What can Safety Cases offer for patient safety? A multisite case study.

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

Quality and reporting of large-scale improvement programmes: a review of maternity initiatives in the English NHS, 2010-2023.

BACKGROUND: Large-scale improvement programmes are a frequent response to quality and safety problems in health systems globally, but have mixed impact. The extent to which they meet criteria for programme quality, particularly in relation to transparency of reporting and evaluation, is unclear. AIM: To identify large-scale improvement programmes focused on intrapartum care implemented in English National Health Service maternity services in the period 2010-2023, and to conduct a structured quality assessment. METHODS: We drew on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidance to inform the design and reporting of our study. We identified relevant programmes using multiple search strategies of grey literature, research databases and other sources. Programmes that met a prespecified definition of improvement programme, that focused on intrapartum care and that had a retrievable evaluation report were subject to structured assessment using selected features of programme quality. RESULTS: We identified 1434 records via databases and other sources. 14 major initiatives in English maternity services could not be quality assessed due to lack of a retrievable evaluation report. Quality assessment of the 15 improvement programmes meeting our criteria for assessment found highly variable quality and reporting. Programme specification was variable and mostly low quality. Only eight reported the evidence base for their interventions. Description of implementation support was poor and none reported customisation for challenged services. None reported reduction of inequalities as an explicit goal. Only seven made use of explicit patient and public involvement practices, and only six explicitly used published theories/models/frameworks to guide implementation. Programmes varied in their reporting of the planning, scope and design of evaluation, with weak designs evident. CONCLUSIONS: Poor transparency of reporting and weak or absent evaluation undermine large-scale improvement programmes by limiting learning and accountability. This review indicates important targets for improving quality in large-scale programmes.

What are the features of high-performing quality improvement collaboratives? A qualitative case study of a state-wide collaboratives programme.

OBJECTIVES: Despite their widespread use, the evidence base for the effectiveness of quality improvement collaboratives remains mixed. Lack of clarity about 'what good looks like' in collaboratives remains a persistent problem. We aimed to identify the distinctive features of a state-wide collaboratives programme that has demonstrated sustained improvements in quality of care in a range of clinical specialties over a long period. DESIGN: Qualitative case study involving interviews with purposively sampled participants, observations and analysis of documents. SETTING: The Michigan Collaborative Quality Initiatives programme. PARTICIPANTS: 38 participants, including clinicians and managers from 10 collaboratives, and staff from the University of Michigan and Blue Cross Blue Shield of Michigan. RESULTS: We identified five features that characterised success in the collaboratives programme: learning from positive deviance; high-quality coordination; high-quality measurement and comparative performance feedback; careful use of motivational levers; and mobilising professional leadership and building community. Rigorous measurement, securing professional leadership and engagement, cultivating a collaborative culture, creating accountability for quality, and relieving participating sites of unnecessary burdens associated with programme participation were all important to high performance. CONCLUSIONS: Our findings offer valuable learning for optimising collaboration-based approaches to improvement in healthcare, with implications for the design, structure and resourcing of quality improvement collaboratives. These findings are likely to be useful to clinicians, managers, policy-makers and health system leaders engaged in multiorganisational approaches to improving quality and safety.

Beyond Received Wisdom and Authorised Accounts: What Knowledge Is Needed to Avoid Repeating History? Comment on "'Attending to History' in Major System Change in Healthcare in England: Specialist Cancer Surgery Service Reconfiguration".

Perry and colleagues' study of a programme to reconfigure cancer surgery provision in Greater Manchester highlights the importance of accounting for history in making successful change. In this short commentary, I expand on some of Perry and colleagues' key findings. I note the way in which those leading change in Greater Manchester combined formal expertise in change management with sensitivity to local context, enhancing their approach to change through attention to details around relationships, events and assumptions that might otherwise have derailed the process. I identify lessons for others in how best to account for history in leading change, highlighting in particular the need to attempt to access and understand forms of history that may be suppressed, difficult-to-articulate, or otherwise marginalised.

Implementing a perioperative care of older people undergoing surgery (POPS) service: findings from a multi-site qualitative implementation study.

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.

Sustaining interventions in care homes initiated by quality improvement projects: a qualitative study.

