New Methods And Guidelines For The Design, Analysis And Reporting Of Cluster-crossover And Stepped Wedge Randomised Trials In Clinical And Public Health Research
Funder
National Health and Medical Research Council
Funding Amount
$391,258.00
Summary
Cluster crossover and stepped wedge designs have emerged recently as study designs used in clinical and public health research settings. However, despite their use there has been very little methodological assessment of the statistical analysis methods used in current practice. The proposed research will assess the correctness of current methods and will produce a toolkit of state-of-the art, defensible trial design, analysis and reporting methods for the clinical/health researcher.
Plasma Exchange And Glucocorticoids In ANCA Associated Vasculitis: A Randomised Controlled Trial (PEXIVAS Australia)
Funder
National Health and Medical Research Council
Funding Amount
$635,243.00
Summary
Vasculitis is a life-threatening disease, and the current treatment for this condition is not satisfactory. This clinical trial aims to determine 1) if plasma exchange can lower mortality and the development of severe kidney failure due to this disease, and 2) if the use of lower doses of corticosteroids can lessen the infectious complications of treatment. This trial is part of a major international effort which will involve a total of 500 patients from Australia, UK, Europe, USA and NZ.
Large-scale Randomised Evidence: The Reliable Detection Or Refutation Of Treatment Effects Through Large, Simple Randomised Trials And Collaborative Meta-analyses Of Trials Using Individual Participant Data
Funder
National Health and Medical Research Council
Funding Amount
$425,897.00
Summary
Randomised controlled trials are the most reliable scientific method of studying medical treatments. Well-designed trials are thus needed to confidently guide doctors, other health professionals and policy-makers, particularly for common conditions such as cardiovascular disease. This Fellowship will study how we can better prevent and treat cardiovascular disease through the design, conduct and analysis of such trials at the University of Oxford, a world-leader in randomised controlled trials.
A Randomised Placebo-controlled Crossover Trial Of Micronised Resveratrol As A Treatment For Friedreich Ataxia
Funder
National Health and Medical Research Council
Funding Amount
$556,287.00
Summary
Friedreich ataxia (FRDA) is the most common inherited cause of ataxia (incoordination). There are currently no treatments proven to slow or reverse its inexorable progression. We have shown that resveratrol holds promise as a treatment in an open-label study and now propose a placebo controlled study that will provide evidence of whether resveratrol can slow or reverse symptoms in this devastating disorder.
Multi-centre RDBC Trial Of Oxygen Vs Air For Relief Of Breathlessness In Terminally-ill Patients With Intractable Dyspno
Funder
National Health and Medical Research Council
Funding Amount
$149,701.00
Summary
This study will compare the effects of oxygen and air in the relief of breathlessness in patients at the end of life who do not currently qualify for home oxygen. This landmark study will provide accurate information about any benefits that oxygen offers for breathlessness in this setting. This international multi-site study will ask 226 people to participate using either oxygen or air for 7 days while keeping a diary. We will measure breathlessness, quality of life, anxiety and side effects exp ....This study will compare the effects of oxygen and air in the relief of breathlessness in patients at the end of life who do not currently qualify for home oxygen. This landmark study will provide accurate information about any benefits that oxygen offers for breathlessness in this setting. This international multi-site study will ask 226 people to participate using either oxygen or air for 7 days while keeping a diary. We will measure breathlessness, quality of life, anxiety and side effects experienced.Read moreRead less
A Randomised Controlled Trial Of The Effect Of Hydrocortisone On Mortality In Critically Ill Patients With Septic Shock
Funder
National Health and Medical Research Council
Funding Amount
$3,432,452.00
Summary
This study performed across Australia and New Zealand will evaluate whether hydrocortisone, a cheap drug when administered to critically ill patients with severe infection, will save lives.
Ketamine Therapy Among Patients With Treatment-resistant Depression: A Randomised, Double-blind, Placebo-controlled Trial
Funder
National Health and Medical Research Council
Funding Amount
$2,069,382.00
Summary
In the last decade, there have been reports of powerful antidepressant effects after a single injection of anaesthetic ketamine, with dramatic (though shortlasting) effects within 24 hours. This will be the first controlled study to test whether a course of repeated ketamine treatments, given over 4 weeks, is effective and safe in treating depression.
Enhancing Efficacy Of Cognitive Behavioural Treatment For Children With Anxiety Disorders: Treating Parent Anxiety.
