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Background The Perioperative care for Older People undergoing Surgery (POPS) service model is increasingly being implemented across care providers in the English and Welsh National Health Services. Objective The study aimed to produce evidence regarding clinical leaders' activities to implement POPS across different service contexts and to produce generalisable recommendations for future implementation. Methods A qualitative interview study was undertaken across six National Health Services hospitals with established POPS services. Interview participants were recruited on the basis of their direct involvement in the implementation and leadership of the service. Data collection involved semi-structured interviews with 26 people carried out between November 2022 and May 2023. Results The implementation of POPS is often hampered by a lack of managerial and financial support, and apprehension amongst surgeons and anaesthetist about new ways of working. POPS leaders address these through five interconnected activities, each targeted at a combination of implementation factors. (i) Securing management and financial support. (ii) Professional engagement. (iii) Evidence building as a resource for demonstrating the clinical and operational benefits of POPS. (iv) Communication and engagement activities to promote and legitimise POPS to stakeholder groups. (v) Designated and distributed leadership to promote and coordinate implementation activities and to spread the service to new pathways. Conclusions Through a combination of activities POPS can be effectively implemented across different organisational contexts. Some aspects of these activities can be guided by shared resources and learning across sites, but others require adaption to local contextual barriers and drivers. [ABSTRACT FROM AUTHOR]

Introduction: A range of nonpharmaceutical public health interventions has been introduced in many countries following the rapid spread of Covid‐19 since 2020, including recommendations or mandates for the use of face masks or coverings in the community. While the effectiveness of face masks in reducing Covid‐19 transmission has been extensively discussed, scant attention has been paid to the lived experience of those wearing face masks. Method: Drawing on 40 narrative interviews with a purposive sample of people in the United Kingdom, with a particular focus on marginalised and minoritized groups, our paper explores experiences of face mask use during the pandemic. Results: We find that face masks have a range of societal, health and safety impacts, and prompted positive and negative emotional responses for users. We map our findings onto Lorenc and Oliver's framework for intervention risks. We suggest that qualitative data offer particular insights into the experiences of public health interventions, allowing the potential downsides and risks of interventions to be more fully considered and informing public health policies that might avoid inadvertent harm, particularly towards marginalised groups. Patient or Public Contribution: The study primarily involved members of the public in the conduct of the research, namely through participation in interviews (email and telephone). The conception for the study involved extensive discussions on social media with a range of people, and we received input and ideas from presentations we delivered on the preliminary analysis. [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]

The use of face masks and coverings has been a central component of efforts to mitigate the impact of the COVID‐19 pandemic and has been legally mandated in some countries. Most academic studies to date, however, have focussed primarily on its effectiveness in reducing SARS‐CoV‐2 transmission, largely neglecting the social dimensions of mask mandates. In this narrative interview‐based study, we consider experiences of face masks, with a particular focus on groups considered to be at a potential disadvantage from compulsory masking. Drawing on 40 telephone, video‐call and e‐mail interviews, we highlight the impact of inconsistent communication and the notion of mask wearing as an act of altruism on participants' experiences. In particular, we show how intolerance towards individuals who did not wear masks could result in stigma and exclusion, regardless of the legitimacy of their reasons. We suggest that more is needed to mitigate the 'dark side' of discourses of collective effort and altruism at a time of societal stress and fracture, and to account for the needs and interests of groups for whom compulsory masking may result in further marginalisation. [ABSTRACT FROM AUTHOR]

Frailty is increasingly used in clinical settings to describe a physiological state resulting from a combination of age-related co-morbidities. Frailty also has a strong 'lay' meaning that conjures a particular way of being. Recent studies have reported how frail older people perceive the term frailty, showing that frailty is often an unwanted and resisted label. While there are many scores and measures that clinicians can use to determine frailty, little has been published regarding how health-care professionals use and make sense of the term. This paper reports the findings of a qualitative study that explored how health professionals perceive frailty. Forty situated interviews were conducted with health-care professionals working in an emergency department in the English Midlands. The interview talk was analysed using discourse analysis. The findings show that the health professionals negotiate an 'ideological dilemma' – a tension between contradictory sets of meanings and consequences for action – based on their 'lay' and clinical experience of the term frailty. It is concluded that this dilemma could have a negative impact on the assessment of frailty depending on the system of assessment used. [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]

