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Hybrid effectiveness-implementation studies allow researchers to combine study of a clinical intervention's effectiveness with study of its implementation with the aim of accelerating the translation of evidence into practice. However, there currently exists limited guidance on how to design and manage such hybrid studies. This is particularly true for studies that include a comparison/control arm that, by design, receives less implementation support than the intervention arm. Lack of such guidance can present a challenge for researchers both in setting up but also in effectively managing participating sites in such trials. This paper uses a narrative review of the literature (Phase 1 of the research) and comparative case study of three studies (Phase 2 of the research) to identify common themes related to study design and management. Based on these, we comment and reflect on: (1) the balance that needs to be struck between fidelity to the study design and tailoring to emerging requests from participating sites as part of the research process, and (2) the modifications to the implementation strategies being evaluated. Hybrid trial teams should carefully consider the impact of design selection, trial management decisions, and any modifications to implementation processes and/or support on the delivery of a controlled evaluation. The rationale for these choices should be systematically reported to fill the gap in the literature.

Socioeconomic deprivation and minority ethnic background are risk factors for adverse pregnancy outcomes. We aimed to quantify the magnitude of these socioeconomic and ethnic inequalities at the population level in England.In this cohort study, we used data compiled by the National Maternity and Perinatal Audit, based on birth records from maternity information systems used by 132 National Health Service hospitals in England, linked to administrative hospital data. We included women who gave birth to a singleton baby with a recorded gestation between 24 and 42 completed weeks. Terminations of pregnancy were excluded. We analysed data on stillbirth, preterm birth (37 weeks of gestation), and fetal growth restriction (FGR; liveborn with birthweight3rd centile by the UK definition) in England, and compared these outcomes by socioeconomic deprivation quintile and ethnic group. We calculated attributable fractions for the entire population and specific groups compared with least deprived groups or White women, both unadjusted and with adjustment for smoking, body-mass index (BMI), and other maternal risk factors.We identified 1 233 184 women with a singleton birth between April 1, 2015, and March 31, 2017, of whom 1 155 981 women were eligible and included in the analysis. 4505 (0·4%) of 1 155 981 births were stillbirths. Of 1 151 476 livebirths, 69 175 (6·0%) were preterm births and 22 679 (2·0%) were births with FGR. Risk of stillbirth was 0·3% in the least socioeconomically deprived group and 0·5% in the most deprived group (p0·0001), risk of a preterm birth was 4·9% in the least deprived group and 7·2% in the most deprived group (p0·0001), and risk of FGR was 1·2% in the least deprived group and 2·2% in the most deprived group (p0·0001). Population attributable fractions indicated that 23·6% (95% CI 16·7-29·8) of stillbirths, 18·5% (16·9-20·2) of preterm births, and 31·1% (28·3-33·8) of births with FGR could be attributed to socioeconomic inequality, and these fractions were substantially reduced when adjusted for ethnic group, smoking, and BMI (11·6% for stillbirths, 11·9% for preterm births, and 16·4% for births with FGR). Risk of stillbirth ranged from 0·3% in White women to 0·7% in Black women (p0·0001); risk of preterm birth was 6·0% in White women, 6·5% in South Asian women, and 6·6% in Black women (p0·0001); and risk of FGR ranged from 1·4% in White women to 3·5% in South Asian women (p0·0001). 11·7% of stillbirths (95% CI 9·8-13·5), 1·2% of preterm births (0·8-1·6), and 16·9% of FGR (16·1-17·8) could be attributed to ethnic inequality. Adjustment for socioeconomic deprivation, smoking, and BMI only had a small effect on these ethnic group attributable fractions (13·0% for stillbirths, 2·6% for preterm births, and 19·2% for births with FGR). Group-specific attributable fractions were especially high in the most socioeconomically deprived South Asian women and Black women for stillbirth (53·5% in South Asian women and 63·7% in Black women) and FGR (71·7% in South Asian women and 55·0% in Black women).Our results indicate that socioeconomic and ethnic inequalities were responsible for a substantial proportion of stillbirths, preterm births, and births with FGR in England. The largest inequalities were seen in Black and South Asian women in the most socioeconomically deprived quintile. Prevention should target the entire population as well as specific minority ethnic groups at high risk of adverse pregnancy outcomes, to address risk factors and wider determinants of health.Healthcare Quality Improvement Partnership.

