Why is safety in intrapartum electronic fetal monitoring so hard? A qualitative study combining human factors/ergonomics and social science analysis.

BACKGROUND: Problems in intrapartum electronic fetal monitoring with cardiotocography (CTG) remain a major area of preventable harm. Poor understanding of the range of influences on safety may have hindered improvement. Taking an interdisciplinary perspective, we sought to characterise the everyday practice of CTG monitoring and the work systems within which it takes place, with the goal of identifying potential sources of risk. METHODS: Human factors/ergonomics (HF/E) experts and social scientists conducted 325 hours of observations and 23 interviews in three maternity units in the UK, focusing on how CTG tasks were undertaken, the influences on this work and the cultural and organisational features of work settings. HF/E analysis was based on the Systems Engineering Initiative for Patient Safety 2.0 model. Social science analysis was based on the constant comparative method. RESULTS: CTG monitoring can be understood as a complex sociotechnical activity, with tasks, people, tools and technology, and organisational and external factors all combining to affect safety. Fetal heart rate patterns need to be recorded and interpreted correctly. Systems are also required for seeking the opinions of others, determining whether the situation warrants concern, escalating concerns and mobilising response. These processes may be inadequately designed or function suboptimally, and may be further complicated by staffing issues, equipment and ergonomics issues, and competing and frequently changing clinical guidelines. Practice may also be affected by variable standards and workflows, variations in clinical competence, teamwork and situation awareness, and the ability to communicate concerns freely. CONCLUSIONS: CTG monitoring is an inherently collective and sociotechnical practice. Improving it will require accounting for complex system interdependencies, rather than focusing solely on discrete factors such as individual technical proficiency in interpreting traces.

How to co-design a prototype of a clinical practice tool: a framework with practical guidance and a case study.

Clinical tools for use in practice-such as medicine reconciliation charts, diagnosis support tools and track-and-trigger charts-are endemic in healthcare, but relatively little attention is given to how to optimise their design. User-centred design approaches and co-design principles offer potential for improving usability and acceptability of clinical tools, but limited practical guidance is currently available. We propose a framework (FRamework for co-dESign of Clinical practice tOols or 'FRESCO') offering practical guidance based on user-centred methods and co-design principles, organised in five steps: (1) establish a multidisciplinary advisory group; (2) develop initial drafts of the prototype; (3) conduct think-aloud usability evaluations; (4) test in clinical simulations; (5) generate a final prototype informed by workshops. We applied the framework in a case study to support co-design of a prototype track-and-trigger chart for detecting and responding to possible fetal deterioration during labour. This started with establishing an advisory group of 22 members with varied expertise. Two initial draft prototypes were developed-one based on a version produced by national bodies, and the other with similar content but designed using human factors principles. Think-aloud usability evaluations of these prototypes were conducted with 15 professionals, and the findings used to inform co-design of an improved draft prototype. This was tested with 52 maternity professionals from five maternity units through clinical simulations. Analysis of these simulations and six workshops were used to co-design the final prototype to the point of readiness for large-scale testing. By codifying existing methods and principles into a single framework, FRESCO supported mobilisation of the expertise and ingenuity of diverse stakeholders to co-design a prototype track-and-trigger chart in an area of pressing service need. Subject to further evaluation, the framework has potential for application beyond the area of clinical practice in which it was applied.

Management of Impacted Fetal Head at Caesarean Birth: Scientific Impact Paper No. 73.

Over one-quarter of women in the UK have a caesarean birth (CB). More than one in 20 of these births occurs near the end of labour, when the cervix is fully dilated (second stage). In these circumstances, and when labour has been prolonged, the baby's head can become lodged deep in the maternal pelvis making it challenging to deliver the baby. During the caesarean birth, difficulty in delivery of the baby's head may result - this emergency is known as impacted fetal head (IFH). These are technically challenging births that pose significant risks to both the woman and baby. Complications for the woman include tears in the womb, serious bleeding and longer hospital stay. Babies are at increased risk of injury including damage to the head and face, lack of oxygen to the brain, nerve damage, and in rare cases, the baby may die from these complications. Maternity staff are increasingly encountering IFH at CB, and reports of associated injuries have risen dramatically in recent years. The latest UK studies suggest that IFH may complicate as many as one in 10 unplanned CBs (1.5% of all births) and that two in 100 babies affected by IFH die or are seriously injured. Moreover, there has been a sharp increase in reports of babies having brain injuries when their birth was complicated by IFH. When an IFH occurs, the maternity team can use different approaches to help deliver the baby's head at CB. These include: an assistant (another obstetrician or midwife) pushing the head up from the vagina; delivering the baby feet first; using a specially designed inflatable balloon device to elevate the baby's head and/or giving the mother a medicine to relax the womb. However, there is currently no consensus for how best to manage these births. This has resulted in a lack of confidence among maternity staff, variable practice and potentially avoidable harm in some circumstances. This paper reviews the current evidence regarding the prediction, prevention and management of IFH at CB, integrating findings from a systematic review commissioned from the National Guideline Alliance.

