ANZCTR search results

The first part of the study aims to investigate whether an innovative allied health expanded scope Treatment Access Pathway (TAP) improves health outcomes compared to a waitlist control. The second part of the study (crossover) will investigate the clinical effectiveness of TAP following 6 months waiting for treatment. Measures of health outcomes will be objective measures of function and patient self-reports of physical function, pain, mood, acceptance, self-efficacy and health related quality of life. A secondary aim of the project is to investigate the cost-effectiveness of TAP utilising a cost-utility ratio, based on delivery cost/quality adjusted life years. We anticipate 196 participants referred to the Gold Coast Interdisciplinary Persistent Pain Centre (IPPC) will be recruited into the study. Participants will be included if they are over 18 years of age, have non-cancer pain of greater than 3 months duration, and able to read and write adequate English to complete questionnaires. Data will be collected from participants from two cohorts: 1) those receiving standard treatment through TAP (treatment) and 2) those on the waitlist (control). As part of routine practice, all IPPC patients receiving treatment complete objective measures and a battery of self-report questionnaires about their health-related quality of life at regular time points. Both the waitlist and treatment groups will complete the questionnaires following referral to the service (time 1) and at 6 months post referral (time 2). Additionally, the waitlist group (who will crossover into the “TAP with wait” treatment group at 6 months post referral) will complete the questionnaires at 12 months post referral (time 3). Study 1 Primary Hypothesis: Treatment Access Pathway (TAP) patients at six months will have clinically important changes in objective physical function and self-report outcome measures (pain, mood, acceptance, self-efficacy, catastrophising and HRQOL) compared with waitlist patients. Secondary Hypothesis: The TAP delivery cost/quality adjusted life year gained will be less than $73,000/QALY 21,23. Study 2 Primary Hypothesis: There is no significant difference in clinical outcomes (changes in pain, objective physical function, mood, acceptance, self-efficacy, and HRQOL) between patients that wait (6 months) and do not wait for TAP. Secondary Hypothesis: There is no significant difference in cost-effectiveness (TAP delivery cost/quality adjusted life year gained) between patients that wait (6 months) and do not wait for TAP.

This study will evaluate the effect of an exercise and education self-management program on physical function and functional recovery in people undergoing surgery for lung cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, plan to undergo surgical treatment for non-small cell lung cancer (NSCLC), and do not currently meet physical activity guidelines. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will continue to receive usual care throughout the study. Participants in the other group will receive an exercise and education self-management program in addition to usual care. The program consists of an appointment with a physiotherapist before hospital discharge post-operatively. Additionally, the patient will receive weekly phone calls up to 12 weeks after surgery to promote adherence to physical activity goals, discuss barriers/issues with their exercise and progress their exercise program. All participants will undergo a number of tests including measurement of physical function, quality of life and physical activity before surgery, at hospital discharge, and 3 and 6 months post-surgery. We will also follow up to look at quality of life, health care resource usage and the cost effectiveness of the intervention over 12 months from surgery, and survival up to 5 years post-surgery. This study will provide important information on the effects of an exercise based intervention for people with lung cancer.

Parents of children with autism experience greater parenting stress than those of typical children or children with other disabilities. While there is some evidence for efficacy of parent-mediated interventions, existing studies are limited in scope focusing on short-term child outcomes rather than potentially important longer-term outcomes for parents. This pragmatic RCT is achievable uniquely within the operations of the Victorian Autism Specific Early Learning and Care Centre (ASELCC), based in Melbourne Australia. We will determine whether a Parent Coaching approach to delivery of the Early Start Denver Model (P-ESDM) adds value to traditional therapist-delivered ESDM intervention, bringing benefits for parents and children with autism alike, over the short and medium term. Participants in this trial will be followed over 2 years. Initially, children will be recruited on the basis of enrolment (not at random) into one of three groups – ASELCC Playrooms and Autism Playmates (two different approaches to therapist-delivered ESDM), and community services Treatment as Usual controls. Following an eligibility assessment, enrolled participants will complete a baseline (BL) assessment including 1) standardised assessments with the child, 2) questionnaires and interviews completed by parents for self-reported mental health/wellbeing and parent-reported child functioning, 3) collection of naturalistic interaction samples for coding of parent and child behaviour, and 4) collection of parental saliva swabs for Cortisol Awakening Response and salivary Alpha Amylase Awakening Response assay. A mid-point assessment will be conducted 5 months later (5m MP) following which half of families will be randomly assigned to receive Parent Coaching or No Coaching (whilst continuing with their existing enrolment). An end-point assessment will occur 10 months post-BL (10m EP), following which all ASELCC-delivered ESDM-based therapy will cease (i.e., ASELCC Playrooms and Autism Playmates enrolment, and Parent Coaching), and families will transition to Treatment as Usual. A final follow-up assessment will occur 12 months later, 22 months post- BL (i.e., 22m FU). Analysis of the efficacy of Parent Coaching vs. No Coaching – as an adjunct to therapist-delivered intervention – will be conducted via intention to treat method on 10m EP data controlling for any 5m MP between-group differences. Planned preliminary analyses on baseline data will be conducted to 1) determine distribution of Clarke QRS scores in this sample to inform appropriate stratification on this measure, and 2) refine the coding framework for quantifying expressed emotion from five-minute speech samples. Further, to comply with reporting requirements of the funding body, planned interim analysis on BL and 5m MP data will be conducted to inform the short-term relative benefit of the two different therapist-delivered ESDM approaches (ASELCC Playrooms, Autism Playmates) vs. Treatment as Usual.

