A 5- versus 3-day course of oral corticosteroids for children with asthma exacerbations who are not hospitalised : a randomised controlled trial

Objective To determine whether a 5-day course of oral prednisolone is superior to a 3-day course in reducing the 2-week morbidity of children with asthma exacerbations who are not hospitalised. Design, setting and participants Double-blind randomised controlled trial of asthma outcomes following a 5-day course of oral prednisolone (1 mg/kg) compared with a 3-day course of prednisolone plus placebo for 2 days. Participants were children aged 2–15 years who presented to the emergency departments of three Queensland hospitals between March 2004 and February 2007 with an acute exacerbation of asthma, but were not hospitalised. Sample size was defined a priori for a study power of 90%. Main outcome measures Difference in proportion of children who were symptom-free at Day 7, as measured by intention-to-treat (ITT) and per-protocol analysis; quality of life (QOL) on Days 7 and 14. Results 201 children were enrolled, and there was an 82% completion rate. There was no difference between groups in the proportion of children who were symptom-free (observed difference, 0.04 [95% CI, − 0.09 to 0.18] by ITT analysis; 0.04 [95% CI, − 0.17 to 0.09] by per-protocol analysis). There was also no difference between groups in QOL (P = 0.42). The difference between groups for the primary outcome was within the equivalence range calculated post priori. Conclusion A 5-day course of oral prednisolone confers no advantage over a 3-day course for children with asthma exacerbations who are not hospitalised.

Randomised controlled trial of amoxycillin clavulanate in children with chronic wet cough

Background Despite guideline recommendations, there are no published randomised controlled trial data on the efficacy of antibiotics for chronic wet cough in children. The majority of children with chronic wet cough have protracted bacterial bronchitis (PBB), a recognised condition in multiple national guidelines. The authors conducted a parallel 1:1 placebo randomised controlled trial to test the hypothesis that a 2-week course of amoxycillin clavulanate is efficacious in the treatment of children with chronic wet cough. Methods 50 children (median age 1.9 years, IQR 0.9–5.1) with chronic (>3 weeks) wet cough were randomised to 2 weeks of twice daily oral amoxycillin clavulanate (22.5 mg/kg/dose) or placebo. The primary outcome was ‘cough resolution’ defined as a >75% reduction in the validated verbal category descriptive cough score within 14 days of treatment compared with baseline scores, or cessation of cough for >3 days. In selected children, flexible bronchoscopy and bronchoalveolar lavage (BAL) were undertaken at baseline. Results Cough resolution rates (48%) were significantly higher in children who received amoxycillin clavulanate compared with those who received placebo (16%), p=0.016. The observed difference between proportions was 0.32 (95% CI 0.08 to 0.56). Post treatment, median verbal category descriptive score in the amoxycillin clavulanate group of 0.5 (IQR 0.0–2.0) was significantly lower than in the placebo group, 2.25 (IQR 1.15–2.9) (p=0.02). Pre-treatment BAL data were consistent with PBB in the majority of children, with no significant difference between groups. Conclusion A 2-week course of amoxycillin clavulanate will achieve cough resolution in a significant number of children with chronic wet cough. BAL data support the diagnosis of PBB in the majority of these children.

Management based on exhaled nitric oxidelevels adjusted for atopy reduces asthma exacerbations in children : A dual centre randomised controlled trial

While several randomised control trials (RCTs) have evaluated the use of fractional exhaled nitric oxide (FeNO) to improve asthma outcomes, none used FeNO cut-offs adjusted for atopy, a determinant of FeNO levels. In a dual centre RCT, we assessed whether a treatment strategy based on FeNO levels, adjusted for atopy, reduces asthma exacerbations compared with the symptoms-based management (controls). Children with asthma from hospital clinics of two hospitals were randomly allocated to receive an a-priori determined treatment hierarchy based on symptoms or FeNO levels. There was a 2-week run-in period and they were then reviewed ten times over 12-months. The primary outcome was the number of children with exacerbations over 12-months. Sixty-three children were randomised (FeNO=31, controls=32); 55 (86%) completed the study. Although we did achieve our planned sample size, significantly fewer children in the FeNO group (6 of 27) had an asthma exacerbation compared to controls (15 of 28), p=0.021; number to treat for benefit=4 (95%CI 3-24). There was no difference between groups for any secondary outcomes (quality of life, symptoms, FEV1). The final daily inhaled corticosteroids (ICS) dose was significantly (p=0.037) higher in the FeNO group (median 400µg, IQR 250-600) compared to the controls (200, IQR100-400). Taking atopy into account when using FeNO to tailor asthma medications is likely beneficial in reducing the number of children with severe exacerbations at the expense of increased ICS use. However, the strategy is unlikely beneficial for improving asthma control. A larger study is required to confirm or refute our findings.