A qualitative study of the dynamics of access to remote antenatal care through the lens of candidacy.

OBJECTIVE: We aimed to explore the experiences and perspectives of pregnant women, antenatal healthcare professionals, and system leaders to understand the impact of the implementation of remote provision of antenatal care during the COVID-19 pandemic and beyond. METHODS: We conducted a qualitative study involving semi-structured interviews with 93 participants, including 45 individuals who had been pregnant during the study period, 34 health care professionals, and 14 managers and system-level stakeholders. Analysis was based on the constant comparative method and used the theoretical framework of candidacy. RESULTS: We found that remote antenatal care had far-reaching effects on access when understood through the lens of candidacy. It altered women's own identification of themselves and their babies as eligible for antenatal care. Navigating services became more challenging, often requiring considerable digital literacy and sociocultural capital. Services became less permeable, meaning that they were more difficult to use and demanding of the personal and social resources of users. Remote consultations were seen as more transactional in character and were limited by lack of face-to-face contact and safe spaces, making it more difficult for women to make their needs - both clinical and social - known, and for professionals to assess them. Operational and institutional challenges, including problems in sharing of antenatal records, were consequential. There were suggestions that a shift to remote provision of antenatal care might increase risks of inequities in access to care in relation to every feature of candidacy we characterised. CONCLUSION: It is important to recognise the implications for access to antenatal care of a shift to remote delivery. It is not a simple swap: it restructures many aspects of candidacy for care in ways that pose risks of amplifying existing intersectional inequalities that lead to poorer outcomes. Addressing these challenges through policy and practice action is needed to tackle these risks.

Validation of a novel birth simulator for impacted fetal head at cesarean section: An observational simulation study.

INTRODUCTION: Impacted fetal head (IFH) is a challenging complication of cesarean section (CS) associated with significant morbidity. Training opportunities for IFH have been reported as inconsistent and inadequate. This study assessed the validity of a novel birth simulator for IFH at cesarean section. MATERIAL AND METHODS: Obstetricians and midwives collaborated with model-making company, Limbs & Things (UK), to modify the original PROMPT Flex® simulator and develop a new "Enhanced CS Module" for IFH at cesarean section. Changes included addition of a retractable uterus and restricted pelvic inlet, and the fetal mannequin was modified to allow accurate limb articulation and flexion at the waist. Obstetricians and midwives from three maternity units in Southwest England were individually recorded, each undertaking three simulated scenarios of IFH at cesarean section. Obstetricians were asked to deliver the fetal head and midwives, to perform a vaginal push-up. Participants completed a questionnaire on realism (face validity) and usefulness for training (content validity) with five-point Likert scale responses. Construct validity was assessed by testing an a priori hypothesis that "experts" (consultant obstetricians with >7 years' experience) would be more likely to achieve delivery than "novices" (registrars with <7 years' experience). Performance variables were compared between groups using Chi-square and Mann-Whitney U-tests. RESULTS: In all, 105 simulated scenarios were undertaken by 35 obstetricians and midwives. A range of techniques were employed to deliver the IFH including change of hand, vaginal disimpaction and reverse breech extraction. Overall, 86% (30/35) described the model as fairly (4)/very realistic (5) (median = 4, interquartile range [IQR] = 4-5). The model was considered fairly (4)/very useful (5) for training by 97% (34/35; median = 5; IQR = 5-5). Experts delivered the fetal head in all simulations (36/36) and novices delivered the head in 76.9% (30/39) (p = 0.002). Experts delivered the fetal head 58% quicker than novices (median = 66.8 s, IQR = 53-86 vs median = 104 s, IQR = 67.7-137). CONCLUSIONS: This novel birth trainer realistically simulates IFH at cesarean section and allows rehearsal of all disimpaction techniques. It was reported to be very useful for training and distinguishes between novice and expert obstetricians. Techniques for IFH are difficult to learn experientially. Simulation is likely to provide an effective and safe form of training.

