Health technology assessment : HTA
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Health Technol Assess · Oct 2013
Randomized Controlled Trial Multicenter StudyA cluster randomised controlled trial and economic evaluation of a structured training programme for caregivers of inpatients after stroke: the TRACS trial.
The majority of stroke patients are discharged home dependent on informal caregivers, usually family members, to provide assistance with activities of daily living (ADL), including bathing, dressing and toileting. Many caregivers feel unprepared for this role and this may have a detrimental effect on both the patient and caregiver. ⋯ We have conducted a robust multicentre, cluster randomised trial, demonstrating for the first time that this methodology is feasible in stroke rehabilitation research. There was no difference between the LSCTC and usual care with respect to improving stroke patients' recovery, reducing caregivers' burden, or improving other physical and psychological outcomes, nor was it cost-effective compared with usual care. Compliance with the intervention varied, but analysis indicated that a dose effect was unlikely. It is possible that the immediate post-stroke period may not be the ideal time for the delivery of structured training. The intervention approach might be more relevant if delivered after discharge by community-based teams.
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Health Technol Assess · Oct 2013
Randomized Controlled TrialMAGNEsium Trial In Children (MAGNETIC): a randomised, placebo-controlled trial and economic evaluation of nebulised magnesium sulphate in acute severe asthma in children.
There are few data on the role of nebulised magnesium sulphate (MgSO4) in the management of acute asthma in children. Those studies that have been published are underpowered, and use different methods, interventions and comparisons. Thus, no firm conclusions can be drawn. ⋯ This study supports the use of nebulised isotonic MgSO4 at the dose of 151 mg given three times in the first hour of treatment as an adjuvant to standard treatment when a child presents with an acute episode of severe asthma. No harm is done by adding magnesium to salbutamol and ipratropium bromide, and in some individuals it may be clinically helpful. The response is likely to be more marked in those children with more severe attacks and with a shorter duration of exacerbation. Although the study was not powered to demonstrate this fully, the data certainly support the hypotheses that nebulised magnesium has a greater clinical effect in children who have more severe exacerbation with shorter duration of symptoms.
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Health Technol Assess · Oct 2013
Randomized Controlled TrialThe impact of continuous haemofiltration with high-volume fluid exchange during cardiopulmonary bypass surgery on the recovery of patients with impaired renal function: a pilot randomised trial.
There is widespread variability in clinical practice within cardiac surgery units worldwide on the use of haemofiltration. The clinical impact and safety of this modality is, however, unknown. ⋯ Given sufficient resources and broadening of the inclusion criteria, the recruitment into a larger multicentre trial is feasible and may demonstrate potential clinical and cost benefits of using intraoperative haemofiltration in this group of patients. However, owing to the small sample size in this pilot trial, no firm conclusions can be drawn from the findings at this stage. The outcomes of this pilot study are very encouraging and suggest that it is feasible to design a continuous superiority trial with the length of ICU stay days or time to tracheal extubation as the primary outcome measure, provided that guidelines for avoiding bias are implemented. An alternative primary outcome measure that avoids bias is mortality. The inclusion criteria should also be widened to include all cardiac surgery patients with impaired renal function.
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Health Technol Assess · Oct 2013
Randomized Controlled TrialA cluster randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of classroom-based cognitive-behavioural therapy (CBT) in reducing symptoms of depression in high-risk adolescents.
Depression in adolescents is a significant problem that impairs everyday functioning and increases the risk of severe mental health disorders in adulthood. Although this is a major problem, relatively few adolescents with, or at risk of developing, depression are identified and referred for treatment. This suggests the need to investigate alternative approaches whereby preventative interventions are made widely available in schools. ⋯ Classroom-based CBT, attention control PSHE and usual PSHE produced similar outcomes. Classroom-based CBT may result in increased self-awareness and reporting of depressive symptoms. Classroom-based CBT was not shown to be cost-effective. While schools are a convenient way of reaching a wide range of young people, implementing classroom-based CBT within schools is challenging, particularly with regard to fitting programmes into a busy timetable, the lack of value placed on PSHE, and difficulties engaging with teachers and young people. Wider use of classroom-based depression prevention programmes should not be undertaken without further research. If universal preventative approaches are to be pursued, their clinical effectiveness and cost-effectiveness with younger children (aged 10-11 years), before the incidence of depression increases, should be investigated. Alternatively, the clinical effectiveness of indicated school-based programmes targeting those already displaying symptoms of depression should be investigated.