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The use of healthcare simulation to identify and address latent safety threats: a scoping review.
BACKGROUND: Simulation is a well-established tool for clinical education and has been used to uncover latent safety threats (LSTs) in healthcare settings. However, the extent to which systems theory underpins efforts to detect and mitigate LSTs remains unclear. OBJECTIVE: This scoping review explores how healthcare simulations have been used to identify and address LSTs, with particular attention to the visibility and application of systems theory in study design, implementation, and analysis. METHODS: Using PRISMA-ScR, we systematically reviewed studies from 2014 to 2024 across MEDLINE, EMBASE, and grey literature sources. Studies were included if simulation was used with the primary aim of identifying LSTs. Data extraction focused on definitions of LSTs, approaches used to identify and analyse LSTs, response strategies, and the visibility of systems theory. RESULTS: Sixty-six studies met inclusion criteria. Most (74.2%) used the term "latent safety threat," though definitions varied. Many studies lacked explicit detail on how LSTs were identified (33.3%) or analysed (41.8%). Systems theory was applied with varying visibility: 36.4% showed unclear or no visibility, 43.9% showed partial visibility, and 19.7% showed full visibility. While 80.3% described actions to address LSTs, approaches ranged from one-off fixes to structured quality improvement strategies. Case studies illustrate best practices and opportunities for improvement in theoretical transparency. CONCLUSIONS: Simulation is a valuable method for identifying LSTs, but inconsistent application of systems theory and variable methodological transparency limit learning and generalisability. Future research should make theoretical underpinnings explicit, define terminology clearly, and align simulation design with both educational and organisational improvement goals.
The latent system factors that influence antimicrobial use and governance in healthcare: a scoping review of high-income health systems.
BACKGROUND: Inappropriate antimicrobial use accelerates antimicrobial resistance (AMR), creating tensions between antimicrobial stewardship and timely treatment. Despite global calls to action, gaps between recommendations and practice persist, largely due to system factors shaping clinical work. This review examines how systems approaches have been applied to the use and governance of antimicrobials. METHODS: This scoping review followed PRISMA-ScR. Eligible sources included empirical studies, reviews, protocols, theses/dissertations, and improvement projects across healthcare settings in high-income countries. Studies required explicit use of systems approaches. EMBASE, MEDLINE, and CINAHL were searched in November 2024. Grey literature was added in February 2025. Search was updated in July 2025. Three researchers extracted data on study characteristics, systems approaches, and organisational implications. Review was preregistered (https://osf.io/p3xsf). FINDINGS: 25 articles were ultimately included. Seven focused on acute care and 18 leveraged interviews. Among studies involving participants (n = 18), 12 involved only frontline level participants, four involved participants from different organisational levels with a focus on frontline settings, and two focused on management settings. Implications of the use of systems approaches were identified across three organisational levels: micro (patient care), meso (management), and macro (leadership). INTERPRETATION: This is the first review to map the implications of systems approaches for AMR at different organisational levels. Findings suggest gaps in the application of systems approaches at levels most responsible for strategic decisions and implementation. Given recent criticism about safety management and calls for strong AMS leadership, this gap represents a missed improvement opportunity. Future research should explore how alignment toward AMS is impacted due to system factors within and between organisational levels. FUNDING: Supported by INEOS Oxbridge Initiative on Antimicrobial Resistance (Project number E4R00010).
Exploring trainee experiences in a structured virtual reality laparoscopic training programme for general surgeons: a longitudinal case study.
BACKGROUND: The acquisition and maintenance of technical skills in surgical specialties has become increasingly challenging for postgraduate trainees, exacerbated by factors such as the shift from traditional apprenticeship models, reduced operative time, and the impact of the COVID-19 pandemic. Virtual reality (VR) simulators offer a promising adjunct to traditional surgical training, though their integration into routine practice remain underexplored. OBJECTIVE: This qualitative study investigates the experiences and motivations of general surgical trainees who engaged with a VR laparoscopic simulator as part of a structured training program. METHODS: A case study methodology was chosen to explore the experiences of 22 general surgery trainees using a VR laparoscopic simulator over a period of 3 months. Each of the trainees were adviced to practise a minimum of five repetitions across 25 laparoscopic simulator exercises. The study was designed using Kopta's theory of technical skill learning, focusing on the cognitive phase, where trainees repetitively practised individual steps with feedback. Data collection involved qualitative questionnaires, semi-structured interviews (of seven of the trainees, 8 months later), and quantitative data from the simulator. The qualitative data was analysed using thematic analysis, and descriptive statistical tests were applied to the quantitative data for triangulation. RESULTS: The study identified key factors influencing trainee engagement, including ease of access, the importance of periodic rather than frequent simulation sessions, Annual Review of Competency Progression (ARCP) overview and the value of setting specific performance goals. The findings suggest that simulation can effectively complement traditional surgical training when incorporated into routine practice, with potential for broader application if barriers such as time constraints and access issues are addressed. CONCLUSION: This study contributes to the literature on surgical education by highlighting the need for targeted strategies to enhance the use of simulation as an adjunct alongside more traditional training.