A case-control study of the interaction of fetal heart rate abnormalities, fetal growth restriction, meconium in the amniotic fluid and tachysystole, in relation to the outcome of labour.

OBJECTIVE: To quantify the incidence of intrapartum risk factors in labours with an adverse outcome, and compare them with the incidence of the same indicators in a series of consecutive labours without adverse outcome. DESIGN: Case-control study. SETTING: Twenty-six maternity units in the UK. POPULATION OR SAMPLE: Sixty-nine labours with an adverse outcome and 198 labours without adverse outcome. METHODS: Observational study. MAIN OUTCOME MEASURES: Incidence of risk factors in hourly assessments for 7 hours before birth in the two groups. RESULTS: A risk score combining suspected fetal growth restriction, tachysystole, meconium in the amniotic fluid and fetal heart rate abnormalities (baseline rate and variability, presence of decelerations) gave the best indication of likely outcome group. CONCLUSIONS: Accurate risk assessment in labour requires fetal heart rate abnormalities to be considered in context with additional intrapartum risk factors.

Temporal trends in stillbirth over eight decades in England and Wales: A longitudinal analysis of over 56 million births and lives saved by improvements in maternity care.

Background: Considering the public health importance of stillbirth, this study quantified the trends in stillbirths over eight decades in England and Wales. Methods: This longitudinal study utilized the publicly available aggregated data from the Office for National Statistics that captured maternity information for babies delivered in England and Wales from 1940 to 2019. We computed the trends in stillbirth with the associated incidence risk difference, incidence risk ratio, and extra lives saved per decade. Results: From 1940-2019, 56 906 273 births were reported. The stillbirth rate declined (85%) drastically up to the early 1980s. In the initial five decades, the estimated number of deaths per decade further decreased by 67 765 (9.49/1000 births) in 1940-1949, 2569 (0.08/1000 births) in 1950-1959, 9121 (3.50/1000 births) in 1960-1969, 15 262 (2.31/1000 births) in 1970-1979, and 10 284 (1.57/1000 births) in 1980-1989. However, the stillbirth rate increased by an additional 3850 (0.58/1000 births) stillbirths in 1990-1999 and 693 (0.11/1000 births) stillbirths in 2000-2009. The stillbirth rate declined again during 2010-2019, with 3714 fewer stillbirths (0.54/1000 births). The incidence of maternal age <20 years reduced over time, but pregnancy among older women (>35 years) increased. Conclusions: The stillbirth rate declined drastically, but the rate of decline slowed in the last three decades. Though teenage pregnancy (<20 years) had reduced, the prevalence of women with a higher risk of stillbirth may have risen due to an increase in advanced maternal age. Improved, more personalised care is required to reduce the stillbirth rate further.

The Tommy's Clinical Decision Tool, a device for reducing the clinical impact of placental dysfunction and preterm birth: protocol for a mixed-methods early implementation evaluation study.

BACKGROUND: Disparities in stillbirth and preterm birth persist even after correction for ethnicity and social deprivation, demonstrating that there is wide geographical variation in the quality of care. To address this inequity, Tommy's National Centre for Maternity Improvement developed the Tommy's Clinical Decision Tool, which aims to support the provision of "the right care at the right time", personalising risk assessment and care according to best evidence. This web-based clinical decision tool assesses the risk of preterm birth and placental dysfunction more accurately than current methods, and recommends best evidenced-based care pathways in a format accessible to both women and healthcare professionals. It also provides links to reliable sources of pregnancy information for women. The aim of this study is to evaluate implementation of Tommy's Clinical Decision Tool in four early-adopter UK maternity services, to inform wider scale-up. METHODS: The Tommy's Clinical Decision Tool has been developed involving maternity service users and healthcare professionals in partnership. This mixed-methods study will evaluate: maternity service user and provider acceptability and experience; barriers and facilitators to implementation; reach (whether particular groups are excluded and why), fidelity (degree to which the intervention is delivered as intended), and unintended consequences. Data will be gathered over 25 months through interviews, focus groups, questionnaires and through the Tommy's Clinical Decision Tool itself. The NASSS framework (Non-adoption or Abandonment of technology by individuals and difficulties achieving Scale-up, Spread and Sustainability) will inform data analysis. DISCUSSION: This paper describes the intervention, Tommy's Clinical Decision Tool, according to TiDIER guidelines, and the protocol for the early adopter implementation evaluation study. Findings will inform future scale up. TRIAL REGISTRATION: This study was prospectively registered on the ISRCTN registry no. 13498237 , on 31st January 2022.

