Self-monitoring blood pressure in Pregnancy: Evaluation of health professional experiences of the BUMP trials.

BACKGROUND: The BUMP trials evaluated a self-monitoring of blood pressure intervention in addition to usual care, testing whether they improved detection or control of hypertension for women at risk of hypertension or with hypertension during pregnancy. This process evaluation aimed to understand healthcare professionals' perspectives and experiences of the BUMP trials of self-monitoring of blood pressure during pregnancy. METHODS: Twenty-two in-depth qualitative interviews and an online survey with 328 healthcare professionals providing care for pregnant people in the BUMP trials were carried out across five maternity units in England. RESULTS: Analysis used Normalisation Process Theory to identify factors required for successful implementation and integration into routine practice. Healthcare professionals felt self-monitoring of blood pressure did not over-medicalise pregnancy for women with, or at risk of, hypertension. Most said self-monitored readings positively affected their clinical encounters and professional roles, provided additive information on which to base decisions and enriched their relationships with pregnant people. Self-monitoring of blood pressure shifts responsibilities. Some healthcare professionals felt women having responsibility to decide on timing of monitoring and whether to act on self-monitored readings was unduly burdensome, and resulted in healthcare professionals taking additional responsibility for supporting them. CONCLUSIONS: Despite healthcare professionals' early concerns that self-monitoring of blood pressure might over-medicalise pregnancy, our analysis shows the opposite was the case when used in the care of pregnant people with, or at higher risk of, hypertension. While professionals retained ultimate clinical responsibility, they viewed self-monitoring of blood pressure as a means of sharing responsibility and empowering women to understand their bodies, to make judgements and decisions, and to contribute to their care.

Quality and reporting of large-scale improvement programmes: a review of maternity initiatives in the English NHS, 2010-2023.

BACKGROUND: Large-scale improvement programmes are a frequent response to quality and safety problems in health systems globally, but have mixed impact. The extent to which they meet criteria for programme quality, particularly in relation to transparency of reporting and evaluation, is unclear. AIM: To identify large-scale improvement programmes focused on intrapartum care implemented in English National Health Service maternity services in the period 2010-2023, and to conduct a structured quality assessment. METHODS: We drew on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidance to inform the design and reporting of our study. We identified relevant programmes using multiple search strategies of grey literature, research databases and other sources. Programmes that met a prespecified definition of improvement programme, that focused on intrapartum care and that had a retrievable evaluation report were subject to structured assessment using selected features of programme quality. RESULTS: We identified 1434 records via databases and other sources. 14 major initiatives in English maternity services could not be quality assessed due to lack of a retrievable evaluation report. Quality assessment of the 15 improvement programmes meeting our criteria for assessment found highly variable quality and reporting. Programme specification was variable and mostly low quality. Only eight reported the evidence base for their interventions. Description of implementation support was poor and none reported customisation for challenged services. None reported reduction of inequalities as an explicit goal. Only seven made use of explicit patient and public involvement practices, and only six explicitly used published theories/models/frameworks to guide implementation. Programmes varied in their reporting of the planning, scope and design of evaluation, with weak designs evident. CONCLUSIONS: Poor transparency of reporting and weak or absent evaluation undermine large-scale improvement programmes by limiting learning and accountability. This review indicates important targets for improving quality in large-scale programmes.

Benefits and harms adopted by health economic assessments evaluating antenatal and newborn screening programmes in OECD countries: A systematic review of 336 articles and reports.

