AI as a Medical Device Adverse Event Reporting in Regulatory Databases: Protocol for a Systematic Review.

BACKGROUND: The reporting of adverse events (AEs) relating to medical devices is a long-standing area of concern, with suboptimal reporting due to a range of factors including a failure to recognize the association of AEs with medical devices, lack of knowledge of how to report AEs, and a general culture of nonreporting. The introduction of artificial intelligence as a medical device (AIaMD) requires a robust safety monitoring environment that recognizes both generic risks of a medical device and some of the increasingly recognized risks of AIaMD (such as algorithmic bias). There is an urgent need to understand the limitations of current AE reporting systems and explore potential mechanisms for how AEs could be detected, attributed, and reported with a view to improving the early detection of safety signals. OBJECTIVE: The systematic review outlined in this protocol aims to yield insights into the frequency and severity of AEs while characterizing the events using existing regulatory guidance. METHODS: Publicly accessible AE databases will be searched to identify AE reports for AIaMD. Scoping searches have identified 3 regulatory territories for which public access to AE reports is provided: the United States, the United Kingdom, and Australia. AEs will be included for analysis if an artificial intelligence (AI) medical device is involved. Software as a medical device without AI is not within the scope of this review. Data extraction will be conducted using a data extraction tool designed for this review and will be done independently by AUK and a second reviewer. Descriptive analysis will be conducted to identify the types of AEs being reported, and their frequency, for different types of AIaMD. AEs will be analyzed and characterized according to existing regulatory guidance. RESULTS: Scoping searches are being conducted with screening to begin in April 2024. Data extraction and synthesis will commence in May 2024, with planned completion by August 2024. The review will highlight the types of AEs being reported for different types of AI medical devices and where the gaps are. It is anticipated that there will be particularly low rates of reporting for indirect harms associated with AIaMD. CONCLUSIONS: To our knowledge, this will be the first systematic review of 3 different regulatory sources reporting AEs associated with AIaMD. The review will focus on real-world evidence, which brings certain limitations, compounded by the opacity of regulatory databases generally. The review will outline the characteristics and frequency of AEs reported for AIaMD and help regulators and policy makers to continue developing robust safety monitoring processes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48156.

Detecting Algorithmic Errors and Patient Harms for AI-Enabled Medical Devices in Randomized Controlled Trials: Protocol for a Systematic Review.

BACKGROUND: Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have shown potential for a range of clinical tasks such as diagnostics, prognostics, and therapeutic decision-making such as drug dosing. There is, however, an urgent need to ensure that these technologies remain safe for all populations. Recent literature demonstrates the need for rigorous performance error analysis to identify issues such as algorithmic encoding of spurious correlations (eg, protected characteristics) or specific failure modes that may lead to patient harm. Guidelines for reporting on studies that evaluate AI medical devices require the mention of performance error analysis; however, there is still a lack of understanding around how performance errors should be analyzed in clinical studies, and what harms authors should aim to detect and report. OBJECTIVE: This systematic review will assess the frequency and severity of AI errors and adverse events (AEs) in randomized controlled trials (RCTs) investigating AI medical devices as interventions in clinical settings. The review will also explore how performance errors are analyzed including whether the analysis includes the investigation of subgroup-level outcomes. METHODS: This systematic review will identify and select RCTs assessing AI medical devices. Search strategies will be deployed in MEDLINE (Ovid), Embase (Ovid), Cochrane CENTRAL, and clinical trial registries to identify relevant papers. RCTs identified in bibliographic databases will be cross-referenced with clinical trial registries. The primary outcomes of interest are the frequency and severity of AI errors, patient harms, and reported AEs. Quality assessment of RCTs will be based on version 2 of the Cochrane risk-of-bias tool (RoB2). Data analysis will include a comparison of error rates and patient harms between study arms, and a meta-analysis of the rates of patient harm in control versus intervention arms will be conducted if appropriate. RESULTS: The project was registered on PROSPERO in February 2023. Preliminary searches have been completed and the search strategy has been designed in consultation with an information specialist and methodologist. Title and abstract screening started in September 2023. Full-text screening is ongoing and data collection and analysis began in April 2024. CONCLUSIONS: Evaluations of AI medical devices have shown promising results; however, reporting of studies has been variable. Detection, analysis, and reporting of performance errors and patient harms is vital to robustly assess the safety of AI medical devices in RCTs. Scoping searches have illustrated that the reporting of harms is variable, often with no mention of AEs. The findings of this systematic review will identify the frequency and severity of AI performance errors and patient harms and generate insights into how errors should be analyzed to account for both overall and subgroup performance. TRIAL REGISTRATION: PROSPERO CRD42023387747; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=387747. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/51614.

