Designing economic evaluations alongside clinical trials in maternal health care: A guide for clinical trial design.

BACKGROUND: Economic evaluations are being conducted with increasing frequency in the maternity care setting, with more randomized controlled trials containing a health economic component. Key emerging criticisms of economic evaluation in maternity care are lack of robust data collection and measurement, inconsistencies in methodology, and lack of adherence to reporting guidelines. METHODS: This article provides a guide to the design of economic evaluations alongside clinical trials in maternal health. We include economic concepts and considerations for the maternity setting and provide examples from the UK and Australia. RESULTS: There are many important considerations for the design of economic evaluations alongside clinical trials. To be effective, researchers must select types of economic evaluation, which align with their study objectives; choose an appropriate evaluation perspective, time horizon, and discount rate; and identify accurate ways to measure and evaluate health outcomes and costs. DISCUSSION: This guide is written for noneconomists and can be used for designing economic evaluations to be conducted as a part of clinical trials. We seek to improve the quality, consistency, and transparency of economic evaluations in maternal health.

Induction of labour for predicted macrosomia: study protocol for the 'Big Baby' randomised controlled trial.

INTRODUCTION: Large-for-gestational age (LGA) fetuses have an increased risk of shoulder dystocia. This can lead to adverse neonatal outcomes and death. Early induction of labour in women with a fetus suspected to be macrosomic may mitigate the risk of shoulder dystocia. The Big Baby Trial aims to find if induction of labour at 38+0-38+4 weeks' gestation, in pregnancies with suspected LGA fetuses, reduces the incidence of shoulder dystocia. METHODS AND ANALYSIS: The Big Baby Trial is a multicentre, prospective, individually randomised controlled trial of induction of labour at 38+0 to 38+4 weeks' gestation vs standard care as per each hospital trust (median gestation of delivery 39+4) among women whose fetuses have an estimated fetal weight >90th customised centile according to ultrasound scan at 35+0 to 38+0 weeks' gestation. There is a parallel cohort study for women who decline randomisation because they opt for induction, expectant management or caesarean section. Up to 4000 women will be recruited and randomised to induction of labour or to standard care. The primary outcome is the incidence of shoulder dystocia; assessed by an independent expert group, blind to treatment allocation, from delivery records. Secondary outcomes include birth trauma, fractures, haemorrhage, caesarean section rate and length of inpatient stay. The main trial is ongoing, following an internal pilot study. A qualitative reporting, health economic evaluation and parallel process evaluation are included. ETHICS AND DISSEMINATION: The study received a favourable opinion from the South West-Cornwall and Plymouth Health Research Authority on 23/03/2018 (IRAS project ID 229163). Study results will be reported in the National Institute for Health Research journal library and published in an open access peer-reviewed journal. We will plan dissemination events for key stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN18229892.

Cost-effectiveness of screening tools for identifying depression in early pregnancy: a decision tree model.

BACKGROUND: Although the effectiveness of screening tools for detecting depression in pregnancy has been investigated, there is limited evidence on the cost-effectiveness. This is vital in providing full information to decision makers. This study aimed to explore the cost-effectiveness of different screening tools to identify depression in early pregnancy compared to no screening. METHODS: A decision tree was developed to model the identification and treatment pathways of depression from the first antenatal appointment to 3-months postpartum using the Whooley questions, the Edinburgh Postnatal Depression Scale (EPDS) and the Whooley questions followed by the EPDS, compared to no screening. The economic evaluation took an NHS and Personal Social Services perspective. Model parameters were taken from a combination of sources including a cross-sectional survey investigating the diagnostic accuracy of screening tools, and other published literature. Cost-effectiveness was assessed in terms of the incremental cost per quality adjusted life years (QALYs). Cost-effectiveness planes and cost-effectiveness acceptability curves were produced using a net-benefit approach based on Monte Carlo simulations of cost-outcome data. RESULTS: In a 4-way comparison, the Whooley, EPDS and Whooley followed by the EPDS each had a similar probability of being cost-effective at around 30% for willingness to pay values from £20,000-30,000 per QALY compared to around 20% for the no screen option. CONCLUSIONS: All three screening approaches tested had a higher probability of being cost-effective than the no-screen option. In the absence of a clear cost-effectiveness advantage for any one of the three screening options, the choice between the screening approaches could be made on other grounds, such as clinical burden of the screening options. Limitations include data availability and short time horizon, thus further research is needed. CLINICAL TRIALS REGISTRATION: N/A.

