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.

General practice patients in the emergency department

One of the mysteries of public policy is that at times the public discourse settles on a perspective that is based on flimsy or even contradictory evidence. One such discussion relates to the factors that contribute to the congestion of hospital emergency departments (EDs) in Australia.

Fatigue self-management : a survey of Chinese cancer patients undergoing chemotherapy

Aims and objectives. To examine Chinese cancer patients’ fatigue self-management, including the types of self-management behaviours used, their confidence in using these behaviours, the degree of relief obtained and the factors associated with patients’ use of fatigue self-management behaviours. Background. Fatigue places significant burden on patients with cancer undergoing chemotherapy. While some studies have explored fatigue self-management in Western settings, very few studies have explored self-management behaviours in China. Design. Cross-sectional self- and/or interviewer-administered survey. Methods. A total of 271 participants with self-reported fatigue in the past week were recruited from a specialist cancer hospital in south-east China. Participants completed measures assessing the use of fatigue self-management behaviours, corresponding self-efficacy, perceived relief levels plus items assessing demographic characteristics, fatigue experiences, distress and social support. Results. A mean of 4_94 (_2_07; range 1–10) fatigue self-management behaviours was reported. Most behaviours were rated as providing moderate relief and were implemented with moderate self-efficacy. Regression analyses identified that having more support from one’s neighbourhood and better functional status predicted the use of a greater number of self-management behaviours. Separate regression analyses identified that greater neighbourhood support predicted greater relief from ‘activity enhancement behaviours’ and that better functional status predicted greater relief from ‘rest and sleep behaviours’. Higher self-efficacy scores predicted greater relief from corresponding behaviours. Conclusions. A range of fatigue self-management behaviours were initiated by Chinese patients with cancer. Individual, condition and environmental factors were found to influence engagement in and relief from fatigue self-managementbehaviours. Relevance to clinical practice. Findings highlight the need for nurses to explore patients’ use of fatigue self-management behaviours and the effectiveness of these behaviours in reducing fatigue. Interventions that improve patients’ self-efficacy and neighbourhood supports have the potential to improve outcomes from fatigue self-management behaviours.

Current practice in nutrition assessment for the management of Parkinson’s disease in Australia and Canada

AIM: To document and compare current practice in nutrition assessment of Parkinson’s disease by dietitians in Australia and Canada in order to identify priority areas for review and development of practice guidelines and direct future research. METHODS: An online survey was distributed to DAA members and PEN subscribers through their email newsletters. The survey captured current practice in the phases of the Nutrition Care Plan. The results of the assessment phase are presented here. RESULTS: Eighty-four dietitians responded. Differences in practice existed in the choice of nutrition screening and assessment tools, including appropriate BMI ranges. Nutrition impact symptoms were commonly assessed, but information about Parkinson’s disease medication interactions were not consistently assessed. CONCLUSIONS: he variation in practice related to the use of screening and assessment methods may result in the identification of different goals for subsequent interventions. Even more practice variation was evident for those items more specific to Parkinson’s disease and may be due to the lack of evidence to guide practice. Further research is required to support decisions for nutrition assessment of Parkinson’s disease.

Self-management of chemotherapy-related nausea and vomiting : a cross-sectional survey of Chinese cancer patients

BACKGROUND Chemotherapy-induced nausea and vomiting (CINV) remain prevalent among cancer patients despite pharmacological advances in CINV therapy. Patients can initiate nonpharmacologic strategies, which potentially play an important role as adjuncts to pharmacological agents in alleviating CINV. Some studies have explored nausea and vomiting self-management (NVSM) behaviors among patients in Western settings; however, little is known about the NVSM behaviors of patients in China. OBJECTIVES This study examines NVSM behaviors of Chinese cancer patients. METHODS A cross-sectional survey was conducted in a specialist cancer hospital in southeast China. RESULTS A sample of 255 cancer patients was recruited. A mean of 8.56 (±3.15) NVSM behaviors was reported. Most NVSM behaviors were rated as moderately effective and were implemented with moderate self-efficacy. Higher distress levels, better functional status, previous similar symptom experiences, receiving chemotherapy as an inpatient, and greater support from multiple levels were related to greater engagement in NVSM; higher self-efficacy levels pertaining to NVSM behaviors were associated with reports of more relief from specific NVSM behaviors. CONCLUSIONS A range of NVSM strategies was initiated by Chinese cancer patients and provided some relief. A range of individual, health status, and environmental factors influenced engagement with and relief from NVSM behaviors. IMPLICATIONS FOR PRACTICE To enhance Chinese patients' NVSM, patients should be supported to engage in behaviors including taking antiemetics, modifying their diet, using psychological strategies, and creating a pleasant environment. The findings highlight the importance of enhancing patients' self-efficacy in NVSM, alleviating symptom distress, and improving social support to achieve better outcomes.

