Nurse-led trials of medical devices: General principles and good practice

Aim To provide an overview of key governance matters relating to medical device trials and practical advice for nurses wishing to initiate or lead them. Background Medical device trials, which are formal research studies that examine the benefits and risks of therapeutic, non-drug treatment medical devices, have traditionally been the purview of physicians and scientists. The role of nurses in medical device trials historically has been as data collectors or co-ordinators rather than as principal investigators. Nurses more recently play an increasing role in initiating and leading medical device trials. Review Methods A review article of nurse-led trials of medical devices. Discussion Central to the quality and safety of all clinical trials is adherence to the International Conference on Harmonization Guidelines for Good Clinical Practice, which is the internationally-agreed standard for the ethically- and scientifically-sound design, conduct and monitoring of a medical device trial, as well as the analysis, reporting and verification of the data derived from that trial. Key considerations include the class of the medical device, type of medical device trial, regulatory status of the device, implementation of standard operating procedures, obligations of the trial sponsor, indemnity of relevant parties, scrutiny of the trial conduct, trial registration, and reporting and publication of the results. Conclusion Nurse-led trials of medical devices are demanding but rewarding research enterprises. As nursing practice and research increasingly embrace technical interventions, it is vital that nurse researchers contemplating such trials understand and implement the principles of Good Clinical Practice to protect both study participants and the research team.

Advice to consult a general medical practitioner in Western Australia : Could it be cancer?

Background: Many people will consult a medical practitioner about lower bowel symptoms, and the demand for access to general practitioners (GPs) is growing. We do not know if people recognise the symptoms of lower bowel cancer when advising others about the need to consult a doctor. A structured vignette survey was conducted in Western Australia. Method: Participants were recruited from the waiting rooms at five general practices. Respondents were invited to complete self-administered questionnaires containing nine vignettes chosen at random from a pool of 64 based on six clinical variables. Twenty-seven vignettes described high-risk bowel cancer scenarios. Respondents were asked if they would recommend a medical consultation for the case described and whether they believed the scenario was a cancer presentation. Logistic regression was used to estimate the independent effects of each variable on the respondent's judgement. Two-hundred and sixty-eight completed responses were collected over eight weeks. Results: The majority (61%) of respondents were female, aged 40 years and older. A history of rectal bleeding, six weeks of symptoms, and weight loss independently increased the odds of recommending a consultation with a medical practitioner by a factor of 7.64, 4.11 and 1.86, respectively. Most cases that were identified as cancer (75.2%) would not be classified as such on current research evidence. Factors that predict recognition of cancer presentations include rectal bleeding, weight loss and diarrhoea.

Australian dispensing doctors' prescribing : quantitative and qualitative analysis

Objective: To evaluate the prescribing practices of Australian dispensing doctors (DDs) and to explore their interpretations of the findings. Design, participants and setting: Sequential explanatory mixed methods. The quantitative phase comprised analysis of Pharmaceutical Benefits Scheme (PBS) claims data of DDs and non-DDs, 1 July 2005 30 June 2007. The qualitative phase involved semi-structured interviews with DDs in rural and remote general practice across Australian states, August 2009 February 2010. Main outcome measures: The number of PBS prescriptions per 1000 patients and use of Regulation 24 of the National Health (Pharmaceutical Benefits) Regulations 1960 (r. 24); DDs' interpretation of the findings. Results: 72 DDs' and 1080 non-DDs' PBS claims data were analysed quantitatively. DDs issued fewer prescriptions per 1000 patients (9452 v 15057; P = 0.003), even with a similar proportion of concessional patients and patients aged >65 years in their populations. DDs issued significantly more r. 24 prescriptions per 1000 prescriptions than non-DDs (314 v 67; P=0.008). Interviews with 22 DDs explained that the fewer prescriptions were due to perceived expectation from their peers regarding prescribing norms and the need to generate less administrative paperwork in small practices. Conclusions: Contrary to overseas findings, we found no evidence that Australian DDs overprescribed because of their additional dispensing role. MJA 2011; 195: 172-175

The role of the board of directors in ensuring a culture of integrity

Corporate scandals are as old as the corporate form itself. Consider, for example, the controversies surrounding the role of one of the first modern corporations, the British East India Company, in the Bengal famine of 1770 and in the Chinese opium trade. Yet it is the increasing scale and scope of unethical acts carried out by individuals in the name, and interests, of corporations that continue to be concerning. Recent revelations surrounding the extent of bribery and covert surveillance used by News Corporation journalists in its British operations continue to shock the world and undermine confidence in that organiszation and journalists in general. Yet despite the systemic nature of many of these unethical activities, corporate leaders generally plead ignorance when transgressions come to light. During the enquity into the News Corporation scandal, Rupert Murdoch, the CEO and chairman, rejected the assertion that he was ultimately 'responsible for this whole fiasco' (House of Commons, 2011, Q.230). Instead, like many corporate leaders before him, Murdoch placed blame on the employees within the newspaper. His responses poses an increasingly important question: Do corporate leaders bear responsibility for the conduct of individuals within a corporation and, if so, why?