Systematic review of types of safety incidents and the processes and systems used for safety incident reporting in care homes.

AIMS: To identify the safety incident reporting systems and processes used within care homes to capture staff reports of safety incidents, and the types and characteristics of safety incidents captured by safety incident reporting systems. DESIGN: Systematic review following PRISMA reporting guidelines. METHODS: Databases were searched January 2023 for studies published after year 2000, written in English, focus on care homes and incident reporting systems. Data were extracted using a bespoke data extraction tool, and quality was assessed. Data were analysed descriptively and using narrative synthesis, with types and characteristics of incidents analysed using the International Classification for Patient Safety. DATA SOURCES: Databases were CINAHL, MEDLINE, PsycINFO, EMBASE, HMIC, ASSISA, Nursing and Allied Health Database, MedNar and OpenGrey. RESULTS: We identified 8150 papers with 106 studies eligible for inclusion, all conducted in high-income countries. Numerous incident reporting processes and systems were identified. Using modalities, typical incident reporting systems captured all types of incidents via electronic computerized reporting, with reports made by nursing staff and captured information about patient demographics, the incident and post-incident actions, whilst some reporting systems included medication- and falls-specific information. Reports were most often used to summarize data and identify trends. Incidents categories most often were patient behaviour, clinical process/procedure, documentation, medication/intravenous fluids and falls. Various contributing and mitigating factors and actions to reduce risk were identified. The most reported action to reduce risk was to improve safety culture. Individual outcomes were often reported, but social/economic impact of incidents and organizational outcomes were rarely reported. CONCLUSIONS: This review has demonstrated a complex picture of incident reporting in care homes with evidence limited to high-income countries, highlighting a significant knowledge gap. The findings emphasize the central role of nursing staff in reporting safety incidents and the lack of standardized reporting systems and processes. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: The findings from this study can inform the development or adaptation of safety incident reporting systems in care home settings, which is of relevance for nurses, care home managers, commissioners and regulators. This can help to improve patient care by identifying common safety issues across various types of care home and inform learning responses, which require further research. IMPACT: This study addresses a gap in the literature on the systems and processes used to report safety incidents in care homes across many countries, and provides a comprehensive overview of safety issues identified via incident reporting. REPORTING METHOD: PRISMA. PATIENT OR PUBLIC CONTRIBUTION: A member of the research team is a patient and public representative, involved from study conception.

Risk Controls Identified in Action Plans Following Serious Incident Investigations in Secondary Care: A Qualitative Study.

OBJECTIVES: The impact of incident investigations in improving patient safety may be linked to the quality of risk controls recommended in investigation reports. We aimed to identify the range and apparent strength of risk controls generated from investigations into serious incidents, map them against contributory factors identified in investigation reports, and characterize the nature of the risk controls proposed. METHODS: We undertook a content analysis of 126 action plans of serious incident investigation reports from a multisite and multispeciality UK hospital over a 3-year period to identify the risk controls proposed. We coded each risk control against the contributory factor it aimed to address. Using a hierarchy of risk controls model, we assessed the strength of proposed risk controls. We used thematic analysis to characterize the nature of proposed risk controls. RESULTS: A substantial proportion (15%) of factors identified in investigation reports as contributing to serious incidents were not addressed by identifiable risk controls. Of the 822 proposed risk controls in action plans, most (74%) were assessed as weak, typically focusing on individualized interventions-even when the problems were organizational or systemic in character. The following 6 broad approaches to risk controls could be identified: improving individual or team performance; defining, standardizing, or reinforcing expected practice; improving the working environment; improving communication; process improvements; and disciplinary actions. CONCLUSIONS: The identified shortfalls in the quality of risk controls following serious incident investigations-including a 15% mismatch between contributory factors and aligned risk controls and 74% of proposed risk controls centering on weaker interventions-represent significant gaps in translating incident investigations into meaningful systemic improvements. Advancing the quality of risk controls after serious incident investigations will require involvement of human factors specialists in their design, a theory-of-change approach, evaluation, and curation and sharing of learning, all supported by a common framework.