open access article Objective: To describe the rates of and risk factors associated with iatrogenic and spontaneous preterm birth and the variation in rates between hospitals. Design: Cohort study using electronic health records. Setting: English National Health Service. Population: Singleton births between 1st April 2015 and 31st March 2017. Methods: Multivariable Poisson regression models were used to estimate adjusted risk ratios (adjRR) to measure association with maternal demographic and clinical risk factors. Main outcome measures: Preterm births (40 1.59 (1.50, 1.69)), and previous caesarean (adjRR 1.88 (1.83, 1.95)). Spontane-ous preterm birth was less common in women with a higher BMI (adjRR BMI>40 0.77 (0.70, 0.84)) and in women with a previous caesarean (adjRR 0.87 (0.83, 0.90)). More variation be-tween NHS hospital trusts was observed in rates of iatrogenic, compared to spontaneous, pre-term births. Conclusions: Just over half of all preterm births resulted from iatrogenic intervention. Iatro-genic births have overlapping but different patterns of maternal demographic and clinical risk factors to spontaneous preterm births. Iatrogenic and spontaneous sub-groups should therefore be measured and monitored separately, as well as in aggregate, to facilitate different preven-tion strategies. This is feasible using routinely acquired hospital data.

This was a retrospective study to review the uptake and outcomes of robotic gynaecological surgery in England between 1st April 2006 and 31st March 2018, analysing Hospital Episode Statistics form National Health Service hospitals in England. Women aged 18 years and above who had elective gynaecological surgery were included and those who had undergone robotic gynaecology surgery were included. Robotic gynaecological procedures were defined as procedures that used a robotic minimal access approach for hysterectomy, adnexal surgery and urogynaecological surgery (sacrocolpopexy, sacrohysteropexy and colposuspension). Numbers of procedures were reviewed by year and mapped to the 44 NHS healthcare regions. Length of stay (nights in hospital), laparotomy (conversion during primary procedure or after return to theatre for management of complication), and 30-day emergency readmission rates were calculated by year and procedure type. Overall 527,217 elective gynaecological procedures were performed in the English NHS (1st April 2006 and 31st March 2018), of which 4384 (0.83%) were performed with robotic assistance (3864 (88%) hysterectomy, 706 (16%) adnexal surgery, 192 (4%) urogynaecological surgery). There was gradual rise in the uptake of robotic surgery but there was a marked geographical variation. Median (IQR) length of stay (LOS) was 1(1-2) night, laparotomy rate was 0.3% and 30-day emergency readmission rate was 4.7%. LOS was statistically, but not clinically, different across time. Other outcomes did not differ by year. Robotic gynaecological procedures are increasingly being used in the English NHS, predominantly for hysterectomy, although in small proportions (2.6% in the most recent study year). There was wide geographical variation in robotic uptake across England and overall, outcomes were comparable to those reported in other countries.

Objective To assess the current antenatal and intrapartum management options for primigravid women of short stature with a clinically large fetus by a survey of UK Obstetricians. Study design An online survey comprised of 15 questions including the options on timing and mode of delivery, counselling about the risk of long-term pelvic floor morbidity following spontaneous vaginal and instrumental deliveries, choice of instruments and the role of episiotomy. The survey was sent to the participants as a part of Royal College of Obstetricians and Gynaecologists (RCOG) Newsletter between September 2017 to October 2018. The scenario described was of a primigravid short stature woman (i.e. height of 160 cm or less) who presents with a clinically large fetus at 38 weeks gestation. Results 424 Obstetricians participated in the survey. The participation ratio cannot be identified as the survey was emailed as a part of the RCOG Newsletter. Sixty five percent respondents stated that they would scan for estimated fetal weight, 48 % would offer induction of labour at 40 weeks and 14 % would offer an elective/planned caesarean section (CS) at 39–40 weeks. Fifty nine percent would discuss all these risks: obstructed labour, shoulder dystocia, instrumental delivery and obstetric anal sphincter injury (OASI). 73 % would not discuss the long-term risks of urinary and/or faecal incontinence and pelvic organ prolapse. In the presence of failure to progress in the second stage of labour, 69 % would attempt a rotational instrumental delivery and 5% would offer a caesarean section. Manual rotation and ‘straight’ forceps application were the most frequent type of rotational delivery, followed by Ventouse and Kiellands forceps. Thirty four percent stated that they do not routinely perform an episiotomy in this scenario. Seventy three percent stated that their choice of instrument was not based on the long-term risk of urinary and faecal incontinence. Conclusion The results suggest that 40 % of the respondents would not discuss all of the complications after vaginal delivery in women of short stature. The most common delivery option would be vaginal delivery.

