Simulation and development of a mock circulation loop with variable compliance

Heart disease is attributed as the highest cause of death in the world. Although this could be alleviated by heart transplantation, there is a chronic shortage of donor hearts and so mechanical solutions are being considered. Currently, many Ventricular Assist Devices (VADs) are being developed worldwide in an effort to increase life expectancy and quality of life for end stage heart failure patients. Current pre-clinical testing methods for VADs involve laboratory testing using Mock Circulation Loops (MCLs), and in vivo testing in animal models. The research and development of highly accurate MCLs is vital to the continuous improvement of VAD performance. The first objective of this study was to develop and validate a mathematical model of a MCL. This model could then be used in the design and construction of a variable compliance chamber to improve the performance of an existing MCL as well as form the basis for a new miniaturised MCL. An extensive review of literature was carried out on MCLs and mathematical modelling of their function. A mathematical model of a MCL was then created in the MATLAB/SIMULINK environment. This model included variable features such as resistance, fluid inertia and volumes (resulting from the pipe lengths and diameters); compliance of Windkessel chambers, atria and ventricles; density of both fluid and compressed air applied to the system; gravitational effects on vertical columns of fluid; and accurately modelled actuators controlling the ventricle contraction. This model was then validated using the physical properties and pressure and flow traces produced from a previously developed MCL. A variable compliance chamber was designed to reproduce parameters determined by the mathematical model. The function of the variability was achieved by controlling the transmural pressure across a diaphragm to alter the compliance of the system. An initial prototype was tested in a previously developed MCL, and a variable level of arterial compliance was successfully produced; however, the complete range of compliance values required for accurate physiological representation was not able to be produced with this initial design. The mathematical model was then used to design a smaller physical mock circulation loop, with the tubing sizes adjusted to produce accurate pressure and flow traces whilst having an appropriate frequency response characteristic. The development of the mathematical model greatly assisted the general design of an in vitro cardiovascular device test rig, while the variable compliance chamber allowed simple and real-time manipulation of MCL compliance to allow accurate transition between a variety of physiological conditions. The newly developed MCL produced an accurate design of a mechanical representation of the human circulatory system for in vitro cardiovascular device testing and education purposes. The continued improvement of VAD test rigs is essential if VAD design is to improve, and hence improve quality of life and life expectancy for heart failure patients.

Clinical supervision in four mental health professions : a review of the evidence

Examines a range of theoretical issues and the empirical evidence relating to clinical supervision in 4 mental health professions: clinical psychology, occupational therapy, social work, and speech pathology. There is widespread acceptance of the value of supervision among practitioners and a large quantity of literature on the topic, but there is very little empirical evidence in this area. To date, there is insufficient evidence to demonstrate which styles of supervision are most beneficial for particular types of staff, in terms of their level of experience or learning style. The data suggest that directive forms of supervision, rather than unstructured approaches, are preferred by relatively inexperienced practitioners, and that experienced clinicians also value direct supervision methods when learning new skills or dealing with complex or crisis situations. The available evidence suggests that supervisors typically receive little training in supervision methods. However, there is little information to guide us as to the most effective ways of training supervisors. While acknowledging the urgent need for research, this paper concludes that supervision is likely to form a valuable component of professional development for mental health professionals.

Clinical significance of Mycobacterium asiaticum isolates in Queensland, Australia

Mycobacterium asiaticum was first reported as a cause of human disease in 1982, with only a few cases in the literature to date. This study aims to review the clinical significance of M. asiaticum isolates in Queensland, Australia. A retrospective review (1989 to 2008) of patients with M. asiaticum isolates was conducted. Data were collected through the Queensland TB Control Centre database. Disease was defined in accordance with the American Thoracic Society criteria. Twenty-four patients (13 female) had a positive culture of M. asiaticum, many residing around the Tropic of Capricorn. M. asiaticum was responsible for pulmonary disease (n = 2), childhood lymphadenitis (n = 1), olecranon bursitis (n = 1), 6 cases of possible pulmonary disease, and 2 possible wound infections. Chronic lung disease was a risk factor for pulmonary infection, and wounds/lacerations were a risk factor for extrapulmonary disease. Extrapulmonary disease responded to local measures. Pulmonary disease responded to ethambutol-isoniazid-rifampin plus pyrazinamide for the first 2 months in one patient, and amikacin-azithromycin-minocycline in another patient. While M. asiaticum is rare in Queensland, there appears to be an environmental niche. Although often a colonizer, it can be a cause of pulmonary and extrapulmonary disease. Treatment of pulmonary disease remains challenging. Extrapulmonary disease does not mandate specific nontuberculous mycobacterium (NTM) treatment.

