ANZCTR search results

This is an observational trial of functional outcomes and chronic pain after elective shoulder surgery. In this study, we will recruit adult patients admitted for elective shoulder surgery at Kareena Private Hospital. Baseline assessment will occur using the PostopQRS, modified Brief Pain Inventory (mBPI), Pain Catastrophizing Scale (PCS), Constant Shoulder Score (CSS), and the Western Ontario Rotator Cuff (WORC) scales. Major timepoints during follow up is Day 3 post-operative for cognitive recovery, Month 3 and 2 years for chronic pain rates, and shoulder function. The primary outcome is Day 3 cognitive domain recovery as assessed using the PostopQRS tool. The secondary outcomes include: 1. Quality of recovery in the individual and overall recovery PostopQRS domains across all time periods up to Month 3 post-operative, in shoulder surgery patients when stratified by age, duration of surgery, and shoulder pathology. 2. Incidence of chronic post-surgical pain (CPSP) at Month 3, Year 1, and Year 2 post-operative, assessed using the mBPI, when stratified by age, duration of surgery, shoulder pathology, and PCS score It is currently unknown what is the rate of medium to long term recovery after shoulder surgery. Our previous concept of recovery was limited to pain, nausea, and mobility in the first 24 hours, but relatively little is known about how patients recovery after major shoulder surgery over the ensuing weeks to months. This study aims to collect data to shed light into the rates of functional recovery and in particular, whether cognition is affected by anaesthesia. Similarly, the incidence of chronic post-surgical pain after shoulder surgery is relatively unknown. In other types of surgery, CPSP is common and impacts on quality of life, and has negative economic and social costs. As a secondary outcome, CPSP will be measured in this study at 3 months and 2 years post-operatively to determine the frequency of this complication.

The primary purpose of this trial is to evaluate the link between body composition and outcomes in pancreatic cancer. Who is it for? You may be eligible to participate in this study if you are aged 18 or over and have been diagnosed with pancreatic ductal adenocarcinoma within the last month. Study details All participants enrolled in this study will complete a number of assessments including hand grip strength testing, a questionnaire and lung function tests at enrolment and 3 and 6 months later. The researchers will also require access to CT scans which have been collected as a part of your cancer management. It is hoped that the findings from this study will inform researchers on the links between muscle mass and function, and cancer outcomes of chemotherapy toxicity and survival.

We have conducted pilot research in the significance of skin microorganisms in the conversion of AK to squamous cell carcinoma (SCC) in healthy volunteers and wish to compare these data to transplant recipients. Transplant patients, who are required to take immune-supressing drugs, are at a much higher risk of skin cancers than people in the general population. There is a necessity to study the relevance of the skin microbiome in transplant recipients as they are more vulnerable to the conversion of AK to SCC. We seek to compare the microbiome of transplant patients who have been immune-supressed for over 1 year, who have no AKs, many AKs, and those with suspected SCCs. The microbiome will be examined by taking skin swabs from participants and analysed by DNA extraction and microbe culture and isolation. In the case of suspected SCCs, patients will undergo routine care for their recommended removal, and the study team will request a copy of the subsequent pathology report to confirm SCC diagnosis. Who is it for? All participants in the study will need to have been immune-suppressed for over 1 year as a result of a kidney or liver transplant, prior to enrolling in the study. They will also need to be over the age of 40 years old. Participants are divided into three specific groups based on whether they have current SCCs (anywhere on the body) or AKs (on either forearm). Study details: Participants will be recruited during their routine follow up visits with the renal/liver transplant services at Princess Alexandra Hospital. If they consent to take part in the study, the study visit can occur after their follow up visit, or scheduled for a later date. Swabs will be taken from standardised control sites of sun-damaged skin on the patients forearm, SCCs, peri-lesional skin to SCCs and AKs. The swabbing technique has been tested in previous pilot studies. All suspected SCCs will be recommended for routine excision and histology. We will request a copy of the subsequent pathology report to confirm SCC diagnosis. The member of the study team will also record information on demographic, and relevant medical history from the patient. Clinical non-identifiable photographs of patient’s forearms and any SCCs will be taken.

