellitus, hypertensive disorders of pregnancy and preterm birth. Postnatal and longitudinal data collection is planned.Ethics and disseminationThe study has been approved by the Western Sydney Local Health District Human Research Ethics Committee (2021/ETH00287). The study will disseminate results by academic publication, conference presentations and targeted implementation partnerships.Trial registration numberRetrospectively registered with the Australian New Zealand Clinical Trials Registry (registration number: ACTRN12624001344583).

Background Vascular prevention trials typically use dichotomous event outcomes although this may be inefficient statistically and gives no indication of event severity. We assessed whether ordinal outcomes would be more efficient and how to best analyse them. Methods Chief investigators of vascular prevention randomised controlled trials that showed evidence of either benefit or harm, or were included in a systematic review that overall showed benefit or harm, shared individual participant data from their trials. Ordered categorical versions of vascular event outcomes (such as stroke and myocardial infarction) were analysed using 15 statistical techniques and their results then ranked, with the result with the smallest p -value given the smallest rank. Friedman and Duncan’s multiple range tests were performed to assess differences between tests by comparing the average ranks for each statistical test. Results Data from 35 trials (254,223 participants) were shared with the collaboration. 13 trials had more than two treatment arms, resulting in 59 comparisons. Analysis approaches (Mann Whitney U, ordinal logistic regression, multiple regression, bootstrapping) that used ordinal outcome data had a smaller average rank and therefore appeared to be more efficient statistically than those that analysed the original binary outcomes. Conclusions Ordinal vascular outcome measures appear to be more efficient statistically than binary outcomes and provide information on the severity of event. We suggest a potential role for using ordinal outcomes in vascular prevention trials.

IntroductionCerebral palsy (CP) is the most common physical disability of childhood worldwide. Historically the diagnosis was made between 12 and 24 months, meaning data about effective early interventions to improve motor outcomes are scant. In high-income countries, two in three children will walk. This evaluator-blinded randomised controlled trial will investigate the efficacy of an early and sustained Goals–Activity–Motor Enrichment approach to improve motor and cognitive skills in infants with suspected or confirmed CP.Methods and analysisParticipants will be recruited from neonatal intensive care units and the community in Australia across four states. To be eligible for inclusion infants will be aged 3–6.5 months corrected for prematurity and have a diagnosis of CP or ‘high risk of CP’ according to the International Clinical Practice Guideline criteria. Eligible participants whose caregivers consent will be randomly allocated to receive usual care or weekly sessions at home from a GAME-trained study physiotherapist or occupational therapist, paired with a daily home programme, until age 2. The study requires 150 participants per group to detect a 0.5 SD difference in motor skills at 2 years of age, measured by the Peabody Developmental Motor Scales-2. Secondary outcomes include gross motor function, cognition, functional independence, social–emotional development and quality of life. A within-trial economic evaluation is also planned.Ethics and disseminationEthical approval was obtained from the Sydney Children’s Hospital Network Human Ethics Committee in April 2017 (ref number HREC/17/SCHN/37). Outcomes will be disseminated through peer-reviewed journal publications, presentations at international conferences and consumer websites.Trial registration numberACTRN12617000006347.

IntroductionThe safest oxygen levels needed for preterm infant respiratory support at birth are uncertain. We aimed to compare the outcomes of infants up to 286 weeks gestation who had respiratory care initiated at birth with fractional inspired oxygen (FiO2) 0.3 or 0.6, which was adjusted to meet specific oxygen saturations (SpO2).MethodsThis randomised controlled phase III trial was stratified by (1) site, (2) gestation and (3) multiplicity. Infants between 23+0 to 28+6 weeks gestation were randomised to initial respiratory support with FiO2 0.3 or 0.6, adjusted to meet common SpO2 targets for the first 10 min.Primary outcomeSurvival to 36 weeks gestation without documented brain injury.AssessmentsFiO2, SpO2 and heart rate were recorded each minute from delivery for 10 min. Assessments were obtained at baseline, 36 weeks, discharge and at 2 years corrected gestation, along with a parent questionnaire.Statistical analysis planAssuming 32% of infants would die or survive with brain injury by 36 weeks, 735 infants per arm (1470 total) were needed to detect a risk difference of 8% (25% relative risk reduction), with 10% non-adherence to protocol, 85% β and 5% α.EthicsApproved by the John Hunter Human Research Ethics Committee (2019/ETH/3837) for waiver of consent for all Australian sites for randomised allocation and primary outcome.ConclusionRecruitment started in 2018 and was achieved on 30 September 2024. The Data and Safety Committee review found no major safety concerns at 50% recruitment.Trial registration numberACTRN 12618000879268.