Development of an International Standard Set of Outcomes and Measurement Methods for Routine Practice for Adults with Epilepsy: The International Consortium for Health Outcomes Measurement Consensus Recommendations.

At present, there is no internationally accepted set of core outcomes or measurement methods for epilepsy clinical practice. Therefore, the International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group of experts in epilepsy, people with epilepsy and their representatives to develop minimum sets of standardized outcomes and outcomes measurement methods for clinical practice that support patient-clinician decision-making and quality improvement. Consensus methods identified 20 core outcomes. Measurement tools were recommended based on their evidence of strong clinical measurement properties, feasibility, and cross-cultural applicability. The essential outcomes included many non-seizure outcomes: anxiety, depression, suicidality, memory and attention, sleep quality, functional status, and the social impact of epilepsy. The proposed set will facilitate the implementation of the use of patient-centered outcomes in daily practice, ensuring holistic care. They also encourage harmonization of outcome measurement, and if widely implemented should reduce the heterogeneity of outcome measurement, accelerate comparative research, and facilitate quality improvement efforts.

Development of an International Standard Set of Outcomes and Measurement Methods for Routine Practice for Infants, Children, and Adolescents with Epilepsy: The International Consortium for Health Outcomes Measurement Consensus Recommendations.

At present, there is no internationally accepted set of core outcomes or measurement methods for epilepsy clinical practice. The International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group of experts in epilepsy, people with epilepsy, and their representatives to develop minimum sets of standardized outcomes and outcome measurement methods for clinical practice. Using modified Delphi consensus methods with consecutive rounds of online voting over 12 months, a core set of outcomes and corresponding measurement tool packages to capture the outcomes were identified for infants, children, and adolescents with epilepsy. Consensus methods identified 20 core outcomes. In addition to the outcomes identified for the ICHOM Epilepsy adult standard set, behavioral, motor, and cognitive/language development outcomes were voted as essential for all infants and children with epilepsy. The proposed set of outcomes and measurement methods will facilitate the implementation of the use of patient-centered outcomes in daily practice.

Scope of practice regulation in medicine: balancing patient safety, access to care and professional autonomy.

Scope of practice regulation in medicine is crucial for ensuring patient safety, access to care and professional autonomy. This paper explores the impact of scope of practice regulation on healthcare delivery, professional responsibilities and patient outcomes. It discusses the variability in standards for safe practice, the challenges in defining boundaries between medical specialties and the recent controversies in cosmetic surgery practice. The paper also examines the potential benefits and drawbacks of rigorous scope of practice regulations, including their impact on clinical innovation, flexibility and access to care. Furthermore, it delves into the implications of defensive medicine and the consequences of restrictive regulations on patient care. The author proposes implementing a proactive, national, artificial intelligence-powered, real-time outcome monitoring system to address these challenges. This system aims to cover every patient undergoing a surgical procedure and could be gradually extended to non-surgical conditions, benefiting all key stakeholders in the health system. The paper emphasises the need for a balanced approach to scope of practice regulation to avoid stifling clinical innovation and professional autonomy, while ensuring patient safety and professional accountability.

Mind wandering may both promote and impair learning.

The present investigation deals with individual differences in habitual (trait-level) mind wandering and their effects on learning. We hypothesized that the 'positive-constructive' type of habitual mind wandering would promote task-related thinking and the 'poor-attention' type to promote task-unrelated thinking. This hypothesis was tested in a study with 200 participants who rated different aspects of their mind wandering in daily life in one session and completed a reading study in a second session. The reading study included thought probes, retrospective questions about readers' thought contents, and comprehension tests after reading. In line with our hypothesis, data analysis revealed that some forms of positive-constructive mind wandering were positively associated with text-related thought, whereas poor-attention mind wandering was positively associated with text-unrelated thought. The present results add to the literature by emphasizing different types of trait-level mind wandering and their potentially opposite effects on learning.

Pembrolizumab-induced acute right L5 neuritis unresponsive to steroids.

