The cost-effectiveness of universal late-pregnancy screening for macrosomia in nulliparous women: a decision analysis.

OBJECTIVE: To identify the most cost-effective policy for detection and management of fetal macrosomia in late-stage pregnancy. DESIGN: Health economic simulation model. SETTING: All English NHS antenatal services. POPULATION: Nulliparous women in the third trimester treated within the UK NHS. METHODS: A health economic simulation model was used to compare long-term maternal-fetal health and cost outcomes for two detection strategies (universal ultrasound scanning at approximately 36 weeks of gestation versus selective ultrasound scanning), combined with three management strategies (planned caesarean section versus induction of labour versus expectant management) of suspected fetal macrosomia. Probabilities, costs and health outcomes were taken from literature. MAIN OUTCOME MEASURES: Expected costs to the NHS and quality-adjusted life-years (QALYs) gained from each strategy, calculation of net benefit and hence identification of most cost-effective strategy. RESULTS: Compared with selective ultrasound, universal ultrasound increased QALYs by 0.0038 (95% CI 0.0012-0.0076), but also costs by £123.50 (95% CI 99.6-149.9). Overall, the health gains were too small to justify the cost increase given current UK thresholds cost-effective policy was selective ultrasound coupled with induction of labour where macrosomia was suspected. CONCLUSIONS: The most cost-effective policy for detection and management of fetal macrosomia is selective ultrasound scanning coupled with induction of labour for all suspected cases of macrosomia. Universal ultrasound scanning for macrosomia in late-stage pregnancy is not cost-effective. TWEETABLE ABSTRACT: Universal late-pregnancy ultrasound screening for fetal macrosomia is not warranted.

Achieving orphan designation for placental insufficiency: annual incidence estimations in Europe.

OBJECTIVE: To determine whether a novel therapy for placental insufficiency could achieve orphan drug status by estimating the annual incidence of placental insufficiency, defined as an estimated fetal weight below the 10th centile in the presence of abnormal umbilical artery Doppler velocimetry, per 10 000 European Union (EU) population as part of an application for European Medicines Agency (EMA) orphan designation. DESIGN: Incidence estimation based on literature review and published national and EU statistics. SETTING AND POPULATION: European Union. METHODS: Data were drawn from published literature, including national and international guidelines, international consensus statements, cohort studies and randomised controlled trials, and published national and EU statistics, including birth rates and stillbirth rates. Rare disease databases were also searched. RESULTS: The proportion of affected pregnancies was estimated as 3.17% (95% CI 2.93-3.43%), using a weighted average of the results from two cohort studies. Using birth rates from 2012 and adjusting for a pregnancy loss rate of 1/100 gave an estimated annual incidence of 3.33 per 10 000 EU population (95% CI 3.07-3.60 per 10 000 EU population). This fell below the EMA threshold of 5 per 10 000 EU population. CONCLUSIONS: Maternal vascular endothelial growth factor gene therapy for placental insufficiency was granted EMA orphan status in 2015 after we demonstrated that it is a rare, life-threatening or chronically debilitating and currently untreatable disease. Developers of other potential obstetric therapies should consider applying for orphan designation, which provides financial and regulatory benefits. TWEETABLE ABSTRACT: Placental insufficiency meets the European Medicines Agency requirements for orphan disease designation.

The incidence, characteristics, management and outcomes of anaphylaxis in pregnancy: a population-based descriptive study.

