ANZCTR search results

This mixed methods RCT of Peers® Plus aims to test the effectiveness, acceptability and feasibility of a face-to-face group delivered Program for the Education and Enrichment of Relational Skills (PEERS®) adapted for children aged 8–13 years with acquired brain injury (ABI) or cerebral palsy (CP). In this pilot randomised controlled trial, we will recruit 32-36 children with brain injuries and their caregiver across Queensland and randomise them to receive PEERS® Plus immediately or be waitlisted for 6 months. PEERS® Plus will be run for groups of 8 children and their caregiver. Four groups will be run over a two-year period in order to deliver the program to the immediate groups and control groups after the waitlist period. Outcomes will be measured before the intervention, after the PEERS® Plus program, and then 3 months later (6 months post baseline) and 9 months later (12 months post baseline). Focus groups using semi-structured interviews will be conducted separately with children and caregivers at the end of the program to explore experiences of participation in PEERS® Plus.

Haemorrhoidectomy (surgical removal of haemorrhoid) is a common surgical procedure carried out by general and colorectal surgeons worldwide. Pain following haemorrhoidectomy is universal and problematic, causing absenteeism from work and school as well as a hospital readmission for pain relief. This is thought to be related to spasm of the anal sphincter muscles or creation of an anal fissure. Topical medications to aid in pain relief are well studied and accepted due to their ready availability and low side effects. Calcium channel blockers (CCB), such as diltiazem and nifedipine, are available in topical preparation, and are thought to aid in pain relief by decreasing muscle spasm. Whilst there are some studies accessing the role of CCB in post haemorrhoidectomy pain relief, most are focussed on diltiazem. Interestingly, nifedipine has reported better healing rates in anal fissure than diltiazem. This study aims to ascertain the effectiveness of topical nifedipine versus placebo as a post operative adjunct in the hopes of reducing pain experienced and reducing the post-operative short-term disability associated with haemorrhoidectomy.

Responsive feeding practices among parents have been shown to improve child eating behaviours and diet quality. Responsive practices are those that attend to a child’s hunger and fullness cues, such as allowing a child to decide how much they eat, rather than pressuring them. Families who experience economic hardship or food insecurity face challenges in child feeding. Aim: Eat, Learn, Grow will design and evaluate an intervention to support parents with economic hardship to use responsive feeding practices. This research program includes 2 phases: Phase I (ethics approval ref: LNR/21/QCHQ/72314): exploratory data collection and co-design of the intervention with parents; and Phase II (ethics approval ref: HREC/23/QCHQ/94215): evaluation of the co-designed intervention. Outcomes: The primary outcome measure is feeding practice - parental responsiveness. Secondary outcomes are uptake, acceptability, and satisfaction. Mediating variables are sociodemographic factors, household food security and chaos. Design: The intervention is called Eat, Learn, Grow and is a brief, low intensity program that includes a series of digital modules delivered via mobile phone with a supplementary mail out package. A randomised controlled trial design (n=150) will be used to pilot the program. Comparative analysis of the control and intervention groups over 3 time points (baseline, 6 weeks, 6 months) will be used as the basis of the evaluation. An online survey using REDCap will be used to collect sociodemographic information, the primary outcome measure and the mediating factors in the control and intervention groups. Validated tools are used to measure parental feeding practices, household food security, and chaos. The control will be wait listed and offered the intervention at the end of the 6 months.

Children with listening difficulties (LiD) have normal sound detection but disproportionate difficulty processing speech, particularly in noisy environments. LiD may be as a consequence of auditory processing, cognitive or language deficits. Clinically, it is challenging to delineate the possible causes of symptoms in individuals, however attention is one cognitive area known to impact listening ability in a large proportion of these children. Remote microphone technology (RMT) improves signal accessibility by transmitting a speaker's voice (via a microphone worn on a lanyard) directly to ear-level receivers worn by the child. These devices are commonly trialled in children with LiD, but the possible assistive benefits for those exhibiting attention deficits have not thoroughly been explored. The current study will investigate the efficacy of remote microphone technology (Phonak Roger Touchscreen Microphone paired with Phonak Roger Focus II receivers) to improve functional listening and cognitive abilities, classroom behaviour and quality of life in children with attention deficits. Based on previous literature, it is hypothesized that 30 weeks of RMT device use will improve classroom behaviour, quality of life, listening and attention skills in children with attention deficits.