INTRODUCTION: Inadequate and varied quality of care in care homes has led to a proliferation of quality improvement (QI) projects. This study examined the sustainability of interventions initiated by such projects. METHOD: This qualitative study explored the sustainability of seven interventions initiated by three QI projects between 2016 and 2018 in UK care homes and explored the perceived influences to the sustainability of interventions. QI projects were followed up in 2019. Staff leading QI projects (n=9) and care home (n=21, from 13 care homes) and healthcare (n=2) staff took part in semi-structured interviews. Interventions were classified as sustained if the intervention was continued at the point of the study. Thematic analysis of interview data was performed, drawing on the Consolidated Framework for Sustainability (CFS), a 40-construct model of sustainability of interventions. RESULTS: Three interventions were sustained and four interventions were not. Seven themes described perceptions around what influenced sustainability: monitoring outcomes and regular check-in; access to replacement intervention materials; staff willingness to dedicate time and effort towards interventions; continuity of staff and thorough handover/inductions in place for new staff; ongoing communication and awareness raising; perceived effectiveness; and addressing care home priorities. All study themes fell within 18 of the 40 CFS constructs. DISCUSSION: Our findings resonate with the CFS and are also consistent with implementation theories, suggesting sustainability is best addressed during implementation rather than treated as a separate process which follows implementation. Commissioning and funding QI projects should address these considerations early on, during implementation.

Why do systems for responding to concerns and complaints so often fail patients, families and healthcare staff? A qualitative study.

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

The role of the informal and formal organisation in voice about concerns in healthcare: A qualitative interview study.

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.

Uncovering, creating or constructing problems? Enacting a new role to support staff who raise concerns about quality and safety in the English National Health Service.

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.

Hospital-level evaluation of the effect of a national quality improvement programme: time-series analysis of registry data.

BACKGROUND AND OBJECTIVES: A clinical trial in 93 National Health Service hospitals evaluated a quality improvement programme for emergency abdominal surgery, designed to improve mortality by improving the patient care pathway. Large variation was observed in implementation approaches, and the main trial result showed no mortality reduction. Our objective therefore was to evaluate whether trial participation led to care pathway implementation and to study the relationship between care pathway implementation and use of six recommended implementation strategies. METHODS: We performed a hospital-level time-series analysis using data from the Enhanced Peri-Operative Care for High-risk patients trial. Care pathway implementation was defined as achievement of >80% median reliability in 10 measured care processes. Mean monthly process performance was plotted on run charts. Process improvement was defined as an observed run chart signal, using probability-based 'shift' and 'runs' rules. A new median performance level was calculated after an observed signal. RESULTS: Of 93 participating hospitals, 80 provided sufficient data for analysis, generating 800 process measure charts from 20 305 patient admissions over 27 months. No hospital reliably implemented all 10 processes. Overall, only 279 of the 800 processes were improved (3 (2-5) per hospital) and 14/80 hospitals improved more than six processes. Mortality risk documented (57/80 (71%)), lactate measurement (42/80 (53%)) and cardiac output guided fluid therapy (32/80 (40%)) were most frequently improved. Consultant-led decision making (14/80 (18%)), consultant review before surgery (17/80 (21%)) and time to surgery (14/80 (18%)) were least frequently improved. In hospitals using ≥5 implementation strategies, 9/30 (30%) hospitals improved ≥6 care processes compared with 0/11 hospitals using ≤2 implementation strategies. CONCLUSION: Only a small number of hospitals improved more than half of the measured care processes, more often when at least five of six implementation strategies were used. In a longer term project, this understanding may have allowed us to adapt the intervention to be effective in more hospitals.

Overruling uncertainty about preventative medications: the social organisation of healthcare professionals' knowledge and practices.

In this article, we draw on an institutional ethnographic (IE) study of cardiovascular disease prevention in general practice, exploring the work of healthcare professionals who introduce a discussion of risk and preventative medications into consultations with patients. Our aim is to explicate, using IE's theoretical ontology and analytical tools, how troubling patient experiences in this clinical context are coordinated institutionally. We focus our attention on the social organisation of healthcare professionals' knowledge and front-line practices, highlighting the textual processes through which they overrule patients' concerns and uncertainties about taking preventative medication, such that some patients feel unable to openly discuss their health needs in preventative consultations. We show how healthcare professionals activate knowledge of 'evidence-based risk reduction' to frame patients' queries as 'barriers' to be overcome. Our analysis points not to deficiencies of healthcare professionals who lack the expertise or inclination to adequately 'share decisions' with patients, but to the ways in which their work is institutionally orientated towards performance measures which will demonstrate to local and national policymakers that they are tackling the 'burden of (cardiovascular) disease'.

Harnessing the power of theorising in implementation science.

