The contribution of assisted reproductive technology to fertility rates and parity transition: An analysis of Australian data

Background: Despite the widespread use of assisted reproductive technology (ART), few studies analyse its impact on the total fertility rate (TFR). Furthermore, very little is known about how ART affects fertility at older reproductive ages and contributes to family size. Objective: We aim to quantify the contribution of ART to total and age-specific fertility rates and in relation to the transition to first and subsequent births in Australia. Methods: Using data from a comprehensive clinical registry of ART treatments, age-specific ART and non-ART fertility rates were calculated and used to decompose the change in the TFR between 2010 and 2017 into ART and non-ART components. Results: ART represented an increasing and relevant contribution to the TFR, corresponding to an impact of the order of 4Š to 5Š per annum, or approximately to 1 in 20 births. Increasing fertility rates at age 33 and above exerted a positive effect on the overall TFR, and they were almost entirely attributable to the increasing use of ART. Women resorted to ART especially to have a first child. Contribution: This is the first study to provide a detailed examination of the contribution of ART to age-specific fertility rates and in relation to parity transition. While most studies focus on the impact of ART on the overall TFR, the importance of ART for the recovery of births at older reproductive ages could be underestimated

Perinatal deaths in Australia 1993–2012

Summary The loss of a baby who was either stillborn or died in the first weeks of life is a tragic event that affects around 3,000 families every year in Australia. Perinatal mortality is widely recognised as an important indicator of population health. While Australia is one of the safest places in the world to give birth, almost 1 in 100 pregnancies will end in a perinatal death. Perinatal deaths in Australia 1993–2012 represents the first comprehensive national report on perinatal mortality in Australia and includes a detailed analysis of data relating to stillbirths and neonatal deaths for the period 2011-2012 and an analysis of trends for 1993–2012. The aim of this report is to gain a better understanding of the causes of perinatal deaths at a population level and identify changes in perinatal mortality over time. Data used for this report come from information recorded in jurisdictional perinatal data collections and information collated by state and territory perinatal mortality review committees. For the 2 years 2011 and 2012, just over 6,000 babies died during the perinatal period: a rate of 9.9 deaths per 1,000 births. Approximately three-quarters of those deaths were stillbirths (4,485) with the remaining 1,580 deaths being neonatal deaths. The rate of perinatal mortality varied by the state or territory in which babies were born, with the highest perinatal mortality rate recorded in Victoria (12.2 deaths per 1,000 births) and the lowest in New South Wales (8.3 deaths per 1,000 births). The rates also varied considerably between different subgroups including those based on mothers\u27 level of remoteness, socioeconomic status, age, smoking status, body mass index (BMI) and Indigenous status. The perinatal mortality rate of babies born to mothers who identified as Aboriginal or Torres Strait Islander was almost double that of babies of non-Indigenous mothers (17.1 versus 9.6 deaths per 1,000 births). Similarly, the perinatal mortality rate was almost 50% higher among babies whose mothers smoked compared with those who did not smoke (13.3 versus 8.9 deaths per 1,000 births). The stillbirth rate for babies of teenage mothers and mothers older than 45 was more than double that for mothers aged 30–34 (13.9 and 17.1 versus 6.4 deaths per 1,000 births). Over the 20-year period 1993–2012, the overall perinatal mortality rate was stable at around 10 deaths per 1,000 live births. There was a decrease in the rate of neonatal death (3.2 to 2.4 deaths per 1,000 live births) and an increase in the stillbirth rate (6.4 to 7.2 deaths per 1,000 births). Although remaining high, the report shows a decrease of 20% in the perinatal mortality rate among babies of Aboriginal and Torres Strait Islander mothers. During 2011 and 2012, congenital abnormality was the leading condition in the fetus classified by the PSANZ Perinatal Death Classification as the cause of stillbirths (26.3% of stillbirths) and neonatal deaths (33.1%). An additional PSANZ Neonatal Death Classification of extreme prematurity was the leading condition contributing to deaths in the neonatal period (33.5%). When examined by Indigenous status, however, the leading cause of perinatal death among babies of Aboriginal and Torres Strait Islander mothers was spontaneous pre-term birth (26.8% of stillbirths and 48.0% of neonatal deaths). This report provides insight into the trends in perinatal mortality in Australia, and highlights variations in some of Australia\u27s most vulnerable and disadvantaged population subgroups. This indicates areas that warrant further investigation and attention by clinicians, researchers and health policy makers