OBJECTIVE: The aim of this study was to estimate the incidence of anaphylaxis in pregnancy and describe the management and outcomes in the UK. DESIGN: A population-based descriptive study using the UK Obstetric Surveillance System (UKOSS). SETTING: All consultant-led maternity units in the UK. POPULATION: All pregnant women who had anaphylaxis between 1 October 2012 and 30 September 2015. Anaphylaxis was defined as a severe, life-threatening generalised or systemic hypersensitivity reaction. METHODS: Prospective case notification using UKOSS. MAIN OUTCOME MEASURES: Maternal mortality, severe maternal morbidity, neonatal mortality and severe neonatal morbidity. RESULTS: There were 37 confirmed cases of anaphylaxis in pregnancy, giving an estimated incidence of 1.6 (95% CI: 1.1-2.2) per 100 000 maternities. Four cases of anaphylaxis were in women with known penicillin allergies: two received co-amoxiclav and two cephalosporins. Twelve women had anaphylaxis following prophylactic use of antibiotics at the time of a caesarean delivery. Prophylactic use of antibiotics for Group B streptococcal infection accounted for anaphylaxis in one woman. Two women died (5%), 14 (38%) women were admitted to intensive care and seven women (19%) had one or more additional severe maternal morbidities, which included three haemorrhagic events, two cardiac arrests, one thrombotic event and one pneumonia. No infants died; however, in those infants whose mother had anaphylaxis before delivery (n = 18) there were seven (41%) neonatal intensive care unit admissions, three preterm births and one baby was cooled for neonatal encephalopathy. CONCLUSIONS: Anaphylaxis is a rare severe complication of pregnancy and frequently the result of a reaction to antibiotic administration. This study highlights the seriousness of the outcomes of this condition for the mother. The low incidence is reassuring given the large proportion of the pregnant population that receive prophylactic antibiotics during delivery. TWEETABLE ABSTRACT: Anaphylaxis is a rare severe complication of pregnancy and frequently the result of a reaction to antibiotic administration.

Caesarean section surgical techniques: 3 year follow-up of the CORONIS fractional, factorial, unmasked, randomised controlled trial.

BACKGROUND: The CORONIS trial reported differences in short-term maternal morbidity when comparing five pairs of alternative surgical techniques for caesarean section. Here we report outcomes at 3 years follow-up. METHODS: The CORONIS trial was a pragmatic international 2 × 2 × 2 × 2× 2 non-regular fractional, factorial, unmasked, randomised controlled trial done at 19 sites in Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan. Pregnant women were eligible if they were to undergo their first or second caesarean section through a planned transverse abdominal incision. Women were randomly assigned by a secure web-based allocation system to one intervention from each of the three assigned pairs. All investigators, surgeons, and participants were unmasked to treatment allocation. In this follow-up study, we compared outcomes at 3 years following blunt versus sharp abdominal entry, exteriorisation of the uterus for repair versus intra-abdominal repair, single versus double layer closure of the uterus, closure versus non-closure of the peritoneum, and chromic catgut versus polyglactin-910 for uterine repair. Outcomes included pelvic pain; deep dyspareunia; hysterectomy and outcomes of subsequent pregnancies. Outcomes were assessed masked to the original trial allocation. This trial is registered with the Current Controlled Trials registry, number ISRCTN31089967. FINDINGS: Between Sept 1, 2011, and Sept 30, 2014, 13,153 (84%) women were followed-up for a mean duration of 3·8 years (SD 0·86). For blunt versus sharp abdominal entry there was no evidence of a difference in risk of abdominal hernias (adjusted RR 0·66; 95% CI 0·39-1·11). We also recorded no evidence of a difference in risk of death or serious morbidity of the children born at the time of trial entry (0·99, 0·83-1·17). For exteriorisation of the uterus versus intra-abdominal repair there was no evidence of a difference in risk of infertility (0·91, 0·71-1·18) or of ectopic pregnancy (0·50, 0·15-1·66). For single versus double layer closure of the uterus there was no evidence of a difference in maternal death (0·78, 0·46-1·32) or a composite of pregnancy complications (1·20, 0·75-1·90). For closure versus non-closure of the peritoneum there was no evidence of a difference in any outcomes relating to symptoms associated with pelvic adhesions such as infertility (0·80, 0·61-1·06). For chromic catgut versus polyglactin-910 sutures there was no evidence of a difference in the main comparisons for adverse pregnancy outcomes in a subsequent pregnancy, such as uterine rupture (3·05, 0·32-29·29). Overall, severe adverse outcomes were uncommon in these settings. INTERPRETATION: Although our study was not powered to detect modest differences in rare but serious events, there was no evidence to favour one technique over another. Other considerations will probably affect clinical practice, such as the time and cost saving of different approaches. FUNDING: UK Medical Research Council and the Department for International Development.

A pilot study to understand feasibility and acceptability of stool and cord blood sample collection for a large-scale longitudinal birth cohort.