Preparation and in vitro evaluation of a polymer based controlled release dry powder inhaler formulation for pulmonary delivery

This thesis described the synthesis of an L-leucine conjugate of the biodegradable polymer, chitosan and its potential application for the development of controlled release nanoparticulate dry powder inhaler (DPI) formulations. The study demonstrated that the physicochemical properties of conjugated chitosan nanoparticles had favourable effects on the dispersibility and controlled release profile of a model drug. The toxicity profile of the nanoparticulate formulation revealed promising outcome for its use in pulmonary delivery. The chitosan conjugate produced in this project would be useful for the application of polymer nanoparticulate systems for efficient lung delivery of drugs.

The ENHANCES study--Enhancing Head and Neck Cancer patients' Experiences of Survivorship: study protocol for a randomized controlled trial

Background Few cancers pose greater challenges than head and neck (H&N) cancer. Residual effects following treatment include body image changes, pain, fatigue and difficulties with appetite, swallowing and speech. Depression is a common comorbidity. There is limited evidence about ways to assist patients to achieve optimal adjustment after completion of treatment. In this study, we aim to examine the effectiveness and feasibility of a model of survivorship care to improve the quality of life of patients who have completed treatment for H&N cancer. Methods This is a preliminary study in which 120 patients will be recruited. A prospective randomised controlled trial of the H&N Cancer Survivor Self-management Care Plan (HNCP) involving pre- and post-intervention assessments will be used. Consecutive patients who have completed a defined treatment protocol for H&N cancer will be recruited from two large cancer services and randomly allocated to one of three study arms: (1) usual care, (2) information in the form of a written resource or (3) the HNCP delivered by an oncology nurse who has participated in manual-based training and skill development in patient self-management support. The trained nurses will meet patients in a face-to-face interview lasting up to 60 minutes to develop an individualised HNCP, based on principles of chronic disease self-management. Participants will be assessed at baseline, 3 and 6 months. The primary outcome measure is quality of life. The secondary outcome measures include mood, self-efficacy and health-care utilisation. The feasibility of implementing this intervention in routine clinical care will be assessed through semistructured interviews with participating nurses, managers and administrators. Interviews with patients who received the HNCP will explore their perceptions of the HNCP, including factors that assisted them in achieving behavioural change. Discussion In this study, we aim to improve the quality of life of a patient population with unique needs by means of a tailored self-management care plan developed upon completion of treatment. Delivery of the intervention by trained oncology nurses is likely to be acceptable to patients and, if successful, will be a model of care that can be implemented for diverse patient populations.

Design of a least-cost battery-supercapacitor energy storage system for realizing dispatchable wind power

A statistical approach is used in the design of a battery-supercapacitor energy storage system for a wind farm. The design exploits the technical merits of the two energy storage mediums, in terms of the differences in their specific power and energy densities, and their ability to accommodate different rates of change in the charging/discharging powers. By treating the input wind power as random and using a proposed coordinated power flows control strategy for the battery and the supercapacitor, the approach evaluates the energy storage capacities, the corresponding expected life cycle cost/year of the storage mediums, and the expected cost/year of unmet power dispatch. A computational procedure is then developed for the design of a least-cost/year hybrid energy storage system to realize wind power dispatch at a specified confidence level.