The aim of this study is to determine how effective the blood vessels (collateral vessels) are that develop around the area where the blockage (occlusion) occurred in patients who have had treatment for a branch retinal vein occlusion (BRVO) or a hemicentral retinal vein occlusion (Hemi-CRVO). The study visit will take place once the patient has been stable for 3 months requiring no anti-VEGF treatment for macula oedema. The duration and number of anti-VEGF treatments that participants have received during their treatment will be recorded. Fluorescein angiography (FA) and optical coherence tomography (OCT) images taken during the treatment will be used to determine how efficient the collateral circulation is that develops. We will also use a new imaging technique called optical coherence angiography (OCT-A) to examine the efficiency retinal circulation at the collateral sites. OCT-A is a non invasive imaging technique and takes about 45 minutes to complete.

Hypothesis: Diagnostic lung ultrasound may be a useful non-invasive bedside tool to assist with clinical decision making during veno-venous-extracorporeal membrane oxygen support and requires further investigation. Objectives Primary: Can diagnostic lung ultrasound be used to monitor the movement of air in the lungs of patients who require on veno-venous ECMO? Secondary: To study the changes of in the movement of air in the lungs using lung ultrasound in comparison to standard measures of lung function and chest X-ray changes up to the point of weaning a patient from extra-corporeal membrane oxygenation Study design Prospective observational cohort study of 10 patients LUS assessment will be undertaken within 48-hours after commencement of ECMO and at 5 and 10 days after ECMO commencement. Standard measurements for VV-ECMO, including ECMO settings (sweep flow, ECMO flow) and arterial blood gases will be undertaken 4-6 hourly and recorded. The portable anterior chest radiograph will undertaken once per day and as clinically indicated.

TrimphDent is an injectable biomaterial for use in dental and maxillofacial applications. TrimphDent consists of two components: (1) the Trimph smart synthetic polymer and (2) a peptide (Thymosin B4). The use of TrimphDent as a regenerative scaffold is aimed to: a) stimulate new bone regeneration following tooth extraction. b) negate the need for bone harvesting operations or other bone grafting procedures following tooth extraction c) reduce post-operative infections risks following oral surgery. This initial pilot study will enrol ten (10) patients from one (1) centre in Western Australia, The study is being conducted in conjunction with standard of care procedures in patients undergoing tooth extraction with subsequent planned dental implant procedure. The primary objective of this pilot study is to identify qualitative measures and analytical methodologies to further investigator the use of TrimphDent. This will be done using three methods including: oral examination, histological evaluation and CT-imaging. These methodologies will be utilised to evaluate bone regeneration in the presence of TrimphDent following tooth extraction.

This is a prospective, single-site, randomised controlled trial on patients undergoing THA. The study will enrol a minimum of 150 patients over a two (2) year period from two orthopaedic surgeons at one (1) site. All cases must satisfy the inclusion/exclusion criteria. Study participants will be recruited from a cohort of THA patients who will receive a femoral stem (MetaFix or TriFit) and Trinity acetabular cup and followed up by Dr Matthew Wilkinson (Mater Health Services North Queensland) and Dr Kaushik Hazratwala (Mater Health Services North Queensland). Preoperative planning using the Corin OPS™ 3D planning component will be used for all study participants to determine the optimal acetabular and femoral component models, type and size for each patient. The preoperative templates will also be used to determine the optimal position and orientation (abduction and anteversion angles) of the implant, relative to the patients’ pelvic parameters, bone geometry and bone landmarks. Whilst the same method will be used for preoperative templating for all study participants, the surgical technique used for executing acetabular and femoral implants intraoperatively will differ. In this study, patients will be randomised to one of three surgical groups: Group 1: Conventional, unassisted (freehand) methods Group 2: Corin Optimised Positioning System (OPS)™ using patient-specific, image-derived instrumentation and laser-assisted positioning technology (IDI+LAT) Group 3: Intellijoint Hip® infrared navigation system only

