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Treatment of cystic fibrosis related diabetes (CFRD) can improve outcomes and use of continuous glucose monitoring (CGM) can positively impact glycemic control. We conducted a systematic review to assess current evidence on CGM compared to self-monitoring of blood glucose (SMBG) in the management of CFRD to determine its effect on glycemic, pulmonary, non-pulmonary and quality of life outcomes.Using pre-defined selection criteria, we searched MEDLINE, Embase, CENTRAL, Evidence-Based Medicine Reviews, grey literature and six relevant journals for studies using CGM and/or SMBG in CFRD with greater than 6 weeks of follow-up and reported change in HbA1c. The primary outcome was weighted mean difference (WMD) in plasma HbA1c between CGM and SMBG groups. Secondary outcomes included exploring interrelationships between CGM metrics and effects on disease-specific pulmonary, non-pulmonary and quality of life outcomes.A total of 1671 references were retrieved, 862 studies screened and 124 full-texts assessed for eligibility. No studies directly compared CGM to SMBG. A meta-analysis of seventeen studies of 416 individuals (CGM = 138, SMBG = 278) found CGM group had 4.1 mmol/mol (95% CI -7.9 to -0.30, p = 0.034) lower HbA1c compared to SMBG group. Most studies demonstrated moderate-to-high risk of bias. Publication bias was also present. Heterogeneity was high and meta-regression identified duration of follow-up in SMBG group as main contributor.Our findings suggest use of CGM may be associated with improved glycemic control compared to SMBG in CFRD, however evidence of benefit on pulmonary, non-pulmonary and psychosocial outcomes are lacking.

Background The time constraints and reprioritization of personal health associated with having children may lead women to adopt less healthy lifestyles. We assessed the patterns of change in weight and lifestyle behaviours associated with having children and whether these differ between primiparous and multiparous women. Methods Data were from Surveys 3 and 5 of the 1973–1978 birth cohort of the Australian Longitudinal Study on Women’s Health. In women who were nulliparous at Survey 3, we assessed changes in weight, energy intake, diet (diet quality, macronutrients and micronutrients), physical activity and sitting time by parity status at Survey 5 using one-way analysis of covariance. Results Of 4927 eligible women, 2503 gave birth (1090 primiparous and 1413 multiparous) by Survey 5. Women who had given birth 6 years later increased weight (1.0 kg; 95% CI 0.5, 1.5), energy intake (833.9 kJ/day; 95% CI 706.7, 961.1) and diet quality (1.5 units; 95% CI 0.8, 2.1), but decreased physical activity [–405.0 Metabolic Equivalent of Task.min/week; 95% CI –464.2, –345.8] and sitting time (–1.8 h/day; 95% CI –1.9, –1.6) (adjusted mean differences) relative to those who remained nulliparous. In subgroup analysis involving further stratification by parity, the increase in diet quality was only seen in women who became primiparous and the decrease in sitting time was more marked in multiparous women. Conclusion Childbearing is associated with increased weight and energy intake, decreased physical activity, increased diet quality and decreased sitting time. More research targeting weight, energy intake and physical activity for improvement in women during the childbearing years is warranted.

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.

Polycystic ovary syndrome (PCOS) affects 8–13% of reproductive-aged women, impacts biopsychosocial factors and creates a significant health-related economic burden across the reproductive, metabolic and psychological spectrum of complications. Despite being a heterogenous condition, recent genomic studies indicate that PCOS, regardless of diagnostic criteria and clinical features, shares similar underlying biologic mechanisms. However, recent advances have shown that clinical reproductive and diagnostic features are poorly correlated to genotypes and do not represent true phenotypes. Until we have a better understanding of genetic and epigenetic influences on PCOS and long-term outcomes, targeted treatment is limited. In the interim, a unified approach to integrate evidence, optimise management and guide future research in PCOS is necessary. This has motivated an international collaboration to develop an International Evidence-Based PCOS Guideline to improve health outcomes in women with PCOS. Dissemination and translation of the guideline into health policy and clinical practice are crucial steps to close the knowledge–-practice gap, guide future research and enhance positive impact on the health of women with PCOS. Here, we review the (i) understanding of aetiology and genetics of PCOS; (ii) development and translation efforts of the 2018 International Evidence-based PCOS Guideline; (iii) current progress and plans for the guideline update, including the involvement of an early career researcher network to assist with evidence synthesis and (iv) the opportunity to target and guide future research for PCOS.

