Working with suicidal mothers during the perinatal period: a reflexive thematic analysis study with mental health professionals.

BACKGROUND: Suicide is the leading cause of death in mothers postpartum and one of the most common causes of death during pregnancy. Mental health professionals who work in perinatal services can offer insights into the factors they perceive as being linked to mothers' suicidal ideation and behaviour, support offered to mothers and improvements to current practices. We aimed to explore the experiences and perceptions of perinatal mental health professionals who have worked with suicidal mothers during the perinatal period. METHOD: Semi-structured interviews were conducted face-to-face or via telephone with mental health professionals working in perinatal mental health inpatient or community services across England. Data were analysed using reflexive thematic analysis. RESULTS: From the professionals' (n = 15) accounts three main themes were developed from their interview data. The first, factors linked to suicidal ideation and behaviour, overarched two sub-themes: (1.1) the mother's context and (1.2) what the baby represents and what this means for the mother. These sub-themes described factors that professionals assessed or deemed contributory in relation to suicidal ideation and behaviour when a mother was under their care. The second main theme, communicating about and identifying suicidal ideation and behaviour, which outlined how professionals enquired about, and perceived, different suicidal experiences, encapsulated two sub-themes: (2.1) how to talk about suicide and (2.2) types of suicidal ideation and attempts. The third main theme, reducing suicidal ideation through changing how a mother views her baby and herself, focused on how professionals supported mothers to reframe the ways in which they viewed their babies and in turn themselves to reduce suicidal ideation. CONCLUSION: Professionals highlighted many factors that should be considered when responding to a mother's risk of suicide during the perinatal period, such as the support around her, whether the pregnancy was planned and what the baby represented for the mother. Professionals' narratives stressed the importance of adopting a tailored approach to discussing suicidal experiences with mothers to encourage disclosure. Our findings also identified psychological factors that professionals perceived as being linked to suicidal outcomes for mothers, such as self-efficacy; these factors should be investigated further.

Best practice recommendations for the integration of trauma-informed approaches in maternal mental health care within the context of perinatal trauma and loss: A systematic review of current guidance.

PURPOSE: The National Health Service (NHS) in England plans to increase accessibility to evidence-based, trauma-informed psychological care for women in the perinatal period. Therefore, this systematic review aimed to 1) synthesise current guidance from clinical guidelines, policy documents, and care standards on trauma-informed approaches to care in maternal mental health settings within the context of pregnancy-related trauma and 2) to offer recommendations informing the implementation and evaluation of this type of care. METHODS: Nine electronic databases were searched and screened. Data were extracted and analysed using narrative synthesis. Included records were quality-assessed. RESULTS: After screening 1095 identified records, 11 records were included. The findings were synthesised into eight recommendations: 1) screening for trauma, 2) access to care, 3) clear and sensitive communication, 4) consistency and continuity of care, 5) offering individualised care whilst recognising diversity, 6) collaboration between women, families, and services, 7) care provider training to enhance skills and knowledge, and 8) supervision and peer support for care providers. CONCLUSIONS: The findings of this review are highly relevant given the current development, delivery, and evaluation of specific maternal mental health services, particularly in the United Kingdom, but also with the increase in perinatal mental health provision more globally.

Psychological intervention priorities according to perinatal women who experienced suicidal thoughts and perinatal mental health professionals: a Q-methodology study.

