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.

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.

Mortality as an indicator of patient safety in orthopaedics: lessons from qualitative analysis of a database of medical errors.

BACKGROUND: Orthopaedic surgery is a high-risk specialty in which errors will undoubtedly occur. Patient safety incidents can yield valuable information to generate solutions and prevent future cases of avoidable harm. The aim of this study was to understand the causative factors leading to all unnecessary deaths in orthopaedics and trauma surgery reported to the National Patient Safety Agency (NPSA) over a four-year period (2005-2009), using a qualitative approach. METHODS: Reports made to the NPSA are categorised and stored in the database as free-text data. A search was undertaken to identify the cases of all-cause mortality in orthopaedic and trauma surgery, and the free-text elements were used for thematic analysis. Descriptive statistics were calculated based on the incidents reported. This included presenting the number of times categories of incidents had the same or similar response. Superordinate and subordinate categories were created. RESULTS: A total of 257 incident reports were analysed. Four main thematic categories emerged. These were: (1) stages of the surgical journey - 118/191 (62%) of deaths occurred in the post-operative phase; (2) causes of patient deaths - 32% were related to severe infections; (3) reported quality of medical interventions - 65% of patients experienced minimal or delayed treatment; (4) skills of healthcare professionals - 44% of deaths had a failure in non-technical skills. CONCLUSIONS: Most complications in orthopaedic surgery can be dealt with adequately, provided they are anticipated and that risk-reduction strategies are instituted. Surgeons take pride in the precision of operative techniques; perhaps it is time to enshrine the multimodal tools available to ensure safer patient care.

When should we operate on elderly patients with a hip fracture? It's about time!

Demographic predictions indicate the annual incidence of hip fractures will rise to 100,000 per annum in 2020. The annual costs to the NHS are approximately two billion pounds. Despite significant advances in the operating technique and management of these fractures, controversies still exist. One such matter for debate is the ideal timing for hip fracture surgery. There are arguments for and against early stabilization, yet all this evidence comes from observational studies. We present data from an often overlooked source, the largest patient safety reporting system in the world housed at the National Patient Safety Agency. Since 2003, 4325/4521 (96%) patients suffered some harm due to their operation being delayed. The issue of the ideal timing for hip surgery warrants an answer. This could be in the form of a controlled trial. A randomized trial comparing early surgery versus standard of care (site dependent) in hip fracture repair may provide some future guidance. In the meantime, current evidence suggests that we should stratify the elderly according to their medical morbidities; both new and old; optimize patient's who develop hypovolemia, accelerated hypertension, untreated infection, symptomatic arrhythmia or cardiopulmonary dysfunction; and attempt to bring patient's suffering from chronic diseases as close to their baseline level of functioning as normal. Hip fracture repair should then occur as soon as possible.

Analysing the benefits of laparoscopic hernia repair compared to open repair: A meta-analysis of observational studies.

BACKGROUND: The purpose of this study is to compare the difference of incidence of post-operative complications, operative time, length of stay and recurrence of patients undergoing laparoscopic or open repair of their ventral/incisional hernia a meta-analytic technique for observational studies. MATERIALS AND METHODS: A literature search was performed using Medline, PubMed, Embase and Cochrane databases for studies reported between 1998 and 2009 comparing laparoscopic and open surgery for the treatment of ventral (incisional) hernia. This meta-analysis of all the observational studies compared the post-operative complications recurrence rate and length of stay. The random effects model was used. Sensitivity and heterogeneity were analysed. RESULTS: Analysis of 15 observational studies comprising 2452 patients qualified for meta-analysis according to the study's inclusion criteria. Laparoscopic surgery was attempted in 1067 out of 2452. The results showed that the length of stay (odds ratio [OR], - 1.00; 95% confidence interval [CI], - 1.09 to - 0.91; P < 0.00001) and operative time (OR, 59.33; 95% CI, 58.55 to 60.11; P < 0.00001) was significantly lower in the laparoscopic group. The results also showed that there was a significant reduction in the formation of abscesses (OR, 0.38; 95% CI, 0.16 to 0.92; P = 0.03) and wound infections (OR, 0.49; 95% CI, 0.29 to 0.82; P = 0.007) post-operatively. There is a trend which indicates that the recurrence of the hernia using laparoscopic repair versus open repair was overall lower with the laparoscopic repair (OR, 0.48; 95% CI, 0.22 to 1.04; P = 0.06), however, this was not significant. CONCLUSION: Laparoscopic incisional hernia repair was associated with a reduced length of stay, operative time and lower incidence of abscess and wound infection post-operatively. This study also highlights the benefit of using observational studies as a form of research and its value as a tool in answering questions where large sample sizes of patient groups would be impossible to accumulate in a reasonable length of time.