Preterm birth, defined as birth before 37 weeks gestation, affects 22,000 pregnancies (7.5%) in Australia each year. While advances in neonatal care and treatments for preterm babies have greatly increased the chances of survival for even the smallest babies, preterm birth is still the leading cause of newborn death. Babies born before 37 weeks are also at risk for serious health problems including breathing difficulties, feeding problems, jaundice and effects on brain functions. Multiple pregnancy is a major risk factor for preterm birth, with 57% of twins born preterm compared to only 7% of singletons. Furthermore, 12% of twins are born before 32 weeks compared with only 2% of singletons. A short cervix, as measured by transvaginal ultrasound during the second trimester, is a powerful predictor of preterm birth. The risk of preterm delivery increases as the cervix shortens. When cervical length is less than 22 mm, women face a 20% probability of preterm delivery, which increases to 50% when the cervical length is less than 15 mm. Two currently available treatments used to reduce the incidence of preterm delivery in high risk women include the cerclage pessary and progesterone. Both of these interventions have been shown to effectively reduce the incidence of preterm birth in women with a short cervix. However, up until now, no study has directly compared the effectiveness of these two treatment options in women with twins. The purpose of this study is to directly compare the effectiveness of progesterone and cerclage pessaries in preventing preterm birth in women with a short cervix and twin pregnancy. Currently there is no standard treatment for short cervix in twin pregnancies. The standard treatment in singleton pregnancies is to offer progesterone. While the cerclage pessary is not widely used in Australia, it is widely used in Europe. A number of sites in Australia do use the cerclage pessary where they think it will be helpful. This study is similar to a larger one currently being conducted in the Netherlands. We will be watching that study closely to see if any of it’s outcomes inform us regarding the conduct of this study here in South Australia.

This pilot study will evaluate the feasibility and safety of a physical activity program in patients who are newly diagnosed with grade III or IV high grade glioma. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been newly diagnosed with grade III or IV high grade glioma. Study details Participants will be allocated to the group depending on participants wishes and abilities , Participants in one group will receive a structured physical activity program plus usual medical care, while the other group will receive usual medical care only. The physical activity program includes 3 x [1hr] supervised sessions per week for 7 weeks followed by once weekly support for weeks 8-14. All participants will be assessed for suitability to determine which group they should go into. Results from this pilot study will guide development of future studies on physical activity intervention programs in brain cancer patients.

There is a biologically plausible mechanism to explain why pre-operative cerebral tissue oxygen saturation (ScO2) can be a surrogate measure of underlying cardiopulmonary function. ScO2, as measured by near-infrared spectroscopy, represents a dynamic balance between oxygen delivery and extraction by cerebral tissue. When not physically active, there is a stable rate of cerebral oxygen extraction. When ScO2 is measured in patients who are resting, breathing room air, and without the influence of medications, the ScO2 value is primarily determined by the effectiveness of oxygen delivery by the cardiopulmonary system. Low pre-operative ScO2 is thus an indication of poor cardiopulmonary reserve. This has been demonstrated in studies correlating pre-operative ScO2 values to existing measures of cardiopulmonary function, including left ventricular ejection fraction, pulmonary artery catheter cardiac output, and with cardiopulmonary exercise testing. Subsequent studies in cardiac surgery patients have found that low pre-operative ScO2 is associated with increased risk of death, delirium, and major adverse events. We performed a pilot study which showed that low pre-operative ScO2 below 68% is similarly observed to increase the risk of mortality or major morbidity in major non-cardiac surgery. To confirm these pilot study results, we intend to perform a prospective, double blinded, multicentre observational study on the predictive role of low pre-operative cerebral tissue saturation and major adverse outcomes in elderly, high risk patients undergoing major elective non-cardiac surgery. Aims The primary outcome of this study is to determine if low resting pre-operative ScO2, measured in room air and with oxygen supplementation, is associated with mortality or major morbidity. The secondary outcome of this study is to determine if low resting pre-operative ScO2 is associated with increased risk of post-operative delirium.