Introduction: Suicide is the leading direct cause of maternal death in the year following birth and the second leading cause during pregnancy, in the UK and Ireland. Currently no evidence-based psychological interventions exist specifically designed to reduce mothers' suicidal experiences during the perinatal period. Reducing suicidal ideation and behaviour in mothers is a priority to prevent deaths and lessen the distress felt by mothers and their families. As Q-methodology measures the consensus and disagreement between individuals on a given topic, the current study used Q-methodology to elicit the priorities for a future psychological intervention aimed at reducing suicidal ideation and behaviour during the perinatal period, from the collective perspectives of both mothers and professionals. Method: As part of this Q-methodology study, we developed a Q-set of 75 statements pertaining to possible elements of a psychological intervention that might help reduce a mother's suicidal ideation and behaviour during the perinatal period. Mothers and professionals were recruited via perinatal mental health services and social media advertisements. Results: Twenty-one mothers and 11 perinatal mental health professionals ranked each Q-set statement depending on its perceived importance in developing a new intervention. A centroid factor analysis was conducted and two factors, which accounted for 42% of the overall variance, were identified: Factor 1 "supporting the mother to create distance between herself and the appeal of suicide" and Factor 2 "establishing positive connections with the therapist, the baby and motherhood." All participants believed that developing plans to keep the mother safe from suicide was the most important aspect for inclusion in a future intervention. Participants who loaded onto Factor 1 also prioritised supporting mothers to learn more about triggers for their suicidal ideation and behaviour. Ensuring a robust therapeutic alliance was more important for those who loaded onto Factor 2. Conclusion: This is the first study using Q-methodology to explore the psychological intervention priorities of mothers and professionals. Findings indicate clear priorities in terms of planning and coping during a crisis, endorsed by all participants, and provide an initial step in the development of a new perinatal suicide prevention intervention.

A Feasibility Randomized Controlled Trial of a Parenting Intervention Offered to Women With Severe Mental Health Problems and Delivered in a Mother and Baby Unit Setting: The IMAgINE Study Outcomes.

Background: Approximately 1-2% of mothers may experience severe mental illness (SMI) requiring admission to an inpatient Mother and Baby Unit (MBU). MBUs aim to provide mental health assessment and treatment and strengthen the mother-infant relationship, essential for infant development. Whilst MBUs offer various interventions, they do not routinely offer structured parenting interventions. The Baby Triple P Positive Parenting Program (BTP) was developed to enhance parenting competence, psychological coping and the quality of partner and other social support. Guided by lived experience consultation, we aimed to determine the feasibility and acceptability of delivering BTP plus Treatment as Usual (TAU) in this setting. Method: A multi-site, parallel-group, single-blind pilot randomized controlled trial (registration: ISRCTN12765736) comparing BTP+TAU to TAU in participants, recruited from two MBUs in England. The Baby Triple P intervention consisted of eight parenting sessions, with the final four being delivered over the telephone following MBU discharge. Feasibility outcomes were participant intervention engagement and study retention. Clinical outcomes including maternal parenting competence, bonding and mental health outcomes were assessed at baseline, post-baseline/intervention (10 weeks) and six-month follow-up. Data were analyzed using descriptive statistics and linear regression models. An economic feasibility analysis was also conducted. Results: Thirty-seven of the 67 eligible participants consented; 34 were randomized (16 to BTP+TAU and 18 to TAU), of whom 20 were retained at post-intervention data collection and 21 at six-month follow-up. Twelve participants (75%) completed the intervention, which was rated as highly acceptable. Clinical outcomes signaled potential improvements in maternal parenting competence, bonding, mood and mental health symptomatology in participants who received the intervention. Healthcare resource use and EQ-5D-5L questionnaires were well-completed by participants. Delivering BTP in this setting is estimated to cost £443-822 per participant. Conclusions: This is the first trial of a parenting intervention in a MBU setting. BTP is feasible and acceptable to mothers with SMI, with a promising signal for treatment efficacy. Although minor modifications may be required for the collection of observer-rated measures post-MBU discharge, the findings indicate that a larger, definitive trial could be conducted, especially if the setting is extended to include perinatal mental health community settings.

What makes a perinatal woman suicidal? A grounded theory study.