Objectives: Calls for major reconfigurations of health services have been accompanied by recommendations that wide ranging stakeholders be involved. In particular, patients and the wider public are seen as critical contributors as both funders and beneficiaries of public health care. But public involvement is fraught with challenges, and little research has focused on involvement in the health service transformation initiatives. This paper examines the design and function of public involvement in reconfiguration of health services within the English NHS. Methods: Qualitative data including interviews, observation and documents were collected in two health service 'transformation' programmes; interviews include involved public and professional participants. Data were analysed using parallel deductive and inductive approaches. Results: Public involvement in the programmes was extensive but its terms of reference, and the individuals involved, were restricted by policy pressures and programme objectives. The degree to which participants descriptively or substantively represented the wider public was limited; participants sought to 'speak for' this public but their views on what was 'acceptable' and likely to influence decision-making led them to constrain their contributions. Conclusions: Public involvement in two major service reconfiguration programmes in England was seen as important and functional, and could not be characterized as tokenistic. Yet involvement in these programmes fell short of normative ideals, and could inadvertently reduce, rather than enlarge, public influence on health service reconfiguration decisions. [ABSTRACT FROM AUTHOR]

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]

Migrants and ethnic minorities are under-represented in spaces created to give citizens voice in healthcare governance. Excluding minority groups from the health participatory sphere may weaken the transformative potential of public participation, (re)producing health inequities. Yet few studies have focused on what enables involvement of marginalised groups in participatory spaces. This paper addresses this issue, using the Participation Chain Model (PCM) as a conceptual framework, and drawing on a case study of user participation in a Dutch mental health advocacy project involving Cape Verdean migrants. Data collection entailed observation, documentary evidence and interviews with Cape Verdeans affected by psychosocial problems (n = 20) and institutional stakeholders (n = 30). We offer practice, policy and theoretical contributions. Practically, we highlight the importance of a proactive approach providing minorities and other marginalised groups with opportunities and incentives that attract, retain and enable them to build and release capacity through involvement. In policy terms, we suggest that both health authorities and civil society organisations have a role in creating ‘hybrid’ spaces that promote the substantive inclusion of marginalised groups in healthcare decision-making. Theoretically, we highlight shortcomings of PCM and its conceptualisation of users' resources, suggesting adaptations to improve its conceptual and practical utility. [ABSTRACT FROM AUTHOR]

In many developed-world countries, there have been efforts to increase the ‘leadership capacity’ of healthcare professionals, particularly lower-status staff without formal managerial power. Creating frontline ‘leaders’ is seen as a means of improving the quality of healthcare, but such efforts face considerable challenges in practice. This article reports on a qualitative, interview-based study of 23 staff in two UK operating theatre departments, mostly nurses by professional background, who were given formal leadership responsibilities by their hospitals and redesignated as ‘team leaders’ and ‘theatre co-ordinators’. While participants were familiar with leadership theory and could offer clear accounts of good leadership in practice, they were often limited in their ability to enact their leadership roles. Professional and managerial hierarchies constrained participants’ leadership capacity, and consequently the exercise of leadership rested on alignment with managerial relationships and mandates. The findings highlight difficulties with accounts of leadership as something to be distributed across organizations; in healthcare organizations, established institutional structures and norms render this approach problematic. Rather, if fostering leadership capacity is to have the transformational effect that policymakers desire, it may need to be accompanied by other, wider changes that attend to institutional, organizational and professional context. [ABSTRACT FROM PUBLISHER]

