Incidence Of Harm Research Articles

Conflict and Contract Law

This article examines an under-explored reason to have contract law: conflict minimization. An important function of contract law, the article contends, is to diminish the wasted time, effort, and resources spent on disputes over economic exchange, and to reduce the incidence of harm resulting from these disputes. Minimizing conflict typically serves the parties’ own interests, and it also serves the public interest in social peace. These insights have implications not just for contract law as a whole but also for its doctrinal details. The article thus discusses how several doctrines of substantive contract law help to minimize conflict, without claiming that currently prevailing contract law regimes are perfectly adapted to this aim. Finally, it defends the normative claim that conflict minimization should be considered one of contract law’s goals.

Fluvastatin for lowering lipids.

Fluvastatin is thought to be the least potent statin on the market, however, the dose-related magnitude of effect of fluvastatin on blood lipids is not known. Primary objectiveTo quantify the effects of various doses of fluvastatin on blood total cholesterol, low-density lipoprotein (LDL cholesterol), high-density lipoprotein (HDL cholesterol), and triglycerides in participants with and without evidence of cardiovascular disease.Secondary objectivesTo quantify the variability of the effect of various doses of fluvastatin.To quantify withdrawals due to adverse effects (WDAEs) in randomised placebo-controlled trials. The Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to February 2017: the Cochrane Central Register of Controlled Trials (CENTRAL) (2017, Issue 1), MEDLINE (1946 to February Week 2 2017), MEDLINE In-Process, MEDLINE Epub Ahead of Print, Embase (1974 to February Week 2 2017), the World Health Organization International Clinical Trials Registry Platform, CDSR, DARE, Epistemonikos and ClinicalTrials.gov. We also contacted authors of relevant papers regarding further published and unpublished work. No language restrictions were applied. Randomised placebo-controlled and uncontrolled before and after trials evaluating the dose response of different fixed doses of fluvastatin on blood lipids over a duration of three to 12 weeks in participants of any age with and without evidence of cardiovascular disease. Two review authors independently assessed eligibility criteria for studies to be included, and extracted data. We entered data from placebo-controlled and uncontrolled before and after trials into Review Manager 5 as continuous and generic inverse variance data, respectively. WDAEs information was collected from the placebo-controlled trials. We assessed all trials using the 'Risk of bias' tool under the categories of sequence generation, allocation concealment, blinding, incomplete outcome data, selective reporting, and other potential biases. One-hundred and forty-five trials (36 placebo controlled and 109 before and after) evaluated the dose-related efficacy of fluvastatin in 18,846 participants. The participants were of any age with and without evidence of cardiovascular disease, and fluvastatin effects were studied within a treatment period of three to 12 weeks. Log dose-response data over doses of 2.5 mg to 80 mg revealed strong linear dose-related effects on blood total cholesterol and LDL cholesterol and a weak linear dose-related effect on blood triglycerides. There was no dose-related effect of fluvastatin on blood HDL cholesterol. Fluvastatin 10 mg/day to 80 mg/day reduced LDL cholesterol by 15% to 33%, total cholesterol by 11% to 25% and triglycerides by 3% to 17.5%. For every two-fold dose increase there was a 6.0% (95% CI 5.4 to 6.6) decrease in blood LDL cholesterol, a 4.2% (95% CI 3.7 to 4.8) decrease in blood total cholesterol and a 4.2% (95% CI 2.0 to 6.3) decrease in blood triglycerides. The quality of evidence for these effects was judged to be high. When compared to atorvastatin and rosuvastatin, fluvastatin was about 12-fold less potent than atorvastatin and 46-fold less potent than rosuvastatin at reducing LDL cholesterol. Very low quality of evidence showed no difference in WDAEs between fluvastatin and placebo in 16 of 36 of these short-term trials (risk ratio 1.52 (95% CI 0.94 to 2.45). Fluvastatin lowers blood total cholesterol, LDL cholesterol and triglyceride in a dose-dependent linear fashion. Based on the effect on LDL cholesterol, fluvastatin is 12-fold less potent than atorvastatin and 46-fold less potent than rosuvastatin. This review did not provide a good estimate of the incidence of harms associated with fluvastatin because of the short duration of the trials and the lack of reporting of adverse effects in 56% of the placebo-controlled trials.

