Learning health systems and evidence ecosystems: a perspective on the future of evidence-based medicine and evidence-based guideline development.

Despite forming the cornerstone of modern clinical practice for decades, implementation of evidence-based medicine at scale remains a crucial challenge for health systems. As a result, there has been a growing need for conceptual models to better contextualise and pragmatize the use of evidence-based medicine, particularly in tandem with patient-centred care. In this commentary, we highlight the emergence of the learning health system as one such model and analyse its potential role in pragmatizing both evidence-based medicine and patient-centred care. We apply the learning health system lens to contextualise the key activity of evidence-based guideline development and implementation, and highlight how current inefficiencies and bottlenecks in the evidence synthesis phase of evidence-based guideline development threaten downstream adherence. Lastly, we introduce the evidence ecosystem as a complementary model to learning health systems, and propose how innovative developments from the evidence ecosystem may be integrated with learning health systems to better enable health impact at speed and scale.

Externally validated prediction models for pre-eclampsia: systematic review and meta-analysis.

OBJECTIVE: This systematic review and meta-analysis aimed to evaluate the performance of existing externally validated prediction models for pre-eclampsia (specifically for any- early- late-onset and preterm pre-eclampsia). METHODS: A systematic search was conducted in five databases (MEDLINE, Embase, Emcare, CINAHL, and Maternity and Infant Care Database) to identify studies based on Population, Index model, Comparator, Outcome, Timing, and Setting (PICOTS) approach until May 20, 2023. We extracted data using the CHARMS checklist and appraised risk of bias using PROBAST tool. Discrimination and calibration performance were meta-analysed when appropriate. RESULTS: Twenty-three publications reported 52 externally validated prediction models on pre-eclampsia (twenty any-onset, seventeen early-onset, fourteen late-onset, and one preterm pre-eclampsia). No model had the same set of predictors. Fifteen, two, and three any-onset pre-eclampsia models were externally validated once, twice, and thrice, respectively, and the Fetal Medicine Foundation (FMF) preterm model was widely validated in sixteen different settings. The most common predictors were maternal characteristics (pre-pregnancy BMI, prior pre-eclampsia, family history of pre-eclampsia, chronic medical conditions, and ethnicity) and biomarkers (uterine artery pulsatility index and pregnancy-associated plasma protein-A). The model for preterm pre-eclampsia (triple test FMF) had the best performances with a pooled area under the receiver operating characteristics curve (AUROC) of 0.90 (95% prediction interval (PI) 0.76 - 0.96) and was well-calibrated. The other models generally had poor to fair discrimination performance (AUROC median 0.66, range 0.53 to 0.77) and were overfitted in calibration after external validation. Apart from the FMF model, only the two most validated models in any-onset pre-eclampsia using isolated maternal characteristics, produced reasonable pooled AUROCs of 0.71 (95% PI 0.66 - 0.76) and 0.73 (0.55 - 0.86). CONCLUSION: Existing externally validated prediction models for any-, early-, and late-onset pre-eclampsia have limited discrimination and calibration performance with inconsistent input variables. The triple test FMF model had excellent discrimination performance in predicting preterm pre-eclampsia in numerous settings, but the inclusion of specialised biomarkers may limit feasibility and implementation outside of high-resource settings. This article is protected by copyright. All rights reserved.

Development, women-centricity and psychometric properties of maternity patient-reported outcome measures (PROMs): A systematic review.

BACKGROUND: Measuring maternity care outcomes based on what women value is critical to promoting woman-centred maternity care. Patient-reported outcome measures (PROMs) are instruments that enable service users to assess healthcare service and system performance. AIM: To identify and critically appraise the risk of bias, woman-centricity (content validity) and psychometric properties of maternity PROMs published in the scientific literature. METHODS: MEDLINE, CINAHL Plus, PsycINFO and Embase were systematically searched for relevant records between 01/01/2010 and 07/10/2021. Included articles underwent risk of bias, content validity and psychometric properties assessments in line with COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidance. PROM results were summarised according to language subgroups and an overall recommendation for use was determined. FINDINGS: Forty-four studies reported on the development and psychometric evaluation of 9 maternity PROMs, grouped into 32 language subgroups. Risk of bias assessments for the PROM development and content validity showed inadequate or doubtful methodological quality. Internal consistency reliability, hypothesis testing (for construct validity), structural validity and test-retest reliability varied markedly in sufficiency and evidence quality. No PROMs received a level 'A' recommendation, required for real-world use. CONCLUSION: Maternity PROMs identified in this systematic review had poor quality evidence for their measurement properties and lacked sufficient content validity, indicating a lack of woman-centricity in instrument development. Future research should prioritise women's voices in deciding what is relevant, comprehensive and comprehensible to measure, as this will impact overall validity and reliability and facilitate real-world use.

