SEA change - the use of significant event analysis in primary care teaching.

BACKGROUND: Significant event analysis (SEA) is a concept familiar to clinicians as a means to facilitate group learning. Our academic primary care teaching team recognised that often significant educational events are not afforded the same formal evaluation and reflection. We designed a proforma for the analysis of events in our setting and scheduled regular meetings to discuss those events raised. In this paper we describe a year long trial of our novel Significant Event Analysis for Education (SEAFE). EVALUATION: The pilot was evaluated using an online questionnaire. DISCUSSION: Over the 12 months of the pilot 19 SEAFEs raised and discussed with a wide range of subjects covered. 78% of our team felt that the use of SEAFEs had imporved their practice as clinical academics and 89% supported the continued use of SEAFE. CONCLUSION: We have demontrated that SEA can be used in an academic primary care educational setting to bring about group learning and improvement in academic practice. We are planning to continue the use of SEAFE within our team with plans to try to pilot this outside of a primary care setting soon.

Understanding and responding when things go wrong: key principles for primary care educators.

Learning from events with unwanted outcomes is an important part of workplace based education and providing evidence for medical appraisal and revalidation. It has been suggested that adopting a 'systems approach' could enhance learning and effective change. We believe the following key principles should be understood by all healthcare staff, especially those with a role in developing and delivering educational content for safety and improvement in primary care. When things go wrong, professional accountability involves accepting there has been a problem, apologising if necessary and committing to learn and change. This is easier in a 'Just Culture' where wilful disregard of safe practice is not tolerated but where decisions commensurate with training and experience do not result in blame and punishment. People usually attempt to achieve successful outcomes, but when things go wrong the contribution of hindsight and attribution bias as well as a lack of understanding of conditions and available information (local rationality) can lead to inappropriately blame 'human error'. System complexity makes reduction into component parts difficult; thus attempting to 'find-and-fix' malfunctioning components may not always be a valid approach. Finally, performance variability by staff is often needed to meet demands or cope with resource constraints. We believe understanding these core principles is a necessary precursor to adopting a 'systems approach' that can increase learning and reduce the damaging effects on morale when 'human error' is blamed. This may result in 'human error' becoming the starting point of an investigation and not the endpoint.

Systematic review of clinical debriefing tools: attributes and evidence for use.

BACKGROUND AND OBJECTIVES: Clinical debriefing (CD) following a clinical event has been found to confer benefits for staff and has potential to improve patient outcomes. Use of a structured tool to facilitate CD may provide a more standardised approach and help overcome barriers to CD; however, we presently know little about the tools available. This systematic review aimed to identify tools for CD in order to explore their attributes and evidence for use. METHODS: A systematic review was conducted in line with PRISMA standards. Five databases were searched. Data were extracted using an electronic form and analysed using critical qualitative synthesis. This was guided by two frameworks: the '5 Es' (defining attributes of CD: educated/experienced facilitator, environment, education, evaluation and emotions) and the modified Kirkpatrick's levels. Tool utility was determined by a scoring system based on these frameworks. RESULTS: Twenty-one studies were included in the systematic review. All the tools were designed for use in an acute care setting. Criteria for debriefing were related to major or adverse clinical events or on staff request. Most tools contained guidance on facilitator role, physical environment and made suggestions relating to psychological safety. All tools addressed points for education and evaluation, although few described a process for implementing change. Staff emotions were variably addressed. Many tools reported evidence for use; however, this was generally low-level, with only one tool demonstrating improved patient outcomes. CONCLUSION: Recommendations for practice based on the findings are made. Future research should aim to further examine outcomes evidence of these tools in order to optimise the potential of CD tools for individuals, teams, healthcare systems and patients.

Extravasation of radiopharmaceuticals: Why report?

