ANZCTR search results

Aims: The goals of the LOBRAS study, were: 1) To evaluate the group-level response to Synvisc-One in knee OA, using patient-centred measures of beneficial and adverse outcome; and 2) To evaluate response and state-attainment criteria and age-specific and gender-specific benchmarks, at the individual patient level, to assess the therapeutic response to Synvisc-One in knee OA. Methods: The LOBRAS study involved a one year long multi-centre, pragmatic, “real-world” evaluation of the response to Synvisc-One, in 131 patients with knee OA. LOBRAS employed an open, quasi-experimental, one group, repeated measures design, and involved consented patients in Australia, fulfilling inclusion/exclusion criteria, and under the care of a medical specialist (Orthopaedic Surgeon, Rheumatologist, Sports and Exercise Medicine Physician), in routine clinical practice. Prior to, and for 52 weeks following, intra-articular Synvisc-One, patients were repeatedly evaluated, using the WOMAC NRS4.1 Index and the SF-36 questionnaire. The WOMAC NRS4.1 was administered by mobile phone (with paper back-up) at baseline, then once weekly for 12 weeks, and once every four weeks thereafter. The SF-36 was administered on paper, at baseline, then every four weeks thereafter. Patients were also monitored for adverse events. Data Analyses: The following analyses were pre-planned: Effectiveness analyses: Primary: Repeated measures analysis based on 26 week outcome for WOMAC pain, stiffness, function and total index scores, using continuous data. Secondary: Repeated measures analysis based on 52 week outcome for WOMAC pain, stiffness, function and total index scores, using continuous data. Responder analyses based on WOMAC pain, stiffness, function and total index scores, using categorical data. a) OMERACT-OARSI Responder Criteria b) Minimum Perceptible Clinical Improvement (MPCI) c) Minimum Clinically Important Improvement (MCII 75) d) WOMAC 20-50-70 Responder Criteria State-attainment analyses based on WOMAC pain, stiffness, function and total index scores, using categorical data. a) Bellamy Low Intensity Symptom State-attainment (BLISS) Index b) WOMAC Age- and Gender-specific normative values c) Patient Acceptable Symptom Severity (PASS 75) Utility analysis using the WOMAC-HUI model for deriving HUI-3 utility values from WOMAC scores Comparison of 26 week vs. 52 week outcomes for above analyses Change in SF-36v2 (BL to week 26 and week 52) Analysis of predictors of outcome at 26 weeks and 52 weeks including age, gender, BMI, KL Grade, Injection site, duration of OA, adverse events. Time to re-injection in repeat treatment subgroup Safety/Tolerability Analyses: Descriptive analysis of adverse events

There is increasing evidence of a relationship between trauma and psychosis. Recent evidence also suggests that there are potential shared mechanisms involved in the genesis of posttraumatic intrusions and posttraumatic voice hearing. The Recall study is a pilot trial aiming to provide initial evidence regarding the acceptability, feasibility and effectiveness of applying established trauma-focussed treatments to voice hearing. In addition, in the spirit of the interventionist-causal approach, the study aims to provide a preliminary assessment of the effects of the intervention on the proposed mechanisms of change. The findings of the pilot study will inform future treatment trials using trauma-focussed therapies for post traumatic voice hearing.

We would like to see whether a running program delivered via a Facebook group is effective in assisting people to improve their fitness and change their attitudes and beliefs about exercise UniSA Run Free is an 8 week running program, targeted at 18-50 year olds, currently not undertaking any running with no health conditions that may prevent participation in a graded exercise program. A Facebook group will be set up to provide a weekly running program, it will also encourage social interaction and provide motivational advice. Participants will be asked to complete an online survey giving details of their physical activity over the last 7 days and answer questions about attitudes to exercise and opinions about social support when exercising. Participants will also be asked to follow an online instructional video and complete a 3 minute step test, which assesses fitness. This test can be completed at home at a time of convenience. The surveys and step test are likely to take less than 30 minutes in total. After baseline assessments are completed, participants will be randomly allocated to the UniSA Facebook group, or will receive a hard copy of the Running Program. Twelve and 20 weeks after participants complete the baseline assessment they will be asked to repeat the online surveys and self-administered step test.