Theories occupy different positions in the scientific circle of enquiry as they vary in scope, abstraction, and complexity. Mid-range theories play a crucial bridging role between raw empirical observations and all-encompassing grand-theoretical schemes. A shift of perspective from 'theories' as products to 'theorising' as a process can enable empirical researchers to capitalise on the two-way relationships between empirical data and different levels of theory and contribute to the advancement of knowledge. This can be facilitated by embracing theoretically informative (in addition to merely theoretically informed) research, developing mechanism-based explanations, and broadening the repertoire of grand-theoretical orientations.

Why is reporting quality improvement so hard? A qualitative study in perioperative care.

OBJECTIVES: Quality improvement (QI) may help to avert or mitigate the risks of suboptimal care, but it is often poorly reported in the healthcare literature. We aimed to identify the influences on reporting QI in the area of perioperative care, with a view to informing improvements in reporting QI across healthcare. DESIGN: Qualitative interview study. SETTING: Healthcare and academic organisations in Australia, Europe and North America. PARTICIPANTS: Stakeholders involved in or influencing the publication, writing or consumption of reports of QI studies in perioperative care. RESULTS: Forty-two participants from six countries took part in the study. Participants included 15 authors (those who write QI reports), 12 consumers of QI reports (practitioners who apply QI research in practice), 11 journal editors and 4 authors of reporting guidelines. Participants identified three principal challenges in achieving high-quality QI reporting. First, the broad scope of QI reporting-ranging from small local projects to multisite research across different disciplines-causes uncertainty about where QI work should be published. Second, context is fundamental to the success of a QI intervention but is difficult to report in ways that support replication and development. Third, reporting is adversely affected by both proximal influences (such as lack of time to write up QI) and more distal, structural influences (such as norms about the format and content of biomedical research reporting), leading to incomplete reporting of QI findings. CONCLUSIONS: Divergent terminology and understandings of QI, along with existing reporting norms and the challenges of capturing context adequately yet succinctly, make for challenges in reporting QI. We offer suggestions for improvement.

How the Availability of Observation Status Affects Emergency Physician Decisionmaking.

STUDY OBJECTIVE: This study seeks to understand how emergency physicians decide to use observation services, and how placing a patient under observation influences physicians' subsequent decisionmaking. METHODS: We conducted detailed semistructured interviews with 24 emergency physicians, including 10 from a hospital in the US Midwest, and 14 from 2 hospitals in central and northern England. Data were extracted from the interview transcripts with open coding and analyzed with axial coding. RESULTS: We found that physicians used a mix of intuitive and analytic thinking in initial decisions to admit, observe, or discharge patients, depending on the physician's individual level of risk aversion. Placing patients under observation made some physicians more systematic, whereas others cautioned against overreliance on observation services in the face of uncertainty. CONCLUSION: Emergency physicians routinely make decisions in a highly resource-constrained environment. Observation services can relax these constraints by providing physicians with additional time, but absent clear protocols and metacognitive reflection on physician practice patterns, this may hinder, rather than facilitate, decisionmaking.

Making soft intelligence hard: a multi-site qualitative study of challenges relating to voice about safety concerns.

BACKGROUND: Healthcare organisations often fail to harvest and make use of the 'soft intelligence' about safety and quality concerns held by their own personnel. We aimed to examine the role of formal channels in encouraging or inhibiting employee voice about concerns. METHODS: Qualitative study involving personnel from three academic hospitals in two countries. Interviews were conducted with 165 participants from a wide range of occupational and professional backgrounds, including senior leaders and those from the sharp end of care. Data analysis was based on the constant comparative method. RESULTS: Leaders reported that they valued employee voice; they identified formal organisational channels as a key route for the expression of concerns by employees. Formal channels and processes were designed to ensure fairness, account for all available evidence and achieve appropriate resolution. When processed through these formal systems, concerns were destined to become evidenced, formal and tractable to organisational intervention. But the way these systems operated meant that some concerns were never voiced. Participants were anxious about having to process their suspicions and concerns into hard evidentiary facts, and they feared being drawn into official procedures designed to allocate consequence. Anxiety about evidence and process was particularly relevant when the intelligence was especially 'soft'-feelings or intuitions that were difficult to resolve into a coherent, compelling reconstruction of an incident or concern. Efforts to make soft intelligence hard thus risked creating 'forbidden knowledge': dangerous to know or share. CONCLUSIONS: The legal and bureaucratic considerations that govern formal channels for the voicing of concerns may, perversely, inhibit staff from speaking up. Leaders responsible for quality and safety should consider complementing formal mechanisms with alternative, informal opportunities for listening to concerns.