Treatment of Gestational Diabetes Mellitus Diagnosed Early in Pregnancy.

BACKGROUND: Whether treatment of gestational diabetes before 20 weeks' gestation improves maternal and infant health is unclear. METHODS: We randomly assigned, in a 1:1 ratio, women between 4 weeks' and 19 weeks 6 days' gestation who had a risk factor for hyperglycemia and a diagnosis of gestational diabetes (World Health Organization 2013 criteria) to receive immediate treatment for gestational diabetes or deferred or no treatment, depending on the results of a repeat oral glucose-tolerance test [OGTT] at 24 to 28 weeks' gestation (control). The trial included three primary outcomes: a composite of adverse neonatal outcomes (birth at <37 weeks' gestation, birth trauma, birth weight of ≥4500 g, respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia), pregnancy-related hypertension (preeclampsia, eclampsia, or gestational hypertension), and neonatal lean body mass. RESULTS: A total of 802 women underwent randomization; 406 were assigned to the immediate-treatment group and 396 to the control group; follow-up data were available for 793 women (98.9%). An initial OGTT was performed at a mean (±SD) gestation of 15.6±2.5 weeks. An adverse neonatal outcome event occurred in 94 of 378 women (24.9%) in the immediate-treatment group and in 113 of 370 women (30.5%) in the control group (adjusted risk difference, -5.6 percentage points; 95% confidence interval [CI], -10.1 to -1.2). Pregnancy-related hypertension occurred in 40 of 378 women (10.6%) in the immediate-treatment group and in 37 of 372 women (9.9%) in the control group (adjusted risk difference, 0.7 percentage points; 95% CI, -1.6 to 2.9). The mean neonatal lean body mass was 2.86 kg in the immediate-treatment group and 2.91 kg in the control group (adjusted mean difference, -0.04 kg; 95% CI, -0.09 to 0.02). No between-group differences were observed with respect to serious adverse events associated with screening and treatment. CONCLUSIONS: Immediate treatment of gestational diabetes before 20 weeks' gestation led to a modestly lower incidence of a composite of adverse neonatal outcomes than no immediate treatment; no material differences were observed for pregnancy-related hypertension or neonatal lean body mass. (Funded by the National Health and Medical Research Council and others; TOBOGM Australian New Zealand Clinical Trials Registry number, ACTRN12616000924459.).

Learning together for better health using an evidence-based Learning Health System framework: a case study in stroke.

BACKGROUND: In the context of expanding digital health tools, the health system is ready for Learning Health System (LHS) models. These models, with proper governance and stakeholder engagement, enable the integration of digital infrastructure to provide feedback to all relevant parties including clinicians and consumers on performance against best practice standards, as well as fostering innovation and aligning healthcare with patient needs. The LHS literature primarily includes opinion or consensus-based frameworks and lacks validation or evidence of benefit. Our aim was to outline a rigorously codesigned, evidence-based LHS framework and present a national case study of an LHS-aligned national stroke program that has delivered clinical benefit. MAIN TEXT: Current core components of a LHS involve capturing evidence from communities and stakeholders (quadrant 1), integrating evidence from research findings (quadrant 2), leveraging evidence from data and practice (quadrant 3), and generating evidence from implementation (quadrant 4) for iterative system-level improvement. The Australian Stroke program was selected as the case study as it provides an exemplar of how an iterative LHS works in practice at a national level encompassing and integrating evidence from all four LHS quadrants. Using this case study, we demonstrate how to apply evidence-based processes to healthcare improvement and embed real-world research for optimising healthcare improvement. We emphasize the transition from research as an endpoint, to research as an enabler and a solution for impact in healthcare improvement. CONCLUSIONS: The Australian Stroke program has nationally improved stroke care since 2007, showcasing the value of integrated LHS-aligned approaches for tangible impact on outcomes. This LHS case study is a practical example for other health conditions and settings to follow suit.

Effects of different insulin sensitisers in the management of polycystic ovary syndrome: A systematic review and meta-analysis.

OBJECTIVE: Characteristic features of polycystic ovary syndrome (PCOS) include insulin resistance and an increased risk for type 2 diabetes. To promote improved insulin sensitivity, insulin sensitisers have been used in PCOS. However, direct comparisons across these agents are limited. This study compared the effects of metformin, rosiglitazone and pioglitazone in the management of PCOS to inform the 2023 International Evidence-based PCOS Guideline. DESIGN: Systematic review and meta-analysis of the literature. PATIENTS: Women with PCOS and treatment with insulin sensitisers. MEASUREMENTS: Hormonal and clinical outcomes, as well as side effects. RESULTS: Of 1660 publications identified, 13 randomised controlled trials were included. Metformin was superior in lowering weight (mean difference [MD]: -4.39, 95% confidence interval [CI]: -7.69 to -1.08 kg), body mass index (MD: -0.95, 95% CI: -1.41 to -0.49 kg/m2 ) and testosterone (MD: -0.10, 95% CI: -0.18 to -0.03 nmol/L) versus rosiglitazone, whereas there was no difference when comparing metformin to pioglitazone. Adding rosiglitazone or pioglitazone to metformin did not improve metabolic outcomes. However, rosiglitazone seemed superior to metformin in lowering lipid concentrations. CONCLUSIONS: Metformin should remain the first-line insulin sensitising treatment in adults with PCOS for the prevention and management of weight and metabolic features. The addition of thiazolidinediones appears to offer little benefit.

