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.

Fresh frozen cadavers as a tool to educate student paramedics in procedural skills

Objectives – To describe the development of an educational workshop to develop procedural skills in undergraduate Paramedic students using fresh frozen cadavers and to report the student’s assessment of the program. Methods – A six-hour anatomy based workshop was developed using fresh frozen cadavers to teach a range of airway and invasive procedural skills to second year undergraduate paramedic students. Embedded QUAN (qual) methodology will be utilised to evaluate the student’s satisfaction, perception and quality of teaching as compared to other existing clinical teaching techniques such as high fidelity simulation. Students will be asked to complete an anonymous validated survey (10 questions formulated on a 5 point Likert scale) and provide a qualitative feedback pre and post the six-hour workshop. Results – This is a prospective study planned for September 2013. Low-risk human research ethics are being sought. Teaching evaluation results from the inaugural 2012 workshop (undergraduate and postgraduate Paramedic students) and interim results for 2013 will be presented. Conclusions – Clinical teaching using fresh frozen cadavers thus far has predominately been used in the education of medical and surgical trainees. A number of studies have found them to be effective and in some cases superior to traditional high fidelity simulation teaching strategies. Fresh frozen cadavers are said to provide perfect anatomy, normal tissue consistency and a realistic operative training experience (Lloyd, Maxwell-Armstrong et al. 2011). The authors believe that this study will show that the use of fresh frozen cadavers offers a safe and effective mode to teach procedural skills to student paramedics that will help bridge the skills gap and increase confidence prior to students undertaking such interventions on living patients. A modified training program may be formulated for general practitioners undertaking Emergency Medicine Advanced Rural Skills.

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.

Changes in health profiles of participants in an Australian police department’s Wellness program

Background: Little is known about the health effects of worksite wellness programs on police department staff. Objective: To examine 1-2 year changes in health profiles of participants in the Queensland Police Service’s wellness program. Methods: Participants underwent yearly physical assessments. Health profile data collected during assessments from 2008 to 2012 were included in the analysis. Data Analysis: Repeated-measures ANOVA was used for continuous outcome variables, related-samples Wilcoxon Signed Rank test for non-normally continuous variables, and McNemar’s test for binary variables. Results: Significant changes in physical measures included decreases in waist circumference and percent body fat, and increases in cardiorespiratory fitness and flexibility (p<0.01). Changes in serum cholesterol, haemoglobin, total cholesterol ratios, HDL, LDL and Triglyceride levels were also significant (p<0.01). Conclusion: Participants’ health profiles mostly improved between cycles although most changes were not clinically significant. As this evaluation used a single-group pre-test post-test design, it provides initial indications that wellness programs can benefit staff in police departments.

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.

Promoting independence in residential care : successful recruitment for a randomised controlled trial

OBJECTIVES: To describe the recruitment strategy and association between facility and staff characteristics and success of resident recruitment for the Promoting Independence in Residential Care (PIRC) trial. DESIGN: Cross-sectional study of staff and facility characteristics and recruitment rates within facilities with calculation of cluster effects of multiple measures. SETTING AND PARTICIPANTS: Staff of low-level dependency residential care facilities and residents able to engage in a physical activity program in 2 cities in New Zealand. MEASURES: A global impression of staff willingness to facilitate research was gauged by research nurses, facility characteristics were measured by staff interview. Relevant outcomes were measured by resident interview and included the following: (1) Function: Late Life FDI scale, timed-up-and-go, FICSIT balance scale and the Elderly Mobility Scale; (2) Quality of Life: EuroQol quality of life scale, Life Satisfaction Index; and (3) falls were assessed by audit of the medical record. Correlation between recruitment rates, facility characteristics and global impression of staff willingness to participate were investigated. Design effects were calculated on outcomes. RESULTS: Forty-one (85%) facilities and 682 (83%) residents participated, median age was 85 years (range 65-101), and 74% were women. Participants had complex health problems. Recruitment rates were associated (but did not increase linearly) with the perceived willingness of staff, and were not associated with facility size. Design effects from the cluster recruitment differed according to outcome. CONCLUSIONS: The recruitment strategy was successful in recruiting a large sample of people with complex comorbidities and high levels of functional disability despite perceptions of staff reluctance. Staff willingness was related to recruitment success.

