ANZCTR search results

Background: Sepsis is the leading cause of early childhood death worldwide, with an estimated 4 million children dying from this final common pathway for severe infections every year. The burden of disease in Australia and New Zealand is unknown, including mortality, duration of hospitalisation, requirement for intensive care and organ support therapies, and long-term functional outcome in sepsis survivors. Early markers of severe disease and predictors of poor outcome in childhood sepsis are unknown. Sepsis-related hospital costs are estimated at $4 billion per annum for children and $12 billion per annum for adults in the United States. The cost of hospitalisation for children with sepsis in Australia and New Zealand is unknown. Variation in guidelines for sepsis treatment in Australia and New Zealand, and adherence to such guidelines, is unknown. The microbiology and resistance patterns of bacterial pathogens in children treated for sepsis in Australia and New Zealand are unknown. Whether current empiric antibiotic recommendations are appropriate to cover bacterial pathogens causing sepsis in Australia and New Zealand is unknown. The prevalence and outcomes in subgroups of vulnerable, high risk children, including those receiving cancer chemotherapy, those self identifying as of Aboriginal or Torres Strait Islander or Maori ethnicity, those with chronic medical conditions, and infants or neonates who are treated for sepsis are unknown. Rationale: Baseline observational data is required to answer fundamental aspects of sepsis care for children in Australia and New Zealand, and to plan future interventional studies. Defining characteristics, prevalence, severity, resource utilisation, cost, variation in care, and antimicrobial stewardship are all important and unexplored components of the paediatric sepsis research landscape that will be addressed by this study. Aim: To describe the epidemiology of hospitalised children treated for sepsis in Australia and New Zealand.

Although we like to think that morphine-type (opioid) drugs are strong painkillers that work for all types of pain, the story turns out to be more complicated. Opioids are commonly prescribed for the pain of hip and knee osteoarthritis where there is little evidence to support their effectiveness, yet there is evidence that they increase harms. Despite this risk, an estimated 24 to 39% of patients undergoing knee or hip arthroplasty use opioids regularly while waiting for surgery. Not only is pre-surgery opioid use not very effective for the pain of severe arthritis, but research has shown that regular use is related to worse pain at the time of the operation, more side effects, longer hospital stays and more complications after discharge from hospital compared to patients who don’t use opioids regularly before surgery. Hip and knee replacements are among the most common elective surgeries performed in Australia, with approximately 100,000 hip or knee replacements performed in 2019. This means approximately 30,000 people annually potentially have their joint replacement outcomes undermined by opioid use. The proposed pilot study aims to reduce these opioid-related harms by measuring whether patients are willing and able to reduce their opioid medication by at least 50% while they are on the waiting list for elective hip or knee replacement. Those patients who agree to participate will be randomised to either a usual waiting list experience or to having a pharmacist work with their General Practitioner to reduce their opioid dose very slowly. Most patients find that their pain does not increase as the doses reduce if tapering is slow and performed in partnership with the patient. Further, individualised tapering that supports the patient, provides them with information relevant to their circumstances and allows their control of the weaning phases. After the patient and pharmacist come to an agreed opioid tapering plan, an Anaesthetist will review this plan to ensure its safety and effectiveness. Whilst the aim is to measure the feasibility of a 50% taper, the patient will decide the point at which they cease to taper. Patients will receive follow-up appointments with the pharmacist one week after each opioid dose reduction. Patients already seeing a pain specialist or undergoing opioid tapering will be invited to join an observational group. This research will be performed at both metropolitan and regional teaching hospitals in NSW, in recognition of the increased community use of, and harms from, opioids in regional areas. Patients who present for surgery while taking regular opioids not only have poorer outcomes but also pose a challenge for anaesthetists and pain management teams. Thus, the proposed research has the potential to improve the perioperative experience for both the patients and their medical teams.

Individuals following a stroke experience an array of clinical problems, including post stroke fatigue (PSF). PSF has been articulated as a feeling of a lack of energy, weariness and aversion to effort. It is considered one of the most detrimental consequences of a stroke and is estimated to affect between 40% and 70% of individuals at six months post-stroke. These values significantly exceed those in the general population, where fatigue is estimated to affect between 10% and 23% of individuals. These figures are alarming, particularly considering the well-documented associations between greater PSF and shorter survival, institutionalisation, poorer functional outcomes and reduced functional independence and quality of life. Treatment strategies aimed at combating post-stroke fatigue are therefore crucial. To date, evaluation of non-pharmaceutical treatment options for PSF have largely focused on the utility of exercise training and psychotherapy. A recent Cochrane report indicated no positive effect of psychotherapy on PSF. The effects of exercise training on PSF are also equivocal with limited high-quality evidence. While not demonstrated in individuals with stroke, light therapy has been demonstrated to positively impact on fatigue in individuals with Parkinson’s disease, traumatic brain injury, seasonal affective disorder and cancer-related fatigue. Considering its positive effect on fatigue in these populations, particularly individuals with Parkinson’s disease and traumatic brain injury who both display neurological damage, it is conceivable that light therapy will have a positive effect on post-stroke fatigue. The purpose of this study is to evaluate the feasibility and therapeutic effects of light therapy in combination with sleep health, compared to sleep health alone, in individuals experiencing post-stroke fatigue at least three months following a stroke. It is hypothesised that both therapies will be feasible and positively impact on fatigue, however, light therapy plus sleep health guidance will prove to be more therapeutically effective than sleep health guidance alone.

