Nurse-led trials of medical devices: General principles and good practice

Aim To provide an overview of key governance matters relating to medical device trials and practical advice for nurses wishing to initiate or lead them. Background Medical device trials, which are formal research studies that examine the benefits and risks of therapeutic, non-drug treatment medical devices, have traditionally been the purview of physicians and scientists. The role of nurses in medical device trials historically has been as data collectors or co-ordinators rather than as principal investigators. Nurses more recently play an increasing role in initiating and leading medical device trials. Review Methods A review article of nurse-led trials of medical devices. Discussion Central to the quality and safety of all clinical trials is adherence to the International Conference on Harmonization Guidelines for Good Clinical Practice, which is the internationally-agreed standard for the ethically- and scientifically-sound design, conduct and monitoring of a medical device trial, as well as the analysis, reporting and verification of the data derived from that trial. Key considerations include the class of the medical device, type of medical device trial, regulatory status of the device, implementation of standard operating procedures, obligations of the trial sponsor, indemnity of relevant parties, scrutiny of the trial conduct, trial registration, and reporting and publication of the results. Conclusion Nurse-led trials of medical devices are demanding but rewarding research enterprises. As nursing practice and research increasingly embrace technical interventions, it is vital that nurse researchers contemplating such trials understand and implement the principles of Good Clinical Practice to protect both study participants and the research team.

What is a good project manager? Reconceptualizing the “do” : an Aristotelian perspective

In Social Science (Organization Studies, Economics, Management Science, Strategy, International Relations, Political Science…) the quest for addressing the question “what is a good practitioner?” has been around for centuries, with the underlying assumptions that good practitioners should lead organizations to higher levels of performance. Hence to ask “what is a good “captain”?” is not a new question, we should add! (e.g. Tsoukas & Cummings, 1997, p. 670; Söderlund, 2004, p. 190). This interrogation leads to consider problems such as the relations between dichotomies Theory and Practice, rigor and relevance of research, ways of knowing and knowledge forms. On the one hand we face the “Enlightenment” assumptions underlying modern positivist Social science, grounded in “unity-of-science dream of transforming and reducing all kinds of knowledge to one basic form and level” and cause-effects relationships (Eikeland, 2012, p. 20), and on the other, the postmodern interpretivist proposal, and its “tendency to make all kinds of knowing equivalent” (Eikeland, 2012, p. 20). In the project management space, this aims at addressing one of the fundamental problems in the field: projects still do not deliver their expected benefits and promises and therefore the socio-economical good (Hodgson & Cicmil, 2007; Bredillet, 2010, Lalonde et al., 2012). The Cartesian tradition supporting projects research and practice for the last 60 years (Bredillet, 2010, p. 4) has led to the lack of relevance to practice of the current conceptual base of project management, despite the sum of research, development of standards, best & good practices and the related development of project management bodies of knowledge (Packendorff, 1995, p. 319-323; Cicmil & Hodgson, 2006, p. 2–6, Hodgson & Cicmil, 2007, p. 436–7; Winter et al., 2006, p. 638). Referring to both Hodgson (2002) and Giddens (1993), we could say that “those who expect a “social-scientific Newton” to revolutionize this young field “are not only waiting for a train that will not arrive, but are in the wrong station altogether” (Hodgson, 2002, p. 809; Giddens, 1993, p. 18). While, in the postmodern stream mainly rooted in the “practice turn” (e.g. Hällgren & Lindahl, 2012), the shift from methodological individualism to social viscosity and the advocated pluralism lead to reinforce the “functional stupidity” (Alvesson & Spicer, 2012, p. 1194) this postmodern stream aims at overcoming. We suggest here that addressing the question “what is a good PM?” requires a philosophy of practice perspective to complement the “usual” philosophy of science perspective. The questioning of the modern Cartesian tradition mirrors a similar one made within Social science (Say, 1964; Koontz, 1961, 1980; Menger, 1985; Warry, 1992; Rothbard, 1997a; Tsoukas & Cummings, 1997; Flyvbjerg, 2001; Boisot & McKelvey, 2010), calling for new thinking. In order to get outside the rationalist ‘box’, Toulmin (1990, p. 11), along with Tsoukas & Cummings (1997, p. 655), suggests a possible path, summarizing the thoughts of many authors: “It can cling to the discredited research program of the purely theoretical (i.e. “modern”) philosophy, which will end up by driving it out of business: it can look for new and less exclusively theoretical ways of working, and develop the methods needed for a more practical (“post-modern”) agenda; or it can return to its pre-17th century traditions, and try to recover the lost (“pre-modern”) topics that were side-tracked by Descartes, but can be usefully taken up for the future” (Toulmin, 1990, p. 11). Thus, paradoxically and interestingly, in their quest for the so-called post-modernism, many authors build on “pre-modern” philosophies such as the Aristotelian one (e.g. MacIntyre, 1985, 2007; Tsoukas & Cummings, 1997; Flyvbjerg, 2001; Blomquist et al., 2010; Lalonde et al., 2012). It is perhaps because the post-modern stream emphasizes a dialogic process restricted to reliance on voice and textual representation, it limits the meaning of communicative praxis, and weaking the practice because it turns away attention from more fundamental issues associated with problem-definition and knowledge-for-use in action (Tedlock, 1983, p. 332–4; Schrag, 1986, p. 30, 46–7; Warry, 1992, p. 157). Eikeland suggests that the Aristotelian “gnoseology allows for reconsidering and reintegrating ways of knowing: traditional, practical, tacit, emotional, experiential, intuitive, etc., marginalised and considered insufficient by modernist [and post-modernist] thinking” (Eikeland, 2012, p. 20—21). By contrast with the modernist one-dimensional thinking and relativist and pluralistic post-modernism, we suggest, in a turn to an Aristotelian pre-modern lens, to re-conceptualise (“re” involving here a “re”-turn to pre-modern thinking) the “do” and to shift the perspective from what a good PM is (philosophy of science lens) to what a good PM does (philosophy of practice lens) (Aristotle, 1926a). As Tsoukas & Cummings put it: “In the Aristotelian tradition to call something good is to make a factual statement. To ask, for example, ’what is a good captain’?’ is not to come up with a list of attributes that good captains share (as modem contingency theorists would have it), but to point out the things that those who are recognized as good captains do.” (Tsoukas & Cummings, 1997, p. 670) Thus, this conversation offers a dialogue and deliberation about a central question: What does a good project manager do? The conversation is organized around a critic of the underlying assumptions supporting the modern, post-modern and pre-modern relations to ways of knowing, forms of knowledge and “practice”.