Quality framework for remote antenatal care: qualitative study with women, healthcare professionals and system-level stakeholders.

BACKGROUND: High-quality antenatal care is important for ensuring optimal birth outcomes and reducing risks of maternal and fetal mortality and morbidity. The COVID-19 pandemic disrupted the usual provision of antenatal care, with much care shifting to remote forms of provision. We aimed to characterise what quality would look like for remote antenatal care from the perspectives of those who use, provide and organise it. METHODS: This UK-wide study involved interviews and an online survey inviting free-text responses with: those who were or had been pregnant since March 2020; maternity professionals and managers of maternity services and system-level stakeholders. Recruitment used network-based approaches, professional and community networks and purposively selected hospitals. Analysis of interview transcripts was based on the constant comparative method. Free-text survey responses were analysed using a coding framework developed by researchers. FINDINGS: Participants included 106 pregnant women and 105 healthcare professionals and managers/stakeholders. Analysis enabled generation of a framework of the domains of quality that appear to be most relevant to stakeholders in remote antenatal care: efficiency and timeliness; effectiveness; safety; accessibility; equity and inclusion; person-centredness and choice and continuity. Participants reported that remote care was not straightforwardly positive or negative across these domains. Care that was more transactional in nature was identified as more suitable for remote modalities, but remote care was also seen as having potential to undermine important aspects of trusting relationships and continuity, to amplify or create new forms of structural inequality and to create possible risks to safety. CONCLUSIONS: This study offers a provisional framework that can help in structuring thinking, policy and practice. By outlining the range of domains relevant to remote antenatal care, this framework is likely to be of value in guiding policy, practice and research.

A study of the healthcare resource use for the management of postpartum haemorrhage in France, Italy, the Netherlands, and the UK.

OBJECTIVE: Postpartum haemorrhage (PPH) complicates approximately 5% of births worldwide and is a leading direct cause of maternal death. Rates of PPH are increasing in many developed countries, particularly PPH related to uterine atony. There is a lack of published up-to-date information about healthcare resource use associated with management of PPH following vaginal birth. The objective of this study was to describe healthcare resource use for the management of minor PPH (blood loss 500-1,000 ml) and major PPH (blood loss > 1,000 ml) compared to uncomplicated birth (no PPH) following hospital vaginal birth in France, Italy, the Netherlands, and the UK. STUDY DESIGN: In-depth interviews with two midwives from each participating country were conducted to establish differences in resource use for the management of minor PPH, major PPH, and uncomplicated birth. A web-survey was then developed and one obstetrician per participating country reviewed the survey. In total, 100 midwives (25 per country) completed the survey. Results were discussed at a multi-professional consensus meeting of midwives and obstetricians/gynaecologists (n = 6). RESULTS AND CONCLUSIONS: Midwives participating in the survey estimated that 80% of women receive Active Management of the Third Stage of Labour (AMTSL) and 93% of participants specified that uterotonics would routinely be used during AMTSL. Most participants (84%) reported that blood loss is routinely measured in their hospital, using a combination of methods. PPH is associated with increased healthcare resource use, including administration of additional uterotonics and use of additional medical interventions, such as urinary catheter, intravenous fluids, and possible requirement for surgery. The number of nurses, obstetricians/gynaecologists, and anaesthetists involved in the management of PPH increases with the occurrence and severity of PPH, as well as the proportion of healthcare personnel providing continuous care. Women may spend an additional 24 h in hospital following major PPH compared to uncomplicated birth. The results of this study highlight the burden of PPH management on healthcare resources. To reduce costs associated with PPH, prevention is the most effective strategy and can be enhanced with the use of an effective uterotonic as part of the active management of the third stage of labour.

PROMPT Wales project: national scaling of an evidence-based intervention to improve safety and training in maternity.