Designing better systems to navigate the sepsis-antimicrobial stewardship tension.
Sepsis is a leading cause of preventable death and requires timely antimicrobial treatment to reduce mortality. Despite extensive sepsis management guidelines, high-income countries continue to have considerable rates of sepsis mortality, indicating a gap between guideline quality, usability, and practical application. Simultaneously, the rise of antimicrobial resistance threatens the efficacy of antimicrobial therapies for infection control, underscoring the tension between sepsis management and antimicrobial stewardship. This Personal View explores how system factors, such as people, environments, tools, technologies, and tasks, influence the sepsis-antimicrobial stewardship tension. With the Systems Engineering Initiative for Patient Safety, we use a case study to highlight how organisational pressures, inadequate diagnostic tools, and sociocultural factors drive the gap between work-as-imagined and work-as-done. These latent safety risks that impede guideline adherence and contribute to unintended antimicrobial use highlight the need to design better systems, not blame individuals for non-compliance. We argue that addressing sepsis and antimicrobial resistance requires a holistic systems approach and that every discipline, including policy makers, clinicians, researchers, and drug developers, should adopt systems thinking in the design of interventions intended to address this problem. This shift is essential to ensuring effective care for patients today while safeguarding the effectiveness of antimicrobials tomorrow.
Reducing inequalities through greater diversity in clinical trials - As important for medical devices as for drugs and therapeutics.
In medicine and public health, the randomised controlled trial (RCT) is generally considered the key generator of 'gold standard' evidence. However, basic and clinical research and trials are often unrepresentative of real-world populations. Recruiting insufficiently diverse cohorts of participants in trials (e.g. in terms of socioeconomic status, racial and ethnic background, or sex and gender) may not only overstate the general effectiveness of a technology; it may also actively increase health inequalities. We highlight some general issues in this domain, before discussing several specific illustrative examples in the context of medical devices. High quality evidence on factors that would improve trial recruitment is extremely limited. There is a clear need for research on candidate strategies for improving recruitment of under-represented groups in RCTs. These could include, for example, offering various forms of financial incentives; non-monetary incentives, such as preferential access to the technologies that are being tested if they are found to be effective; and various types of informational messages and nudges; as well as involvement of community partners and champions in the recruitment process. Ideally, recruitment practices should ultimately be based on evidence generated from RCTs. Studies Within a Trial (SWAT), where randomised experiments are built into the actual recruitment processes in RCTs, are an ideal way to gain this evidence. SWAT studies are seeing an increase in traction, as indicated by funding streams in bodies such as the UK-based NIHR. Making greater funding available for studies of this kind is needed to improve the evidence base on how best to improve diversity in trial recruitment.
Systems analysis of clinical incidents: development of a new edition of the London Protocol.
The investigation of incidents and accidents, together with subsequent reflection and action, is an essential component of safety management in every safety-critical industry, including healthcare. A number of formal methods of incident analysis were developed in the early days of risk management and patient safety, including the London Protocol which was published in 2004. In this paper, we describe the development of a new edition of the London Protocol. We explain the need for a revised and expanded version of the London Protocol, addressing both the changes in healthcare in the last two decades and what has been learnt from the experience of incident analysis across the world. We describe a systematic process of development of the new edition drawing on the findings of a narrative review of incident analysis methods. The principal changes in the new edition are as follows: increased emphasis and guidance on the engagement of patients and families as partners in the investigation; giving more attention to the support of patients, families and staff in the aftermath of an incident; emphasising the value of a small number of in-depth analyses combined with thematic reviews of wider problems; including proposals and guidance for the examination of much longer time periods; emphasising the need to highlight good care as well as problems; adding guidance on direct observation of the work environment; providing a more structured and wide-ranging approach to recommendations and including more guidance on how to write safety incident reports. Finally, we offer some proposals to place research on incident analysis on a firmer foundation and make suggestions for the practice and implementation of incident investigation within safety management systems.