Vibrational spectroscopic studies of laboratory scale polymer melt processing : application to a thermoplastic polyurethane nanocomposite

A laboratory scale twin screw extruder has been interfaced with a near infrared (NIR) spectrometer via a fibre optic link so that NIR spectra can be collected continuously during the small scale experimental melt state processing of polymeric materials. This system can be used to investigate melt state processes such as reactive extrusion, in real time, in order to explore the kinetics and mechanism of the reaction. A further advantage of the system is that it has the capability to measure apparent viscosity simultaneously which gives important additional information about molecular weight changes and polymer degradation during processing. The system was used to study the melt processing of a nanocomposite consisting of a thermoplastic polyurethane and an organically modified layered silicate.

Dual-process action of exercise on appetite control : increase in orexigenic drive but improvement in meal-induced satiety

Background: Exercise could contribute to weight loss by altering the sensitivity of the appetite regulatory system. Objective: The aim of this study was to assess the effects of 12 wk of mandatory exercise on appetite control. Design: Fifty-eight overweight and obese men and women [mean (±SD) body mass index (in kg/m2) = 31.8 ± 4.5, age = 39.6 ± 9.8 y, and maximal oxygen intake = 29.1 ± 5.7 mL · kg–1 · min–1] completed 12 wk of supervised exercise in the laboratory. The exercise sessions were designed to expend 2500 kcal/wk. Subjective appetite sensations and the satiating efficiency of a fixed breakfast were compared at baseline (week 0) and at week 12. An Electronic Appetite Rating System was used to measure subjective appetite sensations immediately before and after the fixed breakfast in the immediate postprandial period and across the whole day. The satiety quotient of the breakfast was determined by calculating the change in appetite scores relative to the breakfast's energy content. Results: Despite large variability, there was a significant reduction in mean body weight (3.2 ± 3.6 kg), fat mass (3.2 ± 2.2 kg), and waist circumference (5.0 ± 3.2 cm) after 12 wk. The analysis showed that a reduction in body weight and body composition was accompanied by an increase in fasting hunger and in average hunger across the day (P < 0.0001). Paradoxically, the immediate and delayed satiety quotient of the breakfast also increased significantly (P < 0.05). Conclusions: These data show that the effect of exercise on appetite regulation involves at least 2 processes: an increase in the overall (orexigenic) drive to eat and a concomitant increase in the satiating efficiency of a fixed meal.

Clinical efficacy and safety of zoledronic acid in osteoporosis and Paget's disease

Osteoporosis and Paget’s bone disease are the most common diseases of the bone. In addition to glucocorticoid treatment, there are many other secondary causes of osteoporosis. Bisphosphonates are used to treat these bone conditions. Zoledronic acid is the most potent bisphosphonate at inhibiting bone resorption. In osteoporosis, zoledronic acid increases bone mineral density for at least 1 year following a single intravenous administration. The efficacy and safety of zoledronic acid in the treatment of osteoporosis and Paget’s bone disease are reviewed. This article also covers the studies of the effects of zoledronic acid in the bone loss associated with the secondary osteoporosis.

Clinical efficacy and safety of zoledronic acid in prostate and breast cancer

The anti-estrogen treatment for hormone-sensitive breast cancer and the androgen deprivation therapy for prostate cancer can lead to the development of osteoporosis and bone fractures. Metastases associated with prostate and breast cancer can also occur in bone. Bisphosphonates are used in these types of bone dysfunction. Zoledronic acid is the most potent bisphosphonate. In osteoporosis, zoledronic acid inhibits bone reabsorption and increases bone mineral density for at least a year after intravenous administration. The efficacy and safety of zoledronic acid in osteoporosis secondary to hormone-sensitive cancers (prostate and breast), and in the bone metastases associated with these cancers are reviewed.

Good clinical endpoints with denosumab in osteoporosis and cancer

Background: Bone loss associated with low oestrogen levels in postmenopausal women, and with androgen deprivation therapy in men with hormone-sensitive prostate cancer, result in an increased incidence of fractures. Denosumab has been shown to increase bone mineral density in these two conditions. Objectives/methods: The objective of this evaluation is to review the clinical trials that have studied clinical endpoints in these conditions. Results: FREEDOM (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) was an International Phase III clinical trial that measured the clinical endpoints with denosumab in postmenopausal women with osteoporosis. At 36 months, new vertebral fractures had occurred in 7.2% of subjects in the placebo group and this was lowered to 2.3% of subjects treated with denosumab. HALT (Denosumab Hormone Ablation Bone Loss Trial) studied the clinical endpoints in men with non-metastatic prostate cancer receiving androgen-deprivation therapy. The incidence of vertebral fractures was significantly lower in the denosumab group (1.5%) than in the placebo group (3.9%). The incidence of adverse effects with denosumab in both clinical trials was low. Conclusions: Denosumab reduces the incidence of fractures in postmenopausal women with osteoporosis and in men with non-metastatic prostate cancer receiving androgen-deprivation therapy. Denosumab is well tolerated.