In this essay, I wish to discuss extravasation in the context of medical imaging and therapy with radiopharmaceuticals. Central to this discussion are two facts. First, they are easily identified, but the frequency of significant extravasations is unclear because there is no generally accepted definition of such an event. And second, there appears to be few reports of injuries from these events. The central thesis of this essay is that these events should be reported and followed so that agreement can be reached on the definition of a "significant" event which should be classified as a medical event in accordance with US Nuclear Regulatory Commission (NRC) regulations. I will also outline steps that can be taken to reduce the risk of extravasations.

Current Irish medicolegal landscape: an unsustainable trajectory.

A number of outstanding clinical claims that are yet to be resolved as well as their associated estimated costs are at a record high in Ireland. By the end of 2022, the Irish government face 3875 active clinical claims which are expected to cost €3.85 billion in total. This does not account for future claims yet to be brought. The financial burden will be borne by the Irish healthcare system which is already facing unprecedented pressures on its services and staff. If current trends continue, the opportunity costs of the current medicolegal landscape will impact the future provision of healthcare. Aside from the financial consequences, clinical claims have numerous negative impacts on all parties involved. Gaining an understanding as to why claims and costs continue to increase relies on access to, and analysis of high-quality patient safety data, including learning from previous litigation. Addressing the causal and perpetuating factors requires efficient implementation of evidence-based recommendations through engagement with stakeholders, including the public. It is necessary to continuously assess the implementation of recommendations as well as measure their impact. This is to ensure that novel efforts from this point onwards do not suffer the same fate as many previous recommendations that, because of a lack of follow-on research, appear to go no further than the page of the report they are written. Action is required now to change the course of the currently unsustainable trajectory of the Irish medicolegal landscape.

Training items for trainee residents in community medicine in rural areas.

OBJECTIVE: To examine the significant events experienced by initial trainees during community medicine training, evaluate their impact on community medicine practice, and support improvements in rural community medicine training. RESULTS: Three faculty teachers independently evaluated the reports of 25 residents who had completed a four-week community medicine training in a rural area to analyze major events. The reports were analyzed using topics from the Model Core Curriculum for Medical Education that relate to rural medicine. The most frequently reported items were identified as follows: Primary care: 9 (36.0%); integrated community care systems: 8 (32.0%); medical care in the local community: 7 (28.0%); home health care and systems, patient-physician relationship, and end-of-life medical treatment and care: 6 each (24.0%). Reports from residents describing events related to home health care and systems and end-of-life medical treatment and care were related to more than one item.

Relationship between the Use of Fentanyl-Based Intravenous Patient-Controlled Analgesia and Clinically Significant Events in Laparoscopic Gynecological Surgery: A Single-Center Retrospective Cohort Study.

Background: This study examined the relationship between the use of fentanyl-based intravenous patient-controlled analgesia (ivPCA) and the incidence of a clinically significant event (CSE), while considering both the analgesic effects and side effects in laparoscopic gynecological surgery. Methods: This study included 816 patients undergoing laparoscopic gynecological surgery under general anesthesia at Kyoto University Hospital between 2012 and 2018. The primary exposure was the use of fentanyl-based ivPCA. We defined an outcome measure­CSE­that integrates severe wound pain and vomiting assumed to negatively affect patient recovery. We performed multivariable logistic regression analysis to assess the independent relationship between ivPCA use and CSE. Results: Multivariable logistic regression analysis revealed that fentanyl-based ivPCA was independently associated with increased CSE (adjusted odds ratio (95% confidence interval): 1.80 (1.24−2.61), p = 0.002). Use of ivPCA was associated with a reduced incidence of postoperative severe wound pain (adjusted odds ratio (95% confidence interval): 0.50 (0.27−0.90), p = 0.022), but was also associated with an increased incidence of vomiting (adjusted odds ratio (95% confidence interval): 2.65 (1.79−3.92), p < 0.001). Conclusion: The use of fentanyl-based ivPCA in laparoscopic gynecological surgery is associated with increased CSE.

How to manage accidental and unintended exposure in radiology: an ESR white paper.

