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.

The potential contributions of traditional Chinese medicine to emergency medicine

BACKGROUND: Despite the fact that traditional Chinese medicine (TCM) has been developed and used to treat acute and urgent illness for many thousands of years. TCM has been widely perceived in western societies that TCM may only be effective to treat chronic diseases. The aim of this article is to provide some scientific evidence regarding the application of TCM in emergency medicine and its future potential. METHODS: Multiple databases (PubMed, ProQuest, Academic Search Elite and Science Direct) were searched using the terms: Traditional Chinese Medicine/ Chinese Medicine, Emergency Medicine, China. In addition, three leading TCM Journals in China were searched via Oriprobe Information Services for relevant articles (published from 1990—2012). Particular attention was paid to those articles that are related to TCM treatments or combined medicine in dealing with intensive and critical care. RESULTS: TCM is a systematic traditional macro medicine. The clinical practice of TCM is guided by the TCM theoretical framework – a methodology founded thousands of years ago. As the methodologies between TCM and Biomedicine are significantly different, it provides an opportunity to combine two medicines, in order to achieve clinical efficacy. Nowadays, combined medicine has become a common clinical model particular in TCM hospitals in China. CONCLUSIONS: It is evident that TCM can provide some assistance in emergency although to combine them in practice is stillits infant form and is mainly at TCM hospitals in China. The future effort could be put into TCM research, both in laboratories and clinics, with high quality designs, so that TCM could be better understood and then applied in emergency medicine.

Advice to consult a general medical practitioner in Western Australia : Could it be cancer?

Background: Many people will consult a medical practitioner about lower bowel symptoms, and the demand for access to general practitioners (GPs) is growing. We do not know if people recognise the symptoms of lower bowel cancer when advising others about the need to consult a doctor. A structured vignette survey was conducted in Western Australia. Method: Participants were recruited from the waiting rooms at five general practices. Respondents were invited to complete self-administered questionnaires containing nine vignettes chosen at random from a pool of 64 based on six clinical variables. Twenty-seven vignettes described high-risk bowel cancer scenarios. Respondents were asked if they would recommend a medical consultation for the case described and whether they believed the scenario was a cancer presentation. Logistic regression was used to estimate the independent effects of each variable on the respondent's judgement. Two-hundred and sixty-eight completed responses were collected over eight weeks. Results: The majority (61%) of respondents were female, aged 40 years and older. A history of rectal bleeding, six weeks of symptoms, and weight loss independently increased the odds of recommending a consultation with a medical practitioner by a factor of 7.64, 4.11 and 1.86, respectively. Most cases that were identified as cancer (75.2%) would not be classified as such on current research evidence. Factors that predict recognition of cancer presentations include rectal bleeding, weight loss and diarrhoea.

Grunt language versus accent : the perceived communication barriers between international medical graduates and patients in Central Wheatbelt catchments

Due to the chronic shortages of GPs in Australian rural and remote regions, considerable numbers of international medical graduates (IMG) have been recruited. IMG experience many difficulties when relocating to Australia with one of the most significant being effective GP-patient communication. Given that this is essential for effective consultation it can have a substantial impact on health care. A purposive sample of seven practising GPs (five IMG, two Australian-trained doctors (ATD)) was interviewed using a semistructured face-to-face interviewing technique. GPs from Nigeria, Egypt, United Kingdom, India, Singapore and Australia participated. Interviews were transcribed and then coded. The authors used qualitative thematic analysis of interview transcripts to identify common themes. IMG-patient communication barriers were considered significant in the Wheatbelt region as identified by both IMG and ATD. ATD indicated they were aware of IMG-patient communication issues resulting in subsequent consults with patients to explain results and diagnoses. Significantly, a lack of communication between ATD and IMG also emerged, creating a further barrier to effective communication. Analysis of the data generated several important findings that rural GP networks should consider when integrating new IMG into the community. Addressing the challenges related to cross-cultural differences should be a priority, in order to enable effective communication. More open communication between ATD and IMG about GP-patient communication barriers and education programs around GP-patient communication would help both GP and patient satisfaction.

