ANZCTR search results

Perioperative respiratory adverse events (PRAE) pose a significant risk in paediatric anaesthesia, with the incidence of PRAE being reported between 15 and 50 %. Accurate detection of those at risk for developing PRAE is vital to enable tailoring of their perioperative management. Traditionally, risk of PRAE is assessed using the patient’s past medical history, family medical history and physical examination. However, given the multifactorial nature of the risk of PRAE and children with complex medical backgrounds such as chronic lung disease, obstructive sleep apnoea or obesity, patients may benefit from additional objective preoperative pulmonary function tests. Recently our group published an educational review identifying the clinical utility of preoperative pulmonary function testing in paediatrics which identified that there is little evidence to support the routine use of lung function in preoperative assessment. However, we noted that the measurement of Peak Cough Flow (PCF) is predictive of the need for respiratory support or cough support following surgery suggesting that a higher PCF may reduce the incidence of PRAE; thus far there is no evidence in the role of PCF in preoperative assessment, however this simple, non-invasive and portable test may help identify high-risk subjects. We propose a prospective cross-sectional interventional study to assess if Peak Cough Flow and spirometry in children with and without respiratory symptoms aged 5-10 years is clinically associated with an increased risk of developing PRAE. Monitoring and recording of PRAE (laryngospasm – closure of the vocal cords, bronchospasm – narrowing of the airways, severe and persistent coughing, airway obstruction, oxygen desaturation (<95%) and postoperative stridor-squeaky noises when breathing) will occur throughout the procedure and in the post anaesthesia care unit (PACU). We hypothesise that children with a higher percent of predicted PCF will be at a reduced risk for developing PRAE.

Current treatments are primarily aimed at short term symptomatic control using oral medications or chemodenervation, with botulinum toxin, to provide relief of the involuntary movements. Physical therapies and rehabilitation, including constraint training and motor training with or without neuromodulation and sensory discriminative training, has shown some improvement but these findings are not definitive. Recently, the use of surgical stereotactic thalamotomy has been shown to provide significant efficacy in the treatment of patients with focal hand dystonia. This is an invasive treatment requiring burr hole and stereotactic probes being passed into the brain with a risk of intracerebral haemorrhage of 1-4%. Advances in minimally invasive surgical techniques using gamma-knife thalamotomy have been shown to be effective in refractory musician’s dystonia. The option of a less invasive neurosurgical technique, using MRI guided focussed ultrasound (MRgFUS), has provided a novel treatment approach for patients with focal dystonia. MRgFUS thalamotomy is a safe and effective treatment modality for essential tremor and other tremor disorders. A recent pilot study of non-invasive thalamotomy using MRgFUS showed promising results with marked improvement in symptoms related to focal hand dystonia with no adverse effects. It is the objective of this research project to establish the efficacy and safety of MRgFUS in an Australian population with focal hand dystonia and establish a database for ongoing research in the use of non-invasive neurosurgical techniques in the treatment of a wide range of movement disorders.

Hospitalisation for older people can result in poor health outcomes, and this is more evident in frail older patients and those with cognitive impairment. Factors such as chronic health conditions, polypharmacy and cognitive and functional decline are associated with increased risk of health care related harm, (such as falls, delirium and poor nutrition) (George, Long, & Vincent, 2013). Pain is also very common in older adults in hospital, however assessment of pain in older patients in hospital can be impacted by the patient’s communication of pain which may be affected by their beliefs about pain as a normal part of ageing, concerns related to use of medications for pain, and cognitive impairment often resulting in under treatment of pain (Schofield et al, 2018). Assessing pain begins with a person’s self-report using pain assessment tools but this can be challenging in older patients, and technology driven pain assessments have been developed for better pain assessment. One such application is PainChek Universal® that enables better assessment of pain at the point of care for those whose ability to communicate fluctuates. PainChek Universal® contains 2 scales 1. Numerical Rating Scale (NRS) for those who can self-report their pain.2. The PainChek scale for those who cannot self-report their pain (using automated facial recognition and analysis to identify pain-related facial micro-expressions, together with a series of user completed checklists of pain behaviours (Atee et al. 2017; Atee et al. 2018a).To minimise the risk of health care-related harm, volunteer programs to support patient care have been established in many hospitals worldwide. Volunteer programs have shown a positive impact on older patients in hospital and have positively upon patient health outcomes related to nutrition, falls and delirium (Naylor et al. 2013; Saunders et al 2019). A non-randomized intervention study will evaluate a model of service delivery for older adults in hospital aged 65 years and older through implementation of technology driven pain assessment and a nurse-led volunteer support program.