We present a case of a patient with metastatic lung adenocarcinoma who developed severe right lower limb radicular pain in a L5-S1 dermatomal distribution 5 months into treatment with carboplatin, pemetrexed and pembrolizumab. MRI of the lumbar spine demonstrated contrast enhancement of the right L5 nerve root consistent with neuritis. The patient was treated with intravenous methylprednisolone 2 mg/kg/day for 3 days, followed by oral prednisolone 1 mg/kg/day with a slow wean over 6 weeks. There was no improvement and their performance status deteriorated to an Eastern Cooperative Oncology Group (ECOG) score of 3, representing capability of only limited self-care. We commenced induction therapy with intravenous immunoglobulin 2 g/kg over 5 days, which resulted in complete resolution of pain sustained for 3 weeks before recurrence of symptoms. We continued maintenance therapy with intravenous immunoglobulin 0.4 g/kg over 2 days at 4-5 weekly intervals, which led to resolution of symptoms and ECOG score to 1.

Melioidosis of the nervous system: atypical presentation of a rare disease in a 48-year-old man.

A 48-year-old man who worked in mining in remote, northern Australia was transferred from a rural hospital 5 days after the onset of headaches, subjective fevers and flaccid paralysis of the left upper limb. Initial investigations demonstrated inflammatory cerebrospinal fluid (CSF) changes and a longitudinally extensive cervical cord lesion. Given two serial negative blood and CSF cultures, he was treated as inflammatory myelitis with intravenous methylprednisolone. Despite the initial improvement in pain and left arm power, the patient's neurological deficit plateaued and then deteriorated with worsening neck pain, diaphragmatic dysfunction and dysphagia requiring intubation and respiratory support. A third CSF culture isolated Burkholderia pseudomallei confirming a diagnosis of neuro-melioidosis. Repeat imaging revealed the rostral extension of the original spinal cord lesion into the medulla and pons. Over the next 4 weeks, the patient's neurological deficits slowly improved with continued intravenous antibiotic therapy with meropenem and oral trimethoprim/sulfamethoxazole.

Effectiveness of a structured, framework-based approach to implementation: the Researching Effective Approaches to Cleaning in Hospitals (REACH) Trial.

BACKGROUND: Implementing sustainable practice change in hospital cleaning has proven to be an ongoing challenge in reducing healthcare associated infections. The purpose of this study was to develop a reliable framework-based approach to implement and quantitatively evaluate the implementation of evidence-based practice change in hospital cleaning. DESIGN/METHODS: The Researching Effective Approaches to Cleaning in Hospitals (REACH) trial was a pragmatic, stepped-wedge randomised trial of an environmental cleaning bundle implemented in 11 Australian hospitals from 2016 to 2017. Using a structured multi-step approach, we adapted the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework to support rigorous and tailored implementation of the cleaning bundle intervention in eleven diverse and complex settings. To evaluate the effectiveness of this strategy we examined post-intervention cleaning bundle alignment calculated as a score (an implementation measure) and cleaning performance audit data collected using ultraviolet (UV) gel markers (an outcome measure). RESULTS: We successfully implemented the bundle and observed improvements in cleaning practice and performance, regardless of hospital size, intervention duration and contextual issues such as staff and organisational readiness at baseline. There was a positive association between bundle alignment scores and cleaning performance at baseline. This diminished over the duration of the intervention, as hospitals with lower baseline scores were able to implement practice change successfully. CONCLUSION: Using a structured framework-based approach allows for pragmatic and successful implementation of clinical trials across diverse settings, and assists with quantitative evaluation of practice change. TRIAL REGISTRATION: Australia New Zealand Clinical Trial Registry ACTRN12615000325505, registered on 4 September 2015.

Cost-effectiveness of an Environmental Cleaning Bundle for Reducing Healthcare-associated Infections.

