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Background: A skin tear is a traumatic wound that occurs in up to one in five hospitalized patients. Nursing care includes application of a dressing to create a moist wound healing environment. Aim: To compare the effectiveness of two standard dressings (adhesive silicone foam vs. meshed silicone interface) to heal hospital‐acquired skin tear. Methods: An intention‐to‐treat pilot study was designed using a randomized, non‐inferiority trial in an Australian tertiary hospital setting. Consenting participants (n = 52) had acquired a skin tear within the previous 24 h and had agreed to a 3‐week follow‐up. Data were collected between 2014 and 2020. The primary outcome measure was wound healing at 21 days. Results: Baseline characteristics were similar in both arms. Per protocol, 86% of skin tears were fully healed at 3 weeks in the adhesive silicone foam group, compared to 59% in the meshed silicone interface group. Greater healing was observed across all skin tear categories in the adhesive silicone foam dressing group. In the intention‐to‐treat sample, healing was 69% and 42%, respectively. Conclusions: Results suggest the adhesive silicone foam dressing may be superior, as it produced clinically significant healing of skin tears at 3 weeks compared to the meshed silicone interface dressing. Accounting for potential loss to follow‐up, a sample of at least 103 participants per arm would be required to power a definitive study. Summary statement: What is already known about this topic? A skin tear is a traumatic wound that is commonly acquired during hospitalization that affects older adults in particular. In hospital settings, it may occur in up to one in five patients.A variety of skin tear dressings have been used in previous studies, with healing rates ranging from 34% to 97% at 21 days; however, evidence for the most effective dressing type is inconclusive.If treated inappropriately, or left untreated, minor skin tears can become chronic or complicated wounds, yet prevalence and treatment of hospital‐acquired injuries are under‐reported. What this paper adds? Based on our per‐protocol results, an adhesive silicone foam dressing may be superior, as it produced clinically significant healing of 86% of skin tears at 3 weeks compared to 59% with the meshed silicone interface dressing.Based on the methods and results from this pilot study, a future definitive trial would be feasible but would need to account for a relatively large loss to follow‐up rate. The implications of this paper: Using our intention‐to‐treat results, a future study would need a sample size of 103 per arm to be sufficiently powered, which may be impractical to achieve within a single hospital setting; thus, a multi‐site study would be advisable. [ABSTRACT FROM AUTHOR]

Background: Many countries are experiencing an increased demand for health care and a shortage of health professionals in rural areas, impacting an individual's ability to receive timely treatment. The management of uncomplicated urinary tract infections by community pharmacists is usual practice in some regions of the United Kingdom and Canada, and Queensland, Australia. Aim: To systematically gather, assess, and synthesize the available peer-reviewed published literature on the management of uncomplicated UTIs by community pharmacists in women aged 16–65 years, provide an understanding of the clinical and economic evidence, while also identifying the essential components of interventions employed. Method: A systematic review was conducted to identify primary studies detailing interventions for the management of uncomplicated UTIs by community pharmacists. PubMed, PsycINFO, Scopus, Cochrane, CINAHL, EMBASE, and Web of Science were searched to February 2023. Non-primary and qualitative studies were excluded. Study details were recorded in a tailored data extraction form. The quality of studies was assessed using the Joanna Briggs Institute tools. Results: Ten publications were included following review of 2129 records. High self-reported cure rates between 84 and 89% and referral rates of about 7% were reported. A single study found pharmacist management was cost effective compared to general practitioner management. No randomized controlled trials were found and papers were of variable quality. Conclusion: Preliminary evidence suggests pharmacist-led management of uncomplicated UTIs is safe and effective, however no firm conclusion can be provided since the methodologies reported in included studies have significant limitations. [ABSTRACT FROM AUTHOR]

Background: Hospitalisation rates for older people are increasing, with end-of-life care becoming a more medicalised experience. Innovative approaches are warranted to support early identification of the end-of-life phase, communicate prognosis, provide care consistent with people's preferences, and improve the use of healthcare resources. The Intervention for Appropriate Care and Treatment (InterACT) trial aimed to increase appropriate care and treatment decisions for older people at the end of life, through implementation of a prospective feedback loop. This paper reports on the care review outcomes.Methods: A stepped-wedge randomised controlled trial was conducted in three large acute hospitals in Queensland, Australia between May 2020 and June 2021. The trial identified older people nearing the end of life using two validated tools for detecting deterioration and short-term death. Admitting clinical teams were provided with details of patients identified as at-risk with the goal of increasing awareness that end of life was approaching to facilitate appropriate patient centred care and avoid non-beneficial treatment. We examined the time between when the patient was identified as 'at-risk' and three outcomes: clinician-led care review discussions, review of care directive measures and palliative care referrals. These were considered useful indicators of appropriate care at the end of life.Results: In two hospitals there was a reduction in the review of care directive measures during the intervention compared with usual care at 21 days (reduced probability of - 0.08; 95% CI: - 0.12 to - 0.04 and - 0.14; 95% CI: - 0.21 to - 0.06). In one hospital there was a large reduction in clinician-led care review discussions at 21 days during the intervention (reduced probability of - 0.20; 95% CI: - 0.28 to - 0.13). There was little change in palliative care referrals in any hospital, with average probability differences at 21 days of - 0.01, 0.02 and 0.04.Discussion: The results are disappointing as an intervention designed to improve care of hospitalised older people appeared to have the opposite effect on care review outcomes. The reasons for this may be a combination of the intervention design and health system challenges due to the pandemic that highlight the complexity of providing more appropriate care at the end of life.Trial Registration: Australia New Zealand Clinical Trial Registry, ACTRN12619000675123 (registered 6 May 2019). [ABSTRACT FROM AUTHOR]

Background: Translation encompasses the continuum from clinical efficacy to widespread adoption within the healthcare service and ultimately routine clinical practice. The Parenting, Eating and Activity for Child Health (PEACH™) program has previously demonstrated clinical effectiveness in the management of child obesity, and has been recently implemented as a large-scale community intervention in Queensland, Australia. This paper aims to describe the translation of the evaluation framework from a randomised controlled trial (RCT) to large-scale community intervention (PEACH™ QLD). Tensions between RCT paradigm and implementation research will be discussed along with lived evaluation challenges, responses to overcome these, and key learnings for future evaluation conducted at scale.Methods: The translation of evaluation from PEACH™ RCT to the large-scale community intervention PEACH™ QLD is described. While the CONSORT Statement was used to report findings from two previous RCTs, the REAIM framework was more suitable for the evaluation of upscaled delivery of the PEACH™ program. Evaluation of PEACH™ QLD was undertaken during the project delivery period from 2013 to 2016.Results: Experiential learnings from conducting the evaluation of PEACH™ QLD to the described evaluation framework are presented for the purposes of informing the future evaluation of upscaled programs. Evaluation changes in response to real-time changes in the delivery of the PEACH™ QLD Project were necessary at stages during the project term. Key evaluation challenges encountered included the collection of complete evaluation data from a diverse and geographically dispersed workforce and the systematic collection of process evaluation data in real time to support program changes during the project.Conclusions: Evaluation of large-scale community interventions in the real world is challenging and divergent from RCTs which are rigourously evaluated within a more tightly-controlled clinical research setting. Constructs explored in an RCT are inadequate in describing the enablers and barriers of upscaled community program implementation. Methods for data collection, analysis and reporting also require consideration. We present a number of experiential reflections and suggestions for the successful evaluation of future upscaled community programs which are scarcely reported in the literature.Trials Registration: PEACH™ QLD was retrospectively registered with the Australian New Zealand Clinical Trials Registry on 28 February 2017 (ACTRN12617000315314). [ABSTRACT FROM AUTHOR]

Simple Summary: This study investigated whether using virtual reality (VR) could help reduce anxiety in women undergoing gynecological cancer surgery. Participants were split into two groups: one receiving VR therapy alongside usual care and the other receiving only usual care. Results showed that VR significantly decreased anxiety levels before surgery compared to the control group. This suggests that VR could be a valuable tool in preparing patients for surgery, potentially improving their experience and outcomes. Further research is needed to explore VR's benefits in other types of surgery and its long-term effects on patient recovery. Perioperative anxiety is common among patients undergoing surgery, potentially leading to negative outcomes. Immersive virtual reality (VR) has shown promise in reducing anxiety in various clinical settings. This study aimed to evaluate the effectiveness of VR in reducing perioperative anxiety in patients undergoing gynecological oncology surgery and was conducted as a single-center, double-arm, single-blinded randomized controlled trial at the Gold Coast University Hospital, Queensland, Australia. Participants were randomized into the VR intervention + care as usual (CAU) group (n = 39) and the CAU group (n = 41). Anxiety scores were assessed using a six-tier visual facial anxiety scale at baseline, after the intervention/CAU on the same day, and, several days up to weeks later, immediately before surgery. There was no significant difference in baseline anxiety scores, type of operation, or suspected cancer between the two groups. The VR intervention significantly reduced anxiety scores from baseline to preoperative assessment (p < 0.001). The median anxiety score in the VR intervention group decreased from 3 (interquartile range 2 to 5) at baseline to 2 (2 to 3) prior to surgery, while the control group's scores were 4 (2 to 5) and 4 (3 to 5), respectively. Multivariate analysis showed that group assignment was the sole outcome predictor, not age, type of procedure, or the time elapsed until surgery. Thus, VR exposure was effective in reducing perioperative anxiety in patients undergoing gynecological oncology surgery. The use of VR as a preparation tool may improve patient experience and contribute to better surgical outcomes, warranting further research into exploring the potential benefits of VR in other surgical specialties and its long-term impact on patient recovery. [ABSTRACT FROM AUTHOR]

