The elephant in the room: Exploring the influence and participation of patients in infection-related care across surgical pathways in South Africa and India.

OBJECTIVE: The irrational use of antibiotics is a leading contributor to antibiotic resistance. Antibiotic stewardship (AS) interventions predominantly focus on prescribers. This study investigated the influence and participation of inpatients in infection-related care, including antibiotic decision-making, within and across two tertiary hospitals in South Africa (Cape Town) and India (Kerala). METHODS: Through ethnographic enquiry of clinical practice in surgical pathways, including direct nonparticipant observation of clinical practices, healthcare worker (HCW), patient and carer interactions in surgical ward rounds and face-to-face interviews with participants (HCWs and patients), we sought to capture the implicit and explicit influence that patients and carers have in infection-related care. Field notes and interview transcripts were thematically coded, aided by NVivo 12® Pro software. RESULTS: Whilst observational data revealed the nuanced roles that patients/carers play in antibiotic decision-making, HCWs did not recognize these roles. Patients and carers, though invested in patient care, are not routinely involved, nor are they aware of the opportunities for engagement in infection-related decision-making. Patients associated clinical improvement with antibiotic use and did not consider hospitalization to be associated with infection acquisition or transmission, highlighting a lack of understanding of the threat of infection and antibiotic resistance. Patients' economic and cultural positionalities may influence their infection-related behaviours. In the study site in India, cultural norms mean that carers play widespread but unrecognized roles in inpatient care, participating in infection prevention activities. CONCLUSION: For patients to have a valuable role in AS and make informed decisions regarding their infection-related care, a mutual understanding of their role in this process among HCWs and patients is crucial. The observed differences between the two study sites indicate the critical need for understanding and addressing the contextual drivers that impact effective patient-centred healthcare delivery. PATIENT OR PUBLIC CONTRIBUTION: Ethnographic observations and interviews conducted in this study involved patients as participants. Patients were recruited for interviews after obtaining signed informed consent forms. Patients' identities were completely anonymized when presenting the study findings.

Organizational resilience in healthcare: a review and descriptive narrative synthesis of approaches to resilience measurement and assessment in empirical studies.

BACKGROUND: The coronavirus pandemic has had a profound impact on organization and delivery of care. The challenges faced by healthcare organizations in dealing with the pandemic have intensified interest in the concept of resilience. While effort has gone into conceptualising resilience, there has been relatively little work on how to evaluate organizational resilience. This paper reports on an extensive review of approaches to resilience measurement and assessment in empirical healthcare studies, and examines their usefulness for researchers, policymakers and healthcare managers. METHODS: Various databases (MEDLINE, EMBASE, PsycINFO, CINAHL (EBSCO host), Cochrane CENTRAL (Wiley), CDSR, Science Citation Index, and Social Science Citation Index) were searched from January 2000 to September 2021. We included quantitative, qualitative and modelling studies that focused on measuring or qualitatively assessing organizational resilience in a healthcare context. All studies were screened based on titles, abstracts and full text. For each approach, information on the format of measurement or assessment, method of data collection and analysis, and other relevant information were extracted. We classified the approaches to organizational resilience into five thematic areas of contrast: (1) type of shock; (2) stage of resilience; (3) included characteristics or indicators; (4) nature of output; and (5) purpose. The approaches were summarised narratively within these thematic areas. RESULTS: Thirty-five studies met the inclusion criteria. We identified a lack of consensus on how to evaluate organizational resilience in healthcare, what should be measured or assessed and when, and using what resilience characteristic and indicators. The measurement and assessment approaches varied in scope, format, content and purpose. Approaches varied in terms of whether they were prospective (resilience pre-shock) or retrospective (during or post-shock), and the extent to which they addressed a pre-defined and shock-specific set of characteristics and indicators. CONCLUSION: A range of approaches with differing characteristics and indicators has been developed to evaluate organizational resilience in healthcare, and may be of value to researchers, policymakers and healthcare managers. The choice of an approach to use in practice should be determined by the type of shock, the purpose of the evaluation, the intended use of results, and the availability of data and resources.

A qualitative study of organisational response to national quality standards for 7-day services in English hospitals.

