Learning from diagnostic errors to improve patient safety when GPs work in or alongside emergency departments: incorporating realist methodology into patient safety incident report analysis.

BACKGROUND: Increasing demand on emergency healthcare systems has prompted introduction of new healthcare service models including the provision of GP services in or alongside emergency departments. In England this led to a policy proposal and £100million (US$130million) of funding for all emergency departments to have co-located GP services. However, there is a lack of evidence for whether such service models are effective and safe. We examined diagnostic errors reported in patient safety incident reports to develop theories to explain how and why they occurred to inform potential priority areas for improvement and inform qualitative data collection at case study sites to further refine the theories. METHODS: We used a mixed-methods design using exploratory descriptive analysis to identify the most frequent and harmful sources of diagnostic error and thematic analysis, incorporating realist methodology to refine theories from an earlier rapid realist review, to describe how and why the events occurred and could be mitigated, to inform improvement recommendations. We used two UK data sources: Coroners' reports to prevent future deaths (30.7.13-14.08.18) and National Reporting and Learning System (NRLS) patient safety incident reports (03.01.05-30.11.15). RESULTS: Nine Coroners' reports (from 1347 community and hospital reports, 2013-2018) and 217 NRLS reports (from 13 million, 2005-2015) were identified describing diagnostic error related to GP services in or alongside emergency departments. Initial theories to describe potential priority areas for improvement included: difficulty identifying appropriate patients for the GP service; under-investigation and misinterpretation of diagnostic tests; and inadequate communication and referral pathways between the emergency and GP services. High-risk presentations included: musculoskeletal injury, chest pain, headache, calf pain and sick children. CONCLUSION: Initial theories include the following topics as potential priority areas for improvement interventions and evaluation to minimise the risk of diagnostic errors when GPs work in or alongside emergency departments: a standardised initial assessment with streaming guidance based on local service provision; clinical decision support for high-risk conditions; and standardised computer systems, communication and referral pathways between emergency and GP services. These theories require refinement and testing with qualitative data collection from case study (hospital) sites.

Patient safety in palliative care: A mixed-methods study of reports to a national database of serious incidents.

BACKGROUND: Patients receiving palliative care are vulnerable to patient safety incidents but little is known about the extent of harm caused or the origins of unsafe care in this population. AIM: To quantify and qualitatively analyse serious incident reports in order to understand the causes and impact of unsafe care in a population receiving palliative care. DESIGN: A mixed-methods approach was used. Following quantification of type of incidents and their location, a qualitative analysis using a modified framework method was used to interpret themes in reports to examine the underlying causes and the nature of resultant harms. SETTING AND PARTICIPANTS: Reports to a national database of 'serious incidents requiring investigation' involving patients receiving palliative care in the National Health Service (NHS) in England during the 12-year period, April 2002 to March 2014. RESULTS: A total of 475 reports were identified: 266 related to pressure ulcers, 91 to medication errors, 46 to falls, 21 to healthcare-associated infections (HCAIs), 18 were other instances of disturbed dying, 14 were allegations against health professions, 8 transfer incidents, 6 suicides and 5 other concerns. The frequency of report types differed according to the care setting. Underlying causes included lack of palliative care experience, under-resourcing and poor service coordination. Resultant harms included worsened symptoms, disrupted dying, serious injury and hastened death. CONCLUSION: Unsafe care presents a risk of significant harm to patients receiving palliative care. Improvements in the coordination of care delivery alongside wider availability of specialist palliative care support may reduce this risk.

Deaths following prehospital safety incidents: an analysis of a national database.