Chemotherapy-induced nausea and vomiting : a review to inform clinical practice

Chemotherapy-induced nausea and vomiting (CINV) is a common sideeffect of cytotoxic treatment and despite the widespread use of anti-emetic medication, it continues to affect a significant proportion of patients with up to 23% and 73% of chemotherapy patients still experiencing vomiting and nausea symptoms, respectively. This is of particular concern in oncology patients as nausea and vomiting may result in malnutrition, decreased quality of life and in extreme cases, treatment stoppage. Therefore, the primary aim of this paper was to inform clinicians on the current literature regarding CINV including its effect on the patient, its pathophysiology, and current treatment options. In addition, this review will also discuss the usage of dietetic interventions as well as less utilised, novel interventions such as oral ginger extracts in the treatment of CINV. In order to address these issues, a systematic literature search was conducted using Pubmed, CINAHL, MEDLINE, Embase, and Health Source (Nursing/Academic Edition). A key finding of this review was that common dietary strategies (e.g. eating slowly, avoiding fatty foods) seem to be solely based on professional opinion as no clinical trials investigating these strategies were identified. In contrast, ginger extracts were found to possess several viable mechanisms that interact with CINV progression including 5-HT3, Substance P and acetylcholine receptor antagonism; anti-inflammatory and antioxidant properties; and gastrointestinal motility and gastric emptying modulation. In conclusion, research investigating dietetic interventions in the management of CINV is sparse and requires further investigation while novel intervention such as ginger, possess multiple mechanisms that may benefit CINV management. This review will discuss the prevalence and significance of CINV, dietetic and novel treatment options, and provide implications for clinical practise and future research.

A wound management education and training needs analysis of health consumers and the relevant health workforce and stocktake of available education and training activities and resources

The goals of this project were to determine the education and training needs of health consumers and the relevant health workforce and to identify and map the available education and training activities and resources. The methods used to collect the data included online surveys and one on one interviews of relevant patients and their carers. The project manager actively sought to engage with the key wound management leaders and advanced clinicians to gain their support and views on the priority education and training issues. The response to all data collection methods was pleasing with almost five hundred responses to the general wound workforce online survey. The data supported the need for more wound management education and training and identified some particular topics of need, such as utilising wound investigations and understanding wound products, pharmaceuticals and devices. The occupational groups with the highest need appear to be those working in primary health care, such as practice nurses and GPs, and those working in residential aged care facilities. The education and training stocktake identified a wide range of activities currently available, the majority being provided in a face to face format. The next stage of the project will be to form some clear and achievable priority action areas based on the available data. An online directory of wound management education and training activities and resources will be developed and further development will be undertaken on a knowledge and skills framework for the wound management workforce. Additionally, transfer of learning factors in the general practice environment will be assessed and strategies will be developed to improve the pre-entry or undergraduate wound management training within relevant higher education programs.

What is the evidence to guide best practice for the management of older people with cognitive impairment presenting to emergency departments? A systematic review

The aim of this study was to conduct a systematic literature review of research-based studies to identify practices designed to meet the specific care needs of older cognitively impaired patients in emergency departments (ED). A systematic literature review of studies was completed using PRIMSA methodology. The search criteria included articles from both emergency and acute care settings. A total of 944 articles were screened, and a total of 43 articles were identified as eligible. The review found a number of intervention studies to improve quality of care for older persons with cognitive impairment carried out or commenced in emergency settings, including interventions to improve cognitive impairment recognition (n = 9) and clinical approaches to reduce falls (n = 1) and both delirium incidence and prevalence (n = 2). Relevant studies carried out in acute care settings regarding cognitive impairment recognition (n = 4) and primary and secondary prevention of delirium (n = 18) and intervention studies that reduced the prescription of deliriogenic drugs (n = 1), reduced behavioral symptoms and discomfort (n = 7), and improved nutritional intake (n = 1) in hospitalized older persons with dementia were also identified. There is limited research available that reports interventions that improve the quality of care of older ED patients with cognitive impairment. Although this review found evidence obtained from the acute care setting, additional research is needed to identify whether these interventions are beneficial in fast-paced emergency settings.