My Baby's Movements: a stepped-wedge cluster-randomised controlled trial of a fetal movement awareness intervention to reduce stillbirths.

OBJECTIVE: The My Baby's Movements (MBM) trial aimed to evaluate the impact on stillbirth rates of a multifaceted awareness package (the MBM intervention). DESIGN: Stepped-wedge cluster-randomised controlled trial. SETTING: Twenty-seven maternity hospitals in Australia and New Zealand. POPULATION: Women with a singleton pregnancy without major fetal anomaly at ≥28 weeks of gestation from August 2016 to May 2019. METHODS: The MBM intervention was implemented at randomly assigned time points, with the sequential introduction of eight groups of between three and five hospitals at 4-monthly intervals. Using generalised linear mixed models, the stillbirth rate was compared in the control and the intervention periods, adjusting for calendar time, study population characteristics and hospital effects. MAIN OUTCOME MEASURES: Stillbirth at ≥28 weeks of gestation. RESULTS: There were 304 850 births with 290 105 births meeting the inclusion criteria: 150 053 in the control and 140 052 in the intervention periods. The stillbirth rate was lower (although not statistically significantly so) during the intervention compared with the control period (2.2/1000 versus 2.4/1000 births; aOR 1.18, 95% CI 0.93-1.50; P = 0.18). The decrease in stillbirth rate was greater across calendar time: 2.7/1000 in the first versus 2.0/1000 in the last 18 months. No increase in secondary outcomes, including obstetric intervention or adverse neonatal outcome, was evident. CONCLUSIONS: The MBM intervention did not reduce stillbirths beyond the downward trend over time. As a result of low uptake, the role of the intervention remains unclear, although the downward trend across time suggests some benefit in lowering the stillbirth rate. In this study setting, an awareness of the importance of fetal movements may have reached pregnant women and clinicians prior to the implementation of the intervention. TWEETABLE ABSTRACT: The My Baby's Movements intervention to raise awareness of decreased fetal movement did not significantly reduce stillbirth rates.

Implementation and evaluation of a quality improvement initiative to reduce late gestation stillbirths in Australia: Safer Baby Bundle study protocol.

BACKGROUND: In 2015, the stillbirth rate after 28 weeks (late gestation) in Australia was 35% higher than countries with the lowest rates globally. Reductions in late gestation stillbirth rates have steadily improved in Australia. However, to amplify and sustain reductions, more needs to be done to reduce practice variation and address sub-optimal care. Implementing bundles for maternity care improvement in the UK have been associated with a 20% reduction in stillbirth rates. A similar approach is underway in Australia; the Safer Baby Bundle (SBB) with five elements: 1) supporting women to stop smoking in pregnancy, 2) improving detection and management of fetal growth restriction, 3) raising awareness and improving care for women with decreased fetal movements, 4) improving awareness of maternal safe going-to-sleep position in late pregnancy, 5) improving decision making about the timing of birth for women with risk factors for stillbirth. METHODS: This is a mixed-methods study of maternity services across three Australian states; Queensland, Victoria and New South Wales. The study includes evaluation of 'targeted' implementer sites (combined total approximately 113,000 births annually, 50% of births in these states) and monitoring of key outcomes state-wide across all maternity services. Progressive implementation over 2.5 years, managed by state Departments of Health, commenced from mid-2019. This study will determine the impact of implementing the SBB on maternity services and perinatal outcomes, specifically for reducing late gestation stillbirth. Comprehensive process, impact, and outcome evaluations will be conducted using routinely collected perinatal data, pre- and post- implementation surveys, clinical audits, focus group discussions and interviews. Evaluations explore the views and experiences of clinicians embedding the SBB into routine practice as well as women's experience with care and the acceptability of the initiative. DISCUSSION: This protocol describes the evaluation of the SBB initiative and will provide evidence for the value of a systematic, but pragmatic, approach to strategies to reduce the evidence-practice gaps across maternity services. We hypothesise successful implementation and uptake across three Australian states (amplified nationally) will be effective in reducing late gestation stillbirths to that of the best performing countries globally, equating to at least 150 lives saved annually. TRIAL REGISTRATION: The Safer Baby Bundle Study was retrospectively registered on the ACTRN12619001777189 database, date assigned 16/12/2019.