Participatory forums, in which lay citizens or users of public services contribute to the governance of public services, have proliferated in recent years. In debates about the quality and influence of such processes, there has been increasing recognition of the importance of emotional as well as rational deliberation, and criticism of the way in which the structures imposed on such forums can exclude certain participants and discourses. This paper presents a study of one such forum, convened by an independent organization to influence the development and management of state services, and governed by self-determined norms of participation and conduct. It highlights both the potential of such public deliberations beyond the state to generate novel outputs that influence public-service provision, but also the way in which such forums, and their lack of imposed rules and norms of deliberation, can themselves work to exclude certain participants and discourses. [ABSTRACT FROM AUTHOR]

Objectives: There have been calls for greater exchange between research and practice in health care policy and management, but little empirical research on what commissioners of research and researchers themselves consider appropriate, good quality research knowledge. This paper addresses this gap, considering the views of commissioners and producers of policy and management research in health care and other fields. Methods: Qualitative semi-structured interviews with 18 commissioners and producers of research, in central government, the NHS and other commissioning organizations, and in universities and independent sector providers. Results: Commissioners and producers agreed that research often fails to fulfil policy-makers' and managers' needs, and that greater interaction is required to improve this relationship. However, they offered differing accounts of the nature of research knowledge (as a 'product' or a 'mindset'), and of what constitutes value, validity and originality in research, reflecting the differing priorities and pressures faced by the two groups. Conclusions: Efforts to promote greater interaction between research, policy and practice, and more critical, reflexive engagement between policy-makers, managers and researchers, are likely to face significant obstacles given these competing constructions of research knowledge and their reinforcement by divergent priorities. [ABSTRACT FROM AUTHOR]

Background: Self-management education programmes are cost-effective in helping people with type 2 diabetes manage their diabetes, but referral and attendance rates are low. This study reports on the effectiveness of the Embedding Package, a programme designed to increase type 2 diabetes self-management programme attendance in primary care. Methods: Using a cluster randomised design, 66 practices were randomised to: (1) a wait-list group that provided usual care for nine months before receiving the Embedding Package for nine months, or (2) an immediate group that received the Embedding Package for 18 months. 'Embedders' supported practices and self-management programme providers to embed programme referral into routine practice, and an online 'toolkit' contained embedding support resources. Patient-level HbA1c (primary outcome), programme referral and attendance data, and clinical data from 92,977 patients with type 2 diabetes were collected at baseline (months − 3–0), step one (months 1–9), step 2 (months 10–18), and 12 months post-intervention. An integrated ethnographic study including observations, interviews, and document analysis was conducted using interpretive thematic analysis and Normalisation Process Theory. Results: No significant difference was found in HbA1c between intervention and control conditions (adjusted mean difference [95% confidence interval]: -0.10 [-0.38, 0.18] mmol/mol; -0.01 [-0.03, 0.02] %). Statistically but not clinically significantly lower levels of HbA1c were found in people of ethnic minority groups compared with non-ethnic minority groups during the intervention condition (-0.64 [-1.08, -0.20] mmol/mol; -0.06% [-0.10, -0.02], p = 0.004), but not greater self-management programme attendance. Twelve months post-intervention data showed statistically but not clinically significantly lower HbA1c (-0.56 [95% confidence interval: -0.71, -0.42] mmol/mol; -0.05 [-0.06, -0.04] %; p < 0.001), and higher self-management programme attendance (adjusted odds ratio: 1.13; 95% confidence interval: 1.02, 1.25; p = 0.017) during intervention conditions. Themes identified through the ethnographic study included challenges for Embedders in making and sustaining contact with practices and providers, and around practices' interactions with the toolkit. Conclusions: Barriers to implementing the Embedding Package may have compromised its effectiveness. Statistically but not clinically significantly improved HbA1c among ethnic minority groups and in longer-term follow-up suggest that future research exploring methods of embedding diabetes self-management programmes into routine care is warranted. Trial registration: ISRCTN23474120, registered 05/04/2018. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the use of the PAM in the English National Health service. The PAM is a validated scale that measures 'activation' (people's knowledge, skills, and confidence in managing their health) and assigns patients to four categories of activation (low-to-high). Some evidence suggests that higher activation levels correlate to better clinical outcomes and patient experiences, and lower healthcare costs. Empirical studies of implementing the PAM are scarce.Methods: An ethnographic study of six healthcare organisations' PAM implementation focused on 'core-teams' who designed projects, and frontline staff and patients' experiences of those. Data comprised 123 hours of observation, 112 interviews, and document reviewing. Analysis used a constant-comparative approach.Results: The PAM appealed as it fitted with different logics of measurement, offering a means of quantifying soft, process-oriented qualitative constructs used in tailoring care, whilst simultaneously producing reliable high-level outcome metrics. Data revealed challenges to these logics. The PAM's developers emphasised fidelity to ensure reliability but, in practice, flexibility was commonplace and often perceived as appropriate and beneficial by frontline staff.Conclusion: The intended logic of measurement is important in determining an appropriate balance of fidelity and flexibility and, therefore, reliability and patient benefit. [ABSTRACT FROM AUTHOR]

