Development and validation of a prognostic model to predict birth weight: individual participant data meta-analysis.

Objective: To predict birth weight at various potential gestational ages of delivery based on data routinely available at the first antenatal visit. Design: Individual participant data meta-analysis. Data sources: Individual participant data of four cohorts (237 228 pregnancies) from the International Prediction of Pregnancy Complications (IPPIC) network dataset. Eligibility criteria for selecting studies: Studies in the IPPIC network were identified by searching major databases for studies reporting risk factors for adverse pregnancy outcomes, such as pre-eclampsia, fetal growth restriction, and stillbirth, from database inception to August 2019. Data of four IPPIC cohorts (237 228 pregnancies) from the US (National Institute of Child Health and Human Development, 2018; 233 483 pregnancies), UK (Allen et al, 2017; 1045 pregnancies), Norway (STORK Groruddalen research programme, 2010; 823 pregnancies), and Australia (Rumbold et al, 2006; 1877 pregnancies) were included in the development of the model. Results: The IPPIC birth weight model was developed with random intercept regression models with backward elimination for variable selection. Internal-external cross validation was performed to assess the study specific and pooled performance of the model, reported as calibration slope, calibration-in-the-large, and observed versus expected average birth weight ratio. Meta-analysis showed that the apparent performance of the model had good calibration (calibration slope 0.99, 95% confidence interval (CI) 0.88 to 1.10; calibration-in-the-large 44.5 g, -18.4 to 107.3) with an observed versus expected average birth weight ratio of 1.02 (95% CI 0.97 to 1.07). The proportion of variation in birth weight explained by the model (R2) was 46.9% (range 32.7-56.1% in each cohort). On internal-external cross validation, the model showed good calibration and predictive performance when validated in three cohorts with a calibration slope of 0.90 (Allen cohort), 1.04 (STORK Groruddalen cohort), and 1.07 (Rumbold cohort), calibration-in-the-large of -22.3 g (Allen cohort), -33.42 (Rumbold cohort), and 86.4 g (STORK Groruddalen cohort), and observed versus expected ratio of 0.99 (Rumbold cohort), 1.00 (Allen cohort), and 1.03 (STORK Groruddalen cohort); respective pooled estimates were 1.00 (95% CI 0.78 to 1.23; calibration slope), 9.7 g (-154.3 to 173.8; calibration-in-the-large), and 1.00 (0.94 to 1.07; observed v expected ratio). The model predictions were more accurate (smaller mean square error) in the lower end of predicted birth weight, which is important in informing clinical decision making. Conclusions: The IPPIC birth weight model allowed birth weight predictions for a range of possible gestational ages. The model explained about 50% of individual variation in birth weights, was well calibrated (especially in babies at high risk of fetal growth restriction and its complications), and showed promising performance in four different populations included in the individual participant data meta-analysis. Further research to examine the generalisability of performance in other countries, settings, and subgroups is required. Trial registration: PROSPERO CRD42019135045.

Tools and frameworks for evaluating the implementation of learning health systems: a scoping review.

INTRODUCTION: Despite increased interest in learning health systems (LHS), a paucity of guidance and tools for evaluating LHS implementation exists. To address this, we aim to undertake a scoping review on existing tools and evaluation of exemplars of LHS implementation. METHODS: We conducted a scoping review of peer-reviewed studies within Scopus, EMBASE, MEDLINE, and MEDLINE in-process that described (1) the evaluation of the implementation of an operating LHS or (2) the development of a framework or tool to facilitate this evaluation. Anima, basic research, abstracts, non-English language articles, and publications before 2018 were excluded. All study designs were considered. FINDINGS: From 1300 studies initially identified, 4 were eligible, revealing three tools with nine implementation evaluation examples. The identified tools shared constructs which were evaluated, including: Stakeholders, Data, Research Evidence, Implementation, and Sociotechnical Infrastructure. However, there was divergence in evaluation methodology. Tools ranged from a five-point numerical rating system for process maturity with a radar chart called the Network Maturity Grid (NMG); the Kaiser Permanente Washington (KPWA) LHS Logic Model, which provides a broad list of constructs and sample measures relevant to LHS operations; and finally LADDERS, a simple tool or form-based template designed for consistent evaluation over time. The NMG tool was the most mature in terms of adaptation and adoption. Notably, two (NMG and the KPWA LHS Logic Model) out of three tools conceptualized the LHS as a suite of processes and devised tools were processes that linked these constructs. IMPLICATIONS FOR TOOLKIT DEVELOPMENT: The evaluation of LHS implementation remains an under explored area of investigation, as this scoping review found only three tools for LHS implementation evaluation. Our findings indicate a need for further empirical research in this area and suggest early consensus in constructs that need to be considered during evaluation.

