Health Insurance Schemes and Their Influences on Healthcare Variation in Asian Countries: A Realist Review and Theory's Testing in Thailand.

BACKGROUND: Various features in health insurance schemes may lead to variation in health care. Unwarranted variations raise concerns about suboptimal quality of care, differing treatments for similar needs, or unnecessary financial burdens on patients and health systems. This realist review aims to explore insurance features that may contribute to health care variation in Asian countries; and to understand influencing mechanisms and contexts. METHODS: We undertook a realist review. First, we developed an initial theory. Second, we conducted a systematic review of peer-reviewed literature in Scopus, MEDLINE, EMBASE, and Web of Science to produce a middle range theory for Asian countries. The Mixed Methods Appraisal Tool (MMAT) was used to appraise the methodological quality of included studies. Finally, we tested the theory in Thailand by interviewing nine experts, and further refined the theory. RESULTS: Our systematic search identified 14 empirical studies. We produced a middle range theory in a context-mechanism-outcome configuration (CMOc) which presented seven insurance features: benefit package, cost-sharing policies, beneficiaries, contracted providers, provider payment methods, budget size, and administration and management, that influenced variation through 20 interlinked demand- and supply-side mechanisms. The refined theory for Thailand added eight mechanisms and discarded six mechanisms irrelevant to the local context. CONCLUSION: Our middle range and refined theories provide information about health insurance features associated with health care variation. We encourage policymakers and researchers to test the CMOc in their specific contexts. Appropriately validated, it can help design interventions in health insurance schemes to prevent or mitigate the detrimental effects of unwarranted health care variation.

An exploration of service use pattern changes and cost analysis following implementation of community perinatal mental health teams in pregnant women with a history of specialist mental healthcare in England: a national population-based cohort study.

BACKGROUND: The National Health Service in England pledged >£365 million to improve access to mental healthcare services via Community Perinatal Mental Health Teams (CPMHTs) and reduce the rate of perinatal relapse in women with severe mental illness. This study aimed to explore changes in service use patterns following the implementation of CPMHTs in pregnant women with a history of specialist mental healthcare in England, and conduct a cost-analysis on these changes. METHODS: This study used a longitudinal cohort design based on existing routine administrative data. The study population was all women residing in England with an onset of pregnancy on or after 1st April 2016 and who gave birth on or before 31st March 2018 with pre-existing mental illness (N = 70,323). Resource use and costs were compared before and after the implementation of CPMHTs. The economic perspective was limited to secondary mental health services, and the time horizon was the perinatal period (from the start of pregnancy to 1-year post-birth, ~ 21 months). RESULTS: The percentage of women using community mental healthcare services over the perinatal period was higher for areas with CPMHTs (30.96%, n=9,653) compared to areas without CPMHTs (24.72%, n=9,615). The overall percentage of women using acute care services (inpatient and crisis resolution teams) over the perinatal period was lower for areas with CPMHTs (4.94%, n=1,540 vs. 5.58%, n=2,171), comprising reduced crisis resolution team contacts (4.41%, n=1,375 vs. 5.23%, n=2,035) but increased psychiatric admissions (1.43%, n=445 vs. 1.13%, n=441). Total mental healthcare costs over the perinatal period were significantly higher for areas with CPMHTs (fully adjusted incremental cost £111, 95% CI £29 to £192, p-value 0.008). CONCLUSIONS: Following implementation of CPMHTs, the percentage of women using acute care decreased while the percentage of women using community care increased. However, the greater use of inpatient admissions alongside greater use of community care resulted in a significantly higher mean cost of secondary mental health service use for women in the CPMHT group compared with no CPMHT. Increased costs must be considered with caution as no data was available on relevant outcomes such as quality of life or satisfaction with services.

Community perinatal mental health teams and associations with perinatal mental health and obstetric and neonatal outcomes in pregnant women with a history of secondary mental health care in England: a national population-based cohort study.

