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.

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.

Preventing public sector corruption : the relationship between parliamentary committees and corruption commissions

Parliamentary committees fulfil several important functions within the Parliament, with one of these being the oversight of various agencies including those that are designed to reduce corruption within the police service and other public sector agencies. The cross-party nature of committees combined with the protections of Parliament make them powerful agencies. Prenzler & Faulkner (2010) suggest that the ideal system for an agency that has oversight of a public sector integrity commission should include monitoring by a parliamentary committee, with an inspector attached to the committee. This occurs in Queensland, New South Wales and Western Australia. There has been very little research conducted on the role of parliamentary committees with oversight responsibilities for public sector integrity agencies. This paper will address this gap by examining the relationship between a parliamentary committee, a parliamentary inspector and a corruption commission. Queensland’s Parliamentary Crime and Misconduct Committee (PCMC/the Committee) and the Parliamentary Crime and Misconduct Commissioner (the Commissioner) provide oversight of the Crime and Misconduct Commission (CMC). By focussing on the PCMC and the Commissioner, the paper will examine the legislative basis for the Committee and Commissioner and their respective roles in providing oversight of the CMC. One key method by which the PCMC provides oversight of the CMC is to conduct and publish a review of the CMC every three years. Additionally, the paper will identify some of the similarities and differences between the PCMC and other committees that operate within the Queensland Parliament. By doing so, the paper will provide insights into the relationships that exist between corruption commissions, parliamentary committees and parliamentary inspectors and demonstrate the important role of the parliamentary committee in preventing instances of public sector corruption.

Health complaints commissions in Australia : Time for a national approach to data collection

Health complaint commissions in Australia: Time for a national approach • There is considerable variation between jurisdictions in the ways complaint data are defined, collected and recorded by the Health complaint commissions. • Complaints from the public are an important accountability mechanism and an indicator of service quality. • The lack of a consistent approach leads to fragmentation of complaint data and a lost opportunity to use national data to assist policy development and identify the main areas causing consumers to complain. • We need a national approach to complaints data collection by the Health complaints commissions in order to better respond to patients’ concerns

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.

Utilizing least significant bit-planes of RONI pixels for medical image watermarking

We propose a computationally efficient image border pixel based watermark embedding scheme for medical images. We considered the border pixels of a medical image as RONI (region of non-interest), since those pixels have no or little interest to doctors and medical professionals irrespective of the image modalities. Although RONI is used for embedding, our proposed scheme still keeps distortion at a minimum level in the embedding region using the optimum number of least significant bit-planes for the border pixels. All these not only ensure that a watermarked image is safe for diagnosis, but also help minimize the legal and ethical concerns of altering all pixels of medical images in any manner (e.g, reversible or irreversible). The proposed scheme avoids the need for RONI segmentation, which incurs capacity and computational overheads. The performance of the proposed scheme has been compared with a relevant scheme in terms of embedding capacity, image perceptual quality (measured by SSIM and PSNR), and computational efficiency. Our experimental results show that the proposed scheme is computationally efficient, offers an image-content-independent embedding capacity, and maintains a good image quality

Towards a translational medical research ecosystem

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

Improved ultra-performance liquid chromatography with electrospray ionization quadrupole-time-of-flight high-definition mass spectrometry method for the rapid analysis of the chemical constituents of a typical medical formula: Liuwei Dihuang Wan

Liuwei Dihuang Wan (LWD), a classic Chinese medicinal formulae, has been used to improve or restore declined functions related to aging and geriatric diseases, such as impaired mobility, vision, hearing, cognition and memory. It has attracted increasingly much attention as one of the most popular and valuable herbal medicines. However, the systematic analysis of the chemical constituents of LDW is difficult and thus has not been well established. In this paper, a rapid, sensitive and reliable ultra-performance liquid chromatography with electrospray ionization quadrupole time-of-flight high-definition mass spectrometry (UPLC-ESI-Q-TOF-MS) method with automated MetaboLynx analysis in positive and negative ion mode was established to characterize the chemical constituents of LDW. The analysis was performed on a Waters UPLCTM HSS T3 using a gradient elution system. MS/MS fragmentation behavior was proposed for aiding the structural identification of the components. Under the optimized conditions, a total of 50 peaks were tentatively characterized by comparing the retention time and MS data. It is concluded that a rapid and robust platform based on UPLC-ESI-Q-TOF-MS has been successfully developed for globally identifying multiple-constituents of traditional Chinese medicine prescriptions. This is the first report on systematic analysis of the chemical constituents of LDW. This article is protected by copyright. All rights reserved.