Chronic Obstructive Pulmonary Disease and Severe Asthma are chronic obstructive airway diseases associated with a high disease burden. They are complex diseases that can be complicated by significant comorbidity. A new and emerging approach to these conditions is to focus on the identification and treatment of the processes that underlie individual disease. These components are termed ‘treatable traits’. An important aspect of the treatable traits approach is objective monitoring to select and continue therapy. Most current monitoring approaches are assessed using nonobjective measures, that do not capture improvements after treatment. Functional lung ventilation imaging with quantification using Technegas may address this clinical need. Tomographic pulmonary scintigraphy (ventilation/perfusion single photon emission computed tomography: V/P SPECT) is a nuclear medicine investigation that gives a 3dimensional functional map of the ventilation and perfusion of the lungs and shows how these are affected by disease. We believe that this new imaging approach may be a useful objective measure of disease and treatment response in severe asthma and COPD. In the current study, we aim to quantify: 1. Whether functional lung ventilation technology can objectively quantify ventilation heterogeneity in patients with severe obstructive airway disease (asthma or COPD). 2. Determine whether functional lung ventilation imaging can be used to quantify response to therapies.

1. Background Burns are a painful and traumatic experience. Literature has found that using pharmacological and non-pharmacological interventions aid in providing appropriate pain management and significantly improve paediatric burn outcomes. Overall, there seems to be some evidence that reduced pain and anxiety positively influences re-epithelialisation rates however current literature fails to fully explain the effects of pain and anxiety and their links with wound healing. This study will determine if Burnaid® is an effective treatment for reducing pain in the acute period of a burn injury. It is hypothesised that a reduction in pain, as well as stress/anxiety, will then improve re-epithelialisation time in comparison to plastic wrap which is standard practice at our institute, a large metropolitan paediatric hospital located in Brisbane, Australia. 1.2 Methods/Design A randomised controlled trial will be conducted assessing the effectiveness of Burnaid® hydrogel dressings as an analgesic adjunct to cold running water (CRW) first aid for the treatment of paediatric burns. Participants will include children aged between 0 – 16 years with an acute thermal burn injury with a total burn surface area (TBSA) of < 20% admitted to our emergency within 24hours of the burn occurring. Participants will be stratified into one of two groups based on factors which increase pain intensity. The trial will then randomise patients into one of two groups: 1) Plastic wrap which will serve as the control arm or 2) Burnaid® which is the intervention arm. The trial requires a minimum of 29 participants per group, which will be assessed from day of injury to re-epithelialisation. The primary outcome of the trial is the effect of the intervention on reducing acute pain. Secondary outcomes include: days to re-epithelialisation, Physiological changes that indicate pain intensity (pulse rate, temperature and respiratory rate), analgesia and distraction techniques required, , cost effectiveness, staff perspectives on the treatmen, Health related Quality of Life (Child Health Utility 9D - CHU9D) and salivary cortisol and a-amylase ratio (informing influences of stress and anxiety) 1.3 Discussion This study will provide comprehensive data on the analgesic properties of Burnaid® hydrogel dressings as an adjunct to CRW first aid for the treatment of acute paediatric thermal burns. If the intervention shows to be effective in reducing acute pain, Burnaid® dressings will be integrated as standard care practices at our institute. This study replicates a real-world scenario in order to identify clinically significant analgesic and would healing effects.

The Rapid Iron Infusion Study (RIIS) is a randomised controlled trial for Aboriginal children with severe iron deficiency anaemia, The aim is to assess whether a single intravenous infusion of ferric carboxymaltose (Ferinject) given over 15 minutes in children prior to their discharge from hospital compared to the standard treatment with intramuscular iron injections as per CARPA Manual, will improve haemoglobin levels and reduce the risk of further anaemia. The potential benefits of rapid iron infusions include higher haemoglobin levels, fewer painful intramuscular injections, better adherence to recommended treatment, and less use of primary health care resources.