Effect of Nurses' Perception of Patient Safety Culture on Reporting of Patient Safety Events

Purpose: This study was done to examine factors influencing nurses" perception of patient safety culture in reporting of patient safety events. Methods: Structured questionnaires were used to collect data from 305 nurses who were involved in direct patient care. Data were analyzed using descriptive statistics, t-test, ANOVA, Pearson correlation coefficients and multiple linear regressions with SPSS/WIN version 24.0. Results: Patient safety events were reported as follows: 4.60±0.63 for harmful incidents, 4.02±0.82 for no harm incidents, and 3.59±0.97 for near misses. Patient safety event reporting was significantly positively correlated with patient safety culture. Regression analysis showed, factors influencing reports of harmful incidents were‘feedback and communication about error’,‘supervisor/manager expectations’and‘carrier of hospital’. Factors influencing reports of no harm incidents were‘feedback and communication about error’. Factors influencing reports on near-misses were ‘teamwork across units’, ‘overall perceptions of safety’, and ‘feedback and communication about error’. Conclusion: Findings show that reports of near misses are relatively low and need to be strengthened. These results provide evidence that reporting on patient safety events would be enhanced through improved patient safety culture. Hospital managers could identify factors that affect reporting of each patient safety event and use it to develop intervention programs for risk management.

Communication at Transitions: One Audacious Bite at a Time.

To be audacious and take significant steps toward achieving the Quadruple Aim (improving the patient experience of care; improving the health of populations; reducing the per capita cost of health care; and improving the work life of clinicians and staff), we patients and caregivers need to better understand key features of our health journeys. When on that health journey, we are patients interacting with a series of care teams: our home team (social network), our community agency teams, our emergency care team, our hospital teams, and on and on. These care teams include ourselves, our caregivers, clinicians, other professionals, and direct care and support staff—people at the center of care. The actions taken by people at the center of care to improve, maintain, or adapt to our health or illness represents our health care. Actions can be diagnostic, taking medications, undergoing procedures, learning, living life and getting help living life. So, our health journey is teams of people at the center of care taking such actions to provide healthcare and service to us. During this journey, we transition from one setting to another, from one team to another, repeatedly. Communication knits this maze of actions, interactions, and transitions together. At its core communication is two or more people or parties sharing some information via some channel (voice, paper, digital, dramatic), one time or several times in a particular setting, hoping to accomplish something that moves us along in our health journey. One of the most persistent and ubiquitous frustrations in health care is that of poor communication. Poor communication at transitions is at the root of much overuse, underuse, and misuse of health resources, and results in the inability of patients to complete recommended treatment. For the patient and their family this means unnecessary delays in returning to health or worse. For those professionals on the care team the incidents of harm, burnout, stress, and frustration cause financial, emotional and career-ending consequences. Poor communication at transitions impacts each of the Quadruple Aims. The potential return for the investment in communication may cross over one or more organizational boundaries. Organization Boards and the C-Suite customarily focus on activities within their institutions, not between. The daunting nature of the challenge, caused by the shear volume and variety of transition nodes, can paralyze those in decision making roles, leading to smaller, more manageable local solutions. I support building a more holistic solution that includes the necessary governance, infrastructure, habits, and relationships. This leads to systematically applied common standards for local, node-specific solutions. Development should include all persons at the center of care in governance, design, operations and learning for systemic and local solutions. Refined clinical work flow should be constructed to respect patient and care partner life flow. Solutions should use interoperable technology to aid, not replace, communication. Transition information and processes should be transparent to patients and their care partners.

Harnessing advances in computer simulation to inform policy and planning to reduce alcohol-related harms

ObjectivesAlcohol misuse is a complex systemic problem. The aim of this study was to explore the feasibility of using a transparent and participatory agent-based modelling approach to develop a robust decision support tool to test alcohol policy scenarios before they are implemented in the real world.MethodsA consortium of Australia’s leading alcohol experts was engaged to collaboratively develop an agent-based model of alcohol consumption behaviour and related harms. As a case study, four policy scenarios were examined.ResultsA 19.5 ± 2.5% reduction in acute alcohol-related harms was estimated with the implementation of a 3 a.m. licensed venue closing time plus 1 a.m. lockout; and a 9 ± 2.6% reduction in incidence was estimated with expansion of treatment services to reach 20% of heavy drinkers. Combining the two scenarios produced a 33.3 ± 2.7% reduction in the incidence of acute alcohol-related harms, suggesting a synergistic effect.ConclusionsThis study demonstrates the feasibility of participatory development of a contextually relevant computer simulation model of alcohol-related harms and highlights the value of the approach in identifying potential policy responses that best leverage limited resources.

