Using Evidence To Set Priorities In Health: An Analysis Of Decisions Of The Pharmaceutical Benefits Advisory Committee
Funder
National Health and Medical Research Council
Funding Amount
$174,575.00
Summary
Australia has pioneered the use of rigorous clinical and economic evidence in the evaluation of drugs prior to funding on our nationally subsidised Pharmaceutical Benefits Scheme. In the ten years since the introduction of the requirement that drugs demonstrate cost effectiveness prior to subsidy being granted there has been no formal independent evaluation of the system to assess its performance. This project will examine the recommendations of the Pharmaceutical Benefits Advisory Committee in ....Australia has pioneered the use of rigorous clinical and economic evidence in the evaluation of drugs prior to funding on our nationally subsidised Pharmaceutical Benefits Scheme. In the ten years since the introduction of the requirement that drugs demonstrate cost effectiveness prior to subsidy being granted there has been no formal independent evaluation of the system to assess its performance. This project will examine the recommendations of the Pharmaceutical Benefits Advisory Committee in the last decade and consider the factors that explain those decisions. At times it has been asserted that those decisions have been arbitrary or based on inappropriate considerations such as the financial cost to government or politics of the day rather than the value for money of the drug in question. We will examine the reasons behind the decisions against the objectives of providing access to life enhancing medicines in a cost effective manner. We will look at what are the key determinants of whether a drug is recommended for listing on the PBS or is rejected. A key focus will be on whether those determinants could be described as legitimate in terms of their consistency with the objectives of the scheme. For example whether the main cause of rejection is a lack of high quality evidence on effectiveness- cost effectiveness or simply because of factors such as the high financial cost to government. The project will create a database of all submissions to the PBAC 1992-2004 that will allow us to explore a number of questions about the effectiveness of the decision making process in using evidence on effectiveness and costs in health more broadly as well as those specific to the PBS. In highlighting some of the problems with the evidence and its interpretation the overall aim is to improve the quality of the decision making process in the future.Read moreRead less
The hERG potassium ion channel is critical for the maintenance of the normal rhythm of the heartbeat. The aim of this study is to map the temporal sequence of the movements of different parts of the hERG K+ channel that regulate the opening and closing of the extracellular gate of the channel. To achieve this, we will use the powerful protein engineering technique of phi-value analysis, a technique that has never before been applied to voltage-gated ion channels.
Inter-rater Reliability And Predictive Validity Of A New Functional Capacity Evaluation For Chronic Back Pain
Funder
National Health and Medical Research Council
Funding Amount
$105,794.00
Summary
Back pain costs the Australian community tens of billions of dollars. Back pain is one of the main causes of work injury and lost time from work. The longer a person is off work, the harder it is to get them back to work. Workers' compensation systems around Australia aim at getting the injured worker with back pain back to work as soon as possible. One of the difficulties in this process is determining what the person with back pain can physically do in the workplace. An evaluation technique, c ....Back pain costs the Australian community tens of billions of dollars. Back pain is one of the main causes of work injury and lost time from work. The longer a person is off work, the harder it is to get them back to work. Workers' compensation systems around Australia aim at getting the injured worker with back pain back to work as soon as possible. One of the difficulties in this process is determining what the person with back pain can physically do in the workplace. An evaluation technique, called functional capacity evaluation (known as FCE), is one method used to find out what the person with back pain physically can and cannot do. In a FCE, a trained health professional such as an occupational therapist, observes the person performing a range of physical activities like the ones he or she may have to perform in a job. The therapist closely observes the person performing activities such as lifting, carrying, kneeling, crouching, balancing, and walking and notes any limitations in the person's ability to complete the activities. The therapist makes comments about what difficulties the person may have on the job and recommendations about how these could be reduced or eliminated. The information gained from these evaluations can be valuable for the treating doctor in deciding whether the person is ready to go back to work and what duties the person can and cannot do on the job. Because of such value they provide, FCE is commonly used in rehabilitation programs endorsed by workers' compensation systems around Australia. This widespread use and endorsement of FCE occurs despite limited research on the soundness of the ratings made from these evaluations. There is a need to see whether recommendations made from FCEs are consistent between therapists (i.e. reliable) and to see if the FCE accurately predicts the person's physical capacity for work. This research will examine these issues with injured workers with back pain.Read moreRead less
