Abstract Objectives People with mental health conditions experience increased rates of diagnostic errors and delays in acute treatment. While causes such as diagnostic overshadowing (misattribution of physical symptoms to mental health conditions) are well documented, less attention has been paid to the organisational and structural conditions that shape diagnostic work. This study examines how physical illness is diagnosed in patients with mental health conditions in emergency departments (EDs), with a focus on the structural conditions that enable or constrain safe diagnostic practice. Method We conducted a multi-site ethnography across three purposively selected EDs in England between April 2023 and April 2024, varying in size, population demographics, and local service configuration. Data were collected through 284 hours of non-participant observation and 20 semi-structured interviews with ED staff. Results Our analysis identified four recurring structural gaps that shaped the conditions under which physical health diagnosis took place for patients with mental health conditions: a design gap, whereby targets and physical layouts constrained diagnostic reasoning; a preparedness gap, reflecting the lack of structural support to allow staff to act on their existing knowledge and skills; a coordination gap, reflecting fragmented ownership and the challenges of joint assessment across mental and physical healthcare teams; and an expectation gap, whereby unmet need elsewhere in the system increased demand for ED services that were beyond its formal scope. These gaps made diagnostic errors and delay more likely for patients with mental health conditions seeking physical healthcare in the ED. Conclusions As new dedicated mental health EDs are introduced in England, there is an opportunity to avoid reproducing these structural gaps in new settings. Our study suggests that improving physical healthcare for patients with mental health conditions requires changes to how EDs are designed, resourced and supported, and how they connect with the wider health and care system.

OBJECTIVE:To report experiences and views of patients, carers, and staff on access to general practice in England in the context of major government plans to reform NHS services. DESIGN:Qualitative interview study. SETTING:Patients and carers in Devon, Medway, Blackpool, Luton, and Lancashire, and NHS general practices in the east of England. PARTICIPANTS:70 interviews with 41 patients and carers and 29 general practice staff, including general practitioners (GPs), nurses and allied health professionals, practice managers, and administrators. Analysis was based on the constant comparative method, with themes mapped to the three shifts-to digital, to community, and to prevention-proposed in the 10 year plan for England. RESULTS:Patient participants represented 12 ethnic groups and diverse personal and medical characteristics. The three shifts offered some benefits to participants but also introduced new risks and disadvantages. The shift to greater digitisation in general practice (mainly in the form of online appointment booking systems and access to medical information) offered more convenience for some patients and improved efficiencies. The shift did little to resolve the fundamental scarcity of appointments with a GP, however, and it introduced new forms of disadvantage and exclusion while failing to address what patients were often seeking: human connection and empathy with a GP they knew. The shift from hospital to community based services, with GPs working over greater geographical scale in new neighbourhood based models, was perceived by participants to offer greater capacity for appointments but faced constraints including practical challenges to coordination and organisation. New services encompassing larger areas risked patients feeling unrecognised and unknown at their practice and undermining the long term relationships with GPs that patients valued. Prevention efforts, while accepted as important, were seen as challenged by their tendency to fragment care, oversimplified models focused on single diseases, and consuming capacity that could otherwise be used for contacts initiated by patients. Concern about increased workload for staff at general practices was consistently expressed. CONCLUSIONS:Although improving access to general practice is a stated priority in government plans to reform NHS services, the three proposed shifts may not be what patients are seeking or what practices want in order to support their work. The proposals will require careful design, implementation, and evaluation in collaboration with key stakeholders, to ensure they do not undermine continuity of care nor fragment existing services.

