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Abstract It is unclear whether polycystic ovary syndrome (PCOS) is an independent risk factor for adverse birth outcomes in the offspring of affected women. Here, we investigate the association of PCOS with birth outcomes in the offspring of women with PCOS overall and by potential confounders. This systematic review and meta-analysis included 73 studies and 92,881 offspring of women with and without PCOS from inception until 13th July 2022. We report that mothers with PCOS are younger and have higher body mass index (BMI) around conception and have greater gestational weight gain. The odds of preterm birth, fetal growth restriction and low birth weight are higher and mean birthweight is lower in PCOS of which a lower mean birthweight and a higher small for gestational age are probably independent of BMI. This work informed the recommendations from the 2023 international evidence-based guideline for the assessment and management of polycystic ovary syndrome, emphasizing that PCOS status should be captured at pregnancy to identify risk and improve birth outcomes in the offspring.

Abstract Screening for polycystic ovary syndrome (PCOS) in antenatal care is inadequate, largely owing to the lack of clarity around whether PCOS is an independent risk factor for pregnancy complications. This systematic review and meta-analysis include 104 studies and 106,690 pregnancies in women with and without PCOS from inception until 13th July 2022. We report that women with PCOS are younger and have higher body mass index (BMI) around conception and have greater gestational weight gain. The odds of miscarriage, gestational diabetes mellitus, gestational hypertension, pre-eclampsia and cesarean section are higher in women with PCOS. The increased odds of adverse outcomes in PCOS remain significant when age and BMI are matched and when analyses are restricted to high-quality studies. This work informed the recommendations from the 2023 international evidence-based guideline for the assessment and management of polycystic ovary syndrome, emphasizing that PCOS status should be captured in all women who are planning to, or have recently become pregnant to facilitate prevention of adverse outcomes and improve pregnancy outcomes.

Summary: Background: Women comprise the majority of the nursing profession, yet nurses are underrepresented in healthcare leadership. We aimed to explore barriers for women nurses to advance in healthcare leadership to inform organisational interventions for career advancement. Methods: In this systematic review and meta-synthesis, studies examining advancing women nurses and midwives in leadership within healthcare and academia in the international literature were included. Six databases (MEDLINE, EMCARE, EMBASE, PsycINFO, PubMed, and CINAHL PLUS) were searched for studies published in English between January 1 2000 and October 17 2023. The Grading of Recommendations Assessment, Development, and Evaluation tools (GRADE) was followed to assess confidence in the findings. Retrieved full texts were assessed for methodological rigour using the Critical Appraisal Skill Programme Qualitative Studies checklist and the Joanna Briggs Institute Cross-sectional and Prevalence Studies checklists. Reported barriers for women nurses’ leadership attainment were identified and generated themes were mapped to the Abilities, Motivation, and Opportunities (AMO) framework. Findings: There were 32 eligible studies; 18 qualitative, 11 quantitative, and 3 mixed-methods. Studies included high-income countries (n = 20), middle-income countries (n = 7) and across countries (n = 3) with two unspecified. Samples included registered nurses, nurse academics, executives, and leaders. The key barriers highlighted were related to: role modelling and leadership development (ability); multiple complex and interacting factors, including gender stereotyping, perception of professionalism, human relations policies, and gender bias (motivation); and systemic issues, such as organisational setting, structure, and support (opportunity). Interpretation: The prevailing belief in the literature is that caregiving is a feminine occupation and along with societal expectations of women's subordinate position, these present substantial obstacles that limit women nurses from advancing into healthcare leadership. Ultimately, these factors restrict women nurses in career advancement and need to be addressed at a systems and organisational level. Funding: The National Health and Medical Research Council (NHMRC), Australia.

Summary: Background: Polycystic ovary syndrome (PCOS) is a common endocrine condition in women of reproductive age that often presents with reproductive, metabolic, and psychological symptoms. While exercise is part of the management of PCOS, it is unclear which form of exercise may be most effective and for which outcomes. Aim: In order to inform the updated 2023 International evidence-based guideline for the assessment and management of polycystic ovary syndrome, this systematic review aimed to determine the exercise modality that provides the greatest improvement in anthropometric, metabolic, hormonal/reproductive, and psychological outcomes in adult women with PCOS. Methods: Five databases were searched from inception to July 2022. Studies eligible for inclusion consisted of those in a PCOS population, that compared two exercise modalities, and reported at least one anthropometric, metabolic, hormonal/reproductive, and/or psychological outcome. Screening, data extraction, and methodological quality assessments were conducted by two independent reviewers. Methodological quality assessment was performed using the Cochrane Risk of Bias tool and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines were used to determine the certainty of evidence. Meta-analysis was performed utilising Comprehensive Meta-Analysis software, Version 3. Results: Of the 4739 records identified, five unique studies were eligible for inclusion in the systematic review and meta-analysis, comprising a total of 216 individuals. Meta-analyses comparing high-intensity interval training (HIIT) to moderate-intensity continuous training (MICT) on anthropometric, metabolic, and hormonal/reproductive parameters found no statistically significant differences in outcomes between groups, and the certainty of evidence was graded as low or very low. Results from single studies showed that HIIT was more effective than MICT for menstrual regularity (odds ratio [95% confidence interval] ​= ​7.875 [1.105, 56.125], p ​= ​0.039, very low certainty). HIIT vs resistance training, and diet ​+ ​MICT vs diet ​+ ​MICT ​+ ​resistance training were examined by a single study each, and no statistically significant differences were found for any outcome, with the certainty of evidence ranked as very low. Conclusion: To date, there are insufficient RCTs comparing exercise modalities in individuals with PCOS to establish with certainty whether one form of exercise is superior to another for the management of PCOS.