As the prevalence of type 2 diabetes continues to escalate, health system reform is seeking better patient outcomes through new models of care that aim to provide the most appropriate care when needed. Patients' experiences of service innovations can shed light on the successes and challenges of implementing change. This paper explores patients' views of a new model of integrated care for patients with type 2 diabetes. A mixed-methods, randomised control trial evaluated a beacon clinic model of care for complex type 2 diabetes led by specialist general practitioners ( GPs) in primary care settings in Brisbane, Australia. In this qualitative sub-study conducted between May 2014 and January 2015, 25 consenting participants were re-interviewed after 12 months using semi-structured questions, to explore their experiences of the new model of care. Interview transcripts were analysed thematically. In the first theme, Organised for patient-centred care, patients appraised the structural elements of the clinic. For most, it was an enabling experience which included convenience, flexibility and prompt communication back to the referring GPs. The preferences of a minority were partly realised, as they tried to understand the clinical purpose in comparison with traditional care. The second theme, Positioned as partners in care, revealed the pivotal role of patient-clinician relationships in patients' engagement with advice and self-care. Most found clinicians' collaborative approach engaging and motivating. A small minority with contextual concerns were disappointed with the focus on diabetes and struggled to engage fully with the model. Most participants valued this model of care, which reflects a capacity to manage the variable and complex needs of most patients referred for care. However, multi-level strategies are also needed to enhance patients' engagement with care and the sustainability of integrated diabetes care. [ABSTRACT FROM AUTHOR]

Background: This paper presents a protocol for a randomised controlled trial of the Cardiac-Diabetes Transcare program which is a transitional care, multi-modal self-management program for patients with acute coronary syndrome comorbid with type 2 diabetes. Prior research has indicated people hospitalised with dual cardiac and diabetes diagnoses are at an elevated risk of hospital readmissions, morbidity and mortality. The primary aim of this study is to evaluate the effectiveness (and cost-effectiveness) of a Cardiac-Diabetes Transcare intervention program on 6-month readmission rate in comparison to usual care.Methods/design: A two-armed, randomised controlled trial with blinded outcome assessment will be conducted to evaluate the comparative effectiveness of two modes of care, including a Usual Care Group and a Cardiac-Diabetes Transcare Intervention (in addition to usual care) Group. The primary outcome is 6-month readmission rate, although a range of secondary outcomes will be collected (including self-efficacy) at baseline, 1, 3 and 6 month reassessments. The intervention group will receive in-hospital education tailored for people recovering from an acute coronary syndrome-related hospital admission who have comorbid diabetes, and they will also receive home visits and telephone follow-up by a trained Research Nurse to reinforce and facilitate disease-management-related behaviour change. Both groups will receive usual care interventions offered or referred from participating hospital facilities. A sample size of 432 participants from participating hospitals in the Australian states of Queensland and Victoria will be recruited for 90% power based on the most conservative scenarios modelled for sample size estimates.Discussion: The study outlined in this protocol will provide valuable insight into the effectiveness of a transitional care intervention targeted for people admitted to hospital with cardiac-related presentations commencing in the inpatient hospital setting and transition to the home environment. The purpose of theory-based intervention comprising face-to-face sessions and telephone follow up for patients with acute coronary syndrome and type 2 diabetes is to increase self-efficacy to enhance self-management behaviours and thus improve health outcomes and reduce hospital readmissions.Trial Registration: This study has been registered with the Australian New Zealand Clinical Trials Registry dated 16/12/2014: ACTRN12614001317684 . [ABSTRACT FROM AUTHOR]

Background: Impairment of prospective memory (PM) is common following traumatic brain injury (TBI) and negatively impacts on independent living. Compensatory approaches to PM rehabilitation have been found to minimize the impact of PM impairment in adults with TBI; however, poor self-awareness after TBI poses a major barrier to the generalization of compensatory strategies in daily life. Metacognitive skills training (MST) is a cognitive rehabilitation approach that aims to facilitate the development of self-awareness in adults with TBI. This paper describes the protocol of a study that aims to evaluate the efficacy of a MST approach to compensatory PM rehabilitation for improving everyday PM performance and psychosocial outcomes after TBI.Methods/design: This randomized controlled trial has three treatment groups: compensatory training plus metacognitive skills training (COMP-MST), compensatory training only (COMP), and waitlist control. Participants in the COMP-MST and COMP groups will complete a 6-week intervention consisting of six 2-h weekly training sessions. Each 1.5-h session will involve compensatory strategy training and 0.5 h will incorporate either MST (COMP-MST group) or filler activity as an active control (COMP group). Participants in the waitlist group receive care as usual for 6 weeks, followed by the COMP-MST intervention. Based on the sample size estimate, 90 participants with moderate to severe TBI will be randomized into the three groups using a stratified sampling approach. The primary outcomes include measures of PM performance in everyday life and level of psychosocial reintegration. Secondary outcomes include measures of PM function on psychometric testing, strategy use, self-awareness, and level of support needs following TBI. Blinded assessments will be conducted pre and post intervention, and at 3-month and 6-month follow-ups.Discussion: This study seeks to determine the efficacy of COMP-MST for improving and maintaining everyday PM performance and level of psychosocial integration in adults with moderate to severe TBI. The findings will advance theoretical understanding of the role of self-awareness in compensatory PM rehabilitation and skills generalization. COMP-MST has the potential to reduce the cost of rehabilitation and lifestyle support following TBI because the intervention could enhance generalization success and lifelong application of PM compensatory strategies.Trial Registration: New Zealand Clinical Trials Registry, ACTRN12615000996561 . Registered on 23 September 2015; retrospectively registered 2 months after commencement. [ABSTRACT FROM AUTHOR]

Aim In this paper, we describe a trial protocol used to assess feasibility related to: study administration (recruitment, randomization, retention, compliance, eligibility criteria, suitability of protocol instructions and data collection questionnaires); resource and data management (suitability of site, time and budget allocation, management of personnel and data); intervention fidelity (treatment dose, violations); and effect size. Background Pressure injury can lead to increases in hospital length of stay and cost. The sacrum is identified as one of the most common anatomical pressure injury sites for hospitalized patients. Silicone foam border dressings have been proposed as one strategy to reduce pressure injury incidence; however, rigorous testing of benefit in a general medical-surgical population is required. Design Randomized controlled trial. Methods Eighty patients will be recruited after assessment of high risk of pressure injury in a large tertiary hospital in south-east Queensland, Australia. Eligible, consenting participants will be randomly allocated to either a control group (routine care) or an intervention group (routine care and a sacral prophylactic dressing). The primary outcomes comprise feasibility criteria as identified above. The secondary measure is the presence and severity of sacral pressure injury via blind assessment of digital photographs. Research ethics approval was received in October 2013. Discussion Prophylactic dressings applied to the sacrum may be an effective method for reducing pressure injury in high-risk general medical-surgical patients. However, more rigorous studies to confirm benefit are required. This pilot study will determine the feasibility and effect size to inform a larger randomized controlled trial. [ABSTRACT FROM AUTHOR]

This paper explores the feasibility of a brief Mindfulness with Metta Training Program (MMTP), targeting the enhancement of mindfulness and self-compassion in a retreat format, as a means of increasing resilience in human services professionals. In this randomised control trial, 44 human services professionals were randomly allocated either to a MMTP retreat group or to a control group. Following the MMTP intervention, no significant differences between the retreat and control groups were found on resilience, mindfulness and self-compassion variables. However, significant improvements were observed over time for the retreat group for mindfulness and self-compassion at one and four months and for resilience at four-months post MMTP intervention. The results of this pilot study show that MMTP in a retreat format is a promising method of increasing resilience, mindfulness and self-compassion in human services professionals. [ABSTRACT FROM AUTHOR]

Background: Lifetime trajectories of mental ill-health are often established during adolescence. Effective interventions to prevent the emergence of mental health problems are needed. In the current study we assessed the efficacy of the cognitive behavioural therapy (CBT)-informed Climate Schools universal eHealth preventive mental health programme, relative to a control. We also explored whether the intervention had differential effects on students with varying degrees of social connectedness. Method: We evaluated the efficacy of the Climate Schools mental health programme (19 participating schools; average age at baseline was 13.6) v. a control group (18 participating schools; average age at baseline was 13.5) which formed part of a large cluster randomised controlled trial in Australian schools. Measures of internalising problems, depression and anxiety were collected at baseline, immediately following the intervention and at 6-, 12- and 18-months post intervention. Immediately following the intervention, 2539 students provided data on at least one outcome of interest (2065 students at 18 months post intervention). Results: Compared to controls, we found evidence that the standalone mental health intervention improved knowledge of mental health, however there was no evidence that the intervention improved other mental health outcomes, relative to a control. Student's social connectedness did not influence intervention outcomes. Conclusion: These results are consistent with recent findings that universal school-based, CBT-informed, preventive interventions for mental health have limited efficacy in improving symptoms of anxiety and depression when delivered alone. We highlight the potential for combined intervention approaches, and more targeted interventions, to better improve mental health outcomes. [ABSTRACT FROM AUTHOR]

