Dr Siobhan McHugh

Objective: To understand how National Health Service organizations routinely responded to, investigated, and learned from patient safety incidents in England before the implementation of the Patient Safety Incident Response Framework, and to identify associated success criteria and barriers. Methods: We followed rapid review methodology and searched 2 electronic databases. We aimed to identify and synthesize literature regarding patient safety incident response, investigation, and learning within the English National Health Service, before the implementation of the Patient Safety Incident Response Framework. Results: Nineteen articles were included. A narrative synthesis generated 4 concepts: (1) a multifaceted reporting culture, (2) investigation processes, (3) the landscape of support and involvement, and (4) opportunities to learn. Barriers to incident reporting included time, task characteristics, a culture of blame, and lack of feedback. Root cause analysis was cited as the most common investigation method. Studies outlined points of support and involvement for patients and families, the importance of supporting and involving patients and families, and acknowledged contributions from patients and families may be overlooked currently. For health care staff, the need for timely and personalized support soon after an incident was emphasized. Studies underlined the limitations of current approaches to learning and improvement. Conclusions: These findings lend support to the challenges associated with health care systems’ infrastructures and strategies for responding to and learning from patient safety incidents. These challenges centre on 2 interrelated issues: the investigative challenges of rigorously conducting systems analysis and learning-oriented improvement; and the relational challenges of supporting genuine relationships of care, open and honest communication, and supportive engagement after patient safety incidents.

Objectives Investigations of healthcare harm often overlook the valuable insights of patients and families. Our review aimed to explore the perspectives of key stakeholders when patients and families were involved in serious incident investigations. Methods The authors searched three databases (Medline, PsycInfo, and CINAHL) and Connected Papers software for qualitative studies in which patients and families were involved in serious incident investigations until no new articles were found. Results Twenty-seven papers were eligible. The perspectives of patients and families, healthcare professionals, nonclinical staff, and legal staff were sought across acute, mental health and maternity settings. Most patients and families valued being involved; however, it was important that investigations were flexible and sensitive to both clinical and emotional aspects of care to avoid compounding harm. This included the following: early active listening with empathy for trauma, sincere and timely apology, fostering trust and transparency, making realistic timelines clear, and establishing effective nonadversarial communication. Most staff perceived that patient and family involvement could improve investigation quality, promote an open culture, and help ensure future safety. However, it was made difficult when multidisciplinary input was absent, workload and staff turnover were high, training and support needs were unmet, and fears surrounded litigation. Potential solutions included enhancing the clarity of roles and responsibilities, adequately training staff, and providing long and short-term support to stakeholders. Conclusions Our review provides insights to ensure patient and family involvement in serious incident investigations considers both clinical and emotional aspects of care, is meaningful for all key stakeholders, and avoids compounding harm. However, significant gaps in the literature remain.

Background Expectations of patient and family involvement in investigations of healthcare harm are becoming conventional. Nonetheless, how people should be involved, is less clear. Therefore, the “Learn Together” guidance was co-designed, aiming to provide practical and emotional support to investigators, patients and families. Aim To longitudinally evaluate use of the Learn Together guidance in practice—designed to support patient and family involvement in investigations of healthcare harm. Methods A 15-month process evaluation took place across five sites, following 29 investigations in which the Learn Together guidance was used. Sites comprised two mental health and two physical health hospital Trusts, and an independent maternity investigatory body in England. Longitudinally, 127 interviews were conducted with investigators, patients, families, staff, and management. Interview and observational data were synthesized using Pen Portraits and analyzed using multi-case thematic analysis. Findings The guidance supported the systematic involvement of patients and families in investigations of healthcare harm and informed them how, why, and when to be involved across settings. However, within hospital Trusts, investigators often had to conduct “pre-investigations” to source appropriate details of people to contact, juggle ethical dilemmas of involving vs. re-traumatizing, and work within contexts of unclear organizational processes and responsibilities. These issues were largely circumvented when investigations were conducted by an independent body, due to better established processes, infrastructure and resources, however independence did introduce challenge to the rebuilding of relationships between families and the hospital Trust. Across settings, the involvement of patients and families fluctuated over time and sharing a draft investigation report marked an important part of the process—perhaps symbolic of organizational ethos surrounding involvement. This was made particularly difficult within hospital Trusts, as investigators often had to navigate systemic barriers alone. Organizational learning was also a challenge across settings. Conclusions Investigations of healthcare harm are complex, relational processes that have the potential to either repair, or compound harm. The Learn Together guidance helped to support patient and family involvement and the evaluation led to further revisions, to better inform and support patients, families and investigators in ways that meet their needs (https://learn-together.org.uk). In particular, the five-stage process is designed to center the needs of patients and families to be heard, and their experiences dignified, before moving to address organizational needs for learning and improvement. However, as a healthcare system, we call for more formal recognition, support and training for the complex challenges investigators face—beyond clinical skills, as well as the appropriate and flexible infrastructure to enable a receptive organizational culture and context for meaningful patient and family involvement.