BACKGROUND: Few data are available to guide biological sample collection around the time of birth for large-scale birth cohorts. We are designing a large UK birth cohort to investigate the role of infection and the developing immune system in determining future health and disease. We undertook a pilot to develop methodology for the main study, gain practical experience of collecting samples, and understand the acceptability of sample collection to women in late pregnancy. METHODS: Between February-July 2014, we piloted the feasibility and acceptability of collecting maternal stool, baby stool and cord blood samples from participants recruited at prolonged pregnancy and planned pre-labour caesarean section clinics at University College London Hospital. Participating women were asked to complete acceptability questionnaires. RESULTS: Overall, 265 women were approached and 171 (65%) participated, with ≥1 sample collected from 113 women or their baby (66%). Women had a mean age of 34 years, were primarily of white ethnicity (130/166, 78%), and half were nulliparous (86/169, 51%). Women undergoing planned pre-labour caesarean section were more likely than those who delivered vaginally to provide ≥1 sample (98% vs 54%), but less likely to provide maternal stool (10% vs 43%). Pre-sample questionnaires were completed by 110/171 women (64%). Most women reported feeling comfortable with samples being collected from their baby (<10% uncomfortable), but were less comfortable about their own stool (19% uncomfortable) or a vaginal swab (24% uncomfortable). CONCLUSIONS: It is possible to collect a range of biological samples from women around the time of delivery, and this was acceptable for most women. These data inform study design and protocol development for large-scale birth cohorts.

Productive efficiency and its determinants in the Community Dental Service in the north-west of England.

OBJECTIVES: To assess the efficiency of service provision in the Community Dental Services and its determinants in the North-West of England. SETTING AND SAMPLE: 40 Community Dental Services sites operating across the North-West of England. BASIC RESEARCH DESIGN: A data envelopment analysis was undertaken of inputs (number of surgeries, hours worked by dental officers, therapists, hygienists and others) and outputs (treatments delivered, number of courses of treatment and patients seen) of the Community Dental Services to produce relative efficiency ratings by health authority. These were further analyzed in order to identify which inputs (determined within the Community Dental Services) or external factors outside the control of the Community Dental Services are associated with efficiency. MAIN OUTCOME MEASURE: Relative efficiency rankings in Community Dental Services production of dental healthcare. RESULTS: Using the quantity of treatments delivered as the measure of output, on average the Community Dental Services in England is operating at a relative efficiency of 85% (95% confidence interval 77%- 99%) compared to the best performing services. Average efficiency is lower when courses of treatment and unique patients seen are used as output measures, 82% and 68% respectively. Neither the input mix nor the patient case mix explained variations in the efficiency across Community Dental Services. CONCLUSIONS: Although large variations in performance exist across Community Dental Services, the data available was not able to explain these variations. A useful next step would be to undertake detailed case studies of several best and under-performing services to explore the factors that influence relative performance levels.

Maternal and perinatal outcomes in women planning vaginal birth after caesarean (VBAC) at home in England: secondary analysis of the Birthplace national prospective cohort study.

OBJECTIVE: To compare vaginal birth rates in women planning vaginal birth after caesarean (VBAC) at home versus in an obstetric unit (OU) and explore transfer rates in women planning home VBAC. DESIGN: Prospective cohort study. SETTING: OUs and planned home births in England. POPULATION: 1436 women planning VBAC in the Birthplace cohort, including 209 planning home VBAC. METHODS: We used Poisson regression to calculate relative risks adjusted for maternal characteristics. MAIN OUTCOMES: (i) vaginal birth and (ii) transfer from planned home birth to OU during labour or immediately after birth. SECONDARY OUTCOMES: (i) composite of maternal blood transfusion or admission to higher level care, (ii) stillbirth or Apgar score <7 at 5 minutes, (iii) neonatal unit admission. RESULTS: Planned VBAC at home was associated with a statistically significant increase in the chances of having a vaginal birth compared with planned VBAC in an OU (adjusted relative risk 1.15, 95% confidence interval 1.06-1.24). The risk of an adverse maternal outcome was around 2-3% in both settings, with a similar risk of an adverse neonatal outcome. Transfer rates were high (37%) and varied markedly by parity (para 1, 56.7% versus para 2+, 24.6%). CONCLUSION: Women in the cohort who planned VBAC at home had an increased chance of a vaginal birth compared with those planning VBAC in an OU, but transfer rates were high, particularly for women with only one previous birth, and the risk of an adverse maternal or perinatal outcome was around 2-3%. No change in guidance can be recommended. TWEETABLE ABSTRACT: Higher vaginal birth rates in planned VBAC at home versus in OU but 2-3% adverse outcomes and high transfer rate.