BACKGROUND: Women with a pre-existing severe mental disorder have an increased risk of relapse after giving birth. We aimed to evaluate associations of the gradual regional implementation of community perinatal mental health teams in England from April, 2016, with access to mental health care and with mental health, obstetric, and neonatal outcomes. METHODS: For this cohort study, we used the national dataset of secondary mental health care provided by National Health Service England, including mental health-care episodes from April 1, 2006, to March 31, 2019, linked at patient level to the Hospital Episode Statistics, and birth notifications from the Personal Demographic Service. We included women (aged ≥18 years) with an onset of pregnancy from April 1, 2016, who had given birth to a singleton baby up to March 31, 2018, and who had a pre-existing mental disorder, defined as contacts with secondary mental health care in the 10 years immediately before pregnancy. The primary outcome was acute relapse, defined as psychiatric hospital admission or crisis resolution team contact in the postnatal period (first year after birth). Secondary outcomes included any secondary mental health care in the perinatal period (pregnancy and postnatal period) and obstetric and neonatal outcomes. Outcomes were compared according to whether a community perinatal mental health team was available before pregnancy, with odds ratios (ORs) adjusted for time trends and maternal characteristics (adjORs). FINDINGS: Of 807 798 maternity episodes in England, we identified 780 026 eligible women with a singleton birth, of whom 70 323 (9·0%) had a pre-existing mental disorder. A postnatal acute relapse was found in 1117 (3·6%) of 31 276 women where a community perinatal mental health team was available and in 1745 (4·5%) of 39 047 women where one was unavailable (adjOR 0·77, 95% CI 0·64-0·92; p=0·0038). Perinatal access to any secondary mental health care was found in 9888 (31·6%) of 31 276 women where a community perinatal mental health team was available and 10 033 (25·7%) of 39 047 women where one was not (adjOR 1·35, 95% CI 1·23-1·49; p<0·0001). Risk of stillbirth and neonatal death was higher where a community perinatal mental health team was available (165 [0·5%] of 30 980 women) than where it was not (151 [0·4%] of 38 693 women; adjOR 1·34, 95% CI 1·09-1·66; p=0·0063), as was the risk of a baby small for gestational age (2227 [7·2%] of 31 030 women vs 2542 [6·6%] of 38 762 women; adjOR 1·10, 1·02-1·20; p=0·016), whereas preterm birth risk was lower (3167 [10·1%] of 31 206 women vs 4341 [11·1%] of 38 961; adjOR 0·86, 0·74-0·99; p=0·032). INTERPRETATION: The regional availability of community perinatal mental health teams reduced the postnatal risk of acute relapse and increased the overall use of secondary mental health care. Community perinatal mental health teams should have close links with maternity services to avoid intensive psychiatric support overshadowing obstetric and neonatal risks. FUNDING: The National Institute for Health and Care Research.

Obstetric and neonatal outcomes in pregnant women with and without a history of specialist mental health care: a national population-based cohort study using linked routinely collected data in England.

BACKGROUND: Pregnant women with pre-existing mental illnesses have increased risks of adverse obstetric and neonatal outcomes compared with pregnant women without pre-existing mental illnesses. We aimed to estimate these differences in risks according to the highest level of pre-pregnancy specialist mental health care, defined as psychiatric hospital admission, crisis resolution team (CRT) contact, or specialist community care only, and the timing of the most recent care episode in the 7 years before pregnancy. METHODS: Hospital and birth registration records of women with singleton births between April 1, 2014, and March 31, 2018 in England were linked to records of babies and records from specialist mental health services provided by the England National Health Service, a publicly funded health-care system. We compared the risks of adverse pregnancy outcomes, including fetal and neonatal death, preterm birth, and babies being born small for gestational age (SGA; birthweight <10th percentile), and composite indicators for neonatal adverse outcomes and maternal morbidity, between women with and without a history of contact with specialist mental health care. We calculated odds ratios adjusted for maternal characteristics (aORs), using logistic regression. FINDINGS: Of 2 081 043 included women (mean age 30·0 years; range 18-55 years; 77·7% White, 11·4% South Asian, 4·7% Black, and 6·2% mixed or other ethnic background), 151 770 (7·3%) had at least one pre-pregnancy specialist mental health-care contact. 7247 (0·3%) had been admitted to a psychiatric hospital, 29 770 (1·4%) had CRT contact, and 114 753 (5·5%) had community care only. With a pre-pregnancy mental health-care contact, risk of stillbirth or neonatal death within 7 days of birth was not significantly increased (0·45-0·49%; aOR 1·11, 95% CI 0·99-1·24): risk of preterm birth (<37 weeks) increased (6·5-9·8%; aOR 1·53, 1·35-1·73), as did risk of SGA (6·2- 7·5%; aOR 1·34, 1·30-1·37) and neonatal adverse outcomes (6·4-8·4%; aOR 1·37, 1·21-1·55). With a pre-pregnancy mental health-care contact, risk of maternal morbidity increased slightly from 0·9% to 1·0% (aOR 1·18, 1·12-1·25). Overall, risks were highest for women who had a psychiatric hospital admission any time or a mental health-care contact in the year before pregnancy. INTERPRETATION: Information about the level and timing of pre-pregnancy specialist mental health-care contacts helps to identify women at increased risk of adverse obstetric and neonatal outcomes. These women are most likely to benefit from dedicated community perinatal mental health teams working closely with maternity services to provide integrated care. FUNDING: National Institute for Health Research.