Effect of treatment for early gestational diabetes mellitus on neonatal respiratory distress: A secondary analysis of the TOBOGM study.

OBJECTIVE: To identify factors associated with neonatal respiratory distress (NRD) in early Gestational diabetes mellitus (eGDM). DESIGN: Nested case-control analysis of the TOBOGM trial. SETTING: Seventeen hospitals: Australia, Sweden, Austria and India. POPULATION: Pregnant women, <20 weeks' gestation, singleton, GDM risk factors. METHODS: Women with GDM risk factors completed an oral glucose tolerance test (OGTT) before 20 weeks: those with eGDM (WHO-2013 criteria) were randomised to immediate or deferred GDM treatment. Logistic regression compared pregnancies with/without NRD, and in pregnancies with NRD, those with/without high-dependency nursery admission for ≤24 h with those admitted for >24 h. Comparisons were adjusted for age, pre-pregnancy body mass index, ethnicity, smoking, primigravity, education and site. Adjusted odds ratios (95% CI) are reported. MAIN OUTCOME MEASURES: NRD definition: ≥4 h of respiratory support (supplemental oxygen or supported ventilation) postpartum. Respiratory distress syndrome (RDS): Supported ventilation and ≥24 h nursery stay. RESULTS: Ninety-nine (12.5%) of 793 infants had NRD; incidence halved (0.50, 0.31-0.79) if GDM treatment was started early. NRD was associated with Caesarean section (2.31, 1.42-3.76), large for gestational age (LGA) (1.83, 1.09-3.08) and shorter gestation (0.95, 0.93-0.97 per day longer). Among NRD infants, >24 h nursery-stay was associated with higher OGTT 1-h glucose (1.38, 1.08-1.76 per mmol/L). Fifteen (2.0%) infants had RDS. CONCLUSIONS: Identifying and treating eGDM reduces NRD risk. NRD is more likely with Caesarean section, LGA and shorter gestation. Further studies are needed to understand the mechanisms behind this eGDM complication and any long-term effects.

2023 International Evidence-Based Polycystic Ovary Syndrome Guideline Update: Insights From a Systematic Review and Meta-Analysis on Elevated Clinical Cardiovascular Disease in Polycystic Ovary Syndrome.