An integrated primary care-based programme of PRE-Pregnancy cARE to improve pregnancy outcomes in women with type 2 Diabetes (The PREPARED study): protocol for a multi-method study of implementation, system adaptation and performance.

BACKGROUND: The number of women of childbearing age with Type 2 diabetes(T2DM) is increasing, and they now account for > 50% of pregnancies in women with pre-existing diabetes. Diabetes pregnancies without adequate pre-pregnancy care have higher risk for poor outcomes (miscarriages, birth-defects, stillbirths) and are associated with increased complications (caesarean deliveries, macrosomic babies, neonatal intensive-care admissions). The risks and costs of these pregnancies can be reduced with pregnancy preparation (HbA1c, ≤ 6.5%, 5 mg folic acid and stopping potentially harmful medicines). However, 90% of women with T2DM, most of whom are based in primary care, are not adequately prepared for pregnancy. This study will evaluate a programme of primary care-based interventions (decision-support systems; pre-pregnancy care-pathways; pregnancy-awareness resources; professional training; and performance monitoring) to improve pregnancy preparation in women with T2DM. METHODS: The study aims to optimise the programme interventions and estimate their impact on pregnancy preparation, pre-pregnancy care uptake and pregnancy outcomes. To evaluate this multimodal intervention, we will use a multi-method research design following Complex Adaptive Systems (CAS) theory, refining the interventions iteratively during the study. Thirty GP practices with ≥ 25 women with T2DM of reproductive age (18-45 years) from two South London boroughs will be exposed to the intervention. This will provide > 750 women with an estimated pregnancy incidence of 80-100 to study. The research involves: a clinical audit of processes and outcomes; a process evaluation informing intervention feasibility, implementation, and behaviour change; and a cost-consequences analysis informing future economic evaluation. Performance data will be collected via audits of GP systems, hospital antenatal clinics and pregnancy outcomes. Following CAS theory, we will use repeated measurements to monitor intervention impact on pregnancy preparation markers at 4-monthly intervals over 18-months. We will use performance and feasibility data to optimise intervention effects iteratively. The target performance for the intervention is a 30% increase in the proportion of women meeting pre-pregnancy care criteria. DISCUSSION: The primary output will be development of an integrated programme of interventions to improve pregnancy preparation, pre-pregnancy care uptake, and reduce adverse pregnancy outcomes in women with T2DM. We will also develop an implementation plan to support the introduction of the interventions across the NHS. TRIAL REGISTRATION: ISRCTN47576591 ; February 8, 2022.

Quantitative assessment of pregnancy outcome following recurrent miscarriage clinic care: a prospective cohort study.

OBJECTIVES: To measure pregnancy outcome following attendance at a recurrent miscarriage service and identify factors that influence outcome. DESIGN: Prospective, observational electronic cohort study. SETTING: Participants attending a specialist recurrent miscarriage clinic, with a history of two or more pregnancy losses. 857 new patients attended over a 30-month period and were invited to participate. Participant data were recorded on a bespoke study database, 'Tommy's Net'. PARTICIPANTS: 777 women consented to participate (90.7% of new patients). 639 (82%) women continued within the cohort, and 138 were lost to follow-up. Mean age of active participants was 34 years for women and 37 years for partners, with a mean of 3.5 (1-19) previous pregnancy losses. Rates of obesity (maternal: 23.8%, paternal: 22.4%), smoking (maternal:7.4%, paternal: 19.4%) and alcohol consumption (maternal: 50%, paternal: 79.2%) were high and 55% of participants were not taking folic acid. OUTCOME MEASURES: Biannual collection of pregnancy outcomes, either through prompted self-reporting, or existing hospital systems. RESULTS: 639 (82%) women were followed up. 404 (83.4%) reported conception and 106 (16.6%) reported no pregnancy, at least 6 months following registration. Of those that conceived, 72.8% (294/404) had a viable pregnancy. Maternal smoking and body mass index (BMI) over 30 were significantly higher in those who did not conceive (p=0.001) CONCLUSIONS: Tommy's Net provides a secure electronic repository on data for couples with recurrent pregnancy loss and associated outcomes. The study identified that subfertility, as well as repeated miscarriage, maternal BMI and smoking status, contributed to failure to achieve live birth. Study findings may enable comparison of clinic outcomes and inform the development of a personalised holistic care package.