Machine Learning Algorithms Versus Classical Regression Models in Pre-Eclampsia Prediction: A Systematic Review.

PURPOSE OF REVIEW: Machine learning (ML) approaches are an emerging alternative for healthcare risk prediction. We aimed to synthesise the literature on ML and classical regression studies exploring potential prognostic factors and to compare prediction performance for pre-eclampsia. RECENT FINDINGS: From 9382 studies retrieved, 82 were included. Sixty-six publications exclusively reported eighty-four classical regression models to predict variable timing of onset of pre-eclampsia. Another six publications reported purely ML algorithms, whilst another 10 publications reported ML algorithms and classical regression models in the same sample with 8 of 10 findings that ML algorithms outperformed classical regression models. The most frequent prognostic factors were age, pre-pregnancy body mass index, chronic medical conditions, parity, prior history of pre-eclampsia, mean arterial pressure, uterine artery pulsatility index, placental growth factor, and pregnancy-associated plasma protein A. Top performing ML algorithms were random forest (area under the curve (AUC) = 0.94, 95% confidence interval (CI) 0.91-0.96) and extreme gradient boosting (AUC = 0.92, 95% CI 0.90-0.94). The competing risk model had similar performance (AUC = 0.92, 95% CI 0.91-0.92) compared with a neural network. Calibration performance was not reported in the majority of publications. ML algorithms had better performance compared to classical regression models in pre-eclampsia prediction. Random forest and boosting-type algorithms had the best prediction performance. Further research should focus on comparing ML algorithms to classical regression models using the same samples and evaluation metrics to gain insight into their performance. External validation of ML algorithms is warranted to gain insights into their generalisability.

Maternal metabolic conditions as predictors of breastfeeding outcomes: Insights from an Australian cohort study.

INTRODUCTION: Breastfeeding represents an important opportunity to optimize health outcomes for both mother and infant, particularly in the context of maternal metabolic conditions such as diabetes and polycystic ovary syndrome. However, evidence suggests that women affected by these conditions breastfeed at reduced rates and durations. Our aim was to use the large, prospective, community-based Australian Longitudinal Study on Women's Health (ALSWH) to conduct an in-depth exploratory analysis of breastfeeding outcomes in Australian women affected by key maternal metabolic conditions. MATERIAL AND METHODS: Data from 12 920 pregnancies to 5605 women from the 1973-1978 birth cohort of the ALSWH were examined. Univariable and multivariable regression using generalized estimating equation models were applied to assess breastfeeding initiation and duration (outcome measures) in relation to key self-reported maternal metabolic diagnoses (pre-gestational type 1 and type 2 diabetes, gestational diabetes, and polycystic ovary syndrome; main explanatory variables). Key sociodemographic and clinical covariates were also considered. RESULTS: Results showed no significant association between specific maternal metabolic diagnoses (pre-gestational or gestational diabetes, or polycystic ovary syndrome) and breastfeeding outcomes. However, maternal body mass index emerged as a key predictor of suboptimal breastfeeding outcomes. Pregnancies affected by maternal obesity were associated with a 2.1-fold increase in the odds of not initiating breastfeeding, after adjusting for other key variables (95% CI 1.67 to 2.60, p < 0.01). Maternal overweight and obesity were, respectively, associated with an adjusted 1.4-fold (95% CI 1.20 to 1.55, p < 0.01) and 1.8-fold increase (95% CI 1.60 to 2.10, p < 0.01) in the odds of a breastfeeding duration less than 6 months. CONCLUSIONS: Maternal obesity, rather than any specific maternal metabolic condition, appears to be a key predictor of breastfeeding outcomes in Australian women.

International evidence-based guideline on assessment and management of PCOS-A Nordic perspective.

Polycystic ovary syndrome (PCOS) affects about 12% of women of reproductive age. In 2018, the first evidence-based guideline on assessment and management of PCOS was published, and an updated extended guideline was released in August 2023. These guidelines followed best practice and are endorsed by 39 organizations worldwide, making them the most robust source of evidence to guide clinical practice. In the 2023 guideline, diagnostic criteria have been further refined as polycystic ovary morphology can now be assessed with gynecological ultrasound or elevated anti-Müllerian hormone levels. A healthy lifestyle should be at the focus of care for all women with PCOS; however, with no specific diet or physical exercise recommended. The latest evidence on medical treatments and fertility management are reviewed, including special considerations regarding long-term follow-up of metabolic and psychiatric comorbidities and pregnancy in women with PCOS. Here we summarize the recommendations from a Nordic perspective.

Ethnic differences in physical activity participation when managing gestational diabetes mellitus: a mixed-methods study comparing ethnic Chinese migrants and Australian women.

