198 resultados para clinical research methodology


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Although Design Science Research (DSR) is now an accepted approach to research in the Information Systems (IS) discipline, consensus on the methodology of DSR has yet to be achieved. Lack of a comprehensive and detailed methodology for Design Science Research (DSR) in the Information System (IS) discipline is a main issue. Prior research (the parent-study) aimed to remedy this situation and resulted in the DSR-Roadmap (Alturki et al., 2011a). Continuing empirical validation and revision of the DSR-Roadmap strives towards a methodology with appropriate levels of detail, integration, and completeness for novice researchers to efficiently and effectively conduct and report DSR in IS. The sub-study reported herein contributes to this larger, ongoing effort. This paper reports results from a formative evaluation effort of the DSR-Roadmap conducted using focus group analysis. Generally, participants endorsed the utility and intuitiveness of the DSR-Roadmap, while also suggesting valuable refinements. Both parent-study and sub-study make methodological contributions. The parent-study is the first attempt of utilizing DSR to develop a research methodology showing an example of how to use DSR in research methodology construction. The sub-study demonstrates the value of the focus group method in DSR for formative product evaluation.

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Background Nursing perspectives play an important role in addressing the health priorities of today’s society. The Australian College of Nursing (ACN) acknowledges the significant contribution that nursing research has made since the first nurse researcher, Florence Nightingale, documented the factors that affected the morbidity and mortality of soldiers wounded in the Crimean war in the 1800s. The nursing profession continues to celebrate the significant contribution nursing research made to improving nursing practice and health outcomes. These significant contributions over recent years include, but are not limited to: 1. Health services research that has demonstrated the importance of nursing services and how such services are designed/organised to ensure safety and quality of care (Duffield, et al., 2011; Fernandez, et al., 2012; Middleton, et al., 2011); 2. Clinical research that has demonstrated the value of specific nursing interventions to improved health outcomes, including enhanced survival, reduced morbidity, and improved quality of life and consumer engagement (Cancer Australia and Cancer Voices Australia, 2011; Kitson, et al., 2013; Middleton, et al., 2012; Rickard, et al., 2012; Zeitz, et al., 2011); 3. Basic science research that has advanced discoveries in terms of understanding the biological mechanisms underpinning nursing interventions (Illi, et al., 2012; Kim, et al., 2012; Miaskowski, et al., 2010; Simonova, et al., 2012); 4. Epidemiological research that has advanced understanding about how individuals and populations respond to health problems (Carrington, et al., 2012); 5. Qualitative research that has advanced understanding about experiences of and responses to health and illness and the processes of care that are important to optimal outcomes (Schulman-Green, et al., 2012; Scott, et al., 2011).

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In this paper we introduce a novel design for a translational medical research ecosystem. Translational medical research is an emerging field of work, which aims to bridge the gap between basic medical science research and clinical research/patient care. We analyze the key challenges of digital ecosystems for translational research, based on real world scenarios posed by the Lab for Translational Research at the Harvard Medical School and the Genomics Research Centre of the Griffith University, and show how traditional IT approaches fail to fulfill these challenges. We then introduce our design for a translational research ecosystem. Several key contributions are made: A novel approach to managing ad-hoc research ecosystems is introduced; a new security approach for translational research is proposed which allows each participating site to retain control over its data and define its own policies to ensure legal and ethical compliance; and a design for a novel interactive access control framework which allows users to easily share data, while adhering to their organization's policies is presented.