Study protocol : establishing good relationships between patients and health care providers while providing cardiac care. Exploring how patient-clinician engagement contributes to health disparities between indigenous and non-indigenous Australians in South Australia

Abstract Background: Studies that compare Indigenous Australian and non-Indigenous patients who experience a cardiac event or chest pain are inconclusive about the reasons for the differences in-hospital and survival rates. The advances in diagnostic accuracy, medication and specialised workforce has contributed to a lower case fatality and lengthen survival rates however this is not evident in the Indigenous Australian population. A possible driver contributing to this disparity may be the impact of patient-clinician interface during key interactions during the health care process. Methods/Design: This study will apply an Indigenous framework to describe the interaction between Indigenous patients and clinicians during the continuum of cardiac health care, i.e. from acute admission, secondary and rehabilitative care. Adopting an Indigenous framework is more aligned with Indigenous realities, knowledge, intellects, histories and experiences. A triple layered designed focus group will be employed to discuss patient-clinician engagement. Focus groups will be arranged by geographic clusters i.e. metropolitan and a regional centre. Patient informants will be identified by Indigenous status (i.e. Indigenous and non-Indigenous) and the focus groups will be convened separately. The health care provider focus groups will be convened on an organisational basis i.e. state health providers and Aboriginal Community Controlled Health Services. Yarning will be used as a research method to facilitate discussion. Yarning is in congruence with the oral traditions that are still a reality in day-to-day Indigenous lives. Discussion: This study is nestled in a larger research program that explores the drivers to the disparity of care and health outcomes for Indigenous and non-Indigenous Australians who experience an acute cardiac admission. A focus on health status, risk factors and clinical interventions may camouflage critical issues within a patient-clinician exchange. This approach may provide a way forward to reduce the appalling health disadvantage experienced within the Indigenous Australian communities. Keywords: Patient-clinician engagement, Qualitative, Cardiovascular disease, Focus groups, Indigenous