Implementing and Evaluating a National Integrated Digital Registry and Clinical Decision Support System in Early Intervention in Psychosis Services (Early Psychosis Informatics Into Care): Co-Designed Protocol.

BACKGROUND: Early intervention in psychosis (EIP) services are nationally mandated in England to provide multidisciplinary care to people experiencing first-episode psychosis, which disproportionately affects deprived and ethnic minority youth. Quality of service provision varies by region, and people from historically underserved populations have unequal access. In other disease areas, including stroke and dementia, national digital registries coupled with clinical decision support systems (CDSSs) have revolutionized the delivery of equitable, evidence-based interventions to transform patient outcomes and reduce population-level disparities in care. Given psychosis is ranked the third most burdensome mental health condition by the World Health Organization, it is essential that we achieve the same parity of health improvements. OBJECTIVE: This paper reports the protocol for the program development phase of this study, in which we aimed to co-design and produce an evidence-based, stakeholder-informed framework for the building, implementation, piloting, and evaluation of a national integrated digital registry and CDSS for psychosis, known as EPICare (Early Psychosis Informatics into Care). METHODS: We conducted 3 concurrent work packages, with reciprocal knowledge exchange between each. In work package 1, using a participatory co-design framework, key stakeholders (clinicians, academics, policy makers, and patient and public contributors) engaged in 4 workshops to review, refine, and identify a core set of essential and desirable measures and features of the EPICare registry and CDSS. Using a modified Delphi approach, we then developed a consensus of data priorities. In work package 2, we collaborated with National Health Service (NHS) informatics teams to identify relevant data currently captured in electronic health records, understand data retrieval methods, and design the software architecture and data model to inform future implementation. In work package 3, observations of stakeholder workshops and individual interviews with representative stakeholders (n=10) were subject to interpretative qualitative analysis, guided by normalization process theory, to identify factors likely to influence the adoption and implementation of EPICare into routine practice. RESULTS: Stage 1 of the EPICare study took place between December 2021 and September 2022. The next steps include stage 2 building, piloting, implementation, and evaluation of EPICare in 5 demonstrator NHS Trusts serving underserved and diverse populations with substantial need for EIP care in England. If successful, this will be followed by stage 3, in which we will seek NHS adoption of EPICare for rollout to all EIP services in England. CONCLUSIONS: By establishing a multistakeholder network and engaging them in an iterative co-design process, we have identified essential and desirable elements of the EPICare registry and CDSS; proactively identified and minimized potential challenges and barriers to uptake and implementation; and addressed key questions related to informatics architecture, infrastructure, governance, and integration in diverse NHS Trusts, enabling us to proceed with the building, piloting, implementation, and evaluation of EPICare. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/50177.

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.

Challenges and improvements associated with transitions between hospitals and care homes during the COVID-19 pandemic: a qualitative study with care home and healthcare staff in England.

BACKGROUND: Care home residents transitioning from hospital are at risk of receiving poor-quality care with their safety being challenged by the SARS-CoV-2 virus (COVID-19) pandemic. Little is known about how care home staff worked with hospital staff and other healthcare professionals to address these challenges and make improvements to increase patient safety. OBJECTIVE: To gain insight into how the COVID-19 pandemic influenced the safety of transitions between hospital and care home. METHOD: Semi-structured interviews were conducted with care home staff and healthcare professionals involved in hospital to care home transitions including doctors, nurses, paramedics, pharmacists, social workers, and occupational therapists. Commonalities and patterns in the data were identified using thematic analysis. RESULTS: Seventy participants were interviewed. Three themes were developed, first, 'new challenges', described care homes were pressurised to receive hospital patients amidst issues with COVID-19 testing, changes to working practices and contentious media attention, which all impacted staff negatively. Second, 'dehumanisation' described how care home residents were treated, being isolated from others amounted to feelings of being imprisoned, caused fear and engendered negative reactions from families. Third, 'better ways of working' described how health and social care workers developed relationships that improved integration and confidence and benefited care provision. CONCLUSION: The COVID-19 pandemic contributed to and compounded high-risk hospital-to-care home discharges. Government policy failed to support care homes. Rapid discharge objectives exposed a myriad of infection control issues causing inhumane conditions for care home residents. However, staff involved in transitions continued to provide and improve upon care provision.