BACKGROUND: Physical activity is a key component in gestational diabetes mellitus management to optimise glycaemic control and reduce adverse pregnancy outcomes. However, inadequate physical activity during pregnancy is common. Underpinned by a woman-centred pregnancy care model, appropriate strategies targeting patients' cultural needs may facilitate physical activity participation. Ethnic Chinese migrants have a four-fold higher risk of gestational diabetes mellitus than the Australian Caucasian host population. To identify potentially effective disease management strategies to improve physical activity participation, understanding and comparing ethnic Chinese migrants' and Caucasian women's views will provide insights into developing an end-user-informed intervention. AIMS: This study aimed to compare perceptions and practices around physical activity participation during pregnancy between 44 ethnic Chinese migrants and 39 Australian-born Caucasian women with gestational diabetes mellitus. METHODS: This mixed-methods study used in-depth, semi-structured audio-recorded interviews, validated pregnancy physical activity questionnaires and pedometers. Qualitative data were thematically analysed and compared between ethnicities. SPSS (SPSS Inc) was used in quantitative data analysis. Data triangulation was made to identify patterns in participant characteristics, physical activity beliefs and participation. RESULTS: Despite both ethnic groups doing less physical activity than recommended, Chinese participants were less physically active than Caucasian participants. Chinese participants expressed greater safety concerns about physical activity and opted for a more sedentary lifestyle. Data triangulation indicated that non-Australian-born Chinese participants whose husbands were Asian were overcautious about miscarriage risk related to physical activity, which promoted a sedentary lifestyle. Chinese participants suggested individualised, specific physical activity advice on safe physical activity during pregnancy would mitigate their concerns. Caucasian participants reported that digital step measurement technologies motivated their participation in physical activity. CONCLUSION: Different strategies are suggested by Chinese and Caucasian participants to improve physical activity participation to manage gestational diabetes mellitus among ethnic Chinese and Caucasian populations, which will be evaluated in future interventions.

Nurses' experiences of hospital-acquired pressure injury prevention in acute healthcare services in Victoria, Australia: A qualitative study using the Theoretical Domains Framework.

We investigated nurses' experiences of hospital-acquired pressure injury (PI) prevention in acute care services to better understand how PI prevention may be optimised. We used the Theoretical Domains Framework to systematically identify barriers and enablers to evidence-based preventive practices as required by the International Guideline. This study was one element of a complex capacity building project on PI surveillance and prevention within the acute health service partners of Monash Partners Academic Health Science Centre, an accredited academic health partnership located in Melbourne, Australia. We adopted a qualitative descriptive design. We interviewed 32 nurses that provided care in intensive care units, general wards and COVID wards of four acute care services. Nurses were recruited from four large acute care services (three public, one private) located in Melbourne. Most of them worked with patients who were at high risk of hospital-acquired PI on a daily basis. Interview transcripts were coded and analysed using thematic analysis guided by the Theoretical Domains Framework. The domains referred to most frequently by all participants included: Knowledge, Skills, Social/Professional Role and Identity, Beliefs about Capabilities, and Environmental Context and Resources. The key barriers discussed by nurses included gaps in nurses' knowledge and skills related to identification and staging of PI, heavy nursing workload and inadequate staffing levels, stigma and self-blame related to PI identification, and exacerbating impacts of the COVID-19 pandemic. Main facilitators discussed were training programmes, nursing audits and feedback, and teamwork. Participants suggested improvements including accessible and tailored training, visual reminders, and addressing heavy workloads and emotional barriers nurses face. Investing in tailored training initiatives to improve nurses' knowledge and organisational changes to address low level staffing and heavy workloads are urgently needed to support nurses in delivering optimal care and preventing hospital-acquired PI.

Long-term cost-effectiveness of implementing a lifestyle intervention during pregnancy to reduce the incidence of gestational diabetes and type 2 diabetes.

AIMS/HYPOTHESIS: The aim of this study was to determine the long-term cost-effectiveness and return on investment of implementing a structured lifestyle intervention to reduce excessive gestational weight gain and associated incidence of gestational diabetes mellitus (GDM) and type 2 diabetes mellitus. METHODS: A decision-analytic Markov model was used to compare the health and cost-effectiveness outcomes for (1) a structured lifestyle intervention during pregnancy to prevent GDM and subsequent type 2 diabetes; and (2) current usual antenatal care. Life table modelling was used to capture type 2 diabetes morbidity, mortality and quality-adjusted life years over a lifetime horizon for all women giving birth in Australia. Costs incorporated both healthcare and societal perspectives. The intervention effect was derived from published meta-analyses. Deterministic and probabilistic sensitivity analyses were used to capture the impact of uncertainty in the model. RESULTS: The model projected a 10% reduction in the number of women subsequently diagnosed with type 2 diabetes through implementation of the lifestyle intervention compared with current usual care. The total net incremental cost of intervention was approximately AU$70 million, and the cost savings from the reduction in costs of antenatal care for GDM, birth complications and type 2 diabetes management were approximately AU$85 million. The intervention was dominant (cost-saving) compared with usual care from a healthcare perspective, and returned AU$1.22 (95% CI 0.53, 2.13) per dollar invested. The results were robust to sensitivity analysis, and remained cost-saving or highly cost-effective in each of the scenarios explored. CONCLUSIONS/INTERPRETATION: This study demonstrates significant cost savings from implementation of a structured lifestyle intervention during pregnancy, due to a reduction in adverse health outcomes for women during both the perinatal period and over their lifetime.

