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.

An overview of level I evidence for the management of radiation dermatitis literature

Background: Despite the technologic advances, radiation dermatitis is still a prevalent and distressing symptom in patients with cancer undergoing radiotherapy. Systematic reviews (SRs) are regarded as level I evidence providing direction for clinical practice and guidelines. This overview aims to provide a critical appraisal of SRs published on interventions for the prevention/management of radiation dermatitis. Methodology: We searched the following electronic databases: MEDLINE, CINAHL, EMBASE, and the Cochrane Library (up to Feb 2012). We also hand-searched reference lists of potentially eligible articles and a number of key journals in the area. Two authors screened all potential articles and included eligible SRs. Two authors critically appraised and extracted key findings from the included reviews using the “A Measurement Tool to Assess Systematic Reviews” (AMSTAR). Results: Of 1837 potential titles, six SRs were included. A number of interventions have been reported to be potentially beneficial for managing radiation dermatitis. Interventions evaluated in these reviews included skin care advice, steroidal/non-steroidal topical agents, systematic therapies, modes of radiation delivery, and dressings. However, all the included SRs reported that there is insufficient evidence supporting any single effective intervention. The methodological quality of the included studies varied, and methodological shortfalls in these reviews may create biases to the overall results or recommendations for clinical practice. Conclusions and implications: An up-to-date high quality SR in preventing/managing radiation dermatitis is needed to guide practice and direction for future research. Clinicians or guideline developers are recommended to critically evaluate the information of SRs in their decision making.

A systematic review on quality of life among patients at 1 year after treatment for head and neck cancer

Introduction: Although advances in treatment modalities have improved the survival of head and neck (H&N) cancer patients over recent years, survivors’ quality of life (QoL) could be impaired for a number of reasons. The investigation of QoL determinants can inform the design of supportive interventions for this population. Objectives: To examine the QoL of H&N cancer survivors at 1 year after treatment and to identify potential determinants affecting their QoL. Methods: A systematic search of literature was done in December 2011 in five databases: Pubmed, Medline, Scopus, Sciencedirect and CINAHL, using combined search terms ‘head and neck cancer’, ‘quality of life’, ‘health-related quality of life’ and ‘systematic review’. The methodological qualities of selected studies were assessed by two reviewers using predefined criteria. The study characteristics and results were abstracted and summarized. Results: Thirty-seven studies met all inclusion criteria with methodological quality from moderate to high. The global QoL of H&N cancer survivors returned to baseline at 1 year after treatment. Significant improvement showed in emotional functioning while physical functioning, xerostomia, sticky/insufficient saliva, and fatigue were consistently worse at 12 months compared with baseline. Age, cancer sites and stages, social support, smoking, presence of feeding tube are significant QoL determinants at 12 months. Conclusions: Although the global QoL of H&N cancer survivors recover by 12 months after treatment, problems with physical functioning, fatigue, xerostomia and sticky saliva persist. Regular assessment should be carried out to monitor these problems. Further research is required to develop appropriate and effective interventions for this population.

Is quality more important if you’re quirky? A review of the literature on differential susceptibility to childcare environments

Evidence concerning the impact of child care on child development suggests that higher-quality environments, particularly those that are more responsive, predict more favourable social and behavioural outcomes. However, the extent of this effect is not as great as might be expected. Impacts on child outcomes are, at best, modest. One recent explanation emerging from a new theoretical perspective of development, differential susceptibility theory, is that a minority of children are more reactive to both positive and negative environments, while the majority are relatively unaffected. These 'quirky' children have temperamental traits that are more extreme, and are often described in research studies as having 'difficult temperaments'. This paper reviews the literature on such children and argues for the need for further research to identify components of childcare environments that optimise the potential of these more sensitive, quirky individuals.

Drying condition effects on fluidization quality and fluidization velocity at initial and final stages of cubical particulates for pet food

In this research fluidization behavior of cubical Bovine intestine samples was studied. Bovine intestine samples were heat pump dried at atmospheric pressure and at emperatures below and above the material freezing points. Experiments were conducted to study fluidization characteristics and drying kinetics at different drying conditions. Bovine particles were characterized according to Geldart classification and minimum fluidization velocity was calculated using Ergun Equation and generalized equation for all drying conditions at the beginning of the trials and end of the trials. Walli’s model was used to categorize stability of the fluidization at the beginning and end of the drying for each trial. Walli’s values determined were positive at the beginning and end of all trials indicating stable fluidisation at the beginning and end for each drying condition.

