The safety profile of perflutren microsphere contrast echocardiography during rest and stress imaging : results from an Australian multicentre cohort

Background Contrast enhanced echocardiography (CEE) is utilised when sub-optimal image quality results in non-diagnostic echocardiograms. However, there have been numerous safety notices issued by regulatory authorities regarding rare but potentially serious adverse reactions (AR). This multi-centre, retrospective analysis was performed to assess the short-term safety of CEE in a broad range of indications. Methods All CEE performed over 58 months at three institutions were assessed for AR within 30 min. Results A total of 5956 CEE were performed in 5576 patients. A total of 4903 were stress CEE and 1053 resting CCE.Bolus administration in 5719, infusion in 237 cases; 89.9% of CCE were outpatients. Commonest CEE indication was functional stress testing (82.3%). There were 16 AR related to CEE (0.27%). All AR were mild, transient and all patients made a full recovery. No cases of serious anaphylaxis or death within 30 min of contrast administration. Comparing those with and without an AR, there were no significant differences in age, gender, BMI, LVEF, patient location, exam type or RVSP. There was a slightly increased likelihood of an AR during infusion versus bolus dosing (p = 0.02). Conclusion CEE is a safe investigation in a broad range of indications and clinical scenarios. AR are very rare, mild and transient.

Evidence for the safety and quality issues associated with the care of patients with cognitive impairment in acute care settings : a rapid review

The Australian Commission on Safety and Quality in Health Care commissioned this rapid review to identify recent evidence in relation to three key questions: 1. What is the current evidence of quality and safety issues regarding the hospital experience of people with cognitive impairment (dementia/delirium)? 2. What are the existing evidence-based pathways, best practice or guidelines for cognitive impairment in hospitals? 3. What are the key components of an ideal patient journey for a person with dementia and/or delirium? The purpose of this review is to identify best practice in caring for patients with cognitive impairment (CI) in acute hospital settings. CI refers to patients with dementia and delirium but can include other conditions. For the purposes of this report, ‘Hospitals’ is defined as acute care settings and includes care provided by acute care institutions in other settings (e.g. Multipurpose Services and Hospital in the Home). It does not include residential aged care settings nor palliative care services that are not part of a service provided by an acute care institution. Method Both peer-reviewed publications and the grey literature were comprehensively searched for recent (primarily post 2010) publications, reports and guidelines that addressed the three key questions. The literature was evaluated and graded according to the National Health and Medical Research Council (NHMRC) levels of criteria (see Evidence Summary – Appendix B). Results Thirty-one recent publications were retrieved in relation to quality and safety issues faced by people with CI in acute hospitals. The results indicate that CI is a common problem in hospitals (upwards of 30% - the rate increases with increasing patient age), although this is likely to be an underestimate, in part, due to numbers of patients without a formal dementia diagnosis. There is a large body of evidence showing that patients with CI have worse outcomes than patients without CI following hospitalisation including increased mortality, more complications, longer hospital stays, increased system costs as well as functional and cognitive decline. 4 To improve the care of patients with CI in hospital, best practice guidelines have been developed, of which sixteen recent guidelines/position statements/standards were identified in this review (Table 2). Four guidelines described standards or quality indicators for providing optimal care for the older person with CI in hospital, in general, while three focused on delirium diagnosis, prevention and management. The remaining guidelines/statements focused on specific issues in relation to the care of patients with CI in acute hospitals including hydration, nutrition, wandering and care in the Emergency Department (ED). A key message in several of the guidelines was that older patients should be assessed for CI at admission and this is particularly important in the case of delirium, which can indicate an emergency, in order to implement treatment. A second clear mess...

Safety at railway level crossings : driver acceptance of potential ITS interventions

There is a continuing need to improve safety at Railway Level Crossings (RLX) particularly those that do not have gates and lights regulating traffic flow. A number of Intelligent Transport System (ITS) interventions have been proposed to improve drivers’ awareness and reduce errors in detecting and responding appropriately at level crossings. However, as with other technologies, successful implementation and ultimately effectiveness rests with the acceptance of the technology by the end user. In the current research, four focus groups were held (n=38) with drivers in metropolitan and regional locations in Queensland to examine their perceptions of potential in-vehicle and road-based ITS interventions to improve safety at RLX. The findings imply that further development of the ITS interventions, in particular the design and related promotion of the final product, must consider ease of use, usefulness and relative cost.