Introduction and hypothesis Obstetric anal sphincter injury (OASI) is a severe form of perineal trauma that can occur during vaginal birth. Long-term morbidities include anal incontinence and psychosocial disorders. To reduce these injuries within England, Scotland and Wales, the OASI Care Bundle was introduced to 16 maternity units (January 2017–March 2018). The OASI Care Bundle comprises four elements: (1) antenatal information, (2) manual perineal protection, (3) medio-lateral episiotomy (when indicated) and 4) recognition and diagnosis of tears. As part of the project evaluation, a qualitative study was conducted to explore women’s experiences of the OASI Care Bundle. Methods Semi-structured interviews were conducted with women (n = 19) who received the OASI Care Bundle as part of their maternity care. This was to explore their experience of each element. A thematic analysis of the interview data was performed. Results Three themes were identified: (1) memories of touch, whereby women reported that a ‘hands-on’ approach to perineal protection was a positive experience; (2) midwife as a supportive guide, where women reported that good communication facilitated a calm birth and post-birth diagnosis; (3) education: women need more information about perineal trauma. Conclusion This study contributes to the literature through its exploration of women’s experiences of perineal protection techniques and diagnosis of perineal trauma. Interviewed women indicated that they did not experience any of the care bundle elements as an intrusion of their physical integrity. Additionally, an urgent need was identified for more information about perineal trauma in terms of risk, prevention and recovery.

Objective To evaluate the impact of a care bundle (antenatal information to women, manual perineal protection and mediolateral episiotomy when indicated) on obstetric anal sphincter injury (OASI) rates. Design Multicentre stepped‐wedge cluster design. Setting Sixteen maternity units located in four regions across England, Scotland and Wales. Population Women with singleton live births between October 2016 and March 2018. Methods Stepwise region by region roll‐out every 3 months starting January 2017. The four maternity units in a region started at the same time. Multi‐level logistic regression was used to estimate the impact of the care bundle, adjusting for time trend and case‐mix factors (age, ethnicity, body mass index, parity, birthweight and mode of birth). Main outcome measures Obstetric anal sphincter injury in singleton live vaginal births. Results A total of 55 060 singleton live vaginal births were included (79% spontaneous and 21% operative). Median maternal age was 30 years (interquartile range 26–34 years) and 46% of women were primiparous. The OASI rate decreased from 3.3% before to 3.0% after care bundle implementation (adjusted odds ratio 0.80, 95% CI 0.65–0.98, P = 0.03). There was no evidence that the effect of the care bundle differed according to parity (P = 0.77) or mode of birth (P = 0.31). There were no significant changes in caesarean section (P = 0.19) or episiotomy rates (P = 0.16) during the study period. Conclusions The implementation of this care bundle reduced OASI rates without affecting caesarean section rates or episiotomy use. These findings demonstrate its potential for reducing perineal trauma during childbirth. Tweetable abstract OASI Care Bundle reduced severe perineal tear rates without affecting caesarean section rates or episiotomy use., Tweetable abstract OASI Care Bundle reduced severe perineal tear rates without affecting caesarean section rates or episiotomy use.

OBJECTIVE: To compare the incidence of systemic conditions between women who had surgical treatment for stress incontinence with mesh and without mesh. DESIGN: National cohort study. SETTING: English National Health Service. POPULATION: Women with no previous record of systemic disease who had first-time urinary incontinence surgery between 1 January 2006 and 31 December 2013, followed up to the earliest of 10 years or 31 March 2019. METHODS: Competing-risks regression was used to estimate hazard ratios (HR), adjusted for patient characteristics, with HR > 1 indicating increased incidence following mesh surgery. MAIN OUTCOME MEASURES: First post-operative admission with a record of autoimmune disease, fibromyalgia or myalgic encephalomyelitis up to 10 years following the first incontinence procedure. Competing-risks regression was used to estimate hazard ratios (HR) of admission, adjusted for patient characteristics, with HR > 1 indicating increased incidence following mesh surgery. RESULTS: The cohort included 88 947 women who had mesh surgery and 3 389 women who had non-mesh surgery. Both treatment groups were similar with respect to age, socio-economic deprivation, comorbidity, and ethnicity. The 10-year cumulative incidence of autoimmune disease, fibromyalgia or myalgic encephalomyelitis was 8.1% (95% confidence interval 7.9% to 8.3%) in the mesh group and 9.0% (8.0% to 10.1%) in the non-mesh group (adjusted HR 0.89 [0.79 to 1.01]; p = 0.07). A sensitivity analysis including only autoimmune diseases as an outcome returned a similar result. CONCLUSIONS: These findings do not support claims that synthetic mesh slings cause systemic disease.

Author's reply.

Rising rates of obstetric anal sphincter injury (OASI) led to a collaborative effort by the Royal College of Obstetricians and Gynaecologists (RCOG) and the Royal College of Midwives (RCM) to develop and evaluate the OASI Care Bundle (OASI-CB). The OASI-CB comprises four practices (antenatal discussion about OASI, manual perineal protection, mediolateral episiotomy at 60° from the midline, and systematic examination of the perineum, vagina and ano-rectum after vaginal birth) and was initially implemented as part of a quality improvement (QI) project—“OASI1”—in 16 maternity units across Great Britain. Evaluation of the OASI1 project found that the care bundle reduced OASI rates and identified several barriers and enablers to implementation. This paper summarises the key findings, including strengths, limitations and lessons learned from the OASI1 QI project, and provides rationale for further evaluation of the OASI-CB.