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This thesis is a work-in-progress that articulates my research journey based on the development of a curriculum innovation in environmental education. This journey had two distinct, but intertwined phases: action research based fieldwork, conducted collaboratively, to create a whole school approach to environmental education curriculum planning; and a phase of analysis and reflection based on the emerging findings, as I sought to create personal "living educational theory" about change and innovation. A key stimulus for the study was the perceived theory-practice gap in environmental education, which is often presented in the literature as a criticism of teachers for failing to achieve the values and action objectives of critical environmental education. Hence, many programs and projects are considered to be superficial and inconsequential in terms of their ability to seriously address environmental issues. The intention of this study was to work with teachers in a project that would be an exemplar of critical environmental education. This would be in the form of a whole school "learnscaping" curriculum in a primary school whereby the schoolgrounds would be utilised for interdisciplinary critical environment education. Parallel with the three cycles of action research in this project, my research objectives were to identify and comment upon the factors that influence the generation of successful educational innovation. It was anticipated that the project would be a collaboration involving me, as researcher-facilitator, and many of the teachers in the school as active participants. As the project proceeded through its action cycles, however, it became obvious that the goal of developing a critical environmental education curriculum, and the use of highly participatory processes, were unrealistic. Institutional and organisational rigidities in education generally, teachers' day-to-day work demands, and the constant juggle of work, family and other responsibilities for all participants acted as significant constraints. Consequently, it became apparent that the learnscaping curriculum would not be the hoped-for exemplar. Progress was slow and, at times, the project was in danger of stalling permanently. While the curriculum had some elements of critical environmental education, these were minor and not well spread throughout the school. Overall, the outcome seemed best described as a "small win"; perhaps just another example of the theory-practice gap that I had hoped this project would bridge. Towards the project's end, however, my continuing reflection led to an exploration of chaos/complexity theory which gave new meaning to the concept of a "small win". According to this theory, change is not the product of linear processes applied methodically in purposeful and diligent ways, but emerges from serendipitous events that cannot be planned for, or forecast in advance. When this perspective of change is applied to human organisations - in this study, a busy school - the context for change is recognised not as a stable, predictable environment, but as a highly complex system where change happens all the time, cannot be controlled, and no one can be really sure where the impacts might lead. This so-called "butterfly effect" is a central idea of this theory where small changes or modifications are created - the effects of which are difficult to know, let alone determine - and which can have large-scale impacts. Allied with this effect is the belief that long term developments in an organisation that takes complexity into account, emerge by spontaneous self-organising evolution, requiring political interaction and learning in groups, rather than systematic progress towards predetermined goals or "visions". Hence, because change itself and the contexts of change are recognised as complex, chaos/complexity theory suggests that change is more likely to be slow and evolutionary - cultural change - rather than fast and revolutionary where the old is quickly ushered out by radical reforms and replaced by new structures and processes. Slow, small-scale changes are "normal", from a complexity viewpoint, while rapid, wholesale change is both unlikely and unrealistic. Therefore, the frustratingly slow, small-scale, imperfect educational changes that teachers create - including environmental education initiatives - should be seen for what they really are. They should be recognised as successful changes, the impacts of which cannot be known, but which have the potential to magnify into large-scale changes into the future. Rather than being regarded as failures for not meeting critical education criteria, "small wins" should be cause for celebration and support. The intertwined phases of collaborative action research and individual researcher reflection are mirrored in the thesis structure. The first three chapters, respectively, provide the thesis overview, the literature underpinning the study's central concern, and the research methodology. Chapters 4, 5, and 6 report on each of the three action research cycles of the study, namely Laying the Groundwork, Down to Work!, and The Never-ending Story. Each of these chapters presents a narrative of events, a literature review specific to developments in the cycle, and analysis and critique of the events, processes and outcomes of each cycle. Chapter 7 provides a synthesis of the whole of the study, outlining my interim propositions about facilitating curriculum change in schools through action research, and the implications of these for environmental education.

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Balancing the demands of research and ethics is always challenging and even more so when recruiting vulnerable groups. Within the context of current legislation and international human rights declarations, it is strongly advocated that research can and must be undertaken with all recipients of health care services. Research in the field of intellectual disability presents particular challenges in regard to consenting processes. This paper is a critical reflection and analysis of the complex processes undertaken and events that occurred in gaining informed consent from people with intellectual disability to participate in a study exploring their experiences of being an inpatient in mental health hospitals within Aotearoa/New Zealand. A framework based on capacity, information and voluntariness is presented with excerpts from the field provided to explore consenting processes. The practical implications of the processes utilised are then discussed in order to stimulate debate regarding clearer and enhanced methods of gaining informed consent from people with intellectual disability.

