Mortality from gastrointestinal congenital anomalies at 264 hospitals in 74 low-income, middle-income, and high-income countries: a multicentre, international, prospective cohort study

Summary Background Congenital anomalies are the fifth leading cause of mortality in children younger than 5 years globally. Many gastrointestinal congenital anomalies are fatal without timely access to neonatal surgical care, but few studies have been done on these conditions in low-income and middle-income countries (LMICs). We compared outcomes of the seven most common gastrointestinal congenital anomalies in low-income, middle-income, and high-income countries globally, and identified factors associated with mortality. Methods We did a multicentre, international prospective cohort study of patients younger than 16 years, presenting to hospital for the first time with oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation, and Hirschsprung’s disease. Recruitment was of consecutive patients for a minimum of 1 month between October, 2018, and April, 2019. We collected data on patient demographics, clinical status, interventions, and outcomes using the REDCap platform. Patients were followed up for 30 days after primary intervention, or 30 days after admission if they did not receive an intervention. The primary outcome was all-cause, in-hospital mortality for all conditions combined and each condition individually, stratified by country income status. We did a complete case analysis. Findings We included 3849 patients with 3975 study conditions (560 with oesophageal atresia, 448 with congenital diaphragmatic hernia, 681 with intestinal atresia, 453 with gastroschisis, 325 with exomphalos, 991 with anorectal malformation, and 517 with Hirschsprung’s disease) from 264 hospitals (89 in high-income countries, 166 in middleincome countries, and nine in low-income countries) in 74 countries. Of the 3849 patients, 2231 (58·0%) were male. Median gestational age at birth was 38 weeks (IQR 36–39) and median bodyweight at presentation was 2·8 kg (2·3–3·3). Mortality among all patients was 37 (39·8%) of 93 in low-income countries, 583 (20·4%) of 2860 in middle-income countries, and 50 (5·6%) of 896 in high-income countries (p<0·0001 between all country income groups). Gastroschisis had the greatest difference in mortality between country income strata (nine [90·0%] of ten in lowincome countries, 97 [31·9%] of 304 in middle-income countries, and two [1·4%] of 139 in high-income countries; p≤0·0001 between all country income groups). Factors significantly associated with higher mortality for all patients combined included country income status (low-income vs high-income countries, risk ratio 2·78 [95% CI 1·88–4·11], p<0·0001; middle-income vs high-income countries, 2·11 [1·59–2·79], p<0·0001), sepsis at presentation (1·20 [1·04–1·40], p=0·016), higher American Society of Anesthesiologists (ASA) score at primary intervention (ASA 4–5 vs ASA 1–2, 1·82 [1·40–2·35], p<0·0001; ASA 3 vs ASA 1–2, 1·58, [1·30–1·92], p<0·0001]), surgical safety checklist not used (1·39 [1·02–1·90], p=0·035), and ventilation or parenteral nutrition unavailable when needed (ventilation 1·96, [1·41–2·71], p=0·0001; parenteral nutrition 1·35, [1·05–1·74], p=0·018). Administration of parenteral nutrition (0·61, [0·47–0·79], p=0·0002) and use of a peripherally inserted central catheter (0·65 [0·50–0·86], p=0·0024) or percutaneous central line (0·69 [0·48–1·00], p=0·049) were associated with lower mortality. Interpretation Unacceptable differences in mortality exist for gastrointestinal congenital anomalies between lowincome, middle-income, and high-income countries. Improving access to quality neonatal surgical care in LMICs will be vital to achieve Sustainable Development Goal 3.2 of ending preventable deaths in neonates and children younger than 5 years by 2030

Maternity admissions to intensive care in England, Wales and Scotland in 2015/16: A report from the National Maternity and Perinatal Audit.

The National Maternity and Perinatal Audit (NMPA) is a national audit of the NHS maternity services across England, Scotland and Wales, commissioned in July 2016 by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England, the Welsh Government and the Health Department of the Scottish Government. The NMPA is led by the Royal College of Obstetricians and Gynaecologists (RCOG) in partnership with the Royal College of Midwives (RCM), the Royal College of Paediatrics and Child Health (RCPCH) and the London School of Hygiene & Tropical Medicine (LSHTM). The overarching objective of the NMPA is to produce high-quality information about NHS maternity and neonatal services that can be used by providers, commissioners and users of the services to benchmark against national standards and recommendations where these exist, and to identify good practice and areas for improvement in the care of women and babies. This report focuses on maternal admissions to intensive care in England, Wales and Scotland. The NMPA, and the data it holds, offers a unique opportunity to link maternity data, which contain information about the mother, her pregnancy and her baby, to data from national data sets for intensive care admissions. The purpose of this report is to describe the feasibility of linking the NMPA’s maternity data to intensive care data and to evaluate the suitability of rates of maternal admission to intensive care as an indicator of care quality. It also describes the demographics of women admitted to intensive care and the reasons for admission

Technical Report: linking the National Maternity and Perinatal Audit Data Set to the National Neonatal Research Database for 2015/16

