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 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.
VITATOPS - A Randomised Controlled Trial Of Vitamins To Prevent Stroke
Funder
National Health and Medical Research Council
Funding Amount
$391,364.00
Summary
A high level of a normal protein component in the blood (homocysteine) is fast becoming recognised as a new risk factor for premature stroke and heart disease, although it remains uncertain whether treatment with vitamins can prevent these diseases from occurring. VITATOPS is a multi-centre, double-blind, placebo-controlled trial designed to examine the efficacy and safety of multi-vitamin therapy (folate, B6 and B12) in the prevention of stroke and other types of vascular disease. The VITATOPS ....A high level of a normal protein component in the blood (homocysteine) is fast becoming recognised as a new risk factor for premature stroke and heart disease, although it remains uncertain whether treatment with vitamins can prevent these diseases from occurring. VITATOPS is a multi-centre, double-blind, placebo-controlled trial designed to examine the efficacy and safety of multi-vitamin therapy (folate, B6 and B12) in the prevention of stroke and other types of vascular disease. The VITATOPS study arises from a large body of consistent, biologically plausible evidence linking homocysteine in a dose-dependent fashion to stroke and other types of vascular disease. A simple, non-toxic, and inexpensive intervention in the form of multivitamins (folate, B6 and B12) has been shown to be highly effective at reducing homocysteine levels, irrespective of the underlying cause. All patients who are referred to a neurologist or general physician in one of the collaborating centres within six months of a stroke or transient ischaemic attack are eligible for the trial. In total, treatment will continue for a period of between 1 and 5 years. During this time, patients will be closely monitored in order to record the occurrence of any vascular events (particularly strokes and heart attacks). Neither the study investigator nor the patient will know which treatment they are receiving (i.e. it is 'double blind'). The number of vascular events in the treatment groups will be compared at the end of the study in order to determine whether vitamin treatment is beneficial. This application is for five years of support to allow the investigators to move from the pilot phase of VITATOPS in Perth to begin recruitment to the definitive trial in other centres across Australia and New Zealand. This study may have a major impact on patient management. If vitamins prove to be effective, we may recommend vitamin supplementation to all of our stroke patients in the future.Read moreRead less
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.
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