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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. [ABSTRACT FROM AUTHOR]

Objective: The National Health Service (NHS) in England has introduced a range of policy measures aimed at fostering greater openness, transparency and candour about quality and safety. We draw on the findings of an evaluation of the implementation of these policies in NHS organisations, with the aim of identifying key implications for policy and practice. Methods: We undertook a mixed-methods policy evaluation, comprising four substudies: a longitudinal analysis of data from surveys of NHS staff and service users; interviews with senior stakeholders in NHS provider organisations and the wider system; a survey of board members of NHS provider organisations and organisational case studies across acute, community and mental health, and ambulance services. Results: Our findings indicate a mixed picture of progress towards improving openness in NHS organisations, influenced by organisational history and memories of past efforts, and complicated by organisational heterogeneity. We identify four features that appear to be necessary conditions for sustained progress in improving openness: (1) authentic integration into organisational mission is crucial in making openness a day-to-day concern; (2) functional and effective administrative systems are vital; (3) these systems must be leavened by flexibility and sensitivity in implementation and (4) a spirit of continuous inquiry, learning and improvement is required to avoid the fallacy that advancing openness can be reduced to a time-limited project. We also identify four persistent challenges in consolidating and sustaining improvement: (1) a reliance on goodwill and discretionary effort; (2) caring for staff, patients and relatives who seek openness; (3) the limits of values-driven approaches on their own and (4) the continued marginality of patients, carers and families. Conclusions: Variation in policy implementation offers important lessons on how organisations can better deliver openness, transparency and candour. These lessons highlight practical actions for policymakers, managers and senior clinicians. [ABSTRACT FROM AUTHOR]

Employee voice is an important source of organizational intelligence about possible problems in quality and patient safety, but effective systems for encouraging and supporting those who seek to speak up have remained elusive. In the English National Health Service, a novel role known as the 'Freedom to Speak Up Guardian' has been introduced to address this problem. We critically examine the role and its realization in practice, drawing on semi-structured interviews with 51 key individuals, including Guardians, clinicians, managers, policymakers, regulators and others. Operationalizing the new role in organizations was not straightforward, since it had to sit in a complex set of existing systems and processes. One response was to seek to bound the scope of Guardians, casting them in a signposting or coordinating role in relation to quality and safety concerns. However, the role proved hard to delimit, not least because the concerns most frequently voiced in practice differed in character from those anticipated in the role's development. Guardians were tasked with making sense of and dealing with issues that could not always straightforwardly be classified, deflected to the right system or escalated to the appropriate authority. Our analysis suggests that the role's potential contribution might be understood less as supporting whistleblowers who bear witness to clear-cut wrongdoing, and more as helping those with lower-level worries to construct their concerns and what to do with them. These findings have implications for how voice is understood, imagined and addressed in healthcare organizations. [ABSTRACT FROM AUTHOR]

Objectives: The prominence given to issues of patient safety in health care organizations varies, but little is known about how or why this variation occurs. We sought to compare and contrast how three English hospitals came to identify, prioritize and address patient safety issues, drawing on insights from the sociological and political science literature on the process of problem definition. Methods: In-depth qualitative fieldwork, involving 99 interviews, 246 hours of ethnographic observation, and document collection, was carried out in three case-study hospitals as part of a wider mixed-methods study. Data analysis was based on the constant comparative method. Results: How problems of patient safety came to be recognized, conceptualized, prioritized and matched to solutions varied across the three hospitals. In each organization, it took certain 'triggers' to problematize safety, with crises having a particularly important role. How problems were constructed – and whose definitions were prioritized in the process – was highly consequential for organizational response, influencing which solutions were seen as most appropriate, and allocation of responsibility for implementing them. Conclusions: A process of problem definition is crucial to raising the profile of patient safety and to rendering problems amenable to intervention. How problems of patient safety are defined and constructed is highly consequential, influencing selection of solutions and their likely sustainability. [ABSTRACT FROM AUTHOR]

The author proposes challenges in providing consistently high-quality, safe care to health systems worldwide. The author said that health services should be better resourced. Economist Anita Charlesworth has shown that the National Health Service is underfunded relative to the mission it is expected to deliver. The author discussed the weakness of the evidence base supporting quality improvement or improvement science.

