Protocol for a randomised controlled trial of a web-based healthy relationship tool and safety decision aid for women experiencing domestic violence (I-DECIDE)

BACKGROUND: Domestic violence is a serious problem affecting the health and wellbeing of women globally. Interventions in health care settings have primarily focused on screening and referral, however, women often may not disclose abuse to health practitioners. The internet offers a confidential space in which women can assess the health of their relationships and make a plan for safety and wellbeing for themselves and their children. This randomised controlled trial is testing the effectiveness of a web-based healthy relationship tool and safety decision aid (I-DECIDE). Based broadly on the IRIS trial in the United States, it has been adapted for the Australian context where it is conducted entirely online and uses the Psychosocial Readiness Model as the basis for the intervention. METHODS/DESIGN: In this two arm, pragmatic randomised controlled trial, women who have experienced abuse or fear of a partner in the previous 6 months will be computer randomised to receive either the I-DECIDE website or a comparator website (basic relationship and safety advice). The intervention includes self-directed reflection exercises on their relationship, danger level, priority setting, and results in an individualised, tailored action plan. Primary self-reported outcomes are: self-efficacy (General Self-Efficacy Scale) immediately after completion, 6 and 12 months post-baseline; and depressive symptoms (Centre for Epidemiologic Studies Depression Scale, Revised, 6 and 12 months post-baseline). Secondary outcomes include mean number of helpful actions for safety and wellbeing, mean level of fear of partner and cost-effectiveness. DISCUSSION: This fully-automated trial will evaluate a web-based self-information, self-reflection and self-management tool for domestic violence. We hypothesise that the improvement in self-efficacy and mental health will be mediated by increased perceived support and awareness encouraging positive change. If shown to be effective, I-DECIDE could be easily incorporated into the community sector and health care settings, providing an alternative to formal services for women not ready or able to acknowledge abuse and access specialised services. TRIAL REGISTRATION: Trial registered on 15(th) December 2014 with the Australian New Zealand Clinical Trials Registry ACTRN12614001306606.

A randomised controlled trial investigating the effects of Mediterranean diet and aerobic exercise on cognition in cognitively healthy older people living independently within aged care facilities: The Lifestyle Intervention in Independent Living Aged Car

Background: The rapid ageing of the population is becoming an area of great concern, both globally and in Australia. On a societal level, the cost of supporting an ageing demographic, particularly with their associated medical requirements, is becoming an ever increasing burden that is only predicted to rise in the foreseeable future. The progressive decline in individuals' cognitive ability as they age, particularly with respect to the ever increasing incidence of Alzheimer's Disease (AD) and other cognitive complications, is in many respects one of the foundation stones of these concerns. There have been numerous observational studies reporting on the positive effects that aerobic exercise and the Mediterranean diet appear to have on improving cognitive ability. However, the ability of such interventions to improve cognitive ability, or even reduce the rate of cognitive ageing, has not been fully examined by substantial interventional studies within an ageing population. Methods: The LIILAC trial will investigate the potential for cognitive change in a cohort of cognitively healthy individuals, between the ages of 60 and 90 years, living in independent accommodation within Australian aged care facilities. This four-arm trial will investigate the cognitive changes which may occur as a result of the introduction of aerobic exercise and/or Mediterranean diet into individuals' lifestyles, as well as the mechanisms by which these changes may be occurring. Participants will be tested at baseline and 6 months on a battery of computer based cognitive assessments, together with cardiovascular and blood biomarker assessments. The cardiovascular measures will assess changes in arterial stiffness and central pulse pressures, while the blood measures will examine changes in metabolic profiles, including brain derived neurotrophic factor (BDNF), inflammatory factors and insulin sensitivity. Conclusion: It is hypothesised that exercise and Mediterranean diet interventions, both individually and in combination, will result in improvements in cognitive performance compared with controls. Positive findings in this research will have potential implications for the management of aged care, particularly in respect to reducing the rate of cognitive decline and the associated impacts both on the individual and the broader community.

Facilitating effects of transcranial direct current stimulation on motor imagery brain-computer interface with robotic feedback for stroke rehabilitation