BACKGROUND: Health economic assessments are used to determine whether the resources needed to generate net benefit from a screening programme, driven by multiple complex benefits and harms, are justifiable. We systematically identified the benefits and harms incorporated within economic assessments evaluating antenatal and newborn screening programmes. METHODS: For this systematic review and thematic analysis, we searched the published and grey literature from January 2000 to January 2021. Studies that included an economic evaluation of an antenatal or newborn screening programme in an OECD country were eligible. We identified benefits and harms using an integrative descriptive analysis, and illustrated a thematic framework. (Systematic review registration PROSPERO, CRD42020165236). FINDINGS: The searches identified 52,244 articles and reports and 336 (242 antenatal and 95 newborn) were included. Eighty-six subthemes grouped into seven themes were identified: 1) diagnosis of screened for condition, 2) life years and health status adjustments, 3) treatment, 4) long-term costs, 5) overdiagnosis, 6) pregnancy loss, and 7) spillover effects on family members. Diagnosis of screened for condition (115 studies, 47.5%), life-years and health status adjustments (90 studies, 37.2%) and treatment (88 studies, 36.4%) accounted for most of the benefits and harms evaluating antenatal screening. The same themes accounted for most of the benefits and harms included in studies assessing newborn screening. Overdiagnosis and spillover effects tended to be ignored. INTERPRETATION: Our proposed framework can be used to guide the development of future health economic assessments evaluating antenatal and newborn screening programmes, to prevent exclusion of important potential benefits and harms.

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.

What would it take to meaningfully attend to ethnicity and race in health research? Learning from a trial intervention development study.

The lack of ethnic diversity in health research participation is a multi-dimensional problem. Racism and intersectional disadvantage compel us to use racial and ethnic categories to explore health, but race theorists warn that these can be essentialising and pathologising. Yet, the alternative, the pursuit of colour-blindness, can render the impact of race and ethnicity on health invisible. This paper describes the attempt to recruit an ethnically diverse sample to inform the development of an intervention for stroke patients. The study revealed deep uncertainties and tensions, which we use to re-examine our own positionalities and perspectives. We focus on the experiences of researchers and participants to show how 'usual' research practices are unwittingly exclusionary and promote 'methodological whiteness' (The British Journal of Sociology, 2017, 68, S214). Calls for greater diversity in research are frequently made, yet health research remains tainted by the use of problematic epistemological starting points, rendering participation by minoritised people uneasy. Medical sociologists, especially those engaged in clinical trials, have a vital role to play in recalibrating health research to attend to ethnicity and race. This requires us to reflect on our practices, to recognise where we are complicit in replicating social inequalities and to actively engage with communities to produce more inclusive research.

Health inequalities, ethnic minorities and COVID19: interactive theatre workshop drawing on a qualitative interview study.

BACKGROUND: The COVID19 pandemic revealed and deepened existing inequalities. These were exacerbated by institutional and interpersonal racism and poorly conceived public health messaging. As a result, people from minority ethnic backgrounds in the UK were disproportionately affected. We conducted a creative interdisciplinary session to support interactive reflection and discussion on these inequalities between the actors and the audience, who was comprised of public health scientists and NHS practitioners, to come up with practical ways to address ethnicity-based health inequalities going forward. METHODS: We prepared a 45 min interactive scenario drawing on forum theatre approaches, which are based on the Theatre of the Oppressed: a set of dramatical techniques created by Augusto Boal. To understand what to include the interactive scenario we carried out a workshop built on a narrative interview study with 70 adults who had Covid between March, 2020, and November, 2021. We adopted a maximum variation sampling strategy focusing on people from minority ethnic backgrounds (45 of total sample). Interviews were done remotely and recorded via video or audio. Study participants were invited to tell their story in their own words, alongside semi-structured prompting. After thematic analysis, the research team worked with theatre practitioners from the Performing Medicine company to create scenarios from verbatim interview content. The format allows audience members to watch scenarios and interact directly with actors, giving advice on how to improve the situation. The study was approved by Berkshire Ethics Committee. Informed verbal and written consent were obtained from all participants. FINDINGS: Five themes from analysis explored in the workshop emerged: (1) existing racialised disadvantages that impacted COVID-19 exposure: employment, housing, and caring responsibilities; (2) unequal access to care, welfare, and support; (3) fears about the health-care system regarding quality of care and vaccine safety; (4) perceptions that the media and public health messaging blamed minority ethnic groups for spreading infection; and (5) increases in acts of direct racism. These informed the development of a 45-minute interactive scenario, which will be performed at the 10th UK Public Health Science conference. INTERPRETATION: There is an urgent need to re-evaluate public health messaging and care for people from minority ethnic backgrounds. This theatre workshop will support reflection to refine workshop content for further dissemination. FUNDING: UK Economic and Social Research Council.