An enduring debate concerns how responsibility for patient safety should be distributed between organisational systems and individual professionals. Though rule-based, calculus-like approaches intended to support a 'just culture' have become popular, they perpetuate an asocial and atomised account. In this article, we use insights from practice theory - which sees organisational phenomena as accomplished in everyday actions, with individual agency and structural conditions as a mutually constitutive, dynamic duality - along with contributions from the political science and ethics literature as a starting point for analysis. Presenting ethnographic data from five hospitals, three in one high-income country and two in low-income countries, we offer an empirically informed, normative rethinking of the role of personal accountability, identifying the collective nature of the healthcare enterprise and the extent to which patient safety depends on contributions from many hands. We show that moral responsibility for actions and behaviours is an irreducible element of professional practice, but that individuals are not somehow 'outside' and separate from 'systems': they create, modify and are subject to the social forces that are an inescapable feature of any organisational system; each element acts on the other. Our work illustrates starkly the structuring effects of the broader institutional and socioeconomic context on opportunities to 'be good'. These findings imply that one of the key responsibilities of organisations and wider institutions in relation to patient safety is the fostering of the conditions of moral community. [ABSTRACT FROM AUTHOR]

Recent decades have seen the influence of the professions decline. Lately, commentators have suggested a revived role for a "new" professionalism in ensuring and enhancing high-quality health care in systems dominated by market and managerial logics. The form this new professionalism might take, however, remains obscure. This article uses data from an ethnographic study of three English health care improvement projects to analyze the place, potential, and limitations of professionalism as a means of engaging clinicians in efforts to improve service quality. We found that appeals to notions of professionalism had strong support among practitioners, but converting enthusiasm for the principle of professionalism into motivation to change practice was not straightforward. Some tactics used in pursuit of this deviated sharply from traditional models of collegial social control. In systems characterized by fissures between professional groups and powerful market and managerial influences, we suggest that professionalism must interact creatively but carefully with other logics. [ABSTRACT FROM AUTHOR]

Improvement (defined broadly as purposive efforts to secure positive change) has become an increasingly important activity and field of inquiry within healthcare. This article offers an overview of possible methods for the study of improvement interventions. The choice of available designs is wide, but debates continue about how far improvement efforts can be simultaneously practical (aimed at producing change) and scientific (aimed at producing new knowledge), and whether the distinction between the practical and the scientific is a real and useful one. Quality improvement projects tend to be applied and, in some senses, self- evaluating. They are not necessarily directed at generating new knowledge, but reports of such projects if well conducted and cautious in their inferences may be of considerable value. They can be distinguished heuristically from research studies, which are motivated by and set out explicitly to test a hypothesis, or otherwise generate new knowledge, and from formal evaluations of improvement projects. We discuss variants of trial designs, quasi-experimental designs, systematic reviews, programme evaluations, process evaluations, qualitative studies, and economic evaluations. We note that designs that are better suited to the evaluation of clearly defined and static interventions may be adopted without giving sufficient attention to the challenges associated with the dynamic nature of improvement interventions and their interactions with contextual factors. Reconciling pragmatism and research rigour is highly desirable in the study of improvement. Trade-offs need to be made wisely, taking into account the objectives involved and inferences to be made. [ABSTRACT FROM AUTHOR]