ICT shared services in the higher education sector : foundations, benefits, success factors and issues

Universities are more and more challenged by the emerging global higher education market, facilitated by advances in Information and Communication Technologies (ICT). This requires them to reconsider their mission and direction in order to function effectively and efficiently, and to be responsive to changes in their environment. In the face of increasing demands and competitive pressures, Universities like other companies, seek to continuously innovate and improve their performance. Universities are considering co-operating or sharing, both internally and externally, in a wide range of areas to achieve cost effectiveness and improvements in performance. Shared services are an effective model for re-organizing to reduce costs, increase quality and create new capabilities. Shared services are not limited to the Higher Education (HE) sector. Organizations across different sectors are adopting shared services, in particular for support functions such as Finance, Accounting, Human Resources and Information Technology. While shared services has been around for more than three decades, commencing in the 1970’s in the banking sector and then been adopted by other sectors, it is an under researched domain, with little consensus on the most fundamental issues even as basic as defining what shared services is. Moreover, the interest in shared services within Higher Education is a global phenomenon. This study on shared services is situated within the Higher Education Sector of Malaysia, and originated as an outcome resulting from a national project (2005 – 2007) conducted by the Ministry of Higher Education (MOHE) entitled "Knowledge, Information Communication Technology Strategic Plan (KICTSP) for Malaysian Public Higher Education"- where progress towards more collaborations via shared services was a key recommendation. The study’s primary objective was to understand the nature and potential for ICT shared services, in particular in the Malaysian HE sector; by laying a foundation in terms of definition, typologies and research agenda and deriving theoretically based conceptualisations of the potential benefits of shared services, success factors and issues of pursuing shared services. The study embarked on this objective with a literature review and pilot case study as a means to further define the context of the study, given the current under-researched status of ICT shared services and of shared services in Higher Education. This context definition phase illustrated a range of unaddressed issues; including a lack of common understanding of what shared services are, how they are formed, what objectives they full fill, who is involved etc. The study thus embarked on a further investigation of a more foundational nature with an exploratory phase that aimed to address these gaps, where a detailed archival analysis of shared services literature within the IS context was conducted to better understand shared services from an IS perspective. The IS literature on shared services was analysed in depth to report on the current status of shared services research in the IS domain; in particular definitions, objectives, stakeholders, the notion of sharing, theories used, and research methods applied were analysed, which provided a firmer base to this study’s design. The study also conducted a detailed content analysis of 36 cases (globally) of shared services implementations in the HE sector to better understand how shared services are structured within the HE sector and what is been shared. The results of the context definition phase and exploratory phase formed a firm basis in the multiple case studies phase which was designed to address the primary goals of this study (as presented above). Three case sites within the Malaysian HE sector was included in this analysis, resulting in empirically supported theoretical conceptualizations of shared services success factors, issues and benefits. A range of contributions are made through this study. First, the detailed archival analysis of shared services in Information Systems (IS) demonstrated the dearth of research on shared services within Information Systems. While the existing literature was synthesised to contribute towards an improved understanding of shared services in the IS domain, the areas that are yet under-developed and requires further exploration is identified and presented as a proposed research agenda for the field. This study also provides theoretical considerations and methodological guidelines to support the research agenda; to conduct better empirical research in this domain. A number of literatures based a priori frameworks (i.e. on the forms of sharing and shared services stakeholders etc) are derived in this phase, contributing to practice and research with early conceptualisations of critical aspects of shared services. Furthermore, the comprehensive archival analysis design presented and executed here is an exemplary approach of a systematic, pre-defined and tool-supported method to extract, analyse and report literature, and is documented as guidelines that can be applied for other similar literature analysis, with particular attention to supporting novice researchers. Second, the content analysis of 36 shared services initiatives in the Higher Education sector presented eight different types of structural arrangements for shared services, as observed in practice, and the salient dimensions along which those types can be usefully differentiated. Each of the eight structural arrangement types are defined and demonstrated through case examples, with further descriptive details and insights to what is shared and how the sharing occurs. This typology, grounded on secondary empirical evidence, can serve as a useful analytical tool for researchers investigating the shared services phenomenon further, and for practitioners considering the introduction or further development of shared services. Finally, the multiple case studies conducted in the Malaysian Higher Education sector, provided further empirical basis to instantiate the conceptual frameworks and typology derived from the prior phases and develops an empirically supported: (i) framework of issues and challenges, (ii) a preliminary theory of shared services success, and (iii) a benefits framework, for shared services in the Higher Education sector.