Key issues for participatory research in the design and implementation of humanitarian assistance: a scoping review.

BACKGROUND: Participatory approaches that engage affected populations are increasingly applied in humanitarian health programs in concert with emerging accountability frameworks and the rapid growth of research in these settings. Participatory initiatives within this domain appear to be largely adopted at an operational level and are infrequently reported as a component of research efforts. Yet the evidence of the benefits of research involving community members is growing worldwide. This is the first review of participatory research (PR) in humanitarian settings. OBJECTIVES: This study sought to understand the extent to which PR values and practices have been adopted in humanitarian health programs and to explore key issues in applying PR in this context. METHODS: This scoping review was based on the approach developed by Arksey and O'Malley. The search for relevant peer-reviewed articles included scientific databases, a humanitarian database, targeted journals and online resources published since 2009. Eleven articles were retrieved and reviewed to identify practices and key issues related to conducting PR in humanitarian settings. RESULTS: Four key themes were identified: building trust with local research stakeholders and participants; the importance of contextual understanding; implications of collaborating with affected populations in PR, and neutrality of researchers and Non-Governmental Organizations (NGOs). Study teams considered PR as a valued approach where there was mistrust or a need for contextualized understanding. The studies described how adaptations made during the study optimized collaboration with affected populations and how the presence of NGOs influenced the approach and results of PR. CONCLUSIONS: One of the most important contributions of humanitarian health programs is to develop 'medical practices that are better adapted to the living conditions and priorities of patients who are generally ignored'. Participatory approaches, such as PR, support the development of health-related practices that are more relevant and sustainable for affected populations.

Public involvement in the governance of population-level biomedical research: unresolved questions and future directions.

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance.

Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials.

INTRODUCTION: Self-monitoring of blood pressure (BP) in pregnancy could improve the detection and management of pregnancy hypertension, while also empowering and engaging women in their own care. Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2). METHODS AND ANALYSES: Both are multicentre, non-masked, parallel group, randomised controlled trials. Participants will be randomised to self-monitoring with telemonitoring or usual care. BUMP 1 will recruit a minimum of 2262 pregnant women at higher risk of pregnancy hypertension and BUMP 2 will recruit a minimum of 512 pregnant women with either gestational or chronic hypertension. The BUMP 1 primary outcome is the time to the first recording of raised BP by a healthcare professional. The BUMP 2 primary outcome is mean systolic BP between baseline and delivery recorded by healthcare professionals. Other outcomes will include maternal and perinatal outcomes, quality of life and adverse events. An economic evaluation of BP self-monitoring in addition to usual care compared with usual care alone will be assessed across both study populations within trial and with modelling to estimate long-term cost-effectiveness. A linked process evaluation will combine quantitative and qualitative data to examine how BP self-monitoring in pregnancy is implemented and accepted in both daily life and routine clinical practice. ETHICS AND DISSEMINATION: The trials have been approved by a Research Ethics Committee (17/WM/0241) and relevant research authorities. They will be published in peer-reviewed journals and presented at national and international conferences. If shown to be effective, BP self-monitoring would be applicable to a large population of pregnant women. TRIAL REGISTRATION NUMBER: NCT03334149.

Patient preferences for management of high blood pressure in the UK: a discrete choice experiment.

BACKGROUND: With a variety of potentially effective hypertension management options, it is important to determine how patients value different models of care, and the relative importance of factors in their decision-making process. AIM: To explore patient preferences for the management of hypertension in the UK. DESIGN AND SETTING: Online survey of patients who have hypertension in the UK including an unlabelled discrete choice experiment (DCE). METHOD: A DCE was developed to assess patient preferences for the management of hypertension based on four attributes: model of care, frequency of blood pressure (BP) measurement, reduction in 5-year cardiovascular risk, and costs to the NHS. A mixed logit model was used to estimate preferences, willingness-to-pay was modelled, and a scenario analysis was conducted to evaluate the impact of changes in attribute levels on the uptake of different models of care. RESULTS: One hundred and sixty-seven participants completed the DCE (aged 61.4 years, 45.0% female, 82.0% >5 years since diagnosis). All four attributes were significant in choice (P<0.05). Reduction in 5-year cardiovascular risk was the main driver of patient preference as evidenced in the scenario and willingness-to-pay analyses. GP management was significantly preferred over self-management. Patients preferred scenarios with more frequent BP measurement, and lower costs to the NHS. CONCLUSION: Participants had similar preferences for GP management, pharmacist management, and telehealth, but a negative preference for self-management. When introducing new models of care for hypertension to patients, discussion of the potential benefits in terms of risk reduction should be prioritised to maximise uptake.

