A Randomised Controlled Trial Of Caseload Midwifery Care
Funder
National Health and Medical Research Council
Funding Amount
$761,311.00
Summary
There is concern about the rising levels of caesarean section in Australia and some evidence that women may benefit from caseload midwifery care. This randomised control trial will determine whether caseload midwifery care can reduce interventions and is as safe as usual hospital maternity care. A Cochrane systematic review of midwifery led care versus routine care was designed to answer these questions.This will be the first randomised controlled trial to contribute to this review
Selective Estrogen Receptor Modulators (SERMs) - A Potential New Treatment For Women Of Child-bearing Age With Psychotic Symptoms Of Schizophrenia
Funder
National Health and Medical Research Council
Funding Amount
$210,480.00
Summary
Schizophrenia is a devastating illness urgently requiring a new treatment approach. We have discovered that estrogen is an effective treatment for women with schizophrenia and are currently trialling a safer Selective Estrogen Receptor Modulator (SERM) known as brain estrogen� in postmenopausal women with schizophrenia. Regulatory permission is now available to trial the SERM in younger women, and we seek to extend our current SERM study into child bearing age women with schizophrenia.
A Randomised Phase III Study Of Radiation Doses And Fractionation Schedules In Non-low Risk DCIS Of The Breast
Funder
National Health and Medical Research Council
Funding Amount
$1,751,209.00
Summary
Treatment of ductal carcinoma in-situ (DCIS), a preinvasive form of breast cancer, is aimed at preventing invasive cancer recurrence. Women with higher-risk DCIS have an increased risk of recurrence. This study aims to individualise treatment for women with DCIS to achieve long-term tumour control with minimal treatment toxicity. After local excision of DCIS, radiotherapy (RT) to the whole breast reduces the recurrence rate. However, it is unclear if escalating radiation dose to the tumour bed i ....Treatment of ductal carcinoma in-situ (DCIS), a preinvasive form of breast cancer, is aimed at preventing invasive cancer recurrence. Women with higher-risk DCIS have an increased risk of recurrence. This study aims to individualise treatment for women with DCIS to achieve long-term tumour control with minimal treatment toxicity. After local excision of DCIS, radiotherapy (RT) to the whole breast reduces the recurrence rate. However, it is unclear if escalating radiation dose to the tumour bed in higher-risk women increases tumour control. It is also uncertain if giving fewer but larger radiation doses over 3-4 weeks would achieve the same tumour control as the standard 5-7 week course of RT to improve patient convenience and access to RT. Thus, this multicentre study of 610 women with higher-risk DCIS will investigate if adding a tumour bed radiation boost after whole breast RT improves tumour control, and the shorter RT course achieves the same tumour control as the standard longer course. Currently, the ability to predict the malignant potential of DCIS and RT toxicity is limited. This study will investigate if there are biological and genetic markers predictive of invasive recurrence and normal tissue toxicity in women with DCIS using state of the art technology. Women need to weigh up the likelihood of cancer control against adverse treatment effects to make an informed treatment decision. However, very little is known about the quality of life (QoL) consequences of the diagnosis and treatment of DCIS. In this study, the QoL, psychological distress, perceived risk of invasive cancer recurrence and perceived cosmetic outcomes of women with DCIS, will be assessed using a questionnaire of validated measures. This study will refine treatment for women with DCIS according to their risks of recurrence. It will significantly advance the understanding of the biology of DCIS and its psychological and QoL outcomes after treatment.Read moreRead less
Value Of Androgen Deprivation And Bisphosphonate Therapy In Patients Treated By Radiotherapy For Limited Prostate Cancer
Funder
National Health and Medical Research Council
Funding Amount
$1,757,375.00
Summary
Prostate cancer depends for its growth on the male hormone, testosterone, which circulates in the blood. As a result treatment which reduces testosterone level ('androgen deprivation'[AD] therapy) can produce clinically important shrinkage of prostate cancer. Each year approximately 4000 men in Australia and New Zealand develop prostate cancer which has not spread widely and which is amenable to attempted cure by surgery or radiation. Results from recent trials, including a large trial run in Au ....Prostate cancer depends for its growth on the male hormone, testosterone, which circulates in the blood. As a result treatment which reduces testosterone level ('androgen deprivation'[AD] therapy) can produce clinically important shrinkage of prostate cancer. Each year approximately 4000 men in Australia and New Zealand develop prostate cancer which has not spread widely and which is amenable to attempted cure by surgery or radiation. Results from recent trials, including a large trial run in Australia and New Zealand by the Trans-Tasman Radiation Oncology Group (TROG) between 1996 and 2000, suggest that 6 months AD will benefit many of these men if administered in conjunction with radiotherapy.The aim of this project is to run a further trial to find out whether 12 months of AD, after radiotherapy will prevent the need for further treatment and prolong more lives than only 6 months AD. Bisphosphonate treatment also offers important benefits to prostate cancer patients because it can increase bony stregth by increasing its density and can also arrest cancerous growth in bones. A further aim of the trial therefore is to determine whether 18 months of bisphosphonate therapy (BP) will prevent bone loss (osteoporosis) caused by AD, and also further reduce the risk of secondary bone cancer developing. This trial will involve recruitment of 1000 men across Australia and New Zealand over a 5 year period. When complete the trial will determine whether further treatment can be delayed and life prolonged in up to half of all men in whom treatment presently fails. This grant will support collection of patient data and the necessary quality checks to ensure that reliable conclusions can be drawn.Read moreRead less