BACKGROUND: Polycystic ovary syndrome (PCOS) is the most prevalent female endocrinopathy. Although increased cardiovascular risk factors are well established for the syndrome, PCOS remains overlooked within the realm of cardiology. We conducted a systematic review and meta-analysis on the risk of clinical cardiovascular disease (CVD) events in women with PCOS to inform the 2023 International Evidence-Based PCOS Guideline. METHODS AND RESULTS: A systematic review and meta-analysis was conducted comparing the risk of clinical CVD events in women with and without PCOS. Medline (Ovid), PsycInfo (Ovid), EMBASE, All EBM (Ovid), and CINAHL were searched from January 1, 2017, until March 1, 2023, to update the 2018 PCOS Guideline. Pooled odds ratios (ORs), incidence rate ratios (IRRs), and hazard ratios (HRs) were calculated. Twenty studies involving 1.06 million women (369 317 with PCOS and 692 963 without PCOS) were included. PCOS was associated with higher risk of composite CVD (OR, 1.68 [95% CI, 1.26-2.23]; I2 = 71.0%), composite ischemic heart disease (OR, 1.48 [95% CI, 1.07-2.05]; I2 = 81.0%), myocardial infarction (OR, 2.50 [95% CI, 1.43-4.38]; I2 = 83.3%), and stroke (OR, 1.71 [95% CI, 1.20-2.44]; I2 = 81.4%). The relationship with cardiovascular mortality was less clear (OR, 1.19 [95% CI, 0.53-2.69]; I2 = 0%). Meta-analyses of IRRs support these findings. Results from pooled HRs were limited by the small number of studies and significant heterogeneity. CONCLUSIONS: This review provides evidence and highlights the importance of recognizing PCOS as a significant risk factor for CVD morbidity. The 2023 International Evidence-Based PCOS Guideline now recommends awareness of increased CVD risk and comprehensive risk assessment in PCOS to help mitigate the burden of CVD in this common and high-risk condition.

Increased Prevalence of Binge Eating Disorder and Bulimia Nervosa in Women With Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis.

CONTEXT: Polycystic ovary syndrome (PCOS) is associated with disordered eating/eating disorders, but prior meta-analyses are limited by small numbers. OBJECTIVE: To inform the 2023 International PCOS Guideline, we performed a systematic review and meta-analysis evaluating the prevalence of disordered eating/eating disorders among women with and without PCOS. METHODS: Ovid MEDLINE, EMBASE, PsycInfo, and All EMB were searched from inception through February 1, 2024, for studies that compared prevalences of eating disordered/disordered eating in adolescent or adult women. Random effects meta-analyses were used to estimate the pooled odds ratios (OR) or standardized mean differences (SMD) of outcomes in women with PCOS compared to controls. Methodological quality was assessed by the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system, and included studies were assessed for risk of bias. RESULTS: Of 1352 articles identified, 20 were included, with a total of 28 922 women with PCOS and 258 619 controls. Individuals with PCOS had higher odds of any eating disorder (OR: 1.53 [1.29, 1.82], 8 studies), which persisted in studies where PCOS was diagnosed by Rotterdam criteria (OR: 2.88 [1.55, 5.34], 4 studies). Odds of bulimia nervosa, binge eating disorder, and disordered eating, but not anorexia nervosa, were increased in PCOS. Mean disordered eating scores were higher in PCOS (SMD: 0.52 [0.28, 0.77], 13 studies), including when stratified by normal and higher weight body mass index. Most included studies were of moderate quality, with no evidence of publication bias. CONCLUSION: Our study informs the 2023 PCOS Guideline recommendations for consideration of the risk of disordered eating/ eating disorders in care of women with PCOS, regardless of weight, especially during providing lifestyle counseling.

Preferred lifestyle intervention characteristics and behaviour change needs of postpartum women following cardiometabolic pregnancy complications.