Background: Up to 80% of Intensive Care Unit patients experience physical, cognitive, and/or psychological complications post-discharge, known as 'Post Intensive Care Syndrome' (PICS). Early diagnosis and intervention are a priority, but while current post-intensive care follow-up processes endorse a multidisciplinary model, incorporating a psychiatric consultation has not been studied. Methods: A pilot, open-label randomised controlled trial was developed by a multidisciplinary team to evaluate the feasibility and acceptability of incorporating a psychiatric review into an existing post-ICU clinic. The study will run for 12 months and aim to recruit 30 participants. Inclusion criteria for participants: a) ICU admission greater than 48 hours, b) no cognitive impairment that prevents participation, c) ≥ 18 years old, d) residing in Australia, e) fluent in English, f) able to provide GP information, and g) likely to be contactable in 6 months. Patient recruitment will be at Redcliffe Hospital, Queensland, Australia, and will involve patients attending the Redcliffe post intensive care clinic. Participants will be allocated to intervention or control using block randomisation and allocation concealment. Participants allocated to the control arm will receive the standard cares provided by the clinic, which involves an unstructured interview about their ICU experience and a battery of surveys about their psychological, cognitive, and physical function. Those allocated to the intervention arm will receive these same cares as well as an appointment with a psychiatrist for a single session intervention. The psychiatric intervention will involve a comprehensive review, including comorbid disorders, substance use, suicidal ideation, psychosocial stressors, social/emotional supports. Psychoeducation and initial treatment will be provided as indicated and recommendations given to the patient and their GP about how to access ongoing care. In addition to surveys conducted as part of standard clinic cares, all participants will complete additional questionnaires about their history, hospital experience, mental and physical health as well as employment circumstances. All participants will be followed up 6 months after their appointment and will be invited to complete follow-up questionnaires about their mental and physical health, as well as health service use and employment circumstances. The trial has been registered with ANZCTR (ACTRN12622000894796). Results: To evaluate the feasibility and acceptability of the intervention to the patient population. Differences between groups will be assessed using an independent samples t-test. Resource requirements to administer the intervention will be evaluated by reporting the mean duration of the EPARIS assessment and approximate cost per patient to provide this service. To estimate the effect size of any treatment effects, changes in secondary outcome measures between baseline and 6 months will be compared between intervention and control groups using Analysis of Covariance regression. As this is a pilot, we will not use p-values or test a null hypothesis, but will give confidence intervals. Conclusions: This protocol provides a pragmatic evaluation of the acceptability of introducing early psychiatric assessment into an existing post-ICU follow-up process, and if considered acceptable will inform future research into the efficacy and generalisability of the intervention. The strengths of EPARIS are the prospective, longitudinal design with a control population, and its use of validated post-ICU outcome measures. [ABSTRACT FROM AUTHOR]

Objective: There is a lack of research on interventions that address the specific psychosocial needs of people with brain tumour and their families. This paper describes the protocol for a pragmatic randomised control trial (RCT) evaluating the clinical efficacy and cost‐effectiveness of the Making Sense of Brain Tumour program delivered via telehealth (Tele‐MAST) relative to standard care. Methods: The 148 adults with primary brain tumour will be randomly allocated to the 10‐session Tele‐MAST videoconferencing program or standard care from a cancer counselling service. The primary outcome is level of depression and secondary outcomes are quality of life, mental health and incremental cost per quality‐adjusted life year. The mental health and quality of life of family members will also be assessed. Assessments will be conducted at pre‐intervention, post‐intervention (primary endpoint), 6‐weeks post‐intervention and 6‐months post‐intervention. The main analysis will determine whether the Tele‐MAST intervention is more effective than standard care at post‐intervention, and whether these effects are sustained at follow‐up. Conclusion: Results will indicate whether the Tele‐MAST program is associated with better clinical outcomes and is more cost‐effective than existing cancer support services. Such outcomes will contribute to effective and accessible psychosocial care for the brain tumour population. [ABSTRACT FROM AUTHOR]

Sports participation is an important goal for children with cerebral palsy classified at GMFCS Level I or II, however there are no studies of parent or physiotherapist perspectives on effectiveness or overall acceptability of transition-to-sports interventions. Parent and physiotherapist perspectives of Sports Stars: a novel, practitioner-led, peer-group sports intervention (Trial registration: ACTRN12617000313336) were collected from Sports Stars Session Reports (39 children, 6–12 years, GMFCS I = 11, II = 28, Female = 12), Fidelity Evaluations (28 children), and Perspectives Surveys (Parents = 29, female = 26; Physiotherapists = 8, female = 5). Outcomes were perceived impact on: (1) sports Participation (Attendance, Involvement), (2) sports Activity Competence across Physical, Social, Cognitive and Psychological Physical Literacy domains and (3) overall acceptability. Over 84% of children Attended most sessions. Physiotherapists rated session Involvement as high (median = 3/4). In Session Reports, physiotherapists recorded quantitative improvements in Physical and Cognitive performance and described improvements across all domains. Parents reported improvements across all domains, with comments focusing on Social and Psychological performance. All physiotherapists (8/8) and most parents (26/29) reported a community-based peer-group was the intervention design of choice for sports-focused goals. Parents and physiotherapists perceived Sports Stars, a practitioner-led, peer-group sports intervention, as effective and acceptable for children with cerebral palsy with sports-focussed goals. Parents and physiotherapists agree that Sports Stars improved sports Participation and Physical, Social, Psychological and Cognitive Activity Competence for children with cerebral palsy. Children with sports-focused goals should be offered practitioner-led, peer-group sports interventions in community environments. Therapists should design sports interventions with Physical, Cognitive, Social and Psychological content and outcomes. [ABSTRACT FROM AUTHOR]

Background: The burden of disease attributable to alcohol and other drug (AOD) use in young people is considerable. Prevention can be effective, yet few programs have demonstrated replicable effects. This study aimed to replicate research behind Climate Schools: Alcohol and Cannabis course among a large cohort of adolescents. Methods: Seventy-one secondary schools across three States participated in a cluster-randomised controlled trial. Year 8 students received either the web-based Climate Schools: Alcohol and Cannabis course (Climate, n = 3236), or health education as usual (Control, n = 3150). Outcomes were measured via self-report and reported here for baseline, 6- and 12-months for alcohol and cannabis knowledge, alcohol, cannabis use and alcohol-related harms. Results: Compared to Controls, students in the Climate group showed greater increases in alcohol- [standardised mean difference (SMD) 0.51, p < 0.001] and cannabis-related knowledge (SMD 0.49, p < 0.001), less increases in the odds of drinking a full standard drink[(odds ratio (OR) 0.62, p = 0.014], and heavy episodic drinking (OR 0.49, p = 0.022). There was no evidence for differences in change over time in the odds of cannabis use (OR 0.57, p = 0.22) or alcohol harms (OR 0.73, p = 0.17). Conclusions: The current study provides support for the effectiveness of the web-based Climate Schools: Alcohol and Cannabis course in increasing knowledge and reducing the uptake of alcohol. It represents one of the first trials of a web-based AOD prevention program to replicate alcohol effects in a large and diverse sample of students. Future research and/or adaptation of the program may be warranted with respect to prevention of cannabis use and alcohol harms. [ABSTRACT FROM AUTHOR]

Objective: The longer-term effectiveness of silicone and pressure burn scar interventions was evaluated at 12-months postburn. Design: Parallel group, randomised trial. Setting: Hospital outpatient clinics, research centre. Participants: Children referred for burn scar management following grafted or spontaneously healed acute burn injuries or scar reconstruction surgery. Interventions: Participants were randomised to: (1) topical silicone gel only, (2) pressure garment only, or (3) combined topical silicone gel and pressure garment. Main measures: Primary outcomes were scar thickness (blinded ultrasound measurement) and itch intensity (caregiver proxy-report, numeric rating scale). Results: Of 153 participants randomised who received the interventions (silicone n = 51, pressure garment n = 49, combined n = 53), 86 were followed-up at 12-months postburn (n = 34, n = 28, n = 24). No differences were identified for the primary outcomes using intention-to-treat analysis. Scar thickness mean difference (95% confidence interval) = 0.00 cm (−0.04, 0.05); −0.03 cm (−0.07, 0.02); 0.03 cm (−0.02, 0.08) and scar itch = 0.09 (−0.88, 1.06); −0.21 (−1.21, 0.79); 0.30 (−0.73, 1.32) for silicone vs pressure; silicone vs combined and combined vs pressure respectively. No serious adverse effects occurred. Conclusion: Similar to short-term results, the combined intervention offered no statistically or clinically significant benefit for improving the primary outcomes compared to each intervention alone. No differences in the primary outcomes were identified between the silicone and pressure alone groups. [ABSTRACT FROM AUTHOR]

Background: Older people living in residential aged care homes experience frequent emergency transfers to hospital. These events are associated with risks of hospital acquired complications and invasive treatments or interventions. Evidence suggests that some hospital transfers may be unnecessary or avoidable. The Early Detection of Deterioration in Elderly residents (EDDIE) program is a multi-component intervention aimed at reducing unnecessary hospital admissions from residential aged care homes by empowering nursing and care staff to detect and manage early signs of resident deterioration. This study aims to implement and evaluate the program in a multi-site randomised study in Queensland, Australia.Methods: A stepped-wedge randomised controlled trial will be conducted at 12 residential aged care homes over 58 weeks. The program has four components: education and training, decision support tools, diagnostic equipment, and implementation facilitation with clinical systems support. The integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework will be used to guide the program implementation and process evaluation. The primary outcome measure will be the number of hospital bed days used by residents, with secondary outcomes assessing emergency department transfer rates, admission rates, length of stay, family awareness and experience, staff self-efficacy and costs of both implementation and health service use. A process evaluation will assess the extent and fidelity of program implementation, mechanisms of impact and the contextual barriers and enablers.Discussion: The intervention is expected to improve outcomes by reducing unnecessary hospital transfers. Fewer hospital transfers and admissions will release resources for other patients with potentially greater needs. Residential aged care home staff might benefit from feelings of empowerment in their ability to proactively manage early signs of resident deterioration. The process evaluation will be useful for supporting wider implementation of this intervention and other similar initiatives.Trial Registration: The trial is prospectively registered with the Australia New Zealand Clinical Trial Registry ( ACTRN12620000507987 , registered 23/04/2020). [ABSTRACT FROM AUTHOR]