BACKGROUND: Healthcare-associated infections (HAIs) remain a significant patient safety issue, with point prevalence estimates being ~5% in high-income countries. In 2016-2017, the Researching Effective Approaches to Cleaning in Hospitals (REACH) study implemented an environmental cleaning bundle targeting communication, staff training, improved cleaning technique, product use, and audit of frequent touch-point cleaning. This study evaluates the cost-effectiveness of the environmental cleaning bundle for reducing the incidence of HAIs. METHODS: A stepped-wedge, cluster-randomized trial was conducted in 11 hospitals recruited from 6 Australian states and territories. Bundle effectiveness was measured by the numbers of Staphylococcus aureus bacteremia, Clostridium difficile infection, and vancomycin-resistant enterococci infections prevented in the intervention phase based on estimated reductions in the relative risk of infection. Changes to costs were defined as the cost of implementing the bundle minus cost savings from fewer infections. Health benefits gained from fewer infections were measured in quality-adjusted life-years (QALYs). Cost-effectiveness was evaluated using the incremental cost-effectiveness ratio and net monetary benefit of adopting the cleaning bundle over existing hospital cleaning practices. RESULTS: Implementing the cleaning bundle cost $349 000 Australian dollars (AUD) and generated AUD$147 500 in cost savings. Infections prevented under the cleaning bundle returned a net monetary benefit of AUD$1.02 million and an incremental cost-effectiveness ratio of $4684 per QALY gained. There was an 86% chance that the bundle was cost-effective compared with existing hospital cleaning practices. CONCLUSIONS: A bundled, evidence-based approach to improving hospital cleaning is a cost-effective intervention for reducing the incidence of HAIs.

An environmental cleaning bundle and health-care-associated infections in hospitals (REACH): a multicentre, randomised trial.

BACKGROUND: The hospital environment is a reservoir for the transmission of microorganisms. The effect of improved cleaning on patient-centred outcomes remains unclear. We aimed to evaluate the effectiveness of an environmental cleaning bundle to reduce health care-associated infections in hospitals. METHODS: The REACH study was a pragmatic, multicentre, randomised trial done in 11 acute care hospitals in Australia. Eligible hospitals had an intensive care unit, were classified by the National Health Performance Authority as a major hospital (public hospitals) or having more than 200 inpatient beds (private hospitals), and had a health-care-associated infection surveillance programme. The stepped-wedge design meant intervention periods varied from 20 weeks to 50 weeks. We introduced the REACH cleaning bundle, a multimodal intervention, focusing on optimising product use, technique, staff training, auditing with feedback, and communication, for routine cleaning. The primary outcomes were incidences of health-care-associated Staphylococcus aureus bacteraemia, Clostridium difficile infection, and vancomycin-resistant enterococci infection. The secondary outcome was the thoroughness of cleaning of frequent touch points, assessed by a fluorescent marking gel. This study is registered with the Australian and New Zealand Clinical Trial Registry, number ACTRN12615000325505. FINDINGS: Between May 9, 2016, and July 30, 2017, we implemented the cleaning bundle in 11 hospitals. In the pre-intervention phase, there were 230 cases of vancomycin-resistant enterococci infection, 362 of S aureus bacteraemia, and 968 C difficile infections, for 3 534 439 occupied bed-days. During intervention, there were 50 cases of vancomycin-resistant enterococci infection, 109 of S aureus bacteraemia, and 278 C difficile infections, for 1 267 134 occupied bed-days. After the intervention, vancomycin-resistant enterococci infections reduced from 0·35 to 0·22 per 10 000 occupied bed-days (relative risk 0·63, 95% CI 0·41-0·97, p=0·0340). The incidences of S aureus bacteraemia (0·97 to 0·80 per 10 000 occupied bed-days; 0·82, 0·60-1·12, p=0·2180) and C difficile infections (2·34 to 2·52 per 10 000 occupied bed-days; 1·07, 0·88-1·30, p=0·4655) did not change significantly. The intervention increased the percentage of frequent touch points cleaned in bathrooms from 55% to 76% (odds ratio 2·07, 1·83-2·34, p<0·0001) and bedrooms from 64% to 86% (1·87, 1·68-2·09, p<0·0001). INTERPRETATION: The REACH cleaning bundle was successful at improving cleaning thoroughness and showed great promise in reducing vancomycin-resistant enterococci infections. Our work will inform hospital cleaning policy and practice, highlighting the value of investment in both routine and discharge cleaning practice. FUNDING: National Health and Medical Research Council (Australia).

Changes in knowledge and attitudes of hospital environmental services staff: The Researching Effective Approaches to Cleaning in Hospitals (REACH) study.