INTRODUCTION: Ensuring patient safety in the prehospital environment is difficult due to the unpredictable nature of the workload and the uncontrolled situations that care is provided in. Studying previous safety incidents can help understand risks and take action to mitigate them. We present an analysis of safety incidents related to patient deaths in ambulance services in England. METHODS: All incidents related to a patient death reported to the National Reporting and Learning System from an ambulance service between 1 June 2010 and 31 October 2012 were subjected to thematic analysis to identify the failings that led to the incident. RESULTS: Sixty-nine incidents were analysed, equating to one safety incident-related death per 168 000 calls received. Just three event categories were identified: delayed response (59%, 41/69), shortfalls in clinical care (35%, 24/69) and injury during transit (6%, 4/69). Primary failures differed for the categories: problems with dispatch caused the majority of delays in response, with equipment problems and bad weather accounting for the remainder. Failure to provide necessary care was predominantly caused by clinical misjudgements by ambulance staff and equipment issues underlay incidents that led to a patient injury. CONCLUSIONS: Improvements intended to address safety related mortality in the ambulance service should include ensuring adequate equipping and resourcing of ambulance services, improving coordination and decision-making during dispatch and supporting individual staff members in the difficult decisions they are faced with.

Oversight role of the Independent Monitoring Board of the Global Polio Eradication Initiative.

The Global Polio Eradication Initiative (GPEI) established its Independent Monitoring Board (IMB) in 2010 to monitor and guide its progress toward stopping polio transmission globally. The concept of an IMB is innovative, with no clear analogue in the history of the GPEI or in any other global health program. The IMB meets with senior program officials every 3-6 months. Its reports provide analysis and recommendations about individual polio-affected countries. The IMB also examines issues affecting the global program as a whole. Its areas of focus have included escalating the level of priority afforded to polio eradication (particularly by recommending a World Health Assembly resolution to declare polio eradication a programmatic emergency, which was enacted in May 2012), placing greater emphasis on people factors in the delivery of the program, encouraging innovation, strengthening focus on the small number of so-called sanctuaries where polio persists, and continuous quality improvement to reach every missed child with vaccination. The IMB's true independence from the agencies and countries delivering the program has enabled it to raise difficult issues that others cannot. Other global health programs might benefit from establishing similar independent monitoring mechanisms.

Patient-safety-related hospital deaths in England: thematic analysis of incidents reported to a national database, 2010-2012.

BACKGROUND: Hospital mortality is increasingly being regarded as a key indicator of patient safety, yet methodologies for assessing mortality are frequently contested and seldom point directly to areas of risk and solutions. The aim of our study was to classify reports of deaths due to unsafe care into broad areas of systemic failure capable of being addressed by stronger policies, procedures, and practices. The deaths were reported to a patient safety incident reporting system after mandatory reporting of such incidents was introduced. METHODS AND FINDINGS: The UK National Health Service database was searched for incidents resulting in a reported death of an adult over the period of the study. The study population comprised 2,010 incidents involving patients aged 16 y and over in acute hospital settings. Each incident report was reviewed by two of the authors, and, by scrutinising the structured information together with the free text, a main reason for the harm was identified and recorded as one of 18 incident types. These incident types were then aggregated into six areas of apparent systemic failure: mismanagement of deterioration (35%), failure of prevention (26%), deficient checking and oversight (11%), dysfunctional patient flow (10%), equipment-related errors (6%), and other (12%). The most common incident types were failure to act on or recognise deterioration (23%), inpatient falls (10%), healthcare-associated infections (10%), unexpected per-operative death (6%), and poor or inadequate handover (5%). Analysis of these 2,010 fatal incidents reveals patterns of issues that point to actionable areas for improvement. CONCLUSIONS: Our approach demonstrates the potential utility of patient safety incident reports in identifying areas of service failure and highlights opportunities for corrective action to save lives.

Reducing the burden of surgical harm: a systematic review of the interventions used to reduce adverse events in surgery.