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. • Candidacy is a framework for understanding influences on access to healthcare. • We studied access to mental healthcare services during the COVID-19 pandemic. • Candidacy was profoundly affected by service changes. • Understandings of entitlement and thresholds for access were reconfigured. • The value of the candidacy framework for mental health contexts is affirmed. [ABSTRACT FROM AUTHOR]

Objectives:We aimed to explore the views of strategic level stakeholders on leadership for quality and safety in the UKNational Health Service.Methods: We interviewed 107 stakeholders with close involvement in quality and safety as professionals, managers,policy makers or commentators. Analysis was based on the constant comparative method.Results: Participants identified the crucial role of leadership in ensuring safe, high quality care. Consistent with theacademic literature, participants distinguished between traditional hierarchical 'concentrated' leadership associated withparticular positions, and distributed leadership involving those with particular skills and abilities across multiple institutionallevels. They clearly and explicitly saw a role for distributed leadership, emphasizing that all staff had responsibilityfor leading on patient safety and quality. They described the particular value of leadership coalitions between managersand clinicians. However, concern was expressed that distributed leadership could mean confusion about who was incharge, and that at national level it risked creating a vacuum of authority, mixed messages, and conflicting expectationsand demands. Participants also argued that hierarchically based leadership was needed to complement distributedleadership, not least to provide focus, practical support and expertise, and managerial clout.Conclusions: Strategic level stakeholders see the most effective form of leadership for quality and safety as one thatblends distributed and concentrated leadership. Policy and academic prescriptions about leadership may benefit from thesophisticated and pragmatic know-how of insiders who work in organizations that remain permeated by traditionalstructures, cleavages and power relationships. [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]

Introduction Patient and public involvement in healthcare planning, service development and health-related research has received significant attention. However, evidence about the role of patient involvement in quality improvement work is more limited. We aimed to characterize patient involvement in three improvement projects and to identify strengths and weaknesses of contrasting approaches. Methods Three case study quality improvement projects were purposively sampled from a broader programme. We used an ethnographic approach involving 126 in-depth interviews, 12 weeks of non-participant observations and documentary analysis. Data analysis was based on the constant comparative method. Results The three projects differed in the ways they involved patients in their quality improvement work, including their rationales for including patients. We characterized three very different models of patient involvement, which were each influenced by project context. Patients played distinctive roles across the three projects, acting in some cases as intermediaries between the wider patient community and clinicians, and sometimes undertaking persuasive work to convince clinicians of the need for change. We identified specific strategies that can be used to help ensure that patient involvement works most effectively and that the enthusiasm of patients to make a difference is not dissipated. Conclusion Patient involvement in quality improvement work needs careful management to realize its full potential. [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]