Which programmes and policies across health and community settings will generate the most significant impacts for youth suicide prevention in Australia and the UK? Protocol for a systems modelling and simulation study.

INTRODUCTION: Suicide is a leading cause of mortality among young people aged 15-24 globally. Despite the deployment of comprehensive suicide prevention strategies, we still do not know which interventions, for which groups of young people, for how long and with what intensity could generate the most significant reductions in suicide rates. System dynamics modelling has the potential to address these gaps. SEYMOUR (System Dynamics Modelling for Suicide Prevention) will develop and evaluate a system dynamics model that will indicate which suicide prevention interventions could generate the most significant reductions in rates of suicide and attempted suicide among young people aged 12-25 in Australia and the UK. METHODS AND ANALYSIS: A comparative case study design, applying participatory system dynamics modelling in North-West Melbourne (Australia) and Birmingham (UK). A computer simulation model of mental health service pathways and suicidal behaviour among young people in North-West Melbourne will be developed through three workshops with expert stakeholder groups (young people with lived experience, carers, clinicians, policy makers, commissioners). The model will be calibrated and validated using national, state and local datasets (inputs). The simulation model will test a series of interventions identified in the workshops for inclusion. Primary model outputs include suicide deaths, self-harm hospitalisations and self-harm presentations to emergency departments. An implementation strategy for the sustainable embedding of promising suicide prevention interventions will be developed. This will be followed by model customisation, re-parameterisation, and validation in Birmingham and adaptation of the implementation strategy. ETHICS AND DISSEMINATION: The project has received approval from the University of Melbourne Human Research Ethics Committee (2022-22885-25971-4), the University of Birmingham Science, Technology, Engineering and Mathematics Ethics Review Committee (ERN_21-02385) and the UK HRA (22/HRA/3826). SEYMOUR's dissemination strategy includes open-access academic publications, conference presentations, accessible findings coproduced with young people, e-briefs to policy makers, webinars for service providers and commissioners.

Becoming active in the micro-politics of healthcare re-organisation: The identity work and political activation of doctors, nurses and managers.

The changing organisation and governance of healthcare work represents a persistent focus of micro-politics. Whilst there is a developed literature describing the micro-political struggles that occur amongst healthcare occupations, there is little understanding about how, when and why actors become politically aware and active. Framed by research on political activation and the concept of identity work, this paper reports on a narrative interview study with 65 people, specifically doctors, nurses and managers, working in the English healthcare system. The narratives show that healthcare workers become increasingly aware of and engaged in micro-political activities through incremental stages based on their accumulating experiences. These stages are opportunities for identity work as actors make sense of their experiences of micro-politics, their occupational affiliations and their evolving sense of self. This identity work is shaped by actors' changing views about the morality of playing politics, the emotional implications of their engagement, and their deepening political commitments. The study shows that political socialisation and activation can vary between occupations and rather than assuming political affiliations are given or acquired the papers highlights the reflective agency of healthcare actors.

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.

What can clinical leaders contribute to the governance of integrated care systems?

BACKGROUND: Integrated care systems present enduring governance challenges associated with fostering interorganisational collaboration. AIM: To understand how clinical leaders can make a distinct contribution to the governance and system leadership of integrated care systems. METHODS: A qualitative interview study carried out between 2018 and 2019 with 24 clinical leaders, and a further 47 non-clinical leaders, involved in the governance of three Sustainability and Transformation Partnership in the English National Health Service. RESULTS: Clinical leaders were found to make four distinct contributions: (1) making analytical insights into integration strategies that ensured their relevance and quality to clinical communities; (2) representing the views of clinicians in system decision-making thereby enhancing the legitimacy of change; (3) translation and communication activities to articulate integration strategies in favourable ways and ensure clinical engagement; and (4) relational work in the form of brokering and building connections and mediating conflict between multiple stakeholders. These activities varied across the levels of system governance and at different stages in the processes of change. CONCLUSIONS: Clinical leaders can make a distinct contribution to the governance and leadership of integrated care systems based on their clinical expertise, membership professional networks, reputation and formal authority.

Acquiring and developing healthcare leaders' political skills: an interview study with healthcare leaders.