Since February 2018, the Directive 2013/59/EURATOM (EU-BSS) requires all EU member states to implement a system for recording and analysis of all accidental or unintended medical exposures (Article 63). An ESR questionnaire in May 2018 among ESR member countries including all EU member states (MS) revealed a very heterogeneous and unsatisfactory situation in transposition of the EU-BSS. Some MS just translated this part of the directive, others used effective dose as reporting criteria and others used physical dose parameters from the modalities. This white paper will help national scientific organisations advice their national regulators and authorities on how to provide a simple and practicable implementation of the directive. ESR recommends notification and reporting criteria for significant events based on physical quantities and units and not on effective dose or text-based criteria like "significantly different" (EU-BSS, Article 4 (99)).

Video intervention to improve incident reporting among medical trainees.

INTRODUCTION/OBJECTIVE: Improving graduate medical trainee involvement with patient safety and incident reporting is an important task in teaching hospitals that has been recognised across the country and led to numerous efforts to address barriers to incident reporting. A variety of studies have started to define the reasons why trainees are not optimally involved and interventions that may be helpful. The present study aims to add to this literature by primarily addressing barriers that can be considered 'non-technical' such as fears surrounding potential professional repercussions after submitting a report, perceptions that reporting incidents is not useful, and concerns about anonymity. METHODS: Barriers to incident reporting were previously analysed at our institution. A video was produced to directly target the barriers discovered. A 2-hour educational session was delivered which included the video intervention. The educational session was part of the standard patient safety curriculum at our institution. Paper surveys were used to capture changes in perceived barriers to incident reporting. Baseline and postintervention surveys were analysed for changes using t-tests and a p value of <0.05 to determine significance. Survey development included literature review, patient safety expert discussion and cognitive interviews. RESULTS: Perceived knowledge about the reporting process significantly improved after the intervention (t=-4.49; p<0.05). Attitudes about reporting also significantly improved with reduction in fear of negative consequences and anonymity. Perceptions of reporting being a futile activity were also diminished after the intervention. CONCLUSIONS: This study demonstrates that targeting non-technical barriers to incident reporting with a video intervention is an effective way to improve perceived knowledge and attitude about incident reporting.

Are morbidity and mortality case review practices in Scottish intensive care units aligned to national standards?

INTRODUCTION: Both Scottish and UK standards guidelines recommend that intensive care units should hold regular, structured, multidisciplinary morbidity and mortality meetings. The aim of this survey was to ascertain the nature of current practice with regards to morbidity and mortality case reviews and meetings in all intensive care units in Scotland. METHODS: Semi-structured telephone interviews were conducted with a consultant from all Scottish intensive care units. A list of intensive care units in Scotland was obtained from the Scottish Intensive Care Society Audit Group annual report. RESULTS: All 24 intensive care units (100%) in Scotland were surveyed. The interviews took an average of 20 min. The three cardiac intensive care units were excluded from analysis. All other intensive care units had morbidity and mortality meetings and 18 units had a morbidity and mortality clinical lead. Nineteen intensive care units held joint morbidity and mortality meetings, eight of which were regular. In all intensive care units, meetings were attended by consultants and trainees. In 14 intensive care units, meetings were attended by nurses, seven by allied health professionals, 1 by a manager and 11 by other professionals. All mortality cases in intensive care unit were discussed in 19 intensive care units, in the other two intensive care units, 10-20% of mortality cases were discussed. CONCLUSION: There is a wide variation in the processes of reviewing mortality cases and significant events in intensive care units across Scotland, and in the way morbidity and mortality meetings are organised and held. Based on this survey, there is scope for improving the consistency of approach to morbidity and mortality case reviews and meetings in order to improve education and facilitate shared learning.

International recommendations for national patient safety incident reporting systems: an expert Delphi consensus-building process.