Something’s coming, something good: Identifying TPACK competence in pre-service teachers’ analyses of learning objects

There is a song at the beginning of the musical, West Side Story, where the character Tony sings that “something’s coming, something good.” The song is an anthem of optimism, brimming with promise. This paper is about the long-held promise of information and communication technology (ICT) to transform teaching and learning, to modernise the learning environment of the classroom, and to create a new digital pedagogy. But much of our experience to date in the schooling sector tells more of resistance and reaction than revolution, of more of the same but with a computer in the corner and of ICT activities as unwelcome time-fillers/time-wasters. Recently, a group of pre-service teachers in a postgraduate primary education degree in an Australian university were introduced to learning objects in an ICT immersion program. Their analyses and related responses, as recorded in online journals, have here been interpreted in terms of TPACK (Technological Pedagogical and Content Knowledge). Against contemporary observation, these students generally displayed high levels of competence and highly positive dispositions of students to the integration of ICT in their future classrooms. In short, they displayed the same optimism and confidence as the fictional “Tony” in believing that something good was coming.

It takes more than good intentions : institutional and attitudinal impediments to engaging young people in participatory planning

While participatory processes have become an important part of planning, young people are a particularly vulnerable group in terms of potential marginalisation and exclusion from effective participation. Including the views of young people in participatory planning is not simply a matter of bringing them into existing processes. Instead, participatory processes must find ways to integrate and accommodate their needs and ways of expressing their views. Without these adjustments young people may simply move from being kept outside the planning process to a situation where, although they are formally included, their claims are not taken seriously and they are not treated with equal respect. In this paper we reflect on the success of a community advisory committee, formed to consider water planning issues, in integrating the views of young people into their deliberations. Using Iris Marion Young’s (1995) ideas of communicative democracy we highlight the challenges and opportunities presented by this participatory approach, as articulated by both the young people involved and the adult participants. We specifically consider how the elements of greeting, rhetoric and narrative were reflected in the committee process. We argue that both planners and adult participants need to ensure that participatory processes allow for the equal engagement of all participants and place equal value on their contributions. Our research shows that this involves both an institutional and attitudinal commitment to include the views of young people. The institutional commitment requires young people to be included in processes and for their involvement to be supported. However, the attitudinal commitment it is equally important and requires that adult participants be prepared not only to accept the views of younger participants but to actively encourage and support their full participation.

One night’s CPAP withdrawal in otherwise compliant OSA patients: marked driving impairment but good awareness of increased sleepiness

Purpose Obstructive sleep apnoea (OSA) patients effectively treated by and compliant with continuous positive air pressure (CPAP) occasionally miss a night’s treatment. The purpose of this study was to use a real car interactive driving simulator to assess the effects of such an occurrence on the next day’s driving, including the extent to which these drivers are aware of increased sleepiness. Methods Eleven long-term compliant CPAP-treated 50–75-year-old male OSA participants completed a 2-h afternoon, simulated, realistic monotonous drive in an instrumented car, twice, following one night: (1) normal sleep with CPAP and (2) nil CPAP. Drifting out of road lane (‘incidents’), subjective sleepiness every 200 s and continuous electroencephalogram (EEG) activities indicative of sleepiness and compensatory effort were monitored. Results Withdrawal of CPAP markedly increased sleep disturbance and led to significantly more incidents, a shorter ‘safe’ driving duration, increased alpha and theta EEG power and greater subjective sleepiness. However, increased EEG beta activity indicated that more compensatory effort was being applied. Importantly, under both conditions, there was a highly significant correlation between subjective and EEG measures of sleepiness, to the extent that participants were well aware of the effects of nil CPAP. Conclusions Patients should be aware that compliance with treatment every night is crucial for safe driving.