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

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

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.

Background Life course studies are designed to “collect once, use multiple times” for observational and, increasingly, interventional research. Core Outcome Sets (COS) are minimum sets developed for clinical trials by multi-stakeholder consensus methodologies. We aimed to synthesize published COS that might guide outcomes selection for early life cohorts with an interventional focus. Methods We searched PubMed, Medline, COMET, and CROWN for COS published before January 2021 relevant to four life stages (pregnancy, newborns, children

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].

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.

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.

Polycystic ovary syndrome (PCOS) is the most common endocrinopathy in reproductive-age women and has reproductive, pregnancy, metabolic, dermatologic, and psychologic complications. Here we summarize current challenges and gaps in PCOS care, and propose a pathway forward to implement high quality international guideline recommendations and resources, through development of a best practice framework and benchmarking for evidence-based, patient-centric models of care (MoC).The majority of women with PCOS are unsatisfied with their healthcare experience due to delayed diagnosis, inadequate information provision and inconsistent advice from diverse healthcare providers. The 2018 International Evidence-based PCOS Guideline recommended co-development of evidence-based, patient centric MoC. High-quality guidelines and resources are now available to help women understand and manage PCOS and to assist healthcare professionals to partner in their care. Leveraging these and developing a best practice framework for patient centric PCOS MoC is now a vital to optimise care and outcomes in this common and neglected condition.Collaborative interdisciplinary efforts from academic leads, healthcare professionals and consumers are now needed to co-develop a framework and benchmarking performance indicators to guide evidence-based, patient centric PCOS MOC to improve experience and outcomes.

Racial and ethnic disparities exist in gestational diabetes prevalence and risk of subsequent type 2 diabetes mellitus (T2DM). Postpartum engagement in healthy behaviours is recommended for prevention and early detection of T2DM, yet uptake is low among women from diverse cultural backgrounds. Greater understanding of factors impacting postpartum health behaviours is needed. Applying the Theoretical Domains Framework (TDF) and Capability, Opportunity, Motivation-Behaviour (COM-B) model, our aim was to synthesise barriers to and enablers of postpartum health behaviours among women from diverse cultural backgrounds with prior GDM and identify relevant intervention components.Databases, reference lists and grey literature were searched from September 2017 to April 2021. Two reviewers screened articles independently against inclusion criteria and extracted data. Using an inductive-deductive model, themes were mapped to the TDF and COM-B model.After screening 5148 citations and 139 full texts, we included 35 studies (N = 787 participants). The main ethnicities included Asian (43%), Indigenous (15%) and African (11%). Barriers and enablers focused on Capability (e.g. knowledge), Opportunity (e.g. competing demands, social support from family, friends and healthcare professionals, culturally appropriate education and resources) and Motivation (e.g. negative emotions, perceived consequences and necessity of health behaviours, social/cultural identity). Five relevant intervention functions are identified to link the barriers and enablers to evidence-based recommendations for communications to support behaviour change.We provide a conceptual model to inform recommendations regarding the development of messaging and interventions to support women from diverse cultural backgrounds in engaging in healthy behaviours to reduce risk of T2DM.

IMPORTANCE: Structured antenatal diet and physical activity interventions have been shown to be associated with reduced adverse pregnancy outcomes and recommended to be routinely offered to all pregnant women. The health cost implications of population-level implementation are unclear. OBJECTIVE: To estimate the budget impact associated with integrating structured diet and physical activity interventions into routine antenatal care. DESIGN, SETTING, AND PARTICIPANTS: This economic evaluation was conducted from the perspective of Australian health funders. An open-source decision-tree model was constructed to compare the projected budget outcomes of implementing lifestyle intervention vs usual care. Scenario, deterministic, and probabilistic sensitivity analysis were completed. The study setting was Australian health services, and the study population was all Australian women projected to give birth in the years 2022 to 2026 (approximately 330 000 per year). INTERVENTIONS: Structured diet and physical activity intervention provided by trained health professionals, integrated into routine antenatal care. Comparator was usual care, which currently in Australia does not include routine structured lifestyle interventions. MAIN OUTCOMES AND MEASURES: Return on investment (ROI) ratio for lifestyle intervention (cost of intervention divided by cost savings attributable to reduced maternal and infant adverse events) from the perspective of Australian health care funders. Adverse events were obtained from a published meta-analysis and population data. Costs were estimated from aggregate trial data and clinical pathways and valued at the year incurred. RESULTS: Intervention offered an ROI ratio of 4.75 over the 5-year program; hence every Australian dollar spent on implementation produced an estimated return of A$4.75. The projected total 5-year intervention cost was A$205 million ($151 million), with cost offsets (from reduced incidence of adverse pregnancy outcomes) of A$1022 million ($755 million), and health budget savings of A$807 million (95% CI, A$129 million to A$1639 million) ($596 million [95% CI, $95 million to $1211 million]); 93.3% of the 10 000 iterations were within cost saving, and results were robust to scenario and sensitivity analyses. CONCLUSIONS AND RELEVANCE: This economic evaluation found that providing access to structured diet and physical activity lifestyle interventions for all pregnant Australian women was estimated to provide strong return on investment for health funders. The open-source model developed can be used by other jurisdictions and health services to explore cost implications of implementation within their patient population.