Quality Assessment Matrix : A Collaborative Evaluation Using Multiple Lines of Evidence

Welcome to the Quality assessment matrix. This matrix is designed for highly qualified discipline experts to evaluate their course, major or unit in a systematic manner. The primary purpose of the Quality assessment matrix is to provide a tool that a group of academic staff at universities can collaboratively review the assessment within a course, major or unit annually. The annual review will result in you being read for an external curricula review at any point in time. This tool is designed for use in a workshop format with one, two or more academic staff, and will lead to an action plan for implementation.

Role of land use and seasonal factors in water quality degradation

Surface water and groundwater are the most important water sources in the natural environment. Land use and seasonal factors play an important role in influencing the quality of these water sources. An in-depth understanding of the role of these two influential factors can help to implement an effective catchment management strategy for the protection of these water sources. This paper discusses the outcomes of an extensive research study which investigated the role of land use and seasonal factors on surface water and groundwater pollution in a mixed land use coastal catchment. The study confirmed that the influence exerted on the water environment by seasonal factors is secondary to that of land use. Furthermore, the influence of land use and seasonal factors on surface water and groundwater quality varies with the pollutant species. This highlights the need to specifically take into consideration the targeted pollutants and the key influential factors for the effective protection of vulnerable receiving water environments.

Nursing practice environment, quality of care and morale of hospital nurses in Japan

The purpose of this study was to describe Japanese hospital nurses’ perceptions of the nursing practice environment and examine its association with nurse-reported ability to provide quality nursing care, quality of patient care and ward morale. A cross-sectional survey design was used including 223 nurses working in 12 acute inpatient wards in a large Japanese teaching hospital. Nurses rated their work environment favorably overall using the Japanese version of the Practice Environment Scale of the Nursing Work Index. Subscale scores indicated high perceptions of physician relations and quality of nursing management, but lower scores for staffing and resources. Ward nurse managers generally rated the practice environment more positively than staff nurses except for staffing and resources. Regression analyses found the practice environment was a significant predictor of quality of patient care and ward morale, whereas perceived ability to provide quality nursing care was most strongly associated with years of clinical experience. These findings support interventions to improve the nursing practice environment, particularly staffing and resource adequacy, to enhance quality of care and ward morale in Japan.

Perception and reality : meeting Australia’s physical activity guidelines for 12-18 year olds

Governments regularly publish empirically derived minimum physical activity (PA) guidelines for youth, in response to the ongoing trend of youth physical inactivity. The purpose of this investigation was to explore parents’ awareness of the national PA guidelines for youth, and adolescents’ and their parents’ perceptions of adolescent PA, and compare these to self-reported adolescent PA. A total of 115 adolescents (aged 12-14) and their parents completed questionnaire assessments. Parents responded to questions concerning their awareness of the national PA guidelines, and whether they believed their child to be sufficiently active. Adolescents completed the International Physical Activity Questionnaire for Adolescents, and questions concerning their perceived level of PA. Adolescents were deemed sufficiently active if they participated in an average of at least 60 minutes of moderate-to-vigorous PA each day. Overall, 104 (90.4%) adolescents and their parents had complete data sets and were included in the analysis. Of the 45 (43.3%) sufficiently and 59 (56.7%) insufficiently active adolescents, 42 (93%) and 41 (69.5%) respectively believed that they were active enough for good general health. Additionally, 41 (91.1%) parents of active and 44 (74.6%) parents of inactive adolescents either agreed or strongly agreed that their child participates in sufficient PA for good general health. Twenty-four (53.3%) parents of active adolescents were unaware of the national PA guidelines, with 10 (22.2%) neither aware or unaware, and 11 (24.4%) aware. Similar results were found for the parents of inactive adolescents with 31 (52.5%) unaware, 17 (28.8%) neither aware or unaware, and 11 (18.6%) aware. These results suggest that the youth PA guidelines are being inadequately received by both adolescents, and their parents. Opportunities to effectively communicate these guidelines such as embedment in curriculum for adolescents, or the dissemination of materials for parents, should be maximised by appropriate authorities.