The Good, the Bad and the Efficient : Productivity, efficiency and technical change in the Airline Industry, 2004:2008

This study models the joint production of desirable and undesirable output production (that is, CO2 emissions) of airlines. The Malmquist-Luenberger productivity index is employed to measure productivity growth when undesirable output production is regulated and unregulated. The results show that pollution abatement activities of airlines lowers productivity growth which suggests the traditional approach of measuring productivity growth, which ignores CO2 emissions, overstate "true" productivity growth.

Selling new neighborhoods as good for walking : issues for measuring self-selection

Background: Self-selection-whether individuals inclined to walk more seek to live in walkable environments-must be accounted for when studying built environment influences on walking. The way neighborhoods are marketed to future residents has the potential to sway residential location choice, and may consequently affect measures of self-selection related to location preferences. We assessed how walking opportunities are promoted to potential buyers, by examining walkability attributes in marketing materials for housing developments. Methods: A content analysis of marketing materials for 32 new housing developments in Perth, Australia was undertaken, to assess how walking was promoted in the text and pictures. Housing developments designed to be pedestrian-friendly (LDs) were compared with conventional developments (CDs). Results: Compared with CDs, LD marketing materials had significantly more references to 'public transport,' small home sites,' walkable parks/open space,' ease of cycling,' safe environment,' and 'boardwalks.' Other walkability attributes approached significance. Conclusion: Findings suggest the way neighborhoods are marketed may contribute to self-reported reasons for choosing particular neighborhoods, especially when attributes are not present at the time of purchase. The marketing of housing developments may be an important factor to consider when measuring self-selection, and its influence on the built environment and walking relationship.

Sedation breaks : are they good for the critically ill patient? A review.

Background:  Tradition has led us to believe that a heavily sedated patient is a comfortable, settled, compliant patient for whom sedation will improve outcome. The current move witnessed in clinical practice today of limiting sedation has led health care in recent years to question the benefit and necessity of routine, continuous sedation for all patients requiring mechanical ventilation. However, as a result there has been a rise in the amount of agitation being reported as being experienced by patients with the daily withdrawal of sedation. Aims:  The purpose of this paper is to review current arguments for and against perserving with agitation versus re-sedating, when it presents during the daily sedation breaks. Findings:  Of the literature reviewed, the question to re-sedate the mechanically ventilated agitated patient during sedation breaks remains an issue of contention. Although there is evidence focusing on the psychological effects of long-term sedation and sedation breaks specifically, the complex nature of critical illness in some cases means that individualized care is of paramount importance and in-depth assessment is crucial when deciding to re-sedate in the face of undetermined agitation. Agitation has been closely linked with several incidents that can be detrimental to patient safety, such as removal of lines and unplanned self-extubation. Conclusion:  The recommendations of this review are that nurses should re-commence sedation if the patient becomes agitated following a sedation break. Aims:  The purpose of this paper is to review current arguments for and against perserving with agitation versus re-sedating, when it presents during the daily sedation breaks. Findings:  Of the literature reviewed, the question to re-sedate the mechanically ventilated agitated patient during sedation breaks remains an issue of contention. Although there is evidence focusing on the psychological effects of long-term sedation and sedation breaks specifically, the complex nature of critical illness in some cases means that individualized care is of paramount importance and in-depth assessment is crucial when deciding to re-sedate in the face of undetermined agitation. Agitation has been closely linked with several incidents that can be detrimental to patient safety, such as removal of lines and unplanned self-extubation. Conclusion:  The recommendations of this review are that nurses should re-commence sedation if the patient becomes agitated following a sedation break.

Good Starts for refugee youth

Good Starts Study for Refugee Youth is a Melbourne-based longitudinal study of 120 young refugee people. The study sought evidence about their experiences, attitudes and social supports, to inform efforts to support their well-being in Australia. The Good Starts study was a collaboration between the La Trobe Refugee Research Centre, La Trobe University (LARRC) and The Victorian Foundation for Survivors of Torture (Foundation House). The study was funded by VicHealth.

