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Abstract 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.

Abstract 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.

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.

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

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

Abstract Objectives To explore associations between type and number of abnormal glucose values on antenatal oral glucose tolerance test (OGTT) with postpartum diabetes in South Asian women diagnosed with gestational diabetes (GDM) using International Association of the Diabetes and Pregnancy Study Groups criteria. Methods This post‐hoc evaluation of the Lifestyle Intervention IN Gestational Diabetes (LIVING) study, a randomized controlled trial, was conducted among women with GDM in the index pregnancy, across 19 centers in Bangladesh, India, and Sri Lanka. Postpartum diabetes (outcome) was defined on OGTT, using American Diabetes Association (ADA) criteria. Results We report data on 1468 women with GDM, aged 30.9 (5.0) years, and with median (interquartile range) follow‐up period of 1.8 (1.4–2.4) years after childbirth following the index pregnancy. We found diabetes in 213 (14.5%) women with an incidence of 8.7 (7.6–10.0)/100 women‐years. The lowest incidence rate was 3.8/100 women years, in those with an isolated fasting plasma glucose (FPG) abnormality, and highest was 19.0/100 women years in participants with three abnormal values. The adjusted hazard ratios for two and three abnormal values compared to one abnormal value were 1.73 (95% confidence interval [CI], 1.18–2.54; p = .005) and 3.56 (95% CI, 2.46–5.16; p

Abstract Background Both obesity and sleep disorders are common among women during pregnancy. Although prior research has identified a relationship between obesity and sleep disorders, those findings are from women later in pregnancy. Objective To explore the relationships between self‐reported sleep duration, insufficient sleep and snoring with body mass index (BMI) among multiethnic women at risk of gestational diabetes mellitus (GDM)in early pregnancy. Methods Cross‐sectional study of baseline data from women at risk of GDM enrolled in the Treatment of BOoking Gestational diabetes Mellitus (TOBOGM) multicentre trial across 12 Australian/Austrian sites. Participants completed a questionnaire before 20 weeks’ gestation to evaluate sleep. BMI 5 days/month was higher in class II and class III obesity (1.38 (1.03–1.85) and 1.34 (1.01–1.80), respectively), and the risk of snoring increased as BMI increased (1.59 (1.25–2.02), 2.68 (2.07–3.48), 4.35 (3.21–5.88) to 4.96 (3.65–6.74), respectively)). Conclusions Obesity is associated with insufficient sleep among pregnant women at risk of GDM. Snoring is more prevalent with increasing BMI.

Introduction Scaling up interventions targeting non-communicable diseases (NCDs) is a global health priority, and implementation research can contribute to that effort. In 2019, the Global Alliance for Chronic Diseases funded 27 implementation research studies to improve evidence for scaling up interventions targeting prevention and/or control of hypertension and/or diabetes in low-resource settings. We examined these studies to improve the understanding of the implementation factors, including challenges and facilitators, that influence the early implementation phase of scale-up research projects targeting NCDs.Methods This qualitative study was undertaken between August 2020 and July 2021. 43 semi-structured interviews were conducted with project investigators, implementers and policymakers, across 19 diverse scale-up projects, being implemented in 20 countries. The transcripts were inductively, open-coded using thematic analysis. Generated themes were mapped systematically to four out of five domain categorisations of the Consolidated Framework for Implementation Research (CFIR); the innovation domain fell outside the scope of this study.Results Highlighted findings using CFIR are: (i) outer setting: influence of politics, lack of coordination between government departments and differing agendas towards NCDs hindered implementation while reliable and trustworthy government connections proved useful; (ii) inner setting: commitment of resources for implementation was a challenge while research capacity, work culture and trustworthy networks facilitated implementation; (iii) individuals: high-level stakeholder support and leadership was essential; (iv) process: extensive time and efforts required for stakeholder engagement towards local contextualisation was challenging, while collaborating, joint reflection, effective communication and adaptation facilitated. COVID-19 provided both challenges and opportunities and these varied depending on the intervention characteristics and study objectives.Conclusion Researchers supporting the scale-up of complex interventions targeting NCDs need to leverage on existing trusting relationships and foster equitable stakeholder partnerships through research. Interpersonal skills and good communication are essential complements to research expertise and must be considered during capacity building.

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.

BackgroundWomen with overweight and obesity are at higher risk of developing complications in pregnancy such as gestational diabetes and longer-term chronic conditions. Research concerning health behavior change interventions during pregnancy and postpartum shows promising effects, but implementation into routine services is sparsely investigated. Most interventions focus on the antenatal or postpartum life stages, failing to meet the needs of women. IMPACT DIABETES Bump2Baby is a multicenter project across 4 high-income countries developed to test the implementation of an antenatal and postpartum evidence-based mobile health (mHealth) coaching intervention called Bump2Baby and Me (B2B&Me) designed to sit alongside usual care in the perinatal period. ObjectiveWe aim to explore the feasibility and implementation of the B2B&Me intervention and investigate the effectiveness of this intervention in women at risk of gestational diabetes. MethodsIMPACT DIABETES Bump2Baby is a hybrid type 2 effectiveness-implementation study, which integrates an evidence-based mHealth coaching app that includes personalized health behavior change coaching provided by health care professionals alongside antenatal care from the first antenatal visit to 12 months postpartum. The mHealth app offers the possibility of synchronous calls, asynchronous contact (including coach-participant text and video messaging exchanges tailored to the participant’s needs), and ongoing access to an extensive library of bespoke intervention materials. Participants will interact asynchronously with their health coach throughout the intervention via the app. This randomized controlled trial across 4 clinical sites within Ireland, the United Kingdom, Spain, and Australia will recruit 800 women in early pregnancy to evaluate the effectiveness on postpartum weight. The Exploration, Preparation, Implementation, and Sustainment implementation framework is the theoretical underpinning of the study. The implementation evaluation will be assessed at the individual, hospital staff, and broader community levels using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Data sources for the RE-AIM evaluation will include app and platform analytics, screening and training records, participant medical records, key informant interviews, participant and partner exit interviews, cost data, study questionnaires, staff surveys, and blood sample analyses. ResultsThe study was approved and registered with the Australian New Zealand Clinical Trials Registry on November 19, 2020. Recruitment commenced on February 9, 2021, and data collection is ongoing. Publication of the results is expected in 2024. ConclusionsThis is the first hybrid effectiveness-implementation study of an 18-month mHealth coaching intervention in at-risk women that we are aware of. As research aims to move toward real-world implementable solutions, it is critical that hybrid studies are conducted. The data from this large multicenter study will be useful in planning the potential implementation and scale-up of evidence-based perinatal health behavior change interventions. Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12620001240932; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380020&isReview=true International Registered Report Identifier (IRRID)DERR1-10.2196/51431

Summary: Background: Anti-androgens and combined oral contraceptive pills (COCPs) may mitigate hyperandrogenism-related symptoms of polycystic ovary syndrome (PCOS). However, their efficacy and safety in PCOS remain unclear as previous reviews have focused on non-PCOS populations. To inform the 2023 International Evidence-based Guideline in PCOS, we conducted the first systematic review and meta-analysis investigating the efficacy and safety of anti-androgens in the management of hormonal and clinical features of PCOS. Methods: We systematically searched MEDLINE, Embase, PsycInfo, All EBM reviews, and CINAHL up to 28th June 2023 for randomised controlled trials (RCTs) examining oral anti-androgen use, alone or in combination with metformin, COCPs, lifestyle, or other interventions, in women of any age, with PCOS diagnosed by Rotterdam, National Institutes of Health or Androgen Excess & PCOS Society criteria, and using a form of contraception. Non-English studies and studies of less than 6 months duration or which used the same anti-androgen regimen in both/all groups were excluded in order to establish efficacy for the clinical outcomes of interest. Three authors screened articles against selection criteria and assessed risk of bias and quality using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework. Critical outcomes (prioritised during guideline development for GRADE purposes) included weight, body mass index (BMI), irregular cycles, hirsutism, liver function, and quality of life. Random effects meta-analyses were conducted where appropriate. This study is registered with PROSPERO, CRD42022345640. Findings: From 1660 studies identified in the search, 27 articles comprising 20 unique studies were included. Of these, 13 studies (n = 961) were pooled in meta-analysis. Seven studies had a high risk of bias, nine moderate and four low. Anti-androgens included finasteride, flutamide, spironolactone, or bicalutamide. In meta-analysis, anti-androgens + lifestyle were superior to metformin + lifestyle for hirsutism (weighted mean difference [WMD] [95% CI]: −1.59 [−3.06, −0.12], p = 0.03; I2 = 74%), SHBG (7.70 nmol/l [0.75, 14.66], p = 0.03; I2 = 0%), fasting insulin and fasting insulin: glucose ratio (−2.11 μU/ml [−3.97, −0.26], p = 0.03; I2 = 0% and −1.12 [−1.44, −0.79], p