BACKGROUND: In healthcare, there is increasing recognition of the importance of developing and testing strategies to scale effective interventions. The NHS long-term plan (2019) acknowledges that often a gold standard approach to a problem already exists somewhere within the NHS, however, it has not been replicated widely across the system. METHODS: We describe the approach and process measures for national scaling of PROMPT (Practical Obstetric Multi-Professional Training) across 12 obstetric-led maternity units in Wales. PROMPT is an evidence-based training package for local maternity staff, previously associated with improvements in maternal and neonatal outcomes, reduction in litigation related to preventable harm and improved safety culture. PROMPT has previously been disseminated internationally using a train-the-trainer model. However, this has been associated with variations in uptake, fidelity and impact. In Wales, the project was supported by Welsh Government, and a structured scaling plan was developed, encompassing ongoing implementation support from a multi-professional team. RESULTS: PROMPT was successfully implemented in all obstetric led units in Wales, with 326 local PROMPT facilitators trained, and 82.5%-100% of maternity staff attended a local PROMPT course in the first 15 months of the project (January 2019-March 2020). All training courses included evidence-based authentic elements, and 93% of courses in the first year (100/107) were supported by a national implementation team, providing coaching, implementation support and quality assurance. CONCLUSIONS: Authentically scaling up complex interventions is a significant challenge. To replicate the improved outcomes demonstrated by PROMPT, intervention reach and fidelity must first be demonstrated.In this national scaling project, our scaling methodology led to the successful implementation of PROMPT across all health boards in Wales. Additionally, we demonstrated reduced variation in adoption, reach, timescale and intervention fidelity between maternity units with varying readiness for change, which had been difficult in two previous large-scale PROMPT implementation projects.

How to specify healthcare process improvements collaboratively using rapid, remote consensus-building: a framework and a case study of its application.

BACKGROUND: Practical methods for facilitating process improvement are needed to support high quality, safe care. How best to specify (identify and define) process improvements - the changes that need to be made in a healthcare process - remains a key question. Methods for doing so collaboratively, rapidly and remotely offer much potential, but are under-developed. We propose an approach for engaging diverse stakeholders remotely in a consensus-building exercise to help specify improvements in a healthcare process, and we illustrate the approach in a case study. METHODS: Organised in a five-step framework, our proposed approach is informed by a participatory ethos, crowdsourcing and consensus-building methods: (1) define scope and objective of the process improvement; (2) produce a draft or prototype of the proposed process improvement specification; (3) identify participant recruitment strategy; (4) design and conduct a remote consensus-building exercise; (5) produce a final specification of the process improvement in light of learning from the exercise. We tested the approach in a case study that sought to specify process improvements for the management of obstetric emergencies during the COVID-19 pandemic. We used a brief video showing a process for managing a post-partum haemorrhage in women with COVID-19 to elicit recommendations on how the process could be improved. Two Delphi rounds were then conducted to reach consensus. RESULTS: We gathered views from 105 participants, with a background in maternity care (n = 36), infection prevention and control (n = 17), or human factors (n = 52). The participants initially generated 818 recommendations for how to improve the process illustrated in the video, which we synthesised into a set of 22 recommendations. The consensus-building exercise yielded a final set of 16 recommendations. These were used to inform the specification of process improvements for managing the obstetric emergency and develop supporting resources, including an updated video. CONCLUSIONS: The proposed methodological approach enabled the expertise and ingenuity of diverse stakeholders to be captured and mobilised to specify process improvements in an area of pressing service need. This approach has the potential to address current challenges in process improvement, but will require further evaluation.

Impacted fetal head: A retrospective cohort study of emergency caesarean section.

OBJECTIVE: To investigate risk factors, management and outcomes of impacted fetal head (IFH) at caesarean section (CS). STUDY DESIGN: This is a retrospective cohort study of all women with singleton, cephalic pregnancies who had an emergency CS during one-year (2016) at North Bristol NHS Trust, UK (n = 838). The incidence of caesarean section at full dilatation (CSFD) and IFH were calculated using the annual birth rate. To identify risk factors for IFH, maternal, perinatal and intrapartum characteristics were compared according to the presence or absence of IFH, and separately for first- and second-stage CS. Techniques employed to disimpact the fetal head were described. Univariable and multivariable comparisons of maternal and perinatal outcomes were made between cases with and without an IFH. Characteristics and outcomes were compared using modified Poisson regression. RESULTS: CSFD accounted for 2.1 % of all births. IFH complicated 1.5 % of all births (11.3 % of emergency CS), with 55.8 % occurring prior to full cervical dilatation. Increased rates of IFH at CS were associated with: oxytocin augmentation (RR = 2.47 [1.61-3.80]), full cervical dilatation (RR = 4.24 [2.96-6.07], mid/low station (RR = 4.14 [2.72-6.32]), moulding (RR = 4.39 [2.55-7.54]) and caput (RR = 6.60 [3.09-14.10]). Junior operators documented IFH more than consultants (RR = 9.61 [1.35-68.2]). The strategies recorded for managing IFH included: tocolysis, reverse breech extraction and vaginal push up (33.7 %, 14.7 % and 11.6 % cases respectively) with two or more techniques used in 21.1 % cases. IFH at CS was independently associated with an increased risk of uterine extensions (RR = 3.09 [1.96-4.87]) and a composite adverse perinatal outcome (RR = 1.66 [1.21-2.28]). CONCLUSIONS: IFH is a common and heterogeneous complication associated with increased complications for both mother and baby, independent of those of CSFD. Obstetricians must remain vigilant to the possibility of IFH at all emergency CS, particularly those at full cervical dilatation or with evidence of obstructed labour. There is an urgent need for a standardised management algorithm and training in evidence-based disimpaction techniques.

