ANZCTR search results

The proposed study will help resolve a long-running controversy in women’s health. For the first time in Australia, it will provide longitudinal (12-year) data abut the relationship between the rate of increase in arterial stiffness in women (a known risk factor for cardiovascular disease) and the withdrawal of oestrogen through the menopausal transition

Atrial fibrillation (AF) is the most common heart arrhythmia, affecting 1 in 4 adults worldwide, and at least 240,000 Australians. Prevalence rises with age from approximately 1% of the whole population to 5% in those over 65 years. People with AF are up to seven times more likely to have a stroke than the general population. Almost one in every three strokes is AF-related, and AF-related strokes are likely to be more severe, with a whole of life cost of each stroke estimated at $103,566. However, strokes in AF can be effectively prevented using oral anticoagulants. Unfortunately in Australia oral anticoagulant prescription is only about 60% even in those patients with known AF who are therefore at high risk for stroke. This gap has been difficult to close despite having therapeutic management guidelines. Many people in the general population are unaware that they have AF, with first diagnosis being made when they are admitted to hospital with a stroke or transient ischaemic attack. The diagnosis of unknown AF can be easily made using a 30 second ECG rhythm strip obtained with a TGA approved smartphone ECG (iECG). Using this device, unknown AF can be identified and treated, thus reducing the number of strokes due to AF. We have previously shown that community screening for AF to prevent stroke is likely to be cost-effective, but the magnitude of the benefit in terms of numbers of strokes prevented, is determined by the proportion of the population screened. This study therefore explores screening for AF in rural primary care, by performing iECG screening for patients attending their general practice. Screening will be offered by practice nurses during annual influenza vaccination (currently administered to over 70% of patients aged 65 or over in general practice) and during annual chronic care assessments such as Diabetes Cycle of Care and Health Assessment for People Aged 75 and Older. General practitioners will also opportunistically screen patients. This opportunistic method of screening, through its reach, could approximate systematic population screening for AF. Screening will be performed in 10 practices across rural NSW to gauge and efficacy and cost effectiveness of community-based AF screening. In addition to the handheld iECG device, this study will also implement the electronic decision support software called HealthTracker-CVD. A special AF module has been designed as part of this software to automatically calculate the stroke risk score for patients with AF, and provide individualised advice on evidence-based management of AF. An automated tool such as this available to both general practitioners and practice nurses is ideal to facilitate closing the gap in oral anticoagulant prescription for stroke prevention in patients with diagnosed AF.

Venous leg ulcers and stasis ulcers are chronic wounds associated with poor circulation in the leg. Despite treatment some of these wounds fair to heal, or persist over many weeks, months or years. This pilot study aims to assess feasibility of a larger study investigating the use of a silver eluting cellulose/collagen matrix (PROMOGRAN PRISMA®) on hard to treat wounds. Patients with venous leg or stasis ulcers that is slow to heal will be treated with PROMOGRAN PRISMA® in conjunction with compression therapy and standard wound care weekly for 6 weeks, and followed up for a further 6 weeks. The study will measure the number of patients recruited in a 4-month period, number of patients competing the study, number of healed wounds after 12 weeks of follow up, wound surface area reduction over 12 weeks, change in percentage of the wound covered by slough, change in ankle and calf measurements and the amount of pain patients have at clinic visits.

OME is the most common cause of hearing loss in childhood. When persistent, and particularly bilateral, the hearing loss resulting from OME has been associated with language delay, poor educational achievement and behavioural and developmental concerns. Aboriginal and Torres Strait Islander children have the highest rate of persistent, severe and complicated otitis media described in the literature. Persistent bilateral OME is the usual reason for surgical insertion of tympanostomy tubes (‘grommets’), the second most common cause of surgical admission to hospital for children in Australia. The net cost of otitis media in Australia in 2008 was estimated to be over one billion dollars. Given the high health and cost burden of OME, a simple low cost management option is urgently needed. Standard care for OME is initial observation, followed by referral for hearing assessment if bilateral OME persists at 3 months, surgical management with tympanostomy tubes (‘grommets’) and treatment for hearing impairment are considered. Unfortunately, in addition to being costly, tympanostomy tubes have lower success rates in Aboriginal children and can be associated with chronic ear discharge in up to 50% of this group, resulting in more hearing loss than prior to surgery. Long term antibiotics are another treatment option for prolonged OME, but have low efficacy and carry the significant risk of promoting antibiotic resistance. This study proposes the use of Otovent® nasal balloon autoinflation device, as a low cost, simple means of mechanically treating OME. High pressure exhaled air, forcibly opens the Eustachian tube (connecting the middle ear and the back of the nose), by blowing up a balloon through each nostril with the mouth closed. This re-introduces air into the middle ear space and allows the fluid to drain away. It has recently been recommended by the Royal Australian College of General Practitioners for use in OME, whilst results in non-Aboriginal children are inconclusive, the Otovent has never been tested in Aboriginal and Torres Strait Islander children. The INFLATE Trial will use RCT evidence to determine whether nasal balloon autoinflation increases resolution of OME in Aboriginal and Torres Strait Islander children at 1 month. The test group will use Otovent® 3 times daily as recommended by the product manufacturer. Duration of treatment in this study will be for a minimum of 1 to maximum of 3 months (if OME persists), in accordance with the current recommended treatment period, The comparator group will consist of standard care, that is, observation only, followed by referral for ENT assessment if reduced hearing or bilateral OME is detected at 3 Months.