BACKGROUND: Suicide is a leading cause of maternal death during pregnancy and up to a year after birth. Psychological and psychosocial risk factors for maternal suicide ideation and behaviour have been identified but do not account for why mothers begin to experience suicidal thoughts. Qualitative research offers a way of identifying what might drive mothers to initially consider suicide and then go on to act on such thoughts; crucial for the development of assessments to identify, and interventions to target, maternal suicide ideation and behaviour. We aimed to develop a grounded theory outlining what makes women think about suicide and/or engage in suicidal behaviour during pregnancy and the first 12 months following birth? METHOD: Semi-structured interviews were conducted with 12 mothers in the UK who had suicidal thoughts during pregnancy and/or the first year following birth. A constructivist approach to grounded theory was adopted which guided the data collection and analysis processes. RESULTS: We developed a model outlining the theorised process of psychological factors that culminates in mothers experiencing suicidal thoughts and then making a suicide attempt during the perinatal period. The process was initiated when mothers felt attacked by motherhood which led to feeling like a failure, self-identifying as a "bad mother" and subsequent appraisals of entrapment and/or defeat. When nothing resolved the distress and as mothers collated reasons for why they perceived they needed to die, suicidal behaviour became a viable and appealing option. We theorised that mothers might make a suicide attempt when they entered a state of intense "darkness" brought on by a trigger, followed by a temporary lapse in the conflict between the desire to live and desire to die and an opportunity to attempt. CONCLUSIONS: Participants stressed the rapid onset of suicidal thoughts. We suggest that healthcare professionals enquire about the mother's feelings towards the baby and of isolation, how she views herself as a mother, feelings of entrapment and defeat during routine contacts to aid identification and prevention of suicidal ideation/behaviour. Suggested interventions to prevent suicidal thoughts and behaviour include helping women manage their expectations for pregnancy and the postpartum period.

Maternal Suicide Ideation and Behaviour During Pregnancy and the First Postpartum Year: A Systematic Review of Psychological and Psychosocial Risk Factors.

Suicide is a leading cause of maternal death during pregnancy and up to a year after birth (perinatal period). Many psychological and psychosocial risk factors for maternal suicidal ideation and behaviour have been investigated. Despite this, there have been no attempts to systematically search the literature on these risk factors. Additionally, few studies have described how the risk factors for suicidal ideation, attempted suicides and suicide deaths differ, which is essential for the development of tools to detect and target suicidal ideation and behaviour. Seven databases were searched up to June 2021 for studies that investigated the association between suicidal ideation and/or suicidal behaviour and psychological/psychosocial risk factors in pregnant and postpartum women. The search identified 17,338 records, of which 59 were included. These 59 studies sampled a total of 49,929 participants and investigated 32 different risk factors. Associations between abuse, experienced recently or during childhood, and maternal suicide ideation, attempted suicide and death were consistently reported. Social support was found to be less associated with suicide ideation but more so with suicide attempts. Identifying women who have experienced domestic violence or childhood abuse and ensuring all women have adequate emotional and practical support during the perinatal period may help to reduce the likelihood of suicidal behaviour.

How is resilience conceptualized and operationalized in occupational therapy and occupational science literature? Protocol for a scoping review / Como a resiliência é conceituada e operacionalizada na literatura de ciência ocupacional e terapia ocupacional? Protocolo para uma revisão de escopo

Abstract Introduction Resilience is a commonly discussed term describing the ability to overcome, adapt to, or cope with stressful/disruptive events. Although researchers and practitioners define resilience in diverse ways - e.g., psychological or disaster resilience - the concept fundamentally encompasses perseverance through adversity. As experts in the interplay between individuals, environments, and occupations, occupational therapists and occupational scientists have great potential to understand and enable resilience, with some similar concepts appearing in occupational theories (e.g., occupational adaptation). However, there are no published reviews of resilience in the occupation-focused literature. Objective We will explore how resilience is conceptualized and operationalized in the occupational therapy and occupational science research literature. Method Guided by the Joanna Briggs Institute scoping review methodology, we will search library databases and other sources for relevant records. Two team members will screen records for inclusion, with discrepancies settled by a third person. We will include English-language literature (including research papers, editorials, dissertations, etc.) published since 1990 which 1) contains the word root 'resilien*' and 2) is occupation focused, according to our criteria (occupational therapist/occupational scientist co-authors or research participants; and/or published in occupation-focused periodical). We will report key information of included literature, such as methodology and resilience theories discussed. Results Our study is ongoing at the time of publication; this manuscript reports its protocol without results. Conclusion Findings will be useful for clinicians and researchers looking for occupational conceptualizations of resilience. From a social justice perspective, our review may highlight evidence that occupational engagement can foster resilience among marginalized communities.