Key components influencing the sustainability of a multi-professional obstetric emergencies training programme in a middle-income setting: a qualitative study.

BACKGROUND: Multi-professional obstetric emergencies training is one promising strategy to improve maternity care. Sustaining training programmes following successful implementation remains a challenge. Understanding, and incorporating, key components within the implementation process can embed interventions within healthcare systems, thereby enhancing sustainability. This study aimed to identify key components influencing sustainability of PRactical Obstetric Multi-Professional Training (PROMPT) in the Philippines, a middle-income setting. METHODS: Three hospitals were purposively sampled to represent private, public and teaching hospital settings. Two focus groups, one comprising local trainers and one comprising training participants, were conducted in each hospital using a semi-structured topic guide. Focus groups were audio recorded. Data were analysed using thematic analysis. Three researchers independently coded transcripts to ensure interpretation consistency. RESULTS: Three themes influencing sustainability were identified; attributes of local champions, multi-level organisational involvement and addressing organisational challenges. CONCLUSIONS: These themes, including potential barriers to sustainability, should be considered when designing and implementing training programmes in middle-income settings. When 'scaling-up', local clinicians should be actively involved in selecting influential implementation champions to identify challenges and strategies specific to their organisation. Network meetings could enable shared learning and sustain enthusiasm amongst local training teams. Policy makers should be engaged early, to support funding and align training with national priorities.

Characterising and describing postpartum haemorrhage emergency kits in context: a protocol for a mixed-methods study.

INTRODUCTION: Postpartum haemorrhage (PPH) is an obstetric emergency requiring prompt and accurate response. PPH emergency kits containing equipment and medications can facilitate this kind of intervention, but their design and contents vary, potentially introducing risk of confusion or delay. Designs may be suboptimal, and relying on localised kit contents may result in supply chain costs, increased waste and missed opportunities for economies of scale. This study aims to characterise contextual influences on current practice in relation to PPH kits and to describe the range of kits currently employed in UK maternity units. METHODS AND ANALYSIS: This mixed-methods study comprises two phases. The first will use field observations and semistructured interviews to research PPH kits in a small number (3-5) of maternity units that will be selected to represent diversity. Analysis will be conducted both using an established human factors and ergonomics framework and using the constant comparative method for qualitative data analysis. The second phase will use a research and development platform (Thiscovery) to conduct a crowdsourced photography-based audit of PPH kits currently in use in the UK. Participants will tag images to indicate which objects have been photographed. Quantitative analysis will report the frequency of inclusion of each item in kits and the content differences between kit and unit types. All maternity units in the UK will be invited to take part, with additional targeted recruitment strategies used, if necessary, to ensure that the final sample includes different maternity unit types, sizes and PPH kit types. Study results will inform future work to develop consensus on effective PPH kit designs. ETHICS AND DISSEMINATION: Approval has been received from the UK Health Research Authority (project ID 274147). Study results will be reported through the research institute's website, presented at conferences and published in peer-reviewed journals.

Impacted foetal head at caesarean section: a national survey of practice and training.

