Trials
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Randomized Controlled Trial
Value of information: interim analysis of a randomized, controlled trial of goal-directed hemodynamic treatment for aged patients.
A randomized, controlled trial, intended to include 460 patients, is currently studying peroperative goal-directed hemodynamic treatment (GDHT) of aged hip-fracture patients. Interim efficacy analysis performed on the first 100 patients was statistically uncertain; thus, the trial is continuing in accordance with the trial protocol. This raised the present investigation's main question: Is it reasonable to continue to fund the trial to decrease uncertainty? To answer this question, a previously developed probabilistic cost-effectiveness model was used. That model depicts (1) a choice between routine fluid treatment and GDHT, given uncertainty of current evidence and (2) the monetary value of further data collection to decrease uncertainty. This monetary value, that is, the expected value of perfect information (EVPI), could be used to compare future research costs. Thus, the primary aim of the present investigation was to analyze EVPI of an ongoing trial with interim efficacy observed. ⋯ If future trial costs are below EVPI, further data collection is potentially cost-effective. When applying a cost-effectiveness model, statements such as 'further research is needed' are replaced with 'further research is cost-effective and 'further funding of a trial is justified'.
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Randomized Controlled Trial
Physiotherapy to improve physical activity in community-dwelling older adults with mobility problems (Coach2Move): study protocol for a randomized controlled trial.
Older adults can benefit from physical activity in numerous ways. Physical activity is considered to be one of the few ways to influence the level of frailty. Standardized exercise programs do not necessarily lead to more physical activity in daily life, however, and a more personalized approach seems appropriate. The main objective of this study is to investigate whether a focused, problem-oriented coaching intervention ('Coach2Move') delivered by a physiotherapist specializing in geriatrics is more effective for improving physical activity, mobility and health status in community-dwelling older adults than usual physiotherapy care. In addition, cost-effectiveness will be determined. ⋯ Most studies on the effect of exercise or physical activity consist of standardized programs. In this study, a personalized approach is evaluated within a group of frail older adults, many of whom suffer from multiple and complex diseases and problems. A complicating factor in evaluating a new approach is that it may not be automatically adopted by clinicians. Specific actions are undertaken to optimize implementation of the Coach2Move strategy during the trial. Whether or not these will be sufficient is a matter we will consider subsequently, using quality indicators and process analysis.
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Randomized Controlled Trial Pragmatic Clinical Trial
Vancouver At Home: pragmatic randomized trials investigating Housing First for homeless and mentally ill adults.
Individuals with mental illnesses are overrepresented among the homeless. Housing First (HF) has been shown to promote positive outcomes in this population. However, key questions remain unresolved, including: how to match support services to client needs, the benefits of housing in scattered sites versus single congregate building, and the effectiveness of HF with individuals actively using substances. The present study aimed to recruit two samples of homeless mentally ill participants who differed in the complexity of their needs. Study details, including recruitment, randomization, and follow-up, are presented. ⋯ The study successfully recruited participants meeting criteria for homelessness and current mental disorder. Both MN and HN groups had high rates of substance dependence, suicidality, and physical illness. Randomization resulted in no meaningful detectable differences between study arms.
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Randomized Controlled Trial
PARot--assessing platelet-rich plasma plus arthroscopic subacromial decompression in the treatment of rotator cuff tendinopathy: study protocol for a randomized controlled trial.
Platelet-rich plasma (PRP) is an autologous platelet concentrate. It is prepared by separating the platelet fraction of whole blood from patients and mixing it with an agent to activate the platelets. In a clinical setting, PRP may be reapplied to the patient to improve and hasten the healing of tissue. The therapeutic effect is based on the presence of growth factors stored in the platelets. Current evidence in orthopedics shows that PRP applications can be used to accelerate bone and soft tissue regeneration following tendon injuries and arthroplasty. Outcomes include decreased inflammation, reduced blood loss and post-treatment pain relief. Recent shoulder research indicates there is poor vascularization present in the area around tendinopathies and this possibly prevents full healing capacity post surgery (Am J Sports Med36(6):1171-1178, 2008). Although it is becoming popular in other areas of orthopedics there is little evidence regarding the use of PRP for shoulder pathologies. The application of PRP may help to revascularize the area and consequently promote tendon healing. Such evidence highlights an opportunity to explore the efficacy of PRP use during arthroscopic shoulder surgery for rotator cuff pathologies. ⋯ PARot is a single center, blinded superiority-type randomized controlled trial assessing the clinical outcomes of PRP applications in patients who undergo shoulder surgery for rotator cuff disease. Patients will be randomized to one of the following treatment groups: arthroscopic subacromial decompression surgery or arthroscopic subacromial decompression surgery with application of PRP.
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Spin in the reporting of randomized controlled trials, where authors report research in a way that potentially misrepresents results and mislead readers, has been demonstrated in the broader medical literature. We investigated spin in wound care trials with (a) no statistically significant result for the primary outcome and (b) no clearly specified primary outcome. ⋯ Spin is a frequent phenomenon in reports of RCTs of wound treatments. Studies without statistically significant results for the primary outcome used spin in 71% of cases. Furthermore, 33% (43/132) of reports of wound RCTs did not specify a primary outcome and there was evidence of spin and selective outcome reporting in the abstracts of these. Readers should be wary of only reading the abstracts of reports of RCTs of wound treatments since they are frequently misleading regarding treatment effects.