A QUM partnership approach to regulating biosimilars in Australia

Despite the realisation of the potential implications from biosimilars is relatively recent, much has already been written about raising the awareness of differences between biosimilars and originating/ reference listed (innovator) pharmaceuticals. The European Medicines Agency has led the global charge in regulating biosimilars. Regardless of sufficient similarities across international regulations, differences do exist across jurisdictions. The consideration of regulating biosimilars demands a congruent approach across all stages: pre-registration (Australian copyright protection, patent, international obligations), registration (confidential information, international regulators, safety and efficacy), post-registration (Pharmaceutical Benefit Scheme, prescriber and dispenser awareness). Our National Medicines Policy could provide the necessary congruent framework and function for national and international regulation of biosimilars. The Policy concedes that pharmaceuticals will be affected by financial policies and trade considerations, international treaty obligations, industrial policies, education policies and the need for public-private partnerships.

The impact of nurse practitioner services on cost, quality of care, satisfaction and wait times in the emergency department: A systematic review

Aims To provide the best available evidence to determine the impact of nurse practitioner services on cost, quality of care, satisfaction and waiting times in the emergency department for adult patients. Background The delivery of quality care in the emergency department is one of the most important service indicators in health delivery. Increasing service pressures in the emergency department have resulted in the adoption of service innovation models: the most common and rapidly expanding of these is emergency nurse practitioner services. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this service model in terms of outcomes related to safety and quality of patient care. Previous research is now outdated and not commensurate with the changing domain of delivering emergency care with nurse practitioner services. Data A comprehensive search of four electronic databases from 2006-­‐2013 was conducted to identify research evaluating nurse practitioner service impact in the emergency department. English language articles were sought using MEDLINE, CINAHL, Embase and Cochrane and included two previous systematic reviews completed five and seven years ago. Methods A three step approach was used. Following a comprehensive search, two reviewers assessed identified studies against the inclusion criteria. From the original 1013 studies, 14 papers were retained for critical appraisal on methodological quality by two independent reviewers and data extracted using standardised tools. Results Narrative synthesis was conducted to summarise and report the findings as insufficient data was available for meta-­‐analysis of results. This systematic review has shown that emergency nurse practitioner service has a positive impact on quality of care, patient satisfaction and waiting times. There was insufficient evidence to draw conclusions regarding impact on costs. Conclusion Synthesis of the available research attempts to provide an evidence base for emergency nurse practitioner service to guide healthcare leaders, policy makers and clinicians in reforming emergency department service provision. The findings suggest that further quality research is required for comparative measures of clinical and service effectiveness of emergency nurse practitioner service. In the context of increased health service demand and the need to provide timely and effective care to patients, such measures will assist in delivering quality patient care.

Migrant worker empowerment in online communities

Our literature review shows that several scholars have conceptualized empowerment in online communities according to context and setting. In general, empowerment by the Internet can be described as the capacity of the Internet to provide information, interactions and collaborations (Amichai-Hamburger, McKenna, & Tal, 2008). Interactions within a social networking site enable people to construct their online identity which potentially empowers them (Zhao, Grasmuck, & Martin, 2008). From a consumer orientation, consumers feel empowered through accessing information which potentially improves their understanding and knowledge in decision making processes (Tina, Kathryn, & Gary, 2006). In health contexts, participation in online communities is seen to empower individuals in coping with health issues (Høybye, Johansen, & Tjørnhøj-Thomsen, 2005; Pitts, 2004; Sharf, 1997; Cornelia F. van Uden-Kraan et al., 2008). In educational contexts, online collaboration processes can empower lecturers and students (Ravid, Kalman, & Rafaeli, 2008). The literature shows that studies of empowerment in online communities are an emerging concept

Q-RARA : a rapid and rigorous method for researching small, primary health care organisations

Understanding the organisational processes driving quality primary care is crucial to the maintaining and improving practice. Qualitative methods are increasingly popular in health services research, but this area is dominated by interview studies. Multiple qualitative methods are rarely used in a systematically integrated fashion. We developed a method to study small primary health care organizations using rapid appraisal and qualitative mixed methods: Q-RARA – Qualitative Rapid Appraisal, Rigorous Analysis