Utilising hospital data to inform product safety prioritisation : the application of RAPEX severity rankings in ICD-coded burn data

Background The implementation of the Australian Consumer Law in 2011 highlighted the need for better use of injury data to improve the effectiveness and responsiveness of product safety (PS) initiatives. In the PS system, resources are allocated to different priority issues using risk assessment tools. The rapid exchange of information (RAPEX) tool to prioritise hazards, developed by the European Commission, is currently being adopted in Australia. Injury data is required as a basic input to the RAPEX tool in the risk assessment process. One of the challenges in utilising injury data in the PS system is the complexity of translating detailed clinical coded data into broad categories such as those used in the RAPEX tool. Aims This study aims to translate hospital burns data into a simplified format by mapping the International Statistical Classification of Disease and Related Health Problems (Tenth Revision) Australian Modification (ICD-10-AM) burn codes into RAPEX severity rankings, using these rankings to identify priority areas in childhood product-related burns data. Methods ICD-10-AM burn codes were mapped into four levels of severity using the RAPEX guide table by assigning rankings from 1-4, in order of increasing severity. RAPEX rankings were determined by the thickness and surface area of the burn (BSA) with information extracted from the fourth character of T20-T30 codes for burn thickness, and the fourth and fifth characters of T31 codes for the BSA. Following the mapping process, secondary data analysis of 2008-2010 Queensland Hospital Admitted Patient Data Collection (QHAPDC) paediatric data was conducted to identify priority areas in product-related burns. Results The application of RAPEX rankings in QHAPDC burn data showed approximately 70% of paediatric burns in Queensland hospitals were categorised under RAPEX levels 1 and 2, 25% under RAPEX 3 and 4, with the remaining 5% unclassifiable. In the PS system, prioritisations are made to issues categorised under RAPEX levels 3 and 4. Analysis of external cause codes within these levels showed that flammable materials (for children aged 10-15yo) and hot substances (for children aged <2yo) were the most frequently identified products. Discussion and conclusions The mapping of ICD-10-AM burn codes into RAPEX rankings showed a favourable degree of compatibility between both classification systems, suggesting that ICD-10-AM coded burn data can be simplified to more effectively support PS initiatives. Additionally, the secondary data analysis showed that only 25% of all admitted burn cases in Queensland were severe enough to trigger a PS response.

Digitally enabled?! An analysis of law and justice students' use of smart devices

The research seeks to understand the nature of law and justice students’ use of technology for their learning purposes. There is often an assumption made that all students have, and engage with, technology to the same degree. The research tests these assumptions by means of a survey conducted of first year law and justice students to determine their actual use of smart devices inside and outside classes. The analysis of results reveals that while the majority of respondents own at least one smart device; most rarely use their device for their learning purposes.

Effective punishment experiences : the need for a more comprehensive approach to conceptualising behavioural punishers and reinforcers in a road safety context

Determining what consequences are likely to serve as effective punishment for any given behaviour is a complex task. This chapter focuses specifically on illegal road user behaviours and the mechanisms used to punish and deter them. Traffic law enforcement has traditionally used the threat and/or receipt of legal sanctions and penalties to deter illegal and risky behaviours. This process represents the use of positive punishment, one of the key behaviour modification mechanisms. Behaviour modification principles describe four types of reinforcers: positive and negative punishments and positive and negative reinforcements. The terms ‘positive’ and ‘negative’ are not used in an evaluative sense here. Rather, they represent the presence (positive) or absence (negative) of stimuli to promote behaviour change. Punishments aim to inhibit behaviour and reinforcements aim to encourage it. This chapter describes a variety of punishments and reinforcements that have been and could be used to modify illegal road user behaviours. In doing so, it draws on several theoretical perspectives that have defined behavioural reinforcement and punishment in different ways. Historically, the main theoretical approach used to deter risky road use has been classical deterrence theory which has focussed on the perceived certainty, severity and swiftness of penalties. Stafford and Warr (1993) extended the traditional deterrence principles to include the positive reinforcement concept of punishment avoidance. Evidence of the association between punishment avoidance experiences and behaviour has been established for a number of risky road user behaviours including drink driving, unlicensed driving, and speeding. We chose a novel way of assessing punishment avoidance by specifying two sub-constructs (detection evasion and punishment evasion). Another theorist, Akers, described the idea of competing reinforcers, termed differential reinforcement, within social learning theory (1977). Differential reinforcement describes a balance of reinforcements and punishments as influential on behaviour. This chapter describes comprehensive way of conceptualising a broad range of reinforcement and punishment concepts, consistent with Akers’ differential reinforcement concept, within a behaviour modification framework that incorporates deterrence principles. The efficacy of three theoretical perspectives to explain self-reported speeding among a sample of 833 Australian car drivers was examined. Results demonstrated that a broad range of variables predicted speeding including personal experiences of evading detection and punishment for speeding, intrinsic sensations, practical benefits expected from speeding, and an absence of punishing effects from being caught. Not surprisingly, being younger was also significantly related to more frequent speeding, although in a regression analysis, gender did not retain a significant influence once all punishment and reinforcement variables were entered. The implications for speed management, as well as road user behaviour modification more generally, are discussed in light of these findings. Overall, the findings reported in this chapter suggest that a more comprehensive approach is required to manage the behaviour of road users which does not rely solely on traditional legal penalties and sanctions.