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This chapter presents the current challenges facing legislators, regulators, researchers, and ethics committees in determining how and when to include women appropriately in research, and ensure that sex analysis of research results is routinely performed. It offers five issues that require attention to address these challenges: that national regulatory statements could provide researchers with definitions of the terms ‘sex’ , ‘gender’, and ‘gender equity’ in research; that sex and gender analysis should be built into health research protocols; the lack of internationally comparable data regarding the rates of inclusion of men and women presents a major hurdle for analysing the efficacy of different regulatory strategies; the accessibility of data would be facilitated by a requirement for publication of the results of health research to include descriptions of sex analysis performed on research data; and that institutional review boards, research ethics committees, and researchers themselves require better education about the scientific and ethical importance of including of women in clinical research.

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Knowledge Management (KM) is vital factor to successfully undertake projects. The temporary nature of projects necessitates employing useful KM practices to reduce any issues such as knowledge leakiness and rework. The Project Management Office (PMO) is a unit within organisations to facilitate and oversee organisational projects. Project Management Maturity Models (PMMM) show the development of PMOs from immature to mature levels. The existing PMMMs have focused on discussing Project Management (PM) practices, however, the management of project knowledge is yet to be addressed, at various levels of maturity. A research project was undertaken to investigate the mentioned gap for addressing KM practices at the existing PMMMs. Due to the exploratory and inductive nature of this research, qualitative methods using case studies were chosen as the research methodology to investigate the problem in the real world. In total, three cases selected from different industries: research; mining and government organisations, to provide broad categories for research and research questions were examined using the developed framework. This paper presents the findings from the investigation of the research organisation with the lowest level of maturity. From KM process point of view, knowledge creation and capturing are the most important processes, while knowledge transferring and reusing received less attention. In addition, it was revealed that provision of “knowledge about client” and “project management knowledge” are the most important types of knowledge that are required at this level of maturity. The results also revealed that PMOs with higher maturity level have better knowledge management, however, some improvement is needed. In addition, the importance of KM processes varies at different levels of maturity. In conclusion, the outcomes of this paper could provide powerful guidance to PMOs at lowest level of maturity from KM point of view.

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Supported by contemporary theories of architectural aesthetics and neuro-aesthetics this paper presents a case for the use of portable fNIRS imaging in the assessment of emotional responses to spatial environments experienced by both blind and sighted. The aim of the paper is to outline the implications of fNIRS for spatial research and practice within the field of architecture, thereby suggesting a potential taxonomy of particular formations of space and affect. Empirical neurological study of affect and spatial experience from an architectural design perspective remains in many instances unchartered. Clinical research using the portable non-invasive neuro-imaging device, functional near infrared spectroscopy (fNIRS) is proving convincing in its ability to detect emotional responses to visual, spatio-auditory and task based stimuli, providing a firm basis to potentially track cortical activity in the appraisal of architectural environments. Additionally, recent neurological studies have sought to explore the manifold sensory abilities of the visually impaired to better understand spatial perception in general. Key studies reveal that early blind participants perform as well as sighted due to higher auditory and somato-sensory spatial acuity. For instance, face vision enables the visually impaired to detect environments through skin pressure, enabling at times an instantaneous impression of the layout of an unfamiliar environment. Studies also report pleasant and unpleasant emotional responses such as ‘weightedness’ or ‘claustrophobia’ within certain interior environments, revealing a deeper perceptual sensitivity then would be expected. We conclude with justification that comparative fNIRS studies between the sighted and blind concerning spatial experience have the potential to provide greater understanding of emotional responses to architectural environments.