Study protocol for a comparative effectiveness trial of two models of perinatal integrated psychosocial assessment: The PIPA project

Background: Studies examining psychosocial and depression assessment programs in maternity settings have not adequately considered the context in which psychosocial assessment occurs or how broader components of integrated care, including clinician decision-making aids, may optimise program delivery and its cost-effectiveness. There is also limited evidence relating to the diagnostic accuracy of symptom-based screening measures used in this context. The Perinatal Integrated Psychosocial Assessment (PIPA) Project was developed to address these knowledge gaps. The primary aims of the PIPA Project are to examine the clinical- and cost-effectiveness of two alternative models of integrated psychosocial care during pregnancy: \u27care as usual\u27 (the SAFE START model) and an alternative model (the PIPA model). The acceptability and perceived benefit of each model of care from the perspective of both pregnant women and their healthcare providers will also be assessed. Our secondary aim is to examine the psychometric properties of a number of symptom-based screening tools for depression and anxiety when used in pregnancy. Methods: This is a comparative-effectiveness study comparing \u27care as usual\u27 to an alternative model sequentially over two 12-month periods. Data will be collected from women at Time 1 (initial antenatal psychosocial assessment), Time 2 (2-weeks after Time 1) and from clinicians at Time 3 for each condition. Primary aims will be evaluated using a between-groups design, and the secondary aim using a within group design. Discussion: The PIPA Project will provide evidence relating to the clinical- and cost- effectiveness of psychosocial assessment integrated with electronic clinician decision making prompts, and referral options that are tailored to the woman\u27s psychosocial risk, in the maternity care setting. It will also address research recommendations from the Australian (2011) and NICE (2015) Clinical Practice Guidelines

Claims of causality in health news: a randomised trial

Background Misleading news claims can be detrimental to public health. We aimed to improve the alignment between causal claims and evidence, without losing news interest (counter to assumptions that news is not interested in communicating caution). Methods We tested two interventions in press releases, which are the main sources for science and health news: (a) aligning the headlines and main causal claims with the underlying evidence (strong for experimental, cautious for correlational) and (b) inserting explicit statements/caveats about inferring causality. The ‘participants’ were press releases on health-related topics (N = 312; control = 89, claim alignment = 64, causality statement = 79, both = 80) from nine press offices (journals, universities, funders). Outcomes were news content (headlines, causal claims, caveats) in English-language international and national media (newspapers, websites, broadcast; N = 2257), news uptake (% press releases gaining news coverage) and feasibility (% press releases implementing cautious statements). Results News headlines showed better alignment to evidence when press releases were aligned (intention-to-treat analysis (ITT) 56% vs 52%, OR = 1.2 to 1.9; as-treated analysis (AT) 60% vs 32%, OR = 1.3 to 4.4). News claims also followed press releases, significant only for AT (ITT 62% vs 60%, OR = 0.7 to 1.6; AT, 67% vs 39%, OR = 1.4 to 5.7). The same was true for causality statements/caveats (ITT 15% vs 10%, OR = 0.9 to 2.6; AT 20% vs 0%, OR 16 to 156). There was no evidence of lost news uptake for press releases with aligned headlines and claims (ITT 55% vs 55%, OR = 0.7 to 1.3, AT 58% vs 60%, OR = 0.7 to 1.7), or causality statements/caveats (ITT 53% vs 56%, OR = 0.8 to 1.0, AT 66% vs 52%, OR = 1.3 to 2.7). Feasibility was demonstrated by a spontaneous increase in cautious headlines, claims and caveats in press releases compared to the pre-trial period (OR = 1.01 to 2.6, 1.3 to 3.4, 1.1 to 26, respectively). Conclusions News claims—even headlines—can become better aligned with evidence. Cautious claims and explicit caveats about correlational findings may penetrate into news without harming news interest. Findings from AT analysis are correlational and may not imply cause, although here the linking mechanism between press releases and news is known. ITT analysis was insensitive due to spontaneous adoption of interventions across conditions

Global changes to the chemotherapy service during the covid-19 pandemic.