Supported Treadmill Training To Establish Walking In Non-ambulatory Patients Early After Stroke
Funder
National Health and Medical Research Council
Funding Amount
$341,349.00
Summary
This project will improve the health and well being of people affected by stroke. Stroke is the most common disabling neurological condition in adults and consumes up to 5% of health care expenditure in developed countries, estimated by the National Stroke Foundation at $1-2 billion per year in Australia. Some 48,000 people suffer a stroke each year in Australia, with approximately one third of these people requiring inpatient rehabilitation and 70% of them are unable to walk on admission to reh ....This project will improve the health and well being of people affected by stroke. Stroke is the most common disabling neurological condition in adults and consumes up to 5% of health care expenditure in developed countries, estimated by the National Stroke Foundation at $1-2 billion per year in Australia. Some 48,000 people suffer a stroke each year in Australia, with approximately one third of these people requiring inpatient rehabilitation and 70% of them are unable to walk on admission to rehabilitation. This randomised controlled trial will investigate whether treadmill walking with partial weight support via an overhead harness is effective at establishing independent walking (i) more often, (ii) earlier and (iii) with a better quality of walking, than current treatment for stroke patients who cannot walk. We will measure (i) whether patients achieve independent walking and (ii) the time taken to achieve independent walking. We will also measure parameters of walking such as speed, step length and step width to evaluate the effect of treadmill training on the quality of walking. Furthermore, by measuring participation in the community at 6 months, we will evaluate the long-term effect of this innovative treatment. Given that independence in walking is a major factor in the decision to discharge patients from inpatient care, earlier independent walking should result in a reduction in length of hospital stay which will save about $800 per patient per day in a teaching hospital setting. Identifying rehabilitation strategies which enhance walking outcome will not only improve quality of life of both stroke patients and their carers by reducing disability and handicap but also reduce the cost of rehabilitation.Read moreRead less
A Study To Investigate Alternative Regimens For Pneumococcal Vaccination Of Infants In A Developing Country
Funder
National Health and Medical Research Council
Funding Amount
$1,622,210.00
Summary
Streptococcus pneumoniae (Pnc) is the leading vaccine preventable cause of serious infection in infants. The current Pnc conjugate vaccine is very expensive (approximately USD $200-infant) so it is unlikely to be affordable for most developing countries. Moreover, as health care access in developing countries may be episodic and unreliable, many children do not receive either complete or timely vaccine courses. Therefore, it is important to investigate affordable and flexible ways to deliver thi ....Streptococcus pneumoniae (Pnc) is the leading vaccine preventable cause of serious infection in infants. The current Pnc conjugate vaccine is very expensive (approximately USD $200-infant) so it is unlikely to be affordable for most developing countries. Moreover, as health care access in developing countries may be episodic and unreliable, many children do not receive either complete or timely vaccine courses. Therefore, it is important to investigate affordable and flexible ways to deliver this vaccine, which are safe and effective. A recent WHO-GAVI meeting to address impediments to the introduction of these vaccines in developing countries recognized the need to evaluate other regimens of Pnc conjugate vaccine as an important research priority. This study has been deliberately formulated with that need in mind. The site for this research is Fiji. Although health services are good, Pnc disease, particularly pneumonia, remains the commonest cause of childhood morbidity and mortality. Fiji has good vaccine coverage and was the first Pacific country to introduce Hib vaccine. The arrival of the new, expensive Pnc conjugate vaccine presents a dilemma for Fiji and many similar countries. The expense of this vaccine would consume a large portion of the health budget. This study has two components: 1. A Phase 2 immunogenicity study (involving 750 infants) to evaluate regimens using reduced numbers of doses of Pnc conjugate vaccine, and using timing of dosing and combinations with the Pnc polysaccharide (PS) vaccine that may be more suited to the epidemiology of Pnc disease in developing countries. 2. An epidemiological study will measure the burden of invasive Pnc disease and pneumonia in Fiji. This will be part of a global effort to address these issues, and will be used to develop rapid assessment tools for these diseases in developing countries. We will seek cofounding for this component.Read moreRead less
A Randomised Controlled Trial Of Alternative Treatments To Intramuscular Penicillin For Impetigo In Aboriginal Children
Funder
National Health and Medical Research Council
Funding Amount
$1,326,182.00
Summary
We will conduct clinical trials to find an effective, simple and cheap oral alternative to injected penicillin for skin sores which could become the universal standard of care whether the patient is in Melbourne or Milingimbi. It would also likely be adopted by the World Health Organization as a standard of care for developing countries. This would lead directly to a reduced burden of skin sores and their complications. It would also open the way for studies to explore even simpler regimens.