Exploring women's preferences for birth settings in England: A discrete choice experiment.

OBJECTIVE: To explore pregnant women's preferences for birth setting in England. DESIGN: Labelled discrete choice experiment (DCE). SETTING: Online survey. SAMPLE: Pregnant women recruited through social media and an online panel. METHODS: We developed a DCE to assess women's preferences for four hypothetical birth settings based on seven attributes: reputation, continuity of care, distance from home, time to see a doctor, partner able to stay overnight, chance of straightforward birth and safety for baby. We used a mixed logit model, with setting modelled as an alternative-specific constant, and conducted a scenario analysis to evaluate the impact of changes in attribute levels on uptake of birth settings. MAIN OUTCOME MEASURES: Women's preferences for birth setting. RESULTS: 257 pregnant women completed the DCE. All birth setting attributes, except 'time to see doctor', were significant in women's choice (p<0.05). There was significant heterogeneity in preferences for some attributes. Changes to levels for 'safety for the baby' and 'partner able to stay overnight' were associated with larger changes from baseline uptake of birth setting. If the preferences identified were translated into the real-world context up to a third of those who reported planning birth in an obstetric unit might choose a midwifery unit assuming universal access to all settings, and knowledge of the differences between settings. CONCLUSIONS: We found that 'safety for the baby', 'chance of a straightforward birth' and 'can the woman's partner stay overnight following birth' were particularly important in women's preferences for hypothetical birth setting. If all birth settings were available to women and they were aware of the differences between them, it is likely that more low risk women who currently plan birth in OUs might choose a midwifery unit.

Birthplace choices: what are the information needs of women when choosing where to give birth in England? A qualitative study using online and face to face focus groups.

BACKGROUND: Current clinical guidelines and national policy in England support offering 'low risk' women a choice of birth setting. Options include: home, free-standing midwifery unit (FMU), alongside midwifery unit (AMU) or obstetric unit (OU). This study, which is part of a broader project designed to inform policy on 'choice' in relation to childbirth, aimed to provide evidence on UK women's experiences of choice and decision-making in the period since the publication of the Birthplace findings (2011) and new NICE guidelines (2014). This paper reports on findings relating to women's information needs when making decisions about where to give birth. METHODS: A qualitative focus group study including 69 women in the last trimester of pregnancy in England in 2015-16. Seven focus groups were conducted online via a bespoke web portal, and one was face-to-face. To explore different aspects of women's experience, each group included women with specific characteristics or options; planning a home birth, living in areas with lots of choice, living in areas with limited choice, first time mothers, living close to a FMU, living in opt-out AMU areas, living in socioeconomically disadvantaged areas and planning to give birth in an OU. Focus group transcripts were analysed thematically. RESULTS: Women drew on multiple sources when making choices about where to give birth. Sources included; the Internet, friends' recommendations and experiences, antenatal classes and their own personal experiences. Their midwife was not the main source of information. Women wanted the option to discuss and consider their birth preferences throughout their pregnancy, not at a fixed point. CONCLUSIONS: Birthplace choice is informed by many factors. Women may encounter fewer overt obstacles to exercising choice than in the past, but women do not consistently receive information about birthplace options from their midwife at a time and in a manner that they find helpful. Introducing options early in pregnancy, but deferring decision-making about birthplace until a woman has had time to consider and explore options and discuss these with her midwife, might facilitate choice.

Support for mothers and their families after life-threatening illness in pregnancy and childbirth: a qualitative study in primary care.