Induction of labour at 39 weeks and adverse outcomes in low-risk pregnancies according to ethnicity, socioeconomic deprivation, and parity: A national cohort study in England.

BACKGROUND: Ethnic and socioeconomic inequalities in obstetric outcomes are well established. However, the role of induction of labour (IOL) to reduce these inequalities is controversial, in part due to insufficient evidence. This national cohort study aimed to identify adverse perinatal outcomes associated with IOL with birth at 39 weeks of gestation ("IOL group") compared to expectant management ("expectant management group") according to maternal characteristics in women with low-risk pregnancies. METHODS AND FINDINGS: All English National Health Service (NHS) hospital births between January 2018 and March 2021 were examined. Using the Hospital Episode Statistics (HES) dataset, maternal and neonatal data (demographic, diagnoses, procedures, labour, and birth details) were linked, with neonatal mortality data from the Office for National Statistics (ONS). Women with a low-risk pregnancy were identified by excluding pregnancies with preexisting comorbidities, previous cesarean section, breech presentation, placenta previa, gestational diabetes, or a baby with congenital abnormalities. Women with premature rupture of membranes, placental abruption, hypertensive disorders of pregnancy, amniotic fluid abnormalities, or antepartum stillbirth were excluded only from the IOL group. Adverse perinatal outcome was defined as stillbirth, neonatal death, or neonatal morbidity, the latter identified using the English composite neonatal outcome indicator (E-NAOI). Binomial regression models estimated risk differences (with 95% confidence intervals (CIs)) between the IOL group and the expectant management group, adjusting for ethnicity, socioeconomic background, maternal age, parity, year of birth, and birthweight centile. Interaction tests examined risk differences according to ethnicity, socioeconomic background, and parity. Of the 1 567 004 women with singleton pregnancies, 501 072 women with low-risk pregnancies and with sufficient data quality were included in the analysis. Approximately 3.3% of births in the IOL group (1 555/47 352) and 3.6% in the expectant management group (16 525/453 720) had an adverse perinatal outcome. After adjustment, a lower risk of adverse perinatal outcomes was found in the IOL group (risk difference -0.28%; 95% CI -0.43%, -0.12%; p = 0.001). This risk difference varied according to socioeconomic background from 0.38% (-0.08%, 0.83%) in the least deprived to -0.48% (-0.76%, -0.20%) in the most deprived national quintile (p-value for interaction = 0.01) and by parity with risk difference of -0.54% (-0.80%, -0.27%) in nulliparous women and -0.15% (-0.35%, 0.04%) in multiparous women (p-value for interaction = 0.02). There was no statistically significant evidence that risk differences varied according to ethnicity (p = 0.19). Key limitations included absence of additional confounding factors such as smoking, BMI, and the indication for induction in the HES datasets, which may mean some higher risk pregnancies were included. CONCLUSIONS: IOL with birth at 39 weeks was associated with a small reduction in the risk of adverse perinatal outcomes, with 360 inductions in low-risk pregnancies needed to avoid 1 adverse outcome. The risk reduction was mainly present in women from more socioeconomically deprived areas and in nulliparous women. There was no significant risk difference found by ethnicity. Increased uptake of IOL at 39 weeks, especially in women from more socioeconomically deprived areas, may help reduce inequalities in adverse perinatal outcomes.

Design and management considerations for control groups in hybrid effectiveness-implementation trials: Narrative review & case studies.

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.

Iatrogenic and spontaneous preterm birth in England: A population-based cohort study.