Factors associated with maternal death from direct pregnancy complications: a UK national case-control study.

OBJECTIVE: To investigate the factors associated with maternal death from direct pregnancy complications in the UK. DESIGN: Unmatched case-control analysis. SETTING: All hospitals caring for pregnant women in the UK. POPULATION: A total of 135 women who died (cases) between 2009 and 2012 from eclampsia, pulmonary embolism, severe sepsis, amniotic fluid embolism, and peripartum haemorrhage, using data from the Confidential Enquiry into Maternal Death, and another 1661 women who survived severe complications (controls) caused by these conditions (2005-2013), using data from the UK Obstetric Surveillance System. METHODS: Multivariable regression analyses were undertaken to identify the factors that were associated with maternal deaths and to estimate the additive odds associated with the presence of one or more of these factors. MAIN OUTCOME MEASURES: Odds ratios associated with maternal death and population-attributable fractions, with 95% confidence intervals. Incremental risk of death associated with the factors using a 'risk factors' score. RESULTS: Six factors were independently associated with maternal death: inadequate use of antenatal care (adjusted odds ratio, aOR 15.87, 95% CI 6.73-37.41); substance misuse (aOR 10.16, 95% CI 1.81-57.04); medical comorbidities (aOR 4.82, 95% CI 3.14-7.40); previous pregnancy problems (aOR 2.21, 95% CI 1.34-3.62); hypertensive disorders of pregnancy (aOR 2.44, 95% CI 1.31-4.52); and Indian ethnicity (aOR 2.70, 95% CI 1.14-6.43). Of the increased risk associated with maternal death, 70% (95% CI 66-73%) could be attributed to these factors. Odds associated with maternal death increased by three and a half times per unit increase in the 'risk factor' score (aOR 3.59, 95% CI 2.83-4.56). CONCLUSIONS: This study shows that medical comorbidities are importantly associated with direct (obstetric) deaths. Further studies are required to understand whether specific aspects of care could be improved to reduce maternal deaths among women with medical comorbidities in the UK.

Is the increased risk of preterm birth following excision for cervical intraepithelial neoplasia restricted to the first birth post treatment?

OBJECTIVE: To explore whether the increased risk of preterm birth following treatment for cervical disease is limited to the first birth following colposcopy. DESIGN: Nested case-control study. SETTING: Twelve NHS hospitals in England. POPULATION: All nonmultiple births from women selected as cases or controls from a cohort of women with both colposcopy and a hospital birth. Cases had a preterm (20-36 weeks of gestation) birth. Controls had a term birth (38-42 weeks) and no preterm. METHODS: Obstetric, colposcopy and pathology details were obtained. MAIN OUTCOME MEASURES: Adjusted odds ratio of preterm birth in first and second or subsequent births following treatment for cervical disease. RESULTS: A total of 2798 births (1021 preterm) from 2001 women were included in the analysis. The risk of preterm birth increased with increasing depth of treatment among first births post treatment [trend per category increase in depth, categories <10 mm, 10-14 mm, 15-19 mm, ≥20 mm: odds ratio (OR) 1.23, 95% confidence interval (95% CI) 1.12-1.36, P < 0.001] and among second and subsequent births post treatment (trend OR 1.34, 95% CI 1.15-1.56, P < 0.001). No trend was observed among births before colposcopy (OR 0.98, 95% CI 0.83-1.16, P = 0.855). The absolute risk of a preterm birth following deep treatments (≥15 mm) was 6.5% among births before colposcopy, 18.9% among first births and 17.2% among second and subsequent births post treatment. Risk of preterm birth (once depth was accounted for) did not differ when comparing first births post colposcopy with second and subsequent births post colposcopy (adjusted OR 1.15, 95% CI 0.89-1.49). CONCLUSIONS: The increased risk of preterm birth following treatment for cervical disease is not restricted to the first birth post colposcopy; it remains for second and subsequent births. These results suggest that once a woman has a deep treatment she remains at higher risk of a preterm birth throughout her reproductive life.