BACKGROUND: Women with cardiometabolic pregnancy complications are at increased risk of future diabetes and heart disease which can be reduced through lifestyle management postpartum. OBJECTIVES: This study aimed to explore preferred intervention characteristics and behaviour change needs of women with or without prior cardiometabolic pregnancy complications for engaging in postpartum lifestyle interventions. DESIGN: Quantitative cross-sectional study. METHODS: Online survey. RESULTS: Overall, 473 women were included, 207 (gestational diabetes (n = 105), gestational hypertension (n = 39), preeclampsia (n = 35), preterm birth (n = 65) and small for gestational age (n = 23)) with and 266 without prior cardiometabolic pregnancy complications. Women with and without complications had similar intervention preferences, with delivery ideally by a healthcare professional with expertise in women's health, occurring during maternal child health nurse visits or online, commencing 7 weeks to 3 months post birth, with 15- to 30-min monthly sessions, lasting 1 year and including monitoring of progress and social support. Women with prior complications preferred intervention content on women's health, mental health, exercise, mother's diet and their children's health and needed to know more about how to change behaviour, have more time to do it and feel they want to do it enough to participate. There were significant differences between groups, with more women with prior cardiometabolic pregnancy complications wanting content on women's health (87.9% vs 80.8%, p = 0.037), mother's diet (72.5% vs 60.5%, p = 0.007), preventing diabetes or heart disease (43.5% vs 27.4%, p < 0.001) and exercise after birth (78.3% vs 68.0%, p = 0.014), having someone to monitor their progress (69.6% vs 58.6%, p = 0.014), needing the necessary materials (47.3% vs 37.6%, p = 0.033), triggers to prompt them (44.0% vs 31.6%, p = 0.006) and feeling they want to do it enough (73.4%, 63.2%, p = 0.018). CONCLUSION: These unique preferences should be considered in future postpartum lifestyle interventions to enhance engagement, improve health and reduce risk of future cardiometabolic disease in these high-risk women.

Challenges experienced by those with polycystic ovary syndrome in healthcare interactions: a qualitative evidence synthesis.

Studies report interaction difficulties between patients with polycystic ovary syndrome (PCOS) and healthcare professionals (HCP). This systematic review and qualitative evidence synthesis aimed to collate and synthesize the existing peer-reviewed literature investigating challenges for people with PCOS when interacting with HCP. Medline, PsycInfo, EMBASE, All EBM and CINAHL were searched from 1990 to September 2022. Study risk of bias (RoB) was performed and all textual data relevant to challenging interactions between patients with PCOS and HCP were extracted and analysed using thematic synthesis. Of the 6353 studies identified, 28 were included. Two were appraised as high, four as moderate and 22 as low RoB. Four analytic themes were derived illustrating that interactions were challenging when: (i) medical information (PCOS, its management) was not shared in the best way; (ii) information provision and deliberation opportunities were insufficient to achieve outcomes that mattered to patients; (iii) interactions prompted but did not support patient activation; and (iv) health system-level barriers (e.g. policies and guidelines) were present or made worse by HCP behaviour. Future research should examine methods for the implementation and evaluation of established frameworks for sharing medical information and supporting patient agency in the context of PCOS care.

Relationship Between Early-Pregnancy Glycemia and Adverse Outcomes: Findings From the TOBOGM Study.

OBJECTIVE: We evaluated associations between early-pregnancy oral glucose tolerance test (OGTT) glucose and complications in the Treatment of Booking Gestational Diabetes Mellitus (TOBOGM) cohort to inform prognostic OGTT thresholds. RESEARCH DESIGN AND METHODS: Individuals with risk factors for hyperglycemia were recruited for an international, multicenter, randomized controlled gestational diabetes mellitus (GDM) (World Health Organization 2013 criteria) treatment trial. A 2-h 75-g OGTT was performed at <20 weeks' gestation. Individuals with early treated hyperglycemia in pregnancy were excluded from the primary analysis. Early OGTT glucose concentrations were analyzed continuously and in glycemic categories (normal, low band, and high band). RESULTS: Overall, 3,645 individuals had an OGTT at (mean ± SD) 15.6 ± 2.5 weeks. For each 1-SD increase in fasting, 1-h, and 2-h glucose values, there were continuous positive associations with late GDM: adjusted odds ratio (aOR) 2.04 (95% CI 1.82-2.27), 3.05 (2.72-3.43), and 2.21 (1.99-2.45), respectively. There were continuous positive associations between 1-h and 2-h glucose and the perinatal composite (birth <37 + 0 weeks, birth trauma, birth weight ≥4,500 g, respiratory distress, phototherapy requirement, stillbirth/neonatal death, and shoulder dystocia), with aOR 1.15 (95% CI 1.04-1.26) and 1.14 (1.04-1.25), respectively, and with large-for-gestational-age offspring, with aOR 1.18 (1.06-1.31) and 1.26 (1.01-1.25), respectively. Significant associations were also observed between 1-h glucose and cesarean section and between fasting and 2-h glucose and neonatal hypoglycemia. In categorical analysis, only the high-band 1-h glucose (≥10.6 mmol/L [191 mg/dL]) predicted the perinatal composite. CONCLUSIONS: There is a continuous positive association between early-pregnancy OGTT glucose and complications. In individuals with hyperglycemia risk factors, only the high-glycemic-band 1-h glucose corresponded to increased risk of major perinatal complications.