Accelerometer validity and placement for detection of changes in physical activity in dogs under controlled conditions on a treadmill

The objective of the research was to determine the optimal location and method of attachment for accelerometer-based motion sensors, and to validate their ability to differentiate rest and increases in speed in healthy dogs moving on a treadmill. Two accelerometers were placed on a harness between the scapulae of dogs with one in a pouch and one directly attached to the harness. Two additional accelerometers were placed (pouched and not pouched) ventrally on the dog's collar. Data were recorded in 1. s epochs with dogs moving in stages lasting 3. min each on a treadmill: (1) at rest, lateral recumbency, (2) treadmill at 0% slope, 3. km/h, (3) treadmill at 0% slope, 5. km/h, (4) treadmill at 0% slope, 7. km/h, (5) treadmill at 5% slope, 5. km/h, and; (6) treadmill at 5% slope, 7. km/h. Only the harness with the accelerometer in a pouch along the dorsal midline yielded statistically significant increases (P< 0.05) in vector magnitude as walking speed of the dogs increased (5-7. km/h) while on the treadmill. Statistically significant increases in vector magnitude were detected in the dogs as the walking speed increased from 5 to 7. km/h, however, changes in vector magnitude were not detected when activity intensity was increased as a result of walking up a 5% grade. Accelerometers are a valid and objective tool able to discriminate between and monitor different levels of activity in dogs in terms of speed of movement but not in energy expenditure that occurs with movement up hill.

Modeling and position-sensorless control of a dual-airgap axial flux permanent magnet machine for flywheel energy storage systems

This paper presents the modeling and position-sensorless vector control of a dual-airgap axial flux permanent magnet (AFPM) machine optimized for use in flywheel energy storage system (FESS) applications. The proposed AFPM machine has two sets of three-phase stator windings but requires only a single power converter to control both the electromagnetic torque and the axial levitation force. The proper controllability of the latter is crucial as it can be utilized to minimize the vertical bearing stress to improve the efficiency of the FESS. The method for controlling both the speed and axial displacement of the machine is discussed. An inherent speed sensorless observer is also proposed for speed estimation. The proposed observer eliminates the rotary encoder, which in turn reduces the overall weight and cost of the system while improving its reliability. The effectiveness of the proposed control scheme has been verified by simulations and experiments on a prototype machine.

Direct integration of battery energy storage systems in distributed power generation

In this paper, a wind energy conversion system interfaced to the grid using a dual inverter is proposed. One of the two inverters in the dual inverter is connected to the rectified output of the wind generator while the other is directly connected to a battery energy storage system (BESS). This approach eliminates the need for an additional dc-dc converter and thus reduces power losses, cost, and complexity. The main issue with this scheme is uncorrelated dynamic changes in dc-link voltages that results in unevenly distributed space vectors. A detailed analysis on the effects of these variations is presented in this paper. Furthermore, a modified modulation technique is proposed to produce undistorted currents even in the presence of unevenly distributed and dynamically changing space vectors. An analysis on the battery charging/discharging process and maximum power point tracking of the wind turbine generator is also presented. Simulation and experimental results are presented to verify the efficacy of the proposed modulation technique and battery charging/discharging process.

Adipose tissue engineering based on the controlled release of fibroblast growth factor-2 in a collagen matrix

Adipose tissue forms when basement membrane extract (Matrigel™) and fibroblast growth factor-2 (FGF-2) are added to our mouse tissue engineering chamber model. A mouse tumor extract, Matrigel is unsuitable for human clinical application, and finding an alternative to Matrigel is essential. In this study we generated adipose tissue in the chamber model without using Matrigel by controlled release of FGF-2 in a type I collagen matrix. FGF-2 was impregnated into biodegradable gelatin microspheres for its slow release. The chambers were filled with these microspheres suspended in 60 μL collagen gel. Injection of collagen containing free FGF-2 or collagen containing gelatin microspheres with buffer alone served as controls. When chambers were harvested 6 weeks after implantation, the volume and weight of the tissue obtained were higher in the group that received collagen and FGF-2 impregnated microspheres than in controls. Histologic analysis of tissue constructs showed the formation of de novo adipose tissue accompanied by angiogenesis. In contrast, control groups did not show extensive adipose tissue formation. In conclusion, this study has shown that de novo formation of adipose tissue can be achieved through controlled release of FGF-2 in collagen type I in the absence of Matrigel.