Perinatal and maternal outcomes in planned home and obstetric unit births in women at 'higher risk' of complications: secondary analysis of the Birthplace national prospective cohort study.

OBJECTIVE: To explore and compare perinatal and maternal outcomes in women at 'higher risk' of complications planning home versus obstetric unit (OU) birth. DESIGN: Prospective cohort study. SETTING: OUs and planned home births in England. POPULATION: 8180 'higher risk' women in the Birthplace cohort. METHODS: We used Poisson regression to calculate relative risks adjusted for maternal characteristics. Sensitivity analyses explored possible effects of differences in risk between groups and alternative outcome measures. MAIN OUTCOME MEASURES: Composite perinatal outcome measure encompassing 'intrapartum related mortality and morbidity' (intrapartum stillbirth, early neonatal death, neonatal encephalopathy, meconium aspiration syndrome, brachial plexus injury, fractured humerus or clavicle) and neonatal admission within 48 hours for more than 48 hours. Two composite maternal outcome measures capturing intrapartum interventions/adverse maternal outcomes and straightforward birth. RESULTS: The risk of 'intrapartum related mortality and morbidity' or neonatal admission for more than 48 hours was lower in planned home births than planned OU births [adjusted relative risks (RR) 0.50, 95% CI 0.31-0.81]. Adjustment for clinical risk factors did not materially affect this finding. The direction of effect was reversed for the more restricted outcome measure 'intrapartum related mortality and morbidity' (RR adjusted for parity 1.92, 95% CI 0.97-3.80). Maternal interventions were lower in planned home births. CONCLUSIONS: The babies of 'higher risk' women who plan birth in an OU appear more likely to be admitted to neonatal care than those whose mothers plan birth at home, but it is unclear if this reflects a real difference in morbidity. Rates of intrapartum related morbidity and mortality did not differ statistically significantly between settings at the 5% level but a larger study would be required to rule out a clinically important difference between the groups.

Caesarean section surgical techniques (CORONIS): a fractional, factorial, unmasked, randomised controlled trial.

BACKGROUND: Variations exist in the surgical techniques used for caesarean section and many have not been rigorously assessed in randomised controlled trials. We aimed to assess whether any surgical techniques were associated with improved outcomes for women and babies. METHODS: CORONIS was a pragmatic international 2×2×2×2×2 non-regular fractional, factorial, unmasked, randomised controlled trial that examined five elements of the caesarean section technique in intervention pairs. CORONIS was undertaken at 19 sites in Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan. Each site was assigned to three of the five intervention pairs: blunt versus sharp abdominal entry; exteriorisation of the uterus for repair versus intra-abdominal repair; single-layer versus double-layer closure of the uterus; closure versus non-closure of the peritoneum (pelvic and parietal); and chromic catgut versus polyglactin-910 for uterine repair. Pregnant women were eligible if they were to undergo their first or second caesarean section through a planned transverse abdominal incision. Women were randomly assigned by a secure web-based number allocation system to one intervention from each of the three assigned pairs. All investigators, surgeons, and participants were unmasked to treatment allocation. The primary outcome was the composite of death, maternal infectious morbidity, further operative procedures, or blood transfusion (>1 unit) up to the 6-week follow-up visit. Women were analysed in the groups into which they were allocated. The CORONIS Trial is registered with Current Controlled Trials: ISRCTN31089967. FINDINGS: Between May 20, 2007, and Dec 31, 2010, 15 935 women were recruited. There were no statistically significant differences within any of the intervention pairs for the primary outcome: blunt versus sharp entry risk ratio 1·03 (95% CI 0·91-1·17), exterior versus intra-abdominal repair 0·96 (0·84-1·08), single-layer versus double-layer closure 0·96 (0·85-1·08), closure versus non-closure 1·06 (0·94-1·20), and chromic catgut versus polyglactin-910 0·90 (0·78-1·04). 144 serious adverse events were reported, of which 26 were possibly related to the intervention. Most of the reported serious adverse events were known complications of surgery or complications of the reasons for the caesarean section. INTERPRETATION: These findings suggest that any of these surgical techniques is acceptable. However, longer-term follow-up is needed to assess whether the absence of evidence of short-term effects will translate into an absence of long-term effects. FUNDING: UK Medical Research Council and WHO.