OBJECTIVE: To perform a systematic review of interventions used to reduce adverse events in surgery. BACKGROUND: Many interventions, which aim to improve patient safety in surgery, have been introduced to hospitals. Little is known about which methods provide a measurable decrease in morbidity and mortality. METHODS: MEDLINE, EMBASE, and Cochrane databases were searched from inception to Week 19, 2012, for systematic reviews, randomized controlled trials (RCTs), and cross-sectional and cohort studies, which reported an intervention aimed toward reducing the incidence of adverse events in surgical patients. The quality of observational studies was measured using the Newcastle-Ottawa Scale. RCTs were assessed using the Cochrane Collaboration's tool for assessing risk of bias. RESULTS: Ninety-one studies met inclusion criteria, 26 relating to structural interventions, 66 described modifying process factors. Only 17 (of 42 medium to high quality studies) reported an intervention that produced a significant decrease in morbidity and mortality. Structural interventions were: improving nurse to patient ratios (P = 0.008) and Intensive Care Unit (ITU) physician involvement in postoperative care (P < 0.05). Subspecialization in surgery reduced technical complications (P < 0.01). Effective process interventions were submission of outcome data to national audit (P < 0.05), use of safety checklists (P < 0.05), and adherence to a care pathway (P < 0.05). Certain safety technology significantly reduced harm (P = 0.02), and team training had a positive effect on patient outcome (P = 0.001). CONCLUSIONS: Only a small cohort of medium- to high-quality interventions effectively reduce surgical harm and are feasible to implement. It is important that future research remains focused on demonstrating a measurable reduction in adverse events from patient safety initiatives.

Epidemiology of lifetime fracture prevalence in England: a population study of adults aged 55 years and over.

BACKGROUND: fractures remain a substantial public health problem but epidemiological studies using survey data are sparse. This study explores the association between lifetime fracture prevalence and socio-demographic factors, health behaviours and health conditions. METHODS: fracture prevalence was calculated using a combined dataset of annual, nationally representative health surveys in England (2002-07) containing 24,725 adults aged 55 years and over. Odds of reporting any fracture was estimated separately for each gender using logistic regression. RESULTS: fracture prevalence was higher in men than women (49 and 40%, respectively). In men, factors having a significant independent association with fracture included being a former regular smoker [odds ratios, OR: 1.18 (1.06-1.31)], having a limiting long-standing illness [OR: 1.47 (1.31-1.66)] and consuming >8 units of alcohol on the heaviest drinking day in the past week [OR: 1.65 (1.37-1.98)]. In women, significant factors included being separated/divorced [OR: 1.30 (1.10-1.55)], having a 12-item General Health Questionnaire (GHQ-12) score of 4+ [OR: 1.59 (1.27-2.00)], consuming >6 units of alcohol in the past week [OR: 2.07 (1.28-3.35)] and being obese [OR: 1.25 (1.03-1.51)]. CONCLUSION: a range of socio-demographic, health behaviour and health conditions, known to increase the risk of chronic disease and premature death, are also associated with fracture occurrence, probably involving the aetiological pathways of poor bone health and fall-related trauma.

Global research priorities to better understand the burden of iatrogenic harm in primary care: an international Delphi exercise.

Using a modified Delphi exercise, Aziz Sheikh and colleagues identify research priorities for patient safety research in primary care contexts. Please see later in the article for the Editors' Summary.

The aspects of healthcare quality that are important to health professionals and patients: A qualitative study.

OBJECTIVE: Existing quality of care frameworks insufficiently integrate the perspectives of physicians, nurses and patients. We collected narrative accounts from these three groups to explore if their perspectives might add new content to these existing definitions. METHODS: Ninety-seven descriptions of "good" and "poor" care episodes were collected from a convenience sample of physicians, nurses and outpatients at eight regional hospitals. Two coders classified the narrative contents into themes related to structures, processes and outcomes of care. RESULTS: The physicians, nurses and patients raised the following "quality of care" aspects: Successful communication among staff, with patients and care companions; staff motivation; frequency of knowledge errors; prioritization of patient-preferred outcomes; institutional emphasis on building "quality cultures"; and organizational implementation of fluid system procedures. CONCLUSION: Respondents primarily referred to care processes in their descriptions of "quality of care." "Hippocratic pride" (in response to care successes) and "Rapid reactivity" (in response to (near) failures) emerged as two new outcome indicators of high-quality care. PRACTICE IMPLICATIONS: This study provides a first qualitative fundament for understanding the components of "quality of care" from a triangulated frontline perspective. Future research needs to validate our findings with quantitative data to explore their usefulness for completing existing quality frameworks.