Evaluation of improvement initiatives in healthcare is essential to establishing whether interventions are effective and to understanding how and why they work in order to enable replication. Although valuable, evaluation is often complicated by tensions and friction between evaluators, implementers and other stakeholders. Drawing on the literature, we suggest that these tensions can arise from a lack of shared understanding of the goals of the evaluation; confusion about roles, relationships and responsibilities; data burdens; issues of data flows and confidentiality; the discomforts of being studied and the impact of disappointing or otherwise unwelcome results. We present a possible approach to managing these tensions involving the co-production and use of a concordat. We describe how we developed a concordat in the context of an evaluation of a complex patient safety improvement programme known as Safer Clinical Systems Phase 2. The concordat development process involved partners (evaluators, designers, funders and others) working together at the outset of the project to agree a set of principles to guide the conduct of the evaluation. We suggest that while the concordat is a useful resource for resolving conflicts that arise during evaluation, the process of producing it is perhaps even more important, helping to make explicit unspoken assumptions, clarify roles and responsibilities, build trust and establish open dialogue and shared understanding. The concordat we developed established some core principles that may be of value for others involved in evaluation to consider. But rather than seeing our document as a ready-made solution, there is a need for recognition of the value of the process of co-producing a locally agreed concordat in enabling partners in the evaluation to work together effectively. [ABSTRACT FROM AUTHOR]

Context 'Meaningful use' of electronic health records to improve quality of care has remained understudied. We evaluated an approach to improving patients' safety and quality of care involving the secondary use of data from a hospital electronic prescribing and decision support system (ePDSS). Methods We conducted a case study of a large English acute care hospital with a well-established ePDSS. Our study was based on ethnographic observations of clinical settings (162 hours) and meetings (28 hours), informal conversations with clinical staff, semistructured interviews with ten senior executives, and the collection of relevant documents. Our data analysis was based on the constant comparative method. Findings This hospital's approach to quality and safety could be characterized as 'technovigilance.' It involved treating the ePDSS as a warehouse of data on clinical activity and performance. The hospital converted the secondary data into intelligence about the performance of individuals, teams, and clinical services and used this as the basis of action for improvement. Through a combination of rapid audit, feedback to clinical teams, detailed and critical review of apparent omissions in executive-led meetings, a focus on personal professional responsibility for patients' safety and quality care, and the correction of organizational or systems defects, technovigilance was-based on the hospital's own evidence-highly effective in improving specific indicators. Measures such as the rate of omitted doses of medication showed marked improvement. As do most interventions, however, technovigilance also had unintended consequences. These included the risk of focusing attention on aspects of patient safety made visible by the system at the expense of other, less measurable but nonetheless important, concerns. Conclusions The secondary use of electronic data can be effective for improving specific indicators of care if accompanied by a range of interventions to ensure proper interpretation and appropriate action. But care is needed to avoid unintended consequences. [ABSTRACT FROM AUTHOR]

Ethnographic studies are valuable in studying patient safety. This is a narrative review of four reports of ethnographic studies of patient safety in UK hospitals conducted as part of the Patient Safety Research Programme. Three of these studies were undertaken in operating theatres and one in an A&E Department. The studies found that hospitals were rarely geared towards ensuring perfect performances. The coordination and mobilization of the large number of inter-dependent processes and resources needed to support the achievement of tasks was rarely optimal. This produced significant strain that staff learned to tolerate by developing various compensatory strategies. Teamwork and inter-professional communication did not always function sufficiently well to ensure that basic procedural information was shared or that the required sequence of events was planned. Staff did not always do the right things, for a wide range of different reasons, including contestations about what counted as the right thing. Structures of authority and accountability were not always clear or well-functioning. Patient safety incidents were usually not reported, though there were many different reasons for this. It can be concluded that securing patient safety is hard. There are multiple interacting influences on safety, and solutions need to be based on a sound understanding of the nature of the problems and which approaches are likely to be best suited to resolving them. Some solutions that appear attractive and straightforward are likely to founder. Addressing safety problems requires acknowledgement that patient safety is not simply a technical issue, but a site of organizational and professional politics. [ABSTRACT FROM AUTHOR]