The NSW Inherited Cardiomyopathy Cohort or NSW HEARTS is a cohort study that aims to recruit over 2,500 participants from NSW with inherited cardiomyopathies, and prospectively follow them over time . The overarching aim of this study is to create a large, well-characterised cohort of patients with inherited cardiomyopathies in NSW for cross-sectional and longitudinal analysis. This will serve as an invaluable resource for numerous other research projects, as well as an opportunity for future data collection waves, extending follow-up even further. Data collected will include clinical information, cardiac investigations, blood sample, cardiac MRI and NSW Health linked data. All participant samples will undergo whole-genome sequencing (WGS), which will allow us to investigate the impact of genetic variants. The resulting dataset will enable us to perform analyses that have the potential to solve the genetic basis of diseases for many families and will be directly translated to improved variant classification criteria. Moreover, we can also seek to understand this new paradigm of non-familial disease and allow precision-based approaches to the care of families.

This clinical investigation is targeted at collecting further clinical effectiveness and safety evidence of HP-OCT (Hyperparallel OCT®) in visualising and measuring anterior and posterior ocular structures/parameters. It is hypothesised that the HP-OCT is not inferior to, or less safe than the current standard devices utilised to measure anterior and posterior ocular structures/parameters. This investigation is composed of two sub-studies. The objective of Sub-study 1 is to (1) determine the precision (repeatability and reproducibility) of HP-OCT in biometric measurements, and (2) investigate the agreement of biometric measurements between the HP-OCT instrument and 3 state-of-the-art comparative devices. Sub-study 2 aims on investigating the reliability of the HP-OCT in generating retinal images to aid qualitative diagnosis. This investigation is a three-site study based on nested design, involving one unit of each of the 4 instruments (HP-OCT and 3 comparative devices) at each of the three sites (12 devices in total). The target enrolment is approximately 150 participants who will be divided into 4 subject/pathological eye populations and go through the non-contact non-invasive ocular scans using the HP-OCT and the comparative devices in a single site visit. All the information, data and images collected are de-identified for communication, analysis, and report. The retinal images obtained for Sub-study 2 will be sent to an image reading centre for qualitative image grading by three independent and masked image graders. The biometric measurements (Sub-study 1) and the retinal image grading results (Sub-study 2) will then be analysed statistically following the pre-specified protocol before the conclusion is drawn and reported in the clinical study report.

Current guidelines suggest invitation of smokers (current or past) of 20 pack years or more (US Preventative Services Task Force) to participate in lung cancer screening. However, a significant proportion of lung cancers will not be detected by these criteria. Therefore, the aim of this study is to determine the feasibility and lung cancer detection rate of identifying and screening at-risk never/light smokers for lung cancer using personalised risk prediction. Who is it for? People aged from 55 to 74 years (inclusive), and have never smoked or are a current/former light smoker. Study details Interested participants will be assessed for screening eligibility by completing a questionnaire which incorporates known risk predictors for never smokers developing lung cancer (age, family history of lung cancer, personal history of cancer, secondhand smoke, indoor / outdoor air pollution, exposures to environmental or occupational lung carcinogens and inflammatory pulmonary diseases). Participants will also be invited to participate in an optional sub-study of blood, breath and body fluid and remnant tissue collection to research novel biopmarkers of lung cancer risk. Participants determined to have a 6-year lung cancer risk more than 1.51%,will proceed to single low-dose spiral chest computerised tomography (LDCT) scan. The LCDT scan will be examined for any lung nodules, and referral for follow-up treatment provided accordingly. Participants will also complete a number of Quality of Life and health status questionnaires annually for 10 years post-enrollment.. Participants found ineligible for LDCT will be enrolled into the health questionnaire component of the study for 10 years to determine whether they develop lung cancer during the study period. It is hoped that this study may show new ways to identify people who may benefit from lung cancer screening. with low dose CT scans..