BACKGROUND: Some studies have suggested that women with SARS-CoV-2 infection during pregnancy are at increased risk of adverse pregnancy and neonatal outcomes, but these associations are still not clear. OBJECTIVE: This study aimed to determine the association between SARS-CoV-2 infection at the time of birth and maternal and perinatal outcomes. STUDY DESIGN: This is a population-based cohort study in England. The inclusion criteria were women with a recorded singleton birth between May 29, 2020, and January 31, 2021, in a national database of hospital admissions. Maternal and perinatal outcomes were compared between pregnant women with a laboratory-confirmed SARS-CoV-2 infection recorded in the birth episode and those without. Study outcomes were fetal death at or beyond 24 weeks' gestation (stillbirth), preterm birth (.05) in the rate of other maternal outcomes. The risk of neonatal adverse outcome (adjusted odds ratio, 1.45; 95% confidence interval, 1.27-1.66; P

Background The Obstetric Anal Sphincter Injury (OASI) Care Bundle comprises four primary and secondary prevention practices that target the rising rates of severe perineal tearing during childbirth, which can have severe debilitating consequences for women. The OASI Care Bundle was implemented in 16 maternity units in Britain in the OASI1 project (2017-2018), which demonstrated the care bundle’s effectiveness in reducing OASI rates. In OASI2, the care bundle will be scaled up to 20 additional National Health Service (NHS) maternity units in a hybrid effectiveness-implementation study that will examine the effectiveness of strategies used to introduce, implement and sustain the care bundle. Methods OASI2 is a two-arm cluster-randomised control trial (C-RCT) of maternity units in England, Scotland and Wales, with an additional non-randomised study arm. C-RCT arm 1 (peer support, n = 10 units) will be supported by ‘buddy’ units to implement the OASI Care Bundle. C-RCT arm 2 (lean implementation, n = 10 units) will implement without external support. The additional study arm (sustainability, n = 10 units) will include some original OASI1 units to evaluate the care bundle’s sustainability and OASI rates over time, from before OASI1 and through the end of OASI2. Units in all three study arms will receive an Implementation Toolkit with training resources and implementation support. The C-RCT arms will be compared in terms of OASI rate reduction (primary effectiveness outcome) and clinicians’ adoption of the care bundle (primary implementation outcome). Clinical data will be collated from maternity information systems; implementation data will be collected through validated surveys with women and clinicians, supplemented by qualitative methods. Descriptive statistics and regression modelling will be used for analysis. Emergent themes from the qualitative data will be assessed using framework analysis. Discussion OASI2 will study the impact of various implementation strategies used to introduce and sustain the OASI Care Bundle, and how these strategies affect the bundle’s clinical effectiveness. The study will generate insights into how to effectively scale-up and sustain uptake and coverage of similar interventions in maternity units. A locally adaptable ‘implementation blueprint’ will be produced to inform development of future guidelines to prevent perineal trauma. Trial registration ISRCTN26523605

Background Waterbirth is widely available in English maternity settings for women who are not at increased risk of complications during labour. Immersion in water during labour is associated with a number of maternal benefits. However for birth in water the situation is less clear, with conclusive evidence on safety lacking and little known about the characteristics of women who give birth in water. This retrospective cohort study uses electronic data routinely collected in the course of maternity care in England in 2015–16 to describe the proportion of births recorded as having occurred in water, the characteristics of women who experienced waterbirth and the odds of key maternal and neonatal complications associated with giving birth in water. Methods Data were obtained from three population level electronic datasets linked together for the purposes of a national audit of maternity care. The study cohort included women who had no risk factors requiring them to give birth in an obstetric unit according to national guidelines. Multivariate logistic regression models were used to examine maternal (postpartum haemorrhage of 1500mls or more, obstetric anal sphincter injury (OASI)) and neonatal (Apgar score less than 7, neonatal unit admission) outcomes associated with waterbirth. Results 46,088 low and intermediate risk singleton term spontaneous vaginal births in 35 NHS Trusts in England were included in the analysis cohort. Of these 6264 (13.6%) were recorded as having occurred in water. Waterbirth was more likely in older women up to the age of 40 (adjusted odds ratio (adjOR) for age group 35–39 1.27, 95% confidence interval (1.15,1.41)) and less common in women under 25 (adjOR 18–24 0.76 (0.70, 0.82)), those of higher parity (parity ≥3 adjOR 0.56 (0.47,0.66)) or who were obese (BMI 30–34.9 adjOR 0.77 (0.70,0.85)). Waterbirth was also less likely in black (adjOR 0.42 (0.36, 0.51)) and Asian (adjOR 0.26 (0.23,0.30)) women and in those from areas of increased socioeconomic deprivation (most affluent versus least affluent areas adjOR 0.47 (0.43, 0.52)). There was no association between delivery in water and low Apgar score (adjOR 0.95 (0.66,1.36)) or incidence of OASI (adjOR 1.00 (0.86,1.16)). There was an association between waterbirth and reduced incidence of postpartum haemorrhage (adjOR 0.68 (0.51,0.90)) and neonatal unit admission (adjOR 0.65 (0.53,0.78)). Conclusions In this large observational cohort study, there was no association between waterbirth and specific adverse outcomes for either the mother or the baby. There was evidence that white women from higher socioeconomic backgrounds were more likely to be recorded as giving birth in water. Maternity services should focus on ensuring equitable access to waterbirth.