Background: Posterior fossa brain tumors (PFBT) are the most common solid tumor in children. Recent increases in survival rates are encouraging; however, survivors may experience a plethora of disease- and treatment-related complications that can persist into adulthood. Therapeutic exercise interventions have been shown to improve quality of survivorship in other pediatric cancer diagnoses. There is also evidence that goal-directed interventions are effective at improving motor activities, function, and self-care in children with complex health conditions. Yet, there is currently no evidence on the efficacy of goal-directed therapeutic exercise in pediatric PFBT survivors. The Physical ACTivity in Survivorship (PACTS) study aims to investigate the effects of a novel goal-directed therapeutic exercise program on cardiorespiratory fitness and physical activity-related goal attainment in pediatric survivors of PFBT.Method: PFBT survivors, aged five to 17 years, who underwent surgery at least 12 months earlier and completed radiation therapy and/or chemotherapy at least 6 months prior will be recruited from the Queensland Children's Hospital (Brisbane, Australia) (target n = 48). Following baseline assessment, participants are randomized into either the intervention or usual care group. The intervention group will receive weekly individualized, goal-directed exercise therapy delivered face-to-face for 12 weeks, along with an accompanying home-based program (three sessions per week). Outcomes will be assessed at baseline, immediately post-intervention, and at 6- and 12-months post-intervention. The primary outcomes are cardiorespiratory fitness (Peak VO2) and physical activity-related goal attainment. Secondary outcomes are cardiorespiratory endurance, high-level mobility skills, functional muscle strength, habitual physical activity, gait, balance, quality of life, fatigue, participation, perceived movement skill competence and parameters of body composition.Discussion: PACTS is the first study to investigate the efficacy of goal-directed therapeutic exercise in children with PFBT and provide evidence needed to inform clinical practice recommendations for managing quality of survivorship in PFBT survivors.Trial Registration: ACTRN12619000841178 . [ABSTRACT FROM AUTHOR]

Background: Patellofemoral pain (PFP) is a common cause of knee pain in adolescents, but there are limited evidence-based treatment options for this population. Foot orthoses can improve pain and function in adults with PFP, and may be effective for adolescents. The primary aim of this study is to determine the feasibility of conducting a full-scale randomised controlled trial (RCT) evaluating the effects of contoured foot orthoses on knee pain severity and patient-perceived global change, compared to flat shoe insoles, in adolescents with PFP. The secondary aim is to provide an estimate of treatment effects for foot orthoses, compared to flat insoles, in adolescents with PFP. Methods: This randomised, controlled, participant- and assessor-blinded, feasibility trial has two parallel groups. Forty adolescents (aged 12–18 years) with clinical symptoms of PFP will be recruited from Queensland, Australia. Participants will be randomised to receive either prefabricated contoured foot orthoses or flat shoe insoles. Both interventions will be fit by a physiotherapist, and worn for 3 months. Feasibility will be evaluated through assessing willingness of volunteers to enrol, number of eligible participants, recruitment rate, adherence with the study protocol, adverse effects, success of blinding, and drop-out rate. Secondary outcomes will evaluate knee-related pain, symptoms, function, quality of life, global rating of change, patient acceptable symptom state, and use of co-interventions, at 6 weeks and 3 months. Primary outcomes will be reported descriptively, while estimates of standard deviation and between-group differences (with 95% confidence intervals) will be reported for secondary outcomes. Discussion: Findings of this study will inform the feasibility of a full-scale RCT investigating the efficacy of contoured foot orthoses in adolescents with PFP. This full-scale study is necessary to improve the evidence base for management of adolescent PFP, and enhance outcomes for this population. Trial registration: ACTRN12619000957190. [ABSTRACT FROM AUTHOR]

Introduction This study examined the effect of a telehealth intervention on the control of type 2 diabetes and subsequent potential cost-savings to the health system. Methods This prospective randomised controlled trial randomised adults with type 2 diabetes to the intervention (diabetes program) or control (usual care) arm. Key eligibility criteria included an HbA1c level of at least 58 mmol/mol (7.5%) without severe or unstable comorbidities. All participants continued their usual healthcare, but participants in the intervention arm received additional diabetes care from a diabetes care coordinator via a home monitor that captured clinical measures. Data collected included biomedical, quality of life measures and healthcare (GP, outpatient and inpatient) costs. The primary outcome was HbA1c collected at baseline and 6 months. Analysis was conducted on a complete case intention-to-treat basis. The healthcare system perspective was taken to calculate the incremental cost per percentage-point reduction in HbA1c. Results Results from 63 participants from each study arm were analysed. HbA1c in the intervention group decreased from a median 68 mmol/mol (8.4%) to 58 mmol/mol (7.5%), and remained unchanged in the control group at median 65 mmol/mol (8.1%) at the 6-month endpoint. The intervention effect on HbA1c change was statistically significant ( p = .004). Total healthcare costs in the intervention group, including the intervention costs, were lower (mean $3781 vs. $4662; p < .001) compared with usual care. Discussion There was a clinically meaningful and statistically significant benefit from the telehealth intervention at a lower cost; thus, telehealth was cost-saving and produced greater health benefits compared with usual care. [ABSTRACT FROM AUTHOR]

Background: Peripherally inserted central catheters (PICCs) are commonly used for delivering intravenous therapy. PICC failure is unacceptably high (up to 40%) due to mechanical, infectious and thrombotic complications. Poor securement potentiates all complication types. This randomised controlled trial (RCT) aimed to examine the feasibility of a large RCT of four dressing and securement methods to prevent PICC failure.Methods: This single-centre pilot RCT included 124 admitted medical/surgical/cancer patients aged ≥ 16 years with a PICC. Interventions were: (i) standard polyurethane dressing and sutureless securement device (SPU + SSD, control); (ii) polyurethane with absorbent lattice pad dressing (PAL + Tape); (iii) combination securement-dressing (CSD); and (iv) tissue adhesive (TA + SPU). All groups except TA + SPU had a chlorhexidine-gluconate (CHG) impregnated disc. Feasibility outcomes were recruitment and safety/acceptability of the interventions. The primary outcome was PICC failure, a composite of PICC removal for local infection, catheter-associated bloodstream infection, dislodgement, occlusion, and/or catheter fracture. Secondary outcomes included individual complications, dressing failure and dwell time, PICC dwell time, skin complications/phlebitis indicators, product costs, and patient and staff satisfaction. Qualitative feedback was also collected.Results: PICC failure incidence was: PAL + CHG + Tape (1/5; 20%; 17.4/1000 days), SPU + SSD + CHG (control) (4/39; 10%; 9.0/1000 days), TA + SPU (3/35; 9%; 9.6/1000 days), and CSD + CHG (3/42; 7%; 9.4/1000 days). Recruitment to PAL + CHG + Tape was ceased after five participants due to concerns of PICC dislodgement when removing the dressing. CSD + CHG, TA + SPU (TA applied only at PICC insertion time), and control treatments were acceptable to patients and health professionals.Conclusion: A large RCT of CSD + CHG and TA + SPU (but not PAL + CHG + Tape) versus standard care is feasible.Trial Registration: Australian and New Zealand Clinical Trials Registry, ACTRN12616000027415 . Registered on 15 January 2016. [ABSTRACT FROM AUTHOR]

Objective: To examine the efficacy of a multi-modal web-based therapy program, Move it to improve it (Mitii™) delivered at home to improve Executive Functioning (EF) in children with an acquired brain injury (ABI). Design: Randomised Waitlist controlled trial. Setting: Home environment. Participants: Sixty children with an ABI were matched in pairs by age and intelligence quotient then randomised to either 20-weeks of Mitii™ training or 20 weeks of Care As Usual (waitlist control; n=30; 17 males; mean age=11y, 11m (±2y, 6m); Full Scale IQ=76.24± 17.84). Fifty-eight children completed baseline assessments (32 males; mean age=11.87±2.47; Full Scale IQ=75.21±16.76). Main Measures: Executive functioning was assessed on four domains: attentional control, cognitive flexibility, goal setting, and information processing using subtests from the Wechsler Intelligence Scale for Children (WISC-IV), Delis-Kaplan Executive Functioning System (D-KEFS), Comprehensive Trail Making Test (CTMT), Tower of London (TOL), and Test of Everyday Attention for Children (Tea-Ch). Executive functioning performance in everyday life was assessed via parent questionnaire (Behaviour Rating Inventory of Executive Functioning; BRIEF). Results: No differences were observed at baseline measures. Groups were compared at 20-weeks using linear regression with no significant differences found between groups on all measures of EF. Out of a potential total dose of 60 hours, children in the Mitii™ group completed a mean of 17 hours of Mitii™ intervention. Conclusion: Results indicate no additional benefit to receiving Mitii™ compared to standard care. Mitii™, in its current form, was not shown to improve EF in children with ABI. [ABSTRACT FROM AUTHOR]