BackgroundUnwarranted extended length of stay (LOS) increases the risk of hospital-acquired complications, morbidity, and all-cause mortality and needs to be recognized and addressed proactively.ObjectiveThis systematic review aimed to identify validated prediction variables and methods used in tools that predict the risk of prolonged LOS in all hospital admissions and specifically General Medicine (GenMed) admissions.MethodLOS prediction tools published since 2010 were identified in five major research databases. The main outcomes were model performance metrics, prediction variables, and level of validation. Meta-analysis was completed for validated models. The risk of bias was assessed using the PROBAST checklist.ResultsOverall, 25 all admission studies and 14 GenMed studies were identified. Statistical and machine learning methods were used almost equally in both groups. Calibration metrics were reported infrequently, with only 2 of 39 studies performing external validation. Meta-analysis of all admissions validation studies revealed a 95% prediction interval for theta of 0.596 to 0.798 for the area under the curve. Important predictor categories were co-morbidity diagnoses and illness severity risk scores, demographics, and admission characteristics. Overall study quality was deemed low due to poor data processing and analysis reporting.ConclusionTo the best of our knowledge, this is the first systematic review assessing the quality of risk prediction models for hospital LOS in GenMed and all admissions groups. Notably, both machine learning and statistical modeling demonstrated good predictive performance, but models were infrequently externally validated and had poor overall study quality. Moving forward, a focus on quality methods by the adoption of existing guidelines and external validation is needed before clinical application.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/, identifier: CRD42021272198.

Abstract Background Process improvement in healthcare is informed by knowledge from the private sector. Skilled individuals may aid the adoption of this knowledge by frontline care delivery workers through knowledge brokering. However, the effectiveness of those who broker knowledge is limited when the context they work within proves unreceptive to their efforts. We therefore need greater insight into the contextual conditions that support individuals to broker process improvement knowledge to the frontline of care delivery, and how policy makers and organizations might generate such conditions. Methods Our research took place in a healthcare system within an Australian State. We undertook a qualitative, embedded single case study over the four year period of a process improvement intervention encompassing 57 semi-structured interviews (with knowledge brokers, policy makers, and executive sponsors), 12 focus groups, and 137 h of observation, which included the frontline implementation of actual process improvement initiatives, where knowledge brokering took place. Results We identified four phases of the process improvement intervention that moved towards a more mature collaboration within which knowledge brokering by improvement advisors began to emerge as effective. In the first phase knowledge brokering was not established. In the second phase, whilst knowledge brokering had been initiated, the knowledge being brokered lacked legitimacy amongst frontline practitioners, resulting in resistance. Only in the fourth and final phase of the intervention did the collective experience of policy makers result in reflections on how they might engender a more receptive context for knowledge brokering. Conclusion We highlight a number of suggested actions that policy makers might consider, if they wish to engender contextual conditions that support knowledge brokering. Policy makers might consider: ensuring they respect local context and experience, by pulling good ideas upward, rather than imposing foreign knowledge from on high; facilitating the lateral diffusion of knowledge by building cultural linkages between people and organizations; strengthening collaboration, not competition, so that trans-organisational flow of ideas might be encouraged; being friend, not foe, to healthcare organizations on their knowledge integration journey. In sum, we suggest that top-down approaches to facilitating the diffusion and adoption of new ideas ought to be reconsidered.

IntroductionThe aim of the study was to identify available polycystic ovary syndrome (PCOS) models of care (MoCs) and describe their characteristics and alignment with the international PCOS guideline.MethodsOvid MEDLINE, All EBM, PsycINFO, Embase, and CINAHL were searched from inception until 11 July 2022. Any study with a description of a PCOS MoC was included. Non-evidence-based guidelines, abstracts, study protocols, and clinical trial registrations were excluded. We also excluded MoCs delivered in research settings to minimize care bias. Meta-analysis was not performed due to heterogeneity across MoCs. We describe and evaluate each MoC based on the recommendations made by the international evidence-based guideline for assessing and managing PCOS.ResultsOf 3,671 articles, six articles describing five MoCs were included in our systematic review. All MoCs described a multidisciplinary approach, including an endocrinologist, dietitian, gynecologist, psychologist, dermatologist, etc. Three MoCs described all aspects of PCOS care aligned with the international guideline recommendations. These include providing education on long-term risks, lifestyle interventions, screening and management of emotional well-being, cardiometabolic diseases, and the dermatological and reproductive elements of PCOS. Three MoCs evaluated patients’ and healthcare professionals’ satisfaction, with generally positive findings. Only one MoC explored the impact of their service on patients’ health outcomes and showed improvement in BMI.ConclusionThere is limited literature describing PCOS MoCs in routine practice. Future research should explore developing cost-effective co-created multidisciplinary PCOS MoCs globally. This may be facilitated by the exchange of best practices between institutions with an established MoC and those who are interested in setting one up.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?RecordID=346539, identifier CRD42022346539.

Objective Systematic review of length of stay (LOS) prediction models to assess the study methods (including prediction variables), study quality, and performance of predictive models (using area under receiver operating curve (AUROC)) for general surgery populations and total knee arthroplasty (TKA). Method LOS prediction models published since 2010 were identified in five major research databases. The main outcomes were model performance metrics including AUROC, prediction variables, and level of validation. Risk of bias was assessed using the PROBAST checklist. Results Five general surgery studies (15 models) and 10 TKA studies (24 models) were identified. All general surgery and 20 TKA models used statistical approaches; 4 TKA models used machine learning approaches. Risk scores, diagnosis, and procedure types were predominant predictors used. Risk of bias was ranked as moderate in 3/15 and high in 12/15 studies. Discrimination measures were reported in 14/15 and calibration measures in 3/15 studies, with only 4/39 externally validated models (3 general surgery and 1 TKA). Meta-analysis of externally validated models (3 general surgery) suggested the AUROC 95% prediction interval is excellent and ranges between 0.803 and 0.970. Conclusion This is the first systematic review assessing quality of risk prediction models for prolonged LOS in general surgery and TKA groups. We showed that these risk prediction models were infrequently externally validated with poor study quality, typically related to poor reporting. Both machine learning and statistical modelling methods, plus the meta-analysis, showed acceptable to good predictive performance, which are encouraging. Moving forward, a focus on quality methods and external validation is needed before clinical application.