During pregnancy, the fetoplacental unit is key in the pronounced physiological endocrine changes which support pregnancy, fetal development and survival, birth and lactation. In healthy women, pregnancy is characterized by changes in insulin sensitivity and increased maternal androgen levels. These are accompanied by a suite of mechanisms that support fetal growth, maintain glucose homeostasis and protect both mother and fetus from adverse effects of pregnancy induced insulin and androgen excess. In pregnancies affected by endocrine, metabolic disorders such as polycystic ovary syndrome (PCOS), diabetes and obesity, there is an imbalance of beneficial and adverse impacts of pregnancy induced endocrine changes. These inter-related conditions are characterized by an interplay of hyperinsulinemia and hyperandrogenism which influence fetoplacental function and are associated with adverse pregnancy outcomes including hypertensive disorders of pregnancy, macrosomia, preterm delivery and caesarean section. However, the exact underlying mechanisms and relationships of the endocrine and metabolic milieu in these disorders and the impact they have on the prenatal endocrine environment and developing fetus remain poorly understood. Here we aim to review the complex endocrine and metabolic interactions in healthy women during normal pregnancies and those in pregnancies complicated by hyperinsulinemic disorders (PCOS, diabetes and obesity). We also explore the relationships between these endocrine and metabolic differences and the fetoplacental unit, pregnancy outcomes and the developing fetus.

Background: Women have poorer quality of postoperative recovery from general anaesthesia than men. This persists for at least 3 days postoperatively, and is more pronounced in premenopausal women. Studies of menstrual cycle effects on pain or postoperative nausea and vomiting report conflicting results. Our aim was to determine whether menstrual cycle phase is associated with quality of recovery after surgery in premenopausal women. Methods: Eligible women aged 18–45 yr undergoing wisdom teeth extraction or laparoscopic cholecystectomy under general anaesthesia with volatile agents were recruited from Epworth HealthCare Richmond in Melbourne, Australia from 2019 to 2021. Menstrual history and progesterone levels were used to determine cycle phase (luteal or non-luteal). Linear mixed and generalised linear regression models were fitted to examine differences in Quality of Recovery-15 (QoR-15) score on postoperative days 1 (primary outcome) and 3, and secondary outcomes (pain, analgesic effectiveness, postoperative nausea and vomiting, prolonged hospital admission), between groups, adjusting for confounders. Results: A total of 177 women were recruited (74 luteal, 103 non-luteal). Six (3%) underwent laparoscopic cholecystectomy. Estimated mean differences (95% confidence interval; P-value) in adjusted QoR-15 scores between luteal and non-luteal groups were –0.05 (–5.86 to 5.76; P=0.986) and 1.40 (–4.41 to 7.21; P=0.636) on postoperative days 1 and 3, respectively. Secondary outcomes were not different between groups. Conclusions: There was no significant difference in postoperative QoR-15 score or other outcomes between women in the luteal and non-luteal phases of their cycle. Women can be reassured that cycle phase does not impact postoperative quality of recovery when undergoing minor surgery under general anaesthesia. Clinical trial registration: ACTRN12618000240246.