A loss of bioscience knowledge in nursing students

Background: Knowledge of the human biosciences is fundamental to the development of competent nurse practitioners (Smales, 2010) with the requisite knowledge and skills, necessary for high quality patient care and good patient outcomes (Logan and Angel, 2011). Many of these students study bioscience units which cover topics in anatomy, physiology, pathophysiology and microbiology. Studies of science recall in general and medical education, report up to 33% loss of knowledge in the first year which declines to 50% in the subsequent year (Custers, 2010). Objectives: The objectives were to test the recall of bioscience knowledge by nursing students and to ascertain their perceptions of the testing. Questions explored: What would the results be for multiple choice questions in fundamental microbiology and gastrointestinal anatomy and physiology (A&P) undertaken by nursing students 4, 9 and 16 months after their first bioscience exam on these topics? Would pre-warning the students of a microbiology quiz and not a gastrointestinal A&P quiz affect the findings? How would the students respond to the testing when surveyed? Recall results: The nursing students performed better in the final exam on gastrointestinal A&P than on fundamental microbiology. There was an approximate 20% loss in knowledge of gastrointestinal A&P after 4 months and this did not change significantly over the next 12 months. Although there was an improved performance in microbiology quizzes after 4 months, there was no significant difference in results over the next 12 months. Survey results: More than 50% of students thought the testing helped them focus for the lectures and made them aware they had some pre-knowledge of the lecture topics. Discussion: Although there was a loss of knowledge of gastrointestinal A&P, it appears that warning the students about the microbiology quiz may have helped their recall. The majority of students valued the testing as a useful learning exercise. References: Custers, E. J. F. M. (2010). Long-term retention of basic science knowledge: a review study. Advances in Health Science Education, 15, 109-128. Smales, K. (2010). Learning and applying biosciences to clinical practice in nursing. Nursing Standard, 24(33), 35-39. Logan, P.A., & Angel, L. (2011). Nursing as a scientific undertaking and the intersection with science in undergraduate studies: implications for nursing management. Journal of Nursing Management, 19(3), 407-417.

Theoretical frameworks to support research of health service innovation

Health service managers and policy makers are increasingly concerned about the sustainability of innovations implemented in health care settings. The increasing demand on health services requires that innovations are both effective and sustainable however research in this field is limited with multiple disciplines, approaches and paradigms influencing the field. These variations prevent a cohesive approach and therefore the accumulation of research findings in development of a body of knowledge. A theoretical framework serves to guide research, determine variables, influence data analysis and is central to the quest for ongoing knowledge development. If left unaddressed, health services research will continue in an ad hoc manner preventing full utilisation of outcomes, recommendations and knowledge for effective provision of health services. The purpose of this paper is to provide an integrative review of the literature and introduce a theoretical framework for health services innovation sustainability research based on integration and synthesis of the literature. Finally recommendations for operationalising and testing this theory will be presented.

Understanding causal relationships between the built and social environment, health and associated behaviours and risk factors

Introduction: Built environment interventions designed to reduce non-communicable diseases and health inequity, complement urban planning agendas focused on creating more ‘liveable’, compact, pedestrian-friendly, less automobile dependent and more socially inclusive cities.However, what constitutes a ‘liveable’ community is not well defined. Moreover, there appears to be a gap between the concept and delivery of ‘liveable’ communities. The recently funded NHMRC Centre of Research Excellence (CRE) in Healthy Liveable Communities established in early 2014, has defined ‘liveability’ from a social determinants of health perspective. Using purpose-designed multilevel longitudinal data sets, it addresses five themes that address key evidence-base gaps for building healthy and liveable communities. The CRE in Healthy Liveable Communities seeks to generate and exchange new knowledge about: 1) measurement of policy-relevant built environment features associated with leading non-communicable disease risk factors (physical activity, obesity) and health outcomes (cardiovascular disease, diabetes) and mental health; 2) causal relationships and thresholds for built environment interventions using data from longitudinal studies and natural experiments; 3) thresholds for built environment interventions; 4) economic benefits of built environment interventions designed to influence health and wellbeing outcomes; and 5) factors, tools, and interventions that facilitate the translation of research into policy and practice. This evidence is critical to inform future policy and practice in health, land use, and transport planning. Moreover, to ensure policy-relevance and facilitate research translation, the CRE in Healthy Liveable Communities builds upon ongoing, and has established new, multi-sector collaborations with national and state policy-makers and practitioners. The symposium will commence with a brief introduction to embed the research within an Australian health and urban planning context, as well as providing an overall outline of the CRE in Healthy Liveable Communities, its structure and team. Next, an overview of the five research themes will be presented. Following these presentations, the Discussant will consider the implications of the research and opportunities for translation and knowledge exchange. Theme 2 will establish whether and to what extent the neighbourhood environment (built and social) is causally related to physical and mental health and associated behaviours and risk factors. In particular, research conducted as part of this theme will use data from large-scale, longitudinal-multilevel studies (HABITAT, RESIDE, AusDiab) to examine relationships that meet causality criteria via statistical methods such as longitudinal mixed-effect and fixed-effect models, multilevel and structural equation models; analyse data on residential preferences to investigate confounding due to neighbourhood self-selection and to use measurement and analysis tools such as propensity score matching and ‘within-person’ change modelling to address confounding; analyse data about individual-level factors that might confound, mediate or modify relationships between the neighbourhood environment and health and well-being (e.g., psychosocial factors, knowledge, perceptions, attitudes, functional status), and; analyse data on both objective neighbourhood characteristics and residents’ perceptions of these objective features to more accurately assess the relative contribution of objective and perceptual factors to outcomes such as health and well-being, physical activity, active transport, obesity, and sedentary behaviour. At the completion of the Theme 2, we will have demonstrated and applied statistical methods appropriate for determining causality and generated evidence about causal relationships between the neighbourhood environment, health, and related outcomes. This will provide planners and policy makers with a more robust (valid and reliable) basis on which to design healthy communities.

