Elements of Improving Quality and Safety in Healthcare – serie

Collaboration-based approaches to healthcare improvement attract much attention. They involve networks of people coming together to cooperate around a common interest, with shared goals of improving care and mutual learning. Longstanding examples of collaborative approaches have been associated with some success in improving outcomes and reducing harm. The evidence for their effectiveness and cost-effectiveness, however, remains inconsistent and contingent on the circumstances in which they are deployed and how they are used for what purpose. Several models for collaboration have been developed, varying in structure, format, and balance between internal leadership and external control. The authors focus on two approaches: quality improvement collaboratives and communities of practice. They explore evidence of their impact on health outcomes, and evidence about how best to organise and implement collaboration-based approaches. Using examples of more and less successful collaborations, they offer guidance on the key challenges involved in using collaboration-based approaches to improve healthcare. This title is also available as Open Access on Cambridge Core.

Healthcare policy frequently invokes notions of cultural change as a means of achieving improvement and good-quality care. This Element unpacks what is meant by organisational culture and explores the evidence for linking culture to healthcare quality and performance. It considers the origins of interest in managing culture within healthcare, conceptual frameworks for understanding culture change, and approaches and tools for measuring the impact of culture on quality and performance. It considers potential facilitators of successful culture change and looks forward towards an emerging research agenda. As the evidence base to support culture change is rather thin, a more realistic assessment of the task of cultural transformation in healthcare is warranted. Simplistic attempts to manage or engineer culture change from above are unlikely to bear fruit; rather, efforts should be sensitive to the complexity and highly stratified nature of culture in an organisation as vast and diffuse as the NHS. This title is also available as Open Access on Cambridge Core.

Operational research is a collection of modelling techniques used to structure, analyse, and solve problems related to the design and operation of complex human systems. While many argue that operational research should play a key role in improving healthcare services, staff may be largely unaware of its potential applications. This Element explores operational research's wartime origins and introduce several approaches that operational researchers use to help healthcare organisations: address well-defined decision problems; account for multiple stakeholder perspectives; and describe how system performance may be impacted by changing the configuration or operation of services. The authors draw on examples that illustrate the valuable perspective that operational research brings to improvement initiatives and the challenges of implementing and scaling operational research solutions. They discuss how operational researchers are working to surmount these problems and suggest further research to help operational researchers have greater beneficial impact in healthcare improvement. This title is also available as Open Access on Cambridge Core.

Many healthcare improvement approaches originated in manufacturing, where end users are framed as consumers. But in healthcare, greater recognition of the complexity of relationships between patients, staff, and services (beyond a provider-consumer exchange) is generating new insights and approaches to healthcare improvement informed directly by patient and staff experience. Co-production sees patients as active contributors to their own health and explores how interactions with staff and services can best be supported. Co-design is a related but distinct creative process, where patients and staff work in partnership to improve services or develop interventions. Both approaches are promoted for their technocratic benefits (better experiences, more effective and safer services) and democratic rationales (enabling inclusivity and equity), but the evidence base remains limited. This Element explores the origins of co-production and co-design, the development of approaches in healthcare, and associated challenges; in reviewing the evidence, it highlights the implications for practice and research. This title is also available as Open Access on Cambridge Core.

This Element introduces and critically reflects on the contribution of implementation science to healthcare improvement efforts. Grounded in several disciplines, implementation science is the study of strategies to promote the uptake of evidence-based interventions into healthcare practice and policy. The field's focus is threefold. First, it encompasses theory and empirical research focused on exploring, identifying, and understanding the systems, behaviours, and practices that influence successful implementation. Second, it examines the evaluation of strategies to address barriers or enablers to implementation in a given context. Last, it increasingly seeks to understand the process of implementation itself: what actually gets implemented, and when, why, and how? Despite the growing body of evidence, challenges remain. Many important messages remain buried in the literature, and their impact on implementation efforts in routine practice may be limited. The challenge is not just to get evidence into practice, but also to get implementation science into practice. This title is also available as Open Access on Cambridge Core.