Summary: Background: Gender inequity in healthcare leadership persists and progress is slow, with the focus firmly on problems, barriers and on requiring women themselves to adapt and compete in a system not designed for them. Women are individually burdened to advance their careers, with little effort given to addressing systemic barriers in the health sector. A recent systematic review prioritised organisational-level approaches and demonstrated effective interventions. In this meta-ethnographic study, we further this work by examining factors in implementation of organisational interventions for advancing women in leadership. Methods: The meta-ethnographic framework applied here follows the Noblit and Hare approach for synthesising findings and applying interpretive analysis to original research. We generated a new line-of-argument with insights for the healthcare sector. The protocol is registered (CRD42020162115) on the International Prospective Register of Systematic Reviews. Three academic databases (MEDLINE, PsycINFO, SCOPUS) were searched systematically between 2000 and 2021. Studies were analysed if they included organisational-level interventions that sought to measurably advance women in leadership. Study characteristics were extracted using a standard template for intervention details. Quality appraisal was conducted using the Critical Appraisal Skills Program tool. Data synthesis was conducted across 19 criteria of the Meta-Ethnography Reporting Guide (eMERGe). Findings: Fifteen qualitative studies were included. Analysis revealed three meta-themes that are central to successful implementation of organisational interventions that advance women in healthcare leadership: (1) leadership commitment and accountability, influenced by internal and external organisational settings, salient for long term outcomes and for developing an inclusive leadership culture; (2) intervention fit with individuals with consideration given to personal beliefs, preferences, experiences, capabilities or life circumstances, including capacity for leadership roles in their broader life context; balanced against maintaining interventional fidelity, and (3) cultural climate and organisational readiness for change, addressing traditional, conservative and constrictive perspectives on gender and leadership in health, highlighting the facilitating role of male colleagues. Interpretation: This meta-ethnographic research extends past work by integrating empirical evidence from a systematic literature review of effective organisational level interventions, with the identification of pragmatic themes to generate, implement, evaluate and embed evidence-based organisational interventions to advance women in healthcare leadership. This work can inform initiatives and policymakers to generate and implement new knowledge to advance women in healthcare leadership. Funding: Epworth Health and Monash University provided scholarships for MM. HT is funded by an NHMRC / MRFF Practitioner Fellowship, JB by an NHMRC fellowship and HS by a Monash Warwick University Professorship.

Abstract Background Maternal obesity is associated with health risks for women and their babies and is exacerbated by excess gestational weight gain. The aim of this study was to describe women’s experiences and perspectives in attending a Healthy Pregnancy Service designed to optimise healthy lifestyle and support recommended gestational weight gain for women with obesity. Methods An explanatory sequential mixed methods study design utilised two questionnaires (completed in early and late pregnancy) to quantify feelings, motivation and satisfaction with the service, followed by semi-structured interviews that explored barriers and enablers of behaviour change. Data were analysed separately and then interpreted together. Results Overall, 49 women attending the service completed either questionnaire 1, 2 or both and were included in the analysis. Fourteen women were interviewed. Prior to pregnancy, many women had gained weight and attempted to lose weight independently, and reported they were highly motivated to achieve a healthy lifestyle. During pregnancy, diet changes were reported as easier to make and sustain than exercise changes. Satisfaction with the service was high. Key factors identified in qualitative analysis were: service support enabled change; motivation to change behaviour, social support, barriers to making change (intrinsic, extrinsic and clinic-related), post-partum lifestyle and needs. On integration of data, qualitative and quantitative findings aligned. Conclusions The Healthy Pregnancy service was valued by women. Barriers and enablers to the delivery of an integrated model of maternity care that supported healthy lifestyle and recommended gestational weight gain were identified. These findings have informed and improved implementation and further scale up of this successful service model, integrating healthy lifestyle into routine antenatal care of women with obesity. Trial registration This trial is registered with the Australian New Zealand Clinical Trials Registry (no.12620000985987). Registration date 30/09/2020, retrospectively registered. http://www.anzctr.org.au/

Abstract Background Polycystic ovary syndrome (PCOS) is challenging to diagnose. While the 2003 Rotterdam criteria are widely used for adults, the 2018 international PCOS guideline recommended updated Rotterdam criteria with both hyperandrogenism and oligo-anovulation for adolescents based on evidence-informed expert consensus. This study compared the prevalence of PCOS using updated and original Rotterdam criteria in community-based adolescents and explored long-term body mass index (BMI) trajectories across different diagnostic phenotypes. Methods Overall, 227 postmenarchal adolescent females from the prospective cohort Raine Study undertook comprehensive PCOS assessment at age 14–16 years. Detailed anthropometric measurements were collected from birth until age 22 years. Cross-sectional and longitudinal BMI were analyzed using t tests and generalized estimating equations. Results PCOS was diagnosed in 66 (29.1%) participants using original criteria versus 37 (16.3%) participants using updated Rotterdam criteria. Using updated criteria, participants with PCOS had higher BMI than participants without PCOS from prepubertal. Only the phenotype meeting the updated criteria was significantly associated with higher long-term BMI gain whereas other PCOS phenotypes had similar BMI trajectories to participants without PCOS (p