Purpose state:Determine the efficacy of Move-it-to-improve-it (Mitii™), a multi-modal web-based program, in improving Executive Function (EF) in children with unilateral cerebral palsy (UCP). Method:Participants (n = 102) were matched in pairs then randomized to: intervention (Mitii™ for 20 weeks;n = 51; 26 males; mean age = 11 years 8 months (SD = 2 years 4 months); Full Scale IQ = 84.65 (SD = 15.19); 28 left UCP; GMFCS-E&R (I = 20, II = 31) or waitlist control (n = 50; 25 males; mean age = 11 years 10 months (SD = 2 years 5 months); Full Scale IQ = 80.75 (SD = 19.81); 20 left UCP; GMFCS-E&R (I = 25, II = 25). Mitii™ targeted working memory (WM), visual processing (VP), upper limb co-ordination and physical activity. EF capacity was assessed: attentional control (DSB; WISC-IV); cognitive flexibility (inhibition and number-letter sequencing DKEFS); goal setting (D-KEFs Tower Test); and information processing (WISC-IV Symbol Search and Coding). EF performance was assessed via parent report (BRIEF). Groups were compared at 20 weeks using linear regression (SPSS 21). Results:There were no significant between group differences in attentional control (DSB;p = 0.20;CI= −0.40,1.87); cognitive flexibility (Inhibition,p = 0.34; CI= −0.73,2.11; number/letter sequencing,p = 0.17; CI= −0.55,2.94); problem solving (Tower;p = 0.28; CI= −0.61,2.09), information processing (Symbol;p = 0.08; CI= −0.16, 2.75; Coding;p = 0.07; CI= −0.12,2.52) or EF performance (p = 0.13; CI= −10.04,1.38). Conclusion:In a large RCT, MitiiTMdid not lead to significant improvements on measures of EF or parent ratings of EF performance in children with UCP.Implications for rehabilitationA large RCT of the multi-modal web based training; Move It to Improve It (MitiiTM) improves motor processing, visual perception, and physical capacity but does demonstrate statistically significant improvements or clinical significance in executive function in children with mild to moderate unilateral cerebral palsy (UCP).MitiiTM training completed by an intervention group was highly variable with few children reaching the target dosage of 60 h. Technical issues including server and internet connectively problems lead to disengagement with the program.Web-based training delivered in the home has the potential to increase therapy dose and accessibility, however, MitiiTM needs to be tailored to include tasks involving goal-setting, more complex problem solving using multi-dimensional strategies, mental flexibility, switching between two cognitively demanding tasks, and greater novelty in order to increase the cognitive component and challenge required to drive changes in EF. [ABSTRACT FROM AUTHOR]

Purpose state: Determine the efficacy of Move-it-to-improve-it (Mitii™), a multi-modal web-based program, in improving Executive Function (EF) in children with unilateral cerebral palsy (UCP). Method: Participants (n=102) were matched in pairs then randomized to: intervention (Mitii™ for 20 weeks; n=51; 26 males; mean age=11 years 8 months (SD=2 years 4 months); Full Scale IQ=84.65 (SD=15.19); 28 left UCP; GMFCS-E&R (I=20, II=31) or waitlist control (n=50; 25 males; mean age=11 years 10 months (SD=2 years 5 months); Full Scale IQ=80.75 (SD=19.81); 20 left UCP; GMFCS-E&R (I=25, II=25). Mitii™ targeted working memory (WM), visual processing (VP), upper limb co-ordination and physical activity. EF capacity was assessed: attentional control (DSB; WISC-IV); cognitive flexibility (inhibition and number-letter sequencing DKEFS); goal setting (D-KEFs Tower Test); and information processing (WISC-IV Symbol Search and Coding). EF performance was assessed via parent report (BRIEF). Groups were compared at 20 weeks using linear regression (SPSS 21). Results: There were no significant between group differences in attentional control (DSB; p=0.20; CI=-0.40,1.87); cognitive flexibility (Inhibition, p=0.34; CI=-0.73,2.11; number/letter sequencing, p=0.17; CI=-0.55,2.94); problem solving (Tower; p=0.28; CI=-0.61,2.09), information processing (Symbol; p=0.08; CI=-0.16, 2.75; Coding; p=0.07; CI=-0.12,2.52) or EF performance (p=0.13; CI=-10.04,1.38). Conclusion: In a large RCT, Mitii™ did not lead to significant improvements on measures of EF or parent ratings of EF performance in children with UCP. [ABSTRACT FROM AUTHOR]

Background: People with decompensated cirrhosis require complex medical care and are often prescribed an intricate and frequently changing medication and lifestyle regimen. However, many patients mismanage their medications or have poor comprehension of their disease and self-management tasks. This can lead to harm, hospitalization, and death.Methods/design: A patient-oriented education and medication management intervention has been developed for implementation at a tertiary hospital hepatology outpatient center in Queensland, Australia. Consenting patients with decompensated cirrhosis will be randomly allocated to education intervention or usual care treatment arms when they attend routine follow-up appointments. In the usual care arm, participants will be reviewed by their hepatologist according to the current model of care in the hepatology clinic. In the intervention arm, participants will be reviewed by a clinical pharmacist to receive the education and medication management intervention at baseline in addition to review by their hepatologist. Intervention participants will also receive three further educational contacts from the clinical pharmacist within the following 6-month period, in addition to routine hepatologist review that is scheduled within this time frame. All participants will be surveyed at baseline and follow-up (approximately 6 months post-enrollment). Validated questionnaire tools will be used to determine participant adherence, medication beliefs, illness perceptions, and quality of life. Patients' knowledge of dietary and lifestyle modifications, their current medications, and other clinical data will be obtained from the survey, patient interview, and medical records. Patient outcome data will be collected at 52 weeks.Discussion: The intervention described within this protocol is ready to adapt and implement in hepatology ambulatory care centers globally. Investigation of potentially modifiable variables that may impact medication management, in addition to the effect of a clinical pharmacist-driven education and medication management intervention on modifying these variables, will provide valuable information for future management of these patients.Trial Registration: Australian and New Zealand Clinical Trial Registry identifier: ACTRN12616000780459 . Registered on 15 June 2016. [ABSTRACT FROM AUTHOR]

Background: Psycho-education can reduce childbirth fear and caesarean section numbers. This study determines the cost-effectiveness of a midwife-led psycho-education intervention for women fearful of birth.Method: One thousand four hundred ten pregnant women in south-east Queensland, Australia were screened for childbirth fear (W-DEQ A ≥ 66). Women with high scores (n = 339) were randomised to the BELIEF Study (Birth Emotions and Looking to Improve Expectant Fear) to receive psycho-education (n = 170) at 24 and 34 weeks of pregnancy or to the control group (n = 169). Women in both groups were surveyed 6 weeks postpartum with total cost for health service use during pregnancy calculated. Logistic regression models assessed the odds ratio of having vaginal birth or caesarean section in the study groups.Result: Of 339 women randomised, 184 (54%) women returned data at 6 weeks postpartum (Intervention Group n = 91; Control Group n = 93). Women receiving psycho-education had a higher likelihood of vaginal birth compared to controls (n = 60, 66% vs. n = 54, 58%; OR 2.34). Mean 'treatment' cost for women receiving psycho-education was AUS$72. Mean cost for health services excluding the cost of psycho-education, was less in the intervention group (AUS$1193 vs. AUS$1236), but not significant (p = 0.78). For every five women who received midwife counselling, one caesarean section was averted. The incremental healthcare cost to prevent one caesarean section using this intervention was AUS$145.Conclusion: Costs of delivering midwife psycho-education to women with childbirth fear during pregnancy are offset by improved vaginal birth rates and reduction in caesarean section numbers.Trial Registration: Australian New Zealand Controlled Trials Registry ACTRN12612000526875 , 17th May 2012 (retrospectively registered one week after enrolment of first participant). [ABSTRACT FROM AUTHOR]

Aim Spot-tests of urine pH are claimed to be an accessible biomarker of net acid excretion ( NAE), and as such, they may be able to determine changes in an individual's intake of acid- or base-forming foods. To test this hypothesis, we aimed to determine if spot-tests of urine pH could index NAE and relay the consumption of a fruit and vegetable (F&V) concentrate whilst determining this concentrate's capacity to modulate NAE. Methods In a double blind, placebo-controlled, cross-over trial, healthy adults (n = 13) were allocated by simple randomisation to receive a F&V concentrate or placebo for three days each, with diet standardised throughout. Measurements of 24-hour NAE, 24-hour urine pH and spot-tests of urine pH were taken throughout the study. Results The 24-hour urine pH predicted 24-hour NAE ( P = <0.0001). However, spot-tested urine pH displayed prediction intervals too wide to infer 24-hour NAE and inconsistent ability to reflect concentrate ingestion, despite 24-hour NAE and 24-hour urine pH decreasing (−25.8 mEq, 95% CI −44.3 to −7.4, P = 0.01, d = 0.94) and increasing (+0.51, 95% CI 0.25-0.79, P = 0.002, d = 1.3), respectively, following supplementation. Conclusions Spot-tests of urine pH are not a valid dietary biomarker of daily NAE and were unable to reliably track changes, despite a F&V concentrate clearly modulating the daily rate of NAE. [ABSTRACT FROM AUTHOR]

Background: Abdominal aortic aneurysm (AAA) is a slowly progressive destructive process of the main abdominal artery. Experimental studies indicate that fibrates exert beneficial effects on AAAs by mechanisms involving both serum lipid modification and favourable changes to the AAA wall.Methods/design: Fenofibrate in the management of AbdoMinal aortic anEurysm (FAME) is a multicentre, randomised, double-blind, placebo-controlled clinical trial to assess the effect of orally administered therapy with fenofibrate on key pathological markers of AAA in patients undergoing open AAA repair. A total of 42 participants scheduled for an elective open AAA repair will be randomly assigned to either 145 mg of fenofibrate per day or identical placebo for a minimum period of 2 weeks prior to surgery. Primary outcome measures will be macrophage number and osteopontin (OPN) concentration within the AAA wall as well as serum concentrations of OPN. Secondary outcome measures will include levels of matrix metalloproteinases and proinflammatory cytokines within the AAA wall, periaortic fat and intramural thrombus and circulating concentrations of AAA biomarkers.Discussion: At present, there is no recognised medical therapy to limit AAA progression. The FAME trial aims to assess the ability of fenofibrate to alter tissue markers of AAA pathology.Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12612001226897 . Registered on 20 November 2012. [ABSTRACT FROM AUTHOR]