A general model for host plant selection in phytophagous insects

We develop a general theoretical framework for exploring the host plant selection behaviour of herbivorous insects. This model can be used to address a number of questions, including the evolution of specialists, generalists, preference hierarchies, and learning. We use our model to: (i) demonstrate the consequences of the extent to which the reproductive success of a foraging female is limited by the rate at which they find host plants (host limitation) or the number of eggs they carry (egg limitation); (ii) emphasize the different consequences of variation in behaviour before and after landing on (locating) a host (termed pre- and post-alighting, respectively); (iii) show that, in contrast to previous predictions, learning can be favoured in post-alighting behaviour--in particular, individuals can be selected to concentrate oviposition on an abundant low-quality host, whilst ignoring a rare higher-quality host; (iv) emphasize the importance of interactions between mechanisms in favouring specialization or learning.

Design, modelling and measurement of hybrid powerplant for unmanned aerial vehicles (UAVs)

The success or effectiveness for any aircraft design is a function of many trade-offs. Over the last 100 years of aircraft design these trade-offs have been optimized and dominant aircraft design philosophies have emerged. Pilotless aircraft (or uninhabited airborne systems, UAS) present new challenges in the optimization of their configuration. Recent developments in battery and motor technology have seen an upsurge in the utility and performance of electric powered aircraft. Thus, the opportunity to explore hybrid-electric aircraft powerplant configurations is compelling. This thesis considers the design of such a configuration from an overall propulsive, and energy efficiency perspective. A prototype system was constructed using a representative small UAS internal combustion engine (10cc methanol two-stroke) and a 600W brushless Direct current (BLDC) motor. These components were chosen to be representative of those that would be found on typical small UAS. The system was tested on a dynamometer in a wind-tunnel and the results show an improvement in overall propulsive efficiency of 17% when compared to a non-hybrid powerplant. In this case, the improvement results from the utilization of a larger propeller that the hybrid solution allows, which shows that general efficiency improvements are possible using hybrid configurations for aircraft propulsion. Additionally this approach provides new improvements in operational and mission flexibility (such as the provision of self-starting) which are outlined in the thesis. Specifically, the opportunity to use the windmilling propeller for energy regeneration was explored. It was found (in the prototype configuration) that significant power (60W) is recoverable in a steep dive, and although the efficiency of regeneration is low, the capability can allow several options for improved mission viability. The thesis concludes with the general statement that a hybrid powerplant improves the overall mission effectiveness and propulsive efficiency of small UAS.

Standardisation of plant and machinery valuation practices in Malaysia

Plant and machinery valuation is important to every company.s annual financial reporting. It is reported under the non-current assets section, and the valuers are generally employed to provide the up to date valuation of the non-current assets valuation such as property, plant and equipment that can make up to 80% of the total assets of a company. The valuation of plant and machinery is also important for other purposes such as securing loan facilities, sales, takeover, insurance and auction. The application of 2005 International Financial Reporting Standard (IFRS) has a subsequent impact on the financial sector, as a whole. The accountants have to choose between the Historical Cost approach and Market Value approach in determining the value of the client.s assets. In Malaysia, the implementation of IFRS has a domino effect on the financial system, especially for plant and machinery valuation for financial reporting. The comparison data for plant and machinery valuation is limited unlike land and building valuation. The question of Malaysian valuer.s ability to comply with the IFRS standard keeps rising every day, not just to the accountants, but also other related parties such as financial institutions, government agencies and the clients. This is happening because of different interpretations of premise of value for plant and machinery, as well as methods been used and differences in standards of reporting among the valuers conducting plant and machinery valuation. The root of the problem lies in the lack of practical guidelines governing plant and machinery valuation practices and different schools of thought among the valuers. Some follow the United Kingdom.s RICS guidelines, whilst some valuers are more comfortable with the United State.s USPAP rules, especially on the premise of value. This research is to investigate the international best practices of plant and machinery valuation and to establish the common valuation concept, awareness and application of valuation methodology and valuation process for plant and machinery valuation in Malaysia. This research uses a combination of the qualitative and quantitative research approach. In the qualitative approach, the content analyses were conducted from the international practices and current Malaysian implementation of plant and machinery valuation. A survey (quantitative approach) via questionnaire was implemented among the registered and probationary valuers in Malaysia to investigate their understanding and opinion relating to plant and machinery valuation based on the current practices. The significance of this research is the identification of international plant and machinery practices and the understanding of current practices of plant and machinery valuation in Malaysia. It is found that issues embedding plant and machinery valuation practices are limited numbers of resources available either from scholars or practitioner. This is supported by the general finding from the research survey that indicates that there are immediate needs for practical notes or guidelines to be developed and implemented to support the Malaysian valuers practising plant and machinery valuation. This move will lead to a better understanding of plant and machinery valuation, reducing discrepancies in valuation of plant and machinery and increased accuracy among practising valuers.