Competency and capacity : the legal and medical interface

Balancing the competing interests of autonomy and protection of individuals is an escalating challenge confronting an ageing Australian society. Legal and medical professionals are increasingly being asked to determine whether individuals are legally competent/capable to make their own testamentary and substitute decision-making, that is financial and/or personal/health care, decisions. No consistent and transparent competency/capacity assessment paradigm currently exists in Australia. Consequently, assessments are currently being undertaken on an ad hoc basis which is concerning as Australia’s population ages and issues of competency/capacity increase. The absence of nationally accepted competency/capacity assessment guidelines and supporting principles results in legal and medical professionals involved with competency/capacity assessment implementing individual processes tailored to their own abilities. Legal and medical approaches differ both between and within the professions. The terminology used also varies. The legal practitioner is concerned with whether the individual has the legal ability to make the decision. A medical practitioner assesses fluctuations in physical and mental abilities. The problem is that the terms competency and capacity are used interchangeably resulting in confusion about what is actually being assessed. The terminological and methodological differences subsequently create miscommunication and misunderstanding between the professions. Consequently, it is not necessarily a simple solution for a legal professional to seek the opinion of a medical practitioner when assessing testamentary and/or substitute decision-making competency/capacity. This research investigates the effects of the current inadequate testamentary and substitute decision-making assessment paradigm and whether there is a more satisfactory approach. This exploration is undertaken within a framework of therapeutic jurisprudence which promotes principles fundamentally important in this context. Empirical research has been undertaken to first, explore the effects of the current process with practising legal and medical professionals; and second, to determine whether miscommunication and misunderstanding actually exist between the professions such that it gives rise to a tense relationship which is not conducive to satisfactory competency/capacity assessments. The necessity of reviewing the adequacy of the existing competency/capacity assessment methodology in the testamentary and substitute decision-making domain will be demonstrated and recommendations for the development of a suitable process made.

Medical nutrition therapy and simple interventions can improve intake in patients who eat poorly in hospital

The Australasian Nutrition Care Day Survey (ANCDS) reported two-in-five patients in Australian and New Zealand hospitals consume ≤50% of the offered food. The ANCDS found a significant association between poor food intake and increased in-hospital mortality after controlling for confounders (nutritional status, age, disease type and severity)1. Evidence for the effectiveness of medical nutrition therapy (MNT) in hospital patients eating poorly is lacking. An exploratory study was conducted in respiratory, neurology and orthopaedic wards of an Australian hospital. At baseline, 24-hour food intake (0%, 25%, 50%, 75%, 100% of offered meals) was evaluated for patients hospitalised for ≥2 days and not under dietetic review. Patients consuming ≤50% of offered meals due to nutrition-impact symptoms were referred to ward dietitians for MNT with food intake re-evaluated on day-7. 184 patients were observed over four weeks. Sixty-two patients (34%) consumed ≤50% of the offered meals. Simple interventions (feeding/menu assistance, diet texture modifications) improved intake to ≥75% in 30 patients who did not require further MNT. Of the 32 patients referred for MNT, baseline and day-7 data were available for 20 patients (68±17years, 65% females, BMI: 22±5kg/m2, median energy, protein intake: 2250kJ, 25g respectively). On day-7, 17 participants (85%) demonstrated significantly higher consumption (4300kJ, 53g; p<0.01). Three participants demonstrated no improvement due to ongoing nutrition-impact symptoms. “Percentage food intake” was a quick tool to identify patients in whom simple interventions could enhance intake. MNT was associated with improved dietary intake in hospital patients. Further research is needed to establish a causal relationship.

An exploratory study to evaluate whether medical nutrition therapy can improve dietary intake in hospital patients who eat poorly

Background and aims The Australasian Nutrition Care Day Survey (ANCDS) reported two-in-five patients consume ≤50% of the offered food in Australian and New Zealand hospitals. After controlling for confounders (nutritional status, age, disease type and severity), the ANCDS also established an independent association between poor food intake and increased in-hospital mortality. This study aimed to evaluate if medical nutrition therapy (MNT) could improve dietary intake in hospital patients eating poorly. Methods An exploratory pilot study was conducted in the respiratory, neurology and orthopaedic wards of an Australian hospital. At baseline, percentage food intake (0%, 25%, 50%, 75%, and 100%) was evaluated for each main meal and snack for a 24-hour period in patients hospitalised for ≥2 days and not under dietetic review. Patients consuming ≤50% of offered meals due to nutrition-impact symptoms were referred to ward dietitians for MNT. Food intake was re-evaluated on the seventh day following recruitment (post-MNT). Results 184 patients were observed over four weeks; 32 patients were referred for MNT. Although baseline and post-MNT data for 20 participants (68±17years, 65% females) indicated a significant increase in median energy and protein intake post-MNT (3600kJ/day, 40g/day) versus baseline (2250kJ/day, 25g/day) (p<0.05), the increased intake met only 50% of dietary requirements. Persistent nutrition impact symptoms affected intake. Conclusion In this pilot study whilst dietary intake improved, it remained inadequate to meet participants’ estimated requirements due to ongoing nutrition-impact symptoms. Appropriate medical management and early enteral feeding could be a possible solution for such patients.