Purpose of Review Reproductive-aged women (aged 19 to 50 years) are a key population warranting focused research for the prevention of overweight and obesity. This review highlights the importance of addressing weight before, during and after pregnancy. Recent Findings Obesity decreases fertility during the preconception period; increases the risk of adverse pregnancy outcomes including gestational diabetes, pre-eclampsia and caesarean section and postpartum weight retention; and increases the long-term health risks for both the mother and offspring. Despite overwhelming efficacy evidence on solutions, there are significant implementation gaps in translating this evidence into pragmatic models of care and real-world solutions. Interventions during preconception, pregnancy and postpartum are likely to be cost-effective or cost-saving, with future investigation needed in the preconception and postpartum period. Summary International clinical guidelines and public health policies are needed for a concerted effort to prevent unhealthy weight gain in these life stages and to reverse the significant adverse health outcomes for women and the next generation.

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.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 140 mg/dL). CGM hyperglycemia in people with normal or abnormal glucose tolerances was used to define an arbitrary CGM-diagnosis of diabetes. The Quality Assessment of Diagnostic Accuracy Studies tool was used to assess risk of bias. Primary outcome was relative risk of an arbitrary CGM-diagnosis of diabetes compared to the oral glucose tolerance test.We identified 1277 publications, of which 19 studies were eligible comprising total of 416 individuals with contemporaneous CGM and oral glucose tolerance test results. Relative risk of an arbitrary CGM-diagnosis of diabetes compared to oral glucose tolerance test was 2.92. Studies analysed were highly heterogenous, prone to bias and inadequately assessed longitudinal associations between CGM and relevant disease-specific sequela.A single reading 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.

There is an increasing need to deliver high-value health care. Here, we discuss how value should be measured and implemented in maternity care through a Learning Health System. High-value maternity care will produce the highest level of benefit for women at a given cost. As pregnancy is not an illness state, and there is no cure or remission to be achieved, we believe that patient-reported outcomes should be an integral component of benefit quantification when measuring value. Furthermore, as care impacts more than just health outcomes-particularly in maternity care-there is also a need to consider patient-reported experiences as a part of defining the level of benefit. However, to move beyond traditional narrow and passive measurement of value, we need to partner with stakeholders to identify priorities for change, identify evidence for how to achieve this change, integrate measurement activities, and promote effective implementation, in a continuous, learning cycle-a Learning Health System. A robust Framework for implementing a Learning Health System has been developed, which could be applied in maternity care.

To evaluate a co-designed early menopause digital resource, including audio/video clips, question prompt list, and information links.Pre/post-test study. Women with early menopause, defined as menopause before age 45 years, were recruited from the community. Following online informed consent, participants were emailed links to the digital resource and online surveys to complete before (baseline) and, immediately and 1 month after viewing the resource. Main outcome measures: Health-related empowerment (Health Education Impact Questionnaire), illness perception (Brief Illness Perception Questionnaire), menopause symptoms (Greene Climacteric Scale), risk perception, and knowledge change.One hundred fifty women participated. Compared to baseline, at 1-month health-related empowerment, 'health directed behavior' scores increased (mean change: +0.13; 95% CI: 0.01-0.24; and P = 0.03), 'emotional distress' decreased (mean change: -0.15; 95% CI: -0.25 to -0.05; and P = 0.003) and physical and emotional menopause symptom scores decreased (P = 0.001 and P = 0.02, respectively). Illness perception scores increased at both immediate and 1-month follow-up versus baseline for 'personal control' (P 0.001 and P = 0.02) and 'coherence' (P = 0.003 and P 0.001). After viewing the digital resource, more women perceived that hormone therapy decreases heart disease risk, reduces hot flashes, and prevents fractures versus baseline (all P 0.05). More women correctly answered questions regarding early menopause prevalence (60% vs 35%), cause (46% vs 33%), risk (76% vs 55%), effect of phytoestrogens (60% vs 27%), and osteoporosis prevention (64% vs 44%) at immediate or 1-month follow-up versus baseline (all P 0.05).A co-designed early menopause digital resource may improve women's health-related empowerment, illness perception, menopause symptoms, risk perception, and knowledge.Video Summary:http://links.lww.com/MENO/A923.