Paediatric mortality related to pandemic influenza A H1N1 infection in England: an observational population-based study.

BACKGROUND: Young people (aged 0-18 years) have been disproportionately affected by pandemic influenza A H1N1 infection. We aimed to analyse paediatric mortality to inform clinical and public health policies for future influenza seasons and pandemics. METHODS: All paediatric deaths related to pandemic influenza A H1N1 infection from June 26, 2009, to March 22, 2010 in England were identified through daily reporting systems and cross-checking of records and were validated by confirmation of influenza infection by laboratory results or death certificates. Clinicians responsible for each individual child provided detailed information about past medical history, presentation, and clinical course of the acute illness. Case estimates of influenza A H1N1 were obtained from the Health Protection Agency. The primary outcome measures were population mortality rates and case-fatality rates. FINDINGS: 70 paediatric deaths related to pandemic influenza A H1N1 were reported. Childhood mortality rate was 6 per million population. The rate was highest for children aged less than 1 year. Mortality rates were higher for Bangladeshi children (47 deaths per million population [95% CI 17-103]) and Pakistani children (36 deaths per million population [18-64]) than for white British children (4 deaths per million [3-6]). 15 (21%) children who died were previously healthy; 45 (64%) had severe pre-existing disorders. The highest age-standardised mortality rate for a pre-existing disorder was for chronic neurological disease (1536 per million population). 19 (27%) deaths occurred before inpatient admission. Children in this subgroup were significantly more likely to have been healthy or had only mild pre-existing disorders than those who died after admission (p=0·0109). Overall, 45 (64%) children had received oseltamivir: seven within 48 h of symptom onset. INTERPRETATION: Vaccination priority should be for children at increased risk of severe illness or death from influenza. This group might include those with specified pre-existing disorders and those in some ethnic minority groups. Early pre-hospital supportive and therapeutic care is also important. FUNDING: Department of Health, UK.

Republished paper: The quest to eliminate intrathecal vincristine errors: a 40-year journey.

BACKGROUND: Intrathecal administration of vincristine is a rare event but catastrophic for the patient, family and clinical team involved. Analysis of this source of harm shows it to be a classic systems error which has proved intractable for nearly 40 years. Failure to learn from history, communicate safety solutions nationally and internationally, create safety agencies which effectively and reliably prevent adverse events, conduct investigations and enquiries which fully reveals how to mitigate system error, develop robust physical design solutions to prevent harm to patients, make effective solutions universal and preparing for the unexpected are all major challenges. CONCLUSIONS: The elimination of rare yet catastrophic errors like this remains one of the tests of whether we can make healthcare safer. In this paper, we discuss why effective learning has been so slow and illustrate lessons for other fields of patient safety.

Identifying safe care processes when GPs work in or alongside emergency departments: a realist evaluation.

BACKGROUND: Increasing pressure on emergency services has led to the development of different models of care delivery including GPs working in or alongside emergency departments (EDs), but with a lack of evidence for patient safety outcomes. AIM: This study aimed to explore how care processes work and how patient safety incidents associated with GPs working in ED settings may be mitigated. DESIGN AND SETTING: Realist methodology with a purposive sample of 13 EDs in England and Wales with different GP service models. The study sought to understand the relationship between contexts, mechanisms, and outcomes to develop theories about how and why patient safety incidents may occur, and how safe care was perceived to be delivered. METHOD: Qualitative data were collected (observations, semi-structured audio-recorded staff interviews, and local patient safety incident reports). Data were coded using 'if, then, because' statements to refine initial theories developed from an earlier rapid realist literature review and analysis of a sample of national patient safety incident reports. RESULTS: The authors developed a programme theory to describe how safe patient care was perceived to be delivered in these service models, including: an experienced streaming nurse using local guidance and early warning scores; support for GPs' clinical decision making, with clear governance processes relevant to the intended role (traditional GP approach or emergency medicine approach); and strong clinical leadership to promote teamwork and improve communication between services. CONCLUSION: The findings of this study can be used as a focus for more in-depth human factors investigations to optimise work conditions in this complex care delivery setting.

