870 resultados para regulatory-type non-clinical safety studies


Relevância:

40.00% 40.00%

Publicador:

Resumo:

Osteoporosis is the most common bone disease. Low levels of oestrogens or testosterone are risk factors for primary osteoporosis. The most common cause of secondary osteoporosis is glucocorticoid treatment, but there are many other secondary causes of osteoporosis. Osteoporosis can be secondary to anti-oestrogen treatment for hormone-sensitive breast cancer and to androgen-deprivation therapy for prostate cancer. Zoledronic is the most potent bisphosphonate at inhibiting bone resorption. In osteoporosis, zoledronic acid increases bone mineral density for at least a year after a single intravenous administration. The efficacy and safety of extended release (once-yearly) zoledronic acid in the treatment of osteoporosis is reviewed.

Relevância:

40.00% 40.00%

Publicador:

Resumo:

This thesis employs the theoretical fusion of disciplinary knowledge, interlacing an analysis from both functional and interpretive frameworks and applies these paradigms to three concepts—organisational identity, the balanced scorecard performance measurement system, and control. As an applied thesis, this study highlights how particular public sector organisations are using a range of multi-disciplinary forms of knowledge constructed for their needs to achieve practical outcomes. Practical evidence of this study is not bound by a single disciplinary field or the concerns raised by academics about the rigorous application of academic knowledge. The study’s value lies in its ability to explore how current communication and accounting knowledge is being used for practical purposes in organisational life. The main focus of this thesis is on identities in an organisational communication context. In exploring the theoretical and practical challenges, the research questions for this thesis were formulated as: 1. Is it possible to effectively control identities in organisations by the use of an integrated performance measurement system—the balanced scorecard—and if so, how? 2. What is the relationship between identities and an integrated performance measurement system—the balanced scorecard—in the identity construction process? Identities in the organisational context have been extensively discussed in graphic design, corporate communication and marketing, strategic management, organisational behaviour, and social psychology literatures. Corporate identity is the self-presentation of the personality of an organisation (Van Riel, 1995; Van Riel & Balmer, 1997), and organisational identity is the statement of central characteristics described by members (Albert & Whetten, 2003). In this study, identity management is positioned as a strategically complex task, embracing not only logo and name, but also multiple dimensions, levels and facets of organisational life. Responding to the collaborative efforts of researchers and practitioners in identity conceptualisation and methodological approaches, this dissertation argues that analysis can be achieved through the use of an integrated framework of identity products, patternings and processes (Cornelissen, Haslam, & Balmer, 2007), transforming conceptualisations of corporate identity, organisational identity and identification studies. Likewise, the performance measurement literature from the accounting field now emphasises the importance of ‘soft’ non-financial measures in gauging performance—potentially allowing the monitoring and regulation of ‘collective’ identities (Cornelissen et al., 2007). The balanced scorecard (BSC) (Kaplan & Norton, 1996a), as the selected integrated performance measurement system, quantifies organisational performance under the four perspectives of finance, customer, internal process, and learning and growth. Broadening the traditional performance measurement boundary, the BSC transforms how organisations perceived themselves (Vaivio, 2007). The rhetorical and communicative value of the BSC has also been emphasised in organisational self-understanding (Malina, Nørreklit, & Selto, 2007; Malmi, 2001; Norreklit, 2000, 2003). Thus, this study establishes a theoretical connection between the controlling effects of the BSC and organisational identity construction. Common to both literatures, the aspects of control became the focus of this dissertation, as ‘the exercise or act of achieving a goal’ (Tompkins & Cheney, 1985, p. 180). This study explores not only traditional technical and bureaucratic control (Edwards, 1981), but also concertive control (Tompkins & Cheney, 1985), shifting the locus of control to employees who make their own decisions towards desired organisational premises (Simon, 1976). The controlling effects on collective identities are explored through the lens of the rhetorical frames mobilised through the power of organisational enthymemes (Tompkins & Cheney, 1985) and identification processes (Ashforth, Harrison, & Corley, 2008). In operationalising the concept of control, two guiding questions were developed to support the research questions: 1.1 How does the use of the balanced scorecard monitor identities in public sector organisations? 