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.

An investigation of Staphylococcus aureus and related species from flood affected and other environmental sources

This research investigated the microbial air quality of flooded houses in Brisbane suburbs following the January 2011 flood event. Flood waters can carry and spread human pathogenic bacteria, and these organisms can be dispersed into residential air by aerosolisation. This study found that the bacterial load was significantly different for indoor and outdoor areas of flood affected houses, but no significant differences were observed between flooded and non-flooded houses. This could be due to the rapid clean-up of flooded houses following the event. Molecular methods were used to identify and characterise staphylococcal species in residential air of flooded and non-flooded houses. A major finding was the diverse population of airborne staphylococci as well as the high rate of methicillin-resistance in these strains. By determining the genetic relatedness of residential air sourced staphylococci, a potential source for pathogenic strains can be identified.

Radiation therapist peer review: Raising the bar on quality and safety in radiation oncology

Purpose An emerging developmental tool to help radiation therapists achieve better outcomes is 'peer review'. This review of the current literature summarises the challenges and benefits of peer review in both individual and departmental practice. Discussion There is compelling evidence supporting peer review implementation at both individual and department level in many professions. Implementing peer review requires that radiation therapists and other radiation oncology professionals embrace a culture that supports safety. Peer review can identify trends and barriers associated with quality radiotherapy and share best practice or recommend changes accordingly. Support for peer review must come from pre-registration educational systems as well as clinical managers. Continuing professional development in the workplace is nurtured by peer review of radiotherapy practice and an aptitude for this should be viewed as important to the profession as technical and clinical skills. Conclusion It is clear that peer review has the potential to facilitate reflective practice, improve staff motivation and help foster a culture of quality and safety in radiation oncology. To drive the issues of quality and safety a step further radiation therapists need to accept the challenge of adopting peer review methods in day-to-day practice.

Increasing the confidence and knowledge of occupational therapy and physiotherapy students when communicating with people with aphasia: A pre–post intervention study

This study investigated occupational therapy and physiotherapy students' level of confidence and knowledge of strategies for communicating with people with aphasia (PWA) before and after a communication partner-training (CPT) program. Twenty-eight physiotherapy and occupational therapy students participated in a pre–post CPT program. Students completed a customized mixed-methods questionnaire before and after the intervention. The CPT program involved a lecture about effective communication strategies followed by a conversation with PWA to practice strategies learnt. Before CPT, students were not confident with the possibility of communicating with PWA. Students demonstrated rudimentary knowledge of supported conversation, identifying a maximum of five strategies for communicating effectively with PWA. Following intervention, students demonstrated increased confidence. Students' knowledge of effective communication strategies improved, with students identifying a maximum of 16 suitable strategies post-training. The results suggest that occupational therapy and physiotherapy students have potential to benefit from practical training in supported communication with PWA, which may assist them during placements in clinical settings with neurological patients or subsequent employment.

A study of safety leadership and safety governance for board members and senior executives

This thesis is an investigation of the fields of leadership and corporate governance in the context of workplace safety. The research has made a contribution by defining four criteria of safety leadership and applying these criteria to board members, senior executives and written communications. The thesis outlines the findings of two studies; the first is an analysis of public disclosures in ASX200 annual reports and CSR reports, and the second comprises two case studies of large Australian companies including interviews with board members and senior executives. The concept of safety governance is defined and a safety governance framework is developed.

Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: Results of a randomised placebo-controlled trial (ABILITY-1)