Positive deviance is an asset-based improvement approach. At its core is the belief that solutions to problems already exist within communities, and that identifying, understanding, and sharing these solutions enables improvements at scale. Originating in the field of international public health in the 1960s, positive deviance is now, with some adaptations, seeing growing application in healthcare. We present examples of how positive deviance has been used to support healthcare improvement. We draw on an emerging view of safety, known as Safety II, to explain why positive deviance has drawn the interest of researchers and improvers alike. In doing so, we identify a set of fundamental values associated with the positive deviance approach and consider how far they align with current use. Throughout, we consider the untapped potential of the approach, reflect on its limitations, and offer insights into the possible challenges of using it in practice. This title is also available as Open Access on Cambridge Core.

Lessons from service and system failures describe the pivotal roles played by governance and leadership in delivering high-quality, safe care. This Element sets out what the terms governance and leadership mean and how thinking about them has developed over time. Using real-world examples, the authors analyse research evidence on the influence of governance and leadership on quality and safety in healthcare at different levels in the health system: macro level (what national health systems do), meso level (what organisations do), and micro level (what teams and individuals do). The authors describe behaviours that may help boards focus on improving quality and show how different leadership approaches may contribute to delivering major system change. The Element presents some critiques of governance and leadership, including some challenges that can arise and gaps in the evidence, and then draws out lessons for those seeking to strengthen governance and leadership for improvement. This title is also available as Open Access on Cambridge Core.

Overuse has become a major issue of healthcare quality, safety, and sustainability around the world. In this Element, the authors discuss concepts, terminology, and the history of concerns. They show how interventions to address overuse target multiple drivers. They highlight successes and promising approaches, but also challenges in generating and using evidence about overuse. They emphasise that different stakeholder perceptions of value must be recognised. System-level efforts to restrict access to services have created tensions between stakeholder groups and stimulated politicised debates about rationing. They argue for clear articulation of priorities, problem definition, mechanisms for interventions, and areas of uncertainty. Policy-makers should prioritise transparency, be alert to inequalities as they seek to reduce overuse, and consider how to balance controlling use with enabling clinicians to respond to individual circumstances. The complexity of the drivers and possible solutions to overuse require the use of multiple research methods, including social science studies. This title is also available as Open Access on Cambridge Core.

Ethics involves examining values and identifying what is good, right, and justified - and why. Diverse values and ethical issues run through healthcare improvement, but they are not always recognised or given the attention they need. While much effort goes into understanding whether intervention X effectively leads to change Y, questions such as 'is X ethically acceptable?', 'does Y count as an improvement?', 'should Y be prioritised?', and 'if so, why?' are sometimes neglected. This Element demonstrates the ethical considerations and rich array of values that inevitably underpin both the goals of healthcare improvement (what aspects of quality or what kinds of good are pursued) and how improvement work is undertaken. It outlines an agenda for improvement ethics with the aim of helping those involved in healthcare improvement to reflect on and discuss ethical aspects of their work more explicitly and rigorously. This title is also available as Open Access on Cambridge Core.

Creating a well-integrated, resilient, and highly transparent supply chain is central to effective and safe patient care. But managing healthcare supply chains is complex; common challenges include the underuse, overuse, and misuse of health resources. This Element introduces the key principles and definitions of healthcare supply chains. Practical insights into the design and operation of healthcare supply chains are provided. Core characteristics of effective supply chain management such as performance management, systems thinking, and supply chain integration are examined along with the application of specific supply chain design and improvement approaches. Finally, the Element proposes areas that require further development both in research and practice. This title is also available as open access on Cambridge Core.

Design creativity describes the process by which needs are explored and translated into requirements for change. This Element examines the role of design creativity within the context of healthcare improvement. It begins by outlining the characteristics of design thinking, and the key status of the Double Diamond Model. It provides practical tools to support design creativity, including ethnographic/observational studies, personas and scenarios, and needs identification and requirements analysis. It also covers brainstorming, Disney, and six thinking hats techniques, the nine windows technique, morphological charts and product architecting, and concept evaluation. The tools, covering all stages of the Double Diamond model, are supported by examples of their use in healthcare improvement. The Element concludes with a critique of design creativity and the evidence for its application in healthcare improvement. This title is also available as Open Access on Cambridge Core.