Raewyn Connell: Hegemonic Masculinities and Men’s Health

This handbook offers a new perspective on the sociology of health, illness and medicine by stressing the importance of social theory, and giving due attention to theorists often overlooked in the healthcare field including Harriet Martineau and Raewyn Connell, as well as more widely known theorists such as Michel Foucault and Max Weber. This is a compendium of both male and female social theorists from the turn of the 19th century to the present day. Leading international sociologists from Europe, America, Britain, Australia, New Zealand and Canada investigate the key concepts and theories of a single theorist, looking at the way their ideas such as medicalisation, reflexivity, capitalism, hegemonic masculinity, the biomedical model and social stigma can be used to understand specific health issues including men's health, Indigenous health, disability, the health professions and chronic illness.

Clinical trials in pediatrics

“Children are not little adults.” Almost all aspects of children's health including clinical trials and drug development are poor cousins of adult health. Over the years, pediatricians worldwide caution against blind extrapolation of adult data to children as it may result in considerable harm [1,2]. Also, it is increasingly recognized that the roots of many chronic diseases in adulthood stem from childhood and tackling health issues in children lead to improved health in adults [3,4]. Furthermore, investment in early childhood has long-term benefits in adults not only in health but also in other aspects of life such as education and crime reduction [4,5]. Arguably, health at birth is the single most important predictor of health in adulthood as the inequality of an infant at birth has intergenerational effects [5]. The Carolina Abecedarian Project showed that early childhood programs that are of high quality result in substantial societal benefits (e.g., reduction of crime, increased earnings, better education) [4,5]. A recent publication from this project found that this benefit also translated into improved adult health outcomes [4]. In a randomized trial, Campbell and colleagues described that disadvantaged children who were randomized to the intervention group (early education, health screenings and nutrition program) had significantly lower rates of metabolic syndrome, obesity and hypertension, when aged in their mid-30s, compared with the control group [4]...

Intercultural Dialogues in Early Childhood Education for Sustainability : Embedding Indigenous Perspectives

Embedding Indigenous perspectives in early childhood education for sustainability (ECEfS) upholds social and political action goals that support a holistic approach to promoting sustainability in educational contexts. Such goals should be responsive to particular contexts and their histories to ensure local issues are a focus of sustainability alongside global areas of concern. This chapter explores how intercultural dialogues and priorities foreground broader themes of sustainability that attend to local issues around culture and diversity, and equity in relations between groups of people. Attending to such themes in educational practice unsettles a standard environmental narrative and broadens the scope and potential for ECEfS in early years settings. Strengthening intercultural priorities in ECEfS requires a commitment to reflective practices that attend to the influence of one's cultural background on teaching and learning processes. Educators committed to reflective practices provide even greater capacity for children to act as change agents (Davis, 2008, 2010) around multiple dimensions of sustainability.

Beyond competencies : using a capability framework in developing practice standards for advanced practice nursing

AIM This paper presents a discussion on the application of a capability framework for advanced practice nursing standards/competencies. BACKGROUND There is acceptance that competencies are useful and necessary for definition and education of practice-based professions. Competencies have been described as appropriate for practice in stable environments with familiar problems. Increasingly competencies are being designed for use in the health sector for advanced practice such as the nurse practitioner role. Nurse practitioners work in environments and roles that are dynamic and unpredictable necessitating attributes and skills to practice at advanced and extended levels in both familiar and unfamiliar clinical situations. Capability has been described as the combination of skills, knowledge, values and self-esteem which enables individuals to manage change, be flexible and move beyond competency. DESIGN A discussion paper exploring 'capability' as a framework for advanced nursing practice standards. DATA SOURCES Data were sourced from electronic databases as described in the background section. IMPLICATIONS FOR NURSING As advanced practice nursing becomes more established and formalized, novel ways of teaching and assessing the practice of experienced clinicians beyond competency are imperative for the changing context of health services. CONCLUSION Leading researchers into capability in health care state that traditional education and training in health disciplines concentrates mainly on developing competence. To ensure that healthcare delivery keeps pace with increasing demand and a continuously changing context there is a need to embrace capability as a framework for advanced practice and education.