Additional file 1. Theory of Change for OASI2

Additional file 2. Summary of data specification for the OASI2 project

Objective To determine the association between ethnic group and likelihood of admission to intensive care in pregnancy and the postnatal period. Design Cohort study. Setting Maternity and intensive care units in England and Wales. Population or sample A total of 631 851 women who had a record of a registerable birth between 1 April 2015 and 31 March 2016 in a database used for national audit. Methods Logistic regression analyses of linked maternity and intensive care records, with multiple imputation to account for missing data. Main outcome measures Admission to intensive care in pregnancy or postnatal period to 6 weeks after birth. Results In all, 2.24 per 1000 maternities were associated with intensive care admission. Black women were more than twice as likely as women from other ethnic groups to be admitted (odds ratio [OR] 2.21, 95% CI 1.82-2.68). This association was only partially explained by demographic, lifestyle, pregnancy and birth factors (adjusted OR 1.69, 95% CI 1.37-2.09). A higher proportion of intensive care admissions in Black women were for obstetric haemorrhage than in women from other ethnic groups. Conclusions Black women have an increased risk of intensive care admission that cannot be explained by demographic, health, lifestyle, pregnancy and birth factors. Clinical and policy intervention should focus on the early identification and management of severe illness, particularly obstetric haemorrhage, in Black women, in order to reduce inequalities in intensive care admission. Tweetable abstract Black women are almost twice as likely as White women to be admitted to intensive care during pregnancy and the postpartum period; this risk remains after accounting for demographic, health, lifestyle, pregnancy and birth factors.

IntroductionObstetric anal sphincter injuries (OASI) can have severe debilitating consequences to women and health systems. The OASI Care Bundle quality improvement programme was introduced in 16 maternity units across England, Scotland and Wales (January 2017 to March 2018) to address increasing OASI rates.ObjectivesTo explore clinicians’ (midwives’ and obstetricians’) perspectives of the OASI Care Bundle with respect to (1) acceptability, (2) feasibility, and (3) sustainability.DesignA qualitative exploratory study using focus groups methodology.SettingA total of 16 focus groups were conducted in 16 maternity units in England, Scotland and Wales where the OASI Care Bundle was implemented. Focus groups took place approximately 3 months following initial implementation of the care bundle in each unit.ParticipantsA total of 101 clinicians participated, with an average of six per focus group. Participants volunteered to take part and compromised of 37 obstetricians and 64 midwives (including eight students). The majority were female and the mean age was 36.5 years.ResultsFour main themes emerged: ‘Implementation strategies’, ‘Opportunities to use the OASI Care Bundle’, ‘Does current practice need to change?’ and ‘Perceptions of what women want’. Midwives were more likely than obstetricians to report themes alluding to ‘what women want’ and variations in intrapartum perineal protection techniques. Both professional groups reported similar views of other themes, in particular regarding the supporting clinical evidence. Gaps were identified in clinicians’ knowledge and experience of intrapartum perineal management.ConclusionsAdoption of the OASI Care Bundle was associated with a number of cognitive and interpersonal factors, such as personal values, interprofessional working and how the intervention was launched; which both facilitated and impeded adoption. The ‘what women want’ theme has implications for maternal autonomy and needs further exploration. Our findings can be used by similar initiatives to reduce perineal trauma both nationally and internationally.Trial registration numberISCTRN 12143325; https://doi.org/10.1186/ISRCTN12143325.