The National Maternity and Perinatal Audit (NMPA) is a national audit of the NHS maternity services across England, Scotland and Wales, commissioned in July 2016 by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England, the Welsh Government and the Health Department of the Scottish Government. The NMPA is led by the Royal College of Obstetricians and Gynaecologists (RCOG) in partnership with the Royal College of Midwives (RCM), the Royal College of Paediatrics and Child Health (RCPCH) and the London School of Hygiene & Tropical Medicine (LSHTM). The overarching aim of the NMPA is to produce high-quality information about NHS maternity and neonatal services which can be used by providers, commissioners and users of the services to benchmark against national standards and recommendations where these exist, and to identify good practice and areas for improvement in the care of women and babies. This short report from the NMPA explores the feasibility of linking the NMPA data set, which contains data relating to the majority of women who give birth, to the National Neonatal Research Database (NNRD), which contains detailed information about the majority of babies admitted to a neonatal unit. This feasibility study is limited to linkage between neonatal records and maternity records in England, as a pilot for developing this linkage across England, Scotland and Wales. The linkage of neonatal data to maternity data offers many potential advantages. In particular, it allows the exploration of associations between maternal antenatal and intrapartum factors and neonatal outcomes. It also offers the potential to use one or more neonatal outcomes, such as admission to neonatal care, as an outcome measure of maternity care, and to explore variation in neonatal outcomes between maternity settings. The purpose of this report is to describe the feasibility of linking the NMPA data set with the NNRD data set. It describes the technical process of linking these data sets and explores whether this linked data set can be used on an annual basis to construct clinically relevant measures of maternity care

National Maternity and Perinatal Audit: Organisational Report 2019

open access reportMaternity and neonatal services in England, Scotland and Wales are going through an eventful time. Wide-ranging transformation plans are being implemented as a result of the English national maternity services review and the Scottish maternity and neonatal services review,1,2 and an updated Welsh vision for maternity care is in preparation at the time of writing. Services are being reconfigured and changes made to ways of working across the three countries. The second organisational survey of the National Maternity and Perinatal Audit (NMPA) maps current service provision as of January 2019 across England, Scotland and Wales. This report describes how services have changed since the last survey in January 2017, where service provision has improved and where further improvement is still needed in order to meet recommendations. It is hoped that this report will help inform the transformation and other improvement initiatives which are underway

National Maternity and Perinatal Audit: Clinical report 2019. Based on births in NHS maternity services between 1 April 2016 and 31 March 2017

In the wake of national maternity and neonatal reviews and other improvement initiatives, changes are being implemented in the delivery of care to mothers and their babies in England, Scotland and Wales. Use of electronic records for maternity care is constantly developing, and provides a rich source of data to understand and evaluate these changes. The National Maternity and Perinatal Audit (NMPA) uses these data to produce information that can usefully support the improvement of maternity and perinatal care. This report presents measures of maternity and perinatal care based on births in English, Welsh and Scottish NHS services between 1 April 2016 and 31 March 2017. The report also provides contextual information describing the characteristics of women and babies cared for by NHS maternity services during this time period. The majority of the measures presented in this report are the same as presented in our previous report on 2015/16 data. One measure has been removed: early elective delivery without documented clinical indication. Four measures have been added. The first is birth without intervention, a composite measure to describe births that start and proceed spontaneously. The other new measures relate to babies admitted to a neonatal unit following birth: the proportions of term and late preterm babies who are admitted to a neonatal unit; the proportion of term babies who receive mechanical ventilation in the first 72 hours of life; and the proportion of babies who develop an encephalopathy in the first 72 hours of life. The results in this report are presented at trust/board level, rather than by site with an obstetric unit, as was the case for most measures in the previous report. This follows feedback from clinical services to the NMPA team,* and enables a more balanced inclusion of births in freestanding midwifery units and at home, as these can be included in trust level results but not as individual sites owing to low numbers.† The majority of trusts have a single obstetric unit and for those trusts this reporting change makes little difference. Site level results continue to be reported on the NMPA website

Stakeholders’ perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study

Objectives The Bronchiolitis Endotracheal Surfactant Study (BESS) is a randomised controlled trial to determine the efficacy of endo-tracheal surfactant therapy for critically ill infants with bronchiolitis. To explore acceptability of BESS, including approach to consent within a limited time frame, we explored parent and staff experiences of trial involvement in the first two bronchiolitis seasons to inform subsequent trial conduct.Design A mixed-method embedded study involving a site staff survey, questionnaires and interviews with parents approached about BESS.Setting Fourteen UK paediatric intensive care units.Participants Of the 179 parents of children approached to take part in BESS, 75 parents (of 69 children) took part in the embedded study. Of these, 55/69 (78%) completed a questionnaire, and 15/69 (21%) were interviewed. Thirty-eight staff completed a questionnaire.Results Parents and staff found the trial acceptable. All constructs of the Adapted Theoretical Framework of Acceptability were met. Parents viewed surfactant as being low risk and hoped their child’s participation would help others in the future. Although parents supported research without prior consent in studies of time critical interventions, they believed there was sufficient time to consider this trial. Parents recommended that prospective informed consent should continue to be sought for BESS. Many felt that the time between the consent process and intervention being administered took too long and should be ‘streamlined’ to avoid delays in administration of trial interventions. Staff described how the training and trial processes worked well, yet patients were missed due to lack of staff to deliver the intervention, particularly at weekends.Conclusion Parents and staff supported BESS trial and highlighted aspects of the protocol, which should be refined, including a streamlined informed consent process. Findings will be useful to inform proportionate approaches to consent in future paediatric trials where there is a short timeframe for consent discussions.Trial registration number ISRCTN11746266