Operations management has an important role in improving healthcare. Some of its core concepts and tools, such as Lean and statistical process control, have their own Elements in this series. In this Element, the authors offer an overview of three major topics in healthcare operations management: capacity and demand, focus, and people and process. They demonstrate how queuing theory reveals counterintuitive insights about capacity utilisation and waiting times, examine how strategic focus can achieve significant productivity gains while creating potential inequities, and explore why process improvements must account for human behaviours like multitasking and workarounds. Using practical examples, the authors illustrate both the critical role and the limitations of operations management against a backdrop of high demand and resource constraints. This title is also available as open access on Cambridge Core.

Despite enormous efforts at healthcare improvement, major challenges remain in achieving optimal outcomes, safety, cost, and value. This Element introduces the concept of learning health systems, which have been proposed as a possible solution. Though many different variants of the concept exist, they share a learning cycle of capturing data from practice, turning it into knowledge, and putting knowledge back into practice. How learning systems are implemented is highly variable. This Element emphasises that they are sociotechnical systems and offers a structured framework to consider their design and operation. It offers a critique of the learning health system approach, recognising that more has been said about the aspiration than perhaps has been delivered. This title is also available as open access on Cambridge Core.

This Element examines economic perspectives on improving quality and safety in healthcare. Though competition is generally recognised by economists as an important driver of improvement, it may not work so straightforwardly in healthcare - in part because some services are provided by very few organisations, but also because people are not always easily able to judge healthcare quality and rarely have to pay the full price for services. Different approaches for stimulating improvement are therefore needed, and the authors look at examples from the care home, primary care, and hospital sectors. They emphasise the need for economic evaluation of improvement efforts, based on the principle that improvement activities should only be undertaken if the benefits are worth at least the costs of implementing and running them. Using examples, they explain the economic approach to evaluating how benefits and costs of improvement efforts can be compared by applying cost-effectiveness analysis. This title is also available as Open Access on Cambridge Core.

Few interventions that succeed in improving healthcare locally end up becoming spread and sustained more widely. This indicates that we need to think differently about spreading improvements in practice. Drawing on a focused review of academic and grey literature, the authors outline how spread, scale-up, and sustainability have been defined and operationalised, highlighting areas of ambiguity and contention. Following an overview of relevant frameworks and models, they focus on three specific approaches and unpack their theoretical assumptions and practical implications: the Dynamic Sustainability Framework, the 3S (structure, strategy, supports) infrastructure approach for scale-up, and the NASSS (non-adoption, abandonment, and challenges to scale-up, spread, and sustainability) framework. Key points are illustrated through empirical case narratives and the Element concludes with actionable learning for those engaged in improvement activities and for researchers. This title is also available as Open Access on Cambridge Core.

The main principles underpinning measurement for healthcare improvement are outlined in this Element. Although there is no single formula for achieving optimal measurement to support improvement, a fundamental principle is the importance of using multiple measures and approaches to gathering data. Using a single measure falls short in capturing the multifaceted aspects of care across diverse patient populations, as well as all the intended and unintended consequences of improvement interventions within various quality domains. Even within a single domain, improvement efforts can succeed in several ways and go wrong in others. Therefore, a family of measures is usually necessary. Clearly communicating a plausible theory outlining how an intervention will lead to desired outcomes informs decisions about the scope and types of measurement used. Improvement teams must tread carefully to avoid imposing undue burdens on patients, clinicians, or organisations. This title is also available as Open Access on Cambridge Core.