People living with mental health conditions face reduced life expectancy, largely associated with under-diagnosed and under-treated physical illnesses. Inequalities in the way physical symptoms are diagnosed may be implicated in these outcomes, but, to date, studies have primarily understood these inequalities in terms of 'diagnostic overshadowing': the misattribution of physical symptoms to mental health conditions. In this paper, we use the candidacy framework to offer an extended analysis of the influences on diagnosis of physical health symptoms in people with mental health conditions presenting to the emergency department (ED)-a crucial node in the diagnostic pathway. We conducted a multi-site ethnography in three English EDs, including 284 h of non-participant observation and 43 interviews with clinicians, patients with mental health conditions, and accompanying persons. We found that, although the ED was seen as an open door, patients often struggled to have their physical symptoms recognised as legitimate concerns. Some delayed seeking care, feeling less deserving or anticipating dismissal; others tried to enhance their candidacy by downplaying their mental health history. The ED's operating conditions-throughput targets, overcrowded bays, and stretched staffing-favoured presentations that were clear-cut, straightforward, and urgent. This left little room for exploring more complex cases, such as those involving overlapping mental and physical health symptoms. Patients, clinicians and others recognised the risk that implicit bias might affect how physical symptoms in people with mental health conditions were interpreted, and they often sought to mitigate the impacts of such biases. This, however, could create its own risks, as different parties framed and reframed patients' presentations without full knowledge of the adjustments made by others-potentially impacting risks of both under-diagnosis and over-investigation in ways that were difficult to gauge. By applying the candidacy framework and examining the entire ED diagnostic pathway, our study illuminates a range of influences on diagnosis that extend beyond diagnostic overshadowing.

Spread and scale-up of evidence-based interventions in healthcare is complex, given the challenges of different contexts, networks of interactions and collaborative processes in healthcare delivery. Quality Improvement Collaboratives (QICs) provide a multi-organisational structured approach to improvement. However, the current evidence base underpinning QICs effectiveness is still limited and effectiveness appears strongly bound to context. Seeing scale-up and spread as a social practice, this paper explores the work of Patient Safety Collaboratives (PSC) in England that support implementation of a nationally mandated perinatal optimisation care bundle. The PremPath study explored implementation of perinatal optimisation at scale across different regions within England. We report from the first work package, comprising scoping interviews with 40 strategic leads from across Patient Safety Collaboratives (PSCs) in England who support implementation and quality improvement of perinatal optimisation. Analysis drew on the constant comparison method and Normalisation Process Theory (NPT) to explore implementation activities and contextual challenges. Findings demonstrate cognitive participation as a key feature of the improvement work undertaken at regional level. This entailed bringing healthcare staff together into a multi-disciplinary community of practice focused on the pathway. Data work underpinned efforts to identify priorities for improvement and track progress. However, fluctuations in performance contrasted with the ideal of continuous improvement. Regional leaders identified turbulence in the context of maternity and neonatal care as contributory factors to fluctuations. Our work highlights, for regional leads, the hidden emotional work and micropolitics of engaging clinical staff in communities of practice and shifts attention from individual implementation efforts to the broader context of maternity and neonatal care, which presented as dynamic, unstable and already crowded with other improvement priorities. Our findings provide an overview of the landscape of perinatal optimisation at regional level in England, helping to open up the ‘black box’ of collaborative efforts managed via national PSCs. Our work highlights the significance of the micropolitical dimensions of regional leads’ improvement work, and raises questions around how best to ensure sustainability of change given the current inelasticity of the implementation environment of maternity and neonatal care.