Background There is a debate about the safety and effectiveness of surgical treatments for stress urinary incontinence. Controversy about the use of synthetic mesh sling insertion has led to an increased uptake of retropubic colposuspension and autologous sling procedures. Comparative evidence on the long-term outcomes from these procedures is needed. Objective To compare the risk of reoperation at 10 years after operation between women treated for stress urinary incontinence with retropubic colposuspension, mesh sling insertion, and autologous sling procedures. Study Design The records of admissions to National Health Service hosptials were used to identify women who had first-time stress incontinence surgery between 2006 and 2013 in England. The first incidence of the following outcomes was assessed: further stress incontinence surgery, surgery for a complication (either mesh removal, prolapse repair, or incisional hernia repair), and any reoperation (either further stress incontinence surgery, mesh removal, prolapse repair, or incisional hernia repair). The cumulative incidence of each of these outcomes up to 10 years after surgery was calculated, considering death as a competing event. Multivariable modeling was then used to estimate the reoperation hazard ratios for the different initial surgery types with adjustments for patient characteristics and concurrent prolapse surgery or hysterectomy. Results The analysis included 2262 women treated with retropubic colposuspension, 92,524 treated with mesh sling insertion, and 1234 treated with autologous sling. The cumulative incidence of any first reoperation at 10 years was 21.3% (95% confidence interval, 19.5–23.0) after retropubic colposuspension, 10.9% (10.7–11.1) after mesh sling insertion, and 12.0% (10.2–13.9) after autologous sling procedures. The women who had a retropubic colposuspension were significantly more likely to have a reoperation than women who had an autologous sling (adjusted hazard ratio for any reoperation: 1.79 [1.47–2.17]; for further stress incontinence surgery: 1.64 [1.19–2.26]; for surgery for complications: 1.89 [1.49–2.40]), whereas the women who had mesh slings had a similar hazard (for any reoperation: 0.90 [0.76–1.07]; for further stress incontinence surgery: 0.75 [0.57–0.99]; for surgery for complications: 1.11 [0.89–1.36]). A sensitivity analysis excluding the women who had concurrent prolapse surgery or hysterectomy produced similar results. Conclusion Retropubic colposuspension is associated with higher risk of reoperation at 10 years after surgery than mesh sling insertion or autologous sling procedures, with 1 in 5 women requiring reoperation.

Additional file 1.

ObjectiveTo describe the accuracy of coding of ethnicity in National Health Service (NHS) administrative hospital records compared with self-declared records in maternity booking systems, and to assess the potential impact of misclassification bias.DesignSecondary analysis of data from records of women giving birth in England (2015–2017).SettingNHS Trusts in England participating in a national audit programme.Participants1 237 213 women who gave birth between 1 April 2015 and 31 March 2017.Primary and secondary outcome measures(1) Proportion of women with complete ethnicity; (2) agreement on coded ethnicity between maternity (maternity information systems (MIS)) and administrative hospital (Hospital Episode Statistics (HES)) records; (3) rates of caesarean section and obstetric anal sphincter injury by ethnic group in MIS and HES.Results91.3% of women had complete information regarding ethnicity in HES. Overall agreement between data sets was 90.4% (κ=0.83); 94.4% when collapsed into aggregate groups of white/South Asian/black/mixed/other (κ=0.86). Most disagreement was seen in women coded as mixed in either data set. Rates of obstetrical events and complications by ethnicity were similar regardless of data set used, with the most differences seen in women coded as mixed.ConclusionsLevels of accuracy in ethnicity coding in administrative hospital records support the use of ethnicity collapsed into groups (white/South Asian/black/mixed/other), but findings for mixed and other groups, and more granular classifications, should be treated with caution. Robustness of results of analyses for associations with ethnicity can be improved by using additional primary data sources.

Strengthening primary health care (PHC) is considered a priority for efficient and responsive health systems, but empirical evidence from low- and middle-income countries is limited. The stepwise introduction of family medicine across all 81 provinces of Turkey (a middle-income country) between 2005 and 2010, aimed at PHC strengthening, presents a natural experiment for assessing the effect of family medicine on health service utilization and user satisfaction.The effect of health system reforms, that introduced family medicine, on utilization was assessed using longitudinal, province-level data for 12 years and multivariate regression models adjusting for supply-side variables, demographics, socio-economic development and underlying yearly trends. User satisfaction with primary and secondary care services was explored using data from annual Life Satisfaction Surveys. Trends in preferred first point of contact (primary vs secondary, public vs. private), reason for choice and health services issues, were described and stratified by patient characteristics, provider type, and rural/urban settings.Between 2002 and 2013, the average number of PHC consultations increased from 1.75 to 2.83 per person per year. In multivariate models, family medicine introduction was associated with an increase of 0.37 PHC consultations per person (P