Objective: To develop and translate rigorous, comprehensive evidence-based guidelines for diagnosis, assessment, and treatment, to improve the lives of those with polycystic ovary syndrome (PCOS) worldwide. Here we will focus on diagnosis. Participants: Extensive health professional and consumer or patient engagement informed the guideline priority areas. International society-nominated panels included consumers, and experts in paediatrics, endocrinology, gynaecology, primary care, reproductive endocrinology, psychology, dietetics, exercise physiology, sleep, bariatric/metabolic surgery, public health, other co-opted experts, project management, evidence synthesis and translation. Evidence: Best practice, evidence-based guideline development involved extensive evidence synthesis and the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework covered evidence quality, feasibility, acceptability, cost, implementation and ultimately recommendation strength. Process: Governance included an international advisory board, project board and five guideline development groups with 52 members, consumer, and translation committees. The Centre for Research Excellence in Women’s Health in Reproductive Life, funded by the Australian National Health and Medical Research Council (NHMRC), and led by Monash University, partnered with the American Society for Reproductive Medicine, the Endocrine Society, the European Society of Endocrinology and the European Society of Human Reproduction and Embryology. Thirty-six organisations collaborated with international meetings over nine months. Fifty-five prioritised clinical questions involved 52 systematic and three narrative reviews, generating evidence-based and consensus recommendations with accompanying practice points. Committee members nominated by collaborating organisations provided international peer review, and evidence expert-reviewed methods and outputs were submitted to NHMRC for independent review. Recommendations: PCOS should be diagnosed using the revised consensus Rotterdam criteria, which are now updated to evidence-based criteria in the International Guideline. In adults this requires the presence of two of i) clinical/biochemical hyperandrogenism ii) ovulatory dysfunction and iii) polycystic ovaries on ultrasound or elevated anti-mullerian hormone (AMH) levels, after other causes of these features are excluded. Where irregular menstrual cycles and hyperandrogenism are present, ultrasound or AMH are not required for diagnosis. In adolescents, both hyperandrogenism and ovulatory dysfunction are required, with ultrasound and AMH not recommended, due to poor specificity. Conclusion: Overall, evidence in PCOS is low to moderate quality. Based on high prevalence and significant health impact, greater priority, funding, and research is recommended. Guideline translation will be extensive including multilingual education outputs and evidence-based resources for consumers (the ASKPCOS app), healthcare professionals and policy makers.

IntroductionWomen with previous gestational diabetes mellitus (GDM) are at increased risk of type 2 diabetes (T2D). Guidelines recommend postnatal diabetes screening (oral glucose tolerance test or HbA1c) typically 6-12 weeks after birth, with screening maintained at regular intervals thereafter. Despite this, around half of women are not screened, representing a critical missed opportunity for early identification of prediabetes or type 2 diabetes. While policy and practice-level recommendations are comprehensive, those at the personal-level primarily focus on increasing screening knowledge and risk perception, potentially missing other influential behavioral determinants. We aimed to identify modifiable, personal-level factors impacting postpartum type 2 diabetes screening among Australian women with prior gestational diabetes and recommend intervention functions and behavior change techniques to underpin intervention content.Research design and methodsSemi-structured interviews with participants recruited via Australia’s National Gestational Diabetes Register, using a guide based on the Theoretical Domains Framework (TDF). Using an inductive-deductive approach, we coded data to TDF domains. We used established criteria to identify ‘important’ domains which we then mapped to the Capability, Opportunity, Motivation–Behavior (COM-B) model.ResultsNineteen women participated: 34 ± 4 years, 19 ± 4 months postpartum, 63% Australian-born, 90% metropolitan, 58% screened for T2D according to guidelines. Eight TDF domains were identified: ‘knowledge’, ‘memory, attention, and decision-making processes’, ‘environmental context and resources’, ‘social influences’, ‘emotion’, ‘beliefs about consequences’, ‘social role and identity’, and ‘beliefs about capabilities’. Study strengths include a methodologically rigorous design; limitations include low recruitment and homogenous sample.ConclusionsThis study identified numerous modifiable barriers and enablers to postpartum T2D screening for women with prior GDM. By mapping to the COM-B, we identified intervention functions and behavior change techniques to underpin intervention content. These findings provide a valuable evidence base for developing messaging and interventions that target the behavioral determinants most likely to optimize T2D screening uptake among women with prior GDM.

Abstract Background Implementation science seeks to enable change, underpinned by theories and frameworks such as the Consolidated Framework for Implementation Research (CFIR). Yet academia and frontline healthcare improvement remain largely siloed, with limited integration of implementation science methods into frontline improvement where the drivers include pragmatic, rapid change. Using the CIFR lens, we aimed to explore how pragmatic and complex healthcare improvement and implementation science can be integrated. Methods Our research involved the investigation of a case study that was undertaking the implementation of an improvement intervention at a large public health service. Our research involved qualitative data collection methods of semi-structured interviews and non-participant observations of the implementation team delivering the intervention. Thematic analysis identified key themes from the qualitative data. We examined our themes through the lens of CFIR to gain in-depth understanding of how the CFIR components operated in a ‘real-world’ context. Results The key themes emerging from our research outlined that leadership, context and process are the key components that dominate and affect the implementation process. Leadership which cultivates connections with front line clinicians, fosters engagement and trust. Navigating context was facilitated by ‘bottom-up’ governance. Multi-disciplinary and cross-sector capability were key processes that supported pragmatic and agile responses in a changing complex environment. Process reflected the theoretically-informed, and iterative implementation approach. Mapping CFIR domains and constructs, with these themes demonstrated close alignment with the CFIR. The findings bring further depth to CFIR. Our research demonstrates that leadership which has a focus on patient need as a key motivator to engage clinicians, which applies and ensures iterative processes which leverage contextual factors can achieve successful, sustained implementation and healthcare improvement outcomes. Conclusions Our longitudinal study highlights insights that strengthen alignment between implementation science and pragmatic frontline healthcare improvement. We identify opportunities to enhance the relevance of CFIR in the ‘real-world’ setting through the interconnected nature of our themes. Our study demonstrates actionable knowledge to enhance the integration of implementation science in healthcare improvement.

Abstract Background Gestational diabetes (GDM) impacts 8–18% of pregnancies and greatly increases both maternal and child risk of developing non-communicable diseases such as type 2 diabetes and obesity. Whilst lifestyle interventions in pregnancy and postpartum reduce this risk, a research translation gap remains around delivering implementable interventions with adequate population penetration and participation. Impact Diabetes Bump2Baby is an implementation project of an evidence-based system of care for the prevention of overweight and obesity. Bump2Baby and Me is the multicentre randomised controlled trial investigating the effectiveness of a mHealth coaching programme in pregnancy and postpartum for women at high risk of developing GDM. Methods Eight hundred women will be recruited in early pregnancy from 4 clinical sites within Ireland, the UK, Spain, and Australia. Women will be screened for eligibility using the validated Monash GDM screening tool. Participants will be enrolled from 12 to 24 weeks’ gestation and randomised on a 1:1 basis into the intervention or control arm. Alongside usual care, the intervention involves mHealth coaching via a smartphone application, which uses a combination of synchronous and asynchronous video and text messaging, and allows for personalised support and goal setting with a trained health coach. The control arm receives usual care. All women and their children will be followed from early pregnancy until 12 months postpartum. The primary outcome will be a difference in maternal body mass index (BMI) of 0.8 kg/m2 at 12 months postpartum. Secondary maternal and infant outcomes include the development of GDM, gestational weight gain, pregnancy outcomes, improvements in diet, physical activity, sleep, and neonatal weight and infant growth patterns. The 5-year project is funded by the EU Commission Horizon 2020 and the Australian National Health and Medical Research Council. Ethical approval has been received. Discussion Previous interventions have not moved beyond tightly controlled efficacy trials into routine service delivery. This project aims to provide evidence-based, sustainable support that could be incorporated into usual care for women during pregnancy and postpartum. This study will contribute evidence to inform the early prevention of non-communicable diseases like obesity and diabetes in mothers and the next generation. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12620001240932 . Registered on 19 November 2020

ContextPre-clinical evidence suggests that prolactin has important metabolic functions in pregnancy and postpartum, in addition to lactogenic actions.ObjectiveTo explore the relationship between prolactin and maternal metabolic outcomes in human pregnancy and postpartum, particularly in relation to gestational diabetes mellitus (GDM).Data sourcesMEDLINE via OVID, CINAHL plus, Embase.Study selectionEligible studies included women who were pregnant or up to 12 months postpartum, reporting at least one maternal serum prolactin level in relation to key metabolic outcomes including GDM, glycaemic parameters, obesity, and gestational weight gain.Data extractionTwo independent reviewers extracted data.Data synthesisTwenty-six articles were included. Meta-analysis showed no relationship between maternal prolactin levels and GDM status, with a weighted mean difference of -2.14 ng/mL (95% CI -12.54 to 8.27 ng/mL, p=0.7) between GDM and controls in early pregnancy (n=3 studies) and -3.89 ng/mL (95% CI, -15.20 to 7.41 ng/mL, p=0.5) in late pregnancy (n=11 studies). In narrative synthesis of other outcomes (due to study heterogeneity and/or lack of data), prolactin levels were not associated with maternal glycaemic or weight-related parameters during pregnancy, but in the postpartum period (particularly with lactation) a high-prolactin environment was associated with low circulating insulin and beta-cell function, and increased insulin sensitivity.ConclusionsCurrent evidence from human studies does not clearly support a relationship between prolactin and metabolic parameters during pregnancy, including with GDM status. Elevated prolactin was associated with lower insulin and beta-cell function and higher insulin sensitivity in the post-partum period, but the direction of causality remains unclear.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier [CRD42021262771].