BACKGROUND:Recent inquiries have demonstrated the significance of safety cultures within maternity and neonatal services. Research has highlighted the benefits of shifting attention away from safety incidents and towards learning about how the mundane, 'normal' accomplishments of safety are shaped by local cultures. However, we still have much to learn about the role of different staff groups in creating conditions that nurture and sustain local safety cultures. AIMS:To explore how staff in middle-management positions worked to influence safety cultures at local maternity and neonatal unit and service level. METHODS:We used a qualitative design, starting with scores obtained from a safety culture survey to identify high-performing organisations in England, in line with a positive deviance approach. Thirteen service leads and 23 unit/safety leads participated in interviews. Analysis used the constant comparative approach, combined with a theoretically-focused coding framework. FINDINGS:Our research revealed how service and unit/safety leads influenced their local cultures of safety: through working across boundaries between the executive board and frontline practice on maternity and neonatal safety priorities; engaging with the service user voice, bringing this into the boardroom and the ward; and using horizon-scanning and political connections to manage the interface between policy initiatives and local practice. CONCLUSIONS AND IMPLICATIONS:Staff in middle-management roles play an important role in nurturing and sustaining local cultures of safety, through boundary working within and outside the organisation and with different stakeholders. This demonstrates the importance of supporting staff in such roles, in efforts to develop local safety cultures. STATEMENT OF SIGNIFICANCE:PROBLEM: problematic cultures/sub-cultures are acknowledged as a contributing factor to failures within healthcare services What is already known: research has highlighted the benefits of shifting attention away from safety incidents and 'extraordinary events', and towards learning how the mundane, 'normal' accomplishments of safety are shaped by local cultures What this paper adds: this paper highlights the important boundary work that staff in middle-management positions undertake to create the conditions that nurture and sustain local safety cultures.

BACKGROUND:The Safety Case is a regulatory technique that requires organisations to demonstrate to regulators that they have systematically identified hazards in their systems and reduced risks to being as low as reasonably practicable. It is used in several high-risk sectors, but only in a very limited way in healthcare. We examined the first documented attempt to apply the Safety Case methodology to clinical pathways.METHODS:Data are drawn from a mixed-methods evaluation of the Safer Clinical Systems programme. The development of a Safety Case for a defined clinical pathway was a centrepiece of the programme. We base our analysis on 143 interviews covering all aspects of the programme and on analysis of 13 Safety Cases produced by clinical teams.RESULTS:The principles behind a proactive, systematic approach to identifying and controlling risk that could be curated in a single document were broadly welcomed by participants, but was not straightforward to deliver. Compiling Safety Cases helped teams to identify safety hazards in clinical pathways, some of which had been previously occluded. However, the work of compiling Safety Cases was demanding of scarce skill and resource. Not all problems identified through proactive methods were tractable to the efforts of front-line staff. Some persistent hazards, originating from institutional and organisational vulnerabilities, appeared also to be out of the scope of control of even the board level of organisations. A particular dilemma for organisational senior leadership was whether to prioritise fixing the risks proactively identified in Safety Cases over other pressing issues, including those that had already resulted in harm.CONCLUSIONS:The Safety Case approach was recognised by those involved in the Safer Clinical Systems programme as having potential value. However, it is also fraught with challenge, highlighting the limitations of efforts to transfer safety management practices to healthcare from other sectors.

BackgroundHigh-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.MethodsThis 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.FindingsParticipants 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.ConclusionsThis 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.

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

ABSTRACT Background and Aims Communication is important in determining how patients understand the diagnostic process. Empirical studies involving direct observation of communication within diagnostic processes are relatively limited. This ethnographic study aimed to identify communicative practices facilitating or inhibiting shared understanding between patients and doctors in UK acute secondary care settings. Methods Data were collected in acute medical sectors of three English hospitals. Researchers observed doctors as they assessed patients; semistructured interviews were undertaken with doctors and patients directly afterwards. Patients were also interviewed 2–4 weeks later. Case studies of individual encounters (consisting of these interviews and observational notes) were created, and were cross‐examined by an interdisciplinary team to identify divergence and convergence between doctors' and patients' narratives. These data were analysed thematically. Results We conducted 228 h of observation, 24 doctor interviews, 32 patient interviews and 15 patient follow‐up interviews. Doctors varied in their communication. Patient diagnostic understanding was sometimes misaligned with that of their doctors; interviews revealed that they often made incorrect assumptions to make sense of the fragmented information received. Thematic analysis identified communicative practices that seemed to facilitate, or inhibit, shared diagnostic understanding between patient and doctor, revealing three themes: (1) communicating what has been understood from the medical record, (2) sharing the thought process and diagnostic reasoning and (3) closing the loop and discharge communication. Shared understanding was best fostered by clear communication about the diagnostic process, what had already been done and what was achievable in acute settings. Written information presents an underutilised tool in such communication. Conclusions In UK acute secondary settings, the provision of more information about the diagnostic process often fostered shared understanding between doctor and patient, helping to minimise the confusion and dissatisfaction that can result from misaligned expectations or conclusions about the diagnosis, and the uncertainty therein. Patient/Public Contribution A patient and public involvement group (of a range of ages and backgrounds) was consulted. They contributed to the design of the protocol, including the timing of interviews, the acceptability of a follow‐up telephone interview, the development of the interview guides and the participant information sheets.