Background Healthcare organisations risk harming patients and their families twofold. First, through the physical, emotional and/or financial harm caused by safety incidents themselves, and second, through the organisational response to incidents. The former is well-researched and targeted by interventions. However, the latter, termed ‘compounded harm’ is rarely acknowledged. Aims We aimed to explore the ways compounded harm is experienced by patients and their families as a result of organisational responses to safety incidents and propose how this may be reduced in practice. Methods We used framework analysis to qualitatively explore data derived from interviews with 42 people with lived or professional experience of safety incident responses. This comprised 18 patients/relatives, 16 investigators, seven healthcare staff and one legal staff. People with lived and professional experience also helped to shape the design, conduct and findings of this study. Findings We identified six ways that patients and their families experienced compounded harm because of incident responses. These were feeling: (1) powerless, (2) inconsequential, (3) manipulated, (4) abandoned, (5) de-humanised and (6) disoriented. Discussion It is imperative to reduce compounded harm experienced by patients and families. We propose three recommendations for policy and practice: (1) the healthcare system to recognise and address epistemic injustice and equitably support people to be equal partners throughout investigations and subsequent learning to reduce the likelihood of patients and families feeling powerless and inconsequential; (2) honest and transparent regulatory and organisational cultures to be fostered and enacted to reduce the likelihood of patients and families feeling manipulated; and (3) the healthcare system to reorient towards providing restorative responses to harm which are human centred, relational and underpinned by dignity, safety and voluntariness to reduce the likelihood of patients and families feeling abandoned, de-humanised and disoriented.

Background: The considered shift from individual blame and sanctions towards a commitment to system-wide learning from incidents in healthcare has led to increased understanding of both the moral and epistemic importance of involving those affected. It is important to understand whether and how local policy describes and prompts involvement with a view to understanding the policy landscape for serious incident investigations in healthcare. This study aimed to explore the way in which involvement of those affected by serious incidents is represented in incident investigation policy documents across acute and mental health services in the English NHS, and to identify guidance for more effective construction of policy for meaningful involvement. Methods: We conducted a documentary analysis of 43 local serious incident investigation policies to explore the way in which involvement in serious incident investigations is represented in policy documents across acute and mental health services in the NHS in England. Results: Three headline findings were generated. First, we identified involvement as a concept was conspicuous by its absence in policy documents. Direct reference to support or involvement of those affected by serious incidents was lacking. Even where involvement and support were recognised as important, this was described as a passive process rather than there being moral or epistemic justification for more active contribution to learning. Second, learning from serious incidents was typically described as a high priority but the language used was unclear and ‘learning’ was more often positioned as construction of an arbitrary set of recommendations rather than a participatory process of deconstruction and reconstruction of specific systems and processes. Third, there was an emphasis placed on a just and open culture but paradoxically this was reinforced by expected compliance, positioning investigations as a tool through which action is governed rather than an opportunity to learn from and with the experiences and expertise of those affected. Conclusions: More effective representation in policy of the moral and epistemic reasons for stakeholder involvement in serious incident investigations may lead to better understanding of its importance, thus increasing potential for organisational learning and reducing the potential for compounded harm. Moreover, understanding how structural elements of policy documents were central to the way in which the document is framed and received is significant for both local and national policy makers to enable more effective construction of healthcare policy documents to prompt meaningful action.