Incidence, clinical management, and mortality risk following self harm among children and adolescents: cohort study in primary care

Objectives To examine temporal trends in sex and age specific incidence of self harm in children and adolescents, clinical management patterns, and risk of cause specific mortality following an index...

Patient safety incidents during interhospital transport of patients: A prospective analysis

IntroductionInterhospital transport of critically ill patients is at risk of complications. The objective of the study was to prospectively record patient safety incidents that occurred during interhospital transports and to determine their risk factors. MethodsWe prospectively collected data during a fifteen-month period in 2 hospitals. Patient and transport characteristics were collected using a specifically designed tool. Patient safety incidents were appraised for health-care associated harm, and categorized as technical, operational, and communication problems. ResultsOur study included 688 patients who were transferred to or from one of both hospitals by physician or nurse led transport, with complete records. A patient safety incident was reported in 16.7% of transports, health-care associated harm was noted in 3.9% of cases. In multivariate analysis, three factors remained significantly associated with an increased risk of healthcare-associated harm: operational incidents (odds ratio=144.93, 95% CI=37.55–767.50, P<0.001), communication incidents (odds ratio=11.05, 95% CI=3.02–52.99, P<0.001) and the Modified Sequential Organ Failure Assessment (M-SOFA) score (odds ratio=1.198, 95% CI=1.038–1.40, P=0.017). ConclusionsThe observed rate of patient safety incidents during interhospital transfers is lower than previously reported in the literature. However, there is limited previous work done on this topic. Operational and communication incidents, and a higher M-SOFA score are significantly associated with increase odds of harmful incident. These findings call for stricter preparation of transfers, with clear and standardized communication.

A call to incorporate systems theory and human factors into the existing investigation of harm in clinical research involving healthcare products.

This is a joint statement from individual pharmacology and pharmaceutical professionals acting in their own capacity, including members of the Alliance for Clinical Research Excellence and Safety (ACRES) and the International Society of Pharmacovigilance (ISoP). By building on the extensive pharmacological and regulatory investigations that already take place, we are calling for a fuller and more robust systems-based approach to the independent investigation of clinical research when serious incidents of harm occur, starting with first-in-human clinical trials. To complement existing activities and regulations, we propose an additional approach blending evidence derived from both pharmacological and organizational science, which addresses human factors and transparency, to enhance organizational learning and continuous improvement. As happens with investigations in other sectors of society, such as the chemical and aviation sector, this systems approach should be seen as an additional way to understand how problems occur and how they might be prevented in the future. We believe that repetition of potentially preventable and adverse outcomes during clinical research, by failing to identify and act upon all systematic vulnerabilities, is a situation that needs urgent change. As we will discuss further on, approaches based on applying systems theory and human factors are much more likely to improve objectivity and transparency, leading to better system design.

Adapting Art Critiques to Address Digital Harm

Abstract How can we use the skills our students have already developed in the art classroom to address digital harm issues? Pre-service art teachers and students who are comfortable with the critiquing process and understand it as a way to systematically explore and discuss the technical, contextual, and interpretive aspects of artwork may be able to apply the same skills to analyze digital harm incidents so they can be better prepared for digital life.

Clinical Effects of a Pharmacist Intervention in Acute Wards - A Randomized Controlled Trial.