A Parent Education And Skills Training Early Intervention For Children With Autism
Funder
National Health and Medical Research Council
Funding Amount
$305,674.00
Summary
Autism is a severely handicapping disorder adversely affecting social interaction, communication, and behaviour, interests and activities. Over the past 9 years our team has conducted a follow-up study of a large group of 111 Australian children and adolescents with autism. The young people have continued to have very high levels of emotional and behavioural disturbance and generally do not improve. Parents of children with autism are under significant amounts of stress; reporting high levels of ....Autism is a severely handicapping disorder adversely affecting social interaction, communication, and behaviour, interests and activities. Over the past 9 years our team has conducted a follow-up study of a large group of 111 Australian children and adolescents with autism. The young people have continued to have very high levels of emotional and behavioural disturbance and generally do not improve. Parents of children with autism are under significant amounts of stress; reporting high levels of disturbed family functioning and mental health problems. Although there is no cure, children benefit most when early help is provided (under 5 years). There are several promising interventions based on intensive behaviour and educational management, for example requiring 40 hours per week of therapist contact over 2 years. Such programs are costly and impractical as widely available treatment options. Training parents to understand and manage their child also shows promise. This study will evaluate the effectiveness of a parent skills training and education treatment program compared to supportive therapy, and to generally available community services. The therapists will follow a treatment manual that will ensure a consistent and replicable approach. The progress of the children with autism and their families will be reassessed immediately after treatment, and at 1 and 2 years post-treatment in order to ascertain immediate and long-term effects of the treatment. If treatment proves to be of use, we will have established a defined, cost efficient, practical and effective model of early treatment that can be easily taught to professionals and widely disseminated throughout early childhood services.Read moreRead less
Multicentre Trial Of Calcium Channel Blocker Versus Calcium Channel Blocker Plus Cox2 Inhibitor In Preterm Labour
Funder
National Health and Medical Research Council
Funding Amount
$644,130.00
Summary
Preterm birth is a major problem in our society, and has enormous consequences for parents and children. It also has a major impact on scarce financial resources. When women present in preterm labor, current therapies have only limited success in stopping contractions and postponing birth. They have not been shown to reduce the rates of the serious neonatal problems associated with prematurity. This project will be coordinated in Newcastle, N.S.W., and will involve major perinatal centres throug ....Preterm birth is a major problem in our society, and has enormous consequences for parents and children. It also has a major impact on scarce financial resources. When women present in preterm labor, current therapies have only limited success in stopping contractions and postponing birth. They have not been shown to reduce the rates of the serious neonatal problems associated with prematurity. This project will be coordinated in Newcastle, N.S.W., and will involve major perinatal centres throughout Australia, along with overseas centres. It will test a new combination of drugs for their ability to postpone delivery in women presenting with preterm labour. It is postulated that the combination of drugs will be more effective than existing therapies. The drugs used in the trial are Nifedipine and Rofecoxib. Complications of prematurity include neonatal death, cerebral palsy, visual and hearing impairment, and chronic lung disease. These complications are most significant in extremely premature infants - in particular, those under 28 weeks gestation at the time of their delivery. For this reason, the study will focus only on women presenting in labour below 28 weeks. The ability to stop labour is important, but the main aim of any treatment for preterm labour is to reduce the rates of neonatal death and handicap. Babies born to women enrolled in this study will be followed for a period of one year after birth to assess their outcomes. It is our hypothesis that the combination of Rofecoxib and Nifedipine will result in lower rates of death and handicap in babies than Nifedipine alone. In addition, we will examine the rates of side effects in women receiving therapy. Currently used therapies, including intravenous ventolin, have high rates of maternal side effects. Nifedipine and Rofecoxib have both been shown to have low rates of maternal side effects.Read moreRead less