BACKGROUND: The Researching Effective Approaches to Cleaning in Hospitals (REACH) study tested a multimodal cleaning intervention in Australian hospitals. This article reports findings from a pre/post questionnaire, embedded into the REACH study, that was administered prior to the implementation of the intervention and at the conclusion of the study. METHODS: A cross-sectional questionnaire, nested within a stepped-wedge trial, was administered. The REACH intervention was a cleaning bundle comprising 5 interdependent components. The questionnaire explored the knowledge, reported practice, attitudes, roles, and perceived organizational support of environmental services staff members in the hospitals participating in the REACH study. RESULTS: Environmental services staff members in 11 participating hospitals completed 616 pre- and 307 post-test questionnaires (n = 923). Increases in knowledge and practice were seen between the pre-and post-test questionnaires. Minimal changes were observed in attitudes regarding the role of cleaning and in perceived organizational support. CONCLUSION: To our knowledge, this is the first study to report changes in knowledge, attitudes, and perceived organizational support in environmental services staff members, in the context of a large multicenter clinical trial. In this underexplored group of hospital workers, findings suggest that environmental services staff members have a high level of knowledge related to cleaning practices and understand the importance of their role.

Exploring the determinants of health and wellbeing in communities living in proximity to coal seam gas developments in regional Queensland.

BACKGROUND: There is some concern that coal seam gas mining may affect health and wellbeing through changes in social determinants such as living and working conditions, local economy and the environment. The onward impact of these conditions on health and wellbeing is often not monitored to the same degree as direct environmental health impacts in the mining context, but merits attention. This study reports on the findings from a recurrent theme that emerged from analysis of the qualitative component of a comprehensive Health Needs Assessment (HNA) conducted in regional Queensland: that health and wellbeing of communities was reportedly affected by nearby coal seam gas (CSG) development beyond direct environmental impacts. METHODS: Qualitative analysis was initially completed using the Framework Method to explore key themes from 11 focus group discussions, 19 in-depth interviews, and 45 key informant interviews with health and wellbeing service providers and community members. A key theme emerged from the analysis that forms the basis of this paper. This study is part of a larger comprehensive HNA involving qualitative and quantitative data collection to explore the health and wellbeing needs of three communities living in proximity to CSG development in regional Queensland, Australia. RESULTS: Communities faced social, economic and environmental impacts from the rapid growth of CSG development, which were perceived to have direct and indirect effects on individual lifestyle factors such as alcohol and drug abuse, family relationships, social capital and mental health; and community-level factors including social connectedness, civic engagement and trust. CONCLUSIONS: Outer regional communities discussed the effects of mining activity on the fabric of their town and community, whereas the inner regional community that had a longer history of industrial activity discussed the impacts on families and individual health and wellbeing. The findings from this study may inform future health service planning in regions affected by CSG in the development /construction phase and provide the mining sector in regional areas with evidence from which to develop social responsibility programs that encompass health, social, economic and environmental assessments that more accurately reflect the needs of the affected communities.

A Cost-Utility Analysis of Prostate Cancer Screening in Australia.

BACKGROUND AND OBJECTIVES: The Göteborg randomised population-based prostate cancer screening trial demonstrated that prostate-specific antigen (PSA)-based screening reduces prostate cancer deaths compared with an age-matched control group. Utilising the prostate cancer detection rates from this study, we investigated the clinical and cost effectiveness of a similar PSA-based screening strategy for an Australian population of men aged 50-69 years. METHODS: A decision model that incorporated Markov processes was developed from a health system perspective. The base-case scenario compared a population-based screening programme with current opportunistic screening practices. Costs, utility values, treatment patterns and background mortality rates were derived from Australian data. All costs were adjusted to reflect July 2015 Australian dollars (A$). An alternative scenario compared systematic with opportunistic screening but with optimisation of active surveillance (AS) uptake in both groups. A discount rate of 5 % for costs and benefits was utilised. Univariate and probabilistic sensitivity analyses were performed to assess the effect of variable uncertainty on model outcomes. RESULTS: Our model very closely replicated the number of deaths from both prostate cancer and background mortality in the Göteborg study. The incremental cost per quality-adjusted life-year (QALY) for PSA screening was A$147,528. However, for years of life gained (LYGs), PSA-based screening (A$45,890/LYG) appeared more favourable. Our alternative scenario with optimised AS improved cost utility to A$45,881/QALY, with screening becoming cost effective at a 92 % AS uptake rate. Both modelled scenarios were most sensitive to the utility of patients before and after intervention, and the discount rate used. CONCLUSION: PSA-based screening is not cost effective compared with Australia's assumed willingness-to-pay threshold of A$50,000/QALY. It appears more cost effective if LYGs are used as the relevant outcome, and is more cost effective than the established Australian breast cancer screening programme on this basis. Optimised utilisation of AS increases the cost effectiveness of prostate cancer screening dramatically.

