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.

Promoting patient safety in India: situational analysis and the way forward.

Unsafe healthcare is a well-recognized issue internationally and is attracting attention in India as well. Drawing upon the various efforts that have been made to address this issue in India and abroad, we explore how we can accelerate developments and build a culture of patient safety in the Indian health sector. Using five international case studies, we describe experiences of promoting patient safety in various ways to inform future developments in India. We offer a roadmap for 2020, which contains suggestions on how India could build a culture of patient safety.

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.

Assessment of machine learning algorithms in national data to classify the risk of self-harm among young adults in hospital: A retrospective study.

BACKGROUND: Self-harm is one of the most common presentations at accident and emergency departments in the UK and is a strong predictor of suicide risk. The UK Government has prioritised identifying risk factors and developing preventative strategies for self-harm. Machine learning offers a potential method to identify complex patterns with predictive value for the risk of self-harm. METHODS: National data in the UK Mental Health Services Data Set were isolated for patients aged 18-30 years who started a mental health hospital admission between Aug 1, 2020 and Aug 1, 2021, and had been discharged by Jan 1, 2022. Data were obtained on age group, gender, ethnicity, employment status, marital status, accommodation status and source of admission to hospital and used to construct seven machine learning models that were used individually and as an ensemble to predict hospital stays that would be associated with a risk of self-harm. OUTCOMES: The training dataset included 23 808 items (including 1081 episodes of self-harm) and the testing dataset 5951 items (including 270 episodes of self-harm). The best performing algorithms were the random forest model (AUC-ROC 0.70, 95%CI:0.66-0.74) and the ensemble model (AUC-ROC 0.77 95%CI:0.75-0.79). INTERPRETATION: Machine learning algorithms could predict hospital stays with a high risk of self-harm based on readily available data that are routinely collected by health providers and recorded in the Mental Health Services Data Set. The findings should be validated externally with other real-world, prospective data. FUNDING: This study was supported by the Midlands and Lancashire Commissioning Support Unit.

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.

The percutaneous compression plate versus the dynamic hip screw: a meta-analysis.

Intertrochanteric fractures are a significant orthopaedic burden. The aim of this study was to assess how the Percutaneous Compression Plate (PCCP) technique performs compared to the traditional dynamic hip screw (DHS). A meta-analysis of all head to head trials (1995-2006) comparing the two techniques was performed. Early mortality (< or = 1 year) was the major outcome of interest. Secondary outcomes of interest included operation time (minutes), blood transfusion requirements, post-operative infection and length of stay in hospital (days). There was a decreased trend in overall mortality in the PCCP group [CI 0.84, (0.48 to 1.47), Chi-square = 1.36, p = 0.51]. Similar trends favouring the PCCP technique were seen with the other outcomes. PCCP being a relatively new technique has the potential to become the gold standard in the repair of intertrochanteric hip fractures. However, owing to the limitations of this meta-analysis, a large randomised controlled trial is required.

Comparison of reports of randomized controlled trials and systematic reviews in surgical journals: literature review.

OBJECTIVES: Randomized controlled trials and systematic reviews of such trials are the gold standard for assessing the effectiveness of interventions. There have been concerns about the anecdotal evidence underpinning many of the interventions used and introduced into surgical care. The American College of Surgeons has prioritized the need for more trials and systematic reviews of trials. To investigate the assertion that the methodological quality of studies conducted in surgery is in general poor and to assess the possible impact of new policy developments in the US, we sought to compare the number and proportion of published randomized controlled trials and systematic reviews in the leading two US and UK general surgical journals. Two reviewers systematically and independently hand searched all issues of these journals over a 12-month period to identify randomised controlled trials and systematic reviews. DESIGN: Systematic searching and independent abstraction of data from all volumes of the top two general surgical journals published in the USA and the UK in 2004. SETTING: 519 original reports in UK journals and 616 original reports in USA journals. MAIN OUTCOME MEASURES: Number and proportion of randomized controlled trials and systematic reviews. RESULTS: Overall, the proportion of randomized controlled trials in all four journals was 5.6% (95% confidence interval [CI] 4.4-7.0) and 5.2% (95% CI 4.1-6.7) for systematic reviews. For journals published in the UK 29/519 (5.6%) of the publications were reports of randomized controlled trials, and for the USA journals this figure was 34/616 (5.5%); odds ratio [OR]=0.99, 95%CI 0.6-1.6; P=0.96. Systematic reviews were significantly more commonly reported in the UK journals: UK 37/519 (7.1%) versus USA 22/616 (3.6%); OR=0.48, 95%CI 0.3-0.8; P<0.01. CONCLUSIONS: The concerns expressed almost a decade ago remain valid: there are still very few reports of randomized controlled trials and systematic reviews published in leading USA and UK surgical journals, with relatively little difference between these countries in the proportion of reported studies employing these designs. The American College of Surgeons initiative has yet to make an impact.

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.

How safe is primary care? A systematic review.

IMPORTANCE: Improving patient safety is at the forefront of policy and practice. While considerable progress has been made in understanding the frequency, causes and consequences of error in hospitals, less is known about the safety of primary care. OBJECTIVE: We investigated how often patient safety incidents occur in primary care and how often these were associated with patient harm. EVIDENCE REVIEW: We searched 18 databases and contacted international experts to identify published and unpublished studies available between 1 January 1980 and 31 July 2014. Patient safety incidents of any type were eligible. Eligible studies were critically appraised using validated instruments and data were descriptively and narratively synthesised. FINDINGS: Nine systematic reviews and 100 primary studies were included. Studies reported between <1 and 24 patient safety incidents per 100 consultations. The median from population-based record review studies was 2-3 incidents for every 100 consultations/records reviewed. It was estimated that around 4% of these incidents may be associated with severe harm, defined as significantly impacting on a patient's well-being, including long-term physical or psychological issues or death (range <1% to 44% of incidents). Incidents relating to diagnosis and prescribing were most likely to result in severe harm. CONCLUSIONS AND RELEVANCE: Millions of people throughout the world use primary care services on any given day. This review suggests that safety incidents are relatively common, but most do not result in serious harm that reaches the patient. Diagnostic and prescribing incidents are the most likely to result in avoidable harm. SYSTEMATIC REVIEW REGISTRATION: This systematic review is registered with the International Prospective Register of Systematic Reviews (PROSPERO CRD42012002304).

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.