Children with listening difficulties (LiD) have normal sound detection but disproportionate difficulty processing speech, particularly in noisy environments. LiD may be as a consequence of auditory processing, cognitive or language deficits. Clinically, it is challenging to delineate the possible causes of symptoms in individuals, however attention is one cognitive area known to impact listening ability in a large proportion of these children. Remote microphone technology (RMT) improves signal accessibility by transmitting a speaker's voice (via a microphone worn on a lanyard) directly to ear-level receivers worn by the child. These devices are commonly trialled in children with LiD, but the possible assistive benefits for those exhibiting attention deficits have not thoroughly been explored. The current study will investigate the efficacy of remote microphone technology (Phonak Roger Touchscreen Microphone paired with Phonak Roger Focus II receivers) to improve functional listening and cognitive abilities, classroom behaviour and quality of life in children with attention deficits.

Children admitted to intensive care units require arterial cannulation for monitoring and blood sampling. In neonates, arterial access can be achieved through umbilical artery catheterization in the first 3-4 days, whereas in older infants and children it is via peripheral arteries. Even in neonates, umbilical arterial catheterization may not be feasible (e.g., abdominal surgical conditions). The radial, posterior tibial, and brachial arteries are commonly used for cannulation in children and neonates. The radial artery cannulation is also being increasingly used for percutaneous cardiac procedures. These arteries are of small calibre, which makes their localization and cannulation challenging and potentially unsuccessful. The radial artery is the most frequently used site for cannulation as it is superficial and has a relatively larger diameter compared to other peripheral arteries. Repeated attempts can lead to bleeding, spasm and dissection of the peripheral arteries. Ultrasound-guided insertion can increase cannulation success but requires high expertise. A recent paediatric audit found that even with ultrasound, the first attempt success rate was only 31%. Resource-limited settings may be limited by the expense of the ultrasound equipment and maintenance. Therefore, increasing the internal diameter and preventing vasospasm are important for successful peripheral arterial cannulation in neonates. Glyceryl trinitrate (GTN) has the potential to increase cannulation success in children by increasing the diameter of peripheral arteries and preventing vasospasm when used as a local application. We hypothesize that local application of GTN in the form of a transdermal patch will achieve adequate dilatation of the radial artery in neonates. We aim to conduct a randomised controlled trial to establish effectiveness and safety of local GTN in increasing the diameter of the radial artery in neonates.

People with PC are treated according to the extent of their disease at diagnosis. One of the problems that doctors face is adequately distinguishing patients who should receive chemotherapy before surgery versus surgery alone. This study aims to test whether a structured radiology report can improve the accuracy of reporting of CT scans in PC to optimise care. Who is it for? You may be eligible for this study if you are an adult who has suspected pancreatic cancer, you have an abdominal CT scan performed for diagnostic purposes and you are attending one of the participating hospitals for this study. Study details Participants included in this study may either have their CT scan reviewed and reported using standard radiology reporting as per usual practices, or using a more structured radiology reporting tool that is being tested for this study. The radiology reporting that participants receive will depend upon the hospital they are being treated at and the timing of their appointments; as all participating hospitals will be randomly allocated to start using the new radiology reporting tool at different times throughout the study. All participants will receive the best standard of care regardless of whether the hospital they are attending has been allocated to use the new reporting tool or not. It is hoped this research will determine the usefulness and reliability of the new structured radiology reporting tool. If this study finds that using the structured tool leads to more accurate diagnosis of pancreatic cancer types that can then in turn optimise the treatment options available to patients, use of the reporting tool may be expanded to a greater number of hospitals.