A protocol for a pragmatic randomized controlled trial evaluating outcomes of emergency nurse practitioner service

Aim To evaluate emergency nurse practitioner service effectiveness on outcomes related to quality of care and service responsiveness. Background Increasing service pressures in the emergency setting have resulted in the adoption of service innovation models; the most common and rapidly expanding of these is the emergency nurse practitioner. The delivery of high quality patient care in the emergency department is one of the most important service indicators to be measured in health services today. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this model in outcomes related to safety and quality of patient care. Design Pragmatic randomized controlled trial at one site with 260 participants. Methods This protocol describes a definitive prospective randomized controlled trial, which will examine the impact of emergency nurse practitioner service on key patient care and service indicators. The study control will be standard emergency department care. The intervention will be emergency nurse practitioner service. The primary outcome measure is pain score reduction and time to analgesia. Secondary outcome measures are waiting time, number of patients who did not wait, length of stay in the emergency department and representations within 48 hours. Discussion Scant research enquiry evaluating emergency nurse practitioner service on patient effectiveness and service responsiveness exists currently. This study is a unique trial that will test the effectiveness of the emergency nurse practitioner service on patients who present to the emergency department with pain. The research will provide an opportunity to further evaluate emergency nurse practitioner models of care and build research capacity into the workforce.

A natural oil-based emulsion containing allantoin versus aqueous cream for managing radiation-induced skin reactions in patients with cancer : a phase III double-blind randomised controlled trial

Purpose To investigate the effects of a natural oil-based emulsion containing allantoin versus aqueous cream for preventing and managing radiation induced skin reactions (RISR). Methods and Materials A total of 174 patients were randomised and participated in the study. Patients either received Cream 1 (the natural oil-based emulsion containing allantoin) or Cream 2 (aqueous cream). Skin toxicity, pain, itching and skin-related quality of life scores were collected for up to four weeks after radiation treatment. Results Patients who received Cream 1 had a significantly lower average level of Common Toxicity Criteria at week 3 (p<0.05), but had statistically higher average levels of skin toxicity at weeks 7, 8 and 9 (all p<0.001). Similar results were observed when skin toxicity was analysed by grades. With regards to pain, patients in the Cream 2 group had a significantly higher average level of worst pain (p<0.05) and itching (p=0.046) compared to the Cream 1 group at week 3, however these differences were not observed at other weeks. In addition, there was a strong trend for Cream 2 to reduce the incidence of grade 2 or more skin toxicity in comparison to Cream 1 (p=0.056). Overall, more participants in the Cream 1 group were required to use another topical treatment at weeks 8 (p=0.049) and 9 (p=0.01). Conclusion The natural oil-based emulsion containing allantoin appears to have similar effects for managing skin toxicity compared to aqueous cream up to week 5, however, it becomes significantly less effective at later weeks into the radiation treatment and beyond treatment completion (week 6 and beyond). There were no major differences in pain, itching and skin-related quality of life. In light of these results, clinicians and patients can base their decision on costs and preferences. Overall, aqueous cream appears to be a more preferred option.

A smoking cessation intervention for people with chronic Hepatitis C : a randomised controlled trial

Purpose The purpose of this study was to examine the validity of current practice in smoking cessation for the general population i.e., a telephone counselling and nicotine replacement therapy (NRT) intervention and its applicability to people with chronic hepatitis-C. Methods A randomised controlled trial was conducted over twelve weeks. Following consent, ninety-two smokers (outpatients) with chronic hepatitis-C were recruited by the Nurse Practitioner hepatology, randomly assigned and stratified by number of cigarettes smoked (i.e., 15 and greater; <15) into the intervention group (telephone counselling and NRT) and control group (telephone counselling). Outcomes measured included socio-demographics, nicotine dependence, depression, anxiety and stress and quality of life (QOL). All statistical data were analysed using SPSS. Results After 12 weeks, the intervention group showed a sustained reduction of smoking i.e., 5.8(CI: 2.4,9.3) cigarettes less per day, whereas the control group showed 1.6(CI:-1.9,5.2) cigarette reduction. Although not statistically significantly different (F=2.9, p=0.090) the intervention group on average smoked 4.2 fewer cigarettes compared to the control group. After twelve weeks, seven patients in the intervention group and three patients in the control group reported quitting. Whilst not statistically significant (Fisher’s Exact, p=0.311) this was a clinically significant result. No differences were found for nicotine dependence or depression, anxiety and stress. The intervention group experienced no change in QOL (-0.1,CI:-0.9, 0.6), however, the environmental score for the control group decreased by 1.8(CI:1.0, 2.6,p= 0.001). This was statistically significant. Conclusion A telephone counselling and nicotine replacement therapy intervention from the nurse practitioner, hepatology reduced smoking in patients with chronic hepatitis-C. The intervention group showed a sustained reduction over the 12 weeks. A total of 10 patients quit smoking at the end of the study. QOL deteriorated in the environmental subscale for the control group. These results informed a nurse practitioner model of care for approaches to smoking cessation.

