Barriers and facilitators for implementation of OptiBreech collaborative care: A qualitative study as part of an implementation process evaluation.

PROBLEM: Lack of opportunity for breech training and clinical experience reduced professional confidence and expertise in supporting vaginal breech birth. BACKGROUND: OptiBreech collaborative care is a care pathway for breech presentation at term that aims to enable improve safety through person-centred care and improved training opportunities for maternity professionals, within dedicated clinics and intrapartum support. In feasibility work, barriers and facilitators to team implementation were observed by team members. AIM: This study sought to describe factors affecting optimal future implementation and safety of OptiBreech care. METHODS: Semi-structured interviews were conducted with staff members at 13 OptiBreech trial sites (17 midwives and 4 obstetricians, n=21), via video conferencing software. The Theoretical Domains Framework (TDF) was used to identify factors impacting team implementation. Themes identified in the TDF were refined in reflexive discussion and grouped into key facilitators, key barriers, and dynamic factors (which span both barriers and facilitators). The interviews were then coded, analysed, and interpreted according to the refined framework. FINDINGS: The key facilitators were broadly categorised within skill development, beliefs about capabilities, and social support from the wider multidisciplinary team. Key barrier categories were resources, social obstacles, and fears about consequences. Dynamic factor categories were individual responsibility, training, and attending births. CONCLUSION: While some factors affecting implementation were specific to the individuals and cultures of certain Trusts, recommendations emerged from analysis that are more widely applicable across multiple settings. These should be considered going forward for future service implementation, and in the next stage of OptiBreech clinical trials.

Good while it lasted? Estimating the long-term and withdrawal effects of results-based financing in Malawi on maternal care utilisation using routine data.

OBJECTIVES: This study aimed to evaluate the effect of introduction and subsequent withdrawal of the Results-based Financing for Maternal and Newborn Health Initiative (RBF4MNH) in Malawi on utilisation of facility-based childbirths, antenatal care (ANC) and postnatal care (PNC). DESIGN: A controlled interrupted time series design was used with secondary data from the Malawian Health Management Information System. SETTING: Healthcare facilities at all levels identified as providing maternity services in four intervention districts and 20 non-intervention districts in Malawi. PARTICIPANTS: Routinely collected, secondary data of total monthly service utilisation of facility-based childbirths, ANC and PNC services. INTERVENTIONS: The intervention is the RBF4MNH initiative, introduced by the Malawian government in 2013 to improve maternal and infant health outcomes and withdrawn in 2018 after ceasing of donor funding. OUTCOME MEASURES: Differences in total volume and trends of utilisation of facility-based childbirths, ANC and PNC services, compared between intervention versus non-intervention districts, for the study period of 90 consecutive months. RESULTS: No significant effect was observed, on utilisation trends for any of the three services during the first 2.5 years of intervention. In the following 2.5 years after full implementation, we observed a small positive increase for facility-based childbirths (+0.62 childbirths/month/facility) and decrease for PNC (-0.55 consultations/month/facility) trends of utilisation respectively. After withdrawal, facility-based childbirths and ANC consultations dropped both in immediate volume after removal (-10.84 childbirths/facility and -20.66 consultations/facility, respectively), and in trends of utilisation over time (-0.27 childbirths/month/facility and -1.38 consultations/month/facility, respectively). PNC utilisation levels seemed unaffected in intervention districts against a decline in the rest of the country. CONCLUSIONS: Concurrent with wider literature, our results suggest that effects of complex health financing interventions, such as RBF4MNH, can take a long time to be seen. They might not be sustained beyond the implementation period if measures are not adopted to reform existing health financing structures.

Women's experiences of maternity care in the United Kingdom during the COVID-19 pandemic: A follow-up systematic review and qualitative evidence synthesis.