Let’s Read is a professional development program for early childhood educators that aims to improve their emergent literacy promoting practices and help them talk to families about their child's emergent literacy. This project aims to evaluate the effectiveness of the Let's Read professional development program through a cluster randomised trial. Participants will be educators working with children aged birth to five years in the Early Childhood Education and Care centres taking part in the study, and parents/guardians of children attending the participating centres who speak and understand English. Educators working in centres who are allocated to receive the Let's Read professional development will complete a Let's Read eLearning course, and then they will receive ongoing support from a literacy skills coach who will assist them in carrying out Let's Read strategies in their work. Coaches will also receive training on how to support educators to carry out Let’s Read. Pre and post intervention measures of changes in educators' emergent literacy promoting practices, and their knowledge, understanding, skills, values, and confidence in relation to emergent literacy and engaging with families about emergent literacy, will be taken. Pre and post intervention measures of changes in parents'/guardians' attitudes towards emergent literacy and engagement in literacy promoting activities with their children will also be taken. These results will be compared with a control group of educators and parents/guardians from centres who did not receive the intervention. We hypothesise that the Let's Read professional development program will enhance the emergent literacy promoting practices of educators working in Early Childhood Education and Care centres, compared to standard practice.

Studies have shown that abnormal amounts of fat (lipids) in the blood are an important cause of heart disease and stroke. Some treatments that lower blood fat level reduce the risk of heart attacks or other cardiovascular events. One type of cholesterol, low density lipoprotein cholesterol (LDL-c), has been found to be a bad type of cholesterol. The purpose of this study is to see if we can significantly reduce blood levels of LDL-cholesterol when the medication Alirocumab (study treatment) is injected under the skin once per month. Participation in this study will last for 24 weeks in total. Once commenced in the study, participants will receive an inactive dose (placebo) for 4 weeks to make sure they don’t have any troubles with the ‘small’ injections. They will then be randomly (like the toss of a coin) assigned to receive active treatment, or continue on the inactive (placebo) therapy. This is important to make sure we can tell how well the study treatment does its job.

Medical patients often present to hospital with both medical and functional problems, including social dependency, reduced mobility and cognitive impairment. As such, discharge planning forms an important part of a patient’s hospital stay. At present, an allied health team – consisting mainly of physiotherapists, occupational therapists, social workers, dieticians and speech pathologists – make recommendations for a discharge destination based on clinical experience. If the patient is not for discharge home they may require further allied health intervention at subacute. This process is potentially problematic when clinicians disagree on discharge destination. This can delay discharge and increase the patient’s length of stay. It can also detrimentally impact on the patient and family experience. We hypothesis that deficits in mobility (both pre-admission and during admission), impaired cognition and inadequate social supports will be closely related to patients needing subacute on acute hospital discharge. There are a number of commonly used tools to measure such factors in the General Medical population. These include the de Morton Mobility Index (DEMMI) which has been used to assess mobility and predict discharge destination in this population, however, it has not considered the interplay of other factors. Other tools, such as the Alpha Functional Independence Measure (AlphaFIM), Charlson Co-morbidity Index (CCI), and the Blaylock Risk Assessment Screening Score (BRASS) and the Rowland Universal Dementia Screening Scale (RUDAS) have considered function, cognition, co-morbidities and social support but they have generally been used to assess current function, predict mortality and length of stay, rather than holistically determine the need for subacute. It is currently unknown which of these tools, when administered during an acute hospital stay, can best predict need for subacute.

A number of studies have reported a high prevalance of people with an acquired brain injury are incarcerated in prisons throughout the world. This study will investigate the prevalence of prisoners in SA prisons who have a history of traumatic or non traumatic brain injury from incident, stroke or substance abuse. This prevalence study forms phase 1 of the trial. Phase 2 of the trial will investigate the neurobehavioural sequelae of those who have experienced an ABI. Phase 3 will involve a qualitative investigation with prisoners being interviewed about their experiences in prison, and preparing to leave prison to manage in the community.