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Schizophrenia results in a profound disruption of one’s capacity to make sense of mental states, coherently narrate self-experiences, and meaningfully relate to others. While current treatment options for people with schizophrenia tend to be symptom-focused, experience in designing and implementing a study focusing on enhancing sense of self demonstrates the feasibility of developing and implementing models of treatment that prioritize the subjective distress and self-experience of people with schizophrenia. There is emerging research evidence, based upon dialogical theory of self, that posits the potential of people with deficits of self to engage in meaningful therapeutic relationships and work toward greater integrity of self and degrees of recovery. The challenge is to translate these ideas into a research methodology that can be successfully applied within therapeutic contexts with people who meet the diagnostic criteria for schizophrenia. Based upon dialogical theory, we developed a principle-based manual for metacognitive narrative psychotherapy: a psychological approach to the treatment of people with schizophrenia, which aims to enhance metacognitive capacity and ability to narrate self-experiences. Five phases of treatment were identified: (1) developing a therapeutic relationship, (2) eliciting narratives, (3) enhancing metacognitive capacity, (4) enriching narratives, and (5) living enriched stories. Proscribed practices were also identified. We then implemented the manual within a university clinic context. Six therapists were trained to implement the model and, in turn, provided therapy to 11 patients who completed 12 to 24 months of treatment. Participants were assessed on metacognitive capacity, narrative coherence, narrative richness, self-reported recovery, and symptomatology at three points in time over the course of therapy. Contrary to expectations, participants were highly engaged in the therapeutic process, with minimal dropout. Overall, over 75% of participants evidenced improvement in their level of recovery over the course of therapy. The manualization and outcome findings demonstrate the feasibility of applying such interventions to a broader clinical population.

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Knowledge Management (KM) is vital factor to successfully undertake projects. The temporary nature of projects necessitates employing useful KM practices for tackling issues such as knowledge leakiness and rework. The Project Management Office (PMO) is a unit within organizations to facilitate and oversee organizational projects. Project Management Maturity Models (PMMM) shows the development of PMOs from immature to mature levels. The existing PMMMs have focused on discussing Project Management (PM) practices, however, the management of project knowledge is yet to be addressed, at various levels of maturity. This research project was undertaken to investigate the mentioned gap for addressing KM practices at the existing PMMMs. Due to the exploratory and inductive nature of this research, qualitative methods were chosen as the research methodology. In total, three cases selected from different industries: research; mining and government organizations, to provide broad categories for research and research questions were examined using the developed framework. This paper presents the partial findings of undertaken investigation of the research organisation with the lowest level of maturity. The result shows that knowledge creation and capturing are the most important processes, while knowledge transferring and reusing are not as important as the other two processes. In addition, it was revealed that provision of “knowledge about client” and “project management knowledge” are the most important types of knowledge that are required at this level of maturity. In conclusion, the outcomes of this paper shall provide powerful guidance to PMOs at lowest level of maturity from KM point of view.

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As detailed by a number of scholars (Emmison & Smith, 2000, 2012; Harrison, 1996, 2002, 2004), photographs and the process of photographing can provide fertile ground for sociological investigation. Examining the production of photography can tell us much about inclusion/omission and power/knowledge in a variety of social settings. Recently, some researchers have begun to utilise the participatory action research methodology, PhotoVoice, where people take and share photographs as a means of communicating and advocating on a specific topic. While medical sociologists have used PhotoVoice to communicate the impacts of disease in vulnerable populations (eg Burles, 2010), little social research has been done that combines PhotoVoice and older persons. This is interesting given the world’s population is ageing and the general lack of research that examines what daily life is like for older people living in aged care (Timonen & O’Dwyer, 2009). In response, a recent project tracked 10 participants who recently transitioned into living in residential aged care (RAC). The project combined the use of PhotoVoice methodology with repeated in-depth interviews. Residents were asked to orally and visually describe the positives and negative aspects of their daily lives. In the first instance, they shared the use of a RAC owned camera and later had the opportunity to access a camera for their sole use. Photographic analysis emphasised the value of centring the participant as an autonomous photographer in social research. In the photographs captured on a shared use camera, the photographs tended to depict predominately positive life stories (e.g. weekly morning tea outings, social activities). In comparison, the photographs captured on the sole use camera also described intimate but everyday activities, spaces, objects and people that frequented in their daily lives. Shifting the responsibility of the camera and photography solely to the participants resulted in the residents disrupting conventions of ‘suitable’ subject matter to photograph (Harrison, 2004) and in doing so, provided a much richer insight into what daily life is like in aged care.