Promoting resilience in children with intellectual disability : a randomized controlled trial in Australian schools

Children with intellectual disability are more vulnerable to adverse developmental outcomes because of the lifelong risks associated with cognitive impairment. Difficulties with learning and adaptive behaviour inevitably produce considerable personal, social and economic disadvantage. Of concern is consistent evidence that psychiatric disorders affect a substantial proportion of people with intellectual disability. The estimated prevalence rate of between 35 and 49 % is three times that found in the general population (Wallander, Dekker, & Koot, 2006). Until recently, mental illness has been relatively neglected for people with intellectual disability, especially in relation to prevention or early detection (Kolaitis, 2008) and most research to date has been descriptive rather than focused on intervention (Bouras, 2013). Yet a considerable body of evidence demonstrates that efficacious interventions do exist for preventing psychopathology and enhancing resilience in typically developing children and adolescents (see Mallin, Walker, & Levin, 2013 for a review). In order to prevent the high comorbidity of intellectual disability and psychopathology, there is a compelling need for evidence-based practices that promote the resilience of individuals with intellectual disability (Matson, Terlonge, & Minshawi, 2008). In this chapter, we describe a randomized controlled trial of an intervention that was designed to enhance the resilience of a group of children with mild intellectual disability as they prepared to make the transition to high school. We report results from our evaluation of this intervention, and reflect on the difficulties of providing successful interventions for children whose lives are complicated not only by intellectual disability, but also by a range of contextual disadvantages.

Исследования и испытания алгоритмов автоматической пилотажно-навигационной системы малогабаритного беспилотного летательного аппарата = Research and testing of automatic navigation management system’s algorithms for small unmanned aerial vehicle

В статье представлено развитие принципа построения автоматической пилотажно-навигационной системы (АПНС) для беспилотного летательного аппарата (БЛА). Принцип заключается в синтезе комплексных систем управления БПЛА не только на основе использования алгоритмов БИНС, но и алгоритмов, объединяющих в себе решение задач формирования и отработки сформированной траектории резервированной системой управления и навигации. Приведены результаты аналитического исследования и данные летных экспериментов разработанных алгоритмов АПНС БЛА, обеспечивающих дополнительное резервирование алгоритмов навигации и наделяющих БЛА новым функциональной способностью по выходу в заданную точку пространства с заданной скоростью в заданный момент времени с учетом атмосферных ветровых возмущений. Предложена и испытана методика идентификации параметров воздушной атмосферы: направления и скорости W ветра. Данные летных испытаний полученного решения задачи терминальной навигации демонстрируют устойчивую работу синтезированных алгоритмов управления в различных метеоусловиях. The article presents a progress in principle of development of automatic navigation management system (ANMS) for small unmanned aerial vehicle (UAV). The principle defines a development of integrated control systems for UAV based on tight coupling of strap down inertial navigation system algorithms and algorithms of redundant flight management system to form and control flight trajectory. The results of the research and flight testing of the developed ANMS UAV algorithms are presented. The system demonstrates advanced functional redundancy of UAV guidance. The system enables new UAV capability to perform autonomous multidimensional navigation along waypoints with controlled speed and time of arrival taking into account wind. The paper describes the technique for real-time identification of atmosphere parameters such as wind direction and wind speed. The flight test results demonstrate robustness of the algorithms in diverse meteorological conditions.