Abstract
Changes in policy focus on patient safety
Patient safety has become a health policy priority throughout the world. This was not a given. The movement was arguably slow to get going in the absence of robust evidence and in the face of professional disbelief but, since the late 1990s, has become a critical policy issue. Since that time, much of the impetus for patient safety has been ‘mainstreamed’ and included in a diverse range of policy agencies and health system actors. However, evidence suggests that the problem of patient safety has not gone away. 1 Some of the landmark events in this movement include the publication of the Harvard Medical Practice Study, which demonstrated the potential scale of patient harm 2 ; the publication of To err is Human 3 in the US and, shortly afterwards in the UK, An Organisation with a Memory, 4 which spearheaded national and international policies; the formation of national agencies such as the US National Patient Safety Foundation, the Health Quality and Safety Commission in New Zealand and the National Patient Safety Agency (NPSA) in England and Wales; and the creation of the World Alliance for Patient Safety, which has championed campaigns from hand hygiene to surgical safety. Today, a diverse range of independent agencies, institutes and centres – such as the US Institute for Health Improvement, the Danish Society for Patient Safety, the Australian Patient Safety Foundation and the UK Health Foundation – work alongside or have come to replace the work of statutory bodies in this area.
With specific reference to the National Health Service (NHS) of England and Wales, the NPSA was set up in the wake of the report, ‘An Organisation with a Memory’ and led national policy developments, until it was abolished in 2012. From 2001 to 2012, the NPSA set up a voluntary incident reporting system (the largest in the world), developed a system for screening incident data and alerting the service to underlying risks, 5 led safety initiatives in areas such as reducing risks of injectable medicines and standardising crash call numbers, and prioritised and funded patient safety research. 6 The existence of a national patient safety research portfolio until 2012 was a focus for activity and knowledge in this area and contributed to advances in theory, methods and evaluation in the field. 7
These activities are now dispersed, some absorbed into the mainstream of central policy processes and performance management (such as the inclusion of safety as a domain in the NHS National Outcomes Framework and the retention of a central hub of patient safety intelligence in NHS England) and others devolved to new regional patient safety collaboratives. Considerable resources have been invested in translational research centres with a specific focus on safety, and patient safety has emerged as a priority for many National Institute for Health Research (NIHR) Collaboratives for Applied Health Research and Care (CLAHRCs) and Academic Health Science Networks. The apparent openness of governments to devolve and distribute power, and the attendant growth of self-governing networks, has been described by some as evidence of a shift from government to governance, with the emergence of a ‘hollowed out state’. 8 This could be deemed a measure of success with the NHS embracing safety as a key part of everyday business and a core quality concern. On the other hand, like Voltaire’s God, patient safety is now everywhere and nowhere.
In some ways, patient safety might be seen as a rhetorical strategy. The public and political power of ‘safety’ as a societal discourse or shared expectation about health care delivery means that the safety label may be used to provide a veneer for reforms or transitions that are arguably more about efficiency or cost-saving than patient care. The conflation of safety with quality and avoidance of waste (‘get it right first time’) is therefore expedient. Research shows, for example, that the ‘appeal to safety’ by service leaders is used in lean health care rhetoric when seeking to enact a range of changes in practice that might not necessarily have a direct bearing on quality. 9 At the same time, there is a case to be made for communicating with the wider public the inherent complexity and uncertainty of health care delivery, so as to promote greater engagement with their own safety and improve standards of care.
In England, recent public concerns over the failings of Mid-Staffordshire NHS Foundation Trust and the subsequent public inquiry has intensified pressure for action on patient safety. The legalistic tone of the 2013 Francis report 10 with its 290 recommendations for action promoting tighter regulation and top–down standards, contrasts with the more diffuse Berwick report, 11 which places greater emphasis on organisational culture and reflective, learning environments. These represent contrasting approaches to safety, where questions of culture, standards and values are seemingly trapped between more structural top–down and emergent bottom–up drivers. Interestingly the Keogh review in 2013 on failing hospitals provides some kind of synthesis between these camps, combining ambitious and aspirational statements to be interpreted locally with more concrete actions. 12 These contrasting recent policy statements on patient safety in England illustrate the very different accounts of patient safety and can be seen in changing trends in knowledge and research.