Moving MobileMums forward: protocol for a larger randomized controlled trial of an improved physical activity program for women with young children

Background: Women with young children (under 5 years) are a key population group for physical activity intervention. Previous evidence highlights the need for individually tailored programs with flexible delivery mechanisms for this group. Our previous pilot study suggested that an intervention primarily delivered via mobile phone text messaging (MobileMums) increased self-reported physical activity in women with young children. An improved version of the MobileMums program is being compared with a minimal contact control group in a large randomised controlled trial (RCT). Methods/design: This RCT will evaluate the efficacy, feasibility and acceptability, cost-effectiveness, mediators and moderators of the MobileMums program. Primary (moderate-vigorous physical activity) and secondary (intervention implementation data, health service use costs, intervention costs, health benefits, theoretical constructs) outcomes are assessed at baseline, 3-months (end of intervention) and 9-months (following 6-month no contact: maintenance period). The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611000481976; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=336109).The intervention commences with a face-to-face session with a behavioural counsellor to initiate rapport and gather information for tailoring the 12-week text message program. During the program participants also have access to a: MobileMums Participant Handbook, MobileMums refrigerator magnet, MobileMums Facebook(C) group, and a MobileMums website with a searchable, on-line exercise directory. A nominated support person also receives text messages for 12-weeks encouraging them to offer their MobileMum social support for physical activity. Discussion: Results of this trial will determine the efficacy and cost-effectiveness of the MobileMums program, and the feasibility of delivering it in a community setting. It will inform the broader literature of physical activity interventions for women with young children and determine whether further investment in the translation of the program is warranted.

Development of school connectedness as a component of an injury prevention program for early adolescents

The current program of research addresses the need for multi-level programs to target the major increase in injury rates that occurs throughout adolescence. Specifically, it involves the investigation of school connectedness as a protective factor for adolescent injury, and the development of school connectedness as a component of an injury prevention program. To date, school-based risk taking and injury prevention has frequently been limited to addressing adolescents' knowledge and attitudes to risk behaviours, and has largely overlooked the importance of the wider school social context as a protective factor in adolescent development. Additionally, school connectedness has been primarily studied in terms of its impact on student achievement, wellbeing and risk taking behaviour, and research has not yet addressed possible links with injury. Further, school connectedness intervention programs have targeted risk taking behaviours without evaluating their potential impact on injury outcomes. This is the first reported research to develop strategies to increase school connectedness as part of a school-based injury prevention program. The research program was conceptualised as three distinct stages. The development of these research stages was informed by a comprehensive review of the literature on adolescent risk taking, injury and school-based prevention, as well as on school connectedness and its importance in adolescence. A review of the school connectedness literature indicated that students' connectedness is largely influenced by relationships within the school context including with teachers and other school staff, and is therefore a potentially modifiable factor that may be targeted in school-based programs. Overall, the literature shows school connectedness to be a key protective factor in adolescent development. This review established a foundation from which the current program of research was designed. The first stage of the research involved an empirical investigation of the relationship between adolescent risk taking-related injuries and school connectedness. Stage one incorporated two studies. The first involved the development of a measure of adolescent injury, the Extended Adolescent Injury Checklist (E-AIC), for use in the current research as well as in future school-based studies and program evaluation. The results of this study also highlighted the extent of the problem of risk-related injury in adolescence. The second study in Stage one examined the relationship between students' reports of school connectedness, risk taking behaviour and risk taking-related injuries on the E-AIC. The results of this study showed significant relationships between increased school connectedness and reduced reported engagement in transport and violence risk taking, and fewer associated injuries. This study therefore suggested the potential for school-based injury prevention programs to incorporate strategies targeting increased adolescent connectedness to school. The second stage of this research involved the compilation of an evidence base to inform the design of a school connectedness intervention. Stage two also incorporated two studies. The first study in Stage two involved a systematic review of programs that have targeted school connectedness for reduced risk taking and injury. The results of this study revealed that interventions targeting school connectedness can be effective in reducing adolescent risk taking behaviour, and also provided an evidence base for the design of the current school connectedness intervention. The second study in Stage two examined teachers' understanding and perceptions of school connectedness. This qualitative study indicated that teachers consider students' connectedness to be an important factor that relates to their risk taking behaviour; and also provided directions and content for the intervention design stage. The third stage of this research built upon the findings of each of the previous studies, and involved the design, implementation and evaluation of a school connectedness intervention as a component of an adolescent injury prevention program, Skills for Preventing Injury in Youth (SPIY). This connectedness intervention was designed as a professional development workshop for teachers of 13 to 14 year old adolescents, and was developed as a complementary component to the curriculum-based SPIY program. The SPIY connectedness component was implemented and evaluated using process and six-month impact evaluation methodologies. The results of this study revealed that teachers saw value in the program and made use of the strategies presented, and that program school students' self-reported violence risk behaviour was reduced at six-month follow-up. Despite these promising findings, the results of this study did not demonstrate a significant impact of the program on change in students' connectedness to school, relative to comparison schools. The positive impact on self-reported violence risk behaviour was however replicated in additional analyses comparing students participating in the connectedness version of SPIY with students participating in an earlier curriculumonly version of the program. This finding indicated that the connectedness component has additional benefits relating to reduction in violence risks, over and above a curriculum-only version of the program. This research was the first reported to address the relationship between school connectedness and adolescent injury outcomes, and to develop school connectedness as a component of an adolescent injury prevention program. Overall, the results of this program of research have demonstrated the importance of incorporating strategies targeting the wider school social context, including school connectedness, in adolescent injury prevention programs. This research has important implications for future research and practice in adolescent injury prevention.

