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.

General practice patients in the emergency department

One of the mysteries of public policy is that at times the public discourse settles on a perspective that is based on flimsy or even contradictory evidence. One such discussion relates to the factors that contribute to the congestion of hospital emergency departments (EDs) in Australia.

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.

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.

Impact of information on intentions to vaccinate in a potential epidemic : Swine-origin Influenza A (H1N1)

Vaccination campaigns to prevent the spread of epidemics are successful only if the targeted populations subscribe to the recommendations of health authorities. However, because compulsory vaccination is hardly conceivable in modern democracies, governments need to convince their populations through efficient and persuasive information campaigns. In the context of the swine-origin A (H1N1) 2009 pandemic, we use an interactive study among the general public in the South of France, with 175 participants, to explore what type of information can induce change in vaccination intentions at both aggregate and individual levels. We find that individual attitudes to vaccination are based on rational appraisal of the situation, and that it is information of a purely scientific nature that has the only significant positive effect on intention to vaccinate.

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.

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.

An exploration of the roles of nurses working in emergency care services in general hospitals in West Java, Indonesia : a grounded theory study

A review of literature on the role of emergency nurses in Indonesia revealed a dearth of research. Anecdotal evidence suggests a lack of clarity in role definition which has led to uncertainty and role ambiguity. Despite advances in the development of specialist nursing roles in Indonesia, that of the emergency nurse remains unclear. This study explored the role of nurses working in emergency care services in three general hospitals in West Java, Indonesia. The theoretical framework is grounded in Charmaz’s constructivist grounded theory. Data collection methods were observation, in-depth interviews and interrogation of related documents. Phase one of data collection involved 74 h of observation and nterviews with 35 nurses working in the three ED settings. For the purposes of theoretical sampling, a second phase of data collection was conducted. This involved a second nterview with eight participants from the three EDs. nterviews were also undertaken with the three key informants of nursing management of three related hospitals; key informants from the Indonesian Nurses Association; the Directorate of Nursing, Ministry of Health; and from the organization for ED nurses. Data analysis drew on Charmaz’s constructivist approach and the concepts of simultaneous data collection and analysis, constant comparison, coding, and theoretical sampling. The analysis generated four theoretical concepts that characterized the role of the emergency nurse: An arbitrary scope of practice, Struggling for recognition, Learning on the job and Looking to better practice. These concepts provided analytical direction for an exploration of the clinical and political dimensions of the role of the emergency nurse in Indonesia.

Reimagining school libraries : children's perspectives and new opportunities

The Federal Government’s recent Building the Education Revolution program resulted in, among other features, the creation of over 600 new school libraries in Queensland alone. This paper reports on a component of a research project carried out with students in six primary schools and one secondary school that benefitted from the program, investigating the influences of these new physical environments on learning and teaching. In particular, this paper discusses one missing voice from the design process - that of the students who would be key users of the newly-created spaces in those schools. While opportunities for real involvement in design were minimal for most potential users of the new spaces, students’ imagined possibilities for school libraries, as submitted to the research project, suggest that students could have contributed different perspectives to enhance learning engagement through imaginative design elements. The findings of the project have relevance for teachers and teacher librarians in reconsidering the ways in which the new learning spaces are used as well as informing school designers in planning engaging school facilities. The findings may be extrapolated to the design and planning of general classrooms and other learning environments.

Pharmacist, general practitioner, and nurse perceptions, experiences, and knowledge of medication dosage form modification

Background: People often modify oral solid dosage forms when they experience difficulty swallowing them. Modifying dosage forms may cause adverse effects to the patient, and the person undertaking the modification. Pharmacists are often the first point of contact for people in the general community seeking advice regarding medications. Nurses are at the forefront of administering medications to patients and are likely to be most directly affected by a patient’s swallowing ability, while general practitioners (GPs) are expected to consider swallowing abilities when prescribing medications. Objective: To compare the perspectives and experiences of GPs, pharmacists, and nurses regarding medication dosage form modification and their knowledge of medication modification. Method: Questionnaires tailored to each profession were posted to 630 GPs, and links to an online version were distributed to 2,090 pharmacists and 505 nurses. Results: When compared to pharmacists and GPs, nurses perceived that a greater proportion of the general community modified solid dosage forms. Pharmacists and GPs were most likely to consider allergies and medical history when deciding whether to prescribe or dispense a medicine, while nurses’ priorities were allergies and swallowing problems when administering medications. While nurses were more likely to ask their patients about their ability to swallow medications, most health professionals reported that patients “rarely” or “never” volunteered information about swallowing difficulties. The majority of health professionals would advise a patient to crush or split noncoated non-sustained-release tablets, and would consult colleagues or reference sources for sustained-release or coated tablets. Health professionals appeared to rely heavily upon the suffix attached to medication names (which suggest modified release properties) to identify potential problems associated with modifying medications. Conclusion: The different professional roles and responsibilities of GPs, pharmacists, and nurses are associated with different perspectives of, and experiences with, people modifying medications in the general community and knowledge about consequences of medication modification.

Developing a model of links between general and workplace belongingness and depressive symptoms

Given the high prevalence of depression in the community there is urgent need to understand the interpersonal predictors of this disorder. Data from large community samples indicates that a diminished sense of belonging appears to be the most salient and immediate antecedent of a rapid depressive response. Belongingness in the workplace is also very important and associated with depressive symptoms over and above associations attributable to general or community belongingness. Finally it appears that the personality factor of interpersonal sensitivity moderates the relationship between belongingness and depressive symptoms. Results have extensive future implications for the prevention and treatment of depression.

Autonomous forced landing system for light general aviation aircraft in unknown environments

This paper presents a system which enhances the capabilities of a light general aviation aircraft to land autonomously in case of an unscheduled event such as engine failure. The proposed system will not only increase the level of autonomy for the general aviation aircraft industry but also increase the level of dependability. Safe autonomous landing in case of an engine failure with a certain level of reliability is the primary focus of our work as both safety and reliability are attributes of dependability. The system is designed for a light general aviation aircraft but can be extended for dependable unmanned aircraft systems. The underlying system components are computationally efficient and provides continuous situation assessment in case of an emergency landing. The proposed system is undergoing an evaluation phase using an experimental platform (Cessna 172R) in real world scenarios.