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

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

Background Implementation of national multiprofessional training for managing the obstetric emergency of impacted fetal head (IFH) at caesarean birth has potential to improve quality and safety in maternity care, but is currently lacking in the UK.Objectives To evaluate a training package for managing IFH at caesarean birth with multiprofessional maternity teams.Methods The training included an evidence-based lecture supported by an animated video showing management of IFH, followed by hands-on workshops and real-time simulations with use of a birth simulation trainer, augmented reality and management algorithms. Guided by the Kirkpatrick framework, we conducted a multimethod evaluation of the training with multiprofessional maternity teams. Participants rated post-training statements about relevance and helpfulness of the training and pre-training and post-training confidence in their knowledge and skills relating to IFH (7-point Likert scales, strongly disagree to strongly agree). An ethnographer recorded sociotechnical observations during the training. Participants provided feedback in post-training focus groups.Results Participants (N=57) included 21 midwives, 25 obstetricians, 7 anaesthetists and 4 other professionals from five maternity units. Over 95% of participants agreed that the training was relevant and helpful for their clinical practice and improving outcomes following IFH. Confidence in technical and non-technical skills relating to managing IFH was variable before the training (5%–92% agreement with the pre-training statements), but improved in nearly all participants after the training (71%–100% agreement with the post-training statements). Participants and ethnographers reported that the training helped to: (i) better understand the complexity of IFH, (ii) recognise the need for multiprofessional training and management and (iii) optimise communication with those in labour and their birth partners.Conclusions The evaluated training package can improve self-reported knowledge, skills and confidence of multiprofessional teams involved in management of IFH at caesarean birth. A larger-scale evaluation is required to validate these findings and establish how best to scale and implement the training.

Abdominal surgery carries with it risks of complications. Little is known about patients' experiences of post-surgical deterioration. There is a real need to understand the psychosocial as well as the biological aspects of deterioration in order to improve care and outcomes for patients. Drawing on in-depth interviews with seven abdominal surgery survivors, we present an idiographic account of participants' experiences, situating their contribution to safety within their personal lived experiences and meaning-making of these episodes of deterioration. Our analysis reveals an overarching group experiential theme of vulnerability in relation to participants' experiences of complications after abdominal surgery. This encapsulates the uncertainty of the situation all the participants found themselves in, and the nature and seriousness of their health conditions. The extent of participants' vulnerability is revealed by detailing how they made sense of their experience, how they negotiated feelings of (un)safety drawing on their relationships with family and staff and the legacy of feelings they were left with when their expectations of care (care as imagined) did not meet the reality of their experiences (care as received). The participants' experiences highlight the power imbalance between patients and professionals in terms of whose knowledge counts within the hospital context. The study reveals the potential for epistemic injustice to arise when patients' concerns are ignored or dismissed. Our data has implications for designing strategies to enable escalation of care, both in terms of supporting staff to deliver compassionate care, and in strengthening patient and family involvement in rescue processes.