Resumo Introdução Resiliência é um termo que descreve a habilidade de superar, adaptar ou lidar com eventos estressantes ou perturbadores. Embora pesquisadores e profissionais definam resiliência de diversas maneiras - como resiliência psicológica ou a desastres - o conceito fundamentalmente engloba perseverança no enfrentamento de adversidades. Como especialistas na interação entre indivíduos, comunidades, ambientes e ocupações, terapeutas ocupacionais e cientistas ocupacionais têm potencial para compreender e propiciar a resiliência, com alguns conceitos semelhantes (como adaptação ocupacional). Entretanto, não há nenhuma revisão publicada sobre resiliência na área. Objetivo Explorar como a resiliência é conceituada e operacionalizada na literatura científica de terapia ocupacional e ciência ocupacional. Método Guiados pela metodologia para revisões de escopo proposta pelo Instituto Joanna Briggs, buscou-se por documentos em bases de dados científicas e outras fontes. Dois membros da equipe revisaram documentos para inclusão e as discrepâncias foram resolvidas por uma terceira pessoa. Utilizou-se literatura em inglês (artigos de pesquisa, editoriais, dissertações etc.) publicada desde 1990 que: (1) contenha 'resilien*' e (2) seja focada na ocupação, desde que: terapeutas ocupacionais ou cientistas ocupacionais fossem coautores ou participantes da pesquisa; e/ou publicada em periódico focado em terapia ocupacional/ciência ocupacional. Foram reportadas as principais informações dos documentos incluídos, como a metodologia e as teorias de resiliência. Resultados Este estudo está em andamento; foca-se aqui no protocolo de pesquisa, sem resultados. Conclusão As discussões serão úteis para profissionais na prática clínica e pesquisadores buscando por uma conceituação ocupacional de resiliência. De uma perspectiva de justiça social, essa revisão pode destacar evidências de que o engajamento com ocupações pode promover resiliência entre comunidades marginalizadas.

Patient and Caregiver Perspectives on an eHealth Tool: A Qualitative Investigation of Preferred Formats, Features and Characteristics of a Presurgical eHealth Education Module.

INTRODUCTION: Total hip and total knee replacement (THR and TKR) are suggested for reducing joint pain resulting from hip and knee osteoarthritis (OA), especially when other interventions have not resulted in desired outcomes. Providing prehabilitation education can improve patients' psychological and physical well-being before and after surgery. The use of electronic health (eHealth) tools can be considered an effective method to increase patients' access to prehabilitation, particularly for those facing barriers to attending diagnosis-specific in-person education sessions. However, limited attention is paid to both caregiver and patient perspectives regarding the delivery formats, features, and characteristics of eHealth tools. METHOD: Patients with hip (n = 46) and knee OA (n = 14) and their family caregivers (n = 16) participated in in-person focus groups or phone interviews. Participants were shown a mock-up of an eHealth module, and asked to share their preferences regarding the formats, features, and characteristics of the eHealth prehabilitation tool. Data was transcribed verbatim and coded using primary thematic and secondary content analyses. RESULT: Analyses revealed 3 main themes: 1. "easier to understand" emphasizes patients' preferences on delivery formats and features; 2. "what does that mean?" highlights requests for clear and simple information; and 3. "Preparation, right?" shows patients' perspectives on the best time to have access to the eHealth tool. DISCUSSION: Participants' preferences for prehabilitation tools included offering eHealth tools in multiple mediums of delivery (eg, written materials, pictures, videos). Participants preferred simplified information that emphasized the key points and rationale for the knowledge. There were differences in preferred timeline for having access to prehabilitation education, such as some participants wanting to receive prehabilitation well in advance, while others stated just before surgery was adequate. Our findings provide novel and actionable information about patient and caregiver perspectives on features and characteristics of prehabilitation education for patients with hip and knee OA.

The Impact of COVID-19-Related Restrictions on Social and Daily Activities of Parents, People With Disabilities, and Older Adults: Protocol for a Longitudinal, Mixed Methods Study.