Assessment of Motivational Cognitions in Diabetes Self-Care: the Motivation Thought Frequency Scales for Glucose Testing, Physical Activity and Healthy Eating.

PURPOSE: There is a need for improved measurement of motivation for diabetes self-care. The Elaborated Intrusion Theory of Desire offers a coherent framework for understanding and identifying the cognitive-affective events that constitute the subjective experience of motivation and may therefore inform the development of such an instrument. Recent research has shown the resultant Motivation Thought Frequency scale (MTF) to have a stable factor structure (Intensity, Incentives Imagery, Self-Efficacy Imagery, Availability) when applied to physical activity, excessive snacking or alcohol use in the general population. The current study aimed to confirm the four-factor structure of the MTF for glucose testing, physical activity and healthy eating in people with type 2 diabetes. Associations with self-reports of concurrent diabetic self-care behaviours were also examined. METHOD: Confirmatory factor analyses tested the internal structure, and multiple regressions assessed the scale's relationship with concurrent self-care behaviours. The MTF was completed by 340 adults with type 2 diabetes, and 237 from that sample also reported self-care behaviours. Separate MTFs assessed motivation for glucose testing, physical activity and healthy eating. Self-care was assessed using questions from the Summary of Diabetes Self-Care Activities. RESULTS: The MTF for each goal achieved an acceptable fit on all indices after selected errors within factors were allowed to intercorrelate. Intensity and Self-Efficacy Imagery provided the strongest and most consistent correlations with relevant self-care behaviours. CONCLUSION: Results provide preliminary support for the MTF in a diabetes sample. Testing of its sensitivity to change and its predictive utility over time is needed.

Examining health and well-being outcomes associated with mining activity in rural communities of high-income countries: A systematic review.

OBJECTIVE: It is recognised internationally that rural communities often experience greater barriers to accessing services and have poorer health outcomes compared to urban communities. In some settings, health disparities may be further exacerbated by mining activity, which can affect the social, physical and economic environment in which rural communities reside. Direct environmental health impacts are often associated with mining activity and are frequently investigated. However, there is evidence of broader, indirect health and well-being implications emerging in the literature. This systematic review examines these health and well-being outcomes in communities living in proximity to mining in high-income countries, and, in doing so, discusses their possible determinants. METHODS: Four databases were systematically searched. Articles were selected if adult residents in mining communities were studied and outcomes were related to health or individual or community-level well-being. A narrative synthesis was conducted. RESULTS: Sixteen publications were included. Evidence of increased prevalence of chronic diseases and poor self-reported health status was reported in the mining communities. Relationship breakdown and poor family health, lack of social connectedness and decreased access to health services were also reported. Changes to the physical landscape; risky health behaviours; shift work of partners in the mine industry; social isolation and cyclical nature of 'boom and bust' activity contributed to poorer outcomes in the communities. CONCLUSION: This review highlights the broader health and well-being outcomes associated with mining activity that should be monitored and addressed in addition to environmental health impacts to support co-existence of mining activities and rural communities.

Researching effective approaches to cleaning in hospitals: protocol of the REACH study, a multi-site stepped-wedge randomised trial.