The importance of employee voice—speaking up and out about concerns—is widely recognised as fundamental to patient safety and quality of care. However, failures of voice continue to occur, often with disastrous consequences. In this article, we argue that the enduring sociological concepts of the informal organisation and formal organisation offer analytical purchase in understanding the causes of such problems and how they can be addressed. We report a qualitative study involving 165 interviews across three healthcare organisations in two high-income countries. Our analysis emphasises the interdependence of the formal and informal organisation. The formal organisation describes codified and formalised elements of structures, procedures and processes for the exercise of voice, but participants often found it frustrating, ambiguous, and poorly designed. The informal organisation—the informal practices, social connections, and methods for making decisions that are key to coordinating organisational activity—could facilitate voice through its capacity to help people to understand complex processes, make sense of their concerns, and frame them in ways likely to prompt an appropriate organisational response. Sometimes the informal organisation compensated for gaps, ambiguities and inconsistencies in formal policies and systems. At the same time, the informal organisation had a dark side, potentially subduing voice by creating informal hierarchies, prioritising social cohesion, and providing opportunities for retaliation. The formal and the informal organisation are not exclusive or independent: they interact with and mutually reinforce each other. Our findings have implications for efforts to improve culture and processes in relation to voice in healthcare organisations, pointing to the need to address deficits in the formal organisation, and to the potential of building on strengths in the informal organisation that are crucial in supporting voice. • Healthcare organisations often struggle to access and make use of employee voice. • The concept of the 'informal organisation' helps to explain and address this issue. • Some aspects of informal organisation may facilitate voice; others inhibit it. • Informal and formal organisation interact with one another in complex ways. • Interventions to improve voice should anticipate and account for these interactions. [ABSTRACT FROM AUTHOR]

The authors discuss the findings of their research on the effect of the second phase of the Safer Patients Initiative (SPI), a large-scale hospital-wide program commissioned by the Health Foundation to transform organizational approaches to delivering safer care in National Health Service hospitals in England. They found a high rate of adherence by hospitals to many standards of safe and effective care. They also observed that SPI hospitals did not improve more than the control hospitals on the study measures.

Formal metrics for monitoring the quality and safety of healthcare have a valuable role, but may not, by themselves, yield full insight into the range of fallibilities in organizations. ‘Soft intelligence’ is usefully understood as the processes and behaviours associated with seeking and interpreting soft data—of the kind that evade easy capture, straightforward classification and simple quantification—to produce forms of knowledge that can provide the basis for intervention. With the aim of examining current and potential practice in relation to soft intelligence, we conducted and analysed 107 in-depth qualitative interviews with senior leaders, including managers and clinicians, involved in healthcare quality and safety in the English National Health Service. We found that participants were in little doubt about the value of softer forms of data, especially for their role in revealing troubling issues that might be obscured by conventional metrics. Their struggles lay in how to access softer data and turn them into a useful form of knowing. Some of the dominant approaches they used risked replicating the limitations of hard, quantitative data. They relied on processes of aggregation and triangulation that prioritised reliability, or on instrumental use of soft data to animate the metrics. The unpredictable, untameable, spontaneous quality of soft data could be lost in efforts to systematize their collection and interpretation to render them more tractable. A more challenging but potentially rewarding approach involved processes and behaviours aimed at disrupting taken-for-granted assumptions about quality, safety, and organizational performance. This approach, which explicitly values the seeking out and the hearing of multiple voices, is consistent with conceptual frameworks of organizational sensemaking and dialogical understandings of knowledge. Using soft intelligence this way can be challenging and discomfiting, but may offer a critical defence against the complacency that can precede crisis. [ABSTRACT FROM AUTHOR]