Women's and Employers' Experiences and Views of Combining Breastfeeding with a Return to Paid Employment: A Systematic Review of Qualitative Studies.

INTRODUCTION: Returning to paid employment is one of the reasons women stop breastfeeding earlier than they planned to. This systematic review aimed to provide insight into the experiences and views of women and employers on breastfeeding and returning to paid employment, with findings used to inform practice and policy. METHODS: The review was guided by the Joanna Briggs Institute (JBI) methodology for systematic reviews of qualitative evidence. Medline, CINAHL, PsycINFO, and Web of Science databases were searched for studies published in English. JBI's meta-aggregative approach informed data analysis. The studies in this analysis included women who stopped breastfeeding before, and those who continued breastfeeding after, returning to paid employment and the employers, work managers, or supervisors of women who continued breastfeeding after returning to paid employment. RESULTS: Twenty-six articles presenting findings from 25 studies were included and critically appraised. Synthesized findings showed that women experienced physical and emotional difficulties and described gender and employment inequalities in accessing and receiving the support they needed. Women reported that the importance of their own motivation and having workplace legislation in place facilitated breastfeeding during employment. Support from employers, colleagues, and family members, as well as access to convenient child care, helped women continue breastfeeding on return to paid employment. Employers' personal experiences influenced their views on breastfeeding and working, and the need for more education and communication between employers and employers on breastfeeding in the workplace was recognized. DISCUSSION: Support from family, work colleagues, and employers was important to reduce the physical and emotional challenges women experienced when combing breastfeeding with return to paid employment. Gender inequalities, especially in low- and middle-income countries, in accessing support exacerbated the difficulties women experienced. Limited data were identified regarding employers' experiences and views, suggesting an urgent need for further research to explore employers' and work colleagues' experiences and views.

Equity in newborn care, evidence from national surveys in low- and middle-income countries.

BACKGROUND: High coverage of care is essential to improving newborn survival; however, gaps exist in access to timely and appropriate newborn care between and within countries. In high mortality burden settings, health inequities due to social and economic factors may also impact on newborn outcomes. This study aimed to examine equity in co-coverage of newborn care interventions in low- and low middle-income countries in sub-Saharan Africa and South Asia. METHODS: We analysed secondary data from recent Demographic and Health Surveys in 16 countries. We created a co-coverage index of five newborn care interventions. We examined differences in coverage and co-coverage of newborn care interventions by country, place of birth, and wealth quintile. Using multilevel logistic regression, we examined the association between high co-coverage of newborn care (4 or 5 interventions) and social determinants of health. RESULTS: Coverage and co-coverage of newborn care showed large between- and within-country gaps for home and facility births, with important inequities based on individual, family, contextual, and structural factors. Wealth-based inequities were smaller amongst facility births compared to non-facility births. CONCLUSION: This analysis underlines the importance of facility birth for improved and more equitable newborn care. Shifting births to facilities, improving facility-based care, and community-based or pro-poor interventions are important to mitigate wealth-based inequities in newborn care, particularly in countries with large differences between the poorest and richest families and in countries with very low coverage of care.

The impact of disasters on contraception in OECD member countries: a scoping review.

OBJECTIVES: Review evidence is lacking about how contraception is affected by severe social disruption, such as that caused by the COVID-19 pandemic. The purpose of this scoping review was to explore the impact of natural and man-made disasters on contraception in OECD member countries. METHODS: Manual searches and systematic searches in six electronic databases were conducted with no language restrictions. All articles were screened by at least two researchers. The data were analysed thematically. RESULTS: 108 articles were included. Most focussed on the Zika virus outbreak (n = 50) and the COVID-19 pandemic (n = 28). Four key themes were identified: importance of contraception during disasters, impact of disasters on contraceptive behaviour, barriers to contraception during disasters and ways of improving use of contraception during disasters. Despite efforts to increase access to contraception including by transforming ways of delivery, barriers to use meant that unmet need persisted. CONCLUSIONS: To prevent adverse health outcomes and reduce health costs as a result of failure to have access to contraception during disasters, there is a need to intensify efforts to remove barriers to use. This should include increasing access and information on methods of contraception and their side effects (e.g., menstrual suppression) and making contraception freely available.