BACKGROUND: National standards are commonly used as an improvement strategy in healthcare, but organisations may respond in diverse and sometimes negative ways to external quality demands. This paper describes how a sample of NHS hospital trusts in England responded to the introduction of national standards for 7-day services (7DS), from an organisational behaviour perspective. METHODS: We conducted 43 semi-structured interviews with executive/director level and clinical staff, in eight NHS trusts that varied in size, location, and levels of specialist staffing at weekends. We explored approaches to implementing standards locally, and the impact of organisational culture and local context on organisational response. RESULTS: Senior staff in the majority of trusts described a focus on hitting targets and achieving compliance with the standards. Compliance-based responses were associated with a hierarchical organisational culture and focus on external performance. In a minority of trusts senior staff described mobilising commitment-based strategies. In these trusts senior staff reframed the external standards in terms of organisational values, and used co-operative strategies for achieving change. Trusts that took a commitment-based approach tended to be described as having a developmental organisational culture and a history of higher performance across the board. Audit data on 7DS showed improvement against standards for most trusts, but commitment-focused trusts were less likely to demonstrate improvements on the 7DS audit. The ability of trusts to respond to external standards was limited when they were under pressure due to a history of overall poor performance or resource limitations. CONCLUSIONS: National standards and audit for service-level improvement generate different types of response in different local settings. Approaches to driving improvement nationally need to be accompanied by resources and tailored support for improvement, taking into account local context and organisational culture.

Reflection in practice: How can patient experience feedback trigger staff reflection in hospital acute care settings?

BACKGROUND: Patient and staff experiences provide important insights into care quality, but health systems have difficulty using these data to improve care. Little attention has been paid to understanding how patient experience feedback can act as a prompt to reflection in practice in the clinical setting. OBJECTIVE: We aimed to identify the ways in which different types of patient experience feedback act as a trigger or prompt for engagement in reflection in clinical practice in acute hospital settings and identify important considerations for enhancing the value of patient experience data for reflective learning. METHODS: We conducted an ethnographic study in eight acute care units in three NHS hospital trusts in England, including 140 hours of observations and 45 semi-structured interviews with nursing, medical and managerial staff working in acute medical units and intensive care units. The data were analysed thematically. FINDINGS: We distinguished between formal patient experience data sources: data purposively collected and collated to capture the patient experience of care, generally at organizational level, including surveys, complaints and comments; and informal sources of feedback on the patient experience recognized by staff alongside the formal data. We also identified patient narratives as an 'in between' source of data. The impact of different types of patient feedback in triggering reflection primarily depended on the extent to which the feedback was experienced as personally relevant, meaningful and emotionally salient. DISCUSSION: Patient experience feedback is multi-faceted, but our study suggests that all types of feedback could be harnessed more effectively to prompt reflection.

Making infection prevention and control everyone's business? Hospital staff views on patient involvement.

CONTEXT: Ensuring an infection-free environment is increasingly seen as requiring the contribution of staff, patients and visitors. There is limited evidence, however, about how staff feel about collaborating with patients and relatives to co-produce that environment. AIMS: This study aims to understand how hospital staff perceive the involvement of patients and relatives in infection prevention and control (IPC) and the main challenges for staff in working together with patients and relatives to reduce the threat of infection. METHODS: Qualitative semi-structured interviews were conducted with 35 frontline health-care professionals and four executive staff, from two hospital trusts. FINDINGS: We found that staff were more supportive of approaches that encourage co-operation from patients and relatives, than of interventions that invoked confrontation. We identified challenges to involvement arising from staff concerns about shifting responsibility for IPC onto patients. Staff were not always able to work with patients to control infection risks as some patients themselves created and perpetuated those risks. CONCLUSIONS: Our work highlights that IPC has particular features that impact on the possibilities for involving patients and relatives at the point of care. Staff acknowledge tensions between the drive to involve patients and respect their autonomy, and their duty to protect patients from risk of unseen harm. The role that patients and relatives can play in IPC is fluctuating and context dependent. Staff responsibility for protecting patients from the risk of infection may sometimes need to take priority over prerogatives to involve patients and relatives in the co-production of IPC.

The international dimensions of antimicrobial resistance: Contextual factors shape distinct ethical challenges in South Africa, Sri Lanka and the United Kingdom.