BACKGROUND: The Researching Effective Approaches to Cleaning in Hospitals (REACH) study will generate evidence about the effectiveness and cost-effectiveness of a novel cleaning initiative that aims to improve the environmental cleanliness of hospitals. The initiative is an environmental cleaning bundle, with five interdependent, evidence-based components (training, technique, product, audit and communication) implemented with environmental services staff to enhance hospital cleaning practices. METHODS/DESIGN: The REACH study will use a stepped-wedge randomised controlled design to test the study intervention, an environmental cleaning bundle, in 11 Australian hospitals. All trial hospitals will receive the intervention and act as their own control, with analysis undertaken of the change within each hospital based on data collected in the control and intervention periods. Each site will be randomised to one of the 11 intervention timings with staggered commencement dates in 2016 and an intervention period between 20 and 50 weeks. All sites complete the trial at the same time in 2017. The inclusion criteria allow for a purposive sample of both public and private hospitals that have higher-risk patient populations for healthcare-associated infections (HAIs). The primary outcome (objective one) is the monthly number of Staphylococcus aureus bacteraemias (SABs), Clostridium difficile infections (CDIs) and vancomycin resistant enterococci (VRE) infections, per 10,000 bed days. Secondary outcomes for objective one include the thoroughness of hospital cleaning assessed using fluorescent marker technology, the bio-burden of frequent touch surfaces post cleaning and changes in staff knowledge and attitudes about environmental cleaning. A cost-effectiveness analysis will determine the second key outcome (objective two): the incremental cost-effectiveness ratio from implementation of the cleaning bundle. The study uses the integrated Promoting Action on Research Implementation in Health Services (iPARIHS) framework to support the tailored implementation of the environmental cleaning bundle in each hospital. DISCUSSION: Evidence from the REACH trial will contribute to future policy and practice guidelines about hospital environmental cleaning. It will be used by healthcare leaders and clinicians to inform decision-making and implementation of best-practice infection prevention strategies to reduce HAIs in hospitals. TRIAL REGISTRATION: Australia New Zealand Clinical Trial Registry ACTRN12615000325505.

Implementing a patient-initiated review system for people with rheumatoid arthritis: a prospective, comparative service evaluation.

RATIONALE, AIMS AND OBJECTIVES: The management of rheumatoid arthritis (RA) usually entails regular hospital reviews with a specialist often when the patient is well rather than during a period of exacerbation. An alternative approach where patients initiate appointments when they need them can improve patient satisfaction and resource use whilst being safe. This service evaluation reports a system-wide implementation of a patient-initiated review appointment system called Direct Access (DA) for people with RA. The aim was to establish the impact on patient satisfaction of the new system versus usual care as well as evaluate the implementation processes. METHODS: As all patients could not start on the new system at once, in order to manage the implementation, patients were randomly allocated to DA or to usual care. Instead of regular follow-up appointments, DA comprised an education session and access to a nurse-led telephone advice line where appointments could be accessed within two weeks. Usual care comprised routine follow-ups with the specialist. Data were collected on patient satisfaction, service use and outcomes of any contact to the advice line. RESULTS: Three hundred and eleven patients with RA were assessed as being suitable for DA. In terms of patient satisfaction, between-group differences were found in favour of DA for accessibility and convenience, ease of contacting the nurse and overall satisfaction with the service. Self-reported visits to the general practitioner were also significantly lower. DA resulted in a greater number of telephone contacts (incidence rate ratio = 1.69; 95% confidence interval 1.07 to 2.68). Hospital costs of the two different service models were similar. Mean waiting time for an appointment was 10.8 days CONCLUSION: This service evaluation found that DA could be implemented and it demonstrated patient benefit in a real-world setting. Further research establishing the broader cost-consequences across the whole patient pathway would add to our findings.

The OnTrack Diabetes Web-Based Program for Type 2 Diabetes and Dysphoria Self-Management: A Randomized Controlled Trial Protocol.

BACKGROUND: The prevalence of type 2 diabetes is rising with the majority of patients practicing inadequate disease self-management. Depression, anxiety, and diabetes-specific distress present motivational challenges to adequate self-care. Health systems globally struggle to deliver routine services that are accessible to the entire population, in particular in rural areas. Web-based diabetes self-management interventions can provide frequent, accessible support regardless of time and location OBJECTIVE: This paper describes the protocol of an Australian national randomized controlled trial (RCT) of the OnTrack Diabetes program, an automated, interactive, self-guided Web program aimed to improve glycemic control, diabetes self-care, and dysphoria symptoms in type 2 diabetes patients. METHODS: A small pilot trial is conducted that primarily tests program functionality, efficacy, and user acceptability and satisfaction. This is followed by the main RCT, which compares 3 treatments: (1) delayed program access: usual diabetes care for 3 months postbaseline followed by access to the full OnTrack Diabetes program; (2) immediate program: full access to the self-guided program from baseline onward; and (3) immediate program plus therapist support via Functional Imagery Training (FIT). Measures are administered at baseline and at 3, 6, and 12 months postbaseline. Primary outcomes are diabetes self-care behaviors (physical activity participation, diet, medication adherence, and blood glucose monitoring), glycated hemoglobin A1c (HbA1c) level, and diabetes-specific distress. Secondary outcomes are depression, anxiety, self-efficacy and adherence, and quality of life. Exposure data in terms of program uptake, use, time on each page, and program completion, as well as implementation feasibility will be conducted. RESULTS: This trial is currently underway with funding support from the Wesley Research Institute in Brisbane, Australia. CONCLUSIONS: This is the first known trial of an automated, self-guided, Web-based support program that uses a holistic approach in targeting both type 2 diabetes self-management and dysphoria. Findings will inform the feasibility of implementing such a program on an ongoing basis, including in rural and regional locations. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registration number: ACTRN12612000620820; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612000620820 (Archived by WebCite at http://www.webcitation.org/6a3BeXC5m).