Identifying Predictor Variables for a Composite Risk Prediction Tool for Gestational Diabetes and Hypertensive Disorders of Pregnancy: A Modified Delphi Study.

A composite cardiometabolic risk prediction tool will support the systematic identification of women at increased cardiometabolic risk during pregnancy to enable early screening and intervention. This study aims to identify and select predictor variables for a composite risk prediction tool for cardiometabolic risk (gestational diabetes mellitus and/or hypertensive disorders of pregnancy) for use in the first trimester. A two-round modified online Delphi study was undertaken. A prior systematic literature review generated fifteen potential predictor variables for inclusion in the tool. Multidisciplinary experts (n = 31) rated the clinical importance of variables in an online survey and nominated additional variables for consideration (Round One). An online meeting (n = 14) was held to deliberate the importance, feasibility and acceptability of collecting variables in early pregnancy. Consensus was reached in a second online survey (Round Two). Overall, 24 variables were considered; 9 were eliminated, and 15 were selected for inclusion in the tool. The final 15 predictor variables related to maternal demographics (age, ethnicity/race), pre-pregnancy history (body mass index, height, history of chronic kidney disease/polycystic ovarian syndrome, family history of diabetes, pre-existing diabetes/hypertension), obstetric history (parity, history of macrosomia/pre-eclampsia/gestational diabetes mellitus), biochemical measures (blood glucose levels), hemodynamic measures (systolic blood pressure). Variables will inform the development of a cardiometabolic risk prediction tool in subsequent research. Evidence-based, clinically relevant and routinely collected variables were selected for a composite cardiometabolic risk prediction tool for early pregnancy.

Geographic Variation in Osteoporosis Treatment in Postmenopausal Women: A 15-Year Longitudinal Analysis.

Context: Osteoporosis affects more than half of older women, but many are not treated. Whether treatment differs between rural and urban areas is unknown. Objective: To examine differences in osteoporosis treatment among postmenopausal women living in urban and rural areas of Australia. Methods: Women participating in the Australian Longitudinal Study on Women's Health, a prospective longitudinal cohort study, born between 1946-1951, and with osteoporosis or fractures, were included. Surveys from 2004 to 2019 were linked to the Pharmaceutical Benefits Scheme (government-subsidized medications) to assess osteoporosis treatment and adherence, comparing geographical areas. Results: Of the 4259 women included (mean age, 55.6 years), 1703 lived in major cities, 1629 inner regional, 794 outer regional, and 133 remote areas. Over the 15-year follow-up, 1401 (32.9%) women received treatment, including 47.4% of women with osteoporosis and 29.9% with fractures. Women in outer regional and remote areas were less likely to use antiosteoporosis treatment than those in major cities on univariable analysis (outer regional odds ratio, 0.83; 95% CI, 0.72-0.95; remote, 0.65; 0.49-0.86), but this did not remain significant on multivariable analysis. Median duration of use was 10 to 36 months, adherence varied by treatment type (34%-100%) but was not related to incident fractures, and of the women who stopped denosumab, 85% did not receive another consolidating treatment. Conclusions: One-third of women with osteoporosis/fractures received treatment, and adherence was low. There was no difference in treatment use between urban and rural areas after adjusting for risk factors, although the specific treatment used, and adherence, differed.