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 1 April 2015 and 31 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 (<37 weeks of gestation) were defined as iatrogenic or spontaneous according to mode of onset of labour. RESULTS: Of the births, 6.1% were preterm and of these, 52.8% were iatrogenic. The proportion of preterm births that were iatrogenic increased after 32 weeks. Both sub-groups were associated with previous preterm birth, extremes of maternal age, socio-economic deprivation and smoking. Iatrogenic preterm birth was associated with higher body mass index (BMI) (BMI >40 kg/m2 adjRR 1.59, 95% CI 1.50-1.69) and previous caesarean (adjRR 1.88, 95% CI 1.83-1.95). Spontaneous preterm birth was less common in women with a higher BMI (BMI >40 kg/m2 adjRR 0.77, 95% CI 0.70-0.84) and in women with a previous caesarean (adjRR 0.87, 95% CI 0.83-0.90). More variation between NHS hospital trusts was observed in rates of iatrogenic, compared with spontaneous, preterm births. CONCLUSIONS: Just over half of all preterm births resulted from iatrogenic intervention. Iatrogenic 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 prevention strategies. This is feasible using routinely acquired hospital data.

Use of induction of labour and emergency caesarean section and perinatal outcomes in English maternity services: a national hospital-level study.

OBJECTIVES: To assess the association between hospital-level rates of induction of labour and emergency caesarean section, as measures of "practice style", and rates of adverse perinatal outcomes. DESIGN: National study using electronic maternity records. SETTING: English National Health Service. PARTICIPANTS: Hospitals providing maternity care to women between April 2015 and March 2017. MAIN OUTCOME MEASURES: Stillbirth, admission to a neonatal unit, and babies receiving mechanical ventilation. RESULTS: Among singleton term births, the risk of stillbirth was 0.15%; of admission to a neonatal unit 5.4%; and of mechanical ventilation 0.54%. There was considerable between-hospital variation in the induction of labour rate (minimum 17.5%, maximum 40.7%) and the emergency caesarean section rate (minimum 5.6%, maximum 17.1%). Women who gave birth in hospitals with a higher induction of labour rate had better perinatal outcomes. For each 5%-point increase in induction, there was a decrease in the risk of term stillbirth by 9% (OR 0.91; 95% CI 0.85 to 0.97) and mechanical ventilation by 14% (OR 0.86; 95% CI 0.79 to 0.94). There was no significant association between hospital-level induction of labour rates and neonatal unit admission at term (p>0.05). There was no significant association between hospital-level emergency caesarean section rates and adverse perinatal outcomes (p always >0.05). CONCLUSIONS: There is considerable between-hospital variation in the use of induction of labour and emergency caesarean section. Hospitals with a higher induction rate had a lower risk of adverse birth outcomes. A similar association was not found for caesarean section.

Obstetric interventions and pregnancy outcomes during the COVID-19 pandemic in England: A nationwide cohort study.