Placental delivery is accelerated by placental cord drainage at vaginal delivery. Hypothesis: This effect may extrapolate to caesarean section, where the blood loss from the vascular uterine incision may make time to delivery of placenta particularly important. Aim: To determine if drainage of the placental cord at caesarean section accelerates delivery of the placenta, compared to delayed clamping of the placental cord. Methods: Randomised Controlled Trial with Intention to Treat Analysis. Women at elective caesarean section without antenatal evidence of placental disease or fetal compromise, randomised to Intervention (Placental Cord Drainage) or Control (Delayed Cord Clamping).

The present study will evaluate the relative efficacy of two digital interventions for recurrent binge eating: a smartphone app and an Internet-based program. The relative efficacy of different technology mediums has yet to be explored. Findings will shed light towards possible technologies that afford an added benefit. The following hypotheses are derived: 1. Participants randomized to the two digital intervention groups will experience greater reductions in primary and secondary outcomes than participants randomized to the waitlist. 2. There will be no differences in outcome variables between those randomized to one of the two digital interventions (app versus web program).

This is a prospective randomised controlled trial (RCT) comparing the outcomes for patients undergoing proximal hamstring tendon avulsion repair with two different post-operative rehabilitation regimes. The first regime includes a period of brace immobilisation and limited weight-bearing with a gradual progression of physiotherapy. The second regime allows immediate full-weight bearing with an accelerated rehabilitation program of physiotherapy. Patient outcomes will be collected and compared between the two rehabilitation regime cohorts over a 24-month post-operative period. This will include validated Patient Reported Outcome Measures (PROMs) investigating pain, symptoms and patient satisfaction, and objective measures of hip range of motion (ROM), muscle girth, peak isokinetic knee flexor (hamstrings) and extensor (quadriceps) strength. Overall satisfaction and assessment of complications will be assessed throughout.

Phase 1 of the study will obtain safety data for the investigational automated insulin delivery EOPatch pump. We hypothesize that the EOPatch pump is as safe and is as effective at reducing post-prandial blood glucose excursions in persons with Type 1 diabetes who under-bolus mealtime insulin.

Burnout is a common problem among medical doctors, with difficulties emerging as early as undergraduate medical training. The current study will deliver a psychological flexibility skills training intervention (Acceptance and Commitment Training) to medical students via an online App, which aims to provide early intervention to improve burnout and wellbeing outcomes. The App-based delivery format aims to make the intervention accessible among a time-poor group that tends not to seek out support due to perceived stigma, as well as facilitate the delivery of an intervention that can be adapted to suit individual skill-building needs (individualised). We will compare the efficacy of an individualised version of the App with a non-individualised version. We expect that medical students who complete either version of the intervention will demonstrate better burnout and wellbeing outcomes than students who have not completed the intervention. We also expect that students who receive the individualised version will benefit more from the intervention than those who receive the non-individualised version.

This study comprises two sections. o Section 1: Co-design section: The aim of this section is to co-design an infographic with the assistance of consumers (in this instance, people who have had a knee replacement). The aim of the infographic is to increase people’s knowledge of physical activity after knee joint replacement surgery. o Section 2: Randomised controlled trial: The aim of this section is to measure how effective the infographic is at increasing people’s knowledge of physical activity after total knee joint replacement with a randomised controlled trial. Outcome measures will be based on previously published questionnaires that evaluate knowledge of physical activity, self-efficacy for exercise and the participant's engagement with the infographic. Measures will take place at baseline, 1 and 6 week after study commencement. Participants for both sections will be recruited from the SMART registry (HREC A 100/14) of total joint replacement surgery maintained by St Vincent’s Hospital, Melbourne, including public and private patients. It is anticipated that 10-15 participants will take part in co-designing the infographic, and 44 participants will take part in the randomised controlled trial. Study hypothesis: We expect that people who receive the co-designed infographic will demonstrate an increase in knowledge of physical activity and an increase in self-efficacy for exercise.

Currently at our institution (Mercy Hospital for Women), approximately 12 women are referred each week for postmenopausal bleeding, or 600 per annum. These women are then seen in the outpatient gynaecology department in any one of four clinics. Pelvic ultrasonography is used as a binary differentiator, as a risk predictor for endometrial cancer. If the endometrial thickness (lining of the womb) is below a certain level (4mm as per national and international guidelines), the risk of endometrial cancer is less than 1%, and thus endometrial sampling is not indicated, in the absence of recurrent episodes or high-risk features. Unfortunately, the time from referral to our clinics, to the time of notification of the histological diagnosis (and thus options for definitive management) is usually 12 weeks at best. The effect of this delay is 2-fold; 1) we believe patients may experience anxiety and frustration at the delay to review and diagnosis, particularly when concerns regarding endometrial cancer have been raised, and 2) seeing women in the outpatient clinic with a normal endometrial thickness (<4mm) is unnecessary, when sampling is not required. We believe these women can be safely managed in the community by their local general practitioner. We thus plan to randomise patients referred to the Endosurgery B unit to either routine care (with outpatient ‘in-person’ clinic review) or a ‘virtual clinic’ utilising telephone consultation with a gynaecologist after pelvic ultrasound results are known. We suspect outcomes to indicate: 1. more efficient throughput of patients with postmenopausal bleeding 2. a change in patient satisfaction impacted by faster contact and review, and individual acceptance of the telephone clinic model 3. clinician satisfaction upon seeing improved efficiency in the management of this common problem 4. shorter outpatient clinic wait times