The trial aims to Demonstrate a Clinical Psychology Intervention for Voice Hallucinations (CPV) plus Treatment As Usual (TAU) is significantly superior to TAU in improving engagement with community therapy, by patient choice, in patients with distressing voice hallucinations and schizophrenia spectrum disorder at the Sir Charles Gairdner Hospital Mental Health Unit (SCGH MHU). A secondary aim is to see if the distress associated with the voice hallucinations and the frequency and intensity of voice hallucinations will decrease with improved engagement in community therapy. There are observed barriers to engagement with community therapy. The higher cost and effectiveness of CPV in overcoming these barriers, compared to the current standard TAU, needs justification by a comparative clinical trial. The Participant group will be voluntary and involuntary residents of the SCGH MHU Tanami ward with schizophrenia spectrum disorder and distressing voice hallucinations who meet eligibility criteria. The clinical trial design is a randomised single blind clinical trial comparing 2 treatments groups: CPV + TAU and TAU. The outcomes measured will be change in: 1) Engagement in community therapy post discharge measured by the Engagement in Community Therapy Questionnaire (ECTQ). 2) Change in Patient’s distress associated with the voice hallucinations measured by the revised Beliefs About Voices questionnaire (BAVQ-R). 3) Frequency and intensity of voice hallucinations measured by the Psychotic Symptom Rating Scale (PSYRATS) hallucinations section. Measures will be collected at baseline, post discharge 1, 3 and 6 months post discharge by a blinded research officer. The expected outcomes are that engagement in external community therapy will be significantly better in CPV + TAU than TAU at 1, 3, 6 months. Significant reductions in the total PSYRATS auditory hallucination score and abnormal beliefs about the voice hallucinations in the BAVQ-R score are expected at 6 months in the CPV + TAU group compared to the TAU group.

The aim is to determine whether sequential optimization of cardiac resynchronization therapy (CRT) can improve outcome in advanced chronic heart failure (CHF). The efficacy of this strategy will be established by assessment of functional capacity using measurement of 6-minute walk test distance (6MWT), B-type natriuretic peptide (BNP), echocardiographic measures and quality of life (QoL, based on a disease specific questionnaire: Minnesota Living with Heart Failure questionnaire, MLHFQ, and the multi-attribute utility indices: EQ-5D and Assessment of Quality of Life (AQoL). The cost- effectiveness of the strategy will also be assessed, relative to non-optimization. The hypotheses are that optimization of atrioventricular delay (AVD) setting will lead to (1) improved exercise capacity (2) improved BNP, LV structure and QoL over the ensuing 6 months, and be (3) cost-effective.

Conventional anaesthesia for Extracorporeal Shockwave Lithotripsy [ESWL] requires ventilation, which results in movement of the kidney during inspiration and expiration. This cause the stone to move out of the focal point of the shockwaves for a significant percentage of treatment time resulting in prolonged operating time and also potential injury to the adjacent normal renal tissue. It is hypothesised that if the patient could remain apnoeic during treatment the majority of energy delivered will be focused on the target with minimal wastage and less adjacent tissue damage. Previous studies have suggested that if the patient could remain apnoeic during the treatment almost all the energy delivered will be transmitted directly on to the stones resulting in more effective treatment. Multiple studies based on this idea have been published in major peer reviewed journals describing methods like high frequency jet ventilation (HFJV) for ventilating patients with minimal diaphragmatic movement. These studies have demonstrated that such ventilation modes result in significantly fewer total shocks than with conventional mechanical ventilation. However HFJV requires additional expertise, poses a further range of risks and side effects and also requires special equipment currently not available at The Prince Charles Hospital (TPCH). High-Flow Nasal Oxygen [HFNO] recently introduced at TPCH, offers a novel method of providing oxygenation during extended periods of apnoea. Multiple studies have proven HFNO as a safe and beneficial method of improving oxygenation and carbon dioxide (CO2) removal in patients with impaired respiratory function or after a period of mechanical respiratory support on a breathing machine. The researchers hypothesise that the usage of HFNO during ESWL will allow a clinically relevant period of apnoea resulting in more effective treatment, fewer shocks and a shorter duration of treatment. The multi factorial benefits can only be completely elucidated by a large prospective randomised controlled trial. The proposed research activity is a pilot study to investigate the feasibility of safe provision of anaesthesia for ESWL using HFNO. It aims to identify potential problems and to help plan and write up a robust methodology for the proposed larger RCT in the future. This study will be a prospective study in 20 patients undergoing elective ESWL at The Prince Charles Hospital [TPCH], who fulfil the inclusion/exclusion criteria and give informed consent to participate. All relevant peri-operative events, all standard patient parameters including routinely monitored vital statistics and any necessary optimisation steps initiated to ensure safe provision of anaesthesia during ESWL will be recorded and analysed.