Systematic review and meta-analysis of pregnancy outcomes in women with polycystic ovary syndrome.

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.

Systematic review and meta-analysis of birth outcomes in women with polycystic ovary syndrome.

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.

Exercise in the management of polycystic ovary syndrome: A position statement from Exercise and Sport Science Australia.

Polycystic ovary syndrome (PCOS) is the most prevalent endocrine condition amongst females of reproductive age, leading to lifelong cardiometabolic, reproductive, psychological, and dermatologic symptoms as well as a reduced quality of life. Lifestyle interventions, which can include structured exercise programmes delivered by appropriately trained exercise professionals such as clinical exercise physiologists, are considered first-line strategies in PCOS management due to their therapeutic effects on various health outcomes and quality of life. This position statement builds on the 2023 International Evidence-based Guideline for the Assessment and Management of PCOS and describes the role of the exercise professional in the context of the multidisciplinary care team which includes physicians and allied health professionals. This position statement aims to equip exercise professionals with a broad understanding of the pathophysiology of PCOS, how it is diagnosed and managed in clinical practice, and evidence- and consensus-based recommendations for physical activity and exercise in PCOS management. In line with the physical activity recommendations for the general public, individuals with PCOS should aim to undertake between 150 to 300min of moderate-intensity or 75 to 150min of vigorous-intensity aerobic activity per week, or an equivalent combination of both spread throughout the week. Additionally, muscle-strengthening activities on two non-consecutive days per week are recommended to maintain health and prevent weight gain. For further health benefits and to achieve modest weight loss, individuals with PCOS should aim for a minimum of 250min of moderate-intensity or 150min of vigorous-intensity aerobic activity per week, or an equivalent combination of both spread throughout the week, plus muscle-strengthening activities on two non-consecutive days per week. Adolescents with PCOS should aim for a minimum of 60min moderate- to vigorous-intensity activity each day, incorporating muscle- and bone-strengthening activities three times per week. Finally, exercise professionals should consider the significant psychological burden, including weight stigma, and the high prevalence of comorbidities amongst individuals with PCOS and take appropriate measures to deliver safe and efficacious exercise 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.

External validation of risk prediction model for gestational diabetes: Individual participant data meta-analysis of randomized trials.

BACKGROUND: An original validated risk prediction model with good discriminatory prognostic performance for predicting gestational diabetes (GDM) diagnosis, has been updated for recent international association of diabetes in pregnancy study group (IADPSG) diagnostic criteria. However, the updated model is yet to be externally validated on an international dataset. AIMS: To perform an external validation of the updated risk prediction model to evaluate model indices such as discrimination and calibration based on data from the International Weight Management in Pregnancy (i-WIP) Collaborative Group. MATERIALS AND METHODS: The i -WIP dataset was used to validate the GDM prediction tool across discrimination and model calibration. RESULTS: Overall 7689 individual patient data were included, with 17.4 % with GDM, however only 113 cases were available using IADPSG (International Association of Diabetes and Pregnancy Groups) criteria for 75 g OGTT glucose load and ACOG (American College of Obstetricians and Gynecologists) for 100 g glucose load and having the routine clinical risk factor data. The GDM model was moderately discriminatory (Area Under the Curve (AUC) of 0.67; 95 % CI 0.59 to 0.75), Sensitivity 81.0 % (95 % CI 66.7 % to 90.9 %), specificity 53 % (40.3 % to 65.4 %). The GDM score showed reasonable calibration for predicting GDM (slope = 0.84, CITL = 0.77). Imputation for missing data increased the sample to n = 253, and vastly improved the discrimination and calibration of the model to AUC = 78 (95 % CI 72 to 85), sensitivity (81 %, 95 % CI 66.7 % to 90.9 %) and specificity (75 %, 95 % CI 68.8 % to 81 %). CONCLUSION: The updated GDM model showed promising discrimination in predicting GDM in an international population sourced from RCT individual patient data. External validations are essential in order for the risk prediction area to advance, and we demonstrate the utility of using existing RCT data from different global settings. Despite limitations associated with harmonising the data to the variable types in the model, the validation model indices were reasonable, supporting generalizability across continents and populations.