BACKGROUND: The COVID-19 pandemic has led to wide-scale changes in societal organization. This has dramatically altered people's daily activities, especially among families with young children, those living with disabilities such as spinal cord injury (SCI), those who have experienced a stroke, and older adults. OBJECTIVE: We aim to (1) investigate how COVID-19 restrictions influence daily activities, (2) track the psychosocial effects of these restrictions over time, and (3) identify strategies to mitigate the potential negative effects of these restrictions. METHODS: This is a longitudinal, concurrent, mixed methods study being conducted in British Columbia (BC), Canada. Data collection occurred at four time points, between April 2020 and February 2021. The first three data collection time points occurred within phases 1 to 3 of the Province of BC's Restart Plan. The final data collection coincided with the initial distribution of the COVID-19 vaccines. At each time point, data regarding participants' sociodemographics, depressive and anxiety symptoms, resilience, boredom, social support, instrumental activities of daily living, and social media and technology use were collected in an online survey. These data supplemented qualitative videoconference interviews exploring participants' COVID-19-related experiences. Participants were also asked to upload photos representing their experience during the restriction period, which facilitated discussion during the final interview. Five groups of participants were recruited: (1) families with children under the age of 18 years, (2) adults with an SCI, (3) adults who experienced a stroke, (4) adults with other types of disabilities, and (5) older adults (>64 years of age) with no self-reported disability. The number of participants we could recruit from each group was limited, which may impact the validity of some subgroup analyses. RESULTS: This study was approved by the University of British Columbia Behavioural Research Ethics Board (Approval No. H20-01109) on April 17, 2020. A total of 81 participants were enrolled in this study and data are being analyzed. Data analyses are expected to be completed in fall 2021; submission of multiple papers for publication is expected by winter 2021. CONCLUSIONS: Findings from our study will inform the development and recommendations of a new resource guide for the post-COVID-19 period and for future public health emergencies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/28337.

Effectiveness of medication assisted treatment for opioid use in prison and jail settings: A meta-analysis and systematic review.

This study examined the state of the literature on the effectiveness of medication assisted treatment (MAT; methadone, buprenorphine, naltrexone) delivered in prisons and jails on community substance use treatment engagement, opioid use, recidivism, and health risk behaviors following release from incarceration. Randomized controlled trials (RCTs) and quasi-experimental studies published through December 2017 that examined induction to or maintenance on methadone (n = 18 studies), buprenorphine (n = 3 studies), or naltrexone (n = 3 studies) in correctional settings were identified from PsycINFO and PubMed databases. There were a sufficient number of methadone RCTs to meta-analyze; there were too few buprenorphine or naltrexone studies. All quasi-experimental studies were systematically reviewed. Data from RCTs involving 807 inmates (treatment n = 407, control n = 400) showed that methadone provided during incarceration increased community treatment engagement (n = 3 studies; OR = 8.69, 95% CI = 2.46; 30.75), reduced illicit opioid use (n = 4 studies; OR = 0.22, 95% CI = 0.15; 0.32) and injection drug use (n = 3 studies; OR = 0.26, 95% CI = 0.12; 0.56), but did not reduce recidivism (n = 4 studies; OR = 0.93, 95% CI = 0.51; 1.68). Data from observational studies of methadone showed consistent findings. Individual review of buprenorphine and naltrexone studies showed these medications were either superior to methadone or to placebo, or were as effective as methadone in reducing illicit opioid use post-release. Results provide the first meta-analytic summary of MATs delivered in correctional settings and support the use of MATs, especially with regard to community substance use treatment engagement and opioid use; additional work is needed to understand the reduction of recidivism and other health risk behaviors.

Correction to: Enhancing maternal and infant wellbeing: study protocol for a feasibility trial of the Baby Triple P Positive Parenting programme for mothers with severe mental health difficulties (the IMAGINE study).

Following publication of the original article [1], the authors reported that Elizabeth Camacho was omitted from the author name list.

Enhancing maternal and infant wellbeing: study protocol for a feasibility trial of the Baby Triple P Positive Parenting programme for mothers with severe mental health difficulties (the IMAGINE study).