OBJECTIVE: To investigate the efficacy and effects of transcranial direct current stimulation (tDCS) on motor imagery brain-computer interface (MI-BCI) with robotic feedback for stroke rehabilitation. DESIGN: A sham-controlled, randomized controlled trial. SETTING: Patients recruited through a hospital stroke rehabilitation program. PARTICIPANTS: Subjects (N=19) who incurred a stroke 0.8 to 4.3 years prior, with moderate to severe upper extremity functional impairment, and passed BCI screening. INTERVENTIONS: Ten sessions of 20 minutes of tDCS or sham before 1 hour of MI-BCI with robotic feedback upper limb stroke rehabilitation for 2 weeks. Each rehabilitation session comprised 8 minutes of evaluation and 1 hour of therapy. MAIN OUTCOME MEASURES: Upper extremity Fugl-Meyer Motor Assessment (FMMA) scores measured end-intervention at week 2 and follow-up at week 4, online BCI accuracies from the evaluation part, and laterality coefficients of the electroencephalogram (EEG) from the therapy part of the 10 rehabilitation sessions. RESULTS: FMMA score improved in both groups at week 4, but no intergroup differences were found at any time points. Online accuracies of the evaluation part from the tDCS group were significantly higher than those from the sham group. The EEG laterality coefficients from the therapy part of the tDCS group were significantly higher than those of the sham group. CONCLUSIONS: The results suggest a role for tDCS in facilitating motor imagery in stroke.

Nonparametric discovery of movement patterns from accelerometer signals

Monitoring daily physical activity plays an important role in disease prevention and intervention. This paper proposes an approach to monitor the body movement intensity levels from accelerometer data. We collect the data using the accelerometer in a realistic setting without any supervision. The ground-truth of activities is provided by the participants themselves using an experience sampling application running on their mobile phones. We compute a novel feature that has a strong correlation with the movement intensity. We use the hierarchical Dirichlet process (HDP) model to detect the activity levels from this feature. Consisting of Bayesian nonparametric priors over the parameters the model can infer the number of levels automatically. By demonstrating the approach on the publicly available USC-HAD dataset that includes ground-truth activity labels, we show a strong correlation between the discovered activity levels and the movement intensity of the activities. This correlation is further confirmed using our newly collected dataset. We further use the extracted patterns as features for clustering and classifying the activity sequences to improve performance.

Family-based interventions for reducing sedentary time in youth: a systematic review of randomized controlled trials

Family involvement in interventions to reduce sedentary time may help foster appropriate long-term screen-based habits in children. This review systematically synthesized evidence from randomized controlled trials of interventions with a family component that targeted reduction of sedentary time, including TV viewing, video games and computer use, in children. MEDLINE, PubMed, PsycInfo, CINAHL and Embase were searched from inception through March 2012. Seventeen articles were considered eligible and included in the review. Studies were judged to be at low-to-moderate risk of bias. Despite inconsistent study results, level of parental involvement, rather than the setting itself, appeared an important determinant of intervention success. Studies including a parental component of medium-to-high intensity were consistently associated with statistically significant changes in sedentary behaviours. Participant age was also identified as a determinant of intervention outcomes; all three studies conducted in pre-school children demonstrated significant decreases in sedentary time. Finally, TV exposure appeared to be related to changes in energy intake rather than physical activity. Future studies should assess the effects of greater parental involvement and child age on success of sedentary behaviour interventions. More research is required to better understand the relationship between screen time and health behaviours, particularly energy intake.

Tailored mesoporous silica nanoparticles for controlled drug delivery: platform fabrication, targeted delivery, and computational design and analysis

Mesoporous silica nanoparticles (MSNs) are exceptionally promising drug carriers for controlled drug delivery systems because their morphology, pore structure, pore volume and pore size can be well tailored to obtain certain drug release profiles. Moreover, they possess the ability to specifically transport and deliver anti-cancer drugs when targeting molecules are properly grafted onto their surface. MSNs based drug delivery systems have the potential to revolutionize cancer therapy. This review provides a comprehensive overview of the fabrication, modification of MSNs and their applications in tumour-targeted delivery. In addition, the characterization and analysis of MSNs with computer aided strategies were described. The existing issues and future prospective concerning the applications of MSNs as drug carriers for controlled drug delivery systems were discussed.

Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial

Background Early mobilisation after stroke is thought to contribute to the eff ects of stroke-unit care; however, the intervention is poorly defined and not underpinned by strong evidence. We aimed to compare the effectiveness of frequent, higher dose, very early mobilisation with usual care after stroke.MethodsWe did this parallel-group, single-blind, randomised controlled trial at 56 acute stroke units in five countries. Patients (aged ≥18 years) with ischaemic or haemorrhagic stroke, first or recurrent, who met physiological criteriawere randomly assigned (1:1), via a web-based computer generated block randomisation procedure (block size of six), to receive usual stroke-unit care alone or very early mobilisation in addition to usual care. Treatment with recombinant tissue plasminogen activator was allowed. Randomisation was stratified by study site and stroke severity. Patients, outcome assessors, and investigators involved in trial and data management were masked to treatment allocation. The primary outcome was a favourable outcome 3 months after stroke, defined as a modified Rankin Scale score of 0–2. We did analysis on an intention-to-treat basis. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12606000185561.FindingsBetween July 18, 2006, and Oct 16, 2014, we randomly assigned 2104 patients to receive either very early mobilisation (n=1054) or usual care (n=1050); 2083 (99%) patients were included in the 3 month follow-up assessment. 965 (92%) patients were mobilised within 24 h in the very early mobilisation group compared with 623 (59%) patients in the usual care group. Fewer patients in the very early mobilisation group had a favourable outcome than those in the usual care group (n=480 [46%] vs n=525 [50%]; adjusted odds ratio [OR] 0·73, 95% CI 0·59–0·90; p=0·004). 88 (8%) patients died in the very early mobilisation group compared with 72 (7%) patients in the usual care group (OR 1·34, 95% CI 0·93–1·93, p=0·113). 201 (19%) patients in the very early mobilisation group and 208 (20%) of those in the usual care group had a non-fatal serious adverse event, with no reduction in immobility-related complications with very early mobilisation.InterpretationFirst mobilisation took place within 24 h for most patients in this trial. The higher dose, very early mobilisation protocol was associated with a reduction in the odds of a favourable outcome at 3 months. Early mobilisation after stroke is recommended in many clinical practice guidelines worldwide, and our findings should affect clinical practice by refi ning present guidelines; however, clinical recommendations should be informed by future analyses of dose–response associations.

