Prospective review of 30-day morbidity and mortality in a paediatric neurosurgical unit

Purpose: The purpose of this study is to record the 30-day and inpatient morbidity and mortality in paediatric patients in a tertiary neuroscience centre over a 2-year period. The intentions were to establish the frequency of significant adverse events, review the current published rates of morbidity in paediatric neurosurgical patients and propose three clinical indicators for future comparison. Methods: All deaths and adverse events were prospectively recorded from 1 January 2014 to 31 December 2015. Each adverse event was categorised, allocated a clinical impact severity score and linked to a neurosurgical procedure wherever possible. Where a patient suffered several adverse events in the same admission, each event was recorded separately. If a patient had been discharged home, an adverse event was recorded if it occurred within 30 days of admission. Results: Five hundred forty-nine procedures were performed in 287 patients (aged <16 years). One hundred thirty significant adverse events were identified. The following are the three clinical indicators: significant adverse event rate: 111 (20.2%) operations were linked to at least one significant adverse event; unscheduled return to theatre rate: 81 (14.8%) operations were associated with an adverse event that resulted in an unscheduled return to theatre; and surgical site infection rate: 29 (5.3%) operations were associated with an infection. Conclusion: Complications and adverse events are common in paediatric neurosurgery. Prospective, continuous surveillance will promote both quality assurance and quality improvement in the neurosurgical care delivered to patients

Action following the discovery of a global association between the whole genome and adverse event risk in a clinical drug-development programme

Observation of adverse drug reactions during drug development can cause closure of the whole programme. However, if association between the genotype and the risk of an adverse event is discovered, then it might suffice to exclude patients of certain genotypes from future recruitment. Various sequential and non-sequential procedures are available to identify an association between the whole genome, or at least a portion of it, and the incidence of adverse events. In this paper we start with a suspected association between the genotype and the risk of an adverse event and suppose that the genetic subgroups with elevated risk can be identified. Our focus is determination of whether the patients identified as being at risk should be excluded from further studies of the drug. We propose using a utility function to determine the appropriate action, taking into account the relative costs of suffering an adverse reaction and of failing to alleviate the patient's disease. Two illustrative examples are presented, one comparing patients who suffer from an adverse event with contemporary patients who do not, and the other making use of a reference control group. We also illustrate two classification methods, LASSO and CART, for identifying patients at risk, but we stress that any appropriate classification method could be used in conjunction with the proposed utility function. Our emphasis is on determining the action to take rather than on providing definitive evidence of an association

Reporting of Clinical Adverse Events Scale: a measure of doctor and nurse attitudes to adverse event reporting

Objective: To develop a validated measure of professionals' attitudes towards clinical adverse event reporting (CAER). Design: Cross-sectional survey with follow-up. Participants: 201 doctors and nurse/nurse-midwives undergoing postqualification training in Leeds, York and Hull Universities in 2003. Materials: A questionnaire which comprised 73 items extracted from interviews with professionals; a second, statistically reduced version of this questionnaire. Results: The analysis supported a 25-item questionnaire comprising five factors: blame as a consequence of reporting (six items); criteria for reporting (six items); colleagues' expectations (six items); perceived benefits of reporting events (five items); and clarity of reporting procedures (two items). The resulting questionnaire, the Reporting of Clinical Adverse Effects Scale (RoCAES), had satisfactory internal consistency (Cronbach's alpha = 0.83) and external reliability (Spearman's correlation = 0.65). The construct validity hypothesis -doctors have less positive attitudes towards CAER than nurses -was supported (t = 5.495; p < 0.0001). Conclusion: Initial development of an evidence-based, psychometrically rigorous measure of attitudes towards CAER has been reported. Following additional testing, RoCAES may be used to systematically elicit professionals' views about, and inform interventions to improve, reporting behaviour

Introducing realist ontology for the representation of adverse events

The goal of the REMINE project is to build a high performance prediction, detection and monitoring platform for managing Risks against Patient Safety (RAPS). Part of the work involves developing in ontology enabling computer-assisted RAPS decision support on the basis of the disease history of a patient as documented in a hospital information system. A requirement of the ontology is to contain a representation for what is commonly referred to by the term 'adverse event', one challenge being that distinct authoritative sources define this term in different and context-dependent ways. The presence of some common ground in all definitions is, however, obvious. Using the analytical principles underlying Basic Formal Ontology and Referent Tracking, both developed in the tradition of philosophical realism, we propose a formal representation of this common ground which combines a reference ontology consisting exclusively of representations of universals and an application ontology which consists representations of defined classes. We argue that what in most cases is referred to by means of the term 'adverse event' - when used generically - is a defined class rather than a universal. In favour of the conception of adverse events as forming a defined class are the arguments that (1) there is no definition for 'adverse event' that carves out a collection of particulars which constitutes the extension of a universal, and (2) the majority of definitions require adverse events to be (variably) the result of some observation, assessment or (absence of) expectation, thereby giving these entities a nominal or epistemological flavour