BACKGROUND: There is a strong evidence base for the benefits of parenting interventions for parents without severe mental illness (SMI). As the impact of maternal SMI can be significant on child development, mothers need support to maximise outcomes for themselves and their children. Some mothers with SMI require admission jointly with their baby to a Mother and Baby Unit (MBU), a psychiatric inpatient ward, for assessment and treatment. However, MBUs do not yet offer formally evaluated, evidence-based parenting interventions as a matter of routine. This paper describes a study to investigate the feasibility and acceptability of conducting a randomised controlled trial (RCT) to evaluate a parenting and psychological intervention targeting the mother's and infant's wellbeing for mothers admitted to a MBU. METHODS/DESIGN: This study is a multisite, single-blind feasibility trial with half the participants randomised to the Baby Triple P Positive Parenting Programme plus treatment as usual (TAU) and the other half randomised to TAU alone. Self-report and observer-rated assessments are collected at baseline, 10 weeks post-baseline and 6 months post-baseline. Participants are mothers admitted to a MBU in the Northwest of England or the Midlands. Participants are included if they are fluent in English to provide informed, written consent. Our objective is to determine whether we can recruit 66 women, randomise 60, and retain them in the intervention and study, and whether the intervention and study procedures are acceptable. As part of a nested process evaluation, qualitative interview data from trial participants and MBU staff will inform feasibility and acceptability. The feasibility of collecting data required to conduct an economic evaluation of the intervention will also be explored. DISCUSSION: Although research has been conducted in relation to mothers with severe mental illness and MBUs, to our knowledge, this is the first controlled trial to test the feasibility, acceptability, uptake and retention alongside the potential efficacy of a parenting intervention for this population. This study is essential to examine the contextual challenges involved in this setting with this population and to identify any refinements required. TRIAL REGISTRATION: ISRCTN12765736 . Date of first registration: 2 February 2017.

A mixed-methods evaluation of continuous electronic fetal monitoring for an extended period.

INTRODUCTION: Continuous fetal monitoring is used to objectively record the fetal heart rate and fetal activity over an extended period of time; however, its feasibility and acceptability to women is currently unknown. The study addressed the hypothesis that continuous fetal monitoring is feasible and acceptable to pregnant women. MATERIAL AND METHODS: Pregnant participants (n = 22) were monitored using a continuous fetal electrocardiography device, the Monica AN24. Signal quality, duration of recording and cardiotocography findings were correlated with maternal and fetal factors. Participants' change in anxiety before and after monitoring was assessed using validated questionnaires. Participants' experiences were explored through a questionnaire (n = 20) and semi-structured interview (n = 13). RESULTS: Recordings were successfully obtained in 19 of the 22 participants (86.3%). The mean recording quality of fetal heart rate was 69.0% (range 17.4%-99.4%) and maternal heart rate was 99.0% (90.9%-100.0%). Recording quality was positively correlated with gestational age (P = 0.05) and negatively correlated with uterine activity and maternal movement (P < 0.001). Overall, participants were satisfied with their experience of continuous fetal monitoring; 30% considered it preferable to intermittent monitoring. Continuous fetal monitoring did not significantly increase maternal anxiety, with a trend towards a reduction in Pregnancy Specific Anxiety score (P = 0.07). Qualitative analysis grouped women's responses into three themes: (a) reassurance and anxiety, (b) the physical device and (c) future developments in continuous fetal monitoring. CONCLUSIONS: Continuous fetal monitoring is a feasible and acceptable form of monitoring to pregnant women although further practical improvements could be incorporated. Further research is required to assess the ability of continuous fetal monitoring to detect fetal compromise.

Mediational Pathways Among Trait Impulsivity, Heroin-use Consequences, and Current Mood State.