Energy efficient virtual machine placement in data centers

Electricity cost has become a major expense for running data centers and server consolidation using virtualization technology has been used as an important technology to improve the energy efficiency of data centers. In this research, a genetic algorithm and a simulation-annealing algorithm are proposed for the static virtual machine placement problem that considers the energy consumption in both the servers and the communication network, and a trading algorithm is proposed for dynamic virtual machine placement. Experimental results have shown that the proposed methods are more energy efficient than existing solutions.

Let the journey begin : cultivating student identity and a sense of belonging through a formal academic welcome

Queensland University of Technology [QUT] Caboolture campus is a satellite campus co-located with Brisbane North Institute of TAFE. Building a sense of belonging on-campus continues to be challenging, with anecdotal evidence suggesting that QUT Caboolture students feel like second-class students, isolated from the prestige and excitement of the city campuses. A student identity and fostering a sense of belonging are fundamental to on-campus engagement and have been linked to retention (Field & Morgan-Klein, 2010). A formal welcome ceremony, including an academic procession in full regalia, was a new inclusion for QUT Caboolture’s 2013 Orientation Day. The ritual was intended to be a temporal mark for students to recognise their personal transition and emerging identity as a university student. Cultural capital is one ingredient in a complex mix of interactions and relationships to build a sense of identity. (Ecclestone, Biesta & Hughes, 2010). Fostering a sense of belonging and a connection to the campus and its staff was also anticipated. Students responded positively to the event, reporting feelings of excitement, inspiration and being welcomed into the university culture. The ceremony marked the beginning of the students’ journey together as QUT Caboolture students.

Computer modeling of diffusion in biological tissues

Molecular-level computer simulations of restricted water diffusion can be used to develop models for relating diffusion tensor imaging measurements of anisotropic tissue to microstructural tissue characteristics. The diffusion tensors resulting from these simulations can then be analyzed in terms of their relationship to the structural anisotropy of the model used. As the translational motion of water molecules is essentially random, their dynamics can be effectively simulated using computers. In addition to modeling water dynamics and water-tissue interactions, the simulation software of the present study was developed to automatically generate collagen fiber networks from user-defined parameters. This flexibility provides the opportunity for further investigations of the relationship between the diffusion tensor of water and morphologically different models representing different anisotropic tissues.

Utilisation of hospital emergency departments among immigrants from refugee source-countries in Queensland

Despite the increasing number of immigrants, there is a limited body of literature describing the use of hospital emergency department (ED) care by immigrants in Australia. This study aims to describe how immigrants from refugee source countries (IRSC) utilise ED care, compared to immigrants from the main English speaking countries (MESC), immigrants from other countries (IOC) and the local population in Queensland. A retrospective analysis of a Queensland state-wide hospital ED dataset (ED Information System) from 1-1-2008 to 31-12-2010 was conducted. Our study showed that immigrants are not a homogenous group. We found that immigrants from IRSC are more likely to use interpreters (8.9%) in the ED compared to IOC. Furthermore, IRSC have a higher rate of ambulance use (odds ratio 1.2, 95% confidence interval (CI) 1.2–1.3), are less likely to be admitted to the hospital from the ED (odds ratio 0.7 (95% CI 0.7–0.8), and have a longer length of stay (LOS; mean differences 33.0, 95% CI 28.8–37.2), in minutes, in the ED compared to the Australian born population. Our findings highlight the need to develop policies and educational interventions to ensure the equitable use of health services among vulnerable immigrant populations.

Redefining and leading the academic discipline in Australian universities

Disciplines have emerged as an alternative administrative structure to departments or schools in Australian universities. We presently investigate the pattern of discipline use and by way of case study examine a role for distributed leadership in discipline management. Over forty per cent of Australian universities currently employ disciplines, especially within faculties of sciences, engineering and medicine. No trend is observed according to institutional age, state, or historical origins. Effective planning, retention of corporate knowledge and good communication are important during the transition period. Moreover, it is vital that professional staff continue to work closely alongside academics as extended members of the discipline. Distributed leadership encourages this interaction. The duties of a discipline leader can be similar to those faced by a head of department. Universities should therefore establish clear policies, position descriptions and appropriate remuneration packages in order to recruit, train and retain staff within this emerging academic management role.