Shifts and developments in patient safety knowledge
Patient safety can be seen variously as a paradigm, a practice, a discipline or a movement which brings together different communities for a common goal. It has been absorbed into mainstream health care practice and activity and is now taught as part of the standard core curriculum for health care professionals. It has also generated a distinct body of knowledge, with dedicated academic journals, conferences and networks. There has been a marked increase in activity, with the number of publications on rising two to three fold between 2000 and 2005 13 and probably more steeply since.
Yet a review of patient safety as a discourse reveals a fluid and fractured intellectual history. It has yoked together very different kinds of theory, practice and communities. In many ways, it is still an immature academic area – for instance, the National Library of Medicine does not yet have a subject heading (MeSH) for patient safety. And there have been interesting tensions and developments in patient safety research and practice over the last 10 years. There has often been an intellectual schism between on the one hand the proponents of rational standardised solutions and evidence-based practice and on the other hand more pragmatic ‘bottom–up’ quality improvement methods, aligned to patient safety as a social movement. 14 There are interesting tensions between these paradigms, at times opening up substantial epistemic gaps between communities of practice in terms of theory, research and improvement.
Charting the origins of patient safety research and knowledge, 15 the work of James Reason and others marked a shift away from notions of individual competence towards an understanding of the importance of latent errors, structural weaknesses and systems thinking. It was also important to raise awareness of the inherent riskiness of health care by a focus on the epidemiology of errors and harm. Although based on relatively small samples, studies from different countries using retrospective case review were remarkably consistent in establishing that around 1 in 10 patients had been harmed during hospital stays and that many were avoidable. 16 Attention then shifted to the causes of error, with a healthy injection of learning and insight from organisational psychology, human factors, design and ergonomics to focus on unsafe practices and conditions for harm. Although often in the abstract, rather than applied, a growing body of research sought to locate individual safety lapses in the context of a team or environmental factors, which have since been summarised by the idea of the clinical micro-system. 17 A review of the UK Patient Safety Research Portfolio observed, for instance, the dominance of human factors research and the study of safety systems as a paradigm for many of the studies that were funded in the first decade of this century. 7
Informed by these ideas, much of the emphasis in patient safety practice and research has been on strengthening safety controls, standardising care processes, enhancing nonclinical skills and designing out error through safer procedures and technologies. Again, most of these have been focused on the clinical team or micro-system rather than the wider care system. Although a nod was sometimes given to evidence-based solutions – for instance, review of the clinical effectiveness of various safety interventions from pressure-relieving mattresses to central line infections 18 – there were often few robust evaluations of safety interventions. 19 The main policy drivers were for standardised solutions and central guidance, despite emerging evidence of limited uptake and impact. 20 In the 1990s, many countries invested in technological solutions – for instance, electronic prescribing systems in hospitals, which were the focus of research interest, 21 as well as design solutions such as non-Luer connectors to prevent wrong route injection errors. 22 There was an emphasis on central, top–down solutions for particular interventions or whole organisation safety programmes. To date, however, the evidence of impact from controlled evaluations of large-scale safety interventions 23 has shown little or none of the transformative effect predicted by clinical champions at the outset. Insights from ethnographic research help to explain why – as a review of observational research in acute settings concludes, ‘patient safety is not simply a technical issue, but a site of organizational and professional politics’. 24
There are unresolved ontological debates, for example, about whether patient safety is a tangible ‘thing’ that can be precisely defined and elaborated as a taxonomy of events, or whether it remains a more nebulous, contested and culturally relative concept. Following these differences, patient safety research reveals distinct traditions from those favouring experimental trials of safety-enhancing interventions to those that focus on exploratory studies of the sociocultural framing of safety and safety improvements. Similarly, safety improvements often centre on introducing more technical solutions, but without full regard to the sociocultural and political context of change; in particular, cultural change remains a prominent issue around which different communities continue to disagree. This has led some commentators to question whether patient safety research and policy has been dominated by a ‘measure and manage’ orthodoxy that might explain the difficulties faced in bringing about desired service improvement. 25 Conversely, others have questioned the utility of researchers offering critical observations from the sidelines without making practical contributions to the real and pressing problems facing the service. 26
One landmark study that provides a useful synthesis between these opposing camps is the theoretically informed evaluation of the successful patient safety initiative to reduce (or even eliminate) central line infections in Michigan by Mary Dixon-Woods and colleagues. 27 This highlighted the use of quantitative measures and evidence-based ‘care bundles’ as key to the initiative’s success, together with effective problem framing, isomorphic pressures of peer influence and other social change techniques. It combines rigorous theoretical knowledge and robust evaluation with practical lessons for others wanting to implement similar ambitious improvement programmes.