Aims: Increasing evidence for benefit of early detection of cystic fibrosis related diabetes (CFRD) coupled with limitations of current diagnostic investigations has led to interest and utilisation of continuous glucose monitoring (CGM). We conducted a systematic review to assess current evidence on CGM compared to reference standard oral glucose tolerance test for the detection of dysglycemia in people with cystic fibrosis without confirmed diabetes. Methods: MEDLINE, Embase, CENTRAL, Evidence-Based Medicine Reviews, grey literature and six relevant journals were searched for studies published after year 2000. Studies reporting contemporaneous CGM metrics and oral glucose tolerance test results were included. Outcomes on oral glucose tolerance tests were categorised into a) normal, b) abnormal (indeterminate and impaired) or c) diabetic as defined by American Diabetes Association criteria. CGM outcomes were defined as hyperglycemia (≥1 peak sensor glucose ≥ 200 mg/dL), dysglycemia (≥1 peak sensor glucose ≥ 140–199 mg/dL) or normoglycemia (all sensor glucose peaks 200 mg/dL on CGM is not appropriate for the diagnosis of CFRD. Prospective studies correlating CGM metrics to disease-specific outcomes are needed to determine appropriate cut-points.

Abstract Background To determine the relationship between clusters of back pain and joint pain and prescription opioid dispensing. Methods Of 11,221 middle-aged participants from the Australian Longitudinal Study of Women’s Health, clusters of back pain and joint pain from 2001 to 2013 were identified using group-based trajectory modelling. Prescription opioid dispensing from 2003 to 2015 was identified by linking the cohort to Pharmaceutical Benefit Scheme dispensing data. Multinomial logistic regression was used to examine the association between back pain and joint pain clusters and dispensing of prescription opioids. The proportion of opioids dispensed in the population attributable to back and join pain was calculated. Results Over 12 years, 68.5 and 72.0% women reported frequent or persistent back pain and joint pain, respectively. There were three clusters (‘none or infrequent’, ‘frequent’ and ‘persistent’) for both back pain and joint pain. Those in the persistent back pain cluster had a 6.33 (95%CI 4.38-9.16) times increased risk of having > 50 opioid prescriptions and those in persistent joint pain cluster had a 6.19 (95%CI 4.18-9.16) times increased risk of having > 50 opioid prescriptions. Frequent and persistent back and joint pain clusters together explained 41.7% (95%CI 34.9-47.8%) of prescription opioid dispensing. Women in the frequent and persistent back pain and joint pain clusters were less educated and reported more depression and physical inactivity. Conclusion Back pain and joint pain are major contributors to opioid prescription dispensing in community-based middle-aged women. Additional approaches to reduce opioid use, targeted at those with frequent and persistent back pain and joint pain, will be important in order to reduce the use of opioids and their consequent harm in this population.

Pregnancy is a high-risk period for excess gestational weight gain and subsequent obesity development. Antenatal lifestyle interventions are prioritised to optimise weight, with current evidence demonstrating efficacy and associated reduction in risk of adverse maternal and neonatal outcomes. Yet, evidence to guide the field from efficacy-based to implementation research within real-world settings is lacking, and several key challenges remain. Here, we discuss key considerations to support the implementation of accessible, relevant, effective, and low-cost lifestyle interventions in routine pregnancy care. This includes identifying what components of lifestyle interventions are most effective, with pragmatic guidance on how to conduct implementation research, improving rigour in reporting to ensure learnings from implementation are captured, and recognising and addressing the socioecological aspects of obesity prevention, including supporting women living with socioeconomic disadvantage and reducing weight stigma.

Background: People with polycystic ovary syndrome (PCOS) have higher weight gain and psychological distress compared to those without PCOS. While COVID-19 restrictions led to population level adverse changes in lifestyle, weight gain and psychological distress, their impact on people with PCOS is unclear. The aim of this study was to investigate the impact the 2020 COVID-19 restrictions had on weight, physical activity, diet and psychological distress for Australians with PCOS. Methods: Australian reproductive-aged women participated in an online survey with assessment of weight, physical activity, diet and psychological distress. Multivariable logistic and linear regression were used to examine associations between PCOS and residential location with health outcomes. Results: On adjusted analysis, those with PCOS gained more weight (2.9%; 95% CI; 0.027–3.020; p = 0.046), were less likely to meet physical activity recommendations (OR 0.50; 95% CI; 0.32–0.79; p = 0.003) and had higher sugar-sweetened beverage intake (OR 1.74; 95% CI 1.10–2.75; p = 0.019) but no differences in psychological distress compared to women without PCOS. Conclusions: People with PCOS were more adversely affected by COVID-19 restrictions, which may worsen their clinical features and disease burden. Additional health care support may be necessary to assist people with PCOS to meet dietary and physical activity recommendations.

BackgroundReproductive-aged women are a high-risk population group for accelerated weight gain and obesity development, with pregnancy recognized as a critical contributory life-phase. Healthy lifestyle interventions during the antenatal period improve maternal and infant health outcomes, yet translation and implementation of such interventions into real-world health care settings remains limited. ObjectiveWe aim to generate key implementation learnings to inform the feasibility of future scale up and determine the effectiveness of intervention delivery methods on engagement, experience, acceptability, knowledge, risk perception, health literacy, and modifiable weight-related health behaviors in women during preconception, pregnancy, and postpartum periods. MethodsThis randomized hybrid implementation effectiveness study will evaluate the penetration, reach, feasibility, acceptability, adoption, and fidelity of a healthy lifestyle intervention (OptimalMe) implemented into, and in partnership with, private health care. Individual health outcomes associated with implementation delivery mode, including knowledge, risk perception, health literacy, self-management, and health behaviors, are secondary outcomes. A total of 300 women aged 18 to 44 years, who are not pregnant but wish to conceive within the next 12 months, and with access to the internet will be recruited. All participants will receive the same digital lifestyle intervention, OptimalMe, which is supported by health coaching and text messages during preconception, pregnancy, and postpartum periods. We will use a parallel 2-arm design to compare telephone with videoconference remote delivery methods for health coaching. Methods are theoretically underpinned by the Consolidated Framework for Implementation Research and outcomes based on the Reach, Engagement, Adaptation, Implementation and Maintenance framework. ResultsThe study was approved on August 16, 2019 and has been registered. Recruitment commenced in July 2020, and data collection is ongoing. Results are expected to be published in 2022. ConclusionsThe study’s design aligns with best practice implementation research. Results will inform translation of evidence from randomized controlled trials on healthy lifestyle interventions into practice targeting women across preconception, pregnancy, and postpartum periods. Learnings will target consumers, program facilitators, health professionals, services, and policy makers to inform future scale up to ultimately benefit the health of women across these life-phases. Trial RegistrationAustralian and New Zealand Clinical Trial Registry ACTRN12620001053910; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378243&isReview=true International Registered Report Identifier (IRRID)DERR1-10.2196/33625

Abstract Background The transition to electronic health records offers the potential for big data to drive the next frontier in healthcare improvement. Yet there are multiple barriers to harnessing the power of data. The Learning Health System (LHS) has emerged as a model to overcome these barriers, yet there remains limited evidence of impact on delivery or outcomes of healthcare. Objective To gather evidence on the effects of LHS data hubs or aligned models that use data to deliver healthcare improvement and impact. Any reported impact on the process, delivery or outcomes of healthcare was captured. Methods Systematic review from CINAHL, EMBASE, MEDLINE, Medline in-process and Web of Science PubMed databases, using learning health system, data hub, data-driven, ehealth, informatics, collaborations, partnerships, and translation terms. English-language, peer-reviewed literature published between January 2014 and Sept 2019 was captured, supplemented by a grey literature search. Eligibility criteria included studies of LHS data hubs that reported research translation leading to health impact. Results Overall, 1076 titles were identified, with 43 eligible studies, across 23 LHS environments. Most LHS environments were in the United States (n = 18) with others in Canada, UK, Sweden and Australia/NZ. Five (21.7%) produced medium-high level of evidence, which were peer-reviewed publications. Conclusions LHS environments are producing impact across multiple continents and settings.