Role Of Post-traumatic Hypoxia In The Exacerbation Of Cerebral Inflammatory Response Elicited By Brain Injury
Funder
National Health and Medical Research Council
Funding Amount
$397,535.00
Summary
Traumatic brain injury is the major cause of death in the young population below the age of 40 years. Approximately 25% of patients that survive head injury remain with permanent neurological disabilities with considerable family, professional and economic costs. Extensive research has shown that not all brain damage occurs at the time of injury, but rather evolves over the hours and days following trauma. Secondary injury may result from various factors including hypoxia (insufficient oxygen) a ....Traumatic brain injury is the major cause of death in the young population below the age of 40 years. Approximately 25% of patients that survive head injury remain with permanent neurological disabilities with considerable family, professional and economic costs. Extensive research has shown that not all brain damage occurs at the time of injury, but rather evolves over the hours and days following trauma. Secondary injury may result from various factors including hypoxia (insufficient oxygen) as a consequence of respiratory distress that occurs in about 50% of patients with severe head trauma. Hypoxia is known to significantly worsen the neurological impairment and potentially lead to death. Brain injury and hypoxia have the ability to separately trigger cerebral inflammation. A dual role has been attributed to inflammation: to promote tissue repair but also add further damage through the release of neurotoxic substances. We hypothesise that hypoxia occurring after traumatic brain injury enhances the inflammatory response in the brain and aggravate tissue damage as well as neurological dysfunction. This hypothesis will be tested on a rat model of brain injury whereby the animals will be exposed to moderate-severe hypoxia immediately after trauma. The production of multiple inflammatory mediators will be quantified in the brain tissue and also in cerebrospinal fluid. The concentration of these mediators will be compared with the levels of cellular injury proteins known to increase following injury to determine whether a correlation exists. In a clinical study on patients, we will measure the same inflammatory mediators and proteins in the cerebrospinal fluid and blood of individuals with severe head injury. The suitability of these factors for potential use as diagnostic-prognostic markers of either hypoxia or injury will be determined.Read moreRead less
Randomised Study Of Radiotherapy (RT) Or ChemoRT To Palliate Symptoms Of Advanced Oesophageal Cancer (OC)
Funder
National Health and Medical Research Council
Funding Amount
$236,375.00
Summary
Cancer of the oesophagus (gullet) causes swallowing problems (dysphagia) by narrowing the gullet and harming food movement to the stomach. >90% of patients with oesophageal cancer (OC) have dysphagia. OC is common, representing >1% of all cancer diagnoses, but is rarely curable, >80% of patients having disease beyond the oesophagus at presentation. Overall survival is thus poor with <10% of patients alive at 3 years. Most have disease obstructing the gullet and thus most patients suf ....Cancer of the oesophagus (gullet) causes swallowing problems (dysphagia) by narrowing the gullet and harming food movement to the stomach. >90% of patients with oesophageal cancer (OC) have dysphagia. OC is common, representing >1% of all cancer diagnoses, but is rarely curable, >80% of patients having disease beyond the oesophagus at presentation. Overall survival is thus poor with <10% of patients alive at 3 years. Most have disease obstructing the gullet and thus most patients suffer dysphagia as they come to terms with dying. This affects both the patient's ability to maintain nutrition and impinges on all areas of quality of life (QoL). Enjoying food is a pleasure of life and an inability to swallow food, water and saliva causes a significant loss of personal self esteem. Relief of dysphagia is the highest priority for treatment. This must be balanced against toxicity of treatment. It is surprising that patients and their doctors must consider this with very little scientific data to help their decisions. The trial uses a simple 2 arm randomisation, radiotherapy (RT) 35Gy in 15 fractions, versus the same with chemotherapy (Cisplatin and Fluorouracil). Both the RT schedule and chemotherapy are commonly used in Australia for this and other cancers. This is the first trial in the world to prospectively assess RT and the first to compare the effect of adding chemotherapy. The trial will:- 1. establish a new method of assessing dysphagia and QoL in all patients with OC using a set of specific questions(EORTC-QLQ-C30+oesophageal module). 2. quantify response and toxicity of a common RT schedule. 3. evaluate the extra benefit and toxicities of chemotherapy. 4. evaluate patient and tumour factors determining outlook, and response to treatment. 5. provide a bench mark for trials of new chemotherapy agents and different RT schedules. The trial will guide management and provide information for incurable patients even if both arms are similar in their effect.Read moreRead less