Abstract Background Integrated utilisation of digital health data has the power to transform healthcare to deliver more efficient and effective services, and the learning health system (LHS) is emerging as a model to achieve this. The LHS uses routine data from service delivery and patient care to generate knowledge to continuously improve healthcare. The aim of this project was to explore key features of a successful and sustainable LHS to inform implementation in an Academic Health Science Centre context. Methods We purposively identified and conducted semi-structured qualitative interviews with leaders, experienced in supporting or developing data driven innovations in healthcare. A thematic analysis using NVivo was undertaken. Results Analysis of 26 interviews revealed five themes thought to be integral in an effective, sustainable LHS: (1) Systematic approaches and iterative, continuous learning with implementation into healthcare contributing to new best-practice care; (2) Broad stakeholder, clinician and academic engagement, with collective vision, leadership, governance and a culture of trust, transparency and co-design; (3) Skilled workforce, capability and capacity building; (4) Resources with sustained investment over time and; (5) Data access, systems and processes being integral to a sustainable LHS. Conclusions This qualitative study provides insights into the elements of a sustainable LHS across a range of leaders in data-driven healthcare improvement. Fundamentally, an LHS requires continuous learning with implementation of new evidence back into frontline care to improve outcomes. Structure, governance, trust, culture, vision and leadership were all seen as important along with a skilled workforce and sustained investment. Processes and systems to optimise access to quality data were also seen as vital in an effective, sustainable LHS. These findings will inform a co-designed framework for implementing a sustainable LHS within the Australian healthcare and Academic Health Science Centre context. It is anticipated that application of these findings will assist to embed and accelerate the use of routine health data to continuously generate new knowledge and ongoing improvement in healthcare delivery and health outcomes.

Abstract Background The goal of the Global Health in Preconception, Pregnancy and Postpartum (HiPPP) Alliance, comprising consumers and leading international multidisciplinary academics and clinicians, is to generate research and translation priorities and build international collaboration around healthy lifestyle and obesity prevention among women across the reproductive years. In doing so, we actively seek to involve consumers in research, implementation and translation initiatives. There are limited frameworks specifically designed to involve women across the key obesity prevention windows before (preconception), during and after pregnancy (postpartum). The aim of this paper is to outline our strategy for the development of the HiPPP Consumer and Community (CCI) Framework, with consumers as central to co-designed, co-implemented and co-disseminated research and translation. Method The development of the framework involved three phases: In Phase 1, 21 Global HiPPP Alliance members participated in a CCI workshop to propose and discuss values and approaches for framework development; Phase 2 comprised a search of peer-reviewed and grey literature for existing CCI frameworks and resources; and Phase 3 entailed collaboration with consumers (i.e., members of the public with lived experience of weight/lifestyle issues in preconception, pregnancy and postpartum) and international CCI experts to workshop and refine the HiPPP CCI Framework (guided by Phases 1 and 2). Results The HiPPP CCI Framework’s values and approaches identified in Phases 1–2 and further refined in Phase 3 were summarized under the following five key principles: 1. Inclusive, 2. Flexible, 3. Transparent, 4. Equitable, and 5. Adaptable. The HiPPP Framework describes values and approaches for involving consumers in research initiatives from design to translation that focus on improving healthy lifestyles and preventing obesity specifically before, during and after pregnancy; importantly it takes into consideration common barriers to partnering in obesity research during perinatal life stages, such as limited availability associated with family caregiving responsibilities. Conclusion The HiPPP CCI Framework aims to describe approaches for implementing meaningful CCI initiatives with women in preconception, pregnancy and postpartum periods. Evaluation of the framework is now needed to understand how effective it is in facilitating meaningful involvement for consumers, researchers and clinicians, and its impact on research to improve healthy lifestyle outcomes.

Objective: To assess and share learnings on the motivators and behavioural adherence across sex and age to evolving strategies in public policy to prevent the spread of SARS-CoV-2 at the end of a first COVID-19 wave and the beginning of a second COVID-19 wave in Australia.Design and Setting: A national longitudinal survey using a framework based on evidence-based behaviour change models. The survey was administered to a national sample representative across sex, age and location was undertaken at two time points: May 1st to 5th, 2020, and July 1st to 7th, 2020.Results: Overall 2,056 surveys were completed across the first and second rounds, with 63% (1,296/2,056) completing both. Age range was 18–99 years (median 53, IQR: 34–64). Suboptimal physical distancing and self-quarantining if unwell/diagnosed was reported in one in four respondents and not getting a test at onset of symptoms reported in one in three. Those non-adherent to all three behaviours (19%, 60/323), were mainly male, younger, lived in major cities and reported fewer concerns or motivators to change behaviour. Overall, government lockdown measures were considered very important by 81% (835/1,032) and appropriate by 75% (772/1,029).Conclusions: Prior to the suppression of a second COVID-19 wave, a significant minority of Australians reported suboptimal behavioural adherence to vital policy strategies to limit SARS-CoV-2 spread, mostly young adults and men. Successful wave 2 suppression required consistent communication from political and health leaders and supportive public health and economic strategies. Additional lockdown and punitive strategies were needed in Victoria and were generally well-supported and adhered to. To limit subsequent lockdown, this work reinforces the need for a mix of communication around saving lives of the vulnerable, and other strategies targeting high risk groups, facilitation of easy testing and minimisation of financial impacts.