Background: Teamwork and communication are recognised as key contributors to safe and high quality patient care. Interventions targeting process and relational aspects of care may therefore provide patient safety solutions that reflect the complex nature of healthcare. Team reflexivity is one such approach with the potential to support improvements in communication and teamwork, where reflexivity is defined as the ability to pay critical attention to individual and team practices with reference to social and contextual information. Objective: To systematically review articles that describe the use of team reflexivity in interprofessional hospital based healthcare teams. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta Analyses guidelines, six electronic databases were searched to identify literature investigating the use of team reflexivity in interprofessional hospital-based healthcare teams. The review includes articles investigating the use of team reflexivity to improve teamwork and communication in any naturally occurring hospital-based healthcare teams. Articles’ eligibility was validated by two second reviewers (5%). Results: Fifteen empirical articles were included in the review. Simulation training and video-reflexive ethnography (VRE) were the most commonly used forms of team reflexivity. Included articles focused on the use of reflexive interventions to improve teamwork and communication within interprofessional healthcare teams. Communication during interprofessional teamworking was the most prominent focus of improvement methods. The nature of this review only allows assessment of team reflexivity as an activity embedded within specific methods. Poorly defined methodological information relating to reflexivity in the reviewed studies made it difficult to draw conclusive evidence about the impact of reflexivity alone. Conclusion: The reviewed literature suggests that VRE is well placed to provide more locally appropriate solutions to contributory patient safety factors, ranging from individual and social learning to improvements in practices and systems. Trial registration number CRD42017055602

Background Video-reflexive ethnography (VRE) has been argued to be an alternative approach to collaborative learning in healthcare teams, more able to capture the complexities of the healthcare environment than simulation. This study aims to explore the feasibility and acceptability of employing VRE as an improvement tool in acute maternity services. Method Focused ethnography and semi-structured interviews (n = 17) explored the feasibility of employing VRE from the perspective of the researcher-facilitator, and that of the healthcare staff participants. Reflexive thematic analysis was used to generate key themes. Results We identified four themes related to feasibility of employing VRE as an improvement approach: laying the groundwork; challenges of capturing in-situ video footage; effective facilitation of reflexive feedback; and, power to change. Of note was the central role of the facilitator in building and maintaining staff trust in the process, particularly in being able to guide collaborative, non-punitive discussion during reflexive feedback sessions. Interestingly, when considering implementation of change, structural hierarchies were evident with more senior staff better able to develop and effect ideas. Two themes related to acceptability of VRE among healthcare staff were identified: staff response to the role of VRE in improvement; and the power of a different perspective. Staff were overwhelmingly positive about their experience of VRE, particularly appreciating the time, space and autonomy it afforded them to navigate and articulate ideas for change and improvement. Conclusion VRE is both feasible and acceptable as an improvement tool with acute, multi-disciplinary maternity staff teams. It is an important healthcare improvement tool that could prompt the development and maintenance of team resilience factors in the face of increasing stress and burn-out of healthcare staff in maternity services.

Background There are multiple reasons for involving patients and families in incident investigations. Fiscally, costs due to clinical negligence claims approximate £4 billion annually. Logically, patients and families provide important information about patient safety incidents. Morally, involving harmed patients and families helps address their concerns. However, little United Kingdom-based evidence was available to support systematic involvement. Objective To co-design processes and resources to guide the involvement of patients and families in incident investigations at a national and local level, and to test these processes to understand their impact upon experience, learning and likelihood of litigation. Design and methods A mixed-methods programme of research was undertaken. Stage 1 comprised a scoping review of evidence for the experience of patients/families in incident investigations, and a documentary analysis of 43 National Health Service Trust incident investigation policies. Stage 2A extended this with 41 qualitative interviews with patients/families, healthcare staff and investigators. Stage 2B synthesised previous data to develop common principles and programme theory. Stage 3 involved a 6-month co-design phase with a ‘co-design community’ of > 50 stakeholders. In stages 4 and 5, co-designed guidance was evaluated in a 15-month ethnography, within four National Health Service Trusts and the national independent investigatory body. Twenty-nine investigations were followed in real time, including 127 interviews and 45 hours of observation. Four final co-design workshops supported iterations to the final guidance and website. A substudy explored meaningful involvement in, and learning from, investigations following suicide via interviews and a qualitative survey involving 32 people (healthcare staff, policy-makers and managers; people bereaved by suicide). Findings Stage 1 found stakeholders valued involvement, but it was not well supported by local policy, even though it likely reduces litigation. Stage 2A found a need for navigational support, and support for other needs. In stage 2B, 10 common principles and a programme theory were developed, emphasising the aim of reducing compounded harm, alongside promoting organisational learning. In stage 3, four draft guidance booklets and a training session were developed. Stage 4 found these to be feasible, with stakeholders positive about involvement, and generally agreed that it aided organisational learning. The guidance supported systematisation of involvement and encouraged relational working, but wider organisational challenges were highlighted. The substudy found that suicide was regarded as somewhat different to other safety events. Meaningful involvement was complicated by a range of factors and should be decoupled from postvention support. Limitations Undertaking research during the pandemic may have impacted sample representativeness in stage 2A. Ethnically minoritised and lower socioeconomic groups were under-represented across the programme. Future research Research should explore how people from minoritised groups experience investigations and any required adaptations to the approach. Research should also explore the possibilities for ‘harm-centred’ rather than ‘incident-centred’ responses to safety. Conclusions Investigations are complex, relational processes. Our guidance was found to be feasible, with stakeholders being positive about involvement and the impact on organisational learning. It may help to reduce the significant and long-lasting experience of compounded harm for patients and families. However, involvement may always be challenging due to the divergent needs of patients/families and organisations. Study registration This study is registered as Current Controlled Trials ISRCTN14463242. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 18/10/02) and is published in full in Health and Social Care Delivery Research; Vol. 13, No. 18. See the NIHR Funding and Awards website for further award information.