Development of the Veritas plot and its application in cardiac surgery: an evidence-synthesis graphic tool for the clinician to assess multiple meta-analyses reporting on a common outcome.

BACKGROUND: Meta-analyses may be prone to generating misleading results because of a paucity of experimental studies (especially in surgery); publication bias; and heterogeneity in study design, intervention and the patient population of included studies. When investigating a specific clinical or scientific question on which several relevant meta-analyses may have been published, value judgments must be applied to determine which analysis represents the most robust evidence. These value judgments should be specifically acknowledged. We designed the Veritas plot to explicitly explore important elements of quality and to facilitate decision-making by highlighting specific areas in which meta-analyses are found to be deficient. Furthermore, as a graphic tool, it may be more intuitive than when similar data are presented in a tabular or text format. METHODS: The Veritas plot is an adaption of the radar plot, a graphic tool for the description of multiattribute data. Key elements of meta-analytical quality such as heterogeneity, publication bias and study design are assessed. Existing qualitative methods such as the Assessment of Multiple Systematic Reviews (AMSTAR) tool have been incorporated in addition to important considerations when interpreting surgical meta-analyses such as the year of publication and population characteristics. To demonstrate the potential of the Veritas plot to inform clinical practice, we apply the Veritas plot to the meta-analytical literature comparing the incidence of 30-day stroke in off-pump coronary artery bypass surgery and conventional coronary artery bypass surgery. RESULTS: We demonstrate that a visually-stimulating and practical evidence-synthesis tool can direct the clinician and scientist to a particular meta-analytical study to inform clinical practice. The Veritas plot is also cumulative and allowed us to assess the quality of evidence over time. CONCLUSION: We have presented a practical graphic application for scientists and clinicians to identify and interpret variability in meta-analyses. Although further validation of the Veritas plot is required, it may have the potential to contribute to the implementation of evidence-based practice.

Assessing the relationship between chronic pain and cardiovascular disease: A systematic review and meta-analysis.

BACKGROUND AND AIMS: Chronic pain is a potentially disabling condition affecting one in three people through impaired physical function and quality of life. While the psychosocial impact of chronic pain is already well established, little is known about the potential biological consequences. Chronic pain may be associated with an increased prevalence of cardiovascular disease, an effect that has been demonstrated across a spectrum of chronic pain conditions including low back pain, pelvic pain, neuropathic pain and fibromyalgia. The aim of this study was to review and summarize the evidence for a link between chronic pain and cardiovascular disease. We sought to clarify the nature of the relationship by examining the basis for a dose-response gradient (whereby increasing pain severity would result in greater cardiovascular disease), and by evaluating the extent to which potentially confounding variables may contribute to this association. METHODS: Major electronic databases MEDLINE, EMBASE, Psychinfo, Cochrane, ProQuest and Web of Science were searched for articles reporting strengths of association between chronic pain (pain in one or more body regions, present for three months or longer) and cardiovascular outcomes (cardiovascular mortality, cardiac disease, and cerebrovascular disease). Meta-analysis was used to pool data analysing the association between chronic pain and the three principal cardiovascular outcomes. The impact of pain severity, and the role of potentially confounding variables were explored narratively. RESULTS: The searches generated 11,141 studies, of which 25 matched our inclusion criteria and were included in the review. Meta-analysis (of unadjusted study outcomes) demonstrated statistically significant associations between chronic pain and mortality from cardiovascular diseases: pooled odds ratio 1.20, (95% confidence intervals 1.05-1.36); chronic pain and cardiac disease: pooled odds ratio 1.73 (95% confidence intervals 1.42-2.04); and chronic pain and cerebrovascular disease: pooled odds ratio 1.81 (95% confidence intervals 1.51-2.10). The systematic review also found evidence supporting a dose-response relationship, with greater pain intensity and distribution producing a stronger association with cardiovascular outcomes. All of the included studies were based on observational data with considerable variation in chronic pain taxonomy, methodology and study populations. The studies took an inconsistent and incomplete approach in their adjustment for potentially confounding variables, making it impossible to pool data after adjustments for confounding variables, so it cannot be concluded that these associations are causal. CONCLUSIONS: Our review supports a possible dose-response type of association between chronic pain and cardiovascular disease, supported by a range of observational studies originating from different countries. Such research has so far failed to satisfactorily rule out that the association is due to confounding variables. What is now needed are further population based longitudinal studies that are designed to allow more robust exploration of a cause and effect relationship. IMPLICATIONS: Given the high prevalence of chronic pain in developed and developing countries our results highlight a significant, but underpublicized, public health concern. Greater acknowledgement of the potentially harmful biological consequences of chronic pain may help to support regional, national and global initiatives aimed at reducing the burden of chronic pain.