This study aims to measure the effect of regular reminders and motivational text messages on waist-to-hip measurements. We hope to show text messages can be used as effective medium to motivate people for healthy lifestyle changes. This will be done by comparing the intervention group to a control. The intervention group will receive motivational messages every second day and weekly reminders to measure their waist-to-hip measurements. The control group will receive informative fortnightly messages. Changes in waist-to-hip measurements and lifestyle choices will be assessed via a pre and post study survey.

Acute behavioural disturbance(ABD), also known as Excited Delirium Syndrome(ExDS), is a medical emergency with reported mortality of 8-10%.. The management of ABD usually necessitates a judicious combination of de-escalation techniques, physical restraints and sedation. Sedation of patients with ABD is usually accomplished with benzodiazepines and antipsychotics, either alone or in combination. The use of these two drug classes can be limited by several factors, primarily respiratory depression with benzodiazepines and a delayed onset of action of up to 20min with antipsychotics. In recent years, several small studies have explored the suitability of ketamine as an alternative agent for sedating patients with ABD in the prehospital, retrieval and emergency settings. Favourable pharmacological properties including rapid onset of action of 2-5min, protection of airway reflexes and maintenance of respiratory drive make ketamine a promising sedative agent in the management of ABD. Nevertheless insufficient data about effectiveness and safety of ketamine in the setting of ABD have prevented it from gaining widespread acceptance for this indication. Firstly, the effectiveness of ketamine sedation in ABD, as measured by sedation failure rates, has varied between no failures in one retrospective study and 10% in a recent prospective study. Furthermore, the reported incidence of endotracheal intubations with ketamine has also varied widely between studies, from no intubations to 39% . Interestingly, a large study looking at the incidence of intubations before and after introduction of a ketamine sedation protocol for ABD found a decrease in incidence from 3.5% to 2.3% while a smaller study using a combination of sedatives including ketamine also reported an intubation rate of 3%. Finally, there is a lack of clarity about the minimum effective ketamine dose needed to achieve safe sedation of behaviorally disturbed patients with reported dose ranges of 0.5-1mg/kg as the initial intravenous dose followed by 1 - 5.56mg/kg/h intravenous infusion and 2.25- 9.42mg/kg as the total intramuscular dose. Along with benzodiazepines and antipsychotics, ketamine has been a part of the Standard Operating Procedure(SOP) for management of ABD at Lifeflight Retrieval Medicine( previously known as Careflight Retrieval Medicine, Queensland),Australia for over 3 years and Royal Flying Doctor Service(RFDS), Queensland, Australia for over 9 years. We want to examine the experience at these organizations to address our research question of whether ketamine is a safe and effective alternative agent for sedation of patients with acute behavioural disturbance in the aeromedical retrieval setting. Our study hypothesis is that in our aeromedical retrieval setting ketamine reduces the incidence of intubations in patients needing sedation for acute behavioural disturbance compared to the reported incidence of intubations in existing literature.

The primary purpose of this study is to assess the acceptability and efficacy of an online training program for oncology health professionals for aiding with the screening and management of anxiety and depression in adults with cancer. Who is it for? You may be eligible to participate in this study if you are an oncology health professional in a role which involves discussing anxiety and depression. Study details All participants in this study will complete the online training program which consists of five modules and takes approximately four hours to complete. It includes explanations about talking to patients and videos with acted scenarios. Participants will complete a questionnaire and participate in three patient simulated consultations (where patients are played by actors) before and after receiving online training to evaluate program acceptability and efficacy.

The Queensland Ambulance Service (QAS) is changing its drug management of acute behavioural disturbance (ABD) from midazolam to droperidol based on the research undertaken by the chief investigator (Page) and one of the principle investigators (Isbister) in the emergency department setting. New South Wales ambulance service has undertaken this change in 2015. Auditing to date of the QAS ambulance report form (ARF) use of midazolam demonstrates poor use of sedation scores, missing information & adverse effects from midazolam. It is therefore planed to audit this change over in drug management with an audit form in addition to standard reporting (ARF). This will be a prospective observational study, as part of a quality assurance monitoring process of this changeover looking at effectiveness and safety of both agents. Possible outcomes will hopefully be a more effective and safer management of this condition.