Study protocol for putting the 'Person' in the PiCTuRE: an exploratory sequential mixed methods-based design, exploring how precision medicine is implemented and experienced by people living with a primary tumour of the craniospinal axis.
INTRODUCTION: Primary tumours of the brain and spine are rare, heterogeneous, and frequently associated with significant morbidity and mortality. Advances in precision oncology and personalised medicine offer the potential to accelerate diagnosis, improve clinical outcomes, and yield critical insights into the molecular biology of these cancers of unmet need. Despite this, patient engagement in this area remains limited. Well-organised neuro-oncological biorepositories-those that are clinically integrated, fully consented, and derived from routine care-are limited and fragmented, which impedes progress. Therefore, it is crucial to examine the barriers to tissue donation and data integration within the NHS by analysing patients' lived experiences. The PiCTuRE (Personalised Consent in Tissue donation for neuroscience Research, lived Experiences) study aims to develop a digital platform that provides customised, individualised, and interactive support to assist patients in their decision-making regarding tissue donation for research and participation in related clinical trials. METHODS & ANALYSIS: PiCTuRE is a multistage, mixed-methods, exploratory sequential investigation aimed at understanding the lived experiences of individuals donating tissue for research. It consists of three phases: Phase 1 involves an online survey to collect lived experience data, followed by semi-structured interviews to further explore individual perspectives. Thematic analysis will be performed to identify key themes. In Phase 2, patient-reported experience data will be gathered through co-design and statistically analysed to validate content for the development of the digital platform. Phase 3 will refine this intervention through iterative cycles of Phases 1 and 2, in collaboration with patients with lived experience of brain or spine tumours, to prepare it for integration into routine clinical practice. ETHICS AND DISSEMINATION: Ethical approval has been obtained via the Medical Sciences Interdivisional Research Ethics Committee (MS IDREC), University of Oxford (R79248/RE001). Findings will be disseminated via podium presentations, public patient initiatives in partnership with charities, in peer-reviewed publications and via social media. TRIAL REGISTRATION NUMBER: ISRCTN12601034.
Patient safety incidents in anaesthesia: a qualitative study of trainee experience from a single UK healthcare region.
BACKGROUND: Anaesthetic training has always had patient safety as part of the curriculum. However, there is limited emphasis on what happens when things do not go to plan. Our aims were to understand the impact of involvement in patient safety incidents on anaesthetic trainees in our region, to describe the range of support currently offered and put forward suggestions for improvement. METHODS: An initial electronic survey was sent to all anaesthetic trainees in a single UK healthcare region to capture qualitative and quantitative information on patient safety incidents. After completing the questionnaire, participants were asked to consent to involvement in a semi-structured interview to provide a more detailed understanding of the impact of safety incidents. Data were analysed from the questionnaires and interview transcripts using descriptive statistics and thematic analysis. RESULTS: Thirty-four completed questionnaires were analysed revealing 27 trainees had been involved in a patient safety incident. Ten semi-structured interviews were conducted and six themes were identified: team dynamics (including adequacy of staffing and supportive departmental culture); context of the event; reflex immediate support post-event; working environment pending completion of the investigation; personal impact (including physical and mental health); and suggestions for future support. CONCLUSION: This study has shown the significant impact of safety incidents on anaesthetic trainees in one training region in the UK and highlights the importance of implementing early, tailored debriefs led by trained facilitators, the value of a supportive work environment and the need to raise awareness of system-based approaches to learning from incident investigations. Further research should guide the format and delivery of support for trainees to provide more helpful and timely interventions after patient safety incidents and reduce the risk of future harm to both patients and trainees.
Strategies for adapting under pressure: an interview study in intensive care units.