YAWL4Industry : reflections on using YAWL for industry projects

The Yet Another Workflow Language (YAWL) language and environment has been used to prototype, verify, execute and analyse business processes in a wide variety of industrial domains, such as telephony, construction, supply chain, insurance services, medical environments, personnel management and the creative arts. These engagements offer the YAWL researcher community a great opportunity to validate our research findings within an industry setting, as well as discovery of possible enhancements from the end user perspective. This paper describes three such industry projects, discusses why YAWL was chosen and how it was used in each, and reacts on the insights gained along the way.

The difficulty of establishing causation in medical negligence cases : two recent Australian decisions

This editorial on health and guardianship law provides an overview of the causation issues that precluded the recovery of two medical negligence claims in the cases of Wallace v Kam [2013] HCA 19 and Waller v James [2013] NSWSC 497.

Numerical simulation of anomalous diffusion with application to medical imaging

The first objective of this project is to develop new efficient numerical methods and supporting error and convergence analysis for solving fractional partial differential equations to study anomalous diffusion in biological tissue such as the human brain. The second objective is to develop a new efficient fractional differential-based approach for texture enhancement in image processing. The results of the thesis highlight that the fractional order analysis captured important features of nuclear magnetic resonance (NMR) relaxation and can be used to improve the quality of medical imaging.

Pharmacokinetics-based elucidation on disparity in clinical effectiveness between varieties of Zhi Zhu Wan, a traditional Chinese medical formula

AIM: Zhi Zhu Wan (ZZW) is a classical Chinese medical formulation used for the treatment of functional dyspepsia that attributed to Spleen-deficiency Syndrome. ZZW contains Atractylodes Rhizome and Fructus Citrus Immaturus, the later originates from both Citrus aurantium L. (BZZW) and Citrus sinensis Osbeck (RZZW). The present study is designed to elucidate disparities in the clinical efficacy of two ZZW varieties based on the pharmacokinetics of naringenin and hesperetin. MEHTOD: After oral administration of ZZWs, blood sample was collected from healthy volunteers at designed time points. Naringenin and hesperetin were detected in plasma by RP-HPLC, pharmacokinetic parameters were processed using mode-independent methods with WINNONLIN. RESULTS: After oral administration of BZZW, both naringenin and hesperetin were detected in plasma, and demonstrated similar pharmacokinetic parameters. Ka was 0.384+/-0.165 and 0.401+/-0.159, T(1/2(ke))(h) was 5.491+/-3.926 and 5.824+/-3.067, the AUC (mg/Lh) was 34.886+/-22.199 and 39.407+/-19.535 for naringenin and hesperetin, respectively. However, in the case of RZZW, only hesperetin was found in plasma, but the pharmacokinetic properties for hesperetin in RZZW was different from that in BZZW. T(max) for hesperetin in RZZW is about 8.515h, and its C(max) is much larger than that of BZZW. Moreover, it was eliminated slowly as it possessed a much larger AUC value. CONCLUSION: The distinct therapeutic orientations of the Chinese medical formula ZZWs with different Fructus Citrus Immaturus could be elucidated based on the pharmacokinetic parameters of constituents after oral administration.

Double standards in special medical research : questioning the discrepancy between requirements for medical research involving incompetent adults and medical research involving children

Medical research represents a substantial departure from conventional medical care. Medical care is patient-orientated, with decisions based on the best interests and/or wishes of the person receiving the care. In contrast, medical research is future-directed. Primarily it aims to contribute new knowledge about illness or disease, or new knowledge about interventions, such as drugs, that impact upon some human condition. Current State and Territory laws and research ethics guidelines in Australia relating to the review of medical research appropriately acknowledge that the functions of medical care and medical research differ. Prior to a medical research project commencing, the study must be reviewed and approved by a Human Research Ethics Committee (HREC). For medical research involving incompetent adults, some jurisdictions require an additional, independent safeguard by way of tribunal or court approval of medical research protocols. This extra review process reflects the uncertainty of medical research involvement, and the difficulties surrogate decision-makers of incompetent adults face in making decisions about others, and deliberating about the risks and benefits of research involvement. Parents of children also face the same difficulties when making decisions about their child’s research involvement. However, unlike the position concerning incompetent adults, there are no similar safeguards under Australian law in relation to the approval of medical research involving children. This column questions why this discrepancy exists with a view to generating further dialogue on the topic.