Lean is one of the most widely used improvement approaches in healthcare. With origins in manufacturing, it focuses on improving efficiency, eliminating waste, and streamlining processes. This Element provides an overview of the evidence for the use of Lean in healthcare, summarises the supporting tools and techniques, and emphasises the importance of developing an organisational culture committed to continuous improvement. The authors offer two case studies of attempts to implement Lean at scale, noting that, despite its popularity, implementation is not straightforward. Challenges include terminology that isn't always easy to grasp, perceived dissonances between the manufacturing origins of Lean based on repetitive, standardised, automated production and the human-centred world of healthcare, and problems with fidelity. The authors make the case that there is a lack of a robust evidence base for Lean and call for well-designed studies to advance the implementation of Lean and associated process improvement techniques in healthcare. This title is also available as open access on Cambridge Core.

Delivering safe, high-quality care needs a competent and capable workforce, particularly as clinical practices change with scientific and technical advances. Structured learning opportunities are a central approach to building and maintaining competencies, but ineffective training wastes the scarce resources and staff time. This Element provides a review of education and training design, implementation, and evaluation methods used in healthcare improvement. Drawing from the general learning sciences and healthcare education and training literatures, the authors describe five pillars of effective training. For each pillar, they provide actionable guidance based on the best available evidence. Three examples of quality and safety programmes are given to illustrate the positive impact of well-designed training, and the challenges of good training design in healthcare improvement. This title is also available as open access on Cambridge Core.

Microsystems are the building blocks of the healthcare system. They are the small functional frontline units that provide most healthcare to most people, be it a clinic or a ward. The microsystem improvement approach engages teams at the frontline of care with patients and families in a structured process to improve the quality of care and outcomes. This Element offers an overview of the theory of the microsystems, mesosystems, and team coaching improvement approaches, using case studies to demonstrate how the approaches have been used in practice. A critique of the emerging evidence base and the strengths and limitations of the approach is given. This title is also available as open access on Cambridge Core.

Statistical process control methodology was developed by Walter Shewhart in the 1920s as part of his work on quality control in industry. Shewhart observed that quality is about hitting target specifications with minimum variation. While every process is subject to variation, that variation can arise from 'common cause' variation, inherent in the process, or 'special cause' variation which operates from outside of that process. This distinction is crucial because the remedial actions are fundamentally different. Reducing common cause variation requires action to change the process; special cause variation can only be addressed if the external cause is identified. Statistical process control methodology seeks to distinguish between the two causes of variation to guide improvement efforts. Using case studies, this Element shows that statistical process control methodology is widely used in healthcare because it offers an intuitive, practical, and robust approach to supporting efforts to monitor and improve healthcare. This title is also available as Open Access on Cambridge Core.

Historically simulation was used as an education and training technique in healthcare, but now has an emerging role in improving quality and safety. Simulation-based techniques can be applied to help understand healthcare settings and the practices and behaviours of those who work in them. Simulation-based interventions can help to improve care and outcomes - for example, by improving readiness of teams to respond effectively to situations or to improve skill and speed. Simulation can also help test planned interventions and infrastructural changes, allowing possible vulnerabilities and risks to be identified and addressed. Challenges include cost, resources, training, and evaluation, and the lack of connection between the simulation and improvement fields, both in practice and in scholarship. The business case for simulation as an improvement technique remains to be established. This Element concludes by offering a way forward for simulation in practice and for future scholarly directions to improve the approach. This title is also available as Open Access on Cambridge Core.

This Element reviews the evidence for three workplace conditions that matter for improving quality and safety in healthcare: staffing; psychological safety, teamwork, and speaking up; and staff health and well-being at work. The authors propose that these are environmental prerequisites for improvement. They examine the relationship between staff numbers and skills in delivering care and the attainment of quality of care and the ability to improve it. They present evidence for the importance of psychological safety, teamwork, and speaking up, noting that these are interrelated and critical for healthcare improvement. They present evidence of associations between staff well-being at work and patient outcomes. Finally, they suggest healthcare improvement should be embedded into the day-to-day work of frontline staff; adequate time and resources must be provided, with quality as the mainstay of professionals' work. Every day at every level, the working context must support the question 'how could we do this better?' This title is also available as Open Access on Cambridge Core.