BACKGROUND: Healthcare systems are operating under substantial pressures. Clinicians and managers are constantly having to make adaptations, which are typically improvised, highly variable and not coordinated across teams. This study aimed to identify and describe the types of everyday pressures in intensive care and the adaptive strategies staff use to respond, with the longer-term aim of developing practical and coordinated strategies for managing under pressure. METHODS: We conducted qualitative semi-structured interviews with 20 senior multidisciplinary healthcare professionals from intensive care units (ICUs) in 4 major hospitals in the UK. The interviews explored the everyday pressures faced by intensive care staff and the strategies they use to adapt. A thematic template analysis approach was used to analyse the data based on our previously empirically developed taxonomy of pressures and strategies. RESULTS: The principal source of pressure described was a shortage of staff with the necessary skills and experience to care for the increased numbers and complexity of patients which, in turn, increased staff workload and reduced patient flow. Strategies were categorised into anticipatory (in advance of anticipated pressures) and on the day. The dynamic and unpredictable demands on ICUs meant that strategies were mostly deployed on the day, most commonly by flexing staff, prioritisation of patients and tasks and increasing modes of communication and support. CONCLUSIONS: ICU staff use a wide variety of adaptive strategies at times of pressure to minimise risk and maintain a reasonable standard of care for patients. These findings provide the foundation for a portfolio of strategies, which can be flexibly employed when under pressure. There is considerable potential for training clinical leaders and teams in the effective use of adaptive strategies.
Mind the Gap: A Scoping Literature Review and Thematic Analysis to Understand the Barriers to Using Technical Skills Simulation in Surgical Training
Purpose: To identify barriers to implementing technical skills simulation in surgical training. Methods: A scoping literature review was conducted in September 2024 by searching Medline and EMBASE databases using predefined terms. The included studies were thematically analysed to understand the barriers to implementing technical skills simulation for surgical training. Results: Of the 201 studies identified, 20 met inclusion criteria, representing diverse global regions and using quantitative (n = 13), qualitative (n = 4), and review (n = 3) methodologies. Six key interrelated barriers were identified: (1) limited faculty availability and support, (2) inadequate simulation space, (3) lack of technical staff, (4) funding constraints, (5) insufficient trainee time and engagement, and (6) absence of long-term sustainability planning. Conclusion: Implementation of technical skills simulation in surgical training faces six interrelated barriers spanning faculty, infrastructure, staffing, funding, trainee engagement, and long-term strategy. Addressing these challenges requires coordinated efforts in faculty development, curriculum reform, and strategic resource planning, alongside a cultural shift to embed sustainable simulation in surgical education.
Prospective randomized evaluation of the sustained impact of assistive artificial intelligence on anesthetists' ultrasound scanning for regional anesthesia.
OBJECTIVES: Ultrasound-guided regional anesthesia (UGRA) relies on acquiring and interpreting an appropriate view of sonoanatomy. Artificial intelligence (AI) has the potential to aid this by applying a color overlay to key sonoanatomical structures.The primary aim was to determine whether an AI-generated color overlay was associated with a difference in participants' ability to identify an appropriate block view over a 2-month period after a standardized teaching session (as judged by a blinded assessor). Secondary outcomes included the ability to identify an appropriate block view (unblinded assessor), global rating score and participant confidence scores. DESIGN: Randomized, partially blinded, prospective cross-over study. SETTING: Simulation scans on healthy volunteers. Initial assessments on 29 November 2022 and 30 November 2022, with follow-up on 25 January 2023 - 27 January 2023. PARTICIPANTS: 57 junior anesthetists undertook initial assessments and 51 (89.47%) returned at 2 months. INTERVENTION: Participants performed ultrasound scans for six peripheral nerve blocks, with AI assistance randomized to half of the blocks. Cross-over assignment was employed for 2 months. MAIN OUTCOME MEASURES: Blinded experts assessed whether the block view acquired was acceptable (yes/no). Unblinded experts also assessed this parameter and provided a global performance rating (0-100). Participants reported scan confidence (0-100). RESULTS: AI assistance was associated with a higher rate of appropriate block view acquisition in both blinded and unblinded assessments (p=0.02 and <0.01, respectively). Participant confidence and expert rating scores were superior throughout (all p<0.01). CONCLUSIONS: Assistive AI was associated with superior ultrasound scanning performance 2 months after formal teaching. It may aid application of sonoanatomical knowledge and skills gained in teaching, to support delivery of UGRA beyond the immediate post-teaching period. TRIAL REGISTRATION NUMBER: www.clinicaltrials.govNCT05583032.
Adopting human factors in early phase and experimental medicine research: A nested pilot study observing controlled human infection with SARS-CoV-2.