In recent years, there has been greater consideration of the influence of context in shaping the design, implementation and success of safety improvements. This often extends analysis beyond the local micro-system to the wider organisational, sociocultural and political landscape of care. This greater understanding of context is important when considering the development of patient safety knowledge which, in the early days, leaned heavily on learning from other high-risk industries, such as airlines and chemical plants. Recent criticisms have centred on the limits of directly transferring particular safety defences – from checklists to handover summaries – from nonhealth care settings. There is a risk that safety defences can be seen as reified entities outside organisational practice and culture. This overlooks the particular workplace hierarchies and dynamics – illustrated in recent ethnographic studies, such as one on the implementation of the surgical time-out procedure, 28 where collaborative practices were subverted by preexisting hierarchies and professional norms. Similarly, research on the implementation of incident reporting and root cause analysis techniques highlights how professional boundaries and hierarchies can inhibit attempts to engender learning.29–31
Ignoring the particular context of safety intervention, limits its impact in two ways. On the one hand, some argue that health care systems have more complexity than other industries. 32 On the other, it is also contended that well-developed, sophisticated safety systems have been crudely and imperfectly imported into health care. Carl Macrae has noted how the activity of flight safety investigators 33 has led to health care being quick to adopt incident reporting systems from aviation, while overlooking the embedded, social, cognitive and organisational structures around them which make them work. His empirical work shows the ways in which skilled aviation investigators use interpretative vigilance and participative networks to create invisible but powerful safety infrastructures to learn from mistakes. The enthusiastic adoption of techniques and strategies from high-risk industries in the early days of patient safety knowledge has been replaced with caution and critical insights into the situated nature of safe working practices. As such, the latest research is characterised by an interest in boundaries, complexity, identity, professionals, power and ambiguity, and in using theory and empirical data together to get greater insight into the realities of working lives and how to make systems safer.
Call for new research on patient safety
Against this backdrop of emerging and expanding knowledge on the complexity and context-dependent nature of patient safety, the NIHR issued a call for new research in 2010. It recognised that existing evidence had focused largely on the implementation of technical interventions, within single domains of health settings, with many studies making assumptions of simple linear relationships between knowing and getting interventions into practice. The new call focused on four particular gaps where new research was needed:
new evaluations of patient safety interventions, with attention to organisational culture and context; boundaries between care processes, services and organisations; a focus on the role of the patient and public in safety improvement; and the costs and financial implications of patient safety.
Research funded under 2010 NIHR call on patient safety in health care organisations.
Note: NIHR: National Institute for Health Research; NHS: National Health Service.
Despite a healthy response to this call from the research community in 2010, no high-quality proposal was received on the financial implications of patient safety and this remains an important, underexplored area. The three other themes in the call are explored below, describing what these new studies add to existing evidence.