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.

PurposeTo examine Australian psychological distress trends from 2001 to 2017/18, including analysis by age, sex, location, and household income.MethodsSecondary analysis of the working age population (18–64 years) in six successive representative national health surveys. Measures were prevalence of psychological distress at very-high symptom level (defined by a Kessler Psychological Distress Scale (K10) score of 30 or more) and combined high/very-high level (K10 score of 22 or more). Very-high K10 scores are associated with mental health problems meeting diagnostic thresholds in past year.ResultsFrom 2001 to 2017/18 Australian rates of K10 very-high distress rose significantly from 3.8 to 5.1% and combined high/very-high from 13.2 to 14.8%. In women aged 55–64, very-high distress rose significantly and substantially from 3.5 to 7.2% and high/very-high distress from 12.4 to 18.7%. In men aged 25–34, very-high distress increased from 2.1 to 4.0% and high/very-high from 10.6 to 11.5%. Income was strongly and inversely associated with distress (lowest vs. highest quintile adjusted OR 11.4). An apparent association of increased distress with regional location disappeared with adjustment for income.ConclusionAustralia’s population level of psychological distress increased significantly from 2001–2017/18, with levels highest in women and with rates inversely associated with income. This is likely to be indicative of increased community rates of mental disorders. Given that this has occurred whilst mental healthcare expenditure has increased, there is an urgent need to reconsider how best to respond to mental illness, including targeting the most vulnerable based on social determinants such as age, gender, and lower incomes.

Abstract Background Large-scale partnerships between universities and health services are widely seen as vehicles for bridging the evidence–practice gap and for accelerating the adoption of new evidence in healthcare. Recently, different versions of these partnerships – often called academic health science centres – have been established across the globe. Although they differ in structure and processes, all aim to improve the integration of research and education with health services. Collectively, these entities are often referred to as Research Translation Centres (RTCs) and both England and Australia have developed relatively new and funded examples of these collaborative centres. Methods This paper presents findings from a rapid review of RTCs in Australia and England that aimed to identify their structures, leadership, workforce development and strategies for involving communities and service users. The review included published academic and grey literature with a customised search of the Google search engine and RTC websites. Results RTCs are complex system-level interventions that will need to disrupt the current paradigms and silos inherent in healthcare, education and research in order to meet their aims. This will require vision, leadership, collaborations and shared learnings, alongside structures, processes and strategies to deliver impact in the face of complexity. The impact of RTCs in overcoming the deeply entrenched silos across organisations, disciplines and sectors needs to be captured at the systems, organisation and individual levels. This includes workforce capacity and public and patient involvement that are vital to understanding the evolution of RTCs. In addition, new models of leadership are needed to support the brokering and mobilisation of knowledge in complex organisations. Conclusions The development and funding of RTCs represents one of the most significant shifts in the health research landscape and it is imperative that we continue to explore how we can progress the integration of research and healthcare and ensure research meets stakeholder needs and is translated via the collaborations supported by these organisations. Because RTCs are a recent addition to the healthcare landscape in Australia, it is instructive to review the processes and infrastructure needed to support their implementation and applied health research in England.

Abstract Background Polycystic Ovary Syndrome (PCOS) is a common female reproductive disorder with multiple manifestations. There are relatively few qualitative studies exploring the nature of living with PCOS despite its high prevalence. Qualitative research can enhance clinical practice via the provision of patient insights into the experience of living with their condition. Methods We conducted two focus groups and three semi-structured interviews of Australian overweight/obese women with PCOS aged 18–46 years between March and April 2017 who were recruited through social media advertising. Interviews and focus groups were audio recorded and transcribed verbatim. Thematic analysis was applied to the data, using the method of constant comparison. Results Ten women contributed data from two focus groups and two semi-structured interviews. Five themes emerged from the data: complexity of the condition with its multiple manifestations, difficulties with delayed diagnosis and lack of information provided after diagnosis, negative experiences on social media and online forums and the need for support, frustration over lack of a “cure”; and the impact of symptoms and concern about long-term sequelae. Conclusions Living with PCOS appears to generate a significant degree of anxiety about the future, dissatisfaction with current treatment models, and loss of feminine identity. Gaps in timely diagnosis, information and support provision need to be addressed. This includes supporting weight management as a fundamental concern for women with PCOS.

Abstract Background Over the past decade, Research Translation Centres (RTCs) have been established in many countries. These centres (sometimes referred to as Academic Health Science Centres) are designed to bring universities and healthcare providers together in order to accelerate the generation and translation of new evidence that is responsive to health service and community priorities. This has the potential to effectively ‘flip’ the traditional research and education paradigms because it requires active participation and continuous engagement with stakeholders (especially service users, the community and frontline clinicians). Although investment and expectations of RTCs are high, the literature confirms a need to better understand the processes that RTCs use to mobilise knowledge, build workforce capacity, and co-produce research with patients and the public to ensure population impact and drive healthcare improvement. Methods Semi-structured interviews were conducted with selected leaders and members from select RTCs in England and Australia. Convenience sampling was utilised to identify RTCs, based on their geography, accessibility and availability. Purposive sampling and a snowballing approach were employed to recruit individual participants for interviews, which were conducted face to face or via videoconferencing. Interviews were recorded, transcribed verbatim and analysed using a reflexive and inductive approach. This involved two researchers comparing codes and interrogating themes that were analysed inductively against the study aims and through meetings with the research team. Results A total of 41 participants, 22 from England and 19 from Australia were interviewed. Five major themes emerged, including (1) dissonant metrics, (2) different models of leadership, (3) public and patient involvement and research co-production, (4) workforce development and (5) barriers to collaboration. Conclusions Participants identified the need for performance measures that capture community impact. Better aligned success metrics, enhanced leadership, strategies to partner with patients and the public, enhanced workforce development and strategies to enhance collaboration were all identified as crucial for RTCs to succeed.