Candidacy, a construct describing how people's eligibility for care is negotiated between themselves and services, has received limited attention in the context of mental health care. In addition, candidacy research has only rarely studied the views of carers and health professionals. In this article, we use concepts relating to candidacy to enable a theoretically informed examination of experiences of access to secondary mental health services during the first wave of the COVID-19 pandemic in England. We report a qualitative study of the views and experiences of service users, carers, and healthcare professionals. Analysis of 65 in-depth interviews was based on the constant comparative method. We found that wide-ranging service changes designed to address the imperatives of the pandemic were highly consequential for people's candidacy. Macro-level changes, including increased emphasis on crisis and risk management and adapted risk assessment systems, produced effects that went far beyond restrictions in the availability of services: they profoundly re-structured service users' identification of their own candidacy, including perceptions of what counted as a problem worthy of attention and whether they as individuals needed, deserved, and were entitled to care. Services became less permeable, such that finding a point of entry to those services that remained open required more work of service users and carers. Healthcare professionals were routinely confronted by complex decisions and ethical dilemmas about provision of care, and their implicit judgements about access may have important implications for equity. Many of the challenges of access exposed by the pandemic related to pre-existing resource deficits and institutional weaknesses in care for people living with mental health difficulties. Overall, these findings affirm the value of the construct of candidacy for explaining access to mental healthcare, but also enable deepened understanding of the specific features of candidacy, offering enduring learning and implications for policy and practice.

Background Workplace programmes to test staff for asymptomatic COVID-19 infection have become common, but raise a number of ethical challenges. In this article, we report the findings of a consultation that informed the development of an ethical framework for organisational decision-making about such programmes. Methods We conducted a mixed-method consultation - a survey and semi-structured interviews during November-December 2020 in a UK case study organisation that had introduced asymptomatic testing for all staff working on-site in its buildings. Analysis of closed-ended survey data was conducted descriptively. An analysis approach based on the Framework Method was used for the open-ended survey responses and interview data. The analyses were then integrated to facilitate systematic analysis across themes. Inferences were based on the integrated findings and combined with other inputs (literature review, ethical analysis, legal and public health guidance, expert discussions) to develop an ethical framework. Results The consultation involved 61 staff members from the case study organisation (50 survey respondents and 11 interview participants). There was strong support for the asymptomatic testing programme: 90% of the survey respondents viewed it as helpful or very helpful. Open-ended survey responses and interviews gave insight into participants' concerns, including those relating to goal drift, risk of false negatives, and potential negative impacts for household members and people whose roles lacked contractual and financial stability. Integration of the consultation findings and the other inputs identified the importance of a whole-system approach with appropriate support for the key control measure of isolation following positive tests. The need to build trust in the testing programme, for example through effective communication from leaders, was also emphasised. Conclusions The consultation, together with other inputs, informed an ethical framework intended to support employers. The framework may support organisational decision-making in areas ranging from design and operation of the programme through to choices about participation. The framework is likely to benefit from further consultation and refinement in new settings.

Objectives Those who work in health care organisations are a potentially valuable source of information about safety concerns, yet failures of voice are persistent. We propose the concept of ‘voiceable concern’ and offer an empirical exploration. Methods We conducted a qualitative study involving 165 semi-structured interviews with a range of staff (clinical, non-clinical and at different hierarchical levels) in three hospitals in two countries. Analysis was based on the constant comparative method. Results Our analysis shows that identifying what counts as a concern, and what counts as a occasion for voice by a given individual, is not a straightforward matter of applying objective criteria. It instead often involves discretionary judgement, exercised in highly specific organisational and cultural contexts. We identified four influences that shape whether incidents, events and patterns were classified as voiceable concerns: certainty that something is wrong and is an occasion for voice; system versus conduct concerns, forgivability and normalisation. Determining what counted as a voiceable concern is not a simple function of the features of the concern; also important is whether the person who noticed the concern felt it was voiceable by them. Conclusions Understanding how those who work in health care organisations come to recognise what counts as a voiceable concern is critical to understanding decisions and actions about speaking out. The concept of a voiceable concern may help to explain aspects of voice behaviour in organisations as well as informing interventions to improve voice.