Antimicrobial resistance (AMR) describes the evolution of treatment-resistant pathogens, with potentially catastrophic consequences for human medicine. AMR is driven by the over-prescription of antibiotics, and could be reduced through consideration of the ethical dimensions of the dilemma faced by doctors. This dilemma involves balancing apparently opposed interests of current and future patients, and unique contextual factors in different countries, which may modify the core dilemma. We describe three example countries with different economic backgrounds and cultures-South Africa, Sri Lanka and the United Kingdom. Then we discuss how country-specific factors impact on the prominence of various ethical dimensions of the dilemma (visibility and moral equality of future generations; Rule of Rescue; prescribing autonomy and conflicts of interest; consensus on collective action). We conclude that a nuanced understanding of national prescribing dilemmas is critical to inform the design of effective stewardship approaches.

Driving sustainable change in antimicrobial prescribing practice: how can social and behavioural sciences help?

Addressing the growing threat of antimicrobial resistance is, in part, reliant on the complex challenge of changing human behaviour-in terms of reducing inappropriate antibiotic use and preventing infection. Whilst there is no 'one size fits all' recommended behavioural solution for improving antimicrobial stewardship, the behavioural and social sciences offer a range of theories, frameworks, methods and evidence-based principles that can help inform the design of behaviour change interventions that are context-specific and thus more likely to be effective. However, the state-of-the-art in antimicrobial stewardship research and practice suggests that behavioural and social influences are often not given due consideration in the design and evaluation of interventions to improve antimicrobial prescribing. In this paper, we discuss four potential areas where the behavioural and social sciences can help drive more effective and sustained behaviour change in antimicrobial stewardship: (i) defining the problem in behavioural terms and understanding current behaviour in context; (ii) adopting a theory-driven, systematic approach to intervention design; (iii) investigating implementation and sustainability of interventions in practice; and (iv) maximizing learning through evidence synthesis and detailed intervention reporting.

Managing uncertainty: a qualitative study of GPs' views on the diagnosis and immediate management of transient ischaemic attack and the potential of a diagnostic tool.

Background: Most patients with transient ischaemic attack (TIA) present to their GP. Early identification and treatment reduces the risk of subsequent stroke and consequent disability and mortality. Objective: To explore GPs' views on the diagnosis and immediate management of suspected TIA, and the potential utility of a diagnostic tool. Methods: This is a qualitative interview study based in Leicestershire, UK. A purposive sample of 10 GPs participated in 30-minute semi-structured telephone interviews. Data were analysed thematically. Results: GPs reported that TIA was more likely to be suspected when patients were more obvious candidates for TIA based on their history, characteristics and symptom presentation. Referrals were in part a strategy to manage risk under conditions of uncertainty and to seek reassurance. GPs valued using a TIA risk stratification tool but felt this did not inform their diagnostic decision making. A diagnostic tool for TIA in primary care was seen to have potential to improve the decision-making process about diagnosis and management and enhance confidence of GPs, particularly in ruling out TIAs. GPs saw benefits of using hard thresholds, but remained concerned about missing TIAs and saw a tool as an adjunct to clinical judgement. Conclusions: GPs weigh up the likelihood of TIA in the context of assessments of candidacy and diverse, often vague, symptoms. A diagnostic tool could support GPs in this process and help reduce reliance on referrals to TIA clinics for reassurance, provided the tool was designed to support decision making in cases of less 'typical' presentations.

Quality and safety of in-hospital care for acute medical patients at weekends: a qualitative study.

BACKGROUND: The increased mortality risk associated with weekend admission to hospital (the 'weekend effect') has been reported across many health systems. More recently research has focused on causal mechanisms. Variations in the organisation and delivery of in-hospital care between weekends and weekdays have been identified, but this is not always to the detriment of weekend admissions, and the impact on mortality is uncertain. The insights of frontline staff and patients have been neglected. This article reports a qualitative study of patients and clinicians, to explore their views on quality and safety of care at weekends. METHODS: We conducted focus groups and interviews with clinicians and patients with experience of acute medical care, recruited from three UK hospital Trusts. We analysed the data using a thematic analysis approach, aided by the use of NVivo, to explore quality and safety of care at weekends. RESULTS: We held four focus groups and completed six in-depth interviews, with 19 clinicians and 12 patients. Four threats to quality and safety were identified as being more prominent at weekends, relating to i) the rescue and stabilisation of sick patients; ii) monitoring and responding to deterioration; iii) timely accurate management of the therapeutic pathway; iv) errors of omission and commission. CONCLUSIONS: At weekends patients and staff are well aware of suboptimal staffing numbers, skill mix and access to resources at weekends, and identify that emergency admissions are prioritised over those already hospitalised. The consequences in terms of quality and safety and patient experience of care are undesirable. Our findings suggest the value of focusing on care processes and systems resilience over the weekends, and how these can be better supported, even in the limited resource environment that exists in many hospitals at weekends.