There is increasing awareness that adaption of existing PSTD treatment approaches for CTSD has had mixed results for individuals who have experienced interpersonal traumas and childhood adversity; often there is a demonstrated attenuation of PTSD symptoms, yet the challenges related to difficulties with DSO remain. There is an internationally recognised need to develop evidence-based clinical interventions that focus on the emotional-, interpersonal-, and self-, dysregulations involved in DSO, and are purpose-built to improve functioning. To date, treatments for the symptoms of DSO have leveraged those more commonly used for personality disorder, such as Dialectical Behaviour Therapy (DBT). DBT is resource intensive, often delivered through extensive one to one therapy over an extended period (up to 2 years) and is not ‘purpose built’ for DSO arising from trauma experiences. It is thus less efficient and less effective than the proposed INTEGRATE program. INTEGRATE is a novel 12-week group-based therapeutic intervention that has been developed in response to this identified need. Importantly, INTEGRATE has been carefully designed to situate as complementary to existing best-practice approaches for treatment of PTSD. The purpose of this study is to evaluate implementation feasibility of INTEGRATE with a community-based sample in collaboration with a Northern Territory (NT) government supported local community service for people who have experienced sexual assault, the Sexual Assault Recovery Centre (SARC). The project has the following aims: 1) to evaluate recruitment capability and gather information about the characteristics of the sample, 2) to evaluate the data collection procedures and outcomes, 3) to evaluate how well the INTEGRATE program is received by participants and suitability of the intervention and data collection procedure for future trials, 4) to gather preliminary evaluation data regarding participants response to the INTEGRATE program, and 5) to gather insights from facilitators and service providers about their perceptions of participants response to INTEGRATE, their evaluations of the benefits, challenges, and impacts of the INTEGRATE program at a client and service level, and identified areas for improvement. Longer-term, the success of INTEGRATE will have both social and economic value to the Australian, and international, community. As a complementary program to those dealing with the symptomology of conventional PTSD reactions, INTEGRTATE will enhance client recovery and act to reduce waitlists of traditional services. INTEGRATE will also reduce treatment costs associated with more lengthy and less efficacious approaches to DSO symptomology. Importantly, INTEGRATE will support holistic client recovery and therefore client function, attenuating the social and economic costs of long-term disability.

Medicine related harms are a national problem, contributing to 250,000 annual hospital admissions and increased health care costs. Medication harms are an even larger issue for residential aged care, with a report showing over 95% of residents experiencing one or more medicine related problems. The ADEPT project is a joint project between the University of South Australia, University of New South Wales, and Flinders University. Our aim is to develop and implement a digitally enabled, evidence-based, pharmacist service to actively detect medicine harms in residential aged care, and to determine the extent to which this model of care reduces medicine induced deterioration.

Bacteria in biofilm contributes to the persistence and recurrence of infection within the middle ear. Our preliminary data shows that as well as biofilm being present on the surface of the middle ear mucosa, bacterial biofilms are also present within extensive DNA scaffolding in the viscous middle ear effusion (MEE). We have demonstrated otopathogenic bacteria both in biofilm microcolonies and singularly throughout DNA strands within 92% of MEEs tested. The DNA appears to be mainly neutrophil derived and is largely produced via an active immune mechanism known as neutrophil extracellular traps (NETs). The extensive DNA stranding and the involvement of biofilm microcolonies is similar to what is observed in broncho-alveolar lavage fluids from children with cystic fibrosis (CF). This DNA increases the viscosity of the sputum in the lung and it is within this viscous fluid that bacterial biofilm aggregates exist. Sputum viscosity is targeted in CF through the use of a recombinant human deoxyribonuclease I (Dornase alfa or Pulmozyme®). Dornase alfa acts to selectively cleave DNA which reduces fluid viscosity and allows bacterial clearance from the lung. We propose that administration of Dornase alfa to the middle ear at time of VTI may help to reduce the viscosity of the MEE and thereby permit clearance of the bacteria that are the cause of recurring ear infections. Our preliminary in vitro studies have demonstrated that Dornase alfa successfully dissociates the DNA scaffolding in MEE from children with OM. Dornase alfa is used extensively in the treatment of CF in adults and in children and has been proven both safe and efficacious in humans when administered by inhalation via a nebuliser. These patients are often administered with 2.5ml of a 1mg/ml solution of the enzyme twice daily. Furthermore, Dornase alfa has been tested in a chinchilla model, testing for toxicity to cochlear outer hair cells and any changes in the auditory brain response following application to the round window. These studies determined that Dornase alfa is non-ototoxic when administered into the middle ear of chinchillas. This group has subsequently gone on to conduct a clinical trial investigating the use of Dornase alfa to unblock clogged ventilation tubes (VTs) in children (ClinicalTrials.gov identifier: NCT00419380). The aim of this study is to evaluate whether Dornase alfa treatment at the time of ventilation tube insertion (VTI) will break down the DNA scaffold and the associated biofilms in the MEE improving bacterial clearance from the middle ear. We believe this will reduce the recurrence of infection and reduce the number of repeat VTIs.