1.2 How does the use of the balanced scorecard regulate identities in public sector organisations? This study adopts qualitative multiple case studies using ethnographic techniques. Data were gathered from interviews of 41 managers, organisational documents, and participant observation from 2003 to 2008, to inform an understanding of organisational practices and members’ perceptions in the five cases of two public sector organisations in Australia. Drawing on the functional and interpretive paradigms, the effective design and use of the systems, as well as the understanding of shared meanings of identities and identifications are simultaneously recognised. The analytical structure guided by the ‘bracketing’ (Lewis & Grimes, 1999) and ‘interplay’ strategies (Schultz & Hatch, 1996) preserved, connected and contrasted the unique findings from the multi-paradigms. The ‘temporal bracketing’ strategy (Langley, 1999) from the process view supports the comparative exploration of the analysis over the periods under study. The findings suggest that the effective use of the BSC can monitor and regulate identity products, patternings and processes. In monitoring identities, the flexible BSC framework allowed the case study organisations to monitor various aspects of finance, customer, improvement and organisational capability that included identity dimensions. Such inclusion legitimises identity management as organisational performance. In regulating identities, the use of the BSC created a mechanism to form collective identities by articulating various perspectives and causal linkages, and through the cascading and alignment of multiple scorecards. The BSC—directly reflecting organisationally valued premises and legitimised symbols—acted as an identity product of communication, visual symbols and behavioural guidance. The selective promotion of the BSC measures filtered organisational focus to shape unique identity multiplicity and characteristics within the cases. Further, the use of the BSC facilitated the assimilation of multiple identities by controlling the direction and strength of identifications, engaging different groups of members. More specifically, the tight authority of the BSC framework and systems are explained both by technical and bureaucratic controls, while subtle communication of organisational premises and information filtering is achieved through concertive control. This study confirms that these macro top-down controls mediated the sensebreaking and sensegiving process of organisational identification, supporting research by Ashforth, Harrison and Corley (2008). This study pays attention to members’ power of self-regulation, filling minor premises of the derived logic of their organisation through the playing out of organisational enthymemes (Tompkins & Cheney, 1985). Members are then encouraged to make their own decisions towards the organisational premises embedded in the BSC, through the micro bottom-up identification processes including: enacting organisationally valued identities; sensemaking; and the construction of identity narratives aligned with those organisationally valued premises. Within the process, the self-referential effect of communication encouraged members to believe the organisational messages embedded in the BSC in transforming collective and individual identities. Therefore, communication through the use of the BSC continued the self-producing of normative performance mechanisms, established meanings of identities, and enabled members’ self-regulation in identity construction. Further, this research establishes the relationship between identity and the use of the BSC in terms of identity multiplicity and attributes. The BSC framework constrained and enabled case study organisations and members to monitor and regulate identity multiplicity across a number of dimensions, levels and facets. The use of the BSC constantly heightened the identity attributes of distinctiveness, relativity, visibility, fluidity and manageability in identity construction over time. Overall, this research explains the reciprocal controlling relationships of multiple structures in organisations to achieve a goal. It bridges the gap among corporate and organisational identity theories by adopting Cornelissen, Haslam and Balmer’s (2007) integrated identity framework, and reduces the gap in understanding between identity and performance measurement studies. Parallel review of the process of monitoring and regulating identities from both literatures synthesised the theoretical strengths of both to conceptualise and operationalise identities. This study extends the discussion on positioning identity, culture, commitment, and image and reputation measures in integrated performance measurement systems as organisational capital. Further, this study applies understanding of the multiple forms of control (Edwards, 1979; Tompkins & Cheney, 1985), emphasising the power of organisational members in identification processes, using the notion of rhetorical organisational enthymemes. This highlights the value of the collaborative theoretical power of identity, communication and performance measurement frameworks. These case studies provide practical insights about the public sector where existing bureaucracy and desired organisational identity directions are competing within a large organisational setting. Further research on personal identity and simple control in organisations that fully cascade the BSC down to individual members would provide enriched data. The extended application of the conceptual framework to other public and private sector organisations with a longitudinal view will also contribute to further theory building.