Investigating the impact of a leadership development program for nurse unit managers on the satisfaction of nursing staff

Background and significance: Nurses' job dissatisfaction is associated with negative nursing and patient outcomes. One of the most powerful reasons for nurses to stay in an organisation is satisfaction with leadership. However, nurses are frequently promoted to leadership positions without appropriate preparation for the role. Although a number of leadership programs have been described, none have been tested for effectiveness, using a randomised control trial methodology. Aims: The aims of this research were to develop an evidence based leadership program and to test its effectiveness on nurse unit managers' (NUMs') and nursing staff's (NS's) job satisfaction, and on the leader behaviour scores of nurse unit managers. Methods: First, the study used a comprehensive literature review to examine the evidence on job satisfaction, leadership and front-line manager competencies. From this evidence a summary of leadership practices was developed to construct a two component leadership model. The components of this model were then combined with the evidence distilled from previous leadership development programs to develop a Leadership Development Program (LDP). This evidence integrated the program's design, its contents, teaching strategies and learning environment. Central to the LDP were the evidence-based leadership practices associated with increasing nurses' job satisfaction. A randomised controlled trial (RCT) design was employed for this research to test the effectiveness of the LDP. A RCT is one of the most powerful tools of research and the use of this method makes this study unique, as a RCT has never been used previously to evaluate any leadership program for front-line nurse managers. Thirty-nine consenting nurse unit managers from a large tertiary hospital were randomly allocated to receive either the leadership program or only the program's written information about leadership. Demographic baseline data were collected from participants in the NUM groups and the nursing staff who reported to them. Validated questionnaires measuring job satisfaction and leader behaviours were administered at baseline, at three months after the commencement of the intervention and at six months after the commencement of the intervention, to the nurse unit managers and to the NS. Independent and paired t-tests were used to analyse continuous outcome variables and Chi Square tests were used for categorical data. Results: The study found that the nurse unit managers' overall job satisfaction score was higher at 3-months (p = 0.016) and at 6-months p = 0.027) post commencement of the intervention in the intervention group compared with the control group. Similarly, at 3-months testing, mean scores in the intervention group were higher in five of the six "positive" sub-categories of the leader behaviour scale when compared to the control group. There was a significant difference in one sub-category; effectiveness, p = 0.015. No differences were observed in leadership behaviour scores between groups by 6-months post commencement of the intervention. Over time, at three month and six month testing there were significant increases in four transformational leader behaviour scores and in one positive transactional leader behaviour scores in the intervention group. Over time at 3-month testing, there were significant increases in the three leader behaviour outcome scores, however at 6-months testing; only one of these leader behaviour outcome scores remained significantly increased. Job satisfaction scores were not significantly increased between the NS groups at three months and at six months post commencement of the intervention. However, over time within the intervention group at 6-month testing there was a significant increase in job satisfaction scores of NS. There were no significant increases in NUM leader behaviour scores in the intervention group, as rated by the nursing staff who reported to them. Over time, at 3-month testing, NS rated nurse unit managers' leader behaviour scores significantly lower in two leader behaviours and two leader behaviour outcome scores. At 6-month testing, over time, one leader behaviour score was rated significantly lower and the nontransactional leader behaviour was rated significantly higher. Discussion: The study represents the first attempt to test the effectiveness of a leadership development program (LDP) for nurse unit managers using a RCT. The program's design, contents, teaching strategies and learning environment were based on a summary of the literature. The overall improvement in role satisfaction was sustained for at least 6-months post intervention. The study's results may reflect the program's evidence-based approach to developing the LDP, which increased the nurse unit managers' confidence in their role and thereby their job satisfaction. Two other factors possibly contributed to nurse unit managers' increased job satisfaction scores. These are: the program's teaching strategies, which included the involvement of the executive nursing team of the hospital, and the fact that the LDP provided recognition of the importance of the NUM role within the hospital. Consequently, participating in the program may have led to nurse unit managers feeling valued and rewarded for their service; hence more satisfied. Leadership behaviours remaining unchanged between groups at the 6 months data collection time may relate to the LDP needing to be conducted for a longer time period. This is suggested because within the intervention group, over time, at 3 and 6 months there were significant increases in self-reported leader behaviours. The lack of significant changes in leader behaviour scores between groups may equally signify that leader behaviours require different interventions to achieve change. Nursing staff results suggest that the LDP's design needs to consider involving NS in the program's aims and progress from the outset. It is also possible that by including regular feedback from NS to the nurse unit managers during the LDP that NS's job satisfaction and their perception of nurse unit managers' leader behaviours may alter. Conclusion/Implications: This study highlights the value of providing an evidence-based leadership program to nurse unit managers to increase their job satisfaction. The evidence based leadership program increased job satisfaction but its effect on leadership behaviour was only seen over time. Further research is required to test interventions which attempt to change leader behaviours. Also further research on NS' job satisfaction is required to test the indirect effects of LDP on NS whose nurse unit managers participate in LDPs.