Objectives To determine the rate of complicated birth at term in women classified at low risk according to the National Institute for Health and Care Excellence guideline for intrapartum care (no pre-existing medical conditions, important obstetric history, or complications during pregnancy) and to assess if the risk classification can be improved by considering parity and the number of risk factors. Design Cohort study using linked electronic maternity records. Participants 276 766 women with a singleton birth at term after a trial of labour in 87 NHS hospital trusts in England between April 2015 and March 2016. Main outcome measure A composite outcome of complicated birth, defined as a birth with use of an instrument, caesarean delivery, anal sphincter injury, postpartum haemorrhage, or Apgar score of 7 or less at five minutes. Results Multiparous women without a history of caesarean section had the lowest rates of complicated birth, varying from 8.8% (4879 of 55 426 women, 95% confidence interval 8.6% to 9.0%) in those without specific risk factors to 21.8% (613 of 2811 women, 20.2% to 23.4%) in those with three or more. The rate of complicated birth was higher in nulliparous women, with corresponding rates varying from 43.4% (25 805 of 59 413 women, 43.0% to 43.8%) to 64.3% (364 of 566 women, 60.3% to 68.3%); and highest in multiparous women with previous caesarean section, with corresponding rates varying from 42.9% (3426 of 7993 women, 41.8% to 44.0%) to 66.3% (554 of 836 women, 63.0% to 69.5%). Conclusions Nulliparous women without risk factors have substantially higher rates of complicated birth than multiparous women without a previous caesarean section even if the latter have multiple risk factors. Grouping women first according to parity and previous mode of birth, and then within these groups according to presence of specific risk factors would provide greater and more informed choice to women, better targeting of interventions, and fewer transfers during labour than according to the presence of risk factors alone.

Objective Caesarean section is increasing in prevalence and with it the proportion of women going into their next pregnancy with a scar on their uterus. For women considering vaginal birth after caesarean (VBAC), accurate information about the associated risks is required. Study design The cohort comprised 192,057 women who had a vaginal delivery of a singleton, term, cephalic infant between the 1st April 2013 and the 31st March 2014 in England: 182,064 women who were having their first baby, and 9993 women who were having a second baby after a previous caesarean delivery. Their risk of an obstetric anal sphincter injury (OASI) was compared using a mixed-effects logistic regression model, adjusting for maternal age, use of instrument, episiotomy, prolonged labour, shoulder dystocia, and demographic factors. Results The OASI rate was 5.0% in primiparous women, 5.8% in secondiparous women undergoing VBAC after previous elective caesarean, and 7.6% in secondiparous women undergoing VBAC after previous emergency caesarean. Women having a VBAC for their second baby following an emergency caesarean section in their first delivery had a higher rate of OASI than primiparous women (adjusted OR 1.31; 95% CI: 1.20, 1.43), For women with a previous elective delivery, the rates are similar to those for primiparous women. Conclusion Women having a VBAC after emergency caesarean have a higher rate of OASI than primiparous women. This is important in the counselling of women considering VBAC.

Importance There is concern about outcomes of midurethral mesh sling insertion for women with stress urinary incontinence. However, there is little evidence on long-term outcomes. Objective To examine long-term mesh removal and reoperation rates in women who had a midurethral mesh sling insertion for stress urinary incontinence. Design, Setting, and Participants This population-based retrospective cohort study included 95 057 women aged 18 years or older who had a first-ever midurethral mesh sling insertion for stress urinary incontinence in the National Health Service hospitals in England between April 1, 2006, and December 31, 2015. Women were followed up until April 1, 2016. Exposures Patient and hospital factors and retropubic or transobturator mesh sling insertions. Main Outcomes and Measures The primary outcome was the risk of midurethral mesh sling removal (partial or total) and secondary outcomes were reoperation for stress urinary incontinence and any reoperation including mesh removal, calculated with death as competing risk. A multivariable Fine-Gray model was used to calculate subdistribution hazard ratios as estimates of relative risk. Results The study population consisted of 95 057 women (median age, 51 years; interquartile range, 44-61 years) with first midurethral mesh sling insertion, including 60 194 with retropubic insertion and 34 863 with transobturator insertion. The median follow-up time was 5.5 years (interquartile range, 3.2-7.5 years). The rate of midurethral mesh sling removal was 1.4% (95% CI, 1.3%-1.4%) at 1 year, 2.7% (95% CI, 2.6%-2.8%) at 5 years, and 3.3% (95% CI, 3.2%-3.4%) at 9 years. Risk of removal declined with age. The 9-year removal risk after transobturator insertion (2.7% [95% CI, 2.4%-2.9%]) was lower than the risk after retropubic insertion (3.6% [95% CI, 3.5%-3.8%]; subdistribution hazard ratio, 0.72 [95% CI, 0.62-0.84]). The rate of reoperation for stress urinary incontinence was 1.3% (95% CI, 1.3%-1.4%) at 1 year, 3.5% (95% CI, 3.4%-3.6%) at 5 years, and 4.5% (95% CI, 4.3%-4.7%) at 9 years. The rate of any reoperation, including mesh removal, was 2.6% (95% CI, 2.5%-2.7%) at 1 year, 5.5% (95% CI, 5.4%-5.7%) at 5 years, and 6.9% (95% CI, 6.7%-7.1%) at 9 years. Conclusions and Relevance Among women undergoing midurethral mesh sling insertion, the rate of mesh sling removal at 9 years was estimated as 3.3%. These findings may guide women and their surgeons when making decisions about surgical treatment of stress urinary incontinence.