Midwifery continuity of care versus standard maternity care for women at increased risk of preterm birth: A hybrid implementation-effectiveness, randomised controlled pilot trial in the UK.

BACKGROUND: Midwifery continuity of care is the only health system intervention shown to reduce preterm birth (PTB) and improve perinatal survival, but no trial evidence exists for women with identified risk factors for PTB. We aimed to assess feasibility, fidelity, and clinical outcomes of a model of midwifery continuity of care linked with a specialist obstetric clinic for women considered at increased risk for PTB. METHODS AND FINDINGS: We conducted a hybrid implementation-effectiveness, randomised, controlled, unblinded, parallel-group pilot trial at an inner-city maternity service in London (UK), in which pregnant women identified at increased risk of PTB were randomly assigned (1:1) to either midwifery continuity of antenatal, intrapartum, and postnatal care (Pilot study Of midwifery Practice in Preterm birth Including women's Experiences [POPPIE] group) or standard care group (maternity care by different midwives working in designated clinical areas). Pregnant women attending for antenatal care at less than 24 weeks' gestation were eligible if they fulfilled one or more of the following criteria: previous cervical surgery, cerclage, premature rupture of membranes, PTB, or late miscarriage; previous short cervix or short cervix this pregnancy; or uterine abnormality and/or current smoker of tobacco. Feasibility outcomes included eligibility, recruitment and attrition rates, and fidelity of the model. The primary outcome was a composite of appropriate and timely interventions for the prevention and/or management of preterm labour and birth. We analysed by intention to treat. Between 9 May 2017 and 30 September 2018, 334 women were recruited; 169 women were allocated to the POPPIE group and 165 to the standard group. Mean maternal age was 31 years; 32% of the women were from Black, Asian, and ethnic minority groups; 70% were in employment; and 46% had a university degree. Nearly 70% of women lived in areas of social deprivation. More than a quarter of women had at least one pre-existing medical condition and multiple risk factors for PTB. More than 75% of antenatal and postnatal visits were provided by a named/partner midwife, and a midwife from the POPPIE team was present at 80% of births. The incidence of the primary composite outcome showed no statistically significant difference between groups (POPPIE group 83.3% versus standard group 84.7%; risk ratio 0.98 [95% confidence interval (CI) 0.90 to 1.08]; p = 0.742). Infants in the POPPIE group were significantly more likely to have skin-to-skin contact after birth, to have it for a longer time, and to breastfeed immediately after birth and at hospital discharge. There were no differences in other secondary outcomes. The number of serious adverse events was similar in both groups and unrelated to the intervention (POPPIE group 6 versus standard group 5). Limitations of this study included the limited power and the nonmasking of group allocation; however, study assignment was masked to the statistician and researchers who analysed the data. CONCLUSIONS: In this study, we found that it is feasible to set up and achieve fidelity of a model of midwifery continuity of care linked with specialist obstetric care for women at increased risk of PTB in an inner-city maternity service in London (UK), but there is no impact on most outcomes for this population group. Larger appropriately powered trials are needed, including in other settings, to evaluate the impact of relational continuity and hypothesised mechanisms of effect based on increased trust and engagement, improved care coordination, and earlier referral on disadvantaged communities, including women with complex social factors and social vulnerability. TRIAL REGISTRATION: We prospectively registered the pilot trial on the UK Clinical Research Network Portfolio Database (ID number: 31951, 24 April 2017). We registered the trial on the International Standard Randomised Controlled Trial Number (ISRCTN) (Number: 37733900, 21 August 2017) and before trial recruitment was completed (30 September 2018) when informed that prospective registration for a pilot trial was also required in a primary clinical trial registry recognised by WHO and the International Committee of Medical Journal Editors (ICMJE). The protocol as registered and published has remained unchanged, and the analysis conforms to the original plan.

A qualitative exploratory study of UK first-time fathers' experiences, mental health and wellbeing needs during their transition to fatherhood.

