Trials
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Randomized Controlled Trial Multicenter Study
Home-based palliative approach for people with severe multiple sclerosis and their carers: study protocol for a randomized controlled trial.
Preliminary evidence suggests that palliative care may be useful for people with severe multiple sclerosis (MS). The aim of this study is to determine the effectiveness of a home-based palliative approach (HPA) for people with severe MS and their carers. ⋯ The results of our study will show whether the HPA is feasible and beneficial to people with severe MS and their carers living in the three Italian geographic areas. The nested qualitative study will add to the understanding of the strengths and limitations of the intervention.
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Randomized Controlled Trial Multicenter Study
Weight bearing or non-weight bearing after surgically fixed ankle fractures, the WOW! Study: study protocol for a randomized controlled trial.
The optimal post-operative care regimen after surgically fixed Lauge Hansen supination exorotation injuries remains to be established. This study compares whether unprotected weight bearing as tolerated is superior to protected weight bearing and unprotected non-weight bearing in terms of functional outcome and safety. ⋯ This trial is designed to compare the effectiveness and safety of unprotected weight bearing with two commonly used post-operative treatment regimens after internal fixation of specified, intrinsically stable but displaced ankle fractures. An expert panel has been established to evaluate every potential subject, which ensures that every patient is strictly screened according to the inclusion and exclusion criteria and that there is a clear indication for surgical fixation.
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Randomized Controlled Trial Multicenter Study
Vertebroplasty for acute painful osteoporotic fractures (VAPOUR): study protocol for a randomized controlled trial.
With increasing human longevity there is increasing prevalence of osteoporosis and of osteoporotic vertebral fractures. Most vertebral fractures do not require medical therapy for pain, but a minority are associated with severe pain and disability. Vertebroplasty has been used increasingly for painful acute osteoporotic fractures. The best available evidence for vertebroplasty is provided by two placebo controlled trials which showed no significant clinical benefit of vertebroplasty over placebo. These were not acute fracture trials with the majority of fractures in both trials being well beyond the acute time frame of 6 weeks. There is evidence from an open label randomized controlled trial of vertebroplasty versus conservative therapy in acute fractures suggesting clinical efficacy in acute vertebral fractures. ⋯ The VAPOUR trial will apply similar methodology to the previous blinded trials but in a patient group with exclusively acute fractures and the most severe pain.
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Randomized Controlled Trial Multicenter Study Comparative Study
Study protocol for two randomized controlled trials examining the effectiveness and safety of current weekend allied health services and a new stakeholder-driven model for acute medical/surgical patients versus no weekend allied health services.
Disinvestment from inefficient or ineffective health services is a growing priority for health care systems. Provision of allied health services over the weekend is now commonplace despite a relative paucity of evidence supporting their provision. The relatively high cost of providing this service combined with the paucity of evidence supporting its provision makes this a potential candidate for disinvestment so that resources consumed can be used in other areas. This study aims to determine the effectiveness, cost-effectiveness and safety of the current model of weekend allied health service and a new stakeholder-driven model of weekend allied health service delivery on acute medical and surgical wards compared to having no weekend allied health service. ⋯ This is the world's first application of the recently described non-inferiority (roll-in) stepped wedge trial design, and the largest investigation of the effectiveness of weekend allied health services on acute medical surgical wards to date.
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Randomized Controlled Trial Multicenter Study
Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial.
Gastroparesis is common in surgical patients and frequently leads to the need for enteral tube feeding. Nasoenteral feeding tubes are usually placed endoscopically by gastroenterologists, but this procedure is relatively cumbersome for patients and labor-intensive for hospital staff. Electromagnetic (EM) guided bedside placement of nasoenteral feeding tubes by nurses may reduce patient discomfort, workload and costs, but randomized studies are lacking, especially in surgical patients. We hypothesize that EM guided bedside placement of nasoenteral feeding tubes is at least as effective as endoscopic placement in surgical patients, at lower costs. ⋯ The CORE trial is designed to generate evidence on the effectiveness of EM guided placement of nasoenteral feeding tubes in surgical patients and the impact on costs as compared to endoscopic placement. The trial potentially offers a strong argument for wider implementation of this technique as method of choice for placement of nasoenteral feeding tubes.