Patient safety matters: reducing the risks of nasogastric tubes.

Nasogastric tube insertion is a common clinical procedure carried out by doctors and nurses in NHS hospitals daily. For the last 30 years, there have been reports in the medical literature of deaths and other harm resulting from misplaced nasogastric tubes, most commonly associated with feed entering the pulmonary system. In 2005 the National Patient Safety Agency in England assembled reports of 11 deaths and one incident of serious harm from wrong insertion of nasogastric tubes over a two-year period. The agency issued a safety alert setting out evidence-based practice for checking tube placement. In the two and a half years following this alert the problem persisted with a further five deaths and six instances of serious harm due to nasogastric tube misplacement. This is a potentially preventable error but safety alerts advocating best practice do not appear to reliably reduce risk. Alternative solutions, such as standardising procedures, may be more effective.

A mixed-methods analysis of patient safety incidents involving opioid substitution treatment with methadone or buprenorphine in community-based care in England and Wales.

BACKGROUND AND AIMS: Opioid substitution treatment is used in many countries as an effective harm minimization strategy. There is a need for more information about patient safety incidents and the resulting harm relating to this treatment. We aimed to characterize patient safety incidents involving opioid substitution treatment with methadone or buprenorphine in community-based care by: (i) identifying the sources and nature of harm and (ii) describing and interpreting themes to identify priorities to focus future improvement work. DESIGN: Mixed-methods study examining patient safety incident reports involving opioid substitution treatment with either methadone or buprenorphine in community-based care. SETTING: Data submitted between 2005 and 2015 from the National Reporting and Learning System (NRLS), a national repository of patient safety incident reports from across England and Wales. PARTICIPANTS: A total of 2284 reports were identified involving patients receiving community-based opioid substitution treatment. MEASUREMENTS: Incident type, contributory factors, incident outcome and severity of harm. Analysis involved data coding, processing and iterative generation of data summaries using descriptive statistical and thematic analysis. FINDINGS: Most risks of harm from opioid substitution treatment came from failure in one of four processes of care delivery: prescribing opioid substitution (n = 151); supervised dispensing (n = 248); non-supervised dispensing (n = 318); and monitoring and communication (n = 1544). Most incidents resulting in harm involved supervised or non-supervised dispensing (n = 91 of 127, 72%). Staff- (e.g. slips during task execution, not following protocols) and organization-related (e.g. poor working conditions or poor continuity of care between services) contributory factors were identified for more than half of incidents. CONCLUSIONS: Risks of harm in delivering opioid substitute treatment in England and Wales appear to arise out of failures in four processes: prescribing opioid substitution, supervised dispensing, non-supervised dispensing and monitoring and communication.

Colorectal cancer incidence among young adults in England: Trends by anatomical sub-site and deprivation.