People of working age who sustain a severe acquired brain injury (sABI) have low return to work (RTW) rates that range from 16-40%. The Vocational Intervention Program (VIP) was developed specifically to facilitate return to competitive employment after sABI. Unlike most vocational rehabilitation models available to people with sABI, the VIP focuses on building skills working towards gaining new employment in those unable to work, not just targeting a return to pre-injury employment in those who have the capacity to do so. This study will examine whether local vocational rehabilitation (VR) providers, partnered with local Brain Injury Rehabilitation Program sites, can deliver the VIP to people with sABI as effectively as a specialist VR unit. It will also examine whether the VIP leads to earlier and stronger return-to-work outcomes and improves quality of life and self-esteem compared to people with sABI that do not complete the VIP.

The objective of the current study is to conduct a Feasibility Trial (FT) for a treatment intervention involving parents of children and young adolescents with a screen-based disorder, or with problematic patterns of screen use. Parents of children and adolescents identified as “at risk” of Internet Gaming Disorder (IGD) or Problematic Screen Use will be invited to take part in the FT. Hypotheses: 1. Given that it is expected a number of parents will not be able to implement the program for the full 6 weeks, it is expected that those who complete will have better results than those who partially complete. That is, that parents who are able to implement the treatment model for all 6 weeks post intervention, compared to those parents who implemented strategies for under 2 weeks and those who implemented them for between 3-6 weeks, will report a greater decrease in child screen use and significantly stronger improvement in their child’s wellbeing as measured by reduced family conflict, improved behaviour, sleep, exercise, social engagement with peers and schoolwork. 2. That children with high levels of Internet Gaming as measured by clinically significant score on the IGD-10 (5+) and/or high/problematic levels on the IGD-10, SABAS and BSMAS (24+) prior to intervention, will report an initial increase in family conflict followed by a steady reduction once the parent strategies are in place. 3. That the parenting intervention strategies employed by the active treatment group will be more effective in the younger sample than in the teenage sample. This hypothesis is based on previous research (Marshall et al., 2022) where we found preliminary evidence for increased IGD symptoms after children start high school and on the basis that teenagers are individuating and therefore less likely to willingly comply with parent rules than primary school children. 4. That parenting strategies will be more effective for children that have ‘at risk’ or sub-clinical presentations rather than clinical levels of IGD/GD, as children and teenagers who meet criteria the full clinical disorder criteria may be more resistant to intervention, more ‘driven’ by the “addiction”, and potentially lacking insight into their disorder. 5. That participants whose parents receive the text message ‘nudge’ will maintain treatment gains longer and/or more consistently than participants who do not.

The objective of this study is to demonstrate that bacteriophage therapy is a safe and well-tolerated adjunct in paediatric patients with cystic fibrosis (CF) with Pseudomonas aeruginosa. Our research questions include; 1. Are bronchoscopically instilled and nebulised bacteriophages safe, tolerable, easily administered and well-tolerated as part of a twice a day treatment regimen for 7 days? 2. Are bacteriophages that are delivered directly into the bronchial tree via bronchoscopy followed by nebulised bacteriophage therapy effective in reducing the colony forming units (CFU/mL) of Pseudomonas aeruginosa within the sputum?

Aim: To demonstrate the efficacy of a practice nurse-coordinated intervention targeting TTs in moderate-severe COPD in general practice for improving health-related quality of life (HRQoL) and reducing hospitalisations/emergency department (ED) visits. Targeting Treatable Traits in COPD to Prevent Hospitalisations (TERRACOTTA) will focus on a national roll-out of the interdisciplinary model of care, to inform its scale-up as a routine service. Methods: A pragmatic, single-blind, cluster randomised controlled trial will be conducted nationally in GP clinics (n=40). Community dwelling adults with a history of moderate-severe COPD will be identified within each clinic (n = 10) by trained practice nurses. Control clinic subjects (n=200) will receive a booklet on ‘lung health’. The intervention includes a multidimensional assessment by a practice nurse to characterise TTs in patients with COPD that will lead to a personalised medicine approach targeting pulmonary, extra-pulmonary and behavioural traits. In the intervention group (n=200), trained practice nurses will coordinate: a personalised COPD action plan, home-based pulmonary rehabilitation, home medicines review, smoking cessation support, and tailored mobile phone-based risk reduction support. A change in HRQoL at 6 months is the primary efficacy end point. Respiratory acute hospital visits per participant at 6 and 12 months will be assessed. Significance: TERRACOTTA will be the first of its kind offering tailored interventions targeting TTs in COPD for individuals at risk of exacerbations, to improve quality of life and avoid hospitalisations. Our findings will inform clinical practice and facilitate continuous quality improvement in COPD.