Experiences of maternity care in New South Wales among women with mental health conditions.

BACKGROUND: High quality maternity care is increasingly understood to represent a continuum of care. As well as ensuring a positive experience for mothers and families, integrated maternity care is responsive to mental health needs of mothers. The aim of this paper is to summarize differences in women's experiences of maternity care between women with and without a self-reported mental health condition. METHODS: Secondary analyses of a randomized, stratified sample patient experience survey of 4787 women who gave birth in a New South Wales public hospital in 2017. We focused on 64 measures of experiences of antenatal care, hospital care during and following birth and follow up at home. Experiences covered eight dimensions: overall impressions, emotional support, respect for preferences, information, involvement, physical comfort and continuity. Multivariable logistic regression was used to compare experiences of women with and without a self-reported longstanding mental health condition. RESULTS: Compared to women without a condition, women with a longstanding mental health condition (n = 353) reported significantly less positive experiences by eight percentage points on average, with significant differences on 41 out of 64 measures after adjusting for age, education, language, parity, type of birth and region. Disparities were pronounced for key measures of emotional support (discussion of worries and fears, trust in providers), physical comfort (assistance, pain management) and overall impressions of care. Most women with mental health conditions (75% or more) reported positive experiences for measures related to guidelines for maternity care for women with mental illness (discussion of emotional health, healthy behaviours, weight gain). Their experiences were not significantly different from those of women with no reported conditions. CONCLUSIONS: Women with a mental health condition had significantly less positive experiences of maternity care across all stages of care compared to women with no condition. However, for some measures, including those related to guidelines for maternity care for women with mental illness, there were highly positive ratings and no significant differences between groups. This suggests disparities in experiences of care for women with mental health conditions are not inevitable. More can be done to improve experiences of maternity care for women with mental health conditions.

Global macroeconomic burden of epilepsy and the role for neurosurgery: a modelling study based upon the 2016 Global Burden of Disease data.

BACKGROUND AND PURPOSE: Although the significant morbidity and mortality burden associated with epilepsy is well understood, associated economic consequences are yet to be estimated on a global scale. We sought to: (i) estimate the value of lost economic welfare attributable to epilepsy among countries included in the 2016 Global Burden of Disease study, (ii) evaluate differences in disease burden between countries of varied income classification and location, and (iii) understand the proportion of this burden that requires neurosurgical consultation and intervention. METHODS: Publicly available morbidity and mortality data were incorporated into a 'full-income' model to generate estimates of the cumulative value of lost economic welfare (VLW) related to epilepsy. Results from a survey of neurosurgeons were then used to estimate the VLW attributable to the proportion of disease requiring neurosurgical consultation and intervention. RESULTS: A total of 195 countries and territories were included in this analysis. We estimate that the cumulative VLW related to epilepsy was $647.37 billion [2016 US dollars (USD), purchasing power parity (PPP)]. Economic welfare losses were equivalent to a mean of 1.45% (±1.00%) of gross domestic product. The value of economic losses attributable to the proportion of the burden necessitating neurosurgical consultation and intervention was $258.95 billion (2016 USD, PPP) and $155.37 billion (2016 USD, PPP) respectively. CONCLUSIONS: Our results indicate that the economic consequences of epilepsy-related morbidity and mortality are substantial. When considered with evidence supporting the cost-effectiveness of various interventions for improved epilepsy diagnosis and management, our findings suggest that the implementation of simple and affordable measures may avert significant economic loss.

My Baby's Movements: a stepped wedge cluster randomised controlled trial to raise maternal awareness of fetal movements during pregnancy study protocol.