Abstract Background Polycystic ovary syndrome (PCOS) is a prevalent women’s health condition with reproductive, metabolic, and psychological manifestations. Weight loss can improve these symptoms and is a key goal; however, many women find this difficult to achieve. Acupuncture is a Chinese medical treatment that involves insertion of very fine metal needles into specific areas of the body and has been shown to be efficacious for weight loss in non-PCOS populations. However, few studies have been conducted in women with PCOS. A variant of acupuncture, auricular electro-acupuncture (AEA), may have beneficial effects on sympathetic tone, which is associated with insulin resistance, obesity and PCOS. Methods This prospective three-arm open label parallel randomised controlled trial will assess feasibility and acceptability of acupuncture and/or AEA for weight loss in women with PCOS. We will enrol 39 women from the community aged between 18 and 45 years, with physician diagnosis of PCOS according to the Rotterdam criteria: body mass index (BMI) between 25 and 40 kg/m2. Women will be randomly allocated to receive one of three treatments for 12 weeks duration: body electro-acupuncture + lifestyle interventions, AEA + lifestyle interventions, or lifestyle interventions alone. The lifestyle intervention in this study is telephone-based health coaching (between 4 and 13 phone calls, depending on individual need), provided by the Get Healthy Service. Primary outcomes of the study are feasibility and acceptability of trial methods as determined by recruitment and retention rates, adherence, acceptability, credibility, and safety. Secondary outcomes include anthropometric (body weight, BMI, waist and hip circumference), metabolic (glucose tolerance and insulin sensitivity obtained from a 2-h 75 g oral glucose tolerance test with area under the curve insulin calculated using the trapezoid rule), reproductive (androgen levels, menstrual cyclicity, clinical hyperandrogenism using the Ferriman-Gallwey scoring system), autonomic (heart rate variability, blood pressure), lifestyle (physical activity levels, diet quality, weight self-efficacy), quality of life, and psychological (depression and anxiety symptoms, internal health locus of control). Discussion This study addresses the feasibility and acceptability of novel interventions to treat overweight/obesity in PCOS. Study findings have the potential to generate a new understanding of the role of acupuncture and auricular acupuncture in weight management. Trial registration Australian New Zealand Clinical Trial Registry, 8/6/18 ACTRN12618000975291

Abstract Background Diagnosing polycystic ovary syndrome (PCOS) during adolescence is challenging because features of normal pubertal development overlap with adult diagnostic criteria. The international evidence-based PCOS Guideline aimed to promote accurate and timely diagnosis, to optimise consistent care, and to improve health outcomes for adolescents and women with PCOS. Methods International healthcare professionals, evidence synthesis teams and consumers informed the priorities, reviewed published data and synthesised the recommendations for the Guideline. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework was applied to appraise the evidence quality and the feasibility, acceptability, cost, implementation and strength of the recommendations. Results This paper focuses on the specific adolescent PCOS Guideline recommendations. Specific criteria to improve diagnostic accuracy and avoid over diagnosis include: (1) irregular menstrual cycles defined according to years post-menarche; > 90 days for any one cycle (> 1 year post-menarche), cycles 45 days (> 1 to 35 days (> 3 years post-menarche) and primary amenorrhea by age 15 or > 3 years post-thelarche. Irregular menstrual cycles (

IntroductionUsing body mass index (BMI) as a proxy, previous Mendelian randomization (MR) studies found total causal effects of general obesity on polycystic ovarian syndrome (PCOS). Hitherto, total and direct causal effects of general- and central obesity on PCOS have not been comprehensively analyzed.ObjectivesTo investigate the causality of central- and general obesity on PCOS using surrogate anthropometric markers.MethodsSummary GWAS data of female-only, large-sample cohorts of European ancestry were retrieved for anthropometric markers of central obesity (waist circumference (WC), hip circumference (HC), waist-to-hip ratio (WHR)) and general obesity (BMI and its constituent variables-weight and height), from the IEU Open GWAS Project. As the outcome, we acquired summary data from a large-sample GWAS (118870 samples; 642 cases and 118228 controls) within the FinnGen cohort. Total causal effects were assessed via univariable two-sample Mendelian randomization (2SMR). Genetic architectures underlying causal associations were explored. Direct causal effects were analyzed by multivariable MR modelling.ResultsInstrumental variables demonstrated no weak instrument bias (F > 10). Four anthropometric exposures, namely, weight (2.69-77.05), BMI (OR: 2.90-4.06), WC (OR: 6.22-20.27), and HC (OR: 6.22-20.27) demonstrated total causal effects as per univariable 2SMR models. We uncovered shared and non-shared genetic architectures underlying causal associations. Direct causal effects of WC and HC on PCOS were revealed by two multivariable MR models containing exclusively the anthropometric markers of central obesity. Other multivariable MR models containing anthropometric markers of both central- and general obesity showed no direct causal effects on PCOS.ConclusionsBoth and general- and central obesity yield total causal effects on PCOS. Findings also indicated potential direct causal effects of normal weight-central obesity and more complex causal mechanisms when both central- and general obesity are present. Results underscore the importance of addressing both central- and general obesity for optimizing PCOS care.

Human placental lactogen (hPL) is a placental hormone which appears to have key metabolic functions in pregnancy. Preclinical studies have putatively linked hPL to maternal and fetal outcomes, yet—despite human observational data spanning several decades—evidence on the role and importance of this hormone remains disparate and conflicting. We aimed to explore (via systematic review and meta-analysis) the relationship between hPL levels, maternal pre-existing and gestational metabolic conditions, and fetal growth. MEDLINE via OVID, CINAHL plus, and Embase were searched from inception through 9 May 2022. Eligible studies included women who were pregnant or up to 12 months post-partum, and reported at least one endogenous maternal serum hPL level during pregnancy in relation to pre-specified metabolic outcomes. Two independent reviewers extracted data. Meta-analysis was conducted where possible; for other outcomes narrative synthesis was performed. 35 studies met eligibility criteria. No relationship was noted between hPL and gestational diabetes status. In type 1 diabetes mellitus, hPL levels appeared lower in early pregnancy (possibly reflecting delayed placental development) and higher in late pregnancy (possibly reflecting increased placental mass). Limited data were found in other pre-existing metabolic conditions. Levels of hPL appear to be positively related to placental mass and infant birthweight in pregnancies affected by maternal diabetes. The relationship between hPL, a purported pregnancy metabolic hormone, and maternal metabolism in human pregnancy is complex and remains unclear. This antenatal biomarker may offer value, but future studies in well-defined contemporary populations are required.

Our healthcare system faces a burgeoning aging population, rising complexity, and escalating costs. Around 10% of healthcare is harmful, and evidence is slow to implement. Innovation to deliver quality and sustainable health systems is vital, and the methods are challenging. The aim of this study is to describe the process and present a perspective on a coproduced Learning Health System framework. The development of the Framework was led by publicly funded, collaborative, Academic Health Research Translation Centres, with a mandate to integrate research into healthcare to deliver impact. The focus of the framework is “learning together for better health,” with coproduction involving leadership by an expert panel, a systematic review, qualitative research, a stakeholder workshop, and iterative online feedback. The coproduced framework incorporates evidence from stakeholders, from research, from data (practice to data and data to new knowledge), and from implementation, to take new knowledge to practice. This continuous learning approach aims to deliver evidence-based healthcare improvement and is currently being implemented and evaluated.

A hospital-acquired pressure injury (HAPI) is a common complication across the globe. The severity of HAPI ranges from skin redness and no skin breakdown to full skin and tissue loss, exposing the tendons and bones. HAPI can significantly impact the quality of life. In addition to the human cost, this injury carries a high economic burden with the cost of treatment far outweighing the preventative measures. The HAPI rates are a key indicator of health services performance. Globally, healthcare services aim to reduce its incidence. In Australia, the federal health minister has prioritised the need for improvement in HAPI surveillance and prevention. Capacity building is vital to optimise pressure injury (PI) surveillance and prevention in acute care services. In this perspective article, we provide a framework for capacity building to optimise HAPI prevention and surveillance in a large cross-sector collaborative partnership in Australia. This framework comprises six key action areas in capacity building to optimise the HAPI outcomes, such as research, organisational development, workforce development, leadership, collaboration, and consumer involvement.