Abstract Background Gestational diabetes (GDM) is increasingly common and has significant implications during pregnancy and for the long-term health of the mother and offspring. However, it is a heterogeneous condition with inter-related factors including ethnicity, body mass index and gestational weight gain significantly modifying the absolute risk of complications at an individual level. Predicting the risk of pregnancy complications for an individual woman with GDM presents a useful adjunct to therapeutic decision-making and patient education. Diagnostic prediction models for GDM are prevalent. In contrast, prediction models for risk of complications in those with GDM are relatively novel. This study will systematically review published prognostic prediction models for pregnancy complications in women with GDM, describe their characteristics, compare performance and assess methodological quality and applicability. Methods Studies will be identified by searching MEDLINE and Embase electronic databases. Title and abstract screening, full-text review and data extraction will be completed independently by two reviewers. The included studies will be systematically assessed for risk of bias and applicability using appropriate tools designed for prediction modelling studies. Extracted data will be tabulated to facilitate qualitative comparison of published prediction models. Quantitative data on predictive performance of these models will be synthesised with meta-analyses if appropriate. Discussion This review will identify and summarise all published prognostic prediction models for pregnancy complications in women with GDM. We will compare model performance across different settings and populations with meta-analysis if appropriate. This work will guide subsequent phases in the prognosis research framework: further model development, external validation and model updating, and impact assessment. The ultimate model will estimate the absolute risk of pregnancy complications for women with GDM and will be implemented into routine care as an evidence-based GDM complication risk prediction model. It is anticipated to offer value to women and their clinicians with individualised risk assessment and may assist decision-making. Ultimately, this systematic review is an important step towards a personalised risk-stratified model-of-care for GDM to allow preventative and therapeutic interventions for the maximal benefit to women and their offspring, whilst sparing expense and harm for those at low risk. Systematic review registration PROSPERO registration number CRD42019115223

Abstract Background The fibrinolytic system and its inhibitors play a number of roles, apart from their function in blood haemostasis and thrombosis, namely in ovarian folliculogenesis and in ovulation. Plasminogen is converted to active plasmin at the time of follicular rupture through a decrease in plasminogen activator inhibitor-1 (PAI-1) and an increase in plasminogen activators. Oligo−/anovulation and follicle arrest are key characteristics of PCOS, but studies evaluating fibrinolytic/proteolytic markers within human or animal PCOS ovaries are lacking. We aimed to investigate and compare the expression and distribution of the plasminogen system markers in PCOS and control ovaries. Methods A hyperandrogenised PCOS mouse model was used that mimics the ovarian, endocrine and metabolic features of the human condition. Immunohistochemistry and digital image analysis were used to investigate and compare fibrinolytic/proteolytic markers plasminogen, plasminogen/plasmin, tissue plasminogen activator, urokinase plasminogen activator and inhibitor PAI-1 in PCOS and control ovaries. Student’s t-test was used to compare data sets for normally distributed data and Wilcoxon-Mann Whitney test for non-normally distributed data. Results We noted differences in the ovarian distribution of PAI-1 that was expressed throughout the PCOS ovary, unlike the peripheral distribution observed in control ovaries. Plasminogen was present in small follicles only in PCOS ovaries but not in small follicles of control ovaries. When we assessed and compared PAI-1 expression within follicles of different developmental stages we also noted significant differences for both the PCOS and control ovaries. While we noted differences in distribution and expression within specific ovarian structures, no differences were noted in the overall ovarian expression of markers assessed between acyclical PCOS mice and control mice at the diestrus stage of the estrous cycle. Conclusions Our novel study, that comprehensively assessed the fibrinolytic/proteolytic system in the mouse ovary, showed the expression, differential localisation and a potential role for the plasminogen system in the physiological mouse ovary and in PCOS. Androgens may be involved in regulating expression of the ovarian plasminogen system. Further studies evaluating these markers at different time-points of ovulation may help to further clarify both physiological and potential pathological actions these markers play in ovulatory processes distorted in PCOS.

Cardiovascular disease, especially coronary heart disease and cerebrovascular disease, is a leading cause of mortality and morbidity in women globally. The development of cardiometabolic conditions in pregnancy, such as gestational diabetes mellitus and hypertensive disorders of pregnancy, portend an increased risk of future cardiovascular disease in women. Pregnancy therefore represents a unique opportunity to detect and manage risk factors, prior to the development of cardiovascular sequelae. Risk prediction models for gestational diabetes mellitus and hypertensive disorders of pregnancy can help identify at-risk women in early pregnancy, allowing timely intervention to mitigate both short- and long-term adverse outcomes. In this narrative review, we outline the shared pathophysiological pathways for gestational diabetes mellitus and hypertensive disorders of pregnancy, summarise contemporary risk prediction models and candidate predictors for these conditions, and discuss the utility of these models in clinical application.