IMPORTANCE: Psychometrically robust patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are critical to evaluating quality and performance across health services and systems. However, the adoption and implementation of PROMs and PREMs remain a challenge in many countries. The aim of this guide is to support instrument selection and implementation to measure health system performance. OBSERVATIONS: The guide is split into 3 step-by-step sections. Step 1: Knowing What to Measure discusses what PROMs and PREMs capture and how they differ from related instruments. Step 2: Choosing the Right Instrument describes the critical psychometric properties of validity, reliability, and responsiveness, and provides resources to support instrument selection and evaluation. Step 3: Mitigating Potential PROM and PREM Implementation Barriers outlines key barriers and supports for instrument implementation at system, service, and individual levels. CONCLUSIONS AND RELEVANCE: This guide aims to provide practical resources for the identification of psychometrically robust PROMs and PREMs, as well as support for their implementation to drive improvements across health systems globally.

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.

Women with recent gestational diabetes (GDM) have increased risk of developing type 2 diabetes.To investigate whether a resource-appropriate and context-appropriate lifestyle intervention could prevent glycemic deterioration among women with recent GDM in South Asia.This randomized, participant-unblinded controlled trial investigated a 12-month lifestyle intervention vs usual care at 19 urban hospitals in India, Sri Lanka, and Bangladesh. Participants included women with recent diagnosis of GDM who did not have type 2 diabetes at an oral glucose tolerance test (OGTT) 3 to 18 months postpartum. They were enrolled from November 2017 to January 2020, and follow-up ended in January 2021. Data were analyzed from April to July 2021.A 12-month lifestyle intervention focused on diet and physical activity involving group and individual sessions, as well as remote engagement, adapted to local context and resources. This was compared with usual care.The primary outcome was worsening category of glycemia based on OGTT using American Diabetes Association criteria: (1) normal glucose tolerance to prediabetes (ie, impaired fasting glucose or impaired glucose tolerance) or type 2 diabetes or (2) prediabetes to type 2 diabetes. The primary analysis consisted of a survival analysis of time to change in glycemic status at or prior to the final patient visit, which occurred at varying times after 12 months for each patient. Secondary outcomes included new-onset type 2 diabetes and change in body weight.A total of 1823 women (baseline mean [SD] age, 30.9 [4.9] years and mean [SD] body mass index, 26.6 [4.6]) underwent OGTT at a median (IQR) 6.5 (4.8-8.2) months postpartum. After excluding 160 women (8.8%) with type 2 diabetes, 2 women (0.1%) who met other exclusion criteria, and 49 women (2.7%) who did not consent or were uncontactable, 1612 women were randomized. Subsequently, 11 randomized participants were identified as ineligible and excluded from the primary analysis, leaving 1601 women randomized (800 women randomized to the intervention group and 801 women randomized to usual care). These included 600 women (37.5%) with prediabetes and 1001 women (62.5%) with normoglycemia. Among participants randomized to the intervention, 644 women (80.5%) received all program content, although COVID-19 lockdowns impacted the delivery model (ie, among 644 participants who engaged in all group sessions, 476 women [73.9%] received some or all content through individual engagement, and 315 women [48.9%] received some or all content remotely). After a median (IQR) 14.1 (11.4-20.1) months of follow-up, 1308 participants (81.2%) had primary outcome data. The intervention, compared with usual care, did not reduce worsening glycemic status (204 women [25.5%] vs 217 women [27.1%]; hazard ratio, 0.92; [95% CI, 0.76-1.12]; P = .42) or improve any secondary outcome.This study found that a large proportion of women in South Asian urban settings developed dysglycemia soon after a GDM-affected pregnancy and that a lifestyle intervention, modified owing to the COVID-19 pandemic, did not prevent subsequent glycemic deterioration. These findings suggest that alternate or additional approaches are needed, especially among high-risk individuals.Clinical Trials Registry of India Identifier: CTRI/2017/06/008744; Sri Lanka Clinical Trials Registry Identifier: SLCTR/2017/001; and ClinicalTrials.gov Identifier: NCT03305939.