The impact of maternal obesity on intrapartum outcomes in otherwise low risk women: secondary analysis of the Birthplace national prospective cohort study.

OBJECTIVES: To evaluate the impact of maternal BMI on intrapartum interventions and adverse outcomes that may influence choice of planned birth setting in healthy women without additional risk factors. DESIGN: Prospective cohort study. SETTING: Stratified random sample of English obstetric units. SAMPLE: 17,230 women without medical or obstetric risk factors other than obesity. METHODS: Multivariable log Poisson regression was used to evaluate the effect of BMI on risk of intrapartum interventions and adverse maternal and perinatal outcomes adjusted for maternal characteristics. MAIN OUTCOME MEASURES: Maternal intervention or adverse outcomes requiring obstetric care (composite of: augmentation, instrumental delivery, intrapartum caesarean section, general anaesthesia, blood transfusion, 3rd/4th degree perineal tear); neonatal unit admission or perinatal death. RESULTS: In otherwise healthy women, obesity was associated with an increased risk of augmentation, intrapartum caesarean section and some adverse maternal outcomes but when interventions and outcomes requiring obstetric care were considered together, the magnitude of the increased risk was modest (adjusted RR 1.12, 95% CI 1.02-1.23, for BMI > 35 kg/m(2) relative to low risk women of normal weight). Nulliparous low risk women of normal weight had higher absolute risks and were more likely to require obstetric intervention or care than otherwise healthy multiparous women with BMI > 35 kg/m(2) (maternal composite outcome: 53% versus 21%). The perinatal composite outcome exhibited a similar pattern. CONCLUSIONS: Otherwise healthy multiparous obese women may have lower intrapartum risks than previously appreciated. BMI should be considered in conjunction with parity when assessing the potential risks associated with birth in non-obstetric unit settings.

The management and outcomes of placenta accreta, increta, and percreta in the UK: a population-based descriptive study.

OBJECTIVE: To describe the management and outcomes of placenta accreta, increta, and percreta in the UK. DESIGN: A population-based descriptive study using the UK Obstetric Surveillance System (UKOSS). SETTING: All 221 UK hospitals with obstetrician-led maternity units. POPULATION: All women diagnosed with placenta accreta, increta, and percreta in the UK between May 2010 and April 2011. METHODS: Prospective case identification through the monthly mailing of UKOSS. MAIN OUTCOME MEASURES: Median estimated blood loss, transfusion requirements. RESULTS: A cohort of 134 women were identified with placenta accreta, increta, or percreta: 50% (66/133) were suspected to have this condition antenatally. In women with a final diagnosis of placenta increta or percreta, antenatal diagnosis was associated with reduced levels of haemorrhage (median estimated blood loss 2750 versus 6100 ml, P = 0.008) and a reduced need for blood transfusion (59 versus 94%, P = 0.014), possibly because antenatally diagnosed women were more likely to have preventative therapies for haemorrhage (74 versus 52%, P = 0.007), and were less likely to have an attempt made to remove their placenta (59 versus 93%, P < 0.001). Making no attempt to remove any of the placenta, in an attempt to conserve the uterus or prior to hysterectomy, was associated with reduced levels of haemorrhage (median estimated blood loss 1750 versus 3700 ml, P = 0.001) and a reduced need for blood transfusion (57 versus 86%, P < 0.001). CONCLUSIONS: Women with placenta accreta, increta, or percreta who have no attempt to remove any of their placenta, with the aim of conserving their uterus, or prior to hysterectomy, have reduced levels of haemorrhage and a reduced need for blood transfusion, supporting the recommendation of this practice.

Eclampsia, a comparison within the International Network of Obstetric Survey Systems.