BACKGROUND: Research suggests health and care leaders need to develop a distinct set of political skills in order to understand and manage the competing interests and agenda that characterise health and care services. AIM: To understand how healthcare leaders describe the acquisition and development of political skills with the aim of providing evidence for leadership development programme. METHODS: A qualitative interview study was carried out between 2018 and 2019 with 66 health and care leaders located within the English National Health Service. Qualitative data were subject to interpretative analysis and coding, with themes related to pre-existing literature on the methods of leadership skill development. RESULTS: The primary method of acquiring and developing political skill is through direct experience in leading and changing services. This is unstructured and incremental in nature with skill development increased through the accumulation of experience. Many participants described mentoring as an important source of political skill development, especially for reflecting on first-hand experiences, understanding the local environment and fine-tuning strategies. A number of participants describe formal learning opportunities as giving them permission to discuss political issues, and providing frameworks for conceptual understanding of organisational politics. Overall, no one approach appears to reflect the changing developmental needs of leaders. CONCLUSIONS: The study suggests that healthcare leaders' development of political skills and behaviours might be supported through an integrative approach that takes into account the evolving learning needs and opportunities at different career stages in the form of a maturation framework.

Using sociotechnical theory to understand medication safety work in primary care and prescribers' use of clinical decision support: a qualitative study.

OBJECTIVES: The concept of safety work draws attention to the intentional work of ensuring safety within care systems. Clinical decision support (CDS) has been designed to enhance medication safety in primary care by providing decision-making support to prescribers. Sociotechnical theory understands that healthcare settings are complex and dynamically connected systems of fluid networks, human agents, changing relationships and social processes. This study aimed to understand the relationship between safety work and the use of CDS. DESIGN AND SETTING: This qualitative study took place across nine different general practices in England. Stakeholders included general practitioners (GPs) and general practice-based pharmacists and nurse prescribers. Semi-structured interviews were conducted to illicit how the system was used by the participants in the context of medication safety work. Data analysis conducted alongside data collection was thematic and drew on socio-technical theory. PARTICIPANTS: Twenty-three interviews were conducted with 14 GPs, three nurse prescribers and three practice pharmacists between February 2018 and June 2020. RESULTS: Safety work was contextually situated in a complex network of relationships. Three interconnected themes were interpreted from the data: (1) the use of CDS within organisational and social practices and workflows; (2) safety work and the use of CDS within the interplay between prescribers, patients and populations; and (3) the affordances embedded in CDS systems. CONCLUSION: The use of sociotechnical theory here extends current thinking in patient safety particularly in the ways that safety work was co-constituted with the use of CDS alerts. This has implications for implementation and use to ensure that the contexts into which such CDS systems are implemented are taken into account. Understanding how alerts can adapt safety culture will help improve the efficacy of CDS systems, enhance prescribing safety and help to further understand how safety work is achieved in primary care.

How do stroke early supported discharge services achieve intensive and responsive service provision? Findings from a realist evaluation study (WISE).

BACKGROUND: Stroke Early Supported Discharge (ESD) involves provision of responsive and intensive rehabilitation to stroke survivors at home and it is recommended as part of the stroke care pathway. Core components have been identified to guide the delivery of evidence-based ESD, however, service provision in England is of variable quality. The study sought to understand how and in what conditions the adoption of these components drives the delivery of responsive and intensive ESD services in real world settings. METHODS: This qualitative study was part of a wider multimethod realist evaluation project (WISE) conducted to inform large-scale ESD implementation. Overarching programme theories and related context-mechanism-outcome configurations were used as a framework to guide data collection and analysis. Six case study sites were purposively selected; interviews and focus groups with ESD staff members were conducted and analysed iteratively. RESULTS: We interviewed 117 ESD staff members including clinicians and service managers. Staff highlighted the role of certain core components including eligibility criteria, capacity, team composition and multidisciplinary team (MDT) coordination in achieving responsive and intensive ESD. Regardless of the geographical setting, adhering to evidence-based selection criteria, promoting an interdisciplinary skillset and supporting the role of rehabilitation assistants, allowed teams to manage capacity issues and maximise therapy time. Gaps in the stroke care pathway, however, meant that teams had to problem solve beyond their remit to cater for the complex needs of patients with severe disabilities. Adjusting MDT structures and processes was seen as key in addressing challenges posed by travel times and rural geography. CONCLUSIONS: Despite variations in the wider service model of operation and geographical location, the adoption of core components of ESD helped teams manage the pressures and deliver services that met evidence-based standards. Findings point to a well-recognised gap in service provision in England for stroke survivors who do not meet the ESD criteria and emphasise the need for a more integrated and comprehensive stroke service provision. Transferable lessons could be drawn to inform improvement interventions aimed at promoting evidence-based service delivery in different settings. TRIAL REGISTRATION: ISRCTN: 15,568,163, registration date: 26 October 2018.