OBJECTIVES: To develop an understanding of men's experiences of first-time fatherhood, their mental health and wellbeing needs. DESIGN: A qualitative study using semi-structured interviews. Data were analysed using framework analysis. SETTING: Two large National Health Service integrated care trusts covering four London (UK) local authority boroughs. PARTICIPANTS: First-time fathers with children under 12 months of age were included. Maximum variation sampling was used, with 21 fathers recruited. Ten of these men described their ethnic background as Indian, seven as White British, one as Spanish, one as Black African, one as Black Caribbean and one as Pakistani. Participants' ages ranged from 20 to over 60 years; completion of full-time education ranged from high school certificate to doctorate level; and annual income ranged from £15 000 to over £61 000. Non-English speaking fathers, those experiencing bereavement following neonatal death, stillbirth, pregnancy loss, sudden infant death, and fathers with existing severe mental illnesses were excluded. RESULTS: Nine major categories were identified: 'preparation for fatherhood', 'rollercoaster of feelings', 'new identity', 'challenges and impact', 'changed relationship: we're in a different place', 'coping and support', 'health professionals and services: experience, provision and support', 'barriers to accessing support', and 'men's perceived needs: what fathers want'. Resident (residing with their partner and baby) and non-resident fathers in this study highlighted broadly similar needs, as did fathers for whom English was their first language and those for whom it was not. A key finding of this study relates to men's own perceived needs and how they would like to be supported during the perinatal period, contributing to the current evidence. CONCLUSIONS: This study provides insight into first-time fathers' experiences during their transition to fatherhood, with important implications for healthcare policy makers, service providers and professionals for how perinatal and early years services are planned and provided for both new parents.

A multicriteria resource allocation model for the redesign of services following birth.

BACKGROUND: Many healthcare services are under considerable pressure to reduce costs while improving quality. This is particularly true in the United Kingdom's National Health Service where postnatal care is sometimes viewed as having a low priority. There is much debate about the service's redesign and the reallocation of resources, both along care pathways and between groups of mothers and babies with different needs. The aim of this study was to develop a decision support tool that would encourage a systemic approach to service redesign and that could assess the various quality and financial implications of service change options making the consequent trade-offs explicit. The paper describes the development process and an initial implementation as a preliminary exploration of the possible merits of this approach. METHODS: Other studies have suggested that combining multicriteria decision analysis with programme budgeting and marginal analysis might offer a suitable basis for resource allocation decisions in healthcare systems. The Postnatal care Resource Allocation Model incorporated this approach in a decision support tool to analyse the consequences of varying design parameters, notably staff contacts and time, on the various quality domains and costs. The initial phase of the study focussed on mapping postnatal care, involving interviews and workshops with a variety of stakeholders. This was supplemented with a literature review and the resultant knowledge base was encoded in the decision support tool. The model was then tested with various stakeholders before being used in an NHS Trust in England. RESULTS: The model provides practical support, helping staff explore options and articulate their proposals for the redesign of postnatal care. The integration of cost and quality domains facilitates trade-offs, allowing staff to explore the benefits of reallocating resources between hospital and community-based care, and different patient-categories. CONCLUSIONS: The main benefits of the model include its structure for assembling the key data, sharing evidence amongst multi-professional teams and encouraging constructive, systemic debate. Although the model was developed in the context of the routine maternity services for mothers and babies in the days following birth it could be adapted for use in other health care services.

Experiences of Improving Access to Psychological Therapy Services for Perinatal Mental Health Difficulties: a Qualitative Study of Women's and Therapists' Views.

BACKGROUND: Perinatal mental health difficulties are highly prevalent. In England, the Improving Access to Psychological Therapy (IAPT) programme provides evidence-based psychological treatment, predominantly in the form of brief manualized cognitive behavioural therapy (CBT), to people with mild to moderate depression or anxiety. Yet little is known about the experiences of women referred to IAPT with perinatal mental health difficulties. AIMS: The aim of this qualitative study was to investigate how women view IAPT support for perinatal mental health. We also gained the perspective of IAPT therapists. METHOD: Semi-structured interviews were conducted with twelve women who had been referred to and/or received therapy from IAPT during the perinatal period. Additionally, fourteen IAPT therapists participated in two focus groups. Thematic analysis was used. RESULTS: Key themes centred on barriers to access and the need to tailor support to (expectant) mothers. Women and therapists suggested that experiences could be improved by supporting healthcare professionals to provide women with more help with referrals, better tailoring support to the perinatal context, improving perinatal-specific training, supervision and resources, and offering a more individualized treatment environment. CONCLUSIONS: Overall, women reported positive experiences of support offered by IAPT for perinatal mental health difficulties. However, services should seek to facilitate access to support and to enable therapists to better tailor treatment.