Good Starts for recently arrived youth with refugee backgrounds : promoting wellbeing in the first three years of settlement in Melbourne, Australia

This report describes the key findings of a longitudinal study (2004—2008) investigating the experiences of settlement among a group of 120 recently arrived young people with refugee backgrounds settling in Melbourne, Australia. Each year, less than one per cent of the world’s refugees are offered resettlement in one of 18 countries participating in The Office of the United Nations High Commissioner for Refugees (UNHCR) resettlement programme. Australia offers places to around 13,500 people per year, of whom about 26 per cent are between the ages of 10 and 19. What are the experiences of these young people in their early settlement years? How do they negotiate the transition from childhood to adulthood given the traumas of their past and the challenges of their present and future in Australia? What are the key social determinants of wellbeing and good settlement and what can we learn from these young people about what social policies and services will most effectively support them to make successful lives in their new home? This study explores these questions, the overall aim being to identify the key social determinants of wellbeing and settlement and to describe the lived experiences of these young people as they shape their lives in Australia.

Good practice report : clinical teaching

Clinical experience, or experience in the ‘real world’ of practice, is a fundamental component of many health professional courses. It often involves students undertaking practical experience in clinical workplace settings, typically referred to as clinical placements, under the supervision of health professionals. Broadly speaking, the role of clinical supervisors, or teachers, is aimed at assisting students to integrate the theoretical and skills based components of the curriculum within the context of patient/client care (Erstzen et al 2009). Clinical experience also provides students with the opportunity to assimilate the attitudes, values and skills which they require to become appropriately skilled professionals in the environments in which they will eventually practise. However, clinical settings are particularly challenging learning environments for students. Unlike classroom learning, students in the clinical setting frequently find themselves involved in unplanned and often complex activities with patients and other health care providers, being supervised by a variety of clinical staff who have very different methods and styles of teaching, and negotiating bureaucratic or hierarchical structures in busy clinical workplaces where they may only be spending a limited amount of time. Kilminster et al (2007) also draw attention to tensions that may exist between the learning needs of students and the provision of quality care or need to prevent harm to the patient (e.g. Elkind et al 2007). All of these factors complicate the realisation of clinical education goals and underscore the need for effective clinical teaching practices that maximise student learning in clinical environments. This report provides a summary of work that has been achieved in relation to ALTC projects and fellowships associated with clinical teaching, and a review of scholarly publications relevant to this field. The report also makes recommendations based on issues identified and/or where further work is indicated. The projects and fellowships reviewed cover a range of discipline areas including Biology, Paramedic Practice, Clinical Exercise Physiology, Occupational Therapy, Speech Pathology, Physiotherapy, Pharmacy, Nursing and Veterinary Science. The main areas of focus cover issues related to curriculum, particularly in relation to industry expectations of ‘work-ready’ graduates and the implications for theoretical and practical, or clinical preparation; development of competency assessment tools that are nationally applicable across discipline-specific courses; and improvement of clinical learning through strategies targeting the clinical learning environment, building the teaching capacity of clinical supervisors and/or enhancing the clinical learning/teaching process.

What is a good project manager? An Aristotelian perspective

The purpose of this paper is to take a critical look at the question “what is a competent project manager?” and bring some fresh added-value insights. This leads us to analyze the definitions, and assessment approaches of project manager competence. Three major standards as prescribed by PMI, IPMA, and GAPPS are considered for review from an attribute-based and performance-based approach and from a deontological and consequentialist ethics perspectives. Two fundamental tensions are identified: an ethical tension between the standards and the related competence assessment frameworks and a tension between attribute and performance-based approaches. Aristotelian ethical and practical philosophy is brought in to reconcile these differences. Considering ethics of character that rises beyond the normative deontological and consequentialist perspectives is suggested. Taking the mediating role of praxis and phrónêsis between theory and practice into consideration is advocated to resolve the tension between performance and attribute-based approaches to competence assessment.