Abstract Background Little is known about how patient reported barriers to health care impact the quality of life (HRQoL) of patients with comorbid disease. We investigated patient reported barriers to health care and low physical and mental well-being among people with diabetes and chronic kidney disease (CKD). Methods Adults with diabetes and CKD (estimated Glomerular Filtration Rate

Abstract Background The association between Institute of Medicine (IOM) guidelines and pregnancy outcomes across ethnicities is uncertain. We evaluated the associations of gestational weight gain (GWG) outside 2009 IOM guidelines, with maternal and infant outcomes across the USA, western Europe and east Asia, with subgroup analyses in Asia. The aim was to explore ethnic differences in maternal prepregnancy body mass index (BMI), GWG and health outcomes across these regions. Methods Systematic review, meta-analysis and meta-regression of observational studies were used for the study. MEDLINE, MEDLINE In-Process, Embase and all Evidence-Based Medicine (EBM) Reviews were searched from 1999 to 2017. Studies were stratified by prepregnancy BMI category and total pregnancy GWG. Odds ratio (ORs) 95% confidence intervals (CI) applied recommended GWG within each BMI category as the reference. Primary outcomes were small for gestational age (SGA), preterm birth and large for gestational age (LGA). Secondary outcomes were macrosomia, caesarean section and gestational diabetes. Results Overall, 5874 studies were identified and 23 were included (n = 1,309,136). Prepregnancy overweight/obesity in the USA, Europe and Asia was measured at 42%, 30% and 10% respectively, with underweight 5%, 3% and 17%. GWG below guidelines in the USA, Europe and Asia was 21%, 18% and 31%, and above was 51%, 51% and 37% respectively. Applying regional BMI categories in Asia showed GWG above guidelines (51%) was similar to that in the USA and Europe. GWG below guidelines was associated with a higher risk of SGA (USA/Europe [OR 1.51; CI 1.39, 1.63]; Asia [1.63; 1.45, 1.82]) and preterm birth (USA/Europe [1.35; 1.17, 1.56]; Asia [1.06; 0.78, 1.44]) than GWG within guidelines. GWG above guidelines was associated with a higher risk of LGA (USA/Europe [1.93; 1.81, 2.06]; Asia [1.68; 1.51 , 1.87]), macrosomia (USA/Europe [1.87; 1.70, 2.06]; Asia [2.18; 1.91, 2.49]) and caesarean (USA/Europe [1.26; 1.21, 1.33]; Asia [1.37; 1.30, 1.45]). Risks remained elevated when regional BMI categories were applied for GWG recommendations. More women in Asia were categorised as having GWG below guidelines using World Health Organization (WHO) (60%) compared to regional BMI categories (16%), yet WHO BMI was not accompanied by increased risks of adverse outcomes. Conclusions Women in the USA and western Europe have higher prepregnancy BMI and higher rates of GWG above guidelines than women in east Asia. However, when using regional BMI categories in east Asia, rates of GWG above guidelines are similar across the three continents. GWG outside guidelines is associated with adverse outcomes across all regions. If regional BMI categories are used in east Asia, IOM guidelines are applicable in the USA, western Europe and east Asia.

Abstract Background Self-management support interventions may potentially delay kidney function decline and associated complications in patients with comorbid diabetes and chronic kidney disease. However, the effectiveness of these interventions remains unclear. We investigated the effectiveness of current self-management support interventions and their specific components and elements in improving patient outcomes. Methods Electronic databases were systematically searched from January 1, 1994, to December 19, 2017. Eligible studies were randomized controlled trials on self-management support interventions for adults with comorbid diabetes and chronic kidney disease. Primary outcomes were systolic blood pressure, diastolic blood pressure, estimated glomerular filtration rate, and glycated hemoglobin. Secondary outcomes included self-management activity, health service utilization, health-related quality of life, medication adherence, and death. Results Of the 48 trials identified, eight studies (835 patients) were eligible. There was moderate-quality evidence that self-management support interventions improved self-management activity (standard mean difference 0.56, 95% CI 0.15 to 0.97, p

The diagnosis of polycystic ovary syndrome (PCOS) remains challenging due to limited data regarding normative cut-offs for the diagnostic features in different subpopulations. We aim to conduct a systematic review, build a comprehensive repository of de-identified individual participant data (IPD), and define normative ranges and diagnostic cut-offs for all PCOS diagnostic features. We will conduct a systematic search of MEDLINE and EMBASE databases for studies that assessed PCOS diagnostic features in unselected women. Two reviewers will assess eligibility and perform quality appraisal. Authors of included studies will be invited to contribute IPD. Primary variables include directly assessed modified Ferriman Gallwey (mFG) scores; menstrual cycle lengths; follicle number per ovary (FNPO), ovarian volume (OV), anti-Müllerian hormone (AMH); circulating androgens, including total testosterone (TT), free testosterone, bioavailable testosterone, free androgen index (FAI), androstenedione (A4), and dehydroepiandrosterone sulphate (DHEAS). Normative ranges and cut-offs will be defined using cluster analysis. Monash University Human Research Ethics Committee granted ethical approval (26938/0 1/12/2020), all IPD will be de-identified and primary studies have ethical approval from their institutional ethics committees. Findings will clarify distinction between PCOS and non-PCOS populations, and inform the update of the international evidence-based guidelines for the assessment and management of PCOS.