Purpose: To evaluate the efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis (nr-axSpA). Methods: Patients fulfilled Assessment of Spondyloarthritis international Society (ASAS) criteria for axial spondyloarthritis, had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥ 4, total back pain score of ≥ 4 (10 cm visual analogue scale) and inadequate response, intolerance or contraindication to non-steroidal anti-inflammatory drugs (NSAIDs); patients fulfilling modified New York criteria for ankylosing spondylitis were excluded. Patients were randomised to adalimumab (N=91) or placebo (N=94). The primary endpoint was the percentage of patients achieving ASAS40 at week 12. Efficacy assessments included BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS). MRI was performed at baseline and week 12 and scored using the Spondyloarthritis Research Consortium of Canada (SPARCC) index. Results: Significantly more patients in the adalimumab group achieved ASAS40 at week 12 compared with patients in the placebo group (36% vs 15%, p<0.001). Significant clinical improvements based on other ASAS responses, ASDAS and BASDAI were also detected at week 12 with adalimumab treatment, as were improvements in quality of life measures. Inflammation in the spine and sacroiliac joints on MRI significantly decreased after 12 weeks of adalimumab treatment. Shorter disease duration, younger age, elevated baseline C-reactive protein or higher SPARCC MRI sacroiliac joint scores were associated with better week 12 responses to adalimumab. The safety profile was consistent with what is known for adalimumab in ankylosing spondylitis and other diseases. Conclusions: In patients with nr-axSpA, adalimumab treatment resulted in effective control of disease activity, decreased inflammation and improved quality of life compared with placebo. Results from ABILITY-1 suggest that adalimumab has a positive benefit-risk profile in active nr-axSpA patients with inadequate response to NSAIDs.

Project Energise: Using participatory approaches and real time computer prompts to reduce occupational sitting and increase work time physical activity in office workers

Objectives This efficacy study assessed the added impact real time computer prompts had on a participatory approach to reduce occupational sedentary exposure and increase physical activity. Design Quasi-experimental. Methods 57 Australian office workers (mean [SD]; age = 47 [11] years; BMI = 28 [5] kg/m2; 46 men) generated a menu of 20 occupational ‘sit less and move more’ strategies through participatory workshops, and were then tasked with implementing strategies for five months (July–November 2014). During implementation, a sub-sample of workers (n = 24) used a chair sensor/software package (Sitting Pad) that gave real time prompts to interrupt desk sitting. Baseline and intervention sedentary behaviour and physical activity (GENEActiv accelerometer; mean work time percentages), and minutes spent sitting at desks (Sitting Pad; mean total time and longest bout) were compared between non-prompt and prompt workers using a two-way ANOVA. Results Workers spent close to three quarters of their work time sedentary, mostly sitting at desks (mean [SD]; total desk sitting time = 371 [71] min/day; longest bout spent desk sitting = 104 [43] min/day). Intervention effects were four times greater in workers who used real time computer prompts (8% decrease in work time sedentary behaviour and increase in light intensity physical activity; p < 0.01). Respective mean differences between baseline and intervention total time spent sitting at desks, and the longest bout spent desk sitting, were 23 and 32 min/day lower in prompt than in non-prompt workers (p < 0.01). Conclusions In this sample of office workers, real time computer prompts facilitated the impact of a participatory approach on reductions in occupational sedentary exposure, and increases in physical activity.

Mobility and safety are conflicting goals for transport policy makers when making decisions about graduated driver licensing

Policy decisions are frequently influenced by more than research results alone. This review examines one road safety countermeasure, graduated driver licensing, in three jurisdictions and identifies how the conflict between mobility and safety goals can influence policy decisions relating to this countermeasure. Evaluations from around the world of graduated driver licensing have demonstrated clear reductions in crashes for young drivers. However, the introduction of this countermeasure may be affected, both positively and negatively, by the conflict some policy makers experience between ensuring individuals remain both mobile and safe as drivers. This review highlights how this conflict in policy decision making can serve to either facilitate or hinder the introduction of graduated driver licensing systems. However, policy makers whose focus on mobility is too strong when compared with safety may be mistaken, with evidence suggesting that after a graduated driver licensing system is introduced young drivers adapt their behaviour to the new system and remain mobile. As a result, policy makers should consciously acknowledge the conflict between mobility and safety and consider an appropriate balance in order to introduce these systems. Improvements to the licensing system can then be made in an incremental manner as the balance between these two priorities change. Policy makers can achieve an appropriate balance by using empirical evidence as a basis for their decisions.