Weekend specialist intensity and admission mortality in acute hospital trusts in England: a cross-sectional study.

BACKGROUND: Increased mortality rates associated with weekend hospital admission (the so-called weekend effect) have been attributed to suboptimum staffing levels of specialist consultants. However, evidence for a causal association is elusive, and the magnitude of the weekend specialist deficit remains unquantified. This uncertainty could hamper efforts by national health systems to introduce 7 day health services. We aimed to examine preliminary associations between specialist intensity and weekend admission mortality across the English National Health Service. METHODS: Eligible hospital trusts were those in England receiving unselected emergency admissions. On Sunday June 15 and Wednesday June 18, 2014, we undertook a point prevalence survey of hospital specialists (consultants) to obtain data relating to the care of patients admitted as emergencies. We defined specialist intensity at each trust as the self-reported estimated number of specialist hours per ten emergency admissions between 0800 h and 2000 h on Sunday and Wednesday. With use of data for all adult emergency admissions for financial year 2013-14, we compared weekend to weekday admission risk of mortality with the Sunday to Wednesday specialist intensity ratio within each trust. We stratified trusts by size quintile. FINDINGS: 127 of 141 eligible acute hospital trusts agreed to participate; 115 (91%) trusts contributed data to the point prevalence survey. Of 34,350 clinicians surveyed, 15,537 (45%) responded. Substantially fewer specialists were present providing care to emergency admissions on Sunday (1667 [11%]) than on Wednesday (6105 [42%]). Specialists present on Sunday spent 40% more time caring for emergency patients than did those present on Wednesday (mean 5·74 h [SD 3·39] vs 3·97 h [3·31]); however, the median specialist intensity on Sunday was only 48% (IQR 40-58) of that on Wednesday. The Sunday to Wednesday intensity ratio was less than 0·7 in 104 (90%) of the contributing trusts. Mortality risk among patients admitted at weekends was higher than among those admitted on weekdays (adjusted odds ratio 1·10, 95% CI 1·08-1·11; p<0·0001). There was no significant association between Sunday to Wednesday specialist intensity ratios and weekend to weekday mortality ratios (r -0·042; p=0·654). INTERPRETATION: This cross-sectional analysis did not detect a correlation between weekend staffing of hospital specialists and mortality risk for emergency admissions. Further investigation is needed to evaluate whole-system secular change during the implementation of 7 day services. Policy makers should exercise caution before attributing the weekend effect mainly to differences in specialist staffing. FUNDING: National Institute for Health Research Health Services and Delivery Research Programme.

A qualitative study of participants' views on re-consent in a longitudinal biobank.

BACKGROUND: Biomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or "biobanks" over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank. METHODS: We conducted a qualitative study involving interviews with 24 people who were participating in a longitudinal biobank. Their views were elicited using a semi-structured interview schedule and scenarios based on a hypothetical biobank. Data analysis was based on the constant comparative method. RESULTS: What participants identified as requiring new consent was not a straightforward matter predictable by algorithms about the scope of the consent, but instead was contingent. They assessed whether proposed new research implied a fundamental alteration in the underlying character of the biobank and whether specific projects were within the scope of the original consent. What mattered most to them was that the cooperative bargain into which they had entered was maintained in good faith. They saw re-consent as one important safeguard in this bargain. In determining what required re-consent, they deployed two logics. First, they used a logic of boundaries, where they sought to detect any possible rupture with their existing framework of cooperation. Second, they used a logic of risk, where they assessed proposed research for any potential threats for them personally or the research endeavour. When they judged that a need for re-consent had been activated, participants saw the process as way of re-actualising and renewing the cooperative bargain. CONCLUSIONS: Participants' perceptions of research as a process of mutual co-operation between volunteer and researcher were fundamental to their views on consent. Consenting arrangements for biobanks should respect the cooperative values that are important to participants, recognise the two logics used by research volunteers, and avoid rigidity. Agility may be favoured by tiered consent combined with strong oversight mechanisms; this approach requires evaluation.