Early vascular unclamping reduces warm ischaemia time in robot-assisted laparoscopic partial nephrectomy.

INTRODUCTION: The aim of this study was to assess the outcomes of early vascular release in robot-assisted laparoscopic partial nephrectomy (RAPN) to reduce warm ischaemia time (WIT) and minimise renal dysfunction. RAPN is increasingly utilised in the management of small renal masses. To this end it is imperative that WIT is kept to a minimum to maintain renal function. METHODS: RAPN was performed via a four-arm robotic transperitoneal approach. The renal artery and vein were individually clamped with robotic vascular bulldog clamps to allow cold scissor excision of the tumour. The cut surface was then sutured with one or two running 3-0 V-Loc (TM) sutures, following which the vascular clamps were released. Specific bleeding vessels were then selectively oversewn and the collecting system repaired. Renorrhaphy was then completed using a running horizontal mattress 0-0 V-Loc (TM) suture. RESULTS: A total of 16 patients underwent RAPN with a median WIT of 15 minutes (range: 8-25), operative time 230 minutes (range: 180-280) and blood loss of 100 mL (range: 50-1000). There were no transfusions, secondary haemorrhages or urine leaks. There was one focal positive margin in a central 5.5 cm pT3a renal cell carcinomas (RCC). Long-term estimated glomerular filtration rate (eGFR) was not significantly different to pre-operative values. CONCLUSION: In this patient series, early vascular release effectively minimised WIT and maintained renal function without compromising perioperative safety.

Development of the OnTrack Diabetes Program.

BACKGROUND: Type 2 diabetes affects an estimated 347 million people worldwide and often leads to serious complications including blindness, kidney disease, and limb amputation. Comorbid dysphoria is common and is an independent risk factor for poor glycaemic control. Professional support for diabetes self-management and dysphoria has limited availability and involves high costs, especially after regular hours, and in rural and remote areas. Web-based cognitive behavior therapy offers highly accessible, acceptable, and cost-effective support for people with diabetes. This paper describes the development of OnTrack Diabetes, a self-guided, Web-based program to promote improved physical and emotional self-management in people with Type 2 diabetes. OBJECTIVE: The objective of the study is to describe the development of the OnTrack Diabetes program, which is a self-guided, Web-based program aimed to promote euthymia and improved disease self-management in people with Type 2 diabetes. METHODS: Semistructured interviews with 12 general practitioners and 13 patients with Type 2 diabetes identified enablers of and barriers to effective diabetes self-management, requirements for additional support, and potential program elements. Existing resources and research data informed the development of content, and consultants from relevant disciplines provided feedback on draft segments and reviewed the program before release. Using a self-guided delivery format contained costs, in addition to adapting program features and modules from an existing OnTrack program. RESULTS: A separate paper describes the protocol for a randomized controlled trial to provide this required evaluation. CONCLUSIONS: Development of the OnTrack Diabetes program demonstrates strategies that help ensure that a program is acceptable to users. The next stages involve testing users' experiences and examining the program's effectiveness and cost-effectiveness in randomized controlled trials. TRIAL REGISTRATION: The Australian New Zealand Clinical Trials Registry (ACTRN): 12614001126606; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614001126606 (Archived by WebCite at http://www.webcitation.org/6U0Fh3vOj).