Healthcare organisations' responses to concerns and complaints often fall short of the expectations of patients and staff who raise them, and substandard responses to concerns and complaints have been implicated in organisational failures. Informed by Habermas's systems theory, we offer new insights into the features of organisations' responses to concerns and complaints that give rise to these problems. We draw on a large qualitative dataset, comprising 88 predominantly narrative interviews with people raising and responding to concerns and complaints in six English NHS organisations. In common with past studies, many participants described frustrations with systems and processes that seemed ill-equipped to deal with concerns of the kinds they raised. Departing from existing analyses, we identify the influence of functional rationality, as conceptualised by Habermas, and embodied in procedures, pathways and scripts for response, in producing this dissatisfaction. Functionally rational processes were well equipped to deal with simple, readily categorised concerns and complaints. They were less well placed to respond adequately to concerns and complaints that were complex, cross-cutting, or irreducible to predetermined criteria for redress and resolution. Drawing on empirical examples and on Habermas's theory of communicative action, we offer suggestions for alternative and supplementary approaches to responding to concerns and complaints that might better address both the expectations of complainants and the improvement of services. • Processes for addressing concerns and complaints often frustrate those who raise them. • We use Habermas's systems theory to identify the reasons why and how to address them. • Processes tend to be well formed to deal with simpler, easily categorised concerns. • They are often ill-suited to respond to complex, multifaceted or cross-cutting concerns. • Communicative rationality offers useful principles for improving these processes. [ABSTRACT FROM AUTHOR]

Measurement of quality and safety has an important role in improving healthcare, but is susceptible to unintended consequences. One frequently made argument is that optimising the benefits from measurement requires controlling the risks of blame, but whether it is possible to do this remains unclear. We examined responses to a programme known as the NHS Safety Thermometer (NHS-ST). Measuring four common patient harms in diverse care settings with the goal of supporting local improvement, the programme explicitly eschews a role for blame. The study design was ethnographic. We conducted 115 hours of observation across 19 care organisations and conducted 126 interviews with frontline staff, senior national leaders, experts in the four harms, and the NHS-ST programme leadership and development team. We also collected and analysed relevant documents. The programme theory of the NHS-ST was based in a logic of measurement for improvement: the designers of the programme sought to avoid the appropriation of the data for any purpose other than supporting improvement. However, organisational participants - both at frontline and senior levels - were concerned that the NHS-ST functioned latently as a blame allocation device. These perceptions were influenced, first, by field-level logics of accountability and managerialism and, second, by specific features of the programme, including public reporting, financial incentives, and ambiguities about definitions that amplified the concerns. In consequence, organisational participants, while they identified some merits of the programme, tended to identify and categorise it as another example of performance management, rich in potential for blame. These findings indicate that the search to optimise the benefits of measurement by controlling the risks of blame remains challenging. They further suggest that a well-intentioned programme theory, while necessary, may not be sufficient for achieving goals for improvement in healthcare systems dominated by institutional logics that run counter to the programme theory. [ABSTRACT FROM AUTHOR]

The article discusses the authors' views on their proposals for improving patient safety and quality of care. Topics covered include how to change the narrative that patient harm is inevitable, the need for health-care organizations to establish improved and well-designed management systems to be used by clinicians, and the use of strategies in other high-risk industries to improve the health-care industry. Also mentioned is the important role of patient in patient safety.

Two understandings of the dynamics of power developed by Foucault have been extensively used in analyses of contemporary healthcare: disciplinary power and governmentality. They are sometimes considered alternative or even contradictory conceptual frameworks. Here, we seek to deploy them as complementary ways of making sense of the complexities of healthcare organisation today. We focus on efforts to improve quality and safety in three UK hospitals. We find a prominent role for disciplinary power, including a panoptic gaze that is to some extent internalised by professionals. We suggest, however, that the role of disciplinary power relies for its impact on complementary strategies that are more akin to governmentality. These strategies foster organisational contexts that are receptive to disciplinary work. More fundamentally, we find that both disciplinary power and governmentality work on subjectivities in rather a different manner from that suggested by conventional accounts. We offer an alternative, less individualised and more socialised, understanding of the way in which power acts upon subjectivity and behaviour in professional contexts. [Copyright &y& Elsevier]