Combined oral contraceptive pill compared with no medical treatment in the management of polycystic ovary syndrome: A systematic review.

OBJECTIVE: As part of the update of the International Evidence-Based Guidelines for the Assessment and Management of polycystic ovary syndrome (PCOS), a systematic review was performed to inform evidence-based recommendations. DESIGN: Systematic review. Only randomised controlled trial were included. PATIENTS: Women with PCOS; the use of combined oral contraceptive pills (COCP) was compared with no medical treatment. MEASUREMENTS: Outcomes were designed in collaboration with clinical experts, researchers, and consumers. Critical outcomes included hirsutism, irregular cycles, quality of life, body mass index (BMI), and weight. RESULTS: 1660 publications were identified, but only four studies were included. No studies could be combined for meta-analysis. COCP treatment improved cycle regularity compared with no medical treatment (100% vs. 0%, with low certainty of evidence). COCP showed no difference in improvement of hirsutism or BMI compared with placebo or lifestyle; a lower weight after COCP compared with no treatment (mean difference [MD] -8.0 (95% confidence interval, CI -11.67); -4.33 kg); and improvement in quality of life (MD 1.2 [95% CI 0.96]; 1.44), but these results were all very low certainty of evidence. CONCLUSION: Results show that COCP benefit cycle regulation, but other benefits or potential adverse effects were only identified with very low certainty of evidence. The COCP is frontline medical treatment in PCOS, but this is still based on established efficacy in the broader general population. Our results show that research in PCOS is seriously lacking and should be prioritised to capture core reproductive, metabolic and psychological outcomes important in PCOS.

High prevalence of medical conditions and unhealthy lifestyle behaviours in women with PCOS during preconception: findings from the Australian Longitudinal Study on Women's Health.

STUDY QUESTION: What are the pre-existing medical conditions and lifestyle behaviours of women with and without PCOS during the preconception period? SUMMARY ANSWER: During the preconception period, medical conditions of obesity, depression, anxiety, and a history of infertility were more highly prevalent in women with than without PCOS, and more women with than without PCOS were engaged in unhealthy lifestyle behaviours. WHAT IS KNOWN ALREADY: Women with PCOS are predisposed to infertility and pregnancy complications. Optimizing preconception medical health and lifestyle behaviours can improve maternal and pregnancy outcomes but, to the best of our knowledge, no study has examined the preconception medical conditions and lifestyle behaviours of women with PCOS. STUDY DESIGN, SIZE DURATION: This is a cross-sectional study on 942 women with PCOS and 7024 women without PCOS, aged 24-30 years from the Australian Longitudinal Study of Women's Health, an ongoing, national survey-based prospective cohort study. PARTICIPANTS/MATERIALS, SETTING, METHODS: The current study analysed self-reported data from Survey 6 collected in 2019 of the cohort of women born between 1989 and 1995. Explored outcomes included BMI, pre-existing medical conditions, and modifiable lifestyle behaviours, including smoking, recreational drug use, alcohol intake, and physical activity level, during the preconception period. Differences between subgroups were tested using Student's t-test, χ2 test, or Fisher's exact test as appropriate. The associations of pregnancy intention with medical conditions and lifestyle behaviours were examined using logistic regression. MAIN RESULTS AND THE ROLE OF CHANCE: Obesity, depression, anxiety, and infertility were highly prevalent in women actively planning for pregnancy. Among women with PCOS, the prevalence of obesity was 47.02%, followed by depression at 32.70%, anxiety at 39.62%, and infertility at 47.17%. Conversely among women without PCOS, the corresponding prevalence was lower, at 22.33% for obesity, 18.98% for depression, 23.93% for anxiety, and 16.42% for infertility. In women actively planning for pregnancy, only those without PCOS demonstrated a lower prevalence of unhealthy lifestyle behaviours compared to non-planning women. The prevalence of unhealthy lifestyle behaviours was similar in women with PCOS regardless of their pregnancy intentions. Multivariable logistic regression revealed that only moderate/high stress with motherhood/children (adjusted odds ratio (OR) 3.31, 95% CI 1.60-6.85) and history of infertility (adjusted OR 9.67, 95% CI 5.02-18.64) were significantly associated with active pregnancy planning in women with PCOS. LIMITATIONS, REASONS FOR CAUTION: The findings were based on self-reported data. The cohort of women surveyed may have a higher level of education than women in the community, therefore our findings may underestimate the true prevalence of pre-existing medical conditions and lifestyle challenges faced by the broader population. WIDER IMPLICATIONS OF THE FINDINGS: A higher proportion of women with than without PCOS had pre-existing medical conditions and engaged in potentially modifiable unhealthy lifestyle behaviours during preconception despite their risk for subfertility and pregnancy complications. Healthcare professionals play a pivotal role in guiding this high-risk group of women during this period, offering counselling, education, and support for the adoption of healthy lifestyles to improve fertility, pregnancy outcomes, and intergenerational health. STUDY FUNDING/COMPETING INTEREST(S): C.T.T. holds a seed grant from the National Health and Medical Research Council (NHMRC) through the Centre of Research Excellence in Women's Health in Reproductive Life (CRE WHiRL) and Royal Australasian College of Physician Foundation Roger Bartop Research Establishment Fellowship. H.T. holds an NHMRC Medical Research Fellowship. C.L.H. holds an NHMRC CRE Health in Preconconception and Pregnancy Senior Postdoctoral Fellowship. A.E.J. holds a CRE WhiRL Early to Mid-career Fellowship. The authors have no conflicts of interest to declare. TRIAL REGISTRATION NUMBER: N/A.

