Articles: outcome-assessment-health-care.
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Randomized Controlled Trial Comparative Study
Tenecteplase versus alteplase for management of acute ischaemic stroke (NOR-TEST): a phase 3, randomised, open-label, blinded endpoint trial.
Tenecteplase is a newer thrombolytic agent with some pharmacological advantages over alteplase. Previous phase 2 trials of tenecteplase in acute ischaemic stroke have shown promising results. We aimed to investigate the safety and efficacy of tenecteplase versus alteplase in patients with acute stroke who were eligible for intravenous thrombolysis. ⋯ Research Council of Norway.
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Clin J Am Soc Nephrol · Sep 2017
Randomized Controlled Trial Multicenter Study Pragmatic Clinical TrialPragmatic Randomized, Controlled Trial of Patient Navigators and Enhanced Personal Health Records in CKD.
Patient navigators and enhanced personal health records improve the quality of health care delivered in other disease states. We aimed to develop a navigator program for patients with CKD and an electronic health record-based enhanced personal health record to disseminate CKD stage-specific goals of care and education. We also conducted a pragmatic randomized clinical trial to compare the effect of a navigator program for patients with CKD with enhanced personal health record and compare their combination compared with usual care among patients with CKD stage 3b/4. ⋯ We successfully developed a patient navigator program and an enhanced personal health record for the CKD population. However, there were no differences in eGFR decline and other outcomes among the study groups. Larger and long-term studies along with cost-effectiveness analyses are needed to evaluate the role of patient navigators and patient education through an enhanced personal health record in those with CKD.
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Randomized Controlled Trial
Safety and efficacy of dual-lead thalamic deep brain stimulation for patients with treatment-refractory multiple sclerosis tremor: a single-centre, randomised, single-blind, pilot trial.
Efficacy in previous studies of surgical treatments of refractory multiple sclerosis tremor using lesioning or deep brain stimulation (DBS) has been variable. The aim of this study was to investigate the safety and efficacy of dual-lead thalamic DBS (one targeting the ventralis intermedius-ventralis oralis posterior nucleus border [the VIM lead] and one targeting the ventralis oralis anterior-ventralis oralis posterior border [the VO lead]) for the treatment of multiple sclerosis tremor. ⋯ US National Institutes of Health, the Cathy Donnellan, Albert E Einstein, and Birdie W Einstein Fund, and the William Merz Professorship.
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Randomized Controlled Trial
The Dose-Dependent Effects of Ketoprofen on Dynamic Pain after Open Heart Surgery.
Non-steroidal anti-inflammatory drugs (NSAIDs) can reduce postoperative pain, in both static (i.e., at rest) and dynamic contexts (e.g., during coughing or mobilization), and reduced doses could improve their efficacy/tolerance balance. ⋯ Although we failed to demonstrate any analgesic effects with low doses of ketoprofen, we confirmed the good efficacy/tolerance balance with this propionic NSAID of intermediate COX2-selectivity. Lower doses of NSAIDs, potentiated by a loading dose, should be tested in the future.IRB approval: CPP Sud-Est VI (Clermont-Ferrand, France), on 12/23/2013.Clinical trial registry: EudraCT (2013-003878-27); ClinicalTrials.gov (NCT02180087).Key words: Non-steroidal anti-inflammatory drugs, ketoprofen, cyclooxygenase, pain, postoperative, sternotomy, postoperative rehabilitation, analgesia, side effects.
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Journal of neurotrauma · Sep 2017
Randomized Controlled TrialRed blood cell transfusion guided by near infrared spectroscopy in neurocritically ill patients with moderate or severe anaemia.
In neurocritically ill patients (NCPs), the use of hemoglobin level as the sole indicator for red blood cell transfusion (RBCT) can result in under- or over-transfusion. This randomized controlled trial was conducted to ascertain whether a transcranial oxygen saturation (rSO2) threshold, as measured by near-infrared spectroscopy, reduces RBCT requirements in anemic NCPs (closed traumatic brain injury, subarachnoid, or intracerebral hemorrhage), compared with a hemoglobin threshold alone. Patients with hemoglobin 70-100 g/L received RBCTs to attain an rSO2 > 60% (rSO2 arm) or to maintain hemoglobin between 85 and 100 g/L (hemoglobin arm). ⋯ There were no differences between the study arms regarding the percentage of transfused patents (59% vs. 71%; relative risk 0.83 [95% CI 0.62-1.11]), stay on neurocritical care unit (21 vs. 20 days), unfavorable Glasgow Outcome Scale scores on hospital discharge (57% vs. 71%), in-hospital mortality (6% vs. 10%), or 1 year mortality (24% vs. 24%). Among NCPs with hemoglobin concentrations of 70-85 g/L, withholding transfusion until rSO2 is <60% may result in reduced RBCs requirements compared with routinely transfusing to attain a hemoglobin level >85 g/L. Further studies are required to confirm this finding and its possible impact on clinically significant outcomes.