BACKGROUND: Stillbirth is a devastating pregnancy outcome that has a profound and lasting impact on women and families. Globally, there are over 2.6 million stillbirths annually and progress in reducing these deaths has been slow. Maternal perception of decreased fetal movements (DFM) is strongly associated with stillbirth. However, maternal awareness of DFM and clinical management of women reporting DFM is often suboptimal. The My Baby's Movements trial aims to evaluate an intervention package for maternity services including a mobile phone application for women and clinician education (MBM intervention) in reducing late gestation stillbirth rates. METHODS/DESIGN: This is a stepped wedge cluster randomised controlled trial with sequential introduction of the MBM intervention to 8 groups of 3-5 hospitals at four-monthly intervals over 3 years. The target population is women with a singleton pregnancy, without lethal fetal abnormality, attending for antenatal care and clinicians providing maternity care at 26 maternity services in Australia and New Zealand. The primary outcome is stillbirth from 28 weeks' gestation. Secondary outcomes address: a) neonatal morbidity and mortality; b) maternal psychosocial outcomes and health-seeking behaviour; c) health services utilisation; d) women's and clinicians' knowledge of fetal movements; and e) cost. 256,700 births (average of 3170 per hospital) will detect a 30% reduction in stillbirth rates from 3/1000 births to 2/1000 births, assuming a significance level of 5%. Analysis will utilise generalised linear mixed models. DISCUSSION: Maternal perception of DFM is a marker of an at-risk pregnancy and commonly precedes a stillbirth. MBM offers a simple, inexpensive resource to reduce the number of stillborn babies, and families suffering the distressing consequences of such a loss. This large pragmatic trial will provide evidence on benefits and potential harms of raising awareness of DFM using a mobile phone app. TRIAL REGISTRATION: ACTRN12614000291684. Registered 19 March 2014. VERSION: Protocol Version 6.1, February 2018.

Disparities in access to health care in Australia for people with mental health conditions.

Objective One aim of Australia's Equally Well National Consensus Statement is to improve monitoring of the physical health of people with mental health conditions, which includes measures of accessibility and people's experiences of physical health care services. The present analysis contributes to this aim by using population survey data to evaluate whether, and in what domains, Australians with a mental health condition experience barriers in accessing care when compared with Australians without a mental health condition. Methods The 2016 Commonwealth Fund International Health Policy Survey includes a sample of 5248 Australian adults. Access to care was measured using 39 survey questions from before to after reaching services. Multivariable logistic regression models were used to identify disparities in barriers to access, comparing experiences of people with and without a self-reported mental health condition, adjusting for age, sex, immigrant status, income and self-rated health. Results Australians with mental health conditions were more likely to experience barriers for 29 of 39 access measures (odds ratio (OR) >1.55; P<0.05). On average, the prevalence of barriers was 10 percentage points higher for those with a condition. When measured as ratios, the largest barriers for people with mental health conditions were for affordability. When measured as percentage point differences, the largest disparities were observed for experiences of not being treated with respect in hospital. Disparities remained after adjusting for income, rurality, education, immigrant status and self-rated health for 25 of 39 measures. Conclusion Compared with the rest of the community, Australians with mental health conditions have additional challenges negotiating the health system, and are more likely to experience barriers to access to care across a wide range of measures. Understanding the extent to which people with mental health conditions experience barriers throughout the pathway to accessing care is crucial to inform care planning and delivery for this vulnerable group. Results may inform improvements in regular performance monitoring of disparities in access for people with mental health conditions. What is known about this topic? A stated national aim of the Equally Well National Consensus Statement is to improve monitoring of the physical health and well-being of people with mental health conditions through measures of service accessibility and people's experiences of physical healthcare services. What does this paper add? This paper highlights areas in which health services are not providing equal access to overall care for people with mental health conditions. The analysis offers quantitative evidence of 'red flag areas' where people with mental health conditions are significantly more likely to experience barriers to access to care. What are the implications for practitioners? Systematic attention across the health system to making care more approachable and accessible for people with mental health conditions is needed. Practitioners may be engaged to discuss possible interventions to improve access disparities for people with mental health conditions.

Youth labour force absence and chronic health conditions in Australia.

Background: Among older workers, chronic disease is known to be a key reason for early retirement. Aims: To determine whether chronic health conditions act as a barrier to young Australians (aged 15-29) participating in the labour force. Methods: Multiple logistic regression analysis to assess the adjusted odds ratio of people with different chronic health conditions being out of the labour force compared to those with no chronic conditions. Negative binomial regression models to predict the number of years people with different chronic health conditions would remain out of the labour force for. Results: Of the 550000 people aged 15-29 who were not in the labour force, 20% cited ill-health as the reason, reducing Australia's gross domestic product by around $3.7 billion per annum. When adjusted for age and education attainment, males with mental and behavioural disorders had 5.95 times the odds (95% confidence interval [CI] 3.90-9.08) of being out of the labour force, and females with development/intellectual disorders had 2.90 times the odds (95% CI 1.47-2.51), compared to those with no chronic health conditions. Males and females with development/intellectual disorders who were out of the labour force were estimated to spend an additional 2.7 and 3.5 years out of the labour force over the next 5 years. Conclusions: Prevention of chronic health conditions may help more younger Australians participate in the labour force, reducing the known long-term health and social problems associated with labour force absence.