Implementing PERFECT-ER with Plan-Do-Study-Act on acute orthopaedic hospital wards: Building knowledge from an implementation study using Normalization Process Theory.

BACKGROUND: Delivering care to growing numbers of patients with increasingly 'complex' needs is currently compromised by a system designed to treat patients within organizational clinical specialties, making this difficult to reconfigure to fit care to needs. Problematic experiences of people with cognitive impairment(s) admitted to hospitals with a hip fracture, exemplify the complex challenges that result if their care is not tailored. This study explored whether a flexible, multicomponent intervention, adapting services to the needs of this patient group, could be implemented in acute hospital settings. METHODS: We used action research with case study design to introduce the intervention using a Plan-Do-Study-Act (PDSA) model to three different hospital sites (cases) across England. The qualitative data for this paper was researcher-generated (notes from observations and teleconference meetings) and change agent-generated (action plans and weekly reflective reports of change agents' activities). Normalization Process Theory (NPT) was used to analyze and explain the work of interacting actors in implementing and then normalizing (embedding) the intervention across contexts and times. Data analysis was abductive, generating inductive codes then identified with NPT constructs. Across the three cases, change agents had to work through numerous implementation challenges: needing to make sense of the intervention package, the PDSA model as implementation method, and their own role as change agents and to orientate these within their action context (coherence). They had to work to encourage colleagues to invest in these changes (cognitive participation) and find ways to implement the intervention by mobilising changes (collective action). Finally, they created strategies for clinical routines to continue to self-review, reconfiguring actions and future plans to enable the intervention to be sustained (reflexive monitoring). CONCLUSIONS: Successful implementation of the (PERFECT-ER) intervention requires change agents to recognize and engage with local values, and then to enable its fit with practice and wider contextual goals. A context of constant change fragments normalization. Thus, sustaining practice change over time is fragile and requires change agents to continue a recursive two-way sense-making process. This enables implementation and normalization to re-energize and overcome barriers to change.

Navigating the micro-politics of major system change: The implementation of Sustainability Transformation Partnerships in the English health and care system.

OBJECTIVE: To investigate how health and care leaders navigate the micro-politics of major system change (MSC) as manifest in the formulation and implementation of Sustainability and Transformation Partnerships (STPs) in the English National Health Service (NHS). METHODS: A comparative qualitative case study of three STPs carried out between 2018-2021. Data collection comprised 72 semi-structured interviews with STP leaders and stakeholders; 49h of observations of STP executive meetings, management teams and thematic committees, and documentary sources. Interpretative analysis involved developing individual and cross case reports to understand the 'disagreements, 'people and interests' and the 'skills, behaviours and practice'. FINDINGS: Three linked political fault-lines underpinned the micro-politics of formulating and implementing STPs: differences in meaning and value, perceptions of winners and losers, and structural differences in power and influence. In managing these issues, STP leaders engaged in a range of complementary strategies to understand and reconcile meanings, appraise and manage risks and benefits, and to redress longstanding power imbalances, as well as those related to their own ambiguous position. CONCLUSION: Given the lack of formal authority and breadth of system change, navigating the micro-politics of MSC requires political skills in listening and engagement, strategic appraisal of the political landscape and effective negotiation and consensus-building.

The evaluation of health care leadership development programmes: a scoping review of reviews.