The purpose of the study was to investigate the clinical effect of a clinical pharmacist (CP) intervention upon admission to hospital on inpatient harm and to assess a potential educational bias. Over 16months, 593 adult patients taking ≥4 medications daily were included from three Danish acute medicine wards. Patients were randomized to either the CP intervention or the usual care (prospective control). To assess a potential educational bias, a retrospective control group was formed by randomization. The CP intervention comprised medication history, medication reconciliation, medication review and entry of proposed prescriptions into the electronic prescribing system. The primary outcome of inpatient harm was identified using triggers from the Institute of Healthcare Improvement Global Trigger Tool. Harms were validated and rated for severity by two independent and blinded outcome panels. Secondary end-points were harms per patient, length of hospital stay, readmissions and 1-year mortality. Harm affected 11% of the patients in the intervention group compared to 17% in the combined control group, odds ratio (OR) 0.57 (CI 0.32-1.02, p=0.06). The incidence of harm was similar in the intervention and prospective control groups, OR 0.80 (CI 0.40-1.59, p=0.52) but occurred less frequently in the intervention than in the retrospective control group OR 0.46 (CI 0.25-0.85, p=0.01). An educational bias from the intervention to the control group might have contributed to this negative outcome. In conclusion, the CP intervention at admission to hospital had no statistically significant effect on inpatient harm.

Nursing student patient safety errors in the practice domain: a scoping review protocol of the quantitative and qualitative evidence.

The objective of this scoping review is to identify the range of patient safety events that includes patient safety errors, harms or near misses that student nurses make while nursing in their clinical placements. The question that will guide this review is: what types of hazards, healthcare-associated harms, patient safety incidents, reportable circumstances, near misses, harmful incidents, no harm incidents and injuries to patients are being made and reported by nursing students during their practice in healthcare facilities?

Emergency Department redirection to primary care: a prospective evaluation of practice.

Background and aim Non-urgent Emergency Department presentations contribute to overcrowding, which can adversely affect patient care. Redirecting patients to a more appropriate service is an option to help address this. We conducted a prospective evaluation of a major Scottish hospital's Emergency Department redirection policy to assess its safety. Methods and results Over two months, 620 patients triggered senior assessment for redirection with 444 (72%) redirected to primary care. Information on presentation was collected with subsequent management and outcome of redirection provided by the patient's general practitioner. Those who required admission within seven days of redirection triggered review. This was carried out independently by an Emergency Department Consultant and a GP Principal to assess the incidence of sub-optimal care or harm as a consequence of redirection. Most patients presented during daytime hours with no significant variation between days. 'Patient factors' accounted for 74% of presentations with 'convenience' (20%) cited as the most common reason. Twenty-two patients were subsequently admitted, with one case of sub-optimal care (incidence 0.23%) and no cases of harm. Conclusions Our redirection policy provides a safe and effective means of directing patients to more appropriate care. The authors believe this to be in the patient s best interest as Emergency Department clinicians are not specifically trained to manage primary care issues.

Understanding the epidemiology of avoidable significant harm in primary care: protocol for a retrospective cross-sectional study

IntroductionMost patient safety research has focused on specialist-care settings where there is an appreciation of the frequency and causes of medical errors, and the resulting burden of adverse events. There...

Improving safety in care homes: protocol for evaluation of the Walsall and Wolverhampton care home improvement programme

BackgroundImproving safety in care homes is becoming increasingly important. Care home residents typically have multiple physical and/or cognitive impairments, and adverse events like falls often lead to hospital attendance or admission. Developing a safety culture is associated with beneficial impacts on safety outcomes, but the complex needs of care home residents, coupled with staffing pressures in the sector, pose challenges for positive safety practices to become embedded at the individual and organisational levels. Staff training and education can positively enforce safety culture and reduce the incidence of harms, but improvement initiatives are often short lived and thorough evaluation is uncommon. This protocol outlines an evaluation of a large-scale care home improvement programme in the West Midlands.MethodsThe programme will run in 35 care homes across Walsall and Wolverhampton over 24 months, and we anticipate that 30 care homes will participate in the evaluation (n = 1500 staff). The programme will train staff and managers in service improvement techniques, with the aim of strengthening safety culture and reducing adverse safety event rates. The evaluation will use a pre-post design with mixed methods. Quantitative data will focus on: care home manager and staff surveys administered at several time points and analysis of adverse event rates. Data on hospital activity by residents at participating care homes will be compared to matched controls. Qualitative data on experience of training and the application of learning to practice will be collected via semi-structured interviews with staff (n = 48 to 64) and programme facilitators (n = 6), and staff focus groups (n = 36 to 48 staff). The primary outcome measure is the change in mean score on the safety climate domain of the Safety Attitudes Questionnaire between baseline and programme end.DiscussionThis mixed methods evaluation of a large-scale care home improvement programme will allow a substantial amount of qualitative and quantitative data to be collected. This will enable an assessment of the extent to which care home staff training can effectively improve safety culture, lower the incidence of adverse safety events such as falls and pressure ulcers, and potentially reduce care home resident’s use of acute services.

