Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Loss of hand function is one of the most devastating consequences of spinal cord injury. Intensive hand training provided on an instrumented exercise workstation in conjunction with functional electrical stimulation may enhance neural recovery and hand function. The aim of this trial is to compare usual care with an 8-week program of intensive hand training and functional electrical stimulation.</p> <p>Methods/design</p> <p>A multicentre randomised controlled trial will be undertaken. Seventy-eight participants with recent tetraplegia (C2 to T1 motor complete or incomplete) undergoing inpatient rehabilitation will be recruited from seven spinal cord injury units in Australia and New Zealand and will be randomised to a control or experimental group. Control participants will receive usual care. Experimental participants will receive usual care and an 8-week program of intensive unilateral hand training using an instrumented exercise workstation and functional electrical stimulation. Participants will drive the functional electrical stimulation of their target hands via a behind-the-ear bluetooth device, which is sensitive to tooth clicks. The bluetooth device will enable the use of various manipulanda to practice functional activities embedded within computer-based games and activities. Training will be provided for one hour, 5 days per week, during the 8-week intervention period. The primary outcome is the Action Research Arm Test. Secondary outcomes include measurements of strength, sensation, function, quality of life and cost effectiveness. All outcomes will be taken at baseline, 8 weeks, 6 months and 12 months by assessors blinded to group allocation. Recruitment commenced in December 2009.</p> <p>Discussion</p> <p>The results of this trial will determine the effectiveness of an 8-week program of intensive hand training with functional electrical stimulation.</p> <p>Trial registration</p> <p><a href="http://www.clinicaltrials.gov/ct2/show/NCT01086930">NCT01086930</a> (12^thMarch 2010)</p> <p><a href="http://www.anzctr.org.au/ACTRN12609000695202.aspx">ACTRN12609000695202</a> (12^thAugust 2009)</p

Cost-utility analysis of telephone-based cognitive behavior therapy in chronic obstructive pulmonary disease (COPD) patients with anxiety and depression comorbidities: an application for willingness to accept concept

Background: This study evaluated the cost-utility of telephone-based cognitive behavioral therapy (TB-CBT) (experimental arm) in comparison with a placebo-befriending (control arm) program in COPD participants with mild to severe depression and/or anxiety. Methods: The decision rule was based on willingness-to-pay if there is an increased unit of effectiveness (a quality-adjusted life year [QALY] gain) and an increase in cost, and willingness-to-accept (WTA) if there is a reduced unit of effectiveness (a QALY loss) and decrease in cost (a cost-saving). Results: TB-CBT group was associated with a reduction in the incremental cost of AUS−$407.3 (p < 0.001, SE:34.1) plus a negative, nonsignificant incremental QALY gain of −0.008 (SE:0.011) per patient compared to control group. The point estimate of the mean incremental cost-utility ratio was AUS$50,284.0 cost saving per QALY sacrificed (the high value associated with small QALY value in the denominator). Ninety-five percent CI was AUS$13,426 cost sacrificed to AUS$32,018 cost gain (lower values associated with larger QALY values in the denominator). If the societal’s minimum (flooring threshold) WTA is AUS$64,000 per QALY forgone, the probability of TB-CBT being cost-effective was 42% Conclusions: This study showed that TB-CBT can be recommended as a cost-saving and preventive approach over usual care plus befriending program

Design and protocol for the Dialysis Optimal Health Program (DOHP) randomised controlled trial