Abstract Background Obesity is common in young women, increasing insulin resistance (IR) and worsening pregnancy complications, including gestational diabetes (GDM). Women with polycystic ovary syndrome (PCOS) are commonly obese, which aggravates the severity of PCOS clinical expression. Relationships between these common insulin-resistant conditions, however, remain unclear. Methods We conducted a secondary analysis of the Australian Longitudinal Study on Women’s Health (ALSWH) database, including data from 8009 women aged 18–36 years across six surveys. We used latent-curve growth modelling to identify distinct body mass index (BMI) trajectories and multinomial logistic regression to explore sociodemographic and health variables characterizing BMI group membership. Logistic regression was used to assess independent risk of GDM. Results A total of 662 women (8.29%, 95% CI 7.68–8.89) reported PCOS. Three distinct BMI trajectories emerged, namely low stable (LSG) (63.8%), defined as an average trajectory remaining at ~25 kg/m2; moderately rising (MRG) (28.8%), a curvilinear trajectory commencing in a healthy BMI and terminating in the overweight range; and high-rising (HRG) (7.4%), a curvilinear trajectory starting and terminating in the obese range. A high BMI in early reproductive life predicted membership in higher trajectories. The HRG BMI trajectory was independently associated with GDM (OR 2.50, 95% CI 1.80–3.48) and was a stronger correlate than PCOS (OR 1.89, 95% CI 1.41–2.54), maternal age, socioeconomic status, or parity. Conclusion Our results suggest heterogeneity in BMI change among Australian women of reproductive age, with and without PCOS. Reducing early adult life weight represents an ideal opportunity to intervene at an early stage of reproductive life and decreases the risk of long-term metabolic complications such as GDM.

Abstract Objective: Obesity is a major public health concern and women living in rural settings present a high‐risk group. With contributing factors poorly explored, we evaluated their association with weight in rural Australian women. Methods: Women aged 18–50 years of any body mass index (BMI) were recruited between October 2012 and April 2013 as part of a larger, randomised controlled trial within 42 rural towns. Measured weight and height as well as self‐reported measures of individual health, physical activity, dietary intake, self‐management, social support and environmental perception were collected. Statistical analysis included linear regression for continuous variables as well as chi‐squared and logistic regression for categorical variables with all results adjusted for clustering. Results: 649 women with a mean baseline age and BMI of 39.6±6.7 years and 28.8±6.9 kg/m2 respectively, were studied. Overall, 65% were overweight or obese and 60% overall reported recent weight gain. There was a high intention to self‐manage weight, with 68% attempting to lose weight recently, compared to 20% of women reporting health professional engagement for weight management. Obese women reported increased weight gain, energy intake, sitting time and prevalence of pre‐existing health conditions. There was an inverse relationship between increased weight and scores for self‐management, social support and health environment perception. Conclusions: Many women in rural communities reported recent weight gain and were attempting to self‐manage their weight with little external support. Implications for public health: Initiatives to prevent weight gain require a multifaceted approach, with self‐management strategies and social support in tandem with building a positive local environmental perception.

Sympathetic nervous system (SNS) activity is increased in polycystic ovary syndrome (PCOS). Moxonidine is a centrally acting sympatholytic drug with known beneficial effects on hypertension, insulin sensitivity, dyslipidemia and inflammation. In this double-blind placebo controlled randomized clinical trial we examined the effect of moxonidine on modulating sympathetic activity and downstream metabolic abnormalities in 48 pre-menopausal women with PCOS (Rotterdam diagnostic criteria), recruited from the community (January 2013–August 2015). Participants received moxonidine (0.2 mg daily initially, up titrated to 0.4 mg daily in 2 weeks) (n = 23) or placebo (n = 25) for 12 weeks. Multiunit muscle sympathetic activity (by microneurography) and plasma noradrenaline levels were measured (primary outcomes). Fasting lipids, insulin resistance, serum androgens, and inflammatory markers were measured as secondary outcomes. Forty three women completed the trial (19 moxonidine, 24 placebo). Mean change in burst frequency (−3 ± 7 vs. −3 ± 8 per minute) and burst incidence (−3 ± 10 vs. −4 ± 12 per 100 heartbeat) did not differ significantly between moxonidine and placebo groups. Women on moxonidine had a significant reduction in hs-CRP compared to placebo group (−0.92 ± 2.3 vs. −0.04 ± 1.5) which did not persist post Bonferroni correction. There was a significant association between markers of insulin resistance at baseline and reduction in sympathetic activity with moxonidine. Moxonidine was not effective in modulating sympathetic activity in PCOS. Anti-inflammatory effects of moxonidine and a relationship between insulin resistance and sympathetic response to moxonidine are suggested which need to be further explored.Clinical Trial Registration Number: (NCT01504321)

Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility in women of reproductive age. Lifestyle change is considered the first line treatment for the management of infertile anovulatory women with PCOS, and weight loss for those who are overweight or obese. First line medical ovulation induction therapy to improve fertility outcomes is letrozole, whilst other less efficacious ovulation induction agents, such as clomiphene citrate, metformin, and metformin combined with clomiphene citrate, may also be considered. Metformin combined with clomiphene citrate is more effective than clomiphene citrate alone. In obese women with PCOS, clomiphene citrate could be used in preference to metformin alone whilst clomiphene citrate could be added to metformin alone in order to improve reproductive outcome in all women with PCOS. Gonadotrophins, which are more effective than clomiphene citrate in therapy naïve women with PCOS, can be considered a first line therapy in the presence of ultrasound monitoring, following counselling on the cost and the potential risk of multiple pregnancy.

In clomiphene-citrate-resistant anovulatory women with polycystic ovary syndrome (PCOS) and no other infertility factors, either metformin combined with clomiphene citrate or gonadotrophins could be used as a second-line pharmacological therapy, although gonadotrophins are more effective. Gonadotrophins could also be used as a second-line pharmacological therapy in anovulatory women with PCOS and clomiphene-citrate-failure. Laparoscopic ovarian surgery can also be used as a second-line therapy for ovulation induction in anovulatory women with clomiphene-citrate-resistant PCOS and no other infertility factors. The usefulness of letrozole as a second-line pharmacological treatment for ovulation induction in clomiphene-citrate-resistant women with PCOS requires further research. In terms of improving fertility, both pharmacological anti-obesity agents and bariatric surgery should be considered an experimental therapy in anovulatory women with PCOS and no other infertility factors. Where first- or second-line ovulation induction therapies have failed, in vitro fertilization (IVF)/ intracytoplasmic sperm injection (ICSI) could be offered as a third-line therapy in women with PCOS in the absence of an absolute indication for IVF/ICSI. For women with PCOS undergoing IVF/ICSI treatment, the gonadotropin-releasing hormone (GnRH) antagonist protocol is preferred and an elective frozen embryo transfer strategy could be considered. In assisted conception units with sufficient expertise, in-vitro maturation (IVM) of oocytes could be offered to women with PCOS.

Introduction The development of type 2 diabetes mellitus disproportionately affects South Asian women with prior gestational diabetes mellitus (GDM). The Lifestyle InterVention IN Gestational diabetes (LIVING) Study is a randomised controlled trial of a low-intensity lifestyle modification programme tailored to women with previous GDM, in India, Bangladesh and Sri Lanka, aimed at preventing diabetes/pre-diabetes. The aim of this process evaluation is to understand what worked, and why, during the LIVING intervention implementation, and to provide additional data that will assist in the interpretation of the LIVING Study results. The findings will also inform future scale-up efforts if the intervention is found to be effective.Methods and analysis The Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) methodological approach informed the evaluation framework. Michie’s Behaviour Change Theory and Normalisation Process Theory were used to guide the design of our qualitative evaluation tools within the overall RE-AIM evaluation framework. Mixed methods including qualitative interviews, focus groups and quantitative analyses will be used to evaluate the intervention from the perspectives of the women receiving the intervention, facilitators, site investigators and project management staff. The evaluation will use evaluation datasets, administratively collected process data accessed during monitoring visits, check lists and logs, quantitative participant evaluation surveys, semistructured interviews and focus group discussions. Interview participants will be recruited using maximum variation purposive sampling. We will undertake thematic analysis of all qualitative data, conducted contemporaneously with data collection until thematic saturation has been achieved. To triangulate data, the analysis team will engage in constant iterative comparison among data from various stakeholders.Ethics and dissemination Ethics approval has been obtained from the respective human research ethics committees of the All India Institute of Medical Sciences, New Delhi, India; University of Sydney, New South Wales, Australia; and site-specific approval at each local site in the three countries: India, Bangladesh and Sri Lanka. This includes approvals from the Institutional Ethics Committee at King Edwards Memorial Hospital, Maharaja Agrasen Hospital, Centre for Disease Control New Delhi, Goa Medical College, Jawaharlal Institute of Postgraduate Medical Education and Research, Madras Diabetes Research Foundation, Christian Medical College Vellore, Fernandez Hospital Foundation, Castle Street Hospital for Women, University of Kelaniya, Topiwala National Medical College and BYL Nair Charitable Hospital, Birdem General Hospital and the International Centre for Diarrhoeal Disease Research. Findings will be documented in academic publications, presentations at scientific meetings and stakeholder workshops.Trial registration numbers Clinical Trials Registry of India (CTRI/2017/06/008744); Sri Lanka Clinical Trials Registry (SLCTR/2017/001) and ClinicalTrials.gov Registry (NCT03305939); Pre-results.