Introduction Using 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. Objectives To investigate the causality of central- and general obesity on PCOS using surrogate anthropometric markers. Methods Summary 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. Results Instrumental 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. Conclusions Both 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.

IntroductionObesity is observed in a majority of women with polycystic ovarian syndrome (PCOS). Using body mass index (BMI) as a proxy, previous Mendelian randomization studies revealed general obesity potentially causes PCOS. Central obesity frequently demonstrates a stronger association with PCOS, although evidence on its causality is sparse.ObjectivesTo investigate causal effects of both central- and general- obesity on the development of PCOS via two-sample Mendelian randomization (2SMR).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 data, we acquired summary data from a large-sample GWAS (96391 samples; 219 cases and 96172 controls) from the FinnGen cohort. Four 2SMR methods were applied: inverse variance weighted (IVW); MR Egger (MRE); weighted median (WME); weighted mode (WMO). Single SNP-, leave-one-out-, heterogeneity-, horizontal pleiotropy- and outlier- analyses were conducted. Genetic architectures underlying causal associations were explored.ResultsAll SNPs selected as instrumental variables demonstrated no weak instrument bias (F > 10). Three anthropometric exposures, namely, BMI (OR: 5.55 – 7.24, WC (OR: 6.79 – 24.56), and HC (OR: 6.78 – 24.56), significantly causally associated with PCOS as per IVW, WME, and WMO models. Single SNP- and leave-one-out- sensitivity analysis results were indicative of robust causal estimates. No significant heterogeneity, horizontal pleiotropy, and outliers were observed. We observed a considerable degree of overlap (7 SNPs; 17 genes) across significant causal findings as well as a number of SNPs and genes that were not shared between causal associations.ConclusionsThis study revealed that both and general- and central obesity potentially cause PCOS. Findings underscore the importance of addressing obesity and adiposity for the prevention and management of PCOS.

This study aimed to explore psychological distress, lifestyle, and demographic factors, as well as their relationship to discretionary choices in women of reproductive age during the coronavirus disease 2019 pandemic in Australia.Reproductive-aged women (18-50 y) in Australia participated in a national online survey. Psychological distress score (using a validated 10-item Kessler Psychological Distress Scale questionnaire) was the primary exposure of interest, and key outcomes were frequencies of discretionary choices (sugar-sweetened beverages [SSBs], alcohol, and discretionary foods). Sociodemographic and physical activity data were also collected. Logistic regression was used to report adjusted odds ratio (aOR) and 95% confidence interval to predict SSBs (less than weekly; most days/daily), total discretionary foods (none/lt;2 times/d; ≥3 times/d), and alcohol use (never/less than monthly; most weeks/daily).A total of 1005 women were included in the study, of whom 40% had a high level of psychological distress. Women with high psychological distress (aOR: 1.96; 95% CI, 1.32-2.91) and those who gained weight during the pandemic (aOR: 1.71; 95% CI, 1.10-2.65) were more likely to consume discretionary foods ≥3 times/d. There was no association between psychological distress and SSB intake or alcohol; however, Australian, New Zealander, or Pacific Islander background (aOR: 1.68; 95% CI, 1.21-2.33) and more hours of sitting time (aOR: 1.88; 95% CI, 1.07-3.29) were associated with SSB consumption on most days/daily. Older age (aOR: 1.70; 95% CI, 1.00-2.89), higher household income (aOR: 1.44; 95% CI, 1.08-1.92), and moderate or high physical activity (aOR: 1.75; 95% CI, 1.10-2.80) were associated with alcohol intake on most weeks/daily.Public health messaging to promote healthy eating should take into account the effect of psychological distress on health behavior. Messages aimed at maintaining a positive relationship between food intake and mental wellbeing, particularly among vulnerable groups, are warranted.