Patient Safety Incidents Involving Sick Children in Primary Care in England and Wales: A Mixed Methods Analysis.

BackgroundThe UK performs poorly relative to other economically developed countries on numerous indicators of care quality for children. The contribution of iatrogenic harm to these outcomes is unclear. As primary care is the first point of healthcare contact for most children, we sought to investigate the safety of care provided to children in this setting.Methods and FindingsWe undertook a mixed methods investigation of reports of primary care patient safety incidents involving sick children from England and Wales’ National Reporting and Learning System between 1 January 2005 and 1 December 2013. Two reviewers independently selected relevant incident reports meeting prespecified criteria, and then descriptively analyzed these reports to identify the most frequent and harmful incident types. This was followed by an in-depth thematic analysis of a purposive sample of reports to understand the reasons underpinning incidents. Key candidate areas for strengthening primary care provision and reducing the risks of systems failures were then identified through multidisciplinary discussions.Of 2,191 safety incidents identified from 2,178 reports, 30% (n = 658) were harmful, including 12 deaths and 41 cases of severe harm. The children involved in these incidents had respiratory conditions (n = 387; 18%), injuries (n = 289; 13%), nonspecific signs and symptoms, e.g., fever (n = 281; 13%), and gastrointestinal or genitourinary conditions (n = 268; 12%), among others. Priority areas for improvement included safer systems for medication provision in community pharmacies; triage processes to enable effective and timely assessment, diagnosis, and referral of acutely sick children attending out-of-hours services; and enhanced communication for robust safety netting between professionals and parents. The main limitations of this study result from underreporting of safety incidents and variable data quality. Our findings therefore require further exploration in longitudinal studies utilizing case review methods.ConclusionsThis study highlights opportunities to reduce iatrogenic harm and avoidable child deaths. Globally, healthcare systems with primary-care-led models of delivery must now examine their existing practices to determine the prevalence and burden of these priority safety issues, and utilize improvement methods to achieve sustainable improvements in care quality.

A call to incorporate systems theory and human factors into the existing investigation of harm in clinical research involving healthcare products

Event Abstract Back to Event A call to incorporate systems theory and human factors into the existing investigation of harm in clinical research involving healthcare products Brian Edwards1*, Bernard Bégaud2, Esther Daemen3, Ioannis Dokas4, Jonathan Fishbein5, Howard Greenberg6, Alan Hochberg7, Herve Le Louet8, Jytte Lyndvig9, Nataliya Mogles10, Kathyryn Owen11, Christine Prendergast12, Martin Rejzek13, Sofia Trantza14, David Webb15, Mathew Whalen16 and Simon Whiteley17 1 ACRES, Product Safety Culture Initiative, UK 2 Universite de Bordeaux, Pharmacology, France 3 Trium Clinical Consulting NV, Clinical Research, Belgium 4 Democirtus University of Thrace, Systems Engimeering, Greece 5 PRA Health Sciences, Medical Services, United States 6 Thomas Jefferson University, Clinical Pharmacology, United States 7 F. Hoffman-La Roche Ltd, Drug Safety, Switzerland 8 Publique Hôpitaux de Paris, Pharmacovigilance, France 9 Danish Medicines Agency (retired), CEO (retired), Denmark 10 University of Bath, Computer Sciences, UK 11 Owen Clinical Consulting Ltd, Consultant, UK 12 Quintiles IMS, Pharmacovigilance, Ireland 13 Zurich University of Applied Sciences, Switzerland 14 National Medicines Agency (EOF);, Pharmacovigilance, Greece 15 University of Edinburgh, Clinical Pharmacology, UK 16 Alliance for Clinical Research Excellence and Safety (Acres), United States 17 Whiteley Aerospace Safety Engineering & Management Ltd; , UK Purpose: We believe that repetition of potentially preventable and adverse outcomes during clinical research through not identifying and acting upon all systematic vulnerabilities is a situation that needs urgent change and that time for action is now. Methods: A joint assessment has been performed by individual pharmacology and pharmaceutical professionals acting in their own capacity including members of the Alliance for Clinical Research Excellence and Safety and the International Society of Pharmacovigilance. Results: By building on the extensive pharmacological and regulatory investigations that already take place, we are calling for a fuller and more robust systems-based approach to the independent investigation of clinical research when serious incidents of harm occur starting with first-into-human trials. To complement existing activities and regulations, we propose an additional approach blending evidence derived from pharmacological and organisational science which addresses human factors and transparency to enhance organisational learning and continuous improvement (1, 2). Conclusions: This systems approach should be seen as an additional way to understand how problems occur and how they might be prevented in the future. Approaches based on applying systems theory and human factors are much more likely to improve objectivity and transparency leading to better systems design and enhanced trust in clinical research.