PURPOSE: The purpose of this paper is to report a scoping review of reviews which investigated HLDP evaluations to determine: how the conceptualisation of leadership development programmes (HLDPs), and despite growing calls for robust evaluations of their pedagogic design, delivery and effectiveness, there are concerns regarding the quality of data associated with their evaluation. This scoping review of reviews investigated the reporting of HLDP evaluations to determine: how the conceptualisation of leadership underpinning HLDPs influence their evaluation; how the pedagogical approaches within HLDPs influence their evaluation; and the evaluation designs and measures used to assess HLDPs. DESIGN/METHODOLOGY/APPROACH: The scoping review was conducted on reviews of HLDPs. Searches were performed on four databases and on the grey literature. Data were extracted and a narrative synthesis was developed. FINDINGS: Thirty-one papers were included in the scoping review of reviews. A great deal of heterogeneity in HLDPs was identified. Evaluations of HLDPs were affected by poor data quality, and there were limitations in the evidence about "what works". Leadership was conceptualised in different ways across HLDPs, and consequently, there was a lack of consistency as to what is being evaluated and the methods used to assess HLDPs. ORIGINALITY/VALUE: This review of reviews summarises the current evidence on the evaluation of HLDPs. Evaluations of HLDPs need to explicitly account for the complexity of health systems, how this complexity impacts on the development and articulation of leadership practice, and how the underlying conceptualisation of leadership and the associated theory of change articulate a set of assumptions about how HLDPs support leaders to affect change within complex systems.

A content analysis of contributory factors reported in serious incident investigation reports in hospital care.

BACKGROUND: Serious incident (SI) investigations aim to identify factors that caused or could have caused serious patient harm. This study aimed to use the Human Factors Analysis and Classification System (HFACS) to characterise the contributory factors identified in SI investigation reports. METHODS: We performed a content analysis of 126 investigation reports from a multi-site NHS trust. We used a HFACS-based framework that was modified through inductive analysis of the data. RESULTS: Using the modified HFACS framework, 'unsafe actions' were the most commonly identified hierarchical level of contributory factors in investigation reports, which were identified 282 times across 99 (79%) incidents. 'Preconditions to unsafe acts' (identified 223 times in 91 (72%) incidents) included miscommunication and environmental factors. Supervisory factors were identified 73 times across 40 (31%) incidents, and organisational factors 115 times across 59 (47%) incidents. We identified 'extra-organisational factors' as a new HFACS level, though it was infrequently described. CONCLUSIONS: Analysis of SI investigation reports using a modified HFACS framework allows important insights into what investigators view as contributory factors. We found an emphasis on human error but little engagement with why it occurs. Better investigations will require independence and professionalisation of investigators, human factors expertise, and a systems approach.

Understanding factors that could influence patient acceptability of the use of the PINCER intervention in primary care: A qualitative exploration using the Theoretical Framework of Acceptability.

INTRODUCTION: Medication errors are an important cause of morbidity and mortality. The pharmacist-led IT-based intervention to reduce clinically important medication errors (PINCER) intervention was shown to reduce medication errors when tested in a cluster randomised controlled trial and when implemented across one region of England. Now that it has been rolled out nationally, and to enhance findings from evaluations with staff and stakeholders, this paper is the first to report patients' perceived acceptability on the use of PINCER in primary care and proposes suggestions on how delivery of PINCER related care could be delivered in a way that is acceptable and not unnecessarily burdensome. METHODS: A total of 46 participants living with long-term health conditions who had experience of medication reviews and/or monitoring were recruited through patient participant groups and social media. Semi-structured, qualitative interviews and focus groups were conducted face-to-face or via telephone. A thematic analysis was conducted and findings mapped to the constructs of the Theoretical Framework of Acceptability (TFA). RESULTS: Two themes were identified and interpreted within the most relevant TFA construct: Perceptions on the purpose and components of PINCER (Affective Attitude and Intervention Coherence) and Perceived patient implications (Burden and Self-efficacy). Overall perceptions on PINCER were positive with participants showing good understanding of the components. Access to medication reviews, which PINCER related care can involve, was reported to be limited and a lack of consistency in practitioners delivering reviews was considered challenging, as was lack of communication between primary care and other health-care providers. Patients thought it would be helpful if medication reviews and prescription renewal times were synchronised. Remote medication review consultations were more convenient for some but viewed as a barrier to communication by others. It was acknowledged that some patients may be more resistant to change and more willing to accept changes initiated by general practitioners. CONCLUSIONS: Participants found the concept of PINCER acceptable; however, acceptability could be improved if awareness on the role of primary care pharmacists is raised and patient-pharmacist relationships enhanced. Being transparent with communication and delivering streamlined and consistent but flexible PINCER related care is recommended.