Handheld computers and the 21st century surgical team: a pilot study.

BACKGROUND: The commercial development and expansion of mobile phone networks has led to the creation of devices combining mobile phones and personal digital assistants, which could prove invaluable in a clinical setting. This pilot study aimed to look at how one such device compared with the current pager system in facilitating inter-professional communication in a hospital clinical team. METHODS: The study looked at a heterogeneous team of doctors (n = 9) working in a busy surgical setting at St. Mary's Hospital in London and compared the use of a personal digital assistant with mobile phone and web-browsing facilities to the existing pager system. The primary feature of this device being compared to the conventional pager was its use as a mobile phone, but other features evaluated included the ability to access the internet, and reference data on the device. A crossover study was carried out for 6 weeks in 2004, with the team having access to the personal digital assistant every alternate week. The primary outcome measure for assessing efficiency of communication was the length of time it took for clinicians to respond to a call. We also sought to assess the ease of adoption of new technology by evaluating the perceptions of the team (n = 9) to personal digital assistants, by administering a questionnaire. RESULTS: Doctors equipped with a personal digital assistant rather than a pager, responded more quickly to a call and had a lower of failure to respond rate (RR: 0.44; 95%CI 0.20-0.93). Clinicians also found this technology easy to adopt as seen by a significant reduction in perceptions of nervousness to the technology over the six-week study period (mean (SD) week 1: 4.10 (SD 1.69) vs. mean (SD) week 6: 2.20 (1.99); p = 0.04). CONCLUSION: The results of this pilot study show the possible effects of replacing the current hospital pager with a newer, more technologically advanced device, and suggest that a combined personal digital assistant and mobile phone device may improve communication between doctors. In the light of these encouraging preliminary findings, we propose a large-scale clinical trial of the use of these devices in facilitating inter-professional communication in a hospital setting.

A cross-sectional mixed methods study protocol to generate learning from patient safety incidents reported from general practice.

INTRODUCTION: Incident reports contain descriptions of errors and harms that occurred during clinical care delivery. Few observational studies have characterised incidents from general practice, and none of these have been from the England and Wales National Reporting and Learning System. This study aims to describe incidents reported from a general practice care setting. METHODS AND ANALYSIS: A general practice patient safety incident classification will be developed to characterise patient safety incidents. A weighted-random sample of 12,500 incidents describing no harm, low harm and moderate harm of patients, and all incidents describing severe harm and death of patients will be classified. Insights from exploratory descriptive statistics and thematic analysis will be combined to identify priority areas for future interventions. ETHICS AND DISSEMINATION: The need for ethical approval was waivered by the Aneurin Bevan University Health Board research risk review committee given the anonymised nature of data (ABHB R&D Ref number: SA/410/13). The authors will submit the results of the study to relevant journals and undertake national and international oral presentations to researchers, clinicians and policymakers.

Errors in the management of cardiac arrests: an observational study of patient safety incidents in England.

