Health technology assessment : HTA
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Health Technol Assess · Oct 2020
Randomized Controlled Trial Multicenter Study Clinical TrialStratified versus usual care for the management of primary care patients with sciatica: the SCOPiC RCT.
Sciatica has a substantial impact on patients and society. Current care is 'stepped', comprising an initial period of simple measures of advice and analgesia, for most patients, commonly followed by physiotherapy, and then by more intensive interventions if symptoms fail to resolve. No study has yet tested a model of stratified care in which patients are subgrouped and matched to different care pathways based on their prognosis and clinical characteristics. ⋯ Other approaches to stratified care may provide superior outcomes for sciatica.
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Health Technol Assess · Jun 2020
Randomized Controlled Trial Multicenter Study Clinical TrialThoracoscopy and talc poudrage compared with intercostal drainage and talc slurry infusion to manage malignant pleural effusion: the TAPPS RCT.
There are around 40,000 new cases of malignant pleural effusion in the UK each year. Insertion of talc slurry via a chest tube is the current standard treatment in the UK. However, some centres prefer local anaesthetic thoracoscopy and talc poudrage. There is no consensus as to which approach is most effective. ⋯ The TAPPS (evaluating the efficacy of Thoracoscopy And talc Poudrage versus Pleurodesis using talc Slurry) trial has robustly demonstrated that there is no additional clinical effectiveness or cost-effectiveness benefit in performing talc poudrage at thoracoscopy over bedside chest drain and talc slurry for the management of malignant pleural effusion.
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Health Technol Assess · Jun 2020
Randomized Controlled Trial Multicenter Study Clinical TrialProgesterone to prevent miscarriage in women with early pregnancy bleeding: the PRISM RCT.
Progesterone is essential for a healthy pregnancy. Several small trials have suggested that progesterone therapy may rescue a pregnancy in women with early pregnancy bleeding, which is a symptom that is strongly associated with miscarriage. ⋯ Progesterone therapy in the first trimester of pregnancy did not result in a significantly higher rate of live births among women with threatened miscarriage overall, but an important subgroup effect was identified. A conclusion on the cost-effectiveness of the PRISM trial would depend on the amount that society is willing to pay to increase the chances of an additional live birth at ≥ 34 weeks. For future work, we plan to conduct an individual participant data meta-analysis using all existing data sets.
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Health Technol Assess · May 2020
Randomized Controlled Trial Multicenter Study Clinical Trial Pragmatic Clinical TrialAn extended stroke rehabilitation service for people who have had a stroke: the EXTRAS RCT.
There is limited evidence about the effectiveness of rehabilitation in meeting the longer-term needs of stroke patients and their carers. ⋯ Further research is required to identify whether or not community-based interventions can improve performance of extended activities of daily living, and to understand the improvements in health-related quality of life and costs seen by provision of intermittent longer-term specialist review.
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Health Technol Assess · May 2020
Randomized Controlled Trial Multicenter Study Clinical Trial Pragmatic Clinical TrialFluoxetine to improve functional outcomes in patients after acute stroke: the FOCUS RCT.
Our Cochrane review of selective serotonin inhibitors for stroke recovery indicated that fluoxetine may improve functional recovery, but the trials were small and most were at high risk of bias. ⋯ 20 mg of fluoxetine daily for 6 months after acute stroke did not improve patients' functional outcome but decreased the occurrence of depression and increased the risk of fractures. These data inform decisions about using fluoxetine after stroke to improve functional outcome or to prevent or treat mood disorders. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) (Australasia/Vietnam) and Efficacy oF Fluoxetine - a randomisEd Controlled Trial in Stroke (EFFECTS) (Sweden) trials recruited an additional 2780 patients and will report their results in 2020. These three trials have an almost identical protocol, which was collaboratively developed. Our planned individual patient data meta-analysis will provide more precise estimates of the effects of fluoxetine after stroke and indicate whether or not effects vary depending on patients' characteristics and health-care setting.