The effect of exercise training on sleep quality in heart failure

Background: Heart failure is a serious condition estimated to affect 1.5-2.0% of the Australian population with a point prevalence of approximately 1% in people aged 50-59 years, 10% in people aged 65 years or more and over 50% in people aged 85 years or over (National Heart Foundation of Australian and the Cardiac Society of Australia and New Zealand, 2006). Sleep disturbances are a common complaint of persons with heart failure. Disturbances of sleep can worsen heart failure symptoms, impair independence, reduce quality of life and lead to increased health care utilisation in patients with heart failure. Previous studies have identified exercise as a possible treatment for poor sleep in patients without cardiac disease however there is limited evidence of the effect of this form of treatment in heart failure. Aim: The primary objective of this study was to examine the effect of a supervised, hospital-based exercise training programme on subjective sleep quality in heart failure patients. Secondary objectives were to examine the association between changes in sleep quality and changes in depression, exercise performance and body mass index. Methods: The sample for the study was recruited from metropolitan and regional heart failure services across Brisbane, Queensland. Patients with a recent heart failure related hospital admission who met study inclusion criteria were recruited. Participants were screened by specialist heart failure exercise staff at each site to ensure exercise safety prior to study enrolment. Demographic data, medical history, medications, Pittsburgh Sleep Quality Index score, Geriatric Depression Score, exercise performance (six minute walk test), weight and height were collected at Baseline. Pittsburgh Sleep Quality Index score, Geriatric Depression Score, exercise performance and weight were repeated at 3 months. One hundred and six patients admitted to hospital with heart failure were randomly allocated to a 3-month disease-based management programme of education and self-management support including standard exercise advice (Control) or to the same disease management programme as the Control group with the addition of a tailored physical activity program (Intervention). The intervention consisted of 1 hour of aerobic and resistance exercise twice a week. Programs were designed and supervised by an exercise specialist. The main outcome measure was achievement of a clinically significant change (.3 points) in global Pittsburgh Sleep Quality score. Results: Intervention group participants reported significantly greater clinical improvement in global sleep quality than Control (p=0.016). These patients also exhibited significant improvements in component sleep disturbance (p=0.004), component sleep quality (p=0.015) and global sleep quality (p=0.032) after 3 months of supervised exercise intervention. Improvements in sleep quality correlated with improvements in depression (p<0.001) and six minute walk distance (p=0.04). When study results were examined categorically, with subjects classified as either "poor" or "good" sleepers, subjects in the Control group were significantly more likely to report "poor" sleep at 3 months (p=0.039) while Intervention participants were likely to report "good" sleep at this time (p=0.08). Conclusion: Three months of supervised, hospital based, aerobic and resistance exercise training improved subjective sleep quality in patients with heart failure. This is the first randomised controlled trial to examine the role of aerobic and resistance exercise training in the improvement of sleep quality for patients with this disease. While this study establishes exercise as a therapy for poor sleep quality, further research is needed to investigate the effect of exercise training on objective parameters of sleep in this population.

Humans, ‘things’ and space : costing hospital infection control interventions

Background: Previous attempts at costing infection control programmes have tended to focus on accounting costs rather than economic costs. For studies using economic costs, estimates tend to be quite crude and probably underestimate the true cost. One of the largest costs of any intervention is staff time, but this cost is difficult to quantify and has been largely ignored in previous attempts. Aim: To design and evaluate the costs of hospital-based infection control interventions or programmes. This article also discusses several issues to consider when costing interventions, and suggests strategies for overcoming these issues. Methods: Previous literature and techniques in both health economics and psychology are reviewed and synthesized. Findings: This article provides a set of generic, transferable costing guidelines. Key principles such as definition of study scope and focus on large costs, as well as pitfalls (e.g. overconfidence and uncertainty), are discussed. Conclusion: These new guidelines can be used by hospital staff and other researchers to cost their infection control programmes and interventions more accurately.