Relevância:

40.00% 40.00%

Publicador:

Resumo:

The paper details the results of the first phase of an on-going research into the sociocultural factors that influence the supervision of higher degrees research (HDR) engineering students in the Faculty of Built Environment and Engineering (BEE) and Faculty of Science and Technology (FaST) at Queensland University of Technology. A quantitative analysis was performed on the results from an online survey that was administered to 179 engineering students. The study reveals that cultural barriers impact their progression and developing confidence in their research programs. We argue that in order to assist international and non-English speaking background (NESB) research students to triumph over such culturally embedded challenges in engineering research, it is important for supervisors to understand this cohort's unique pedagogical needs and develop intercultural sensitivity in their pedagogical practice in postgraduate research supervision. To facilitate this, the governing body (Office of Research) can play a vital role in not only creating the required support structures but also their uniform implementation across the board.

Relevância:

40.00% 40.00%

Publicador:

Resumo:

Osteoarthritis (OA) is a chronic, non-inflammatory type of arthritis, which usually affects the movable and weight bearing joints of the body. It is the most common joint disease in human beings and common in elderly people. Till date, there are no safe and effective diseases modifying OA drugs (DMOADs) to treat the millions of patients suffering from this serious and debilitating disease. However, recent studies provide strong evidence for the use of mesenchymal stem cell (MSC) therapy in curing cartilage related disorders. Due to their natural differentiation properties, MSCs can serve as vehicles for the delivery of effective, targeted treatment to damaged cartilage in OA disease. In vitro, MSCs can readily be tailored with transgenes with anti-catabolic or pro-anabolic effects to create cartilage-friendly therapeutic vehicles. On the other hand, tissue engineering constructs with scaffolds and biomaterials holds promising biological cartilage therapy. Many of these strategies have been validated in a wide range of in vitro and in vivo studies assessing treatment feasibility or efficacy. In this review, we provide an outline of the rationale and status of stem-cell-based treatments for OA cartilage, and we discuss prospects for clinical implementation and the factors crucial for maintaining the drive towards this goal.

Relevância:

40.00% 40.00%

Publicador:

Resumo:

Currently, well-established clinical therapeutic approaches for bone reconstruction are restricted to the transplantation of autografts and allografts, and the implantation of metal devices or ceramic-based implants to assist bone regeneration. Bone grafts possess osteoconductive and osteoinductive properties, however they are limited in access and availability and associated with donor site morbidity, haemorrhage, risk of infection, insufficient transplant integration, graft devitalisation, and subsequent resorption resulting in decreased mechanical stability. As a result, recent research focuses on the development of alternative therapeutic concepts. Analysing the tissue engineering literature it can be concluded that bone regeneration has become a focus area in the field. Hence, a considerable number of research groups and commercial entities work on the development of tissue engineered constructs for bone regeneration. However, bench to bedside translations are still infrequent as the process towards approval by regulatory bodies is protracted and costly, requiring both comprehensive in vitro and in vivo studies. In translational orthopaedic research, the utilisation of large preclinical animal models is a conditio sine qua non. Consequently, to allow comparison between different studies and their outcomes, it is essential that animal models, fixation devices, surgical procedures and methods of taking measurements are well standardized to produce reliable data pools as a base for further research directions. The following chapter reviews animal models of the weight-bearing lower extremity utilized in the field which include representations of fracture-healing, segmental bone defects, and fracture non-unions.

Relevância:

40.00% 40.00%

Publicador:

Resumo:

Background Significant ongoing learning needs for nurses have occurred as a direct result of the continuous introduction of technological innovations and research developments in the healthcare environment. Despite an increased worldwide emphasis on the importance of continuing education, there continues to be an absence of empirical evidence of program and session effectiveness. Few studies determine whether continuing education enhances or develops practice and the relative cost benefits of health professionals’ participation in professional development. The implications for future clinical practice and associated educational approaches to meet the needs of an increasingly diverse multigenerational and multicultural workforce are also not well documented. There is minimal research confirming that continuing education programs contribute to improved patient outcomes, nurses’ earlier detection of patient deterioration or that standards of continuing competence are maintained. Crucially, evidence-based practice is demonstrated and international quality and safety benchmarks are adhered to. An integrated clinical learning model was developed to inform ongoing education for acute care nurses. Educational strategies included the use of integrated learning approaches, interactive teaching concepts and learner-centred pedagogies. A Respiratory Skills Update education (ReSKU) program was used as the content for the educational intervention to inform surgical nurses’ clinical practice in the area of respiratory assessment. The aim of the research was to evaluate the effectiveness of implementing the ReSKU program using teaching and learning strategies, in the context of organisational utility, on improving surgical nurses’ practice in the area of respiratory assessment. The education program aimed to facilitate better awareness, knowledge and understanding of respiratory dysfunction in the postoperative clinical environment. This research was guided by the work of Forneris (2004), who developed a theoretical framework to operationalise a critical thinking process incorporating the complexities of the clinical context. The framework used educational strategies that are learner-centred and participatory. These strategies aimed to engage the clinician in dynamic thinking processes in clinical practice situations guided by coaches and educators. Methods A quasi experimental pre test, post test non–equivalent control group design was used to evaluate the impact of the ReSKU program on the clinical practice of surgical nurses. The research tested the hypothesis that participation in the ReSKU program improves the reported beliefs and attitudes of surgical nurses, increases their knowledge and reported use of respiratory assessment skills. The study was conducted in a 400 bed regional referral public hospital, the central hub of three smaller hospitals, in a health district servicing the coastal and hinterland areas north of Brisbane. The sample included 90 nurses working in the three surgical wards eligible for inclusion in the study. The experimental group consisted of 36 surgical nurses who had chosen to attend the ReSKU program and consented to be part of the study intervention group. The comparison group included the 39 surgical nurses who elected not to attend the ReSKU program, but agreed to participate in the study. Findings One of the most notable findings was that nurses choosing not to participate were older, more experienced and less well educated. The data demonstrated that there was a barrier for training which impacted on educational strategies as this mature aged cohort was less likely to take up educational opportunities. The study demonstrated statistically significant differences between groups regarding reported use of respiratory skills, three months after ReSKU program attendance. Between group data analysis indicated that the intervention group’s reported beliefs and attitudes pertaining to subscale descriptors showed statistically significant differences in three of the six subscales following attendance at the ReSKU program. These subscales included influence on nursing care, educational preparation and clinical development. Findings suggest that the use of an integrated educational model underpinned by a robust theoretical framework is a strong factor in some perceptions of the ReSKU program relating to attitudes and behaviour. There were minimal differences in knowledge between groups across time. Conclusions This study was consistent with contemporary educational approaches using multi-modal, interactive teaching strategies and a robust overarching theoretical framework to support study concepts. The construct of critical thinking in the clinical context, combined with clinical reasoning and purposeful and collective reflection, was a powerful educational strategy to enhance competency and capability in clinicians.