This is a national survey of UK obstetric trainees and consultant labour ward leads designed to investigate the current practice and training for an impacted foetal head (IFH) at Caesarean Section (CS). An anonymous, on-line survey was disseminated to trainees via Postgraduate Schools and RCOG trainee representatives, and to labour ward leads via their national network. Three hundred and forty-five obstetric trainees and consultants responded. The results show that IFH is variably defined and encountered by most UK obstetricians (98% had encountered IFH and 76% had experienced it before full cervical dilatation). There is significant variation in management strategies, although most respondents would use a vaginal push up to assist delivery prior to reverse breech extraction. Responses revealed a paucity of training and lack of confidence in disimpaction techniques: over one in ten respondents had not received any training for IFH and less than half had received instruction in reverse breech extraction.Impact statementWhat is already known on the subject? IFH is an increasingly recognised, technically challenging complication of intrapartum CS. A recent report suggested that birth injuries associated with IFH are now as common as with shoulder dystocia. However, there is no consensus nor guidelines regarding the best practice for management or training.What do the results of this study add? This study demonstrates that IFH is poorly defined and commonly encountered by UK obstetricians. It highlights that IFH is not restricted to CS at full dilatation and reveals the ubiquity of the vaginal push method in UK practice. We found evidence that UK obstetricians are using techniques which have not been investigated and are not recommended for managing an IFH. Moreover, this survey is an eye-opener as to the paucity of training, highlighting that UK obstetric trainees are not adequately prepared to manage this emergency.What are the implications of these findings for clinical practice and/or further research? There is a pressing need to standardise the definition, guidance and training for IFH at CS. Further research should clarify the appropriate techniques for IFH and establish consensus for the best practice. An evidence-based simulation training package, which allows clinicians to learn and practice recognised disimpaction techniques is urgently required.

Seven features of safety in maternity units: a framework based on multisite ethnography and stakeholder consultation.

BACKGROUND: Reducing avoidable harm in maternity services is a priority globally. As well as learning from mistakes, it is important to produce rigorous descriptions of 'what good looks like'. OBJECTIVE: We aimed to characterise features of safety in maternity units and to generate a plain language framework that could be used to guide learning and improvement. METHODS: We conducted a multisite ethnography involving 401 hours of non-participant observations 33 semistructured interviews with staff across six maternity units, and a stakeholder consultation involving 65 semistructured telephone interviews and one focus group. RESULTS: We identified seven features of safety in maternity units and summarised them into a framework, named For Us (For Unit Safety). The features include: (1) commitment to safety and improvement at all levels, with everyone involved; (2) technical competence, supported by formal training and informal learning; (3) teamwork, cooperation and positive working relationships; (4) constant reinforcing of safe, ethical and respectful behaviours; (5) multiple problem-sensing systems, used as basis of action; (6) systems and processes designed for safety, and regularly reviewed and optimised; (7) effective coordination and ability to mobilise quickly. These features appear to have a synergistic character, such that each feature is necessary but not sufficient on its own: the features operate in concert through multiple forms of feedback and amplification. CONCLUSIONS: This large qualitative study has enabled the generation of a new plain language framework-For Us-that identifies the behaviours and practices that appear to be features of safe care in hospital-based maternity units.

Effect of hands-on interprofessional simulation training for local emergencies in Scotland: the THISTLE stepped-wedge design randomised controlled trial.

OBJECTIVE: To assess whether the implementation of an intrapartum training package (PROMPT (PRactical Obstetric Multi-Professional Training)) across a health service reduced the proportion of term babies born with Apgar score <7 at 5 min (<75mins). DESIGN: Stepped-wedge cluster randomised controlled trial. SETTING: Twelve randomised maternity units with ≥900 births/year in Scotland. Three additional units were included in a supplementary analysis to assess the effect across Scotland. The intervention commenced in March 2014 with follow-up until September 2016. INTERVENTION: The PROMPT training package (Second edition), with subsequent unit-level implementation of PROMPT courses for all maternity staff. MAIN OUTCOME MEASURES: The primary outcome was the proportion of term babies with Apgar<75mins. RESULTS: 87 204 eligible births (99.2% with an Apgar score), of which 1291 infants had an Apgar<75mins were delivered in the 12 randomised maternity units. Two units did not implement the intervention. The overall Apgar<75mins rate observed in the 12 randomised units was 1.49%, increasing from 1.32% preintervention to 1.59% postintervention. Once adjusted for a secular time trend, the 'intention-to-treat' analysis indicated a moderate but non-significant reduction in the rate of term babies with an Apgar scores <75mins following PROMPT training (OR=0.79 95%CI(0.63 to 1.01)). However, some units implemented the intervention earlier than their allocated step, whereas others delayed the intervention. The content and authenticity of the implemented intervention varied widely at unit level. When the actual date of implementation of the intervention in each unit was considered in the analysis, there was no evidence of improvement (OR=1.01 (0.84 to 1.22)). No intervention effect was detected by broadening the analysis to include all 15 large Scottish maternity units. Units with a history of higher rates of Apgar<75mins maintained higher Apgar rates during the study (OR=2.09 (1.28 to 3.41)) compared with units with pre-study rates aligned to the national rate. CONCLUSIONS: PROMPT training, as implemented, had no effect on the rate of Apgar <75mins in Scotland during the study period. Local implementation at scale was found to be more difficult than anticipated. Further research is required to understand why the positive effects observed in other single-unit studies have not been replicated in Scottish maternity units, and how units can be best supported to locally implement the intervention authentically and effectively. TRIAL REGISTRATION NUMBER: ISRCTN11640515.