A cost effectiveness analysis of midwife psycho-education for fearful pregnant women - a health system perspective for the antenatal period.

BACKGROUND: Psycho-education can reduce childbirth fear and caesarean section numbers. This study determines the cost-effectiveness of a midwife-led psycho-education intervention for women fearful of birth. METHOD: One thousand four hundred ten pregnant women in south-east Queensland, Australia were screened for childbirth fear (W-DEQ A ≥ 66). Women with high scores (n = 339) were randomised to the BELIEF Study (Birth Emotions and Looking to Improve Expectant Fear) to receive psycho-education (n = 170) at 24 and 34 weeks of pregnancy or to the control group (n = 169). Women in both groups were surveyed 6 weeks postpartum with total cost for health service use during pregnancy calculated. Logistic regression models assessed the odds ratio of having vaginal birth or caesarean section in the study groups. RESULT: Of 339 women randomised, 184 (54%) women returned data at 6 weeks postpartum (Intervention Group n = 91; Control Group n = 93). Women receiving psycho-education had a higher likelihood of vaginal birth compared to controls (n = 60, 66% vs. n = 54, 58%; OR 2.34). Mean 'treatment' cost for women receiving psycho-education was AUS$72. Mean cost for health services excluding the cost of psycho-education, was less in the intervention group (AUS$1193 vs. AUS$1236), but not significant (p = 0.78). For every five women who received midwife counselling, one caesarean section was averted. The incremental healthcare cost to prevent one caesarean section using this intervention was AUS$145. CONCLUSION: Costs of delivering midwife psycho-education to women with childbirth fear during pregnancy are offset by improved vaginal birth rates and reduction in caesarean section numbers. TRIAL REGISTRATION: Australian New Zealand Controlled Trials Registry ACTRN12612000526875 , 17th May 2012 (retrospectively registered one week after enrolment of first participant).

Lifetime impact of injury on education, employment and income for Australians of labour force participation age.

BACKGROUND: Research shows that employment rates are low post injury. AIMS: To quantify the economic impact of a long-term injury and identify whether having a tertiary level of education attainment would offset this impact. METHODS: Cross-sectional analysis of the 2012 Survey of Disability, Aging and Carers, which is nationally representative of the Australian population. RESULTS: Males with any long-term injury had incomes 41% less than males with no chronic health condition (95% confidence interval [CI] -49.3%, -31.6%). For males with a long-term injury, there was no significant difference in the likelihood of being not in the labour force between those with and without a tertiary qualification (odds ratio [OR] 0.83, 95% CI 0.45-1.52). There was no significant difference in the incomes of females with any long-term injury compared with those with no chronic health conditions. For females with a long-term injury, there was a significant difference in the likelihood of being not in the labour force between those with and without a tertiary qualification (OR 0.37, 95% CI 0.17-0.80). If men with a long-term injury had the same probability of participating in the workforce as women, the percentage of men not in the labour force would reduce from 37 to 18%. CONCLUSIONS: Having a long-term injury was a significant personal cost in terms of labour force absence and lower income for males regardless of higher education attainment. For females, sustaining a long-term injury did not appear to significantly affect income.

The impact of poverty on self-efficacy: an Australian longitudinal study.

BACKGROUND: People with strong feelings of 'self-efficacy', i.e. how much a person feels they have control over their life, perform better in the workplace. However, little is known about negative influences on feelings of self-efficacy. In view of the increasing number of people whose income places them below the poverty line despite being in employment, poverty may negatively influence feelings of self-efficacy and hence workplace productivity. AIMS: To assess whether falling into poverty lowers self-efficacy. METHODS: Longitudinal analysis of waves 7 to 11 of the nationally representative Household, Income and Labour Dynamics in Australia (HILDA) survey, using linear regression models. RESULTS: Those who fell into multidimensional poverty (income poverty plus poor health or insufficient level of education attainment) had significantly lower self-efficacy scores (up to 18% lower (95% CI -31% to -1%, P < 0.05)) than those never in poverty, after accounting for initial self-efficacy score and other confounding factors. Income uniquely accounted for 3% of the variance in self-efficacy scores, physical health for 10%, mental health for 78% and education for 1%. CONCLUSIONS: Given the known links between self-efficacy and workplace productivity, workers who are below the poverty line may be at risk of poor productivity due to the experience of poverty. In addition to the poor outcomes from the employer's perceptive, this may also lead to a negative spiral for the employee.