What these new studies add
Many early patient safety studies focused on the influence of contributory latent factors within the local work environment. The wider organisational and managerial context was rarely developed as a distinct analytical dimension. In particular, there was limited consideration of the role played by senior and middle managers in the implementation of safety interventions and governance of safety issues. In direct recognition of this gap, Mannion and colleagues 34 examine the contribution and influence of hospital trust board governance and behaviour around patient safety. This combines descriptive data on board activity – from safety walkabouts to discussion of ‘never events’ at board meetings – with competing theoretical frameworks of the role of boards. These range from agency theory, in which the board provides a check to unsafe practices to stewardship theory, in which boards encourage and nurture staff who will tend to do a good job. As well as these instrumental theories, Mannion also considers the symbolic role of the board in which the performance aspects of their work are foregrounded. This work builds on a wider body of evidence bringing insights into organisational culture and how it mediates and transforms policy and practice. 35 Their work adds new theoretical insight on the role of organisational governance structures, processes and practices in promoting and managing patient safety.
Much existing safety research has focused on the clinical micro-system and particular clinical domains such as operating theatres or emergency departments, mostly in acute hospitals. This has led to calls for enhanced understanding of the wider organisational and system context. Where Mannion and colleagues bring new understanding to the role of senior management and organisational governance, Waring and colleagues examine the threats to patient safety found between care organisations and processes. 36 Specifically, they focus on the realities of hospital discharge or care transition for stroke and hip fracture patients, providing rich insights into the hidden interdependencies and partial sightlines of different parts of the system ‘framed by boundaries of knowledge, culture and organisation’. In particular, this contribution reframes analysis of patient safety beyond the clinical micro-system and linear error chains, to consider instead how safety is shaped by the interdependencies of actors and agencies working in a complex system.
Similar interest in the boundaries and interfaces between care providers is seen in the study by Sujan and colleagues of handover practices in emergency care. 37 Handovers highlight the linkages and interdependencies between care teams and departments, and despite a growing body of research calling for enhanced communication during handover, handover remains a high-risk period in the patient journey. Ethnographic work uncovers how practitioners manage competing demands, making extra effort to coordinate care in the interests of the patient, with paramedics sometimes taking part in a ‘secret second handover’, waiting to brief the attending doctor rather than relying on the formal handoff with the triage nurse. This study shows the limits of reliance on the standardised boundary object of the structured handover summary, which often fails to allow for different professional perspectives and discourses to be shared and reconciled. Furthermore, the influence of macro-level pressures such as targets and management of patient flow is also consistently underrecognised in safety interventions and solutions to improve handover.
The issue of handover and emergency care surfaces again in the study by O’Hara and colleagues on decision making by ambulance staff. 38 The focus on urgent care in this and in Sujan and colleagues’ study is welcome as an example of a complex system or web of systems, providing an antidote to the dominance in previous research of studies within hospitals or single organisations. O’Hara and colleagues’ study of decision making on ambulances, using immersive ethnographic methods, from observation of ambulance shifts to digital diaries held by paramedics, provides important insights into the complexity of decisions made by frontline staff. This is typified by the dilemmas of nonconveyance decisions faced by ambulance staff attending older people who have fallen, given limited information and availability of alternatives to emergency departments. The range of clinical and nonclinical factors that individuals need to take into account and the complexity of the decisions makes algorithms and other standardised safety instruments of limited use. There is thus a focus on individual agency and praxis, and the different ways in which staff make sense of existing rules, mirroring perhaps parallel debates on the limits of simplistic, rational models of evidence-based medicine for complex decision making by clinical frontline staff. 39
At the same time as broadening the horizons of patient safety research to engage with boundaries and wider system issues, recent research has also provided a deeper understanding of particular clinical contexts and how they affect health and care practices. Both perspectives are needed in current safety knowledge. A recurrent theme in all these studies – and indeed in the wider literature – is the way in which professional boundaries and cultures can hinder the implementation of safety improvements. 40 Recent safety science has focused on more tailored interventions and solutions, based on a deeper understanding of particular teams and micro-systems. The study by Benn and colleagues on performance feedback to clinicians emphasises the importance of tailoring interventions and information to the specific clinical setting (in this case, anaesthesia) in order to get engagement and commitment to safety measurement systems. 41
