ANZCTR search results

Irritable bowel syndrome (IBS) is a gut function disorder which causes chronic pan, bloating, diarrhoea and constipation. IBS affects 11% of the world’s population and is notoriously difficult to diagnose, because it causes no obvious structural changes. Experts recommend use of the Rome IV questionnaire about symptoms to diagnose IBS, but this gives a lot of false negatives, and is not commonly used. Typically doctors diagnose IBS by ruling out other gastrointestinal diseases with similar symptoms using colonoscopies. These are costly and invasive and still don’t provide a positive diagnosis for IBS, which leaves patients confused and reluctant to start treatment. We have developed an acoustic belt and associated software that analyses gut noises. This allows us to tell apart people with healthy guts and IBS with high accuracy. However, IBS diagnosis also involves differentiation between IBS and organic diseases, with similar symptoms. The objective of this study is to develop and test the differential diagnosis capabilities of the acoustic belt. We will collect gut sound recordings from patients with coeliac disease, Crohn’s disease and ulcerative colitis at the time of diagnosis by gastroenterologists. We will then use features from the sound recordings to build optimal models (software) that characterise the conditions. We will then test the accuracy of these models with a new set of study participants. Again, these participants will be patients newly referred to gastroenterologists by GPs or Emergency Departments for investigation of lower abdominal symptoms. All will undertake the reference standard: clinical investigations, pathology tests and scoping to arrive at a diagnosis. This is arrived at as part of routine care. They will also undertake the sound recording test (with the technicians and sound analysts blind to their condition). The results of the reference standard and the sound test will be compared to arrive at measures of accuracy for the sound test. The project is a key step in assessing the feasibility of a sound based, non-invasive approach for screening for organic disease and IBS diagnosis.

Anxiety disorders are common, cause significant impairment in childhood, and increase the risk for lifelong disability. Sadly, 30% of Australian children are unable to access evidence-based treatments. Online interventions for anxious children and adolescents improve access to care across Australia and are effective. Yet, current evidence suggests that frequent therapist support is required alongside these programs to obtain good clinical outcomes, limiting their cost-effectiveness and reach. Recent research in adult online interventions suggests that similar outcomes are possible with minimal or no therapist guidance. In this study we will compare the efficacy and cost-effectiveness of a validated online intervention, Cool Kids Online, delivered with varying degrees of therapist support. Using a gold-standard randomised controlled trial design, we will compare scheduled therapist guidance, optional (on request) therapist guidance and self-guidance (i.e. unguided) delivered using practices perfected in adult online intervention research. A waitlist condition will also be employed, and we will explore predictors and moderators of treatment outcome. The project hypotheses are as follows: Hypothesis 1a: Cool Kids Online (regardless of degree of therapist support) will result in significant reductions in diagnoses and anxiety symptoms, and improvements in quality of life immediately after treatment. Hypothesis 1b: These effects will be maintained six months following treatment. Hypothesis 2a: The three treatment conditions will show cost-efficacy compared to the control condition. Hypothesis 2b: Optional and self-guided treatment will show cost-efficacy compared to therapist guidance (mostly due to the reduced costs of therapist and supervision time in the reduced guidance conditions). Finally, we will explore demographic, diagnostic, family factors, treatment preference, and therapist support as moderators and predictors of treatment outcome, but because this study aim is exploratory no specific hypothesis can be made. However, results will inform recommendations for broad implementation of iCBT for child anxiety.

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of combination of vemurafenib and cobimetinib in a population of participants with newly diagnosed metastatic non-squamous small cell lung cancer (NSCLC) or other tumours harbouring BRAF V600 mutations detected using comprehensive genomic profiling. Who is it for? You may be eligible to join the study if you are aged 18 years and older, with pathologically confirmed advanced and/or metastatic NSCLC or solid tumour of any histologic type or an earlier diagnosis of a poor prognosis cancer. Your tumour will need to express a BRAF V600 mutation. Study details: Participants will receive both vemurafenib and cobimetinib treatments. The vemurafenib and cobimetinib are to be taken orally, at 960mg twice daily (days 1 to 28 in a 28-day cycle) for vemurafenib and at 60mg daily (days 1 to 21 in a 28-day cycle) for cobimetinib. Both vemurafenib and cobimetinib will be given to participants continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo imaging assessments at 8 weekly intervals from first treatment until progression. Safety and tolerability of treatment will be assessed at 4 weekly intervals. Health related quality of life during treatment will be assessed at 4 weekly intervals and then every 8 weeks after end of treatment until progression. We cannot guarantee that participants will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that vemurafenib and cobimetinib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

Patients with hypertension, coronary artery disease,obesity and diabetes are at higher risk of COVID-19 mortality or severe illness. Many high risk patients are not attending regular medical reviews due to these risks. It is likely the COVID-19 pandemic will accelerate the transition to digital healthcare systems but it is important to establish that these systems are safe and potentially improve care of high risk patients. Systems that allow ongoing care of patients in isolation without physical attendance may be very important for high risk patients with cardiac disease. This study will potentially validate this model of care, assess improvement in patient outcomes and define obstacles to implementation of digital based patient care models. It may then potentially serve as a model of care for other high risk patient conditions in COVID-19 isolation (e.g. diabetes).