PURPOSE: In response to the COVID-19 pandemic, changes to chemotherapy services were implemented as a means of managing imposed workload strains within health services and protecting patients from contracting COVID-19. Given the rapidly evolving nature of the pandemic many changes were rapidly adopted and were not substantiated by robust evidence. This study aimed to describe the changes adopted internationally to chemotherapy services, which may be used to guide future changes to treatment delivery. METHODS: A survey was developed to understand the impact of COVID-19 on the delivery of systemic anti-cancer therapies (SACT). It comprised 22 questions and examined the strategies implemented during the pandemic to prioritise and protect patients receiving SACT and the participants' professional opinion of the strategies employed. The survey was available in English, Spanish and French and was distributed via professional bodies. RESULTS: 129 responses were obtained from healthcare professionals working across 17 different countries. 45% of institutions had to implement treatment prioritisation strategies and all hospitals implemented changes in the delivery of treatment, including: reduction in treatments (69%), using less immunosuppressive agents (50%), allowing treatment breaks (14%) and switching to oral therapies (45%). Virtual clinic visits were perceived by participants as the most effective strategy to protect patients. CONCLUSIONS: The pandemic has forced chemotherapy healthcare professionals to adopt new ways of working by reducing health interactions. Many areas of research are needed following this period, including understanding patients' perceptions of risks to treatment, utilisation of oral treatments and the impact of treatment breaks on cancer outcomes

Protocol for the development and validation of a risk prediction model for stillbirths from 35 weeks gestation in Australia

Abstract: Background: Despite advances in the care of women and their babies in the past century, an estimated 1.7 million babies are born still each year throughout the world. A robust method to estimate a pregnant woman’s individualized risk of late-pregnancy stillbirth is needed to inform decision-making around the timing of birth to reduce the risk of stillbirth from 35 weeks of gestation in Australia, a high-resource setting. Methods: This is a protocol for a cross-sectional study of all late-pregnancy births in Australia (2005–2015) from 35 weeks of gestation including 5188 stillbirths among 3.1 million births at an estimated rate of 1.7 stillbirths per 1000 births. A multivariable logistic regression model will be developed in line with current TransparentReporting of a multivariable prediction model forIndividualPrognosis orDiagnosis (TRIPOD) guidelines to estimate the gestation-specific probability of stillbirth with prediction intervals. Candidate predictors were identified from systematic reviews and clinical consultation and will be described through univariable regression analysis. To generate a final model, elimination by backward stepwise multivariable logistic regression will be performed. The model will be internally validated using bootstrapping with 1000 repetitions and externally validated using a temporally unique dataset. Overall model performance will be assessed with R2, calibration, and discrimination. Calibration will be reported using a calibration plot with 95% confidence intervals (α = 0.05). Discrimination will be measured by the C-statistic and area underneath the receiver-operator curves. Clinical usefulness will be reported as positive and negative predictive values, and a decision curve analysis will be considered. Discussion: A robust method to predict a pregnant woman’s individualized risk of late-pregnancy stillbirth is needed to inform timely, appropriate care to reduce stillbirth. Among existing prediction models designed for obstetric use, few have been subject to internal and external validation and many fail to meet recommended reporting standards. In developing a risk prediction model for late-gestation stillbirth with both providers and pregnant women in mind, we endeavor to develop a validated model for clinical use in Australia that meets current reporting standards

Protocol for the development and validation of a risk prediction model for stillbirths from 35 weeks gestation in Australia