Road safety in Australia : successes, challenges for the future, and possibilities for the USA

Overview - Role of CARRS-Q - Australia’s road safety performance - Key features of Australia’s approach to road safety: - Strong reliance on traffic law enforcement, supported by mass media public education - Adoption of the Safe Systems approach - Ambitious road trauma reduction targets? - Ongoing challenges - Possibilities for the USA

Translating vision research into policy and practice to improve the visibility, and hence safety, or road workers at night

The process of translating research into policy and practice is not well understood. This paper uses a case study approach to interpret an example of translation with respect to theoretical approaches identified in the literature. The case study concerns research into “biological motion” or “biomotion”: when lights are placed on the moveable joints of the body and the person moves in a dark setting, there is immediate and accurate recognition of the human form although only the lights can be seen. QUT was successful in gaining Australian Research Council funding with the support of the predecessors of the Queensland Department of Transport and Main Roads (TMR) to research the biomotion effect in road worker clothing using reflective tape rather than lights, and this resulted in the incorporation of biomotion marking into AS/NZS 4602.1 2011. The most promising approach to understanding the success of this translation, SWOV’s “knowledge utilisation approach” provided some insights but was more descriptive than predictive and provided “necessary but not sufficient” conditions for translation. In particular, the supportive efforts of TMR staff engaged in the review and promulgation of national standards were critical in this case. A model of the conclusions is presented. The experiences gained in this case should provide insights into the processes involved in effectively translating research into practice.

An examination of the legislative framework governing commuter safety in the Queensland Mining Industry

Commuting in the mining industry -Background -The problem -Journey management -The structure of the legislative framework Legislation and Regulation -Workplace safety in Queensland mining -Risk management -Mining legislation and journey management -Commuting and employee responsibilities -Queensland Workers’ Compensation Scheme Industry standards -Industry standards and journey management Regulated and organisational policy documents -Policy documents and journey management Observations & Conclusions

Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment : the M77001 study group

Purpose: This randomized, multicenter trial compared first-line trastuzumab plus docetaxel versus docetaxel alone in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Patients and Methods: Patients were randomly assigned to six cycles of docetaxel 100 mg/m 2 every 3 weeks, with or without trastuzumab 4 mg/kg loading dose followed by 2 mg/kg weekly until disease progression. Results: A total of 186 patients received at least one dose of the study drug. Trastuzumab plus docetaxel was significantly superior to docetaxel alone in terms of overall response rate (61% v 34%; P = .0002), overall survival (median, 31.2 v 22.7 months; P = .0325), time to disease progression (median, 11.7 v 6.1 months; P = .0001), time to treatment failure (median, 9.8 v 5.3 months; P = .0001), and duration of response (median, 11.7 v 5.7 months; P = .009). There was little difference in the number and severity of adverse events between the arms. Grade 3 to 4 neutropenia was seen more commonly with the combination (32%) than with docetaxel alone (22%), and there was a slightly higher incidence of febrile neutropenia in the combination arm (23% v 17%). One patient in the combination arm experienced symptomatic heart failure (1%). Another patient experienced symptomatic heart failure 5 months after discontinuation of trastuzumab because of disease progression, while being treated with an investigational anthracycline for 4 months. Conclusion: Trastuzumab combined with docetaxel is superior to docetaxel alone as first-line treatment of patients with HER2-positive MBC in terms of overall survival, response rate, response duration, time to progression, and time to treatment failure, with little additional toxicity. © 2005 by American Society of Clinical Oncology.

Utilising hospital data to inform product safety prioritisation : the application of RAPEX severity rankings in ICD-coded Burn Data