Relevância:

40.00% 40.00%

Publicador:

Resumo:

Expertise in nursing has been widely studied although there have been no previous studies into what constitutes expertise in nephrology (renal) nursing. This paper, which is abstracted from a larger study into the acquisition and exercise of nephrology nursing expertise, provides evidence of the characteristics and practices of non-expert nephrology nurses. Using the grounded theory method, the study took place in one renal unit in New South Wales, Australia, and involved six non-expert and 11 expert nurses. Sampling was purposive then theoretical. Simultaneous data collection and analysis using participant observation, review of nursing documentation and semistructured interviews was undertaken. The study revealed a three-stage skills-acquisitive process that was identified as non-expert, experienced non-expert and expert stages. Non-expert nurses showed superficial nephrology nursing knowledge and limited experience; they were acquiring basic nephrology nursing skills and possessed a narrow focus of practice.

Relevância:

40.00% 40.00%

Publicador:

Resumo:

We suspect that the array of silly names used to refer to temporary staff worldwide may be indicative of the extent to which these nurses have been relegated to, and we would argue, remain in, a type of underclass – relatively unsupported by employers in terms of professional practice and ipso facto excluded from contributing professionally to team work, practice development, clinical governance and evidence based practice. This may be acceptable to some but in a climate of risk averseness and in the interests of strategic planning we would suggest it is an accident waiting to happen. The recent UK Royal College of Nursing (RCN) (Ball & Pike, 2006) survey of bank and agency nurses brings a welcome focus on a group of nurses that make a significant contribution to the smooth running of health services in many countries.

Relevância:

40.00% 40.00%

Publicador:

Resumo:

Background There has been increasing interest in assessing the impacts of temperature on mortality. However, few studies have used a case–crossover design to examine non-linear and distributed lag effects of temperature on mortality. Additionally, little evidence is available on the temperature-mortality relationship in China, or what temperature measure is the best predictor of mortality. Objectives To use a distributed lag non-linear model (DLNM) as a part of case–crossover design. To examine the non-linear and distributed lag effects of temperature on mortality in Tianjin, China. To explore which temperature measure is the best predictor of mortality; Methods: The DLNM was applied to a case¬−crossover design to assess the non-linear and delayed effects of temperatures (maximum, mean and minimum) on deaths (non-accidental, cardiopulmonary, cardiovascular and respiratory). Results A U-shaped relationship was consistently found between temperature and mortality. Cold effects (significantly increased mortality associated with low temperatures) were delayed by 3 days, and persisted for 10 days. Hot effects (significantly increased mortality associated with high temperatures) were acute and lasted for three days, and were followed by mortality displacement for non-accidental, cardiopulmonary, and cardiovascular deaths. Mean temperature was a better predictor of mortality (based on model fit) than maximum or minimum temperature. Conclusions In Tianjin, extreme cold and hot temperatures increased the risk of mortality. Results suggest that the effects of cold last longer than the effects of heat. It is possible to combine the case−crossover design with DLNMs. This allows the case−crossover design to flexibly estimate the non-linear and delayed effects of temperature (or air pollution) whilst controlling for season.