Recommendations from the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome†.

STUDY QUESTION: What is the recommended assessment and management of those with polycystic ovary syndrome (PCOS), based on the best available evidence, clinical expertise, and consumer preference? SUMMARY ANSWER: International evidence-based guidelines address prioritized questions and outcomes and include 254 recommendations and practice points, to promote consistent, evidence-based care and improve the experience and health outcomes in PCOS. WHAT IS KNOWN ALREADY: The 2018 International PCOS Guideline was independently evaluated as high quality and integrated multidisciplinary and consumer perspectives from six continents; it is now used in 196 countries and is widely cited. It was based on best available, but generally very low to low quality, evidence. It applied robust methodological processes and addressed shared priorities. The guideline transitioned from consensus based to evidence-based diagnostic criteria and enhanced accuracy of diagnosis, whilst promoting consistency of care. However, diagnosis is still delayed, the needs of those with PCOS are not being adequately met, evidence quality was low and evidence-practice gaps persist. STUDY DESIGN, SIZE, DURATION: The 2023 International Evidence-based Guideline update reengaged the 2018 network across professional societies and consumer organizations, with multidisciplinary experts and women with PCOS directly involved at all stages. Extensive evidence synthesis was completed. Appraisal of Guidelines for Research and Evaluation-II (AGREEII)-compliant processes were followed. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied across evidence quality, feasibility, acceptability, cost, implementation and ultimately recommendation strength and diversity and inclusion were considered throughout. PARTICIPANTS/MATERIALS, SETTING, METHODS: This summary should be read in conjunction with the full Guideline for detailed participants and methods. Governance included a six-continent international advisory and management committee, five guideline development groups, and paediatric, consumer, and translation committees. Extensive consumer engagement and guideline experts informed the update scope and priorities. Engaged international society-nominated panels included paediatrics, endocrinology, gynaecology, primary care, reproductive endocrinology, obstetrics, psychiatry, psychology, dietetics, exercise physiology, obesity care, public health and other experts, alongside consumers, project management, evidence synthesis, statisticians and translation experts. Thirty-nine professional and consumer organizations covering 71 countries engaged in the process. Twenty meetings and five face-to-face forums over 12 months addressed 58 prioritized clinical questions involving 52 systematic and 3 narrative reviews. Evidence-based recommendations were developed and approved via consensus across five guideline panels, modified based on international feedback and peer review, independently reviewed for methodological rigour, and approved by the Australian Government National Health and Medical Research Council (NHMRC). MAIN RESULTS AND THE ROLE OF CHANCE: The evidence in the assessment and management of PCOS has generally improved in the past five years, but remains of low to moderate quality. The technical evidence report and analyses (∼6000 pages) underpins 77 evidence-based and 54 consensus recommendations, with 123 practice points. Key updates include: i) further refinement of individual diagnostic criteria, a simplified diagnostic algorithm and inclusion of anti-Müllerian hormone (AMH) levels as an alternative to ultrasound in adults only; ii) strengthening recognition of broader features of PCOS including metabolic risk factors, cardiovascular disease, sleep apnea, very high prevalence of psychological features, and high risk status for adverse outcomes during pregnancy; iii) emphasizing the poorly recognized, diverse burden of disease and the need for greater healthcare professional education, evidence-based patient information, improved models of care and shared decision making to improve patient experience, alongside greater research; iv) maintained emphasis on healthy lifestyle, emotional wellbeing and quality of life, with awareness and consideration of weight stigma; and v) emphasizing evidence-based medical therapy and cheaper and safer fertility management. LIMITATIONS, REASONS FOR CAUTION: Overall, recommendations are strengthened and evidence is improved, but remains generally low to moderate quality. Significantly greater research is now needed in this neglected, yet common condition. Regional health system variation was considered and acknowledged, with a further process for guideline and translation resource adaptation provided. WIDER IMPLICATIONS OF THE FINDINGS: The 2023 International Guideline for the Assessment and Management of PCOS provides clinicians and patients with clear advice on best practice, based on the best available evidence, expert multidisciplinary input and consumer preferences. Research recommendations have been generated and a comprehensive multifaceted dissemination and translation program supports the Guideline with an integrated evaluation program. STUDY FUNDING/COMPETING INTEREST(S): This effort was primarily funded by the Australian Government via the National Health Medical Research Council (NHMRC) (APP1171592), supported by a partnership with American Society for Reproductive Medicine, Endocrine Society, European Society for Human Reproduction and Embryology, and European Society for Endocrinology. The Commonwealth Government of Australia also supported Guideline translation through the Medical Research Future Fund (MRFCRI000266). HJT and AM are funded by NHMRC fellowships. JT is funded by a Royal Australasian College of Physicians (RACP) fellowship. Guideline development group members were volunteers. Travel expenses were covered by the partnering organizations. Disclosures of interest were strictly managed according to NHMRC policy and are available with the full guideline, technical evidence report, peer review and responses (www.monash.edu/medicine/mchri/pcos). Of named authors HJT, CTT, AD, LM, LR, JBoyle, AM have no conflicts of interest to declare. JL declares grant from Ferring and Merck; consulting fees from Ferring and Titus Health Care; speaker's fees from Ferring; unpaid consultancy for Ferring, Roche Diagnostics and Ansh Labs; and sits on advisory boards for Ferring, Roche Diagnostics, Ansh Labs, and Gedeon Richter. TP declares a grant from Roche; consulting fees from Gedeon Richter and Organon; speaker's fees from Gedeon Richter and Exeltis; travel support from Gedeon Richter and Exeltis; unpaid consultancy for Roche Diagnostics; and sits on advisory boards for Roche Diagnostics. MC declares travels support from Merck; and sits on an advisory board for Merck. JBoivin declares grants from Merck Serono Ltd.; consulting fees from Ferring B.V; speaker's fees from Ferring Arzneimittell GmbH; travel support from Organon; and sits on an advisory board for the Office of Health Economics. RJN has received speaker's fees from Merck and sits on an advisory board for Ferring. AJoham has received speaker's fees from Novo Nordisk and Boehringer Ingelheim. The guideline was peer reviewed by special interest groups across our 39 partner and collaborating organizations, was independently methodologically assessed against AGREEII criteria and was approved by all members of the guideline development groups and by the NHMRC.