Bringing skills and general competences back into technological education

In this paper we show that industry-based student training is not limited to work experience; work integrated learning, internship or extended vacation work. It is also about bringing back the lost parts of technological education. We experience the unilateral focus on theoretical knowledge at the expense of skills and general competences as one important challenge in technological education. The lacking facilitation and training of practical skills and general competences in the curricula and programs are identified, but many institutions have failed to address the problem. Today’s curricula in many ways reduce technology to abstract concepts, calculations and models, and create a gap between the academic programs and the practical applications in the society. We explore two (Australia and Norway) initiatives on industry-based student training and discuss how these initiatives address and bridge the gap. We argue that these initiatives of industry-based student training contribute to bringing skills and general competences back into technological education, and that the effects are not limited to increased employability, but also include increased academic performance.

Mortality and cost outcomes of elderly trauma patients admitted to intensive care and the general wards of an Australian tertiary referral hospital

Mortality and cost outcomes of elderly intensive care unit (ICU) trauma patients were characterised in a retrospective cohort study from an Australian tertiary ICU. Trauma patients admitted between January 2000 and December 2005 were grouped into three major age categories: aged ≥65 years admitted into ICU (n=272); aged ≥65 years admitted into general ward (n=610) and aged <65 years admitted into ICU (n=1617). Hospital mortality predictors were characterised as odds ratios (OR) using logistic regression. The impact of predictor variables on (log) total hospital-stay costs was determined using least squares regression. An alternate treatment-effects regression model estimated the mortality cost-effect as an endogenous variable. Mortality predictors (P ≤0.0001, comparator: ICU ≥65 years, ventilated) were: ICU <65 not-ventilated (OR 0.014); ICU <65 ventilated (OR 0.090); ICU age ≥65 not-ventilated (OR 0.061) and ward ≥65 (OR 0.086); increasing injury severity score and increased Charlson comorbidity index of 1 and 2, compared with zero (OR 2.21 [1.40 to 3.48] and OR 2.57 [1.45 to 4.55]). The raw mean daily ICU and hospital costs in A$ 2005 (US$) for age <65 and ≥65 to ICU, and ≥65 to the ward were; for year 2000: ICU, $2717 (1462) and $2777 (1494); hospital, $1837 (988) and $1590 (855); ward $933 (502); for year 2005: ICU, $3202 (2393) and $3086 (2307); hospital, $1938 (1449) and $1914 (1431); ward $1180 (882). Cost increments were predicted by age ≥65 and ICU admission, increasing injury severity score, mechanical ventilation, Charlson comorbidity index increments and hospital survival. Mortalitycost-effect was estimated at -63% by least squares regression and -82% by treatment-effects regression model. Patient demographic factors, injury severity and its consequences predict both cost and survival in trauma. The cost mortality effect was biased upwards by conventional least squares regression estimation.

Integration-segregation decisions under general value functions: "create your own bundle - choose 1, 2, or all 3!",

Whether to keep products segregated (e.g., unbundled) or integrate some or all of them (e.g., bundle) has been a problem of profound interest in areas such as portfolio theory in finance, risk capital allocations in insurance and marketing of consumer products. Such decisions are inherently complex and depend on factors such as the underlying product values and consumer preferences, the latter being frequently described using value functions, also known as utility functions in economics. In this paper, we develop decision rules for multiple products, which we generally call ‘exposure units’ to naturally cover manifold scenarios spanning well beyond ‘products’. Our findings show, e.g. that the celebrated Thaler's principles of mental accounting hold as originally postulated when the values of all exposure units are positive (i.e. all are gains) or all negative (i.e. all are losses). In the case of exposure units with mixed-sign values, decision rules are much more complex and rely on cataloging the Bell number of cases that grow very fast depending on the number of exposure units. Consequently, in the present paper, we provide detailed rules for the integration and segregation decisions in the case up to three exposure units, and partial rules for the arbitrary number of units.