Background Whilst patients and families can and do support patient safety in several ways, empirical evidence for the specific impact of involvement in patient safety incident investigations and their outcomes, has been limited, with little information about how to undertake involvement meaningfully. Aim We aimed to (i) develop a set of common principles to guide involvement of patients and families in patient safety incident investigations; (ii) develop a working programme theory for how these might be enacted; (iii) co-design guidance to support the meaningful involvement of patients and families in patient safety incident investigations. Methods We synthesised three existing data sets (a literature review, a documentary analysis of incident investigation policies and 42 interviews with patients, families, lawyers, incident investigators, and healthcare staff) relating to patient and family involvement in incident investigations. Ten common principles and a working programme theory were drafted. Within a convened co-design community, we then developed guidance for patients, families, staff, and investigators in local NHS Trust and national investigations, via a series of workshops. Findings We developed ten ‘common principles” and a working programme theory for an approach that might support meaningful patient and family involvement in incidents investigations. Based on these principles and the programme theory, we co-designed guidance to be used within NHS Trust and national investigations of harm that follow patient safety incidents. The guidance includes information, resources and tools to enable better understanding and practice, from the perspective of patients, families, investigators and staff, on how to be meaningfully involved. Conclusions Our ten common principles and co-designed guidance emphasise two key things. First, that organizational learning is not the only desired outcome for incident investigations, with patients, families and staff reporting the need for restoration and repair. Second, that investigations can be part of reparation, but when it fails to address the needs of stakeholders arising from investigations, it can compound the harm of the original incident. As a result, we juxtapose existing theories, and illuminate new insights, proposing a theory of “restorative learning”. We see design as an ongoing phenomenon—the guidance is our current iteration, and we learnt several valuable lessons about doing co-design.

Following publication of the original article [1], the authors reported missing information in the ‘Acknowledgements’ section. The statement in the ‘Acknowledgements’ section originally read: None. The statement in the ‘Acknowledgements’ section should read: The authors would like to thank Mr Dileep Wijeratne for his extensive support in both the set up and delivery of this research project. We would also like to thank all of the staff from Leeds Teaching Hospitals maternity services, in particular the clinical leads for anaesthetics, obstetrics and the head of midwifery for their time and support. The original article [1] has been updated.

Background There is a growing international policy focus on involving those affected by healthcare safety incidents, in subsequent investigations. Nonetheless, there remains little UK-based evidence exploring how this relates to the experiences of those affected over time, including the factors influencing decisions to litigate. Aims We aimed to explore the experiences of patients, families, staff and legal representatives affected by safety incidents over time, and the factors influencing decisions to litigate. Methods Participants were purposively recruited via (i) communication from four NHS hospital Trusts or an independent national investigator in England, (ii) relevant charitable organizations, (iii) social media, and (iv) word of mouth to take part in a qualitative semi-structured interview study. Data were analyzed using an inductive reflexive thematic approach. Findings 42 people with personal or professional experience of safety incident investigations participated, comprising patients and families (n = 18), healthcare staff (n = 7), legal staff (n = 1), and investigators (n = 16). Patients and families started investigation processes with cautious hope, but over time, came to realize that they lacked power, knowledge, and support to navigate the system, made clear in awaited investigation reports. Systemic fear of litigation not only failed to meet the needs of those affected, but also inadvertently led to some pursuing litigation. Staff had parallel experiences of exclusion, lacking support and feeling left with an incomplete narrative. Importantly, investigating was often perceived as a lonely, invisible and undervalued role involving skilled “work” with limited training, resources, and infrastructure. Ultimately, elusive “organizational agendas” were prioritized above the needs of all affected. Conclusions Incident investigations fail to acknowledge and address emotional distress experienced by all affected, resulting in compounded harm. To address this, we propose five key recommendations, to: (1) prioritize the needs of those affected by incidents, (2) overcome culturally engrained fears of litigation to re-humanize processes and reduce rates of unnecessary litigation, (3) recognize and value the emotionally laborious and skilled work of investigators (4) inform and support those affected, (5) proceed in ways that recognize and seek to reduce social inequities.