Models Predicting Postpartum Glucose Intolerance Among Women with a History of Gestational Diabetes Mellitus: a Systematic Review.

PURPOSE OF REVIEW: Despite the crucial role that prediction models play in guiding early risk stratification and timely intervention to prevent type 2 diabetes after gestational diabetes mellitus (GDM), their use is not widespread in clinical practice. The purpose of this review is to examine the methodological characteristics and quality of existing prognostic models predicting postpartum glucose intolerance following GDM. RECENT FINDINGS: A systematic review was conducted on relevant risk prediction models, resulting in 15 eligible publications from research groups in various countries. Our review found that traditional statistical models were more common than machine learning models, and only two were assessed to have a low risk of bias. Seven were internally validated, but none were externally validated. Model discrimination and calibration were done in 13 and four studies, respectively. Various predictors were identified, including body mass index, fasting glucose concentration during pregnancy, maternal age, family history of diabetes, biochemical variables, oral glucose tolerance test, use of insulin in pregnancy, postnatal fasting glucose level, genetic risk factors, hemoglobin A1c, and weight. The existing prognostic models for glucose intolerance following GDM have various methodological shortcomings, with only a few models being assessed to have low risk of bias and validated internally. Future research should prioritize the development of robust, high-quality risk prediction models that follow appropriate guidelines, in order to advance this area and improve early risk stratification and intervention for glucose intolerance and type 2 diabetes among women who have had GDM.

The value of maternity care in Queensland, 2012-18, based on an analysis of administrative data: a retrospective observational study.

OBJECTIVE: To quantify the value of maternity health care - the relationship of outcomes to costs - in Queensland during 2012-18. STUDY DESIGN: Retrospective observational study; analysis of Queensland Perinatal Data Collection data linked with the Queensland Health Admitted Patient, Non-Admitted Patient, and Emergency Data Collections, and with the Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) databases. SETTING, PARTICIPANTS: All births in Queensland during 1 July 2012 - 30 June 2018. MAIN OUTCOME MEASURES: Maternity care costs per birth (reported in 2021-22 Australian dollars), both overall and by funder type (public hospital funders, MBS, PBS, private health insurers, out-of-pocket costs); value of care, defined as total cost per positive birth outcome (composite measure). RESULTS: The mean cost per birth (all funders) increased from $20 471 (standard deviation [SD], $17 513) during the second half of 2012 to $30 000 (SD, $22 323) during the first half of 2018; the annual total costs for all births increased from $1.31 billion to $1.84 billion, despite a slight decline in the total number of births. In a mixed effects linear analysis adjusted for demographic, clinical, and birth characteristics, the mean total cost per birth in the second half of 2018 was $9493 higher (99.9% confidence interval, $8930-10 056) than during the first half of 2012. The proportion of births that did not satisfy our criteria for a positive birth outcome increased from 27.1% (8404 births) during the second half of 2012 to 30.5% (9041 births) during the first half of 2018. CONCLUSION: The costs of maternity care have increased in Queensland, and many adverse birth outcomes have become more frequent. Broad clinical collaboration, effective prevention and treatment strategies, as well as maternal health services focused on all dimensions of value, are needed to ensure the quality and viability of maternity care in Australia.

