Trials
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Randomized Controlled Trial Multicenter Study
Influence of early goal-directed therapy using arterial waveform analysis on major complications after high-risk abdominal surgery: study protocol for a multicenter randomized controlled superiority trial.
Early goal-directed therapy refers to the use of predefined hemodynamic goals to optimize tissue oxygen delivery in critically ill patients. Its application in high-risk abdominal surgery is, however, hindered by safety concerns and practical limitations of perioperative hemodynamic monitoring. Arterial waveform analysis provides an easy, minimally invasive alternative to conventional monitoring techniques, and could be valuable in early goal-directed strategies. We therefore investigate the effects of early goal-directed therapy using arterial waveform analysis on complications, quality of life and healthcare costs after high-risk abdominal surgery. ⋯ Before the start of the study, hemodynamic optimization by early goal-directed therapy with arterial waveform analysis had only been investigated in small, single-center studies, including minor complications as primary endpoint. Moreover, these studies did not include quality of life, healthcare costs, and long-term outcome in their analysis. As a result, the definitive role of arterial waveform analysis in the perioperative hemodynamic assessment and care for high-risk surgical patients is unknown, which gave rise to the present trial. Patient inclusion started in May 2012 and is expected to end in 2016.
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A number of research funders, biomedical journals, pharmaceutical companies, and regulatory agencies have adopted policies advocating or mandating that clinical trialists share data with external investigators. We therefore sought to determine whether certain characteristics of trialists or their trials are associated with more unfavorable perceptions of data sharing. To date, no prior research has addressed this issue. ⋯ Respondents indicated strong support for data sharing overall. There were few notable differences in how trialists viewed the benefits and risks of data sharing when categorized by trialists' academic productivity and geographic location, trial funding source and size, and the journal in which it was published.
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Randomized Controlled Trial Comparative Study
The effect on knee-joint load of instruction in analgesic use compared with neuromuscular exercise in patients with knee osteoarthritis: study protocol for a randomized, single-blind, controlled trial (the EXERPHARMA trial).
Knee osteoarthritis (OA) is a mechanically driven disease, and it is suggested that medial tibiofemoral knee-joint load increases with pharmacologic pain relief, indicating that pharmacologic pain relief may be positively associated with disease progression. Treatment modalities that can both relieve pain and reduce knee-joint load would be preferable. The knee-joint load is influenced by functional alignment of the trunk, pelvis, and lower-limb segments with respect to the knee, as well as the ground-reaction force generated during movement. Neuromuscular exercise can influence knee load and decrease knee pain. It includes exercises to improve balance, muscle activation, functional alignment, and functional knee stability. The primary objective of this randomized controlled trial (RCT) is to investigate the efficacy of a NEuroMuscular EXercise (NEMEX) therapy program, compared with optimized analgesics and antiinflammatory drug use, on the measures of knee-joint load in people with mild to moderate medial tibiofemoral knee osteoarthritis. ⋯ These findings will help determine whether 8 weeks of neuromuscular exercise is superior to optimized use of analgesics and antiinflammatory drugs regarding knee-joint load, pain and physical function in people with mild to moderate knee osteoarthritis.
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Randomized Controlled Trial Comparative Study
Guided (VENTRI-GUIDE) versus freehand ventriculostomy: study protocol for a randomized controlled trial.
Despite the widespread use of external ventricular drainage, revision rates, and associated complications are reported between 10 and 40%. Current available image-guided techniques using stereotaxy, endoscopy, or ultrasound for catheter placements remain time-consuming techniques. Recently, a smartphone-assisted guide with high precision has been described. The development of an easy-to-use, portable, image-guided system could reduce the need for multiple passes and improve the rate of accurate catheter placement. This study aims to prospectively compare in a randomized controlled manner the accuracy of the freehand pass technique versus an easy-to-use, portable, adjustable guiding device for ventriculostomy catheter placement. ⋯ This is the study design of a single center, prospective, randomized controlled trial to investigate whether guided ventriculostomy is superior to the standard freehand technique. One strength of this study is the prospective, randomized, interventional type of study testing a new easy-to-handle guided versus freehand ventricular catheter placement. A second strength of this study is that the power calculation is based on catheter accuracy using an available grading system for catheter tip location, and is calculated with the use of recent study results of our own population, supported by data from prominent studies.
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The aim of this study was to assess the endorsement of reporting guidelines in Korean traditional medicine (TM) journals by reviewing their instructions to authors. We examined the instructions to authors in all of the TM journals published in Korea to assess the appropriate use of reporting guidelines for research studies. The randomized controlled trials (RCTs) published after 2010 in journals that endorsed reporting guidelines were obtained. ⋯ In the RCT studies before and after the endorsement of CONSORT and STRICTA guidelines by each journal, all of the STRICTA items had significant improvement, whereas the CONSORT-NPT items improved without statistical significance. The endorsement of reporting guidelines is limited in the TM journals in Korea. Authors should adhere to the reporting guidelines, and editorial departments should refer authors to the various reporting guidelines to improve the quality of their articles.