Assessment of a six-week computer-based remediation program for social cognition in chronic schizophrenia

Background: Programs to remediate cognitive deficits have shown promising results in schizophrenia, but remediation of social cognition deficits is less well understood. Social cognitive deficits may cause more disability than the widely recognized neurocognitive deficits, suggesting that this is an area worthy of further investigation. Aim: Implement and evaluate a brief computerized cognitive remediation program designed to improve memory, attention, and facial affect recognition (FAR) in outpatients with chronic schizophrenia.

Methods: Baseline assessments of FAR and of clinical, cognitive, and psychosocial functioning were completed on 20 males with schizophrenia enrolled in an outpatient rehabilitation program at the Shanghai Mental Health Center (the intervention group) and on 20 males with schizophrenia recruited from among regular outpatients at the Center (the control group). Both groups received treatment as usual, but the intervention group also completed an average of 12.7 sessions of a computer-based remediation program for neurocognitive, social, and FAR functioning over a 6-week period. The baseline measures were repeated in both groups at the end of the 6-week trial.

Results: There were no statistically significant differences in the changes in clinical symptoms (assessed by the Positive and Negative Syndrome Scale, PANSS) or cognitive measures (assessed using the Hong Kong List Learning Test and the Letter-Number Sequencing Task) between the intervention and control groups over the 6-week trial, but there were modest improvements on the PANSS for the intervention group between baseline and after the intervention. There was a significantly greater improvement in the social functioning measure (the Personal and Social Performance scale, PSP) in the intervention group than in the control group. The pre-post change in the total facial recognition score in the intervention group was statistically significant (paired t-test=-2.60, p=0.018), and there was a statistical trend of a greater improvement in facial recognition in the intervention group than in the control group (F(1,37)=2.93; p=0.092).

Conclusions: Integration of FAR training with a short, computer-administrated cognitive remediation program may improve recognition of facial emotions by individuals with schizophrenia, and, thus, improve their social functioning. But more work on developing the FAR training modules and on testing them in larger, more diverse samples will be needed before this can be recommended as a standard part of cognitive remediation programs.

Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study

BACKGROUND: The absence of trial data comparing robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy is a crucial knowledge gap in uro-oncology. We aimed to compare these two approaches in terms of functional and oncological outcomes and report the early postoperative outcomes at 12 weeks. METHOD: In this randomised controlled phase 3 study, men who had newly diagnosed clinically localised prostate cancer and who had chosen surgery as their treatment approach, were able to read and speak English, had no previous history of head injury, dementia, or psychiatric illness or no other concurrent cancer, had an estimated life expectancy of 10 years or more, and were aged between 35 years and 70 years were eligible and recruited from the Royal Brisbane and Women's Hospital (Brisbane, QLD). Participants were randomly assigned (1:1) to receive either robot-assisted laparoscopic prostatectomy or radical retropubic prostatectomy. Randomisation was computer generated and occurred in blocks of ten. This was an open trial; however, study investigators involved in data analysis were masked to each patient's condition. Further, a masked central pathologist reviewed the biopsy and radical prostatectomy specimens. Primary outcomes were urinary function (urinary domain of EPIC) and sexual function (sexual domain of EPIC and IIEF) at 6 weeks, 12 weeks, and 24 months and oncological outcome (positive surgical margin status and biochemical and imaging evidence of progression at 24 months). The trial was powered to assess health-related and domain-specific quality of life outcomes over 24 months. We report here the early outcomes at 6 weeks and 12 weeks. The per-protocol populations were included in the primary and safety analyses. This trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), number ACTRN12611000661976. FINDINGS: Between Aug 23, 2010, and Nov 25, 2014, 326 men were enrolled, of whom 163 were randomly assigned to radical retropubic prostatectomy and 163 to robot-assisted laparoscopic prostatectomy. 18 withdrew (12 assigned to radical retropubic prostatectomy and six assigned to robot-assisted laparoscopic prostatectomy); thus, 151 in the radical retropubic prostatectomy group proceeded to surgery and 157 in the robot-assisted laparoscopic prostatectomy group. 121 assigned to radical retropubic prostatectomy completed the 12 week questionnaire versus 131 assigned to robot-assisted laparoscopic prostatectomy. Urinary function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (74·50 vs 71·10; p=0·09) or 12 weeks post-surgery (83·80 vs 82·50; p=0·48). Sexual function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (30·70 vs 32·70; p=0·45) or 12 weeks post-surgery (35·00 vs 38·90; p=0·18). Equivalence testing on the difference between the proportion of positive surgical margins between the two groups (15 [10%] in the radical retropubic prostatectomy group vs 23 [15%] in the robot-assisted laparoscopic prostatectomy group) showed that equality between the two techniques could not be established based on a 90% CI with a Δ of 10%. However, a superiority test showed that the two proportions were not significantly different (p=0·21). 14 patients (9%) in the radical retropubic prostatectomy group versus six (4%) in the robot-assisted laparoscopic prostatectomy group had postoperative complications (p=0·052). 12 (8%) men receiving radical retropubic prostatectomy and three (2%) men receiving robot-assisted laparoscopic prostatectomy experienced intraoperative adverse events. INTERPRETATION: These two techniques yield similar functional outcomes at 12 weeks. Longer term follow-up is needed. In the interim, we encourage patients to choose an experienced surgeon they trust and with whom they have rapport, rather than a specific surgical approach. FUNDING: Cancer Council Queensland.

Development and evaluation of a computer-based, self-management tool for people recently diagnosed with type 2 diabetes

Aim. The purpose of this study was to develop and evaluate a computer-based, dietary, and physical activity self-management program for people recently diagnosed with type 2 diabetes. Methods. The computer-based program was developed in conjunction with the target group and evaluated in a 12-week randomised controlled trial (RCT). Participants were randomised to the intervention (computer-program) or control group (usual care). Primary outcomes were diabetes knowledge and goal setting (ADKnowl questionnaire, Diabetes Obstacles Questionnaire (DOQ)) measured at baseline and week 12. User feedback on the program was obtained via a questionnaire and focus groups. Results. Seventy participants completed the 12-week RCT (32 intervention, 38 control, mean age 59 (SD) years). After completion there was a significant between-group difference in the "knowledge and beliefs scale" of the DOQ. Two-thirds of the intervention group rated the program as either good or very good, 92% would recommend the program to others, and 96% agreed that the information within the program was clear and easy to understand. Conclusions. The computer-program resulted in a small but statistically significant improvement in diet-related knowledge and user satisfaction was high. With some further development, this computer-based educational tool may be a useful adjunct to diabetes self-management. This trial is registered with clinicaltrials.gov NCT number NCT00877851.

Randomised controlled trial of a digitally assisted low intensity intervention to promote personal recovery in persisting psychosis: SMART-Therapy study protocol

BACKGROUND: Psychosocial interventions have an important role in promoting recovery in people with persisting psychotic disorders such as schizophrenia. Readily available, digital technology provides a means of developing therapeutic resources for use together by practitioners and mental health service users. As part of the Self-Management and Recovery Technology (SMART) research program, we have developed an online resource providing materials on illness self-management and personal recovery based on the Connectedness-Hope-Identity-Meaning-Empowerment (CHIME) framework. Content is communicated using videos featuring persons with lived experience of psychosis discussing how they have navigated issues in their own recovery. This was developed to be suitable for use on a tablet computer during sessions with a mental health worker to promote discussion about recovery.

METHODS/DESIGN: This is a rater-blinded randomised controlled trial comparing a low intensity recovery intervention of eight one-to-one face-to-face sessions with a mental health worker using the SMART website alongside routine care, versus an eight-session comparison condition, befriending. The recruitment target is 148 participants with a schizophrenia-related disorder or mood disorder with a history of psychosis, recruited from mental health services in Victoria, Australia. Following baseline assessment, participants are randomised to intervention, and complete follow up assessments at 3, 6 and 9 months post-baseline. The primary outcome is personal recovery measured using the Process of Recovery Questionnaire (QPR). Secondary outcomes include positive and negative symptoms assessed with the Positive and Negative Syndrome Scale, subjective experiences of psychosis, emotional symptoms, quality of life and resource use. Mechanisms of change via effects on self-stigma and self-efficacy will be examined.

DISCUSSION: This protocol describes a novel intervention which tests new therapeutic methods including in-session tablet computer use and video-based peer modelling. It also informs a possible low intensity intervention model potentially viable for delivery across the mental health workforce.