IntroductionWoman-centred care is the right of every woman receiving maternity care, irrespective of where care is being received and who is providing care. This protocol describes a planned systematic review that will identify, describe and critically appraise the psychometric properties of maternity patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs). The woman-centricity of PROM and PREM development and content validation (ie, the extent to which women were involved in these processes) will also be assessed. This information will be used to develop a maternity PROMs and PREMs database to support service and system performance measurement, and value-based maternity care initiatives.Methods and analysisThis study will be guided by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guideline for systematic reviews of outcome measurement instruments. Studies identified via MEDLINE, CINAHL Plus, PsycINFO and EMBASE describing the development, content validation and/or psychometric evaluation of PROMs and PREMs specifically designed for maternity populations throughout pregnancy, childbirth and postnatal periods will be considered if published from 2010 onward, in English, and available in full text. The COSMIN risk of bias checklist will be used to evaluate the quality of studies reporting on the development, content validation and/or psychometric evaluation of PROMs and PREMs. COSMIN criteria for good content validity will be used to assess the woman-centricity of PROM and PREM development and content validation studies. COSMIN standards of good psychometric properties will be used to evaluate the validity and reliability of the identified instruments.Ethics and disseminationEthical permission for this research is not required. The findings of this research will be submitted for publication in an international, peer-reviewed journal. Abstracts for national and international conference presentations will also be submitted. The proposed maternity PROMs and PREMs database will be freely accessible online, and developed with consumer input to ensure its usefulness to a range of maternity care stakeholders.PROSPERO registration numberCRD42021288854.

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.

This project is funded by the European Union Commission Horizon 2020 grant entitled `Implementation Action to Prevent Diabetes From Bump 2 Baby (IMPACT DIABETES B2B)' under grant agreement 847984, with collaborative National Health and Medical Research Council, Australia cofunding under grant number APP1194234. The project is sponsored by the University College Dublin. The funders and the sponsor have no role in the design of the study; the collection, analysis, and interpretation of the data; or writing of the manuscript or decision to publish. Financial audits are carried out by the European Union Commission., 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., European Union Commission Horizon 2020 grant entitled 'Implementation Action to Prevent Diabetes From Bump 2 Baby (IMPACT DIABETES B2B)' 847984, National Health and Medical Research Council of Australia APP1194234, University College Dublin, European Commission

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.

Background Reproductive-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. Objective We 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. Methods This 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. Results The 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. Conclusions The 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 Registration Australian 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

BACKGROUND Reproductive-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. OBJECTIVE We 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. METHODS This 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. RESULTS The 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. CONCLUSIONS The 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. CLINICALTRIAL Australian and New Zealand Clinical Trial Registry ACTRN12620001053910; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378243&isReview=true INTERNATIONAL REGISTERED REPORT DERR1-10.2196/33625

Women with prior gestational diabetes have nearly 10 times the risk of developing type 2 diabetes. Postpartum screening for type 2 diabetes is recommended for early diagnosis and management, yet uptake is low. This work updates a previous systematic review and advances it through the application of the Theoretical Domains Framework (TDF) to synthesise personal-level factors impacting type 2 diabetes screening and the Capability, Opportunity, Motivation-Behaviour model (COM-B), to develop messaging recommendations for use in clinical practice and screening promotion interventions.We searched seven academic databases from September 2017 (prior review) to April 2021, reference lists and grey literature. Two reviewers independently screened articles against inclusion criteria (qualitative studies exploring factors impacting postpartum diabetes screening, any language) and extracted data. Using an inductive-deductive model, we coded determinants to the TDF and mapped onto the COM-B model.We identified 38 eligible papers from 34 studies (N = 1291 participants). Most (71%) reported sample sizes of N ≥ 16. The ratio of barriers to enablers was three to one. Eight key TDF domains were identified. Evidence-based recommendations include addressing knowledge, risk perception, fear of diabetes diagnosis, low prioritisation of personal health and fatalism. The risk of bias was low and confidence in findings was moderate to high. A limitation was conceptual overlap between TDF domains, which we addressed via the study procedure.The theoretical categorisation of determinants enables the development of messaging and interventions at the personal level, to promote women's uptake of postpartum type 2 diabetes screening.

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.

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

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

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

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

Background: Over the past decade Research Translation Centres (RTC’s) have been established in many countries. These Centres (sometimes referred to as Academic Health Science Centres) are designed to bring universities and health care 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 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 is needed. Methods: Semi structured interviews were conducted with selected leaders and members from select RTCs in England and Australia. Convenience sampling was utilised to identify RTC’s, based on their geography, accessibility and availability. Purposive sampling and a snowballing approach was employed to recruit individual participants for interviews that 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-patient involvement and research co-production (4) workforce development (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.