Development of a risk prediction model for postpartum onset of type 2 diabetes mellitus, following gestational diabetes; the lifestyle InterVention in gestational diabetes (LIVING) study.

AIMS: This study aimed to develop a prediction model for identifying a woman with gestational diabetes mellitus (GDM) at high risk of type 2 diabetes (T2DM) post-birth. METHODS: Utilising data from 1299 women in the Lifestyle Intervention IN Gestational Diabetes (LIVING) study, two models were developed: one for pregnancy and another for postpartum. Key predictors included glucose test results, medical history, and biometric indicators. RESULTS: Of the initial cohort, 124 women developed T2DM within three years. The study identified seven predictors for the antenatal T2DM risk prediction model and four for the postnatal one. The models demonstrated good to excellent predictive ability, with Area under the ROC Curve (AUC) values of 0.76 (95% CI: 0.72 to 0.80) and 0.85 (95% CI: 0.81 to 0.88) for the antenatal and postnatal models, respectively. Both models underwent rigorous validation, showing minimal optimism in predictive capability. Antenatal model, considering the Youden index optimal cut-off point of 0.096, sensitivity, specificity, and accuracy were measured as 70.97%, 70.81%, and 70.82%, respectively. For the postnatal model, considering the cut-off point 0.086, sensitivity, specificity, and accuracy were measured as 81.40%, 75.60%, and 76.10%, respectively. CONCLUSIONS: These models are effective for predicting T2DM risk in women with GDM, although external validation is recommended before widespread application.

Anti-müllerian hormone as a diagnostic biomarker for polycystic ovary syndrome and polycystic ovarian morphology: a systematic review and meta-analysis.

IMPORTANCE: As part of the 2023 international evidence-based polycystic ovary syndrome (PCOS) guideline, this meta-analysis investigated the inclusion of Anti-Müllerian hormone (AMH) levels in the diagnostic criteria for PCOS. OBJECTIVE: To answer the following three questions: 1) Are AMH levels effective in diagnosing PCOS in adult women? 2) Are AMH levels effective in diagnosing PCOS in adolescents? Are AMH levels effective in diagnosing polycystic ovarian morphology (PCOM)? DATA SOURCES: Searches were conducted in six databases until July 31, 2023. STUDY SELECTION AND SYNTHESIS: Eligible studies were those conducted in humans, published in English, and reporting sensitivity, specificity, and/or area under the curve values. Extracted data included study population, age, body mass index, AMH assay, cut-off value of AMH levels, sensitivity, specificity, and area under the curve values. The risk of bias was assessed using the quality assessment of diagnostic accuracy studies tool. A random effects model was used to test diagnostic accuracy. MAIN OUTCOMES: Pooled sensitivity and specificity to use AMH levels for PCOS diagnosis in adults as well as adolescents and for detecting PCOM in adults. RESULTS: Eighty-two studies were included. The adult AMH-PCOS meta-analyses (n = 68) showed a pooled sensitivity and specificity of 0.79 (95% confidence interval [CI], 0.76-0.82; I2 = 86%) and 0.87 (95% CI, 0.84-0.89; I2 = 91%). The adolescent AMH-PCOS meta-analysis (n = 11) showed a pooled sensitivity and specificity of 0.66 (95% CI, 0.58-0.73; I2 = 74%) and 0.78 (95% CI, 0.71-0.83; I2 = 45%). The adult AMH-PCOM meta-analysis (n = 7) showed a pooled sensitivity and specificity of 0.79 (95% CI, 0.72-0.85; I2 = 94%) and 0.87 (95% CI, 0.78-0.93; I2 = 94%). CONCLUSION AND RELEVANCE: This study investigated the most profound change in the 2023 international evidence-based PCOS guideline, which now recommends AMH levels for defining PCOM in adults in accordance with the diagnostic algorithm. Antimüllerian hormone levels alone are insufficient for PCOS diagnosis and are nonspecific for PCOM in adolescents. Multiple factors influence AMH levels and cause heterogeneity as well as limitations in this study. Consequently, no international cut-off value could be recommended, emphasizing the need for research on more individualized cut-off values.