Exercise in type 1 diabetes may lead to increased variability in glucose levels and hypoglycaemia. Glucose management around exercise may be therefore challenging for people living with in type 1 diabetes and prevent them from undertaking exercise. At the same time, there was deficiency of easily accessible information to help stabilise glycaemia around exercise and prevent hypoglycaemia in type 1 diabetes. The aim of the trial was to establish whether educational online tool: ext1d may reduce hypoglycaemia following exercise. This educational website was developed specifically for people with type 1 diabetes and was based on current literature recommendations. It consists of several learning modules. The educational modules discussed the glycaemia secondary to exercise and suggested insulin adjustment and carbohydrate supplementation. Topics included: increased insulin sensitivity following exercise and the role of hormones regulating glucose levels around exercise; dose reduction and timing of meal bolus and/or temporary basal insulin for a given exercise, additional carbohydrate type and amount in relation to exercise. Participants were asked to review the learning modules on glucose management in type 1 diabetes in relation to exercise. Participants chose recommendations related to exercise and stabilising glucose, that best suited them and then incorporated those recommendations into their usual exercise routine. Participants were encouraged to utilise the online tool ‘dashboard’ which suggests possible individualised insulin dose tailoring, typically an exercise-related reduction, as well as carbohydrate supplementation amount for a given exercise regimen. The study design was a prospective randomised controlled trial with crossover of the Control group into the Intervention. Following a baseline CGM Study Period (CGM1) participants underwent computer randomisation and were assigned to either the Control or the Intervention group. During the following 5-week period participants in the Intervention group accessed the website and the Control group continued with usual care. Subsequently, all participants underwent a second CGM Study Period (CGM2). This was followed by the second 5-week period during which the Intervention group continued with the website viewing and education and the Control group gained access to the website, in the partial cross-over design. The second five-week period concluded the trial with CGM Study Period (CGM3). During each CGM period participants wore continuous glucose monitoring system (Medtronic iPro2) to monitor for exercise and non- exercise related hypoglycaemia. Hypoglycaemia data was based on continuous glucose monitoring system output. For a primary outcome, the exercise-related hypoglycaemia data, was compared between the Intervention group which already had access to the educational modules for 5 weeks and the Control group, which did not have access to the educational modules in the past 5 weeks.

Clinical management of asthma involves tailoring medication to minimise the frequency and intensity of symptoms and prevent exacerbations. However, management is currently based on subjective patient recall of symptoms, rather than objective and personalised measures of current status and predictors of future risk of exacerbations. A potential solution may be offered by daily home monitoring using Forced Oscillation Technique (FOT), which patients can measure unsupervised at home due to its ease of use compared to peak flow or spirometry. We have shown potential clinical utility of advanced analyses to study the day­-to­day variability in lung function in asthma in a series of retrospective studies, including the ability to predict future exacerbations within a month in an individual. This project aims to adapt such analyses to FOT data as the basis of a home telemonitoring system, and initiate a prospective study investigating the potential benefit of long-­term FOT home monitoring in Australian patients with both well­-controlled and uncontrolled asthma. We aim to show that FOT variability (i) predicts occurrence of exacerbations, (ii) is related to asthma control, and (iii) is sensitive to treatment changes. We will demonstrate this by studying moderate-to-severe asthma patients in a pragmatic, observational study in well­-controlled asthma patients who are being considered for reduction of their inhaled corticosteroid treatment dose. Treatment is initiated by the physician according to Australian guidelines independent of participation in the study, and we will study these relationships regardless of the nature of treatment. We will monitor unsupervised FOT measurements and symptoms over a period of 10-­24 weeks. Data will be uploaded automatically via mobile internet to encrypted servers and regularly checked for quality. We will also monitor exacerbations and asthma control via weekly telephone interviews and questionnaires. From these results, we eventually hope to develop an automated alert system which can signal to the patient whether or not they are about to deteriorate and to initiate self-treatment, enabling them to gain control of their disease.