OBJECTIVE: To compare incidences, characteristics, management and outcome of eclampsia in the Netherlands and the UK. DESIGN: A comparative analysis of two population-based prospective cohort studies. SETTING: All hospitals with consultant-led maternity units. POPULATION: Women with eclampsia in the Netherlands (226) and the UK (264). METHODS: Comparison of individual level data from national studies in the Netherlands and the UK (LEMMoN 2004-06; UKOSS 2005/06). MAIN OUTCOME MEASURES: Incidence, maternal complications and differences in management strategies. RESULTS: Incidences of eclampsia differed significantly between both countries: the Netherlands 5.4/10,000 deliveries versus UK 2.7/10,000 (relative risk [RR] 1.94, 95% confidence intervals [95% CI] 1.6-2.4). The proportion of women with a preceding diagnosis of pre-eclampsia was comparable between both countries (the Netherlands 42%; UK 43%), as was the proportion who received magnesium sulphate prophylaxis. Women in the Netherlands had a significantly higher maximum diastolic blood pressure (111 mmHg versus 95 mmHg, P < 0.001); significantly fewer received anti-hypertensive medication (16% versus 71%; RR 0.2, 95% CI 0.1-0.3) and were treated less often with magnesium sulphate after their first fit (95% versus 99%; RR 0.96, 95% CI 0.92-0.99). Maternal death occurred in three cases in the Netherlands compared with zero in the UK. CONCLUSIONS: The incidence of eclampsia in the Netherlands was twice as high compared with the UK when using uniform definitions. Women with eclampsia in the Netherlands were not managed according to guidelines, particularly with respect to blood pressure management. Changes in management practice may reduce both incidence and poor outcomes.

Experiences with maternal and perinatal death reviews in the UK--the MBRRACE-UK programme.

Established in 1952, the programme of surveillance and Confidential Enquiries into Maternal Deaths in the UK is the longest running such programme worldwide. Although more recently instituted, surveillance and confidential enquiries into perinatal deaths are also now well established nationally. Recent changes to funding and commissioning of the Enquiries have enabled both a reinvigoration of the processes and improvements to the methodology with an increased frequency of future reporting. Close engagement with stakeholders and a regulator requirement for doctors to participate have both supported the impetus for involvement of all professionals leading to greater potential for improved quality of care for women and babies.

Modelling the hierarchical structure in datasets with very small clusters: a simulation study to explore the effect of the proportion of clusters when the outcome is continuous.

In cluster-randomised trials, the problem of non-independence within clusters is well known, and appropriate statistical analysis documented. Clusters typically seen in cluster trials are large in size and few in number, whereas datasets of preterm infants incorporate clusters of size two (twins), size three (triplets) and so on, with the majority of infants being in 'clusters' of size one. In such situations, it is unclear whether adjustment for clustering is needed or even possible. In this paper, we compared analyses allowing for clustering (linear mixed model) with analyses ignoring clustering (linear regression). Through simulations based on two real datasets, we explored estimation bias in predictors of a continuous outcome in different size datasets typical of preterm samples, with varying percentages of twins. Overall, the biases for estimated coefficients were similar for linear regression and mixed models, but the standard errors were consistently much less well estimated when using a linear model. Non-convergence was rare but was observed in approximately 5% of mixed models for samples below 200 and percentage of twins 2% or less. We conclude that in datasets with small clusters, mixed models should be the method of choice irrespective of the percentage of twins. If the mixed model does not converge, a linear regression can be fitted, but standard error will be underestimated, and so type I error may be inflated.

A qualitative evaluation of a Local Professional Network programme "Baby Teeth DO Matter".

OBJECTIVE: The objective of this study was to use a qualitative approach to examine the perceptions of dentists who led a health promotion programme entitled "Baby Teeth DO Matter". BASIC RESEARCH DESIGN: Semi-structured interviews were undertaken with a variety of participants in a health promotional programme facilitated by a shadow Local Professional Network. These were then recorded and transcribed verbatim. The transcripts were line numbered and subjected to thematic analysis to develop a coding frame. Overarching themes were developed from the coded transcripts by organising them into clusters based on the similarity of their meaning and checked against the coded extracts and the raw data. CLINICAL SETTING: General Dental Practice. PARTICIPANTS: General Dental Practitioners. INTERVENTIONS: A Greater Manchester-wide prevention programme entitled "Baby teeth DO Matter". MAIN OUTCOME MEASURES: To determine the perceptions of involved clinicians and whether "clinically owned and clinically led" services add value. RESULTS: Eight codes were generated: "Success of the project", "Down-stream to up-stream", "Importance of clinically led and clinically owned", "Keeping the approach simple", "Importance of networking", "Importance of Dental Public Health", "Importance of task and finish" and "Threats to the future of the Local Professional Network". These were organised into three over-arching themes. CONCLUSIONS: "Clinically Led and Clinically Owned" projects appear to empower local practitioners and add value. They encourage community-facing practitioners, build capacity and develop personal skills;--all in accordance with the fundamental principles of the Ottawa Charter. Distributed leadership was seen to be effective and Dental Public Health input, "Task and Finishing", resources and clarity of communication were all considered to be of critical importance.