BACKGROUND: This study examined whether lifetime heroin-use consequences mediate the relationship between trait impulsivity and three current mood outcomes: depression symptoms, stress levels, and perception of life events. METHOD: Regular heroin users (N = 163) were assessed using the Barratt Impulsiveness Scale (BIS-11) to measure trait impulsivity; a standardized Drug History and Use Questionnaire to measure lifetime adverse consequences of heroin use; Beck Depression Inventory II to measure current depression symptoms; Stress subscale of the Depression Anxiety Stress scale; and Hassles and Uplifts scale to measure perception of life events. RESULTS: BIS-11 Attentional and Motor impulsivity were positively related to number of adverse heroin-use consequences, depression symptoms, and stress level, and negatively associated with positive perception of events. A greater number of heroin-use consequences was related to more depression symptoms, higher stress, more negative perception of events, injection heroin use, and earlier ages of first and regular heroin use. In six mediation models, lifetime heroin-use consequences partially mediated relationships between two trait impulsivity domains (Attentional, Motor) and current mood measures (depression symptoms, stress, perception of events). CONCLUSIONS: The present findings suggest that current negative mood can be a response to the accumulated burden of heroin-use consequences, particularly in the presence of high trait impulsivity.

'Just an extra pair of hands'? A qualitative study of obstetric service users' and professionals' views towards 24/7 consultant presence on a single UK tertiary maternity unit.

OBJECTIVES: To explore the views of maternity service users and professionals towards obstetric consultant presence 24 hours a day, 7 days a week. DESIGN: Semistructured interviews conducted face to face with maternity service users and professionals in March and April 2016. All responses were analysed together (ie, both service users' and professionals' responses) using an inductive thematic analysis. SETTING: A large tertiary maternity unit in the North West of England that has implemented 24/7 obstetric consultant presence. PARTICIPANTS: Antenatal and postnatal inpatient service users (n=10), midwives, obstetrics and gynaecology specialty trainees and consultant obstetricians (n=10). RESULTS: Five themes were developed: (1) 'Just an extra pair of hands?' (the consultant's role), (2) the context, (3) the team, (4) training and (5) change for the consultant. Respondents acknowledged that obstetrics is an acute specialty, and consultants resolve intrapartum complications. However, variability in consultant experience and behaviour altered perception of its impact. Service users were generally positive towards 24/7 consultant presence but were not aware that it was not standard practice across the UK. Professionals were more pragmatic and discussed how the implementation of 24/7 working had affected their work, development of trainees and potential impacts on future consultants. CONCLUSIONS: The findings raised several issues that should be considered by practitioners and policymakers when making decisions about the implementation of 24/7 consultant presence in other maternity units, including attributes of the consultants, the needs of maternity units, the team hierarchy, trainee development, consultants' other duties and consultant absences.

Saving babies' lives project impact and results evaluation (SPiRE): a mixed methodology study.

BACKGROUND: Reducing stillbirth and early neonatal death is a national priority in the UK. Current evidence indicates this is potentially achievable through application of four key interventions within routine maternity care delivered as the National Health Service (NHS) England's Saving Babies' Lives care bundle. However, there is significant variation in the degree of implementation of the care bundle between and within maternity units and the effectiveness in reducing stillbirth and improving service delivery has not yet been evaluated. This study aims to evaluate the impact of implementing the care bundle on UK maternity services and perinatal outcomes. METHODS: The Saving Babies' Lives Project Impact and Results Evaluation (SPiRE) study is a multicentre evaluation of maternity care delivered through the Saving Babies' Lives care bundle using both quantitative and qualitative methodologies. The study will be conducted in twenty NHS Hospital Trusts and will include approximately 100,000 births. It involves participation by both service users and care providers. To determine the impact of the care bundle on pregnancy outcomes, birth data and other clinical measures will be extracted from maternity databases and case-note audit from before and after implementation. Additionally, this study will employ questionnaires with organisational leads and review clinical guidelines to assess how resources, leadership and governance may affect implementation in diverse hospital settings. The cost of implementing the care bundle, and the cost per stillbirth avoided, will also be estimated as part of a health economic analysis. The views and experiences of service users and service providers towards maternity care in relation to the care bundle will be also be sought using questionnaires. DISCUSSION: This protocol describes a pragmatic study design which is necessarily limited by the availability of data and limitations of timescales and funding. In particular there was no opportunity to prospectively gather pre-intervention data or design a phased implementation such as a stepped-wedge study. Nevertheless this study will provide useful practice-based evidence which will advance knowledge about the processes that underpin successful implementation of the care bundle so that it can be further developed and refined. TRIAL REGISTRATION: www.clinicaltrials.gov NCT03231007 (26th July 2017).