Background The implementation of the Australian Consumer Law in 2011 highlighted the need for better use of injury data to improve the effectiveness and responsiveness of product safety (PS) initiatives. In the PS system, resources are allocated to different priority issues using risk assessment tools. The rapid exchange of information (RAPEX) tool to prioritise hazards, developed by the European Commission, is currently being adopted in Australia. Injury data is required as a basic input to the RAPEX tool in the risk assessment process. One of the challenges in utilising injury data in the PS system is the complexity of translating detailed clinical coded data into broad categories such as those used in the RAPEX tool. Aims This study aims to translate hospital burns data into a simplified format by mapping the International Statistical Classification of Disease and Related Health Problems (Tenth Revision) Australian Modification (ICD-10-AM) burn codes into RAPEX severity rankings, using these rankings to identify priority areas in childhood product-related burns data. Methods ICD-10-AM burn codes were mapped into four levels of severity using the RAPEX guide table by assigning rankings from 1-4, in order of increasing severity. RAPEX rankings were determined by the thickness and surface area of the burn (BSA) with information extracted from the fourth character of T20-T30 codes for burn thickness, and the fourth and fifth characters of T31 codes for the BSA. Following the mapping process, secondary data analysis of 2008-2010 Queensland Hospital Admitted Patient Data Collection (QHAPDC) paediatric data was conducted to identify priority areas in product-related burns. Results The application of RAPEX rankings in QHAPDC burn data showed approximately 70% of paediatric burns in Queensland hospitals were categorised under RAPEX levels 1 and 2, 25% under RAPEX 3 and 4, with the remaining 5% unclassifiable. In the PS system, prioritisations are made to issues categorised under RAPEX levels 3 and 4. Analysis of external cause codes within these levels showed that flammable materials (for children aged 10-15yo) and hot substances (for children aged <2yo) were the most frequently identified products. Discussion and conclusions The mapping of ICD-10-AM burn codes into RAPEX rankings showed a favourable degree of compatibility between both classification systems, suggesting that ICD-10-AM coded burn data can be simplified to more effectively support PS initiatives. Additionally, the secondary data analysis showed that only 25% of all admitted burn cases in Queensland were severe enough to trigger a PS response.

Safety and efficacy of the combination of trastuzumab with docetaxel for HER2-positive women with advanced breast cancer : a review of the existing clinical trials and results of the expanded access programme in the UK

Trastuzumab is a humanised monoclonal antibody against the extracellular domain of HER2 (human epidermal growth factor receptor-2) that is overexpressed in about 25% of human breast cancers. It has shown clinical benefit in HER2-positive breast cancer cases when used alone or in combination with chemotherapy. Trastuzumab increases the response rate to chemotherapy and prolongs survival when used in combination with taxanes. In this article, we review the clinical trials where trastuzumab has been administered together with docetaxel, and we present the results of the trastuzumab expanded access programme (EAP) in the UK. Combination of trastuzumab with docetaxel results in similar response rates and time-to-progression with the trastuzumab/paclitaxel combinations. The toxicity of the combination and the risk of heart failure are low. The clinical data for the docetaxel/trastuzumab combination indicate a favourable profile from both the efficacy and the safety point of view and confirm the feasibility and safety of trastuzumab administration both as monotherapy and in combination with docetaxel. © 2004 Blackwell Publishing Ltd.

Using GPS and accelerometry to assess older adults' driving behaviours and performance : challenges and future directions

With the projected increase in older adults, the older driver population is estimated to be the fastest growing cohort of drivers among many developed countries. The increased physical fragility associated with the aging process make older adults who drive private automobiles a vulnerable road user group. Much of the current research on older drivers’ behaviours and practices rely on self-report data. This paper explores the utility of in-vehicle devices (Global Positioning Systems and recording accelerometers) in assessing older drivers’ habitual driving behaviours. Seventy-eight older drivers (above 65 years of age), from the Australian Capital Territory, Australia, participated in the current study. The driving behaviours and practices of these participants were prospectively assessed over a two-week period. The use of combined GPS and recording accelerometers to improve understanding of older drivers’ driving behaviours show promise within the current study. The challenges of using multiple in-vehicle devices in assessing driving beahaviours and performances within this cohort will be discussed. Based on the current findings, recommendations for future research regarding the use of in-vehicle devices among the older driver cohort are proposed.

A point prevalence study of cancer nursing practices for managing intravascular devices in an Australian tertiary cancer center

Purpose The use of intravascular devices is associated with a number of potential complications. Despite a number of evidence-based clinical guidelines in this area, there continues to be nursing practice discrepancies. This study aims to examine nursing practice in a cancer care setting to identify nursing practice and areas for improvement respective to best available evidence. Methods A point prevalence survey was undertaken in a tertiary cancer care centre in Queensland, Australia. On a randomly selected day, four nurses assessed intravascular device related nursing practices and collected data using a standardized survey tool. Results 58 inpatients (100%) were assessed. Forty-eight (83%) had a device in situ, comprising 14 Peripheral Intravenous Catheters (29.2%), 14 Peripherally Inserted Central Catheters (29.2%), 14 Hickman catheters (29.2%) and six Port-a-Caths (12.4%). Suboptimal outcomes such as incidences of local site complications, incorrect/inadequate documentation, lack of flushing orders, and unclean/non intact dressings were observed. Conclusions This study has highlighted a number of intravascular device related nursing practice discrepancies compared with current hospital policy. Education and other implementation strategies can be applied to improve nursing practice. Following education strategies, it will be valuable to repeat this survey on a regular basis to provide feedback to nursing staff and implement strategies to improve practice. More research is required to provide evidence to clinical practice with regards to intravascular device related consumables, flushing technique and protocols.