955 resultados para registration
Resumo:
Three proof requirements as essential for a sustainable land registration system. These were proof of identity, proof of ownership, and authority to deal. Our attention in this paper is drawn to the latter two requirements and will ask whether the introduction of the Property Exchange of Australia (PEXA), and its underpinning regulatory regime will meet the concerns that we have in relation to proof of ownership and authority to deal. In drawing out some problems with PEXA, we then offer an innovative idea, sourced from the transfer of equities that could serve to generate discussion on how we can ensure the Torrens system of land registration is sustainable for another 160 years.
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The biosimilars market is potentially the single fastest growing pharmaceutical sector with an estimated worth of US$67bn in global sales by 2020. This market generally refers to larger molecule, biological, protein-based pharmaceuticals which have lost its patent. This has stimulated the emergence of non-conventional pharmaceutical investors such as Fujifilm and Samsung as well as host countries such as Brazil, Mexico, China, India, South Korea, Turkey and Russia, which view biosimilars as a key macroeconomic driver of growth. Internationally, the European Medicines Agency has led the regulation of the quality, safety and efficacy of biosimilars; however, many countries have developed their own biosimilar regulatory frameworks. Despite the similarity of these with European guidelines, differences do exist across jurisdictions and have implications for cross-jurisdictional registration and regulation. The consideration of biosimilar regulation, however, demands attention beyond quality, safety and efficacy. The potential implications of extended patent protection, international trade and globalisation require a congruent policy approach to their regulation. Notwithstanding the fact that Australia is a relatively small pharmaceutical market and that there are only 14 biosimilar products currently approved for use, Australia’s geographical proximity to pharm-emerging countries and its trade relation with the major pharmaceutical markets have positioned Australia in a unique position to influence international development and regulation of biosimilars. Australia’s National Medicines Policy (2000) potentially provides the foundation for a partnership approach to biosimilar regulation, minimise duplication of regulatory efforts while at the same time fostering a viable pharmaceutical industry.
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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.
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With an ever changing landscape including National Registration, endorsed areas of practice, establishment of Sport and Exercise Psychology coordinators within National Sporting Organisations, changes to the National and State Sporting Insitutions, this forum looks to explore through collegiate discussion the impacts, current and future implications for our profession across training, supervision, research and applied practice in Australia.
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Background Chronic respiratory illnesses are the most common group of childhood chronic health conditions and are overrepresented in socially isolated groups. Objective To conduct a randomized controlled pilot trial to evaluate the efficacy of Breathe Easier Online (BEO), an Internet-based problem-solving program with minimal facilitator involvement to improve psychosocial well-being in children and adolescents with a chronic respiratory condition. Methods We randomly assigned 42 socially isolated children and adolescents (18 males), aged between 10 and 17 years to either a BEO (final n = 19) or a wait-list control (final n = 20) condition. In total, 3 participants (2 from BEO and 1 from control) did not complete the intervention. Psychosocial well-being was operationalized through self-reported scores on depression symptoms and social problem solving. Secondary outcome measures included self-reported attitudes toward their illness and spirometry results. Paper-and-pencil questionnaires were completed at the hospital when participants attended a briefing session at baseline (time 1) and in their homes after the intervention for the BEO group or a matched 9-week time period for the wait-list group (time 2). Results The two groups were comparable at baseline across all demographic measures (all F < 1). For the primary outcome measures, there were no significant group differences on depression (P = .17) or social problem solving (P = .61). However, following the online intervention, those in the BEO group reported significantly lower depression (P = .04), less impulsive/careless problem solving (P = .01), and an improvement in positive attitude toward their illness (P = .04) compared with baseline. The wait-list group did not show these differences. Children in the BEO group and their parents rated the online modules very favorably. Conclusions Although there were no significant group differences on primary outcome measures, our pilot data provide tentative support for the feasibility (acceptability and user satisfaction) and initial efficacy of an Internet-based intervention for improving well-being in children and adolescents with a chronic respiratory condition. Trial registration Australian New Zealand Clinical Trials Registry number: ACTRN12610000214033;
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1. In March 2009, the Australian Government, through IP Australia its administrator of Intellectual Property Rights (IPR) acquired by registration or grant, issued two consultation papers for comment by interested stakeholders. 2. The Consultation Papers have invited written submissions directed towards the object of the paper, namely encouraging discussion on certain proposed changes and their impact on business and innovation. 3. I understand the invitation to make written submissions is predominantly in the areas raised by the Consultation Papers and the questions posed. However, I have made a brief reference to several other areas of concern with the current Australian patent law, which in my opinion inhibit innovation and therefore come under the wider agenda of the government to work toward a stronger and more efficient IP rights system. 4. In this regard, the Consultation Papers indicate that if the IPR are less likely to be invalidated and more likely to be enforced, this confidence will reflect in a greater investment in research leading to innovation. 5. This submission relates to the Balance Paper.
