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.
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
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
A Controlled Trial Of Topical Lavender Oil As A Treatment Of Behavioural Symptoms Of Dementia
Funder
National Health and Medical Research Council
Funding Amount
$211,179.00
Summary
Many nursing home residents with dementia have challenging behavioural symptoms. This study will test if pure lavender oil, when massaged onto the forearms of confused nursing home residents, relieves their agitation better than a placebo oil. Researchers will measure residents' behaviour directly and will not be aware which oil is being applied.
Fluid resuscitation is widely used in the management of critically ill patients. There are a variety of different fluids available to doctors but there is little evidence regarding how effective they are. One of the most commonly used fluids, a hydroxyethyl starch was recently approved by the TGA for use in Australia. This project aims to compare how effective and safe this fluid is compared to another widely used fluid, saline, for resuscitation of critically ill patients in intensive care.
Efficacy And Cost-effectiveness Of Physiotherapy For Chronic Rotator Cuff Pathology
Funder
National Health and Medical Research Council
Funding Amount
$384,675.00
Summary
Shoulder disorders are common, being third only to back and neck complaints as musculoskeletal reasons for medical consultation and accounting for 10% of all physiotherapy referrals. The painful shoulder affects up to 2-5% of the general population, being more common in middle to older age. One of the most common shoulder disorders is chronic rotator cuff pathology. This causes significant pain and disability that restricts activities of daily living as well as work, sleep and leisure. Forty per ....Shoulder disorders are common, being third only to back and neck complaints as musculoskeletal reasons for medical consultation and accounting for 10% of all physiotherapy referrals. The painful shoulder affects up to 2-5% of the general population, being more common in middle to older age. One of the most common shoulder disorders is chronic rotator cuff pathology. This causes significant pain and disability that restricts activities of daily living as well as work, sleep and leisure. Forty percent of sufferers will continue to have symptoms beyond 3 years and 15% will have persistent disability which may require surgical intervention. Because this disorder is prevalent, it imposes a considerable burden on the Australian health care system. Physiotherapy is a common conservative treatment option but its efficacy has not been well established. A recent Cochrane review of the literature revealed several problems with many of the existing studies: (i) the populations have included a mix of shoulder diagnostic categories; (ii) the research designs have major flaws and (iii) a single physiotherapy modality has been evaluated rather than a combined program as is current clinical practice. Thus, this novel research project involving 200 participants will answer important questions about the efficacy of a physiotherapy program for chronic rotator cuff pathology and whether benefits can be maintained. In addition it will determine whether the costs of physiotherapy represent good value for money which is important in today's economic climate. The results of this project can be easily and immediately translated into clinical practice as recommendations can be made about the usefulness of physiotherapy for this patient population. The results will be of major benefit not just to the physiotherapy profession but to the medical profession who must justify patient referral to physiotherapy and to funding and compensable bodies.Read moreRead less
Efficacy Of Physiotherapy After Hydrodilatation For The Painful Stiff Shoulder: A Randomised Placebo-controlled Trial
Funder
National Health and Medical Research Council
Funding Amount
$269,020.00
Summary
Shoulder disorders are common, being third only to back and neck complaints as musculoskeletal reasons for medical consultation and they account for 10% of all physiotherapy referrals. The stiff painful shoulder affects up to 2-5% of the general population, being more common in middle age and diabetes. It causes significant pain and disability that restricts activities of daily living as well as work and leisure. Forty percent of sufferers will continue to have symptoms and restricted movements ....Shoulder disorders are common, being third only to back and neck complaints as musculoskeletal reasons for medical consultation and they account for 10% of all physiotherapy referrals. The stiff painful shoulder affects up to 2-5% of the general population, being more common in middle age and diabetes. It causes significant pain and disability that restricts activities of daily living as well as work and leisure. Forty percent of sufferers will continue to have symptoms and restricted movements beyond 3 years and 15% will have persistent disability. Because this disease is prevalent, it imposes a considerable burden on the Australian health care system. Shoulder hydrodilatation is a common conservative treatment option that has been shown by our research group to have short-term but not long-term benefits. Physiotherapy may be prescribed following hydrodilatation on the basis that it may maintain the initial benefits seen with hydrodilatation. However, there are no studies to either support or refute this hypothesis. Thus, this novel research project will answer important questions about the efficacy of a physiotherapy program in addition to hydrodilatation for the stiff painful shoulder. We will determine whether physiotherapy offers a benefit over hydrodilatation alone and if so, whether this benefit is sustained. In addition we will determine whether the additional costs of physiotherapy represent good value for money. The results of this project can then be easily and immediately translated into clinical practice as recommendations can be made about the usefulness of physiotherapy for this patient population. The results will be of major benefit not just to the physiotherapy profession but to the medical profession who must justify patient referral to physiotherapy.Read moreRead less
Evaluation And Improvement Of The Implementation Of The Intention To Treat Model In Controlled Trials Of Psychotherapies
Funder
National Health and Medical Research Council
Funding Amount
$409,000.00
Summary
Randomized controlled trials (RCTs) are the best way to determine whether patients benefit from a new treatment. In these trials patients are randomly assigned to the new, active treatment, or to a placebo or existing treatment. The groups are compared at the end of the trial. RCTs may be mounted for psychotherapy and educational programs as well as for new drugs and other medical procedures. A major problem for RCTs concerns their statistical analysis when some participants drop out before the ....Randomized controlled trials (RCTs) are the best way to determine whether patients benefit from a new treatment. In these trials patients are randomly assigned to the new, active treatment, or to a placebo or existing treatment. The groups are compared at the end of the trial. RCTs may be mounted for psychotherapy and educational programs as well as for new drugs and other medical procedures. A major problem for RCTs concerns their statistical analysis when some participants drop out before the end of the trial. Dropout is common in trials. Participants may drop out because they feel no benefit from the treatment, dislike side effects, or even because they have recovered quickly. Thus, to compare the groups remaining at the end of trial may introduce serious bias. The Intention to Treat (ITT) principle which has been widely adopted states that outcomes from all patients who enter a trial should be compared at its end. To achieve this, the last available observation for a participant who withdraws is often 'carried forward' to the end of the trial. While currently believed to be conservative, there is evidence that this approach is not always optimal. This project will examine the way in which dropout is treated in trials of two common psychiatric conditions: depression and anxiety disorders. The project will also undertake simulation research to investigate which of a number of modern methods of data analysis yield the most accurate results when participants drop out, and how changes in the design of trials might improve accuracy. The project is important because it will enable researchers to improve the conduct of trials in the future. Erroneous conclusions drawn from RCTs stand to condemn those suffering from disorders to ineffective treatment and to lead to the premature abandonment of potentially useful interventions which are falsely claimed to lack efficacy.Read moreRead less