This project aims to generate experimental evidence from one online randomised controlled trial to determine the relative effect of proposed added sugar labels to facilitate healthier choices by consumers. We hypothesise that added sugar labelling on food and drink items will reduce the proportion of intended purchases of products that are high sugar, compared to no added sugar labels. This new evidence will be critical to the development of effective labelling policies to reduce added sugar consumption for all Australians and New Zealanders.

The COVID-19 Work and Health study aims to examine the health and employment of Australians who have lost their jobs or lost work during the COVID-19 pandemic. The study seeks to understand what impact job and work loss is having on mental and physical wellbeing, who is at greatest risk, and how and when people recover. We also want to know if and when people are returning to work, and how their health changes over time. For those still working, we want to know how well they have handled any changes to their work environment and how their workplaces have adapted. The study uses a prospective cohort design, with participants completing a baseline survey and then further surveys one, three and six months later. The study will track changes in people’s self-reported health, work and financial circumstances.

The primary purpose of this study is to determine the diagnostic accuracy of a nurse performed shortened heart scan protocol to detect severe heart defects in newborn infants 30 days of life or less. The study team hypothesise that the nurse performed shortened heart scan can accurately detect severe heart defects in newborns 30 days of age or less.

There is pressing urgency to better understand the pathogenesis and physiologic consequences of COVID-19. The aim of the ADAPT study is to increase scientific knowledge regarding the immune and pathophysiologic consequences of COVID-19 infection. The aim of the ADAPT-C sub-study is to create SARS-CoV-2 negative control cohorts to the ADAPT study and enable development of serological assays to manage the disease burden of SARS-CoV-2.

The World Health Organisation (WHO) released a surgical safety checklist for use in any operating theatre environment. It was launched as part of the initiative: “Safe Surgery Saves Lifes” in 2008, aiming to reduce the number of surgical death around the world. However, surgical incident reports including near misses are still ongoing issues in hospitals nationally. It is therefore important to monitor compliance of surgical checklist completion and also its effectiveness. The use of remote video auditing has been described in the operating theatre to improve patient quality care because it influences healthcare worker’s behaviour, encourages best practice and also helps objectively analyse any adverse events. At the Royal Melbourne Hospital, we are installing remote video cameras in the operating theatre complex. The aim of this study is to assess the compliance of surgical checklist completion. We will compare the compliance rate before and after feedback with the use of remote video auditing. This study will be conducted over an 8-week period – 4 weeks without feedback of results to healthcare workers (HCW), followed by 4 weeks of weekly feedback of performance reports to HCW. We hypothesise that the compliance rate will improve with weekly feedback of performance.

Aims/Objectives To evaluate the effect of an existing standardized Quality Improvement (Q.I.) process of “Delta Therapy Dogs” in the Canberra Hospital Intensive Care Unit (ICU) on patient and family member’s anxiety. Summary Data regarding Animal Assisted Therapy in the ICU are scant, with narratives suggesting that animal presence is beneficial to patients. To date, there are no Australian studies that have examined the use of therapy dogs in an ICU. Further research is required to adequately assess the potential benefits of dog therapy in this specialised environment. Given the absence of research to support therapy dogs in the ICU setting, this study will provide evidence that could demonstrate the effects of dog therapy on anxiety in ICU patients and their family members. The data collected could assist with scientific evidence to support this as a non-pharmacological intervention to reduce anxiety in the ICU environment. Hypothesis Delta Therapy dogs in the ICU setting will assist in reducing anxiety for the patient and family members who meet the inclusion criteria for this study. Outcome Primary Outcome: • To compare anxiety levels in ICU patients and their families prior to and after the therapy dog visit. Secondary Outcomes: • To assess whether the change in level of anxiety experienced is sustained in long term patients and their relatives/immediate families who have received multiple therapy dog visits throughout their ICU stay. • To assess physiological change in patients before and after therapy dog visit (e.g. pain levels, vital signs, minute ventilation, etc.)