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With respect to “shape” marks, there would appear to be a “break”, imposed by the Australian Courts, in the logical conclusion that registration of a shape, which performs a functional purpose, or even further, is indistinguishable from the shape of the item or product, creates a perpetual monopoly in the manufacture of that product.
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Introduction Clinical guidelines for the treatment of chronic low back pain suggest the use of supervised exercise. Motor control (MC) based exercise is widely used within clinical practice but its efficacy is equivalent to general exercise therapy. MC exercise targets the trunk musculature. Considering the mechanical links between the hip, pelvis, and lumbar spine, surprisingly little focus has been on investigating the contribution of the hip musculature to lumbopelvic support. The purpose of this study is to compare the efficacy of two exercise programs for the treatment of non-specific low back pain (NSLBP). Methods Eighty individuals aged 18-65 years of age were randomized into two groups to participate in this trial. The primary outcome measures included self-reported pain intensity (0-100mm VAS) and percent disability (Oswestry Disability Index V2). Bilateral measures of hip strength (N/kg) and two dimensional frontal plane mechanics (º) were the secondary outcomes. Outcomes were measured at baseline and following a six-week home based exercise program including weekly sessions of real-time ultrasound imaging. Results Within group comparisons revealed clinically meaningful reductions in pain for both groups. The MC exercise only (N= 40, xˉ =-20.9mm, 95%CI -25.7, -16.1) and the combined MC and hip exercise (N= 40, xˉ = -24.9mm, 95%CI -30.8, -19.0). There was no statistical difference in the change of pain (xˉ =-4.0mm, t= -1.07, p=0.29, 95%CI -11.5, 3.5) or disability (xˉ =-0.3%, t=-0.19, p=0.85, 95%CI -11.5, 3.5) between groups. Conclusion Both exercise programs had similar and positive effects on NSLBP which support the use of the home based exercise programs with weekly supervised visits. However, the addition of specific hip strengthening exercises to a MC based exercise program did not result in significantly greater reductions in pain or disability. Trial Registration NCTO1567566 Funding: Worker’s Compensation Board Alberta Research Grant.
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There is a new type of home education parent challenging long-held assumptions about homeschooling (cf. Morton 2012). These parents are well educated (cf. Beck 2010) but have chosen to eschew the social and cultural capital (Bourdieu & Wacquant 1992) of school in favour of some- thing completely different. They are unschoolers, which involves ‘allow- ing children as much freedom to learn in the world as their parents can possibly bear’ (cf. Holt & Farenga 2003: 238). This chapter presents the approach taken by one researcher to explore the reasons families choose unschooling. These families can be difficult to access, because they often fail to register with home education units and thus remain outside the education system (cf. Townsend 2012). Their lack of registration makes them largely invisible, affecting their ability to make an important contribution to debates around education. In spite of this invisibility, many unschoolers are keen to talk to researchers to increase wider understanding of unschooling.
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We have previously suggested that three proof requirements are essential for a sustainable land registration system. These were proof of identity, proof of ownership and authority to deal. Our attention in this article is drawn to the security framework that surrounds these requirements. We will ask whether the introduction of the Property Exchange of Australia (PEXA), and its underpinning regulatory regime will meet the concerns that we have in relation to them. In drawing out some problems with PEXA, we then offer an innovative idea, sourced from the transfer of equities that could serve to generate discussion on how we can ensure the Torrens system of land registration is sustainable for another 160 years. We also canvass some more incremental suggestions that evolve out of what we currently do, as well as outlining some comparative externally sourced ideas as to how the transfer and ownership of land can be made safer for all citizens. Such a goal is imperative when land transfer and secure property ownership is a critical component of the economic infrastructure of a modern society.