This study examined intervention outcomes for mothers and their preterm infants. The objective was to evaluate the effects of the parenting intervention Baby Triple P (BTP) for parents' of very preterm infants (<32-weeks gestational age), on the quality of the mother-infant relationship and a mother's attachment and responsiveness to her infant at 6-weeks and 12-months corrected-age. A randomized controlled trial was conducted with 120 families being randomly assigned to the BTP or Care as Usual groups. The primary outcome was the quality of the mother-very preterm infant relationship which was evaluated in a mother-infant observation and measured by the Emotional Availability Scales. Secondary outcomes were maternal attachment as measured by the Maternal Postnatal Attachment Scale and maternal responsiveness as measured by the Maternal Infant Responsiveness Instrument. The results showed that at 6-weeks corrected-age, no significant differences were found between groups on the outcome measures. At 12-months corrected-age, the Care as Usual mothers scored significantly higher for self-reported maternal attachment compared to the BTP mothers. This study found no evidence that BTP improved the quality of the mother-very preterm infant relationship, maternal attachment or responsiveness at 6-weeks corrected-age or 12-months corrected-age. Results will be examined at 24-months corrected-age to determine if BTP impacts on child behavior, emotional problems, cognitive development, language and motor abilities. [ABSTRACT FROM AUTHOR]

Aim: Adolescents with intellectual disability experience poorer heath than their peers in the general population, partially due to communication barriers and knowledge gaps in their health history. This study aimed to test a health intervention package against usual care for a range of health promotion and disease detection outcomes.Method: A parallel-group cluster randomized controlled trial was conducted with Australian adolescents with intellectual disability living in the community. Randomization occurred at school level. The intervention package consisted of classroom-based health education, a hand-held personalized health record, and a health check. Evidence of health promotion, disease prevention, and case-finding activities were extracted from general practitioners' records for 12 months post-intervention.Results: Clinical data was available for 435 of 592 (73.5%) participants from 85 schools. Adolescents allocated to receive the health intervention were more likely to have their vision (odds ratio [OR] 3.3; 95% confidence interval [CI] 1.8-6.1) and hearing (OR 2.7; 95% CI 1.0-7.3) tested, their blood pressure checked (OR 2.4; 95% CI 1.6-3.7), and weight recorded (OR 4.8; 95% CI 3.1-7.6). There was no difference between health intervention and usual care for identification of new diseases.Interpretation: The school-based intervention package increased healthcare activity in adolescents with intellectual disability living in the community. [ABSTRACT FROM AUTHOR]

Aim: To examine the reproducibility in measurement of physical activity performance using the ActiGraph®GT3X+ accelerometer in children aged 8–16 years with Acquired Brain Injury (ABI). Methods: Reproducibility of standardized tasks: Thirty-two children with ABI (12 years 1 month, SD = 2 years 4 months; 20 males; Gross Motor Function Classification System I = 17, II = 15) performed the following activities on 2 consecutive days while wearing an accelerometer and a heart rate monitor: quiet sitting, slow walking (SW), moderate walking (MW), fast walking (FW) and rapid stepping on/off a block (STEP). Intra-class correlation coefficients (ICC) were calculated. Performance variability: Fifty-one participants (12 years 1 month, SD = 2 years 5 months; 27 males; GMFCS I = 26, II = 25) wore an accelerometer for 4 days in the community and reliability coefficients were calculated using standardized 12-hour time spent in moderate-to-vigorous physical activity (MVPA). Results: Test–re-test reproducibility was excellent for all activities (SW, ICC = 0.90; MW, ICC = 0.83; FW, ICC = 0.91; STEP, ICC = 0.89). Three days of monitoring produced excellent variability estimates of MVPA (R= 0.78). Conclusion: Therapists can confidently use accelerometry as a reproducible measure of physical activity under standardized walking and stepping conditions, as well as in the community for children with ABI. [ABSTRACT FROM PUBLISHER]

Aim Nutrition is important for pressure ulcer prevention. This randomised control pilot study assessed the feasibility of conducting a larger trial to test the effectiveness of a patient-centred intervention for improving the dietary intakes of patients at risk of pressure ulcer in hospital. Methods A 3-day intervention targeting patients at risk of pressure ulcer was developed, based on three main foundations: patient education, patient participation and guided goal setting. The intervention was piloted in three wards in a metropolitan hospital in Queensland, Australia. Participants were randomised into control or intervention groups and had their oral intakes monitored. A subset of intervention patients was interviewed on their perceptions of the intervention. Feasibility was tested against three criteria: ≥75% recruitment; ≥80% retention; and ≥80% intervention fidelity. Secondary outcomes related to effects on energy and protein intakes. Results Eighty patients participated in the study and 66 were included in final analysis. The recruitment rate was 82%, retention rate was 88%, and 100% of intervention patients received the intervention. Patients viewed the intervention as motivating and met significantly more of their estimated energy and protein requirements over time. Conclusion This pilot study indicates that the intervention is feasible and acceptable by patients at risk of pressure ulcer. A larger trial is needed to confirm the effectiveness of the intervention in the clinical setting. [ABSTRACT FROM AUTHOR]

Background: Pressure garment therapy (PGT) is well accepted and commonly used by clinicians in the treatment of burns scars and grafts. The medium to high pressures (24-40 mmHg) in these garments can support scar minimisation, and evidence is well documented for this particular application. However, PGT specifically for burn donor sites, of which a sequela is also scarring, is not well documented. This study protocol investigates the impact of a low pressure (4-6 mmHg) interim garment on donor site healing and scarring. With a primary purpose of holding donor dressings in place, the application of the interim pressure garment (IPG) appears to have been twofold. IPGs for donor sites have involved inconsistent application with a focus on securing wound dressing rather than scar management. However, anecdotal and observational evidence suggests that IPGs also make a difference to some patient's scar outcomes for donor sites. This study protocol outlines a randomised controlled trial designed to test the effectiveness of this treatment on reducing scarring to burn donor sites. Methods/design: This study is a single-centre, single (assessor)-blinded, randomised control trial in patients with burns donor sites to their thighs. Patients will be randomly allocated to a control group (with no compression to donor sites) or to an experimental group (with compression to donor sites) as the comparative treatment. Groups will be compared at baseline regarding the important prognostic indicators: donor site location, depth, size, age, and time since graft (5 days). The IPG treatment will be administered post-operatively (on day 5). Follow-up assessments and garment replacement will be undertaken fortnightly for a period of 2 months. Discussion: This study focuses on a unique area of burns scar management using a low-pressure tubular support garment for the reduction of donor site scars. Such therapy specifically for donor scar management is poorly represented in the literature. This study was designed to test a potentially cost-effective scar prevention for patients with donor sites to the thigh. No known studies of this nature have been carried out to date, and there is a need for rigorous clinical evidence for low-pressure support garments for donor site scar minimisation. Trial Registration: Australian New Zealand Clinical Trials Registry identifier ACTRN12610000127000 . Registered 8 Mar 2010. [ABSTRACT FROM AUTHOR]

Aims and Objectives The study aims to evaluate the effects of a communication skills training programme on community aged care staff's knowledge of communication support in dementia and on staff's care experience. Background Dementia can lead to impairments in communication. Therefore, quality community-based dementia care requires that staff be skilled communicators, equipped to facilitate interactions with people with dementia. The current investigation evaluated the effectiveness of the MESSAGE Communication Strategies in Dementia for Care Staff training programme with respect to knowledge of communication support and the staff/caregiver experience. Design A multi-centre controlled pretest/post-test design with randomised cohort allocation was used. Outcome measures were completed at baseline, immediately after training (training group only), and at three-month follow-up. Methods Thirty-eight care staff working in community aged care participated and completed all outcome measures (training = 22; control = 16).Training and control groups completed the following outcome measures: knowledge of communication support strategies, self-efficacy, preparedness to provide care, strain in nursing care and attitude to dementia care. Staff in the training group provided written feedback on the training. Results A significant improvement in knowledge scores from baseline was found for the training group both immediately after training and at three-month follow-up. There was also a significant training effect for self-efficacy and preparedness to provide care. No significant difference was found for the control group for any measure. No significant training effects were found for measures of strain or attitudes to dementia care. Feedback from staff suggests that the training was well received. Conclusions The MESSAGE training was positively received by staff and had a significant effect on care staff knowledge, and confidence to provide care for people with dementia. Relevance to clinical practice The easily accessible multimedia training programme is well received by staff and has the potential to improve quality of care. [ABSTRACT FROM AUTHOR]

Quality of life is shown to be lower in people diagnosed with mental illness in comparison to the general population. The aim of this study is to examine the Quality of life in a subset of people accessing mental health services in a regional Queensland Centre. Thirty-seven people accessing mental health services completed the SF36 Health Survey on three occasions. Differences and relationships between Physical Composite Scores and Mental Composite Scores, comparisons with Australian population norms, and temporal change in Quality of Life were examined. Physical Composite Scores were significantly different to, but significantly correlated with, Mental Composite Scores on each occasion. Physical Composite Scores and Mental Composite Scores were significantly different to population norms, and did not vary significantly across time. The poor Quality of life of people with mental illness remains a significant challenge for the mental health workforce. [ABSTRACT FROM PUBLISHER]