BACKGROUND: Maternity care services in the United Kingdom have undergone drastic changes due to pandemic-related restrictions. Prior research has shown maternity care during the pandemic was negatively experienced by women and led to poor physical and mental health outcomes in pregnancy. A synthesis is required of published research on women's experiences of maternity care during the latter half of the COVID-19 pandemic. AIM: To update a previous systematic review of maternity care experiences during the pandemic to June 2021, exploring experiences of maternity care specifically within the United Kingdom and how they may have changed, in order to inform future maternity services. METHODS: A systematic review of qualitative literature was conducted using comprehensive searches of five electronic databases and the Cochrane COVID Study Register, published between 1 June 2021 and 13 October 2022, and further updated to 30 September 2023. Thematic Synthesis was utilised for data synthesis. FINDINGS: Of 21,860 records identified, 27 studies were identified for inclusion. Findings included 14 descriptive themes across the five core concepts: (1)Care-seeking and experience; (2)Virtual care; (3)Self-monitoring; (4)COVID-19 vaccination; (5)Ethical future of maternity care. DISCUSSION: Our findings in the UK are consistent with those globally, and extend those of the previous systematic review, particularly about women's perceptions of the COVID-19 vaccine during pregnancy. CONCLUSION: Our findings suggest the following are important to women for future maternity care: personalisation and inclusiveness; clear and evidence-based communication to facilitate informed decision-making; and achieving balance between social commitments and time spent settling into motherhood.

The feasibility of team care for women seeking to plan a vaginal breech birth (OptiBreech 1): an observational implementation feasibility study in preparation for a pilot trial.

BACKGROUND: OptiBreech Care is a care pathway for breech presentation at term, including where chosen, physiological breech birth attended by professionals with advanced training and/or proficiency. We aimed to assess the feasibility of implementing OptiBreech team care prior to proceeding with a planned pilot randomised controlled trial. METHODS: Our design was an observational implementation feasibility assessment across England and Wales, January 2021-June 2022. Our objectives were to determine whether Trusts could provide attendants with advanced training (implementation feasibility), who deliver protocol-consistent care (fidelity), within existing resources (costs), while maintaining low neonatal admission rates (safety) and adequate recruitment rates (trial feasibility). Participants included women > 37 weeks pregnant with a breech-presenting foetus, requesting support for a vaginal breech birth following standard counselling, and staff involved in the study. No randomisation occurred in this first stage of feasibility work. RESULTS: Thirteen National Health Service sites were recruited. A total of 82 women planned births in the study. Sites with a breech specialist midwife recruited at double the rate of sites without (0.90/month, 95% CI 0.64-1.16 vs 0.40, 95% CI 0.12-0.68). Referrals into the study came from midwives (46%), obstetricians (34%) and women themselves (20%). Vaginal births were attended by staff with OptiBreech training at 87.5% (35/40, 95% CI 0.732-0.958) and by staff who met additional proficiency criteria at 67.5% (27/40, 95% CI 0.509-0.814). Fidelity criteria were more consistently met by staff who also met proficiency criteria. There were four neonatal admissions (4.9%, 4/82), including one serious adverse outcome (1.2%, 1/82). CONCLUSIONS: A prospective observational cohort of OptiBreech collaborative care, which could potentially support nested or cluster randomisation, appears feasible in sites willing to establish a dedicated clinic and strategically develop further proficient members of staff, with back-up plans for supporting rapidly progressing births. Randomisation procedures remain to be feasibility tested. It is funded by the NIHR (NIHR300582).

Breech specialist midwives and clinics in the OptiBreech Trial feasibility study: An implementation process evaluation.

BACKGROUND: Attendance of skilled and experienced professionals at breech births has been associated with a reduction in adverse perinatal outcomes. We aimed to determine whether United Kingdom National Health Service (NHS) sites could reliably provide attendants with OptiBreech training and/or advanced proficiency (intervention feasibility) and consistent care (fidelity) that meets women's needs (acceptability), with low neonatal admission rates (safety) and recruitment adequate to support a clinical trial (trial feasibility). METHODS: Mixed methods implementation evaluation was used. Settings were 13 services in England and Wales. Participants were 82 women requesting support for a vaginal breech birth (VBB) at term. Outcomes were descriptively analyzed. Twenty-one women were interviewed, and transcripts were analyzed using the Theoretical Framework of Acceptability. Iterative analysis informed subsequent interviews and the ongoing process of implementation across sites. RESULTS: Although we initially suggested multidisciplinary teams, actively recruiting Trusts yielded services where VBB care was provided through a dedicated clinic, organized and delivered primarily by a lead midwife who functioned as a specialist. This model achieved 87.5% fidelity with the intervention's goal of ensuring the attendance of OptiBreech-trained professionals. Neonatal outcomes remained stable, with an admission rate of 5.5%. Women reported care from specialist midwives as highly acceptable, but the model is vulnerable without a strategic effort to develop additional proficient team members. CONCLUSIONS: Dedicated clinics coordinated by specialist midwives appear to be an acceptable and feasible implementation strategy to test the safety and effectiveness of proficient team care for VBB in a clinical trial. Back-up arrangements should be maintained while additional members of the team develop proficiency.