Preventing injuries on a state-wide basis : researchers and parliamentary committees are partners in turning injury prevention and safety research into practice and policy

Context: Parliamentary committees established in Westminster parliaments, such as Queensland, provide a cross-party structure that enables them to recommend policy and legislative changes that may otherwise be difficult for one party to recommend. The overall parliamentary committee process tends to be more cooperative and less adversarial than the main chamber of parliament and, as a result, this process permits parliamentary committees to make recommendations more on the available research evidence and less on political or party considerations. Objectives: This paper considers the contributions that parliamentary committees in Queensland have made in the past in the areas of road safety, drug use as well as organ and tissue donation. The paper also discusses the importance of researchers actively engaging with parliamentary committees to ensure the best evidence based policy outcomes. Key messages: In the past, parliamentary committees have successfully facilitated important safety changes with many committee recommendations based on research results. In order to maximise the benefits of the parliamentary committee process it is essential that researchers inform committees about their work and become key stakeholders in the inquiry process. Researchers can keep committees informed by making submissions to their inquiries, responding to requests for information and appearing as witnesses at public hearings. Researchers should emphasise the key findings and implications of their research as well as considering the jurisdictional implications and political consequences. It is important that researchers understand the differences between lobbying and providing informed recommendations when interacting with committees. Discussion and conclusions: Parliamentary committees in Queensland have successfully assisted in the introduction of evidence based policy and legislation. In order to present best practice recommendations, committees rely on the evidence presented to them including the results of researchers. Actively engaging with parliamentary committees will help researchers to turn their results into practice with a corresponding decrease in injuries and fatalities. Developing an understanding of parliamentary committees, and the typical inquiry process used by these committees, will help researchers to present their research results in a manner that will encourage the adoption of their ideas by parliamentary committees, the presentation of these results as recommendations within the report and the subsequent enactment of the committee’s recommendations by the government.

Safety culture research in the construction sector : interlocked projects in safety competency and safety effectiveness indicators

Safety culture is a concept that has long been accepted in high risk industries such as aviation, nuclear industries and mining, however, considerable research is now being undertaken within the construction sector, with varying levels of success. The current paper discusses three recent interlocked projects that have had some success in the Australian construction industry. The first project examined the development and implementation of a safety competency framework targeted at safety critical positions across first tier construction organisations. Combining qualitative and quantitative methods, the project: developed a matrix of safety critical positions (n=11) and safety managements tasks (SMTs; n=39); mapped the process steps for their acquisition and ongoing development; detailed the knowledge, skills and behaviours required for all SMTs; and outlined organisational cultural outcomes that could be anticipated in a successful implementation of the framework. The second project extended research on safety competency and leadership to develop behavioural guidelines for leaders to drive safety culture change down to second tier companies. This was designed to assist smaller construction companies to customise their own competency framework and develop implementation guidelines that match their aspirations and resources. The third interlocked project explored the use of safety effectiveness indicators (SEIs) as an industry-relevant assessment tool for reducing risk on construction sites. With direct linkages to safety competencies and safety management tasks, the SEIs are the next step towards an integrated safety cultural approach to safety and extend the concept of positive performance indicators (PPIs) by providing a valid, reliable, and user friendly measurement platform. Taken together, the results of the interlocked projects suggest that safety culture research has many potential benefits for the construction industry, particularly when research is conducted in partnership with industry stakeholders. Suggestions are made for future research, including further application and testing of the safety competency framework and aligning SEIs across construction projects of varying size, location and design.

Evaluation of screening tests for predicting older driver performance and safety assessed by an on-road test

A number of tests and test batteries are available for the prediction of older driver safety, but many of these have not been validated against standardized driving outcome measures. The aim of this study was to evaluate a series of previously described screening tests in terms of their ability to predict the potential for safe and unsafe driving. Participants included 79 community-dwelling older drivers (M=72.16 years, SD=5.46; range 65-88 years; 57 males and 22 females) who completed a previously validated multi-disciplinary driving assessment, a hazard perception test, a hazard change detection test and a battery of vision and cognitive tests. Participants also completed a standardized on-road driving assessment. The multi-disciplinary test battery had the highest predictive ability with a sensitivity of 80% and a specificity of 73%, followed by the hazard perception test which demonstrated a sensitivity of 75% and a specificity of 61%. These findings suggest that a relatively simple and practical battery of tests from a range of domains has the capacity to predict safe and unsafe driving in older adults.