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Background: Alcohol is a major preventable cause of injury, disability and death in young people. Large numbers of young people with alcohol-related injuries and medical conditions present to hospital emergency departments (EDs). Access to brief, efficacious, accessible and cost effective treatment is an international health priority within this age group. While there is growing evidence for the efficacy of brief motivational interviewing (MI) for reducing alcohol use in young people, there is significant scope to increase its impact, and determine if it is the most efficacious and cost effective type of brief intervention available. The efficacy of personality-targeted interventions (PIs) for alcohol misuse delivered individually to young people is yet to be determined or compared to MI, despite growing evidence for school-based PIs. This study protocol describes a randomized controlled trial comparing the efficacy and cost-effectiveness of telephone-delivered MI, PI and an Assessment Feedback/Information (AF/I) only control for reducing alcohol use and related harm in young people. Methods/design: Participants will be 390 young people aged 16 to 25 years presenting to a crisis support service or ED with alcohol-related injuries and illnesses (including severe alcohol intoxication). This single blinded superiority trial randomized young people to (i) 2 sessions of MI; (ii) 2 sessions of a new PI or (iii) a 1 session AF/I only control. Participants are reassessed at 1, 3, 6 and 12 months on the primary outcomes of alcohol use and related problems and secondary outcomes of mental health symptoms, functioning, severity of problematic alcohol use, alcohol injuries, alcohol-related knowledge, coping self-efficacy to resist using alcohol, and cost effectiveness. Discussion: This study will identify the most efficacious and cost-effective telephone-delivered brief intervention for reducing alcohol misuse and related problems in young people presenting to crisis support services or EDs. We expect efficacy will be greatest for PI, followed by MI, and then AF/I at 1, 3, 6 and 12 months on the primary and secondary outcome variables. Telephone-delivered brief interventions could provide a youth-friendly, accessible, efficacious, cost-effective and easily disseminated treatment for addressing the significant public health issue of alcohol misuse and related harm in young people. Trial registration: This trial is registered with the Australian and New Zealand Clinical Trials Registry ACTRN12613000108718.
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BACKGROUND: Within Australia and internationally (Health Workforce Australia, 2012) an increasing and on-going nursing workforce shortage is documented. Recent international estimates indicate that there will be ongoing and significant gaps in the supply of a nursing workforce; the United Kingdom is predicted to have a reduction of 12.12% nurses over the coming eight years if a current 'steady state' is maintained (Buchan and Seacombe, 2011); Canada is predicted to have a shortage of 60,000 nurses by 2022 (Tomblin et al., 2012) with Australia's anticipated nursing shortage reported as over 90,000 by the year 2025 (Health Workforce Australia, 2012). Queensland Health in response to their tracked emerging nursing and midwifery workforce shortages developed a nursing and midwifery refresher programme to return registered staff back to the workforce. A study was undertaken between 2008 and 2010 to provide an understanding of how non-practising nurses and midwives maybe supported back into the workforce. METHODS: Programme applicants (444) were invited to respond to an on-line survey designed to understand what aspects of the programme supported their learning and ability to return to the workforce. This number represents those who applied but not all completed or commenced the programme. Descriptive statistics (Polit and Beck, 2008) were used to collate quantifiable survey responses and free text and unsolicited responses were themed. RESULTS: The survey received a 35.5% response rate (n=158) with a return of 20% of unsolicited comments in the form of e-mail responses which were included in the themed results. Key themes supporting participants' learning and ability to return to the workforce were: Respondents were 94% female and 6% male, with 37.7% >51 years of age. Child rearing was the foremost reason for female staff relinquishing workforce roles (36.6%). The primary reason for returning to the workforce was maintenance of registration (40.5%). Both theory and clinical placement components were seen by participants as contributing to their confidence to return to the health workforce. CONCLUSION: The Queensland Nursing and Midwifery Refresher Programs provided a structured programme for registered, non-practising nurses and midwives to return to the Queensland Health workforce. Responses indicated that clinical supervision and contract learning should be central to a return to workforce induction programme for registered but non-practising nurses and midwives. The majority of nurses and midwives returning to the workforce were approaching retirement age in 10-15 years.