BACKGROUND: Chronic kidney disease (CKD) and end-stage kidney disease (ESKD) are serious and growing health problems with enormous impact on psychological and social functioning. Despite high rates of comorbid depression and anxiety in these patient populations, and the adverse impact these have upon treatment adherence, quality of life, social connectedness and healthcare costs there has been little attention focused on the prevention or management of these problems. Thus, our aim was to evaluate the Dialysis Optimal Health Program (DOHP) that adopts a person-centred approach and engages collaborative therapy to educate and support those diagnosed with ESKD who are commencing dialysis. METHODS: The study design is a randomised controlled trial. Ninety-six adult patients initiating haemodialysis or peritoneal dialysis will be randomly allocated to either the intervention (DOHP) or usual care group. Participants receiving the intervention will receive nine (8 + 1 booster session) sequential sessions based on a structured information/workbook, psychosocial and educational supports and skills building. The primary outcome measures are depression and anxiety (assessed by the Hospital Anxiety and Depression Scale; HADS). Secondary outcomes include health-related quality of life (assessed by the Kidney Disease Quality of Life instrument; KDQOL), self-efficacy (assessed by General Self-Efficacy Scale) and clinical indices (e.g. albumin and haemoglobin levels). Cost-effectiveness analysis and process evaluation will also be performed to assess the economic value and efficacy of the DOHP. Primary and secondary measures will be collected at baseline and at 3-, 6-, and 12-month follow-up time points. DISCUSSION: We believe that this innovative trial will enhance knowledge of interventions aimed at supporting patients in the process of starting dialysis, and will broaden the focus from physical symptoms to include psychosocial factors such as depression, anxiety, self-efficacy, wellbeing and community support. The outcomes associated with this study are significant in terms of enhancing an at-risk population's psychosocial health and reducing treatment-related costs and associated pressures on the healthcare system. TRIAL REGISTRATION: ANZCTR no. 12615000810516 . Registered on 5 August 2015

Factors Associated with the Patient/Client Use of Report Cards, Physician Rating Websites, Social Media, and Google for Hospital and Physician Selection: A Nationwide Survey

Objective: To explore the factors associated with the different uses of report cards, physician rating websites, social media, and Google, including awareness, physician finding, and decision-making based on reviews from the patient/client perspective. Methods: We used computer-assisted telephone interviews to conduct a nationwide representative survey in Taiwan. Results: The urbanization level of the area, income, and long-term health conditions were not associated with the three kinds of usage of the websites studied. Seeking health information was an important factor in the three kinds of website use. The employment industry was associated with awareness, and education level was associated with physician seeking and actions based on reviews. Conclusions: Different factors influenced the three kinds of usage: awareness, actual use (i.e., finding an appropriate physician), and decision-making based on reviews. Seeking health information is of primary importance regardless of how the websites are used. Practical implications: Policy-makers should focus on educating individuals working outside the health care sector to increase awareness of these websites and to assist individuals with low levels of education in increasing their use of these websites

The Stroke and Carer Optimal Health Program (SCOHP) to enhance psychosocial health Study protocol for a randomized controlled trial

Stroke is a leading cause of disability and distress, and often profoundly affects the quality of life of stroke survivors and their carers. With the support of carers, many stroke survivors are returning to live in the community despite the presence of disability and ongoing challenges. The sudden and catastrophic changes caused by stroke affects the mental, emotional and social health of both stroke survivors and carers. The aim of this study is to evaluate a Stroke and Carer Optimal Health Program (SCOHP) that adopts a person-centred approach and engages collaborative therapy to educate, support and improve the psychosocial health of stroke survivors and their carers

A method for risk assessment for three contaminated sites in Northern Italy

A stepwise human health risk assessment procedure carried out using American Society for Testing and Materials methodology was applied to three contaminated sites located in northern Italy: ail uncontrolled landfill. an abandoned industrial site and an industrial waste contaminated land. Two different tiers of analysis were performed by means of the analytical model RBCA Tool Kit and the numerical model API-DSS, respectively. The latter was applied according to both a deterministic and a probabilistic risk analysis. The comparison of the two approaches highlighted the great benefit provided by probabilistic analysis for the risk assessment based on site specific parameters and more complex models, in particular for groundwater exposure route. Finally, the risk-based site specific target levels were compared to the generic regulatory threshold limits fixed by the Italian regulation. The comparison showed the regulatory limits generally too restrictive for non-carcinogenic Substances but less protective for carcinogenic chemicals, outlining the need of a site-specific risk assessment especially for carcinogenic substances