OBJECTIVE: The aim of this qualitative study is to better understand the types of error occurring during the management of cardiac arrests that led to a death. METHODS: All patient safety incidents involving management of cardiac arrests and resulting in death which were reported to a national patient safety database over a 17-month period were analysed. Structured data from each report were extracted and these together with the free text, were subjected to content analysis which was inductive, with the coding scheme emerged from continuous reading and re-reading of incidents. RESULTS: There were 30 patient safety incidents involving management of cardiac arrests and resulting in death. The reviewers identified a main shortfall in the management of each cardiac arrest and this resulted in 12 different factors being documented. These were grouped into four themes that highlighted systemic weaknesses: miscommunication involving crash number (4/30, 13%), shortfalls in staff attending the arrest (4/30, 13%), equipment deficits (11/30, 36%), and poor application of knowledge and skills (11/30, 37%). CONCLUSION: The factors identified represent serious shortfalls in the quality of response to cardiac arrests resulting in death in hospital. No firm conclusion can be drawn about how many deaths in the study population would have been averted if the emergency had been managed to a high standard. The effective management of cardiac arrests should be considered as one of the markers of safe care within a healthcare organisation.

Identifying systems failures in the pathway to a catastrophic event: an analysis of national incident report data relating to vinca alkaloids.

BACKGROUND: Catastrophic errors in healthcare are rare, yet the consequences are so serious that where possible, special procedures are put in place to prevent them. As systems become safer, it becomes progressively more difficult to detect the remaining vulnerabilities. Using inadvertent intrathecal administration of vinca alkaloids as an example, we investigated whether analysis of incident report data describing low-harm events could bridge this gap. METHODS: We studied nine million patient safety incidents reported from England and Wales between November 2003 and May 2013. We searched for reports relating to administration of vinca alkaloids in patients also receiving intrathecal medication, and classified the failures identified against steps in the relevant national protocol. RESULTS: Of 38 reports that met our inclusion criteria, none resulted in actual harm. The stage of the medication process most commonly involved was 'supply, transport and storage' (15 cases). Seven cases related to dispensing, six to documentation, and four each to prescribing and administration. Defences most commonly breached related to separation of intravenous vinca alkaloids and intrathecal medication in timing (n=16) and location (n=8); potential for confusion due to inadequate separation of these drugs therefore remains. Problems involved in six cases did not align with the procedural defences in place, some of which represented major hazards. CONCLUSIONS: We identified areas of concern even within the context of a highly controlled standardised national process. If incident reporting systems include and encourage reports of no-harm incidents in addition to actual patient harm, they can facilitate monitoring the resilience of healthcare processes. Patient safety incidents that produce the most serious harm are often rare, and it is difficult to know whether patients are adequately protected. Our approach provides a potential solution.

What is the risk of death or severe harm due to bone cement implantation syndrome among patients undergoing hip hemiarthroplasty for fractured neck of femur? A patient safety surveillance study.

OBJECTIVE: To estimate the risk of death or severe harm due to bone cement implantation syndrome (BCIS) among patients undergoing hip hemiarthroplasty for fractured neck of femur. SETTING: Hospitals providing secondary and tertiary care throughout the National Health Service (NHS) in England and Wales. PARTICIPANTS: Cases reported to the National Reporting and Learning System (NRLS) in which the reporter clearly describes severe acute patient deterioration associated with cement use in hip hemiarthroplasty for fractured neck of femur (assessed independently by two reviewers). OUTCOME MEASURES: Primary-number of reported deaths, cardiac arrests and periarrests per year. Secondary-timing of deterioration and outcome in relation to cement insertion. RESULTS: Between 2005 and 2012, the NRLS received 62 reports that clearly describe death or severe harm associated with the use of cement in hip hemiarthroplasty for fractured neck of femur. There was one such incident for every 2900 hemiarthroplasties for fractured neck of femur during the period. Of the 62 reports, 41 patients died, 14 were resuscitated from cardiac arrest and 7 from periarrest. Most reports (55/62, 89%) describe acute deterioration occurring during or within a few minutes of cement insertion. The vast majority of deaths (33/41, 80%) occurred on the operating table. CONCLUSIONS: These reports provide narrative evidence from England and Wales that cement use in hip hemiarthroplasty for fractured neck of femur is associated with instances of perioperative death or severe harm consistent with BCIS. In 2009, the National Patient Safety Agency publicised this issue and encouraged the use of mitigation measures. Three-quarters of the deaths in this study have occurred since that alert, suggesting incomplete implementation or effectiveness of those mitigation measures. There is a need for stronger evidence that weighs the risks and benefits of cement in hip hemiarthroplasty for fractured neck of femur.