BACKGROUND: Patient safety incident reporting systems (PSRS) have been established for over a decade, but uncertainty remains regarding the role that they can and ought to play in quantifying healthcare-related harm and improving care. OBJECTIVE: To establish international, expert consensus on the purpose of PSRS regarding monitoring and learning from incidents and developing recommendations for their future role. METHODS: After a scoping review of the literature, semi-structured interviews with experts in PSRS were conducted. Based on these findings, a survey-based questionnaire was developed and subsequently completed by a larger expert panel. Using a Delphi approach, consensus was reached regarding the ideal role of PSRSs. Recommendations for best practice were devised. RESULTS: Forty recommendations emerged from the Delphi procedure on the role and use of PSRS. Experts agreed reporting system should not be used as an epidemiological tool to monitor the rate of harm over time or to appraise the relative safety of hospitals. They agreed reporting is a valuable mechanism for identifying organisational safety needs. The benefit of a national system was clear with respect to medication error, device failures, hospital-acquired infections and never events as these problems often require solutions at a national level. Experts recommended training for senior healthcare professionals in incident investigation. Consensus recommendation was for hospitals to take responsibility for creating safety solutions locally that could be shared nationally. CONCLUSIONS: We obtained reasonable consensus among experts on aims and specifications of PSRS. This information can be used to reflect on existing and future PSRS, and their role within the wider patient safety landscape. The role of PSRS as instruments for learning needs to be elaborated and developed further internationally.

Our current approach to root cause analysis: is it contributing to our failure to improve patient safety?

BACKGROUND: Despite over a decade of efforts to reduce the adverse event rate in healthcare, the rate has remained relatively unchanged. Root cause analysis (RCA) is a process used by hospitals in an attempt to reduce adverse event rates; however, the outputs of this process have not been well studied in healthcare. This study aimed to examine the types of solutions proposed in RCAs over an 8-year period at a major academic medical institution. METHODS: All state-reportable adverse events were gathered, and those for which an RCA was performed were analysed. A consensus rating process was used to determine a severity rating for each case. A qualitative approach was used to categorise the types of solutions proposed by the RCA team in each case and descriptive statistics were calculated. RESULTS: 302 RCAs were reviewed. The most common event types involved a procedure complication, followed by cardiopulmonary arrest, neurological deficit and retained foreign body. In 106 RCAs, solutions were proposed. A large proportion (38.7%) of RCAs with solutions proposed involved a patient death. Of the 731 proposed solutions, the most common solution types were training (20%), process change (19.6%) and policy reinforcement (15.2%). We found that multiple event types were repeated in the study period, despite repeated RCAs. CONCLUSIONS: This study found that the most commonly proposed solutions were weaker actions, which were less likely to decrease event recurrence. These findings support recent attempts to improve the RCA process and to develop guidance for the creation of effective and sustainable solutions to be used by RCA teams.

El reciclaje: Hecho significativo del valor ambiental desde el entorno educativo y su influencia en la salud / Recycling: a significant fact of environmental value from the educational environment and its influence on health

El reciclaje, la reutilización y la reducción en el consumo, es la demostración más concreta de una toma de conciencia en el ser y su papel protagonista en los procesos transformadores de nuestra realidad como especie. En este sentido, vemos que inculcar conocimientos en el área, desde las más jóvenes generaciones, hasta nuestros ancianos, puede lograr positivos cambios para la salud general, tanto del planeta, como del ser humano, siendo el propósito de la investigación conocer la importancia del reciclaje como un hecho significativo para exaltar el valor ambiental en los estudiantes. En cuanto al apartado epistemo­metodológico, se trabajó bajo el paradigma interpretativo, con un método fenomenológico­hermenéutico, usando la observación participante y la entrevista en profundidad, como técnicas de recolección de información, las cuales se aplicaron a un sujeto informante del aula de 4to año, siendo éste seleccionado por ser el más adecuado para el estudio. La técnica de análisis fue reducciones fenomenológicas a los extractos más importantes de la información, la cual fue proporcionada por el sujeto informante durante la entrevista, donde surgieron las categorías que se desglosaron en un cierre eidético que dio a conocer las ideas de la esencia verdadera del pensamiento del informante, así como también se hizo un giro hermenéutico, el cual logró proporcionar sentido a lo que se expresó en la investigación, como un aporte del investigador para dar visión a todo aquello en lo que se puede ir más allá del proceso investigativo(AU)