BACKGROUND: The COVID-19 pandemic has disrupted maternity services worldwide and imposed restrictions on societal behaviours. This national study aimed to compare obstetric intervention and pregnancy outcome rates in England during the pandemic and corresponding pre-pandemic calendar periods, and to assess whether differences in these rates varied according to ethnic and socioeconomic background. METHODS AND FINDINGS: We conducted a national study of singleton births in English National Health Service hospitals. We compared births during the COVID-19 pandemic period (23 March 2020 to 22 February 2021) with births during the corresponding calendar period 1 year earlier. The Hospital Episode Statistics database provided administrative hospital data about maternal characteristics, obstetric inventions (induction of labour, elective or emergency cesarean section, and instrumental birth), and outcomes (stillbirth, preterm birth, small for gestational age [SGA; birthweight < 10th centile], prolonged maternal length of stay (≥3 days), and maternal 42-day readmission). Multi-level logistic regression models were used to compare intervention and outcome rates between the corresponding pre-pandemic and pandemic calendar periods and to test for interactions between pandemic period and ethnic and socioeconomic background. All models were adjusted for maternal characteristics including age, obstetric history, comorbidities, and COVID-19 status at birth. The study included 948,020 singleton births (maternal characteristics: median age 30 years, 41.6% primiparous, 8.3% with gestational diabetes, 2.4% with preeclampsia, and 1.6% with pre-existing diabetes or hypertension); 451,727 births occurred during the defined pandemic period. Maternal characteristics were similar in the pre-pandemic and pandemic periods. Compared to the pre-pandemic period, stillbirth rates remained similar (0.36% pandemic versus 0.37% pre-pandemic, p = 0.16). Preterm birth and SGA birth rates were slightly lower during the pandemic (6.0% versus 6.1% for preterm births, adjusted odds ratio [aOR] 0.96, 95% CI 0.94-0.97; 5.6% versus 5.8% for SGA births, aOR 0.95, 95% CI 0.93-0.96; both p < 0.001). Slightly higher rates of obstetric intervention were observed during the pandemic (40.4% versus 39.1% for induction of labour, aOR 1.04, 95% CI 1.03-1.05; 13.9% versus 12.9% for elective cesarean section, aOR 1.13, 95% CI 1.11-1.14; 18.4% versus 17.0% for emergency cesarean section, aOR 1.07, 95% CI 1.06-1.08; all p < 0.001). Lower rates of prolonged maternal length of stay (16.7% versus 20.2%, aOR 0.77, 95% CI 0.76-0.78, p < 0.001) and maternal readmission (3.0% versus 3.3%, aOR 0.88, 95% CI 0.86-0.90, p < 0.001) were observed during the pandemic period. There was some evidence that differences in the rates of preterm birth, emergency cesarean section, and unassisted vaginal birth varied according to the mother's ethnic background but not according to her socioeconomic background. A key limitation is that multiple comparisons were made, increasing the chance of false-positive results. CONCLUSIONS: In this study, we found very small decreases in preterm birth and SGA birth rates and very small increases in induction of labour and elective and emergency cesarean section during the COVID-19 pandemic, with some evidence of a slightly different pattern of results in women from ethnic minority backgrounds. These changes in obstetric intervention rates and pregnancy outcomes may be linked to women's behaviour, environmental exposure, changes in maternity practice, or reduced staffing levels.

Risk of postpartum haemorrhage is associated with ethnicity: A cohort study of 981 801 births in England.

OBJECTIVE: To determine the association between ethnic group and risk of postpartum haemorrhage in women giving birth. DESIGN: Cohort study. SETTING: Maternity units in England. SAMPLE: A total of 981 801 records of births between 1 April 2015 and 31 March 2017 in a national clinical database. METHODS: Multivariable logistic regression analyses with multiple imputation to account for missing data and robust standard errors to account for clustering within hospitals. MAIN OUTCOME MEASURE: Postpartum haemorrhage of ≥1500 ml (PPH). RESULTS: A total of 28 268 (2.9%) births were complicated by PPH. Risks were higher in women from black (3.9%) and other (3.5%) ethnic backgrounds. Following adjustment for maternal and fetal characteristics, and care at birth, there was evidence of an increased risk of PPH in women from all ethnic minority groups, with the largest increase seen in black women (adjusted OR 1.54, 95% CI 1.45-1.63). The increase in risk was robust to sensitivity analyses, which included changing the outcome to PPH of ≥3000 ml. CONCLUSIONS: In England, women from ethnic minority backgrounds have an increased risk of PPH, when maternal, fetal and birth characteristics are taken into account. Factors contributing to this increased risk need further investigation. Perinatal care for women from ethnic minority backgrounds should focus on preventative measures to optimise maternal outcomes. TWEETABLE ABSTRACT: Women with an ethnic minority background giving birth in England have an increased risk of postpartum haemorrhage, even when characteristics of the mother, the baby and the care received are taken into account.

Adverse pregnancy outcomes attributable to socioeconomic and ethnic inequalities in England: a national cohort study.

BACKGROUND: 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. METHODS: 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 birthweight <3rd 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. FINDINGS: 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 (p<0·0001), risk of a preterm birth was 4·9% in the least deprived group and 7·2% in the most deprived group (p<0·0001), and risk of FGR was 1·2% in the least deprived group and 2·2% in the most deprived group (p<0·0001). 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 (p<0·0001); risk of preterm birth was 6·0% in White women, 6·5% in South Asian women, and 6·6% in Black women (p<0·0001); and risk of FGR ranged from 1·4% in White women to 3·5% in South Asian women (p<0·0001). 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). INTERPRETATION: 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. FUNDING: Healthcare Quality Improvement Partnership.