Cost-effectiveness of diagnosis and treatment of early gestational diabetes mellitus: economic evaluation of the TOBOGM study, an international multicenter randomized controlled trial.

Background: A recently undertaken multicenter randomized controlled trial (RCT) "Treatment Of BOoking Gestational diabetes Mellitus" (TOBOGM: 2017-2022) found that the diagnosis and treatment of pregnant women with early gestational diabetes mellitus (GDM) improved pregnancy outcomes. Based on data from the trial, this study aimed to assess the cost-effectiveness of diagnosis and treatment of early GDM (from <20 weeks') among women with risk factors for hyperglycemia in pregnancy compared with usual care (no treatment until 24-28 weeks') from a healthcare perspective. Methods: Participants' healthcare resource utilization data were collected from their self-reported questionnaires and hospital records, and valued using the unit costs obtained from standard Australian national sources. Costs were reported in US dollars ($) using the purchasing power parity (PPP) estimates to facilitate comparison of costs across countries. Intention-to-treat (ITT) principle was followed. Missing cost data were replaced using multiple imputations. Bootstrapping method was used to estimate the uncertainty around mean cost difference and cost-effectiveness results. Bootstrapped cost-effect pairs were used to plot the cost-effectiveness (CE) plane and cost-effectiveness acceptability curve (CEAC). Findings: Diagnosis and treatment of early GDM was more effective and tended to be less costly, i.e., dominant (cost-saving) [-5.6% composite adverse pregnancy outcome (95% CI: -10.1%, -1.2%), -$1373 (95% CI: -$3,749, $642)] compared with usual care. Our findings were confirmed by both the CE plane (88% of the bootstrapped cost-effect pairs fall in the south-west quadrant), and CEAC (the probability of the intervention being cost-effective ranged from 84% at a willingness-to-pay (WTP) threshold value of $10,000-99% at a WTP threshold value of $100,000 per composite adverse pregnancy outcome prevented). Sub-group analyses demonstrated that diagnosis and treatment of early GDM among women in the higher glycemic range (fasting blood glucose 95-109 mg/dl [5.3-6.0 mmol/L], 1-h blood glucose ≥191 mg/dl [10.6 mmol/L] and/or 2-h blood glucose 162-199 mg/dl [9.0-11.0 mmol/L]) was more effective and less costly (dominant) [-7.8% composite adverse pregnancy outcome (95% CI: -14.6%, -0.9%), -$2795 (95% CI: -$6,638, -$533)]; the intervention was more effective and tended to be less costly [-8.9% composite adverse pregnancy outcome (95% CI: -15.1%, -2.6%), -$5548 (95% CI: -$16,740, $1547)] among women diagnosed before 14 weeks' gestation as well. Interpretation: Our findings highlight the potential health and economic benefits from the diagnosis and treatment of early GDM among women with risk factors for hyperglycemia in pregnancy and supports its implementation. Long-term follow-up studies are recommended as a key future area of research to assess the potential long-term health benefits and economic consequences of the intervention. Funding: National Health and Medical Research Council (grants 1104231 and 2009326), Region O¨rebro Research Committee (grants Dnr OLL-970566 and OLL-942177), Medical Scientific Fund of the Mayor of Vienna (project 15,205 and project 23,026), South Western Sydney Local Health District Academic Unit (grant 2016), and Western Sydney University Ainsworth Trust Grant (2019).

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.