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Background: Exercise and adequate self-management capacity may be important strategies in the management of venous leg ulcers. However, it remains unclear if exercise improves the healing rates of venous leg ulcers and if a self-management exercise program based on self-efficacy theory is well adhered to. Method/Design: This is a randomised controlled in adults with venous leg ulcers to determine the effectiveness of a self-efficacy based exercise intervention. Participants with venous leg ulcers are recruited from 3 clinical sites in Australia. After collection of baseline data, participants are randomised to either an intervention group or control group. The control group receive usual care, as recommended by evidence based guidelines. The intervention group receive an individualised program of calf muscle exercises and walking. The twelve week exercise program integrates multiple elements, including up to six telephone delivered behavioural coaching and goal setting sessions, supported by written materials, a pedometer and two follow-up booster calls if required. Participants are encouraged to seek social support among their friends, self-monitor their weekly steps and lower limb exercises. The control group are supported by a generic information sheet that the intervention group also receive encouraging lower limb exercises, a pedometer for self-management and phone calls at the same time points as the intervention group. The primary outcome is the healing rates of venous leg ulcers which are assessed at fortnightly clinic appointments. Secondary outcomes, assessed at baseline and 12 weeks: functional ability (range of ankle motion and Tinetti gait and balance score), quality of life and self-management scores. Discussion: This study seeks to address a significant gap in current wound management practice by providing evidence for the effectiveness of a home-based exercise program for adults with venous leg ulcers. Theory-driven, evidence-based strategies that can improve an individual’s exercise self-efficacy and self-management capacity could have a significant impact in improving the management of people with venous leg ulcers. Information gained from this study will provide much needed information on management of this chronic disease to promote health and independence in this population. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12612000475842 Trial status: Current follow up
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Background Breastfeeding is recognised as the optimal method for feeding infants with health gains made by reducing infectious diseases in infancy; and chronic diseases, including obesity, in childhood, adolescence and adulthood. Despite this, exclusivity and duration in developed countries remains resistant to improvement. The objectives of this research were to test if an automated mobile phone text messaging intervention, delivering one text message a week, could increase “any” breastfeeding rates and improve breastfeeding self-efficacy and coping. Methods Women were eligible to participate if they were: over eighteen years; had an infant less than three months old; were currently breastfeeding; no diagnosed mental illness; and used a mobile phone . Women in the intervention group received MumBubConnect, a text messaging service with automated responses delivered once a week for 8 weeks. Women in the comparison group received their usual care and were sampled two years after the intervention group. Data collection included online surveys at two time points, week zero and week nine, to measure breastfeeding exclusivity and duration, coping, emotions, accountability and self-efficacy. A range of statistical analyses were used to test for differences between groups. Hierarchical regression was used to investigate change in breastfeeding outcome, between groups, adjusting for co-variates. Results The intervention group had 120 participants at commencement and 114 at completion, the comparison group had 114 participants at commencement and 86 at completion. MumBubConnect had a positive impact on the primary outcome of breastfeeding behaviors with women receiving the intervention more likely to continue exclusive breastfeeding; with a 6% decrease in exclusive breastfeeding in the intervention group, compared to a 14% decrease in the comparison group (p < 0.001). This remained significant after controlling for infant age, mother’s income, education and delivery type (p = 0.04). Women in the intervention group demonstrated active coping and were less likely to display emotions-focussed coping (p < .001). There was no discernible statistical effect on self-efficacy or accountability. Conclusions A fully automated text messaging services appears to improve exclusive breastfeeding duration. The service provides a well-accepted, personalised support service that empowers women to actively resolve breastfeeding issues. Trial registration Australian New Zealand Clinical Trials Registry: ACTRN12614001091695.
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INTRODUCTION Influenza vaccination in pregnancy is recommended for all women in Australia, particularly those who will be in their second or third trimester during the influenza season. However, there has been no systematic monitoring of influenza vaccine uptake among pregnant women in Australia. Evidence is emerging of benefit to the infant with respect to preventing influenza infection in the first 6 months of life. The FluMum study aims to systematically monitor influenza vaccine uptake during pregnancy in Australia and determine the effectiveness of maternal vaccination in preventing laboratory-confirmed influenza in their offspring up to 6 months of age. METHODS AND ANALYSIS A prospective cohort study of 10 106 mother-infant pairs recruited between 38 weeks gestation and 55 days postdelivery in six Australian capital cities. Detailed maternal and infant information is collected at enrolment, including influenza illness and vaccination history with a follow-up data collection time point at infant age 6 months. The primary outcome is laboratory-confirmed influenza in the infant. Case ascertainment occurs through searches of Australian notifiable diseases data sets once the infant turns 6 months of age (with parental consent). The primary analysis involves calculating vaccine effectiveness against laboratory-confirmed influenza by comparing the incidence of influenza in infants of vaccinated mothers to the incidence in infants of unvaccinated mothers. Secondary analyses include annual and pooled estimates of the proportion of mothers vaccinated during pregnancy, the effectiveness of maternal vaccination in preventing hospitalisation for acute respiratory illness and modelling to assess the determinants of vaccination. ETHICS AND DISSEMINATION The study was approved by all institutional Human Research Ethics Committees responsible for participating sites. Study findings will be published in peer review journals and presented at national and international conferences. TRIAL REGISTRATION NUMBER The study is registered with the Australia and New Zealand Clinical Trials Registry (ANZCTR) number: 12612000175875.