Modeling the impact of potential vaccines on epidemics of sexually transmitted chlamydia trachomatis infection

Background. We investigated the likely impact of vaccines on the prevalence of and morbidity due to Chlamydia trachomatis (chlamydia) infections in heterosexual populations. Methods.An individual‐based mathematical model of chlamydia transmission was developed and linked to the infection course in chlamydia‐infected individuals. The model describes the impact of a vaccine through its effect on the chlamydial load required to infect susceptible individuals (the “critical load”), the load in infected individuals, and their subsequent infectiousness. The model was calibrated using behavioral, biological, and clinical data. Results.A fully protective chlamydia vaccine administered before sexual debut can theoretically eliminate chlamydia epidemics within 20 years. Partially effective vaccines can still greatly reduce the incidence of chlamydia infection. Vaccines should aim primarily to increase the critical load in susceptible individuals and secondarily to decrease the peak load and/or the duration of infection in vaccinated individuals who become infected. Vaccinating both sexes has a beneficial impact on chlamydia‐related morbidity, but targeting women is more effective than targeting men. Conclusions.Our findings can be used in laboratory settings to evaluate vaccine candidates in animal models, by regulatory bodies in the promotion of candidates for clinical trials, and by public health authorities in deciding on optimal intervention strategies.

A grounded theory study of nursing students’ experiences in the off-campus clinical setting

Poor workplace relations are an issue of concern in many workplaces and this phenomenon is not restricted to the nursing profession. The issue of workplace violence in nursing is well documented and there are an increasing number of studies which have investigated the notion of horizontal violence amongst graduate nurses. The impact that poor workplace relations has on the development of a professional identity by nursing students in the off-campus clinical setting is significant in light of the current global shortage of nurses. There is a dearth of knowledge in understanding how Australian undergraduate nursing students experience the off-campus clinical setting and subsequently develop a professional identity as a nurse. Therefore the aim of this study was to discover and describe the phenomena in order to develop a substantive theory that explains the experiences of the undergraduate nursing students in a regional setting. Constructivist grounded theory methods were utilised in the conduct of the study. A sample of 29 participants was recruited permitting the formulation of a substantive theory regarding the development of a professional identity in nursing students. This substantive theory contributes knowledge relevant to the undergraduate nursing students, nurse educators, nursing workforce planners, and the tertiary educational institutions offering nursing. This is achieved through discovering, describing and explaining the phenomenon of ‘anxiety’ which the nursing students experience as a result of the interrelationship and interactions of tradition bearing, staff and student performance. These interactions intersect to form expectations of where the student fits within the hierarchy of the facility and the nursing profession in general. An understanding of the issues associated with tradition bearing, staff performance, and student performance and the impact that the interaction of these conditions has upon the student’s developing professional identity as a nurse is necessary to allow for the implementation of corrective strategies.

Clinical whole-body skin examination reduces the incidence of thick melanomas

Survival from melanoma is strongly related to tumour thickness, thus earlier diagnosis has the potential to reduce mortality from this disease. However, in the absence of conclusive evidence that clinical skin examination reduces mortality, evidence-based assessments do not recommend population screening. We aimed to assess whether clinical whole-body skin examination is associated with a reduced incidence of thick melanoma and also whether screening is associated with an increased incidence of thin lesions (possible overdiagnosis). A population-based case-control study of all Queensland residents aged 20-75 years with a histologically confirmed first primary invasive cutaneous melanoma diagnosed between January 2000 and December 2003. Telephone interviews were completed by 3,762 eligible cases (78.0%) and 3,824 eligible controls (50.4%) Whole-body clinical skin examination in the three years before diagnosis was associated with a 14% lower risk of being diagnosed with a thick melanoma (>0.75mm) (OR= 0.86, 95% CI=0.75, 0.98). Risk decreased for melanomas of increasing thickness: the risk of being diagnosed with a melanoma 0.76-1.49mm was reduced by 7% (OR=0.93, 95% CI 0.79, 1.10), by 17% for melanomas 1.50-2.99mm (OR=0.83, 95% CI=0.65, 1.05) and by 40% for melanomas ≥3mm (OR=0.60, 95% CI=0.43, 0.83). Screening was associated with a 38% higher risk of being diagnosed with a thin invasive melanoma (≤0.75mm) (OR=1.38, 95% CI=1.22, 1.56). This is the strongest evidence to date that whole-body clinical skin examination reduces the incidence of thick melanoma. Because survival from melanoma is strongly related to tumour thickness, these results suggest that screening would reduce melanoma mortality.