The effects of interactive training of healthcare providers on the management of life-threatening emergencies in hospital.

BACKGROUND: Preparing healthcare providers to manage relatively rare life-threatening emergency situations effectively is a challenge. Training sessions enable staff to rehearse for these events and are recommended by several reports and guidelines. In this review we have focused on interactive training, this includes any element where the training is not solely didactic but provides opportunity for discussions, rehearsals, or interaction with faculty or technology. It is important to understand the effective methods and essential elements for successful emergency training so that resources can be appropriately targeted to improve outcomes. OBJECTIVES: To assess the effects of interactive training of healthcare providers on the management of life-threatening emergencies in hospital on patient outcomes, clinical care practices, or organisational practices, and to identify essential components of effective interactive emergency training programmes. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL and ERIC and two trials registers up to 11 March 2019. We searched references of included studies, conference proceedings, and contacted study authors. SELECTION CRITERIA: We included randomised trials and cluster-randomised trials comparing interactive training for emergency situations with standard/no training. We defined emergency situations as those in which immediate lifesaving action is required, for example cardiac arrests and major haemorrhage. We included all studies where healthcare workers involved in providing direct clinical care were participants. We excluded studies outside of a hospital setting or where the intervention was not targeted at practicing healthcare workers. We included trials irrespective of publication status, date, and language. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane and Cochrane Effective Practice and Organisation of Care (EPOC) Group. Two review authors independently extracted data and assessed the risk of bias of each included trial. Due to the small number of studies and the heterogeneity in outcome measures, we were unable to perform the planned meta-analysis. We provide a structured synthesis for the following outcomes: survival to hospital discharge, morbidity rate, protocol or guideline adherence, patient outcomes, clinical practice outcomes, and organisation-of-care outcomes. We used the GRADE approach to rate the certainty of the evidence and the strength of recommendations for each outcome. MAIN RESULTS: We included 11 studies that reported on 2000 healthcare providers and over 300,000 patients; one study did not report the number of participants. Seven were cluster randomised trials and four were single centre studies. Four studies focused on obstetric training, three on obstetric and neonatal care, two on neonatal training, one on trauma and one on general resuscitations. The studies were spread across high-, middle- and low-income settings.Interactive training may make little or no difference in survival to hospital discharge for patients requiring resuscitation (1 study; 30 participants; 98 events; low-certainty evidence). We are uncertain if emergency training changes morbidity rate, as the certainty of the evidence is very low (3 studies; 1778 participants; 57,193 patients, when reported). We are uncertain if training alters healthcare providers' adherence to clinical protocols or guidelines, as the certainty of the evidence is very low (3 studies; 156 participants; 558 patients). We are uncertain if there were improvements in patient outcomes following interactive training for emergency situations, as we assessed the evidence as very low-certainty (5 studies, 951 participants; 314,055 patients). We are uncertain if training for emergency situations improves clinical practice outcomes as the certainty of the evidence is very low (4 studies; 1417 participants; 28,676 patients, when reported). Two studies reported organisation-of-care outcomes, we are uncertain if interactive emergency training has any effect on this outcome as the certainty of the evidence is very low (634 participants; 179,400 patient population).We examined prespecified subgroups and found no clear commonalities in effect of multidisciplinary training, location of training, duration of the course, or duration of follow-up. We also examined areas arising from the studies including focus of training, proportion of staff trained, leadership of intervention, and incentive/trigger to participate, and again identified no clear mediating factors. The sources of funding for the studies were governmental, local organisations, or philanthropic donors. AUTHORS' CONCLUSIONS: We are uncertain if there are any benefits of interactive training of healthcare providers on the management of life-threatening emergencies in hospital as the certainty of the evidence is very low. We were unable to identify any factors that may have allowed us to identify an essential element of these interactive training courses.We found a lack of consistent reporting, which contributed to the inability to meta-analyse across specialities. More trials are required to build the evidence base for the optimum way to prepare healthcare providers for rare life-threatening emergency events. These trials need to be conducted with attention to outcomes important to patients, healthcare providers, and policymakers. It is vitally important to develop high-quality studies adequately powered and with attention to minimising the risk of bias.