Whilst the widening participation programme aims to increase the accessibility of undergraduate study for students with a lower socio-economic status, much less support is available for students wishing to progress to postgraduate study. Postgraduate study risks becoming a discipline exclusive to those from upper-middle class and upper-class backgrounds, with too few role models from lower socioeconomic backgrounds encouraging uptake. To explore class-related inequalities in academia reported by existing data through the lens of access to postgraduate study, we developed, and piloted, the CLASS (championing lower-class academic and social success) programme within our university. The programme aims to harness the lived experience of working class individuals to uncover the barriers to postgraduate study and to develop strategies at an institutional level. An initial understanding of the barriers and challenges current students experience have been captured in our pilot programme. Future CLASS initiatives include assessment of these barriers at a national level to harness findings through the development of strategies with universities.

People with type 2 diabetes (T2DM) are more likely to develop cancer and experience poorer cancer-related outcomes. Despite this, women with diabetes are less likely to participate in cancer screening than women without diabetes. Previous research suggests there are diabetes-related barriers to cancer screening, but very few studies have sought to identify and characterise these barriers. The current PhD aimed to address this research gap, by advancing knowledge and understanding of diabetes-related barriers to cancer screening and potential intervention strategies. Study one undertook a novel, comprehensive systematic review of qualitative research, exploring barriers and facilitators to cancer screening among people living with any type of chronic illness or disability (n = 70 articles). The review revealed a paucity of studies examining bowel cancer screening, and which have been conducted outside the USA. Only one study exclusively examined cancer screening among people with diabetes. Consequently, study two conducted, for the first time, in-depth qualitative interviews examining views and experiences of cervical, breast and bowel cancer screening among women with T2DM in England (n = 25). Interviews identified several diabetes-related barriers and facilitators to cancer screening and potential ways to address and promote these, respectively. Study three developed a novel, brief written intervention (containing a threat and/or coping message), based on Protection Motivation Theory, to address lack of awareness of the T2DM-increased risk of bowel cancer (a key diabetes-related barrier identified in the interviews). An online randomised controlled experiment (n = 349) found no effects of the intervention on cancer screening intentions, likely due in part to a ceiling effect. However, the coping message significantly increased self-efficacy, and decreased response costs and perceived severity. Overall, the thesis findings elucidate how having diabetes can both heighten and add barriers to cancer screening and indicate multifaceted potential intervention targets and strategies to address these.

Background Reducing avoidable harm in maternity services is a priority globally. As well as learning from mistakes, it is important to produce rigorous descriptions of ‘what good looks like’. Objective We aimed to characterise features of safety in maternity units and to generate a plain language framework that could be used to guide learning and improvement. Methods We conducted a multisite ethnography involving 401 hours of non-participant observations 33 semistructured interviews with staff across six maternity units, and a stakeholder consultation involving 65 semistructured telephone interviews and one focus group. Results We identified seven features of safety in maternity units and summarised them into a framework, namedFor Us(For Unit Safety). The features include: (1) commitment to safety and improvement at all levels, with everyone involved; (2) technical competence, supported by formal training and informal learning; (3) teamwork, cooperation and positive working relationships; (4) constant reinforcing of safe, ethical and respectful behaviours; (5) multiple problem-sensing systems, used as basis of action; (6) systems and processes designed for safety, and regularly reviewed and optimised; (7) effective coordination and ability to mobilise quickly. These features appear to have a synergistic character, such that each feature is necessary but not sufficient on its own: the features operate in concert through multiple forms of feedback and amplification. Conclusions This large qualitative study has enabled the generation of a new plain language framework—For Us—that identifies the behaviours and practices that appear to be features of safe care in hospital-based maternity units.