BACKGROUND: Colorectal cancer incidence in the UK and other high-income countries has been increasing rapidly among young adults. This is the first analysis of colorectal cancer incidence trends by sub-site and socioeconomic deprivation in young adults in a European country. METHODS: We examined age-specific national trends in colorectal cancer incidence among all adults (20-99 years) diagnosed during 1971-2014, using Joinpoint regression to analyse data from the population-based cancer registry for England. We fitted a generalised linear model to the incidence rates, with a maximum of two knots. We present the annual percentage change in incidence rates in up to three successive calendar periods, by sex, age, deprivation and anatomical sub-site. RESULTS: Annual incidence rates among the youngest adults (20-39 years) fell slightly between 1971 and the early 1990s, but increased rapidly from then onwards. Incidence Rates (IR) among adults 20-29 years rose from 0.8 per 100,000 in 1993 to 2.8 per 100,000 in 2014, an average annual increase of 8%. An annual increase of 8.1% was observed for adults aged 30-39 years during 2005-2014. Among the two youngest age groups (20-39 years), the average annual increase for the right colon was 5.2% between 1991 and 2010, rising to 19.4% per year between 2010 (IR = 1.2) and 2014 (IR = 2.5). The large increase in incidence rates for cancers of the right colon since 2010 were more marked among the most affluent young adults. Smaller but substantial increases were observed for cancers of the left colon and rectum. Incidence rates in those aged 50 years and older remained stable or decreased over the same periods. CONCLUSIONS: Despite the overall stabilising trend of colorectal cancer incidence in England, incidence rates have increased rapidly among young adults (aged 20-39 years). Changes in the prevalence of obesity and other risk factors may have affected the young population but more research is needed on the cause of the observed birth cohort effect. Extension of mass screening may not be justifiable due to the low number of newly diagnosed cases but clinicians should be alert to this trend.

Serious incidents after death: content analysis of incidents reported to a national database.

Objectives To describe serious incidents occurring in the management of patient remains after their death. Design Incidents occurring after patient deaths were analysed using content analysis to determine what happened, why it happened and the outcome. Setting The Strategic Executive Information System database of serious incidents requiring investigation occurring in the National Health Service in England. Participants All cases describing an incident that occurred following death, regardless of the age of the patient. Main outcome measures The nature of the incident, the underlying cause or causes of the incident and the outcome of the incident. Results One hundred and thirty-two incidents were analysed; these related to the storage, management or disposal of deceased patient remains. Fifty-four incidents concerned problems with the storage of bodies or body parts. Forty-three incidents concerned problems with the management of bodies, including 25 errors in postmortem examination, or postmortems on the wrong body. Thirty-one incidents related to the disposal of bodies, 25 bodies were released from the mortuary to undertakers in error; of these, nine were buried or cremated by the wrong family. The reported underlying causes were similar to those known to be associated with safety incidents occurring before death and included weaknesses in or failures to follow protocol and procedure, poor communication and informal working practices. Conclusions Serious incidents in the management of deceased patient remains have significant implications for families, hospitals and the health service more broadly. Safe mortuary care may be improved by applying lessons learned from existing patient safety work.

Patterns of regional variation of opioid prescribing in primary care in England: a retrospective observational study.

BACKGROUND: Opioids are a widely prescribed class of drug with potentially harmful short-term and long-term side effects. There are concerns about the amounts of these drugs being prescribed in England given that they are increasingly considered ineffective in the context of long-term non-cancer pain, which is one of the major reasons for their prescription. AIM: To assess the amount and type of opioids prescribed in primary care in England, and patterns of regional variation in prescribing. DESIGN AND SETTING: Retrospective observational study using publicly available government data from various sources pertaining to opioids prescribed in primary practice in England and Indices of Social Deprivation. METHOD: Official government data were analysed for opioid prescriptions from August 2010 to February 2014. The total amount of opioid prescribed was calculated and standardised to allow for geographical comparisons. RESULTS: The total amount of opioid prescribed, in equivalent milligrams of morphine, increased (r = 0.48) over the study period. More opioids were prescribed in the north than in the south of England (r = 0.66, P<0.0001), and more opioids were prescribed in areas of greater social deprivation (r = 0.56, P<0.0001). CONCLUSION: Long-term opioid prescribing is increasing despite poor efficacy for non-cancer pain, potential harm, and incompatibility with best practice. Questions of equality of care arise from higher prescription rates in the north of England and in areas of greater social deprivation. A national registry of patients with high opioid use would improve patient safety for this high-risk demographic, as well as provide more focused epidemiological data regarding patterns of prescribing.