Not all systematic reviews are systematic : a meta-review of the quality of systematic reviews for non-invasive remote monitoring in heart failure

Remote monitoring for heart failure has been evaluated in numerous systematic reviews. The aim of this meta-review was to appraise their quality and synthesise results. We electronically searched online databases, performed a forward citation search and hand-searched bibliographies. Systematic reviews of remote monitoring interventions that were used for surveillance of heart failure patients were included. Seven (41%) systematic reviews pooled results for meta-analysis. Eight (47%) considered all non-invasive remote monitoring strategies. Five (29%) focused on telemonitoring. Four (24%) included both non-invasive and invasive technologies. According to AMSTAR criteria, ten (58%) systematic reviews were of poor methodological quality. In high quality reviews, the relative risk of mortality in patients who received remote monitoring ranged from 0.53 (95% CI=0.29-0.96) to 0.88 (95% CI=0.76-1.01). High quality reviews also reported that remote monitoring reduced the relative risk of all-cause (0.52; 95% CI=0.28-0.96 to 0.96; 95% CI=0.90–1.03) and heart failure-related hospitalizations (0.72; 95% CI=0.64–0.81 to RR 0.79; 95% CI=0.67-0.94) and, as a consequence, healthcare costs. As the high quality reviews reported that remote monitoring reduced hospitalizations, mortality and healthcare costs, research efforts should now be directed towards optimising these interventions in preparation for more widespread implementation.

Improving sleep quality for patients after cardiac surgery

Research has consistently described that patients after cardiac surgery experience disturbed sleep yet there has been limited investigation into methods to improve this experience. Complementary therapies may be a method of addressing this issue. Aim: To determine if using progressive muscle relaxation improves self-rated sleep quality for patients following cardiac surgery. Methods and Results: Thirty-five participants' quantitative data on sleep quality were obtained via questionnaire during their first post-operative week after cardiac surgery. Qualitative data were obtained through written responses to open-ended questions. No significant differences in sleep quality scores were found between pre and post-intervention of progressive muscle relaxation using the Wilcoxon Signed Ranks Test. However, the qualitative analysis discovered the intervention aided some participants in initiating their sleep by diversion of thought, inducing relaxation or alleviating pain and anxiety. Conclusions: Qualitative findings suggest that progressive muscle relaxation may help patients who have undergone cardiac surgery initiate their sleep.

Not all systematic reviews are systematic : a meta-review of the quality of current systematic reviews and meta-analyses for remote monitoring in heart failure

Background/aims: Remote monitoring for heart failure has not only been evaluated in a large number of randomised controlled trials, but also in many systematic reviews and meta-analyses. The aim of this meta-review was to identify, appraise and synthesise existing systematic reviews that have evaluated the effects of remote monitoring in heart failure. Methods: Using a Cochrane methodology, we electronically searched all relevant online databases and search engines, performed a forward citation search as well as hand-searched bibliographies. Only fully published systematic reviews of invasive and/or non-invasive remote monitoring interventions were included. Two reviewers independently extracted data. Results: Sixty-five publications from 3333 citations were identified. Seventeen fulfilled the inclusion and exclusion criteria. Quality varied with A Measurement Tool to Assess Systematic Reviews (AMSTAR scores) ranging from 2 to 11 (mean 5.88). Seven reviews (41%) pooled results from individual studies for meta-analysis. Eight (47%) considered all non-invasive remote monitoring strategies. Four (24%) focused specifically on telemonitoring. Four (24%) included studies investigating both non-invasive and invasive technologies. Population characteristics of the included studies were not reported consistently. Mortality and hospitalisations were the most frequently reported outcomes 12 (70%). Only five reviews (29%) reported healthcare costs and compliance. A high degree of heterogeneity was reported in many of the meta-analyses. Conclusions: These results should be considered in context of two negative RCTs of remote monitoring for heart failure that have been published since the meta-analyses (TIM-HF and Tele-HF). However, high quality reviews demonstrated improved mortality, quality of life, reduction in hospitalisations and healthcare costs.