Despite being highlighted as a gap in the 2010 patient safety research call, few high-quality responses were received on the topic of patient involvement in patient safety. However, there were some important contributions, including a study by Birks and colleagues on ‘open disclosure’ to patients who have been harmed while receiving health care. 42 This is important, given that existing studies suggest that less than a third of harmful errors are discussed with patients at present. There is a small but growing amount of evidence on this topic, largely from Australia or the United States, much involving only small-scale training or pilot initiatives. The study led by Birks provides new insights from studying a comprehensive national programme of open disclosure in England and Wales. It also brings together evidence from around the world on policy and practice in health care in disclosing to patients when mistakes are made. This review shows that despite commitment in most systems to open disclosure, it is far from clear what exactly is required and why. Indeed, problems of definition of what constitutes a ‘disclosable’ event is evident in the qualitative research with practitioners and decision makers. This mirrors work by Josephine Ocloo and others, which shows how even notions of harm have been quite narrowly defined within a clinical, predominantly medical, frame and lexicon. 43 The review by Birks and colleagues further explores tensions and ambiguities in the process of disclosure. A central difficulty is the requirement for organisations and individuals to cede control and manage uncertainty in conversations with patients who have been harmed. This challenges competing safety imperatives to exert control over professional practice and behaviour.
Another study funded in this NIHR call highlights the needs of particular vulnerable patient populations, focusing on the care of adults with learning disabilities in six hospitals. 44 This has become an important safety issue, after sentinel events like the death of an inpatient with learning difficulties who was not fed for 21 days. Despite public concern and focus, this study suggests that many of these patients remain invisible and at risk of delayed or omitted care. The role of informal carers is also not well understood or engaged in current systems and health practices. The focus on particular marginalised patients provides important insights into wider safety issues and vulnerabilities affecting all patients.
Context, sense making and power
So what do these new research studies contribute? One of the main advances in learning over the last five years is the realisation that we cannot import a safety solution from one setting to another without allowing for context in terms of professional and organisational ‘ways of seeing’. These are problems of interpretation – just as between languages word for word translation is not necessarily possible (for instance, there is no single word in Russian for cheese), 45 so too in patient safety much is context dependent and contingent. Patient safety has borrowed selectively from industries like aviation without full understanding of differences in work practices, culture and infrastructure. Within health care, the use of boundary objects or standardised safety defences – from safety checklists to handover summaries to discharge processes – will be enacted and understood differently by different individuals and groups, subject to cultural and organisational norms.
There is a focus on the messy but illuminating realities of implementing safety practice – from handover to discharge. The contribution of ethnographic research provides real insights into the realities of working lives, partial sightlines and sense making 46 by different individuals and communities, from ward sisters involved in discharge to ambulance crews conveying patients to emergency departments. There is a focus on gaps and interfaces – not only as a problem threatening safe processes but also as spaces where staff often exhibit resilience, foresight and patient-centred care. Observational research in the operating theatre and elsewhere show the rational behaviour of staff engaged in workarounds or rule breaking (such as reuse of single-use devices). 47 This parallels deep understanding of clinical resistance to information technology 48 through use of structuration and actor-network theory. New research combines knowledge of power, organisational and cultural norms together with individual agency and decision making to provide insights into how frontline staff practise and what this means for safety. There are hidden rules and infrastructures, which govern behaviour, from handover to talking about mistakes with patients.
Many of these new studies also show an increasing interest in unpacking the multiple and sometimes competing interests of different actors and agents in health care practice. This includes a focus on the power asymmetries within and between professional groups, patients and organisations, and the need to understand cultural and political contexts of action and debate. 49 For too long, as argued by Antonsen in a discussion on broader safety research across sectors, safety literature has assumed a ‘harmony model of organisational life’. 50 To understand the success and failure of different safety initiatives, some of these tensions and power relations within complex systems need greater elucidation in future research.