Risk of reoperation 10 years after surgical treatment for stress urinary incontinence: a national population-based cohort study.

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.

Validation of ethnicity in administrative hospital data in women giving birth in England: cohort study.

OBJECTIVE: To 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. DESIGN: Secondary analysis of data from records of women giving birth in England (2015-2017). SETTING: NHS Trusts in England participating in a national audit programme. PARTICIPANTS: 1 237 213 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. RESULTS: 91.3% 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. CONCLUSIONS: Levels 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.

Global changes in maternity care provision during the COVID-19 pandemic: A systematic review and meta-analysis.

BACKGROUND: The COVID-19 pandemic has had a profound impact on healthcare systems globally, with a worrying increase in adverse maternal and foetal outcomes. We aimed to assess the changes in maternity healthcare provision and healthcare-seeking by pregnant women during the COVID-19 pandemic. METHODS: We performed a systematic review and meta-analysis of studies of the effects of the pandemic on provision of, access to and attendance at maternity services (CRD42020211753). We searched MEDLINE and Embase in accordance with PRISMA guidelines from January 1st, 2020 to April 17th 2021 for controlled observational studies and research letters reporting primary data comparing maternity healthcare-seeking and healthcare delivery during compared to before the COVID-19 pandemic. Case reports and series, systematic literature reviews, and pre-print studies were excluded. Meta-analysis was performed on comparable outcomes that were reported in two or more studies. Data were combined using random-effects meta-analysis, using risk ratios (RR) or incidence rate ratios (IRR) with 95% confidence intervals (CI). FINDINGS: Of 4743 citations identified, 56 were included in the systematic review, and 21 in the meta-analysis. We identified a significant decrease in the number of antenatal clinic visits (IRR 0614, 95% CI 0486-0776, P<00001, I2=54.6%) and unscheduled care visits (IRR 0741, 95% CI 0602-0911, P = 00046, I2=00%) per week, and an increase in virtual or remote antenatal care (IRR 4656 95% CI 7762-2794, P<00001, I2=90.6%) and hospitalisation of unscheduled attendees (RR 1214, 95% CI 1118-1319, P<00001, I2=00%). There was a decrease in the use of GA for category 1 Caesarean sections (CS) (RR 0529, 95% CI 0407-0690, P<00001, I2=00%). There was no significant change in intrapartum epidural use (P = 00896) or the use of GA for elective CS (P = 079). INTERPRETATION: Reduced maternity healthcare-seeking and healthcare provision during the COVID-19 pandemic has been global, and must be considered as potentially contributing to worsening of pregnancy outcomes observed during the pandemic.

OASI2: a cluster randomised hybrid evaluation of strategies for sustainable implementation of the Obstetric Anal Sphincter Injury Care Bundle in maternity units in Great Britain.

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.

Maternal and perinatal outcomes of pregnant women with SARS-CoV-2 infection at the time of birth in England: national cohort study.

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 (<37 weeks' gestation), small for gestational age infant (small for gestational age; birthweight at the .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<.001), need for specialist neonatal care (adjusted odds ratio, 1.24; 95% confidence interval, 1.02-1.51; P=.03), and prolonged neonatal admission after birth (adjusted odds ratio, 1.61; 95% confidence interval, 1.49-1.75; P<.001) were all significantly higher for infants with mothers with laboratory-confirmed SARS-CoV-2 infection. When the analysis was restricted to pregnancies delivered at term (≥37 weeks), there were no significant differences in neonatal adverse outcome (P=.78), need for specialist neonatal care after birth (P=.22), or neonatal readmission within 4 weeks of birth (P=.05). Neonates born at term to mothers with laboratory-confirmed SARS-CoV-2 infection were more likely to have prolonged admission after birth (21.1% compared with 14.6%; adjusted odds ratio, 1.61; 95% confidence interval, 1.49-1.75; P<.001). CONCLUSION: SARS-CoV-2 infection at the time of birth is associated with higher rates of fetal death, preterm birth, preeclampsia, and emergency cesarean delivery. There were no additional adverse neonatal outcomes, other than those related to preterm delivery. Pregnant women should be counseled regarding risks of SARS-CoV-2 infection and should be considered a priority for vaccination.

The OASI care bundle quality improvement project: lessons learned and future direction.

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.