AIMS: The influence of human factors on safety in healthcare settings is well established, with targeted interventions reducing risk and enhancing team performance. In experimental and early phase clinical research participant safety is paramount and safeguarded by guidelines, protocolized care and staff training; however, the real-world interaction and implementation of these risk-mitigating measures has never been subjected to formal system-based assessment. METHODS: Independent structured observations, systematic review of study documents, and interviews and focus groups were used to collate data on three key tasks undertaken in a clinical research facility (CRF) during a SARS CoV-2 controlled human infection model (CHIM) study. The Systems Engineering Initiative for Patient Safety (SEIPS) was employed to analyse and categorize findings, and develop recommendations for safety interventions. RESULTS: High levels of team functioning and a clear focus on participant safety were evident throughout the study. Despite this, latent risks in both study-specific and CRF work systems were identified in all four SEIPS domains (people, environment, tasks and tools). Fourteen actionable recommendations were generated collaboratively. These included inter-organization and inter-study standardization, optimized checklists for safety critical tasks, and use of simulation for team training and exploration of work systems. CONCLUSIONS: This pioneering application of human factors techniques to analyse work systems during the conduct of research in a CRF revealed risks unidentified by routine review and appraisal, and despite international guideline adherence. SEIPS may aid categorization of system problems and the formulation of recommendations that reduce risk and mitigate potential harm applicable across a trials portfolio.
Artificial intelligence for ultrasound scanning in regional anaesthesia: a scoping review of the evidence from multiple disciplines.
BACKGROUND: Artificial intelligence (AI) for ultrasound scanning in regional anaesthesia is a rapidly developing interdisciplinary field. There is a risk that work could be undertaken in parallel by different elements of the community but with a lack of knowledge transfer between disciplines, leading to repetition and diverging methodologies. This scoping review aimed to identify and map the available literature on the accuracy and utility of AI systems for ultrasound scanning in regional anaesthesia. METHODS: A literature search was conducted using Medline, Embase, CINAHL, IEEE Xplore, and ACM Digital Library. Clinical trial registries, a registry of doctoral theses, regulatory authority databases, and websites of learned societies in the field were searched. Online commercial sources were also reviewed. RESULTS: In total, 13,014 sources were identified; 116 were included for full-text review. A marked change in AI techniques was noted in 2016-17, from which point on the predominant technique used was deep learning. Methods of evaluating accuracy are variable, meaning it is impossible to compare the performance of one model with another. Evaluations of utility are more comparable, but predominantly gained from the simulation setting with limited clinical data on efficacy or safety. Study methodology and reporting lack standardisation. CONCLUSIONS: There is a lack of structure to the evaluation of accuracy and utility of AI for ultrasound scanning in regional anaesthesia, which hinders rigorous appraisal and clinical uptake. A framework for consistent evaluation is needed to inform model evaluation, allow comparison between approaches/models, and facilitate appropriate clinical adoption.
Adaptive strategies used by surgical teams under pressure: an interview study among senior healthcare professionals in four major hospitals in the United Kingdom.
BACKGROUND: Healthcare systems are operating under substantial pressures, and often simply cannot provide the standard of care they aspire to within the available resources. Organisations, managers, and individual clinicians make constant adaptations in response to these pressures, which are typically improvised, highly variable and not coordinated across clinical teams. The purpose of this study was to identify and describe the types of everyday pressures experienced by surgical teams and the adaptive strategies they use to respond to these pressures. METHODS: We conducted interviews with 20 senior multidisciplinary healthcare professionals from surgical teams in four major hospitals in the United Kingdom. The interviews explored the types of everyday pressures staff were experiencing, the strategies they use to adapt, and how these strategies might be taught to others. RESULTS: The primary pressures described by senior clinicians in surgery were increased numbers and complexity of patients alongside shortages in staff, theatre space and post-surgical beds. These pressures led to more difficult working conditions (e.g. high workloads) and problems with system functioning such as patient flow and cancellation of lists. Strategies for responding to these pressures were categorised into increasing or flexing resources, controlling and prioritising patient demand and strategies for managing the workload (scheduling for efficiency, communication and coordination, leadership, and teamwork strategies). CONCLUSIONS: Teams are deploying a range of strategies and making adaptations to the way care is delivered. These findings could be used as the basis for training programmes for surgical teams to develop coordinated strategies for adapting under pressure and to assess the impact of different combinations of strategies on patient safety and surgical outcomes.