Background: Osteoporosis affects over half of adults over 50 years worldwide. With an ageing population, osteoporosis, fractures and their associated costs are increasing. Unfortunately, despite effective therapies, many with osteoporosis remain undiagnosed and untreated. Models of care (MoC) to improve outcomes include fracture liaison services, screening, education, and exercise programs, however efficacy for these is mixed. The aim of this study is to summarise MoC in osteoporosis and describe implementation characteristics and evidence for improving outcomes. Methods: This systematic scoping review identified articles via Ovid Medline and Embase, published in English between 01/01/2009 and 15/06/2021, describing MoC for adults aged ≥18 years with, or at risk of, osteoporosis and / or health professionals caring for this group. All included at least one of clinical, consumer or clinician outcomes, with fractures and bone mineral density (BMD) change the primary clinical outcomes. Exclusion criteria were studies assessing pharmaceuticals or procedures without other interventions, or insufficient operational details. All study designs were included, with no comparator necessary. Title and abstract were reviewed by two reviewers. Full text review and data extraction was performed by these reviewers for 20% of article and, thereafter by a single author. As the review was predominantly descriptive, no comparator statistics were used. Findings: 314 articles were identified describing 289 MoC with fracture liaison services (n=89) and education programs (n=86) predominating. The population had prior fragility fracture in 77 studies, the median (IQR) patient number was 210 (87, 667) and the median (IQR) follow-up duration for outcome assessment was 12 (6, 12·5) months. Fracture reduction was reported by 65 studies, with 16 (37%) graded as high quality, and 19 / 47 studies with a comparator group found a reduction in fractures. BMD change was reported by 73 studies, with 41 finding improved BMD. Implementation characteristics including reach, fidelity and loss to follow-up were under-reported, and consumer and clinician perspectives rare. Interpretation: This comprehensive review of MoC for osteoporosis demonstrated inconsistent evidence for improving outcomes despite similar types of models. Future studies should include implementation outcomes, consumer and clinician perspectives, and fracture or BMD outcomes with sufficient duration of follow-up. Authors should consider pragmatic trial designs and co-design with clinicians and consumers. Funding: None.

Abstract Background High Body Mass Index (BMI) and gestational weight gain (GWG) affect an increasing number of pregnancies. The Institute of Medicine (IOM) has issued recommendations on the optimal GWG for women according to their pre-pregnancy BMI (healthy, overweight or obese). It has been shown that pregnant women rarely met the recommendations; however, it is unclear by how much. Previous studies also adjusted the analyses for various women’s characteristics making their comparison challenging. Methods We analysed individual participant data (IPD) of healthy women with a singleton pregnancy and a BMI of 18.5 kg/m2 or more from the control arms of 36 randomised trials (16 countries). Adjusted odds ratios (aOR) and 95% confidence intervals (CI) were used to describe the association between GWG outside (above or below) the IOM recommendations (2009) and risks of caesarean section, preterm birth, and large or small for gestational age (LGA or SGA) infants. The association was examined overall, within the BMI categories and by quartile of GWG departure from the IOM recommendations. We obtained aOR using mixed-effects logistic regression, accounting for the within-study clustering and a priori identified characteristics. Results Out of 4429 women (from 33 trials) meeting the inclusion criteria, two thirds gained weight outside the IOM recommendations (1646 above; 1291 below). The median GWG outside the IOM recommendations was 3.1 kg above and 2.7 kg below. In comparison to GWG within the IOM recommendations, GWG above was associated with increased odds of caesarean section (aOR 1.50; 95%CI 1.25, 1.80), LGA (2.00; 1.58, 2.54), and reduced odds of SGA (0.66; 0.50, 0.87); no significant effect on preterm birth was detected. The relationship between GWG below the IOM recommendation and caesarean section or LGA was inconclusive; however, the odds of preterm birth (1.94; 1.31, 2.28) and SGA (1.52; 1.18, 1.96) were increased. Conclusions Consistently with previous findings, adherence to the IOM recommendations seem to help achieve better pregnancy outcomes. Nevertheless, even in the context of clinical trials, women find it difficult to adhere to them. Further research should focus on identifying ways of achieving a healthier GWG as defined by the IOM recommendations.

Abstract Background Polycystic Ovary Syndrome (PCOS) is a common female reproductive disorder with multiple manifestations. Weight management is a key therapeutic goal. Acupuncture is a potential adjunctive weight loss treatment in non-PCOS populations. We aimed to engage patients in co-design and assess the feasibility and acceptability of methods for a randomised controlled trial (RCT) on acupuncture and telephone-based health coaching for weight management in overweight or obese women with PCOS using qualitative methods. Methods We recruited women who had PCOS and were aged 18–45 years and with a body mass index of 25 kg/m2 and over, using social media. Two face-to-face focus group meetings and three semi-structured telephone interviews were conducted (n = 10). We analysed data using thematic analysis and aimed to compare and contrast motivations for joining the trial between women who were actively trying to conceive (n = 7) and not trying to conceive (n = 3). Attitudes to, knowledge and experiences of acupuncture; perceptions and attitudes towards the interventions in the RCT (real acupuncture, sham acupuncture and telephone-based health coaching); the outcomes of importance; and barriers and facilitators to successful trial recruitment and retention were collected. Results Women were both acupuncture-naive and acupuncture-experienced. Overall, attitudes towards acupuncture were positive, and the trial design was acceptable with appointment flexibility requested. Ideal enrolment time, if women were trying to conceive, was six months prior to conception. Women supported three-month intervention and the use of sham acupuncture as a control. Financial incentives were not believed to be necessary, and women spoke of altruistic intentions in enrolling for such a trial. Women who were trying to conceive voiced a need for support from their family, health coaches, and peers. The telephone-based health coaching offered welcome support and accountability, noted as possible facilitators of weight loss. Conclusions Our findings show that acupuncture is a likely acceptable adjunct to lifestyle interventions for weight loss in PCOS, and that a sham-controlled trial is feasible and acceptable to PCOS women. Further research is required in order to evaluate the efficacy of acupuncture together with lifestyle for weight management in PCOS.

Coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was identified in China in December 2019 and became a pandemic in a short period of time. While most infected people might have mild symptoms, older people and people with chronic illnesses may develop acute respiratory distress syndrome (ARDS). Patients with ARDS with worsening hypoxemia require prone positioning to improve the respiratory mechanics and oxygenation. Intubated patients may stay in a prone position up to 12–16 h, increasing the risk of pressure injury (PI). Frequent skin inspections and PI risk assessment in COVID-19 patients will be challenging due to hospital infection control measures aimed to reduce the risk for health professionals. In this perspective article, we summarize the best practice recommendations for prevention of PI in SARS-CoV-2-infected ARDS patients in prone positioning. Prior to positioning patients in prone position, the main recommendations are to (1) conduct a skin assessment, (2) use pressure redistribution devices, (3) select an appropriate mattress or an overlay, (4) ensure that the endotracheal tube securing device is removed and the endotracheal tube is secured with tapes, (5) use a liquid film-forming protective dressing, and (6) lubricate the eyes and tape them closed. Once a patient is in prone position, it is recommended to (1) use the swimmer's position, (2) reposition the patient every 2 h, and (3) keep the skin clean. When the patient is repositioned to supine position, healthcare professionals are advised to (1) assess the pressure points and (2) promote early mobilization.

The rates of maternal overweight and obesity, but also excess gestational weight gain, are increasing. Pregnancy complications, including gestational diabetes mellitus, gestational hypertension, pre-eclampsia and delivery of a preterm or growth restricted baby, are higher for both women with overweight and obesity and women who gain excess weight during their pregnancy. Other conditions such as polycystic ovary syndrome are also strongly linked to overweight and obesity and worsened pregnancy complications. All of these conditions place women at increased risk for future cardiometabolic diseases. If overweight and obesity, but also excess gestational weight gain, can be reduced in women of reproductive age, then multiple comorbidities associated with pregnancy complications may also be reduced in the years after childbirth. This narrative review highlights the association between maternal overweight and obesity and gestational weight gain, with gestational diabetes, pre-eclampsia, polycystic ovary syndrome and delivery of a preterm or growth restricted baby. This review also addresses how these adverse conditions are linked to cardiometabolic diseases after birth. We report that while the independent associations between obesity and gestational weight gain are evident across many of the adverse conditions assessed, whether body mass index or gestational weight gain is a stronger driving factor for many of these is currently unclear. Mechanisms linking gestational diabetes mellitus, gestational hypertension, pre-eclampsia, preterm delivery and polycystic ovary syndrome to heightened risk for cardiometabolic diseases are multifactorial but relate to cardiovascular and inflammatory pathways that are also found in overweight and obesity. The need for post-partum cardiovascular risk assessment and follow-up care remains overlooked. Such early detection and intervention for women with pregnancy-related complications will significantly attenuate risk for cardiovascular disease.