This Element examines economic perspectives on improving quality and safety in healthcare. Though competition is generally recognised by economists as an important driver of improvement, it may not work so straightforwardly in healthcare - in part because some services are provided by very few organisations, but also because people are not always easily able to judge healthcare quality and rarely have to pay the full price for services. Different approaches for stimulating improvement are therefore needed, and the authors look at examples from the care home, primary care, and hospital sectors. They emphasise the need for economic evaluation of improvement efforts, based on the principle that improvement activities should only be undertaken if the benefits are worth at least the costs of implementing and running them. Using examples, they explain the economic approach to evaluating how benefits and costs of improvement efforts can be compared by applying cost-effectiveness analysis. This title is also available as Open Access on Cambridge Core.

Lessons from service and system failures describe the pivotal roles played by governance and leadership in delivering high-quality, safe care. This Element sets out what the terms governance and leadership mean and how thinking about them has developed over time. Using real-world examples, the authors analyse research evidence on the influence of governance and leadership on quality and safety in healthcare at different levels in the health system: macro level (what national health systems do), meso level (what organisations do), and micro level (what teams and individuals do). The authors describe behaviours that may help boards focus on improving quality and show how different leadership approaches may contribute to delivering major system change. The Element presents some critiques of governance and leadership, including some challenges that can arise and gaps in the evidence, and then draws out lessons for those seeking to strengthen governance and leadership for improvement. This title is also available as Open Access on Cambridge Core.

Few interventions that succeed in improving healthcare locally end up becoming spread and sustained more widely. This indicates that we need to think differently about spreading improvements in practice. Drawing on a focused review of academic and grey literature, the authors outline how spread, scale-up, and sustainability have been defined and operationalised, highlighting areas of ambiguity and contention. Following an overview of relevant frameworks and models, they focus on three specific approaches and unpack their theoretical assumptions and practical implications: the Dynamic Sustainability Framework, the 3S (structure, strategy, supports) infrastructure approach for scale-up, and the NASSS (non-adoption, abandonment, and challenges to scale-up, spread, and sustainability) framework. Key points are illustrated through empirical case narratives and the Element concludes with actionable learning for those engaged in improvement activities and for researchers. This title is also available as Open Access on Cambridge Core.

Statistical process control methodology was developed by Walter Shewhart in the 1920s as part of his work on quality control in industry. Shewhart observed that quality is about hitting target specifications with minimum variation. While every process is subject to variation, that variation can arise from 'common cause' variation, inherent in the process, or 'special cause' variation which operates from outside of that process. This distinction is crucial because the remedial actions are fundamentally different. Reducing common cause variation requires action to change the process; special cause variation can only be addressed if the external cause is identified. Statistical process control methodology seeks to distinguish between the two causes of variation to guide improvement efforts. Using case studies, this Element shows that statistical process control methodology is widely used in healthcare because it offers an intuitive, practical, and robust approach to supporting efforts to monitor and improve healthcare. This title is also available as Open Access on Cambridge Core.

Using audit to identify where improvement is needed and providing feedback to healthcare professionals to encourage behaviour change is an important healthcare improvement strategy. In this Element, the authors review the evidence base for using audit and feedback to support improvement, summarising its historical origins, the theories that guide it, and the evidence that supports it. Finally, the authors review limitations and risks with the approach, and outline opportunities for future research. This title is also available as open access on Cambridge Core.

Human Factors and Ergonomics (HFE) is a discipline concerned with designing interactions in sociotechnical systems to improve both system performance and human well-being. This Element introduces the core principles of HFE, tracing its development from multidisciplinary efforts to solve practical problems in military operations during the Second World War to its current application in healthcare improvement. The Element acknowledges the growing role of HFE in areas such as the design of the physical environment, medical device design, learning from patient safety incidents, and safety investigations. A critical reflection highlights persistent challenges, including conceptual ambiguity, structural and practical barriers to HFE integration, and the need both for a stronger evidence base and a compelling business case. The Element concludes by identifying future priorities for advancing HFE in healthcare, including continuing professional development and career pathways, embedding HFE in regulation and policy, and adopting evaluation approaches suited to complex systems. This title is also available as open access on Cambridge Core.