An evolutionary approach to the representation of adverse events

One way to detect, monitor and prevent adverse events with the help of Information Technology is by using ontologies capable of representing three levels of reality: what is the case, what is believed about reality, and what is represented. We report on how Basic Formal Ontology and Referent Tracking exhibit this capability and how they are used to develop an adverse event ontology and related data annotation scheme for the European ReMINE project

Pattern discovery in adverse event data

Imperial Users onl

Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada.

This survey analyzes two national pharmacovigilance databases in order to determine the major adverse reactions observed with the use of cholinesterase inhibitors in dementia. We conducted a statistical analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS) and the Canada Vigilance Adverse Reaction Database (CVARD) concerning the side effects of cholinesterase inhibitors. The statistics calculated for each adverse event were the frequency and the reporting odds ratios (ROR). A total of 9877 and 2247 reports were extracted from the FAERS and CVARD databases, respectively. A disproportionately higher frequency of reports of death as an adverse event for rivastigmine, compared to the other acetylcholinesterase inhibiting drugs, was observed in both the FAERS (ROR = 3.42; CI95% = 2.94-3.98; P&lt;0.0001) and CVARD (ROR = 3.67; CI95% = 1.92-7.00; P = 0.001) databases. While cholinesterase inhibitors remain to be an important therapeutic tool against Alzheimer's disease, the disproportionate prevalence of fatal outcomes with rivastigmine compared with alternatives should be taken into consideration

Darbepoetin alfa given every 1 or 2 weeks alleviates anaemia associated with cancer chemotherapy.

In part A of this study, patients were randomised to cohorts receiving darbepoetin alfa at doses of 0.5 to 8.0 m.c.g x kg(-1) x wk(-1) or to a control group receiving epoetin alfa at an initial dose of 150 U x kg(-1) three times weekly. In part B, the cohorts were darbepoetin alfa 3.0 to 9.0 m.c.g x kg(-1) every 2 weeks or epoetin alfa, initial dose 40 000 U x wk(-1). Safety was assessed by adverse events, changes in blood pressure, and formation of antibodies to darbepoetin alfa. Efficacy was assessed by several haematologic endpoints, including change in haemoglobin from baseline. The adverse event profile of darbepoetin alfa was similar to that of epoetin alfa. No relationship between the rapidity of haemoglobin response and any adverse event was observed. No antibodies to darbepoetin alfa were detected. Higher doses of darbepoetin alfa increased the proportion of patients with a haemoglobin response and decreased the median time to response. The overall dose of darbepoetin alfa required to produce a mean increase in haemoglobin does not increase when the dosing interval is increased from 1 to 2 weeks. Therapy with darbepoetin alfa is safe and effective in producing a dose-related increase in haemoglobin levels in patients with cancer receiving chemotherapy

Rural Hospital Nursing Skill Mix and Work Environment Associated with Frequency of Adverse Events.

Introduction: Though rural hospitals serve about one fifth of the United States (U.S.), few studies have investigated relationships among nursing resources and rural hospital adverse events. Objectives: The purpose was to determine relationships among nursing skill mix (proportion of Registered Nurses (RNs) to all nursing staff), the work environment and adverse events (medication errors, patient falls with injury, pressure ulcers, and urinary tract infections) in rural hospitals. Methods: Using a cross-sectional design, nurse survey data from a large study examining nurse organizational factors, patient safety, and quality from four U.S. states were linked to the 2006 American Hospital Association data. The work environment was measured using the Practice Environment Scale of the Nursing Work Index (PES-NWI). Nurses reported adverse event frequency. Data analyses were descriptive and inferential. Results: On average, 72% of nursing staff were RNs (range = 45% to 100%). Adverse event frequency ranged from 0% to 67%, across 76 hospitals. In regression models, a 10-point increase in the proportion of RNs among all nursing staff and a one standard deviation increase in the PES-NWI score were significantly associated with decreased odds of frequent adverse events. Conclusion: Rural hospitals that increase the nursing skill mix and improve the work environment may achieve reduced adverse event frequency