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The goal of this study was to describe researchers' experiences in submitting ethical proposals focused on older adult populations, including studies with persons with dementia, to ethical review boards. Ethical approval was granted for an online survey. Researchers were recruited via listservs and snowballing techniques. Participants included 157 persons (73% female) from Australia and the United States, with a mean age of 46 (±13). Six main issues were encountered by researchers who participated in this survey. In descending order, these included questions regarding: informed consent and information requirements (61.1%), participants' vulnerability, particularly for those with cognitive impairments (58.6%), participant burden (44.6%), data access (29.3%), adverse effects of data collection/intervention (26.8%), and study methodology (25.5%). An inductive content analysis of responses revealed a range of encounters with ethical review panels spanning positive, negative, and neutral experiences. Concerns voiced about ethical review boards included committees being overly focused on legal risk, as well as not always hearing the voice of older research participants, both potential and actual. Respondents noted inability to move forward on studies, as well as loss of researchers and participant groups from gerontological and clinical research as a result of negative interactions with ethics committees. Positive interactions with the committees reinforced researchers' need to carefully construct their research approaches with persons with dementia in particular. Suggested guidelines for committees when dealing with ethics applications involving older adults include self-reflecting on potential biases and stereotypes, and seeking further clarification and information from gerontological researchers before arriving at decisions.

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Social media enable advertising agencies to engage directly with the public by participating in-and observing-real conversations. The current study recruited a Delphi panel to explore how some of the world's leading advertising professionals view the use of social media to test, track, and evaluate advertising campaigns and how they identify related risks and ethical considerations. The findings suggest that agencies primarily use social media as a tool for understanding consumers and igniting insight, not as a means of testing creative ideas. The authors believe this research provides an important benchmark of agency best practice in social-media research and outlines ethical implications.

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Background: Overviews of systematic reviews (SRs) are useful for public health policy; however there is an absence of Cochrane Overviews covering public health (PH) topics. Objectives: We sought to analyze the methodological approaches used in existing Cochrane Overviews and Protocols for overviews (primarily clinical in nature), and compare these to the methods and approaches used in PH overviews (non-Cochrane). The intent was to identify issues that would be relevant for undertaking Cochrane overviews. Methods: We conducted a descriptive analysis of overviews published between 1999 and 2014. We searched the Cochrane Database of Systematic Reviews for Cochrane Protocols for overviews and Cochrane Overviews, and the HealthEvidence.org for PH overviews. The primary characteristics of the overviews and elements of the methodology were extracted and compared. Results: A total of 61 overviews of SRs were included in our analysis; specifically, this included 21 Cochrane Protocols for overviews, 15 Cochrane Overviews, and 27 non-Cochrane PH overviews. Amongst the overviews, the most significant differences are that PH overviews (non-Cochrane) tend to: include earlier and more reviews, greater number of participants, allow lower levels of evidence, use assessment tools other than AMSTAR (A Measurement Tool to Assess Systematic Reviews, i.e. a tool for assessing quality of SRs), not assess quality of evidence in reviews, search more databases overall, specify search limits including English-only reviews, and not consider recent primary studies for inclusion. Some of these differences clearly related to quality, however many relate to the nuances of PH interventions. Conclusions: The methodology in Cochrane overviews and PH overviews varies widely. Future PH overviews may benefit from the Cochrane methodology but the Cochrane approach requires modification to accommodate PH research methodology. Additionally, the use of databases that pre-screen and quality assess relevant PH systematic reviews may help expedite the search process.