Recycling, reuse and reduction in consumption is the most concrete demonstration of an awareness of being and its leading role in the transforming processes of our reality as a species. In this sense, we see that instilling knowledge in the area, from the youngest generations, to our elders, can achieve positive changes for the general health, both of the planet and of the human being, the purpose of the research being to know the importance of recycling as a significant fact to exalt the environmental value in students. As for the epistemological-methodological section, we worked under the interpretive paradigm, with a phenomenological-hermeneutic method, using participant observation and in-depth interview, as information collection techniques, which were applied to an informant subject from the classroom of 4th year, this being selected for being the most suitable for the study. The analysis technique was phenomenological reductions to the most important extracts of the information, which was provided by the informant subject during the interview, where the categories emerged that were broken down into an eidetic closure that revealed the ideas of the true essence of the informant's thought, as well as a hermeneutical turn, which managed to provide meaning to what was expressed in the investigation, as a contribution of the researcher to give vision to everything in which one can go beyond the investigative process(AU)

Patient Safety in Complementary Medicine through the Application of Clinical Risk Management in the Public Health System.

Aim: To develop a systematic approach to detect and prevent clinical risks in complementary medicine (CM) and increase patient safety through the analysis of activities in homeopathy and acupuncture centres in the Tuscan region using a significant event audit (SEA) and failure modes and effects analysis (FMEA). Methods: SEA is the selected tool for studying adverse events (AE) and detecting the best solutions to prevent future incidents in our Regional Healthcare Service (RHS). This requires the active participation of all the actors and external experts to validate the analysis. FMEA is a proactive risk assessment tool involving the selection of the clinical process, the input of a multidisciplinary group of experts, description of the process, identification of the failure modes (FMs) for each step, estimates of the frequency, severity, and detectability of FMs, calculation of the risk priority number (RPN), and prioritized improvement actions to prevent FMs. Results: In homeopathy, the greatest risk depends on the decision to switch from allopathic to homeopathic therapy. In acupuncture, major problems can arise, mainly from delayed treatment and from the modalities of needle insertion. Conclusions: The combination of SEA and FMEA can reveal potential risks for patients and suggest actions for safer and more reliable services in CM.

Patient safety incident reporting: a qualitative study of thoughts and perceptions of experts 15†years after 'To Err is Human'.

One of the key recommendations of the Institute of Medicine's (IOM) report, To Err is Human, 15 years ago was for greater attention to incident reporting in healthcare, analogous to the role it has played in aviation and other high-risk industries. With the passage of time and maturation of the patient safety field, we conducted semistructured interviews with 11 international patient safety experts with knowledge of the US healthcare and meeting at least one of the following criteria: (1) involved in the development of the IOM's recommendations, (2) responsible for the design and/or implementation of national or regional incident reporting systems, (3) conducted research on patient safety/incident reporting at a national level. Five key challenges emerged to explain why incident reporting has not reached its potential: poor processing of incident reports (triaging, analysis, recommendations), inadequate engagement of doctors, insufficient subsequent visible action, inadequate funding and institutional support of incident reporting systems and inadequate usage of evolving health information technology. Leading patient safety experts acknowledge the current challenges of incident reports. The future of incident reporting lies in targeted incident reporting, effective triaging and robust analysis of the incident reports and meaningful engagement of doctors. Incident reporting must be coupled with visible, sustainable action and linkage of incident reports to the electronic health record. If the healthcare industry wants to learn from its mistakes, miss or near miss events, it will need to take incident reporting as seriously as the health budget.

Patient safety in primary care: incident reporting and significant event reviews in British general practice.