Depression is a potentially life threatening affective disorder that is highly prevalent in individuals with autism spectrum disorders (ASD). This study aimed to evaluate the feasibility, acceptability and preliminary efficacy of a cognitive behavioural intervention for depression in adolescents with ASD. Participants were randomly assigned to the intervention group, or wait-list control group. Although recruitment was extremely difficult, attendance was favourable and attrition was low, and participants reported being satisfied with the programme. No significant treatment effect was revealed on the Beck Depression Inventory or Emotion Regulation Questionnaire. However despite the small sample size ( n = 20), there was a trending treatment effect measured by the Depression Anxiety Stress Scale: Depression Subscale. Limitations and areas of future research are discussed. [ABSTRACT FROM AUTHOR]

Background: Dry mouth is a common and troublesome symptom in palliative care. Pilocarpine is a cholinergic agent that promotes salivation. Aim: This study aimed to test the feasibility of using n-of-1 trials to test pilocarpine drops compared to placebo, for patients of palliative care units with advanced cancer, who experienced dry mouth. Design: This was an N-of-1 study, in which each participant was offered three cycles of pilocarpine drops 4% (6 mg tds) (3 days) and placebo drops (3 days) in random order. Setting/participants: Participants were patients of specialist palliative care services with advanced cancer assessed as having a dry mouth, defined as having a score of ⩾3 on an 11-point self-rated xerostomia numerical rating scale, from any cause. Patients self-completed a diary using validated symptom and quality-of-life scores. The randomisation order was unmasked at the end of each person’s trial by a clinician independent of the trial to allow a treatment decisions for individual patients to be made. Results: Nine patients completed at least 1 cycle; 33 cycles of data were completed in total, comprising 438 doses of pilocarpine. Four patients completed the trial: two responded and two did not. Most withdrawals related to deteriorating condition, unacceptable toxicity, non-compliance with study procedures or withdrawal of consent. Many issues contributed to slow recruitment and high withdrawal rate. Conclusion: The formulation of pilocarpine drops proved unacceptable to most participants. More work is required to determine an appropriate formulation, dose and method of delivery and then a retest of pilocarpine drops for this symptom. [ABSTRACT FROM AUTHOR]

Background Gut hormones change with weight loss in adults but are not well studied in obese youth. Objective The primary aim was to evaluate how gut hormones and subjective appetite measure change with dietary weight loss in obese adolescents. Methods Participants were a subset of those taking part in the 'Eat Smart Study'. They were aged 10-17 years with body mass index ( BMI) > 90th centile and were randomized to one of three groups: wait-listed control, structured reduced carbohydrate or structured low-fat dietary intervention for 12 weeks. Outcomes were fasting glucose, insulin, leptin, adiponectin, total amylin, acylated ghrelin, active glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide ( GIP), pancreatic polypeptide ( PP) and total peptide tyrosine-tyrosine. Pre- and postprandial subjective sensations of appetite were assessed using visual analogue scales. Results Of 87 'Eat Smart' participants, 74 participated in this sub-study. The mean (standard deviation) BMI z-score was 2.1 (0.4) in the intervention groups at week 12 compared with 2.2 (0.4) in the control group. Fasting insulin ( P = 0.05) and leptin ( P = 0.03) levels decreased, while adiponectin levels increased ( P = 0.05) in the intervention groups compared with control. The intervention groups were not significantly different from each other. A decrease in BMI z-score at week 12 was associated with decreased fasting insulin ( P < 0.001), homeostatic model of assessment-insulin resistance ( P < 0.001), leptin ( P < 0.001), total amylin ( P = 0.03), GIP ( P = 0.01), PP ( P = 0.02) and increased adiponectin ( P < 0.001). There was no significant difference in appetite sensations. Conclusions Modest weight loss in obese adolescents leads to changes in some adipokines and gut hormones that may favour weight regain. [ABSTRACT FROM AUTHOR]

Background: Experimental studies suggest that angiotensin II plays a central role in the pathogenesis of abdominal aortic aneurysm. This trial aims to evaluate the efficacy of the angiotensin receptor blocker telmisartan in limiting the progression of abdominal aortic aneurysm.Methods/design: Telmisartan in the management of abdominal aortic aneurysm (TEDY) is a multicentre, parallel-design, randomised, double-blind, placebo-controlled trial with an intention-to-treat analysis. We aim to randomly assign 300 participants with small abdominal aortic aneurysm to either 40 mg of telmisartan or identical placebo and follow patients over 2 years. The primary endpoint will be abdominal aortic aneurysm growth as measured by 1) maximum infra-renal aortic volume on computed tomographic angiography, 2) maximum orthogonal diameter on computed tomographic angiography, and 3) maximum diameter on ultrasound. Secondary endpoints include change in resting brachial blood pressure, abdominal aortic aneurysm biomarker profile and health-related quality of life. TEDY is an international collaboration conducted from major vascular centres in Australia, the United States and the Netherlands.Discussion: Currently, no medication has been convincingly demonstrated to limit abdominal aortic aneurysm progression. TEDY will examine the potential of a promising treatment strategy for patients with small abdominal aortic aneurysms.Trial Registration: Australian and Leiden study centres: Australian New Zealand Clinical Trials Registry ACTRN12611000931976 , registered on 30 August 2011; Stanford study centre: clinicaltrials.gov NCT01683084 , registered on 5 September 2012. [ABSTRACT FROM AUTHOR]

Background Childbirth fear is associated with increased obstetric interventions and poor emotional and psychological health for women. The purpose of this study is to test an antenatal psycho-education intervention by midwives in reducing women's childbirth fear. Methods Women ( n = 1,410) attending three hospitals in South East Queensland, Australia, were recruited into the BELIEF trial. Participants reporting high fear were randomly allocated to intervention ( n = 170) or control ( n = 169) groups. All women received a decision-aid booklet on childbirth choices. The telephone counseling intervention was offered at 24 and 34 weeks of pregnancy. The control group received usual care offered by public maternity services. Primary outcome was reduction in childbirth fear ( WDEQ-A) from second trimester to 36 weeks' gestation. Secondary outcomes were improved childbirth self-efficacy, and reduced decisional conflict and depressive symptoms. Demographic, obstetric & psychometric measures were administered at recruitment, and 36 weeks of pregnancy. Results There were significant differences between groups on postintervention scores for fear of birth ( p < 0.001) and childbirth self-efficacy ( p = 0.002). Decisional conflict and depressive symptoms reduced but were not significant. Conclusion Psycho-education by trained midwives was effective in reducing high childbirth fear levels and increasing childbirth confidence in pregnant women. Improving antenatal emotional well-being may have wider positive social and maternity care implications for optimal childbirth experiences. [ABSTRACT FROM AUTHOR]

Purpose This article reports baseline data from a randomized controlled trial investigating the impact of a specialist cardiometabolic healthcare nurse on physical health care. Design and Methods Survey of community-based mental health consumers randomized to a cardiometabolic health nurse intervention. Findings Findings show a high prevalence of respiratory conditions, hypercholesterolemia, hypertension, and low quality of life. Participants reported regular blood pressure but infrequent cholesterol and blood glucose testing. Few received advice about smoking cessation, diet, or physical activity. Participants were mostly satisfied with physical healthcare provision; however, positive health behaviors are lacking. Practice Implications An individualized intervention based on knowledge and attitudes may be necessary. [ABSTRACT FROM AUTHOR]

Background. Obese women undergoing caesarean section (CS) are at increased risk of surgical site infection (SSI). Negative pressure wound therapy (NPWT) is growing in use as a prophylactic approach to prevent wound complications such as SSI, yet there is little evidence regarding its benefits. The aim of this pilot study was to evaluate the feasibility of undertaking a randomised controlled trial using NPWT in obese women undergoing elective CS. Method. Obese women undergoing elective CS were recruited from the antenatal clinic in a metropolitan hospital in Queensland, Australia, between 2012 and 2013. Using parallel 1:1 randomisation, 18 of these women received the intervention following closure of their wound in operating room (NPWT, PICOTM dressing) and 17 women received standard care (Comfeel Plus® dressing). Pre-defined criteria used to assess feasibility included: recruitment (>75% participation), loss to follow-up (<10%), intervention fidelity (=95%), and interrater reliability (kappa =0.8). Ethics approval was granted by the hospital and university human research ethics committees. Results. Of the 55 women approached, 48 (87%) consented to participate, 35 (63.6%) were randomised and 33 (94%) women completed post-discharge follow-up. All women received the intended dressing with the exception of one (2.8%) who later crossed over during dressing change. A kappa score of 0.87 (p<.0001) for SSI (yes/no) and an intraclass correlation coefficient score of 0.95 (p<.0001) for type of SSI were achieved. Conclusion. As shown in this study, careful planning and study site selection is critical to the success of the overall study. The results indicate that women with newborns are willing to participate in trials involving interventions and short-term follow-up. [ABSTRACT FROM AUTHOR]

Objective: To determine feasibility of gaming console exercise and its effect on endurance, gait and balance in people following acquired brain injury (ABI). Method: Twenty-one people following ABI were recruited to an 8-week randomized cross-over trial where 4 weeks of gaming console exercise in addition to usual therapy and 4 weeks of usual therapy alone were received. Feasibility measures included compliance, session duration and adverse events. Measures included endurance measured using a 6-minute walk test, spatiotemporal gait parameters (GAITRite) and balance using Balance Outcome Measure for Elder Rehabilitation (BOOMER). Motivation was measured using the Change Assessment Questionnaire. Results: Compliance with gaming console exercise was high (99%), the majority of sessions reached duration target (82%) and there were no adverse events. There were small, though non-significant increases in 6-minute walk distance (18 metres, 95% CI = −33 to 69), gait speed (0.11 m s−1, 95% CI = −0.18 to 0.29) and balance compared to after usual therapy after gaming console exercise. Conclusions: Gaming console exercise appears feasible in people with ABI. Four weeks of gaming console exercise in addition to usual therapy appears to result in similar improvements in endurance, gait and balance compared to usual therapy alone and may enhance active engagement in therapy. [ABSTRACT FROM AUTHOR]