Persistent Orofacial Pain Attendances at General Medical Practitioners.

Patients with persistent orofacial pain (POFP) can go through complex care pathways to receive a diagnosis and management, which can negatively affect their pain. This study aimed to describe 44-y trends in attendances at Welsh medical practices for POFP and establish the number of attendances per patient and referrals associated with orofacial pain and factors that may predict whether a patient is referred. A retrospective observational study was completed using the nationwide Secure Anonymised Information Linkage Databank of visits to general medical practices in Wales (UK). Data were extracted using diagnostic codes ("Read codes"). Orofacial and migraine Read codes were extracted between 1974 and 2017. Data were analyzed using descriptive statistics and univariate and multivariable logistic regression. Over the 44-y period, there were 468,827 POFP and migraine diagnostic codes, accounting for 468,137 patient attendances, or 301,832 patients. The overall attendance rate was 4.22 attendances per 1,000 patient-years (95% confidence interval [CI], 4.21-4.23). The attendance rate increased over the study period. Almost one-third of patients (n = 92,192, 30.54%) attended more than once over the study period, and 15.83% attended more than once within a 12-mo period. There were 20,103 referral codes that were associated with 8,183 patients, with over half these patients being referred more than once. Odds of receiving a referral were highest in females (odds ratio [OR], 1.23; 95% CI, 1.17-1.29), in those living in rural locations (OR, 1.17; 95% CI, 1.12-1.22), and in the least deprived quintile (OR, 1.39; 95% CI, 1.29-1.48). Odds also increased with increasing age (OR, 1.03; 95% CI, 1.03-1.03). The increasing attendance may be explained by the increasing incidence of POFP within the population. These patients can attend on a repeated basis, and very few are referred, but when they are, this may occur multiple times; therefore, current care pathways could be improved.

Dental Attendances to General Medical Practitioners in Wales: A 44 Year-Analysis.

One-third of the UK population is composed of problem-oriented dental attenders, seeking dental care only when they have acute dental pain or problems. Patients seek urgent dental care from a range of health care professionals, including general medical practitioners. This study aimed to identify trends in dental attendance at Welsh medical practices over a 44-y period, specifically in relation to dental policy change and factors associated with repeat attendance. A retrospective observational study was completed via the nationwide Secure Anonymised Information Linkage (SAIL) Databank of visits to general medical practice in Wales. Read codes associated with dental diagnoses were extracted for patients attending their general medical practitioner between 1974 and 2017. Data were analyzed with descriptive statistics and univariate and multivariable logistic regression. Over the 44-y period, there were 439,361 dental Read codes, accounting for 288,147 patient attendances. The overall attendance rate was 2.60 attendances per 1,000 patient-years (95% CI, 2.59 to 2.61). The attendance rate was negligible through 1987 but increased sharply to 5.0 per 1,000 patient-years in 2006 (95% CI, 4.94 to 5.09) before almost halving to 2.6 per 1,000 in 2017 (95% CI, 2.53 to 2.63) to a pattern that coincided with changes to National Health Service policies. Overall 26,312 patients were repeat attenders and were associated with living in an area classified as urban and deprived (odds ratio [OR], 1.22; 95% CI, 1.19 to 1.25; P < 0.0001) or rural (OR, 0.84; 95% CI, 0.83 to 0.85; P < 0.0001). Repeat attendance was associated with greater odds of having received an antibiotic prescription (OR, 2.53; 95% CI, 2.50 to 2.56; P < 0.0001) but lower odds of having been referred to another service (OR, 0.75; 95% CI, 0.70 to 0.81; P < 0.0001). Welsh patients' reliance on medical care for dental problems was influenced by social deprivation and health policy. This indicates that future interventions to discourage dental attendance at medical practitioners should be targeted at those in the most deprived urban areas or rural areas. In addition, health policy may influence attendance rates positively and negatively and should be considered in the future when decisions related to policy change are made.