'Falling through gaps': primary care patients' accounts of breakdowns in experienced continuity of care.

BACKGROUND: Experienced continuity is important for good quality primary care but may be challenging to achieve. Little is known about how discontinuities or gaps in care may arise, how they impact on patients' experiences and how best to understand them so that they can be avoided or managed. OBJECTIVES: Using the theoretical framework of candidacy, we aim to explore patients' experiences of discontinuities in care and to gain insight into how gaps come to be bridged and why they might remain unresolved. METHODS: A secondary analysis was undertaken of interview data from a large study into continuity in primary care, involving a diverse sample of 50 patients, recruited from 15 general practices, one walk-in centre and community settings in Leicestershire, UK. Analysis was conducted using a constant comparative approach. RESULTS: Experiences of gaps in care were common, arising from failures in communication and coordination of care. Although some gaps were easily bridged, many patients described 'falling through gaps' because of difficulties establishing their candidacy for ongoing care when gaps occurred. These patients commonly had complex, chronic conditions and multi-morbidity. Bridging gaps required resources; relationship continuity was a valuable resource for preventing and repairing gaps in care. When gaps were not bridged, distress and dysfunctional use of health services followed. CONCLUSION: This study demonstrates that some patients with complex chronic conditions and multi-morbidity may be unable to get the continuity they need and highlights the potential for relationship continuity to help prevent vulnerable patients falling through gaps in care.

The struggling student: a thematic analysis from the self-regulated learning perspective.

CONTEXT: Students who engage in self-regulated learning (SRL) are more likely to achieve academic success compared with students who have deficits in SRL and tend to struggle with academic performance. Understanding how poor SRL affects the response to failure at assessment will inform the development of better remediation. METHODS: Semi-structured interviews were conducted with 55 students who had failed the final re-sit assessment at two medical schools in the UK to explore their use of SRL processes. A thematic analysis approach was used to identify the factors, from an SRL perspective, that prevented students from appropriately and adaptively overcoming failure, and confined them to a cycle of recurrent failure. RESULTS: Struggling students did not utilise key SRL processes, which caused them to make inappropriate choices of learning strategies for written and clinical formats of assessment, and to use maladaptive strategies for coping with failure. Their normalisation of the experience and external attribution of failure represented barriers to their taking up of formal support and seeking informal help from peers. CONCLUSIONS: This study identified that struggling students had problems with SRL, which caused them to enter a cycle of failure as a result of their limited attempts to access formal and informal support. Implications for how medical schools can create a culture that supports the seeking of help and the development of SRL, and improves remediation for struggling students, are discussed.

Consent revisited: the impact of return of results on participants' views and expectations about trial participation.

BACKGROUND: Increasingly, the sharing of study results with participants is advocated as an element of good research practice. Yet little is known about how receiving the results of trials may impact on participants' perceptions of their original decision to consent. OBJECTIVE: We explored participants' views of their decision to consent to a clinical trial after they received results showing adverse outcomes in some arms of the trial. METHOD: Semi-structured interviews were conducted with a purposive sample of 38 women in the UK who participated in a trial of antibiotics in pregnancy. All had received results from a follow-up study that reported increased risk of adverse outcomes for children of participants in some of the trial intervention arms. Data analysis was based on the constant comparative method. RESULTS: Participants' original decisions to consent to the trial had been based on hope of personal benefit and assumptions of safety. On receiving the results, most made sense of their experience in ways that enabled them to remain content with their decision to take part. But for some, the results provoked recognition that their original expectations might have been mistaken or that they had not understood the implications of their decision to participate. These participants experienced guilt, a sense of betrayal by the maternity staff and researchers involved in the trial, and damage to trust. CONCLUSIONS: Sharing of study results is not a wholly benign practice, and requires careful development of suitable approaches for further evaluation before widespread adoption.

Junior doctors' views on reporting concerns about patient safety: a qualitative study.