Background Nutrition supplements enriched with immune function enhancing nutrients have been developed to aid wound-healing, although evidence regarding their effectiveness is limited and systematic reviews have lead to inconsistent recommendations. The present pragmatic, randomised, prospective open trial evaluated a wound-specific oral nutrition supplement enriched with arginine, vitamin C and zinc compared to a standard supplement with respect to outcomes in patients with chronic wounds in an acute care setting. Methods Twenty-four patients [11 males and 13 females; mean (SD) age: 67.8 (22.3) years] with chronic wounds (14 diabetic or venous ulcers; 10 pressure ulcers or chronic surgical wounds) were randomised to receive either a wound-specific supplement ( n = 12) or standard supplement ( n = 12) for 4 weeks, with ongoing best wound and nutrition care for an additional 4 weeks. At baseline, and at 4 and 8 weeks, the rate of wound-healing, nutritional status, protein and energy intake, quality of life and product satisfaction were measured. Linear mixed effects modelling with random intercepts and slopes were fitted to determine whether the wound-specific nutritional supplement had any effect. Results There was a significant improvement in wound-healing in patients receiving the standard nutrition supplement compared to a wound-specific supplement ( P = 0.044), although there was no effect on nutritional status, dietary intake, quality of life and patient satisfaction. Conclusions The results of the present study indicate that a standard oral nutrition supplement may be more effective at wound-healing than a specialised wound supplement in this clinical setting. [ABSTRACT FROM AUTHOR]

Background Health assessments for people with intellectual disability have been implemented in the UK, New Zealand and Australia, and have led to improved health outcomes. The Comprehensive Health Assessment Program (CHAP) has been shown to improve the health of people with intellectual disability. Similar to other health assessments, it is designed to address healthcare needs, many of which are often overlooked in this population, through better communication between the general practitioner (GP), support worker and the person with intellectual disability. This study investigates GP views of the perceived and actual benefits, gains and barriers associated with its uptake and use in practice. Method As part of a larger randomised controlled trial of the CHAP, 46 GPs in Queensland, Australia, completed two telephone interviews that included open-ended questions about their perceptions of the health assessment. The GPs were enrolled in the intervention arm of the trial. Interviews took place at commencement and conclusion of the trial to gain the views of GPs as they experienced using the CHAP. Thematic analysis was used to identify key themes and patterns from the GP responses. Results Four themes were identified: better healthcare and uncertain benefits captured GP perceptions of the potential gains associated with use of the CHAP, while two further themes, organisational barriers in the general practice setting and engagement across the healthcare triad highlighted strengths and barriers related to implementation. Anticipated concerns about time raised by GPs at commencement of the trial were borne out in practice, but concerns about communication and cooperation of people with disabilities were not. Matters associated with support worker engagement emerged as an area of concern. Conclusions GPs perceive the CHAP as a structured and comprehensive approach to the detection of medical problems as well as an aid in overcoming communication barriers between the doctor and the person with disability. Our findings suggest that some GPs may find it difficult to predict the benefits of using health assessments such as the CHAP. Achieving optimal uptake is likely to require attention at policy and systems levels to address: GP time constraints in providing healthcare to this population; enhancement of support worker training and organisational structures to encourage comprehensive health assessment and follow-up activities; and GP awareness of the improved health outcomes shown to derive from the use of comprehensive health assessments. [ABSTRACT FROM AUTHOR]

Background: Participation in coronary heart disease secondary prevention programs is low. Innovative programs to meet this treatment gap are required. Purpose: To aim of this study is to describe the effectiveness of a telephone-delivered secondary prevention program for myocardial infarction patients. Methods: Four hundred and thirty adult myocardial infarction patients in Brisbane, Australia were randomised to a 6-month secondary prevention program or usual care. Primary outcomes were health-related quality of life (Short Form-36) and physical activity (Active Australia Survey). Results: Significant intervention effects were observed for health-related quality of life on the mental component summary score ( p = 0.02), and the social functioning ( p = 0.04) and role-emotional ( p = 0.03) subscales, compared with usual care. Intervention participants were also more likely to meet recommended levels of physical activity ( p = 0.02), body mass index ( p = 0.05), vegetable intake ( p = 0.04) and alcohol consumption ( p = 0.05). Conclusions: Telephone-delivered secondary prevention programs can significantly improve health outcomes and could meet the treatment gap for myocardial infarction patients. [ABSTRACT FROM AUTHOR]

Aim To test the effect of a nurse-led intervention on weight gain in people with serious mental illness prescribed and taking second generation antipsychotic medication. Background Weight gain and obesity has reached epidemic proportions in the general population with the prevalence of Metabolic Syndrome reaching 20-25% of the global population. People with serious mental illness are at even higher risk, particularly those taking second generation antipsychotic medication. Design An experimental randomized controlled trial was undertaken. Method The control group received a 12-week healthy lifestyle booklet. In addition to the booklet, the intervention group received weekly nutrition and exercise education, exercise sessions, and nurse support. Participants ( n = 101) were assessed at baseline and 12 weeks. Data were collected between March 2008-December 2010. Seven outcome measures were used: body measurements included girth (cm), weight (kg), height (cm), and body mass index (kg/m2); questionnaires included the medication compliance questionnaire, the Drug Attitude Inventory, the Liverpool University Neuroleptic Side Effect Rating Scale, and the Medical Outcomes Study Short Form 36. Differences in primary outcome measures between baseline and 12 weeks follow-up were compared between intervention and control groups using standard bi-variate statistical tests. The study was conducted between 2008-2010. Results The analysis of outcome measures for the control group ( n = 50) and intervention group ( n = 51) was not statistically significant. There was a mean weight change of −0·74 kg at 12 weeks for the intervention group ( n = 51), while the control group ( n = 50) had a mean weight change of −0·17 kg at 12 weeks. Conclusion The results were not statistically significant. [ABSTRACT FROM AUTHOR]

International Journal of Paediatric Dentistry 2013; 23: 216-224 Objectives. This randomised, controlled trial compared the effectiveness of 0.12% chlorhexidine (CHX) gel and 304% fluoride toothpaste to prevent early childhood caries (ECC) in a birth cohort by 24 months. Methods. The participants were randomised to receive either (i) twice daily toothbrushing with toothpaste and once daily 0.12% CHX gel ( n = 110) or (ii) twice daily toothbrushing with toothpaste only (study controls) ( n = 89). The primary outcome measured was caries incidence and the secondary outcome was percentage of children with mutans streptococci (MS). All mothers were contacted by telephone at 6, 12, and 18 months. At 24 months, all children were examined at a community dental clinic. Results. At 24 months, the caries prevalence was 5% (3/61) in the CHX and 7% (4/58) in the controls ( P = 0.7). There were no differences in percentages of MS-positive children between the CHX and control groups (54% vs 53%). Only 20% applied the CHX gel once daily and 80% less than once daily. Conclusions. Toothbrushing using 304% fluoride toothpaste with or without the application of chlorhexidine gel (0.12%) reduces ECC from 23% found in the general community to 5-7%. The lack of effect with chlorhexidine is likely to be due to low compliance. [ABSTRACT FROM AUTHOR]

Chemotherapy-induced nausea and vomiting ( CINV) is a common side-effect of cytotoxic treatment. It continues to affect a significant proportion of patients despite the widespread use of antiemetic medication. In traditional medicine, ginger ( Zingiber officinale) has been used to prevent and treat nausea in many cultures for thousands of years. However, its use has not been confirmed in the chemotherapy context. To determine the potential use of ginger as a prophylactic or treatment for CINV, a systematic literature review was conducted. Reviewed studies comprised randomized controlled trials or crossover trials that investigated the anti- CINV effect of ginger as the sole independent variable in chemotherapy patients. Seven studies met the inclusion criteria. All studies were assessed on methodological quality and their limitations were identified. Studies were mixed in their support of ginger as an anti- CINV treatment in patients receiving chemotherapy, with three demonstrating a positive effect, two in favor but with caveats, and two showing no effect on measures of CINV. Future studies are required to address the limitations identified before clinical use can be recommended. [ABSTRACT FROM AUTHOR]

The safety and efficacy of three-layer (3 L) tubular bandaging as a treatment for venous ulcer healing has not been evaluated despite its use in many clinical settings to treat people with venous leg ulcers. We evaluated the safety and efficacy of 3 L tubular bandage compared with short-stretch compression bandage to heal venous ulcers in a multicenter, open-label, parallel-group, randomized controlled trial. We randomized 45 patients with venous leg ulcers of up to 20 cm2 area and an ankle brachial pressure index of >0.8 from hospital outpatient wound clinics in Victoria and Queensland, Australia. We measured time to healing and percentage reduction of wound size from baseline to week 12. Secondary outcomes were proportion of ulcers healed, self-reported compliance of compression bandage, and health-related quality of life, costs, recurrence rates, and adverse events. A total of 27 ulcers healed, the proportion of healed ulcers was higher for the 3 L group (17/23 [74%] vs. 10/22 [46%]) ( p = 0.05). Reported bandage tolerance at all treatment visits was 21 (91%) in 3 L group vs. 17 (73%) ( p = 0.10). There was no difference between the groups in adverse events. Costs were substantially less in 3 L group. [ABSTRACT FROM AUTHOR]