CPD : Using evidence based clinical practice guidelines in the management of anaemia in patients with chronic renal failure

Anaemia is a chronic problem in patients with renal insufficiency, especially chronic renal failure (CRF). In patients with CRF, anaemia is primarily due to a deficiency in erythropoietin (EPO), a glycoprotein growth factor that stimulates RBC production. The long-term effects and burden of anaemia for patients with CRF can be physical, emotional and financial. With efficient, systematic management of anaemia, clinicians have the potential to realise not only better clinical outcomes for CRF patients but also significant cost savings for them and the health system. During the last decade, significant advances have been made in clinicians’ understanding of how best to manage anaemia in this vulnerable population. One of the most important efforts to improve clinical practice has been the development of best practice guidelines.

Can Business Continuity Management Create Reliability in Airports? (Issues from Theory into Practice)

The advances made within the aviation industry over the past several decades have significantly improved the availability, affordability and convenience of air travel and have been greatly beneficial in both social and economic terms. Air transport has developed into an irreplaceable service being relied on by millions of people each day and as such airports have become critical elements of national infrastructure to facilitate the movement of people and goods. As components of critical infrastructure (CI), airports are integral parts of a national economy supporting regional as well as national trade, commercial activity and employment. Therefore, any disruption or crisis which impacts the continuity of operations at airports can have significant negative consequences for the airport as a business, for the local economy and other nodes of transport infrastructure as well as for society. Due to the highly dynamic and volatile environment in which airports operate in, the aviation industry has faced many different challenges over the years ranging from terrorist attacks such as September 11, to health crises such as the SARS epidemic to system breakdowns such as the recent computer system outage at Virgin Blue Airlines in Australia. All these events have highlighted the vulnerability of airport systems to a range of disturbances as well as the gravity and widespread impact of any kind of discontinuity in airport functions. Such incidents thus emphasise the need for increasing resilience and reliability of airports and ensuring business continuity in the event of a crisis...

The environmental enigma : why do producers professing stewardship continue to practice poor natural resource management?

Despite a wide acceptance that primary producers in Australia subscribe to a stewardship ethic, land and water degradation remains an ongoing problem. Recent calculations suggest that the economic cost of Australia's environmental degradation is amounting to more than $A3.5 billion a year with an estimated cost of managing (not overcoming) problems of salinity, acidification, soil erosion totalling $A60 billion over the next decade. This paper argues that stewardship itself is an unsatisfactory concept when looking to landholders to respond to environmental problems, for rarely does the attitude of stewardship translate into behaviours of improving natural resource management practices on private land. Whilst there is some acceptance of the environmental problem among primary producers, a number of external constraints may also impede the uptake of conservation-orientated practices. In light of the prevailing accounts of poor adoption of sustainable practices a number of policy options are reviewed in this paper, including formal regional partnerships, regulatory frameworks and market-based measures. It is concluded that the contentious nature of some of these new opportunities for change will mean that any moves aimed at reversing environmental degradation in Australia will be slow.

Advancing Nursing Practice in Pain Management

This book showcases the development and evaluation of innovative examples of pain management initiatives by advanced practitioners. It considers each service development or community initiative both in terms of advanced practice nursing and pain management. There is a wide range of examples of innovation in pain management included - from the introduction of ketamine use in one trust, to wider issues around meeting the needs of pain management in the community. The book considers issues including use of research, education and interprofessional working in the advanced practitioner role. Each chapter looks at development of the service, challenges of implementation, evaluation of the service's success and justifying the importance of the advanced nurse in the service's achievements.

Introduction to Advancing Practice in Pain Management

This chapter contains sections titled: Introduction Advanced practice The context of pain management: definitions and prevalence Advancing practice in pain management Bringing together advanced practice and pain management Conclusions References

Nurse Prescribing in Acute and Chronic Pain Management

This chapter contains sections titled: Introduction Acute pain Chronic pain Rationale for service development Evaluation use of audit and CPD Justifying the advanced nursing contribution to develop nurse prescribing in pain management Conclusions References

New Knowledge for Advancing Practice in Pain Management

This chapter contains sections titled: Introduction Advancing practice in pain management Conclusions References