On race and ethnicity during a global pandemic: An 'imperfect mosaic' of maternal and child health services in ethnically-diverse South London, United Kingdom.

Background: The SARS-CoV-2 pandemic has brought racial and ethnic inequity into sharp focus, as Black, Asian, and Minority Ethnic people were reported to have greater clinical vulnerability. During the pandemic, priority was given to ongoing, reconfigured maternity and children's healthcare. This study aimed to understand the intersection between race and ethnicity, and healthcare provision amongst maternity and children's healthcare professionals, during the SARS-CoV-2 pandemic. Methods: A qualitative study consisting of semi-structured interviews (N = 53) was undertaken with maternity (n = 29; August-November 2020) and children's (n = 24; June-July 2021) healthcare professionals from an NHS Trust in ethnically-diverse South London, UK. Data pertinent to ethnicity and race were subject to Grounded Theory Analysis, whereby data was subjected to iterative coding and interpretive analysis. Using this methodology, data are compared between transcripts to generate lower and higher order codes, before super-categories are formed, which are finally worked into themes. The inter-relationship between these themes is interpreted as a final theory. Findings: Grounded Theory Analysis led to the theory: An 'Imperfect Mosaic', comprising four themes: (1) 'A System Set in Plaster'; (2) 'The Marginalised Majority'; (3) 'Self-Discharging Responsibility for Change-Making'; and (4) 'Slow Progress, Not No Progress'. The NHS was observed to be brittle, lacking plasticity to deliver change at pace. Overt racism based on skin colour has been replaced by micro-aggressions between in-groups and out-groups, defined not just by ethnicity, but by other social determinants. Contemporaneously, responsibility for health, wellbeing, and psychological safety in the workplace is discharged to, and accepted by, the individual. Interpretation: Our findings suggest three practicable solutions: (1) Representation of marginalised groups at all NHS levels; (2) Engagement in cultural humility which extends to other social factors; and (3) Collective action at system and individual levels, including prioritising equity over simplistic notions of equality. Funding: This service evaluation was supported by the King's College London King's Together Rapid COVID-19 Call, successfully awarded to Laura A. Magee, Sergio A. Silverio, Abigail Easter, & colleagues (reference:- 204823/Z/16/Z), as part of a rapid response call for research proposals. The King's Together Fund is a Wellcome Trust funded initiative.

Development of a core outcome set for effectiveness studies of breech birth at term (Breech-COS)-an international multi-stakeholder Delphi study: study protocol.

BACKGROUND: Women pregnant with a breech-presenting foetus at term are at increased risk of adverse pregnancy outcomes. The most common intervention used to improve neonatal outcomes is planned delivery by caesarean section. But this is not always possible, and some women prefer to plan a vaginal birth. A number of providers have proposed alternative interventions, such as delivery protocols or specialist teams, but heterogeneity in reported outcomes and their measurements prevents meaningful comparisons. The aim of this paper is to present a protocol for a study to develop a Breech Core Outcome Set (Breech-COS) for studies evaluating the effectiveness of interventions to improve outcomes associated with term breech birth. METHODS: The development of a Breech-COS includes three phases. First, a systematic literature review will be conducted to identify outcomes previously used in effectiveness studies of breech birth at term. A focus group discussion will be conducted with the study's pre-established Patient and Public Involvement (PPI) group, to enable service user perspectives on the results of the literature review to influence the design of the Delphi survey instrument. Second, an international Delphi survey will be conducted to prioritise outcomes for inclusion in the Breech-COS from the point of view of key stakeholders, including perinatal care providers and families who have experienced a term breech pregnancy. Finally, a consensus meeting will be held with stakeholders to ratify the Breech-COS and disseminate findings for application in future effectiveness studies. DISCUSSION: The expectation is that the Breech-COS will always be collected in all clinical trials, audits of practice and other forms of observation research that concern breech birth at term, along with other outcomes of interest. This will facilitate comparing, contrasting and combining studies with the ultimate goal of improved maternal and neonatal outcomes. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials (COMET) #1749.