BACKGROUND: One in 100 women who give birth in the UK develop life-threatening illnesses during childbirth. Without urgent medical attention these illnesses could lead to the mother's death. Little is known about how the experience of severe illness in childbirth affects the mother, baby, and family. AIM: As part of the UK National Maternal Near-miss Surveillance Programme, this study explored the experiences of women and their partners of life-threatening illnesses in childbirth, to identify the long-term impact on women and their families. DESIGN AND SETTING: Qualitative study based on semi-structured narrative interviews. Interviews were conducted in patients' homes in England and Scotland from 2010 to 2014. METHOD: An in-depth interview study was conducted with 36 women and 11 partners. A maximum variation sample was sought and interviews transcribed for thematic analysis with constant comparison. RESULTS: Women's birth-related illnesses often had long-lasting effects on their mental as well as physical health, including anxiety, panic attacks, and post-traumatic stress disorder. In some cases the partner's mental health was also affected. Women often described feeling isolated. Their experiences can have a profound impact on their relationships, family life, career, and future fertility. While some women described receiving good support from their GP, others felt there was little support available for them or their families after discharge from hospital. CONCLUSION: A near-miss event can have long-lasting and major effects on women and their families. Support in primary care, including watchful waiting for mental health impacts, can play a valuable role in helping these families come to terms with their emergency experience. The findings highlight the importance of communication between primary and secondary care.

Are We Missing the Mark? The Implementation of Community Based Participatory Education in Cancer Disparities Curriculum Development.

OBJECTIVE: The Chicago south side, even more so than national populations, continues to be burdened with widening gaps of disparities in cancer outcomes. Therefore, Chicago community members were engaged in addressing the following content areas for a cancer disparities curriculum: (1) the south side Chicago community interest in participating in curriculum design, (2) how community members should be involved in designing cancer disparities curriculum, and (3) what community members believe the curriculum should address to positively impact their community. METHODS: Eighty-six community members from 19 different zip code areas of Chicago attended the deliberative session. A survey composed of three quantitative and three short-answer content questions was analyzed. RESULTS: The majority of participants were from the south side of Chicago (62 %) and females (86 %). Most, 94 %, believed community members should be involved in cancer disparities curriculum development. Moreover, 56 % wanted to be involved in designing the curriculum, and 61 % reported an interest in taking a course in cancer disparities. Three categorical themes were derived from the qualitative questions: (1) community empowerment through disparities education-"a prescription for change," (2) student skill development in community engagement and advocacy training, and (3) community expression of shared experiences in cancer health disparities. CONCLUSION: The community provided valuable input for curricular content and has an interest in collaborating on cancer disparities curriculum design. Community participation must be galvanized to improve disparities curricular development and delivery to successfully address the challenges of eliminating disparities in health.

Citizen and staff involvement in health service decision-making: have National Health Service foundation trusts in England given stakeholders a louder voice?

OBJECTIVES: National Health Service (NHS) foundation trusts have been created to decentralize the management of NHS provider organizations through the substitution of central government control with local accountability to citizens and employed staff. Our aim was to explore the roles adopted by elected and appointed governors of a first wave NHS foundation trust and the extent to which governors shared power with trust directors and influenced the management of the trust. METHODS: A one-year case study of a single NHS foundation trust (Homerton Hospital in East London) was conducted. Data were collected using face-to-face interviews with a sample of governors and directors, as well as through non-participant observation of public and private meetings of governors and documentary analysis. RESULTS: Governors and directors found the new role of foundation trust governor ambiguous and difficult to define. This lack of clarity impeded the development of the new governance function. Governors perceived that they had made little impact on the decisions of the Trust during the year of study. However, evidence was found of an increased involvement of governors and the public in the activities of the Trust. CONCLUSIONS: Government plans to decentralize accountability of public hospitals to local communities appear problematic, at least in the short term. Unless the effectiveness of the new local governance arrangements is addressed, an accountability 'gap' may emerge as prior mechanisms for public accountability to the centre are dismantled. In these circumstances, decentralization may lead in practice to a loss of public accountability.