Effects of modulator therapies on endocrine complications in adults with cystic fibrosis: a narrative review.

Cystic fibrosis is a monogenic disorder caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) protein, which transports chloride ions in secretory organs. Modulator therapies are small molecules that correct CFTR dysfunction and can lead to a wide range of benefits for both pulmonary and extrapulmonary complications of cystic fibrosis. With advancements in airway, antimicrobial and nutritional therapies and now introduction of modulator therapies, most people living with cystic fibrosis in Australia are now adults. For adults with cystic fibrosis, endocrine manifestations such as cystic fibrosis-related diabetes, metabolic bone disease, and reproductive health are becoming increasingly important, and emerging evidence on the endocrine effects of CFTR modulator therapies is promising and is shifting paradigms in our understanding and management of these conditions. The management of cystic fibrosis-related diabetes will likely need to pivot for high responders to modulator therapy with dietary adaptions and potential use of medications traditionally reserved for adults with type 2 diabetes, but evidence to support changing clinical care needs is currently lacking. Increased attention to diabetes-related complications screening will also be required. Increased exercise capacity due to improved lung function, nutrition and potentially direct modulator effect may have a positive impact on cystic fibrosis-related bone disease, but supporting evidence to date is limited. Fertility can improve in women with cystic fibrosis taking modulator therapy. This has important implications for pregnancy and lactation, but evidence is lacking to guide pre-conception and antenatal management. Provision of multidisciplinary clinical care remains ever-important to ensure the emergence of endocrine and metabolic complications are optimised in adults with cystic fibrosis.

Priorities to improve woman-centred gestational diabetes mellitus care: A qualitative study to compare views between clinical and consumer end-users.

BACKGROUND: Immigrants worldwide have a two-fold higher risk of gestational diabetes mellitus (GDM) than women of the host country. Providing culturally appropriate woman-centred GDM care to attenuate adverse maternal and neonatal health outcomes is a persistent challenge for health services. Underpinned by the Knowledge to Action Framework, understanding and comparing the views of patients from different ethnic backgrounds and healthcare professionals (HCPs) about current and optimal GDM care can highlight priority areas to improve woman-centred care. This qualitative study aimed to compare the views of ethnic Chinese and Australian-born Caucasian women and their HCPs, including endocrinologists, obstetricians, midwives, diabetes nurse educators and dietitians, about what constitutes optimal GDM care and how to improve woman-centred GDM care. METHODS: Purposive sampling was used to recruit 42 Chinese and 30 Caucasian women with GDM and 17 HCPs from two large Australian hospital maternity services to complete in-depth, semi-structured interviews. Patients' and HCPs' views were thematically analysed and compared. RESULTS: Four out of nine themes showed misalignments between patients' and HCPs' views on GDM care, reflecting priority areas to improve woman-centred care by (i) reaching agreement on the attitudes towards different treatment targets between HCPs; (ii) enhancing inter-professional communication; (iii) improving GDM care transition to postpartum care; and (iv) providing detailed dietary advice tailored to Chinese patients' cultural diet. CONCLUSIONS: Further research on reaching consensus on treatment targets, enhancing inter-professional communication, developing a perinatal care transition model from pregnancy to postpartum, and developing Chinese patient-oriented educational resources is required to improve woman-centred care.

Prolactin in Pregnancies Affected by Pre-Existing Maternal Metabolic Conditions: A Systematic Review.

Women affected by maternal pregestational diabetes mellitus (type 1 or type 2) or by polycystic ovary syndrome experience an increased risk of pregnancy complications, as well as suboptimal lactation outcomes. The hormone prolactin plays important roles in pregnancy and postpartum, both as a metabolic and lactogenic hormone. We aimed to explore, through a systematic review, the relationship between pregestational maternal metabolic conditions and prolactin levels in pregnancy and postpartum. MEDLINE via OVID, CINAHL Plus, and Embase were searched from inception to 9 May 2022. Eligible studies included women who were pregnant or up to 12 months postpartum and had a pre-existing diagnosis of type 1 or type 2 diabetes mellitus or polycystic ovary syndrome; with reporting of at least one endogenous maternal serum prolactin level during this time. Two independent reviewers extracted the data. Eleven studies met the eligibility criteria. The studies were too diverse and heterogeneous to enable meta-analysis. Overall, prolactin levels appeared to be lower in pregnancies affected by type 1 diabetes mellitus. There was little data in polycystic ovary syndrome or type 2 diabetes pregnancy, but prolactin increment across pregnancy in polycystic ovary syndrome emerged as an area for future study. During postpartum, lactation difficulties in women with metabolic disease present before pregnancy are well-described, but the relationship to prolactin remains unclear. Overall, preliminary evidence suggests that pre-existing maternal metabolic disease may alter prolactin dynamics in pregnancy and postpartum. Further well-designed studies in modern cohorts, with standardised collection and serial sampling across pregnancy and postpartum, are required to clarify these associations.

Negative associations of ideal family size achievement with hypertension, obesity and maternal age in women with and without polycystic ovary syndrome.