Implementing An Integrated In-Situ Coaching, Observational Audit, and Story-Telling Intervention to Support Safe Surgery

This article describes an intervention that combined in-situ coaching, observational audits and story-telling to educate theatre teams at University College London Hospitals about the Five steps to safer surgery (NPSA 2010). Our philosophy was to educate theatre teams about 'what goes right' (good catches, exemplary leadership etc) as well as 'what could be improved'. Results showed improvements on 'behavioural reliability' metrics, a 68% increase in near miss reporting and a reduction in surgical harm incidents.

Identification of priorities for improvement of medication safety in primary care: a PRIORITIZE study.

BackgroundMedication error is a frequent, harmful and costly patient safety incident. Research to date has mostly focused on medication errors in hospitals. In this study, we aimed to identify the main causes of, and solutions to, medication error in primary care.MethodsWe used a novel priority-setting method for identifying and ranking patient safety problems and solutions called PRIORITIZE. We invited 500 North West London primary care clinicians to complete an open-ended questionnaire to identify three main problems and solutions relating to medication error in primary care. 113 clinicians submitted responses, which we thematically synthesized into a composite list of 48 distinct problems and 45 solutions. A group of 57 clinicians randomly selected from the initial cohort scored these and an overall ranking was derived. The agreement between the clinicians’ scores was presented using the average expert agreement (AEA). The study was conducted between September 2013 and November 2014.ResultsThe top three problems were incomplete reconciliation of medication during patient ‘hand-overs’, inadequate patient education about their medication use and poor discharge summaries. The highest ranked solutions included development of a standardized discharge summary template, reduction of unnecessary prescribing, and minimisation of polypharmacy. Overall, better communication between the healthcare provider and patient, quality assurance approaches during medication prescribing and monitoring, and patient education on how to use their medication were considered the top priorities. The highest ranked suggestions received the strongest agreement among the clinicians, i.e. the highest AEA score.ConclusionsClinicians identified a range of suggestions for better medication management, quality assurance procedures and patient education. According to clinicians, medication errors can be largely prevented with feasible and affordable interventions. PRIORITIZE is a new, convenient, systematic, and replicable method, and merits further exploration with a view to becoming a part of a routine preventative patient safety monitoring mechanism.Electronic supplementary materialThe online version of this article (doi:10.1186/s12875-016-0552-6) contains supplementary material, which is available to authorized users.

Clinician-identified problems and solutions for delayed diagnosis in primary care: a PRIORITIZE study.

