Exploring clinicians' perspectives on the 'Obstetric Anal Sphincter Injury Care Bundle' national quality improvement programme: a qualitative study.

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

The Birthplace in England national prospective cohort study: further analyses to enhance policy and service delivery decision-making for planned place of birth

Background: Evidence from the Birthplace in England Research Programme supported a policy of offering ‘low risk’ women a choice of birth setting, but a number of unanswered questions remained. Aims: This project aimed to provide further evidence to support the development and delivery of maternity services and inform women’s choice of birth setting: specifically, to explore maternal and organisational factors associated with intervention, transfer and other outcomes in each birth setting in ‘low risk’ and ‘higher risk’ women. Design: Five component studies using secondary analysis of the Birthplace prospective cohort study (studies 2–5) and ecological analysis of unit/NHS trust-level data (studies 1 and 5). Setting: Obstetric units (OUs), alongside midwifery units (AMUs), freestanding midwifery units (FMUs) and planned home births in England. Participants: Studies 1–4 focused on ‘low risk’ women with ‘term’ pregnancies planning vaginal birth in 43 AMUs (n = 16,573), in 53 FMUs (n = 11,210), at home in 147 NHS trusts (n = 16,632) and in a stratified, random sample of 36 OUs (n = 19,379) in 2008–10. Study 5 focused on women with pre-existing medical and obstetric risk factors (‘higher risk’ women). Main outcome measures: Interventions (instrumental delivery, intrapartum caesarean section), a measure of low intervention (‘normal birth’), a measure of spontaneous vaginal birth without complications (‘straightforward birth’), transfer during labour and a composite measure of adverse perinatal outcome (‘intrapartum-related mortality and morbidity’ or neonatal admission within 48 hours for > 48 hours). In studies 1 and 3, rates of intervention/maternal outcome and transfer were adjusted for maternal characteristics. Analysis: We used (a) funnel plots to explore variation in rates of intervention/maternal outcome and transfer between units/trusts, (b) simple, weighted linear regression to evaluate associations between unit/trust characteristics and rates of intervention/maternal outcome and transfer, (c) multivariable Poisson regression to evaluate associations between planned place of birth, maternal characteristics and study outcomes, and (d) logistic regression to investigate associations between time of day/day of the week and study outcomes. Results: Study 1 – unit-/trust-level variations in rates of interventions, transfer and maternal outcomes were not explained by differences in maternal characteristics. The magnitude of identified associations between unit/trust characteristics and intervention, transfer and outcome rates was generally small, but some aspects of configuration were associated with rates of transfer and intervention. Study 2 – ‘low risk’ women planning non-OU birth had a reduced risk of intervention irrespective of ethnicity or area deprivation score. In nulliparous women planning non-OU birth the risk of intervention increased with increasing age, but women of all ages planning non-OU birth experienced a reduced risk of intervention. Study 3 – parity, maternal age, gestational age and ‘complicating conditions’ identified at the start of care in labour were independently associated with variation in the risk of transfer in ‘low risk’ women planning non-OU birth. Transfers did not vary by time of day/day of the week in any meaningful way. The duration of transfer from planned FMU and home births was around 50–60 minutes; transfers for ‘potentially urgent’ reasons were quicker than transfers for ‘non-urgent’ reasons. Study 4 – the occurrence of some interventions varied by time of the day/day of the week in ‘low risk’ women planning OU birth. Study 5 – ‘higher risk’ women planning birth in a non-OU setting had fewer risk factors than ‘higher risk’ women planning OU birth and these risk factors were different. Compared with ‘low risk’ women planning home birth, ‘higher risk’ women planning home birth had a significantly increased risk of our composite adverse perinatal outcome measure. However, in ‘higher risk’ women, the risk of this outcome was lower in planned home births than in planned OU births, even after adjustment for clinical risk factors. Conclusions: Expansion in the capacity of non-OU intrapartum care could reduce intervention rates in ‘low risk’ women, and the benefits of midwifery-led intrapartum care apply to all ‘low risk’ women irrespective of age, ethnicity or area deprivation score. Intervention rates differ considerably between units, however, for reasons that are not understood. The impact of major changes in the configuration of maternity care on outcomes should be monitored and evaluated. The impact of non-clinical factors, including labour ward practices, staffing and skill mix and women’s preferences and expectations, on intervention requires further investigation. All women planning non-OU birth should be informed of their chances of transfer and, in particular, older nulliparous women and those more than 1 week past their due date should be advised of their increased chances of transfer. No change in the guidance on planning place of birth for ‘higher risk’ women is recommended, but research is required to evaluate the safety of planned AMU birth for women with selected relatively common risk factors. Funding: The National Institute for Health Research Health Services and Delivery Research programme

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

A mindfulness parent well-being course: evaluation of outcomes for parents of children with autism and related disabilities recruited through special schools

Parents of children with intellectual disabilities and/or autism have been shown to experience higher levels of distress than other parents. Despite such data having been available for several decades, the evidence base for psychological interventions to support parental well-being is small. Recent data suggest that both mindfulness and acceptance processes are associated with decreased psychological distress for parents of children with intellectual disability and/or autism. In addition, some controlled evaluations of mindfulness-based interventions for these parents have resulted in positive outcomes for mothers in particular. In the present study 18 mothers and 3 fathers were recruited via special schools who then attended a Mindfulness Based Well-Being for Parents (MBW-P) group over eight weeks. Parents completed questionnaire measures before and at the end of the course. Statistical analysis showed significant reported increases in mindfulness and self-compassion, and reduced general stress. Parents also reported reductions in anxiety and depression, although these changes were not statistically significant. No significant reductions in their child’s behaviour problems or increases in the child’s prosocial behaviour were found. Parents also reported high levels of satisfaction with the course. These preliminary data suggest that further research studies testing the effectiveness of the MBW-P course are warranted

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

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

Women's experiences of the OASI Care Bundle; a package of care to reduce severe perineal trauma.

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

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

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