Funder
National Health and Medical Research Council
Funding Amount
$377,961.00
Summary
Much attention is focused on childhood problems such as attention-deficit, depression and substance abuse. However, the most prevalent psychological problem experienced in childhood is anxiety. There is even some evidence to suggest that anxiety may lead to later problems such as depression or substance abuse. We know that anxiety disorders are a widespread problem in our youth. We also know that anxiety, if left untreated, will persist through the child's life and cause significant disruption t ....Much attention is focused on childhood problems such as attention-deficit, depression and substance abuse. However, the most prevalent psychological problem experienced in childhood is anxiety. There is even some evidence to suggest that anxiety may lead to later problems such as depression or substance abuse. We know that anxiety disorders are a widespread problem in our youth. We also know that anxiety, if left untreated, will persist through the child's life and cause significant disruption to their life. The good news is that there has been an increased interest in these disorders and as a result treatments that work have been developed. However, a recent review of the best psychological treatments for anxiety in children showed that on average studies are reporting remission rates of only 56.5%. Clearly we need to develop more effective treatments for anxious children. One possible approach to improve outcomes for children with anxiety is to provide additional treatment for the parents. We know that anxiety runs in families: anxious children are more likely than non-anxious children to have anxious parents. A number of theories have suggested that parental anxiety plays an important role in the development of anxiety in children: An anxious parent may model anxious behaviour, encourage avoidance of anxious situations and reinforce anxious behaviour in their child. The results of this study will determine whether it is possible to improve the efficacy of treatments for anxiety in children by addressing anxiety in their parents. If the data show no additional benefit of the modified treatment, therapists can be more efficient in their treatment of anxious children by ignoring the parent's own anxiety. However, if as expected the modified treatment proves to be more efficacious, then we will have identified an important strategy to increase the efficacy of intervention for this highly prevalent and debilitating childhood problem.Read moreRead less
Knee osteoarthritis (OA) affects about 30% of Australians over the age of 65, but also at younger ages. It causes joint pain and stiffness, especially on exercise. The cause is unknown but it results in loss of joint cartilage. There are few treatments available to stop the progression, which can finally result in need for an artificial joint. Most treatments such as paracetamol and non-steroid anti-inflammatory drugs (NSAIDs) reduce pain but have no effect on cartilage. NSAIDs can have serious ....Knee osteoarthritis (OA) affects about 30% of Australians over the age of 65, but also at younger ages. It causes joint pain and stiffness, especially on exercise. The cause is unknown but it results in loss of joint cartilage. There are few treatments available to stop the progression, which can finally result in need for an artificial joint. Most treatments such as paracetamol and non-steroid anti-inflammatory drugs (NSAIDs) reduce pain but have no effect on cartilage. NSAIDs can have serious side effects such as stomach ulcers and increased cardiovascular events (such as heart attacks). Fish oil has possible benefits in OA as it decreases pain and inflammation in rheumatoid arthritis (RA, another type of arthritis with joint inflammation and swelling), less use of NSAID in patients with RA, and in laboratory experiments may reduce cartilage breakdown in OA. It is likely that fish oil will have few side effects and decrease blood cholesterol. Many people with OA are already taking fish oil, however, there is no studies to know if it is effective in OA. The aim of this proposal is to study the effect of fish oil on pain and progression of knee OA, by doing a randomised clinical trial. Participants with knee OA will be given either high dose fish oil or similar oil with low levels of fish oil. The study will run for 2 years and during that time, we will measure pain and blood levels of fatty acids (part of the fish oil) and cholesterol. At the beginning and end of the study, magnetic resonance imaging (MRI) of the knee, a knee xray, and bone density testing will be done. The outcomes of the study will be to determine if fish oil affects pain and function (measured by questionnaires) and progression of OA (measured by cartilage changes on MRI). If fish oil is shown to reduce pain and disability and cartilage loss in OA, it will provide Australians with OA an alternative treatment that is low in side effects with positive effects on cardiovascular disease.Read moreRead less
The Trans Tasman Radiation Oncology Group is an experienced research group conducting cancer clinical trials involving radiotherapy (RT) in order to improve cure rates, quality of life and to reduce side-effects of treatment. Fifty per cent of all cancer patients need RT as part of their treatment. The aim of the proposal is to strengthen the quality and safety of RT trials by (a) enabling rapid review and checking of treatment by electronic means and (b) improve trial design.