EUS guided fine-needle aspiration (FNA) or fine-needle biopsy (FNB) is a well-established and accurate method of obtaining tissue for the diagnosis of intra-abdominal or mediastinal lesions. Initial findings, have suggested that rapid on-site evaluation (ROSE) using cytological smears (with or without cell block preparation) has the biggest impact with increased diagnostic accuracy and reduced needle passes. However, newer evidence has brought the value of ROSE into question. Recent reports show conflicting results on whether ROSE actually does influence outcome in EUS FNA. Also a recent meta-analysis suggests that ROSE may not result in higher diagnostic yield, specimen adequacy or pooled sensitivity and specificity. The utilization of cell blocks or direct histological processing to prepare FNA specimens, involve placing all needle contents into liquid fixative and therefore do not require ROSE. Reports show high diagnostic yield with both, exceeding 89%. These also avoid the need for smear preparation, which requires training and can result in inadvertent loss of diagnostic material. Prospective randomised data comparing these techniques is lacking and therefore the best method for preparing EUS FNA specimens is unknown. We hypothesize that without ROSE, direct histology or cell block is the tissue preparation technique of choice, as smearing often has low diagnostic yield and may result in loss of diagnostic material. The aim of this study is to compare the diagnostic yield of the different methods for EUS FNA/FNB specimen processing in a randomized fashion and to identify the most optimal method of tissue preparation in the absence of ROSE. All patients who were referred to our unit for EUS guided FNA of a solid mass or lymph nodes in or adjacent to the upper GI tract over an 8-month period were prospectively recruited for the study.

Paediatric distal forearm fractures, usually of the radius, are a common presentation to the emergency department (ED). Buckle, or torus, fractures occur in children due to the deformation of their soft bone, without breech of cortex. The gold standard for diagnosis of these fractures is x-ray imaging, which can then be effectively treated with a wrist splint. It has also been demonstrated that they can be accurately diagnosed by a rapid ultrasound protocol that can be easily learnt. Ultrasound is not typically utilised in this fashion in a tertiary paediatric ED due to readily available x-ray imaging. However, regional services often have limited radiographic services after-hours. Nurse practitioners (NPs) are frontline workers in the ambulatory care area of the ED where they are heavily relied upon for the diagnosis and management of paediatric fractures. If it can be demonstrated that NPs with limited ultrasound experience can diagnose distal forearm buckle fractures with high accuracy after a short training course, there may be validity in similar front-line workers being trained in this modality in resource-limited environments. This pilot study will determine the acceptability, tolerability (pain compared to radiograph), feasibility (time of scan), and the accuracy of NPs to diagnose buckle fractures using ultrasound compared to radiograph as the gold standard. The results from the pilot study would be used to inform the development of a larger multi-centre research project that incorporates regional sites.

This project seeks to improve and maintain the oral health of people who move into residential aged care by providing an objective way to document they are receiving effective oral care. The project developed as the result of a suggestion by staff at a residential care community in northern Tasmania (Australia) during their participation in a current federally-funded initiative with researchers at the University of Tasmania. The purpose of this project is to determine the impact of a 6-week period of 2-minutes of teeth cleaning after meals, or daily denture cleaning, on the type and load of oral bacteria in the mouths of residents. The hypothesis is that the 6-week intervention will lead to a change in the type and load of oral bacteria, increase residents' oral health, and reduce their risk of aspiration pneumonia.

Anaemia, a global public health problem, is common in developing and developed countries, particularly among hospitalized patients. The World Health Organization defines anaemia as a haemoglobin concentration below 130 grams per litre in males and 120 grams in litre in females. A recent systematic review and meta-analysis on preoperative anaemia and outcomes after cardiac and non-cardiac surgery reported 39% of patients were admitted anaemic. These anaemic patients had three-fold higher odds of mortality, four-fold higher odds of acute kidney injury and twice the odds of infection. Not surprisingly, anaemia was also associated with increased transfusion, with anaemic patients five-times more likely to receive a red blood cell transfusion. As these results indicate, red blood cell transfusions are often administered to correct low haemoglobin levels. However, correcting anaemia with transfusion is problematic as red blood cell transfusion has a dose-dependent association with increased mortality, morbidity, hospital and ICU length of stay, readmissions, and cost. Large risk-adjusted observational studies demonstrate that even transfusing a single unit of red blood cells is associated with increased adverse outcomes in surgical patients, thus recommending caution before transfusing. In an attempt to find the “optimal” transfusion threshold, many randomized controlled trials have investigated the difference between using restrictive pre-transfusion haemoglobin thresholds compared with liberal thresholds. A restrictive strategy refers to a policy of administering red blood cell transfusions at comparatively lower pre-defined haemoglobin levels, with the goal of minimizing the use of blood. Though not always the case, restrictive transfusion thresholds are often defined as haemoglobin levels between 70 grams per litre and 80 grams per litre and liberal transfusion thresholds are commonly defined as haemoglobin levels between 90 grams per litre and 100 grams per litre. A recent systematic review and meta-analysis published in the Cochrane Library concluded there is no difference in morbidity or mortality between restrictive and liberal transfusion strategies. However, these trials are often confounded by transfusions administered pre-randomization, a lack of comparable transfusion dosing regimens between studies, and at times small differences in actual mean pre-transfusion haemoglobin levels between control and intervention arms. In addition, these randomized controlled trials do not address transfusion efficacy and still leave many important questions unanswered. For example, whether haemoglobin thresholds lower than 70 grams per litre are just as effective as haemoglobin levels higher than 70 grams per litre. Some have suggested lower haemoglobin thresholds may be just as effective. The aim of this study is to determine what effect red blood cell transfusion has on mortality and length of stay at various levels of nadir haemoglobin.