BackgroundDelayed diagnosis in primary care is a common, harmful and costly patient safety incident. Its measurement and monitoring are underdeveloped and underutilised. We created and implemented a novel approach to identify problems leading to and solutions for delayed diagnosis in primary care.MethodsWe developed a novel priority-setting method for patient safety problems and solutions called PRIORITIZE. We invited more than 500 NW London clinicians via an open-ended questionnaire to identify three main problems and solutions relating to delayed diagnosis in primary care. 113 clinicians submitted their suggestions which were thematically grouped and synthesized into a composite list of 33 distinct problems and 27 solutions. A random group of 75 clinicians from the initial cohort scored these and an overall ranking was derived. The agreement between the clinicians’ scores was presented using the Average Expert Agreement.ResultsThe top ranked problems were poor communication between secondary and primary care and the inverse care law, i.e. a mismatch between patients’ medical needs and healthcare supply. The highest ranked solutions included: a more rigorous system of communicating abnormal results of investigations to patients, direct hotlines to specialists for GPs to discuss patient problems and better training of primary care clinicians in relevant areas. A priority highlighted throughout the findings is a need to improve communication between clinicians as well as with patients. The highest ranked suggestions had the highest consensus between experts.ConclusionsThe novel method we have developed is highly feasible, informative and scalable, and merits wider exploration with a view of becoming part of a routine pro-active and preventative system for patient safety assessment. Clinicians proposed a range of concrete suggestions with an emphasis on improving communication among clinicians and with patients and better GP training. In their view, delayed diagnosis can be largely prevented with interventions requiring relatively minor investment. Rankings of identified problems and solutions can serve as an aid to policy makers and commissioners of care in prioritization of scarce healthcare resources.Electronic supplementary materialThe online version of this article (doi:10.1186/s12875-016-0530-z) contains supplementary material, which is available to authorized users.

Characterising the nature of primary care patient safety incident reports in the England and Wales National Reporting and Learning System: a mixed-methods agenda-setting study for general practice

BackgroundThere is an emerging interest in the inadvertent harm caused to patients by the provision of primary health-care services. To date (up to 2015), there has been limited research interest and few policy directives focused on patient safety in primary care. In 2003, a major investment was made in the National Reporting and Learning System to better understand patient safety incidents occurring in England and Wales. This is now the largest repository of patient safety incidents in the world. Over 40,000 safety incident reports have arisen from general practice. These have never been systematically analysed, and a key challenge to exploiting these data has been the largely unstructured, free-text data.AimsTo characterise the nature and range of incidents reported from general practice in England and Wales (2005–13) in order to identify the most frequent and most harmful patient safety incidents, and relevant contributory issues, to inform recommendations for improving the safety of primary care provision in key strategic areas.MethodsWe undertook a cross-sectional mixed-methods evaluation of general practice patient safety incident reports. We developed our own classification (coding) system using an iterative approach to describe the incident, contributory factors and incident outcomes. Exploratory data analysis methods with subsequent thematic analysis was undertaken to identify the most harmful and most frequent incident types, and the underlying contributory themes. The study team discussed quantitative and qualitative analyses, and vignette examples, to propose recommendations for practice.Main findingsWe have identified considerable variation in reporting culture across England and Wales between organisations. Two-thirds of all reports did not describe explicit reasons about why an incident occurred. Diagnosis- and assessment-related incidents described the highest proportion of harm to patients; over three-quarters of these reports (79%) described a harmful outcome, and half of the total reports described serious harm or death (n = 366, 50%). Nine hundred and ninety-six reports described serious harm or death of a patient. Four main contributory themes underpinned serious harm- and death-related incidents: (1) communication errors in the referral and discharge of patients; (2) physician decision-making; (3) unfamiliar symptom presentation and inadequate administration delaying cancer diagnoses; and (4) delayed management or mismanagement following failures to recognise signs of clinical (medical, surgical and mental health) deterioration.ConclusionsAlthough there are recognised limitations of safety-reporting system data, this study has generated hypotheses, through an inductive process, that now require development and testing through future research and improvement efforts in clinical practice. Cross-cutting priority recommendations include maximising opportunities to learn from patient safety incidents; building information technology infrastructure to enable details of all health-care encounters to be recorded in one system; developing and testing methods to identify and manage vulnerable patients at risk of deterioration, unscheduled hospital admission or readmission following discharge from hospital; and identifying ways patients, parents and carers can help prevent safety incidents. Further work must now involve a wider characterisation of reports contributed by the rest of the primary care disciplines (pharmacy, midwifery, health visiting, nursing and dentistry), include scoping reviews to identify interventions and improvement initiatives that address priority recommendations, and continue to advance the methods used to generate learning from safety reports.FundingThe National Institute for Health Research Health Services and Delivery Research programme.