Development of a core outcome set for effectiveness studies of breech birth at term (Breech-COS): A systematic review on variations in outcome reporting.

Women pregnant with a breech-presenting fetus at term are at an increased risk of adverse outcomes. Although the most common intervention is planned delivery by caesarean section, this is not always possible or desirable. Comparing alternative interventions is difficult due to heterogeneity in reported outcomes and their measurements. Additionally, the evidence, particularly for women in labour with a breech-presenting fetus, is very low quality, with several outcomes viewed as critical and important to decision-making not reported at all. There is a need to develop a core outcome set of minimum outcomes in all studies evaluating the effectiveness of interventions to improve outcomes associated with term breech birth (Breech-COS). Our objectives were to (1) identify outcomes currently reported in effectiveness studies of breech birth at term using a systematic review of the literature; (2) assess the methodological quality of outcome reporting in the included studies; and (3) engage with members of an established Patient and Public Involvement (PPI) group about the results, to help frame our understanding from the perspective of service users. We searched three databases (MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials) for all effectiveness studies associated with vaginal breech birth published in English between 2000 and 2020. Two reviewers independently screened and extracted the data. Outcomes were categorised into neonatal, maternal, features of labour, and long-term maternal and hierarchy of outcome classification (primary, secondary, part of composite, or undesignated). Frequency of reporting was calculated for each. An adapted methodological assessment was done for each study investigating whether primary and secondary objectives were clearly stated and defined. The results of the systematic review were then discussed with a PPI group to consider importance and relevance to service users. A total of 211 outcomes were extracted from 108 included studies, comprising of short (43) and long-term (39) neonatal, short (54) and long-term (39) maternal and features of labour (36) outcomes. The most frequently reported outcome in each category was: APGAR score at 5 min, developmental vulnerability/neurological morbidity, maternal mortality, urinary incontinence, and actual mode of birth respectively. Long-term outcomes were infrequently reported in the included studies, with outcomes for future pregnancies not reported at all, although these were each deemed important by service users. There was a lack of consensus in definition and measurement of outcomes, with only 36% of the included studies having clearly stated primary and secondary objectives. The observed heterogeneity in reported outcomes, lack of consensus in definition and measurement, as well as desire expressed by service users to have robust risk statistics for outcomes important to them highlights the need to develop a core outcome set for evaluating effectiveness studies of breech birth at term. A Breech-COS will enable useful synthesis of evidence and contribute to supported decision-making for women pregnant with a breech-presenting fetus at term.

A Comparison of Smoflipid® and Intralipid® in the Early Management of Infants with Intestinal Failure.

PURPOSE: Cholestasis is problematic for infants with intestinal failure (IF). The soy-based lipid Intralipid® (IL) has been implicated. An alternative, Smoflipid® (SMOF), is increasingly used. However, its role in cholestasis prevention is unclear. This study compares the incidence and degree of cholestasis between infants with IF receiving SMOF or IL. METHODS: Infants with IF receiving SMOF or IL during the first 8 weeks of parenteral nutrition (PN) support between 2014 and 2017 were reviewed. Clinical characteristics, cholestasis incidence (conjugated bilirubin (Cbili) >2 mg/dL for >2 weeks), and nutritional parameters were compared using Welch's t-test. RESULTS: 91% (21/23) of IL and 76% (16/21) of SMOF babies became cholestatic (p = 0.18). There was no significant difference in median peak Cbili, but SMOF babies normalized more quickly (p = 0.04). Median z-scores for weight were similar throughout the study. SMOF patients getting full PN had a lower incidence of cholestasis compared to IL patients (78% vs. 92%, p = 0.057), but those with cholestasis had similar peak Cbili, time to resolution, and growth. CONCLUSION: Early use of Smoflipid® did not reduce the incidence of cholestasis compared to Intralipid® in infants with IF, but hyperbilirubinemia did resolve more quickly. SMOF may be most beneficial for infants tolerating no enteral nutrition. LEVEL OF EVIDENCE: Level III Retrospective Comparative Treatment Study. TYPE OF STUDY: Retrospective Review.