Building the toolkit of quality monitoring clinical outcomes as a means of assessing quality in residential care

Residential aged care in Australia does not have a system of quality assessment related to clinical outcomes, creating a significant gap in quality monitoring. Clinical outcomes represent the results of all inputs into care, thus providing an indication of the success of those inputs. To fill this gap, an assessment tool based on resident outcomes (the ResCareQA) was developed and evaluated in collaboration with residential care providers. A useful output of the ResCareQA is a profile of resident clinical status, and this paper will use such outputs to present a snapshot of nine residential facilities. Such comprehensive data has not yet been available within Australia, so this will provide an important insight. ResCareQA data was collected from all residents (N=498) of nine aged care facilities from two major aged care providers. For each facility, numerator–denominator data were calculated to assess the degree of potential clinical problems. Results varied across clinical areas and across facilities, and rank-ordered facility results for selected clinical areas are reviewed and discussed. Use of the ResCareQA to generate clinical outcome data provides a concrete means of monitoring care quality within residential facilities; regular use of the ResCareQA could thus contribute to improved care outcomes within residential aged care.

Continuous infusion of ticarcillin-clavulanate for home treatment of serious infections : clinical efficacy, safety, pharmacokinetics and pharmacodynamics

Continuous infusion (CI) ticarcillin–clavulanate is a potential therapeutic improvement over conventional intermittent dosing because the major pharmacodynamic (PD) predictor of efficacy of β-lactams is the time that free drug levels exceed the MIC. This study incorporated a 6-year retrospective arm evaluating efficacy and safety of CI ticarcillin–clavulanate in the home treatment of serious infections and a prospective arm additionally evaluating pharmacokinetics (PK) and PD. In the prospective arm, steady-state serum ticarcillin and clavulanate levels and MIC testing of significant pathogens were performed. One hundred and twelve patients (median age, 56 years) were treated with a CI dose of 9.3–12.4 g/day and mean CI duration of 18.0 days. Infections treated included osteomyelitis (50 patients), septic arthritis (6), cellulitis (17), pulmonary infections (12), febrile neutropenia (7), vascular infections (7), intra-abdominal infections (2), and Gram-negative endocarditis (2); 91/112 (81%) of patients were cured, 14 (13%) had partial response and 7 (6%) failed therapy. Nine patients had PICC line complications and five patients had drug adverse events. Eighteen patients had prospective PK/PD assessment although only four patients had sufficient data for a full PK/PD evaluation (both serum steady-state drug levels and ticarcillin and clavulanate MICs from a bacteriological isolate), as this was difficult to obtain in home-based patients, particularly as serum clavulanate levels were found to deteriorate rapidly on storage. Three of four patients with matched PK/PD assessment had free drug levels exceeding the MIC of the pathogen. Home CI of ticarcillin–clavulanate is a safe, effective, convenient and practical therapy and is a therapeutic advance over traditional intermittent dosing when used in the home setting.

Development and use of clinical guidelines

The purpose of this chapter is to provide an overview of the development and use of clinical guidelines as a tool for decision making in clinical practice. Nurses have always developed and used tools to guide clinical decision making related to interventions in practice. Since Florence Nightingale (Nightingale 1860) gave us ‘notes’ on nursing in the late 1800s, nurses have continued to use tools, such as standards, policies and procedures, protocols, algorithms, clinical pathways and clinical guidelines, to assist them in making appropriate decisions about patient care that eventuate in the best desired patient outcomes. Clinical guidelines have enjoyed growing popularity as a comprehensive tool for synthesising clinical evidence and information into user-friendly recommendations for practice. Historically, clinical guidelines were developed by individual experts or groups of experts by consensus, with no transparent process for the user to determine the validity and reliability of the recommendations. The acceptance of the evidence-based practice (EBP) movement as a paradigm for clinical decision making underscores the imperative for clinical guidelines to be systematically developed and based on the best available research evidence. Clinicians are faced with the dilemma of choosing from an abundance of guidelines of variable quality, or developing new guidelines. Where do you start? How do you find an existing guideline to fit your practice? How do you know if a guideline is evidence-based, valid and reliable? Should you apply an existing guideline in your practice or develop a new guideline? How do you get clinicians to use the guidelines? How do you know if using the guideline will make any difference in care delivery or patient outcomes? Whatever the choice, the challenge lies in choosing or developing a clinical guideline that is credible as a decision-making tool for the delivery of quality, efficient and effective care. This chapter will address the posed questions through an exploration of the ins and outs of clinical guidelines, from development to application to evaluation.