ObjectivesUsing a nationally-representative, cross-sectional cohort, we examined nutritional markers of undiagnosed type 2 diabetes in adults via machine learning.MethodsA total of 16429 men and non-pregnant women ≥ 20 years of age were analysed from five consecutive cycles of the National Health and Nutrition Examination Survey. Cohorts from years 2013-2016 (n = 6673) was used for external validation. Undiagnosed type 2 diabetes was determined by a negative response to the question "Have you ever been told by a doctor that you have diabetes?" and a positive glycaemic response to one or more of the three diagnostic tests (HbA1c > 6.4% or FPG >125 mg/dl or 2-hr post-OGTT glucose > 200mg/dl). Following comprehensive literature search, 114 potential nutritional markers were modelled with 13 behavioural and 12 socio-economic variables. We tested three machine learning algorithms on original and resampled training datasets built using three resampling methods. From this, the derived 12 predictive models were validated on internal- and external validation cohorts. Magnitudes of associations were gauged through odds ratios in logistic models and variable importance in others. Models were benchmarked against the ADA diabetes risk test.ResultsThe prevalence of undiagnosed type 2 diabetes was 5.26%. Four best-performing models (AUROC range: 74.9%-75.7%) classified 39 markers of undiagnosed type 2 diabetes; 28 via one or more of the three best-performing non-linear/ensemble models and 11 uniquely by the logistic model. They comprised 14 nutrient-based, 12 anthropometry-based, 9 socio-behavioural, and 4 diet-associated markers. AUROC of all models were on a par with ADA diabetes risk test on both internal and external validation cohorts (p>0.05).ConclusionsModels performed comparably to the chosen benchmark. Novel behavioural markers such as the number of meals not prepared from home were revealed. This approach may be useful in nutritional epidemiology to unravel new associations with type 2 diabetes.

ObjectiveTo evaluate the impact of an integrated diabetes and kidney disease model of care on health-related quality of life (HRQOL) of patients with comorbid diabetes and chronic kidney disease (CKD).Research design and methodsA longitudinal study of adult patients (over 18 years) with comorbid diabetes and CKD (stage 3a or worse) who attended a new diabetes kidney disease service was conducted at a tertiary hospital. A questionnaire consisting of demographics, clinical data, and the Kidney Disease Quality of Life (KDQOL-36) was administered at baseline and after 12 months. Paired t-tests were used to compare baseline and 12-month scores. A subgroup analysis examined the effects by patient gender. Multiple regression analysis examined the factors associated with changes in scores.Results179 patients, 36% of whom were female, with baseline mean±SD age of 65.9±11.3 years, were studied. Across all subscales, HRQOL did not significantly change over time (p value for all mean differences >0.05). However, on subgroup analysis, symptom problem list and physical composite summary scores increased among women (MD=9.0, 95% CI 1.25 to 16.67; p=0.02 and MD=4.5, 95% CI 0.57 to 8.42; p=0.03 respectively) and physical composite scores decreased among men (MD=−3.35, 95% CI −6.26 to −0.44; p=0.03).ConclusionThe HRQOL of patients with comorbid diabetes and CKD attending a new codesigned, integrated diabetes and kidney disease model of care was maintained over 12 months. Given that HRQOL is known to deteriorate over time in this high-risk population, the impact of these findings on clinical outcomes warrants further investigation.

ObjectiveThere are concerns that lumbar spine imaging represents low value care. Our aim was to examine the use of lumbar spine imaging [radiography, computed tomography (CT), magnetic resonance imaging (MRI)] over 20 years, and costs and person-level characteristics of imaging in a large cohort of Australian women.MethodsThe Australian Longitudinal Study on Women's Health (ALSWH) is a longitudinal population-based survey of women randomly selected from national health insurance scheme (Medicare) database. This study examined 13458 women born in 1973-1978 who consented to link their ALSWH and Medical Benefits Scheme records. Self-reported data on demographics, body mass index, depression, physical and mental health, and back pain were collected in each survey performed in 1996, 2000, 2003, 2006, 2009, 2012, and 2015. Data on lumbar spine imaging from 1996 to 2015 were obtained from the Medical Benefits Scheme database.Results38.9% of women underwent some form of lumbar spine imaging over 20 years. While radiography increased from 1996 to 2011 and decreased thereafter, CT and MRI continued to increase from 1996 to 2015. In women with self-reported back pain, depression and poorer physical health were associated with imaging, with no significant differences in types of imaging. Based on imaging rates in ALSWH, the estimated costs for Australian women aged 30-39 years were AU$51,735,649 over 2011-2015.ConclusionsLumbar spine imaging was common in population-based Australian women, with rates increasing over 20 years. Depression and poor physical health were associated with lumbar spine imaging. Raising awareness of this in clinicians is likely to result in significant cost savings if clinical guidelines are followed, with the potential of freeing resources for high value care and health outcomes.

The association between type 1 diabetes mellitus (T1DM) and bone health has garnered interest over the years. Fracture risk is known to be increased in individuals with T1DM, although bone health assessment is not often performed in the clinical setting. We describe the case of a 21-year-old male with longstanding T1DM with multilevel vertebral fractures on imaging, after presenting with acute back pain without apparent trauma. Dual-energy X-ray absorptiometry (DXA) revealed significantly reduced bone mineral density at the lumbar spine and femoral neck. Extensive investigations for other secondary or genetic causes of osteoporosis were unremarkable, apart from moderate vitamin D deficiency. High-resolution peripheral quantitative computed tomography and bone biospy revealed significant alterations of trabecular bone microarchitecture. It later transpired that the patient had sustained vertebral fractures secondary to unrecognised nocturnal hypoglycaemic seizures. Intravenous zoledronic acid was administered for secondary fracture prevention. Despite anti-resorptive therapy, the patient sustained a new vertebral fracture after experiencing another hypoglycaemic seizure in his sleep. Bone health in T1DM is complex and not well understood. There are significant challenges in the assessment and management of osteoporosis in T1DM, particularly in young adults, where fracture prediction tools have not been validated. Clinicians should be aware of hypoglycaemia as a significant risk factor for fracture in patients with T1DM.

Abstract Background Knee pain is common with obesity and weight gain being important risk factors. Previous clinical trials have focused on overweight or obese adults with knee pain and osteoarthritis and demonstrated modest effects of intense weight loss programs on reducing knee pain despite very significant weight loss. There has been no lifestyle intervention that targets community-based adults to test its effect on prevention of knee pain. We aimed to determine the effect of a simple low-intensity self-management lifestyle intervention (HeLP-her), proven in randomised controlled trials to improve lifestyle and prevent weight gain, on knee pain in community-based young to middle-aged rural women. Methods A 1-year pragmatic, cluster randomised controlled trial was conducted in 649 community-based women (aged 18–50 years) to receive either the HeLP-her program (consisting of one group session, monthly SMS text messages, one phone coaching session, and a program manual) or one general women’s health education session. Secondary analyses were performed in 390 women who had knee pain measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline and 12-month follow-up. “Any knee pain” was defined as a WOMAC pain score ≥ 1. Knee pain worsening was defined as an increase in WOMAC pain score over 12 months. Results Thirty-five percent of women had “any knee pain” at baseline. The risk of knee pain worsening did not differ between the intervention and control groups over 12 months. For women with any knee pain at baseline, those in the intervention arm had a lower risk of knee pain worsening compared with those in the control arm (OR 0.37, 95% CI 0.14–1.01, p = 0.05), with a stronger effect observed in women with body mass index ≥ 25 kg/m2 (OR 0.28, 95% CI 0.09–0.87, p = 0.03). Conclusions In community-based young to middle-aged women, a simple low-intensity lifestyle program reduced the risk of knee pain worsening in those with any knee pain at baseline, particularly in those overweight or obese. Pragmatic lifestyle programs such as HeLP-her may represent a feasible lifestyle intervention to reduce the burden of knee pain in the community. Trial registration ACTRN12612000115831, registered 24 January 2012.