Identification of poor performance in a national medical workforce over 11 years: an observational study.

BACKGROUND: Poorly performing doctors are a source of harm but do not commonly feature in discussions of patient safety. Few countries have national mechanisms to deal with these doctors; most opt for suspension and/or exclusion from clinical practice. This study reports on the 11-year experience of dealing with concerns about doctors' performance in the UK National Health Service (NHS). The aim of this study was to describe the frequency with which doctors were referred due to performance-related concerns, examine demographic and specialty differences, and identify the nature of the concerns prompting referral. METHODS: This observational study uses data collected by the National Clinical Assessment Service for each referral (n=6179 doctors) over an 11-year period (April 2001-March 2012) in England to examine the rate at which concerns about doctors' performance occur, understand differences in rates between practitioner groups, and changes over time. FINDINGS: The annual referral rate was five per 1000 doctors (95% CI 4.6 to 5.4). Doctors whose first medical qualification was gained outside the UK were more than twice as likely to be referred as UK-qualified doctors; male doctors were more than twice as likely to be referred as women doctors; and doctors in the late stages of their career were nearly six times as likely to be referred as early career doctors. DISCUSSION: The UK holds a consistently collected national dataset on performance concerns about doctors. This allows risk groups to be identified so that preventive action and early intervention can be targeted most effectively to reduce harm to patients. A feature of past handling of poor clinical performance has been late presentation and a lack of thematic study of causation.

The acute and long-term management of anaphylaxis: protocol for a systematic review.

BACKGROUND: The European Academy of Allergy and Clinical Immunology is in the process of developing its Guideline for Food Allergy and Anaphylaxis, and this systematic review is one of seven inter-linked evidence syntheses that are being undertaken in order to provide a state-of-the-art synopsis of the current evidence base in relation to epidemiology, prevention, diagnosis and clinical management and impact on quality of life, which will be used to inform clinical recommendations.The aims of this systematic review will be to assess the effectiveness of interventions for the acute management of anaphylaxis, and pharmacological and non-pharmacological approaches for the long-term management of anaphylaxis. METHODS: A highly sensitive search strategy has been developed, and validated study design filters will be applied to retrieve all articles pertaining to the management of anaphylaxis from electronic bibliographic databases. We will systematically review the literature on the acute management of anaphylaxis by assessing the effectiveness of epinephrine, H1-antihistamines (versus placebo), systemic glucocorticosteroids, methylxanthines or any other treatments for the emergency management of people experiencing anaphylaxis. The main interventions that have been studied in the context of long-term management are anaphylaxis management plans and allergen-specific immunotherapy. DISCUSSION: There is at present little in the way of robust evidence to guide decisions on the acute and/or long-term management of anaphylaxis. Given the risk of death and the considerable morbidity associated with anaphylaxis these evidence gaps need to be filled wherever possible; this systematic review will make a start in this area.

Disease-specific health-related quality of life (HRQL) instruments for food allergy: protocol for a systematic review.

BACKGROUND: The European Academy of Allergy and Clinical Immunology is in the process of developing its Guideline for Food Allergy and Anaphylaxis, and this systematic review is one of seven inter-linked evidence syntheses that are being undertaken in order to provide a state-of-the-art synopsis of the current evidence base in relation to epidemiology, prevention, diagnosis and clinical management, and impact on quality of life, which will be used to inform clinical recommendations. The aim of this systematic review will be to determine which validated instruments can be employed to enable assessment of the impact of, and investigations and interventions for, food allergy on health-related quality of life. METHODS: Seven bibliographic databases were searched from their inception to September 30, 2012 for disease-specific HRQL questionnaires that were specifically designed for use with patients/carers and any articles relating to the description, development and/or the validation of the above identified HRQLs. There were no language or geographic restrictions. We will assess the development of the instruments identified and their performance properties including: validity; generalizability; responsiveness; managing missing data; how variation in patient demography was managed; and cross-cultural and linguistic adaptation, using a previously reported quality assessment tool. DISCUSSION: Using appropriately developed and validated instruments is critical to the accurate evaluation of HRQL in people with food allergy. This review will systematically appraise the evidence on the subject and help to identify any gaps.