Abstract: Background: Despite advances in the care of women and their babies in the past century, an estimated 1.7 million babies are born still each year throughout the world. A robust method to estimate a pregnant woman’s individualized risk of late-pregnancy stillbirth is needed to inform decision-making around the timing of birth to reduce the risk of stillbirth from 35 weeks of gestation in Australia, a high-resource setting. Methods: This is a protocol for a cross-sectional study of all late-pregnancy births in Australia (2005–2015) from 35 weeks of gestation including 5188 stillbirths among 3.1 million births at an estimated rate of 1.7 stillbirths per 1000 births. A multivariable logistic regression model will be developed in line with current TransparentReporting of a multivariable prediction model forIndividualPrognosis orDiagnosis (TRIPOD) guidelines to estimate the gestation-specific probability of stillbirth with prediction intervals. Candidate predictors were identified from systematic reviews and clinical consultation and will be described through univariable regression analysis. To generate a final model, elimination by backward stepwise multivariable logistic regression will be performed. The model will be internally validated using bootstrapping with 1000 repetitions and externally validated using a temporally unique dataset. Overall model performance will be assessed with R2, calibration, and discrimination. Calibration will be reported using a calibration plot with 95% confidence intervals (α = 0.05). Discrimination will be measured by the C-statistic and area underneath the receiver-operator curves. Clinical usefulness will be reported as positive and negative predictive values, and a decision curve analysis will be considered. Discussion: A robust method to predict a pregnant woman’s individualized risk of late-pregnancy stillbirth is needed to inform timely, appropriate care to reduce stillbirth. Among existing prediction models designed for obstetric use, few have been subject to internal and external validation and many fail to meet recommended reporting standards. In developing a risk prediction model for late-gestation stillbirth with both providers and pregnant women in mind, we endeavor to develop a validated model for clinical use in Australia that meets current reporting standards

Developing a core outcome set for future infertility research : An international consensus development study

STUDY QUESTION: Can a core outcome set to standardize outcome selection, collection and reporting across future infertility research be developed? SUMMARY ANSWER: A minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCTs) and systematic reviews evaluating potential treatments for infertility. WHAT IS KNOWN ALREADY: Complex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret. STUDY DESIGN, SIZE, DURATION: A three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries). PARTICIPANTS/MATERIALS, SETTING, METHODS: Healthcare professionals, researchers and people with fertility problems were brought together in an open and transparent process using formal consensus science methods. MAIN RESULTS AND THE ROLE OF CHANCE: The core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when applicable. LIMITATIONS, REASONS FOR CAUTION: We used consensus development methods which have inherent limitations, including the representativeness of the participant sample, Delphi survey attrition and an arbitrary consensus threshold. WIDER IMPLICATIONS OF THE FINDINGS: Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection and reporting of core outcomes. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Fertility and Sterility and Human Reproduction, have committed to implementing this core outcome set. STUDY FUNDING/COMPETING INTEREST(S): This research was funded by the Catalyst Fund, Royal Society of New Zealand, Auckland Medical Research Fund and Maurice and Phyllis Paykel Trust. The funder had no role in the design and conduct of the study, the collection, management, analysis or interpretation of data, or manuscript preparation. B.W.J.M. is supported by a National Health and Medical Research Council Practitioner Fellowship (GNT1082548). S.B. was supported by University of Auckland Foundation Seelye Travelling Fellowship. S.B. reports being the Editor-in-Chief of Human Reproduction Open and an editor of the Cochrane Gynaecology and Fertility group. J.L.H.E. reports being the Editor Emeritus of Human Reproduction. J.M.L.K. reports research sponsorship from Ferring and Theramex. R.S.L. reports consultancy fees from Abbvie, Bayer, Ferring, Fractyl, Insud Pharma and Kindex and research sponsorship from Guerbet and Hass Avocado Board. B.W.J.M. reports consultancy fees from Guerbet, iGenomix, Merck, Merck KGaA and ObsEva. C.N. reports being the Co Editor-in-Chief of Fertility and Sterility and Section Editor of the Journal of Urology, research sponsorship from Ferring, and retains a financial interest in NexHand. A.S. reports consultancy fees from Guerbet. E.H.Y.N. reports research sponsorship from Merck. N.L.V. reports consultancy and conference fees from Ferring, Merck and Merck Sharp and Dohme. The remaining authors declare no competing interests in relation to the work presented. All authors have completed the disclosure form