Over the past 20 years, healthcare has adapted to the 'quality revolution' by moving away from direct provision and hierarchical control mechanisms. In their place, new structures based on contractual relationships are being developed coupled with attempts to create an organisational culture that shares learning and that scrutinises existing practice so that it can be improved. The issue here is that contractual arrangements require surveillance, monitoring, regulation and governance systems that can be perceived as antipathetic to the examination of practice and subsequent learning. Historically, reporting levels from general practice have remained low; little information is shared and consequently lessons are not shared across the general practice community. Given large-scale under-engagement of general practitioners (GPs) in incident reporting systems, significant event analysis is advocated to encourage sharing of information about incidents to inform the patient safety agenda at a local and national level. Previous research has concentrated on the secondary care environment and little is known about the situation in primary care, where the majority of patient contacts with healthcare occur. To explore attitudes to incident reporting, the study adopted a qualitative approach to GPs working in a mixture of urban and rural practices reporting to a Welsh Local Health Board. The study found that GPs used significant event analysis methodology to report incidents within their practice, but acknowledged under-reporting. They were less enthusiastic about reporting externally. A number of barriers exist to reporting, including insufficient time to report, lack of feedback, fear of blame, and damage to reputations and patient confidence in a competitive environment. If incident reporting processes are perceived as supportive and formative, and where protected time is allocated to discuss incidents, then GPs are willing to participate. They also need to know how the information is used, and whether lessons are being learnt from errors.

The complexity and difficulty of diagnosing lung cancer: findings from a national primary-care study in Wales.

AIM: This paper aims to provide a detailed analysis of the diagnostic process of lung cancer from a primary-care perspective. BACKGROUND: Diagnosing lung cancer at a stage where curative treatment is possible remains a challenge. Beginning to understand the complexity and difficulty in the diagnostic journey should enable the development of interventions in order to facilitate timelier diagnosis. METHODS: A national study of significant events was conducted whereby general practitioners (GPs) in Wales were asked to report data relating to the diagnostic process of recent lung cancer diagnoses using a standard template. Both qualitative and quantitative data were analysed. Findings Case reports were received from 96 general practices on 118 patients. A total of 96 patients (81.4%) presented with respiratory symptoms. A total of 79 patients (66.9%) had a GP-initiated X-ray before diagnosis. A total of 23 patients (19.5%) had a chest X-ray that did not initially show suspicion of lung cancer. A total of 25 patients (21.2%) were diagnosed after a GP-initiated acute admission. Analysis of free-text qualitative data showed that, for many patients, their GP behaved in an exemplary manner. However, for some patients, the GP could have made more of the opportunities presented for timelier diagnosis. There were a number of atypical and complex presentations, where the opportunities for more timely diagnosis were more limited. A variety of causes of diagnostic delays in secondary care were reported. These findings will inform health policy, and will inform the design of interventions to try to facilitate more timely diagnosis for symptomatic patients. We encourage greater compliance with diagnostic guidelines and greater vigilance for patients presenting with atypical symptoms, as well as for patients whose initial chest X-rays are normal.

Using decision trees to characterize verbal communication during change and stuck episodes in the therapeutic process.

Methods are needed for creating models to characterize verbal communication between therapists and their patients that are suitable for teaching purposes without losing analytical potential. A technique meeting these twin requirements is proposed that uses decision trees to identify both change and stuck episodes in therapist-patient communication. Three decision tree algorithms (C4.5, NBTree, and REPTree) are applied to the problem of characterizing verbal responses into change and stuck episodes in the therapeutic process. The data for the problem is derived from a corpus of 8 successful individual therapy sessions with 1760 speaking turns in a psychodynamic context. The decision tree model that performed best was generated by the C4.5 algorithm. It delivered 15 rules characterizing the verbal communication in the two types of episodes. Decision trees are a promising technique for analyzing verbal communication during significant therapy events and have much potential for use in teaching practice on changes in therapeutic communication. The development of pedagogical methods using decision trees can support the transmission of academic knowledge to therapeutic practice.