A hierarchical decomposition approach for coordinated dispatch of plug-in electric vehicles

Plug-in electric vehicles (PEVs) are increasingly popular in the global trend of energy saving and environmental protection. However, the uncoordinated charging of numerous PEVs can produce significant negative impacts on the secure and economic operation of the power system concerned. In this context, a hierarchical decomposition approach is presented to coordinate the charging/discharging behaviors of PEVs. The major objective of the upper-level model is to minimize the total cost of system operation by jointly dispatching generators and electric vehicle aggregators (EVAs). On the other hand, the lower-level model aims at strictly following the dispatching instructions from the upper-level decision-maker by designing appropriate charging/discharging strategies for each individual PEV in a specified dispatching period. Two highly efficient commercial solvers, namely AMPL/IPOPT and AMPL/CPLEX, respectively, are used to solve the developed hierarchical decomposition model. Finally, a modified IEEE 118-bus testing system including 6 EVAs is employed to demonstrate the performance of the developed model and method.

A practical approach to developing the general capabilities in middle-years English

Described as a three-dimensional “living” document, the new Australian Curriculum delineates the knowledge, understandings and skills considered necessary for students in the 21st Century to become confident and creative individuals, successful learners and active and informed citizens. The Australian Curriculum comprises discipline-based learning areas, general capabilities and contemporary cross-curriculum priorities. Teachers have particularly indicated the need for more professional development in relation to the general capabilities notably personal and social capability, ethical behaviour and intercultural understanding. This article provides ideas, activities and resources for middle-years English and literacy teachers to recognise and create opportunities for teaching and learning about these three general capabilities in their classrooms.

Genome-wide association study reveals three susceptibility loci for common migraine in the general population

Migraine is a common, heterogeneous and heritable neurological disorder. Its pathophysiology is incompletely understood, and its genetic influences at the population level are unknown. In a population-based genome-wide analysis including 5,122 migraineurs and 18,108 non-migraineurs, rs2651899 (1p36.32, PRDM16), rs10166942 (2q37.1, TRPM8) and rs11172113 (12q13.3, LRP1) were among the top seven associations (P < 5 × 10(-6)) with migraine. These SNPs were significant in a meta-analysis among three replication cohorts and met genome-wide significance in a meta-analysis combining the discovery and replication cohorts (rs2651899, odds ratio (OR) = 1.11, P = 3.8 × 10(-9); rs10166942, OR = 0.85, P = 5.5 × 10(-12); and rs11172113, OR = 0.90, P = 4.3 × 10(-9)). The associations at rs2651899 and rs10166942 were specific for migraine compared with non-migraine headache. None of the three SNP associations was preferential for migraine with aura or without aura, nor were any associations specific for migraine features. TRPM8 has been the focus of neuropathic pain models, whereas LRP1 modulates neuronal glutamate signaling, plausibly linking both genes to migraine pathophysiology.

Baseline study of alcohol dependence among general drivers and drunk driving offenders in Guangzhou, China

This study aimed to investigate drink driving in a sample of general drivers and convicted drunk driving offenders in Guangzhou, China. The study also aimed to explore some potential factors that impact on alcohol-related driving behaviour. Samples of 406 general drivers and 101 drunk driving offenders were recruited between May and October 2012. A survey was used to collect information about demographic characteristics, knowledge, attitudes and practices related to drink driving. The Alcohol Use Disorders Identification Test (AUDIT) was used to assess possible drinking problems. The average age reported for starting to drink alcohol for both groups of participants was around 19 years old. The mean AUDIT score of general drivers was 7.4 (SD = 5.4) representing a low level of alcohol problems, and for convicted drunk driving offenders was 11.1 (SD = 5.9) representing a medium level of alcohol problems (significant difference between means, t = 5.75, p < 0.001). AUDIT scores indicated that a substantial proportion (65%) of the offenders had medium to high levels of alcohol use disorders, compared with 38.5% among general drivers. Offenders who knew the drunk driving legal limit had a lower AUDIT score (M = 9.8, SD = 5.16) than those who did not know it (M = 12.2, SD = 6.257, t = -1.987. p = 0.05). In addition, offenders who were novice drivers (licensed less than 2 years) had a higher AUDIT score (M = 16.4, SD = 7.6) than the other three driver experience categories used.

From production to purpose : using design led innovation to Build Strategic Potential in a Family-Owned SME

There is an evident need to develop the strategic capabilities of companies from within, to ensure competitive competence in a time where strategy is a necessity. This paper is based on the first 4 months of a longitudinal embedded case study of a family-owned Australian small to medium enterprise, in their journey towards design integration. The first author was embedded as a ‘Design Innovation Catalyst’ to collaborate on overcoming early barriers of strategic development, using design led innovation. Action research methodology, semi-structured interviews with seven out of eight employees and a reflective journal revealed the absence of a shared vision, conflicting drivers and a focus on operational efficiency rather than strategy. Through the Catalyst’s facilitation, a company vision, general awareness, practice and knowledge in strategic development have emerged as the first steps to generating strategic design competence within the firm.