BACKGROUND: Enabling healthcare staff to report concerns is critical for improving patient safety. Junior doctors are one of the groups least likely to engage in incident reporting. This matters both for the present and for the future, as many will eventually be in leadership positions. Little is known about junior doctors' attitudes towards formally reporting concerns. AIMS: To explore the attitudes and barriers to junior doctors formally reporting concerns about patient safety to the organisations in which they are training. METHODS: A qualitative study comprising three focus groups with 10 junior doctors at an Acute Teaching Hospital Trust in the Midlands, UK, conducted in 2013. Focus group discussions were transcribed verbatim and analysed using a thematic approach, facilitated by NVivo 10. RESULTS: Participants were supportive of the idea of playing a role in helping healthcare organisations become more aware of risks to patient safety, but identified that existing incident reporting systems could frustrate efforts to report concerns. They described barriers to reporting, including a lack of role modelling and senior leadership, a culture within medicine that was not conducive to reporting concerns, and a lack of feedback providing evidence that formal reporting was worthwhile. They reported a tendency to rely on informal ways of dealing with concerns as an alternative to engaging with formal reporting systems. CONCLUSIONS: If healthcare organisations are to be able to gather and learn from intelligence about risks to patient safety from junior doctors, this will require attention to the features of reporting systems, as well as the implications of hierarchies and the wider cultural context in which junior doctors work.

Psychological safety in an ECMO retrieval team: a qualitative study to inform improvement.

INTRODUCTION: In healthcare teams, psychological safety is associated with improved performance, communication, collaboration and patient safety. Extracorporeal membrane oxygenation (ECMO) retrieval teams are multidisciplinary teams that initiate ECMO therapy for patients with severe acute respiratory failure in referring hospitals and transfer patients to regional specialised centres for ongoing care. The present study aimed to explore an ECMO team's experience of psychological safety and generate recommendations to strengthen psychological safety. METHODS: The study was conducted in the Royal Brompton Hospital (RBH), part of Guy's and St Thomas' NHS Foundation Trust in London. RBH is one of six centres commissioned to provide ECMO therapy in the UK. 10 participants were recruited: 2 consultants, 5 nurses and 3 perfusionists. Semistructured interviews were used to explore the team members' views on teamwork, their perceived ability to discuss concerns within the team and the interaction between speaking up, teamwork and hierarchy. A Reflexive Thematic Analysis approach was used to explore the interview data. RESULTS: The analysis of the interview dataset identified structural and team factors shaping psychological safety in the specific context of the ECMO team. The high-risk environment in which the team operates, the clearly defined process and functions and the structured opportunities that provide legitimate moments to reflect together influence how psychological safety is experienced. Furthermore, speaking up is shaped by the familiarity among team members, the interdependent work, which requires boundary spanning across different roles, and leadership behaviour. A hierarchy of expertise is privileged over traditional institutional ranking. CONCLUSION: This study surfaced the structural and team factors that influence speaking up in the specific context of an ECMO retrieval team. Such information is used to suggest interventions to improve and strengthen psychological safety.

Role of coproduction in the sustainability of innovations in applied health and social care research: a scoping review.

BACKGROUND: Innovations such as toolkits and frameworks are developed through applied health and social care research, to address identified gaps in quality or safety of care. The intention is to subsequently implement these innovations into practice to bring about improvements. Challenges can arise from poor choice of implementation strategies or lack of alignment to local contexts. Research has identified the importance of involving and engaging patients, health professionals and other stakeholders in the design and delivery of the underpinning research, and in informing subsequent implementation. However, how and why such coproduction influences the sustainability of innovations in health and social care is unclear. OBJECTIVE: The objective of this scoping review is to identify and present the available evidence regarding the role of coproduction in the sustainability of innovations in applied health and social care research. INCLUSION CRITERIA: This scoping review includes papers related to the role of coproduction in the sustainability of innovations in applied health and social care research published in peer-reviewed journals. The review is limited to articles reporting applied health and social care research conducted in the United Kingdom. METHODS: Scopus, Web of Science, CINAHL and MEDLINE were searched for studies. Titles and abstracts were screened by two independent reviewers for assessment against the inclusion criteria, followed by a full-text review and data extraction. Data were extracted using a data extraction form developed by the reviewers. The completed forms were imported into NVivo and analysed using basic qualitative content analysis. RESULTS: Our review provides insight into the role of coproduction in the sustainability of innovations in applied health and social care research. Our findings highlight that sustainability is a dynamic process, supported by coproduction activities such as ongoing collaborative partnerships; these can be planned for in both the research design and implementation phases of a project.

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.