A multicentre, randomised controlled trial of position during the late stages of labour in nulliparous women with an epidural: clinical effectiveness and an economic evaluation (BUMPES).

BACKGROUND: Epidural analgesia leads to increased risk of instrumental vaginal delivery (IVD). There is debate about whether or not posture in second-stage labour influences the incidence of spontaneous vaginal birth (SVB). OBJECTIVES: In nulliparous women with epidural analgesia, does a policy of adopting an 'upright position' throughout second-stage labour increase the incidence of SVB compared with a policy of adopting a 'lying-down' position? DESIGN: Two-arm randomised controlled trial. SETTING: Maternity units in England and Wales. PARTICIPANTS: Nulliparous women aged ≥ 16 years, at ≥ 37 weeks' gestation with singleton cephalic presentation and intended SVB, in second-stage labour with an epidural providing effective pain relief. INTERVENTIONS: (1) Upright position to maintain the pelvis in as vertical a plane as possible; and (2) lying-down position to maintain the pelvis in as horizontal a plane as possible. MAIN OUTCOME MEASURES: The primary outcome measure was incidence of SVB. Secondary outcomes included augmentation, interventions to maintain blood pressure, duration of labour, episiotomy, genital tract trauma, post-partum haemorrhage, maternal satisfaction, neonatal metabolic acidosis, 5-minute Apgar score of < 4, resuscitation at birth and admission to neonatal unit. At 1 year for (1) women: urinary or faecal incontinence, dyspareunia and health-related quality of life; (2) for infants: major morbidity. A cost-consequences analysis with a time horizon of 1 year after the birth from a NHS perspective. RESULTS: Between October 2010 and January 2014, 3236 women were randomised from 41 centres in England and Wales. There was a statistically significant difference in the incidence of SVB between groups, with 35.2% of women achieving a SVB in the upright group, compared with 41.1% in the lying-down group (adjusted risk ratio 0.86, 95% confidence interval 0.78 to 0.94). There was no evidence of differences in most of the secondary maternal or neonatal outcomes, or in long-term outcomes at the 12-month follow-up. No significant overall cost differences were observed between upright and lying-down positions for mothers or their babies. LIMITATIONS: Measurement of adherence was challenging in this unmasked trial, and adherence could be influenced by midwives' beliefs about the allocated positions. If adherence was poor, this would have diluted the difference between the two groups. CONCLUSIONS: There is clear evidence of the benefit of adopting a lying-down position in second-stage labour in nulliparous women with epidural analgesia, with no apparent disadvantages in either short- or long-term outcomes for mother or baby, and this is cost neutral for the NHS. FUTURE WORK: Questions remain about whether or not other positions could increase the incidence of SVB further in this group of women. The results also raise questions about the role of maternal position in second-stage labour in women without an epidural. TRIAL REGISTRATION: Current Controlled Trials ISRCTN35706297. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in Health Technology Assessment, Vol 21, No. 65. See the NIHR Journals Library website for further project information.

Caesarean birth rates in public and privately funded hospitals: a cross-sectional study.

OBJECTIVE: To examine maternal and obstetric factors influencing births by cesarean section according to health care funding. METHODS: A cross-sectional study with data from Southeastern Brazil. Caesarean section births from February 2011 to July 2012 were included. Data were obtained from interviews with women whose care was publicly or privately funded, and from their obstetric and neonatal records. Univariate and multivariate analyses were conducted to generate crude and adjusted odds ratios (OR) with 95% confidence intervals (95%CI) for caesarean section births. RESULTS: The overall caesarean section rate was 53% among 9,828 women for whom data were available, with the highest rates among women whose maternity care was privately funded. Reasons for performing a c-section were infrequently documented in women's maternity records. The variables that increased the likelihood of c-section regardless of health care funding were the following: paid employment, previous c-section, primiparity, antenatal and labor complications. Older maternal age, university education, and higher socioeconomic status were only associated with c-section in the public system. CONCLUSIONS: Higher maternal socioeconomic status was associated with greater likelihood of a caesarean section birth in publicly funded settings, but not in the private sector, where funding source alone determined the mode of birth rather than maternal or obstetric characteristics. Maternal socioeconomic status and private healthcare funding continue to drive high rates of caesarean section births in Brazil, with women who have a higher socioeconomic status more likely to have a caesarean section birth in all birth settings.