OBJECTIVE: To investigate lifetime reproductive outcomes and the relationship of ideal family size (IFS) achievement with metabolic, psychiatric and reproductive history in women with and without polycystic ovary syndrome (PCOS). DESIGN: Cross-sectional. PATIENT(S): A total of 9034 women with (n = 778) and without self-reported PCOS (n = 8256) born between 1973 and 1978 in the Australian Longitudinal Study on Women's Health. MEASUREMENTS: Self-reported IFS achievement and total number of live births. RESULTS: Women with and without PCOS aspired for similar IFS. Compared with women without PCOS, significantly less women with PCOS achieved their IFS (53.08% vs. 60.47%, p < 0.001). Higher proportion of women with PCOS did not achieve a live birth (37.15% vs. 31.64%, p = 0.002) and their median total number of live births was also lower (1 vs. 2, p < 0.001) than women without PCOS. After controlling for sociodemographic factors, negative associations were observed between IFS achievement and PCOS status, various metabolic, psychiatric and reproductive history. However, only hypertension (adjusted odds ratio [OR]: 0.82, 95% confidence interval [CI]: 0.67-1.00), obesity (adjusted OR: 0.79, 95% CI: 0.69-0.90), history of in vitro fertilisation use (IVF) (adjusted OR: 0.49, 95% CI: 0.38-0.63) and maternal age at first childbirth (adjusted OR: 0.92, 95% CI: 0.91-0.93) remained inversely associated with achievement of IFS in further multivariable regression models. CONCLUSION: Metabolic conditions and reproductive history of maternal age at first childbirth and history of IVF use, but not psychological conditions, were associated with reduced odds of achieving IFS. Early family planning/initiation and optimisation of metabolic health may help to improve reproductive outcomes.

Diagnosis experiences of adolescents with polycystic ovary syndrome: Cross-sectional study.

OBJECTIVE: Women with polycystic ovary syndrome (PCOS) report delayed diagnosis of the condition and receiving inadequate information at diagnosis. No studies have investigated the diagnosis experiences of adolescents with PCOS. Our objective was to investigate the adolescents' experiences of PCOS diagnosis and their concerns about the condition. DESIGN: Cross-sectional study. PATIENT(S): Eighty-six adolescents (aged 13-19 years) were diagnosed with PCOS by a medical practitioner. Adolescents were recruited consecutively from paediatric and women's outpatient hospital clinics in South Australia and online PCOS support organisations in Australia and the United Kingdom (May 2017-June 2019). MEASUREMENTS: PCOS diagnosis experience and information received at the time of diagnosis were evaluated using a validated questionnaire. RESULTS: The majority of the adolescents (n = 67, 78%) were diagnosed with PCOS in less than 1 year from their first doctor's visit but 11 (13%) were diagnosed more than 2 years from that visit. Fifty-three adolescents (66%) saw 1-2 health professionals before the diagnosis was made. Forty-nine adolescents (57%) were satisfied with the overall diagnosis experience but adolescents were either dissatisfied or reported that the information was not mentioned after diagnosis in relation to lifestyle management (n = 47, 55%), long-term complications (n = 53, 62%) and emotional support and counselling (n = 65, 76%). CONCLUSIONS: The majority of adolescent girls with PCOS are receiving a timely diagnosis, but delayed diagnosis still occurs in a minority of adolescents. Current information provided at diagnosis is not meeting the needs of adolescents and is a lost opportunity for preventive healthcare at a critical transition to adult care period.

Menstrual cycle regularity as a predictor for heart disease and diabetes: Findings from a large population-based longitudinal cohort study.

OBJECTIVE: Menstrual cycle regularity underpins the diagnosis of polycystic ovary syndrome (PCOS), which is linked to adverse cardio-metabolic profile. However, links between menstrual disorders and metabolic conditions are often under-appreciated and not considered when assessing cardio-metabolic risk in women. We aimed to assess the risk of diabetes and heart disease in women with irregular menstrual cycles and those whose cycles were regular. METHODS: This was a community based longitudinal cohort study. We utilized the 1946 to 1951 birth cohort database (N = 13,714) of the Australian Longitudinal Study on Women's Health (ALSWH) over a 20-year follow-up period. Data were analysed using Cox regression models. RESULTS: Women with irregular menstrual cycles had 20% higher risk of developing heart disease [adjusted hazard ratio [HR]: 1.20, 95% confidence interval [CI]: 1.01-1.43) compared with those with regular menstrual cycles. We also observed 17% higher risk of diabetes (HR: 1.17, 95% CI: 1.00-1.38) in women who had irregular menstrual cycles than in women who had regular menstrual cycles. The diabetes risk was 30% higher (HR: 1.30, 95% CI: 1.09-1.55) if women had irregular cycles and did not use hormone replacement therapy, but this was not significant on adjustment for all covariates. CONCLUSION: Having irregular menstrual cycles appears to be an early indicator for heart disease and diabetes. These findings suggest that irregular cycles among women in their forties may be linked to adverse cardio-metabolic outcomes. These women may benefit from screening and prevention strategies as recommended by related guidelines such as the international evidence-based guideline for the assessment and management of PCOS.