Background In 2003, the Turkish government introduced a major health system reform, the Health Transformation Program (HTP), aimed at achieving Universal Health Coverage (UHC). HTP has helped to expand insurance coverage and health benefits for the uninsured population groups, which included low-income households and the unemployed, through the Green Card scheme, a non-contributory health insurance funded by the government. The Green Card scheme expansion began in 2005 and increased rapidly after 2008, following the introduction of a new comprehensive benefits package, to cover an additional 13 million people. Methods We examine the impact of the Green Card scheme on the utilization of outpatient, inpatient, specialist, and diagnostics services using the Turkish Health Survey data (2010), using a kinked regression design. We take advantage of a sharp break in the availability of health insurance at a particular income level (minimum wage) to examine the impact of the Green Card scheme on health service utilization. Results Our results show that having a Green Card increases the fraction of people using outpatient services by 68.30 percentage points, inpatient visit by 34.60 percentage points, and specialist visit by 74.10 percentage points. Conclusions Our findings suggest that a non-contributory health insurance program, such as the Green Card scheme in Turkey, could provide increased access to health care services by the poor and provide important lessons for countries which aim to introduce health programs targeting poor as part of a transition to UHC.

Third and fourth degree perineal tears, or obstetric anal sphincter injuries (OASI), sustained during childbirth can result in anal incontinence and psychosocial problems which require ongoing treatment. Within the English National Health System (NHS) reported rates of OASI have gradually increased. In response, a care bundle was developed incorporating four elements: 1) antenatal information to women, 2) manual perineal protection during all vaginal births, 3) episiotomy to be performed with a 60° mediolateral angle at crowning (when clinically indicated) and 4) perineal examination (including per rectum) after childbirth. Implementation of the OASI Care Bundle is aided by a skills development module and an awareness campaign. The project is a collaboration between two national professional bodies, an NHS hospital trust and an academic institution. Implementation of the OASI Care Bundle will be evaluated using a stepped-wedge design. From January 2017 sixteen maternity units across England, Wales and Scotland will participate in the study over a 15-month period, with sequential roll-out of the intervention in four blocks (regions) of four units. The primary clinical outcome is OASI rate. Regression analysis will adjust for differences in organisational characteristics and obstetric risk factors in women who gave birth before and after implementation of the care bundle. Focus group discussions and in-depth interviews with clinicians will evaluate the feasibility of integrating the care bundle into routine practice. Interviews with women will explore the acceptability of the intervention. This protocol outlines the evaluation of our quality improvement project which aims to prevent OASI using a bundle of evidence-based interventions that are each widely used in practice. The OASI project aims to 1) standardise practice to prevent OASI in a way that is acceptable to clinicians and women and 2) identify the barriers and enablers associated with upscaling interventions within maternity units. If found to be effective, feasible and acceptable, the OASI Care Bundle will be shared with a range of audiences using the communication channels available to the professional bodies. The OASI Project was retrospectively registered on the ISCTRN12143325 database date assigned 03/10/2017.

Hospital administrative data are attractive for comparing performance of maternity units because of their often large sample sizes, lack of selection bias and the relatively low costs of accessing these data compared with conducting primary data collection. However, using administrative data to develop indicators can also present challenges including varying data quality, the limited detail on clinical risk factors and a lack of structural and user experience measures. This review illustrates how to develop performance indicators for maternity units using hospital administrative data, including methods to address the challenges that administrative data pose. Tweetable abstract How to develop maternity indicators from administrative data.

Objective To investigate, among women who have had a third- or fourth-degree perineal tear, the mode of delivery in subsequent pregnancies as well as the recurrence rate of third- or fourth-degree tears. Design A retrospective cohort study of deliveries using a national administrative database. Setting The English National Health Service between 1 April 2004 and 31 March 2012. Population A total of 639 402 primiparous women who had a singleton, term, vaginal live birth between April 2004 and March 2011, and a second birth before April 2012. Methods Multivariable logistic regression models were used to estimate odds ratios, adjusted for other risk factors. Main outcome measures Mode of delivery and recurrence of tears at second birth. Results The rate of elective caesarean at second birth was 24.2% for women with a third- or fourth-degree tear at first birth, and 1.5% for women without (adjusted odds ratio, aOR 18.3, 95% confidence interval, 95% CI 16.4–20.4). Among women who had a vaginal delivery at second birth, the rate of third- or fourth-degree tears was 7.2% for women with a third- or fourth-degree tear at first birth, compared with 1.3% for women without (aOR 5.5, 95% CI 5.2–5.9). Conclusions The risk of a severe perineal tear is increased five-fold in women who had a third- or fourth-degree tear in their first delivery. This increased risk should be taken into account when decisions about mode of delivery are made.