Initial protocol for a national evaluation of an area-based intervention programme (A Better Start) on early-life outcomes: a longitudinal cohort study with comparison (control) cohort samples.

INTRODUCTION: Pregnancy and the first few years of a child's life are important windows of opportunity in which to equalise life chances. A Better Start (ABS) is an area-based intervention being delivered in five areas of socioeconomic disadvantage across England. This protocol describes an evaluation of the impact and cost-effectiveness of ABS. METHODS AND ANALYSIS: The evaluation of ABS comprises a mixed-methods design including impact, cost-effectiveness and process components. It involves a cohort study in the 5 ABS areas and 15 matched comparison sites (n=2885), beginning in pregnancy in 2017 and ending in 2024 when the child is age 7, with a separate cross-sectional baseline survey in 2016/2017. Process data will include a profiling of the structure and services being provided in the five ABS sites at baseline and yearly thereafter, and data regarding the participating families and the services that they receive. Eligible participants will include pregnant women living within the designated sites, with recruitment beginning at 16 weeks of pregnancy. Data collection will involve interviewer-administered and self-completion surveys at eight time points. Primary outcomes include nutrition, socioemotional development, speech, language and learning. Data analysis will include the use of propensity score techniques to construct matched programme and comparison groups, and a range of statistical techniques to calculate the difference in differences between the intervention and comparison groups. The economic evaluation will involve a within-cohort study economic evaluation to compare individual-level costs and outcomes, and a decision analytic cost-effectiveness model to estimate the expected incremental cost per unit change in primary outcomes for ABS in comparison to usual care. ETHICS AND DISSEMINATION: Ethical approval to conduct the study has been obtained. The learning and dissemination workstream involves working within and across the sites to generate learning via communities of practice and a range of learning and dissemination events.

First-time fathers' needs and experiences of transition to fatherhood in relation to their mental health and wellbeing: a qualitative systematic review protocol.

REVIEW QUESTION/OBJECTIVE: This qualitative review seeks to identify first-time fathers' needs and experiences in relation to their mental health and wellbeing during their transition to fatherhood. This will include resident first-time fathers who are either the biological or non-biological father.The objectives are to explore first-time fathers' experiences in relation to.

The effects of cash transfers and vouchers on the use and quality of maternity care services: A systematic review.

BACKGROUND: Cash transfers and vouchers are forms of 'demand-side financing' that have been widely used to promote maternal and newborn health in low- and middle-income countries during the last 15 years. METHODS: This systematic review consolidates evidence from seven published systematic reviews on the effects of different types of cash transfers and vouchers on the use and quality of maternity care services, and updates the systematic searches to June 2015 using the Joanna Briggs Institute approach for systematic reviewing. The review protocol for this update was registered with PROSPERO (CRD42015020637). RESULTS: Data from 51 studies (15 more than previous reviews) and 22 cash transfer and voucher programmes suggest that approaches tied to service use (either via payment conditionalities or vouchers for selected services) can increase use of antenatal care, use of a skilled attendant at birth and in the case of vouchers, postnatal care too. The strongest evidence of positive effect was for conditional cash transfers and uptake of antenatal care, and for vouchers for maternity care services and birth with a skilled birth attendant. However, effects appear to be shaped by a complex set of social and healthcare system barriers and facilitators. Studies have typically focused on an initial programme period, usually two or three years after initiation, and many lack a counterfactual comparison with supply-side investment. There are few studies to indicate that programmes have led to improvements in quality of maternity care or maternal and newborn health outcomes. CONCLUSION: Future research should use multiple intervention arms to compare cost-effectiveness with similar investment in public services, and should look beyond short- to medium-term service utilisation by examining programme costs, longer-term effects on service utilisation and health outcomes, and the equity of those effects.