Reflecting on this new and emerging body of research, we propose that a focus on relationships might provide the basis of future theoretical, empirical and practice-based advances. Rather than studying ‘things’ or safety as a ‘thing’, we might do better by studying safety as a relational property, which emerges in dynamic form. Such studies would bring to the fore relations of accountability, for example, between patient and professional in the context of open disclosure, and in the relationships between services leaders, regulators and society in the context of board governance. They would also highlight the interdependencies between different care providers, agencies and professionals, especially in the area of admissions and discharges where patients move between different parts of the wider care system. This ‘relational turn’ reinforces the need for methods that examine issues of accountability, communication and collaboration as situated and real-time activities. Significantly, cultures cannot be easily detected or measured through individuals, but need to be understood as interactional and intersubjective, or operating in the connected practices between people. Observational methods, narrative perspectives, techniques that meaningfully engage with patients, and, possibly, other forms of relational network analysis are essential to the future of patient safety research, alongside more traditional evaluation perspectives. This also leads to the suggestion that advances in patient safety should focus more on improving the quality and resilience of relationships between people, processes and organisations. This might include a continued focus on team behaviours and communication skills, but also attention to the complex realities of health care organisation and delivery in terms of the barriers and drivers that enable different groups to work together effectively.
Another key gap in the patient safety research landscape is high-quality work on costs and costing. Despite the NIHR call encouraging research on finance and safety, this remains a significantly underresearched and important area. Better accounting of the cost of harm is needed, not just in the remedial costs of rectifying patient harm in additional clinical care, such as surgical revisions, or extra bed days, but also in terms of litigation and damages, including reputational harm. Like earlier studies that aimed to define and measure the scale of the problem, more accurate estimates of costs might also encourage service leaders and regulators to pay greater attention to the human and financial consequences of harm. Linked to this, safety interventions should also be evaluated more robustly in terms of the relative costs and benefits of providing training or new IT systems over and above existing practices. Increased attention is given to the issue of ‘context’ in shaping safety and safety improvements, but the totality of the health and care system is rarely considered, especially the influence of wider institutional forces, political and regulatory pressures and the inherent complexity of the care system. 36 The Francis report, for example, highlights the bureaucratic burden of overregulation and its potential perverse influence of day-to-day clinical practices, where doing the system’s business comes ahead of patient care.
Future research might also broaden the scope of research to include settings and locations outside the hospital, especially in residential care homes, the third sector and in people’s homes. Given that policies increasingly seek to relocate chronic care outside the hospital and promote tele- or self-care, the role of the patient in promoting their own safety is possibly the biggest and yet least understood spatial domain for safety. For example, many of the concerns about medicine adherence, falls and infection are often influenced by the nonhealth care environment. Research in Australia highlights the potential social and spatial inequalities in safety, showing, for example, how the likelihood of harm is greater amongst the elderly and in the home. 51 Although there has been great interest in learning from highly reliable industries, safety improvements might also be developed from within health services, especially through closer and more collaborative engagement amongst different stakeholders. There is growing interest in the role of quality improvement collaboratives and even social movement theories as a basis of engendering change within health care organisations. 14 Further consideration might be given to supporting the use and evaluating the impact of these novel approaches to patient safety. The contributions in this Supplement show that we have come a long way in understanding patient safety, but there remain interesting new directions for future research.
Footnotes
Acknowledgement
We would like to thank colleagues at the NIHR Health Services & Delivery Research Programme for their work in supporting funded projects featured in this supplement and organising this supplement, in particular Stephanie Garfield-Birkbeck (Assistant Director) and Ruth Saw (Programme Manager).
Declaration of conflicting interests
None declared.
Funding
The paper received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.